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Breaking News andMarket Intelligence forthe Clinical Trials Industry
PRA wins U.S. Clinical Company of the Year award…2
Quintiles partners with Vietnam Ministry of Health…3
The Pulse on Technology…6 CWWeekly launches a new Pulse column today.
Insider Insights…7 Clinverse
Drug & Device Pipeline News…9 16 drugs have entered a new trial phase.
Trial Results…10 CenterWatch reports on results for three drugs.
Biotech Review…11 Biotech briefs from BioWorld Today.
CWMarketplace…12 Industry service provider profiles.
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page 5 »
The Physician Payments Sunshine Act—the new law designed to bring transparency to financial relation-
ships between physicians, teaching hospi-tals and the pharmaceutical industry—has many in the industry scrambling to meet the requirements for documenting payments and other transfers of value.
Under the law, manufacturers of drugs, medical devices and biologics that partici-pate in U.S. federal healthcare programs are required to track and report certain payments and items of value given to U.S. physicians and U.S. teaching hospitals to the Center for Medicare & Medicaid Services (CMS) by the 90th day of each subsequent year. The initial tracking period runs from
Aug. 1, 2013 to Dec. 31, 2013, with the first reporting deadline approaching March 31, 2014.
Among the payments to doctors that must be reported are grants—which must be approved, speaker’s honoraria, travel expenses, meals, entertainment, gifts, edu-cational materials, charitable contributions and current or prospective ownership or investment interest in a sponsor held on or after Aug. 1, 2013.
These have led to a scramble by drug and device companies of all sizes to determine how best to meet the reporting rules, ac-cording to Robyn S. Shapiro, a partner in Milwaukee law firm Drinker, Biddle & Reath
During the past year, TransCelerate BioPharma has become one of the most ambitious and successful
industry collaborations to date, bringing to-gether major pharmaceutical companies to share resources and work toward improving the overall efficiency of the R&D process.
As it begins its second year, membership has grown from 10 to 18 companies and the consortium has completed five projects that help standardize drug development processes and reduce inefficiencies for both sponsors and investigative sites.
Now, the collaboration has launched three new global initiatives: Create a stan-dardized template for clinical trial protocols, develop a network of sites that specialize
in clinical trials for pediatric and minority populations and establish a global registry of qualified investigators.
“TransCelerate has made significant gains in improving clinical trial efficiencies and streamlining the drug development pro-cess,” said Paul Stofells, M.D., chief scientific officer and worldwide chairman of pharma-ceuticals at Johnson & Johnson. “We are very pleased to see the power of collabora-tion at work for the benefit of patients.”
While the consortium has focused on addressing common problems in the pre-competitive environment, it also establishes a model for how companies competing to develop drugs that target the same disease
Companies scramble as Sunshine Act reporting requirements become a reality
TransCelerate launches second year with initiatives including protocol templates, investigator registry
CWWeekly (ISSN 1528-5731)Cheryl Appel Rosenfeld Editor-in-ChiefTracy Lawton, Stephanie Hill Drug IntelligenceMelissa Nazzaro AdvertisingHolly Rose Production
■■ PRA was named U.S. Clinical Company of the Year by the 2013 U.S. Clinical Researcher of the Year competition, organized by Phar-maTimes and supported by professional organizations including ACRP, CenterWatch and CORE. The competition recognizes the clinical excellence of U.S. researchers through a series of competency-based challenges reflecting real-life scenarios, judged by a panel of more than 30 senior industry execu-tives. This year, 64 finalists from 17 research institutions, pharma companies and CROs competed. “In the hustle and bustle of our day jobs, it is sometimes hard to find time to acknowledge the brilliance and expertise of our team members and what a fantastic job they do in driving forward clinical research. PRA is extremely pleased to be recognized in these efforts,” the company said in a state-ment. Covance won Clinical Team of the Year, Narvelle Delabruere of Children’s Hospital Central California won the Study Nurse title, Rebecca York of PPD won New CRA of the Year, Allison Tallon of INC Research won Experienced CRA of the Year and Promise Lawrence of PRA won Project Manager of the Year. The key theme of the 2013 competition was strategic partnering. The list of winners and finalists can be found at www.usclinicalresearcher.com, with photos and videos. The competition repre-sents a collaboration of pharma, CROs and site management organizations recognizing and encouraging talented clinical research professionals. Eileen Daniel, senior director, development operations at Endo Pharmaceuticals, is the new chair of the U.S. competition’s executive committee.
■■ Synexus has partnered with Northumbria Healthcare NHS Foundation Trust to es-tablish a clinical research facility at Hexham General Hospital, in North East England. Northumbria Healthcare NHS Foundation Trust is one of the largest and top perform-
ing NHS foundation trusts in the country and now is the first NHS hospital and com-munity health services provider to forge such a clinical trials partnership.
