BSI-July-2016-Raj Gunashekar

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

BIOSPECTRUM

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IPR POLICY

JULY 2016

Volume 14 Issue 7 July 2016 www.biospectrumindia.com

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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

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

BIOSPECTRUM

NEW

IPR POLICY

JULY 2016

Volume 14 Issue 7 July 2016 www.biospectrumindia.com

An Publication

`100

Tota

l pag

es in

clud

ing

cove

r 68



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

COVERDESIGN BY: SHIHAB K A

BioContents

REGULARS

7 BIOEDIT

8 BIOMAIL

13 BIONEWS

59 BIOPEOPLE

61 BIOSUPPLIERS

COVERSTORY 24

BIOTALK

10 57

DR MANDAR KULKARNI CTO, Cancer Genetics India

ANTHONY MACDONALD President, Spectrum Labs

PERSONALIZED MEDICINE LOWERS TREATMENT COST

BETTING BIG ON INDIA’S BIOSEPARATION SPACE

Is The New IPR Policy On The Right Path?THE NATIONAL INTELLECTUAL PROPERTY RIGHTS POLICY WAS APPROVED BY THE CABINET

A SUGAR PILL FOR THE INDUSTRY?30

NEW IPR POLICY A THRUST TO INNOVATIONS36

IMPACT ON BIOTECHNOLOGY AND PHARMACEUTICAL SECTOR32

PROTECT AND ENCOURAGE INNOVATION38

CREATIVE INDIA, INNOVATIVE INDIA34

IPRs THE JOURNEY TO ECONOMIC PROGRESS40


BioContents

BIOPRENEUR

ARMORING AGAINST ALLERGIES AND INFECTIONS

64

BIOFEATURE

BioSpectrum peeks into the Indian Life Sciences start-ups scene unearthing mysteries and decoding the art of de-risking start-ups

START-UPS: DECIPHERING THE DE-RISKING STRATEGY

50

BIOSPECIAL

TECHNOLOGY ADVANCEMENTS: DIGITAL PATHOLOGY

42

How does the future look for Indian clinical research industry? Read on to find out…

Imagine warding off allergies and infections just by armoring yourself with anti-microbial textiles!

HAVE THE REVISED NORMS IMPROVED CLINICAL RESEARCH ENVIRONMENT?

20

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BioEdit

The recent two reports by CRISIL and ABLE can be read togeth-er. They seem to be showing two differ-ent trends in allied

segments.

CRISIL foresees sharp decline - from annual 19% in the last decade to 10-12% per year in the coming five years - in export growth in for-

mulations. It says exports of generics have been the growth engine for a long while. Indian drug companies exported drugs worth $11.6 billion in 2014-15, one third of which was to US alone, worth $3.8 billion. They have been making cheaper, generic versions of drugs capturing 16% of the $800 billion US pharma market. But this rosy picture may fade away. CRISIL has cited the reason for this as the expected slowdown in the growth in sales of generic drugs in US.

Some other experts feel that along with the generic drugs, the oral formulations market is also shrinking. The previous year, oral for-mulations accounted for largest share of the pharmaceutical excipients, as per the report of a market research firm.

CRISIL points out that the competition has been intensifying, particularly for the large players, because of the huge number of abbre-viated new drug applications (ANDAs) being filed with the USFDA, including by mid-sized domestic ones looking to step up presence in the biggest market. Furthermore, consolida-tion of distribution channels in the US could reduce the pricing power of domestic drug makers. While the generic small-molecule in-dustry looks to be under pressure due to vari-ous internal and external factors, some peo-ple are hinting towards a trend shifting from chemicals based oral formulations to injectable products predominantly of recombinant origin.

The ABLE report indicates that India’s biotech-nology industry has generated a compounded annual growth rate of around 20% and this fast

growing bio-economy in Indian has crossed $35.1 billion the previous year as per the ini-tial estimate. The possibility is that the actual size can be even bigger. The country has set an ambitious target of achieving $100 billion by 2025. A major share of that must be of bio pharma and related segments.

Big pharmas had caught on to the trend early on by steadily moving focus from small-mole-cules to biologics, primarily through targeted acquisitions. As per Evaluate Pharma Report, by 2020, more than 50% of products amongst top 20 selling drugs will be of biotechnology origin.

When CRISIL has pointed out that sharper fo-cus on innovation and R&D has become an im-perative. CRISIL study shows that Indian com-panies have increased their spending on R&D, but still is much less than the global standards. Besides increasing the budgets of R&D, Indian pharma companies can think of shifting their focus to biosimilars also. Analysts expect the worldwide biosimilars market to reach $25 bil-lion to $35 billion by 2020. Indian companies can examine the scope of more export of bio-simlars and biotech products which can help overall Indian industry exports.

But, for Indian biopharmas to compete glob-ally, Indian regulatory system needs to consoli-date and follow a similar structure to regula-tory agencies in the markets into which India sells active pharmaceutical ingredients and finished products. ABLE in its report has sug-gested some measures for that. Apart from regulatory facilitation, exploring partnerships with local companies within target countries for joint-development & commercialization of biosimilars may also prove to be important for Indian companies. Thus, if CRISIL report is a cautionary warning, ABLE report shows the possibilities and opportunities to overcome the challenges. BS

Milind KokjeChief Editor

[email protected]

Challenges and opportunities


BioMail

Vol 14; Issue 6; June 2016

Vol 14; Issue 7; July 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: Shihab KASales 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

Precision MedicineWith reference to the article on Precision Medicine, I think we are already utilizing this approach in traditional medicine. As for modern medicine it may take some time to fully appreciate its value. I believe it’s important to encourage more and more physicians to take up this ap-proach as at present it is confined only to big hospitals. In the near future, precision medicine will become an indis-pensable part of healthcare.

Rajat Paliwal, Ahmedabad

Biosimilars The article on Biosimilars was informative. India certain-ly does have the expertise to dominate this class of drugs, provided all the impediments are carefully dealt with. Regulatory issue for examples, could be more detailed and transparent. As for bearing cost of the development, perhaps big companies can collaborate with the small ones. A detailed study could perhaps suggest a direction

for the productive growth of this sector.Deepak Koul, Hyderabad

Informative issue The latest issue of BioSpectrum was an interesting read as always. All the stories highlighted the important issues. In particular, I like the cover story on Precision Medicine. In my opinion, we need a precion medicine initiative as it improves our quality of healthcare.

Ali Wilson, Goa

Corrigendum

In the June issue, on page 35, the photo under the name Dr Sooraj Ratnakumar was wrong. The er-ror is deeply regretted.

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BioTalk

Personalized Medicine lowers treatment cost

C ancer Genetics (CGI), founded by world-renowned cytogeneticist Dr R S K Cha-ganti, offers diagnostic products and ser-vices that enable precision medicine in the field of oncology and has presence in the US, India, and China.

In 2013, CGI launched a joint venture with Mayo Clinic, Oncospire Genomics. Working to meet areas of critical need in oncology, Oncospire Genomics seeks to improve cancer care by discovering and commercializing diagnos-tic tests that leverage NGS technology.

In 2014, CGI acquired Gentris (based in Raleigh, NC) and

Bioserve Biotechnologis based in Hyderabad.

In an email interaction, Dr Mandar Kulkarni, Chief Tech-nological Officer, Cancer Genetics India, discuss CGI’s operations, kind of services the company offers, precision medicine across the globe and the firm’s future plans.

Q What is the main focus of your work at CGI and what are some of your core priorities?

AWith our CEO – Panna Sharma, I manage all the Indian operations of CGI, CG-India (Bioserve). We are an ‘end-to-end’ genomics service provider and

offer services in three major areas – research/discovery

Dr Mandar Kulkarni CTO, Cancer Genetics India

BioTalk


BioTalk

services, clinical/diagnostic services, and biopharma ser-vices. We have been a trusted partner for oligonucleotide synthesis, Sanger sequencing, next generation sequenc-ing, microarray, and bioinformatics.

I have three core priorities at this time. Firstly, we wish to enable researchers at all government institutes to gain meaningful insight from the experiments that they per-form in their laboratories. We usually begin with a pre-experimental conference that allows us to understand the scientific goal of the experiment and to make suggestions that will ensure the most appropriate workflow is used. We ensure that the quality of every step is checked and only high quality data and interpretation is delivered on time.

Secondly, we offer clinical/diagnostic services with clini-cal interpretation for personalized medicine for various cancers. This process is guided by our highly qualified and experienced scientific leadership.

Lastly, we support the biopharma industry by developing customized services e.g. pharmacogenomic analysis, sig-naling pathway panels, multi-gene panel testing etc.

Q A lot of personalized medicine firms have sprouted in India in the recent past. How do you plan to tackle the competition?

AAt CGI, we have several years of leadership in de-veloping next generation sequencing based diag-nostic tests and clinical interpretation guidelines

for such tests. CGI has invested in the development of diagnostic tests that are specific for various cancer types. The number and set of genes mutated in any cancer are tissue-specific. Moreover, certain mutations can give rise to drastically different genomic landscapes for the same cancer type from two individuals. We ensure that all such

variations are detectable from a single next generation sequencing based test. We also provide clinically action-able information that increases the accuracy of diagnosis, prognosis, and theranosis, which minimizes the overall diagnosis and treatment cost of cancer. This distinguish-es us from the competition.

Q How do you assess chances of personalized medicine in India compared to USA or China market?

A I think this is a big challenge even in the USA, where most diagnostic testing is paid through insurance reimbursements, which are driven by FDA-approv-

als. Currently, the FDA is reviewing the guidelines and ensuring that the testing is not wasteful. On the other hand, a major advantage for such testing in the US is the availability of well-curated databases that define the ef-fect of mutations on the disease state in terms of progno-sis, clinical outcome and treatment options.

Unless we adopt the tests and begin this exercise, we will not be able to identify epidemiological and etiological dif-ferences that contribute to cancer in India. Because the burden of cancer in India is very high, the personalized medicine industry has received attention although the market is in its infancy. It is expected to grow rapidly over the next few years and be a center piece of cancer care by lowering the total cost of treatment for patients.

Q When we hear about personalized medicine we still think it is largely limited to the confines of large academic medical

centers in developed world. Do you think it is too early to start thinking about PM in India and emerging markets?

A Absolutely not. The primary reason for India and emerging markets to adopt this testing is that it re-ally lowers the total treatment cost and increases

the accuracy of diagnosis. CGI has several next genera-tion sequencing based tests in various stages of develop-ment for personalization of diagnosis and treatment. The second major reason to use such testing is to create an epidemiological and etiological landscape of cancer for the Indian population. The perception of this being con-fined to large academic centers is because some of the

The personalized medicine industry has received attention although the market is in its infancy


BioTalk

preliminary work that contributes to the design of such testing usually begins at academic centers. Most of the development and validation work is then performed at commercial entities, such as CGI.

Q How do you see precision medicine in cancer care evolving over the next few years?

A Although precision medicine has applications for many diseases, its relevance is heightened in the context of cancer because cancer is caused by a

multitude of genetic aberrations and the overall muta-tional landscape directly affects diagnosis and clinical management of the disease. Identification of all such ab-errations in a single test, instead of iterative testing, saves precious time and reduces the total cost of treatment.

Q What are the major challenges you are currently facing, and which additional challenges do you see arising in a few

years?

A A major current challenge is that all the benefits of next generation sequencing based tests are not ad-equately understood by the prescribing medical on-

cologist. Secondly, a clinical report with carefully inter-preted actionable information is not always provided with the results. At times, genetic variants that are novel and/or of unknown clinical significance may present a challenge for clinical interpretation until we have a well-curated database that correlates the effect of such vari-

ants with clinical parameters.

Our clinical team puts tireless effort into ensuring that our reports are guided by the most updated knowledge-base and have high accuracy. A significant challenge of the future will be to comply with regulatory guidelines that will be formulated by the government. Today there are no guidelines that regulate such testing. For CGI, this may present only a small challenge because most tests released by CGI comply with at least one set of western guidelines. The cognizance and experience of complying with guidelines will enable us to meet the challenge with relatively lesser efforts.

Q One of the cornerstone for personalized medicine companies is handling the logistics of patient sample, how do you

confront that?

A One way of effectively addressing this is to partner with marketing diagnostic companies that do not maintain a full service laboratory for next genera-

tion based testing. We have already partnered with a few such companies and will continue to explore such oppor-tunities. Another approach would be to partner with a well-established logistics management company.

QWhat are CGI’s future plans?

A As the research services industry has nearly ma-tured and is expected to be at the cutting edge with-in a few years, we wish to be the market leader in

providing high quality timely service across every govern-ment lab that requires oligonucleotide synthesis, Sanger and next generation sequencing, microarray, and bioin-formatics analyses. We also plan on establishing a state-of-the art bioinformatics team that provide additional dimensions/insights into their own datasets and helps researchers make major discoveries by comparing their datasets with publicly available similar datasets. On the clinical services front, we plan on bringing the diagnostic tests developed in the US to the Indian market. Like our US operations that support 7 of the top 10 biopharma companies, we expect to become a close collaborator and trusted partner of the Indian biopharma industry. BS

Challenge will be to comply with regulatory guidelines.

Ayesha Siddiqui


BioNews

Biocon, Quark initiates studyof QPI-1007 inrare eye diseaseBiocon and Quark Pharmaceuti-cals, a leader in the discovery and development of novel RNA inter-ference (RNAi)-based therapeutics, announced the randomization of the first patient in India in the piv-otal global Phase II/III study of QPI-1007, a novel siRNA (small interfer-ing RNA) drug candidate for ocular neuroprotection.

Biocon and its partner, Quark Phar-maceuticals, have received approval from the Drug Controller General of India (DCGI) to proceed with the study, the first ever clinical trial of a siRNA therapy in India.

