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.

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.

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.

Rodney Sleith is a Principal Biostatistician Consultant at Veristat. With more than 25 years in the clinical research industry and almost 15 with Veristat, Rodney provides statistical and strategic input into Phase I – IV clinical trial development and the reporting of clinical trial results. Rodney has mastered aligning his technical knowledge with customer-focused objectives, functioning as a lead statistician on study-specific and global clinical program development, including clinical development planning, protocols, study design, biostatistical strategy and analysis, and regulatory submissions.

As a multi-faceted biostatistician, Rodney collaborates closely with sponsors, clinical teams, data managers, and programmers to ensure there is continued high-quality and timely delivery of statistical data, analytics, and reporting to support a sponsor’s goals. Possessing a notable track record of success, Rodney is experienced with NDA submissions for complex studies in oncology (solid tumors), neurology, rare diseases, genetic disorders, and ophthalmology, and works closely with the FDA throughout the clinical trial and submission process. With an academic background in computer science, Rodney is an avid SAS coder and has contributed a number of solutions, including permutation tests, simulation studies, and an implementation of a Biomarker Adaptive Threshold Design developed by Jiang et al.

Rodney joined Veristat from PAREXEL International where as a Senior Biostatistician, he was responsible for the management, programming, statistical analysis, and interpretation of Phase IIb through Phase IV studies, and served as a lead mentor to junior biostatisticians.

Rodney graduated from Keene State College with a Bachelor of Science/Bachelor of Arts double major in mathematics and computer mathematics and received his Master of Science degree in applied statistics from Worcester Polytechnic Institute.

Debora Manning is Strategic Consulting Fellow and Biostatistician at Veristat. Debora is a strategic contributor, providing consulting services on study-specific and global programs, including input towards clinical development plans, protocols, study design, biostatistical plans and analysis, and regulatory submissions, and offering expert guidance and support throughout a product’s lifecycle.

A biostatistician by training with an affinity for regulatory affairs, Debora possesses a deep understanding of what global health authorities will expect in a clinical development program. Her wide-ranging therapeutic expertise includes oncology, neurological disorders, immunodeficiency disorders, and rare diseases. Debora has played pivotal roles in leading interactions with regulators and developing successful marketing applications (NDA, BLA, MAA). She has experience with planning and executing traditional clinical trials and master protocols, and can advise sponsors as they seek new and innovative ways to increase productivity and move their innovations forward. Debora enjoys working as part of a team with our sponsors and is highly effective at cross-functional collaboration by taking a thoughtful and holistic approach to problem-solving.

Debora joined Veristat in 2014 from Boston Children’s Hospital where she was responsible for all aspects of data management and reporting for multi-site pediatric clinical trials. Prior to that, she worked in clinical trials and community programs for patients, family members, and caregivers at the Parkinson's Disease and Movement Disorders Center at Boston University School of Medicine and Boston Medical Center.

Debora received her BA in mathematics from Wheaton College (MA), her MPH in biostatistics from Boston University School of Public Health, and her graduate certificate in regulatory affairs and health policy from the Massachusetts College of Pharmacy and Health Sciences.