Today NDA Group announced the expansion of the unique NDA Advisory Board with the appointment of Dr. Susan Jerian a NCI trained oncologist with over two decades of leadership and experience in the Industry and the FDA.
Dr. Jerian is a NDA expert in drug and biologic development for hematology and oncology indications, combination product development including companion diagnostics, biosimilars, clinical trial design and regulatory strategy with special emphasis on US FDA requirements.
The announcement follows on to NDA Group’s expansion in the US in the regions of Princeton, Boston and San Francisco. The appointment of Dr. Jerian expands on NDA Group’s already formidable expertise in the oncology area, providing companies in this space with improved access to world leading FDA oncology experience.
Dr. Jerian is joining the NDA Advisory Board, a unique team of experts comprising some of the most well-known names in the industry, many of whom have been involved in designing the regulatory and HTA systems in place today. Together, they provide strategic advice and unbiased second opinions to pharmaceutical clients during part of, or the complete end-to-end drug development life cycle. This also includes support and advice during interaction with regulatory agencies, be it at scientific advice, during review of a marketing authorisation application or at any stage post-authorisation.
Dr. Werner Van den Eynde, Vice President NDA Advisory Board, commented on the appointment:
“The NDA Advisory Board is one of a kind – no other professional body comes as close to reflecting the current opinions and practices of the world’s regulatory and reimbursement agencies. I am very excited to welcome Dr. Jerian on board. With her experience in and in-depth knowledge of oncology product development as well as her FDA expertise she will be able to add tremendous value to clients in these areas and help them to make new and promising medicines available to patients.”
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NDA is an independent consulting group with offices in Stockholm, London, Zürich, Munich, Princeton, Boston and San Francisco. Its mission is to ensure that good medicines reach patients without unnecessary delay. It accomplishes this by providing the pharmaceutical industry with a comprehensive range of professional drug development services focusing on regulatory affairs, health technology assessment, pharmacovigilance and quality assurance. NDA’s team of more than 150 full time professionals is comprised of more than 25% ex-regulators from major EU Agencies, and a specialist Advisory Board consisting of Europe’s leading regulatory and HTA experts. The NDA Advisory Board provides scientific advice to pharmaceutical companies supporting them in gaining fast and constructive assessment of applications from regulatory agencies and HTA bodies. www.ndareg.com