Mark Fletcher, MD
With more than 20 years of experience in the pharmaceutical industry, Dr. Mark Fletcher worked at Pfizer as head of the Immuno-Vaccinology Group.
In this role, he developed an internal immunologic safety function to globally support Pfizer’s Biotherapeutics (BioTx) programs and improve the likelihood of success as well as increase Pfizer’s external footprint as a major BioTx company; provided clinical immunology support to the therapeutic vaccines and regenerative medicine research programs.
Dr. Fletcher conceptualized, developed and chaired Pfizer’s first clinically-focused and broadly matrixed BioTx Safety Council. To that end, he championed the development of and wrote significant sections of internal BioTx-focused safety white papers and other learning tools to improve the level of BioTx expertise; as well as enhanced Pfizer’s external reputation in BioTxs via collaborations with both FDA and EMA on development of multiple regulatory workshops on BioTx safety-related topics. Dr. Fletcher also contributed directly to major comments and revisions on the clinical and statistics sections of WHO’s draft guidance on development of Similar Biotherapeutics Products (biosimilars, follow-on biologics). Additionally, he provided Clinical Immunology Technical support to Pfizer’s therapeutic vaccines and regenerative medicine research programs.
Dr. Mark Fletcher supports clients and internal teams in all areas of clinical development, including clinical protocol writing, global clinical plan development and regulatory strategy, and product defense. He serves as expert advisor to internal scientists and clients in the area of biosimilars, particularly their development efforts and publications. Dr. Fletcher earned his Medical Doctor Licensure at the University of California, Davis, School of Medicine.