Why Veristat
Science Advisory Board
Veristat’s Executive and Scientific Leaders are guided by a Science Advisory Board comprised of accomplished medical, scientific and business experts who bring insightful perspectives on the rapidly evolving field of clinical research and new therapy approval, access, and adoption. Board members play a visionary role, ensuring our organizational priorities are fully aligned with the current and future needs of our clients and the patients they serve.

John Balser, PhD
President & Chief Statistical Officer

John Balser, PhD
President & Chief Statistical Officer
Prior to founding Veristat in 1994, John served as Vice President, Biostatistics, and Data Management at Medical & Technical Research Associates, Inc. He has held positions of increasing responsibility in the biostatistics departments at various pharmaceutical companies including E.R. Squibb, Biogen, and Miles.
John received his MS and PhD in Biometrics from Cornell University, and has been actively engaged in clinical biostatistics for over 30 years. John is an avid runner and has competed in the Boston Marathon.

Barbara Balser, VMD
Executive Vice President & Chief Scientific Officer

Barbara Balser, VMD
Executive Vice President & Chief Scientific Officer
Barbara has participated in the writing, oversight, and submission of multiple marketing applications to US, Canadian, Japanese, and European Union regulatory authorities. Prior to co-founding Veristat, Barbara served as Associate Director of Clinical Research at Medical & Technical Research Associates, Inc. where she was responsible for strategic planning, design, and management of clinical development programs; preparation and submission of regulatory applications; and scientific communications. Barbara began her career in the pharmaceutical industry at Miles, Inc. (currently Bayer Corporation). In her capacity as Assistant Director of Clinical Research at Miles, Barbara assisted with strategic planning for the clinical development of anti-infective compounds from Phases 2 to 4 and with the planning, writing, and compilation of two successful NDAs for anti-infective products. Prior to joining the pharmaceutical and biotech industry, Barbara practiced veterinary medicine at a private veterinary hospital. Barbara holds a BS in Chemical Engineering from the University of Pennsylvania, School of Engineering and Applied Science, and a VMD from the University of Pennsylvania, School of Veterinary Medicine. When Barbara isn’t busy traveling the world for our clients, she enjoys spending time on the beach with a good book.

Lee Brettman, MD
Founder and Principal, Greystone BioConsulting, Inc.

Lee Brettman, MD
Founder and Principal, Greystone BioConsulting, Inc.
Prior to joining LeukoSite, Dr. Brettman worked at Vertex Pharmaceuticals, the Schering Plough Research Institute, and the Robert Wood Johnson Pharmaceutical Research Institute of J & J. Dr. Brettman played a major role in the successful development of a number of small molecules and biologics that included ofloxacin (FloxinÒ), l- ofloxacin (LevoquinÒ), isepamicin, agenerase (AmprenavirÒ), alemtuzumab (Campath), bortezomib (VelcadeÒ) and vedolizumab (ENTYVIOÒ), all of which were subsequently commercialized.
Dr. Brettman is a graduate of MIT and received his M.D. from the Baylor College of Medicine. He completed his training in Internal Medicine at University Hospitals of the Case Western Reserve School of Medicine and his fellowship in Infectious Diseases and Immunology at Bellevue Hospital and the New York University Medical School. He is board certified in Internal Medicine and Infectious Diseases and is a Fellow of the American College of Physicians and the Infectious Disease Society of America, and a past President of the Connecticut Infectious Disease Society.

James Valentine, JD, MHS
Senior Associate, Hyman, Phelps & McNamara

James Valentine, JD, MHS
Senior Associate, Hyman, Phelps & McNamara
In private practice, James has focused on the development and approval of drugs for serious, often rare conditions. He and his firm colleagues have helped usher in the approval of quite a few new drugs that represent important advances in the treatment of patients’ unmet needs. He continues to help ensure the patient voice is at the center of drug development and regulatory review. In fact, James has helped organize and moderated around 75% of the 55+ externally led PFDD meetings to date.
In recognition of his efforts for rare disease patients, in 2019, Global Genes named James a RARE Champion of Hope. He received his Master of Health Science from the Johns Hopkins Bloomberg School of Public Health and his Juris Doctor from the University of Maryland Carey School of Law. James and his wife are avid skiers and novice golfers.

