By Gail Dutton, Contributing Writer
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The number of precompetitive collaborations among pharmaceutical companies increased nine-fold between 2005 and 2014 when compared against the 1995 to 2005 period. Meanwhile, traditional partnerships merely doubled, according to “Partnering for Progress: How Collaborations are Fueling Biomedical Advances,” a new study by Deloitte and PhRMA.
The popularity of precompetitive collaborations is due to their ability to share risks, streamline development, and educate patients in an environment in which the scientific, technical, and regulatory challenges are increasingly complex.
“Precompetitive collaborations often form in areas of research that are very difficult for a single company to pursue on its own,” says Guy Seabrook, Ph.D., global lead, neuroscience external innovation at Johnson & Johnson Innovation. Such partnerships seek to expand understanding around one or more indications, therapeutic areas, or operational capabilities.
The Alzheimer’s Disease Neuroimaging Initiative (ADNI) is one example. With more than 30 partners — many of which are life sciences companies — it formed in 2004 to enhance scientists’ understanding of Alzheimer’s disease. Since then, ADNI has developed methods for early detection, standardized clinical testing, and improved the efficiency of clinical trials for this disease.
“You can’t do everything well yourself,” Neil Lesser, principal, life sciences strategy at Deloitte, says. “Precompetitive collaborations let organizations access the best outside capabilities without the costs and complexity of bringing them inside as fixed infrastructure.”
COLLABORATIONS PUSH NEW PARADIGMS
Precompetitive arrangements have also made a ton of progress in areas like advancing the understanding of diseases at the molecular level, public health, and clinical trial execution, which helped those companies develop their own programs. Deloitte reports that some precompetitive collaborations already are capitalizing on advances in those areas to develop new paradigms for conducting clinical research. For example:
- The Lung Master Protocol consortium is developing multidrug clinical trials for squamous cell carcinoma patients using genetic profiling. Success will further advance precision medicine.
- The Collaborative Novel-Novel Combination Therapies (CoNNCT) consortium is accelerating the identification of effective drug combinations that target cancer. Success will simplify testing, shorten studies, and reduce their cost while speeding the development of new treatments.
- The California Institute for Biomedical Research (Calibr) is advancing translational research in areas of unmet medical need by bringing together partners with deep understanding of the science, regulatory concerns, and development capabilities. Commercial partnerships may emerge.
Disease-focused areas will remain important in the future, but “the next wave of partnerships will focus on cutting the costs and cycle times for drug discovery, making drug development more patient-centric, and developing standards for evidence collected from realworld data sources. If you can leverage new sources of data in a way that is acceptable to global regulatory authorities, it can have a great impact on R&D productivity,” Lesser says. Many pharmaceutical leaders are discussing the collaborative possibilities of integrating new data-collection methods and sources into pharmaceutical databases.
Those discussions may lead to precompetitive partnerships with IT companies to develop an industrywide infrastructure around informatics. Seabrook says, “This will be a rich area to think about.”
TWO COMMON STRUCTURES
Joint ventures and consortia are the two most common structures for precompetitive agreements mentioned in the Deloitte study. Deloitte defines joint ventures as agreements in which at least two entities collaborate on R&D to reach a specific objective while sharing risks and rewards. They grew from 4 percent of all new pharmaceutical R&D partnerships in 2005 to 16 percent in 2014.
"Precompetitive collaborations can last many years, so organizations need a mechanism to redirect the research and a way for participants to exit if necessary"
Guy Seabrook, Ph.D.
Global Lead, Neuroscience External Innovation Johnson & Johnson Innovation
Calibr is an example of a precompetitive joint venture. It was formed as a nonprofit by Merck in 2012 to translate lab discoveries into tangible patient outcomes. With heavy involvement from academic and nonprofit scientists, this partnership is unique in that it distributes profits from the sales or licensing of discoveries equally among participating scientists. Ongoing projects include advancing CAR-T cell therapies for cancer therapies and drug candidates for MS, cystic fibrosis, chronic obstructive disease, and tuberculosis.
Consortia, the other major type of precompetitive structure, involve more participants than joint ventures — at least three, but often 20 or more. Their formation peaked in 2011 when 62 precompetitive consortia were formed. They tend to have large goals that accelerate scientific discovery or industrywide development.
TransCelerate BioPharma Inc. is one example. It involves 18 biopharmaceutical companies, industry groups, and regulatory agencies in an effort to improve clinical standards. In addition to developing best practices for risk-based monitoring and comparator drug supply, it has created a centralized investigator platform.
The Deloitte study also lumps collaborations to provide financial resources or marketing, educational, and promotional programs into the precompetitive category. Projects to increase awareness of certain disease, like those of the Parkinson’s Disease Education Consortium, are examples. This consortium was founded by the Michael J. Fox Foundation, seven pharmaceutical companies, and other stakeholders to educate patients and their families about Parkinson’s disease.
SECRETS OF SUCCESSFUL PARTNERSHIPS
Simply forming or participating in a precompetitive collaboration doesn’t ensure your goals will be met, of course. “For a transformative impact, senior-level sponsorship is imperative,” Lesser says. These champions need to be actively involved, engaging and mentoring their representatives to the partnership to ensure the collaboration makes progress and remains on track.
Also, as the collaboration forms, establish governance and oversight, detail resource commitment, and clarify roles and responsibilities. “The best precompetitive collaboration teams are closely aligned at the outset about what they want to accomplish,” Seabrook stresses. Outline the specific objectives and incentives for each individual partner. Understanding these points up front will help the collaborative team design the right milestones, structures, and incentives to help all participants meet their goals.
Track the direction of the consortia against its stated objectives, too. The mission may change as projects evolve, so participants need to be aware of any shifts and how those changes affect their own goals for participation. To do this, Janssen’s neuroscience catalyst program includes milestones to help rein in any projects that may veer off-track. A Gantt chart depicting timelines for each activity within a project also helps, serving as both a project motivator and a productivity tool.
“It’s not just the details of contracting that make a collaboration successful, but also the speed and focus,” Seabrook says. “Precompetitive collaborations can last many years, so organizations need a mechanism to redirect the research and a way for participants to exit if necessary.”
Precompetitive agreements are likely to continue to grow, both in terms of numbers of agreements and in their scope. Regulators and payers are demanding more evidence of efficacy that, increasingly, includes patient-reported information. Innovators are responding by gathering a wide range of stakeholders into precompetitive collaborations to provide the scientific, technological, and operational insights needed to develop innovative, efficacious drugs and deliver them to patients quickly and safely.