Contractual matters

An overview of recent news on the CRO and CMO fronts

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The contract research and contract manufacturing organizations—and the companies that serve them—often work in the background so effectively that we never see them, so let’s bring a few into the limelight and see what they’re up to.

INC Research launches site advocacy group
RALEIGH, N.C.—This summer, INC Research Holdings Inc., a global Phase 1 to 4 contract research organization, announced the launch of what it says is the industry’s first site advocacy group (SAG) devoted to the scientific and operational aspects of clinical research. The SAG initially will focus on central nervous system (CNS) protocols—recognized as among the more complex therapeutic areas in clinical research—targeting psychiatry studies that will include, but are not limited to, those in schizophrenia, attention-deficit/hyperactivity disorder, depression and bipolar disorder.
“Through this forum, INC Research will collaborate with clinical research sites that have direct experience in psychiatry studies to gain their insights into the most common challenges and operational efficiencies that can be implemented for future studies,” said Clare Grace, vice president of site and patient access. “We will leverage these expert insights to incorporate the site and patient voice in the evaluation of psychiatry study protocols for scientific merit and operational success. Ultimately, we expect our Site Advocacy Group to embed efficiencies in the planning phase and increase the quality and speed of these clinical trials for our customers.”
A recent study by the Tufts Center for the Study of Drug Development found that drugs to treat CNS diseases such as epilepsy, Alzheimer’s, autism, schizophrenia and depression take 35 percent longer to develop than other drugs. Progress can be difficult to quantify with these diseases, making it even more critical for investigators and site staff to follow protocols consistently.
“Creating this SAG underscores INC Research’s commitment to better leveraging the expertise of clinical research sites worldwide in developing treatments for important health conditions,” said Dr. Michael Gibertini, president of clinical development. “Engaging with sites early on and in a meaningful way is critical to enhancing protocol design and study conduct. Our focus is on driving improved collaborations and innovative approaches to connecting more effectively with sites across all therapeutic areas as we work together to deliver on our ultimate goal of bringing new medicines to market for patients in need.”

PharmaCyte Biotech’s CRO voted Australia’s favorite for 2015
SILVER SPRING, Md.—Early summer saw PharmaCyte Biotech Inc., a clinical-stage biotechnology company focused on developing targeted treatments for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, announce on behalf of contract research organization (CRO) Clinical Network Services (CNS) that the latter had been voted Australia’s favorite contract research organization for 2015.
CNS was chosen by PharmaCyte Biotech as its CRO to prepare for and conduct PharmaCyte’s upcoming Phase 2b clinical trial in pancreatic cancer.
The award was presented to CNS at the 2015 ARCS Scientific Congress and was based on votes from local investigational study sites and from local and international sponsors of clinical trials. ARCS Australia Ltd., previously known as the Association of Regulatory and Clinical Scientists, is a professional development organization for those working in the development of disease therapies.
“As a company, CNS has always been committed to maintaining a positive culture focused on how we interact with each other, our clients and importantly the wonderful clinicians, coordinators and pharmacists who are at the forefront of delivering our trials to patients,” said Gabrielle McKee, chief operating officer of CNS.
PharmaCyte CEO Kenneth L. Waggoner offered his company’s congratulations, stating, “When we were evaluating CROs that might best assist us in our Phase 2b clinical trial in those with advanced pancreatic cancer in Australia, it became evident early on in that process that CNS was one of Australia’s leading CROs.”

Quotient Clinical expands its data sciences capabilities
NOTTINGHAM, U.K.—Quotient Clinical, which touts itself as “the Translational Pharmaceutics company,” has expanded its data sciences services in response to increasing customer demand, doubling the footprint of its facilities in Edinburgh and Nottingham, as well as increasing its specialist headcount and appointing a new vice president. Quotient notes that data sciences are an integral part of its services, delivering real-time data to customers for review and interpretation, enabling crucial dosing decisions to be made during the course of a study. Greg Johnson, the new vice president of data sciences, has more than 25 years of industry experience in directing biometrics and data sciences at large contract research organizations.
“Greg brings a wealth of industry experience that will be invaluable as we grow our data sciences offering,” noted Mark Egerton, CEO of Quotient Clinical. “Demand for these services is rapidly increasing, and we are now undertaking electronic data capture, data management, pharmacokinetics, modeling and simulation, biostatistics and reporting on over 80 percent of our customer programs, compared to just 50 percent a few years ago.”
“Translational Pharmaceutics can have a profound impact on reducing development timelines and associated costs, and this is driving an increase in demand for all our services,” Johnson said. “I look forward to leading the growth of our data sciences capabilities, ensuring that we deliver integrated solutions for our customers.”

ViiV and Desano manufacturing deal will allow competitive supply of dolutegravir
LONDON—ViiV Healthcare and Desano Pharmaceuticals announced this summer a strategic manufacturing agreement to enable production in China of dolutegravir. The agreement will offer an additional source of the dolutegravir active pharmaceutical ingredient (API) and will allow ViiV Healthcare to offer a competitive supply of the finished product (dolutegravir 50mg, marketed under the name Tivicay) for China and a number of developing countries, subject to national approvals. This strengthens ViiV Healthcare’s commitment to improve access to its treatments for people living with HIV, especially in countries hardest hit by the disease.
“This manufacturing agreement with Desano for dolutegravir is a significant achievement to facilitate access to our medicines. With our recent agreement with the Medicines Patent Pool and our other access initiatives, this deal is aligned with our ongoing commitment to improve access to our medicines in countries where the need is greatest,” said Dr. Dominique Limet, CEO of ViiV Healthcare, adding that Shanghai-based Desano is a high-quality manufacturer that is well suited to partner with ViiV.
Under the agreement, Desano will manufacture the API of dolutegravir to feed in to the GlaxoSmithKline/ViiV Healthcare supply chain for onward sale in China and developing countries covered by the agreement. ViiV Healthcare and Desano are also exploring further options for future manufacture of finished drug product and fixed dose combinations of dolutegravir with APIs.
“As one of the leading Chinese pharmaceutical companies dedicated to developing, manufacturing and supplying antiretroviral APIs for HIV and finished pharmaceutical products, Desano is honored to cooperate with ViiV Healthcare to manufacture a high-quality, competitive supply of dolutegravir and its combinations,” said Ying Kan, President of Desano Pharmaceuticals. “We believe that working together with ViiV Healthcare we can better contribute to the global goal of making treatment options available to patients across the globe.”

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