Ethics/Regulatory
■■ Following the publication of the report on innovation in regulating healthcare by the Medicines and Healthcare Products Regu-latory Agency (MHRA), the BioIndustry Association (BIA) urges the U.K. government to implement a properly funded and reim-bursed Earlier Access to medicines Scheme (EAS), which the group makes its number one recommendation. “I am pleased that the ex-pert group wants the European Medicines Agency to launch a call for adaptive licensing so companies could put forward pilot prod-ucts, and that the group proposes the idea of a new breakthrough designation for new therapies both at a U.K. and E.U. level,” said Steve Bates, BIA’s CEO. “In just a year since new rules were put in place in the U.S., 32 drugs have been granted Breakthrough Designation by the FDA,” he said, two of which already have been approved by the FDA. “If U.K. pa-tients are to benefit from the most promising new drugs and U.K. biotech companies are to develop those therapies here rather than overseas, we need a similar Breakthrough Designation scheme here,” said Bates.
CROs/Service Providers
■■ CROs ICRC-Weyer and Allied Clinical Man-agement have partnered to form MEDIS Research Group, combining clinical research
experience and services across all stages of clinical development. The decision came after observing a shift in the market toward consol-idation in the industry over the last few years. ICRC-Weyer and Allied Clinical Management, both based in Berlin, have been working together on several clinical trials, with Allied handling trial conduct, site management and monitoring, and ICRC-Weyer providing clinical data management, biostatistics and medical writing. MEDIS Research Group is in discus-sions with clinical labs and medical communi-cation experts to join the group and complete the range of services. The two companies have developed and implemented SOPs to streamline their collaboration processes and ensure one contract and one contact person to guide each project.
■■ JLL Partners, a middle-market private equity firm, and Royal DSM, a global life sci-ences and materials sciences company, have created a new global contract development and manufacturing organization (CDMO) for the pharmaceutical industry, with antici-pated sales of around $2 billion. It will be 51% owned by JLL and 49% owned by DSM. The company (provisionally called NewCo) has not yet been named. NewCo will be formed by combining DSM’s business group DSM Pharmaceutical Products (DPP) with CDMO Patheon. NewCo will have an end-to-end offering from finished dosage (drug products) to active substances (APIs) and a global footprint of 23 locations across North America, Europe, Latin America and Australia with about 8,300 employees. It will operate
as an independent standalone company. JLL will contribute $489 million in cash; DSM will contribute DPP. NewCo will acquire Patheon for $9.32 per share in cash, for a total value of $1.95 billion. Jim Mullen, CEO of Patheon, will be appointed CEO of NewCo. Mullen joined Patheon in 2011 as CEO; previously, he was CEO and president at Biogen Idec.
■■ The Vietnam Ministry of Health’s Admin-istration of Science, Technology and Training (ASTT) has signed a two-year agreement with Quintiles to enhance clinical research in Vietnam. They will collaborate to form a larger working group to address topics including improved processes for trial management, development of streamlined processes to improve trial efficiency and quality and train-ing for investigators and ethics committees. Quintiles has operated in Vietnam since 2005 and has offices in Ho Chi Minh City and Hanoi.
■■ Quintiles has launched Data-driven Trial Execution, leveraging risk-based monitoring to improve trial delivery. While the industry’s current approach to risk-based monitoring focuses solely on clinical trial monitoring, Data-driven Trial Execution combines study startup, project management, clinical moni-toring, data management and analytics to optimize trial conduct while meeting regula-tory demands and quality requirements for Good Clinical Practice (GCP). Quintiles Data-driven Trial Execution includes a central data surveillance team that performs ongoing reviews of data to monitor risk and facilitate the right action at the right time. It is pow-
ered by Quintiles Infosario platform, adding advanced analytics to provide a real-time view of a study’s status and progression.
■■ CRO Covance and NeoGenomics, a provider of oncology-focused genetics testing services, are collaborating to provide anatomic pathol-ogy and specialty laboratory testing services for global clinical trials. Covance’s clients will gain access to fully integrated anatomic pathology and histology (APH) services, including immunohistochemistry (IHC), fluorescence in-situ hybridization (FISH) and molecular testing. Covance will establish a laboratory at NeoGenomics’ Fort Myers, Fla., facility and, with NeoGenomics, will provide a full range of APH, tissue-based biomark-ers and other specialty testing services. The companies will then expand joint capabilities globally at Covance’s central labs in Shanghai, Geneva and Singapore. Covance will have access to NeoGenomics’ medical and scientific networks of more than 500 pathologists. Ne-oGenomics gains access to Covance’s market reach, client relationships and trial experience.
