HOW DO I GET INTO PHASE 1 TRIALS WITH MY COMPOUND?
Learn how to get into Phase 1 trials with your compound!
Nonclinical safety studies are required to establish a safe starting dose for the initial human clinical trials, but how do you know which studies are required to get your compound to the clinic and what special considerations need to be made for your program?
Careful assessment of the potential for toxicity is vital to advance novel therapeutics into the clinic. To improve the odds of selecting the right lead candidate and conducting the right studies in the right way, it’s important to know how to design your nonclinical program for a successful IND submission.
On March 10, join us for our live webinar “How Do I Get Into Phase 1 Trials with My Compound?” Presented by Sinclair Research’s Senior Vice President of Research, Dr. Scott E. Boley, PhD, DABT, this live webinar will explore how to get your compound into Phase 1 trials.
In our webinar, Sinclair will help you learn:
- Regulatory considerations
- Different approaches for small molecules and biopharmaceuticals
- Specific considerations based on your indication
- Tips for selecting an effective CRO partner to support your program
About the Presenter:
Dr. Scott E. Boley, PhD, DABT, has advised Sponsors on their nonclinical needs for the last 15 years and managed toxicology programs for 19 years. He has extensive expertise in drug development as well as the regulatory expectations for a variety of test article types and indications. In his role as Senior Vice President of Research, Scott oversees the Research, Report Services, and SEND groups at Sinclair Research that supports each Sponsor’s nonclinical safety programs. Scott is a diplomate of the American Board of Toxicology and holds a B.Sc. in Biochemistry and a Ph.D. in Biochemistry/Environmental Toxicology from Michigan State University.