BSI_Aug 2016_Raj Gunashekar

1An MM Activ Publication | www.biospectrumindia.com | August 2016 | BioSpectrum

BIOSPECTRUM

NEW

IPR POLICY

JULY 2016

Volume 14 Issue 7 July 2016 www.biospectrumindia.com

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IS THE NEWIPR POLICY ONTHE RIGHT PATH?

IS THE NEWIPR POLICY ONTHE RIGHT PATH?

THE NATIONAL INTELLECTUAL PROPERTYRIGHTS POLICY WAS APPROVED BY THE CABINET

HAVE THE REVISED NORMS IMPROVEDCLINICAL RESEARCH ENVIRONMENT?

BIOSPECIAL

START-UPS: DECIPHERINGTHE DE-RISKING STRATEGY

BIOFEATURE

Volume 14 Issue 8 August 2016

What kills a Life Sciences

?Biotech has a unique advantage, says Dr Renu Swarup

DPCO: A nightmare for pharma firms?

4 BioSpectrum | August 2016 | www.biospectrumindia.com | An MM Activ Publication

COVERDESIGN BY: VIDYA M V

REGULARS

7 BIOEDIT

8 BIOMAIL

13 BIONEWS

48 BIOPEOPLE

50 BIOSUPPLIERS

COVERSTORY................................ 24

BIOTALK

10 55

SIR MALCOLM GRANT

Chairman, NHSQuadio Devices Team (L-R) Mr Anurag Sharma, Co-founder & CTO; Mr Neeraj Dotel, CEO; and Mr Paresh Patel, Co-founder

WE CAN HELP SHAPE INDIAN HEALTH SERVICES: NHS

THE SOUND OF HEARING

What kills a Life Sciences start-up?

Mistakes are unavoidable in an entrepreneurial journey. Some mistakes are

significant and others -- though insignificant -- can act as a pillar for learning.

But often those mistakes end up being costly and start-ups and organizations

have paid a heavy price all throughout history. Learning from mistakes and

avoiding them a second time sounds wise. But what if an entrepreneur can

identify the tell-tale signs of the end-game earlier? Is it possible to resurrect a

dying or a dead Life Sciences start-up? What’d it take to make a big comeback

on the scene to slay newer and bigger dragons? BioSpectrum finds out.


BIOPRENEUR

DISRUPTING INDIAN CARDIAC DIAGNOSTICS

64

BIOFEATURE

The launch of the Mangalyaan was a proud moment for Indian Science so is the contribution that the country made in the detection of gravitational waves. Atomic and space sciences are the two big areas of science where the country excels, BioSpectrum assess research scenario in biological sciences (perhaps the most neglected) in the country.

WHERE INDIA STANDS IN RESEARCH AND INNOVATION

34

BIOSPECIAL

A GATEWAY TO EUROPEAN MARKETS58

Britain’s exit from the European Union (EU) has shaken the world economy. There is uncertainty in the business world across sectors, and biotech is no different.

Launched in 2011, Cardiac Design Labs (CDL) was created with the aim of impacting the society by enabling easier form of detecting and diagnosing early cardiac problems.

WHAT WOULD BREXIT MEAN FOR BIOTECH?

53

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BIOCLUSTER

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BioEdit

Just a month back when India was attempting to connect with some Afri-can nations, using even healthcare diplomacy,

United Kingdom began the process of parting away from European Union, potentially affecting many sectors including healthcare.

Prime Minister Narendra Modi’s visit to four African nations in first

week of July seems to have given a fresh angle to India’s relations with Africa, using health-care and pharma sectors as one more dimen-sion of engagement. The PM’s visit was marked by important developments -- India gifting state-of-the-art cancer therapy machine, and planning to set up a pharmaceutical company, cancer hospitals and gifting medical equip-ment and medicines for public healthcare sys-tem. Thousands of patients from Africa come to India for medical treatment. Various gifts by India may reduce the inflow of African patients to some extent.

These initiatives coincided with pharmaceuti-cal major Cipla announcing plans to set up a biosimilars manufacturing facility in South Af-rica with an investment of 1.3 billion rand (Rs 597 crore). This is more significant since this will be South Africa’s first biotech manufactur-ing unit.

Both India and Africa appear to be assuming importance to health sector while building their relationship as among the aid and invest-ment commitments by India to Africa the last year, $10 million was committed to India-Afri-ca health fund.

India and African nations are using healthcare sector as one of the corridors for strengthen-ing their relationship. Just prior to that United Kingdom decided to part company with Euro-pean Union. In this parting, one of the sectors that is feared to have widespread repercussions is healthcare and pharma.

Among the repercussions, one issue is related

to regulatory processes and market authoriza-tion of drugs. With UK withdrawing from EU, after two years what would be the procedure for drug regulation and market authorization. Much depends upon what type of relationship UK maintains with EU – if it joins European Economic Area (EEA) or joins European Free Trade Association (EFTA) or completely dis-tances itself from EU.

For companies exporting drugs to EU, includ-ing UK, this assumes significance since they may have to take two market authorisations, one for EU and another for UK, instead of one, complicating the procedure, which may result in delays. Indian pharma exporters will have to watch the situation as after US, UK is the sec-ond largest export destination for Indian phar-ma companies. It is also significant to note that among the top five Indian companies operating in UK, two are pharma. Even UK companies may suffer as they will have to individually ap-ply to each EU country for clinical trials.

Another issue is related to personnel in health sector. Large number of medical profession-als at different levels from EU countries are employed in UK. The inflow of professionals from EU to UK may reduce as immigration was one of the important issues in Brexit, adding to UK’s problem of likely shortage of medical professionals and care givers. Though it is con-sidered that this could boost Indian immigra-tion as Indian professionals can fill in the gap, there are apprehensions problem of immigra-tion may come in the way there too. Addition-ally, India may have to renegotiate Free Trade Agreement (FTA) with EU and separately with UK. Overall, there could be many uncertainties for some period.

While preparing to face these uncertainties, one relief Indian pharma companies have is in form of possible new opportunities opening up in parts of Africa.

Milind KokjeChief Editor

[email protected]

Window of opportunity


Vol 14; Issue7 ; July 2016

Vol 14; Issue 8; August 2016

Publisher and Managing Editor: Vijay Thombre

Editorial:Chief Editor: Milind KokjeExecutive Editor: Srinivas RasoorSenior Correspondent: Raj GunashekarChief of Bureau (Goa): Suuhas TenddulkarProduction:Sr. Assistant Editor: Ajay GhatageSub Editor: Ayesha SiddiquiDesign: Vidya MVSales and Marketing:Associate Vice-President -Sales and Marketing: Gurunath AngadiGM – International Sales, Delhi: Vikas MongaAssistant Manager, Mumbai – Sandeep ShetyeSr. Executive, Digital Marketing – Sayali DamleConsultant, Global Market Development: Kavita PoteSr. Product Executive: Pavana PraveenAPAC Region:Vice President: Kingshuk SircarSr. Assistant Editor: Amrita TejasviCirculation:Sr. VP: Rachna GargaGM, Print Services: T SrirenganCirculation and Subscription:Jagdeep Khanna, C Ramachandran, Raghavendra, S Raju SalveAudience Service: Sarita ShridharMIS & Database: RavikanthPress Coordinator: Harak Singh

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Our Offices - Editorial and Business

IPR PolicyI agree that the new IPR policy intents to encourage in-novation in the county. But only intent is not enough. We need action to translate India into an innovation hub as the country is slipping in Global Innovation Index.

Radhika, Bhopal

Clinical Research It’s good to know that the gloom over Indian clinical re-search industry has finally been lifted. Though, the right policies are good, its proper implementation will be the key in making India a hotspot for clinical trials again. Much has changed in two years. To revive its position we need new strategies to make it a preferred destination for clinical trials.

Ayaan Nair, Madurai

Start-up articles

I am an avid reader of BioSpectrum. Of late, I have no-ticed the magazine is quite focused on articles for start-ups, which is very interesting and inspiring. The de-risk-ing strategy was no different. It provided good advice for new companies. I hope to start my own firm soon, and reading these stories is providing very good groundwork.

Karan Thakral, Bangalore

Digital Pathology

Article on digital pathology made for very interesting and inspiring read. Technology is revolutionizing healthcare, be it telemedicine, robotic surgeries, or digital health, so why not pathology.

Sapna Oberoi, Noida


We can help shape Indian health services: NHS

In June 2016, National Health Service’s (NHS) Chairman Sir Malcolm Grant was in India and led a world-class delegation which exhibited and show-cased its expertise in Delhi and Mumbai. This is said

to be a leading, high-powered healthcare trade mission in the form of smart healthcare demonstrator featuring the very best of UK companies in modern healthcare, spe-cifically chosen for their ability to support India’s smart healthcare initiatives.

This delegation is a part of the agreement between UK-India during PM Modi’s visit to the UK where the two Prime Ministers emphasized the potential to increase investment and co-operation in health and related sec-tors. The UK’s healthcare sector is a thriving ecosystem of researchers, scientists, engineers, designers, National Health Service clinicians, and an unrivalled database and network of healthcare professionals.

In his exclusive interview with BioSpectrum, Sir Grant shares the NHS’ inside innovations, Indo-UK Smart Healthcare collaborations, India’s opportunities, the or-ganization’s strategy and investments in India, and its growth plans for the next couple of years.

Give us a glimpse about the innovative happenings in the UK’s smart healthcare sector.

It is hard to give just a glimpse: there is so much to say! One of the most innovative things about the

NHS is that it provides a complete healthcare system for all its citizens, it is the embodiment of Universal Health-care in practice. Through our Five Year Forward View, we are now taking this to new levels with our unique New Models of Care programme where services will provide a fully-integrated service across primary, secondary and tertiary care.

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Sir Malcolm Grant

Chairman, NHS


Our RightCare programme aims to address deep seated inequalities in health and healthcare and ensure patients get the right treatment at the right time. This will involve patients even more in their own care, improve health out-comes and make the system more cost-effective.

Our NHS digital programme promotes self-management apps and systems for patients and confidential sharing of data between professionals to make care more effective and efficient. Our 1,00,000 Genomes Project puts the UK in the forefront of developing personalised medicine where genetic technology will mean patients get exactly the right treatment they need and are not treated unnec-essarily.

What is most exciting about the NHS is the day-to-day innovation that goes on across our services: we see inno-vative ways of keeping people from unnecessary visits or admissions to hospital, reducing delays when a patient is in hospital, or systems to ensure the right staff are always in the right place. The UK offers one of the widest range of tax incentives and specials funds to incentivise invest-ment in our vibrant life sciences industry. Our industry is at the forefront of discovery and innovation in, for exam-ple, genomics, cellular biology and imaging physics. This has given us 77 Nobel prizes for contributions to biomedi-cal science.

What opportunities are available for the Indian smart healthcare sector in the UK? We want to encourage Indian companies to work with the NHS in solving the challenges faced by all

healthcare systems. One example of this are our NHS Test Beds where innovative companies from across the world will work with frontline NHS staff to pioneer and evaluate novel combinations of interconnected devices like wear-able monitors, data analysis and ways of working to help patients stay well and monitor their conditions at home. Five Test Beds have been announced so far.

We welcome investment by Indian smart healthcare com-panies into the UK, and provide incentives for them to do so.

How do you think the UK can contribute in shaping the Indian healthcare sector?

In five main areas of building design and man-agement, effective clinical practice, top-class training, specialist digital applications and whole system man-agement. The UK has some of the best designers and en-gineers for creating and managing healthcare buildings and facilities. These promote health and recovery for pa-

tients, well-being for staff, and efficient for the funders. They are sustainable buildings that reduce energy use and will adapt to changes in climate and medical practice.

The UK is known for the highest quality clinical practice informed by world class research, training, equipment and systems. We can help shape Indian health services to give the best outcomes and highest satisfaction for pa-tients.

We also have top-class universities, colleges and train-ing companies that can provide specialist post graduate training for all professional staff in every speciality. We can provide this online and face-to-face in India and the UK.

The UK has innovative digital systems that collect rel-evant data for managing the quality of clinical services, and uses big data to ensure the right diagnosis; treat-ments are given and services are efficient. Whilst India has great digital innovations, the UK has some niche ap-plications, for example, in telemedicine and creating safe facilities.

We have experience in managing services for whole pop-ulations of insured patients: whether behavioural inter-ventions to promote health or systems, to ensure consis-tently high standards of care are maintained.

What collaborations do you think India and the UK healthcare sector needs to im-mediately work upon?The UK can help design smart city health systems that ensure people live and work in a healthy envi-

ronment and live a healthy lifestyle. We can show how-providing a range of accessible services reduces ill-health and unnecessary use of hospital services.

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We can work on systems to make hospitals top-class in both quality and efficiency. We can partner with Indian digital companies to bring specialist niche expertise to make healthcare work better.

We recognize that most of the new investment is going into the private sector and aim to work with investors, developers and operators in this sector whilst maintain-ing our supportive role with National and State govern-ments.

According to you where do you think In-dian healthcare system lacks or can further improve upon?I am very impressed with the energy, innovation and splendid facilities in some of your best hospitals. But

this is not the case across the system and we think we can bring our experience of one of the most cost-effective health systems in the world in a wider range of existing and new hospitals and healthcare services.

What would be your strategy in India? How do you intend to work in the Indian healthcare landscape?We will continue to work with the Union govern-ment and states to support India in major chal-

lenges such as healthcare education, the development of primary care, and anti-microbial resistance.

We believe in developing and maintaining trusted rela-tionships with major healthcare providers and develop-ers to ensure NHS organizations, UK universities, and companies can do business in a healthy partnership: as PM Modi says, an unbeatable combination.

What challenges do you foresee that may need to be addressed while collaborating?

We have a challenge in demonstrating just how much the UK can offer. So for example, in June

2016, I lead a delegation which exhibited and showcased its expertise in two venues in Delhi and Mumbai.

We know that UK prices are not sustainable in the Indian markets, so we encourage our suppliers to develop cost-effective methods in partnership with Indian suppliers.

And we have to continue to convince UK suppliers that India is a great place to do business and that concerns, for example, about trustworthiness in business and the distance from the UK can be overcome.

What can the Indian healthcare system learn from the NHS?Fundamentally, we can help produce what the US Commonwealth Fund has named (in 2014) as the

most effective healthcare service in the developed world in an Indian context. This may be a privately funded sys-tem or if required, a government system.

Any newer implementations that can we can anticipate from NHS in the next couple of years?We expect to see the first of a series of new Indo-UK Institutes of Health come up in the next couple of

years. This is a partnership with Kings College Hospital NHS Foundation Trust in London and other UK suppliers to create UK standard hospitals and training institutes.

We also hope to see UK companies who normally work with the NHS working with partners in India to respond to government tenders as we have done in the Maharash-tra ambulance service.

There are also some exciting collaborations, in particular specialities, and in training programs which are happen-ing between major Indian hospitals and the NHS, and UK private healthcare sector which I hope will be announced in the coming months.

I am very impressed with the energy, innovation and splendid facilities in some of your best hospitals.

Raj Gunashekar

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Merck Animal Health pact to acquire controlling interest in Brazilian companyMerck Animal Health (known as MSD Animal Health outside the United States and Canada) announced it has executed an agreement to acquire a controlling interest in Vallée S.A., a leading privately-held producer of animal health products in Brazil.

Vallée has an extensive portfolio of more than 100 products spanning parasiticides, anti-infectives and vac-cines. The company’s portfolio in-cludes products for livestock, horses, and companion animals. Vallée was founded with the mission of produc-ing a Foot and Mouth Disease (FMD) vaccine for Brazil and has expanded significantly, with distribution cen-ters in Brazil and operations in Para-guay, Venezuela, Mexico and Bolivia.

The agriculture industry is an impor-tant driver of the economy in Latin America. This region contributes 11% of the value of the world food production and a significant number of the cattle in the region are vacci-nated with Vallée S.A. vaccines. Un-der terms of the agreement, Merck Animal Health, through a subsidiary, will acquire approximately 93% of the shares of Vallée S.A. at closing, in exchange for a payment of $400 million, based on current exchange rates. This agreement is subject to regulatory review and certain closing conditions.

