PAREXEL, a global biopharmaceutical services provider, announced the appointment of three former senior regulatory consulting executives from the FDA and Oncology industry positions. The new hires are part of PAREXEL’s Global Integrated Product Development and Compliance team and will be focused on helping PAREXEL clients deliver commercially viable, reimbursable products to market faster and more cost-effectively.
Robert Iser, Vice President of Regulatory Consulting Service: Mr. Iser joins PAREXEL from his post as Director of the FDA’s Office of Process & Facilities, and will be focused on helping clients avoid market delays due to compliance or quality problems. Over more than 14 years with the agency, Mr. Iser reviewed product quality and assessed manufacturing processes and pre-approval inspections, and was responsible for developing and implementing CMC guidance. Prior to joining the FDA, he spent seven years in the pharmaceutical industry managing quality systems, and supporting manufacturing process development, scale-up, and validation.
Dr. Bob (Bhardwaj) Desai, Vice President of Consulting, Technical (Oncology): With more than 10 years of experience leading global oncology and biologic/biosimilar drug development programs for Astellas Oncology, Pfizer, Hospira, and Abbott/Abbvie, Dr. Desai’s expertise extends to all phases of oncology drug development and all product classes, from chemical compounds to recombinant biologics, including mAbs, biosimilars and antibody drug conjugates (ADCs). Dr. Desai has worked closely with the FDA and other global regulatory authorities to expedite the review and approval of multiple compounds, including a successful oral presentation to the European Medicines Agency (EMA) for the approval of the first biosimilar monoclonal antibody.
Dr. Chang Lee, Vice President of Consulting, APAC: Dr. Lee brings both industry and regulatory agency experience to PAREXEL. He led Regulatory and Clinical Affairs at Capsugel, KV Pharmaceuticals, Morton Grove Pharmaceuticals, TAP Pharmaceutical Products Inc., Novartis OTC, and Igenix, and served as a Medical Officer at the FDA’s Center for Drug Evaluation. U.S. board-certified in Clinical Pathology, he is knowledgeable in global clinical and regulatory product development, including risk management, and has worked with many global regulatory authorities, including FDA, EMA, the Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada, the Central Drugs Standard Control Organization (CDSCO) in India, and the China Food and Drug Administration (CFDA).
These new team members join other recent additions to the PAREXEL Consulting, Integrated Product Development teams, including former FDA Clinical Team Leader Ron Farkas, Vice President, Technical.
“At PAREXEL, our approach to drug development necessitates an integrated strategy that demonstrates product value and mitigates risk. As such, we are always focused on building a robust team with global and diverse expertise,” said Dr. Paul Bridges, Worldwide Head of PAREXEL Consulting. “These new team members will contribute to our mission of helping clients take their products through development swiftly, successfully, and profitably, and ultimately, to the patients who need them most.”