Our Scientific Team

David Young, Pharm,D., Ph.D. - President, CEO and Founder

Dr. Young has over 30 years of pharmaceutical research, drug development, and corporate experience. Dr. Young was Chief Scientific Officer of Questcor Pharmaceuticals from 2009-2014 and was responsible for working with the FDA on modernizing the Acthar Gel label and in obtaining FDA approval in Infantile Spasms, events critical to Questcor’s subsequent success. From 2006-2009 prior to joining the executive management team, Dr. Young served as an independent Director on the Questcor Board of Directors. During the 8 years that Dr. Young was involved with Questcor as an independent Director and Chief Scientific Officer, Questcor transitioned to an orphan drug specialty pharmaceutical company, moving from near bankruptcy in 2007 to a valuation of approximately $5.6 billion in 2014.

While serving on Questcor’s Board of Directors, Dr. Young was Executive Director & President, U.S. Operations of AGI Therapeutics plc. Dr. Young has also served as the Executive Vice President of the Strategic Drug Development Division of ICON plc, an international CRO, and was the founder and CEO of GloboMax LLC, a CRO specializing in FDA drug development, purchased by ICON plc in 2003. Prior to forming GloboMax, Dr. Young was an Associate Professor at the School of Pharmacy, University of Maryland, where he led a group of 30 faculty, scientists, postdocs, graduate students and technicians in evaluating the biological properties of drugs and drug delivery systems in animals and humans.

Dr. Young is an expert in small molecule and protein non-clinical and clinical drug development. He has served on FDA Advisory Committees, was Co-Principal Investigator on a FDA funded Clinical Pharmacology contract, was responsible for the analytical and pharmacokinetic evaluation of all oral products manufactured in the UMAB-FDA contract which lead to the SUPAC and IVIVC FDA Guidances, has taught FDA reviewers as part of the UMAB-FDA contract, has served on NIH grant review committees, and was Co-PI on an NCI contract to evaluate new oncology drugs.

Dr. Young has met more than 100 times with the FDA on more than 50 drug products and has been a key team member on more than 30 NDA/sNDA approvals. Dr. Young has more than 150 presentations-authored publications-book chapters, including formal presentations to the FDA, FDA Advisory Committees, and numerous invited presentations at both scientific and investment meetings.

Dr. Young received his B.S. in Physiology from the University of California at Berkeley, his M.S. in Medical Physics from the University of Wisconsin at Madison, and his Pharm.D. - Ph.D. with emphasis in Pharmacokinetics and Pharmaceutical Sciences from the University of Southern California.

Sian Bigora, Pharm.D.
Partner

Dr. Bigora has over 20 years of pharmaceutical research, regulatory strategy and drug development experience. She was Vice President of Regulatory Affairs at Questcor Pharmaceuticals (acquired by Mallinckrodt Pharmaceuticals in 2014) from 2009-2015, including leading efforts on modernizing the Acthar Gel label and in obtaining FDA approval in Infantile Spasms, events critical to Questcor's subsequent success. During her time at Questcor she built an expert regulatory group to address both the commercial and development needs for complex products such as Acthar. Dr. Bigora's role at Questcor included heading up the development of a safety pharmacovigilance group and a clinical quality group.

Prior to her position at Questcor, Dr. Bigora was Vice President of Clinical and Regulatory Affairs, U.S. Operations of AGI Therapeutics, plc. In this role she was responsible fro the development and implementation of Global Phase 3 studies and interactions with regulatory authorities. Previously she operated her own consulting company, serving as the regulatory and drug development expert team member for multiple small and mid-sized pharmaceutical companies. Dr. Bigora held multiple positions in regulatory affairs, operations and project management ending as VP of Regulatory Affairs at the Strategic Drug Development Division of ICON, plc, an international CRO, and at GloboMax LLC, a CRO specializing in FDA drug development, purchased by ICON plc in 2003. Prior to GloboMax, she worked in pharmacokinetcs and pharmacocynamics at the Pharmackinetics and Biopharmaceutics Laborary at the School of Pharmacy, University of Maryland.

Dr. Bigora received a Pharm.D. from the School of Pharmacy at the University of Maryland at Baltimore. She also completed a Fellowship in Pharmacokinetics and Pediatric Infectious Diseases at the University of Maryland at Baltimore.

James Noveroske, Ph.D.
Toxicology

Dr. Noveroske has over 40 years' experience in Toxicology. He has extensive experience writing and editing pharmacology/toxicology sections and summaries for IND and NDA submission. Dr. Noveroske's report authorship includes over 600 studies in preclinical pharmacology/toxicology encompassing major classes of biologic and synthetically derived compounds. Additional expertise includes representing clients at agency meetings and the development of pre-IND briefing document strategies, including biosimilars. He received an M.A. and B.A. from the Indiana University of Zoology and a Ph.D. from the University of Illinois in Reproductive Endocrinology.

Helen Pentikis, Ph.D.
Drug Development

Dr. Pentikis is an expert in regulatory and strategic drug development in pharmacokinetics (PK), pharmacodynamics (PD), and biopharmaceutics and in numerous therapeutic areas. She is an expert in PK/PD modeling strategy and implementation using various speciality software programs including NONMEM and WinNonlin. She has over 20 years' experience in key scientific roles in the pharmaceutical industry. Dr. Pentikis was a partner and key member of senior management and scientific project teams in a successful start-up CRO which resulted in an acquisition by a multinational CRO. She was a senior manager in a successful venture capital-backed, start-up pharmaceutical company which resulted in an acquisition valued at $300M. Dr. Pentikis has extensive experience in the identification, development, and implementation of internal processes and procedures in the start-up company environment. She is a highly motivated professional with excellent leadership, communication and interpersonal skills. She received a B.S. in Biology from Wake Forest University, and a Ph.D. in Pharmacology and Toxicology from the Unviersity of Maryland. Dr. Pentikis completed a Pharmacokinetics Fellowship at the FDA where she studied population PK and PD mixed effects modeling and in vitro drug metabolism using human liver microsomes.