Avery McIntosh is a researcher and drug developer based in Pennsylvania. He has over a decade of experience moving candidate drugs from preclinical through post-marketing stages, and has taught and lectured on biostatistics, computing, and drug development.
Core Topics
Drug development evidence strategy
Trial design & interpretation
Model-informed drug development
Real-world evidence & external controls
CRM/obesity development
Conference Talks and Short Courses
Model Informed Drug Development for Advanced Therapeutics. New England Rare Disease Symposium. 2025.
Developing Gene Therapies: A Statistician’s Guide. Instats. 2025.
Practical and Statistical Considerations for the Long Term Follow-Up of Gene Therapy Trial Participants. Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard. 2025.
Model Informed Drug Development for Advanced Therapeutics. American Society for Clinical Pharmacology Annual Meeting. 2025.
Development of Gene Therapies: Open Questions on Design, Analysis, and Statistical Strategy. American Statistical Association Boston Chapter. 2024.
Statistical Considerations for the LTFU of Gene Therapy Trial Participants: Platform LTFU Trials for Real-World Comparative Research of CGTs. International Society of Pharmacoepidemiology. Berlin, Germany. 2024
Development of Gene Therapies: Thoughts on Innovation and Best Practices for Biostatistics. American Statistical Association Philadelphia Chapter. 2024.
Understanding The Role Of RWD-Based External Controls in Defining the Long-Term Benefit–Risk Profile of Cell and Gene Therapies: A Multistakeholder Perspective. The Evidence Base. 2024.
Designing and Optimizing a Clinical Development Program for a Rare Neurodegenerative Indication. Society for Clinical Trials. Boston MA. 2024.
Development of Gene Therapies: Strategic, Scientific, Regulatory, and Access Considerations. Statisticians in the Pharmaceutical Industry (PSI). 2024.
Statistical Considerations for the LTFU of Gene Therapy Trial Participants. American Statistical Association Biopharmaceutical Section Regulatory-Industry Working Group. 2024
Designing and Optimizing a Clinical Development Program for a Rare Neurodegenerative Indication. New England Statistical Society--UConn 2024.
Quantitative Drug Development in the Age of Genetic Medicine: Landscape and Opportunities. American Society of Clinical Pharmacology & Therapeutics Annual Meeting: Rare Disease Session. 2022.
Statistics & Pharmacometrics Using R. Two-Day Course at University of Havana, Cuba. 2019.
Selected Publications
Books
Development of Gene Therapies: Strategic, Scientific, Regulatory, and Access Considerations. Taylor & Francis/CRC Press.
Editorial
Associate Editor and Chief Statistical Consultant for Clinical Pharmacology & Therapeutics, flagship journal of the American Society for Clinical Pharmacology & Therapeutics (ASCPT)