As translational research and drug discovery move into the academic setting, there is a greater local need to understand the requirements of moving novel agents to clinical trials.  The regulatory burden for the academic investigator can be challenging and difficult to navigate.

Preclinical research encompasses laboratory and animal studies performed to test a drug, device or diagnostic test before the product enters into human testing.  The goals of preclinical testing include evaluation of toxic and pharmacologic effects and identification of potential safety issues.  

This 2 hour workshop will present an overview of preclinical research activities.   The workshop will focus on the following key points:

• Resources available through NC TraCS to support preclinical research
• The process of product development
• Types of preclinical studies (safety and pharmacology, pharmacokinetics, toxicology), ADME requirements
• Trial design considerations based on preclinical findings
• The regulatory submission and review process  

The goal of this workshop is to provide researchers with general knowledge, tools and resources to aid in the preclinical development process at the academic level and beyond. Depending on the interest and needs of the audience, future sessions may be scheduled that will provide more comprehensive insight into specific areas (i.e., devices, biologics, diagnostics).

Speakers may have time to discuss topics in more detail, and participants will have opportunities to ask questions and participate in discussions.

Audience:   academic researchers, scientists and students engaged in preclinical work and/or clinical trials involving novel agents

This workshop is sponsored by The North Carolina Translational Sciences Institute (NC TraCS) in collaboration with Research Triangle Institute (RTI)