Posted on: October 11, 2021
Mark S. Berger, MD ’80, has been named to the newly-created position of chief medical officer of Genprex, Inc., a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes.
Berger is an oncologist and senior executive with 25 years of biotech and pharmaceutical company experience in the development of oncology therapeutics. He has successfully brought two drugs through the regulatory process to approval and excels in strategic development, team management and collaborative leadership. Berger joins Genprex from Actinium Pharmaceuticals, Inc., where since January 2017 he served as chief medical officer and was responsible for clinical strategy and development of radioisotope-labeled antibodies for therapy in oncology, including the company’s Phase 3 SIERRA trial. Before that, he was senior vice president-clinical research at Kadmon Corporation from 2013 through 2017, where he led all aspects of the company’s new drug development, including clinical trial design and management of the oncology programs in non-small cell lung cancer and breast cancer, among others.
Prior to that, Berger was chief medical officer of Deciphera Pharmaceuticals from June 2011 to September 2013. Before Deciphera, he was vice president for clinical development at Gemin X Pharmaceuticals, where he led the clinical strategy, design and management of clinical trials for two novel oncology agents including obatoclax. Based on the results of a randomized Phase 2 clinical trial of obatoclax, Gemin X was acquired by Cephalon in March of 2011. Before his work with biotechnology companies, Berger held key positions in two global pharmaceutical companies. He previously served as group director, medicine development centre-oncology for GlaxoSmithKline. In this position he managed the development of Tykerb (lapatinib) in lung and breast cancer where he designed and led two Phase 2 clinical trials before planning and leading a 399 patient pivotal Phase 3 trial that resulted in the FDA approval of Tykerb in breast cancer. In addition, he managed the Lapatinib Expanded Access Program that enrolled over 4,000 patients on a global basis. Berger began his career in drug development at Wyeth Research where he led the planning and execution of the pivotal Phase 2 trial for Mylotarg, which was the first antibody targeted chemotherapy agent. He presented the Mylotarg clinical data at the FDA’s Oncology Drug Advisory Committee meeting, after which Mylotarg received accelerated FDA approval for patients with relapsed AML.
Berger holds a B.A. in biology from Wesleyan University and an MD from the University of Virginia School of Medicine. He did his hematology/oncology fellowship at the University of Pennsylvania, where he was an assistant professor of medicine, and also was a research fellow at the Ludwig Institute for Cancer Research and the Imperial Cancer Research Fund, both in London. Berger is board certified in internal medicine, hematology and medical oncology.