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Punam Sandhu, PhD

Head of Oncology, Global Regulatory Affairs
Jazz Pharmaceuticals

Punam Sandhu, Ph.D, is Head of Oncology, Global Regulatory Affairs at Jazz Pharmaceuticals in Philadelphia, Pennsylvania. Prior to joining Jazz in 2018, Dr. Sandhu was at Merck & Co. Inc., Pennsylvania, for 20 years, where she had the opportunity to work in Oncology, Neuroscience, and Infectious Diseases spanning drug discovery, early and late-stage development, as well as life-cycle management. Dr. Sandhu has participated in several regulatory agency meetings with the FDA, EMA, Health Canada, PMDA, TGA and ANVISA, involving End-of-Phase 1/2, pre-Phase 3, post-NDA, BLA, RTOR/ORBIS, pre-NDS and CMC meetings. Some of the marketed compounds that Dr. Sandhu had the opportunity to work on in Oncology include Keytruda for solid tumors, Zolinza for CTCL, Defibrotide for t-VOD, Vyxeos for t-AML/AML-MRC, Lurbinectedin for SCLC and Rylaze for ALL/LBL. Regulatory approvals in other therapeutic areas include Cancidas (for aspergillosis and esophageal candidiasis), and Zerbaxa (for complicated urinary tract and intra-abdominal infections) in Infectious Diseases, and Xywav and Sunosi for sleep-related conditions in Neuroscience.

In 2016, Dr. Sandhu co-led a cross-Pharma White Paper initiative on Physiologically-Based Pharmacokinetic Model Qualification and Reporting Procedures for regulatory submissions. This white paper served as a rebuttal to FDA’s and EMA’s draft guidances to help address gaps in this area.

Dr. Sandhu has a B.Sc. in Biochemistry (Honors), M.Sc. in Toxicology, and a Ph.D. in Cancer Research. She pursued a postdoctoral research fellowship at Vanderbilt University, Tennessee, under Professor Fred Guengerich. Her postdoctoral work led to a patent on “Expression and Purification of Human Cytochrome P450s in E. Coli”. Dr. Sandhu has authored/co-authored 50+ publications and has lectured Pharmacy students at Vanderbilt University and developed a course on Drug Discovery and Development for Yale Medical Students. Additionally, Dr. Sandhu serves as Adjunct Assistant Professor in the School of Medicine and Health Sciences at The George Washington University.

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