Frontage's Chris Ryan shares experiences and stories, as well as suggestions for how to set up a successful IND approach. We hope you will find our discussion insightful and help you avoid unexpected surprises in your IND-directed studies.

Chris Ryan is Senior Director of Business Development with Frontage Laboratories, Inc. supporting non-clinical safety and toxicology and drug metabolism and pharmacokinetics (’DMPK’) for pharma and biotech clients’ drug development programs. Mr. Ryan has worked for several Contract Research Organizations in drug development for over 18 years. As a former project manager for IND-directed programs, he has helped dozens of companies work through the complexities of pre-clinical safety and toxicology programs.

Intraperitoneal (IP) dose administration is the preferred method of dosing in the treatment of certain cancers as well as for peritonitis. Unfortunately, replicating IP administration in dogs in order to evaluate drug toxicity has posed multiple, serious challenges, rendering the approach unworkable in the laboratory. It is possible, however, to overcome these challenges by using a modified catheter with an access port to administer the investigational product. Frontage Labs has successfully applied this technique in dosing dogs as part of a study of a chemotherapy drug for ovarian cancer, demonstrating the viability of this method.

In this paper, we provide practical advice on how to usher a small molecule through preliminary toxicology testing and derive information required to design IND-enabling studies. Indeed, with a rigorous exploratory toxicity program, sponsors can mitigate the risk of unexpected challenges and optimize the Good Laboratory Practice (GLP) study plan.