R&D Trends
■■ Berg, a biopharmaceutical company com-mitted to a data-driven, biological research approach, and the Icahn School of Medicine at Mount Sinai have formed a five-year phar-maceutical and diagnostic R&D partnership to leverage the power of multi-omic biology and data analytics to obtain novel insights and potential therapeutics for cancer, central nervous system and endocrine disorders.
Berg will leverage its Interrogative Biology platform in combination with Mount Sinai’s experience in big data, advanced analytics and biological network modeling. Berg and Mount Sinai will adopt an innovative risk and return sharing approach, with downstream royalties significantly higher than the industry standard for academia-pharma partnerships. “The partnership with Mount Sinai flips the traditional public-private partnership model and sets a new standard for pharmaceuti-cal research and development,” said Niven R. Narain, co-founder, president and chief technology officer of Berg.
Technology Solutions
■■ PharmaPros, a provider of integrated technology and services for clinical trials, has changed its name to eClinical Insights, to reflect its recent business transition from a technology-enabled services organization to a SaaS-based software firm focused on improving clinical trial performance. “After a decade of running clinical trials for custom-ers, we had a unique vantage point from which to develop software that enabled real-time collaboration and process im-provement,” said Peg Regan, president and CEO of eClinical Insights. “The technology platform delivers process automation, data visualization and business analytics through the cloud. The outsourced clinical trials land-scape has significantly reduced sponsors’ control over the performance of their trials. CROs are being asked to provide metrics, KPIs and trending on trial progress.”
COAs & Regulatory LabelingClaims: Information& Limitations
TransCelerate CEO Dalvir Gill, Ph.D., said industry executives already have begun discussions about the possibility of sharing clinical trials since many diseases, such as cancer or autoimmune disorders, require combination treatments with drugs from different companies. Therefore, he said it would make sense for those companies to run trials together to develop combination treatments.
“Considering the huge challenges of un-met medical needs in many therapeutic ar-eas, we have to take out redundancies from the system wherever possible,” said Gill. “It would be a win-win situation for companies, regulators and, most importantly, patients. It will take a while to get used to this new, pre-competitive thinking, and there also are operational, legal and anti-trust aspects to be considered, but I think this will happen—and sooner than we would imagine.”
Gill believes pharmaceutical companies today need to forge new, collaborative part-nerships, since the industry faces significant challenges in bringing new drugs to market. As development costs continue to rise, the number of products reaching the market does not sustain R&D activities.
“We no longer have a choice,” said Gill. “There is widespread alignment among the heads of R&D at major biopharmaceutical companies that there is a critical need to substantially increase the number and qual-ity of innovative new medicines while elimi-nating inefficiencies that drive up R&D costs. Pre-competitive, cross-company collabora-tion is one way to tackle these inefficiencies.”
While other collaborations among phar-maceutical companies have had mixed suc-cess, TransCelerate, which is backed by some of the largest pharmaceutical companies in the world, has quickly moved beyond intel-lectual discussions and delivered tangible results in its first year as an organization.
Gill attributes the consortium’s success
to many factors, including the choice of highly pragmatic, “doable” projects that are important to the R&D community. In addition, member companies have assigned significant FTE allocations of some of their best people to TransCelerate projects, which Gill said are run with the same discipline one would expect within member companies—a defined project leader, strong teams, ad-hered to scope, timelines, budgets and de-liverables. The consortium also has support from the highest levels within each member company’s R&D organization.
“Our board and operations committee is comprised of industry leaders who have significant internal and external influence. They help us define projects and facilitate implementation within their companies when appropriate,” he said.
In one of its new initiatives, TransCelerate will work closely with regulators and other industry stakeholders to standardize the format of clinical trial protocols and develop standards for required endpoints. While every study protocol is unique, Gill said op-portunities for standardization clearly exist.
“Currently, study protocols are way too complex, insisting on the collection of much more data than regulatory agencies need for decision making. Streamlining and simplify-
ing the study protocols will reduce the bur-den on sponsors, their CRO partners, IRBs, the regulators, the investigative sites and, hopefully, trickle down to a reduced burden on patients participating in our clinical trials.”
Other new projects are the creation of an investigator registry, which shares investiga-tor contact details and site-related data, and to develop a global network of investigators and sites that conduct clinical trials for pe-diatric or minority populations. Gill said this initiative to develop clinical trial networks for special populations is particularly important, since the U.S. Senate recently passed legisla-tion to establish a pediatric clinical trials network.
“With this initiative we hope to work together with industry, academia, investiga-tive sites and regulators to speed up the development of new drugs for children and adolescents, and we hope to improve the participation of minority patients in our clini-cal trials,” said Gill.
