On July 23, 2018 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage company developing novel epigenetic therapies, reported the appointment of Dr. Shefali Agarwal as chief medical officer, effective July 23, 2018 (Press release, Epizyme, JUL 23, 2018, View Source [SID1234527842]). In this role, Dr. Agarwal will oversee all of the company’s activities related to the global strategic development of tazemetostat, a potent, selective, orally available EZH2 inhibitor, as well as additional pipeline candidates. A trained physician with expertise in medical oncology, Dr. Agarwal brings nearly two decades of clinical research and regulatory experience to Epizyme.
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"Dr. Agarwal’s distinguished career in both academia and the biotech industry make her an ideal candidate to lead our clinical organization and oversee the development of innovative therapies to potentially treat a range of solid tumor and hematological malignancies for which significant needs exist," said Robert Bazemore, president and chief executive officer of Epizyme. "Her proven leadership and understanding of the patient community, as well as the healthcare providers who care for them, will be instrumental as we continue to advance our lead product candidate, tazemetostat."
"I look forward to joining this dynamic management team, and leading the next phase of clinical development for tazemetostat, as well as for EZM8266, our novel agent that targets G9a for the treatment of sickle cell disease, as we prepare it to enter the clinic," said Dr. Agarwal. "I believe that Epizyme’s scientific vision and innovative approach will drive the continued success of the company, as we work together to deliver promising new options for underserved patients."
Over the span of her career, Dr. Agarwal has held leadership positions across medical research, clinical development, clinical operations, and medical affairs. She has led clinical and regulatory engagements for small molecules, biologics, liposomal and cell therapy products across the full spectrum of drug development, from pre-IND work to filing. Dr. Agarwal most recently served as chief medical officer at SQZ Biotech, where she built and led the clinical development organization, which included clinical research operations and the regulatory function. She brings significant oncology experience to Epizyme, having held leadership positions at Curis and Tesaro. At Curis, Dr. Agarwal oversaw the Phase 2 study for its dual HDAC/PI3K inhibitor in diffuse large B-cell lymphoma, and the Phase 1 study in solid tumors for its oral checkpoint inhibitor. At Tesaro, Dr. Agarwal led the NDA and EMA submissions for ZEJULA (niraparib) in ovarian cancer. She has also held positions of increasing responsibility at Covidien, AVEO Oncology and Pfizer.
In addition to receiving her MBBS medical degree from Karnataka University’s Mahadevappa Rampure Medical School in India, Dr. Agarwal earned a master’s of public health from Johns Hopkins University, where she led clinical research in the Department of Anesthesiology and Critical Care Medicine. She also holds a master’s of science in business from the University of Baltimore’s Merrick School of Business.