Science finally delivering break-throughs in oncology drug development
The conference room was too small to hold the audience that gathered to hear the discussion at BIO-Europe 2009 entitled, ‘How Personalized Medicine Could Change Oncology Deals.’
Participants crowded the aisles, sat on the floor and spilled out into the corridor to hear executives from Genentech and Abbott Molecular spell out requirements for new cancer drug programs.
The high interest in the panel discussion was not surprising considering there is a 20-year supply of new oncology compounds under development in various stages from preclinical to late-stage.
Panel moderator John Freshley from Compendia Bioscience told the audience that recent drug development has been over reliant on the same case studies to make their argument, Herceptin in breast cancer and Gleevec in CML. Skeptics have been quick to claim that these cases were the rare exception rather than the rule, he said.
He said developments in 2008 and 2009 in the use of biomarkers and molecular diagnostics have finally provided breakthroughs for harder science in tough to treat disease settings, citing the examples of Plexxikon’s B-Raf inhibitor in B-Raf mutant melanoma, KuDos/AstraZeneca’s Parp inhibitor in BRCA1/2 mutant breast cancer, Gleevec in C-Kit mutant melanoma and Pfizer’s Alk inhibitor in EML-ALK fusion positive non-small cell lung cancer.
“We are making scientific progress measured by strong clinical results,” he said, but added that the business value of personalized medicine in oncology is still unclear, making deal structures equally unclear.
Linda Pullan of Pullan Consulting reported an increase of 85 percent in the number of deals done from 2008 to 2009. However, since there are no details on these deals she believes their value to be small.
The business model of biomarker and companion diagnostic deals is still not well-defined based on the relatively small number of case examples.
The discussion in the crowded room intensified on the issue of whether diagnostic companies will be able to claim a percentage of the Net Present Value (NPV) in the indications they define.
Kinney Horn of Genentech said these deals are not currently being done while Freshley suggested that once some of the new scientific successes make it to market the game may change and become more favorable to the diagnostic partners.
“More case examples and more data are on the way to provide clarity”, he said, but cautioned that the field of personalized medicine will be subject to increasing levels of regulatory scrutiny even though the review agencies support the approach.
Addressing the topic, Tracey Colpitts from Abbott Molecular said effective biomarkers can identify more focused patient populations and increase response rates, citing the use of epidermal growth factor receptor (EGFR) therapies as an example.
“Biomarkers may be complex”, she said, “but diagnostics must be kept simple. In the end a diagnosis must be interpretable by providers in a community hospital setting.”
Kinney Horn from Genentech, who was asked to provide the big biotech/big pharma perspective, went on to explain how the Genentech Research and Early Development (gRED) group sources its own deals and prepares compounds for phase III trials where the full Roche global organization is brought to bear to develop and commercialize drugs.
“Genentech remains a science driven organization”, he said, “looking for compounds that are first-in-class or best-in-class, and targeting a wide variety of mechanisms.”
Because the target is not well validated, the biological rationale becomes key, including how targets and the compounds will improve and work with the standard of care.
Horn was unequivocal in saying that for Genentech biomarkers and companion diagnostics are critical because they can increase the chances of technical success.
Biomarkers and companion diagnostics are key tools for not only more effective development of the drug but also for adoption by the oncology community and payors, he added.
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