AMP - Accelerating Medicines Partnership
In February, we wrote about the National Institutes of Health (NIH) announcement of a partnership with ten drug makers, as well as eight non-profit organizations, to accelerate the discovery of new therapies for Alzheimer's disease, type 2 diabetes, rheumatoid arthritis, and lupus. Under the collaboration, termed the Accelerating Medicines Partnership (AMP), the companies and the NIH have agreed to contribute scientists, along with relevant data and samples from clinical trials, and to share costs. The goal is to transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets of disease.
Last week, the Lupus Foundation of America and the Rheumatology Research Foundation, two of the non-profit organizations working together in AMP, convened on Capitol Hill to update Congress about the AMP project and to discuss how Congress can support biomedical innovation. Ticker Report covered the event.
Sandra C. Raymond, President and CEO of the Lupus Foundation stated that her organization is "pleased to be working together with the Rheumatology Research Foundation to educate members of Congress and their staff about the importance of making biomedical research and innovation of autoimmune diseases, like lupus, a priority on the nation’s health agenda.” Currently, there is no cure for lupus, and only one drug has been approved by the FDA that was designed specifically to treat the disease.
“While we have seen great progress over the past decade, we still have much work to do to find the next breakthrough that will improve the care and quality of life for people with lupus," states Raymond. "With the support of Congress and all of our partners, we believe the AMP initiative will ultimately lead to a new understanding of the underlying causes of lupus along with new therapies for this devastating disease.” (Ticker Report)
“Without sufficient funding from public and private sources, research efforts into the causes of lupus and the discovery of new treatments will be delayed, and the search for a cure will be seriously impaired,” adds Raymond. “We took to Capitol Hill today to urge Congress to make biomedical research and innovation for lupus, the prototypical autoimmune disease, a priority. We need Congress to invest and fund biomedical research at the NIH and throughout the federal government. This robust funding is vital to moving lupus research forward.”
President Obama also previously weighed in on AMP, noting the usefulness of public-private partnerships:
“Today, my Administration is taking action to accelerate the development of life-saving drugs and to help identify new treatments and cures for diseases like Alzheimer's and diabetes. This new public-private partnership – the Accelerating Medicine Partnership – combines the considerable resources of America's government with the innovation of our private sector companies in an effort to find new answers to today's domestic and global public health challenges.”
GSK and NIH Collaboration for Ebola Vaccine
NIH recently announced that "initial human testing of an investigational vaccine to prevent Ebola virus disease will begin next week by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
PDUFA and accelerating patient access
As published by the Campaign for Modern Medicines (CMM), although AMP is a new initiative, it is not the only effort to accelerate patient access to breakthrough medicines.
CMM notes: The fifth iteration of the Prescription Drug User Fee Act (PDUFA V), which went into effect in 2011, highlights another way the U.S. has been committed to bringing new medicines to patients faster through collaboration. This latest version of PDUFA includes an enhanced risk/benefit analysis that gives those living with a disease an unprecedented opportunity to have a voice in the FDA review process. "We must consider how patients view the benefits and risks of new medicines," stated moderator Kay Holcombe, Senior Vice President of Science Policy at BIO.
Lessons from collaboration
CMM continues: So what lesson can we learn from initiatives like AMP and policies like PDUFA? It's simple: collaboration is key to speeding new medicines to patients in need. Collaboration stretches beyond the laboratory, where sharing data can make developing new medicines more streamlined and efficient. it must include the viewpoints of patients, their families, and caregivers, who come face to face with disease every day.