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What are expectations that can come from the Accelerating Medicines Partnership?

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What are expectations that can come from the Accelerating Medicines Partnership?

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What are expectations that can come from the Accelerating Medicines Partnership?

Autoimmune diseases affect 50 million Americans and are a leading cause of death and disability — yet we have no cure. Historically, the first goal of treatment is to reduce inflammation focusing on making quality of life as good as possible. However, more needs to be done on greater research options for all autoimmune disease-related patients. In existing research, 80-100 different autoimmune diseases have been identified and researchers suspect at least 40 additional diseases of having an autoimmune basis. These diseases are chronic and can be life-threatening.

The American Autoimmune Related Diseases Association (AARDA) is excited about the newly announced partnership between NIH, 10 biopharmaceutical companies, numerous non-profits and PhRMA to create the Accelerating Medicines Partnership (AMP). The goals of the AMP are a small victory for champions of increased research and hopefully treatment options, as well as reducing the time to develop these new methods for patients suffering from all types of autoimmune diseases.

With additional research, discovery, and collaboration to take place under AMP, patients of rare autoimmune diseases could see new found hope – and everyone can agree that’s a good thing.

The AMP will begin with three to five year pilot projects including the autoimmune disorders of rheumatoid arthritis and systemic lupus erythematosus (lupus) as well as Alzheimer’s disease and type 2 diabetes. Research conducted could ultimately lead towards greater findings for other autoimmune diseases, and provide a pathway to life-saving medicines down the road.

While an autoimmune disease can affect anyone, women disproportionately bear the brunt of the disease 75 percent of the time or three times more than men. Further, because autoimmune disease research has been scattered there tends to be a lack of general focus on autoimmunity as an underlying cause of a disease.

The AMP partnership could mean hope for new treatments and save countless lives by the sharing of research and data — a hopeful sign on top of other recent actions. The Prescription Drug User Fee Act (PDUFA) that President Obama signed into law in 2012 continued FDA programs while also creating new ones aimed at facilitating the review and approval of life-saving drugs.

While there is no cure for autoimmune diseases the collaborative AMP partnership is an important marker and offers new found optimism towards combatting these diseases.

Virginia T. Ladd
President , AARDA

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Virginia T. Ladd
President , AARDA

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Virginia T. Ladd, R.T. – Virginia Ladd is the President and Executive Director of the American Autoimmune Related Diseases Association, Inc. (AARDA), an organization that she founded to bring a national focus to autoimmunity and increase collaboration in autoimmune research, education, awareness, and advocacy. She has been involved in the nonprofit community for over 30 years as a patient advocate and educator. Mrs. Ladd served as president and executive director of the Lupus Foundation of America.

Mrs. Ladd was instrumental in the formation of the International Alliance of Patients’ Organizations (IAPO), an alliance dedicated to advocacy for patient centered health care, and is an immediate past member of its board of governors. She has served as a member of the board of directors for the UN NGO Health Committee and is a past member of the board of directors of the National Health Council. She is the founder and facilitator for the National Coalition of Autoimmune Patient Groups (NCAPG), an organization of 33 national autoimmune disease-specific groups.

She was the first non-researcher to be awarded the “AESKU.AWARD for Life Contribution to Autoimmunity,” which was presented to her at the 7th International Congress on Autoimmunity,” in Ljubljana, Slovenia.  She is also the recipient of the prestigious Heritage Award of the Johns Hopkins University Alumni Association.

She has spoken literally all over the world at workshops, meetings and international conferences  and spoke on “Women and Autoimmune Diseases: Gender and Biological Peespective" as part of the UN Commission on the Status of Women 2000.

Mrs. Ladd serves on several committees of the National Institutes of Health, including the Autoimmune Diseases Coordinating Committee; the Public Interest Committee for the National Institute of Heart, Lung and Blood; the Public Interest Group for the National Institute of Environmental Health Sciences; and the Panel of Experts for the NIH Autoimmune Diseases Research Plan. 

She has written, co-authored and/or published scores of scholarly and consumer articles, reports  and papers on autoimmunity.

 

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What are expectations that can come from the Accelerating Medicines Partnership?

Alzheimer’s disease in the United States is the sixth leading cause of death with more than five million Americans currently struggling with it on a daily basis. Alzheimer’s also represents an area of treatment which has largely failed to materialize. One recent report noted that, “Since 1998, there have been more than 100 attempts to develop a treatment, and all have failed.” Existing treatment options for patients have eased symptoms for a few months, but the disease continues its progression, robbing the memories of its victims. Unfortunately, despite ongoing efforts on the part of industry and the public sector alike, Alzheimer’s also lacks any cure.

The recently announced Accelerating Medicines Partnership (AMP) represents a new approach to biopharmaceutical research, discovery, and collaboration. GlaxoSmithKline (GSK) largely exited the neurodegenerative ailments space several years ago, not because we weren’t interested in it, but because diseases such as Alzheimer’s are too complex to be solved by any one organization. The AMP, however, allows GSK and public and private sector partners to join forces as a team to combat this. Alzheimer’s is one of three disease areas the AMP will research under the five year pilot program.