Xavier Luria, MD
Independent Regulatory Consultant & Former EMA Officer

Xavier Luria, MD
Independent Regulatory Consultant & Former EMA Officer
Prior to joining Veristat in 2021, Dr. Luria was CEO and Founder of Drug Development and Regulation (DDR), a European-headquartered consultancy organization focused on providing scientific and regulatory expertise for the global development and registration of drugs and medical devices. Dr. Luria built and oversaw a team of professionals who served as trusted partners to a number of small and midsized companies largely involved in rare diseases and cancers among others, helping them achieve commercial success, transforming their businesses, and supporting positive patient outcomes.
Prior to DDR, from 2005-2012, Dr. Luria was Head of Safety and Efficacy of Medicines at the European Medicines Agency (EMA), where he coordinated regulatory teams from the 28 European Member States in order to evaluate medicinal products for the entire European Union. Dr. Luria participated and led several cross-agency projects.
Previous to his tenure at the EMA, Dr. Luria worked for 18 years in the pharmaceutical industry as International Medical Director with responsibilities in international clinical development, medical affairs, drug safety, and other corporate functions. He is a recognized expert on regulatory systems and benefit-risk assessment.
In addition to Dr. Luria’s specialty in internal medicine, and pharmaceutical medicine and biostatistics (University Autonomous Barcelona), he has developed expertise in several specific therapeutic areas, carried out postgraduate qualification in clinical pharmacology, drug development and regulation (Tufts University School of Medicine, Boston), and he is a recognized expert on regulatory systems and benefit-risk assessment (modelling, development and methodologies).
Furthermore, he is member of the Board of Directors of the IFAPP-King’s College Postgraduate Course, Senior Visiting Lecturer at the King’s College in London and lecturer at several other academic institutions in Europe and the United States.

Kathleen M. Kirby
Principal, Viridian Strategies

Kathleen M. Kirby
Principal, Viridian Strategies
Kathleen has worked in a variety of senior clinical operations roles over the last 35 years and has made significant contributions at organizations including Biogen, Millennium, bluebird bio, and BridgeBio. Kathleen was a member of the early-development teams responsible for gaining approval for the successful gene therapies, Zynteglo and SKYSONA.
An architect of foundational program studies that include natural history, prescreening, rare disease and gene therapy, Kathleen is an advocate for data-sharing efforts when multiple natural histories exist for a disease. She is highly regarded within the industry for her work with startup companies and has an ardent enthusiasm for developing clinical operations and program management teams, spearheading efficient and quality processes, fostering positive cross-functional relationships by bridging efforts between clinical strategy and clinical trial execution, and mentoring teams to achieve their goals.
Kathleen received her B.S. degree in Biotechnology from Rochester Institute of Technology.
She actively supports disease foundations, specifically Cure GM1, the Canavan Foundation, and Cure Sanfilippo Foundation. For Cure GM1, in addition to providing overall support, Kathleen is helping to lead a data-sharing effort of natural history data across 7 different academic and industry studies.

Robin Bliss, PhD
Vice President, Strategic Consulting

Robin Bliss, PhD
Vice President, Strategic Consulting
Prior to joining Veristat, Robin worked with Brigham and Women's Hospital Orthopedic and Arthritis Center for Outcomes Research and with Boston University School of Public Health Environmental Health Department.
Robin earned her PhD and MA in Biostatistics from Boston University and her BA in Mathematics from Williams College in Williamstown, MA. When not at work, you can find Robin outside, staying active with her family.
Team Member Name
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