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 28
- Implicit Bias in Early Phase Clinical Trials: The Sociocultural Implications of Advancing the Science
- Role of Clinical Pharmacology Guidances and Policies in Enhancing Drug Development
- Challenges and Opportunities in Early Development of RNA Therapeutics
Tuesday, June 29
- Continuing the Conversation: What’s New in Gene Therapy and Gene Editing
- Brave New World: Early Clinical Trials in a Pandemic
- Epigenetic Drugs: Taking it to the Clinic - An Up and Coming Mode of Targeting Disease
- Gene Therapy Research in Pediatric Populations: Ethical Issues
Wednesday, June 30
- It’s Like Building the Airplane While Flying It: Biomarker Discovery and Development in Clinical Trials
- Antibody-Drug Conjugate Drug Development: From Novel Technology to New Patient Therapy
Thursday, July 1
- A New Path Forward for Biosimilar Drug Development
- Is it the “New Normal? Will We be Able to Maintain the Accelerated Pace of Drug Development Post COVID-19?
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.