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Precompetitive collaboration: Transforming innovation in drug discovery & development

Posted on July 21st, 2016 by in Pharma R&D

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In 2013, Barbara Mittleman, former director of the Public-Private Partnership Program at the US National Institutes of Health and colleagues assessed the status of precompetitive consortia. They pointed to some successes, such as the Biomarkers Consortium, the Critical Path Institute’s Predictive Safety and Toxicology Consortium and the Patient-Oriented Outcomes Consortium. Nevertheless, they stated that “too few precompetitive consortia are being formed to mitigate lost opportunities and deliver on other potential gains for public and private stakeholders in drug development.”

Where we are

In a few short years, the situation has changed. Prompted by the realization that there has been too much duplication of efforts, too much money spent and too little innovation—and under increasing pressure from the public sector to make research more widely available — industry has become more amenable to sharing.

A recent example is the Joint European Compound Library (JECL),  a high-throughput screening collection comprised of more than 400,000 compounds from seven pharmaceutical companies, now available at no cost to academic groups and SMEs (small and medium-sized enterprises). The  JECL is a key component of the Innovative Medicines Initiative’s European Lead Factory (ELF), a public-private 30-member consortium formed to create an open innovation platform for industry and academia.

According to an ELF update, in addition to expanding JECL, the consortium has embarked since its inception on more than 60 screening programs of novel drug targets submitted by academic and SME researchers from 13 European countries, as well as more than 80 internal programs on targets under investigation by its pharmaceutical company partners.

Last December, the US Food and Drug Administration launched PrecisionFDA, a cloud-based “community platform for NGS assay evaluation and regulatory science exploration.” On July 6, the agency used the platform to issue two draft guidances aimed at streamlining regulatory oversight for NGS screening tests.

Individual companies also are spearheading open innovation collaborations with academics, nonprofits and industry partners. For example, GlaxoSmithKline’s Open Lab Foundation allows independent researchers to access GSK facilities, resources and expertise to help them advance their own research into diseases that affect the developing world. Those researchers are encouraged to share their work with others.

Another example is AstraZeneca’s Open Innovation program, which welcomes partnerships that span all stages of drug discovery and development. The company provides research partners with access to its clinical compound bank, a pharmacology toolbox, new molecule profiling through its screening program and other opportunities.

Where we’re going

Before precompetitive collaborations can become the norm, however, several challenges need to be addressed. When corporate screening collections are made available to partners, the origin, ownership rights and usage of the compounds need to be agreed upon; the workflow needs to be managed, and compounds need to be tracked. New bioinformatics systems are emerging to handle these issues.

One example is the ELF Honest Broker. This system supports the full ELF workflow, providing tools that enable researchers to select the right compounds while applying the rules of the workflow to safeguard intellectual property. The system also provides project management tools and an auditing capability to track compounds and their destinations.

The Compound Passport Service (CPS), another example, was developed by AstraZeneca when the company realized that its compound asset infrastructure wasn’t designed to handle open innovation projects, with all the implications of shared rights and access. The company was also concerned that it might mistakenly release to collaborators structures of hits that were already the subject of an agreement with another collaborator. The CPS solves that problem by managing an asset throughout its lifecycle, maintaining a record of when its structure was shared.

 Why it matters

Precompetitive collaboration is taking R&D into uncharted territory by pushing boundaries among organizations in the service of faster, more efficient and less costly drug discovery and development. A bioinformatics system that enables companies to find relevant connections by regularly screening a range of information sources (e.g., the literature, clinical trial results, internal and external data as well as existing collaborative networks) is a critical enabler of open innovation, as are innovative new workflow solutions aimed at managing IP concerns. While collaborators are the immediate beneficiaries, other researchers and, most importantly, patients, benefit too.


 

All opinions shared in this post are the author’s own.

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