Beyond the clouds At the moment, it can be difficult for drug developers to see beyond the economic cloud that currently shrouds the pharma industry. Based on her interviews with several pharmaceutical research and development executives, Carolyn Gretton, writer of this month’s Forum, reports that despite the belief that they face a difficult road in the short term, clinical operations leaders expressed a general sense of optimism about the future, as companies continue to unravel the underlying mechanisms of complicated diseases and disorders and develop best practices for cost-efficient development. Christoph Schnorr, senior VP, global clinical operations, Merck Serono, a division of Merck KGaA, observes that oncology, which was once almost unilaterally a life-threatening disease, has been transformed in many cases to a chronic, sometimes even curable, condition. Roger Garceau, M.D., FAAP., senior VP and chief medical officer, NPS Pharmaceuticals Inc., agrees that there will be continued advances in areas of high unmet medical needs with niche populations. “There is still a lot of unmet need in larger areas, such as Alzheimer’s and cancer that are very attractive for companies to investigate," he adds. Dr. Garceau also foresees that there will be a huge impact from biosimilars on biotech firms in the United States, given their acceptance in Europe and the impact that generic competition has had on traditional pharma companies. “I think this will stimulate the development of new medicines for us as we go forward," he observes. James Baker Jr., M.D., CEO, founder, and executive chairman, at NanoBio Corp., believes that as developers strive to obtain more information earlier in the clinical-trial process, this will facilitate faster go/no-go decisions. “I think the days of a 20-person Phase II open study are gone, and that’s in no small part because most of those drugs did not do well," he observes. “Given the cost of development, I think there is going to be more effort to try and get more hits and more information before drugs are brought into the clinic; the goal is to improve the outcome of clinical trials." Randall Whitcomb, M.D., chief medical officer at Arete Therapeutics Inc., predicts that large pharmaceutical companies will continue to build clinical research functions internally, while smaller companies will rely on CROs to remain lean and efficient in the current economic environment. “I believe it is much more effective to leverage the expertise of CROs, which we can hire and, if need be, fire, rather than building the infrastructure in house," he says. The efficient development of new drugs, according to Luc Truyen, M.D., Ph.D., senior VP and head of global clinical operations, at Johnson & Johnson Pharmaceutical Research & Development LLC, will require some rethinking about the meaning of intellectual property and how this is handled as a value driver. How best practices are shared, as well as certain data, not only between single companies and outside research groups but also between companies, will foster a “new frontier" of openness that should improve pharma’s overall output as an industry. Please turn to page 6 to read more from these thought leaders in the clinical arena. Taren Grom Editor Taren Grom See you in San Diego at the 45th DIA Annual Meeting. Stop by Booth 1300 to say hello. Publisher Lisa Banket Editor Taren Grom Creative Director Marah Walsh EDitorS Carolyn Gretton Denise Myshko Kim Ribbink Robin Robinson design associate Ariel Medel national account manager Cathy Tracy Copyright 2009 by PharmaLinx LLC, Titusville, NJ Printed in the U.S.A. Volume Seven, Number Two VIEW is published as a supplement to PharmaVOICE, which is published monthly except August and December, by PharmaLinx LLC, P.O. Box 327, Titusville, NJ 08560. Periodicals postage paid at Titusville, NJ 08560 and additional mailing offices. 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