Tarolyn Carlton
Executive Director, Late-Stage Clinical Strategy Definium Therapeutics
Tarolyn Carlton, PharmD is Executive Director of Late Stage Clinical Strategy at Definium Therapeutics, with more than 20 years of experience spanning medical affairs, neuroscience, rare disease and digital therapeutics. Her career includes leadership of global medical strategy, field medical teams and evidence generation, with previous experience at Otsuka Pharmaceutical and Bristol Myers Squibb. She currently leads late-stage clinical strategy for DT-120 and has previously supported medical strategy for an ALS pipeline therapy and emerging digital health technologies.
Seminars
Thursday 25th March 2027
Establishing Early Access Programs for Controlled Substances: Navigating Regulatory, Operational & Stakeholder Complexity
4:30 pm
- Understanding the additional regulatory requirements and approvals required when setting up Expanded Access Programs for controlled substances
- Building internal processes and governance models that support compliance while maintaining timely patient access
- Coordinating effectively across Medical, Regulatory, Clinical Operations, Supply Chain, and Quality teams
- Lessons learned from launching and operationalizing controlled substance access programs, including common challenges and practical solutions
