Pharmaceutical Technology - October 2020

PharmTech - Regulatory Sourcebook - October

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Page 59 of 75

60 Pharmaceutical Technology Regulatory Sourcebook October 2020 P h a r mTe c h . c o m Quality P harmaceutical development is a long, risky, and expensive process. In this highly competitive market, pharmaceu- tical companies are under constant pressure to deliver innovation via new therapeutics, new technology, and im- proved efficiency and effectiveness (1). Precompetitive collaboration is recognized as a mechanism to enhance efficiency, mitigate risks, and share costs that can benefit industry, academia, and government agencies. For the purposes of this viewpoint, "precompetitive col- laboration" may be defined as collaborations between pharmaceuti- cal companies and third parties to produce an efficiency-enhancing advancement or refinement that will be made broadly available to the public (i.e., publication, commercialization of a new product). Over the past decade, pharmaceutical consortia have emerged as collaborative forums where industry, academia, and government agencies can leverage broad technical expertise, standardize meth- ods and data, share best practices, and partner to enhance global regulatory strategies (2–10). Establishing and managing consortia for precompetitive collaborations presents several challenges, including ensuring the ability to share information across companies, safe- guarding intellectual property, and obtaining commitment from required subject matter experts (SMEs). When successfully executed, however, precompetitive collaboration confers valuable benefits that far exceed those achieved by the independent operations of industry, academia, and government agencies. The benefits of precompetitive industry collaborations focused on common scientific, technical, and regulatory issues became better known in the past 20 years (2, 11–14). However, in 2009, notwithstanding the Margaret M. Faul* is vice- president, Drug Product Technologies, Process Development, Amgen. Carl L. McMillian is vice- President, Toxicology, Drug Disposition, PK/PD, Eli Lilly and Company. Pierre Boulas is executive director, Product and Technology Development, Biogen. Reginaldo A. Saraceno is director, Material and Analytical Sciences, Boehringer Ingelheim Pharmaceuticals. Mary Devlin Capizzi is Partner, Faegre Drinker Biddle & Reath LLP. Maureen T. Cruz is Senior Manager, Science, Regulation and Policy, Faegre Drinker Biddle & Reath LLP. All authors are members of the IQ Consortium. *To whom all correspondence should be addressed. TEX VECTOR - STOCK.ADOBE.COM Viewpoint: Precompetitive Collaboration Drives Pharma Industry Innovation Margaret M. Faul, Carl L. McMillian, Pierre Boulas, Reginaldo A. Saraceno, Mary Devlin Capizzi, and Maureen T. Cruz The IQ Consortium marks a decade of impactful innovation of collaboration through a network of pharmaceutical companies driving change for the bio/ pharmaceutical industry.

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