Dr. Westelinck brings an extraordinary level of knowledge and expertise in oncology research, product development, and regulatory pathways in both the US and EU that will greatly benefit our clients in this field.
Madison, Virginia (PRWEB) August 16, 2014
Dr. Carl Peck, MD, Chairman of NDA Partners LLC announced today that Agnes Westelinck, PharmD, has joined the firm as a Premier Expert consultant. NDA Partners Premier Experts are top tier consultants whose expertise and professional stature enable them to bring extraordinary value to the company’s clients. Premier Experts collaborate to design and implement critical solutions to help clients successfully develop their medical products, pursue optimal regulatory pathways, build companies that are attractive to professional investors, and initiate access to global markets. Dr. Westelinck is a highly regarded pharmaceutical industry senior executive with significant experience in the development and regulatory approval of drugs in the US, EU and Asia. She was formerly Executive Director and Global Head of Regulatory Affairs, Oncology, for GlaxoSmithKline, Director of Regulatory Affairs at Hoffman-La Roche, and Visiting Scientist/Executive at the US Food & Drug Administration (FDA), Office of Drug Evaluation, Division of Oncology (CDER).
“Dr. Westelinck brings an extraordinary level of knowledge and expertise in oncology research, product development, and regulatory pathways in both the US and EU that will greatly benefit our clients in this field,” said Dr. Peck. “Oncology is presently a very active area for new drug development and we welcome Dr. Westelinck as a key contributor and leader in this practice area.”
In addition to global product development and regulatory strategy, Dr. Westelinck’s expertise includes innovative approaches in drug development (targeted therapies, immunotherapy, breakthrough therapies, novel-novel combinations, companion diagnostics, and innovative study designs) and emerging technologies (cell therapies, therapeutic RNA). She also provides strategic input for portfolio and licensing/deal-making decisions, and guidance for IND and NDA submissions, rare diseases, biomarkers, and accelerated approvals.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of approximately 40 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.