Cures Acceleration Network
Background
A growing frustration in the patient community with the lack of progress over the last ten
years in advancing cures has generated some dramatic changes in the approach to disease
research. The most frequently cited obstacle to progress has been the so-called “valley of
death,” meaning the gap between academic basic research and corporate pharmaceutical
development. To overcome this problem, some organizations have been looking for
more innovative approaches, focusing on translational research. The Leukemia &
Lymphoma Society (LLS) has launched a more proactive research effort known as the
Therapy Acceleration Program (TAP). The TAP program is structured to speed the
development of treatments either by partnering with biotech companies to de-risk
research projects or by providing academic researchers with development assistance.
Congress also recognized the potential of this approach when it created the Cures
Acceleration Network (CAN) in 2010 with incentives for public-private partnerships to
speed basic research into bedside treatments and to encourage innovative research
programs like TAP.
The new entity is under the authority of the NIH Director with advice from a 24-member
Review Board including a chair and co-chair appointed by the Secretary for Health and
Human Services (HHS). The board will be diverse and include at least four members
with a venture capital or private equity background and at least eight members from
patient advocacy organizations. The board members will be appointed based on their
level of expertise in at least one of seven knowledge areas including: basic research;
medicine; biopharmaceuticals; discovery and delivery of medical products;
bioinformatics and gene therapy; medical instrumentation; and regulatory review and
approval of medical products
The NIH Director will be responsible for issuing grants, contracts or cooperative
agreements to eligible entities which will: promote technological innovations to support
advanced research to develop high need cures (high need cures are of priority conditions
that the private sector won’t develop) including through the development of medical
products and behavioral therapies; accelerate the development of those high need cures
through developing medical products, behavioral therapies, and biomarkers that
demonstrate the safety or effectiveness of medical products; or help the grant award
recipient navigate the FDA approval process. Entities eligible to receive CAN grants
include patient advocacy organizations, universities, biotech companies, research
institutions or pharmaceutical companies. The awards may be up to $15 million and can
be supplemented in successive years, again up to $15 million. These awards will
generally require a match of 1 private dollar for every 3 federal dollars. All grants will
have to be awarded competitively.
CAN is particularly appropriate for blood cancer research because of the pioneering
tradition of that research and the high prospect for partnerships and development
opportunities. LLS itself is also poised to leverage this program through its innovative
TAP program and the guidance of its portfolio and expertise.
CAN represents a new approach to research at the NIH in public-private partnerships that
fund innovative research and focus on cures. Its promise, however, depends on its
funding. When the Cures Acceleration Network was created last year, it was capped at
an amount of $500 million. To date, it has not received any funding. To initiate this
promising new research program, LLS requests that Congress fund the Cures
Acceleration Network at $100 million in fiscal year 2012.
For more information, please contact George Dahlman, SVP, LLS’s Office of Public
Policy, at george.dahlman@lls.org or (202) 336-8245.
National Human Genome Research
Institute (NHGRI)/ www.genome.gov
National Heart, Lung and Blood Institute
(NHLBI)/ www.nhlbi.nih.gov
FOR IMMEDIATE RELEASE
NIH and Non-Profits Sign Groundbreaking Research and
Development Agreement
The National Institutes of Health (NIH) today announced a landmark agreement between
the University of Kansas (KU), the Leukemia & Lymphoma Society, the NIH
Therapeutics for Rare and Neglected Diseases (TRND) program and the Hematology
Branch within the National Heart, Lung and Blood Institute (NHLBI), to accelerate
development of drugs and treatments for rare blood cancers.
The agreement between the two NIH Institutes and two non-profit partners, known as a
Cooperative Research and Development Agreement, or CRADA, grew out of a June
2010 Memorandum of Understanding between the TRND program and LLS and KU's
Institute for Advancing Medical Innovation (KU-IAMI). The collaboration is called The
Learning Collaborative (TLC). TLC has a shared commitment to accelerate the
development of therapies for rare blood cancers into clinical proof-of-concept studies that
can eventually be commercialized.