For GSK, joining the AMP simply made sense.

Ultimately, we hope that the research and discovery the AMP provides will lead to new and better treatment options. The urgency cannot be understated: along with the immeasurable human suffering and societal implications, the economic impact is significant. According to the Alzheimer’s Association, “In 2013, the direct costs of caring for those with Alzheimer’s to American society will total an estimated $203 billion.”

We are excited about the potential of this partnership to help elevate our collective efforts. The AMP’s stated goal to “increase the number of new diagnostics and therapies for patients and reduce the time and cost of developing them” is a highly worthy one, consistent with our mission of serving patients and discovering new treatments that improve and save lives. We look forward to future discussions that move us all closer to this shared goal.

Lon Cardon
SVP, Alternative Discovery & Development, GlaxoSmithKline

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Lon Cardon
SVP, Alternative Discovery & Development, GlaxoSmithKline

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Dr. Lon Cardon joined GlaxoSmithKline in 2008, initially as Head of Genetics and now as current position as Head of Alternative Discovery and Development, a pan-therapeutic division focused on non-traditional approaches for drug discovery and development. The unit takes on new diseases for GSK, such as ophthalmology and rare diseases, new modalities including gene therapy, stem cells and oligonucleotides, and bespoke academic and biotechnology partnership models. Prior to joining GSK, Lon was a senior academic in the UK and USA, as Professor of Bioinformatics at the University of Oxford until 2006 and then as Professor of Biostatistics at the University of Washington and Fred Hutchinson Cancer Research Center in Seattle. He received his PhD training from the Institute for Behavioral Genetics at the University of Colorado and conducted his postdoctoral research in the Department of Mathematics at Stanford University. He has received a number of scientific awards, including election to the UK’s Academy of Medical Sciences in 2005. He has authored more than 200 scientific publications and 15 books and chapters.

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What are expectations that can come from the Accelerating Medicines Partnership?

It has been said that all boats rise with the tide.

That’s the analogy that comes to mind when thinking about the potential of the Accelerating Medicines Partnership (AMP). By bringing together stakeholders from the National Institutes of Health (NIH), biopharmaceutical companies and several non-profit organizations, AMP is a great opportunity for all of us to join together and develop a broad-based understanding about some of the chronic conditions facing patients today. Sanofi is excited to be participating in two of the AMP focus areas: type 2 diabetes and rheumatoid arthritis/lupus.

It may seem counterintuitive for 10 biopharmaceutical companies who usually are in competition to join forces for an effort such as AMP. But one of the major barriers we all have encountered in pursuit of developing better treatments – or even cures – for diabetes, lupus and rheumatoid arthritis is that very little is understood about these conditions.

The puzzle is too big for any one organization to solve. By joining forces in this public-private partnership, the AMP will combine the resources, brainpower and knowledge necessary to start the process of understanding these conditions and how to treat them. Only then will we as a healthcare community reach the point where innovative new medicines are a realistic possibility.

Scientific advancements rely on experimentation – testing, seeing results and learning from them. In large part, the AMP is an experiment in and of itself. Whether or not there is a breakthrough in the illnesses the AMP is targeting, this new research and discovery formula is laying the groundwork for next-generation therapies and the possibility for cures. 

Dr. Gary J. Nabel
Chief Scientific Officer, Sanofi

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Dr. Gary J. Nabel
Chief Scientific Officer, Sanofi

Dr. Nabel has an extensive and distinguished background of academic and hospital appointments, and committee memberships including numerous prestigious awards and honors and an extensive publication record. He graduated magna cum laude from Harvard College in 1975 and continued his graduate studies at Harvard University, completing his Ph.D. in 1980 and his M.D. in 1982. He served as a postdoctoral fellow in the laboratory of David Baltimore at MIT’s Whitehead Institute. Before his appointment at the Vaccine Research Center, Dr. Nabel served as the Henry Sewall Professor of Internal Medicine, Professor of Biochemistry, and Howard Hughes Medical Institute Investigator at the University of Michigan in Ann Arbor. In addition to his faculty positions, Dr. Nabel also served as the Director of the Center for Gene Therapy and co-director of the Center for Molecular Medicine at the

University of Michigan. In recognition of his expertise at the forefront of virology, immunology, gene therapy, and molecular biology, Dr. Nabel was elected as a member of the Institute of Medicine of the National Academy of Sciences in 1998.

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What are expectations that can come from the Accelerating Medicines Partnership?