As it moves forward, TransCelerate also will build on some of its original initiatives begun last year. As part of a project that resulted in member companies agreeing on minimum criteria for Good Clinical Practice (GCP) training, TransCelerate aims to create a standardized process for qualifying sites and criteria for training site personnel new to clinical research. The consortium also will expand its comparator network, which allows direct shipment of marketed products used in comparative clinical trials between participating companies, to include distri-bution of additional products, and to allow member companies the option of offering product discounts.
“Our focus in this second year will be to expand upon our principles of collaboration among the organization’s member compa-nies to address new initiatives directed at resolving common challenges impeding R&D in the industry,” said Gill, “and expand the scope and success of our original work.”
—Karyn Korieth
“We no longer have a choice… There is a critical
need to substantially increase the number and quality of innovative new
medicines while eliminating inefficiencies that drive up
Sunshine Actand a specialist in the Sunshine Act, which is a core part of the 2010 Patient Protection and Affordable Care Act.
“There are just so many more detailed types of reporting than people expected,” she said. “And the government’s initial prediction of what it will cost—such as how many Full Time Equivalents [companies would need]—was way off the mark, in terms of understanding what is required and what everyone is expected to do.”
Shapiro, along with F. Lisa Murtha, a part-ner at Washington, D.C., law firm Dentons, spoke about the Sunshine Act’s regulations and implications at the Public Responsibil-ity in Medicine and Research (PRIM&R) conference in Boston this month.
“For clinical trials, drug manufacturers are intending to provide research fund-ing to the person—a physician—or to an academic teaching facility,” said Murtha. “They would end up essentially having to fill out the required forms on the CMS web site and indicate they are paying an amount in connection with research and will make the appropriate publication and reporting obligation within specific time frames as articulated in the regulations. They have to state they have pending research, but will not fill out reports on recipients until the research is completed.”
She noted some academic medical centers and large research organization are starting to do some awareness training with physicians so they have a better understand-ing of the new law.
“Those physicians/researchers will need to be working on their web sites to deter-mine whether the information that’s been reported to them is accurate,” said Murtha. “At the same time these research sites also will have to monitor their own private inter-ests and disclosures made by the recipient to see if it is covered, to determine if the information is consistent.”
Asked how the Sunshine Act will affect CROs functioning on behalf of sponsors, Sha-piro said the same rules apply. CROs must
report to CMS payments made to teaching hospitals, including exactly when and how much they were paid.
“From my legal practice, I am seeing more complicated contracts between drug compa-nies and CROs due to the Sunshine Act, par-ticularly as it applies to potential penalties, whereby the drug company will have to pay if the CRO does not do this reporting cor-rectly or timely or accurately, “said Shapiro. “So sponsors, in turn, are imposing these contractual obligations that CROs must have data assurance mechanisms for good track-ing systems when payments are made.”
As for penalties and non-compliance, failure to report payments to physicians, other transfer of value or ownership/invest-ment will be fined between $1,000 and $10,000 per unreported payment, with a cap of $150,000 per year. Knowingly failing to re-port payments will result in fines of $10,000 to $100,000 per offense, with an annual cap of $1 million.
A dispute resolution rule gives both sides up to 60 days to meet and work out a settle-ment.
Both Murtha and Shapiro anticipate CMS will devote nearly a year to help companies better understand the Sunshine Act’s various rules with little enforcement and initially will avoid levying fines. CMS, which compiles the reported payment data, will allow physicians and teaching hospitals to review them and dispute any errors. After the review period, the reports will be placed on a public web site scheduled to launch in September 2014.
—Ronald Rosenberg
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“I am seeing more complicated contracts between drug
companies and CROs due to the Sunshine Act, particularly as it applies to potential penalties,
whereby the drug company will have to pay if the CRO does not do this reporting correctly or timely
or accurately. So sponsors, in turn, are imposing these contractual
obligations that CROs must have data assurance mechanisms for
good tracking systems when payments are made.”
—Robyn S. Shapiro, partner, Drinker, Biddle & Reath
Today, CWWeekly debuts The Pulse on Technology, a new column by Ashley Tointon that will focus on the use of the internet, software and other high-tech tools in clinical trials—from social listening tools and e-learning to patient recruitment and site operations, and everything in between.
T echnology has revolutionized the clinical trials industry and has automated many processes that traditionally have taken so
long to complete. The industry has benefitted from process improvements of regulations such as title 21 CFR Part 11, which standardized the use of electronic records and signatures.
As technology continues to progress at such a rapid pace, updated guidance has not been introduced to address many of these advances, including the use of social media listening.
Social media listening, also referred to as social media monitoring, is the process of min-ing the internet to identify and assess what is being said about a particular subject. The focus can be anything from a person to a company to a particular product or brand. Marketers have used this tool primarily to gain insight into both their own brands and their competition.
