Abstract
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.
Current Topics in Medicinal Chemistry
Title:Foundation-Industry Relationships - A New Business Model Joint-Venture Philanthropy in Therapy Development
Volume: 14 Issue: 3
Author(s): Ronald J. Bartek
Affiliation:
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.
Abstract: 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.
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Cite this article as:
Bartek J. Ronald, Foundation-Industry Relationships - A New Business Model Joint-Venture Philanthropy in Therapy Development, Current Topics in Medicinal Chemistry 2014; 14 (3) . https://dx.doi.org/10.2174/1568026613666131127154903
DOI https://dx.doi.org/10.2174/1568026613666131127154903 |
Print ISSN 1568-0266 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-4294 |
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