The QRK207 study will determine the effect of QPI-1007 on visual function in subjects with acute non-arteritic ischemic optic neuropathy (NAION), which is a rare ocular disorder with an unmet need globally.

This is part of a global Phase II/III study run by Quark in collabora-tion with “Neuro-Ophthalmology Research Disease Investigator Con-sortium” (NORDIC) and is already enrolling in the US and a number of other countries.

Biocon Chairperson & Managing Di-rector Kiran Mazumdar-Shaw said Biocon is committed to develop inno-vative therapies that address unmet medical needs.

BioNews

Pharma cos looking to innovatehigh-risk, first-in-class productsWith the cost of bringing a single novel drug to market estimated to be $2.6 billion in 2015, pharmaceutical companies are increasingly looking towards developing first-in-class treatments to maximize revenue and stay ahead of competition, according to business intelligence provider GBI Re-search.

The company’s latest report states that the growth in drug research and development (R&D) costs appears to stem from an increased clinical fail-ure rate and emphasis on proving superiority over comparator drugs in technology assessments, as well as an increasing level of sophistication from payers when assessing the cost-effectiveness of drugs.

Dominic Trewartha, Managing Analyst for GBI Research, explains: “Due to the inherently limited life cycle of a patented drug and growing R&D costs as a percentage of net sales, the pharmaceutical industry has the highest R&D expenditure of all industries. As such, imperatives for phar-maceutical companies include reducing product development costs, maxi-mizing the annual product revenue, and optimizing the life cycle of a drug, primarily by minimizing the impact of the entry of generics.

e-Pharmacy seek govt help for level playing field

In the wake of growing harassment faced by entrepreneurs in the field of e-Pharmacy, the Indian Internet Pharmacy Association has sought support from regulators and the government.

Prashant Tandon, co-founder of 1mg.com, along with IIPC members has urged the government “to create a level playing field for the upcoming e-Pharmacy model to thrive”. The e-Pharmacy business model has been in news for various reasons.

Maharashtra FDA recently lodged a complaint against PharmEasy, one of India’s leading e-Pharmacy platform, however, police investigated the mat-ter and come to the conclusion that there is was no violation of FDA rules and regulations, vindicating PharmEasy’s stand.


BioNews

Merck to acquire Afferent PharmaceuticalsMerck, known as MSD outside the United States and Canada, and Af-ferent Pharmaceuticals announced that the two companies have signed a definitive agreement under which Merck will acquire this privately held pharmaceutical company.

Afferent Pharmaceuticals is a lead-er in the development of thera-peutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neu-rogenic conditions. Afferent’s lead investigational candidate, AF-219, is a selective, non-narcotic, orally-administered P2X3 antagonist cur-rently being evaluated in a Phase 2b clinical trial for the treatment of refractory, chronic cough as well as in a Phase 2 clinical trial in id-iopathic pulmonary fibrosis (IPF) with cough.

“Afferent has pioneered the clini-cal development of novel investiga-tional candidates selectively target-ing the P2X3 receptor, an exciting area of research,” said Dr Roger M Perlmutter, president, Merck Re-search Laboratories. “We look for-ward to advancing these innovative molecules for patients with condi-tions like chronic cough, an area of

significant unmet medical need.”

Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of Af-ferent in exchange for an upfront payment of $500 million in cash. Also, Afferent shareholders will be eligible to receive a total of up to an additional $750 million associated with the attainment of certain clini-cal development and commercial milestones for multiple indications and candidates, including AF-219.

“This achievement is a reflection of the talent and hard work of the experienced Afferent team in ad-vancing the science of P2X3 recep-tors and the clinical development of our novel therapeutic candidates,” said Kathleen Sereda Glaub, chief executive officer, Afferent Phar-maceuticals. “We are very pleased to enter into this agreement given Merck’s reputation for maximizing opportunities around novel mecha-nisms. This agreement with Merck creates significant value for Affer-ent shareholders while enhancing the potential of our portfolio to pro-vide meaningful benefits to patients globally.”

Data on cough frequency from the first cohort of a Phase 2b dose-es-calation clinical trial of AF-219 in patients with chronic cough were presented at the 2016 American Thoracic Society (ATS) Interna-tional Conference. The results of the second cohort, which is exam-ining lower doses, are expected to be presented at a future scientific congress.

The closing of the transaction will be subject to certain conditions.

Cipla pact with Nacimbio for antiretroviral drugsNational Immunobiological Com-pany (State Corporation Rostech) together with Cipla, a global pharma-ceutical company, during SPIEF’16 signed Memorandum of Understand-ing on innovative antiviral medical products for HIV and Hepatitis C treatment and on technology trans-fer and active pharmaceutical ingre-dients (API) manufacturing. New drugs production will help to change therapeutic regimens and substan-tially increase availability of drugs for Russian patients. By 2019 total market share for anti-HIV drugs will increase to 60 percent.

Nacimbio CEO Nikolay Semenov and Chandru Chawla, Head of Cipla New Ventures, signed the Memoran-dum of Understanding on technology transfer for manufacturing of anti-HIV drugs and drugs for Hepatitis C treatment.

“Today patients undergoing anti-HIV treatment have to take a lot of drugs every day. Our preparations will meet the expectations of Russian patients and will solve this problem. In 2017 we will finalize construction and validation of the manufacturing plant together with Cipla, products will be commercially available in 2018. Total investment in the project will be over 2.8 billion roubles, stated Nacimbio CEO Nikolay Semenov.”

“Currently there is no technology for full-cycle manufacturing of HIV treatment drugs in Russia,” said Subhanu Saxena, MD & Global CEO, Cipla. “We are glad that, as a respon-sible partner together with Nacimbio we will be able to improve drug avail-ability for patients and make our con-tribution to the fight against HIV.”


BioNews

Pharmaceutical licensing deals record $46.2 bn in 2015Licensing deal values in the pharmaceutical industry rose by 37.1 percent year-to-year, from $33.7 billion in 2014 to $46.2 billion in 2015, driven primarily by Sanofi, which struck three licensing deals that totaled nearly $9 billion, according to research and consulting firm GlobalData.

In the company’s latest whitepaper, Gianfranco Zeppetelli, GlobalData’s Deals Analyst, explains: “Sanofi inked two key partnerships for meta-bolic indications, the first of which was a $4.3 billion partnership with South Korea’s Hanmi Pharma. Sano-fi gained exclusive worldwide license to develop and commercialize three pipeline products for the treatment of type 2 diabetes.

“Sanofi also made a $1.7 billion agreement with Lexicon Pharma to manufacture and sell sotagliflozin

(LX-4211), an investigational oral dual inhibitor of SGLT-1 and SGLT-2 currently in Phase III development.”

GlobalData’s whitepaper states that there has been a surge in investment of deals in the Immuno-Oncology

(I-O) space over the past five years, as immunotherapies have advanced significantly, becoming the pillar of cancer treatment. In the I-O space, Sanofi signed a $2.7 billion deal to co-develop Regeneron’s REGN-2810, a programmed cell death pro-tein 1 (PD-1) inhibitor currently in Phase I testing.

Another important I-O partnership was Pfizer’s $2.9 billion agreement with Merck KGaA to develop and commercialize avelumab (MSB-0010718C), an investigational anti-PD-L1 monoclonal antibody.


BioNews

Dr Reddy’s to acquire product portfolio from TEVA for US marketDr Reddy’s Laboratories has entered into a definitive agreement with Teva Pharmaceutical Industries and an affiliate of Allergan to acquire a portfolio of eight Ab-breviated New Drug Applications (ANDAs) in the US for $350 million in cash at closing.

The acquired portfolio consists of products that are being divested by Teva as a precondition to its closing of the ac-quisition of Allergan’s generics business. The acquisition of these ANDAs is also contingent on the closing of the Teva/Allergan generics transaction and approval by the US Federal Trade Commission of Dr Reddy’s as a buyer

The portfolio being acquired is a mix of filed ANDAs pending approval and an approved ANDA, and com-prised of complex generic products across diverse dosage forms. The combined sales of the branded versions of the products in the US is approximately $3.5 billion MAT for the most recent twelve months ending in April 2016 ac-cording to IMS Health.

India’s BioEconomy crosses $35 billion : ABLE ReportIndia’s fast-growing BioEconomy has crossed the $35.1 billion in 2015, according to a special report prepared by the Association of Biotechnology-Led Enterprises (ABLE) and released on the inaugural day of the BIO In-ternational Conference at Moscone Convention Center in San Francisco on June 7.

“This is just an initial estimate and the actual size of the country’s BioEconomy could be actually much more,” said ABLE Chairperson and CMD of Biocon, Dr Kiran Mazumdar-Shaw, while releasing the special report at the India Pavilion at the BIO Convention. The BioEconomy report is part of the Make in India Biotechnology Hand-book 2016 brought out by ABLE with support from DBT, BIRAC, CII, KBITS, Bangalore BioInnovation Center, Biocon and Syngene.

Dr Shaw released the report along with Ms Holly Vine-yard, Assistant Secretary of US Department of Com-merce, and Nandamuri Ramakrishna, member of Andhra Pradesh Legislative Assembly and Venkatesan Ashok, the Consul General of India-San Francisco.

Global Type 2 diabetes market to doubleto $58.7 bn by 2025GlobalData’s latest report states that this growth, which will occur across the nine major markets of the US, France, Germany, Italy, Spain, the UK, Japan, China, and India, will primarily be attributable to a dramatic increase in the diagnosis and prevalence of the disease, and the fact that the rise in type 2 diabe-tes-related comorbidities has fueled a more aggressive approach in treatment and the use of multiple-drug therapies.

Dr Jesus Cuaron, GlobalData’s Analyst covering Car-diovascular and Metabolic Disorders, explains: “In-creases in disease incidences will result from increased life expectancy and lifestyle changes, such as dietary changes and a reduction in exercise.

“Indeed, the US will be impacted the most by such changes, increasing its global market share from 58 percent to 66 percent during the forecast period.”

Due to the increasing prevalence and progressive na-ture of type 2 diabetes, there are considerably high un-met needs within the indication.

Overall, these unmet needs are interrelated and in-clude improved durability of treatment, a better bal-ance of efficacy of glycemic control with cardiovascu-lar safety, hypoglycemia avoidance, and tolerability and ease of compliance.

Dr Cuaron continues: “Currently, all available treat-ments for type 2 diabetes are initially effective and reduce complication rates. The need for drugs which are able to maintain glycemic control in the long term, however, represents a significant growth opportunity for new patent-protected products.


BioNews

AstraZeneca off-loads anesthetic portfolio to AspenBritish drug giant AstraZeneca has sold market rights to its portfolio of seven anesthetic medicines worth $770 million to South African firm Aspen Group outside the US. Aspen, South Africa’s largest drug maker, operates in 50 countries and employs more than 10,000 people.

As per the terms, Aspen will pay $520 million upfront for the prod-ucts, which include general anes-thetic Diprivan and local anaesthetic Marcaine. An extra $250 million could be paid in installments over the next two years, dependent on sales, as well as double-digit percentage trademark royalties.

The news comes a day after Aspen secured a €3 billion funding boost. It

has spent more than $2 billion on ac-quisitions from pharma firms includ-ing GlaxoSmithKline and Merck over the past few years.

AstraZeneca will continue to manu-

facture and supply the products on a cost plus basis to Aspen for an initial 10 years. The products are sold in more than 100 countries, including China, Japan, Australia and Brazil, and currently bringing in revenue of $592 million a year.

The company’s CEO, Pascal Soriot mentioned that the deal will help As-tra focus on its three main therapy areas - oncology, respiratory, and cardiovascular and metabolic dis-ease and would “extend the reach of our established portfolio to a greater number of patients through (Aspen’s) extensive commercial net-work. This agreement supports our strategic focus on the new medicines in three main therapy areas, said Sa-riot in a statement.”


BioNews

Dr Reddy’s launches plaque psoriasis drugDr Reddy’s Laboratories has an-nounced that its US subsidiary, Promius Pharma, has launched Ser-nivo (betamethasone dipropionate) Spray, 0.05% in the US. Sernivo Spray, a prescription topical steroid approved by the Food and Drug Ad-ministration (FDA) in February of 2016, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older.

“We are proud to bring Sernivo Spray to patients across the US,” said Raghav Chari, Executive Vice Presi-dent, Proprietary Products Group at Dr Reddy’s Laboratories. “This is an-other significant milestone for Prom-ius Pharma. As an emerging leader

in the dermatology space, we are committed to developing innovative treatment options.”

Promius has conducted two multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evalu-ate the safety and efficacy of Sernivo Spray.

In both trials, randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement be-tween 10 percent to 20 percent and an Investigator Global Assessment

(IGA) score of 3 (moderate). Efficacy was assessed as the proportion of subjects who were considered a treat-ment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-scale reduction from baseline). Treatment success was achieved in significantly more subjects using Sernivo Spray than ve-hicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, Sernivo Spray achieved treat-ment success of 42.7 percent and 34.5 percent compared to vehicle success rates of 11.7 percent and 13.6 percent, respectively (p < 0.001).

“Plaque psoriasis can be a frustrat-ing condition for patients and physi-cians alike. For patients, it is not only itchy and painful, but depending on where on the body it occurs, it can be embarrassing for them and decrease their quality of life,” said Dr Leon H Kircik, clinical associate professor of dermatology at Indiana University School of Medicine. “As one of the researchers for Sernivo Spray, I’m excited to see this new treatment op-tion added to our tool chest. With Sernivo Spray, I will now have a ver-satile option for patients that is easy to use in difficult to treat areas, like elbows and knees.”

Datwyler to open FirstLine production site in IndiaDatwyler, a leading supplier of customized sealing solu-tions to manufacturers and companies which operate in the healthcare and automotive industry, as well as the market segments civil engineering and consumer goods, has announced the construction of its most advanced manufacturing facility - FirstLine - at the Datwyler India site in Satara, Maharashtra.