BioNews

Biocon announced that close on the heels of receiving approval for its Insulin Glargine from the Japanese regulator last quarter, its partner FU-JIFILM Pharma (FFP) has launched the product in Japan.

Insulin Glargine BS Injection Kit (FFP) has been developed & manu-factured by Biocon, and is being com-mercialized by FFP in Japan. The product is a ready-to-use, prefilled disposable pen with 3 ml of 100IU In-

sulin Glargine. It will provide a high quality, yet affordable, world-class long-acting biosimilar basal Insulin Glargine for patients of diabetes in Japan.

The company through its partner aims to capture a significant share of the Japanese Glargine market of $144 million, which is the second largest market outside of North America & Europe, and is largely dominated by disposable pens.

Biocon’s Insulin Glargine launched in Japan

Sun Pharma Launches Gemcitabine InfuSMARTAs part of its business strategy to build a meaningful and differenti-ating presence in Global Oncology Therapy market, Sun Pharma has an-nounced the roll-out of Gemcitabine InfuSMART in Europe. InfuSMART is a technology in which oncology products are developed in a Ready-To-Administer (RTA) bag.

With the roll-out of Gemcitabine InfuSMART, Sun Pharma becomes world’s first pharmaceutical com-pany to manufacture and launch a licensed RTA oncology product. This innovatively differentiated product will have a shelf life of two years. Over the next few months, Sun Pharma

will launch Gemcitabine InfuSMART across Netherlands, UK, Spain, Ger-many, Italy & France.

Sun Pharma received regulatory ap-proval to produce Gemcitabine In-fuSMART in eight key SKUs. The InfuSMART concept involves dose banding practice whereby, through agreement between prescribers and pharmacists, standardized doses of intravenous cytotoxic drugs are used for ranges (or ‘bands’) of doses calcu-lated for individual patients.

More InfuSMART oncology products are currently in Sun Pharma’s pipe-line to be rolled out in the future.


Zydus Cadila, a leading global healthcare provider has signed a non-exclusive, royalty free agree-ment with The Medicines Patent Pool (MPP) for the generic produc-tion of Bristol-Myers Squibb’s da-clatasvir, a novel direct-acting an-tiviral (DAA) that is proven to help cure multiple genotypes of the Hep-atitis C virus (HCV). The agreement sub-licences Zydus to produce and sell daclatasvir in 112 low and mid-

dle income countries.

Between 130 and 150 million peo-ple worldwide are estimated to have HCV. The vast majority lives in low and middle income countries. The MPP licence allows generic manu-facturers to develop fixed-dose combinations that offer the po-tential to treat all of the six major genotypes of HCV. Daclatasvir, in combination with other DAAs, for example sofosbuvir, produces high cure rates after 12 weeks of treat-ment, with recent Phase III stud-ies demonstrating that the regimen could cure up to 100% of HCV pa-tients depending on genotype and stage of liver disease.

Zydus partners with The Medicines Patent Pool for Hepatitis C medicine

Hetero recently announced the launch of biosimilar of ‘Bevaci-zumab’, used in treating metastatic colorectal cancer (mCRC), under the brand name CizumabTM. Hy-derabad-based Hetero is one of the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS.

Approved by the Drug Controller General of India (DCGI), the drug is used as a first-line treatment for mCRC, Hetero said in a statement. Commenting on the launch, BPS Reddy, CMD, Hetero, said, “It has been an exciting journey for us in bi-ologics. Hetero’s Bevacizumab is the third product in our biologics portfo-lio, after Darbepoetin alfa and Ritux-imab. We believe CizumabTM will be a cost-effective treatment option to patients.”

The drug will be marketed and dis-tributed by Hetero Healthcare, a group company of Hetero. The prod-uct will be made available to pa-tients in a single dose vial with two strengths, 100 mg and 400 mg. The product will be manufactured in Het-ero’s dedicated state-of-the-art Bio-logics facility based in Hyderabad, India.

Hetreo launches biosimilar for colorectal cancer

India to set up regional biotechnology center

The Indian government recently passed a bill approving the estab-lishment of regional centers for biotechnology in the National Cap-ital Region. Under the auspices of United Nations Educational, Sci-entific and Cultural Organization (UNESCO), the center will be an institution of national importance which imparts scientific or techni-cal education, and is empowered to

grant degrees.

The Regional Center for Biotech-nology will take up research and innovation and impart education and training in the new areas of biotechnology at the interface of multiple disciplines of science cre-ating a hub of technology expertise.

The Bill says that the objectives of the Regional Centre will in-clude disseminating knowledge by providing teaching and research facilities in biotechnology and re-lated fields, facilitating transfer of technology and knowledge in the SAARC region and Asia, creating a hub of biotechnology expertise, and promoting cooperation at the international level.

BioNews


AstraZeneca (AZ) Pharma India (AstraZeneca India) has announced a collaboration with STEMI India Charitable Trust, a not-for-profit organization founded by leading car-diologists Dr Thomas Alexander and Dr Ajit S Mullasari (STEMI India).

Under the collaboration, STEMI India and AstraZeneca In-dia will work together to emphasize the importance of the ‘Golden Hour’ and appropriate treatment strategies across the country for improving the standard of care for heart at-tack patients. India has a high burden of coronary artery dis-ease (CAD) in the world; upwards of 3 million heart attacks occur in India every year. One of the gravest complications of CAD is ST-elevation myocardial infarction (STEMI), a life threatening medical emergency that results from a sudden, occlusive thrombus in the coronary artery.

If treated within 2 hours of onset of symptoms, much of the damage can be controlled and many more lives saved. Cur-rent data suggest that patients are brought in to a hospital only after about 300 minutes.

AZ India collaborates with STEMI India

ICON to acquire Clinical Research ManagementICON has announced that it has agreed, subject to certain customary closing conditions (including ap-plicable regulatory approvals), to acquire Clinical Research Management (ClinicalRM).

The acquisition will enhance ICON’s ability to access the market for government sponsored research and further enhances ICON’s capabilities in the areas of Vaccines and Infectious Disease.

ClinicalRM provide full service and functional re-search solutions to a broad range of US government agencies.

Their extensive expertise extends across basic and applied research, infectious diseases, vaccines devel-opment and testing and the response to bio-threats. They have worked in collaboration with government and commercial customers to respond to the threat of global viral epidemics.

10TH CALL FOR PROPOSALS

Last date for Submission of proposals

15th September,

2016

CONTRACT RESEARCH SCHEME (CRS)Supporting Academia for Translational Research (August 1, 2016 – September 15, 2016)

Academia has to be the Primary Applicant with one or more partners of which at least one is an industry. The proposers, if so desired can opt for additional partners from another Industry and/or academia

Eligibility criteria for the partner(s) Indian company/ies registered under “The Indian Companies Act 2013” with minimum 51% Indian shareholding, and

having DSIR recognized in-house R&D unit Public/ Private Universities and Research Institutions having a well-established support system for basic and/or applied

research with registration/recognition from a statutory body are eligible.

Who

can

app

ly

Proposals for the Scheme are required to be submitted online only. For scheme details and information regarding submission of proposal, please log on to BIRAC website (www.birac.nic.in)Ho

w to

ap

ply

Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking of Department of Biotechnology, Ministry of Science & Technology (Govt. of India) is an interface agency to nurture innovation research and promote affordable product development through Public-Private Partnership

Biotechnology Industry Research Assistance Council(A Govt. of India Enterprise)

For queries, please contact Head - Investment, BIRAC [email protected]

Contract Research Scheme (CRS) supports academia across the country to take forward their research leads through validation and translation by industry.

Key features of the scheme Funding is in the form of Grant-in-aid which

is given to both the academic as well as industrial partner

The academia should necessarily have an established lead supported by scientific data for validation by industry

The scheme also supports academia for some specific services such as toxicology studies, gene sequencing studies etc. as a part of validation studies and commercial scale development

Grant-in-aid is provided to the academia for In-House research which forms a part of validation of the PoC

While the IP rights reside with academia, the industrial partner has the first right of refusal with regard to commercial exploitation of New IP

(Exploratory research or fundamental discovery without PoC is not supported)

BioNews


Cancer Genetics partners with Sayre TherapeuticsCancer Genetics announced an ex-clusive distribution agreement that provides Sayre Therapeutics sales and marketing rights of Cancer Ge-netics’ Tissue of Origin (TOO) test in India and South Asia. TOO data gen-erated by the use of the test in India will contribute to the expansion of CGI’s knowledge base to further vali-date the clinical utility of the test on a global basis.

CGI’s TOO is a microarray-based gene expression test that aids in iden-tifying challenging tumors, including metastatic, poorly differentiated, and undifferentiated cancers. It is able to

report the tissue of origin of 15 of the most common tumor types (thyroid, breast, non-small cell lung, pancreat-ic, gastric, colorectal, liver, bladder, kidney, non-Hodgkin’s lymphoma, melanoma, ovarian, sarcoma, testic-ular germ cell, and prostate tumors), representing 58 cancer morphologies and covering 90% of all solid tumors. TOO leads to a change in treatment 65% of the time.

Sayre has begun active marketing ef-forts in major metro markets of India and South Asia and has held semi-nars and workshops with key opinion leaders and clinicians.

Sanofi, Boehringer swap animal, consumer health businesses

Sanofi and Boehringer Ingelheim announced the signing of contracts to secure the strategic transaction initiated in December 2015 which consists of an exchange of Sanofi’s animal health business (Merial) and Boehringer Ingelheim’s consumer healthcare (CHC) business. This step marks a major milestone before clos-ing of the transaction which is ex-pected by year-end 2016 and remains subject to approval by all regulatory authorities in different territories.

The Boehringer Ingelheim Animal Health business would more than double its sales to approx. €3.8 bn based upon 2015 global sales. With this transaction, Sanofi would inte-grate Boehringer Ingelheim’s CHC business in all countries except Chi-na. Joint CHC sales would amount to approx. €4.9 bn2 based upon 2015 global sales. Thanks to the addition of a highly complementary product and brand portfolio, Sanofi would enhance its position in several of its strategic categories - Pain Care, Al-lergy Solutions, Cough & Cold Care, Feminine Care, Digestive Health and Vitamins, Minerals and Supplements.

Medtronic has announced the US Food and Drug Administration (FDA) 510(k) clearance of the CD Horizon Fenestrated Screw Set, which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. This marks the first US clearance for ce-ment-augmented pedicle screws. The CD Horizon Fenestrated Screws are used with Medtronic’s HV-R Fenes-trated Screw Cement, a polymethyl-methacrylate (PMMA) cement, and are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.

Medtronic’s CD Horizon Fenestrated Screw Set features cannulated ped-icle screws designed with six holes (fenestrations) located near the end of the screw, allowing controlled ce-ment injection into the targeted ver-tebral body after having placed all of

the screws. This self-curing PMMA cement provides immediate screw fixation in the patient’s spine and significantly increases the screw pull-out strength compared to standard screws.

The cement is injected through a

Medtronic gets FDA nod for pedicle screws

continuous tract in the adapter and into the screw cannula. This continu-ous tract delivery system is designed to have a completely secure chan-nel that can be visually verified out-side the patient to help reduce the likelihood of cement leakage at the adapter/screw interface while being compatible for minimally invasive surgery (MIS) and open procedures.

BioNews


IMS Health has partnered with Cloudera Enterprise to support its Big Data Factory, a cloud-based platform that transforms data into intelligence for life sciences and healthcare clients as they navigate dynamic markets, drive operational excellence and demonstrate the value of medicines.

The combined solution will support:

Next-generation data processing. Cloudera’s latest open source technology platforms support machine learning - which uses cognitive systems to automate quality control, data bridging and modeling, and other repetitive tasks-to drive evidence-based decisions for clients. Using the Hadoop cluster technology, IMS Health can extract, store and analyze vast quantities of unstructured data for gen-erating new, more comprehensive insights for customers.

Accelerated time to insight. The IMS Health Big Data Factory will harness Hadoop’s parallel processing tech-nology to streamline data acquisition and management,

delivering powerful insights with higher efficiency.

Scalable data management. The Hadoop distributed file system (HDFS) eliminates data transfer bottlenecks, storage capacity delays and time spent adding new serv-ers to augment traditional data clusters - enabling IMS Health to improve the speed and scalability of Big Data management.

IMS Health partners with Cloudera Enterprise

BioNews


Dr Reddy’s Laboratories announced that it has launched Omeprazole and Sodium bicarbonate capsules, 20mg/1100mg and 40mg/1100mg, a therapeutic equivalent generic version of Zegerid (omeprazole/sodium bicarbonate) capsules in the Unit-ed States market, having been approved by the US Food & Drug Administration (USFDA).

The Zegerid brand and generic had US sales of approximately $306.7 million

Dr Reddy’s launch Omeprazole and Sodium bicarbonate capsules in US

Mylan NV and Biocon has an-nounced that the European Medi-cines Agency (EMA) has accepted for review, Mylan’s Marketing Autho-rization Application (MAA) for our proposed biosimilar Pegfilgrastim, which is used to reduce the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and my-elodysplastic syndromes).

Mylan and Biocon, who have co-developed the proposed biosimilar, received EMA’s acceptance of the submission for review. In addition to analytical, functional and pre-clinical data, the application includes clinical data from pivotal Pharmaco-kinetic/Pharmacodynamic (PK/PD) and confirmatory efficacy, safety and immunogenicity studies completed earlier in 2016. The results from the studies are expected to be presented at the prestigious European Society of Medical Oncology (ESMO) Annual Congress to be held in Copenhagen

in October 2016.

Pegfilgrastim is prescribed for can-cer patients to help them with some of the side-effects of their treatment. It reduces the duration of neutrope-nia (low levels of neutrophils, a type of white blood cell that fights infec-tions) and the incidence of febrile neutropenia (neutropenia with fever) that are a result of their chemothera-py treatment.

Biocon and Mylan are exclusive part-ners on a broad portfolio of biosimi-lars and generic insulin analogs. The proposed biosimilar Pegfilgrastim is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the proposed biosimilar Pegfil-grastim in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.

Mylan & Biocon’s Biosimilar Pegfilgrastim accepted for review

SPARC licenses ELEPSIA XR (Levetiracetam ER Tablets)

Pharma Advanced Research Com-pany and Sun Pharma announced a licensing arrangement for SPARC’s ELEPSIA XRTM (Levetiracetam Ex-tended Release tablets).

As per the agreement, SPARC will license ELEPSIA XRTM (Leveti-racetam Extended Release tablets) to a wholly-owned subsidiary of Sun Pharma for the US market. SPARC will receive an up-front payment of $10 million from Sun Pharma. It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XRTM.

ELEPSIA XRTM was approved by the USFDA in March 2015. However, in September 2015, SPARC received a complete response letter (CRL) from the USFDA rescinding its ear-lier approval, citing that the compli-ance status of the manufacturing fa-cility viz., Halol site of Sun Pharma was not acceptable on the date of ap-proval. Sun Pharma has undertaken a detailed remediation at Halol for restoring cGMP compliance status for the site.

MAT for the most recent 12 months ending in May 2016 according to IMS Health.

Dr Reddy’s Omeprazole and sodium bicarbonate capsules 20 mg/1100 mg and 40 mg/1100 mg are available in bottle count size of 30. Zegerid is a registered trademark of Santarus, a wholly owned subsidiary of Salix Pharmaceuticals.

BioNews


Sanofi India expands diabetes portfolio

Sanofi-Synthelabo (India) an-nounced the launch of two drugs for type 2 diabetes patients in India: LYXUMIA (lixisenatide) and ZEMI-GLO (gemigliptin). LYXUMIA is a once daily, non-insulin injectable drug and ZEMIGLO is a once daily, oral tablet.

Sanofi India’s integrated portfolio of marketed products provides treat-ment, monitoring and support at every stage of the diabetes journey. Lyxumia (lixisenatide) and Zemiglo (gemigliptin) are critical elements of this portfolio.