A social media listing tool can be utilized to pull comments from Facebook, Twitter, discus-sion forums or blogs. Social listening can be done with advanced software tools or simply by reading message boards. Varied uses and flexible applications have made social listening/monitor-ing a powerful customer intelligence tool.
This type of technology can be adapted to clinical research and is beginning to gain momentum in certain areas, including site fea-sibility. For example, an organization that wants to do more than get the estimated number of patients in its database can embark on influ-ence mapping. With a social listening tool, an organization can conduct queries measuring the level of influence physicians have in any given area. This influence mapping can measure the conversation themes such as trial results, general research or industry news. It also shows what media types are being used, the type of post
and whether physicians are engaging online outside their areas of specialization.
Additionally, social listening can be used to develop strategy for patient recruitment advertising by developing a profile. A typical profile provides an overview of what is being said about a particular indication on social me-dia platforms defined by a set time period and location. Profile reports reveal the total number of conversations that contained the disease state and on which social media channels they were found. A disease state profile also reveals if the majority of social media conversations about that disease state were from people searching for advice on diagnosis, symptoms and treat-ment options. It may further show if people are telling their personal stories and challenges, and offering support. The profile also can identify organizations using social media to promote fundraising events or solicit donations for disease research and care. This is crucial informa-tion if you are planning an online recruitment campaign. If a web analysis shows the majority of people discussing the disease state use Face-book, you likely will want to allocate a signifi-cant percentage of your advertising campaign budget to targeted Facebook ads.
Social listening tools may be disturbing due to a lack of understanding and regulatory guid-ance, and potential liabilities of online discus-sions. On the other hand, we must understand what is destined to become standard practice across the industry. To date, the FDA has not generated any guidance regarding the use of social media or social listening, so we are forced to attempt to adapt the old rules to new tools.
As we seek more information through social listening or consider giving it a try, it is good to know the different routes you can take. Rahlyn
Gossen of Rebar Interactive outlines the three basic options for using social media in patient recruitment on her company blog, Social Media for Patient Recruitment: 3 Major Options: “Listen, Borrow or Build.” She writes if you simply want a “no-strings-attached relationship” with social media, the “Listening” option is for you. Listening poses the least risk and does not require any social presence. It is where you should start your social media journey.
Perhaps you would like to step it up a notch and “Borrow”the social media presence of oth-ers. Rahlyn cautions if you choose this option, it is “imperative that you do some informal listening first.” There are multiple communities from which you can borrow. Finding the ideal community for your needs will require research.
Lastly, if you are ready to dive deep into social media and “Build” a long-term social media presence that you own, you will need to make a serious commitment. In this option you are building an audience that “knows, likes and trusts you,” she says, and it is the “most powerful and rewarding route you can take.”
As we await industry guidance, keep in mind medical decisions are being influenced every day by information on the internet, and it behooves us to understand our options and, at least, passively listen in and understand what is being said.
Ashley Tointon directs patient engagement programs at ePharma Solutions, combining traditional methods with innovative, data-driven techniques to provide sponsors high-impact, cost-effective recruitment and retention pro-grams. She has more than 18 years of patient recruitment and project management experi-ence. Email [email protected].
Social media for patient recruitment: your three options1. Listen 2. Borrow 3. Build
Commitment None to low Low to medium Medium to high
Engagement None Low to medium Medium to high
Timeline Any Shorter term Longer termSource: Rebar Interactive
CWWeekly’s semi-monthly company profile feature, Insider Insights, interviews executives of companies and organizations in the clinical trials space. Writer Ronald Rosenberg sat down with Denis Connaghan, chief executive officer of Clinverse.
Q Although some CROs use their own payment systems, what do you
estimate is the penetration for e-clinical financial lifecycle systems both in the U.S. clinical trials industry and globally?
A This is an emerging market, with only a few structured solutions in the space.
All clinical trials have the problem, but this is like the early days of EDC. Some people made a lot of money processing paper and it took a while to go to EDC.
Where we are for the electronic payments to sites and associated financial support systems is very early. I think the penetration is very low at the moment, and you can look at some of the labor-intensive manual processes or cobbled together systems that are currently being used. We look at ourselves and there are one or two others doing what we are doing with fairly small penetration. There is a lot of headroom—expansion—for all of us. So I am not sure how to get my hands around that to measure the total size of this market.
Q How has the Sunshine Act/open payments
changed how CROs and sites do business, and what has been the impact on Clinverse?
A As I looked at this business and talked to
people more about the chal-lenges of financial reporting and controls, one of the things I learned from a couple of CFOs I spoke with is the challenge of complying with the Sunshine Act reporting
requirements. The Sunshine Act requires sponsors to report to the government pay-ments and financial benefits investigators receive from sponsors, and sponsors are putting that burden on CROs. Over 90% of the research related reporting requirements are payments to sites in clinical trials. We can provide the necessary data to allow them to accurately report their obligations under the Sunshine Act.