The FirstLine facility will be integrated in the existing premises, and will be fully operational in 2017. An ad-ditional area of 24,000 m2 is available for future growth. The most complex rubber components produced at the FirstLine site belong to the Omniflex family of vial and

syringe components, which prevent any interaction with the drugs due to their total fluoropolymer coating. These components are exclusively manufactured at the First-Line sites.

The Omniflex coating process is a Datwyler proprietary process. Omniflex is an inert, flexible, fluorinated poly-mer coating for pharmaceutical rubber closures, which covers the entire product surface. The chemical inertness of the fluorinated polymer coating provides a very high degree of compatibility with pharmaceutical or biotech-nology products. Datwyler India will supply the products to the company’s customers worldwide.


Biospecial

Have the revised norms improved clinical

research environment?

The most significant of these changes were revisions to compensation guidelines and audio visual recording

during clinical trials which were ma-jor barriers for sponsors conducting clinical trials in India.

“The compensation guidelines are now more balanced and rational; we are beginning to see more predict-able approval timelines with the ex-pansion of the Subject Expert Com-mittees and the expected roll-out of the accreditation process is projected to have a significant impact on the quality of research,” Dr Rajashree Devarakonda, Vice President, India and Asia Pacific, Voisin Consulting Life Sciences (VCLS).

She added, “This is a major im-provement from the previous guide-line and brings India back to almost the same level playground as other global counterparts. In addition, CDSCO has launched a new online clinical trial submission system as part of efforts to increase account-ability, transparency and efficiency in processing clinical trial applica-tions.”

However, it will take time to see the real impact of these changes. “The environment is certainly more posi-tive but rebuilding trust and con-fidence is a long and slow process. What has been extremely encourag-ing is the inclusive approach adopted by the Indian regulators whereby stakeholder feedback has been ac-

tively sought and acted upon in many cases. We now have a regula-tory system that is balanced, aligned with global trends and one that ad-dresses our uniqueness as a country and society. This is a significant de-velopment,” says Ms Suneela Thatte, President, ISCR (Indian Society for Clinical Research).

The Indian Clinical Research Industry went through a difficult phase in 2013 and 2014. However, 2015

saw steps being taken by the Indian regulators to mitigate the challenges posed by regulatory uncertainty and address stakeholder concerns

through amendments in regulations, new orders and further guidance on existing ones. Have these new guidelines improved the clinical research sce-nario? How does the future look for Indian clinical

research industry? Read on to find out…


Biospecial

India: Numero Uno, Again?While Indian clinical research indus-try was going through a turbulent phase, South Korea (and many other Asian countries) has emerged as the preferred destination for clinical tri-als. Would India be Numero Uno again?

“I would, at the outset, like to clarify that India was never a country that had a very high percentage of trials relative to trials being done in the rest of the world nor is it our objec-tive to be the number one country in the region or globally for trials. What is important is that the trials being done in India are significant enough to address our growing bur-den disease and the unique health-care requirements of our country,” Ms Thatte points out.

She further added that the Govern-ment of India sponsored Work-ing Group on Disease Burden for the 12th Plan refers to the ‘triple burden of disease’ that developing countries like ours are facing arising from communicable diseases (like TB, Leprosy, vector borne diseases,

water-borne diseases, zoonotic dis-eases and vaccine preventable dis-eases), emerging non-communicable diseases related to lifestyles (like cancer, cardiovascular diseases) and emerging infectious diseases (like Ebola virus, SARS, H1N1). Therefore clinical research in our country is a health imperative and important for progress of the health of our people

and the economy.

“Positive changes around regulatory framework and policies are happen-ing. Changes to compensation issue and audiovisual recording, improved review time of clinical trial applica-tion, improved monitoring etc. has slowly started attracting sponsors from other countries back to India,” said Dr Devarakonda.

Attraction of India in terms of its large patient pool, low cost of doing business, availability of expert re-searchers, and, huge market oppor-tunities still remain. It is a possibility for India to regain its position com-pared to other Asian countries.

“However, regulatory approvals and extended timelines in clinical trials need a coherent set of stand-alone rules and safe drugs adhering to Good Clinical Practices, the compul-sion of conducting clinical trials to improve therapeutics should be ef-fectively communicated to the pub-lic, patients, media and policy mak-ers, new regulatory personnel to be recruited and trained on an ongoing basis to meet the growing require-ments of clinical trial applications. In summary, capabilities building for development of new drug that can help the country tackle public health challenges,” said Dr Devarakonda.

Enabling more trials in IndiaIndia has the highest burden of dis-ease in the world, the second largest patient population and yet less than 1.4% of global clinical trials are done in India. What do we need to do to address our triple burden of disease and ensure better, cheaper and more accessible medicines for our popula-tion?

“We need a robust, regulatory frame-work that ensures that clinical re-

DR RAJASHREE DEVARAKONDA, Vice President, India and Asia Pacific, Voisin Consulting Life

Sciences (VCLS).


Biospecial

search is conducted in a fair and transparent manner, safeguarding the interests of patients while keep-ing in line with the basic tenets of science. India needs to take a more proactive role in conducting clinical research for India. A more conducive regulatory framework for the conduct of clinical research in the country will enable this and encourage local inno-vation, ensuring that Make in India is a reality for the drug development and clinical research sector in India” stated Ms Thatte.

“However, India should undertake operational research on diseases and should establish good surveillance systems and develop validated data banks which in turn will enable more number of clinical trials/research. The data gaps need to be addressed with high priority given to operation-al research and adequate resources being allocated,” said Dr Devara-konda.

She continued, “The necessity of con-ducting clinical trials for better ther-apeutics should be effectively com-

municated to the public, patients, media, policy makers, more and more participation in clinical trials so that number of these medications could be made available to Indian population not only during clinical trials but also in some cases post trial before even products gets commer-cialized when proven beneficial with reduced risks.”

Future outlookThe future for clinical research in India certainly looks more encourag-ing today than it did 2-3 years ago. One of our greatest challenges is to instill confidence and trust amongst global stakeholders about the evolv-ing and more scientific regulatory environment in India and the fact that there is now a more conducive environment for clinical research in the country.

“Few global companies have already started testing the water as India offers a substantial cost advantage relative to developed and emerging economies, the urban healthcare in-frastructure in terms of beds/phy-sicians/nurses will be comparable with the global average. India of-fers an abundant and growing pool of skilled, talented and experienced medical professionals, several gov-ernment-funded pharmaceutical and medical institutions with state-of-the-art facilities, which can serve as ideal centers for multi-centered clini-cal trials,” said Dr Devarakonda.

It is the collective responsibility of all stakeholders across clinical research to restore confidence in a clinical re-search process that stands not only for quality and innovation, but also safety and ethics, while also high-lighting the need for clinical research in the country.

“We hope that we will eventually reach a state where we are recog-

nized for the high quality of clinical research done in the country, there is more acceptance and realization across the public at large about the role and relevance of clinical re-search in India and that it contrib-utes to the greater good of everyone, patients are acknowledged for their selfless contribution to bringing new drugs and new treatment to market and we will, in particular, discover new drugs and treatment to treat ill-nesses that are endemic in our coun-try,” said Ms Thatte.

It is the hope of Indian clinical trial fraternity that new and reformed regulations once amended further will be able to bring back Indian clinical research industry to the highest global ethical standards very soon.

Ayesha Siddiqui

Revamping of regulatory review and ap-proval process

Governance over glinical research conduct at sites

Monitoring of clinical trials

Monitoring of ethics committees, ethics committees registration, establishment of subject matter experts committees for review of clinical trial application

Scientific discussion with sponsors before clinical trial application so that critical aspects of the study could be discussed and concerns addressed

Limiting the number of trials performed by principle investigators at the same time

Limiting recruitment of too many patients at one site within a set period of time

Improved review of clinical trial applica-tions by reducing the timeline to almost 6-7 months

Compensation to only events related to clini-cal trial drug and audiovisual recording for selected clinical trials

SOME OF THE POSITIVE DEVELOPMENTS

SUNEELA THATTE President, ISCR (Indian Society for

Clinical Research)

BS

Biospectrum_20X27.pdf 1 27-05-2016 18:55:55


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CoverStory

Is The New IPR Policy On The Right Path?

Ayesha Siddiqui

A SUGAR PILL FOR THE INDUSTRY?30

NEW IPR POLICY A THRUST TO INNOVATIONS36

IMPACT ON BIOTECHNOLOGY AND PHARMACEUTICAL SECTOR32

PROTECT AND ENCOURAGE INNOVATION38

CREATIVE INDIA, INNOVATIVE INDIA34

IPRs THE JOURNEY TO ECONOMIC PROGRESS40

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T he National Intellectual Property Rights policy was approved by the cabinet on May 12, 2016 and released to the public on May 13, 2016. This is the first time that the government is covering all forms of intellectual property together in a single

framework. Some legal fraternity say that the new IPR policy has been formulated at a time when India has been facing tremendous political pressure from the United States to change its intellectual property (IP) regime primarily to serve the interests of pharmaceutical trans-national corporations (TNCs). The IP policy contains a vision statement, a mission statement and seven objec-tives. The operational part of the policy consists of seven objectives with a brief explanation and proposed policy measures. However, the main thrust of the policy is its unquestioning faith in the potential of IP as a develop-ment tool.

Context of the new IPR policyCreativity and innovation have been a constant in growth and development of any knowledge economy. There is an abundance of creative and innovative energies flowing in India. The evolution of the film and music industry; con-tribution of the Indian pharmaceutical sector in enabling access to affordable medicines globally and its transfor-mation to being the pharmacy of the world; a strong and dynamic software industry; a considerably diverse handi-craft and textile industry; richness and versatility of the Indian systems of medicines such as Ayurveda, Unani, Siddha and Yoga; the advances made in the Indian space programme and the pioneering role of our scientists in keeping it cost effective; these are but a few examples of these energies.

While India has always been an innovative society, much of the intellectual property (IP) created remains unpro-tected both on account of lack of awareness and the per-ception that IP protection is either not required or that the process to obtain it is unnecessarily complicated. The rationale for the new national IPR policy lies in the need to create awareness about the importance of intellectual property rights (IPRs) as a marketable financial asset and economic tool. India has robust IP laws and a strong IP jurisprudence. The legal framework does reflect the un-derlying policy orientation and national priorities, which have evolved over time, taking into account development needs and international commitments.

Why robust IPR policy was needed?An all-encompassing IPR policy will promote a holistic and conducive ecosystem to catalyse the full potential of intellectual property for India's economic growth and socio-cultural development, while protecting public in-terest. Such a policy will nurture the IP culture, guiding and enabling all creators and inventors to realise their potential for generating, protecting and utilising IPRs which would contribute to wealth creation, employment opportunities and business development.

This policy shall weave in the strengths of the government, research and development organisations, educational in-stitutions, corporate entities including MSMEs, start-ups and other stakeholders in the creation of an innovation-conducive environment. It will complement the strengths of our substantive laws with transparent, predictable and efficient administrative and procedural mechanisms as also well-informed adjudicatory structure.

OBJECTIVES OF NEW IPR POLICYThe policy lays down seven objectives which are elabo-rated with steps to be undertaken by the identified nodal ministry/department. The implementing or nodal minis-try/department shall coordinate with all other concerned stakeholders, including other ministries/departments, to-wards attaining the objectives.

OBJECTIVE 1: IPR awareness: Outreach and promotion: To create public awareness about the economic, social and cultural benefits of IPRs among all sections of society

OBJECTIVE 2: Generation of IPRs: To stimulate the genera-tion of IPRs

OBJECTIVE 3: Legal and legislative framework: To have

strong and effective IPR laws, which balance the interests of rights owners with larger public interest

OBJECTIVE 4: Administration and management: To mod-ernize and strengthen service-oriented IPR administration

OBJECTIVE 5: Commercialization of IPR: Get value for IPRs through commercialization

OBJECTIVE 6: Enforcement and adjudication: To strength-en the enforcement and adjudicatory mechanisms for combating IPR infringements

OBJECTIVE 7: Human capital development: To strengthen and expand human resources, institutions and capacities for teaching, training, research and skill building in IPRs

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Current laws in India related to IP protection

The statutes governing different kinds of IPRs in India are Patents Act, 1970; Trade Marks Act, 1999; Designs Act, 2000; Geographical Indications of Goods (Registra-tion and Protection) Act, 1999; Copyright Act, 1957; Pro-tection of Plant Varieties and Farmers’ Rights Act, 2001; Semiconductor Integrated Circuits Layout-Design Act, 2000 and Biological Diversity Act, 2002.

ConclusionIntellectual property in India is regulated by several laws, rules and regulations under the jurisdiction of different ministries/departments. A number of authorities and of-fices administer the laws. The legal provisions need to be implemented harmoniously so as to avoid conflict, over-lap or inconsistencies among them. It is necessary that

In his article at Economic and Political weekly, K M Gopakumar, lawyer

specialising in Intellectual Property Rights and legal adviser, Third World

Network, states that the policy is inadequate. The policy neither explains the

reasons for the measures suggested nor provides any evidence to back the policy measures.

There is no information as to whether the IPR think tank, which drafted the initial version of

the policy, carried out a study to identify India’s experiences after implementation of TRIPS

regime. He further states that the new IPR policy is based on an erroneous understanding

of the role of IP in the socio-economic development of India. IP essentially operates as a

monopoly and provides leverage to the IP owner to charge high prices for IP protected goods

and services, while preventing competition from other manufacturers. In many developing

countries, including India, IP protection acts as a tool to manage competition rather than

incentivise research and development (R&D), innovation and creativity. EX

PE

RT’

S C

OM

ME

NTS

the authorities concerned administer the laws in co-ordination with each other in the interest of efficient administration and user satisfaction. Legal, techno-logical, economic and socio-cultural issues arise in dif-ferent fields of IP which intersect with each other and need to be addressed and resolved by consensus in the best public interest. International, regional and bilater-al negotiations require developing a common national position in consultation with different ministries, au-thorities and stakeholders.

