Critical Path for Parkinson’s Consortium 2017 Annual Meeting

The Critical Path for Parkinson’s (CPP) Consortium, cofounded by C-Path and Parkinson’s UK, held its second annual consortium member meeting on June 12 in Bethesda, MD. The meeting brought together scientists from the biopharmaceutical industry, academic institutions, and government agencies; people living with Parkinson’s; patient-advocacy associations; and U.S. Food and Drug Administration regulators to align on the collaborative ways to increase efficiency, safety, and speed in developing new therapies for Parkinson’s.

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.

Parkinson’s UK Receives CAMD Nonprofit Organization Award

DianeandArthur

Dr. Arthur Roach, Director of Research at Parkinson’s UK accepts the first Nonprofit Organization Award from CAMD presented by Dr. Diane Stephenson, Critical Path Institute, at the annual meeting held at FDA on Oct 20th, 2015. Parkinson’s UK is recognized for their leadership in supporting the launch of a fully dedicated consortium aimed at integrating patient level data from Parkinson’s disease patients around the world.

PD Imaging Biomarker Team at European Medicines Agency (EMA)

IMG_1065

Experts of the Parkinson’s disease imaging biomarker team participated in a Scientific Advice meeting at the European Medicines Agency on October 7th 2015. The purpose of this meeting was to review the evidence provided to the Agency that supports the use of Molecular Imaging of the Dopamine Transporter as an enrichment biomarker in clinical trials targeting subjects at first signs and symptoms of PD. Team members from left: Steve Arneric, C-Path; Derek Hill, Ixico; Klaus Romero, C-Path; Patricia Cole, Takeda; Arthur Roach, Parkinson’s UK; Ken Marek, MNI; Diane Stephenson, C-Path; Dawn Matthews, ADm Diagnostics; Mark Gordon, Boerhinger Ingelheim.

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)

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