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 23 | Short Courses
Monday, June 24
- On the Soapbox: Designing Babies - Medical, Ethical, and Social Questions
- Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology
- Precision Medicines in Clinical Trials: Understanding and Overcoming Barriers to Adoption
- On the Soapbox: Designing Babies - Medical, Ethical, and Social Questions
Tuesday, June 25
- Emerging Issues in CRISPR and Gene Editing Symposium
- The Rare Disease Experience in Clinical Trials
- Drug Development for Ocular Disease, New Therapies, Regulations, and Patient Perspectives
- Immuno-Oncology Product Development: Overcoming Scientific and Regulatory Challenges
- The Responsibility Industry, Agencies, and Early Education own in Cure-Model Based Therapeutics
Wednesday, June 26
- Neoantigen-Based Cancer Therapies: Regulatory Challenges and Opportunities
- Exploring the Evolving Requirements for the Clinical Assessment of Abuse and Dependence Potential of CNS-Active Drugs
- Neurogenerative Diseases: Early-Stage Challenges and Optimal Models in Drug Development
- The Importance of Human Translation for Successful Preclinical Drug Discovery and Cardiac Safety
Thursday, June 27
Watch one of our video interviews from DIA 2018 with DIA Global Chief Executive Barbara Lopez Kunz as she discusses FDA's modernization plan and its impact on developing innovative therapies with Nancy Myers, President and Founder, Catalyst Healthcare Consulting.
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.