Life Science Leader Magazine

APR 2013

The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.

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Exclusive Life Science Feature diseases, including REVLIMID and POMALYST for patients with multiple myeloma. Some pharmaceutical sector analysts estimate REVLIMID will generate sales in excess of $6.7 billion by 2018. That's good for society long term since it creates multiple opportunities for Celgene to reinvest in the next generation of life-enhancing therapies that may enable healthcare providers to turn more terminal diseases into long-term manageable ones. But if that is the only number which impresses you, then you didn't think nearly big enough nor nearly long-term enough. Big problems require long-term solutions — and spokespersons like you — to preserve the U.S. medical innovation R&D; engine. Medical innovation is the crown jewel of America. It has contributed so greatly to the economic success of our country over the last 50 years, and it offers enormous potential to make a meaningful difference in the quality and length of our lives in the next 50 years. Of all the critical trends that will create a prosperous future, medical innovation will be the most important. For those of us who believe that medical innovation in a culture of change in science and medicine will be part of the solution, we must stand up and advocate for public policies and laws that support a positive environment and positive solutions to the challenges we face. Certainly, here in America, we have to believe in a positive future and be bold and courageous as we create it. expect more THE IMPORTANCE OF THE FDA INCENTIVIZING INNOVATION Tropical diseases are not a prevalent problem in the United States. So why then did the FDA create a policy that incentivizes companies to develop new drugs geared toward treating these diseases? Because if you want companies to invest in developing new innovative drugs, which may not be commercially viable in the U.S. but will prove beneficial in solving global health problems, create a program that rewards these companies for their efforts. The FDA voucher program falls under the FDA Amendment Act of 2007 (FDAAA), and here is how it works. If a company develops a drug for a tropical disease treatment (e.g. TB) and receives FDA approval for it, the company is eligible to receive a transferrable voucher that allows the bearer to designate a single human drug application (i.e. another drug in the company's pipeline) submitted under section 505(b) (1) or section 351 of the PHS Act, to receive six-month priority review status. I think this is a great example of pro-innovation policy. If you want new innovative therapies that advance the treatment paradigm, stimulate the economy, and reduce the burden on our healthcare system, provide appropriate incentives. Not only is the FDA helping to treat diseases found primarily in poor and developing countries, but who knows what else might develop from this research? 2TQHGUUKQPCNKUO 2CUUKQP Siegfried combines professionalism with passion Our professionalism plays a pivotal role in your project from start to fnish, ensuring that, besides excellence in project management and absolute reliability, you proft from a broad range of technical capabilities and capacities along the value-chain. Creating chemical processes and formulations is our passion. You can expect us to offer the relevant expertise & know-how at each step of your project, coupled with a keen enthusiasm. Expect more with Siegfried as your preferred partner www.siegfried.ch April 2013 LifeScienceLeader.com 29

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