Life Science Leader Magazine Supplements

CMO 2015

The vision of Life Science Leader is to help facilitate connections and foster collaborations in pharma and med device development to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute

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ROUNDTABLE leaders LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 8 Choose the wrong CMO and your project could easily be derailed, costing your company billions. But how do you avoid making such a mistake? To help answer that question, Life Science Leader brought together a panel of outsourcing experts at the inaugural Outsourced Pharma West conference and exhibition in San Francisco last November. Our panelists share some personal experiences and lessons learned on the topic. The panel participants included: 1 WHAT ARE SOME CHALLENGES TO FINDING A PARTNER THAT ALIGNS WITH YOUR NEEDS? Terry Novak, Pernix Therapeutics: When you ask that question, you will always hear people saying the same thingsā€¦ capabilities, quality, and regulatory. And all of those factors are important. But I believe sponsors need to take a very detailed approach to these partnerships, much like performing due diligence when acquiring a new product. I like to look at quality, regulatory, and delivery history, but I ask a lot of other questions as well. What is their turnover rate? How long has the management team been in place? Are they able to scale up? If they can't, am I going to have to pay for the capital? These are all questions that should be addressed up front. I was always big on case studies and whether they had worked on a project like mine and were able to deliver. Be as detailed as you possibly can be and HOW TO QUALIFY A CMO'S CAPABILITIES AND BENCHMARK ITS PERFORMANCE By E. Miseta FIRELLI ALONSO-CAPLEN Senior director of biotherapeutics & vaccines, Pfizer JOE GUILES Director of process chemistry, Medivation HEIDI HOFFMANN Senior director of manufacturing, Sutro Biopharma JUNNING LEE SVP technical operations, Theravance Biopharma TERRY NOVAK COO, Pernix Therapeutics

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