Maximizing Regulatory Interactions

Simon Cooper is the Chief Medical Officer of LifeMine Therapeutics.  He is an accomplished leader in drug development with an extensive background in translational medicine and clinical development. Over the course of his career, he has worked across multiple modalities and therapeutic areas from first-in-human studies through FDA submissions and approvals of highly successful therapeutics.Prior to joining LifeMine, Simon was CMO of Morphic Therapeutic (acquired by Eli Lilly). Earlier, he served as Chief Medical Officer of Keros Therapeutics, Kadmon Holdings and Anokion, where he drove significant advances in program development and built key functional areas to support clinical development for assets in the autoimmune, inflammatory, and immuno-oncology areas.  Earlier in this career, Simon held roles of increasing responsibility at research and development organizations including Wyeth Research, Roche, Human Genome Sciences, Novartis, Sanofi and AbbVie.

Mark Sumeray has 25 years of experience across the pharmaceutical, medical devices and biotech industries, both in the US and EU. Prior to his current role as CMO at Amolyt, he spent six years as chief medical officer at Amryt Pharmaceuticals, where he was responsible for development, regulatory and safety areas of the company. He was closely involved in support for the approval and launch of new treatments for patients with acromegaly, lipodystrophy, epidermolysis bullosa and homozygous familial hypercholesterolemia and led the clinical and scientific interactions with global health authorities. Prior to Amryt, he spent five years as chief medical officer at Aegerion Pharmaceuticals. Earlier in his career, he worked at Bristol-Myers Squibb, where he led a large US medical affairs team within the cardiovascular and metabolics area. He also previously worked at Ethicon, a Johnson & Johnson medical device company, where he was responsible for the clinical group. He spent nine years in clinical practice in the NHS, specializing in cardiovascular surgery and physiology. Mark received his bachelor’s and M.D. from University College London and FRCS qualification from Royal College of Surgeons.

TBA

Born and raised in Torino (Italy) where in 1992 he obtained his medical degree and in 1997 completed his residency in Respiratory Medicine at the University of Torino. Attending physician and investigator in thoracic oncology in Torino till 2010 including several phase II-III clinical trials in NSCLC and SCLC and mesothelioma and author of papers on peer-reviewed journals and abstracts at main conferences (presenter at ASCO, ESMO, IASLC). Medical Director in Cancer Immunotherapy with GSK till 2012, then in Novartis Oncology till 2014 to develop ceritinib (ALK inhibitor) in NSCLC. VP of Clinical development in Oncolytics till January 2016 when he took the role of Lung cancer Program Lead at BMS till March 2019 leading to nivolumab approval in SCLC. Chief Medical officer at Xcovery since March 2019 to lead the company to first NDA submission of an ALK TKI for NSCLC.