Biopharma External Advisory Group
Bonnie A. Brescia (BBK Worldwide)
Ms Brescia is one of the two founding principals of BBK Worldwide, Bonnie led the company’s evolution as a first-of its-kind marketing consultancy specializing in patient recruitment for the clinical R&D segments of the pharmaceutical, biotechnology, and medical device industries. A well-
recognized thought leader in patient recruitment, Bonnie firmly established BBK as a pioneer in developing marketing and technology solutions that ease bottlenecks in the clinical development process. With over 30 years of marketing communications and financial management experience, Bonnie manages and develops BBK’s worldwide alliance of companies, ensuring a multinational foundation for initiatives like BBK’s global investigator network and Web-based recruitment portal.
Barton Cobert, MD, FACP, FACG, FFPH
Dr. Cobert has had a long career in the clinical practice of Gastroenterology and Internal Medicine as well as in the pharmaceutical industry specializing in clinical research, drug safety and compliance/risk management. For over a decade he was Global Head of Drug Safety (side effects) for the ScheringPlough Research Institute and held similar positions for Novartis Consumer Health Inc. He has also worked in the information technology industry at Medidata Solutions. Dr. Cobert received his MD from New York University School of Medicine where he also trained in medicine and gastroenterology. He did a post-doc in hepatology in Pars, France. He is board certified in Internal Medicine and Gastroenterology. He is a fellow of the American College of Physicians, the American College of Gastroenterology and the Faculty of Pharmaceutical Medicine (UK). He has written and lectured extensively both nationally and internationally. He has written three books on drug safety including the Manual of Drug Safety and Pharmacovigiliance which is used as a textbook in courses on drug safety. Dr. Cobert is now president of BLCMD Associates LLC, a drug safety pharmacovigilance consultancy.
David H. Hom, MS (Boston University)
Mr. Hom has over 20 years experience in the development, conduct and management of IND phase IIII clinical trials. His initial work including working onsite in Uganda, in the early 1990’s as part of a research team established by Case Western Reserve University and Makerere University conducting early research into HIV/AIDS pathogenesis and associated opportunistic infections. Later trials included a large phase III trial of preventive therapy for TB in high-risk PPD+ subjects sponsored by the US CDC; a variety of phase II trials of various immunoadjuvants for TB sponsored by NIH/NIAID; a phase I/II trial of a NNRTI (nevirapine) for preventing mother-to-child HIV transmission sponsored by Boehringer Ingelheim Pharmaceuticals, Inc and Africa’s first HIV preventative trial (AlVAC-vCP250) sponsored by Pasteur-Merieux Connaught and NIH-NIAID. He also directed the Clinical and Data Coordinating Center for the NIH’s Tuberculosis Research and Prevention Unit (TBRU) based at CWRU. He has over 50 peer-reviewed publications and 100 peer-reviewed abstracts presented at national and international conferences.
Kenneth A. Getz, MBA (Tufts Center For The Study Of Drug Development)
Kenneth Getz is a Senior Research Fellow at the Tufts Center for the Study of Drug Development where he focuses on studying R&D management, study volunteer trends, and policies affecting the Biopharmaceutical industry. Ken is also the chairman of the Center for Information & Study of Clinical Research Participation and founder and owner of CenterWatch. In addition he has an extensive presentation list and has published more than 200 articles and book chapters. He is an active member of the DIA and is serving as the chair of their Annual meeting in Chicago in 2011. Ken holds an AMBA from the J.L. Kellogg Graduate School of Management at Northwestern University.
Laura Perry, MBA, MSW, LSW ( Extraordinary Parent Coaching)
Laura Perry is the founder and an education advocate of Extraordinary Parent Coaching where she focuses on adoptive families and those with special needs including mental health issues. She is a dedicated social services professional with experience and training that includes PTSD, developmental trauma and interpersonal violence as well as program coordination, family advocacy and social work case management. Laura is a former executive in the biopharmaceutical industry with extensive staff management and operations experience across the sector. Laura holds an advisory board position on the San Fernando Valley Counseling Center as well as volunteers as an education advocate at CASA for Children of Essex County.
