Drug-Drug Interactions: Understanding Proposed FDA Regulatory Updates and Applying In Vitro and Physiologically Based Techniques

Drug Discovery and Development, Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Monday, December 17, 2018 | 11am EST (NA) / 4pm GMT (UK) / 5pm CET (EU-Central)
  • 60 min

As the population ages, approximately 33 percent of patients are considered polypharmacy, taking multiple drugs at the same time (Bjerrum, Gonzalez Lopez-Valcarcel et al. 2008). The percentage of the population taking at least five different medications increases from 25 percent to 46 percent as the population ages from age 65 to 79 (Charlesworth, Smit et al. 2015). Based on these statistics, it is not a surprise that many patients have experienced a problem with how drugs or other substances (like coffee) interact in their body.

It’s the responsibility of drug developers to understand how a potential new substance will interact with other drugs.

In this webinar featured speakers will:

  • Review the proposed changes to the FDA regulatory guidance to ensure that the appropriate data are being captured in your drug development program
  • Explore what else can be done with data to better understand enzymes, transporters and drug disposition
  • Present case studies demonstrating the use of PBPK models to simulate potential exposure changes of both the victim and perpetrator compounds and discuss how these results can be used in regulatory conversations and how they can help you design additional experiments to optimize your program

 

Speakers

Dan Albaugh, Senior Manager, Global Drug Metabolism, Covance

Dan is an experienced in vitro and metabolite identification scientist with over 20 years of drug development experience. He currently leads a large multidisciplinary team of DMPK scientists at Covance Laboratories supporting clients, including academia and large pharma, to characterize the disposition of their investigational entities with an emphasis on CYP metabolism and drug transporter characterization. Prior to joining Covance, Dan was a DMPK Project Discipline Leader at Boehringer Ingelheim Pharmaceuticals.

Message Presenter

Joshua Fohey, Senior Manager, Global PK/PD Modeling and Simulation, Covance

Joshua is an experience PK/PD scientist with over 15 years of drug development experience. He currently leads a large global group of PK/PD scientists at Covance Laboratories with a focus on translation modeling and simulation utilizing NCA, compartmental, PK/PD, PBPK, and population PK modeling to guide drug development. Prior to taking over leadership of this group, Joshua was a pharmacokineticist supporting drug development programs from early discovery through clinical development.

Message Presenter

Who Should Attend?

  • CRO outsourcing leads
  • DMPK scientists
  • PK/PD and PBPK modeling and simulation scientists
  • Clinicians interested in drug-drug interactions

 

What You Will Learn

Join this webinar for a:

  • Review of the proposed changes to the FDA regulatory guidance on drug-drug interaction studies
  • Presentation of case studies demonstrating the use of physiologically based pharmacokinetic (PBPK) models to simulate potential exposure changes of both the victim and perpetrator compounds
  • Discussion of how these results can be used in regulatory conversations and how they can help you design additional experiments to optimize your program

Xtalks Partner

Covance

Covance Inc., the drug development business of Laboratory Corporation of America Holdings (LabCorp) headquartered in Princeton, New Jersey, USA, is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real®.

Our unique perspectives, built from decades of scientific expertise and precision delivery of the largest volume of drug development data in the world, helps our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Information on Covance’s solutions can be obtained through its website at www.covance.com.

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