Track 6: Preclinical Development and Early-Phase Clinical Research
Preclinical and early-phase clinical research provides initial dosing and safety data for new drugs. This track focuses on the latest strategies used in early-stage compound selection, updates on safety considerations for both drugs and biologics, how PK/PD affects dosing strategies, and methods to improve data quality and integrity for proper downstream decision-making.
Sessions in Preclinical Development and Early-Phase Clinical Research
Monday, June 15
- Leveraging Clinical Pharmacology to Transform Real World Data into Real World Evidence for Special Patient Populations
- Non-Profit Organizations Role in Accelerating Preclinical Compound Testing to Fuel the Rare Disease Clinical Pipeline
Tuesday, June 16
- Next Generation Analytics: Harnessing the Power of Nonclinical SEND Datasets to Improve Success in Early Clinical Development
- Patient Voice and its Role in Bringing Meaningfulness into Selection of Clinical Outcome Measures
Wednesday, June 17
Thursday, June 18
- Phase 1 Gene Transfer Research: Special Considerations for CMC, Regulatory Approvals, and Site Preparation
- Bridging Bench to Bedside with Novel Biomarkers
- Developing Products by the FDA Animal Rule: Working with FDA and Real World Challenges
- Microbiome Therapies Beyond Fecal Microbiota Transplantation: Challenges and Opportunities
- Combination Therapies of Investigational Agents
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.