Barbara Balser

Biography

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. 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.

Research Interest

planning, design, and management of clinical development programs