Foundation-Industry Relationships - A New Business Model Joint-Venture Philanthropy in Therapy Development
Ronald J. Bartek.
The business model for medical therapy development has changed drastically. Large companies that once conducted
their own Research and Development (R&D) and funded all the preclinical studies, all phases of clinical development
and marketing of the products are increasingly turning to others for more and more of the earlier work in hopes of
being able to in-license a de-risked program well downstream, take it through the final phases of clinical development and
into the marketplace. This new paradigm has required patient-advocacy foundations, especially in the rare-disease space,
to become far more effective in building relationships with all the players along the therapy-development pathway -- academic
scientists, government agencies, other foundations with overlapping interests, biotechs, small biopharmaceutical
entities and even the larger industry companies. From the perspective of the patient-advocacy community, these increasingly
essential public-private partnerships have taken on the nature of what could be called joint-venture philanthropy and
involve a broad spectrum of collaborations and financial relationships between foundations and industry partners that are
not without concerns about potential conflicts of interest.
Keywords: Patients, patient-advocacy organization, patient registry, natural history, clinical trial design; clinical endpoints,
public-private partnership, joint-venture philanthropy, industry partners, government agencies, de-risking, valley of death, conflict
of interest, benefit-risk evaluation.
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