The selection of commercially viable drug candidates and advancing their development
toward worldwide markets is a complex and challenging task that requires people with a broad
range of different qualifications and drug development know-how.

Pam Hirtzer

CMC specialist

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Pam is founder of PHarmDev Associates, a company that provides specialized chemistry, manufacturing & controls (CMC) services. She studied chemistry and biochemistry at the University of California, Davis, and completed post-graduate research at Harvard Medical School. Pam has held positions in companies with responsibilities for pharmaceutical development, manufacturing and controls. From 1989 to 1994, she worked in development at Glycomed, Inc. From 1996 to 2001, she was Associate Director, Pharmaceutical Development, at Elan (South San Francisco), where she managed drug substance, analytical and drug product development efforts from pre-IND, IND to BLA for several products in clinical trials. Pam’s expertise includes moving lead candidates toward INDs, supporting clinical trials with expert CMC planning, managing development timelines for NDAs or BLAs, due diligence efforts, project teams, budgets and FDA responses.