Existing Public Private Partnerships

Topics on this Page:

• Biomarker Consortium (BMC)
• Cardiac Safety Research Consortium (CSRC)
• FDA-Entelos, Inc. Drug-Induced Liver Injury (DILI)
• FDA/Alliance for NanoHealth Nanotechnology Initiative (FANTI)
• FDA collaborations with NCI and NIST on Nanotechnology
• Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative
• University of Rochester Telemetric and Holter ECG Warehouse (THEW)

For additional information on these programs, please contact us [Link to Contact us webpage]

 The Biomarker Consortium (BMC)

A biomarker is characteristic that is objectively measured and evaluated as an indicator of normal biologic process, pathogenic processes, or pharmacologic responses to a therapeutic intervention (Biomarkers Definition Working Group, Clin. Pharmacol. Ther. 2001 69:89-95). In this regard, biomarkers can be invaluable in diagnosis, assessing response to therapeutic intervention, patient management, and in evidence-based medicine.  They can also facilitate early go/no-go decisions during R&D of medical products. To promote the discovery, clinical qualification and development of biomarkers, and to accelerate the delivery of successful new technologies, medicines, and therapies for prevention, early detection, diagnosis, and treatment of disease, FDA joined with the National Institutes of Health (NIH), the Centers for Medicare and Medicaid Services and other stakeholders to form the Biomarker Consortium. 

The Biomarker Consortium was launched in October 2006, is a public-private partnership including the NIH; the Food and Drug Administration (FDA) as part of FDA’s Critical Path Initiative; the Centers for Medicare & Medicaid Services; the pharmaceutical, biotechnology, diagnostics, and medical device industries; non-profit organizations and associations; and advocacy groups. The BC is managed by the Foundation for the National Institutes of Health (FNIH).

For more information about the BMC visit http://ppp.od.nih.gov/pppinfo/examples.asp

 Cardiac Safety Research Consortium (CSRC)

Cardiovascular disease is the leading cause of death in the United States, accounting for over one quarter of all deaths every year.  Some medical products intended to treat cardiovascular disease and other diseases have significant and potentially dangerous side effects related to their effects on the heart.  The Cardiac Safety Research Consortium was launched in 2006 as a public-private partnership whose mission is:  “To advance scientific knowledge on cardiac safety for new and existing medical products by building a collaborative environment based upon the principles of the FDA’s Critical Path Initiative as well as other public health priorities.”

Key objectives of CSRC are to facilitate focused pragmatic research that will inform the regulatory process and to develop knowledge and improve the evaluative sciences in relation to cardiac safety and product development with a specific attention to the use and qualification of biomarkers for the assessment of cardiac safety.  Current projects include publishing consensus whitepapers on a number of topics related to assessment of cardiac risk of medical products, including “QT assessment in Anti-Cancer Drug Development”, “Evaluation of Ventricular Arrhythmias in Early Stage Development”, “Use of Cardiac Troponin Measurement during Drug Development”, and “QT Evaluation of Biologics and Large Molecule”, among others.

A separate, but aligned effort addressing cardiac safety and the need to pool significant amounts of data to identify subtle risks for cardiac events in drug development, was the development of FDA’s digital Electrocardiogram (ECG) Warehouse.  This warehouse was designed and built under the terms and conditions of a Cooperative Research and Development Agreement (CRADA) with Mortara Instruments, Inc.  The ECG Warehouse currently holds over 2.5 million ECG records, representing one of the largest repositories of ECG data in the world.  Through CSRC, FDA is working with the pharmaceutical companies who own the data in the warehouse to make a substantial portion of these records publicly available.  The publicly available data set will provide researchers and ECG analysis algorithm developers with a valuable tool for discovering new ways to identify important characteristics of the ECG which denote potential risks to patients, while also expanding the understanding and limitations of existing techniques.

For more information about the CSRC visit MOU 225-06-8404 and http://www.fda.gov/bbs/topics/NEWS/2006/NEW01467.html

 FDA-Entelos, Inc. Drug-Induced Liver Injury (DILI) Program

Drug-induced liver injury (DILI) is one of the most common reasons for regulatory actions concerning drugs in development and for withdrawal of drugs from marketing and use in clinical practice. Worldwide, the estimated global annual incidence rate of DILI is 13.9-24.0 per 100,000 inhabitants, and DILI accounts for an estimated 3%-9% of all adverse drug reactions reported to health authorities.  In August 2007, FDA entered into a Cooperative Research and Development Agreement (CRADA) with Entelos, Inc. to collaborate on the development of a computer model to predict Drug-Induced Liver Injury (DILI).  Under the terms of the CRADA, Entelos and FDA are working together with leading academic researchers and pharmaceutical companies to work toward a “virtual patient” computer model simulation to predict whether new drugs will produce DILI.  In addition to the CRADA, FDA issued a contract with Entelos, Inc in September 2008 to perform an exhaustive review of the scientific literature and produce the first implementation step of the computer model, describing the currently known and hypothesized mechanisms for DILI.

For more information about the FDA-Entelos DILI Program visit https://www.fbo.gov/index?s=opportunity&mode=form&id=115fa05b754f40a41d8fac395edc5dda&tab=core&_cview=1

 FDA/Alliance for NanoHealth Nanotechnology Initiative (FANTI)

Nanoengineered products are poised to impact all products under FDA’s jurisdiction.  While there are demonstrated benefits of these products, there remain unanswered questions about how these products may behave in complex biological systems.  In this regard, FDA is interested in understanding the risks and benefits of nanoengineered medical products, and to expanding the body of information to facilitate the regulatory review and evaluation of new products that incorporate nanotechnology platforms and nanoscale particles. 
One of the collaborative efforts FDA is engaged in is collaboration with the Houston-based Alliance for NanoHealth (ANH) and its eight member institutions to help speed development of safe and effective medical products in the emerging field of nanotechnology.