It's often said that baseball players have to generate 4 hits out of every 10 at-bats to be considered a Hall of Fame-caliber player.  Meteorologists are criticized for inaccurate forecasts more often than not.  But think about the drug development business: only one in every 5,000 to 10,000 compounds in drug discovery will make it through regulatory approval and even treatments that reach clinical trials only have a 16% chance of approval. (Source: Tufts Center for the Study of Drug Development. "Large Pharma Success Rate for Drugs Entering Clinical Trials in 1993-2004: 16%." Impact Report 2009; innovation.org)

What if a baseball player was able to identify a technique that would improve his batting average?  Of if the weather person had a tool that would improve forecasting accuracy? The goal of the Accelerated Medicines Partnership (AMP) is to develop a greater understanding of the molecular pathways underlying complex chronic diseases and identify and validate biomarkers to accelerate the development of effective therapies in Alzheimer's and autoimmune diseases and type 2 diabetes. AMP is, in effect, the tool that has the potential to help us improve the industry's "batting average". 

The pharmaceutical industry spends billions annually on research and development.  The ability to improve our success rate and productivity will have a exponential impact on our resources to devote to further research. Every delay or research setback represents a cost - both financial and non-financial - to the healthcare system, patients and their loved ones and caregivers.

AbbVie is proud to collaborate with our peers and the National Institutes of Health to share our collective knowledge and expertise in Alzheimer's and autoimmune diseases.  Together, we can uncover new insight into these areas of significant and growing medical need and improve the success of drug development around the world, ultimately accelerating the delivery of necessary treatments to patients.

James P. Sullivan, Ph.D.
VP, Pharmaceuticals Discovery, AbbVie

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James P. Sullivan, Ph.D.
VP, Pharmaceuticals Discovery, AbbVie

James Sullivan, Ph.D., is Vice President, Pharmaceuticals Discovery. In this role, he is responsible for AbbVie’s research efforts in a variety of diseases including cancer, Alzheimer’s disease, hepatitis C, renal disease, and arthritis. He oversees a global network of scientists that includes AbbVie researchers at sites in the United States, Europe, and China, and external research partners around the world. Dr. Sullivan is a member of the Pharmaceutical Executive Committee and is chair of the Scientific Governing Board for Abbvie. He is also an executive sponsor for the AbbVie Women in Science organization. Jim joined Abbott in 1991 and has held various positions in the discovery organization including leadership positions in CNS and pain research.

Jim has advanced more than 60 compounds into clinical development, has more than 130 scientific publications and is an inventor on 11 patents. He is an adjunct faculty member at Northwestern University of Chicago. He earned his bachelor's degree and Ph.D. in biochemistry from Trinity College in Dublin, Ireland, and conducted post-doctoral research in neurobiology at Northwestern University.

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What are expectations that can come from the Accelerating Medicines Partnership?

We believe this initiative will ultimately lead to new understanding of the underlying causes of lupus along with new therapies for this disease and ultimately an improved quality of life for people living with lupus. For us it is all about the patient!

Lupus is  complex and is arguably the most clinically diverse of all autoimmune diseases. Because of this, the scope of the Accelerating Medicines Partnership (AMP)  is tailor made for a collaborative effort among the NIH, industry, academic medical research centers and non profit organization.

Lupus was selected for this project because of the lack of effective targeted therapies for the most severe forms of the disease, such as when lupus affects the kidneys or the central nervous system. We at the Lupus Foundation of America know that in order to unlock the mysteries of lupus, collaboration is key to progress. In 2009, the Lupus Foundation of America commissioned a first-of-its-kind report to detail obstacles and provide a roadmap to speed development of new safe, effective and more tolerable treatments for lupus.  The report, authored by the respected health policy research organization The Lewin Group, called for organizing a new coordinated national effort to overcome the barriers that exist which have made developing safe, more tolerable and less toxic treatment options for people with lupus so difficult.  The report recommended that the scientific community and NIH collaborate on a research agenda to provide a clear pathway to drug development in lupus.

Now more than ever, we must bring stakeholders together to focus our energies and efforts on scientific areas that will accelerate the pace of lupus research.  We believe this initiative will ultimately lead to new understanding of the underlying causes of lupus along with new therapies for this devastating disease.

Leslie Hanrahan
VP, Education & Research, Lupus Foundation

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Leslie Hanrahan
VP, Education & Research, Lupus Foundation

Leslie Hanrahan has over 22 years’ experience in health communications, education and research programming.

Since 2005, Ms. Hanrahan has led the strategic development and growth of the Education and Research Department of the Lupus Foundation of America (LFA).  The Lupus Foundation of America is the only national force devoted to solving the mystery of lupus, one of the world’s cruelest, most unpredictable and devastating diseases, while giving caring support to those who suffer from its brutal impact.  Prior to joining the LFA, Ms. Hanrahan held the position of Vice President of Account Services for Spotlight Health, Inc., a health communications firm in Great Falls, Virginia.  From 2001-2004 Ms. Hanrahan held the position of Vice President at MMG, a health communications company in Rockville, MD that specializes in developing and implementing patient recruitment programs for clinical trials.  In this and in former positions at health communications agencies in New York City, Ms. Hanrahan developed and executed innovative health education programs and disease awareness programs for national and international pharmaceutical, biotechnology, medical device development companies, and non-profit organizations. 

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