Translational R&D Models Like Precompetitive Alliances Needed To Energize Drug Discovery - Indian Symposium

AHMEDABAD, India - Precompetitive collaborations between pharmaceutical companies mainly aimed at identifying biomarkers should intensify further to help weed out undesirable molecules in trials sooner than in expensive Phase II or III studies. Industry-academia alliances are increasingly gravitating in the same direction.

This was the emphasis of a talk delivered earlier this week by William Chin, professor of Medicine at Harvard Medical School, during the Ramanbhai Foundation Symposium in Ahmedabad, a city in the Western Indian state of Gujarat that is rapidly growing as a preferred biopharma investment destination.

Additionally, Professor Chin spoke about the potential in precompetitive alliances in areas such as predictive animal and human disease models, target identification and validation like genetics and translational science besides reagents and assays.

Team Up To Accelerate R&D

"Every company wants to develop its own biomarker and some people still say that there are competitive advantages but my argument is that we end up spending too much money on these things without sharing them," Chin said, criticizing companies for not complementing each other's research strengths and getting loaded down with duplication.

"In my days in Eli Lilly, I knew that Merck and Pfizer were developing assays that could be useful to me and I was doing something that could be useful to them, but we never shared them and so everybody doesn't gain that way," Chin, who held R&D responsibilities at Lilly from 1999 and continues to be on the company's senior management council, reminisced.

Galaxy Of Scientists Land In India

Focused on advances in translational research and medicine, the Ahmedabad symposium is backed by one of India's largest pharmaceutical companies Zydus Cadila. Cadila is poised to join an elite list of Indian companies such as Sun Pharma, Cipla and Dr. Reddy's that make over $1 billion in annual revenues.

The symposium could have passed off like any other routine event but for its particularly noticeable high-profile speakers and attendees.

Among those spotted were a dozen or so renowned scientists in the field of pharmaceutical research including Nobel Laureate Rolf Zinkernagel, who has worked extensively in the field of immunology; Nancy Thornberry, who initiated and led the discovery of Merck's biggest anti-diabetes DPP-4 inhibitor Januvia; and Richard DiMarchi, who co-developed blockbuster Humalog insulin for Lilly. Marcadia Biotech, which was co-founded by DiMarchi, was recently acquired by Roche (Also see "Roche Acquires Diabetes Biotech Marcadia" - Pink Sheet, 30 Dec, 2010.).

Advantage Biomarkers

Addressing hundreds of scientists and academicians drawn from Indian and multinational companies, Chin said that if a biomarker can help indicate safety and efficacy in Phase Ib, it can provide clues on if a drug should be moved into research or killed. "In a normal function, this analysis could take many months to get a definitive answer but via a biomarker this can be learned sooner," he remarked.

Speaking to PharmAsia News along the sidelines of the conference, Chin said another way to increase the certainty about a molecule could be to identify a biomarker that is similar in humans and animals. If a biomarker co-relates well in animals and a similar effect is seen in humans, then the whole animal model could become more reliable.

Chin supported the concept of translational research in quickening the pace of drug development, especially against the backdrop of significant hurdles like imprecise disease definitions, complex targets and pathways with multiple mechanisms. Chin quoted research studies that pointed at the advantages of translational or systems drug discovery against linear non-translational drug discovery programs.

Several industry leaders have spoken about the distinct advantages of forging pre-competitive collaborations that can accelerate research efforts (Also see "Pre-Competitive Collaboration Would Help Pharmaceutical Productivity Crisis - If Lawyers Could Get Out Of The Way" - Scrip, 11 May, 2010.).

Chin advocated sustained innovation in challenging times and stressed the need for incremental innovation, matching work with current budget realities, expanding access to innovation and better using existing knowledge while influencing changes in policies that limit innovation.

The Harvard professor cited several examples of precompetitive research alliances of which the most prominent was the Asian Cancer Research Group formed last year between Lilly, Merck and Pfizer. The three pharmaceutical giants have formed an entity to study two cancers prevalent in the Chinese population - lung and gastric cancer (Also see "Pfizer, Lilly And Merck Strike Up Cancer Research Partnership In Asia" - Scrip, 24 Feb, 2010.).

- Vikas Dandekar ([email protected])