The FDA Group’s CEO Nick Capman sits down with Dan Donovan, an expert in rare disease drug development, to explore the unique challenges and new opportunities presented in the rare disease space.

They discuss:

» The critical role of patient advocates and caregivers in conducting successful studies and applications for bringing a rare disease drug to market.

» The financial and resource challenges faced in the field of rare diseases and drug development.

» The potential for individuals to contribute to the rare disease sector, specifically through the Five Voices program.

» Successful and unsuccessful attempts to bring rare disease drugs to market, including the success story of Sarepta in getting the first drug for Duchenne muscular dystrophy approved and the failure of a company to enroll patients for their trial due to poor community relations.

» The unique approach required for rare disease drug development, termed as "hyper-targeting," which emphasizes focusing resources on specific rare disease communities and expert centers—and ongoing engagement with the community from the development phase through to commercialization.

» The role of rareLife Solutions is providing in guiding to companies interested in the hyper-targeting approach.

» The personal aspect of working in the field of rare diseases, including the importance of passion for the work and the need to channel it positively for the benefit of others.

Dan is the visionary behind rareLife Solutions and oneVoice, and has spent his career innovating in the medical and pharmaceutical industries. Introduced to the world of rare diseases through his involvement as an investor and Chief Business Officer at Cancer Prevention Pharmaceuticals (CPP), he observed the fragmented nature of rare disease communities, which inspired him to establish oneVoice, a platform for guided communities specific to rare diseases.

Earlier in his career, Dan founded Envision Pharma, where he served as President and developed Datavision, a leader in medical publications technology. The company was acquired by United BioSource Corporation (UBC), where he served as Senior Vice President Strategy and Market Development.

Who is The FDA Group? The FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. https://www.thefdagroup.com/