The present IP policy aims to integrate IP as a policy and strategic tool in national development plans. It foresees a coordinated and integrated development of IP system in India and the need for a holistic approach to be taken on IP legal, administrative, institutional and enforcement related matters. BS

BIOSPECTRUM

BIOCON SPIN

-OFFS

MAY 2014


CoverStory

A SUGAR PILL FOR THE INDUSTRY?

Dr Milind Antani Partner in charge of the Pharma, Biotech & Healthcare Practice, Nishith Desai Associates

Anay Shukla Member of the Pharma, Medical Device and Healthcare team at Nishith Desai Associates.

Darren Punnen Member of the Pharmaceutical, Medical Device and Healthcare team, Nishith Desai Associates.

India has once again found itself on the recent ‘Special 301’ Re-port’s Priority Watch List along with eleven other countries such

as China, Russia and Ukraine. The report, published by the United States Trade Representative, reviews the global state of IPR protection and enforcement and places countries with inadequate IPR protection on its watch list. What does this mean for a country with such a strong pharma-ceutical and biotechnology sector?

There have been some major changes in the Indian legislative landscape over the years, and a stronger IPR regime had been in the pipeline for a while. The Department of Industrial Policy and Promotion has now re-leased the National IPR Policy 2016 (NIPR), which is hoped to be a pre-cursor to more concrete changes in the IPR law. The policy proposes to

use IPR as a tool to promote innova-tion and development in the coun-try. The NIPR, however, has not laid down a clear roadmap on the imple-mentation.

In terms of benefits to the Indian pharmaceutical and biotechnology industry, certain objectives in the policy seem to stand out. The NIPR has suggested a study to examine the feasibility of IPR exchanges. The policy, through its encouragement of such exchanges, aims at facilitating investments in IPR driven industries and bringing investors and IPR own-ers together. India has already estab-lished one such exchange, which is one of the first in South Asia. With IPR being a major component of the pharmaceutical and biotechnology in-dustry, such an exchange would help in easier and more convenient IPR commercialization for companies.

Another interesting concept that is touched upon in the NIPR is that of open source initiatives, which is de-signed to challenge the traditional incentivization theory of IP, which is based on monopoly rights. In an open source development frame-work, any IP generated is universally licensed without royalty. This IP is usually accompanied by an agree-ment that any subsequent IP created using the existing IP would also be universally licensed without royalty. A more pharma-centric open source concept is the Open Source Drug Discovery initiative (OSDD) devel-oped by the Council for Scientific and Industrial Research, which the NIPR aims to encourage. OSDD is a col-laborative open source model of dis-covery of drugs to treat diseases that affect a poorer population. Drugs discovered through this model would be free from IPR encumbrances and


CoverStory

marketed as a generic drugs. Its suc-cessful implementation has led to 7,900 participants from 130 coun-tries collaborating to fight diseases that afflict the poor in India and other nations. The encouragement of this program could change the land-scape of the pharmaceutical industry and its approach to drug discovery.

India has an abundance of Traditional Knowledge (TK) that has been passed on from generation to generation. The need for the protection of TK had at-tracted international attention after several patent filings of Indian TK in the USA and Europe. A Traditional Knowledge Digital Library (TKDL) was developed in India in 2001, which serves as an evidence to refute the claims for patent registrations in foreign countries based on Indian TK. It has collated the TK of the nation in various languages such as Sanskrit and Urdu. The NIPR recognizes the richness of Indian traditional me-dicinal knowledge and stresses on the need to protect the same from exploi-tation. It also proposes to explore pos-sibilities of using the TKDL for further research and development.

Access to affordable medicines and related healthcare solutions are also one of the objectives of the NIPR, with suggestions for cross-sector partnerships and collaborations be-

tween universities, public research facilities, the private sector and NGOs. While there may not be mon-etary incentives, private participants are hoped to be roped in with other incentives and benefits such as tax exemptions. Additionally, the NIPR suggests incentives for the domestic manufacturing of Active Pharma-ceutical Ingredients so as to reduce the dependency on imports. Another recommendation in the policy is the revival of the long-buried Public Sec-tor Undertakings in the health sector.

The NIPR has made some interesting and forward-looking suggestions, but closer examination reveals that many of these suggestions have already been in place for a while. Recommen-dations in the NIPR could still lead to an advancement in the Indian IPR re-gime and foster innovation and tech-nology in the country, especially in the pharmaceutical and biotechnol-ogy sector. To implement these rec-ommendations, however, they must ultimately be reflected in the law, and this is where the NIPR is unfor-tunately silent. The implementation of the policy is left up to the govern-ment departments with no timeframe or guidelines. It remains to be seen if these suggestions, while remarkable on paper, turn into something that actually addresses issues in the IPR law in the country. BS

The NIPR has made some interesting and forward-looking suggestions. Closer examination shows that many of these are already in place


CoverStory

IMPACT ON BIOTECHNOLOGY AND PHARMACEUTICAL SECTOR

Prity Khastgir Patent Attorney and Partner, Tech Corp Legal

Biotech and pharmaceutical companies embody business models that extensively bank upon intellectual property rights, and corresponding intangible assets created by em-ploying such intellectual property rights. Often, patents play

a crucial role during growth of pharmaceutical and biotech compa-nies and such patents are usually a result of collaborative research partnership between public and private sector.

Consequently, public policy pertaining to intellectual property rights (IPR) play a significant role in promoting innovation and expanding a healthy business environment. Recently, the Government of India approved a National Intellectual Property Rights (IPR) policy aimed at encouraging innovation and improving access to healthcare, food security and environmental protection.

Specifically, the National Intellectual Property Rights Policy is aimed at promoting novel licensing models in addition to strengthening the already existing provisions of compulsory licensing, which have been a topic of debate and discussion among multiple stakeholders since its early days of conception. Among various objectives, the primary goal of National IPR Policy has been structured under seven catego-ries, including:

1. IPR Awareness: Outreach and promotion

2. Generation of IPRs

3. Legal and legislative framework

4. Administration and management

5. Commercialization of IPR

6. Enforcement and adjudication

7. Human capital development

As far as commercialization of IPR is concerned the value and economic reward for the owners of IP rights comes only from their commercialization.


CoverStory

The Government of India believes that it is necessary to reach out to the less-visible IP generators and hold-ers, especially in rural and remote areas, wherein emphasis would be laid on creating awareness regarding the rich heritage of India in terms of our Geographical Indications, Tradi-tional Knowledge, Genetic Resourc-es, Traditional Cultural Expressions and Folklore.

Even though India will adhere to the Doha declaration on TRIPS agree-ment and public health in general, there remains a need to protect In-dian traditional medicinal knowl-edge which exists in diverse forms in our country, and it is important to protect the same from foreign com-panies who file for Intellectual prop-erty rights claiming such traditional medicinal knowledge that existed from many centuries in India. Patent rights are given to an invention when it is new, non-obvious to the expert person in that particular domain and has industrial applicability. Howev-er, time and again foreign companies have been claiming different formu-lations comprising the Indian tradi-tional medicinal knowledge and fil-ing patents across the globe. This has to stop and currently we have Tra-ditional Knowledge Digital Library (TKDL) database which is accessible to patent offices worldwide.

This can bolster the growth path for pharmaceutical and biotech com-panies as companies offering prod-ucts in India can align their product portfolio towards chronic therapies for diseases such as such as cardio-vascular, diabetes, anti-depressants and anti-cancers that are on the rise, which when combined with initia-tives undertaken by the Indian gov-ernment to reduce costs and bring down healthcare expenses can fa-cilitate a rapid introduction of drugs into the market. Furthermore, the fo-

cus on rural health programmes, life-saving drugs and preventive vaccines can further assist the companies in positioning themselves as market leaders by focussing on rural India.

However, much before the National IPR Policy was formally published in May 2016, there have been strong discussions among various stake-holders regarding pressure from de-veloped jurisdictions on India, spe-cifically the United States. In past, such bilateral discussions resulted in the creation of a high-level working group to discuss IP issues and sub-sequent formulation of the new IP policy attracted significant interest from the US government and the US industry groups.

Around the same time as the Na-tional IPR Policy was published, the Indian Patent Office under the guid-ance of the Department of Industrial Policy and Promotion (DIPP) pro-posed amendments to the Guide-lines for Examination of Computer Related Inventions (CRIs), which may indirectly ease the restrictions pertaining to patenting of software in India. However, subsequent inter-vention of public interest groups and comments offered by different stake-holders (patent attorneys, law firms, software companies etc.) forced the DIPP to cancel the amendment.

Additionally, around same time, the Indian patent office rejected the compulsory licence application by Lee Pharma on AstraZeneca’s diabe-tes medicine Saxagliptin, and further rejected the pre-grant opposition on Sofosbuvir, an anti-hepatitis drug. These developments may or may not imply a direct or indirect influence of US pressure on National IPR Policy and related legal proceedings, but the timing can cast some doubt on the way things have progressed so far.

Moreover, an important point to consider is the underlying fact that the National IPR Policy does not recommend any changes in the ex-isting IPR laws. In contrast, the new policy highlights a need to introduce changes in such laws by recommend-ing a review of existing laws with the purpose of updating and improving these or to remove anomalies and in-consistencies.

Therefore, to stimulate the genera-tion of intellectual property rights proper guidance will be provided to researchers and innovators in sec-tors like energy and food security, healthcare and agriculture, as well as specific sectors such as biotechnol-ogy, data analytics, nanotechnology, new material and ICT. Another ob-jective would be to encourage public funded R&D institutes and industry to develop affordable drugs relating to neglected diseases.

Most important objective would be encourage R&D including open source based research such as Open Source Drug Discovery (OSDD) by the Council of Scientific and Indus-trial Research (CSIR) for novel in-ventions relating to prevention of diseases, diagnosis and treatment of diseases, especially those that are life threatening and those that have high incidence in India. BS

Biotech and pharmaceutical companies have to keep a close watch on legal and regulatory developments that can provide further clarity on doing business


CoverStory

CREATIVE INDIA, INNOVATIVE INDIATarun Kumar Bansal Director, Sagacious Research

First draft of National IPR Policy was made available for public comments on December 19, 2014 and af-

ter a long radio silence, the Minis-try of Commerce and Industry of the Government of India released the first ever National IPR Policy (the Policy) on May 13, 2016, with a vision to transform India as a knowledge economy. Key high-lights of the policy are as follows:

the policy will catalyze the eco-system towards India’s economic development and socio-cultural development;

the vision of the policy is em-powering development for the ‘benefit of all’ and in accepting the philosophy that ‘knowledge owned is transformed into knowledge shared’ is honorable;

the policy governs the follow-ing Acts: Patents, Trade Marks, Design, Geographical Indica-tions of Goods, Copyright, Pro-tection of Plant Varieties and Farmers’ Rights, Semiconductor Integrated Circuits Layout De-sign and Biological Diversity;

the policy will accelerate the growth of numerous sectors such

as pharmaceuticals, software, electronics and communications, seeds, environmental goods, re-newable energy, agricultural and health biotechnology, and infor-mation and communications;

the policy provides the plat-form to drive the development of industry, publicly-funded re-search and development organi-zations, educational institutions and government departments in India starting now and into the foreseeable future;

the policy strongly recom-mends speedy disposal of pend-ing IPR applications with re-spective authorities.

Analysis of the policy: India shows immense potential not just as a destination for new era pharmaceuticals, biotech products and diagnostics but on the other hand is turning into an important hub for outsourc-ing of clinical trials and contract research.

Facts: Pharma industry in India is performing at par in comparison with global pharma industry and expected to grow over 15% annu-

The government of India will surely take positive and constructive steps to alleviate the miseries and sufferings of the creators and innovators


CoverStory

ally up to 2020.

The biotech industry in India is try-ing to get onto the tracks in compari-son with the global biotech industry and is able to achieve Compound An-nual Growth Rate (CAGR) of 20%.

Impacts of the policy: counsels for strong IPR protection for creations, innovations and busi-nesses related to pharmaceuticals and biotech sector;

firmly confirms the neutrality of Indian IPR laws and affirms full com-pliance of TRIPS (Trade-Related As-pects of Intellectual Property Rights) Agreement;

further supports the above-men-tioned neutrality by recommending strong measures against as spurious

or counterfeit and treating generic drugs as one of them;

discusses the concerns of Indian generic pharmaceutical companies and provides recommendations to promote innovations among such corporations;

mentions the dire need of stream-lining Food and Drugs Adminis-tration (FDA) approval process for manufacturing and marketing of drugs while maintaining safety and efficacy standards;

discusses about the need of involve-ment of public funded R&D institutes and industry to develop affordable drugs relating to neglected diseases;

highlights the need of a common public platform which assist innova-

tors involved in Biotech sector to con-nect with potential buyers/licensee/users/investors in order to figure out white spaces and hence enable them carry out innovative activities in an unexplored regions of the industry;

advises on establishing effective coordination between Intellectual Property office, National Biodiver-sity Authority and other concerned Ministries/departments which en-able streamlining of processing of patent applications related biological resources and associated traditional knowledge.

To conclude, the government of In-dia will surely take positive and con-structive steps to alleviate the miser-ies and sufferings of the creators and innovators (domestic as well as inter-national). BS


CoverStory

NEW IPR POLICY A THRUST TO INNOVATIONS

Dr Shirshendu Mukherjee Senior Startegic advisor – India Initiatives, Wellcome Trust

The New IPR policy approved by the Union Cabinet on May 13, 2016 is a catalyst to support innovation and start up cul-ture in India. It will provide a big boost to make in India programme and innovation initiative of the government.