Lyxumia is currently approved in over 70 countries worldwide for the treatment of type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. It has been filed in the US for approvals. Zemiglo has been approved in South Korea in 2012 and already has over three years of clini-cal experience.

Suven Life Sciences (Suven) an-nounced that the grant of one (1) product patent from Europe (2507225) and two (2) product pat-ents from Eurasia (023293 and 023260) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these patents are valid through 2029, 2030 and 2031 respectively.

The granted claims of the patents are from the mechanism of action include the class of selective 5-HT4

compounds, Alpha4Beta2 and H3 Inverse agonist compounds and are being developed as therapeutic agents and are useful in the treat-ment of cognitive impairment as-sociated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactiv-ity disorder (ADHD), Huntington’s disease, Major Depressive disorder (MDD), Parkinson and Schizophre-nia. With these new patents, Suven has a total of 21 granted patents from Europe and 19 granted patents from Eurasia.

Suven Life secures three product patents in Europe and Eurasia

USFDA completes Strides’ facility inspection in BangaloreStrides Shasun announced success-ful completion of USFDA inspection at its flagship Oral Dosage Facility in Bangalore with Zero 483s. The com-pany is a vertically integrated global pharmaceutical company headquar-tered in Bangalore.

The audit was carried out related to a product filed from the new, semi-solids block from where the company has made a series of filings. With the recently closed Establishment In-

spection Report (EIR) announced on June 7, 2016, the entire facility is now USFDA compliant.

The Oral Dosage facility in Bangalore manufactures oral dosage forms in-cluding tablets, capsules (both hard and soft gelatine), ointments and liq-uids.

The manufacturing plant supports important current and future sub-missions for the US market.

Torrent Pharma has entered into a binding agreement to acquire the Vizag API manufacturing unit of Hyderabad-based Glochem Industries Limited along with a few Drug Master Files (DMF) as a going concern on slump sale ba-sis. The company currently has five formulation manu-facturing units and with this acquisition it will have 3 API

facilities for the regulated markets, in the near future.

The API unit approved by the US FDA and the European regulatory authorities is a multi-product facility, with a capacity to manufacture Advance Intermediates & Active Pharmaceutical Ingredients (APIs). This will be benefi-cial in company’s growth trajectory. The acquisition will help Torrent Pharma in vertically integrating its Abbrevi-ated New Drug Application (ANDA) filings in the future.

Torrent Pharma acquires manufacturing unit of Glochem

BioNews


BioAnalysis

DPCO: A nightmare for pharma firms?

In order to make drugs more affordable and accessible to patients, National Pharmaceutical Pricing Authority (NPPA) has capped the price of the (essential) drugs, which has sent

pharma sector in a turmoil, most of the pharma companies have witnessed a hit on their profit margins.

DPCO impact on pharma sectorThe NLEM (National List of Essen-tial Medicines) list has been expand-ed since DPCO 2013 with amended DPCO in March 2016 taking total notified formulation to 820 from ear-lier 628. NPPA has fixed ceiling price for 530 of these in March 2016 with overall ~12% of industry coming un-der price control as on date.

This has resulted in incremental im-pact for the industry as indicated in slowing growth over last 3 months (accentuated by ban on FDC drugs).

The volumes for DPCO covered drugs has been on a declining trend while overall drug volumes in the market has been increasing.

“DPCO 2013 had a considerable impact on domestic business of In-dian Pharmaceutical industry with industry growth (in MAT terms) reducing to low single digits in FY2014 from mid double digits ear-lier. Along with cut in drug prices, it also resulted in trade related is-sues further impacting overall sup-ply chain. The industry, though, has recovered over last two fiscals with

domestic MAT growth at 12-13% in FY2015 and FY2016. The recovery has been driven by volume and price growth in non DPCO portfolio and WPI linked price growth in DPCO portfolio. Pharma companies have launched new products including non DPCO combinations to protect their margins along with increased penetration to support growth,” said Subrata Ray, Sr. Group Vice Presi-dent, ICRA Limited.

IMS Health report, ‘Assessing the Impact of Price Control Measures on Access to Medicines in India’ men


tions that DPCO has an impact on the tail-end brands than the leading players thereby increasing market concentration and resulting in dis-continuation of brands, with aver-age number of brands in DPCO mol-ecules reducing from 36 in 2013 to 32 in 2015. These market forces can move towards strengthening of oli-gopolistic behaviour, which will re-sult in reduced set of choices for the doctors/patients.

The report further stated that price control and unstable regulatory en-vironment has increased the margin pressures for companies, thereby impacting their sustainability espe-cially small and midsized players. This further impacts the employment generation potential of the industry. These factors dampen the sentiments across the industry and potential do-mestic and international investors.

The move has also impacted our ex-port growth, as per the IMS Health report post 2013, while the volumes grew at 9%, value growth was signifi-cantly lesser at 5%. India’s pharma exports to other developing countries accounts for ~12% of our total ex-ports of pharmaceuticals. PPP wise price comparison against these coun-tries indicates that average prices of Indian drugs is lower than the pric-es in these countries. These coun-tries could benchmark their prices

drug which has the market potential to be priced higher, affects the entire business plan for its development and lowers the returns on invest-ments made for that drug, making the entire project financially infea-sible, causing rejection,” explains N Venkat, co-founder and CEO, Vyome Biosciences.

Decline in R&D resulting in fewer new introductions of generic prod-ucts; post DPCO 2013, the average number of new introductions in DPCO molecules has declined, which also indicates increasing concentra-tion and reducing competitive inten-

against domestic Indian prices and negatively impact our growing ex-ports market.

R&D slump? DPCO would impact the R&D de-velopment for pharma firms, most notably innovation driven biophar-maceutical firms in India. DPCO might inhibit the R&D companies to significantly invest in development of drugs which might come under DPCO scanner in future and affect scale ups, expansions and the inter-national quality.

“This is because curbing the price of a

Subrata RaySr Group Vice President, ICRA Limited

Dr Shailesh Ayyangar, President, OPPI and Managing Director - Sanofi India Limited.

N. Venkat, Co-Founder & CEO Vyome Biosciences

BioAnalysis


sity, the IMS Health report stated.

“From last six months hardly new formulations has introduced in do-mestic market. Even MNCs are not planning to introduce any new thera-py in our country due to lack of prop-er drug and pricing policies,” said Dr Sanjay Agarwal, Pharmaceuticals Consultant.

However, Ray feels DPCO may not di-rectly impact R&D. He explains, “The R&D budget of domestic pharma companies are largely export focused and same has actually increased con-siderably over last few years. While, DPCO does not have a direct impact on R&D/investments by the indus-try however significant expansion of the scope of NLEM, may potentially impact the profitability of domestic business - this in turn may limit the ability of Indian pharma to generate cash surplus for quality/R&D invest-ments.”

It will also have impact on marketing budget of these specific drugs. It is possible that both marketing budget and R&D budget will take a hit. The impact varies from company to com-pany based on allocation of available funds.

Making drugs affordableSome reports suggest that many companies have cut down on manu-facturing of (essential) drugs, which in turn deflects the purpose of price control.

According to IMS Health report, for low income households that are reliant on the government system for healthcare, DPCO would not improve the patient’s ability to pur-chase drugs. This is supported by the fact that no significant penetration of price controlled molecules in rural markets is visible, with consumption in rural towns decreasing at ~7% over the last 2 years. The price controlled molecules has also witnessed muted growth in prescriptions outside met-ros (town class I) as compared to 5% Rx growth in non-DPCO molecules.

What could be the alternative of mak-ing drugs affordable and accessible while ensuring pharma firms remain interested in manufacturing these (essential) drugs and profitable?

“Bringing the notional loss due to curb on pricing under CSR programs in addition to the required contri-butions and asking for companies’ commitment to provide pre-defined quantities of drugs per year to pa-

tients while simultaneously provid-ing them benefit of CSR contribu-tion,” suggests Venkat. He further recommends a three-way arrange-ment between NPPA, drug manu-facturers and insurance companies whereby the drugs under DPCO to be covered under insurance plans re-imbursement partially up to a mini-mum limit before imposing DPCO. This will not only improve profitabil-ity of the manufacturers, but will also increase the insurance cover in India.

Other benefits like income tax ex-emptions on profits made on essen-tial drugs, can be explored.

“With India’s enormous population, one of the biggest hurdles that we face is access to quality healthcare for all our citizens. Contrary to popular belief, price control has limited im-pact on improving patient access to medicines. A good place to begin is to prioritize healthcare and enhance public expenditure towards it. Addi-tionally, there is a need for increased focus on infrastructure and capacity building. A viable public healthcare model requires a combination of financing and non-financing mea-sures,” suggests Dr Shailesh Ayyan-gar, President, OPPI and Managing Director – Sanofi India.

DPCO may not be a nuisance for pharma companies if rolled out with clear provisions and also incorpo-rating some changes and extending some benefits to companies which take into account the profitability of the companies, especially for those companies which are involved in in-novation driven work.

“DPCO should improve patients’ ac-cess to essential medicine, but should also incentivize the pharma companies to invest in innovation, quality and ex-pansion,” Venkat concluded. BS

Ayesha Siddiqui

BioAnalysis


CoverStory

What kills a Life Sciences start-up?

Raj Gunashekar

Mistakes are unavoidable in an entrepreneurial journey. Some

mistakes are significant and others -- though insignificant -- can act as a pillar for learning. But often those mistakes end up being costly and start-ups and organizations have paid a heavy price all throughout

history. Learning from mistakes and avoiding them a second time sounds wise. But what if an entrepreneur

can identify the tell-tale signs of the end-game earlier? Is it

possible to resurrect a dying or a dead Life Sciences start-up? What’d it take to make a big

comeback on the scene to slay newer and bigger dragons?

BioSpectrum finds out.

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An unstable team is perceived as the first sign of a dying start-up which displays a teams’ disbelief in their venture.

“Lack of skilled personnel in the core tech-nology is another indication that a venture

is in trouble. Apart from the aforesaid point, lack of mar-ket space for the developed product is a clear sign of a dying start-up,” comments Dr Kavitha Sairam, Director, FIB-SOL Life Technologies.

Pushing on outdated scientific concepts, working on old technology platforms, and difficulty in attracting funding or top talents are the symptoms of a dying start-up, says Sam Santhosh, Chairman, MedGenome.

Improper business plans and lack of innovations can also act as a root cause for a start-up’s deathblow.

Pawan Samdani, Director & Founder, Eumentis Infor-matics, says, “I do not think the tell-tale signs of a dy-ing Life Science start-up is any different from start-ups in other sectors. Bad quality of products or services, lacking funds and having an unbalanced team are major signs.”

Clinical or regulatory set-back is a loud death knell for any Life Sciences company.

However, there is a proven history of medical technology innovations that failed miserably while addressing the original clinical condition, but were extremely successful, and financially lucrative, in their cautionary conditions.

“In the medical devices side, the use of Doppler failed miserably during cardiac catheterization, but eventually had an impactful contribution in treating pediatric pa-tients. The key is to figure out your product-market fit on a molecular scale that can be stretched over years some-

times,” points Nishith Chasmawala, Co-founder, Consure Medical.

Dr Aman Sharma, Founder & Director, ExoCan Health-care Technologies, voices that a dying Life Sciences start-up is not a rare species.

“Simply put,” he states, “dried up funds, no visibility, shrinking team, no signs of products or services in the near future, and diminishing spirit to innovate are im-portant signs.”

Lower employee morale can also be taken as a best sign for a dying start-up.

“Other signs may include lesser visibility, disinterest in serving customers, desperate measures for sales or col-lection,” notes Tony Jose, CEO, Clevergene Biocorp.

Life Sciences start-ups typically go through multiple rounds of funding. The idea is to hit specific milestones like completion of preclinical or clinical trials, USFDA approval, and CE certification among others.

“If at any stage, a Life Sciences company is unable to at-tract new fundings -- either because it hasn’t achieved its own targets or because investors are not confident about the company’s prospects -- then it is a biggest tell-tale sign,” mentions Dr Nilay Lakhkar, Founder & CEO, Syn-Thera Biomedical.

Anant Agarwal, Founder, Indoriv Clinical, feels that bad hiring decisions, untrained professionals, lack of commu-nication, and poor documentation processes are bad for start-ups.

He opines, “Life Sciences is complicated. While a lot of companies do have a good process flow and structure,


many factors come up in the middle which have to be dealt with intelligently. This requires intelligent staff. My first mentor told me that it is okay to make mistakes in this sector, but it is not okay to hide them. Any form of cover-ups or poor documentations will come and bite you back.”

Killer mistakesTo the contrary belief, too much possessiveness about a particular idea or a product can serve as a stumbling block for a start-up.

“….Procrastination, not having a clear commercialization vision, failing to raise enough capital, over dependence on organic growth; failing to connect with potential cus-tomers, can kill a start-up,” says Tony.

Ms Monisha, Founder, ScientiaBio, voices that having no long-term plan and unique selling point (USP) can be dangerous to an entrepreneur.

“Another important mistake committed by service-based Life Science start-up is not having the ability to change or modify the services as per the market demand from time-to-time,” she adds.

Life Sciences is an evolving field and it is very important to evolve with it. The science and regulation of Life Sci-ences change regularly. Thus, it is essential that entrepre-neurs are updated with these changes.

“One of the key elements that can kill a Life Sciences start-up is the inability to follow protocols. Whether it is a clinical research or pharmaceuticals, or a biotech or med-ical devices company, all are surrounded by Standard Operating Procedures (SOPs). These SOPs are not just mere words; they represent what the regulators and the global healthcare community expect out of you,” Anant explains. “It is also important to note that SOPs are dif-ficult to follow because they are not standardized. Global standards are different from local standards. In fact lo-cal standards also vary from state-to- state. On top of this, SOPs can also vary from one individual to another. To read between the lines and maintain a balance is ex-tremely important in keeping a start-up alive.”

Most start-ups in the Life Sciences sector have a common goal of making their products extremely cheaper.

Pawan comments that it is a misconception that cheaper the product, the easier it would be to get a grant or fund-ing.

“The founders should look at the problem that they are trying to solve and the technology that can enable them to solve it, and then decide if it is feasible to reduce the product costs. Most of the time, the problems in the Life Sciences domain are too complex and therefore require technologies that are not currently cheap,” he observes.

Innovation is the key in Life Science startups, and is the only way to ensure longer life for the company. If a start-

Dr Aman Sharma, Founder & Director, ExoCan Healthcare

Technologies

Anant AgarwalFounder, Indoriv Clinical

Pawan SamdaniDirector & Founder, Eumentis Informatics

CoverStory


up is developing a novel product, then they should also develop a good IPR strategy.

“This will enable them to reap benefits for their inven-tions for a very long time without worrying about compe-tition copying their idea,” advises Pawan.

Sometimes, start-ups focus too much on research and product development, and not enough on sales and mar-keting.

Most Life Sciences start-up founders are technical profes-sionals and are naturally inclined to concentrate on the technical aspects of the business, but ignore the equally crucial sales and marketing strategy.

Pawan strongly believes that sales and marketing are as important as developing a good product.

“Companies that do not have strong sales and market-ing plans are definitely going to fail no matter how good the product is. Improper usage of funds can surely kill a start-up,” he says.

Dr Kavitha clarifies that lack of focus on proposed prod-ucts, having unrealistic solutions, and improper resource planning could be deadly to a start-up.

Start-ups that have committed to older technologies are caught flat footed, points Sam.

“Newer scientific developments make companies obso-lete. When gorillas fight, monkey can get trampled upon. Life Sciences industry is typically dominated by large players. Certain situations like IP disputes and M&As can severely distort the ecosystem that a start-up is in. If careful attention is not paid to the industry develop-ments, a start-up can get trampled severely,” he states.

Cash flow management is also a crucial factor in the suc-cess of a Life Sciences start-up, particularly when consid-ering that the average product development cycle from idea-to-market in this domain can be up to 5 years or even more.

“Failure to effectively manage cash flows or to understand what customers, product regulators, and patent authori-ties want are detrimental to a start-up,” Dr Nilay stresses.

