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February 9, 2023 PRINT PDF

April 18 – 20 | 2023 CDRC Annual Meeting

 

C-Path’s Cure Drug Repurposing Collaboratory will host an in-person, three-day annual Conference and Regulatory Workshop on April 18-20, 2023, at the Hyatt Regency Crystal City in Arlington, Virginia.  Together with key stakeholder groups including clinicians, researchers, foundations, nonprofits, patient advocates and regulators, CDRC will host a series of talks and roundtable discussions to share recent accomplishments.

This conference will better define how CDRC can best collaborate to capture real-world data to generate hypothesis regarding treatment efficacy using repurposed drugs for diseases of high unmet clinical need and where there is a lack of commercial incentives. The meeting will include key opinion leaders from numerous disease communities, experts on automated EHR data extraction, regulators from the global community, and partnerships to inform and champion large adaptive platform trials.  

Agenda
April 18

CDRC Regulatory Workshop Day 1: Tuesday, April 18

International workshop for publicly funded repurposing programs focusing on projects which do not have a commercial sponsor.

  • Regulatory Drug Repurposing Workshop
    • Introduction: Rosie Lovett | 9:00-9:20
  • Cochairs: Marco Schito & John Liddicoat
  • 8 Speakers (5 min lightning talks)| 9:00 – 10:00
    • Rosie Lovett (NHS) | 9:15 – 9:20
    • Heather Stone (FDA) | 9:20 – 9:25
    • Sundeep Agrawal (FDA) | 9:25–9:30
    • Pedrita Taylor Zapada (NICHD) | 9:30-9:35
    • Sabine Grimm (REPO4EU) 9:35 – 9:40
    • Donald Lo (REMIDi4ALL) | 9:40–9:45
    • Marjon Pasmooij (Netherlands – MEB) | 9:45–9:50
    • Blanca Bradley (Spain – AEMPS) | 9:50–9:55
    • Charlotte Asker-Hagelberg (Sweden – MPA) | 9:55–10:00
    • Questions/Answers | 10:00-10:15

Break

  • Cochairs: Rosie Lovett & Donald Lo
    • Panel 1: Candidate Identification | 10:30-12:00
    • Sundeep Agrawal
    • Sabine Grimm
    • Charlotte Asker-Hagelberg
    • Marjon Pasmooij
    • Perdita Taylor-Zapata

Lunch | 12:00-1:00

  • Cochairs: Marco Schito & David Simon
    • Zaneta Zemla-Pacud (1:00-1:30)
    • James Robinson (UC-Berkley) 1:30-2:00
  • Panel 2: RCTs, licensing, trial funding: | 2:00-3:30
    • Patricia Van damme (Anticancer fund)
    • Amit Aggarwal (ABPI)
    • James Robinson (UCB)
    • Vidula Sukhatme (Morningside)
    • Cynthia Adinig (Patient)
  • Next steps (close of open session) | 3:30-3:45

Break | 3:45-4:00

  • Cochairs: Rosie Lovett and Heather Stone
    • Closed session with publicly funded programs| 4:00-5:00
April 19 AM

CDRC Annual Meeting Day 2: Wednesday, April 19

Development of open-sourced tools to automate the collection of repurposed drugs from electronic medical records to generate real-world data.

Morning: Meeting kickoff on automating data extraction from EHRs

  • Welcome and Overview:: Marco Schito (C-Path) and Heather Stone (FDA) | 8:00-8:15
  • Keynote: Jacqueline Corrigan -Curay (FDA) | 8:15-8:45
  • Cochairs: Jagdeep Podichetty (C-Path) & Matthew Robinson (JHU)
  • EHRs Data Extraction
    • Danielle Boyce (JHU) – Pulling structured data and the Edge tool | 8:45-9:00
    • Wes Anderson (C-Path) Unstructured data using AWS NLP | 9″00-9:15
    • Ruth Kurtycz (CDC) – Propensity score modeling |9:15-9:30
    • Kerry Howard (Clemson) – Lasso regression | 9:30-9:45

