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The Petrie-Flom Center
January 29, 2018

Learn More about the Project!

January 30, 2018 - The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is launching the Innovative Funding Models in Translational Research Project to explore the bioethical, legal, and risk management challenges of translational research funded by private for-profit entities. The purpose of the Project is to investigate the ethical safeguards necessary to accelerate the development and application of new health care technologies through intelligent and thoughtful private for-profit investment and support. The goal of the Project will be to articulate the best ethical practices for for-profit involvement in early stage health care startups and translational research.

In the age of frequent governmental budget crisis and government spending cutbacks, relying primarily on a government agency to promote innovative medical and scientific research is increasingly challenging. An obvious solution to the funding gap that exists in current health care and biomedical research is the close investment and involvement of private, for-profit entities. By supporting early stage research development, intelligent investors can help refine the translational model and encourage the recruitment of talented researchers to translational activities.

It is unclear how the involvement of for-profit private funders in early stage science, especially coupled with an emphasis on translational research, changes the regulatory and ethical research landscape. The purpose of this Project is to map out and answer the pressing ethical questions in clinical and scientific research raised by increasing for-profit involvement.

“The involvement of for-profit entities and their focus on translation is a departure from the NIH-funded basic science research model that has been prevalent since the end of World War II,” notes Petrie-Flom Center Faculty Director Professor I. Glenn Cohen. “It is exciting but also brings many ethical challenges, and we are excited to explore this new landscape.”

The initial year of the Project will focus on facilitating conversations with key stakeholders from leading research institutes, hospitals, universities, and industry around the scope of the regulatory and ethical questions raised by the trend to innovative funding models for translational research. The Project will host a working group of leaders in this area to articulate concerns around innovative funding models in this space and then produce a report evaluating the extent to which utilizing non-governmental sources of funding for translational research, especially in the early stages, raises legal and ethical questions distinct from government-funded clinical and translational research. This report is intended to be a road map for ethicists and other scholars working in this area.

“The response from leading scientists, research institute management, and industry has been overwhelmingly positive about this Project,” states Senior Fellow Doug Eby. “There is a clear need to have thoughtful conversations around new approaches to funding our scientific and medical innovations.”

“Many leading American medical and scientific research institutes have been concerned about how to best promote biomedical research innovation, especially in light of declining federal funding,” commented Dr. Laurie Glimcher, President and Chief Executive Officer of the Dana-Farber Cancer Institute. “Creating a forum for serious discussions and explorations of innovative funding models is an important development in addressing this growing issue.”

Leading the Innovative Funding Models Project for the Petrie-Flom Center will be inaugural Senior Fellow Douglas Eby. Mr. Eby, who also serves as the Chief Executive Officer of Cambridge Science Corporation, brings extensive experience in investment management with a focus on health care. Professor I. Glenn Cohen, Faculty Director of the Petrie-Flom Center, and Carmel Shachar, Executive Director of the Petrie-Flom Center will also be closely involved.

For more information, visit the Petrie-Flom Center’s website or contact Executive Director Carmel Shachar, Petrie-Flom Center, Harvard Law School, 617-384-5475 / cshachar@law.harvard.edu.

Learn More about the Project!

Tags

global health   health law policy   innovation   regulation   research   research funding