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Issue link: https://lifescienceleadermag.epubxp.com/i/140470
Contract Sourcing 2012 is the overarching legislation that authorizes user-fee programs for all pharma sectors, including the Bio-Similar User Fee Act (BsUFA) following close on GDUFA's heels. No doubt the FDA will apply some of the lessons learned with GDUFA to the biosimilars program, and there will be numerous analogies between both programs' effects on originator and follow-up manufacturers. Again, the larger CMOs may have the advantage of housing both small-molecule and large-molecule production and applying their experience to one side to the other. It would be a mistake to assume too many similarities between GDUFA and BsUFA, however; for example, a vast difference in sheer numbers of reviewed products predicates disparate goal structures: "eliminating backlogs" for generics vs. annual review rates for biosimilars. In short, BsUFA seems more closely modeled on PDUFA, the branded pharmaceutical user-fee program, than on its generics equivalent. Still, the simple existence of user-fee programs now established or under construction for all the industry sectors gives them something significant in common and serves to underscore my central point. FROM COMMONALITIES TO UNITED PURPOSE In my mountain-top dream of an industry common ground, I can imagine GDUFA as a great stimulator of technological progress for all companies doing business through the manufacturing of medicines. As in real life, however, the progress will be evolutionary — and, therefore, imperfect. It will take longer than planned, kick up a hive full of inconsistencies and unexpected problems, exalt some players and ruin others, and perhaps never get the credit it deserves. But GDUFA has the potential of breaking the status quo and raising the benchmark for pharma manufacturing technology as a whole. Some interesting hybrids may result. For example, a large pharma or biotech company might team up with a specialty pharma or generics company to create an entirely original product with superior targeting, potency, and stability. Oh wait … that's already happened, hasn't it? Arguably, one example might be Genzyme and Isis codeveloping Kynamro (mipomersen) for familial hypercholesterolemia, though I invite readers to nominate other candidates. But here is a genuinely unrealized goal: companies from every sector coming together to take a great leap forward in drug efficacy and safety through advanced manufacturing and delivery techniques alone. This industry, broadly including all life sciences companies and leaders, rarely sees itself as others see it. Patients and people in general hardly ever distinguish between the various sectors or concern themselves with the competitive struggle among them; instead, they look at the industry in the broadest strokes, illuminated by the light of its works. Either they trust you — or they don't. That is the common ground. July 2013 LifeScienceLeader.com 47