C-Path and IMI 2nd Annual Meeting
Accelerating the Development of Drugs, Diagnostics, and Devices: Partnerships to Expand the Precompetitive Space
Wednesday, December 3, 2014
Bethesda, MD, USA
On December 3, 2014, the Critical Path Institute (C-Path) and Innovative Medicines Initiative (IMI) convened an international group of thought leaders to identify new ways to collaborate and achieve a common goal of a robust regulatory science infrastructure that better supports efficient and productive medical product development.
The meeting, Accelerating the Development of Drugs, Diagnostics and Devices: Partnerships to Expand the Precompetitive Space was the second annual meeting of C-Path and IMI, and explored key topics around public-private partnerships (PPPs) to advance regulatory science, data-sharing and patient safety biomarkers.
The organizations explored lessons learned from the PPP model and discussed the importance of leveraging resources and avoiding duplication of efforts. IMI and C-Path have been working together and sharing best practices for many years now, and, as IMI Executive Director Professor Michel Goldman characterized it, the event was “an excellent opportunity to discuss how open collaboration models can contribute to solving medicine’s greatest challenges.”
The ideas, goals, and progress discussed during the conference were subsequently featured in the January 15, 2015 issue of Biocentury Innovations in an article entitled “Consortium Crosstalk.”
Welcome with Martha Brumfield (C-Path) and Michel Goldman (IMI)
Session 1: Partnerships to Advance Regulatory Science and Leverage Global Biopharmaceutical DevelopmentCo-chair/Moderators: Martha Brumfield (C-Path) and Michel Goldman (IMI)Panelist: Janet Woodcock (FDA), Dalvir Gill (TransCelerate BioPharma Inc), David Wholley (FNIH), William Chin (PhRMA)Panel Discussion Topics:
Session 2: Safety Biomarkers: The PSTC and SAFE-T CollaborationCo-chair/Moderators: John-Michael Sauer (C-Path) and Michael Lawton (Pfizer)Panelist: Denise Robinson-Gravatt (formerly Pfizer), Douglas Keller (Sanofi), John-Michael Sauer (C-Path), Michael Lawton (Pfizer), Ameeta Parekh (FDA), Maria Teresa De Magistris (IMI SAFE-T), Frank D. Sistare (Merck), Thorsten Vetter (EMA)Panel Presentations:
Expert Opinion: ShaAvhrée Buckman-Garner (FDA)
Panel Discussion Topics:
Session 3: Maximizing the value of data shared by multiple organizationsCo-chair/Moderators: Enrique Avilés (C-Path) and Ann Martin (IMI)Panelist: Sharon Hesterlee (PPMD), Kald Abdallah (Project DataSphere), Ed Bowen (Pfizer, TransCelerate BioPharma Inc.), Keith Elliston (tranSMART Foundation), Bron Kisler (CDISC), Mary Ann Slack (FDA)Panel Discussion Topics:
Closing Remarks: Identification of key next steps Michel Goldman and Martha Brumfield