Watch now: RDCA-DAP and EATRIS Present Rare Disease Drug Develoment Webinar

January 21, 2021 | 5:00 p.m. – 6:30 p.m. CET
Data Sharing and Analysis to Support Rare Disease Drug Development

The European infrastructure for translational medicine, EATRIS, has invited the Rare Disease Cures Accelerator-Data and Analytics Platform team to present as part of its webinar series, EATx, to introduce RDCA-DAP to the European academic and industry audience. The webinar will discuss how RDCA-DAP works with European entities and how data sharing within Europe, and between Europe and other countries, can be achieved with RDCA-DAP.


Applying Regulatory Science to Neonates: Second Annual Scientific Workshop at European Medicines Agency (EMA)

Date:  September 12-13, 2016

Location: European Medicines Agency, Canary Wharf, London

Sponsors: Critical Path Institute and European Medicines Agency

The International Neonatal Consortium (INC) organized a two day workshop at the European Medicines Agency (EMA) on September 12-13, 2016.  Focused on applying regulatory science to neonates, INC members explored approaches that family and neonatal nursing organizations can take to embrace a research  culture.  Workshop participants also provided an update on INC’s progress in the first year and identified additional initiatives to accelerate the development of safe and effective therapies for neonates.

The workshop was free and open to the public.

The proceedings from this meeting can be viewed here.

C-Path and IMI 2nd Annual Meeting

critical_path_institute_no_tag  IMI-logo

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.”

Agenda Event videos
8:45-9:00 am
Welcome with Martha Brumfield (C-­Path) and Michel Goldman (IMI)

Martha Brumfield

Michel Goldman

9:00-11:00 am
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:

  • What have partnerships produced that could not have been accomplished by a single organization?
  • What metrics should be applied to evaluating partnerships?
  • What are the key challenges facing today’s partnerships, and how can those challenges be optimally addressed?
  • What factors should be considered when partners prioritize projects?
  • How can newly formed partnerships leverage ongoing efforts of established partnerships?
  • How to ensure coordination?

Session 1 –

Janet Woodcock

Dalvir Gill
BioPharma Inc)

David Wholley

William Chin

Session 1 –
Panel Discussion

1:30-1:00 pm
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:

  • The past: Key lessons learned from the SAFE-­T/PSTC collaboration Denise Robinson-­Gravatt (Pfizer)
  • The present: benefits from the ongoing collaboration; preclinical and clinical qualification of markers for BSEP inhibition Douglas Keller (Sanofi)
  • The future: How to build on a successful collaboration John-­Michael Sauer (C-­Path) and Michael Lawton (Pfizer)

Expert Opinion: ShaAvhrée Buckman-­Garner (FDA)

Panel Discussion Topics:

  • How has the SAFE-­T/PSTC collaboration been set up?
  • What has been achieved through this collaboration (e.g. Strategic benefits: capitalizing on synergies and improving regulatory interactions, a real-­life example: preclinical and clinical qualification approaches of markers for BSEP inhibition)
  • What are the key lessons learned from the SAFE-­T/PSTC collaboration?
  • What were major obstacles in setting up the collaborative agreement?
  • What is needed to be more efficient in the future?
  • How to build on a successful collaboration and what areas would benefit from more collaboration

Session 2 –


(formerly Pfizer)

Douglas Keller

John-­Michael Sauer

Michael Lawton



Session 2 –
Panel Discussion

2:00-4:00 pm
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:

  • What are the best methods to maximize the research utility of data contributed by multiple organizations to a collaborative effort?
  • Success stories in analyzing & pooling data to yield new insights & tools
  • Harmonization of approaches to data sharing/aggregating of data
  • How to increase collaboration across existing data sharing initiatives
  • Integrating Electronic Health Records into Clinical Trial databases

Session 3 –

Sharon Hesterlee

Kald Abdallah
(Project DataSphere)

Ed Bowen
BioPharma Inc.)

Keith Elliston

Bron Kisler

Mary Ann Slack

Session 3 –
Panel Discussion

4:00-4:30 pm
Closing Remarks: Identification of key next steps Michel Goldman and Martha Brumfield

Martha Brumfield

Michel Goldman

Collaborating for Cures Leveraging Global Public-Private Partnerships to Accelerate Biopharmaceuticals Development

Event Date: 03/07/2013

Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) and Critical Path Institute (C-Path) held a joint event in Brussels, Belgium on the challenges and opportunities of public-private partnerships (PPPs). More than 120 participants attended the conference and many more followed the live webcast.

This first ever public conference co-sponsored by IMI and C-Path featured cross-sector participants discussing challenges and opportunities in the rapidly-evolving PPP space. The lively discussion focused on identifying mechanisms for enhancing the productivity of PPPs, coordinating individual PPP efforts to avoid duplication, and adopting best practices on data sharing, intellectual property, patient involvement in research, and other cross-cutting issues in order to streamline biopharmaceuticals development world-wide.

  • Download the agenda
  • Watch the entire conference online here
  • Read the highlights of the event on twitter at #CollaboratingForCures



Innovative solutions to shared challenges

Introduction: Collaborating for Cures – Leveraging Global Public-Private Partnerships to Accelerate Biopharmaceuticals Development
Michel Goldman, Executive Director, IMI Martha Brumfield, President and CEO, C-Path

Harnessing the Discovery Engine of NIH to Maximize Translation
Maria Freire, President, Foundation for the National Institutes of Health (FNIH)

How Technology Transfer and other IP Agreements can Spur Bench to Bedside Translation
Tania Bubela, Associate Professor, School of Public Health, University of Alberta

How patients supply more than a voice in Accelerating Medical Product development
Alastair Benbow, Chief Executive, The Age of the Brain

How FDA Promotes Partnerships to Accelerate Medical Product Development
ShaAvhree Buckman-Garner, Director, Office of Translational Sciences, CDER, FDA


IMI and C-Path collaboration on Alzheimer’s disease

Prediction and Faster Assessment of Functional Properties of New Drug Candidates for Alzheimer’s Disease in Early Clinical Development: The IMI PharmaCog project
Jill Richardson, EFPIA coordinator IMI PharmaCog / Director, External Alliances and Development, GSK R&D China

European Medical Informatics Framework (EMIF)
Simon Lovestone, Director Biomedical Research Centre for Mental Health and Dementia, King’s College London

Coalition Against Major Diseases: Regulatory Science can Accelerate Drug Development for Neurodegeneration
Diane Stephenson, Executive Director, Coalition Against Major Diseases, Critical Path Institute

The Regulator’s View
Maria Isaac, Scientific Advisor, European Medicines Agency


IMI and C-Path collaboration on tuberculosis

PreDiCT-TB Model-based preclinical development of antituberculosis drug combinations
Gerry Davies, Senior Lecturer in Infection pharmacology, University of Liverpool

CPTR Mission, Structure & Goals for Innovation
Debra Hanna, Executive Director, Critical Path to TB Drug Regimens