What Sponsors Always Wanted to Know About DDI Waivers, Cocktails and Modeling, but Were Afraid to Ask
As today’s patients are prescribed an increasing number of medications, drug development sponsors must be aware of potential drug-drug interactions (DDIs) for their product, in order to avoid unexpected pharmacological effects and to provide accurate labeling.
Join this educational webinar to hear three specialists share their expertise on how sponsors can optimize their DDI evaluation process, spanning from preclinical to clinical.
The first part of this webinar will provide an overview of in vitro DDI assays and the use of physiologically-based pharmacokinetic (PBPK) modeling to help interpret results, support waivers and focus on interactions with clinical DDI risk, before moving into study design considerations to ensure robust and efficient assessment. Finally, population pharmacokinetics (PopPK) strategies will be presented to explain how modeling and simulation can help evaluate DDI risk and support labeling.
Dan Albaugh, MS, Associate Director, Global Metabolism and Environmental Sciences, Covance
Dan Albaugh has over 20 years of drug development experience in the pharmaceutical industry. Prior to his current position at Covance, he served as senior manager of in vitro metabolism and metabolite identification, where he led a multi-disciplinary scientific team responsible for the conduct of in vitro and in vivo metabolism and metabolite identification studies. He was also Manager, Metabolism Laboratory Operations, where he managed a team responsible for the conduct of in vitro metabolism studies. He is skilled in in vitro DDI, metabolite identification, liquid chromatography-mass spectrometry (LC-MS), biotechnology, drug metabolism and drug discovery.Message Presenter
Andreas M. Reichl, MD, Scientific Director, Clinical Pharmacology, Medical and Scientific Affairs, Covance
Dr. Andreas Reichl has a strong background in early clinical strategy and study design. He offers sponsors a track record of applied study design optimization and customization approaches to help create time and cost efficiencies when planning clinical pharmacology trials. Dr. Reichl has 22 years of industry experience, spanning roles in clinical operations (including CRU clinic director), project management, and medical and scientific affairs. He currently oversees a team of clinical scientists and the clinical PK team within clinical pharmacology, medical and scientific affairs.Message Presenter
Brandon Gufford, PharmD, PhD, Senior Pharmacokineticist, Clinical Pharmacology Services, Covance
Dr. Brandon Gufford has more than 10 years of experience evaluating drug disposition and interactions as a clinician, academic investigator, and clinical pharmacokineticist. He possesses a wide range of DDI experience including in vitro assessment, clinical study design and optimization, pharmacogenetic considerations, and advanced modeling and simulation approaches. Dr. Gufford has served as an academic faculty member, focusing his expertise in drug metabolism, pharmacokinetics, and quantitative pharmacology on the translational prediction and clinical evaluation of complex natural product-drug and drug-drug interactions.Message Presenter
Who Should Attend?
- DMPK Scientist
- Nonclinical Pharmacokineticist
- Clinical Pharmacologist
- Clinical Pharmacokineticist
- PK Modeling Expert
- Outsourcing Manager
What You Will Learn
- Get an overview of in vitro DDI assays
- Learn how PBPK modeling helps interpret in vitro DDI results
- Understand how PBPK modeling can be used to obtain a DDI waiver
- Hear study design considerations related to clinical DDI evaluation
- Learn how to optimize complex clinical DDI assessments
- Understand PopPK strategies to further evaluate DDI risk and support labeling
Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.
Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.
Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.