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October 29, 2019 PRINT PDF

2019 Annual Meeting and Regulatory Science Workshop

October 29, 2019 Crystal Gateway Marriott | Arlington, VA

The key objectives of the meeting are:

  • To discuss the proposed strategy for CPAD of developing comprehensive solutions for AD drug development, based on a quantitative understanding of disease progression across the entire AD continuum
  • To review and define a path to advance the progress of acquiring datasets which will inform the expansion of the CPAD patient-level database, intended to support the generation of the proposed quantitative models of disease progression across the AD continuum

 

Agenda

7:15 – 8:00 am Continental Breakfast
8:00 – 8:10 am

Welcome and CPAD Impact in 2019

Joseph Scheeren (C-Path, President & Chief Executive Officer)
8:10 – 8:20 am Welcome Remarks

  • Sudhir Sivakumaran (C-Path, Associate Director, CPAD)
  • Michael Gold (AbbVie, Vice President, Neuroscience Development)

SESSION I: Building Alignment & Vision for the Future – C-Path Data Sharing Initiative

Moderator: Martha Brumfield (C-Path, Special Advisor and Past President & CEO)
8:20 – 9:05 am Industry Data Sharing Initiative – Strategy and Early Successes

  • Samantha Budd Haeberlein (Biogen, Vice-President, Late Stage Clinical Development Unit Head)
  • Billy Dunn (FDA, Director, Division of Neurology Products)
9:05 – 10:05 am Early Successes – Clinical Studies and Data Sharing Experiences
10:05 – 10:10 am “Data Sharing Pioneer” Awards
10:10 – 10:30 am

Panel Discussion ­– Lessons Learned in Data Sharing  

All Speakers
10:30 – 10:45 am Break

SESSION II: CPAD’s Quantitative Modeling Strategy

Moderator: Klaus Romero (C-Path, Executive Director, Clinical Pharmacology & Quantitative Medicine)
10:45 – 11:05 am

The Future is Now: CPAD’s Modeling Strategy

Klaus Romero (C-Path, Executive Director, Clinical Pharmacology & Quantitative Medicine)
11:05 – 11:45 am  Learnings Across Quantitative Approaches at C-Path
11:45 – 12:45 pm

Panel Discussion

All Speakers

  • Malidi Ahamadi (Merck, Principal Scientist, Modeling & Simulation)
  • Ping He (Biogen, Medical Director)
  • Kevin Krudys (FDA, Senior Clinical Analyst for Quantitative Analysis and Modeling, Division of Neurology Products)
  • Nitin Mehrotra (Merck, Senior Principal Scientist & Therapeutic Area Lead for Neuroscience, Quantitative Pharmacology and Pharmaco-metrics)
  • Ivan Nestorov (Biogen, Senior Director, Head of Pharmacometrics)
  • Vikram Sinha (Merck, Vice President & Head, Quantitative Pharmacology & Pharmacometrics) – Remote Participation
12:45 – 1:45 pm Lunch

Session III: Current Tools and New Initiatives

Moderator: Sudhir Sivakumaran (C-Path, Associate Director, CPAD)
1:45 – 2:00 pm

Updates to Existing Tools and the Clinical Trial Simulator for Pre-Dementia

Klaus Romero (C-Path, Executive Director, Clinical Pharmacology & Quantitative Medicine) 
2:00 – 2:15 pm

Cutting-edge Approaches to Model Multiple Measures through a Machine Learning Framework

Jagdeep Podichetty (C-Path, Scientific Director, Quantitative Medicine) 
2:15 – 2:45 pm Measurement Gaps: Essential Next Steps to Identify Potential Solutions (Triangulation Approach)

  • Integration of Existing Information Regarding Clinically Meaningful Aspects of Disease at Specific Stages in the Continuum
  • Inventory of Existing Measures
  • Determination of Measurement Gaps

Klaus Romero (C-Path, Executive Director, Clinical Pharmacology & Quantitative Medicine)
2:45 – 3:00 pm

Unlearn.AI – Overview

Charles Fisher (Unlearn.AI Inc., Founder & CEO)
3:00 – 3:45 pm

Panel Discussion

All Speakers

  • Robert C. Alexander (Takeda, Vice-President & Head, Global Clinical Science Neuroscience TAU)
  • Eric Bastings (FDA, Acting Director, Division of Neurology Products)
  • Michael Gold (AbbVie, Vice President, Neuroscience Development)
  • Kevin Krudys (FDA, Senior Clinical Analyst for Quantitative Analysis and Modeling, Division of Neurology Products)
  • Diane Stephenson (C-Path, Executive Director CPP)
3:45 – 4:00 pm Break

SESSION IV:

Solving Industry Needs Through Data Sharing: From Prevention to Treatment of Dementia

Moderators:

  • Martha Brumfield (C-Path, Special Advisor and Past President & CEO),
  • Samantha Budd Haeberlein (Biogen, Vice-President, Late Stage Clinical Development Unit Head)
  • Billy Dunn (FDA, Director, Division of Neurology Products)
  • Klaus Romero (C-Path, Executive Director, Clinical Pharmacology & Quantitative Medicine)
  • Sudhir Sivakumaran (C-Path, Associate Director, CPAD)
4:00 – 4:50 pm

Working Roundtable Discussion

All Workshop Attendants

4:50 – 5:00 pm

Closing Remarks

Sudhir Sivakumaran (C-Path, Associate Director, CPAD)

 

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