How the New FDA Drug-Drug Interaction Guidance Fits Within the Drug Development De-Risking Model

Drug Discovery and Development, Drug Safety, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • Wednesday, July 25, 2018

The pharmaceutical industry is inherently risky. To develop a molecule that has a desired, efficacious, but safe, effect in humans is a remarkable achievement considering the numbers. If all the molecules in discovery and development were added together over recent years and compared to the number of successful drug approvals each year, the ratio is (approximately) 10,000:1 [1]. In other words, for every 10,000 molecules entering drug discovery, 9,999 will fail during some stage of the development process and only one will become a successful marketed drug (and even then, it is not certain development costs will be recouped). Couple this extraordinarily high attrition rate with a lengthy, complex and expensive process (average 12 years in development and cost of £1.15 billion [1]) and it is clear that drug development is an industry where the risk of expensive failure is high.

Join this webinar to learn about the FDA’s new drug-drug interaction guidance and how these metabolic risks can contribute to non-approval, delay and withdrawal from the market. The featured speaker will discuss how in vitro assays can be used to identify potential metabolic risks during drug development and how to use this information to de-risk your drug.

[1] Torjesen, I. (2015, May 12). Drug development: the journey of a medicine from lab to shelf. Retrieved from https://www.pharmaceutical-journal.com/publications/tomorrows-pharmacist/drugdevelopment-the-journey-of-a-medicine-fromlab-to-shelf/20068196.article

Speaker

Guy Webber, BSc (Hons), MSc (Dist), Scientific Manager for In Vitro & DDI Interactions Sciences, Envigo

Guy is an experienced senior DMPK scientist and manager with over 25 years’ experience in pharma and contract research. Currently, he is the Scientific Manager for in vitro and drug-drug interaction sciences in the DMPK department. He manages the In Vitro Sciences and Drug-Drug Interaction Team and future scientific strategy to complement our current comprehensive contract in vitro and DDI services. Guy’s current research and development focus is on investigating risk in pharma development, developing new in vitro DDI assays (UGT enzymes and drug transporters) for regulatory (FDA/EMA/JMHLW-PMDA) compliant DDI assessment of NCEs.

Message Presenter

Who Should Attend?

Chief Medical Officers, Chief Scientific Officers, Head of DMPK, plus senior level professionals from:

  • Drug Discovery
  • Clinical Trial Design
  • Pharmacokinetics
  • Project Management

What You Will Learn

  • Explore the metabolic risks leading to non-approval, delay & withdrawal from the market
  • Understand when these risks occur
  • Discover how certain in vitro assays are used to identify potential metabolic risk during drug development
  • Learn how to de-risk your drug against DDI, DILI & MIST

Xtalks Partner

Envigo

Envigo provides mission-critical products and research services for pharmaceutical, crop protection, and chemical companies as well as universities, governments, and other research organizations. Our company is founded on the principle that research partnerships depend on unmatched expertise, unwavering dedication to customer service and shared goals, Envigo is committed to helping customers realize the full potential of their products and research which contribute to enhancing the lives of people and animals as well as protecting the environment.

With over 3,300+ employees serving over 65 countries with a network of more than 25 operating facilities worldwide, Envigo provides comprehensive scientific expertise and a full service offering in non-clinical research and development, research models and services, regulatory consulting, and analytical support to our customers. Envigo is a privately held global company with corporate headquarters in New Jersey.

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