Digital Course: A Reasoned Approach to Proof-of-Concept Decision Making


CONFERENCE SERIES: BioPharma Strategy 

Recorded at: Accelerating Proof-of-Concept

 

Order DVD2012 DVD Cover About this Product: 

The Pharmaceutical Industry is currently faced with major issues due to decreased revenue generation and low productivity. Consequently it has been actively adopting a variety of strategies, aimed at managing costs and increasing the flow of novel compounds into their pipelines. Strategies aimed at R&D productivity include downsizing and outsourcing, increasing access to new drugs and technologies through partnering, acquisitions and mergers, R&D realignments with a more narrowly focused portfolio. New revenue generating strategies include repurposing old drugs, expanding into emerging markets, greater reliance on biologics, and expansion into vaccines, consumer health, animal health and diagnostics.

These strategies are being adopted as means to maintain revenue streams and to mitigate some risk, but fundamentally they are being driven by the low output of new medicines from the R&D divisions of Pharma. How did we get here? Despite the huge increases in the investments made in Pharma R&D over the last few decades productivity, as measured by the NDA approval of new molecular entities, has remained fairly constant. The 20 NMEs produced yearly is not sufficient to sustain an R&D based pharmaceutical industry that relies heavily on NMEs to drive future revenue streams.

Analysis of benchmarking data reveals that Phase II survival is the Achilles Heel of R&D industry, as 1 in 5 drugs entered into a Phase II proof-of-concept study (POC) will successfully transition into Phase III. This is only marginally better than the 50% attrition from Phase III to submission. Clearly changes need to be implemented in order to ensure survival of the industry. This digital course will discuss the key criteria that underpin quality PoC decisions for both NMEs and repositioned drugs as well as highlight strategies to consider in achieving a PoC in a timely and cost effective manner. Retrospective analysis of the consequences of poor scientific and business decision making in Phase II will be used to highlight the impact on Phase III success.

Preview: 

 

About this Product:
1 Presentations
42 Slides
Over 84 Minutes
Individual: $345
Site License: $1380

Agenda At A Glance: 

  • Scene setting on current state of Pharma and role of attrition.
  • Interactive session to investigate causes of attrition at each Phase of development.
  • Focus on Phase II attrition
  • Group discussion on defining a POC and how far in advance of a POC the decision criteria need to be agreed. How and why things go wrong when a POC fails
  • Science driving PoC
  • Break
  • Development strategy options for PoC
  • Group Discussion and Summary on learnings that lead to a quality POC decision.
  • Q&A and Wrap Up

 

Instructors: 

John ArrowsmithJohn Arrowsmith
A PhD chemist by training, whose current role is as Science Director, Life Sciences Consulting , Thomson Reuters in London. Previously John was an Executive Director with Pfizer leading the Competitive Intelligence Group in R&D. John has a total of 30 year Biopharmaceutical Research and Development experience in drug discovery and development, intellectual property, licensing, portfolio information systems, portfolio prioritization, continuous improvement processes, performance measures and scorecards. John has worked in UK, US and Japan with his last 8 years being based at Pfizer’s R&D facility in Connecticut John is the author/contributor to 2 books, 16 publications and 18 patents. Co-inventor of Tikosyn® an anti-arrhythmic drug.

 

Richard HarrisonRichard K. Harrison
Dr. Richard K. Harrison has over 30 years of experience in the life sciences industry. His career has focused on all aspects of pre-clinical drug discovery. During this time he has held positions of increasing responsibility at Aventis, Merck, DuPont and Wyeth Pharmaceuticals where he delivered numerous clinical candidates and worked on several marketed drugs. In addition, he served as a founding scientist in two successful venture funded computational and structure based drug design companies. Dr. Harrison has authored over 40 peer reviewed publications and book chapters in all areas of drug discovery and has presented over 50 invited lectures on these subjects, He earned his Ph.D. in Biophysical Chemistry and Enzymology and currently serves as an adjunct professor at several universities.

About the Conference: 

How do you define proof-of-concept? Researchers and executives at the 4th annual Accelerating Proof-of-Concept conference addressed this question and many more. Industry and academic experts presented the latest in Phase II clinical trials, highlighting the use of both pharmacodynamic and predictive biomarkers, as well as the impact of discovery trials (Phase 0) is being felt throughout the industry. Experts in data analysis and quantitative decision making introduced valuable new strategies and methods for data analysis for better decision making. How much data is enough? What data is “must have” versus “nice to have?” Leaders in the field shared their experiences from both preclinical & clinical studies.



By Series:
By Region:


Conference
& Course Catalog

CHI Catalog 


Short Course DVDs