• The Role of Scientific Consortia in Drug Development

• Critical Path Initiative: The Role of Consortia

• Engagement with PPPs and Consortia

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The Role of Scientific Consortia in Drug Development

Background Information

The Critical Path Initiative (CPI), and the Strategic Plan for Advancing Regulatory Science Initiative seek to help modernize the development, evaluation, manufacture and use of FDA regulated products. Through collaborations with other government agencies, global organizations, academia, industry, patient advocacy groups, and other stakeholders, these initiatives promote the development of new tools, methods and approaches to foster innovation and bring efficiency into the FDA regulated product development. Examples include novel biomarkers, imaging tools, clinical outcome assessment instruments, clinical trial considerations for unmet needs, laboratory assays, genetic tests, and state-of-the art information technology, animal and in-silico models, etc. In this collaborative effort, FDA plays the role of a facilitator in the creation of partnerships and collaborations, and an advisor to support specific scientific projects.

What is a Public-Private Partnership (PPP) or consortium?

A PPP or a consortium is a collaborative group managed by a convening or coordinating organization involving multiple stakeholder organizations including at least one non-profit or 501(c)(3) organization (e.g., academia, government, or foundation) and at least one for-profit organization (e.g., pharmaceutical, biotechnology, or medical device company). A PPP may involve multiple committees and working groups.  

Why is CDER involved?

CDER is engaged in a number of PPPs and consortia with other government, academic, scientific, patient, and industry organizations to foster scientific collaborations to support the Critical Path Initiative and activities to advance regulatory science. These efforts encourage the development of new tools to facilitate innovation in medical product development. 

How does CDER benefit from involvement in PPP or consortium activities?

Public health needs and CDER’s review activities often identify gaps in regulatory science that require a coalition of resources, expertise and partnering. A PPP or consortium is established to address issues that are beyond the capacity and resources of a single organization. When CDER engages in a PPP or consortium to address specific regulatory science gaps and needs, CDER staff can keep the focus of the PPP or consortium activities on addressing the regulatory science deliverable, and the products of the partnerships are shared in public domain for a wider uptake.

What is the process for requesting CDER staff engagement in PPP and consortia activities?

For consistency and continuity, CDER has established a process for CDER staff to engage with consortia and PPPs. CDER staff can be appointed by CDER Director to engage in consortia and PPP discussions when the project objectives are viewed to be valuable to CDER’s mission, and where CDER staff has the potential to aid the consortium or PPP in achieving the objectives.

To request CDER staff engagement with a consortium or PPP, the convener should submit a Request for CDER Participation in a Public Private Partnership or Consortium Activity form attached to Manual of Policies and Procedures (MAPP) 4100.2  available on CDER website and send to [email protected].

Critical Path Initiative: The Role of Consortia:

• US Food and Drug Administration: Critical Path Initiative
• Advancing Regulatory Science at FDA: A Strategic Plan (August 2011)
• The Role of Public-Private Partnerships in Catalyzing the Critical Path
• The Role of Consortia in Biomarker Development and Qualification

Engagement with PPPs and Consortia:

CDER established the Manual of Policies and Procedures (MAPP) 4100.2, titled, “CDER Staff Participation in Public Private Partnerships and Consortia” to facilitate consistency and continuity throughout CDER as the Center engages in PPPs and consortia. MAPP 4100.2 establishes a process for CDER staff to obtain clearance for participation in these activities, and to obtain appropriate assurances regarding CDER’s terms and conditions for engagement from external organizations with which we engage. The MAPP also defines responsibilities for CDER PPP Liaisons who are engaged with a PPP or consortium convened by an external organization to support scientific projects.

