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Lost in Translation? Charting the Course in Preclinical Therapeutic Development: A Panel Discussion
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See also our Drug Development Database and Tutorial.
Howard Fillit, Jordan Tang, Frank Longo, Eli Michaelis, and Jens Eckstein led this live discussion on 16 September 2005. Readers are invited to submit additional comments by using our Comments form at the bottom of the page.
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 View Transcript of Live Discussion — Posted 15 October 2005
Introduction
Better treatments for Alzheimer disease—and other neurodegenerative diseases—are badly needed. But while many researchers have uncovered pathways, mechanisms, and molecules that could serve as valid drug targets, the idea of turning a basic research discovery into a drug development program may be daunting. Have you ever entertained the idea of venturing into drug discovery? Have you been bogged down by red tape, limited capital, lack of expertise, insufficient knowledge? Or has your pilot program never even gotten off the ground for all or any of the same reasons?
If you are in the midst of translating an important scientific discovery into a drug development program, or even better, if you are considering the possibility, then this live discussion is for you. This is a great opportunity to tap into the expertise of our five panelists who together can answer just about any question you might have on translational research. Are you aware, for example, of the following financial considerations:
NIH funding, even the translational research funding, is generally insufficient to carry the preclinical drug development to Investigative New Drug (IND) status. If one seriously entertains the idea of drug development, it is necessary to consider a new venture.
For a potential new venture, the lack of good business advice is often an obstacle to getting started. Unless you are located in a biotech hot bed, good business advice may not be easily available.
People in the business and venture world seem to operate on different value concepts and ethical guidelines from those that commonly operate in the scientific world. The cultural shock can be severe.
The difficulty in finding venture capital. Most venture capitalists want low risk and high return, which translates to a general lack of interest in early-stage drug development.
For scientists who are developing a career in basic research, it is a hard choice of whether or not to spend time away from the lab. Do you want to risk the next grant renewal for a start-up? Or the following practical considerations:
For academic-based investigators, a common limiting factor is readily available expertise in small molecule target validation and strategies for characterizing pharmacokinetics and toxicology properties of novel compounds.
Availability, costs and housing requirements for transgenic mouse AD models present a challenge for preclinical studies. In addition, few of these models are commercially available.
Much of the current AD transgenic mouse model work has focused on decreasing amyloid deposition as an endpoint. Other endpoints such as neuritic dystrophy and loss of synaptic function are not as well studied; thus, designing preclinical trials with these endpoints is more difficult.
Animal behavioral studies are important but require a significant degree of expertise and are labor-intensive. Finding an appropriate collaborator can be a challenge. These financial and practical hurdles can be overcome, and our panel is here to advise.
Howard Fillit is the executive director of the Institute for the Study of Aging (ISOA), a biomedical venture philanthropy that funds AD drug discovery. Since 1998, the ISOA has committed more than $23 million in support of 133 research projects and conferences.
Jordan Tang, head of the Protein Studies Research Program at the Oklahoma Medical Research Foundation, is no stranger to translational research. Jordan holds countless patents, including several for ß-secretase inhibitors.
Frank Longo is chairman of the neurology department at the University of North Carolina School of Medicine. Frank brings to the discussion his expertise as a physician and clinical trial leader. He also serves on the scientific advisory board of the ISOA.
Eli Michaelis is University Distinguished Professor and Chairman of the Department of Pharmacology and Toxicology at the University of Kansas. He is also the Director Higuchi Biosciences Center and Center for Neurobiology and Immunology Research.
Jens Eckstein is a principal at the Boston office of the venture capital firm Techno Venture Management. He brings a unique blend of expertise to the discussion. Having spent several years as chief research scientist in the biotech industry, he can speak to both sides of the venture capital coin.
For further background information, see our Drug Development Database and Tutorial
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