At AbbVie, research and innovation are the cornerstones of our business as a global biopharmaceutical company. We focus on developing medicines that deliver strong clinical performance, provide more patient benefit and deliver economic value, particularly where there is significant need around the world in certain disease areas.
Arthritis is an example of a disease where we have the opportunity to continue to make headway to improve the lives of patients. According to the U.S. Centers for Disease Control and Prevention (CDC) prevalence of musculoskeletal diseases could increase from 52 million people in the U.S. to 67 million by 2030 if current trends continue.1
As an expert in autoimmune diseases and therapies, we are focused on developing new medicines to address chronic progressive diseases in the field of immunology. We are investigating several diseases which have few or no treatments, including osteoarthritis and lupus, and we are progressing next-generation therapies in rheumatoid arthritis with the objective to improve patient care.
Our understanding of the pathophysiology of arthritis and related diseases is allowing us to explore new approaches. We currently have five compounds in Phase 2 clinical development for rheumatoid arthritis. We recognize the importance of public-private partnerships in building our understanding of the pathophysiology of the disease and ensuring that development of therapies is focused on the needs of patients first and foremost. We are very pleased to have joined forces with the National Institute of Health and others to advance our understanding of the disease and explore a potentially new generation of approaches.
Our scientists understand that the patient is waiting and that they have the opportunity to discover and develop solutions that may improve the lives of patients living with rheumatoid arthritis and other autoimmune diseases. That’s why we continue to use our expertise in immunology to drive for more and better solutions. Our mission is to make a significant impact and improve the lives of the patients we serve.
1 Arthritis Foundation, www.arthritis.org
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.
To improve the lives of people with arthritis, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is working toward a better understanding of the basic biology of diseases affecting the joints, better diagnosis and treatment of arthritis, and better tools to facilitate clinical trials.
NIAMS was a key contributor to the development of tofacitinib, the first oral disease modifying antirheumatic drug (DMARD) for rheumatoid arthritis (RA) in a decade, which recently received approval from the U.S. Food and Drug Administration. In the early 1990’s, NIAMS intramural researchers discovered Janus kinase 3, one member of the Janus kinases (JAKs) family of proteins, which are important in regulating the human immune system. This discovery, in concert with other studies, led to the idea that drugs blocking JAKs would suppress the immune system. A public-private collaboration between NIH and Pfizer led to the development of tofacitinib and, importantly, a new class of drugs, the JAK inhibitors. Continued exploration of basic biology in health and disease will be necessary to identify new targets for intervention.
In addition to continued basic research, new methods to diagnose and treat individuals who have, or are at risk of developing, arthritis are needed. NIAMS is participating in both the NIH Accelerating Medicines Partnership (AMP) and the Foundation for the NIH’s Biomarkers Consortium. The AMP aims to develop models for identifying and validating promising biological targets for new diagnostics and drug development. One of the first AMP pilot projects will focus on autoimmune disease; in particular, rheumatoid arthritis and lupus. The Biomarkers Consortium endeavors to discover, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics. The Osteoarthritis Biomarkers Project seeks to evaluate multiple biochemical and imaging biomarkers in hopes of finding more precise ways to measure the progression of the disease and, potentially, the effectiveness of new treatments. Using the data generated by both partnerships, researchers will be able to identify biological targets most likely to interfere with disease processes. In addition, clinicians will be able to more specifically diagnose a patient’s condition, and personalize his or her treatment plan based on individual disease signature.
Arthritis begins before joint damage and pain become evident. One barrier to the development of drugs that block the underlying causes is the lack of objective and measurable standards by which to evaluate disease progression. To overcome this problem, the NIH partnered with private sponsors to create the Osteoarthritis Initiative (OAI). When complete, the OAI will provide an unparalleled state-of-the-art research resource to illuminate the natural progression of the disease, and provide information on risk factors, joint changes, and outcome measures. In addition, NIAMS has led the development of patient-reported outcomes tools through the Patient Reported Outcomes Measurement Information System (PROMIS). PROMIS measures can be used as primary or secondary endpoints in clinical studies examining the effectiveness of treatment. In addition, PROMIS tools can be used across a wide variety of chronic diseases and conditions in the general population. Through the use of these tools and others, researchers will be able to design better clinical trials of shorter duration with more specific clinical endpoints, and potentially target them to populations who would most benefit.
NIAMS is committed to working with the scientific and patient communities to expand upon recent successes in arthritic diseases. Through basic research, development of better diagnostics and treatments, and new tools for clinical research, we are poised to continue making great strides in improving outcomes for the millions of individuals affected by arthritis.
Amanda Niskar, DrPH, MPH, BSN, combines her experience in nursing, epidemiology and health policy to successfully bring together crosscutting leaders to make important decisions that turn discoveries into actionable, high-impact programs. She supervises all aspects of the Arthritis Foundation’s scientific program. Amanda is an accomplished author and has received many honors, including international recognition, for research measuring the impact of arthritis on health and well-being. Her accomplishments span the globe, encompassing renowned places such as the Office of the U.S. Secretary of Health, Tel Aviv University and Deloitte Consulting. Amanda’s goal: “I want to take the science off the shelf and translate it into high-impact results that make a positive difference for people with arthritis. This is an amazing opportunity to make a huge difference in their lives.”