Another fundamental mistake would be not picking up and pursuing unforeseen observations (UFOs) or results, which in fact may yield a totally new product.

“These UFOs could belong to scientific data, product building strategy, or IP strategization. Other vital mis-takes are lack of scientific vision or product-building strategy. An entrepreneur should have an innovation-entrepreneur or inno-ventrepreneur spirit. An inno-ventrepreneur is essentially an entrepreneur who has an innovative mind, and a commercialization vision. In lay-man’s language, I could say a combination of both Wright

Dr Nilay LakhkarFounder & CEO, SynThera Biomedical

Nishith ChasmawalaCo-founder, Consure Medical

MonishaFounder, ScientiaBio

CoverStory


Brothers and JP Morgan,” Dr Aman adds.

Nishith says, “Unfavorable clinical evidence, ill-conceived or poorly executed regulatory strategy and inadequate resources to survive long gestation cycles can damage a start-up.”

Dragon slaying attitudeAttitudes really do determine an entrepreneur’s altitude. Psychologists say that it is not about the circumstances surrounding us, but rather it is all about how we respond to them that determines our success or failure.

Entrepreneurs mandatorily need to fuel their mojo tank on a regular, daily basis. Once they set out on their jour-ney, there is no place for pity-parties or caving in. Either they can slay dragons or go home.

Sam says that a strong passion towards science and a clear understanding of translating it for the industry is important to succeed in the Life Sciences.

“Most people with science background will not have an MBA or business-related experience; so a co-founder with strong business experience is needed,” he says.

On similar lines, Nishith points that it is essential to have nuts and bolts knowledge of health-economic environ-ment.

“Up to a certain extent entrepreneurial DNA is univer-sally alike... Ability to identify a latent clinical need, a flair to synthesize science to a story, and the stamina to run an ultra-marathon while chewing glasses will keep entrepre-neurs moving further,” he comments.

For entrepreneurs, it is significant to have the sharpest possible understanding of their target market and com-petition.

Dr Nilay explains, “Tailoring your products or services to satisfy the needs of your customers at acceptable price points should also be economically viable for a start-up. Entrepreneurs should also stay abreast of the prevailing regulatory environment as well as patents landscape.”

Out of all the entrepreneurial qualities, perseverance oc-cupies the top position, which often gets mentioned in the Life Sciences start-up ecosystem.

“Undeniably, all entrepreneurs share common qualities and attitudes. But a Life Sciences entrepreneur should

have more perseverance. This quality will help over-come uncertainties in a biology-related product develop-ment space. They should have a quest for updating their knowledge, and should be able to deliver affordable tech-nologies for social cause. Being passionate in technolo-gies will convince investors to be a part of the venture,” Dr Kavitha notes. “Most Life Sciences entrepreneurs are passionate about their technology, which drives them to business rather than the market or money.”

“This could be both advantageous as well as disadvanta-geous. Their passion keeps them going through the odds of business. It may as well hinder the entrepreneur from taking dynamic decisions,” she further adds.

High self-confidence, agility and high emotional intelli-gence are important says Tony.

“In principle, there shouldn’t be any difference between a Life Sciences entrepreneur and entrepreneurs in oth-er sectors. But many times, entrepreneurs with scien-tific backgrounds tend to be over-possessive about their ideas,” he highlights.

There are various types of leaderships in the corporate world. But the Life Sciences industry requires a visionary.

The most important skill any entrepreneur needs to have is being a great communicator.

“We get much business owing to our company’s great communication ability. We keep in touch with all parts of the industry and effectively resolve and reply to their queries diligently,” Anant states.

“Constantly motivating your team, investing in their de-velopment and keeping your team happy is extremely im-portant. Personally I have also experienced that one can-not keep everyone happy. Entrepreneurs might have the best products, but it affects different people differently. Therefore, while it is important to take inputs from ev-eryone, do not change your goals; be flexible about your methods,” he advises.

A couple of decades ago, Life Sciences firms were run by management, lawyers and marketing professionals who decided the course and direction of the company. Today, however, it’s a different picture altogether.

“Today entrepreneurs sit with scientists and healthcare professionals to understand what works and how things need to be shaped up. A Life Sciences entrepreneur is

CoverStory


Sam Santhosh Chairman & Global CEO, MedGenome

Tony JoseCEO, Clevergene Biocorp

Anant Raheja & Dr Kavitha Sairam

Founders, FIB-SOL

usually someone who understands the specific field and the science behind it…” Anant elaborates. “Life Sciences directly impacts peoples’ health, so it needs to be more responsible and factual. This field can give you very high returns, but one mistake can also bring you down. Fi-nances have to be monitored and divided carefully. There needs to be a ‘R&D fund’ and ‘Risk fund’ that needs to be separated to keep the company in good balance. Overall a Life Sciences start-up needs to have a more disciplined approach to things than other start-ups.”

For a Life Sciences entrepreneur, technical competence is a given. Dr Nilay thinks that the most essential attributes for being a Life Sciences entrepreneur are patience and passion.

He says, “The road to profitability in Life Sciences is a long one; entrepreneurs must therefore have the patience to deal with all sorts of ups and downs along the way and the passion for their work to keep going regardless of the situation. Also, the commercial regulatory framework -- registrations with various authorities, timely filing of re-turns -- needs to be understood and meticulously imple-mented…Entrepreneurs in this space tend to be focused mainly on the technology side of the business. Often that means they may not pay the same attention to other as-pects of their business, such as finance, company affairs, and marketing…”

Stronger vision and willpower, good ethics and morality, deeper domain knowledge, mindfulness, eye for detail,

and being actively involved in various developments are indispensable qualities, says Pawan.

“… Entrepreneurs need to be ready to accept failures and learn from past mistakes. It is almost impossible to inno-vate or build novel products without extensive research. That means a lot of failures and getting stuck at various steps... They should listen to their gut while making criti-cal decisions,” he asserts.

Both intentional and unintentional mistakes in a Life Sci-ences start-up can lead to regulatory challenges and para-lyze its business.

“In Life Sciences, entrepreneurs can play with their ideas at R&D stage. But the penalty for doing a mistake in the final product will be huge, and sometimes unforgivable,” adds Monisha.

Life Sciences is a need-based industry and not a want-based one. Entrepreneurs here need to have a problem-solving attitude towards their target communities.

“Entrepreneurs need to ask how they are going to solve a problem, will their technology or product make a dif-ference, or is it just a lifestyle option,” expresses Firoza Kothari, Co-Founder & CTO, Anatomiz3D.

Another much-needed entrepreneurial attitude is self-motivation.

CoverStory


“Entrepreneurs should be self-driven, and a challenge lover. Moreover, good PR skills, risk taking but de-risk-ing efficiency, imaginative but creative, being patient and practical are few of the traits of a Life Sciences entrepre-neur,” Dr Aman lists. “Since attracting investors in early stages is not easy in this sector, entrepreneurs should be aggressive enough to take early R&D leads into individu-al products or services to raise the company’s credibility even well before delivering key products. Life Sciences entrepreneurs are not wealthy like their counterparts in the IT or e-commerce industry. Probably the former are older in age and they face societal pressure since it takes longer incubation time for recognition.”

Resurrection possible?When a Life Sciences start-up is experiencing near-death experience or is close to death, can there be a silver lin-ing?

Most entrepreneurs believe it is possible. How to go about it? That solely is believed to depend on the founders, their resurrection strategy and the space they operate in.

“If the founders believe that their start-up still has a po-tential to make a high impact, they should quickly iden-tify the faults within the system and rectify them without wasting any time. This may include inviting resourceful professionals to the team, building systems for better ac-countability, identifying and focusing on crucial aspects of the operations, getting razor-sharp focus on primary offerings, and getting into alliances to boost growth. If funding is an issue, put everything else behind and raise it quickly,” stresses Tony.

Nishith shares that usually a determined entrepreneur or a dogged inventor will eventually find clinical success.

“Most pragmatic investors and entrepreneurs engage in collaborative development, where a portion of the tech-nology is licensed off for a milestone-based payout down the line,” he says.

Developing new strategies and letting go of previous in-vestments are also seen as a part of the resurrection plan.

“Bringing in new scientific advisors who are involved in the latest developments, and collaborating internation-ally with leading centres of excellence. Many NRI scien-tists are leading numerous efforts globally. This can help revive a start-up,” Sam opines.

Monisha agrees to the point in engaging with qualified

mentors or advisors. “Mentors should be experienced in Life Science and marketing, who can lead the team with their sales strategy, marketing and funding. Other men-tors should be technical experts having the ability to lead the team for executing the strategy,” she advices.

Dr Aman recommends exploration of off-track products or services. “To get some oxygen for the next few months, start-ups can adopt a service model aligned with the team’s strength and infrastructure. The company should vigilantly look for parallel funding options since grants take anywhere between 6 to 12 months post application process. It is also recommended to extend the network, in the meantime, by surviving on service model or advi-sory,” he says.

“Once the signs of uncertainty are identified,” Dr Kavitha says, “the first thing to do is to improvise the team by hir-ing highly-skilled professionals in core technologies... Increasing compatibility, and distributing jobs equally across the team is advisable. Raising necessary funds could help sustain the team...”

It is essential for Life Sciences start-ups to be able to de-vise and, if necessary, implement pivoting strategies to deal with a dynamic market environment.

In simple words, if plan A doesn’t work, the entrepreneur must be ready to shift to plan B, C or D, or any other plan that can bring the company back on its track to profit-ability.

“Often this can mean diversifying into new sectors or markets, or shifting from product development to prod-uct distribution or contract services, or leveraging IP portfolio by licensing all or part of the technology to other companies, or initiating strategic tie-ups,” adds Dr Nilay.

Life Sciences entrepreneurs endure a lot of start-up tur-moil. They face the usual challenges of understanding the market’s nuances, developing an air-tight business model and, acquiring sufficient capital.

Entrepreneurs in Medical Technologies and Biotech must navigate additional obstacles, which sometimes include gaining regulatory clearances, succeeding in clinical tri-als, and ensuring a strong pipeline of products.

“But even after the essential steps are complete, perhaps the biggest challenge for Life Sciences start-ups is dem-onstrating commercial viability, especially in a dynamic and challenging market as India,” Nishith ends. BS

CoverStory


BioFeature

Where India stands in research and innovation in

biological sciences?The launch of the Mangalyaan was a proud moment for

Indian Science so is the contribution that the country made in the detection of gravitational waves. Atomic and space

sciences are the two big areas of science where the country excels, BioSpectrum assess research scenario in biological

sciences (perhaps the most neglected) in the country.


At present India ranks 13th in R&D spending, and 81 in Global Innova-tion Index. Research in biological sciences is said to be largely medio-cre though pockets of excellence do exist.

To assess the research scenario, one needs to go beyond ‘macro’ numbers that hide the heterogeneity under-neath, says Dr Premnath Venugopa-lan, Head, NCL Innovations; Head, IP Group; Scientist, NCL; Director, Venture Center.

He added, “As far as R&D is con-cerned, India has certain centers of excellence and outstanding research-ers with considerable potential for global standing. But a majority of re-search is mediocre and research in-vestment is sub-critical. Most of the R&D spending is still publicly funded and R&D spending in industry is still too little and too shortsighted. Given the financial constraints of a developing economy, India will need to bet on a few centers of excellence and strengthen them further rather than distributing ‘poverty’. R&D is an activity that bears fruits only af-ter many years of nurturing -- some-thing that cannot be accelerated by merely pumping more funds.”

Regarding innovation, India has been sliding in the Global Innovation Index. This largely reflects a lack of understanding of how an innovation

culture, ecosystem and economy is created, nurtured and allowed to de-liver results. Innovation is a numbers game and investment has to spread out wide.

“India is still trying to pick winners upfront when it is well-known that that is a wrong strategy for pursuing innovation. There is a severe dearth of professionals who understand in-novation and innovation manage-ment especially science-led and tech-nology innovation. In my view, India needs to step up early stage innova-tion funding and spread it wide with a portfolio investment approach. This is very different than research funding. In certain domains, India holds the potential to leap frog and take the lead in innovation,” added Dr Venugopalan.

“The total spending is not a good way to judge. I think the amount of spending we do as a percentage of GDP is a better measure. Here in India non-defense expenditure on research as a percentage of GDP is worse. So, we need serious thought on (i) increasing funding for scientif-ic research and (ii) spending it more

intelligently,” said Dr Ramaswamy S, Professor at Institute for Stem Cell Biology and Regenerative Medicine (inStem).

By and large Central Universities and National Research labs are do-ing well. However, the same cannot be said for state universities. Earlier in an interview with us, 2016 Padma Bhushan Awardee, Dr Alla Venkata Rama Rao had said, “Today, unfor-tunately, research in state universi-ties have totally vanished. They are focused now only on teaching. In all the state universities the quality of education and research has gone down mainly because of inbreed-ing. A person joined as a lecturer becomes a reader after 10 years, no posts get advertised. Earlier, most of the universities used to attract the best available talent as professor. To-day, most of the state universities, do not hire people from outside. Num-ber of research papers published are increasing but unfortunately quality of research is decreasing.”

Though number of patent applica-tions are on the rise, (as per Nature India, India is one of the world’s

Dr Premnath Venugopalan, Head, NCL Innovations; Head, IP Group; Scientist, NCL; Director, Venture Center.

BioFeature


leading ¬fillers of patents but it reg-isters far fewer applications per cap-ita than any other top fi¬ling nation. Multinationals in India have boosted the country’s rate of fi¬ling) the pat-ents granted are much less.

Dr Venugopalan explains, “Patent grant numbers appear small in India compared to patents filed because of the 7-8 years lag between filing and grant. Number of grants will always be less than the numbers filed, and that is not such a bad thing. Patent filing sometimes needs to be done to keep your doors open long enough to assess and evaluate the technol-ogy opportunity better. If the oppor-tunity does not look too promising after a couple of years, one should promptly abandon the patent appli-cation without worry about getting it granted.”

He continued, “In terms of patent filing, India is a ‘baby in the woods’. We are far behind the numbers we should be filing. My worry about the poor patent filing numbers is not one about global standing but the fact that weak patent filing numbers in-dicate that we are not really working in cutting edge technology domains and/or are not serious about having technology leadership in certain do-mains. The bottomline is that if In-dia wishes to be a global technology powerhouse and leader, it needs to invest in patent filings in cutting edge ideas in emerging areas.”

According to Dr Pawan K Dhar, Professor, School of Biotechnology, JNU, “People are significantly more sensitized towards IPR for the last several years. However, in certain cases, its a mad rush to file a large number of patent applications for generating temporary statistics. If careful attention is paid to non-obvi-ousness and novelty, I do not see why patents will not be granted. It may be

worth mentioning that globally less than 5% patents are commercially successful.”

Funding fallacyIndia spends 0.2 percent of GDP in R&D expenditure and much of the funding is said to be gathered by atomic and space science than bio-logical science.

“Yes! But, what we need is more money for space, more for atomic en-ergy and much more for life sciences. Not take away money from the other two agencies,” agreed Dr Ramaswa-my.

If the quality of research in biologi-cal sciences is sub-standard, one of the reason is not enough amount of funding.

“There is a threshold amount of funding required to do good re-search. Only then will we get bang for the buck. The total budget of DBT – about 1,600 crore is less than the research funding of the 30th largest medical school in the USA,” said Dr Ramaswamy.

“Yes, for certain projects. For ex-ample for research in computational sciences and mathematics, one does not require big budget. For high-end science in physics, chemistry and bi-ology one does need high end tech-nologies. In some areas, one does not

need much money --- for example, theory, computation and modeling. But many other areas need consider-able funding,” said Dr Dhar.

If our scientists are to take risk pur-suing path breaking ideas, funding needs to be adequate.

“Otherwise, people will choose top-ics according to what is do-able rather than posing the questions that matter the most. For example, the recent direct detection of gravi-tational waves needed the expen-sive Advanced LIGO set-up which the Americans set-up and hence got most of the credit. The Indians con-tributed with what was within their reach --- theory and analysis,” said Dr Venugopalan.