Break | 9:45-10:00

Moderators: Ewy Mathe (NCATS) & Raghav Tirupathi (C-Path)

  • Smitty Heavner (C-Path) – Analysis of initial COVID results | 10:00-10:15
  • Roundtable: Discussion of results of Edge tool extraction and analysis | 10:15-11:45
    • Laura Evans (SCCM)
    • Nathalie Strub-Wourgaft (DNDi)
    • Matt Robinson (JHU)
    • Anup Challa (AstraZeneca)
  • Wrap up and next steps |11:45-12:00
April 19 PM

Lunch | 12:00-1:00

Challenges and opportunities for confirming hypothesis generated by real-world data for repurposed drugs through randomized clinical trials.

Afternoon: Pragmatic adaptive platform trials

  • Welcome and Overview: Marco Schito (C-Path) and Heather Stone (FDA) | 1:00-1:15
  • Keynote: David Fajgenbaum (Every Cure and CDRC AC Co-Chair) | 1:15-1:45
  • Cochairs: Marco Schito (C-Path) and Leonard Sacks (FDA)
  • Undiagnosed Diseases Network (UDN): Discovering Rare Disease Therapies Through Team Science| 1:45-2:00
  • FFRDC for repurposing drugs – Vikas Sukhatme (Emory Morningside Center for Innovative and Affordable Medicine) | 2:00-2:15

Break | 2:15-2:30

  • Roundtable Discussions on decentralized trials and embedding trials in clinical practice.
    • Inpatient trials and innovations in embedding trials in practice | 2:30-3:45
  • Moderators: David Fajgenbaum (U Penn) and Heather Stone (FDA)
  • Panelists:
    • Trevan Locke (Duke Margolis)
    • Raghave Tirupathi (WellSpan Health)
    • Stacey Coe (C-Path)
    • Barbara Goodman (Cures within Reach)
    • Cynthia Adinig (Patient)

Break | 3:45-4:00

  • Outpatient/decentralized/patient-centric trials | 4:00 —5:00
    • Chris Lindsell (Duke)
    • Nathalie Strub -Wourgraft (DNDi)
    • Suanna Buinooge (ASCO)
    • Oved Amitay (Solve CFS)
    • Amy Morris (Emory)
  • Wrap up and next steps | 5:00-5:15

Evening: Reception | 6:00-9:00

  • Poster Session
  • Keynote: Patient advocate
  • Hors d’oeuvres
  • Open bar
  • Taco stand
April 20 AM

CDRC Annual Meeting Day 3: Thursday April 20

Utility of generating real-world data for assessing repurposed drugs in rare and ultrarare cancers.

Morning: closed door meetings

  • CDRC Advisory Committee | 8:30-10:00 a.m.

BREAK | 10:00-10:15 a.m.

  • Session with FDA and NIH | 10:15-11:45 a.m.

LUNCH | 12:00-1:00
April 20 PM Afternoon: Rare Cancer (Sarcomas)

  • Welcome Marco Schito (C-Path) (1:00-1:15)
    • Cochair: Bill Tap (MSKCC)
  • CDRC plans for rare and ultrarare cancers | 1:15-1:45
  • Patient data: Denise Robinson (EHE360) | 1:45-2:00
  • RWD from EHRs: Mark Shapiro (xCures) | 2:00-2:15
  • Clinical trials: Vidula Sukhatme (Morningside) (2:15-2:30)

BREAK (2:30-2:45)

Moderator: Marco Schito (C-Path)

  • Challenges and opportunities (Harnessing RWD to advance repurposed drugs for rare cancers) | 2:45-3:00
  • Panel Discussion | 3:00-4:00
    • Brandi Felser (SFA)
    • Christine Heske (NCI)
    • Barbara Goodman (Cures within Reach)
    • Andrea Gross (NCI)
    • Patricia Van damme (Anticancer fund)
    • Suanna Bruinooge (ASCO)
    • Lennie Woods (Clear Cell Sarcoma Foundation)
  • Next steps | 4:00-4:15

Adjourn | 4:15

 

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