Speakers

Dr. Firelli Alonso is Senior Director, External Supply at Pfizer, Inc.  She heads the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development.  Fi has more than 38 years of combined experience in research, development, and cGMP production of biological products and vaccines, and more than 18 years of experience in outsourcing, project / contract management, and technology transfer to qualified third parties.  Her areas of expertise include viral vectors and vaccine development, biotherapeutics and vaccine process development and cGMP production, project management, technology transfer, and outsourcing.

She obtained her Ph.D. in Microbiology from the University of Alabama in Birmingham, followed by postdoctoral research at the U.S. Army Medical Research Institute for Infectious Diseases, Sloan-Kettering Institute for Cancer Research, and Rutgers University Center for Advanced Biotechnology and Medicine.  Prior to working for Wyeth / Pfizer in 1996, Fi was at The Salk Institute (Government Services Division), a vaccine contract manufacturer for the U.S. Army.

 

Presentation Title: Building Robust Sourcing Strategies to Meet the Challenges of Global Biologics Development & Rollout

Abstract: The complex nature of novel biotherapeutic products, like gene therapy, mRNA vaccines, and oncolytic viruses, has created significant challenges for an outsourced development approach. There are many concerns to be addressed: external manufacturing capacity, raw materials supply, changing Regulatory guidance, evolving technology, and quality concerns. An effective outsourcing strategy must take into account all of these challenges and must be flexible enough to account for changing project requirements. An overview of the complications related to outsourcing challenges in mRNA vaccines as a case study, and suggested approaches, will be discussed in the presentation.

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