Senior Management
Sally Van Doren, PharmD, President and CEO
Dr. Van Doren is President and CEO of BioSoteria, Inc., and has 25 years of clinical pharmacy practice and biopharmaceutical industry experience. She previously held leadership positions in drug and biologic safety, clinical development and medical affairs in industry prior to founding BioSoteria. Dr. Van Doren has been directly involved in safety analyses for several NDA, BLA, 505(b)2, 510(k) and MAA product marketing applications and has advised numerous companies in a broad range of product safety issues. Prior to entering the pharmaceutical industry, Dr. Van Doren conducted drug utilization studies at a tertiary care center in the Middle East and educated nurses, pharmacists and physicians on appropriate drug use. For the past few years, she has been an Instructor of drug safety at University of California Berkeley Extension as part of the Clinical Research and Management Certification Program, is a Member of the Board of Visitors at the University of MD School of Pharmacy (an advisory role to the Dean), and is a Member of the Community Advisory Board, UCSF AIDS Health Project.
Madeline Miller, D.V.M, M.S., Executive Vice President and Chief Operating Officer
Dr. Miller joined BioSoteria with extensive executive and operational experience in the biopharmaceutical industry, including directing operations on multiple clinical research and development programs. She also brings leadership experience directing medical affairs operations. Prior to joining BioSoteria, Dr. Miller served as VP, Clinical Operations at Point BioMedical Corp. She also held several important posts during her 11-year tenure at Gilead Sciences, including Senior Director of Project and Portfolio Management, Senior Director of Medical Affairs Operations, and Director of Clinical Research Operations. She began her biopharmaceutical career at Biometric Research Institute in San Francisco, which became Quintiles Transnational Corporation in 1996. Before joining the industry, she was a practicing veterinarian and worked in large animal, companion animal, and emergency practices. Dr. Miller earned a veterinary medicine degree from Michigan State University, and both a B.S. and M.S., in Biological Sciences from the University of Michigan.
James Buchanan, PharmD, Senior Vice President, Pharmacovigilance and Risk Management
Dr. Buchanan has more than 20 years of drug safety industry experience and is currently the Senior Vice President, Pharmacovigilance and Risk Management at BioSoteria, Inc. Dr. Buchanan began his industry career at Genentech, where he worked for nine years in the areas of medical information and drug safety in the clinical development department. He subsequently moved to Gilead Sciences to establish the company’s drug safety department. Following Gilead Sciences, Dr. Buchanan created the drug safety department at Tularik, where he acted as Chief Safety Officer until the company was acquired five years later by Amgen. Dr. Buchanan then moved to Nuvelo to establish a drug safety department, act as Chief Safety Officer, and take responsibility for clinical operations, biostatistics and data management. Prior to his industry career, Dr. Buchanan worked in the area of clinical toxicology at the Bay Area Regional Poison Control Center at San Francisco General Hospital. He has maintained an academic affiliation over the past 25 years as an Assistant Clinical Professor of Pharmacy at the UC San Francisco School of Pharmacy and, more recently, has joined the volunteer faculty at the Touro College of Pharmacy and is an instructor in drug safety at UC Berkeley Extension. Dr. Buchanan graduated from the University of California, San Francisco with a PharmD degree in clinical pharmacy.
Charles Schwamlein, MD, MPH, Chief Medical Safety Officer
Dr. Schwamlein has extensive clinical experience in the practice of internal medicine, with more than a decade of senior level management and operations experience across all phases and processes of pharmacovigilance, drug safety, and risk management, including safety reporting, risk management, MedDRA coding, and pharmacoepidemiology.
Michelle Nolin Flewell, CPLP, Vice President of eLearning and Informatics
Ms. Flewell joins BioSoteria with more than 15 years of medical communications and health care training experience. Prior to joining BioSoteria, she developed multimedia training for the biopharmaceutical and medical device industry for more than a decade, during which she directed, wrote, edited, and instructionally designed print-based training, eLearning, live and online synchronous workshops, and audio/video-based training. She also spent several years covering international medical conferences as a continuing education medical writer. Ms. Flewell is a Certified Professional in Learning and Performance (CPLP) and a two-time American Medical Writers Association-award winner for editorial excellence. She is also an active member in the Drug Information Association’s (DIA) Professional Education, Training, and Development (PETD) Special Interest Area Community (SIAC); a national member of the American Society for Training and Development (ASTD); and a member of the Research Triangle Park (RTP) ASTD chapter.
