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
(C-Path)

Michel Goldman
(IMI)

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 –
Introduction

Janet Woodcock
(FDA)

Dalvir Gill
(TransCelerate
BioPharma Inc)

David Wholley
(FNIH)

William Chin
(PhRMA)

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 –
Introduction

Denise
Robinson-­Gravatt

(formerly Pfizer)

Douglas Keller
(Sanofi)

John-­Michael Sauer
(C-­Path)

Michael Lawton
(Pfizer)

ShaAvhrée
Buckman-­Garner

(FDA)

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 –
Introduction

Sharon Hesterlee
(PPMD)

Kald Abdallah
(Project DataSphere)

Ed Bowen
(Pfizer,
TransCelerate
BioPharma Inc.)

Keith Elliston
(tranSMART
Foundation)

Bron Kisler
(CDISC)

Mary Ann Slack
(FDA)

Session 3 –
Panel Discussion

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

Martha Brumfield
(C-Path)

Michel Goldman
(IMI)

Conference Highlights Public Private Partnership Role in Medical Product Development

December 3, 2014 | Download PDF

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Conference Highlights Public Private Partnership Role in Medical Product Development

Global organizations convene cross-sector thought leaders to discuss public-private partnerships


BETHESDA, MD, December 3, 2014—Today, the Critical Path Institute (C-Path) and Innovative Medicines Initiative (IMI) are convening 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. Accelerating the Development of Drugs, Diagnostics and Devices: Partnerships to Expand the Precompetitive Space is the second annual meeting of C-Path and IMI, and will explore key topics around partnerships to advance regulatory science, data-sharing and patient safety biomarkers.

“We are proud to partner with our colleagues at IMI to host a discussion on the role of public-private partnerships,” said Martha Brumfield, Ph.D., president and chief executive officer of C-Path. “No single entity has adequate resources, experience and data to tackle the complex issues in disease areas such as Alzheimer’s, Parkinson’s, schizophrenia, and diabetes. Global, collaborative efforts, along with the early engagement of regulatory authorities, advance innovation in these and other areas of unmet need.”

Public-private partnerships (PPPs) are at the forefront of a cross-sector effort to transform the expensive, time-consuming, high-risk and complicated process that delivers new treatment options. In its second annual conference, the two organizations will explore lessons learned with the PPP model and identify additional ways to leverage resources and avoid duplication of efforts.

“Collaboration is essential if we are to solve the biggest challenges in medicines development and to ensure patients gain rapid access to innovative therapies,” said Michel Goldman, M.D., Ph.D., executive director of IMI. “IMI and C-Path have been working together and sharing best practices for many years now, and this event represents an excellent opportunity to discuss how open collaboration models can contribute to solving medicine’s greatest challenges.”

Three separate panel discussions, moderated by C-Path and IMI, will draw on the perspective of government officials, researchers, regulators, and pharmaceutical industry representatives. The sessions include:

  • Partnerships to Advance Regulatory Science and Leverage Global Biopharmaceutical Development will feature a discussion between Janet Woodcock of the U.S. Food and Drug Administration (FDA), Dalvir Gill of TransCelerate BioPharma, William Chin of Pharmaceutical Research and Manufacturers of America (PhRMA) and David Wholley of the Foundation for the National Institutes of Health (FNIH).
  • In session two, Safety Biomarkers: The Predictive Safety Testing Consortium (PSTC) and Safer and Faster Evidence-based Translation (SAFE-T) Collaboration conversation, John-Michael Sauer of C-Path and Michael Merz of Novartis will moderate a discussion with representatives from Merck, Sanofi, the FDA and European Medicines Agency.
  • The third panel, Maximizing the Value of Data Shared by Multiple Organizations, brings together representatives from non-profit organizations and government to discuss ways to maximize the research utility of data.

PPPs have been successfully used to create new data standards and to identify biomarkers in several therapeutic areas, including pressing public health concerns such as Alzheimer’s disease, tuberculosis and kidney safety. “These models are the future of drug development and while significant progress has been made, today’s conversations will certainly push us forward,” said Brumfield.

Michel Goldman added, “Public-private partnerships are now an established feature of the drug development landscape. Today’s meeting will allow us to review what PPPs can do and how we can do even more to contribute to the development of the medicines of the future, for the benefit of patients and society.”



Notes to Editors

The event will be held at the Hyatt Regency Bethesda, One Bethesda Metro Center, 7400 Wisconsin Avenue, Bethesda, MD 20814. It will also be possible to view the slides and hear the event audio via WebEx: https://pstcevent.webex.com/pstcevent/onstage/g.php?MTID=e6c6c0956270c0c4b7c3cc2d0f8ee970e

Password: Cpath

About the Critical Path Institute

The Critical Path Institute (C-Path) is an independent, non-profit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the U.S. Food and Drug Administration (FDA).  C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world.  An international leader in forming collaborations, C-Path has established seven global, public-private partnerships that currently include over 1,300 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies.  C-Path is headquartered in Tucson, Arizona.  For more information, visit www.c-path.org and at @cpathinstitute.

About the Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is working to improve health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need. It does this by facilitating collaboration between the key players involved in healthcare research, including universities, the pharmaceutical and other industries, small and medium-sized enterprises (SMEs), patient organisations, and medicines regulators.

IMI is a partnership between the European Union and the European pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA). IMI has a budget of €3.3 billion for the period 2014-2024. Half of this comes from the EU’s research and innovation programme, Horizon 2020. The other half comes from large companies, mostly from the pharmaceutical sector; these do not receive any EU funding, but contribute to the projects ‘in kind’, for example by donating their researchers’ time or providing access to research facilities or resources. For more information, visit www.imi.europa.eu and at @IMI_JU.

Contact
C-Path: Catherine Brady at (617) 945-9316
IMI:  Alessandra Paccamiccio at (32) 2 221 8183

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

 

Presentations

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

Leading US and European Medical Public-Private Partnerships Announce Agreement

The Predictive Safety Testing Consortium (PSTC) led by the Critical Path Institute (C-Path) and the Safer and Faster Evidence-based Translation (SAFE-T) consortium sponsored by the Innovative Medicines Initiative (IMI), announced today the signature of an agreement to work together in their efforts to improve drug safety.

FDA, IMI, and Patient Advocates to Present at CDISC 2012 International Interchange Formal Launch of CFAST – Collaboration between C-Path and CDISC

The Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path) announce the launch of the Coalition For Accelerating Standards and Therapies (CFAST), a follow-up to the partnership agreement signed earlier this year. The official launch of CFAST will take place at the CDISC 2012 International Interchange in Baltimore, Maryland (24-26 October 2012).

Critical Path Institute and Innovative Medicines Initiative Announce Formal Collaboration

Internationally renowned organizations share common commitment to advancing science that improves medical product development. Critical Path Institute and the Innovative Medicines Initiative (IMI) announced today that they have signed a Memorandum of Understanding to further the missions of both organizations.