For many companies, it has been more dif-ficult without an automated system that tracks the data. There is a lot more manual effort for them to keep up with it and have it all in one place. What a credible solution does is help them centralize the collection of that data. It is a more accurate, simple and efficient solution for anybody who can use an automated process with the ability to export data in various formats to sponsors’ aggregate tracking systems.
Q What are the top issues clinical trial cli-ents miss when negotiating payments
without your services?
A The accuracy of payments and the timeliness of payments is Number One.
If you are using a system and can point to the successes you’ve had with other studies and relationships with other sites, in which sites are paid more accurately and on a timely basis, then you have a much easier
time recruiting. So you are able to pursue the sites you want to attract. Sites have a much more positive experience when they are paid timely and accurately, so that makes it easier
to attract sites for future studies.There also is a reduction in cost, because
with our system the manual labor is mostly eliminated. You hear stories about manual pro-
cesses and people being paid incorrectly, mostly underpaid. There is a whole reconciliation process that is burdensome on both ends. With our system, the cost is down and the satisfaction is higher. The sponsor can pay on a more regular basis without a lot of extra effort, which
improves site satisfaction and in the long run makes it much easier for recruitment.
Sometimes the payment terms are fairly
Clinverse Headquarters: 2008Year founded: Durham, N.C.Description: A technology company solely focused
on the financial management of clinical trials and associated payments, it links a site’s con-tract terms directly to the data captured in EDC, CDMS and other systems to generate payments. In its clinical trial payment process, patients can be paid via debit cards, and internationally Clinverse pays out in 140 different currencies in dozens of countries. The ClinPay program can manage any term negotiated in a clinical trial management agreement, and its workflow process and collaboration tools reduce study start-up time. The company, a Medidata tech-nology partner, also has trials using Medidata Rave, Inform, Data-tabs and Nextrials.
Officers: Denis Connaghan, chief executive officer Jeff Rogers, chief commercial officer Tim Immel, chief product officer, founder Steve Ayala, president and co-founder
Offices: Durham; San Jose; Costa Rica (development office); Boise, Idaho
Employees: 45Transactions: 350,000 between October 2011 and
October 2013Clients: Small to medium-sized biopharmaceutical
companies and CROsWeb site: www.clinverse.com
“Our future is the financial planning management and execution around clinical studies. Sponsors are far more conscious of the financial management and the tools they need.”Denis Connaghan, chief executive officer, Clinverse
complex, and we are able to automate any complex term in the site contracts. So from a customer standpoint, with an automated solution you are able to handle most of the com-plexities much more simply and more accurately than you normally would be able to in a manual or cobbled together system.
Q How have payments to principal inves-tigators changed as a result of having a
collaborative and transparent financial manage-ment and payment platform?
A Investigators now are able to be paid more frequently and accurately without
the limits and restrictions that are inherent in a manual process. Also, investigators have more transparency into the status of the payment, so there are fewer inquiries about inaccurate or missing payments.
Reconciliation at the end of the trial is no longer necessary, as that function can be performed throughout the course of the trial. This allows sites to collect any payments that have been held back, that otherwise would not have been disbursed until a full reconciliation was performed at the end of the trial, which can last months. Again, we have seen increasing satisfaction with our payment platform, and that is becoming a bigger deal when we talk to and recruit sites. We are seeing an increase in site satisfaction because people are being paid more accurately and on time, versus what they experienced previously.
Q How does a cloud-based clinical finan-cial lifecycle system enable Clinverse
to offer additional services that clients are seeking, and where do you see this technol-ogy going in the next five years?
A The main thing for the type of solution we provide is that it needs to be acces-
sible quite broadly and to parties outside our control. Providing the broad accessibil-ity is something we can best achieve with a cloud-based solution.
This is a rapidly emerging market, so the needs of the market are developing. As a com-pany, we need to respond quickly, developing and then deploying extensions to existing functionality across our entire customer and user database. The cloud-based solution al-lows us to do that. We have an aggressive plan to add valuable functionality to our existing product suite, and the ability to quickly make it available to our customers is a benefit of being cloud-based.
We also have to stay ahead of our competi-tion and develop and deploy functionality very quickly. This technology helps us. We are a global solutions provider, and as you think of how more clinical trials are conducted glob-ally, we have a need to provide system access into geographically dispersed population areas where studies are being conducted. This cloud-based technology definitely helps us provide that accessibility globally.
Q How do you see Clinverse, which has sev-eral competitors, growing in the coming
years beyond specific products to becoming a financial management services provider for companies conducting clinical trials?
