Innovative Funding Models in Translational Research Project
Launched in early 2018, the Innovative Funding Models in Translational Research Project explores the bioethical, legal, and risk management challenges of translational research in the context of a shift from governmental funding to private funding for cutting edge biomedical research. 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.
Translational research is vital, as targeted translation science can ensure that new treatments and research knowledge actually reach the patients or populations waiting for these breakthroughs. Improving the “bench-to-beside” pipeline has been a focus of many, including the National Institutes of Health, which established in 2002 the Clinical and Translational Science Award program to promote translation science. Nevertheless, in the age of frequent governmental budget crisis and government spending cutbacks, relying primarily on a government agency to promote such important developments may be problematic.
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. These for-profit entities can pursue a role similar to that of non-profit organizations as funders of mission-oriented programs explicitly emphasizing the importance of bench-to-bedside innovations. By supporting early stage research development, intelligent investors can help refine the translational model and encourage the recruitment of talented researchers to translational activities.
The involvement of for-profit entities and their focus on translation, however, is a departure from the NIH funded basic science research model that has been prevalent since the end of World War II. 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. As such, many of the pressing ethical questions in clinical and scientific research need to be revisited through the lens of this model.
Questions that the Project will potentially address include:
How are research priorities articulated when the funder is a for-profit entity with a focus on translational research? What are the principles that should guide prioritization of projects in the for-profit translational model?
Do private entities funding translational research have ethical obligations beyond their fiduciary goals? If so, how are these obligations set and articulated? When fiduciary goals conflict with the public good, how are these conflicts resolved?
To what extent does the involvement of for-profit funders and a focus on outcomes (the bedside) change the research process (the bench)? What ethical concerns arise due to the focus on outcomes in this setting?
What are the ethical standards around reporting results of research, including drug trial failures, and potential conflicts of interest?
What role will social and policy goals play, if any, in light of the move from a centralized governmental funding structure to an emphasis on individual funders?
How can the needs of vulnerable populations, such as communities of color or individuals living with disabilities, be reflected and valued in this new model?
The goal of this project is to better understand the unique ethical considerations of shifting to a translational model of research funded by for-profit individual entities.
The initial year of the Project (2018) will focus on facilitating conversations with key stakeholders about the scope of the regulatory and ethical questions raised by the trend to innovative funding models for translational research. The Petrie-Flom Center, led by the Senior Fellow, will convene a working group to articulate concerns around innovative funding models in this space. The Center, again led by the Senior Fellow, will 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 governmental funded clinical and translational research. This report is intended to be a road map for ethicists and other scholars working in this area.
Leading the Innovative Funding Models Project for the Center will be the inaugural Senior Fellow, Douglas Eby. Doug’s role will be to advance the work of the Project by developing a policy/research agenda for the Project, planning the convening of the working group, co-authoring a report on the group's findings, and being available as a resource for interested members of the Harvard community.
As a 2017 Fellow in Harvard University’s Advanced Leadership Initiative, Doug’s efforts have been focused on innovative financing models to meet the unprecedented gap that currently exists in translational research. His work at Harvard led to the formation of Cambridge Science Corporation, where Doug serves as the Chief Executive Officer. Cambridge Science Corporation’s mission is to improve global health by accelerating the pace of medical technology innovation.
Prior to founding Cambridge Science, Doug worked in the investment management industry. He has extensive experience in the health care sector as an institutional investor across all stages of the capital continuum: public, private equity, venture capital and angel startup financings. Most recently, Doug was the President and Portfolio Manager for an investment advisor managing institutional assets for clients in the US equity markets deploying a long-term value based strategy. Doug has served as a director of several NYSE listed public companies including the Markel Corporation, Level 3 Communications, and CBRE Realty Finance, and as an advisory director of the Student Loan Marketing Association (Sallie Mae). He has served on the boards of numerous nonprofits including Suburban Hospital-Johns Hopkins Medicine, where he was chairman of the hospital's investment committee and the Boys and Girls Clubs of Greater Washington, DC, where he served as chairman of the board.
Doug Eby graduated with a BA in economics from Catholic University, Washington, DC, and earned an MBA in finance and accounting from Indiana University in Bloomington, Indiana.