Program prepares drugs for use

By KATE RAMSAYER

Transforming intriguing lab results into a useful clinical treatment doesn’t always come naturally for many basic research scientists. Now, however, a new collaboration called PharmaSTART hopes to ease this transition.

As part of the program, the nonprofit research institute SRI will provide faculty at the Stanford School of Medicine, UC-San Diego, UC-San Francisco and the California Institute for Quantitative Biomedical Research with guidance on how to navigate procedures and protocols to make a drug marketable.

“This is a program that has the potential to enhance translation of basic research toward procedures, devices and therapeutics that will improve patient health. That’s the goal everybody has,” said Harry Greenberg, MD, senior associate dean for research at the School of Medicine. Greenberg and Charles Prober, MD, professor of pediatrics and of microbiology and immunology, are the Stanford representatives to the PharmaSTART steering committee.

Researchers with a potential therapeutic candidate can apply for one of Stanford’s approximately 10 spots a year in the program, a number the group hopes will grow with additional funding.

Once accepted, they will receive up to 30 hours of free consults with development experts at SRI, who will review what tests have already been done, determine where the researchers want to take the product and map out the best way to get there. Together with experts in such areas as regulatory affairs, medicinal chemistry, drug metabolism, product manufacturing and toxicity in animals or humans, researchers will lay out a drug development timeline and budget.

While researchers and their institutions still finance the early stages of the drug or therapy testing, SRI has had much success in obtaining government grants with university faculty and will advise researchers about available development-focused grants and contracts. In the past, universities often translated research into marketable therapies by forming spin-off companies or licensing the technology to biotech or pharmaceutical companies, explained Glenn Rice, PhD, vice president of the biosciences divisions at SRI.

But today’s investors are more cautious and are interested in products at a later stage of testing.

“Consequently, many interesting opportunities are being left at the bench at universities,” said Rice. “We need to figure out a way to bridge that gap, and one way is to reduce the investment risk.”

With PharmaSTART, the organizers hope to do this by handing investors a product ready for clinical testing. PharmaSTART is particularly interested in developing drugs to treat “orphan” diseases, uncommon illnesses often overlooked by the pharmaceutical industry.

Study calculates outlay of pharmaceutical marketing (5/21/03)