Indian science on world mapThough we have research institutes which are doing some great work, we do not see universities/institutes in any of the world university rankings. One reason is most of the research output in India comes from non-ac-ademic R&D institutions like CSIR, TIFR etc which is not factored into the rankings.

Dr Dhar explains, “Lack of grand challenge projects, lack of large net-work projects and lack of continuity. Added to this is low science budget and enormous delay for funds to get released. Unlike IT sector, there is low interest of corporate sector in bio-technology. If there was a large scale adoption of networking projects, big and sustained science funding, the situation would have been different.”

“Our policies for funding research are archaic – DST grants are 60L for three years else they need to be ap-proved by a higher committee. Any good life science research requires that much a year. Assuming you get

Dr Pawan K DharProfessor, School of Biotechnology, JNU,

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this grant, it still comes with so many strings attached that it is almost im-possible to spend it. We need a thor-ough overhaul of the administration of our research funding agencies,” said Dr Ramaswamy.

World university rankings are de-cided based on certain metrics that emphasize investments, facilities and resources, different research outputs, reputation amongst vari-ous stakeholders etc. Even the best of Indian universities are relatively under-resourced and have not really delivered outstanding research out-put in a global sense. The best Indian universities are reputed for specific contributions but do not have across the board excellence to show.

“I believe that Indian institutions should not worry about global rank-ings but instead should aim to be the global best in niche areas,” said Dr Premnath.

In addition, a lot of NRIs has bagged getting prestigious awards like No-bel Prize. However, we are yet to see Indians working here grabbing the prize.

“Noble Prizes are given for the most path breaking research findings. To make path breaking discoveries, you need to have courage to pick the most challenging problems and not neces-sarily follow trends (where the key discoveries have already been made). Researchers in India have been shy-ing away from working on the most challenging problems --- some it is because of lack of funding support, some due to a culture that does not allow for failures, some due to a re-search peer group that does not know to distinguish between peaks of ex-cellence vs voluminous mediocrity. Some part of the problem lies in the fact that great research environments often have great research ecosystems with excellence in multiple comple-menting competencies and resources etc. India has been weak here,” said Dr Venugopalan.

Lack of scientific ecosystem is another reason. “The NRIs are working in environ-ments where there is a thriving sci-entific culture and a threshold num-ber of people who do great science. However, in India we simply do not

have that threshold mass. We need to get many more scientists in India and fund them much more, before we ask why we don't get Nobel prizes. Science needs an environment,” said Dr Ramaswamy.

Generally speaking, the environment for doing high-end science is bet-ter than most of the places in India. However, situation has significantly changed in our country.

“A lot of brilliant young minds are passionately implementing their in-novative ideas now. I see that in the next ten years, Indians working in India, will bag several big prizes,” said Dr Dhar.

Brain gainIn the recent past, there is also growing number of scientists who are returning to India. Government schemes such as Ramalingaswami Fellowship are also helpful in bring-ing back overseas talent.

"There are a growing number of peo-ple coming. Yes, fellowships are help-ing. They are also coming because the situation in the West is becoming

BioFeature


harder. I think this is a good time for India to capitalize. However, we also need to be able to attract mid-career scientists. Many of these people are probably OCI’s. We need to learn to treat in science jobs that all people are equal. We cannot want to attract good people and treat them badly,” said Dr Ramaswamy.

Sometimes, the reason for returning can also be personal.

"From what I understand, the fore-most reason is their family compul-sions. Personally, it took me enor-mous energy and motivation to overcome systemic inertia and un-derstand complex feedback loops. After an initial struggle, I am happy to have landed in a good environ-ment to fast forward our ideas,” said Dr Dhar.

Dr Venugopalan points out other dif-ferent reasons, “Some scientists are coming back because they want to contribute in their homeland. Some feel that they make much more use-ful contributions in India. Some feel that the developed world is saturated with too many highly qualified sci-entists, so much so that many sci-entists remain post docs for several years with no research position in sight. Some return due to the heat of a poor economy and visa regulations. Some are also lured by the possibility of raising grant funding a lot easier than in US or EU.”

Ramalingaswami Fellowship is a good way to attract talent back to In-

dia. Nevertheless, there is a room for launching more schemes for generat-ing higher and sustained impact.

Philanthropy in scienceResearch in India is largely funded by government, more than 80% re-search spending in India takes place in publicly funded research institu-tion. Even the research spending by Indian industry is weak, unlike in the West where private research fund-ing bodies as well as HNWIs (high net worth individuals) also donate to the research community. HNWIs and corporates in India have focused more on providing named prizes rather than research funding for re-searchers.

“This needs to change. Indians are good at charity – I hope they get good at philanthropy,” said Dr Ramaswa-my.

Echoing similar views, Dr Dhar said, “Definitely, just like US, in India too personal wealth needs to be donated for supporting good research. This will, not only, help develop a good research base but also generate a healthy competition in our country.”

Dr Venugopalan, however, believes, this type of system won’t work in In-dia.

“In my opinion, private funding of research is more likely when a) so-

ciety has the historical track record and maturity to notice the impact of investments of science, b) society has resolved some of the more pressing/urgent problems needing funding such as hospitals, food and nutrition, etc, and so society has resources to spare, c) other competing opportuni-ties for investment are less attractive. India is not yet ready for large scale private investment in research be-cause a), b) and c) are not favorable.”

India as a scientific super powerIndia is a 'rising economic super-power.’ How far are we from making India a scientific superpower?

“When we at least invest 2% of our GDP in non-defense related science, we can become a scientific superpow-er,” said Dr Ramaswamy.

India needs to focus on a few pockets of excellence to be a scientific super power rather than spread itself too thin. In my opinion, we have the ba-sic abilities to excel but need the right environment to allow excellence to thrive --- and that can be done only in small pockets in India given the limited resources available.

“We should realize that mere vol-umes and numbers does not make you a scientific super power. Noble prizes are not awarded for a lifetime of voluminous work. It is awarded for one piece of outstanding work. Cre-ating a very high number of poorly trained scientific professionals will not lead to being a scientific super-power,” said Dr Venugopalan.

In the space sciences, we are already considered a superpower. In other areas, our country requires big ideas and funding to accelerate the mo-mentum.

Dr Ramaswamy SProfessor at Institute for Stem Cell Biology

and Regenerative Medicine (inStem).

BS

Ayesha Siddiqui

BioFeature


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‘India recognized as global manufacturing destination’

Leader: Datwyler Sealing Solutions develops, designs and manufactures solutions for injectable packaging and drug delivery

systems. This 100-year-old organization has a global manufacturing footprint on three continents, and sales in over 100 countries.

Datwyler Sealing Solutions has been present in India since 2010 and the firm is rapidly

expanding its footprint in India.In an interview Rahul Dev, Vice President,

Datwyler India, tells us about its operations in India. :

What is the focus of your work and what are some of your core priorities?

The Datwyler Group is listed in the Swiss Stock Ex-change and has celebrated its 100-year-anniversary

at the end of 2015. Within the healthcare division, Dat-wyler develops, designs and manufactures high-quality solutions for injectable packaging and drug delivery sys-tems which enables customers to create a safer medical environment.

We are a leading partner to global pharmaceutical com-panies and global number two for closure solutions for injectable medicines, as we produce 15 billion compo-nents for healthcare products each year.

In the Indian market, we are presently focusing on high-end rubber formulations for products like plunger stoppers, Lyo, serum stoppers and customized rubber stoppers. Our latest investment in India through the commencement of the FirstLine facility in Satara (Maha-rashtra) underlines this focus.

Provide us with an overview of the struc-ture of Datwyler operations?

The Datwyler Group is a focused industrial supplier with leading positions in global and regional market

segments. With its technological leadership and custom-ised solutions, the Group delivers added value to cus-tomers in the markets served. Datwyler concentrates on markets that offer opportunities to create more value and sustain profitable growth. The Sealing Solutions division is a leading supplier of custom sealing solutions to global market segments, such as healthcare, automotive, civil engineering and consumer goods industries. We have a global manufacturing footprint on three continents and sell our products in over 100 countries. Globally, the divi-sion has a workforce of more than 5,500 employees.

What was the rationale behind setting up an office in India?India’s pharmaceutical and biotech markets are evolving rapidly and during the past years, they were

able to gain traction from global manufacturers, suppli

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Rahul DevVice President, Datwyler India

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ers and customers. The country is also being recognized as one of the global manufacturing destinations. Our new facility in Satara makes a great business case for us as we look at catering to global markets. Datwyler Sealing Solu-tions is one of the leading producers of closure solutions for injectable and vial medicines. The company’s products are supplied to the world’s leading pharmaceutical and biotechnology companies to support their efforts towards safe and effective drug delivery for a healthier world.

Please tell us about Datwyler Healthcare's op-erations in India. Datwyler Sealing Solutions has been present in In-dia since 2010. With our operations, we are dedi-cated to guaranteeing the highest level of quality

and safety, and continue to make investments aimed at meeting global regulatory requirements. Recently, we have announced construction of our most advanced manufacturing facility: FirstLine. The new facility at the Datwyler India site in Satara, Maharashtra, is part of the company’s commitment to India and the Asian markets. Spread over an area of 24,000 m², the facility will be in-tegrated in the existing premise and will start to operate in 2017. The plant has been delivering commercial sup-plies to customers worldwide since 2013. The site also of-fers additional 24,000 m² for future growth.

The most complex rubber components produced at the FirstLine site belong to the Omniflex family of vial and syringe components. They prevent any interaction with the drugs due to their total fluoropolymer coating. These components are exclusively manufactured at the Datwy-ler FirstLine sites.

What products make up the largest faction of the company output?In the healthcare segment, the largest faction of the company´s output is generated by the following three products: Stoppers for blood collection de-

vices, stoppers for vials and plungers for prefill syringes.

The packaging industry is in continuous evolution and to remain competitive you have to constantly create technological in-novation. How do you achieve such com-petitiveness?

Datwyler has invested a significant amount of mon-ey into R&D in the past and will continue to do so

in the future. We also place great importance on direct contact to our customers in order to understand their re-quirements and develop our products in line with their needs. Our dedicated teams provide our customers with expert knowledge in material, surface treatments, and simulation for innovative sealing solutions. Furthermore, Datwyler always aims for new innovations and a future-oriented working approach.

What is your international expansion strategy?Presently Datwyler is expanding in India. The com-pany has also purchased 10 additional acres adja-

cent to the plant for future growth.

How has Datwyler evolved from its found-ing in 1915 to its current role? Major changes have taken place in the industry in general, and particularly in the packaging compo-

nent industry that we are operating in. First, there is an increasing globalization of the industry. Our customers are becoming more global and are expecting us as their supplier to cater to their ever changing needs, large or little. Datwyler has long understood this concept, which is why, for instance, the company diversified into rubber for pharmaceutical application approximately 50 years ago. As a result of these developments, Datwyler has become a global player itself. Considerable and constant invest-ments are made to improve our global manufacturing footprint and keep the company’s leading position in the market.

Ayesha Siddiqui

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‘India recognized as global manufacturing destination’

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‘Biotech has a unique advantage of contributing immensely to all sectors’

What are the startup trends in the recent times?

Startup ecosystem is growing and DBT and BIRAC is nurturing it from past four years. Now with the

Prime Minister announcing ‘Startup India and Stand Up India’ program, we are giving it more importance. Today

over 500-600 startups are supported through BIRAC and the trend is increasing. Sector wise, I would say focus is more on healthcare - within healthcare more on medical devices and diagnostics. The reason for that is obviously less complex regulation and huge market place. Also in-frastructure and Capex requirement to set up initially is

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Dr Renu Swarup is presently Senior Adviser to the Department of Biotechnology (DBT). At DBT, she heads the National Bioresource

Development Board and is involved in developing, funding and monitoring programmes in the area of Energy

Biosciences, Bioresource Development and Utilization and Plant Biotechnology

- Bio prospecting, Tissue Culture and other Biomass associated programmes.

Issues related to policy planning and implementation are also a part of her

assignment. She was actively engaged in formulation of the Biotechnology Vision

in 2001 and National Biotechnology Development Strategy in 2007 as the

Member Secretary of the Expert Committee. She was also a member of the Task Force on Women in Science constituted by the

Scientific Advisory Committee to the Prime Minister. She was awarded the ‘BioSpectrum

Person of the Year Award’ in 2012.Recently BioSpectrum team met her in her office to discuss various funding aspects of BIRAC and Startup trends in India: Excerpts:

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Dr Renu SwarupSenior Adviser to the Department of Biotech-nology and Managing Director of BioTech-nology Industry Research Assistance Council (BIRAC)

BioFeature


not complex. But having said that more and more people are moving towards discovery research startups. Agricul-ture and industrial process is also slowly picking up.

How is BIRAC positioning itself so as to contribute to DBT’s Mission $100 billion by 2025?BIRAC is DBT’s arm for fulfilling all public-private partnerships, government’s ‘Startup India -Standup

India’ mandate and connecting industry and academia. All this translates into BIRAC’s mandate. BIRAC’s vision and strategy is aligned towards this.

BIRAC’s grants are popular among start-ups. Considering the high turnout of ap-plications for these grants, only few get selected. Are there any plans to launch new schemes?

We do not consider different schemes for different groups. Our schemes look at product development

cycle as a whole. We take it from idea to product develop-ment. That’s how all our schemes work. For example ‘Ig-nition Grant’ goes to individual or a startup idea, through proof of concept (POC) we do late stage validation, social relevance program through our ‘Sparsh’ scheme. We have looked at all components. We also look at current incuba-tion schemes. Here we are doing university incubation.

We are working with National Innovation Foundation (Srishti) for school and college students to give them in-novation grants. Right now our schemes get to meet the needs of entrepreneurs. Currently new scheme of modal-ity is not on the anvil.

How do we look at funding in terms of Angel funding, seed funding. In our action plan we have announced Bio-Tech equity fund. That’s the next step. We are waiting for internal approval and systems in place to get the money. Very shortly we will have Biotech equity fund where BI-RAC will be co-investing. The BIRAC equity seed fund, which we will run through our incubation centre, will be able to invest in companies and will have equity stake and BIRAC will also hold nominal equity stake. When entire equity fund comes this would be ‘funds of funds’.

Many startups we have spoken to claim that funding is available but the amount of time it takes to get it is a long and painful process. How are you going to address this?Let me make it clear that the current mechanism is for about 4-5 months, maximum 6 months. If we

compare with international standards it is on par or bet-

ter. Having said that entrepreneurs are in a rush. We are studying the internal processes to see how we can better this. Some of the larger projects need stringent due dili-gence and also we go by the tiered mechanism. If we get 200 applications we can fund only 10 percent. We can’t pick those 10 randomly. All of them are good. We need to make sure that we are funding the best. There are two reasons for restricting funding to small numbers:

1. Our own kitty is not too large for funding.

2. We want to fund only meritorious startups.

More than anything else, we are not providing research grant for academic purpose, which will help us bring pub-lications and patents, which is important. Already DBT is funding a lot of them. This is where an entrepreneur or startup company bases their entrepreneur venture on us. If we don’t correct them if their idea or business plan is wrong at this point of time then it is not correct on our part.

There is no point in leading them on a wrong path. The effort we make requires some amount of time. We are taking minimum time for due diligence. We started with 7-8 months. We brought it down to 5-6 months. We are open to it. This is a dynamic process. We keep looking at it and ponder on how to improve our process. Being cent percent online improves transparency in the system and improves speed also. We can work towards making it bet-ter. It is fairly good right now.

As you said if 200 people apply 10% is what you could support. But there could be 40 such actually deserving support. For the rest do you give certification that the pro-posal is validated by BIRAC and is deserv-ing?

As of now we haven’t rejected a project because it did not fall in the funding aspect. In some of the

Ignition fund, we have given guidance on how they can become better. It is ranking amongst them. There is no certification but we do provide guidance on how they can improve and come back for funding.

We are now trying to work out how our funding works as a catalyst and rope in more fund givers into the kitty and make it larger. We are already working on that. We are hoping to start an innovation market place where innovators, who have completed a POC and are ready to showcase, meet investors whom we hope to bring for-ward.

