Collaboration doesn’t always come easily, but it is a major key to success in the biomedical research and development environment. Despite the explosion of research consortia around the globe, the consortia landscape has gone largely unmapped, resulting in confusion about the efforts and how to participate. Over the last two years, FasterCures’ Consortia-pedia project has been mapping and analyzing the breadth and scope of approaches that a wide range of consortia have adopted to bring together non-traditional partners with a shared R&D goal. In the first FasterCures Webinar of 2016, a panel of experts addressed how to ensure that these collaborations maximize their value to the ecosystem and create thoughtful, productive partnerships.
Moderated by Margaret Anderson of FasterCures,
speakers Jane Larkindale of Critical Path Institute, Dalvir Gill of
TransCelerate BioPharma and ShaAvhrée Buckman-Garner of the Center for
Drug Evaluation and Research (CDER) at the U.S. Food and Drug
Administration (FDA) spoke on key themes that lead to success when
starting a consortium, ensuring a productive work stream and
facilitating outputs to use in the regulatory space. Starting a New Consortium
To discuss laying a strong foundation for a consortium, Larkindale drew on her experience in leading the Duchenne Regulatory Science Consortium (D-RSC), founded in August 2015. One of the major lessons learned in establishing this collaboration was the importance of gaining buy-in from all stakeholders for the project. Larkindale spoke of the importance to look beyond just the needs of different stakeholder groups and consider what incentives will drive their participation and what timeline will work for their needs.
Not only is listening to the stakeholder community important, but also, Larkindale noted, “Educating the community and understanding what incentives they’re after was very important for getting the buy-in.” She gave the example of groups in the Duchenne space who may have a great deal of experience and knowledge related to the disease and its progression, but have little experience with working with regulatory bodies that endorse the model. Taking the time to educate them about the regulatory process and how it fits into the work the consortium is going to take on was a crucial step.
Larkindale also spoke to the nuts and bolts of getting stakeholder agreement through governance, project management and legal agreements. Since different partners bring different assets to the table, she noted the importance of balancing governance to be equal to each group’s contributions. Finally, all of the needs for each stakeholder group needs to be reflected in the legal agreements. A major issue arose when Larkindale’s team initially developed the agreements for D-RSC with companies in mind. These agreements were unacceptable to state universities, which sent them back to the drawing board.
Critical Factors for a Successful Collaboration
TransCelerate BioPharma is a unique consortium model, representing a single stakeholder group, biopharmaceutical companies. In the last three years, the collaboration has grown to 19 member companies and 14 active initiatives. Gill outlined the five strategic priorities created by the founding member companies, which assess industry challenges and align with all current and future initiatives of the group. Gill said it is important for TransCelerate to remain focused on these priorities because “in order to fulfill the promise of today’s science, we need to be more efficient with what we have.”
Despite having a single stakeholder group represented in TransCelerate’s membership, the consortium interacts with other stakeholders who have the same goal of improving clinical trials. This includes other industry initiatives, investigator sites, the research and contract research organization community and regulatory bodies.
To guide its work internally and externally, Gill outlined three critical factors that lead to success for TransCelerate: leadership, focus and discipline. A strong level of commitment from the membership companies has allowed the consortium to develop the laser-sharp focus and key strategic priorities that have led to major accomplishments in risk-based monitoring and other areas. Another learning moment for TransCelerate was in seeing that many consortia often try take on more work than is feasible, which often leads to failures. Gill said this pattern drove TransCelerate to focus on a small number of projects and generate successes before branching out into further initiatives. Finally, discipline in project management, budgets and accountability throughout the partnership ensures delivery of the consortium’s goals and does not allow projects to linger, wasting the time and resources of its members.
Where Have We Been and Where are We Going?
Buckman-Garner reflected on the history of the consortium model in order to show what is possible and what the consortia world needs for the future. In 2004, FDA launched the Critical Path Initiative, and a 2006 report called for increased infrastructure in the areas of biomedical informatics, biomarker development and interoperable clinical trials. In the following 10 years, a variety of consortia were founded to engage in these efforts and draw upon the power of uniting multiple stakeholder groups. As a result, CDER built several tools to engage with these collaborative models, including the Critical Path Innovation Meetings, the Drug Development Tool Qualifier Program and dedicated program staff to facilitate technology transfer.
Biomarker development is a hot topic in the medical research arena, and Buckman-Garner presented an ideal model where individual data from labs or consortia could be aggregated and shared through a biomarker database to ease and speed up the biomarker qualification process. She noted, “The more that we are able to start to aggregate information, share that information and make that information available to support qualification review,” this information can have more utility for the FDA. This kind of data sharing and aggregation is applicable in other areas of research and could have many of the same benefits it would bring to biomarker development and qualification.
Buckman-Garner pointed out other ways to advance consortia, such as improving approaches for consortia to share information with each other, like the Consortia-pedia Catalogue. “This society for consortia to share improved approaches with each other is critical,” she noted. Developing a willingness to share information from both successful and failed studies through data repositories and enhanced adoption of data standards will help prevent consortia from duplicating efforts and wasting resources. Finally, Buckman-Garner is looking for new models to train future generations of regulatory scientists through interdisciplinary approaches and new reward systems that value team success over individual successes. With these improved approaches to collaboration, the medical research community can band together in an effort to deliver faster and better treatments for patients.
This strong team of speakers reflected on the power of collaborative research models and where consortia work can continue to improve the field in the future. FasterCures has been dedicated to enhancing collaboration since day one and will continue to analyze, enhance and facilitate partnerships for the benefit of all patients.
Related resources:
- Watch the archive of the webinar
- Find more than 400 consortia in FasterCures' Consortia-pedia Catalogue
No comments:
Post a Comment