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 OTS-PPPCoordinator@fda.hhs.gov.
- 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
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.
PPPs/Consortia with CDER Staff Participation
- Accelerating Medicines Partnership (AMP)
- Accumulus SynergyExternal Link Disclaimer
- Alcohol Clinical Trials Initiative (ACTive)External Link Disclaimer
- American Society of Pharmacovigilance (ASP) - STRIPE Collaborative CommunityExternal Link Disclaimer
- American Statistical Association (ASA) Biopharmaceutical (BIOP) Safety Working GroupExternal Link Disclaimer
- Amyloidosis Research Consortium (ARC)External Link Disclaimer
- Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities and Networks Initiative (ACTTION)/Pediatric Anesthesia Safety Initiative (PASI)External Link Disclaimer
- BioCelerate Working Group to Evaluate Cross-Study Analyses of CDISC SEND DatasetsExternal Link Disclaimer
- Biomarkers Consortium (BC)External Link Disclaimer
- Cardiac Safety Research Consortium (CSRC)External Link Disclaimer
- Coalition For Accelerating Standards and Therapies (CFAST)External Link Disclaimer
- Critical Path for Alzheimer's Disease (CPAD)External Link Disclaimer
- Critical Path for Parkinson’s (CPP)External Link Disclaimer
- Critical Path for Sickle Cell Disease (CP-SCD)External Link Disclaimer
- Critical Path to TB Drug Regimens Consortium (CPTR)External Link Disclaimer
- Critical Path to Therapeutics for the Ataxias (CPTA)External Link Disclaimer
- Clinical Trials Transformation Initiative (CTTI) - Digital Health Technologies ProjectExternal Link Disclaimer
- Cures Within Reach - ReGRow Pilot ProgramExternal Link Disclaimer
- Dental Quality Alliance (DQA)External Link Disclaimer
- Duchenne Regulatory Science Consortium (D-RSC)External Link Disclaimer
- Electronic Patient-Reported Outcome (ePRO) ConsortiumExternal Link Disclaimer
- Forum for Collaborative - The Liver ForumExternal Link Disclaimer
- Forum for Collaborative Research - HIV ForumExternal Link Disclaimer
- Global Pediatric Clinical Trials Network Pre-Launch Consortium (PTC)External Link Disclaimer
- Heart Failure CollaboratoryExternal Link Disclaimer
- Huntington’s Disease Regulatory Science Consortium (HD-RSC)External Link Disclaimer
- ILSI-HESI Cardiac Safety Technical CommitteeExternal Link Disclaimer
- ILSI-HESI Developmental and Reproductive Toxicology Committee (DART)External Link Disclaimer
- Innovation in Medical Evidence Development and Surveillance (IMEDS) programExternal Link Disclaimer
- Institute for Safe Medication Practices (ISMP)External Link Disclaimer
- International Neonatal Consortium (INC)External Link Disclaimer
- International Rare Diseases Research Consortium (IRDiRC)External Link Disclaimer
- IQ Consortium- In-Use Microbial Stability Working Group
- IQ Consortium-Accelerated Drug Development Working GroupExternal Link Disclaimer
- IQ Consortium-DILI InitativeExternal Link Disclaimer
- IQ Consortium-Drug Product Leadership Group (DPLG) - Pediatric Working GroupExternal Link Disclaimer
- IQ Consortium-Microphysiological Systems Affiliate (MPS)External Link Disclaimer
- Kidney Health Initiative (KHI)External Link Disclaimer
- Lupus Accelerating Breakthroughs Consortium
- Multiple Sclerosis Outcome Assessments Consortium (MSOAC)External Link Disclaimer
- National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)External Link Disclaimer
- National Institute for Pharmaceutical Technology and Education (NIPTE)External Link Disclaimer
- NYU Working Group on Compassionate Use and Preapproval Access (CUPA)External Link Disclaimer
- OMERACT Pre-competitive Consortium Osteoarthritis Short-Term and Long Term Outcome Measures
- Partnership for DSCSA Governance, INC. (PDG)External Link Disclaimer
- Patient Reported Outcome Consortium (PRO)External Link Disclaimer
- Polycystic Kidney Disease Outcomes Consortium (PKDOC)External Link Disclaimer
- Predictive Safety Testing Consortium (PSTC)External Link Disclaimer
- Pediatric Dermatology Research Alliance (PEDRA) - Guidelines for Use of Methotrexate in Pediatric Inflammatory Skin DiseaseExternal Link Disclaimer
- Pediatric IBD Consortium’s Children’s REgistry for the Advancement of ThErapeutics (CREATE)External Link Disclaimer
- Pharmaceutical Users Software Exchange (PhUSE)External Link Disclaimer
- Physiochemical In-Use Stability Testing Working GroupExternal Link Disclaimer
- Pistoia Alliance - In Vitro Pharmacology Working GroupExternal Link Disclaimer
- PREFER ConsortiumExternal Link Disclaimer
- Product Quality Research Institute (PQRI)External Link Disclaimer
- Protect Initiative
- Rare Disease Clinical Outcome Assessment Consortium (RD-COAC)External Link Disclaimer
- Setting International Standards of Quality of Life and Patient Reported Outcomes Endpoints- Innovative Medicines Initiative (SISAQOL-IMI)External Link Disclaimer
- Society of Clinical Data Management (SCDM)External Link Disclaimer
- Transplant Therapeutics Consortium (TTC)External Link Disclaimer
- Type 1 Diabetes (T1D) Consortium External Link Disclaimer
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 OTS-PPPCoordinator@fda.hhs.gov.