The policy will make IPR a marketable asset and economic tool and will lay a foundation of IP development in the country.

The key areas which the IP policy will focus on will be Awareness which an essential element in IP development, our academia and start-ups need to be aware about the landscape of the programme and the innovations which they would like to exploit to create a busi-ness model around the IP.

Next key area in which the policy will focus on is on Generation of IPs, the policy seeks to encourage the innovators to file IPs around innovations and commercialise them for a successful business mod-els. The other area which the policy will focus on is the legal frame-work creating an innovator friendly legal system. The legal frame-work will synergise to the international framework and norms.

Human capital development will be another area which the policy will focus on and will be a major thrust area, a strong human capital is needed to, understand Innovations, manage innovations and ex-ploit innovations which will lead to create strong business models.

Policy envisages creation of platforms accessible to users as common data base for IPRs which will really help in building connections be-tween innovators, users and funding agencies. It will help to scout technologies in unmet need areas specially Biotechnology, Nano tech-nology, agri-biotech, life sciences etc. It will also provide guidance to researchers and innovators to focus on national areas of importance in healthcare, food security, biotechnology, agriculture etc. BS

The new policy will create an innovator friendly environment in the country which will lead to roll out of affordable products for common man


CoverStory

PROTECT AND ENCOURAGE INNOVATION

Kanchana TK Director General, Organisation of Pharmaceutical Producers of India (OPPI)

‘Creativity is thinking up new things. Innovation is doing new things’… said Theodore Levitt, an American econo-mist and professor at Harvard Business School. So when innovations take place, one way to encourage them is

by rewarding it. Patents are important to protect innovation. It pro-vides the innovator with legal means to prevent others from replicat-ing the same innovation, albeit, without the original intellectual as well as financial inputs.

The recently announced National IPR Policy by the Government of India is a welcome step. The policy shows intent of the govern-ment to respect all forms of intellectual property and foster a cul-ture of innovation. The policy will be a boon for all industries where Intellectual Property including patents is the bloodline. Industries benefitting from a robust IPR policy include Start-ups, IT, and Bio-Pharmaceuticals among others.

A significant initiative that the policy highlights is the inclusion of IPR as part of academic curriculum in educational institutes. This will address two important issues: Firstly, it will help the younger generation understand the value of creating an eco-system which re-spects innovation. Creating awareness on the importance of innova-tion among the young minds will help improve the existing practices. Second, while there are multiple applications for patents, very few are actually processed till its final stage. An education and aware-ness initiative will help generate better understanding about appli-cations and protection of innovation. As Indian companies begin to invest heavily in R&D and start operating in multiple geographies, an awareness of safeguarding innovations becomes critical.

Though the policy provides clear direction towards an innovation-driven approach, it falls short in the area of how precisely it can safe-

Hopefully, the policy will lead to an interpretation of the Indian Patent Act that respects innovation, encourages research and facilitates effective enforcement mechanisms.


CoverStory

guard these innovations. One of the apparent shortfalls of the policy is that while one of its previous draft recog-nised the need for patent cases to be adjudicated expeditiously, the final one does not cover the earlier recom-mendation of specialised benches in the High Courts of Bombay, Calcutta, Delhi and Madras, neither does it sug-gest designated district level IP courts.

The research-based pharmaceutical industry is driven by innovation and therefore depends on patents and other intellectual property rights. Hopefully, the policy will lead to an interpretation of the Indian Patent Act that respects innovation, encour-ages research and facilitates effective enforcement mechanisms.

While some argue that IPRs are in-sensitive towards challenges posed

by socio-economic conditions of countries like India thereby brand-ing IPRs as an anti-thesis of generic medicines and affordability, it is im-portant to understand innovation is the seed and the root for finding new medicines which eventually be-come generics! For the system to function effectively, it is important to have a strong concrete IP Policy in place. There are safeguards in TRIPS for meeting a country’s healthcare emergencies.

To reiterate, the National IPR policy is a welcome step. The interpretation and implementation of the policy in the coming days will indicate the di-rection it takes. A strong and mean-ingful IP regime is critical for fostering innovation without which it will be dif-ficult for companies to fund the prog-ress of new ideas. BS

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CoverStory

IPRs THE JOURNEY TO ECONOMIC PROGRESS

Ranjit Shahani President Emeritus - OPPI

Consequently, public policy pertaining to intellectual prop-erty rights (IPR) play a significant role in promoting in-novation and expanding a healthy business environment. Recently, the Government of India approved a National

Intellectual Property Rights (IPR) policy aimed at encouraging in-novation and improving access to healthcare, food security and en-vironmental protection.

Intellectual Property Rights (IPR) is an important part of India’s journey to economic progress. On May 13, 2016, the Government of India announced the much awaited National IPR Policy to a barrage of feedback from all those interested in IPR. While this was certainly a positive step in the right direction, the pharmaceutical industry had been looking forward to this announcement with a mixture of trepidation and equanimity.

It has done well to encourage creativity and innovation while stimu-lating generation and commercialisation of IPRs at various levels. However, the focus appears to be primarily on government or gov-ernment supported innovation as opposed to energising R&D in the private sector where drug development actually takes place. The Pol-icy was well received by industry though there is so much more that could have and should be done! Having said that, industry welcomes with open arms the moves by the Government to hasten the journey particularly with assigning the Department of Industrial Policy & Promotion (DIPP) as the central Indian IP agency.

The Policy has made DIPP as the nodal point to coordinate, guide and oversee implementation and future development of Intellectual Property Rights in India while the state governments, the public and private sector institutions as well as other stakeholders will be in-volved in the implementation process.

The Policy has made DIPP as the nodal point to coordinate, guide and oversee implementation and future development of Intellectual Property Rights in India


CoverStory

The Policy stresses on balancing the rights of the public so that Intellectual Property Rights are not abused in any way and that there are enough safe-guards to protect public interest. These safeguards are important and for the overall good of society. There are issues that remain unresolved especially with regards to the Pharmaceutical sector and the Policy unfortunately is simply a watered down ver-sion of earlier drafts.

A long-standing demand for specialised Patent Benches to hear and settle patent disputes finds no place in the Policy and merely recommends adju-dication through Commercial Courts set up at the appropriate level. The Policy is also silent on key matters such as regulatory data protection, a long standing demand of the research oriented pharma-ceutical companies, and the strong need for patent linkage while granting marketing approval has been ignored. Paradoxically the Policy actually states that the existing IP laws are fully compliant with TRIPS and India will continue to use the flexibilities avail-able to it under the TRIPS Agreement.

Among the positives is the recognition accorded to the need for modernising and strengthening the different Indian Patent Offices, making them more efficient, cost-effective and user-friendly. The Policy has done well to recommend capacity building of these offices and other IP enforcement agencies while also recom-mending the hosting of regular workshops on IPR at the judicial academies and other fora for the judiciary to facilitate effective adjudication of IPR disputes.

The Pharmaceutical industry is in a special position considering the tremendous resources that are put into this sector in India. Therefore if India were to put in place a truly world class IP regime the coun-try and the industry would see results of a very high order that would by far surpass what other countries have witnessed in the past. India, it must be remem-bered, has the world’s third largest pool of qualified and trained scientists. Home-grown pharmaceuti-cal companies are beginning to see the value of IP protection and are seeking that for their own inno-vations. Stronger IPR will only serve to actually en-courage these companies to invest more in R&D.

To truly foster innovation the Government needs to have more specifics and bring in more transparency. It is time to see the benefits that a strong IP ecosys-tem can bring for the country! BS


Biospecial

Healthcare is per-haps the only sector which re-mains impervi-ous to technology advancements ,

though things are changing at a pret-ty fast space.

Digital pathology involves scanning of whole histopathology or cytopa-thology glass slides into digital im-ages interpretable on a computer screen, along with data management, translates to additional functional-ities such as web accessibility, anno-tations, automated image analysis, and a host of breakthrough applica-tions in the practice of pathology, and healthcare systems as a whole.

Digital pathology verses conventional pathologyTraditional pathology workflows have innate delays built into the pro-cesses. Transferring unique glass slides runs the risk of loss, and when

collaborating with others requires time, which delays diagnostics.

“Digitizing images that are normally viewed through a microscope can help improve the operational effi-ciency of a lab. Direct access to files can make diagnosis – in particular consults – simpler, more efficient and safer.

It lowers barriers for internal and external consults, and can be done more quickly since colleagues can view the same case at the same time. This all can help increase the quality and speed of the lab. Furthermore, a digital workflow is the prerequisite and first important step to unlock the

huge potential of future digital anal-ysis in pathology,” said Hans Dries-sen, Marketing & Communications Manager, Philips Digital Pathology Solutions.

Virtual slides can be transmitted from remote locations for review by pathologists and for second opinion. This is even more beneficial in cancer diagnosis. The conventional method involves transportation of slides to avail opinion of experts and this has a direct impact on time taken for di-agnosis.

“Digital pathology has made it easy to obtain second opinion from experts, across geographies, without trans-porting slides. This facilitates faster reporting. The only prerequisites are the scanned digital images and a good internet speed! This innovation brings several advantages to differ-ent stakeholders associated with an anatomic pathology lab. Pathologists can provide faster consultation and

Technology Advancements: Digital Pathology

BioSpectrum takes a look at how computing technology is revolu-tionizing pathology and some of the products available in the market.

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Biospecial

diagnosis, while clinicians see a fast-er turnaround time for referrals. The histotechnologists benefit due to im-provement in efficiency on account of reduced glass slide movement,” said Dr Sandeep Sewlikar, Head – Medi-cal & Scientific Affairs, Roche Diag-nostics India.

Digital pathology also plays a key role in education, by providing an inter-active learning environment. Virtual slides are single (although complex) giant images, they can be placed on a server with a URL and thus can be used in web-based education.

“Imagine changing the teaching methods from the conventional methods of reading each slide under a microscope, one student at a time, verses the use of a digital image with zoom, pan, annotate, crop feature in a classroom on a projector wall. The same concept can be easily ex-

tended to tele-pathology, and hence increase the reach of a pathology lab and closer to areas which lack full fledged pathology labs and qualified pathologists,” said Prasanth Perugu-palli co-founder and CEO at Spectral Insights.

Adoption in developing verses developed worldAdoption of this technology is at a rather slow pace. The reason for the delayed adoption is primarily linked to the need for investment, as the

high-end, whole slide imaging (WSI) scanners are expensive. Since the im-age sizes are also huge (ranging from a few MB to several GB) the image storage servers also contribute to further increasing the overall invest-ment cost.

“Western world had adopted digital pathology for several years now, driv-en initially by insurance mandates as well as lack of skilled manpower. As the advantages of digital pathology started to become more and more evident, there has been tremendous push towards digitization becoming a de-facto standard,” said Dr Sewlikar. He added, “However, there are still no standards for digital pathology in lines of digital radiology. Also, the systems made to address the primary drivers as stated above have been very expensive due to heavy reliance on robotics and automation.”

The new generation WSI scanners are fast and specifically intended to facilitate complete digitization with-in the lab. This has encouraged faster adoption. The advent of high com-puter processing power, improved storage capability at reduced costs, high data transfer speed due to im-provement in internet services are all facilitators to early adoption.

In the developing world, the problems and challenges are different “The emphasis is on lowering the test costs while providing accurate analysis. The systems built for west-ern world have not been successful in finding markets in the developing world because of high pricing as well as stringent environmental require-ments for cleanliness, conditioned labs, etc. Also, the servicing of such equipment is a concern,” stated Pe-rugupalli.

Due to these constraints, and also the

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Biospecial

DR SANDEEP SEWLIKAR Head – Medical & Scientific Affairs,

Roche Diagnostics India

historical lack of mid-high tier com-puting and networking capabilities at pathology labs and hospitals, digital pathology has remained at a nascent state for several years now.

“The opportunity is for developing world to take a big stride in health-care by embracing digital pathology to bridge gaps in coverage and qual-ity between the few central labs in large cities and the rest of the labs elsewhere across the country,” said Perugupalli.

Digitization involves a mindset change that demands moving from microscopes to monitors for diagno-sis and this is also one of the reasons for delayed adoption.

“Studies have shown that the attitude of the pathologist towards the digi-

tal workflow is important. For more than a 100 years pathologists have been working with the conventional microscope, so the most difficult part is to learn to trust the digital image,” said Driessen.

He continued, “the digital transition of the pathology workflow is much more than a technical experience, and change management is key to be successful. Education and user-training, together with the digital pathology vendor, can help. Though the old way was good, the new way knows no boundaries. While work-ing with the digital workflow, it will show pathologist what this innova-tion means to their profession.”

Digital pathology makes tele-pathol-ogy a reality, and fills holes in the basic infrastructure prevalent in the

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Biospecial

developing world. It raises quality of services, while raising productivity of the specialists. These factors, coupled with innovative business models, are expected to make digital pathology wide-spread in the developing world. However, to achieve this goal, sys-tems need to be designed keeping the local conditions in mind, and a one-size-fits-all solution has less likeli-hood to be successful.

Limitations of WSI

The biggest limitation to widespread adoption of WSI has been cost. High-end microscope with automated scanning stage is needed, and also large amount of storage and image processing software is required to perform WSI.

“WSI can be used to review histologic sections, cytology slides, and/or he-matology slides to render diagnosis. Validation of WSI is crucial to ensure that diagnostic performance based on digitized slides is at least equiva-lent to that of glass slides and light microscopy. Currently, there are lim-ited standard guidelines regarding validation of WSI for diagnostic use,” said Dr Sewlikar.

Driessen added, “Until now, there has been little public guidance provided to the industry with respect to the regulatory route in the United States. Through close collaboration among all the benefactor members of the Digital Pathology Association (DPA) including Leica Biosystems, Omnyx, Philips and Roche, the industry was able to work with the FDA to gain valuable clarity and guidance.”

