Manohar Katakam, PH.D.
Founder & CEO
About
Experienced biotech/pharma entrepreneur with more than 25 years of experience in developing and marketing a diverse therapeutic area products. Dr. Katakam raised equity and debt capital and managed operations leading to many successful high-valued corporate exits. Major pharmaceutical industry experience included successful tenures at Centocor, Aventis, Wyeth, and Pfizer. Dr Katakam co-founded NuTherapeutics to develop and commercialize thin-film dosage forms of prescription products which he guided to a successful exit.
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He established the orphan disease product company, Makindus, and led product development to Phase 3 readiness in both the US and in EU. He obtained his bachelor's degree in pharmacy from Kakatiya University and his MS and Ph.D. in Pharmaceutical Sciences from Auburn University.
Constantine A Stratakis
Executive Medical Director
About
Professor Constantine A Stratakis is a renowned medical geneticist, endocrinologist, translational investigator, and executive leader with extensive experience in healthcare, clinical trials, genetics, policy, government regulations, and patient advocacy. He served as the Chief Scientific Officer of ELPEN Pharmaceuticals and directed the efforts to build a new ELPEN Research Institute. He led the National Institutes of Health (NIH/NICHD) genetics and endocrinology programs and the NICHD intramural research program for over 18 years in the United States, training over 200 trainees. He has authored over 800 publications and received numerous awards and honors for his work.
Arthur Schwartz, Ph. D.
Senior Advisor, Scientific Affairs
About
Dr. Arthur Schwartz has been an emeritus professor at Temple Medical School since 2007. He received his B.A. from Johns Hopkins University, Ph.D. from Harvard University (Microbiology and Immunology) and did postdoctoral work at the University of Oxford and Albert Einstein College of Medicine in New York. He has spent his professional academic career at Temple Medical School in the Fels Institute for Cancer Research and Molecular Biology and as a Professor of Microbiology and Immunology. Dr. Schwartz has done extensive research in the areas of cancer prevention and experimental gerontology and was the principle investigator on numerous grants from the National Cancer Institute and Institute on Aging. He was the first to demonstrate the cancer preventive and potential age-retarding effects of DHEA in laboratory animals and the link between DHEA action and the beneficial effects of caloric restriction. Dr. Schwartz was the principle investigator in the development of non-androgenic DHEA analogs as potential drugs in humans. He was the scientific founder of Aeson Therapeutics, Inc., a biotech company focused on the commercial development of DHEA analogs. He has over 40 publications on the biological actions and mechanism of action of DHEA and structural analogs and is the primary inventor on 14 US and foreign patents claiming novel DHEA analogs, methods of use, and pharmaceutical compositions and delivery systems.
Bo Allen, PH.D.
Senior VP, Regulatory Affairs
About
Carroll “Bo” Allen has over 40 years experience in multiple leadership positions within the pharmaceutical industry including 20 years in major pharmaceutical companies (Boehringer Ingelheim, Ciba Geigy, Sandoz, and Novartis). He has executive experience in various start-up biopharmaceutical companies including CoCensys, Kimeragen, and IgX. He founded Asklepion Biopharmaceuticals and Versalion Pharmaceuticals. He has extensive experience in the United States and global orphan drug markets and regulations as well as the implementation of orphan drug strategies.
He is experienced in clinical development, business development and marketing activities for orphan products as well as FDA and EMEA regulatory documentation and compliance, planning and implementation including cGMP, GLP and HIPPA practices. Dr. Allen has a Masters in Biologics Sciences from the University of Tennessee Knoxville and a Ph.D. from South Hampton University, UK.