September 21, 11:20 – 12:00 PM EST
Supply Chain for Complex Biologics: Not Mission Impossible
Firelli Alonso, Ph.D.
Biotherapeutics and Vaccines Outsourcing
BioTherapeutics Pharmaceutical Sciences
The complex nature of novel biotherapeutic products, like gene therapy and mRNA vaccines 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 gene therapy and mRNA vaccines as case studies, and suggested approaches, will be discussed in the presentation.
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 39 years of collective experience in research, development, and cGMP production of biological products and vaccines, and 19 years of experience in outsourcing, contract / project management, and technology transfer to qualified third parties. Her areas of expertise include viral vectors and viral vaccine development, recombinant proteins and biologics process development and cGMP manufacture.
She obtained her Ph.D. in Microbiology / Virology 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’s Center for Advanced Biotechnology and Medicine. Prior to joining Wyeth / Pfizer in 1996, Fi worked at The Salk Institute-Government Services Division, a vaccine contract manufacturer for the U.S. Armed Forces.