A seasoned team with extensive GI experience
Nikhilesh Singh, PhD
President and Chief Executive Officer
Nikhilesh Singh, Ph.D., Co-founder and Chief Executive Officer of OrphoMed, has more than 25 years of leadership experience in the development and commercialization of pharmaceutical products, including OTC and prescription drugs. He is the primary inventor on several U.S. and international patents that cover a products ranging from OTC (Vicks® Formula 44), prescription (Intermezzo®) and new chemical entities, including OrphoMed’s novel dimer therapeutics. Dr. Singh founded OrphoMed in 2014 to develop drugs based on a proprietary dimer technology platform. Previously, Dr. Singh founded Transcept Pharmaceuticals to develop, launch, and commercialize Intermezzo®, a proprietary, novel sublingual tablet for the treatment of insomnia.
Dr. Singh is a Fellow of the American College of Clinical Pharmacology and earned a Ph.D. in Pharmaceutical Sciences from the University of Alberta, Canada.
Gail M Comer, MD
Chief Medical Officer
Gail M Comer, M.D., Chief Medical Officer of OrphoMed, is a board-certified gastroenterologist / hepatologist with 20 years of industry experience and 14 years of experience in academic medicine. Dr. Comer has conducted clinical studies for all phases of development and has been the medical leader for two New Drug Applications (NDA), two supplemental NDAs, and five Investigational New Drug (IND) applications. Before joining OrphoMed in 2016, Dr. Comer was Senior Director at Wyeth/Pfizer Inc. where she led the development of Protonix and several drugs for inflammatory bowel disease. Subsequently, Dr. Comer served as Chief Medical Officer for Synergy Pharmaceuticals, leading the development of Trulance™ for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation. Dr. Comer is a Fellow of the American College of Physicians and American College of Gastroenterology and earned an M.D. from the Albert Einstein College of Medicine.
VP, Finance & Operations
Greg Beyer, Vice President, Finance & Operations for OrphoMed, has more than 25 years of finance, accounting, and operations experience. Before joining OrphoMed in 2015, Mr. Beyer founded Beyer Financial Consulting in 2009 to serve clients in the biotechnology and technology industries. In this role, he provided financial and accounting expertise to companies. In addition, he developed and implemented strategies to increase revenue, enhance profitability, control costs, and improve return on investment. Previously, Mr. Beyer held senior financial roles at Novacea, Inc. and 3Com Corporation. He earned a B.B.A. with a concentration in Finance and Accounting from the University of Michigan Ross School of Business.
Virginia Sanders, PhD
VP, Preclinical Development & Program Management
Virginia Sanders, Ph.D., Vice President, Preclinical Development & Program Management for OrphoMed, has over 20 years of experience in research and development in the biopharmaceutical industry. Dr. Sanders was involved in the early proof-of-concept work for OrphoMed’s lead therapy ORP-101. Prior to joining OrphoMed in 2015, she was Director of Program Management at Raptor Pharmaceuticals. Previously, she was a Program Management Consultant for Transcept Pharmaceuticals. Earlier, Dr. Sanders was Associate Director of Program Management at Anacor Pharmaceuticals (Pfizer) where she led the early development work for Kerydin®. Dr. Sanders received a B.A. in Neurobiology from Wellesley College. She earned a Ph.D. in Neuroscience from University of California, Los Angeles.
Michelle Usher, RAC
VP, Regulatory Affairs & Quality Assurance
Michelle Usher, RAC, Vice President, Regulatory Affairs & Quality Assurance for OrphoMed, has over 25 years of experience leading the regulatory affairs, QA, CMC, and drug development functions for biopharmaceutical companies and contract research organizations (CROs). Over her career, Ms. Usher has managed over 100 regulatory submissions including 16 NDAs/MAAs in the U.S. and in Europe. Prior to joining OrphoMed in May, Ms. Usher served as Head of Regulatory Affairs and Compliance for Furiex Pharmaceuticals, where she led the European development and was involved with the U.S. regulatory approval of eluxadoline. Previously, she served as Head of North America/Latin America Regulatory Affairs and Medical Writing departments for Pharmaceutical Product Development, LLC, a CRO. Ms. Usher received a B.S. in Chemistry from North Carolina State University and completed a Regulatory Affairs Certification in 1994.
Lisa Turner, RPh
VP, Clinical & Medical
Lisa Turner, RPh, Vice President, Clinical & Medical for OrphoMed, has over 25 years of experience in the pharmaceutical industry. Before joining OrphoMed in 2017, she served as Executive Director, Clinical Operations for Furiex Pharmaceuticals, where she was responsible for advancing an antibiotic program from Phase 1 to Phase 2/3 clinical development and for managing one of the Phase 3 clinical trials for eluxadoline. In 1991, Ms. Turner joined Pharmaceutical Product Development (PPD), a contract research organization. At PPD, as a member of the compound partnering group, she served as program lead for two compounds, participated in technical due diligence for numerous compounds, and helped create development programs for compounds of interest. At PPD, she also served as Chair of the Global Steering Committee, where she facilitated the global implementation of an internal project management system, and she managed the General Medicine division for several years. Ms. Turner is a registered pharmacist who has practiced in retail and hospital settings. She has a B.S. in Pharmaceutical Sciences from the University of North Carolina at Chapel Hill.
J Michael Davenport, PhD
Head, Pharmacokinetics, Bioanalytical and Biostatistics
Michael Davenport, Ph.D., Head, Pharmacokinetics, Bioanalytical and Biostatistics for OrphoMed, has over 25 years of experience leading clinical, preclinical, research and development functions in the biopharmaceutical industry. He also has extensive experience in the pharmacokinetic aspects of drug development. Before joining OrphoMed in 2017, he founded AccuVanceKinetics, a sole proprietor LLC company that offers strategic drug development and of early stage programs from preIND through Phase 2. Previously, Dr. Davenport was the Executive Director of Clinical Pharmacology and Biostatistics at Furiex Pharmaceuticals, where he was responsible for clinical pharmacology, biostatistics, data management, bioanalytical, and central laboratories. Previously, he worked at Pharmaceutical Product Development (PPD), a contract research organization. At PPD, he served as Senior Director of Clinical Pharmacology and created development strategies and provided pharmacokinetic support to clients. He holds a B.S. in Mathematics and a Master’s degree in Statistics from the University of the Arkansas and a doctorate in biostatistics from the Virginia Commonwealth University.
Timothy Costello, PhD
Head, Product Development
Timothy Costello, Ph.D., Head of Product Development for OrphoMed, has 30 years of experience in chemical process in pharmaceutical process discovery and development with 12 overlapping years of experience in pharmaceutical drug development in the biopharmaceutical industry. Before joining OrphoMed in 2017 he served as Senior Director for Furiex Pharmaceuticals, where he led CMC, scale up, clinical supplies, and commercial production of drug candidates and approved pharmaceutical products. Previously, he worked at Pharmaceutical Product Development (PPD), a contract research organization, serving as Senior Director. Before, he served as Director of Process Chemistry for Forest Laboratories. Dr. Costello began his career at DuPont, where he served for two decades, first in Central Research & Development then in Process Chemistry with DuPont Pharma. He received a BS in Chemistry from the Duke University and earned a Ph.D. in Physical Organic Chemistry from the University of Pittsburgh.