A We have a different orientation to a similar problem. We are very focused
on site payments and payments in general by sponsors and on the part of sponsors. The genesis of [companies including] Greenphire, as I understand it, is patient reimbursement—they are coming at this from the site payment, while we come at it from the sponsor’s side.
I see growth in the short term being somewhat exponential. It is generated by companies likes ours and from within CROs and sponsors who appreciate that they have a problem in house with annual payment systems. The growth is being driven by a number of forces. In the next couple of years there will be significant growth opportunities in this market.
For us, our future is the financial planning management and execution around clinical studies. Sponsors are far more conscious of the financial management and the tools they need. So we have to continue to build out support so sponsors can put financial controls and management depth around those studies.
We distinguish ourselves with technology infrastructure that is very robust. We have accounting solution embedded in what we do. We also view cloud computing as a delivery vehicle for a global environment that is underway and is critical for delivering function within wide geographic areas.
So what we are doing is just the beginning in playing a major financial management role working with sponsors.
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■■ Clinuvel Pharmaceuticals reported results of a phase III study of SCENESSE (afamela-notide 16mg) to patients with erythropoietic protoporphyria (EPP). The six-month, ran-domized, multicenter, double-blind, placebo-controlled study enrolled 93 adult EPP patients in the U.S. Patients were random-ized into two treatment groups and given either SCENESSE or placebo implants every two months. Median total direct sunlight exposure was 64.13 hours (range 0 to 650.5 hours) in the active group compared with 47.5 hours (range 0 to 224 hours) for placebo recipients (p=0.107, Kruskal-Wallis test). The distribution of the number of days with sun exposure of various time intervals (30-minute intervals) was significantly different between the treatment groups (p<0.001, Cochran-Mantel-Haenszel test). SCENESSE recipients reported more days when they had pain-free exposure of 60 minutes or more (the time of greatest risk of burns). The results showed that after receiving their second SCENESSE administration, patients had a significantly higher tolerance to light irradiation on the lower back and back of the hand (median change from baseline in minimum symptom dose on lower back at day 90, 227.5 v. -2.4 J/cm2; p<0.001, Wilcoxon test). The difference in the distribution of days during which pain was experienced was significant between the two treatment groups (p<0.0001, Cochran-Mantel-Haenszel test). The final stage of EMA review of SCENESSE is expected to continue in January 2014.
Genetic Disease
■■ Alnylam Pharmaceuticals issued results of its phase II trial of patisiran (ALN-TTR02), an RNAi therapeutic targeting the transthyretin (TTR) gene for the treatment of TTR-mediated amyloidosis (ATTR). The international study in 29 patients was an open-label, multi-center, multi-dose, dose-escalation trial. Patients received two doses of patisiran in five cohorts with doses ranging from 0.01mg/kg to 0.30mg/kg, using either a once-every-four-week or once-every-three-week dosing regimen. As compared with the lowest dose group of 0.01mg/kg, there was a statistically significant knockdown of serum TTR at doses of 0.15mg/kg (p<0.05) and 0.30mg/kg (p<0.001). The study results support further evaluation of patisiran at the 0.30mg/kg dose administered once every three weeks. With this dose and regimen, mean TTR knockdown at nadir of 83.8% and 86.7% was observed following the first and second doses, respectively, with maximum TTR knockdown of up to 96.0%. Results showed 1:1 correspondence in knockdown of mutant and wild-type TTR (r2=0.95, p<0.001), with essentially superimposable pharmacodynamic effects toward both protein species. Serum TTR knockdown was highly correlated with a reduction in circulating levels of retinol binding protein (RBP) (r2=0.89, p<0.001) and vitamin A (r2=0.90, p<0.001). Alnylam plans to develop and commercialize the ALN-TTR program globally.
Hematology
■■ Relypsa released results of a phase IIb trial of patiromer as a treatment for hyper-kalemia. The open-label, randomized, dose-ranging trial enrolled 306 patients. In the eight-week Treatment Initiation Period, patients were eligible for enrollment if they were hyperkalemic, had chronic kidney disease and type 2 diabetes mellitus and were taking a renin angiotensin aldoste-rone system (RAAS) inhibitor medication prior to screening. Patients were assigned to Stratum 1 (baseline serum potassium 5.1mEq/L to 5.5mEq/L) or Stratum 2 (base-line serum potassium 5.6mEq/L to less than 6mEq/L), and were randomized to one of three different starting doses of patiromer depending on the stratum. All patients could continue receiving patiromer in the 44-week Long-term Maintenance Period for a total of one year of treatment. For patients in Stratum 1, the change from baseline in serum potassium was –0.47mEq/L (95% CI -0.55, -0.40; p. For patients in Stratum 2, the change from baseline in serum potassium was –0.92mEq/L (95% CI -1.07, -0.78; p. Throughout the Long-Term Maintenance Period (following the eight-week Treat-ment Initiation Period), the mean serum potassium in both Stratum 1 and Stratum 2 remained in the target serum potassium range (3.8mEq/L to 5mEq/L). At week 52, the proportion of patients with a serum potassium in the target range was 85.5% in Stratum 1 (95% CI 78.7%, 90.8%) and 89.8% in Stratum 2 (95% CI 77.8%, 96.6%).
