Former FDA and MHRA regulators join Parexel Consulting
pharmafile | June 16, 2010 | News story | Research and Development | CRO, Parexel, appointment, research and development
Parexel Consulting has appointed former regulators Toby Silverman, M.D. and Keith Watson, Ph.D. as principal consultants.
The company is a business unit of Parexel International, best known as a provider of contract research services. It says its new experts will help address the industry’s growing need to support accelerated approvals of innovative biotechnology and blood product platforms.
Dr Silverman served at the FDA’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.
He was responsible for key CBER initiatives related to biologic development, pharmacovigilance and haemovigilance, which involved safety monitoring of blood and related components.
Prior to this Dr Silverman was formerly branch chief of the Clinical Review Branch in the FDA’s Division of Haematology.
Dr Watson joins the company from the UK’s medicines regulator the MHRA, where he was a member of key biotechnology advisory groups in Europe, including the Biologicals and Vaccines Expert Advisory Group (BVEAG), Biologics Working Party (BWP) and the Committee for Medicinal Products for Human Use (CHMP).
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.
“Last year, approximately half of new drug approvals were for novel biotech products, and this area is expected to continue to grow, especially as governments seek to preferentially reimburse life-impacting treatments and biopharmaceutical companies look to commercialise the next generation of innovator and biosimilar products,” said Paul Bridges, vice president of Parexel Consulting.
“As our clients increasingly turn to us for specialised biotechnology expertise, Parexel Consulting is committed to further expanding our related consulting capabilities to help them accelerate their global development programmes. We expect Dr Silverman and Dr Watson to provide valuable assistance to our clients’ development programmes. They will support our clients in navigating challenging global regulatory environments and creating new regulatory pathways for innovative products that address unmet medical needs.”
Andrew McConaghie
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