Many people are unaware of the impact of arthritis and related musculoskeletal diseases in the United States. They affect approximately 52.5 million Americans of all ages, races and genders.
The biopharmaceutical industry is making great strides towards new treatments with 92 medicines in the pipeline which have the potential to help patients live more active and productive lives. Work on these treatments is more imperative than ever as 67 million people could be diagnosed with some form of musculoskeletal disease by 2030, according to the U.S. Centers for Disease Control and Prevention.
Earlier this year, PhRMA joined 10 biopharmaceutical companies, the National Institutes of Health and several non-profit disease foundations to form the Accelerating Medicines Partnership (AMP). The goal of AMP is to increase the number of new diagnostics and treatments available to patients while decreasing the time and cost of developing them. One of the three initial pilot programs focuses on identifying and validating biological targets of the autoimmune disorders of rheumatoid arthritis (RA) and systemic lupus erythematosus.
Biopharmaceutical researchers are working to developing new RA treatments for the 1.5 million Americans affected by this debilitating disease, as demonstrated by the 55 medicines in the pipeline. It is essential that patients have access to new therapies as they become available. Unfortunately, patients with new health insurance exchange coverage may face high out-of-pocket costs for needed medicines. As a result, patients may choose to cut back on treatment or forego their medicines altogether. RA patients deserve a chance at remission, but the burden of high out-of-pocket costs in the exchange plans may jeopardize that chance.
Looking to the future, continued research and development of innovative new treatments is critical to improve the quality of life for the millions of Americans with arthritis and related musculoskeletal diseases. Public-private partnerships such as AMP that draw upon combined resources and knowledge have the potential speed the development of new treatments for the patients who need them.
Gabriela Lavezzari, Ph.D., M.B.A. joined PhRMA in July 2012 as Assistant Vice President, Scientific Affairs. In this role, Dr. Lavezzari is the primary staff lead for a variety of strategic initiatives aimed at establishing PhRMA as a valuable source of scientific expertise in innovative biopharmaceutical research and development within the Scientific & Regulatory Affairs (S&RA) division of PhRMA. Dr. Lavezzari brings to PhRMA over ten years of combined research experience in the government and industry, with multi-disciplinary expertise in Personalized Medicine and Regulatory Science.
Prior to joining PhRMA, Dr. Lavezzari served as Director Extramural Development at the Medco Research Institute, a subsidiary of Medco Health Solutions, where she led clinical utility and cost-effectiveness research to create value-based reimbursement decisions for a variety of diagnostics products across different therapeutic areas. Prior to Medco, Dr. Lavezzari spent two years at Theranostics Health, a proteomic-based diagnostics company where she led the laboratory operations and the oncology product development. Prior to Theranostics, Dr. Lavezzari worked at Social Scientific Systems where she provided scientific support to and managed multiple Adult Clinical Trial Group (HIV/AIDS), laboratory science, laboratory technical and specialty laboratory committees, subcommittees and working groups.
In addition to her experience in the industry, Dr. Lavezzari spent almost five years in research at the National Institutes of Health (NIH), National Institute of Neurological Disorder and Stroke (NINDS) and at Georgetown University, where she completed her post-doctoral training in Neuroscience.
Dr. Lavezzari received her PhD in Biological Sciences from University of Milano (Italy), and has received her MBA from the New York Institute of Technology (NYIT, NY).
Millions of Americans with psoriatic arthritis—a serious disease that causes pain, swelling and stiffness of the joints and tendons, and can result in joint damage if left untreated—struggle to get the health care and treatments they need to manage their condition. National Psoriasis Foundation plans to change with the largest realignment and expansion of its psoriatic arthritis program.
For nearly two decades, the Psoriasis Foundation has provided disease-management services and information to people with psoriatic arthritis (PsA), which affects as many as one in three people with psoriasis, the most common autoimmune disease in the country. In 2012, an estimated 75,000 people with PsA accessed the Psoriasis Foundation for information and services.
Despite sharing similarities with rheumatoid arthritis—including painful symptoms and disease prevalence of approximately 1 million people—there are significantly fewer resources for people with psoriatic arthritis than for those with rheumatoid arthritis. People with psoriatic arthritis require more!
To address these disparities, the National Psoriasis Foundation PsA Project will focus on four areas:
The design committee, comprised of key medical experts in rheumatology and dermatology, psoriatic arthritis researchers and patients, will guide the organization in accomplishing its aggressive goals to better serve its community of people with psoriatic arthritis.
To learn more and support the National Psoriasis Foundation PsA Project, visit www.psoriasis.org/PsAProject.
Learn more about psoriatic arthritis at www.psoriasis.org/about-psoriatic-arthritis.
The mission of the National Psoriasis Foundation (NPF) is to drive efforts to cure psoriatic disease and improve the lives of those affected. National Psoriasis Foundation provides people with psoriasis—the most common autoimmune disease in the country, affecting up to 7.5 million Americans—and psoriatic arthritis—a chronic, inflammatory arthritis affecting up to 30 percent of people with psoriasis—the services they need to best manage their condition, while promoting research to find a cure. In addition to serving more than 2.1 million people annually through our patient and professional education and advocacy initiatives, NPF has funded more than $10 million in psoriatic disease research grants and fellowships. Learn more at www.psoriasis.org.