Parexel Consulting, a business unit of Parexel International, has appointed former regulators Toby Silverman, M.D. and Keith Watson, Ph.D. as principal consultants.

These appointments further expand Parexel Consulting’s global team of regulatory and product development experts to address a growing need among its clients to support accelerated approvals of innovative biotechnology and blood product platforms.

Dr. Silverman served at the U.S. Food and Drug Administration’s  Center for Biologics Evaluation and Research (CBER) for 20 years and was most recently senior advisor in the Office of Blood Research and Review.  Dr. Silverman was responsible for key CBER initiatives related to biologic development, pharmacovigilance and hemovigilance. Dr. Silverman was also formerly branch chief of the Clinical Review Branch in the Division of Hematology at FDA.

Dr. Watson joins Parexel from The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, where he was engaged with key biotechnology advisory groups in Europe, including the Biologicals and Vaccines Expert Advisory Group, Biologics Working Party and the Committee for Medicinal Products for Human Use. Previously, Dr. Watson held senior level positions within the biopharmaceutical industry, which were focused on biologics manufacturing and quality as well as monoclonal antibody technologies.

“We expect Dr. Silverman and Dr. Watson to provide valuable assistance to our clients’ development programs. They will support our clients in navigating challenging global regulatory environments and creating new regulatory pathways for innovative products that address unmet medical needs” said Paul Bridges, Ph.D., vice president, Parexel Consulting.