New systems are being proposed around the world to bring digital pa-thology and WSI to neighborhood labs, while making compromises on some aspects that are specific to de-mographics.

Digital pathology for personalized medicineThe use of digital pathology has the potential to enhance the patholo-gist’s contribution in the successful development of personalized target-ed therapy. One of the components of personalized medicine for cancer patients includes the standardization of biomarkers for identification of a molecular target, and the application of an effective therapy against it.

“In digital pathology, there are in-built quantitative companion diag-nostic algorithms that help in selec-tion of patients for targeted therapy. For clinical laboratory applications, the confidence levels for reporting is further enhanced if these algorithms are backed by regulatory approvals like the FDA,” said Dr Sewlikar.

Personalized treatment options de-mand a more confident diagnosis. Collaborative involvement to obtain and integrate relevant information from different disciplines is neces-sary to achieve this goal.

“Developing an effective treatment plan requires access to related patient

information from multiple sources (EMR, LIS, PACS). The development of specific algorithms for automated interpretation of advanced stains will facilitate the objective analysis of im-ages.

By developing advanced algorithms and data management systems, we can help researchers translate the ‘Big Data’ promise into knowledge,” said Driessen.

With digital images, the ability to run many software tests as you can on the same images provides the potential to flag any abnormalities that weren’t prescribed for testing at the current time. This has the potential to dis-cover and alert conditions that may be at nascent stages and yet to cause a noticeable physiological change to the patient.

“Based on digital images obtained from a number of specimens, new predictive insights can be drawn that have a bearing on demographics, socio-economic and environmen-tal conditions, leading to actionable outcomes from personal as well as public health level,” said Perugupalli.Although digital pathology was pri-marily intended for second opinions and consultations, the biggest benefit it provides is in terms of improved workflow management in the ana-tomic pathology lab.

While embarking on a journey of digitization, it is important to iden-tify an industry partner who can provide the requisite high speed scanners and also support entire journey from IT integration to effi-cient image and workflow manage-ment. Ultimately this digital pa-thology workflow will help increase service levels to physicians, reduce cost and improve care. BS

PRASANTH PERUGUPALLI co-founder and CEO at Spectral

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BioFeature

In the entrepreneurial world, the ‘R’ word is the most hated word as much as it is popular. Start-ups

very well know that ‘R’ stands for ‘Risks’ – an inevitable and a mandatory bait every entrepreneur

has to bite -- either bite the dust or the biggest ever Apples.

Risks are said to be the biggest opportunities to any start-up -- a part-and-parcel of any

entrepreneurs’ journey. Not all risks are bad. Risks, in fact, help steer a company in the right

direction or innovative ideas. What really matters is which risks are worth taking or otherwise, and

how those risks are handled, which determine the unpredictable outcomes. BioSpectrum peeks

into the Indian Life Sciences start-ups scene unearthing mysteries and decoding the art of de-risking

start-ups – all straight from the industry’s entrepreneurial captains.

Start-ups: Deciphering the de-risking strategy

BioFeature

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BioFeature

B y virtue, all start-ups have inherent risks. Life Sciences start-ups are seen to be more risky than other fields like e-

commerce or Information Technol-ogy (IT). In healthcare, despite its engineering, scientific, designing and execution prowess, there is always a risk of setbacks.

“However, entrepreneurs or inven-tors would be rewarded with enor-mous impact on healthcare, and the associated economic benefits, if they are able to persevere and if they take their invention on a wider commercial adoption,” adds Nishith Chasmawala, co-founder, Consure Medical.

According to him, Consure Medical has had some momentary setbacks but fortunately there were no trajec-tory altering situations or compli-cations where it has not recovered from. “On the other hand, challenges like clinical adoption, pricing, reim-bursement, manufacturability, team, and investment cycles, are scenarios where entrepreneurs must continue to persevere,” he advices.

But Pawan Samdani, a graduate from Indian Institute of Technology (IIT) Delhi, and director and founder of Eumentis Informatics, says that ven-turing into Life Sciences cannot be termed as risky.

“I would call it as ‘more difficult’. It is not easy to secure funds in this space. These start-ups have direct impact on human lives and hence have strict regulations and quality control mea-sures which need to be meticulously followed. Lengthier product lifecy-cles and huge infrastructure needs coupled with greater fundings and delayed profit generation are the main reasons,” he comments.

The director of FIB-SOL Life Tech-nologies Dr Kavitha Sairam feels risks are unavoidable when starting up in the Life Sciences.

“However, starting up in this area can be turned into a myth through a thorough study of the problem, proposing simple and affordable so-lutions, and having a beta product which could be marketed to win the confidence of investors,” she voices.

She points that risky situations may be different for different start-ups, depending on their existent stage.

“In our case, the initial sustenance of the team was an issue, and a big

threat due to shortage of funds. My co-founder had to support himself by taking up another job in a differ-ent city, and had to shuttle to and fro. It was indeed a very difficult time for us, but we kept up together and tried to resolve the issue by getting more money into the company. Our knowledge in the technology, and our network helped us overcome the situ-ation, and we raised sufficient funds to sustain,” she recalls.

She lists a few risks worth handling and those that are not. “Venturing into new ideas is worth exploring. A market with huge competitors could be chosen if the start-up is able to offer solutions to problems the com-

Nishith Chasmawala Co-founder, Consure Medical

Looking at the entire development and commercial timeline as early as possible.

Identifying regions of greatest challenge or uncertainty with the technology or company, and developing contingency plans to address these questions early.

Leveraging the global industry and community knowledge, and experience.

Keeping multiple growth options, and even more options for survival.

Fundraising and structuring efficiently to get through the key milestones as needed.

Sam Santhosh Chairman, MedGenome

Developing services component in an area synergistic to the main product area -- ensuring cash flow and industry exposure.

Focusing on building intellectual properties and skills in a key domain where large companies have interest. This would allow future licensing opportunities or collaborations with leading players.

Reading and publishing in

DE-RISKING A START-UP: FROM THE INDUSTRY’S

ENTREPRENEURIAL CAPTAINS

Challenges like clinical adoption, pricing and investment cycles are scenarios where entrepreneurs must continue to persevere


BioFeature

petitors do not address. One can also try unexplored technical solutions to existing problems. It is also impor-tant to afford a good team and facili-ties without compromise. This will greatly help to develop innovative technologies,” Kavitha explains.

“Raising funds more than you re-quire might dilute you at an early stage and could deviate you from your core competences. It is also not worth to disclose your technol-ogy to collaborators without a formal agreement. To be very passionate with the technology is a boon, but clinging too much to the technology may blindfold one from identifying the right markets. This would also prevent start-ups from reinventing new technologies in case of failures,” she says. “At the end of the day a Life Sciences start-up is a risky one, and we know it. But on the other side, success in this sector would mean a lot to entrepreneurs and as well as the society as most of the solutions offered by biotech start-ups has huge societal impact.”

Ms Firoza Kothari, co-founder, Anatomiz3D Healthcare, agrees that though it is risky to start a business in the Life Sciences, having a sound knowledge about the problem, prod-uct and regulations can de-risk a start-up to a great extent.

Risks in the Life Sciences isn’t a myth, shares Ms Monisha Hajra, founder of Bangalore-based start-up ScientiaBio.

“If one is coming up with new servic-es or products, then market research, technical advancement knowledge, and regulatory bottlenecks needs to be checked properly...” she high-lights.

In 2009, when ScientiaBio was start-ed with emphasis in consulting and

training in the clinical trials domain, the company witnessed very good business in the first 3 years.

“After that we saw a deep downfall in the business in India because of regulatory challenges. The Supreme Court verdict threw the clinical tri-als space into darkness. We soon started focusing on countries like Singapore, Malaysia, and UAE where

it was more promising. In India, we expanded beyond the clinical trials’ vertical, and went into the domains of pharma where there is very good scope,” she states.

Dr Aman Sharma, Founder & Direc-tor, ExoCan Healthcare Technolo-gies, categorizes risks as societal, fi-nancials, and growth risks.

“However, the hidden truth is that large number of opportunities go in parallel during the R&D phase of



renowned scientific magazines.

Keeping track of scientific and technological developments.

Attending scientific conferences.

Avoid cocooning – collaborate with leading institutions globally.

Avoiding looking up to the Gov-ernment for subsidies and SOPs.

Standing on own feet.

Pawan Samdani Director & Founder, Eumentis Informatics

Following regulations, good manufacturing and quality control practices.

Good fund management.

Hiring qualified, diverse team.

Dr Kavitha Sairam, Director, FIB-SOL Life Technologies

Focusing on prevalent problems and addressing them with simple technical solutions.

Developing technologies driven by market, than the passion for technologies.

Avoiding venturing into spaces with no competitors – an indicator of high-risks and increased failures. Trying existing markets with more innovative products.

Attracting investors who could possibly be technical and business collaborators.


BioFeature

a start-up. With every experiment yielding anticipated or unanticipated results, one has the potential possi-bility of identifying serendipity in sci-ence and converting it into a product or a service,” he opines.

He states that risks are ever prevail-ing in Life Sciences until there is a validated and marketable product.

“Since most of the time goes in per-forming R&D, the many variables keep the uncertainty on for a Life Sci-ences start-up. We also faced a situ-ation where we anticipated that in a given timeframe we may not be able to get over with our proposed R&D. The beauty is that in a Life Sciences start-up, with more uncertainty you get more chances of observing things and one of them could be your un-anticipated product or technology. The classical example is the discov-ery of antibiotics. I believe that a Life Sciences start-up brings along one-thousand risks, albeit with an in-herent de-risking possibility,” Aman elaborates.

He advices, “Build a good team, in-vest in R&D, and expand the network by connecting with like-minded sci-entists and individuals. Invest op-timal in patents, as these intangible assets add up to the valuation of company. Do not unnecessary fall prey to awards and competitions as one might lose focus. They will follow once you have a product or a service.”

On the other hand, Anant Agarwal, Founder, Indoriv Clinical, a Kolkata-based start-up, adds that partial risks are encountered by Life Sciences start-ups.

“Excellent documentation is ex-tremely essential in Life Sciences. The industry will give you several conflicting views on how to man-age something. But build your own.

Stick to the basics. Don't overwrite and over think…. Keep a proper track of finances. Streamline the payment process. This small step goes a long way in keeping your start-up alive. Hiring a simple and good accountant can do this trick,” he stresses.

He feels that it is worth a risk in spending on good technologies and machines.

“They will eventually give you good returns even though the gestation periods might be higher. People are getting focused on their health ev-ery day. More than 90 percent of our Healthcare and Life Sciences technol-ogies in our country is not updated…

Besides technology, it makes sense to keep some extra trained hands in the company…” Anant says.

Dr Nilay Lakhkar, Founder & CEO, SynThera Biomedical, notes that Life Sciences start-ups are no different from other start-ups.

“….Risks are an inherent part of all the steps in the Life Sciences start-up lifecycle. For instance, a product test results may not be as good as antici-pated, or one may face difficulties in maintaining quality as they scale up their technology, or they may find that their technology itself is at risk of becoming obsolete even before they make their first sale. The regu-



Ms Monisha Hajra Founder, ScientiaBio

Optimizing as less as possible on financial risks.

Starting a new company while launching newer products or services.

Having good mentors or advisors.

Dr Aman Sharma Founder & Director, ExoCan Healthcare

Technologies

Providing best services.

Envisaging time-bound pipeline of potential end-products and services.

Strong project management.

Interlinking projects save costs, technical expertise, and accelerate R&D.

Anant Agarwal Founder, Indoriv Clinical

Reading and more reading.

Hiring intelligently.

Planning business and

The beauty is that life sciences start-up with more uncertainty you get more chances of observing things


BioFeature

latory scenario for a proposed prod-uct may change overnight, leading to cost and time over-runs. Finally, start-ups may even find that they don’t have the resources to deal with competitors who may be MNCs with deep pockets. Any aspiring Life Sci-ences entrepreneur must be willing to face these risks and accordingly shape their company’s strategy,” he expresses.

SynThera, in fact, faced its own risky situation during the funding pro-cess post applying for a Government grant in 2015.

The founders didn’t receive funds despite doing well in the final round of selections. They weren’t given proper feedback explaining why they didn’t receive the funding. Hence they weren’t sure what they could do to improve their application if they wanted to apply again.

“However, we decided to take this setback as an opportunity to intro-spect and understand how we could improve our product offering. We took the time to re-evaluate who ex-actly we wanted to sell our products to. Once we decided our customer base, we talked to dozens of prospec-tive customers within that customer base who gave us very useful feed-back on what they wanted to see in any products we sold them. Finally, we looked much more closely at our competition to understand the gaps in the market where our products and technologies could play a major role. The result was a much sharper proposal when we applied again for the same grant, and we received the funding after the grants committee appreciated our technical expertise and, crucially, our in-depth under-standing of the target market,” Dr Nilay recalls.

There are risks which are termed as

calculated ones, which are seen as more favorable by many entrepre-neurs. Dr Nilay justifies, “An aspir-ing Life Sciences entrepreneur would probably do well to first obtain sev-eral years of work experience in the Life Sciences sector before taking on an entrepreneurial role. This would provide a more realistic picture of both the challenges and the oppor-tunities that the entrepreneur can

expect once they decides to take the plunge.”

Ms Monisha emphasizes that there cannot be any rules on taking risks.

“Start-ups should keep taking smaller risks at regular intervals. One needs to take calculated risks -- of course some decision may backfire. But if we don't take some risky and bold deci-sions, how will we know which one will backfire and which will reward?” she asks.

financial goals.

Networking and communicating with the industry.

Dr Nilay Lakhkar Founder & CEO, SynThera Biomedical

Gaining in-depth understanding of target market and knowing potential customers.