Under a Memorandum of Understanding, the FDA/ANH Nanotechnology Initiative will work to expand knowledge of how nanoparticles behave and affect biologic systems, and to facilitate the development of tests and processes that might mitigate the risks associated with nanoengineered products. All outcomes from this public-private partnership will be placed in the public domain for the benefit of all stakeholders

The eight academic institutions include Baylor College of Medicine, the University of Texas’ M.D. Anderson Cancer Center, Rice University, the University of Houston, the University of Texas Health Science Center at Houston, Texas A & M Health Science Center, the University of Texas Medical Branch at Galveston, and the Methodist Hospital Research Institute.

For more information about FANTI visit MOU 225-07-8006 and http://www.fda.gov/bbs/topics/NEWS/2009/NEW01971.html

 FDA collaborations with NCI and NIST on Nanotechnology

Recognizing that extensive cross-sector and multi-disciplinary efforts are needed to understand and develop nanotechnology-based platforms and tools for cancer research as well as diagnostic and therapeutic applications,  FDA, the National Cancer Institute (NCI), and the National Institute for Standards and Technology (NIST), embarked upon a partnership that leverages each party’s core expertise and resources to facilitate nanotechnology.

This effort was an expansion of an already robust collaboration between FDA and NCI under the auspices of the Interagency Oncology Task Force (IOTF), started in 2003. The nanotechnology subcommittee under the IOTF, with a mission to foster greater understanding of the biomedical applications of nanotechnology maintains this collaboration in nanotechnology. These joint activities include active participation with the staff at the Nanotechnology Characterization Laboratory (NCL) of the NCI. Other activities include:

• Co-development of characterization assay cascades associated with NCI’s Nanotechnology Characterization Laboratory (http://ncl.cancer.gov/ncl_business_plan.asp)
• FDA staff on the  standardization of approaches for evaluating nanoscale particles submitted to the NCL
• FDA providing scientific and regulatory input and guidance to the investigators and partners within the NCI’s Alliance for Nanotechnology in Cancer (http://nano.cancer.gov/)

For more information about the FDA/NCI/NIST collaboration in nanotechnology, visit: MOU 225-07-8006

 Safety of Key Inhaled and Intravenous Drugs in Pediatrics (SAFEKIDS) Initiative

Millions of children receive anesthesia each year. Non-clinical studies in juvenile animal models show exposure to some anesthetics and sedatives is associated with memory and learning deficits and other neurodegenerative changes in the central nervous system. Insufficient human data exist to support or refute the possibility that similar effects could occur in children.  The FDA is partnering with multiple stakeholders (e.g. professional anesthesiology societies, academic research institutions, patient advocacy groups, industry and other government and nonprofit organizations) to launch the SAFEKIDS Initiative, a multi-year effort to address major gaps in scientific information concerning the safe use of anesthetics and sedatives on children.  FDA has awarded five contracts under the auspices of the SAFEKIDS initiative.  Current partners include:

• The International Anesthesia Research Society (IARS) is responsible for leading the administrative oversight and the overarching framework for this Public-Private Partnership under which multiple stakeholders will join, with FDA, to support the scientific studies and for assessing and developing additional studies over time.
• Children’s Hospital Boston – Harvard University is conducting a long-term study with neurodevelopmental outcomes in pediatric patients administered regional or general anesthesia as neonates or infants
• Arkansas Children’s Hospital Research Institute – will research the pharmacokinetic, pharmacodynamic, and neurotoxic effects of an anesthetic agent in infants undergoing various surgical procedures
• Columbia University – will evaluate the effects of anesthetic exposure on neurocognitive, emotional, and behavioral outcomes in pediatric patients
• Mayo Clinic – will study long-term cognitive development following exposure to general anesthetic agents during infancy 

For more information on the SAFEKIDS Initiative please visit https://www.fbo.gov/index?s=opportunity&mode=form&id=0c841a89459250061526954191d56864&
tab=core&_cview=1&cck=1&au=&ck=

 University of Rochester Telemetric and Holter ECG Warehouse (THEW)

The Telemetric and Holter ECG Warehouse (THEW) is a research platform for sharing data, tools and expertise for the development of ECG-related technologies hosted at the University of Rochester (UR) Medical Center (NY).  Striving to advance the field of cardiac safety, the THEW initiative is developed under an agreement with FDA for facilitating collaborative discussions between THEW members, and for leveraging resources to implement joint projects among FDA, UR, and other public and private stakeholders.  THEW is a publicly accessible data warehouse where scientists from academia, industry, and government can develop and test new computer algorithms related to quantitative electrocardiography.  Designed to inform cardiac safety and medical product development, the THEW enables access to unique data and tools to develop automatic ECG analysis algorithms. Current research projects aim at increasing QT measurement accuracy used in drug safety trials, which would result in smaller, faster, and therefore more cost- and time-effective drug development processes. Better ECG markers and high precision detection techniques will benefit all stakeholders by ensuring that unsafe drugs do not get to market, while reducing the chances of a “false positive” signal.