Track 6: Preclinical Development and Early-Phase Clinical Research
Preclinical and early-phase clinical research provide initial safety, tolerability, and efficacy data for new drugs. This track focuses on topics ranging from early-stage compound selection, PK, and safety considerations for both drugs and biologics, as well as dosing strategies to data integrity for proper downstream decision-making.
Sessions in Preclinical Development and Early-Phase Clinical Research
Sunday, June 24 | Short Courses
Monday, June 25
- Regenerative Medicine Advanced Therapies: Efforts to Facilitate Product Development and Approval at the Center for Biologics Evaluation and Research
- Development of Microbiome-Derived Therapeutics
- Facilitating Nonclinical Data Sharing and Access Across the Industry
Tuesday, June 26
- Novel Approaches for Accessing the CNS: Nonclinical and Clinical Challenges
- Personalized Medicine Approaches During Early-Phase Clinical Research
- Optimizing Clinical Development with Adaptive Trial Designs
- Gene Therapy: Advances in Translating Technology
Wednesday, June 27
- Evolution and Harmonization of First-in-Human Guidelines
- Balancing Regulatory, Medical, and Operational Pillars to Get Pediatric Trials Done Globally
- Gene Therapy Clinical Trials: Current Challenges
- Special Population Study Challenges
Thursday, June 28
Who is This Track Designed For?
Professionals involved in: pharmacology and toxicology, nonclinical safety testing, clinical research, clinical operations, safety and pharmacovigilance, project management, patient centricity, and statistics; formulation science, pharmacokinetics/pharmacodynamics, epidemiology, toxicology, and regulatory affairs..