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Exclusive Life Science Feature with personalized medicines, which have received some criticism for creating tiny commercial segments while escalating prices to unprecedented heights. But Pappas perceives a larger value to the personalized medicine strategy. "So-called ultrasegmentation requires the developer to go through the FDA and the payer processes in a way that confirms MoA (mechanism of action) and PoC (proof of concept), usually in a smaller trial with a very targeted base. In time, the discipline of personalized medicine will be seen as a favorable approach to developing medicines for broader areas as well." Along with the regulatory breakthroughs, Pappas also sees other strengths emerging among young companies and their funders: "The Darwinian element is playing out on a number of different fronts. All of our companies have become more capital-efficient — the whole industry has become more capital-efficient. And the chance to have this kind of constructive dialogue with regulators about very novel and unique medicines, just by definition, has made it easier to speed their progress through review. The FDA has realized it needs to give us better clarity and predictability as we start new trials." Experience makes a world of difference. Ash Stevens has been providing the Life Sciences industry with contract pharmaceutical manufacturing services for more than 50 years. s s s s s s Process research, development, and scale-up Early-stage to commercial API manufacturing Highly potent drug substance development and cGMP manufacturing Analytical development and validation Comprehensive regulatory support Preparation of documentation for submission (IND, NDA, DMF, CTD) To see how our experience can help your drug development program succeed, call or click today. 734-282-3370 ashstevens.com Visit Ash Stevens at ChemOutsourcing Booth # 87 28 LifeScienceLeader.com September 2013 FINDING FUNDS IN ALL THE RIGHT PLACES Downturns naturally precede turnarounds, and there may be a large cyclical component of the latest upsurge in life science investment, but also perhaps some unique elements. One possible benefit of VC flight from the industry is the creative response of companies that had to look elsewhere for funding support — thus giving rise to new, nontraditional funding mechanisms often customized to each company. Limited, semipublic offerings, biodefense grants, philanthropic funds, and corporate capital groups such as GSK's SR-One have become some of the more widely employed vehicles for filling the funding gap. According to Pappas, such groups have not only supported small-company innovation, but have done so at only a marginal cost to the pharma companies that support them. "The estimated amount of cash Big Pharma had on its balance sheet in 2003 was about $70 billion; today, it's around $130 billion. If we added up all the corporate VC funds, including their overhead and infrastructure costs, it would be a very small fraction of that cash amount. All of those corporate VC efforts are primarily off balance sheet and clearly an effective business and R&D; development approach." As corporate VC groups have entered the scene and grown in sophistication, another new source of funding has emerged in parallel: venture philanthropy. Not only have the philanthropy groups increased in numbers and size of funds, but they have also enlarged their roles in the entire process of drug dis-