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Exclusive Life Science Feature pers how he views investment highs and lows. "Even though the industry is in flux, I don't see it as an overall bad place. Funds have resized themselves so, at least at this juncture, the right amount of capital is there to move some of the new technology and products forward. The limited-partnership investor base has become much more sophisticated and better understands the asset class, as well as the importance of investment in innovation from a societal and an economic perspective." SURPRISING BONUS? REGULATORY ACCELERATION A large part of the credit for the sunnier investment climate goes rightfully to the industry's regulators. A spike in product approvals, especially by the FDA, as well as the agency's aggressive use of priority reviews and accelerated approvals, has put the spotlight on novel therapies and diagnostics for unmet medical needs. In many cases, new investors have rushed into the sector without much information to distract them. But the prospect that the high approvals rate will continue has also drawn former funders back to the fold. Pappas believes the surge of approvals signals more than a change in FDA policy — and that companies have also brought more to the table. "Where there is unmet medical need, the FDA has been the most cooperative, the most transparent, and the most predictable for companies developing new drugs," he says. "But when companies have tried to rush drugs with marginal improvements through the regulatory process, the agency has been very difficult to deal with." He cites oncology as one area where developers of innovative drugs addressing a clear medical need have received strong support from the FDA. Oncology has also gotten a boost of late from the FDA's cancer czar, Richard Pazdur, whose office had once grown infamous for its multiple refusals to approve new drugs. Pazdur gets little flack these days when he says the new approved therapies are superior to past candidates and NDA (new drug application) submissions have also improved. Beyond oncology, drugs for treating orphan diseases have been the leading model of the FDA's support for "unmet need" therapies, largely because orphan drugs enjoy a natural base of support and a dedicated regulatory pathway based on need in small populations. Orphan drugs bear a close relationship, and often overlap, We deliver more val-ue noun / 'val-(,)yü / 1: A fair return or equivalent in goods, services, or money for something exchanged 2: A recent Industry Standard Research report highlighted LabCorp Clinical Trials as one of the top global central laboratories. Sponsors perceived that LabCorp ofered the highest overall value among central labs while meeting customer expectations on price. LabCorp was also the only central lab to meet or exceed client expectations across all key service attributes. Furthermore, the report showed that LabCorp's top service attributes as rated by customers were "high value", "broad test menu","geographic coverage" and "quality". Visit us at the Clinical Collaboration Congress! Booth 26 September 25-27, 2013 Boston, MA labcorp.com/clinicaltrials Global Central Laboratories Belgium - China - Singapore - United States September 2013 LifeScienceLeader.com 27