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Research-by-consortia: Passing fad or industry standard?

05/28/2014

Getting new medical products from discovery to patients requires all sectors—academia, industry, government, clinical care, nonprofits, and philanthropy— to work together throughout the research and development process. But collaboration is a complex endeavor, and integrating the right partners is far from easy.

The concept of collaboration is not new to biomedical research and it comes in all forms. Researchers are continuously introduced to new tools that help us understand the biology of disease as well further our ability to discover and develop new drugs. However, these tools are complex and no single researcher - and very few organizations - has all the expertise and resources to take the challenge on their own. Collaborations between competing organizations used to be a rarity, but now they are bread-and-butter of biomedical research. And nowhere is this more apparent than the explosion of research consortia around the globe.

FasterCures identified 387 consortia - formalized frameworks for temporary collaborations that aim to solve a shared research challenge – that have been launched since 1995, with 62 in 2012 alone. However, the landscape has gone largely unmapped, resulting in confusion about the multitude of efforts and mechanisms for participation. In order to better understand the operational tools and metrics used to manage these complex collaborations, FasterCures launched our Consortia-pedia project in 2013.

As part of this project, we convened, last week, a panel of individuals who are behind some of the most interesting and creative consortia in medical research in a webinar to discuss their motivations for engaging in a consortium, the challenges they face, and their predictions for the future of this unique model for collaboration. It was obvious from these discussions that the science for setting up and running a consortium is still at its nascent stages, but there is a lot of excitement that research-by-consortium is here to stay.

Kald Abdallah, whose day job is VP of North America Medical Affairs at Sanofi US, reflected on his own experiences launching Project Data Sphere a couple of months ago, saying that the consortium allows researchers to “act as a system, not as an individual [solving] complex problems”. As a vision of multiple pharmaceutical industry CEOs, Project Data Sphere aims to make patient-level, comparator-arm, Phase III cancer trial data available to the research community. The eventual beneficiary of Project Data Sphere is the cancer patient, as the increased sharing between researchers hold promise for new discoveries and treatments.

However, as described in the patient participation section of our Consortia-pedia report, the patient isn’t just at receiving-end of a consortium or just acting as a participant, they can also drive it. Walter Capone, president of the Multiple Myeloma Research Foundation, described their motivations behind the many efforts running under the umbrella of the Multiple Myeloma Research Consortium. Driven by the fact that multiple myeloma is the second leading blood cancer, this patient-run organization wanted to accelerate the use of biomarker-driven tools, such as genomics, in the development of new cures for their disease. The consortium model allowed the foundation to focus the resources of a diversity of researchers in the creation of a data and biospecimen resource that would be available to the broader scientific community.

A BioWorld article covering the FasterCures Webinar also highlighted how the Michael J. Fox Foundation for Parkinson’s Research is also using the consortium model to create new scientific opportunities for the use of biomarkers to accelerate research in Parkinson’s disease.

Representing another consortium stakeholder are regulatory officials whose day jobs are to determine the safety and efficacy of any medical product. Approximately 21% of all biomedical research consortia involve the participation of a regulatory scientist, and their primary reasons are to strengthen the regulatory science needed for their evaluations. ShaAvhrée Buckman-Garner, director of the office of translational sciences at FDA’s Center for Drug Evaluation and Research, described FDA’s involvement in numerous consortia, adding that “we realize that we need reduced uncertainty about medical products…no single entity has all the answers.”

There were a couple of lessons-learned and opportunities for those managing or participating in a consortium provided by the Webinar panelists:

  • Progress takes time and consortia should focus on small pilot initiatives to learn and optimize the dynamics behind their collaboration. Quoting FDA CDER’s Janet Woodcock, Buckman-Garner recommended setting expectations appropriately. “We don’t have to boil the ocean”, particularly with the numerous low-hanging scientific challenges that still need attention. Abdallah added that the objectives should be aimed at “quality, not quantity”.
  • The external community is still confused about research-by-consortium. To address this, consortia need to better communicate their accomplishments, which can come in the form of white papers, data repositories, publications, and qualified tools such as clinical outcome assessments and biomarkers.
  • Consortia need to find ways to collaborate with each other.

It’s an exciting time to be part of the biomedical research ecosystem and the growth of consortia only provides evidence that silos are coming down through enhanced collaboration and sharing.

Download Consortia-pedia report »

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Stay tuned to FasterCures’ Consortia-pedia project as we announce some of the resources being prepared for the R&D community. This includes our just-released Framework Report, which analyzes a wide range of existing biomedical research consortia to understand the operational tools and metrics used to start and run these complex collaborations, and upcoming research report in the June edition of Science Translational Medicine that provides a landscape analysis to current existing research consortia.  Additionally, we are preparing to launch an open-source and freely available database of biomedical research consortia available at the end of this year.

Our intent behind all of these products is to provide some clarity of this unique model for collaboration. By highlighting their activities and operational structure, we hope that these resources can be used to optimize existing consortia, design efficient ones, and enhance cross-consortia collaboration.