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It is some sort of certification where we state that these are innovators whose technical due diligence has been done and feel they have a wonderful business plan. Good investors can approach them and invest. We will fund cer-tain percentage while the rest is taken care of by the par-ties concerned. All BIRAC supported innovation will be filtered and pooled and taken to this innovation market place. We are working on it and hope to place it in public domain. We should be doing it in a couple of months. By next month we should have the guidelines in place.

The fund granting committee mainly con-sists of academicians and researchers who do not have prior enterprise background. Many start-ups want to see inclusion of ex-perienced entrepreneurs and industry vet-erans as part of the funds committee. What do you have to say about this? Will this sug-gestion be considered?First of all let me tell you that as a government or-ganization to come forward to run a major industry

funding program is a big thing. There are serious issues of conflict of interest like data protection, IP protection etc. We bring in experts who are not only academic ex-perts but experts and mentors who have industry experi-ence and are with various organizations like accelerators, incubators and startups. People who come onto the se-lection committee have to be beyond academician or in-novator. They bring in large holistic experience as many of them are sitting on boards, companies, startups. If you say today you have active startup who is working I have to bring somebody from that area with that domain knowl-edge or product. How can I bring it for evolution. That’s a peer-to-peer valuation. It is not done any way. So we have

panels with well chosen experts with lot of national and global recognition. They have experience in how startups work, entrepreneurs work, business plans are monitored. Many of them we source from accelerators, incubators who run them. They are the ones who sit on investment bodies. We bring in investors on our panel. We can do that much.

Does the growth of biotech industry in re-cent years match your forecast?

We would like to see it growing at a faster pace. We had originally, in our strategy meet, put certain fig-

ures. We are very confident it has picked up and moving in the right direction. We should be able to achieve the set timelines. There was flat pace couple of years back. From past 2 years it is moving on the correct path.

Is BIRAC working with Asian countries?We have international collaborations but nothing specific to APAC. Mostly with European region.

There is no specific reason why we have not gone to Asian countries. We would be happy to work with Japan, Korea and Singapore to name a few. We would like to see how things works. People from these regions come for discus-sions, some incubators, investors show interest but no formal collaborations take place.

What is the significance of global and In-dian partnerships for you?Huge significance. One of BIRAC’s key strategy is to work on partnerships which we have mentioned

in our vision and mission statements on the website. We look at it from two angels. 1. The strength that exists in various bodies which are well suited to take forward. We

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Kris Gopalakrishnan at BIRAC's 4th Foundation Day with K VijayRaghavan

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can work with them and leverage that strength. BIRAC is a nimble organization hence where strength exists we look to partner.

2. BIRAC is a catalyst. Being a catalyst one has to put in the right combination. That’s what we intend to do. Not only in investments and funding but many of our part-nerships are developed for creating network platforms, creating opportunities for startups and mentorships. Any activity that BIRAC does is in partnership except those which are specific funding schemes.

How do you think biotechnology can help in the overall development of science proj-ects?Our biotech strategy clearly outlines the scope. Biotech has a unique advantage of contributing

immensely to all sectors. Be it agriculture, healthcare, pharma, industry - any sector you think of biotech con-tributes greatly. Look at healthcare - vaccines, enzymes, biosimilars. I don’t need to specify anything on vaccine. You know that better. India is a leading vaccine devel-oper. In agri products - so many agri companies use biotechnology. You can find them in bio fertilizers, bio pesticides.

Industry feels the CRO policy regime is not very encouraging and supportive.I think ministry of health is already looking into it. Things are looking better. Strengthening the DGCI

system, technical upgradation etc. So on the whole things

are moving in the right direction. I am sure things will improve.

What is your dream for BIRAC?BIRAC should be able to address the country’s needs in achieving much more than targeted. 2,000 is the

number we projected. That’s only for the next 5 years. But we are growing much beyond that because the potential is huge. BIRAC can be in the driver’s seat to ensure In-dia becomes the leading biotech startup eco system. One hears about IT sector being third in the IT startup ecosys-tem. We should be able to do this for the biotech sector too. We should definitely be in the first four or five. BI-RAC is just not a funder, we are doing much beyond that.

Not only as an ecosystem accelerator but also as one in-terested to see how we could get this to go beyond one’s expectations as there is potential. We are only thinking that far, but now we can think beyond that because the potential is huge.

There is untapped potential. We are now looking at set-ting up regional entrepreneurship center. We already have regional innovation center at IKP where we send many of our startups. We also send startups to Cam-bridge University for training. We are now tying up with techies and innovators in the field. We are doing this to help them understand. We are trying to bring faculties to India to train.

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BioPeopleNeeraj Jain to lead PATH in IndiaPATH has named Neeraj Jain as its country program leader for India. Jain is based in PATH’s New Delhi office and assumed his role on June 13, 2016.

PATH has worked in India since 1978, improving health and sav-ing lives through creativity and collaboration with local part-ners. Jain brings to PATH a broad

range of leadership and organiza-tional development experience in the public and private sectors. As leader of PATH’s India country pro-gram, Jain will oversee partnerships with government officials, com-mercial firms, and communities to develop and scale up new vaccines,

improve the health of mothers and newborns through better nutrition and safer births, and establish a unique public-private partnership to control tuberculosis in the crowd-ed slums of Mumbai.

Jain’s career includes more than 27 years of extensive experience in strengthening organizations. Prior to joining PATH, Jain led WaterAid India through a dynamic phase of transition as its Chief Executive. He has also worked with the Children’s Investment Fund Foundation and served as the head of the Asia region for Vestergaard Frandsen.

TNAU scientist Dr N Senthil receives 2016 Best Researcher AwardAt the 46th Foundation Day celebrations of Tamil Nadu Agricultural University, Dr N Senthil, Project Director, Centre of Innovation, AC&RI, Madurai, and Tamil Nadu Agricultural University, received the Best Researcher Award for the year 2016. Dr Senthil was bestowed with this award for his outstanding contribution to agricultural research, particu-larly on millets.

Dr Senthil was involved in the development of several small millet variet-ies and wheat varieties suitable for cultivation in Tamil Nadu. He has the expertise and is actively involved in the development of maize varieties though marker assisted breeding for specialty traits like beta carotene.

Dr Senthil has been involved in millet breeding program. Dr Senthil and his Japanese co-researcher Professor Takao Komatsuda have together identified the genes responsible for barley’s domestication that trans-formed this once wild foodgrain into an item for mass consumption. Their research work was published in the journal Cell on July 30, 2015

Roche India appoints new MDRoche Diagnostics India, a company in the in-vitro diagnostics (IVD) industry, announced the appointment of Dr Shravan Subramanyam as the managing director, for its operations in India and the neighboring markets, comprising Bangladesh, Nepal, Sri Lanka and Bhutan.

Guido Sander, who was earlier the MD of Roche Diagnostics India, has shifted base to Singapore, to head high growth markets for Roche Diagnostics’ APAC business. His portfolio, which includes India, now also covers Vietnam, Myan-mar, Pakistan and Indonesia. A phy-sician from Madras Medical College, Dr Shravan completed his Masters’ degree in health administration at Cor-nell University, where he served on the alumni board.

Awards

Taro Pharmaceutical Industries announced that its CEO, Kal Sundaram, has informed Taro’s Board of Directors (Board) of his in-tention to step down as CEO by the end of the current calendar year. Sundaram will return to India, to assume an executive po-sition at Sun Pharma’s global headquarters after the completion of his assignment at Taro at the end of 2016.

The company’s board will con-duct a formal process to appoint a CEO to solely focus on Taro. Sundaram will assist the Board with its search, and will remain with Taro through the end of 2016 to ensure a smooth and successful transition for his suc-cessor.

Sartorius Stedim Biotech (SSB) announced that its subsidiary Bio-Outsource has appointed Ravin Mehta as Technical Sales Special-ist to enable customers to have ac-cess to Cellca and BioOutsource’s early stage development services for biosimilar drug candidates.

Prior to joining BioOutsource, Ravin spent over 10 years in bi-osimilar product development, where he gained experience in cGMP manufacturing as an up-stream bioprocess scientist with two of India’s major biopharma-ceutical companies.

Taro CEO Kal Sundaram to Return to Sun Pharma

Sartorius Stedim BioOutsource appoints Technical Sales Specialist in India

facebook.com/BioSpectrumMagazine bit.ly/BS-LinkedInhttps://twitter.com/BioSpectrumMag

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Boston Scientific India officially opened a 1,00,000 sq. ft. research and development, training and com-mercial center that will enable it to develop and sell minimally invasive technologies fit for India and the greater Asian market, and train phy-sicians in using them effectively.

The new facility marks a strategic investment by Boston Scientific. The Research and Development (R&D) center will focus on creating market-appropriate products based on un-met clinical needs in emerging mar-

kets, and will also serve as a global product engineering center. The state-of-the-art Institute for Advanc-ing Science (IAS), a physician train-ing facility equipped with world-class simulators for hands-on training on innovative technologies, is the new-est addition to the growing global network of Boston Scientific IAS fa-cilities.

By establishing a consolidated pres-ence in the region, Boston Scientific will extend its reach in India, offering solutions to physicians and patients combatting conditions in areas such as cardiovascular disease, cardiac ar-rhythmias, gastrointestinal and uro-logic disorders, and chronic pain.

BioSuppliersBoston Scientific announces launch of integrated facility in India

Agilent Technologies enhanced its line of scientific instruments with two new models of the company’s 7000 Series Triple Quadrupole Gas Chromatography/Mass Spectrom-etry systems.

“Increasingly, laboratories that test the safety of our food and water are turning to triple quadrupole GC/MS systems because their selectiv-ity makes them better able to handle complex matrices than standard single quadrupole systems,” said Monty Benefiel, vice president and general manager of Agilent’s Mass Spectrometry Division. “Both of our new instruments - the 7000D and

7010B - include enhancements that not only improve analytical perfor-mance but make them easier to use

than any previous triple quad GC/MS system.”

Benefiel noted that Agilent’s exten-sive single quad GC/MS installed customer base, who want to run sam-ples on their triple quad, can open existing single quad GC/MS methods with a single mouse click using Agi-lent MassHunter software. “Nobody else makes it that easy to distribute your total workload among all of your available Agilent GC/MS sys-tems, adding greater capacity to their laboratory,” he said. “This capability also streamlines the transition from SIM on the single quad to MS/MS on the triple quad.”

Agilent launches New Triple Quadrupole GC/MS Instruments

Sartorius Stedim Biotech (SSB) an-nounced the launch of a new Re-leased N-Glycan Assay for the in-depth profiling of IgG glycosylation. This new physico-chemical assay, developed by SSB’s subsidiary Bio-Outsource and offered in combina-tion with its unique Antibody De-pendent Cell Cytotoxicity (ADCC) assay platform, combines data on the molecular structure with a key thera-peutic mechanism of action. This will generate comprehensive, highly ac-

curate biosimilar comparability data, driving shorter drug development timelines.

The new N-Glycan Assay is one of a range of orthogonal methods, in-cluding analysis by CD16a (FcγRIIIa) and SPR binding, as well as ADCC functional assays that BioOutsource offers to provide a detailed testing package to generate evidence suit-able for regulatory submissions.

BioOutsource’s new assay involves enzymatically-removing glycans from the antibody, functionally de-rivatizing them and separating the glycans by UHPLC. The glycans are then identified by on-line electro-spray ionization mass spectrometry (ESI-MS), enabling confident assign-ment and precise quantification of the different structures.

Sartorius Stedim BioOutsource introduces new N-Glycan Assay

PerkinElmer held an opening cer-emony for its new Taipei Customer Knowledge Center (CKC) located in Neihu District, Taipei City. President of PerkinElmer’s Environmental Health business, Jon DiVincenzo, as well as Vice President and General Manager of Global Sales and Service, Nam-Hoon Kim, hosted more than 70 guests from the environmental, chemicals and semiconductor testing industries and academia, along with PerkinElmer representatives from the Asia-Pacific region.

This new Taipei CKC is a relocation and expansion of PerkinElmer’s presence in Taiwan, where it has been present for more than 25 years.

PerkinElmer opens new knowledge center

Your landmark to reach Nutritionals and Nutraceuticals Industry

www.nuffoodsspectrum.in

India’s No.1 monthly B2B magazinecovering the entire spectrum

of Nutritionals and Nutraceuticals Industry

BioSuppliers


Sartorius, a leading internation-al pharmaceutical and laboratory equipment provider, announced the acquisition of US based IntelliCyt Corporation, an award-winning in-novator and manufacturer of novel cell screening platforms used in drug discovery.

Through the acquisition, Sartorius expands its current lab portfolio into bio analytics, thus substantially strengthening its offering for bio-pharma customers and academia.

Sartorius purchased IntelliCyt for $90 million in cash, which includes approx. $5 million in future tax sav-ings. The company focuses on phar-ma, biotech and academic custom-ers, and achieved strong double-digit annual growth during the past few years. Based in Albuquerque, New Mexico, USA, IntelliCyt currently employs 55 people and is expected to generate sales revenue of more than $18 million in 2016 and to break even on underlying EBITDA by year-end 2017.

Sartorius acquires cell screening specialist IntelliCyt

Clinical oncology researchers who need to draw more meaningful ge-netic data, now have access to the new Oncomine Lung Cell-Free DNA (cfDNA) Assay designed to target mutations in non-small cell lung can-cer (NSCLC) samples derived from circulating cfDNA in blood. When combined with Thermo Fisher Sci-entific’s Ion S5 System, the research assay meets a critical need for a multi-targeted, next-generation se-quencing (NGS)-based solution that enables highly sensitive detection across a broad set of gene variants.

The new assay contains gene targets, such as EGFR and KRAS, confirmed as relevant by industry-leading clini-cal research partners at the OncoN-etwork Consortia. Enabling analysis with as little as 1 ng of DNA obtained from a single tube of blood, this as-say helps clinical researchers obtain results from the initial sample or

samples collected over time from the same subject. Verification data us-ing the Oncomine Lung cfDNA As-say shows 90 percent sensitivity and >98 percent specificity at 0.1 percent limit of detection.

The Oncomine cfDNA Assay is part of a comprehensive solution that en-ables sample to answer variant data analyses in a single workflow. By using tag sequencing, a technology in which DNA fragments are each tagged with a unique molecular tag, Ion Torrent informatics software simply and easily detects and deter-mines mutations to help limit the number of false positive data points for single nucleotide variants (SNVs) and insertions-deletions (indels) de-tected at such low allele frequencies.

Oncomine Lung cfDNA Assay is for research use only; not for use in diag-nostic procedures.

Thermo Fisher Scientific announces Next-Gen sequencing assay

Consure Medical is a privately-held medical device company focused on expanding the continuum of care by developing novel and elegant medi-cal devices for the management of critical care and long-term care pa-tients. The company announced that it has received 510(k) clearance from the US Food and Drug Administra-tion (FDA) to market three devices under its novel Qora Stool Manage-ment Kit (SMK) platform, to help manage faecal incontinence (FI) in non-ambulatory patients.

FI is the inability to control bowel movements, leading to the involun-tary and untimely release of faeces or flatus. It is an especially embar-rassing and distressing condition for nearly 10 million US hospitalized pa-tients and their caretakers. With cur-rent management options, patients are more likely to acquire bedsores, dermatitis, nosocomial infections and extend their length of stay in the hospital.

Such facility acquired complications impact the CMS reimbursement re-ceived by these healthcare facilities, costing nearly 2 billion dollars annu-ally.

Consure wins USFDA clearance for Qora

BioSuppliers


BioSpecial

What would Brexit mean for biotech?

Britain’s exit from the European Union (EU) has

shaken the world economy. There is uncertainty in

the business world across sectors, and biotech is

no different. Britain is a very important market

for biotech and pharma, and one of the immediate

challenges is the fate of the European Medicines

Agency (EMA) among others.

