What CMOs Need to Know about Partnering with Hospitals & Clinical Research Sites

Dr Feldman is currently Professor of Oncology and Director of the Early Phase Clinical Trial Program at the Montefiore Einstein Cancer Center. His research centers primarily on developmental therapeutics in cancer, with a focus on antibody-based therapeutics. His clinical background is in hematology and medical oncology with specific training in stem cell transplantation and expertise in the management of patients with myeloid malignancies. In addition to 30+ years in the academic world, He has been Head of Development and Chief Medical Officer at several leading biotech companies, heading the pre-clinical and clinical development of immuno-oncology agents, including bi-specific and multi-specific antibodies in both hematologic malignancies and solid tumors.

Serena Hung is the former Chief Medical Officer of Arkuda Therapeutics, a biotechnology company that focuses on lysosomal dysfunction in neurodegenerative diseases. She joined Arkuda in April 2020. She is a board-certified neurologist with subspecialty training in movement disorders. She has approximately 20 years of clinical research experience both in industry and academia, including leadership roles in Phase I through Phase III development with successful INDs, BLA/NDAs. She has experience in multiple therapeutic areas in CNS and rare diseases including Parkinson’s disease and other movement disorders, Huntington’s disease, dementia, ALS, ataxia, and multiple sclerosis. Previously she worked at Wave Life Sciences and Biogen, where she assumed roles of increasing scope and responsibility. She holds a medical degree from Wake Forest University School of Medicine, and a BSE in chemical engineering at the University of Michigan.She is a Board Director at the National Ataxia Foundation.

Dr. Dezube is Senior Vice President, Head of Clinical Development of Xilio Therapeutics, a company whose mission is to develop tumor-activated immune- oncology therapies for patients with solid tumors. Dr. Dezube joined Xilio from Mustang, where he served as Chief Medical Offer of Mustang Bio, which is developing the next generation of gene and cell therapies. Prior to that, Dr. Dezube served as Vice President and Clinical Head of Oncology at Alkermes, where he oversaw the advancement of the company’s interleukin-2 variant from Phase 1 to registrational studies for the treatment of cancers. Before Alkermes, Dr. Dezube spent more than 9 years with Millennium (now Takeda Oncology) and Tesaro (now GlaxoSmithKline), where he held positions of increasing responsibility related to the development of their oncology pipelines.  Fields of industry focus include colorectal cancer, lymphoma, myelodysplastic syndromes (MDS), acute myelogenous leukemia (AML), ovarian cancer, breast cancer, melanoma, and renal cell cancer. Earlier in his career, Dr. Dezube was an Associate Professor of Medicine at Harvard Medical School/Beth Israel Deaconess Medical Center where he served as an Attending Physician for more than 20 years.  There he served on the Board of Trustees and was the Director of the Experimental Therapeutics/Phase 1 unit, Director of AIDS Oncology, and Deputy Director of the Cancer Center Clinical Trials Office.  He is triple board certified- internal medicine, hematology, and oncology and has authored more than 200 publications on PubMed.  He completed his internal medicine residency training at Tufts/New England Medical Center and hematology-oncology fellowship at Beth Israel Deaconess Medical Center/Harvard Medical School.

Manoj Malhotra, M.D., is the chief medical officer at Ovid Therapeutics. As a member of the Company’s leadership team, Dr. Malhotra endeavors to strengthen Ovid’s capabilities in identifying and developing new medicines for resistant epilepsies and will support our mission to meaningfully help people affected by these devastating conditions.Dr. Malhotra is a trained neurologist with a specialty in epilepsy. Over his career, he has supported or led more than 10 mid-to late-stage epilepsy clinical trials in rare diseases, including Dravet and Lennox-Gastaut syndromes, and other neurologic diseases. Before joining Ovid, Dr. Malhotra served at Eisai’s Neurology Group leading global medical affairs for its epilepsy and multiple sclerosis businesses. He was a Global Senior Medical Director at Mallinckrodt Pharmaceuticals autoimmune and rare disease unit and held senior roles at Takeda supporting its Alzheimer’s program and within Novartis Medical Affairs. Throughout his career in industry, Dr. Malhotra developed expertise in rare neurological diseases.Prior to his career in industry, Dr. Malhotra completed his residency in neurology and his fellowship in neurophysiology at the Cleveland Clinic Foundation, after which, he went on to become the Chief of Neurology at Kaiser Permanente. Dr. Malhotra’s experience as a treating physician and as a pharmaceutical executive brings deep medical expertise to Ovid and the community we strive to serve.

Karen Ivester has over twenty-five (25) years of experience in the pharmaceutical industry and is a Registered Nurse (RN) with a master’s degree. She has spent twenty-three (23) years working in Oncology clinical research and drug development across CROs, biotech, pharmaceutical, community-based research, and academic cancer center environments. She has an insider’s view of operations within multiple clinical research centers. She has extensive experience in leading high functioning Project and Clinical Operations teams in portfolio delivery of highly complex trials (Umbrella, Basket, Immuno-Oncology and Cell & Gene Therapy). She is PMP certified and has taught and mentored project managers, research nurses and other research personnel as they gained clinical research experience and certifications. Karen is also a Certified Life Coach and uses this knowledge to mentor and develop teams and individual contributors.