Adopting an Open-Source Approach to Pharmaceutical Research and Development

Authors: Michael Stebbins, Miranda Bain, Rena Conti, Nicholaos Krenteras, Nicoleta Krenteras, Jaykumar Menon, and Bernard Munos


Summary 

The U.S. pharmaceutical industry conducts over half the world’s research and development (R&D) in pharmaceuticals and accounts for well over $1 trillion in economic output annually. Yet despite the industry’s massive size, there are still no approved therapies for approximately 95% of human diseases—diseases that affect hundreds of millions in the United States and around the world. The disparity between industry inputs and societally valuable outputs can be attributed to two key market failures. First, many medicines and vaccines have high public value but low commercial potential. Most diseases are either rare (afflicting few), rapidly treated (e.g., by antibiotics), and/or predominantly affect the global poor. Therapies for such diseases therefore generate limited revenue streams for pharmaceutical companies. Second, the knowledge required to make many high-value drugs is either underdeveloped or undershared. Proprietary considerations may prevent holders of key pieces of knowledge from exchanging and integrating information.

To address these market failures and accelerate progress on addressing the overwhelming majority of human diseases, the next administration should launch a new program that takes an open-source approach to pharmaceutical R&D. Just as open-source software has proven a valuable complement to the proprietary systems developed by computer giants, so too will an open-source approach to pharmaceutical R&D complement the efforts and activities of the for-profit pharmaceutical sector. An open-source approach to pharmaceutical R&D will provide access to the totality of human knowledge and scientific expertise, enabling the nation to work quickly and cooperatively to generate low-cost advances in areas of great health need.


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About the Authors

Michael Stebbins, Ph.D. is a geneticist and public-policy expert who served as the Assistant Director for Biotechnology in the Obama White House Office of Science and Technology Policy. He is currently the President of Science Advisors, a science and health consulting firm he founded in 2018 to provide science, technology, and public-policy guidance to private companies, philanthropies, and non-profit organizations. While at the White House, Dr. Stebbins’ work led to large initiatives across the federal government to address antibiotic resistance, protect pollinators, improve veterans’ mental health, increase access to federally funded scientific publications and data, promote the preferential purchasing of antibiotic-free meats, reform the regulatory system for biotechnology products, drive federal purchasing of bio-based products, and improve the management of scientific collections. Dr. Stebbins previously served as the Vice President of Science and Technology for the Laura and John Arnold Foundation, science advisor to the Obama Presidential Campaign, and on the Obama White House Transition Team. He is the former director of biology policy for the Federation of American Scientists and worked for U.S. Senator Harry Reid and at the National Human Genome Research Institute. Before coming to Washington, he was a senior editor at Nature Genetics. Dr. Stebbins is on the Board of the Value in Cancer Care Consortium and chair of the Board for Vivli. He serves on the scientific advisory boards for Datavant KOKOMI, and Amida Technology Solutions. He can be reached on Twitter @stebbins.


Miranda Bain is a gender, migration, and health-policy researcher. She has conducted policy and advocacy work and published articles on the intersection of these subjects. She graduated with Phi Beta Kappa honors from the Johns Hopkins School of Advanced International Studies.



Rena Conti is the Associate Research Director of Biopharma & Public Policy for the Boston University Institute for Health System Innovation & Policy. She is also an Associate Professor at the Boston University Questrom School of Business. From 2006 through June 2018, Professor Conti was an Associate Professor of Health Economics and Policy at the University of Chicago and the Harris School of Public Policy. Dr. Conti is a health economist. Her research focuses on the organization, financing, and regulation of medical care. She has written extensively on the pricing, demand, and supply of prescription drugs.



Nicholaos Krenteras has almost 20 years of experience in venture capital and private equity and has worked with more than 50 start-up companies in his career. Mr. Krenteras holds an A.B. in International Relations from Brown University and an M.B.A. from the Columbia Business School, where he was a member of the Beta Gamma Sigma Honor Society.







Nicoleta Krenteras is an undergraduate student at New York University pursuing a B.A. in Mathematics and Environmental Studies.









Jaykumar Menon is a human-rights lawyer and social entrepreneur, working to creatively realize basic human rights at large scale. He is a Senior Fellow at the Harvard Global Health Institute, a Visiting Scientist at the Harvard School of Public Health, and a co-founder and the chair of the Open Source Pharma Foundation. As a litigator, he helped exonerate a man serving life for murder, as the fifteenth lawyer to take up the case; freed a man from death row; and represented the student leaders of Tiananmen Square and victims of the Bosnian genocide. He has co-founded an effort to address the world’s most widespread form of malnutrition by adding iron to iodized salt; the effort has reached millions of people. He is a winner of the Brown University alumni association’s highest honor, given to one alum per year, and a life member of the Council on Foreign Relations.



Bernard Munos is a Senior Fellow at FasterCures, a center of the Milken Institute, a co-founder of the Open Source Pharma Foundation, and the founder of the InnoThink Center for Research in Biomedical Innovation, a consultancy that helps biomedical research organizations become better innovators. Before that, he served as an advisor for corporate strategy at Eli Lilly, where he focused on disruptive innovation and the radical redesign of R&D. Several of Munos’ research papers — published in Nature and Science — have helped stimulate a broad rethinking of the pharmaceutical business model by industry, investors, policymakers, regulators, and patient advocates. His work has been profiled by Forbes magazine, and the popular industry publication FiercePharma has named him one of the 25 most influential people in biopharma. He is a member of the Advisory Board of Science Translational Medicine; a non-executive Director of Glenmark Pharmaceuticals; a Board member or Advisor to a dozen other companies or publicly-financed research organizations; a former member of the National Academy of Medicine’s Drug Forum and of the Advisory Council of the National Institutes of Health’s National Center for Translational Sciences (NCATS). He received his MBA from Stanford University, and holds other graduate degrees in animal science and agricultural economics from the Paris Institute of Technology for Life, Food and Environmental Sciences and the University of California, Davis.