Carlotta M. Rodriguez, BS, CIP (RBHS)
Carlotta M. Rodriguez, BS, CIP, is the director of the University of Medicine and Dentistry of New Jersey Newark Campus IRB, where she is responsible for managing four IRB committees. As a member of the Institutional Animal Care and Usage Committee, Institutional Biosafety Committee, and the Radiation Safety Committee, she serves as a liaison between these committees, university administration, and researchers and educators amongst the nine distinct schools that form the university. She is currently overseeing the implementation of a campus-wide eIRB submission and reviewer process. She is a member of PRIM&R (Public Responsibility in Medicine and Research), ACRP (Association of Clinical Research Professionals) and SRA (Society of Research Administrators). Prior to assuming her role as IRB director, she worked within the Human Subjects Protection Office to develop the current department-focused approach employed university-wide.
Nancy C. Santanello, M.D., M.S. (Merck Research Laboratories)
Dr. Santanello is a physician-epidemiologist trained in Emergency Medicine and Preventive Medicine with a Masters of Science degree in Epidemiology. She is board certified by the American College of Preventive Medicine in Preventive Medicine and Epidemiology. Prior to joining Merck, Dr. Santanello was a Medical Officer with the National Heart, Lung, and Blood Institute (NHLBI) Prevention and Demonstration Research Branch of the Division of Epidemiology and Clinical Applications (1987-1991). From 1991 to present, Dr. Santanello has been in the Department of Epidemiology at Merck Research Laboratories; in 2003 she was appointed to the position of head of that department. Her areas of research interest include: the development and validation of outcome measures for use in clinical trials, study design, adherence to therapy, satisfaction with and preference for therapy, effectiveness studies, and drug and vaccine safety/pharmacoepidemiology. In 1998 Dr. Santanello received the Merck Directors Award, the Company’s highest honor, from the Board of Directors for her work in support of clinical and outcomes research measures for asthma. Dr. Santanello has published over 60 peer-reviewed manuscripts. Dr. Santanello is the President-Elect of the International Society for Pharmacoepidemiology (ISPE).
Meredith Y. Smith, MPA, PhD. (Abbott Laboratories)
Dr. Smith is Senior Scientific Director of Risk Management in Global Pharmaceutical Research and Development at Abbott Laboratories. Dr. Smith has a background in both public health and health services research and has held positions in local, state and federal agencies including the U.S. Centers for Disease Control. She has more than 10 years experience in the pharmaceutical industry in the area of health outcomes research and risk management. In her current position she develops, implements and evaluates global risk minimization strategies for an array of pharmaceutical products, including opioid analgesics, biologics and drug-device combination products. Previously, she served as Director of Risk Management at Purdue Pharma, LLP. Prior to joining the pharmaceutical industry, Dr. Smith held faculty positions at Memorial Sloan-Kettering Cancer Center and the Mount Sinai School of Medicine in New York City. Dr. Smith has received research grants from the National Institutes of Health, the Agency for Health Care Research and Quality, the
American Cancer Society and the Susan B. Komen Cancer Foundation and has published over 40 peer-reviewed articles. She currently serves as a member of the CIOMS Working Group IX “Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management.”
Erika Stevens, MA (Ernst & Young)
Erika Stevens is a Senior Manager in the Advisory Services practice of Ernst & Young. She has over 15 years of clinical research experience, including over 12 years in clinical research management serving in roles such as the Director of Clinical Trials Office, Regulatory Training Manager, Interim Executive Director of Clinical Trials Office and Director of Research Operations Prior to joining Ernst and Young, Erika served as the Director of Clinical Trials Office at Dartmouth Hitchcock Medical Center, where she lead the promotion, development, management/operations and strategic plan for clinical trial research including the financial, regulatory, training, operations and compliance services to Dartmouth College and Dartmouth-Hitchcock facilities. She also served as the Interim Executive Director of the Clinical Trials Office at Columbia University Medical Center, Director of Research Operations at Washington University School of Medicine and worked in project management at the University of Pennsylvania School of Medicine.