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
Included Topic Areas in Preclinical Development and Early-Phase Clinical Research
DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.
- Best practices in early-stage product development decision-making: data sharing and expanded communication of potential toxicity
- The future of drug development: leveraging artificial intelligence in compound screening, genomics, and evaluating toxicity in the 21st Century
- Preclinical and early-stage challenges for sponsors, CROs, academics, and regulators in development of personalized medicine products
- Reconciling FDA and EMEA guidelines for first-in-human (FIH) studies: how to get the most bang for your buck in Phase 1
- Drug-device and biologic-device combination products: working with multiple FDA centers and how much is enough?
- Transitioning a product from academia to the fast-paced world of a biotech: from publications to IND and into the clinic
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..