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■■ Awaiting the president’s signature before becoming law, the Drug Quality and Secu-rity Act expressly preempts more stringent state track-and-trace requirements and gives everyone in the drug supply chain more time to implement a product identi-fier system. The law will phase in a uniform national system for drug tracking and serialization to replace the current patch-work of state regulations. Congress has been pushing the FDA for years to set up a national tracking system to guard against counterfeit and other suspect drugs. The Act is more exacting than previous con-gressional efforts and sets up a rigid, but lengthy, time frame for implementing the various parts of a national system. It gives the FDA one year to publish standards for an interoperable exchange of transaction information as products travel through the supply chain. Within four years it must be electronic. By Jan. 1 , 2015, manufactur-ers will be limited to authorized trading partners, must have systems in place to in-vestigate and quarantine suspect product and must include transaction documen-tation with drugs leaving their facilities. Drugmakers will have four years to imple-ment serialization—a two-dimensional barcode that’s either human- or machine-readable—on packages and homogenous cases of product. The bill also calls for a fully interoperable, electronic tracing sys-tem, at the package level, within 10 years. The bill will require the FDA to maintain a database of wholesalers on its public web site. Industry welcomed the passage of the bill. Multinational companies already are installing tracking systems that have the flexibility to meet diverse global require-ments; China’s tracking regulations will be in full effect by 2015, and unit-level track-ing will be required by 2017 for all drugs sold in the European Union.
■■ Asia rapidly is becoming the location of choice for clinical studies by many leading
drug developers, with the number of stud-ies in East Asia already topping 14,000, and Mainland China, Hong Kong, South Korea and Taiwan emerging as popular locations. The focus is moving from the south to the east. “Asia’s clinical trials landscape is be-ginning to reshape itself,” said Alex Wong, assistant clinical director at Sanofi. “With new areas of opportunity emerging, the region remains an integral part of major drug developers’ global programs.” Pharma and biotech companies are building new manufacturing and R&D facilities in Asia. That ongoing investment opens more doors for more clinical trials. And CROs are growing and expanding into new coun-tries, investing more in training to ensure investigators meet GCP and ICH standards.
■■ The FDA issued a draft guidance on how proprietary and established names of drugs should be displayed in all advertis-ing and promotional material, including social media. The established name must accompany the brand name every time it’s used in such materials, but the FDA said it intends to use its enforcement discretion to relax that requirement—as long as the established name appears at least once, accompanying the most prominent use of the brand name. Comments on the draft are due by Jan. 19.
■■ Elan of Dublin said shareholders approved the company’s acquisition by Perrigo of Allegan, Mich., at two special meetings. The closing of the $8.6 billion transaction remains subject to the approval of the Irish High Court and is expected to occur by yearend.
■■ Merck Serono, the biopharmaceutical division of Merck, plans to invest $107.9 million in a pharmaceutical manufactur-ing facility in China’s Nantong Economical Technological Development Area near Shanghai. The facility will focus on bulk
production and packaging of Glucophage, Concor and Euthyrox, Merck brands to treat diabetes, cardiovascular diseases and thyroid disorders, respectively. Construc-tion is scheduled to begin next year and be completed in 2016, with commercial production expected to begin in 2017. The facility will become Merck Serono’s second largest pharmaceutical manufacturing site.
■■ In many ways, China is a latecomer to biotech and biological drugs. Many drugs that have long been marketed in the West were only approved in China years later. China’s pharmaceutical market is worth $70 billion now and will reach $100 billion by 2015. By 2020, it should be the largest market in the world, if growth continues at the same pace. There are more than 7,000 life science-related companies in China, of which 500 are large pharmaceuticals. About half of the large multinational phar-maceutical companies have set up R&D centers in China and designated it one of their top three priorities. Four overriding factors are behind that growth. First is a rapidly aging society: about 24% will soon be over age 50, up to 36% over the next 20 years. Second is a rise in the rates of chronic disease; by 2020, 33% of adults are likely to suffer from hypertension. Third is increasing affluence and the emergence of a middle class that can afford more expen-sive biologic drugs. Fourth is increasing ur-banization; by 2020, there will be 273 new small or mid-sized cities in China.
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