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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Page 33 of 83

CHOOSING A CMO sourcing By E. Miseta HOW TO MATCH A VENDOR TO YOUR STAGE OF DEVELOPMENT LIFESCIENCELEADER.COM THE CMO LEADERSHIP AWARDS 2015 34 assurance assessment should also be per- formed. That can be a two- or three-day visit during which an actual fill activity is observed. The entire process, either an actual or engineering run, should be observed and analyzed. According to at least one speaker, the entire process can take six months, if you're lucky, perhaps longer if any devia- tions are noted. RELATIONSHIPS ARE CRITICAL Once a relationship is established, it must be properly developed and cultivated. That way, when things are not going so well, you have solid relationships that you can fall back on. This process should include developing peer-to-peer relationships. These ties should range from the CEOs all the way down to the project managers. This is an organizational alignment where like folks are constantly interacting – finance to finance, lawyer to lawyer, regulatory to regulatory, project manager to project manager. When the relationship is thrown a curve ball, you will not have the confidentiality agreement and non- disclosure agreement. One of the critical first steps should also be a site visit. "This is a must," noted one panelist. "You have to see what you are getting into." Often a supplier will look good on its website, but you don't know how old the facility is or if the photo is even of the facility in question. One Big Pharma executive told me the story of one such visit. The website showed a beauti- ful building which supposedly housed expertise in analytical testing. "I sent someone with experience in analytical testing to check out the facility," he said. "When he found the laboratory, it was an empty building with the company name on the door." If the initial site visit goes well, the next step is to send a technical evaluation team to the vendor. That team should be cross- functional and include personnel with expertise in processes, analytical, regula- tory, and quality functions. If the CMO passes the technical evaluation, a quality audit will need to be performed. In the case of a drug-product facility, a sterility ith a lineup of panelists that included Firelli Alonso-Caplen of Pfizer, Joe Guiles of Medivation, Bob Munday of CMC Biologics, Patrick Murphy of Versartis, David Enloe of Althea, and Jon Crate of FAI Testing Services, attendees were sure to hear from executives with first-hand knowl- edge of the topic. The speakers did not disappoint. Finding a CMO that can manufacture your product, meet your requirements, and work closely with your team dur- ing bad times and good is not an easy endeavor. Several themes that emerged throughout the session can be culled into best practices to keep in mind throughout the selection process. THE PROCESS CAN TAKE 6 MONTHS … OR LONGER If you are conducting your search prop- erly, expect it to take a considerable amount of time. There are agreements that will need to be completed at the outset of the qualification process, including How To Match A Vendor To Your Stage Of Development E D M I S E T A Executive Editor One of the most informative sessions from last fall's Outsourced Pharma West Conference & Exhibition in San Francisco discussed matching a vendor to your stage of development. W @OutsourcedPharm

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