Science Advisory Board

John Balser, PhD, co-founder, President and Chief Statistical Officer of Veristat, has developed the company as industry leaders in areas of clinical monitoring, data management, biostatistics and programming, medical writing, and project management. John is actively involved with clinical projects in his role as one of Veristat’s principal statistical consultants. In this role, he assists clients with clinical study design and program development based on his many years of experience in the statistical aspects of clinical research. He is often called upon to assist clients on a variety of statistical issues at meetings with regulatory agencies.

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, co-founder, Executive Vice President and Chief Scientific Officer of Veristat, is primarily responsible for strategic planning and consulting, medical oversight and production of regulatory submission documents. Barbara has more than 30 years of clinical research experience that encompasses both the pharmaceutical and contract research organization industries. Her experience includes oversight and production of Investigational New Drug (IND) applications, regulatory agency briefing documents, preparation for and representation at advisory panel meetings, and consultation across Phase 1 to 4 trials in multiple therapeutic areas with a specific focus in oncology and anti-infectives.

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.

Dr. Lee R. Brettman is a distinguished member of Veristat’s Science Advisory Board. Dr. Brettman is Founder and Principal of biotechnology consulting firm, Greystone BioConsulting, Inc. Prior to Greystone, he was co-founder, President and CEO of Dynogen Pharmaceuticals, Inc., CMO of Alnara Pharmacuticals, Entrepreneur in Residence at Oxford Bioscience Partners, and Chief Medical Officer and Senior Vice President of Medical and Regulatory Affairs at Millennium Pharmaceuticals. Dr. Brettman held a similar role at LeukoSite Inc. prior to its merger with Millennium, where at both organizations he was responsible for building and directing clinical research and regulatory affairs as well as directing development programs in oncology, GI and inflammation. His work led to the successful development and registration of Millennium's first marketed therapeutic products, Campath and Velcade.

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, is a distinguished member of Veristat’s Science Advisory Board and currently senior associate at the law firm of Hyman, Phelps & McNamara in Washington, DC, where he works with drug developers as well as patient advocacy organizations on navigating the FDA pre-approval process for new drugs and biologics. James has worked the last 14 years as a champion for the patient voice as part of the regulatory process. James previously worked at the FDA where he helped to incorporate the patient voice into medical product review across the FDA’s various medical product centers and review divisions. There, he helped to develop and launch the Patient-Focused Drug Development (PFDD) initiative. James also worked at the Center for Drug Evaluation and Research’s Office of Regulatory Policy.

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, is a physician and independent regulatory consultant supporting the advancement of drugs and devices to market. He is the former Vice President, Regulatory Affairs Europe of Veristat, where he provided strategic and implementation counsel across the spectrum of global regulatory and pharmacovigilance services for drugs, IVDs, and medical devices. Levering his deep expertise, Dr. Luria drives productive communication with health authorities and associated meetings and submissions, along with overseeing the development of impeccable project regulatory documentation and safety reporting.

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 Kirby is a prominent member of Veristat’s Science Advisory Board and is currently Principal at Viridian Strategies, Boston, MA, where she advises early phase drug developers on clinical trial strategy and execution to guide the successful development and approval of new medicinal products. 

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 joined Veristat in 2011 and is currently Vice President, Strategic Consulting. In her role, Robin oversees and executes Strategic Clinical Development Consulting, collaborating with Regulatory Consulting, Clinical and Medical Consulting and Statistical Consulting. Robin has a passion for cross- functional collaboration and problem solving, delivering with her colleagues approaches for the planning and execution of clinical trials and marketing applications. A statistically-oriented professional with 15+ years’ experience in clinical biostatistics, Robin is highly experienced in planning and implementing complex study protocols and designs including adaptive design as well as in planning and executing study analysis, regulatory submissions, and providing statistical and strategy representation at regulatory agency meetings.  

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.