As per Norton Rose Fulbright, a global law

firm, “After Brexit (2018+) the impact upon life sciences and healthcare sector largely depends on what model the UK adopts for its relationship with the EU. If UK remains in the European Economic Area (EEA), then the changes may be minimal. If UK joins the European Free Trade Association (EFTA)

and negotiates sector specific access to the single market, then the landscape depends on the exact nature of that relationship. If UK distances itself further from the EU, then the

changes may be more extensive.Whatever the relationship ultimately is, UK has a strong track record in the life sciences and

healthcare sector with tax incentives, investment and funding, R&D and other key drivers high on its agenda. We would expect that to continue. The UK accounts for approximately 25% of the EU market and will remain a key market. Switzerland (which is not in the EU) is a

prime example of how the sector can develop effectively outside of the EU.”We contacted industry captains to understand their views on BREXIT and whether it will have any impact on Indian life science, pharma and biotech sector. Here’s what they say:


“We respect the democratic decision reached in this referendum. We ex-pect that there will now be a protracted period of transition and we will engage with all the relevant stakeholders to safeguard the competitive-ness of the life science industry and the speed of patient access to in-novative medicines. We also expect that there will be a period of intense negotiations to determine how the UK will work with Europe and the rest of the world and this could take several years to complete. We therefore believe that the effects of Brexit will not be immediate and it is too early to discuss its impact on the industry.”

Sanjay Murdeshwar, Managing Director, AstraZeneca India

“Brexit is likely to have an impact on the pharmaceutical industry which includes life sciences and the biotech sectors. Membership of the EU has meant that Britain had tariff free access to the EU the second largest economy in the world. The ma-jority of Britain’s exports are to the EU. There is expected to be a sizeable impact on scientific research in the UK including clinical research. While Britain contributes money to the EU to fund science and technology research it also gets back a signifi-cant amount by way of grants for R&D. In fact of the 28 countries that form part of the EU it receives the highest grants towards research after Germany.

The decline in the value of the amount is likely to have immediate impact on Indian companies that have an exposure to the UK market. Many existing contracts of pharmaceutical companies with manufacturing and R&D will be losing proposi-

tions unless these are renegotiated. However, there is an opportunity to strengthen India-UK economic ties given the long history of these two nations.

One of the immediate challenges as a result of Brexit is the fate of the European Medicines Agency (EMA) itself which is currently located in London and oversees drug regulation and approval for all EU nations. If it comes to a stage where EMA has no jurisdiction over Britain then pharmaceutical companies in UK would need to get approval in both the UK and the EU translating into more time and energy to get drug approvals and bring new medicines to patients in these countries. Brexit puts under jeopardy the ability of pharmaceutical companies in Britain to access the large pool of patients in the EU market not only for its drugs but also for clinical trials. The EU is estimated to have around 500 million patients.”

- Ranjit Shahani, President Emeritus, OPPI

“It would not mean anything for bioscience industry, unless other members of EU also start exiting EU.

As for Indian pharma/life sciences/biotech sector, nothing foreseen, except a minor blip for some companies that have UK as a major market. We have to wait and watch. It’s too early to comment.”

Dr K R Rajyashri, Director & CSO, Navya Biologicals

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BioTalk

The sound of hearingIn 2009, IITians Paresh Patel and

Anurag Sharma together co-founded Quadio Devices in Pune. Though

Patel’s hearing ability was challenged, he desired to lead an unhindered life

and wanted to help other hearing-impaired people to improve their lives. The result was the birth of

Quadio. Hearing loss in India is largely unaddressed and the existing

hearing health facilities are scarce and unaffordable for many.

Quadio aims to bridge this gap by empowering people by providing accessible and affordable hearing

care solutions, from hearing aids to portable diagnostics. Recently, the

company launched its indigenously developed India’s first hearing app,

Q+, a smartphone app which converts a contemporary smartphone into hearing aids by harnessing the phone’s processing power, microphone and wired headsets for delivering

sound to the user.BioSpectrum caught up with Quadio’s CEO Neeraj Dotel, who shares the company’s vision

and strategy in making hearing solutions affordable to the common man and Quadio’s innovations in the pipeline.

Tell us about Quadio’s recent innovations.

Initially, we started making hearing aids but then we soon realized that the real challenge was accessibili-

ty. The company then started developing Net Dispensing, a solution built around internet and mobile technologies with a goal to improve the accessibility, affordability and

adoption of hearing solutions. We recently launched In-dia’s first hearing app, Q+, which comes with an in-built hearing test and automatic sound enhancement based on the user’s hearing loss.

Quadio’s hearing solutions -- hearing aids and apps -- for

Quadio Devices Team (L-R) Mr Anurag Sharma, Co-founder & CTO; Mr Neeraj Dotel, CEO; and Mr Paresh Patel, Co-founder

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individuals are do-it-yourself (DIY), programmable, per-sonalizable and rechargeable, thus making them easy-to-use and low on maintenance.

For hearing health solutions, Quadio dovetails internet and mobile technologies to connect its highly qualified pool of audiologists to the last mile point-of-care, thereby pushing the boundaries of telemedicine and hearing care.

What trends are impacting the global hear-ing solutions space?Globally, there is an increased awareness about the numerous medical, social and psychological conse-

quences of untreated hearing loss. In India, however, the awareness remains extremely low. Earlier this was pre-sumed to be an age-related impairment, but hearing loss is beginning to affect young adults due to lifestyle chang-es, such as excessive use of headphones for long periods on personal devices, and increased noise pollution. Ac-cording to a 2015 report by World Health Organization (WHO), over 1.1 billion young adults are at risk of hearing loss.

In terms of trends, consumers are rapidly moving to-wards pre-programmed and customizable devices that give greater control on hearing experiences.

Increasingly people are buying hearing solutions over the internet in the US and Europe, since there are various af-fordable options available at the click of a button.

What is your business model?Quadio’s business model centers on traditional hearing aids, services, and mobile and internet-

based solutions.

What’s the market size for hearing solu-tions in India?The market for hearing aid products is over Rs 350 crore and growing at 15 to 20 percent per year. How-

ever, the market size has nothing to do with market po-tential.

WHO data states that only 1.4 percent of affected people actually use hearing devices in India as opposed to 20 to 30 percent in developed countries. Quadio aims to mas-sively increase penetration of low-cost assisted hearing in India.

What’s your market share in the country?Our growth has taken off after introducing net dis-pensing (telemedicine) and the Q+ app. Both of

these will dis-rupt the hearing industry as it will be no longer nec-essary to rely on brick-and-mor-tar infrastruc-ture to find and provide service to customers.

In the coming three years we aim to be amongst the top hearing care providers in the country.

What are the top growth drivers for Qua-dio?Our biggest growth driver is the Q+ hearing app which can be downloaded by anyone who needs

hearing care.

People who need advanced diagnostics opt for our net dispensing solutions (telemedicine) that provides easy accessibility to professional hearing care from anywhere in the country through our partners like hospitals, ENT surgeons, NGOs and social organizations. Net dispensing is a proprietary solution that converts any point of care to a virtual hearing clinic.

What are the mammoth challenges in the Indian market?The biggest challenge is awareness and access to affordable hearing care. This is followed by lack of

adoption for assisted hearing due to social stigma. Most people aren’t aware that hearing starts degrading with age, with lifestyle preferences along with work hazards adding to it on a regular basis.

Educating everybody about this is really important as hearing loss leads to depression, dementia, cognitive decline, physical injuries, Alzheimer’s disease and even mortality.

India also doesn’t have enough number of practicing au-diologists. The country has only 2,000 for a population of 1.2 billion. The few practicing audiologists that we have are mostly situated in the tier 1 and 2 cities, leaving the large rural population without much options. Besides this, a good pair of hearing devices cost upwards of Rs 40,000 for each ear, thus putting it out of reach for the common man.

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What’s unique about Q+ app, though we have other apps in the same space?

Q+ app has the following features that differentiate it from the other apps available in the market:

• Inbuilt hearing tests calibrated for precision per ANSI standards

• Intelligently-adjusted sound per hearing test results• High quality sound enhancement by using the same

algorithms as hearing aids• Wide bandwidth - up to 8250 Hz - for improved com-

prehension and clarity of sound• Automatic adjustment of amplification to reduce

feedback (whistling sound)• Versatile controls for customizing listening experi-

ences• Environmental noise reductionMost free apps only amplify sounds while Q+ app is de-signed to reduce feedback and background noise. It also provides a wider sound bandwidth.

How do you address a price-sensitive mar-ket like India?By giving a hearing aid that is free on a smart phone! Our Q+ app can work very well for an individual who

suffers from mild to severe hearing loss. The Lite version of this app is free for download and the Pro version will be available for a one-time fee of Rs 500.

The app is compatible on both iOS 8 and above, and An-droid 5 and above platforms, and hence will drastically lower the price points for hearing mechanisms in India.

Our traditional hearing aids provide significant value for money in terms of features, customizability, and user control and are priced direct-to-customer.

What are the differences between In-dian market and others when it comes to launching a new product?The stark differences are very visible in reach, awareness and affordability when introducing a new

product.

India is still a developing nation, and hence consider-able effort is required for any launch. Customization in regional languages is also a pre-requisite for the Indian market.

What partnerships are you looking out for?We are ready to partner with anyone looking to offer hearing care services with little or no upfront invest-

ment.

We have partnered with hospitals, ENT surgeons, NGOs and eye care specialists to reach a large swathe of the population that needs hearing services.

About your clientele?Our clientele are customers who require hearing care at affordable prices. We also engage with health

care providers who we operate with on revenue share to provide net dispensing and remote fitting of hearing aids.

We are also working with heavy industries with loud fac-tories to provide counselling around noise management as well as services for diagnostics and rehabilitation for employees.

Are you be open to M&As?We are not looking for M&As. However, any com-pany we tie-up with has to be passionate about ac-

cessibility and affordability of hearing care.

To which cities or countries are you plan-ning to expand?India is a huge market and we wish to increase the percentage of hearing solutions from 1 percent to 5

percent in the near future.

The BRIC countries also have low penetration and Qua-dio plans to add value to these markets by providing them with high-quality Quadio hearing care services.

The Q+ hearing app is a game changer in global markets, and we are seeing lot of downloads in the US and Europe. We will be addressing those markets as well at the ap-propriate time.

Where are your products designed and manufactured?Pune.

What’d be your revenue target for the next couple of years?We plan to be a Rs 3 crore company this year, and then continue to grow in multiples of that in the

coming years.

What next for Quadio?We have some very interesting research and cool

products that are not just for hearing impaired individu-als but for anybody looking to have superior hearing ex-periences.

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BioCluster

A gateway to European markets

IDA Ireland (Investment & Development Agency) is Irish Government’s investment and

development agency responsible for attracting Foreign Direct Investment (FDI) to Ireland. The country houses tech giants including Facebook, Sanofi, Intel, Yahoo, Adobe, Microsoft, SAP, HP,

Apple, LinkedIn, Deutsche Bank, Google and Amazon among others. IDA is in business since the 1950s, and has offices in Australia, China, India, Japan, Korea and Singapore. It employs

over 300 people and half of them are from overseas.

Based in Shanghai, John Conlon is the EVP and head of APAC Operations at IDA Ireland. He recently visited India on a business trip, and spoke exclusively to BioSpectrum providing

deep insights and happenings in Ireland’s Life Sciences sector, and why Indian Pharma and

Biotech companies should consider investing more in Ireland than ever before.

For Ireland, 70 percent of its business comes from the US, 20 percent from Europe and the rest from APAC. In the next two to

five years, the country aims to accel-erate its business to the next level.

With a population of 5 million, the country is a host to 2 million work-force. Ireland’s GDP stands at €215 billion and its exports are worth €200 billion. The country’s pharma exports amounts to €64 billion, and medtech alone is about €15 billion, totaling the Life Sciences business to

a value of €79 billion.

Thriving ecosystemDecades ago, Pfizer was the first pharma company to invest in Ire-land. The country now boasts of hav-ing nine out of top 10 global pharma companies including Novartis, John-

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John ConlonEVP & Head of APAC Ops, Investment & Development Agency (IDA) Ireland


son & Johnson, Sanofi and AbbVie, except AstraZeneca.

In the medtech industry, out of the top 15 global companies, 13 of them operate in Ireland. Its Life Sciences sector alone employs 50,000 profes-sionals and mainly focuses on novel drugs and generics.

Ireland produces 30 percent of the world’s contact lenses and 25 percent of the global injectables for diabetes. It also manufactures 75 percent of the world’s orthopedic knees and 90 percent of Botox.

“In 2015, Ireland encountered over 200 major investments. Fifty per-cent of those companies which in-vested have never done business in Ireland before. Pharma and Biotech

alone have seen investments worth 10 billion Euros in the last 10 years. Between 2012 and 2015, we have had 4 billion Euros worth investments in this sector,” said Conlon.

Manufacturing excellence in Bio-pharmaceuticals is a hallmark of Ireland’s success in the sector. The country has now developed 18 manu-facturing sites till 2015.

Clinical trialsMajor Indian corporates in Ireland include Wockhardt, Infosys, Tata, Wipro and Tech Mahindra to name a few.

Ireland is more known for its excel-lence in managing clinical trials than running them.

“The population is very small. If you want to run clinical trials Europe would be the best place. But we are more on the clinical trials manage-ment space,” stated Conlon.

Ireland is the gateway to the Europe-an markets, he said. Indian compa-nies in Ireland face the same market challenges as elsewhere. The Irish Government has become cost-con-scious and it controls the healthcare spends.

Irish fundingsIndian companies are expected in providing best quality of services and products. “India is strong in gener-ics, and its quality should meet the EU standards. If Indian companies want to access the EU markets, then Ireland would be the place to start

BioCluster


with,” Conlon held.

There are many fundings of differ-ent varieties offered by the Irish Government to international com-panies. Science Foundation Ireland (SFI) funds basic research in the Bio-pharmaceutical sector in the areas of cancer, auto-immune disease and Alzheimer’s.

Recently, SFI signed a deal with Pfiz-er for a jointly-funded Biomedical re-search, helping Pfizer’s drug discov-ery efforts in and out of Ireland.

The Irish Government provides capi-tal grants, employment grants, and for existing companies it offers train-ing grants, R&D development grants, and R&D tax credits which is about 25 percent.

“There are many financial mecha-nisms which depend on the budget and the relevancy of the companies. Organizations will not get all of the grants but it will a combination of grants, which makes sense. Grants are provided as an assistance to set-up in Ireland and not a reason to set-

up. Companies are there for talent, track record, ability to run facilities and export products,” emphasized Conlon.

Ease of businessHe also pointed about the excellence in Ireland’s education system and the ease of doing business.

“One can easily setup companies in Ireland. The ease of doing business is excellent. English speaking tal-ent, access to the EU market, being a member of the European Single Cur-rency, exceptional talent base includ-ing engineers, managers, sales and R&D professionals, and excellent University system all add to Ireland’s great business ecosystem,” noted Conlon.

The National Institute for Bioprocess Research and Training (NIBRT), cre-ated from a €60 million investment by the IDA, offers practical training to thousands of people every year.

Start-up ecosystemEnterprise Ireland is the Govern-ment organization responsible for the development and growth of Irish enterprises in global markets.

“It helps grow Irish companies. They fund three start-ups per week. Ire-land is one of the entrepreneurial countries in Europe,” expressed Con-lon.

The country has a concentrated clus-ter of electronics, IT and Biotech companies. “We have Pfizer, Micro-soft, Google, eBay, Yahoo, IBM lo-cated next to each other. It leads to interesting collaborations giving rise to hybrid products,” he highlighted.

Conlon advises companies to first hire the best general manager while setting up in Ireland.

“A good general manager can man-age a bad business. But bad general managers can mess up a good busi-ness. It’s worth spending good mon-ey in hiring the best personnel who come with great experience, network and culture, and can build business better,” he advised.

R&D activitiesThe Irish Government has commit-ted €8 billion to research funding to further bolster Ireland’s reputation as a growing hub for R&D.

“A lot of pharma R&D takes place at companies’ headquarters which house large labs and facilities. Very little happens in Ireland,” he added. “In Ireland, it is more of process de-velopment when it comes to cost and drug delivery. However, a lot hap-pens in the medtech space in Ire-land.”

