David Young, Pharm.D., Ph.D.
Chief Executive Officer, Chairman of the Board and Founder
Dr. Young has over 30 years of pharmaceutical research, drug development, and corporate experience. He was a Founder and CEO of Promet Therapeutics, LLC since its formation in August 2015. 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. 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 eight years that Dr. Young was involved with Questcor, 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 a Tenured 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 Guidance's, for 5 years taught FDA reviewers as part of the UMAB-FDA contract, has served on NIH grant review committees, and was Co-Principal Investigator on a National Cancer Institute 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/supplemental NDA 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.
Chief Development Officer and Founder
Dr. Bigora has over 20 years of pharmaceutical research, regulatory strategy and drug development experience working closely with Dr. Young. She was Co-Founder, Director, and Chief Development Officer at Promet Therapeutics, LLC. Prior to Promet, Dr. Bigora 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 of material importance to Questcor's subsequent success. During her time at Questcor she assisted in building an expert regulatory group to address both 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 for 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 the Pharmacokinetics and Biopharmaceutics Laboratory at the School of Pharmacy, University of Maryland on the FDA funded Clinical Pharmacology contract and UMAB-FDA contract as a clinical scientist and instructor for FDA reviewers.
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.
Vice President, Project Management
Ms. Madden has approximately 20 years' experience in project management primarily in pharmaceutical research and development. Prior to her current role she was responsible for the development and leadership of the Project Management function at Mallinckrodt Pharmaceuticals (formerly Questcor). This involved project management of all internal clinical and nonclinical programs for its autoimmune and rare disease programs and external collaborations. Prior to this role she worked on international cross functional teams and spent over eight years with Elan Pharmaceuticals, Ireland working on both internal programs and collaborations with major pharma; she was responsible for the project management of development programs for both ANDA and NDA submissions that utilized Elan's proprietary controlled release delivery technology. Yvonne received a B.S. from Kansas State University.
Mary G. Nyberg
Vice President, Clinical Operations
Ms. Nyberg has over 20 years of experience in various roles within Clinical Operations, including over 13 years of Clinical Project Management. Mary has successfully managed global clinical trials (Phase 1-4) for biotech/pharmaceutical companies as well as non-profit organizations in many different therapeutic areas including Autoimmune Diseases, Oncology, Nephrology, Infectious Disease and Endocrinology. Prior to joining Processa, Mary served as an Associate Director of Clinical Project Management within Immunology and Internal Medicine at Quintiles, Inc. She served in a variety of roles, including Director of Clinical Operations, at Questor Pharmaceuticals, which was acquired by Mallinckrodt Pharmaceuticals in August of 2014. She has also worked at Crucell Biologics, Aeras Global TB Vaccine Foundation, MacroGenics Inc. and Human Genome Sciences.
Mary received a B.A. from Montclair State University and her M.B.A at University of Phoenix.
Chang-Rung Chen, Ph.D.
Senior Director, Translational Science & Founder
Dr. Chen has over 14 years of pharmaceutical research and development experience. He was Director of Translational Research/Pharmacology at Mallinckrodt and Questcor Pharmaceuticals from 2015 -2016, including leading efforts on understanding the mechanism of action of Acthar Gel and on generating biological data for regulatory interaction with FDA. Prior to his position at Mallinckrodt and Questcor, Dr. Chen was Director of Biomolecular Discovery of ArQule Inc. In this role he was responsible for the discovery and preclinical development of several oncology compounds currently undergoing clinical evaluation, including a FGFR inhibitor in phase III for intrahepatic cholangiocarcinoma, an NQO1 modulator in phase II for pancreatic cancer, an AKT inhibitor in phase I for Proteus syndrome and a BTK inhibitor in phase I for B-cell malignancies. Dr. Chen received a B.S. in Animal Science from Tunghai University, Taiwan and both Master and Ph.D. degrees in Molecular & Cellular Biology and Biochemistry from New York University, New York.
Peter D. Franks
Director, Drug Development
Pete has over 18 years of experience in various roles within Pharmaceutical R&D, Project Management, and Regulatory Affairs. He has worked as a Scientist and Project Manager for early-stage in vitro drug development programs, as a Senior Scientist at PPD in a GLP-compliant bioanalytical laboratory, and as a Senior Manager in Global Regulatory Affairs for ICON. He served as an Associate Director of Project Management at Questcor Pharmaceuticals, which was acquired by Mallinckrodt Pharmaceuticals in August of 2014, where he successfully managed a variety of nonclinical and clinical programs for autoimmune and rare diseases. Prior to joining Processa, Pete worked at the Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research (CDER) in the Office of New Drugs (Office of Cardiology, Hematology, Endocrinology, and Nephrology), where he facilitated and managed more than 25 FDA meetings while serving as the Regulatory Project Manager on review teams for diabetes therapies, including Ozempic, Rybelsus, and Trulicity.
Pete received a B.S. in Biology from University of Richmond and his M.S. in Regulatory Science from Johns Hopkins University. He is also a certified Project Management Professional (PMP).
Director, Clinical Operations
Ms. Smythe-Pinkerton has over 18 years of experience in clinical operations and development working on early and late phase trials in multiple pharmaceutical companies and contract research organizations. Prior to joining Processa, Shanique served as a Senior Consultant at Halloran Consulting Group where she helped clients with their clinical development strategy, IND submissions and managing clinical trials. She has also worked for companies such as IQVIA, Cmed Clinical Research, Regenxbio, and Questcor Pharmaceuticals. Shanique brings a strong global clinical management background in leading Phase I-IV global trials across more than 20 countries, touching hundreds of sites and reaching subjects in hard to enroll indications. Her therapeutic experience includes neurology, nephrology, immunology, infectious diseases, oncology and gastroenterology.
Shanique earned a Master of Science in Healthcare Administration from the University of Maryland University College and Bachelor of Science in Biology from University of Maryland Eastern Shore. She also holds a Project Management Professional (PMP) certification since 2012.
Clinical Research Associate
Ms. Parks is a Clinical Research Associate in Clinical Operations. Kayla works with the team to ensure that all the programs that are in clinic run smoothly. She previously worked for Marinus Pharmaceuticals where she had been in Clinical Operations since 2019. While at Marinus, Kayla was heavily involved in a global pivotal clinical trial in children with CDKL5 deficiency disorder and has experience in studies relating to rare diseases. She received her B.S. in Biology from the University of Mary Washington and her M.S. in Medical Physiology from Case Western Reserve University.