Upcoming Xtalks Webinar: How the New FDA Drug-Drug Interaction Guidance Fits Within the Drug Development De-Risking Model

Pharmaceutical development is inherently risky. To develop a molecule that has a desired, efficacious, but safe, effect in humans is a remarkable achievement considering the statistics.

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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, 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 live webinar on Wednesday, July 25, 2018, at 11 a.m. EDT (4 p.m. BST/UK) 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.

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

For more information about this complimentary event, visit: How the New FDA Drug-Drug Interaction Guidance Fits Within the Drug Development De-Risking Model.

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Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks, visit http://xtalks.com.

For information about hosting a webinar, visit http://xtalks.com/why-host-a-webinar/.

Contact:

Nima Rajan​
Tel: +1 (416) 977-6555 ext 352​
​Email: nrajan@xtalks.com

Reference:

[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

Source: Xtalks


Categories: Pharmaceuticals and Biotech

Tags: DMPK, Drug Development, Drug Discovery, Drug Safety, Envigo, In Vitro Assays, Pharmaceutical Regulation, Xtalks


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Xtalks is a leading provider of educational webinars to the global life science, food and medical device community.