Outlining a pediatric clinical and safety assessment plan for investigational drugs is a required part of drug development due to regulatory legislation. These plans may include juvenile toxicity studies in animals to ensure safe and effective medicines for children. Juvenile toxicity studies are warranted when safety concerns can’t be adequately, ethically, or safely assessed in pediatric clinical trials. Deciding whether a juvenile animal study is needed, and if so, how it should be designed, and when it should be conducted are critical decisions.
This webinar will focus on the principles of juvenile toxicology and how they may vary from general toxicology, especially in a pharmaceutical setting. This webinar will be in the form of a dialog between a general toxicologist and the questions that they might have for a juvenile toxicologist.
Some topics included will be juvenile toxicology, comparative organ development, ICH S11, nonclinical safety of pediatric medicine development, study design and timing, species differences, dosing guidelines, regulatory guidance, drug type and formulation considerations, and more.
About Our Speakers:
Dr. Christina Riordan is currently a Senior Director of Integrated Drug Development at Certara. Christina has almost 19 years of industry experience in toxicology working at a CRO and at small and large companies with both biologics and small molecules serving as the toxicology/safety lead on several multidisciplinary drug development teams. Christina has been involved in toxicology and safety pharmacology studies from early to late development including general toxicology and pharmacokinetic studies, genetic toxicology, reproductive toxicology, drug abuse liability studies, cardiovascular studies and more and has extensive regulatory writing experience. She has worked in many therapeutic areas and most recently with a focus on immuno-oncology and inflammation. Dr. Riordan holds a doctorate in molecular genetics from the University of Albany.
Dr. Susan Laffan is currently a Head of the Nonclinical Global Investigative Safety group at GlaxoSmithKline. She has over 18 years of pharmaceutical industry experience. Susan is the nonclinical chair of GSK’s Medicines for Children Network providing advice to drug development teams on their pediatric development plans. Dr. Laffan represented PhRMA on the ICH S11 Working Group. She is an expert in reproductive and developmental toxicology and has been directly involved on the drug development teams supporting the safety assessment of compounds from discovery through marketing. Susan earned a PhD in toxicology from the University of North Carolina and Chapel Hill, conducting her dissertation at the USEPA, Research Triangle Park, NC, and a BS in Chemistry from University of Wisconsin, Madison. She is an active member of the Birth Defects Research and Prevention Society, Society of Toxicology and the HESI DART Technical Committee.