"The time and resources necessary to discover and develop drugs necessitate that all
stakeholders—government, academic, philanthropies, industry— must work together
with partners in industry to achieve this goal. I hope this agreement is the first of many
we can enter into," said Dr. Christopher P. Austin, M.D., director of the TRND program
and scientific director of the NIH Center for Translational Therapeutics, currently
administered by the National Human Genome Research Institute, part of NIH.
"This agreement recognizes that academic, philanthropic and patient organizations have a
role – and a responsibility – to be active leaders in the drug discovery process," added
Roy A. Jensen, M.D., director, The University of Kansas Cancer Center. "I hope this
agreement can serve as a model to other academic and patient communities."
The collaboration's first project focuses on further development of an existing small
molecule drug used to treat arthritis, called Auranofin, in a new indication for the
treatment of relapsed chronic lymphocytic leukemia (CLL) – one of the four major types
of leukemia and one that typically affects older people. Approximately 15,000 people in
the US receive a diagnosis of CLL each year. The goal is to accelerate the development
of this drug and complete preclinical through Phase II clinical trial studies within two
years, at which time an industry partner will be engaged. This project is also a TRND
pilot project.
"Development of new therapies for diseases like the blood cancers poses both scientific
and economic challenges," said Dr. Louis J. DeGennaro, executive vice president and
chief mission officer, LLS. "Partnerships are the key to addressing this significant unmet
medical need and LLS is proud to be part of this collaboration."
“CLL is a clinically complex disease that, while treatable, is incurable with
chemotherapy,” said Dr. Adrian Wiestner, an investigator in the NHLBI’s Hematology
Branch. “There is an especially urgent need to develop novel therapies for chemotherapyresistant disease, and through this agreement the Hematology Branch can bolster its
clinical and translational research program in CLL as well as other hematologic diseases
with unmet clinical needs.”
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The National Institutes of Health (NIH) Therapeutics for Rare and Neglected Diseases
(TRND) program, http://trnd.nih.gov is a congressionally mandated program to
encourage and speed the development of new drugs for rare and neglected diseases. This
unique program creates a drug development pipeline within the NIH and is specifically
intended to stimulate research collaborations with academic scientists, non-profit
organizations, and pharmaceutical and biotechnology companies working on rare and
neglected illnesses. The TRND program provides an opportunity to partner with, and
gain access to, drug development scientific capabilities, expertise, and resources in a
collaborative environment with the goal of moving promising therapeutics into clinical
testing.
NHGRI is one of the 27 institutes and centers at the NIH, an agency of the Department of
Health and Human Services. The NHGRI Division of Intramural Research develops and
implements technology to understand, diagnose and treat genomic and genetic diseases.
Additional information about NHGRI can be found at its website, www.genome.gov.
The NHLBI plans, conducts, and supports research related to the causes, prevention,
diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep
disorders. The Institute also administers national health education campaigns on women
and heart disease, asthma and chronic obstructive pulmonary disease, and other topics.
NHLBI press releases and other materials are available online at www.nhlbi.nih.gov .
The National Institutes of Health (NIH) — The Nation's Medical Research Agency —
includes 27 Institutes and Centers and is a component of the U.S. Department of Health
and Human Services. It is the primary federal agency for conducting and supporting
basic, clinical and translational medical research, and it investigates the causes,
treatments, and cures for both common and rare diseases. For more information about
NIH and its programs, visit www.nih.gov.
The Institute for Advancing Medical Innovation (IAMI) focuses on research and
education with an emphasis on product development and commercialization of novel
medical innovations to accelerate the numbers and quality of new drugs and devices; and
ensures an entrepreneurship focus of the next generation of innovators. IAMI leverages
the Kansas region’s impressive history in drug development by partnering with nearby
companies to perform all the functions needed to take innovative products to market.
The Leukemia & Lymphoma Society (LLS) is the world's largest voluntary health
organization dedicated to funding blood cancer research, education and patient services.
LLS's mission: Cure leukemia, lymphoma, Hodgkin's disease and myeloma, and improve
the quality of life of patients and their families. Since the first funding in 1954, LLS has
awarded more than $700 million in research