Susan B. Nichols, CEO, Susan is best known in the global cell and gene therapy market as a Business Connectivity Matchmaker, Innovative Commercial Strategist, and is a Networking Powerhouse. Susan has more than twenty years of corporate management and leadership experience in high growth biotech, entering the cell therapy arena in 2010. Susan brings a unique perspective having served in executive management roles with early stage, emerging, and fortune 500 companies such as Thermo Fisher, Hitachi Chemical, Baebies, and Invetech, a division of Fortive Corporation. At her core Susan is a Builder. Throughout her career, she has successfully built market opportunities, product platforms, high performing teams, and pipelines in excess of one billion dollars collectively. Susan has an impressive track record of “first-ever” leadership often blazing the trail for others to follow. Ms Nichols has managed corporate departments relating to sales, marketing, business development and collaborations between private and public-sector entities, including the FDA and EMA. Susan grew up in Harrisburg Pennsylvania where she lived before moving to Raleigh NC in 2012. She is the founder and Chair W.O.M.E.N in advanced therapies 2017- present. Chair of Women in Bio RTP, 2013 - 2015. Founder and Chair Women in Bio Board of Supporters, 2015 - 2017. Board of Supporters Cystic Fibrosis Foundation 2013 - present.
Joy A. Cavagnaro, PhD, DABT, RAC, Regulatory Advisor, former VP Regulatory Affairs and Integrated Compliance at Human Genome Sciences, where she established the Regulatory Affairs Department, which included regulatory affairs and clinical data management data programming functions and assisted in identifying and developing new pre-clinical opportunities. She served as company spokesperson with the FDA and foreign agencies in all aspects of the regulatory process. Before that she was Senior Pharmacologist & Director of Quality Assurance Office of the Center Director of FDA CBER responsible for policy guidance for the pre-clinical development and safety assessment of biological projects. She also served as FDA safety topic lead for the International Conference on Harmonization of Technical requirements for Pharmaceuticals (ICH) initiative and as rapporteur for the ICH S6 guidance on pre-clinical safety evaluation of biotechnology-derived pharmaceuticals.
Raluca Dumitru, MD PhD, Falcon’s Head of Cell Manufacturing, has over ten years of experience in the stem cell field. She was previously the Director of the Human Stem Cell Core Facility at the University of North Carolina at Chapel Hill. She started working with the Hingtgen lab on the transdifferentiation technology in 2012 and soon after they published their results in Nature Communications and Science Translational Medicine. She currently heads the cell manufacturing laboratory housed at BioLabs focusing on different strategies to manufacture NSC-like cells for therapeutic applications.
Fred Miesowicz, PhD, Lead CMC
Frederick Miesowicz brings to Falcon Therapeutics his extensive experience in the manufacturing of individualized cellular therapies. In a consultant capacity, he will assist management in the development of GMP manufacturing process both at the manual and automated stages. Prior to Falcon, Dr Miesowicz was the Chief Operating Officer of Argos Therapeutics, a position which he held for 14 years. Argos Therapeutics developed immunotherapies by reprograming dendritic cells to target antigens specific to each person’s disease. Prior to this, Dr. Miesowicz was the Vice President of Operations for Gamida-Cell, a stem cell company. He was Senior Vice President and General Manager of Hybridon Specialty Products which manufactured GMP oligonucleotides for cancer therapeutics and research applications and was acquired by Merck. He served as Vice President and General Manager of Cellcor, a subsidiary of Cytogen, Inc., from 1995 to 1998, where he directed all operations related to Cellcor’s cellular immunotherapy programs. He also served as Senior Vice President of Scientific Affairs at Cellcor from 1992 to 1995.
Dr. Miesowicz has an extensive background in cellular therapies and medical devices. Prior to joining Cellcor, he managed the U.S. and European SteriCell Division of the Terumo Medical Corporation after it was acquired from DuPont, and was with E.I. DuPont de Nemours & Company for 14 years managing both immunotherapy and immunodiagnostic R&D groups. Dr. Miesowicz holds a B.S. degree in Chemistry from Siena College and received a Ph.D. in Chemistry from Harvard University.