• MAPP 4100.2 CDER Staff Participation in PPPs and Consortia (PDF)
  PPP or consortia coordinators: Submit Attachment 3 of MAPP 4100.02 to request CDER participation in a PPP or Consortium.
  • Request for CDER Participation in a Public Private Partnership or Consortium Activity form  (PDF - 1 MB)

PPPs/Consortia with CDER Staff Participation

Accumulus
Alcohol Clinical Trials Initiative (ACTIVE)
The Analgesic Clinical Trial Translations, Innovations, Opportunities and Networks Initiative (ACTTION)
American Society of Pharmacovigilance (ASP) - STRIPE Collaborative Community
Accelerating Medicines Partnership (AMP)
Amyloidosis Research Consortium (ARC)
ASA Biopharmaceutical Safety Working Group (ASA BIOP SWG)
BioCelerate Working Group to Evaluate Cross-Study Analyses of CDISC SEND Datasets
Biomarkers Consortium (BC)
The Coalition Against Major Disease Consortium (CAMD)/Critical Path for Alzheimer's Disease (CPAD)
Coalition For Accelerating Standards and Therapies (CFAST)
Critical Path for Parkinson’s (CPP)
Critical Path for Sickle Cell Disease (CP-SCD)
Critical Path to Therapeutics for the Ataxias (CPTA)
Pediatric IBD Consortium’s Children’s REgistry for the Advancement of ThErapeutics (CREATE)
The Clinical Trials Transformation Initiative (CTTI)
The Critical Path to TB Drug Regimens Consortium (CPTR)
Cardiac Safety Research Consortium (CSRC)
Cures Within Reach - ReGRow Pilot Program
Dental Quality Alliance (DQA)
Dissolution Working Group
DruSafe Impurities Safety Working Group
Duchenne Regulatory Science Consortium (D-RSC)
Electronic Patient-Reported Outcome (ePRO) Consortium
Forum for Collaborative Research
GS-1
Heart Failure Collaboratory
HESI Cardiac Safety Technical Committee
HESI Developmental and Reproductive Toxicology Committee (DART)
Huntington’s Disease Regulatory Science Consortium (HD-RSC)
Innovation in Medical Evidence Development and Surveillance (IMEDS) program
IQ- Accelerated Drug Development Working Group
IQ-Clinical Pharmacology Leadership Group (CPLG) - Pediatric Working Group
IQ-DILI Initiative IQ-Drug Product Leadership Group (DPLG) - Pediatric Working Group
IQ- In-Use Microbial Stability Working Group
IQ- Microphysiological System Affiliate (MPS)
IMI TRIALS@HOME
International Neonatal Consortium (INC)
International Serious Adverse Events Consortium (iSAEC)
Institute for Safe Medication Practices (ISMP)
Kidney Health Initiative (KHI)
Multiple Sclerosis Outcome Assessments Consortium (MSOAC)
National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)  
National Institute for Pharmaceutical Technology and Education (NIPTE)  
Pediatric Dermatology Research Alliance (PEDRA) - Guidelines for Use of Methotrexate in Pediatric Inflammatory Skin Disease
Pharmaceutical Users Software Exchange (PhUSE)
The Polycystic Kidney Disease Outcomes Consortium (PKDOC)
Product Quality Research Institute (PQRI)
The Patient Reported Outcome Consortium (PRO)
Partnership for DSCSA Governance, INC. (PDG)
Protect Initiative
Project Data Sphere (PDS)
The Global Pediatric Clinical Trials Network Pre-Launch Consortium (PTC)
The Predictive Safety Testing Consortium (PSTC)
RX-360
Setting International Standards of Quality of Life and Patient Reported Outcomes Endpoints – Innovative Medicines Initiative (SISAQOL-IMI)
SmartTots 
Society of Clinical Data Management (SCDM)
Type 1 Diabetes (T1D) Consortium
TransCelerate BioPharma Inc.
Transplant Therapeutics Consortium (TTC)
Worldwide Innovative Networking (WIN) Consortium

 

For a listing of additional consortia and partnerships compiled by an external group FasterCures, a Center of the Milken Institute, see Consortia-pedia.

For further information or questions contact us at [email protected].