Networking and expert advice.

Focusing on single key product.

Determining IP scenario for products.

Being realistic on business assumptions.

Responding quickly to changes in business environment.

Maintaining a healthy work-life balance.

Tony Jose, CEO, Clevergene Biocorp

Having a vision for the company to measure progress.

Maintaining good relationship between the entrepreneur and the team in identifying issues and solutions.




BioFeature

FIB-SOL's founders Mr Anant Raheja & Dr Kavitha Sairam

She further adds, “In my 9 years’ journey as an entre-preneur, I have learned that one can't learn from other people’s mistakes.

“Every entrepreneur’s situation, business and market idea is very different. So, each entrepreneur should have their own rule book for mistakes, learning and rewards. Being a Life Sciences entrepreneur is not an easy call-ing. We directly or indirectly deal with human life. One mistake can be very every expensive. We don't have the luxury of ‘return policy’. Be proud of yourself on having the ability to take the holy dip of being in such a risky business.”

Business in general is risky, and the same degree of risk is applicable for Life Sciences too, believes Tony Jose, CEO, Clevergene Biocorp.

“Taking risks is very subjective and hard to explain. Per-sonally I am willing to take risks that at least will give me a life lesson!” he mentions. BS

Raj Gunashekar

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


BioTalk

Betting big on India’s bioseparation space

US-based Spectrum Labs -- a leader in developing and manufacturing prod-ucts for the bioseparations and cell line management -- ambitiously entered the Indian market in January this year. The company’s president Anthony J

MacDonald, who was formerly with Pall Corporation, recently visited India in setting up and overseeing the company’s establishment in Bangalore. He exclusively spoke to BioSpectrum offering a glimpse into Spectrum’s India expansion strategies, further investments, plans on M&As, and the market outlook.

Spectrum Labs makes products and services to the Bio-pharmaceutical and Pharmaceutical industry. It majorly manufactures filtration, purification and separation-re-lated products.

The company, a private firm, was founded in 1970, and is headquartered in Los Angeles, California, USA. It has 3 manufacturing sites in the US, along with an engineering

site, and 2 logistics sites, totaling up to 6 campuses in the US alone. In 2012, it ventured into China, and the same year extended its European office further. In January 2016, India witnessed the entry of Spectrum Labs into the country in Bangalore city.

“Our intention in India is to help customers, and grow with them in the biotech and biopharma space. We di-rectly want to service our customers. The type of products we make involve a lot of interactions with them, and we want a crystal clear understanding of their requirements and provide the necessary services,” voiced Anthony MacDonald, president, Spectrum Labs.

Currently, the bioseparation industry is seeing a major trend, which is, going from the traditional fed-batch fer-mentation process to perfusion fermentation, a continu-ous process.

MacDonald added that India has multiple growth driving factors for the company. “Firstly, a lot of companies are

Anthony MacDonald President, Spectrum Labs


BioTalk

expanding vaccine manufacturing in a big way here in In-dia. Then there is biosimilars entering the Indian market in a big way. They are going to be our growth drivers in India,” he commented.

When asked about the company’s strategies in handling competition from small and medium enterprises (SMEs), MacDonald shared, “We make our separation technology in a competitive manner, which is best in the US and Eu-rope. We compete well with the SMEs and take on the challenge. When we bump into them, we always see what their advantages are and play on those. We ensure cus-tomers see the value of our products and services.”

“We are getting familiar on how to do the business in India. There are a lot of regulatory challenges. We have an experienced director here in India who is now guid-ing us. Indian market is different from other markets. When we opened our China office in 2012, it was quite a learning curve. We use that as a blueprint in conducting business in India. We apply that concept and work with the local consulting group. People say Chinese market is hard. Yes, it is! But India has more pages of regulations to work with. Indian market is not necessarily difficult but you just need to know how to, and be familiar with the market,” he explained. The company’s president also revealed that Spectrum Labs will expand further within India in a stronger way.

He opined, “We are profit-driven. We want to get to a profitable stage in India. Once we are there and can main-tain a good sustainability, we are going to add other sites in India. But for now, first we want to build the business in Bangalore. Once we are up and running here, we will invest in other sites. We are working on that right now. Our next destination could be metros like Chennai, Hy-derabad, or Mumbai.”

Spectrum’s R&D happens predominantly in the US. It in-vests a significant 2% to 5% of its revenue into its R&D annually. “As we expand further, our R&D will happen at various centers. Our technology is evolutionary, and we are working along with our customers. Our R&D product development comes from the field, and from our technol-ogy sales force, and also from the in-house engineering teams,” MacDonald expressed.

Most of the company’s revenue is generated from the US markets. He highlighted, “But the revenue percent-age will decline as we grow further. For example, 12 years ago, our revenue from North America was 80%. Today, it is down to 60%. The rest of the world contributes 40%.

“Right now our Asian revenue stands at 15%. But, in the next few years, Asia will represent over 30%.

“We also believe that our distribution revenue will be 40% in the US, and 60% from the rest of the world. In the next 5 years or so, out of this 60%, Asia and Europe will contribute to 30% each.”

The company has a plethora of reasons in choosing Ban-galore as an entry point to the Indian market.

“Bangalore is the home to the IT industry. As we grow and invest in business, IT is going to play a bigger part in it. Companies who are competing with us are also based in Bangalore. It’s a home to our type of industry, and the weather is simply perfect,” MacDonald justified. As of now, the company is very bullish about the Indian market. “We invest a lot of time and money in membrane technology and its applications. We are looking forward to work with Indian customers in the biotech, biophar-maceutical and pharmaceutical industries to help them grow.

Will the company take M&A route in India? ‘Yes,’ Mac-Donald stated. “We are open to M&As. We cannot share anything about it at the moment. But we do have plans for M&As in India.” BS

The company has a plethora of reasons in choosing Bangalore as an entry point to the Indian market.

Raj Gunashekar


BioPeopleA

ppoi

ntm

ents

NuGEN Technologies appoints New CEONitin Sood comes to N u G E N from Perki-n E l m e r , where he served as Vice Presi-dent and G e n e r a l

Manager of their life science instru-ments business spanning a portfo-lio of products in imaging, detec-tion, tissue pathology, automation and NGS sample prep.

Prior to his current role, Sood was the Chief Executive Officer of Bore-al Genomics, a developer of ‘liquid biopsy’ tools for non-invasive de-tection of tumor mutation profiles.

Prior to that, Sood served as Gen-eral Manager of the Automation and Electrophoresis business units at Agilent Technologies, where he commercialized several successful products in the sample prep mar-kets. He holds master’s degrees in both computer science and molecu-lar biology.

He succeeds Elizabeth Hutt who recently left to pursue another op-portunity.

“Nitin’s track record of success, technical expertise, and exten-sive experience in product com-mercialization made him the ideal person to lead NuGEN through its next phase of growth and innova-tion,” said Jeff Bird, Chairman of NuGEN’s Board of Directors and a Managing Director at Sutter Hill Ventures.

BioPeople

127, Bussa Udyog Bhavan, Tokershi Jivraj Road, Sewri Mumbai - 400 015. INDIA

Tel: 91 22 24166630 / 24173493 Fax: 91 22 66627766 E-mail [email protected] www.rosalina.in

m-VROC is the leading small sample viscometer in biopharmaceutical

applications used routinely by the leading biopharmaceutical companies at

multiple locations globally. m-VROC is the ultimate viscometer for small sample

protein therapeutics as little as 20 microliter and high shear rate viscosity

measurement up to 1,400,000 s .

Accuracy: 2% of readings

Repeatability: 0.5% of the range

Viscosity range: 0.2 ~ 100,000 m-Pas

Shear rate range: 0.5 ~ 1,400,000 s

Sample volume: 20 microliter +

Specification :

Description Accurate, Precise and top-of-the-line viscometer for R&D application

Min sample volume 20 µl

Maximum shear rate, s-1 0.5 ~ 1,400,000

Viscosity range, mPa-s (cP) 0.2 ~ 100,000

Temperature range* 4~70 oC

Portable No

Accuracy 2% of Reading

Repeatability 0.5% of full scale

Temperature sensor Built-in

Software Included

Non-Newtonians ? Yes

Temperature sweep Yes

Shear rate sweep Yes

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BioPeople

Sanofi India elects new Chairman

Sanofi India Limited (SIL) an-nounced the election of Aditya Na-rayan as the Chairman of the Board of Directors.

“Sanofi India Limited is privileged to have Aditya Narayan as Chairman of the Board of Directors”, said Dr Shailesh Ayyangar, Managing Direc-tor - Sanofi India Limited. “For over 60 years, Sanofi India has played the role of a committed and respon-sible company by making world-class medicines accessible in India, and meeting the challenges of our na-tion’s growing disease burden. Sano-fi India welcomes Narayan, with his

commendable track record as a cor-porate leader, to guide it through the emerging complexities in the Indian pharmaceutical environment.”

Commenting on his new role, Aditya Narayan, Chairman, Sanofi India Limited, said, “Sanofi India Limited has a superb track record of build-ing strong pharmaceutical brands, several of which are now household names. Its world class manufactur-ing facilities and ethical marketing practices enjoy a reputation for ex-cellence in serving its growing cus-tomers in India and overseas. It is a privilege for me to have been en-trusted with the role of the Chairman of the Board of Directors of Sanofi India Limited and I look forward to the support of all its stakeholders in discharging my responsibilities.”

Aditya Narayan, 64, has rich experi-ence in industry for over 40 years. He served ICI Limited, now Akzo Nobel India Limited, for about 30 years across diverse functions and busi-nesses. He was its Managing Director during 1996-2003.

Mundipharma’s Raman Singh listed among top five in global Power List

Raman Singh, president, Mundip-harma Asia Pacific, Latin America, the Middle East and Africa, has been ranked the world’s fourth most in-fluential person in the pharmaceu-tical industry by the UK’s Medicine Maker.

This comes after Mundipharma achieved year-on-year growth of 79 percent, expanded its business hub in Singapore and begun construction of an R&D and manufacturing facil-ity in the city-state. Singh was among only two executives from the private sector, and the only Asian-based per-son, to be ranked within the top five.

The Medicine Maker’s Power List ranks the top 100 most influential people in the global pharmaceuti-cal industry who inspire change by solving business problems, founding research and championing causes. It includes top executives, academics and other professionals from leading companies.

PPD appoints veteran bioanalytical leader as Immunochemistry HeadPharmaceutical Product Develop-ment has announced that Bruce Stouffer has joined PPD as executive director of immunochemistry in the PPD Laboratories’ bioanalytical lab.

“Bruce brings extensive experience and strong leadership skills to our tal-ented immunochemistry team,” said Dr David Johnston, executive vice president of global laboratory servic-es for PPD. “As a recognized industry leader, Bruce is an exceptional asset for our clients’ research programs.”

Stouffer previously served as direc-tor of analytical and bioanalytical de-velopment for Bristol-Myers Squibb, where he managed a group of scien-tists with responsibilities including contract operations, quality control, and small and large molecule bio-analytical project management. Pre-viously, Stouffer was responsible for the bioanalytical sciences late-phase group, responsible for management of post-Phase II bioanalysis, as well as support for new chemical entity (NCE) filings.

Awards


BioSuppliers

Research support ‘BYOD’ approach in clinical trialsICON has announced research show-ing many pharmaceutical and clini-cal research organisations (CROs) support the use of a ‘Bring Your Own Device’ (BYOD) approach in clini-cal studies, enabling patients to use their own mobile devices to collect patient-reported outcomes (PRO) data. The research highlights how commonly-cited concerns around the use of patients’ own devices are not as much of a deterrent to adop-tion as is often thought.

There are two main areas of con-cern in using a BYOD approach for PRO data collection in clinical stud-ies. The first relates to equivalence and how different device sizes and

operating systems might affect the measurement properties of a PRO instrument. The second relates to the technical and practical aspects of us-ing a patient’s own device, including data capacity, upgrades to operating systems and a change of device mid-

study, which could negatively impact PRO data collection.

ICON’s research, completed in as-sociation with Medidata and mProve Health, measured attitudes towards these perceived concerns and pro-vides industry with further infor-mation to devise future strategies for BYOD adoption. The survey measured attitudes from 79 respon-dents from biopharma, CROs, ePRO providers, patient advocates and research institutions. The survey results found that biopharma and CRO professionals appear to be sig-nificantly less deterred by challenges of equivalence and the practical and technical challenges.

GE launches Biacore molecular interaction analysis platformGE Healthcare’s Life Sciences busi-ness launched the first of a next gen-eration of Biacore systems harnessing Surface Plasmon Resonance (SPR) technology. Biacore 8K marks the start of a new generation of Biacore systems maintaining the high data quality expected from Biacore at high throughput. New design features effi-ciently address current industry chal-lenges such as understanding com-plex targets in drug discovery.

Label-free SPR analysis is a vital tool in the scientist’s analytical toolbox, providing a dynamic understanding of how molecules interact and en-abling a thorough understanding of drug/target interactions. This new platform further enables the use of

SPR throughout drug discovery, de-velopment, and manufacturing. Bi-acore 8K specifically supports small molecule and biotherapeutic screen-ing and characterization with the quality of affinity and kinetics data scientists expect, increasing opera-tional efficiency.

“As users push the boundaries of SPR, we are working closely with them to deliver the type and speed of analysis that they are looking for,” commented Ms Cindy Collins, CEO/GM, Protein Purification & Analy-sis and Cell Therapy for GE Health-care’s Life Sciences business. “We are also seeing an increase in the use of label-free SPR-based analysis in the immuno-assay area, replacing tra-

ditional ELISA-based methods and some cell-based assays. Supporting early-stage complex biotherapeu-tics development is also in demand, as well as process development and quality assurance.”

