Amar concentrated on educating the audience on the ways and means of harnessing NIH resources that are not being well utilized: the publicly available scientific resources useful in both the lab and clinic. The objective was to tell the audience what resources are available and, even more importantly, how to access them.
The first speaker, Bonny Harbinger, Ph.D., deputy director, office of technology transfer at NIH, presented a new text-mining application developed at NIH that makes it possible to match a company’s research interests with NIH and FDA funded inventions. The tool aggregates information from a variety of sources, including the U.S. Patent and Trademark Office, NIH CRISP (database of federally funded extramural biomedical research projects), PubMed, and news articles.
Barbara B. Mittleman, M.D., director, program on public private partnerships, at the office of science policy and office of science policy analysis at the NIH, presented information on public-private partnerships that allow the private sector and academic institutions to partner with NIH for the more rapid and effective achievement of common goals and objectives.
To provide an industry perspective on all of the above, Alan Naidoff, associate director of external scientific affairs for Merck & Co. (www.merck.com), provided examples of Merck’s success stories with NIH interactions. Finally, Gregory Curt, M.D., U.S. senior medical lead, AstraZeneca (www.astrazeneca.com), used his experiences with the NCI as an example of successful industry collaborations with the NIH.
Alfred Yen, professor of law at Boston College Law School, chaired the panel for “Challenges in Reviving/Repositioning Old Compounds to Address Unmet Medical Needs.” As biotech and biopharmaceutical companies explore alternative means to accelerate pipeline building, previously abandoned drug candidates or new combinations of existing drugs may be worth examining when they match an unmet medical need or fit into a therapeutic parameter, according to the panelists. The discussion, which addressed challenges, lessons, and cautions, revolved around two issues.
How can companies discover existing compounds that can be repositioned for commercial success? Three general methods were discussed—fortuity, personal knowledge of scientific literature, and technological approaches. The panelists—Robert Zerbe, M.D., CEO and founder of QuatRx Pharmaceuticals (www.quatrx.com); Michael Bonney, president and CEO, Cubist Pharmaceuticals (www.cubist.com); James Czaban, partner, at WilmerHale (www.wilmerhale.com); and Alexis Borisy, president, CEO, and founder, Combinatorix (www.combinatorix.com)—related experiences their companies and clients have had with these approaches.
Once a compound has been identified, what challenges will companies face in bringing them to market? The panelists divided these challenges into marketing/ public perception, regulatory, IP, and financial issues, based on their experiences. They also discussed future uncertainties that may present new challenges, as much is changing on the IP and regulatory fronts in particular. Panelists outlined the costs and benefits to consider upfront, discussed relevant case studies demonstrating both success and failure, and presented specific problem-solving techniques for acquisition of external compounds, IP, and the regulatory path forward.