Craig Lipset

Craig Lipset is the founder of Clinical Innovation Partners, an advisory practice working at the intersection of clinical research, digital health, and patient engagement, and a clinical leader for the Buffalo Initiative. He is also the co-founder and co-chair of the Decentralized Trials & Research Alliance, a global nonprofit dedicated to making clinical research participation more accessible.

Lipset has worked in drug development for more than two decades. He previously served as head of clinical innovation and a venture partner at Pfizer, was a member of the founding operations committee of TransCelerate Biopharma, and sat on the founding management teams of two startup ventures. He teaches as adjunct faculty in health informatics at Rutgers University and in the Center for Health and Technology at the University of Rochester, and serves on the boards of the Foundation for Sarcoidosis Research and the MedStar Health Research Institute.

His work has long centered on expanding the role of patients in clinical research and on reforming how the industry adopts innovation. He is himself a patient living with sarcoidosis, a rare disease, which informs his advocacy for patients across the rare-disease spectrum.

Lipset appeared on Open Door Salon alongside Sunitha Malepati, founder of the Buffalo Initiative, for a conversation on why patient organizations are increasingly stepping into the role of drug developer. Lipset’s central point was that pharmaceutical companies cannot be expected to pursue thousands of individually small disease populations, and that the field must stop appealing to them to do so. Instead, he argued, the definition of who can sponsor drug development is expanding from pharmaceutical companies, to biotech, and now to highly motivated patient-led organizations.

Drawing on a career spent trying to move large institutions toward change, Lipset framed the Buffalo Initiative as a way to derisk innovation through the urgency of the rare-disease community, creating models that the broader industry can then adopt and fast-follow once the path has been proven.