Article | August 4, 2014

Learn Pfizer's Guiding Principles For Externalization At Outsourced Pharma West

Source: Outsourced Pharma West Conference & Exhibition

By Louis Garguilo, Chief Editor, Outsourced Pharma


Firelli Alonso-Caplen has been managing outsourcing for 10 years, first at Wyeth and then Pfizer. “The key really is the initial selection process for the CDMO,” she said in a recent conversation regarding our panel at Outsourced Pharma West, in San Francisco, November 10-11. “I think companies still don’t fully realize there is a lot of risk associated with this activity. Knowing what the individual risks are and their impact on a project being considered for outsourcing is very important. These risks also differ if you are outsourcing biologics and vaccines projects or small molecules.”

Alonso-Caplen’s lessons and advice on outsourcing will be shared during the Qualifying CDMO Capabilities panel discussion. Her experience starts when she tactically placed her career on the trajectory of the outsourcing industry. “In 2004, I was supposed to move to regulatory affairs, but the SVP of vaccines at Wyeth asked me to stay and said I could pick any job. So I actually “created” my job, in a way, both focused toward outsourcing and operations,” she recalls. “We were three people at that time. Setting up overall strategy for externalization was really great. Of course now outsourcing is an integral part of the overall strategy in placing and positioning the product pipeline.”

Best practices learned over the years start with the concept of “proactive outsourcing,” a series of steps and procedures to prequalify and then select providers. According to Alonso-Caplen, this includes technical evaluation by a cross-functional team, gap analysis, gap assessments, and GMP audits. She says that at times she will even set up a master service agreement (MSA) with CDMOs ahead of projects materializing, because MSAs can end up taking so much time. “So when a project does come in – particularly R&D and some development projects, they do not give you much prior notice – we are ready to move,” she explains. “Let’s say it’s an antibody drug conjugates project; we’ll just send our RFP to our “pool” of prequalified providers and ask them to bid. This gets us a jump on starting the project.”

At the conference in November, Alonso-Caplen will also discuss Pfizer’s “guiding principles for externalization,” which are six factors with different weightings and analysis of CDMOs. One of those, adaptability, is more subjective than the others. “This one is more like a look at cultural fit,” she explains. ”We have questions that we ask the contractors to help us understand certain cultural aspects of their organizations.” She adds, “I look forward to answering questions and talking about all of these topics in November.”

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