Dr. Firelli Alonso, a retired Senior Director at Pfizer, Inc., led the BioTherapeutics and Vaccines Outsourcing group in Worldwide Research and Development. With 40 years of experience in research, development, and cGMP production of biological products and vaccines, as well as 20 years in outsourcing, project management, and technology transfer, Dr. Alonso's expertise spans viral vectors, viral vaccine development, recombinant proteins, antibody-drug conjugates, and mAb process development and cGMP production.
In March 2024, Dr. Alonso founded ConsultFi Biologics, LLC, offering consulting services aimed at optimizing the outsourcing process for biopharma companies and assisting in selecting suitable Contract Development & Manufacturing Organizations (CDMOs). Her services involve navigating the complexities of CDMOs, assessing capabilities and capacities, and ensuring compatibility with the requirements of Sponsors. Dr. Alonso supports clients throughout the technology transfer process and effectively manages contracts for successful biologics manufacturing and testing.
She earned her Ph.D. in Microbiology/Virology from the University of Alabama in Birmingham and pursued postdoctoral research at esteemed institutions such as 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. Before her tenure at Wyeth/Pfizer starting in 1996, Dr. Alonso worked at The Salk Institute-Government Services Division, specializing in vaccine manufacturing for the U.S. Armed Forces. After nearly 28 years of service, she concluded her career at Pfizer in December 2023.
Beyond her professional endeavors, Dr. Alonso is dedicated to orchid culture and judging. She currently serves as Vice President of the Atlanta Orchid Society and has been an active American Orchid Society Certified Judge at the Atlanta Judging Center. Dr. Alonso's judging experience includes judging at various orchid shows across different states, showcasing her passion for orchids.

Presentation Title: Acquiring ADC Manufacturing Capacities and Capabilities: Insights from an Outsourcing Career

Abstract: In the biopharmaceutical industry, a significant portion of companies increasingly depend on external partners for developing and producing biological drug substances and products for clinical trials and commercial distribution. The complexity deepens when dealing with Antibody Drug Conjugates (ADCs), as sourcing multiple components like monoclonal antibodies, linkers, payloads, and outsourcing the conjugation process
for drug substance production, as well as formulation and filling processes for drug product manufacture become essential. Moreover, the challenge escalates in identifying the appropriate Contract Development & Manufacturing Organization (CDMO) capable of managing cytotoxic materials and ensuring the proper containment measures are in place.

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