Acer Therapeutics Management
EU Business Operations Consultant
Mr. Girard is the founder of Christian Girard E.I.R.L., d/b/a Orphan Drugs Industry Advisory & Intelligence with more than 20 years of domestic and cross-border industry and management consulting experience. He has extensive experience in operations, business development, funding and industry/patients organizations interactions in the rare diseases space. Mr. Girard is a frequent speaker at orphan drugs conferences and has published numerous articles on these topics. Based in France, he is a graduate from ESCP Europe, a leading business school.
Mr. Masukawa is President and founder of Diligentia, LLC, a life-sciences consultancy that develops commercial business strategies and tactical commercialization requirements for manufacturers of rare orphan and specialty drugs, cell and gene therapies, and other novel emerging medical innovations. Prior to founding Diligentia, Joff was Vice President and Global Head of Government Relations and Public Affairs at Shire, where he designed and led strategies to build the company’s brand, engagement and leadership with government representatives and agencies, patient advocacy groups, payors, industry associations and other key external stakeholders. Joff has held senior level leadership roles spanning commercial and corporate functions, including market access, government and public affairs, patient and provider services, and sales and marketing at Shire, Genzyme, Visible Genetics, Gentiva and Labcorp. He has developed and executed numerous launch strategies for first-in-class products and services. He serves on the Board of Directors of Caregiver Action Network, The Center for Healthcare Innovation, and ICORD, the International Collaboration on Rare Diseases and Orphan Drugs.
Richard Ridgewell, Ph.D.
Nonclinical Development Consultant
As Founder and Principal Consultant at Ridgewell Consulting, LLC, Dr. Ridgewell is responsible for guiding clients with strategic direction and development plan execution for the nonclinical aspects of drug development programs. He provides consultation focused on scientific and regulatory aspects of nonclinical drug development across the disciplines of pharmacology, toxicology and drug metabolism and pharmacokinetics. Dr. Ridgewell’s expertise includes the integration of nonclinical findings toward prediction of human dose and exposure, efficacy, and safety toward successful regulatory submissions. Before establishing Ridgewell Consulting, he held positions of increasing responsibility and influence over more than 28 years in Drug Discovery and Drug Development within the pharmaceutical industry in North America, including Upsher-Smith, Boehringer-Ingelheim, Pharmacia (Pfizer), 3M Pharmaceuticals and Bristol-Myers Squibb. Dr. Ridgewell also gained direct contract research experience as a Research Director at Covance Laboratories. He has presented on twelve drug discovery and development topics at scientific conferences, participated as an instructor in continuing education courses for pharmaceutical scientists, authored nine peer-reviewed publications, and co-authored a book chapter on drug-transporter interactions. Dr. Ridgewell holds a Bachelor’s degree in Chemistry and a Ph.D. in Medicinal Chemistry from the University of Minnesota.
Philip T. Sager, M.D., FACC, FAHA, FHRS.
Dr. Sager is an Adjunct Professor of Medicine at the Stanford University School of Medicine, the previous chair of the FDA Cardiovascular and Renal Drugs Advisory Committee, and an Executive Committee member of the FDA-Sponsored Cardiac Safety Research Consortium. He has played a major leadership role in CV safety issues in drug development. Dr. Sager was the ICH E14 (“the QT Guidance”) PhARMA Expert Working Group Topic Leader and is a Steering Committee Member of the FDA Comprehensive In Vitro Proarrhythmia Assay (CIPA) effort. He is a member of the Board of Directors of Anthera, Inc. Previous roles have included a tenured faculty appointment at the UCLA School of Medicine, senior leadership roles in the pharmaceutical industry, including Vice President, CV/Metabolic Development at Gilead Sciences and Executive Director at AstraZeneca. Dr. Sager has major development leadership on multiple drugs including Zetia®, Vytorin®, Crestor®, Ranexa®, Letairis®, and Brilinta. He holds an M.D. from Yale University School of Medicine, B.S. degrees in biology and chemistry from the Massachusetts Institute of Technology, trained in internal medicine and cardiology at the Yale School of Medicine, and has published more than 200 original manuscripts and abstracts.
Pamela M. Williamson, RAC, FRAPS
Pamela Williamson, RAC, FRAPS, joins Acer with over 30 years of experience in regulatory affairs, quality assurance and compliance, pharmacovigilance, clinical and product development and manufacturing operations with the biopharmaceutical industry. Prior to joining Acer, Pam was senior vice president of global regulatory affairs and patient safety at Alexion Pharmaceuticals where she was responsible for supporting the development of late stage internal research and development and external business development efforts. During her tenure at Genzyme Corporation, Pam was senior vice president of regulatory affairs and corporate quality systems followed by senior vice president, global head, for regulatory affairs and compliance where she was responsible for optimizing approval timelines and maximizing the value of the international product portfolio and pipeline. Prior to that, she held several positions with Serono and Ares-Serono, where she directed numerous cross-functional, multilevel teams. She led strategic and operational aspects of regulatory affairs, directed finished drug product technology transfer, manufacturing, operations logistics, and materials management. Pam is a member of the board of trustees for the Albany College of Pharmacy and Health Sciences and a member of the Pharmaceutical Research and Manufacturers of America, Biotechnology Industry Organization, Massachusetts Biotechnology Council, Food and Drug Law Institute, Drug Information Association, and Regulatory Affairs Professionals Society (Fellow). She has an MBA from Northeastern University in Boston.