Sally Van Doren, PharmD

President and Chief Executive Officer

Dr. Van Doren is President and Chief Executive Officer of BioSoteria, Inc. a drug safety and risk management consulting firm headquartered in Emeryville, CA.  She has over 23 years of biotechnology and pharmaceutical industry experience and has been directly involved in management of all aspects of safety surveillance operations, clinical and postmarketing signal detection, safety data analyses, pre- and post-marketing risk assessment, authoring sections for NDA, BLA, and MAA submissions, REMS and EU-RMP development, and product labeling and company core data sheets (CCDS).  Dr. Van Doren has advised over 60 companies while serving as a senior consultant at BioSoteria on a broad range of product safety issues.  She has also served as an expert legal witness regarding product safety liability issues.  Prior to founding BioSoteria, she previously held leadership positions in drug and biologic safety, clinical drug development and medical affairs at Gilead Sciences, Cerus Corporation, Peninsula Pharmaceuticals, Intermune and Syntex Laboratories.  Prior to entering the pharmaceutical industry, Dr. Van Doren conducted drug utilization studies at an international tertiary care hospital and research center in Saudi Arabia.  She also previously provided poison and medical information at the Maryland Regional Poison Center.  She is presently an Adjunct Assistant Professor in the Department of Pharmaceutical Health Sciences Research at University of MD School of Pharmacy and an Instructor in drug safety at University of California Berkeley Extension as part of the Clinical Research and Management Certification Program, is an invited instructor at UCSF School of Pharmacy on drug safety topics, is a Member of the Board of Visitors at the University of MD School of Pharmacy, and is a Member of the Community Advisory Board, UCSF AIDS Health Project.  Dr. Van Doren has a Doctor of Pharmacy degree from the University of Maryland School of Pharmacy and completed a residency in clinical pharmacy at University of California San Francisco Medical Center.  She has published over 40 articles in the area of drug safety, safety assessment, risk management, and drug utilization as well as co-author on several clinical studies during her career.

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 20-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 24 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 and was Associate Director then Director of Drug Safety. Following Gilead Sciences, Dr. Buchanan established a drug safety department at Tularik, where he served as Chief Safety Officer until the company was acquired five years later by Amgen. Dr. Buchanan then became Sr. Director of Drug Safety and Biometrics at Nuvelo, also served as Chief Safety Officer, and was also responsible 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 30 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, BioSoteria, Inc.

Dr. Schwamlein is a specialist in Internal Medicine and Epidemiology . He has had extensive clinical medicine experience and more than 15 years of experience in the pharmaceutical industry, having served as Senior Director of Epidemiology at Abbott Laboratories and as Chief Medical Safety Officer with BioSoteria. Dr. Schwamlein received his undergraduate degree at Bucknell University, his MD at Temple University and his MPH from the University of Rochester. He has been a member of the Internal Medicine Faculty at University of Rochester (Infectious Disease), University of Illinois at Chicago (Epidemiology) and, now, with University of California Berkeley Extension (Epidemiology). He is a member of the UC Berkeley Clinical Research Conduct and Management Advisory Board and the Community Advisory Board, UCSF, AIDS Health Project. He has published extensively in the areas of Epidemiology and Drug Safety.

Judy Smith, RN

Director of Drug Safety Operations

Judy Smith, RN is presently Director of Drug Safety Operations at BioSoteria, managing drug safety associates and managers in individual case safety report (ICSR) management of clinical and postmarketing surveillance projects, aggregate safety report development, standard operating procedure development, quality assurance, and training. Judy has more than 14 years of industry drug safety experience, where she held safety operations positions of increasing responsibility at ALZA Corporation, PRUS, Gilead Sciences, and Amgen before joining Biosoteria in 2007. Judy is a registered nurse with prior clinical practice experience, providing acute care to Medical/Surgical, Orthopedic, Coronary Care, and ICU patients and working at a Hemodialysis Center serving acute care and ambulatory out-patients. She was a member of the Pneumococcal Pneumonia Vaccine Project Surveillance Team at the Kaiser Permanente Clinic, San Francisco, CA, and the Stanford Blood Bank as a Blood Bank Specialist and Resource Nurse, Palo Alto, CA.

Les Williams

Director of Business Development

Mr. Williams is Director of Business Development for BioSoteria. He has expertise in marketing, business development, project management and finance. Prior to joining BioSoteria, he was Director of Corporate Sales and Marketing for Accord Interests, LLC, where he developed, managed and implemented the sales, communications and marketing plan while providing leadership, professional guidance, training and evaluation to sales staff. He was awarded with the Principal Award for Excellence during his first year at Accord. Previously, Mr. Williams worked with the Anti-Defamation League as Associate Director of Development. He was responsible for a multi-million dollar fundraising campaign. He budgeted, planned and supervised fundraising events while managing committees of volunteers and staff. He developed new relationships and secured funding from corporations, individuals and foundations to include grants to support programming. He graduated Cum Laude from the University of Maryland Baltimore County with a Bachelor of Arts Degree.