Companies entering Ireland can reg-ister their patents in Ireland and can use the same registration to patent in Europe.

“In IPs, Ireland is very similar to In-dia. The process is straight-forward and clear. Companies will see patent protection as an advantage,” Conlon said.

Global economy, economic crisis and politics – all of them affect invest-ments in Ireland.

“There are many commonalities be-tween India and Ireland starting from our national flags. Indian com-panies and professionals do well in Ireland. We look forward in engag-ing with Indian companies,” he con-cluded.

THE BIG PICTURE* 9 of the top 10 world’s

pharmaceutical companies operate in Ireland

* 7th largest exporter of medicinal and pharmaceutical products in the world in 2014

* €39 billion in annual exports of pharma, bio and chemistry produce

* 75+ pharmaceutical companies

* 33 FDA approved pharma & biopharma plants

* 12.5% rate of Corporation Tax on trading activities

Raj Gunashekar

BioCluster

BS


Biopreneur

Enabling global clinical trials in India

After graduating in Biomedical Engineering from the University of Sheffield (UK) in 2011, Anant Agarwal (27) returned to India with a broken knee. Little did he know that his broken knee would lead him along the path to his ultimate destiny – the birth of his Kolkata-based

start-up Indoriv Clinical.

After recovering from his physical ailment for a year, Anant Agarwal found an internship as a clinical research coordi-

nator in Kolkata in 2012. He enjoyed his position and space, and explored it furthermore ardently.

Agarwal received positive feedback and good reviews for his initial proj-ects and started receiving projects from other pharma companies and CROs.

He also bagged a major stem cell project from a popular CRO. He tackled it fully as a one-man army. He was also fortunate enough to find credible mentors and valuable guid-ance from doctors and healthcare professionals around him.

It was then he decided to convert all of his learnings into an entrepre-neurial venture, which he also long dreamt of during his student days in the UK.

Indoriv Clinical is now a four-year-old clinical research consultancy lo-cated in West Bengal.

“It’s funny that when I started, I didn’t have a plan at all,” says Anant Agarwal. “I just went with it. Clini-cal research is a complex field to be in, since it has many diversifications. Back then I was just 22, and was still learning about the industry. I had very limited knowledge of clinical research project management and that’s what I was doing. So I decided to stick to clinical project manage-ment at ground level and develop a clinical research consultancy.”

Implementing innovationsWhen a pharma company or a CRO comes out with a new drug, device, or a cosmetic product, they require clinical data to prove its safety and efficacy for commercializing.

All this is monitored under India’s Drugs and Cosmetics Act which makes Indoriv’s role pivotal in the ecosystem of clinical research.

“Indoriv is essentially a clinical data generation start-up. Our work is re-sponsible in determining whether or not a drug is safe to be released in the market. Our main target is to organize clinical research in India to

improve speed and quality of a clini-cal trial and making sure that a pa-tient’s right is protected. We leverage our expertise to manage this on the ground. We tie up with doctors and registered hospitals to manage hu-man clinical trials.

“Every country in the world is becom-ing compliance-based and all medical products are being thoroughly tested before they are released in the mar-ket. Every medical innovation has to go through this process. So in short we are the implementers of medical innovation,” explains Agarwal.

Apart from management services, the start-up has also started its own diagnostic laboratory which is now providing centralized pathology so-lutions and medical archival.

Agarwal says, “We have also started clinical trial medical supply, and have now come up with our very own digitization platform – MPET -- which is aimed at digitizing clinical research in India.”

He expects MPET to be a turning point for his company since it is a


different form of clinical research business in itself which will help several pharmaceutical companies worldwide.

Trial turmoil and challengesThe clinical research industry in India is still going through several regulatory changes. In fact 2013, all clinical trials were stopped in India, where the Ethics Committee of all hospitals were registered before pro-ceeding for clinical trials.

Agarwal points, “Lack of awareness and training among doctors, health-care professionals and hospitals is a challenge. Even though this situation has improved, there is still a huge scope for better training and aware-ness. Another challenge is the exist-ing vague regulatory laws, and the slow rate of clinical trials approval from the drug controller general of India.”

However, he feels that the regulatory bodies have become faster and the laws are now becoming clearer.

“Clinical research is a booming in-dustry to be in and more importantly has a huge potential for entrepre-neurs in this field,” he adds.

So far, locally, the start-up never re-quired funding. “During the initial

ally, and integrate seamlessly with medical databases worldwide. This will improve quality compliance and will also allow global trials to in-crease in India. Currently, only 2 to 3 percent of all global clinical trials happen in India, which has a disease burden of 18 percent. This would re-quire development and marketing in-vestments. Our exit strategy is either IPO or M&A.”

Ambitious revenueFor Indoriv, this is its fourth year in business, and it has achieved its tar-get revenue of Rs 1 crore without any investment in the company.

“We are aiming to quadruple this revenue in the next two years based on contracts and clients we have, and also projects we have signed up. If relevant funding is obtained for MPET, we would potentially be tar-geting a revenue of around Rs 30 to 40 crore in the next 5 years,” Agarwal comments.

Given the nature of collaborative work, the start-up’s collaborators in-clude several leading hospitals from both Government and private sec-tors, diagnostic centres (including radiology), doctors, healthcare pro-fessionals and pharmacies.

He has couple of suggestions to the Government. “We need clarity of guidelines, a smarter and flexible framework for operations. The Gov-ernment can also look at digitization of Adverse Events (AE) and Serious Adverse Events (SAE), and drug monitoring procedures to streamline the whole process. We also need local research centres for faster processing of documents and monitoring,” he recommends.

Healthcare penetrationEducated in the UK, he feels that the regulatory framework and structure

stages, my company did not require very heavy funding. Today I have the projects, and the confidence that my work could be scaled up to huge po-tential which is why we are currently looking to raise funds actively,” he explains.

Indoriv’s infrastructure, including technology hardware and medical equipment, were acquired through retained earnings.

“Fortunately, we had enough work to work through our cash flow for salaries and other costs. However, to expand in India it is important to ac-quire funding for cash flow and mar-keting requirements,” he voices.

Indoriv Clinical’s client list boasts of top 10 pharma and CROs including Biocon, Sun Pharmaceuticals, Syn-gene, Dr Reddy’s, Alkem Pharmaceu-ticals, Cliantha Research, Lambda Therapeutic Research, Manipal Acu-nova, Veeda Clinical Research, Kar-mic Life Sciences and Zydus Cadila.

Exit strategyIndoriv’s growth strategy is based on two parallels, reveals Agarwal.

First, it intends to expand its work and services pan India specifically in tier-2 cities where the majority of the population lives.

“Our work requires a large pool of patient population enabling speeding up of clinical trials process. This re-quires investment in terms of work-ing cash flow and marketing. We al-ready have the work and projects. We are ready to expand,” says Agarwal.

The second parallel is its upcoming software MPET, which aims to digi-tize clinical research at its source.

He voices, “This will help in captur-ing data which is missed out manu-

Anant Agarwal, Founder & Director, Indoriv Clinical

Biopreneur


is very clear and precise in the West.

“Talent is awarded. An investor and entrepreneur need to work together to create a big company. The sup-port given to an entrepreneur there is much better than that in India,” he adds. “In India, investment is usually given to companies who have already proved their models. The risk-taking capacity here is relatively lower. Most businesses would not be given invest-ment in their ideation stage. This trend is changing slowly and should gain more traction in the coming years. However, we also need to be cautious about the start-up bubble.”

He views 3D Bioprinting and Tele-medicine as good areas for start-ups to venture.

“What the healthcare industry in In-dia needs right now is penetration of Medtech in all areas of healthcare, which will not only improve the qual-ity of healthcare but also help health-care penetration to tier-2 cities and rural areas of India,” he notes.

Potential and scalabilityHealthcare and clinical research overall is seen to produce huge mar-gins and amazing scalability poten-tial with good exit options.

“However, healthcare in general takes time to build. Venture capital-ists and shareholders might need to be patient for a while. Once the initial framework is over, it has a potential to grow several times their invest-ment,” Agarwal justifies.

He points that Mumbai and Delhi are becoming new start-up destinations.

“Start-ups emerge with the collabo-ration of ideas and the support, and funds to back them up. Delhi and Mumbai have all these essential ele-ments. This is also supported by the

penetration of technology in these cities, and the purchasing power of the people to use those start-ups’ product and services,” he observes.

He states that crowdfunding could be a great way of raising funds for a start-up.

“This is very popular abroad. I am not sure if this is regulated in India, but it could be a great method of rais-ing funds,” Agarwal suggests, a lover of music and movies.

Compliance! Compliance!The clinical research industry is all about protocol, compliance and dis-cipline, Agarwal shares.

“My first auditor in clinical research told me something that I still follow as a golden rule even today. He said, ‘You are allowed to make mistakes in clinical research; you are not al-lowed to hide them.’ Thus our work cannot be done under false pretense. Therefore, apart from discipline and compliance it is very important to be good at documentation and being transparent in operations wherever healthcare is involved,” he opines.

He thinks that losing patience is one of the biggest mistakes entrepreneurs commit while running their dream.

“The younger generation has amaz-ing ideas today. However, everything takes time to settle down and estab-lish itself. When you start something it is important to stick to your idea and keep reinventing and renovat-ing to make it right. You might just end up having a completely different business than what you started with. Start-ups by its very nature is some-thing new whose market credibility has not been proved. A lot of people want to become overnight sensa-tions,” he reasons.

He has also learnt the hard way in making right hiring decisions. “The right team can take you either to top or put you under the ground,” he highlights.

Start-up basicsAs a start-up entrepreneur, Agarwal adds that communication and trans-parency are two very important ele-ments in work.

“It is important to keep talking to people -- regularly and constantly. Trust-building takes time. A lot of people begin a start-up for the sake of erecting a start-up. What you want to achieve should be clearer even if the methods keep changing with time,” he expresses.

“Don’t settle for less!” he advices young start-up entrepreneurs.

“Since most start-ups lack the con-fidence, they usually end up making the wrong decisions and settle for less -- which I have personally done for a very long time. It is important to assess your worth versus what you are charging for your services…. Keep at it. Believe in your idea and don’t lose patience. You will end up managing your work brilliantly,” he signs-off.

Raj Gunashekar

Prateek Agarwal, Head - Diagnostic Operations, Indoriv Clinical

Biopreneur

BS


Disrupting Indian cardiac diagnostics

Launched in 2011, Cardiac Design Labs (CDL) was created with the aim of impacting the society by enabling easier form of detecting and diagnosing early cardiac problems.

In the Indian clinical landscape, other than large hospitals or specialty centers, the ability to do a proper cardiac diagnosis is

mostly absent.

“This is the case globally in all emerg-ing markets,” reveals Anand Madan-agopal, the CEO of CDL. “There is no frontline devices for diagnosing Arrhythmia and Coronary Artery Diseases (CAD) other than Resting Electrocardiogram (ECG) in smaller hospitals.”

He feels, the 10-second Resting ECG is an inadequate tool to diagnose the above conditions effectively.

“Both these conditions require ECG taken during ambulatory mode for comprehensive analysis,” he says.

With higher number of patients suf-fering from heart diseases, and the available specialized products in cardiac diagnosis are operable only in tertiary care centers, the reach of precision diagnosis is limited.

Madanagopal points that the whole cardiac care system is tedious and expensive.

“Thus, we built a solution that gives the power to cardiologists to do bet-

ter diagnostics and help take quick decisions based on in-depth, vali-dated information, without the need of being present near the patient, and still be able to run this kind of com-prehensive analysis in small and me-dium hospitals. This will completely change the cardiac diagnostics sce-nario,” he highlights.

Currently, no Rhythmanalysis is fea-sible in smaller hospitals where large number of cardiac patients go in to-day.

Madanagopal emphasizes, “Even when products are available -- like

RAINING MILESTONES* Winner of ‘Grand Jury Prize’ at

StartupIndia Launchpad 2016 by Google

* Winner of ‘Popular Choice and Impact’ award at IoTNext 2015

* Winner of ‘Best IoT Startup 2015’ award

* Winner of ‘Walk The Talk’ competition at Intel Conference 2015

* MIRCaM awarded ‘The Most Innovative Product’ at IESA Technovation Awards 2014

Biopreneur

CDL Team: (L-R) Mosin Badkar, Ravi B Kaushik, Praveen L Murthy & Anand Madanagopal


large hospitals -- it is expensive to operate because of the need to run heavy, back-end teams. Post-opera-tive monitoring is also very limited when it comes to smaller hospitals.”

The start-up has created a first-of-its-kind, advanced cardiac diagnostic

products to be used in smaller set-tings.

“This will enable larger population to be tested in early stages for better management of the disease. Earlier, all diagnostics had to be done strictly at a hospital. Now, technology allows

us to perform diagnostics at home,” voices Madanagopal.

CDL’s team consists of 3 founders including Anand Madanagopal the CEO; Praveen L Murthy heads the Hardware and Production; Mosin Badkar as the head of R&D and En-

MAJOR CLIENTS* Heart & Rhythm Clinic

* Sri Sri College of Ayurvedic Science and Research Hospital

* Telerad RxDx

START-UP LESSONS LEARNT

* Being patient

* Bringing right people on board

* Good advisory team which is critical, wishes well

* Talking to the team about vision, journey

START-UP MYTHS* Should be a service-based

start-up to generate revenue quickly

* Should be an aggregator

* Should have a pedigree

* Should have a five-year revenue plan

Biopreneur


gineering; and a fourth team member Ravi B Kaushik, who leads the start-up’s Business Development.

The team is a mix of experienced pro-fessionals including engineers and doctors having vast knowledge in product design and ambulatory ECG analysis.

CDL’s potential is in instrumentation engineering for clinical application in all the associated areas of R&D.

Its key products include MIRCaM 12-Lead multifunction diagnostic plat-form and its award-winning MIR-CaM Diagnostic Patch.

MIRCaM stands for Mobile Intelli-gent Remote Cardiac Monitoring.

The start-up claims that MIRCaM is the only solution in the world to provide comprehensive real-time, 12-Lead ECG diagnostics as cardiac events occur, and from remote loca-tions.

Currently, the products are offered as a service on a pay-per-use model.

The start-up’s area of expertise en-compasses R&D, manufacturing, clinical engineering, mathematics and marketing. The plan of action began with the building of prototype and proving its feasibility.

This was followed by creating algo-rithms and building the diagnostics part.

Later, the feasibility of integrating with vendors who already had algo-

HANDLING START-UP STRESS

* Engaging with team (apart from mundane work)

* Ignoring negative energy advise

* Talking to well-wishers

ENTREPRENEURIAL MISTAKES TO AVOID

* ‘Make it all, do it all’ attitude

* Unwisely choosing critical components

* Not integrating other vendor components

* Raising funds early from institutional investors

DESIRABLE QUALITIES IN LIFE SCIENCES ENTREPRENEURS

* Ability in understanding medicine and engineering

* Bringing all skillsets together

* Sustaining for longer terms with limited budgets

“A bad team will definitely harm any start-up…”

rithms were worked upon.

This led to the next step of conduct-ing product testing in various hospi-tals. Lastly, the team built the com-plete workflow, and launched into the market.

Initially, the start-up met up with challenges unique to its own -- from building the algorithm to under-standing the clinical requirements, to getting the right skillsets together.

The start-up has invested about $2,50,000 capital investment, raised through Angel investors and well-wishers.

It has already collaborated with lead-ing universities, silicon manufactur-ers and healthcare firms.

The start-up targets a revenue of Rs 5 crore in the next couple of years.

All Madanagopal requests the Gov-ernment to do is to generate an eco-system for testing in Government hospitals, and providing grants for deployment and testing.

Madanagopal says that intelligent healthcare will be a prime area for start-ups to look at moving forward.

He advocates raising funds from An-gel investors from known circles, and as well as customers, as an ideal way to build a life sciences start-up.

According to him, what kills a start-up? “A bad team will definitely harm

any start-up. Irresponsible spending and raising money quickly are other factors,” he concludes.

Raj Gunashekar

Biopreneur

BS


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