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The Pipeline Success Summit

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!

  

RJV

PFC

MOA

 
CONFERENCE HIGHLIGHTS

  • New Tools and Techniques to Improve the Productivity and ROI
  • Accelerate Development While Reducing Risk and Attrition
  • Focus Resources on the Most Promising Candidates
  • Maximize the Total Value of Your Drug Development Pipeline


Featuring a Pre-Conference Short Course:
Tuesday, October 13 (9:00 am - 12:00 pm)


Predicting Outcomes in Pre-Clinical Development
John Arrowsmith, Ph.D., Executive Director and Head, Competitive Intelligence, Pfizer Global Research and Development

The course will explore some of the fundamental factors that go into a POC decision. It will analyze the underlying science that drives those decisions and how to influence investments and behaviors to make more of the right choices and fewer wrong choices.

This interactive short course will cover:
• Introduction to the general idea of attrition, pointing out obvious productivity and economic impacts.

• Investigate causes of attrition. 

• Focus on Phase II attrition specifically and the importance of POC.

Group discussion on defining a POC and how far in advance of a POC the decision criteria need to be agreed.

• Discuss how and why things go wrong when a POC fails.

 Novel and non-novel POC's, the Proof of Mechanism and translation from pre-clinical to clinical for safety and efficacy measures. 

• Types of risk being taken on at POC, since all are not are born equal.

• Group discussion around planning and executing POC's.

• Leveraging benchmark data and use after action reviews.

• Final wrap up discussion and Q&A.

*Separate Registration Required

 

WHITE PAPER

Click here to download the "Understanding The 505(b)(2) Approval Pathway" white paper
 

 


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