Biacore 8K is the first of a new gen-eration platform specifically devel-oped to deliver enhanced produc-tivity and performance up to eight times faster. Completely redesigned hardware and software takes label-free SPR-based analysis well into the future, delivering high-quality data that supports better and faster deci-sion-making across all areas of drug discovery, including small molecule and biotherapeutic screening and characterization.

BioSuppliers


BioSuppliers

Boston Scientific conducts awareness and screening campsOver 1,000 people received free check ups and counselling for digestive problems at patient screening camps that were held in nine cities (Delhi, Kolkata, Bengaluru, Kollam, Hyderabad, Manipal, Kota, Ahmedabad and Indore). In these camps, leading medical devices company Boston Scien-tific India offered free check ups and counselling for people with any diges-tive tract problems.

Prabal Chakraborty, Vice President and Managing Director, Boston Sci-entific India said, “Our mission: Advancing science for life” accurately re-flects what we do for patients, physicians, and healthcare systems globally. Our intent behind this initiative was to encourage people to come forward and take charge of their digestive health, which is an often ignored and misunderstood area. For example, many individuals do not understand that a heartburn has nothing to do with the heart but is a form of indiges-tion. Parents are often unable to understand what might be wrong when their kid complains of a stomach ache. Problems in the digestive tract can be very distressful. But increased awareness about the causes and symp-toms of common digestive health problems along with advanced medical

devices and procedures leads to better prevention, diagnosis and treatment of digestive disorders.”

1,000 patients attended the awareness and screening camps.The gastrointestinal problems in-vestigated were: Gastroesophage-al Reflux Disease (GERD); Inflam-matory Bowel Diseases (IBD) such as Crohn’s Disease and Ulcerative Colitis that cause abdominal pain, diarrhea, rectal bleeding, weight loss and fever.

Medtronic, Qualcomm collaboratefor diabetesMedtronic and Qualcomm through its wholly-owned subsidiary, Qual-comm Life, announced a global, multi-year collaboration to jointly develop future generation continu-ous glucose monitoring (CGM) sys-tems that aim to improve health out-comes for people with diabetes.

By giving insights to doctors and people with type 2 diabetes concern-ing glucose levels, the companies in-tend to enable more informed care, especially for those who do not have control of their diabetes today.

The collaboration seeks to lever-age Medtronic’s market-leadership in diabetes management and Qual-comm Life’s expertise in developing reference designs for wireless, single-use and small integrated modules to create more affordable, easier-to-use CGM systems, including a new sen-sor and smaller design that can pro-vide near real-time and retrospective glucose data. The initial focus of the collaboration will be to develop a sin-gle-use CGM system.

Frontier Mediville to pioneer mechanical artificial heartsDr K M Cherian of Chennai-based Frontier Mediville signed an MoU with SPUTNIK, Russian Federation for the manufacture of a mechanical artificial heart. It is to be noted that SPUTNIK, the Russian organization, was responsible for launching the 1st Space Shuttle in Octo-ber 1957, which took the Americans by surprise and now the company has further excited the World by creating mechanical artificial hearts.

The MoU was signed with Sergey Sannikov in the presence of Padma Bhushan Dr A Sivathanu Pillai, Father of Brah-mos Missiles. According to the memorandum, it will be possible to produce the mechanical artificial heart within

the cost of Rs 30 lakhs, which will be very cheap and af-fordable to many in the world compared to the others.

At the press briefing, Dr Cherian, said, “There are more than one lakh patients who had artificial hearts last year in North America alone. The latest artificial heart cost Rs 90.5 lakhs including implantation and it goes beyond 1.25 crores. It is essential for the hospital to have a stand-by heart in case if the implanted one fails. So the actual cost for the hospital/patient is around 2.5 crores. As you can imagine how many of our 1.2 billion population can afford it? The artificial hearts are made in US by Heart Mate, Thoratec Corporation, California, USA.”


BioSuppliers

Medtronic strengthens commitment to Asia

PacificMedtronic announced the opening of its new Asia Pacific regional headquarters in Singapore. The new facility, which houses the Asia Pacific Service and Re-pair Centre of Excellence, will strengthen and support Medtronic operations across 80 locations in Asia Pa-cific.

This will further help Medtronic deliver on the grow-ing demand for medical products and services.

With the opening, Medtronic International signed a Memorandum of Understanding with SingHealth to develop a Centre of Excellence in the treatment of dia-betes across Southeast Asia.

“The opening of Medtronic regional headquarters in Singapore marks an important milestone in our grow-ing presence in Asia Pacific. We continue to leverage our regional expertise and partnerships to reach more patients, in more places and through more ways via collaborating with new partners,” said Bob White, president, Asia Pacific at Medtronic.

“The rising prevalence of diabetes in the region is driv-ing up healthcare costs and adversely impacting the lives of millions of people. There is tremendous oppor-tunity to improve treatments across the diabetes care continuum via meaningful innovation and collabora-tion. We are excited to work with SingHealth as our strategic partner to explore new approaches in solving

challenges as-sociated with diabetes care.”

The alli-ance will pair Medtronic expertise in advanced diabetes man-agement so-lutions with SingHealth’s experience in holistic diabe-tes care.


Biopreneur

Biopreneur

I SHIELD

Armoring against allergies and infections

Imagine warding off allergies and infections just by armoring yourself with anti-microbial textiles! Sounds like one’s figment of imagination straight out of a Hollywood fantasy film

isn’t it? No. The medical textile armor that we are talking about may as well be real and happening right now as you read this.

According to World Aller-gy Organization (WAO), about 20-30 percent of Indians suffer from one or more allergies. In fact,

National Health Service (NHS), UK, states that 58 percent of allergies caused at homes are due to dust mites.

Adding to these woes is Healthcare - or Hospital-Acquired Infections (HAIs), which is a huge cost on the industry. The global HAI market is valued at $50 billion. Out of which, the US alone is worth $20 billion. One in 3 deaths in the ICUs is be-cause of infections.

About 90 percent of infections spread occurring in day-to-day life is via con-tact with soft surfaces which include bed linens, pillow cases, scrubs, doc-tor jackets and others.

The global infection control market is estimated to reach $16.7 billion by

I Shield’s Team: (L-R) Ashok Vohra, Director; Ms Aradhana Vohra, Operations; Dr Anand Anandkumar, Chairman; and Prasanna Raviraj, Operations


Biopreneur

2020, growing at a CAGR of 6.7 per-cent between 2015-20.

Dust mites are a common cause of asthma in children. Dust mites alone are responsible for 70 percent of common allergies medically termed as Allergic Rhinitis, which serves as a trigger point for asthma. There is a close relationship between fungus and dust mites, usually found on mattresses, bedding and furniture.

Fungus play an important role in the food chain of dust mites. It feeds on dead skin and hair and releases its byproducts, which are in turn fed by dust mites. Once the fungus is exter-minated, dust mites starve to death.Mattresses are a hot breeding ground for germs and dust mites, and is one of the major routes through which in-fection spreads.

Birth of a start-upBangalore-based InfectionShield (I Shield) Technology is the first bio-tech start-up to come up with anti-microbial textiles treated in a non-metal-based coating form, attacking both allergies and infections.

I Shield is involved in developing anti-infection and anti-allergy prod-ucts and technologies by integrating specialized molecules onto different delivery mechanisms like textiles, electronics and paints among others.

“We are able to bring science, ma-terial, textiles and build business around it,” says Dr Anand Anandku-mar, Chairman, I Shield Technology. He is the CEO and founder of anoth-er start-up Bugworks, and as well as one of the founders of Escape Veloc-ity Accelerator (EVA).

Armed with this basis, the I Shield team came up with textiles treated with non-metallic substrates in the form of bed linens, doctors’ jackets,

ups in the healthcare and life scienc-es space.

In 2015, EVA and SKL Medtech joined hands to spin-off I Shield.

The start-up took 6-8 months for its entire R&D activities including de-signing and developing its products.

The start-up’s advisory board in-cludes Prof S Ramaswamy, CEO of CCAMP & Dean of InStem; and Dr Shrikumar Suryanarayan, CEO of Sea6 Energy & former President, R&D, Biocon.

I Shield has a mix of talented profes-sionals with extensive experience in biotechnology, manufacturing, tech-nical textiles and material sciences.

The start-up now employees less than 10 professionals including the operations and sales team in Banga-lore, and at the factory in Tirupur in Tamil Nadu.

Innovative textilesI Shield’s anti-infection linen is a pre-mium grade cotton linen which has incorporated the company’s technol-ogy onto it which actively kills infec-tion causing germs and allergy caus-ing dust mites.

The start-up’s anti-infection mask is a 4-layered product, where each layer contributes to a unique function.

The first layer is anti-bacterial and actively kills pathogens. The next layer is a N99 particulate filter which filters out 99% of the particulate matter.

The third layer contains a layer of ac-tivated carbon which reduces odor. The last layer is anti-bacterial made of cotton, which kills pathogens on the inside as valve. In a hospital setting, doctors’ white jackets have

I SHIELD’S TECHNICAL TEXTILES:

Bed Linen

Doctors’ Jackets

Face Masks

Pillows & Pillow Cases

Uniforms for Caregivers, Food handling & Military personnel

face masks, pillows & pillow cases, uniforms for caregivers, food han-dling & military personnel.

Currently, the existing anti-microbial textiles in the market is metal-based, i.e., they are coated with silver, cop-per or zinc which act as antimicrobial agents.

But the process is expensive, and the products’ potential leaches over time along with the depleting efficacy of the metallic coating.

”The metal-based textiles work on the principles of leaching. Their ac-tive ingredients efficiency drops over time. Also, their residues can be an environmental hazard. In fact, zinc and silver take time to get active after exposure to microbial agents. Silver, for example, takes about an hour,” reveals Dr Anand.

Synergistic backgroundIn 2014, Tirupur-based Shakthi Knit-ting (SKL), a manufacturer and ex-porter of apparel solutions, spun-off its healthcare start-up SKL Medtech, with a mission to provide innova-tive healthcare solutions by offering medical and protective textiles. SKL Medtech is currently being acceler-ated at EVA in Bangalore.

EVA was founded in 2014 to acceler-ate innovative and promising start-


Biopreneur

been reported to be a carrier of infec-tions from one patient to another. I Shield’s anti-infection jackets active-ly kill germs and controls the infec-tions’ spread.

“We strongly believe that by con-trolling infections and allergies us-ing products that consumers use on a day-to-day basis, we can improve the overall quality of life,” comments Ms Aradhana Vohra, who heads I Shield’s operations.

Today, hospital infections are in-creasing and consumer awareness has gained grounds.

“India is the diabetic capital of the world. Diabetics have higher chances of acquiring infections. Also, cancer patients, post their therapies, show a compromised immune system mak-ing them prone to infections,” ex-plains Dr Anand.

According to the company, the textile substrates are tested on various mi-croscopic agents including bacteria, yeast, fungi, and dust mites.

The company has tested its products in Germany, Switzerland, Singapore, and India for different bacteria, en-suring the products’ safety and effec-tiveness under different conditions.

The start-up intends to first bring its products to Bangalore. “We are look-ing at global markets as well since our products are global. We want to reach out to other international mar-kets,” adds Dr Anand. I Shield has closed deals with Telerad RxDx (Ban-galore), Lifeline Hospitals (Chennai) and a hospital in Kolar district.

Another operations team member Prasanna Raviraj voices, “We are targeting the hospital and homecare segment which includes elderly citi-zens, diabetics, post-cancer therapy

patients, young children, immuno-compromised patients, and consum-ers who just want to create a healthy environment for their children.”

Raising fundsThe seed money for I Shield was channeled together by EVA and SKL. Close to Rs 1 crore has been the in-vestment in to the start-up.

“We’ll continue to be funded by both the entities. But this will change in the next 6 months. We’ll be approaching external investors by showing them our traction,” states Dr Anand.The start-up intends to raise Rs 4-5 crore depending on its expansion agenda.

In terms of valuation, it aims to touch $200-300 million in the next 5 years.

Moving aheadIn a few months from now, Singapore and the US will be I Shield’s prime markets for exporting its products.

“We want to engage with strategic partners in these geographies. First, we want to understand the markets well, ensuring our products get ab-sorbed well. We also would focus on understanding the regulatory mecha-nisms of other markets – Japan -- for example,” observes Prasanna. While the allergy and infection awareness has started increasing, it is still in its early lift-off stage in India.

“We have a lot of work to do to bol-ster awareness and educating con-sumers. Getting the right sales team and training our sales force with our medical message will definitely be

a challenge. The traction may take time. Funding too, will be a chal-lenge. Building a credible Indian brand is quite rough because people are more skeptical when it comes to Indian brands,” Dr Anand points.

He also emphasizes that India has run out of antibiotics and it is now left to the body’s immune system to fight infections.

“Drug-resistance in Bangalore can be up to 70 percent. Newer antibiot-ics will take time to happen. While we don’t have antibiotics, what we can do is we can change our policies to prevent the abuse of antibiotics in the food and pharma industry. The government should fund antibiot-ics research in the country which is a long-term solution. There must be newer policies preventing the sale of antibiotics and reduction of its use in foods,” he urges.

In the future, the start-up expects every household to have an I Shield product, where its products become a standard to fight infections. “A few years from now we’ll discover new anti-microbial salts, newer ways of connecting those salts and materials; and making wood anti-allergic and anti-infectious along with other sur-faces like doorknobs, tables and ev-ery surface that can be protected with safe material,” highlights Dr Anand.

Well, ask him what kills a biotech start-up? “If you don’t execute your plans you are dead meat! Plan execu-tion and taking advantage of situa-tions is crucial. If you have a product that is too ahead of the market, then all you do is create a platform for some big competitor. Most compa-nies close because their products are ahead of markets. Funding and rest are all secondary,” he says. BS

Raj Gunashekar

Diabetics have higher chances of acquiring infections.

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