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Joel Welch is the Associate Director for Science& Biosimilar Strategy in the Office of Biotechnology Products in the Office of Pharmaceutical Quality in CDER at the US Food and Drug Administration. He is responsible for assessing emerging, complex, or precedent-setting issues impacting science policies of the office with particular emphasis on the biosimilar program. He also serves as the Rapporteur for the ICH revision to Q5A(R1) and the Chair for the Emerging Technology Program. In his time at FDA, he has also served as a Review Chief, Team Leader, Primary Assessor and Regulatory Project Manager. Prior to joining FDA, he spent 6 years in industry supporting late state analytical development of small molecules.