Scientific Leaders

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.

Shaheen Limbada is the Executive Vice President of Innovation and Strategy of Veristat. In this role, Shaheen oversees identifying and building strategic, innovative solutions to advance the clinical development goals of our clients. With over 22 years of experience running clinical trials, he excels in innovative clinical trial solutions, clinical trial execution, business strategy and business growth. He will initially be focused on applying his skills to enhance and build Veristat's pharmacovigilance, commercialization, and decentralized clinical trial solutions.

Shaheen spent four years as the Executive Vice President of Global Clinical Operations at Veristat, where he fully integrated new processes for adopting digital and virtual components to improve the patient experience of participating in clinical trials. He joined Veristat through the acquisition of Topstone Research, a Canadian-based CRO he co-founded, and held the position of Managing Director. Before Topstone, he worked in clinical operations, project management, and leadership roles at various clinical research organizations (CROs) and pharmaceutical firms, including Leo Pharma, Cetero Research, and AstraZeneca.

Mr. Limbada graduated from the University of Toronto and quickly began his career in clinical trials with AstraZeneca Canada Inc.

Shayesteh Fürst-Ladani joined Veristat in 2022, following the acquisition of SFL (Solutions for Life Sciences), a Swiss-headquartered multi-disciplinary strategic consultancy where she was Founder and CEO, bringing a highly credentialed team and unique capabilities to support a growing number of biotech, pharmaceutical and medtech companies.

At Veristat, Shayesteh jointly oversees the SFL team as Senior Vice President, SFL, and Head of SFL Group. She has longstanding experience in providing comprehensive strategic advice for development of products including small molecules, biologics, drug & device combination products, medical devices, in vitro diagnostics (IVDs) and advanced therapy medicinal products (ATMPs). Shayesteh has distinguished capabilities in negotiating the interests of organizations at senior level meetings with regulators.

Shayesteh serves as President of the Board of Directors of the not-for-profit associations Rare Disease Action Forum (RDAF) and Medtech & Pharma Platform (MPP), and she lectures in Regulatory Affairs at the IFAPP Academy, Kings College London.

Before founding SFL, Shayesteh held senior level positions at various biotech and pharmaceutical companies, including as Head of Global Regulatory Affairs and Head of Regulatory Affairs for Development Products.

Shayesteh received her MSc in Microbiology from the University of Vienna, Austria, and an MBA from the Open University Business School, Milton Keynes, UK. She is Global Fellow in Medicines Development (GFMD) from IFFAPP.

Xavier Luria, MD, is Vice President, Regulatory Affairs Europe of Veristat, responsible for providing 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.

As Vice President, Europe of Veristat, Dr. Barceló will drive the strategic European growth plan and expand services through organic and acquisition growth initiatives to ensure customer success. Veristat will continue to broaden its customer base and clinical operations, biometrics, pharmacovigilance, and regulatory operations throughout Europe. Montse will ensure that all growth maintains the high-quality scientific standards that the Company provides clients across its North American, Taiwan, and European geographies.

Dr. Barceló received her medical doctor degree from the University of Barcelona in Spain in General Medicine and Surgery. She started her pharma services career as the General Manager for Spain at Clinical Data Care, a Swedish data management CRO. Later in her career, she joined the Scandinavian CRO, TFS, as Regional Managing Director, ascending to the role of Global Chief Operating Officer, where she was responsible for 18 countries globally and more than 600 clinical research professionals across 23 affiliate locations.

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.

Agnes recently joined Veristat through its acquisition of Certus PV. In her new role at Veristat, she will lead and expand the pre-approval and post-marketing pharmacovigilance and safety surveillance team.

Agnes has over 21 years of experience in the pharmaceutical industry. She has 18 years of experience in global and Canadian pharmacovigilance and senior PV consultancy roles. In addition to pharmacovigilance, Agnes's expertise includes medical information, regulatory affairs, and pharmaceutical sales.

Before co-founding Certus PV, Agnes was a Director, PV at OptumInsight. In this leadership function, she headed the PV & MI Department at one of Canada's ten most prominent pharmaceutical companies. She provided strategic PV & MI advice for over 15 other clients. Having led numerous PV audits of contractual partners and vendors on behalf of Marketing Authorisation Holders, Agnes is an expert PV auditor. She is also a recognized PV trainer. Her extensive industry experience includes nine years in PV & MI roles at Bayer Inc. Agnes is a member of the Drug Information Association (DIA) as well as a member of the Canadian Pharmacovigilance Network.

She holds an MSc degree in pharmacology and toxicology.

Nan Shao is EVP of Global Operations at Veristat. In her role, Nan oversees the clinical trial data, analytics, and reporting organization across all regions, devising and implementing strategic solutions shaped by her combined perspective of the pharmaceutical and CRO industries, high quality standards, and efficient deployment approaches.

A successful business leader, clinical research professional, and statistician with 19 years of pharmaceutical industry experience and ten years leading global biometrics operations and strategic divisions, Nan brings extensive expertise in analytics strategy, biostatistics, statistical programming, data management, pharmacokinetics, and data standards. She is highly skilled in the clinical development life cycle across a range of therapeutic areas, collaborating with sponsors to achieve their operational and business goals.

Prior to joining Veristat in 2022, Nan served as Global Head of Analytics Strategy, Global Head of Biostatistics and Statistical Programming, and Global Head of Clinical Data Services at Parexel International where she led the global operations and strategy teams, championing a first-time quality mindset, promoting analytics innovations and driving the advancement of clinical research through real-world evidence (RWE), decentralized clinical trials (DCTs), and AI/ML applications.

Prior to Parexel, Nan held leadership positions at organizations that included Covance/LabCorp, Premier Research, and pharmaceutical companies where she built and directed high-performing teams responsible for statistical activities related to regulatory strategies, clinical development programs, study designs, and trial optimization. Nan has served as a mentor and subject matter expert both within organizations and the clinical operations community-at-large, participating in industry-wide forums as an expert statistician to help solve complex problems.

Nan graduated from Rutgers University with a Ph.D. in Ecology and M.S. in Statistics, and from Peking University with a B.S. in Environmental Sciences and an LL.B. in Intellectual Property Law. Nan is an MBA candidate at the University of Oxford. She is a certified Six Sigma Green Belt by the American Society for Quality since 2007.