Julia Varshavsky, Ph.D.

Data Strategy and Policy, Data Science and Analytics, Clinical Program Development
Julia

Julia Varshavsky, Ph.D.

Statistics, biometrics, Digital health Analysis, drug development, clinical, FDA, life cycle management, trials, global regulatory submissions, Biostatistics, data management, startups

Founder and Managing Director, OccamPoint

Dr. Varshavsky has over 15 years of drug development experience spanning areas from drug discovery through commercialization and life-cycle management. Her therapeutic area expertise includes orphan and non-orphan indications across therapeutic areas encompassing endocrinology, asthma, allergy, immunology, critical care, oncology, CNS and sleep and movement disorders.

During her tenure in the industry, Dr. Varshavsky served in a variety of leadership roles in both large R&D (Eli Lilly, Genentech) and small-to-midsize pharma (Jazz Pharmaceuticals, Corcept Therapeutics) organizations, building and leading Biostatistical, Biometrics and Development teams towards key deliverables such as global BLAs and NDAs, development and life cycle plans, and business opportunity assessments. As a member of corporate leadership teams, Dr. Varshavsky conducted benefit-risk assessments of clinical programs to enable positive and negative portfolio decisions. She represented sponsors at Data Monitoring Committees, Advisory Boards, patient advocacy groups, and NIH.

As a Life Sciences Council member for Springboard Enterprises, Dr. Varshavsky works with peers in finance, legal and investment communities to foster success of female-led healthcare and digital health startups, coaching on a broad range of topics including indication-specific product development, use of AI for patient selection and diagnostics, as well as scalable and efficient data aggregation and sharing strategies. As a member of investment groups, Dr. Varshavsky conducts due diligence to help guide investment decisions in transformative healthcare technologies and medicines.

Dr. Varshavsky holds a Ph.D. in Statistics from Purdue University. She has published and presented on theoretical and applied aspects of Bayesian statistics, clinical trial design and analysis, and drug development process optimization.