DURHAM, N.C.—In the hunt for good pharmacogenetics talent, Eli Lilly and Co. in November turned to fledgling consulting company Cabernet Pharmaceuticals Inc., entering into an alliance to further integrate pharmacogenetics (PGx) into Lilly's drug development efforts. The founder of Cabernet is PGx expert Dr. Allen D. Roses, who retired from GlaxoSmithKline last year, and is now tapping his network of colleagues and peers to make PGx expertise more widely available.
Lilly is hoping the relationship will give a boost to its FDA submissions, enhance how new products are viewed by providing additional information on who should or should not take those new products, and perhaps even lead to new blockbuster drugs.
Under the agreement, Cabernet consultants will join clinical development teams at Lilly to assist in applying PGx to selected development projects. The aim is to identify which patient populations are most likely to benefit from specific drugs, which are least likely to respond and which are more likely or less likely to experience side effects. Financial terms of the deal were not disclosed.
"Pharmacogenetics has come of age," says Stephen Eck, vice president, Translational Medicine and Pharmacogenomics, at Lilly. "It is one of the tools we increasingly bring to developing tailored therapeutics for better-defined patient groups. The experience of Cabernet in applying pharmacogenetics to drug development will supplement Lilly's in-house capabilities, providing us a flexible resource as we manage the dynamics of our R&D pipeline."
Furthermore, gaining greater understanding of how genes affect variations in drug response is very cost effective, Eck notes, and knowing which patients will most benefit from a new drug can only enhance uptake by physicians and patients.
The service model of Cabernet is to make pharmacogenetics experts directly available to its clients' drug development teams.
"This is to say that the Cabernet consultants will effectively become part of those teams," Roses explains. "These consultants will evaluate projects to see whether they are suitable for PGx studies. They will help to design the studies. They will facilitate the collection of DNA and informed consents. They will assist in analyzing study results and communicating them to regulators. They will work alongside Lilly teams and assist and train team members. The important thing is that these consultants have experience in applying PGx to pipeline management, and that they are a flexible resource."
Roses isn't aware of any direct competition for this market niche; no one else is "making available to project teams embedded consultants with experience in applying PGx to pipeline management."
There are, of course, companies that will sequence DNA and store samples and so on, Roses notes, and through contacts with these companies, Cabernet can make those services available to clients who need them, as they need them.
"Our core business is to assist in designing efficacy proof-of-concept, design of development studies, creation of on-time companion diagnostic content, assistance with regulatory consultations, assistance in interfacing with governments and payors, and monitoring for safety signals across the pipeline and into the marketplace," says Roses, who also directs Duke University's Deane Drug Discovery Institute.
Now is the right time to launch Cabernet and provide this kind of consulting service because pharmacogenetics has demonstrated its value in drug development, Roses asserts.
"Consider the changes the FDA has made in the labels of warfarin and abacavir to note the value of PGx in prescribing decisions," he says. "Yet some companies are loath to build up a PGx capacity in-house, since the need for that capacity varies with changes in the pipeline. Cabernet provides a flexible and experienced resource to meet this dynamic need." DDN
