CASSS – Sharing Science Solutions has honored Marjorie Shapiro, PhD with its prestigious Hancock Award for Outstanding Achievement in CMC Regulatory Science. The annual award recognizes outstanding and sustained contributions in the field of regulatory science. Shapiro was announced as the 2025 honoree during CASSS’ Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products (WCBP), held in Washington D.C., January 28-30.
Sarah Kennett, who currently serves on the CASSS Board of Directors and has been a longtime mentee of Shapiro, presented the award. She shared, “Marjie has helped develop a generation of reviewers and colleagues in industry. She always shared her time with everyone from lab-based staff, reviewers, industry, whether it was years of training individuals directly under her supervision, mentoring, coaching, or working with industry counterparts and strategies of their product.”
When accepting the award, Shapiro reflected, “We need to continue to be curious and open to new ideas, that conventional wisdom is sometimes wrong and how health authorities and industry can work together to apply new knowledge for both old and new products to ensure that patients can continue to get safe and effective medicines.”
Shapiro recently retired from the U.S. Food and Drug Administration after 31 years of service to the Agency and more than 34 years in government service, 20 of those years serving as Chief of the Laboratory of Molecular and Developmental Immunology within the Office of Biotechnology Products. Shapiro led the only FDA research program with a direct focus on antibodies and oversaw a broader laboratory group assessing mission-critical topics ranging from immune system effector function-based mechanisms of action to prions. In her capacity as a Reviewer and Researcher at the FDA, she contributed to the review of INDs, BLAs, NDAs, PMAs, MFs, and subsequent amendments and supplements, ensuring quality of biotechnological products. Shapiro was a reviewer or Lead for many FDA approval “firsts,” including the first radio immunotherapeutic approved for the treatment of cancer, the first antibody-drug conjugate, and the first protein therapeutic claiming a manufacturing design space.
Shapiro’s broad experience and expertise, along with her ability to follow and apply new scientific knowledge, led to her involvement in many advancements in the growing and ever transitioning fields of biotechnology and regulatory science. Shapiro was involved in or led the development of the majority of FDA’s antibody- and other therapeutic protein-related guidance documents, from the 1997 Points to Consider for Monoclonal Antibodies, to Transgenic Plants to Biosimilars to COVID-19 related documents. She played important roles in developing and communicating policy on many precedent-setting topics, emerging and complex issues regarding novel products, processes, analytics, and regulatory pathways, and the naming of antibodies. She is well-known for her major contributions to the regulation of antibody-drug conjugates, complex antibody-related formats, and biosimilars.
During her time at the FDA, Shapiro influenced policies and practices in support of risk-based, fit-for-purpose, and state-of-the-art concepts. Importantly, in addition to communication through guidance, she frequently spoke internally to FDA and globally and authored publications to not only present but also explain policies and expectations, and she spent countless hours mentoring FDA reviewers. She reached out and listened to regulators internally and externally and industry large and small, including serving as a member of the NIH study Section for Small Business Innovative Research and Small Business Technology Transfer Grants and being involved in FDA Small Business Regulatory Education for Industry.
Shapiro has been a supporter and active member of the CASSS community since the first WCBP conference, where she presented the new policy on generic and modular viral clearance – one of the many novel concepts she helped develop during her time at the FDA. She served as the FDA Co-Chair of WCBP for 5 years, and for 10 years has been a member of the WCBP Steering Committee. She also co-chaired seven WCBP Plenary sessions and several workshops. She presented talks and sat on panels at WCBP, CMC Strategy Forum North America, CMC Strategy Forum Japan, Bioassays, Midwest Discussion Group, Northern California Discussion Group, and a CASSS webinar.
Beyond CASSS, Shapiro lectured at The University of Maryland Baltimore County and Georgetown University. She has provided training through PERI, CHI, and the Society of Toxicology. She has been a moderator for conferences with ISPE and New York Academy of Sciences. She has presented talks at numerous additional conferences, including DIA, IBC, CHI, AAPS, ACS, European Antibody Congress, Land O’Lakes Bioanalytical Conference, IBC Well Characterized Biological Products, IBC BioProcess International, American College of Rheumatology, Biotherapeutics Analytical Summit, New Vaccines, New Technologies, ECI, AACP, World Biosimilar Congress, and Americas Antibody Congress.
Shapiro has a Ph.D. in Immunology from The University of Pennsylvania, Fox Chase Center for Cancer Research, and an M.S. in Zoology/Animal Biology from The University of Maryland. She was a Fellow in the Laboratory of Immunopathology, National Institute of Allergy and Infectious Disease, NIH, and is the author of over 30 scientific publications, reviews, and book chapters in the fields of regulatory science, immunology, and biotechnology.