Monil Shah, PharmD, MBA, is formerly Chief Operating Officer at IRX Therapeutics and has over 18 years of pharmaceutical and biotechnology industry experience in oncology drug development. Prior to joining Brooklyn ImmunoTherapeutics, Dr. Shah was the Medical Affairs Lead for Immuno-Oncology at Bristol Myers Squibb. Dr. Shah helped was Head of Clinical Operations and Development at Ventrus Biosciences prior to its merger with Assembly Biosciences. Prior to Ventrus, Dr. Shah led the solid tumor development programs and led the clinical portfolio and strategic planning function at Celgene Corporation. He led the Oncology Development and Operations activities at Fibrogen and Novacea. Dr. Shah began his career at Novartis in the Oncology Early Development Group leading clinical trials prior to joining the Medical Sciences Group at Amgen. Dr. Shah received his BS and PharmD degrees from Rutgers, The State University of New Jersey and his MBA from Florida Institute of Technology.
Ron Guido is Executive Vice President Regulatory Affairs and Quality Systems at Brooklyn ImmunoTherapeutics and formerly Senior VP Regulatory Affairs and Quality Systems at IRX Therapeutics. Prior to joining the company in January 2017, Mr. Guido was Senior Vice-President Global Regulatory Affairs and Chief Compliance Officer for Veloxis Pharmaceuticals, Denmark. Mr. Guido was previously Senior Director and Therapeutic Area Head for Cardiovascular Medicine – Worldwide Regulatory Strategy for Pfizer. Ron Guido has held senior roles areas of preclinical screening, clinical research, regulatory affairs, product development and quality systems with Retrophin, V.I. Technologies/ Precision Pharma Services, Whitehall-Robins Healthcare, Fresenius Pharma USA, and Wyeth-Ayerst Laboratories. These responsibilities have included international and domestic regulatory affairs development programs encompassing drugs, devices, biologics, and nutritionals. Mr. Guido holds an M.S. in Technical Communications from the Polytechnic University, New York, and an MSc Pharmaceutical Medicine from Hibernia College, Dublin. He is currently Lecturer in Biology, in the Masters of Biotechnology Program at Columbia University of the City of New York.
Lynn Sadowski Mason is the Executive Vice President Clinical Operations at Brooklyn ImmunoTherapeutics. Prior to joining Brooklyn Immunotherapeutics, she was the Head of Operations at IRX Therapeutics. Lynn has 19 years of pharmaceutical and biotechnology industry experience in clinical operations. For the last 13 years, she has been working to operationalize ImmunoOncology studies around the globe, including working on critical studies with Yervoy, Opdivo, and Elotuzumab. Lynn spent 12 years at Bristol Myers Squibb (BMS). In her most recent role at BMS, Lynn was the Connecticut site head for Global Clinical Operations and Strategy, where she led a team of up to 50 clinical operations staff. Prior to that, Lynn spent three years on assignment in Europe where she oversaw clinical operations activities in Romania, Czech Republic, Hungary and Turkey. Prior to BMS, Lynn worked for various small pharmaceutical companies and Contract Research Organizations. Lynn received her BS in Biology from Indiana University, and her Masters Degree in Drug and Regulatory Affairs from Massachusetts College of Pharmacy and Health Sciences.
Dr. Michael Wyand is Senior Technical Advisor to Brooklyn ImmunoTherapeutics, providing strategic manufacturing and development counsel. Dr. Wyand is President of Oxeia BioPharmaceuticals and was President/COO of Epirus Biopharmaceuticals where he managed a portfolio of biosimilar monoclonal antibodies at both development and commercial stages with global partners in Europe and Asia. Prior to Epirus Dr. Wyand headed R&D at Percivia, a J&J/DSM joint venture; BioAssets Development, acquired by Cephalon for $120M; and Therion Biologics, a pioneering cancer vaccine company. At Therion, Dr. Wyand led the development of PROSTVAC, a pox-virus based immunotherapeutic vaccine for prostate cancer, licensed by Bristol-Myers Squibb Company for $975M in 2015 and managed the design/build of a cGMP manufacturing plant. Dr. Wyand started his career at Mason Laboratory a wholly owned subsidiary of Genzyme Transgenics where he was President and CSO. Dr. Wyand trained in comparative pathology at Harvard Medical School, received his DVM from Purdue University and his PhD in Pathology from the University of Connecticut. He received a BS in Biology from the University of Connecticut where he graduated with honors as a University Scholar.