We’ve seen great strides to treat arthritis and related diseases. How do we continue to make headway to improve the lives of patients?

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We’ve seen great strides to treat arthritis and related diseases. How do we continue to make headway to improve the lives of patients?

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.

Stephen I. Katz
Director, NIAMS

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Stephen I. Katz
Director, NIAMS

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Stephen I. Katz, M.D., Ph.D. has been Director of the National Institute of Arthritis and Musculoskeletal and Skin Diseases since August 1995 and is also a Senior Investigator in the Dermatology Branch of the National Cancer Institute. He was born in New York in 1941 and his early years were spent in the Washington, D.C., and Bethesda, Maryland areas. After attending the University of Maryland, where he graduated with honors, he graduated from the Tulane University Medical School with honors in 1966. He completed a medical internship at Los Angeles County Hospital and did his dermatology residency at the University of Miami Medical Center from 1967 to 1970. He served in the U.S. military at Walter Reed Army Medical Center from 1970 to 1972. From 1972 to1974, Dr. Katz did a postdoctoral fellowship at the Royal College of Surgeons of England and obtained a Ph.D. degree in immunology from the University of London in 1974. He then became Senior Investigator in the Dermatology Branch of the National Cancer Institute and assumed the position of Acting Chief in 1977. In 1980, he became Chief of the Branch, a position he held until 2002. In 1989, Dr. Katz also assumed the position of Marion B. Sulzberger Professor of Dermatology at the Uniformed Services University of the Health Sciences in Bethesda, Maryland, a position that he held until 1995. 
 
Dr. Katz has focused his studies on immunology and the skin. His research has demonstrated that skin is an important component of the immune system both in its normal function and as a target in immunologically-mediated disease. In addition to studying Langerhans cells and epidermally-derived cytokines, Dr. Katz and his colleagues have added considerable new knowledge about inherited and acquired blistering skin diseases. 
 
Dr. Katz has trained a large number of outstanding immunodermatologists in the U.S., Japan, Korea, and Europe. Many of these individuals are now leading their own high-quality, independent research programs. He has served many professional societies in leadership positions including as a member of the Board of Directors and President of the Society for Investigative Dermatology; on the Board of the Association of Professors of Dermatology; as Secretary-General of the 18th World Congress of Dermatology in New York in 1992; as Secretary-Treasurer of the Clinical Immunology Society; and as President of both the International League of Dermatological Societies and the International Committee of Dermatology. Dr. Katz has also served on the editorial boards of a number of clinical and investigative dermatology journals, as well as several immunology journals. He has received many honors and awards, including the Master Dermatologist Award and the Sulzberger Lecture Award of the American Academy of Dermatology; the National Cancer Institute’s Outstanding Mentor Award; the Harvey J. Bullock, Jr., EEO Award in recognition of his extraordinary leadership in scientific, programmatic, and administrative arenas; the Excellence in Leadership Award from the Intl. Pemphigus Foundation; the "Change It" Champion Award from Parent Project Muscular Dystrophy; the Paul G. Rogers Leadership Award from the National Osteoporosis Foundation; honorary membership in the American Academy of Dermatology and the Society for Investigative Dermatology, as well as numerous international dermatological societies; and election into the Institute of Medicine of the National Academy of Sciences (USA). He has also received the Alfred Marchionini Gold Medal; the Lifetime Achievement Award of the American Skin Association; Doctor Honoris Causa Degrees from Semmelweis University in Budapest, Hungary, Ludwig Maximilian University in Munich, Germany, and the University of Athens in Greece. He also received the Rothman Award for distinguished service to investigative cutaneous medicine and the Kligman/Frost Award, both from the Society for Investigative Dermatology. Dr. Katz has been honored by the Japan government from which he received the Order of the Rising Sun, Gold Rays with Neck Ribbon from the Japanese Emperor. Dr. Katz has twice received the Meritorious Rank Award and has also received the Distinguished Executive Presidential Rank Award, the highest honor that can be bestowed upon a civil servant. Dr. Katz received the following awards in 2013/14: Austrian Society for Dermatology & Venereology Gold Medal Award, November 2013, American Society of Bone and Mineral Research Distinguished Leader Award, Oct. 2013; Women’s Dermatologic Society The Walter B. Shelly MD Leadership Award, March 2014; Dermatology Foundation Lifetime Career Educator Award, March 2014; and the American Skin Association Leadership Academic Medicine Award, April 2014. 
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We’ve seen great strides to treat arthritis and related diseases. How do we continue to make headway to improve the lives of patients?

For almost 70 years, the Arthritis Foundation has initiated and supported scientific discoveries that improve health outcomes for people with arthritis. Research holds the key to finding better diagnostics and treatments—and one day a cure—for more than 50 million Americans who face the daily challenges of arthritis. At the Foundation, we are focused on providing scientific leadership and direction to improve everyday life for people with arthritis and to find a cure.
 
Information from the Medicines in Development report issued by the Pharmaceutical Research Manufacturers of America (PhRMA), about medicines that are in clinical trials or under review by the Food and Drug Administration, is a welcome sign for people with arthritis who are looking for relief.
 
The Arthritis Foundation is also proud to be part of the Accelerating Medicines Partnership (AMP), a groundbreaking partnership between the National Institutes of Health, several nonprofit disease foundations, 10 biopharmaceutical companies and PhRMA, which began this year. The initiative will start with three- to five-year pilot projects focused on the autoimmune diseases, such as rheumatoid arthritis (RA) and lupus. 
 
For everyone affected by arthritis and musculoskeletal diseases, the medicines in development are offering hope and direct opportunities to new treatments previously unavailable. With greater awareness, faster approvals by the FDA of new medications and continued research and development of new medications, people with arthritis will be on the receiving end of better and healthier lives.
 

Amanda Niskar
National Scientific Director, Arthritis Foundation

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Amanda Niskar
National Scientific Director, Arthritis Foundation

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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.”

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We’ve seen great strides to treat arthritis and related diseases. How do we continue to make headway to improve the lives of patients?

Like PhRMA, improving the lives of people with arthritis is one of the cornerstones of the mission of the Arthritis Foundation.
 
The Foundation achieves this mission in several ways including help and support for people with arthritis, advocacy and access to critical medications, and research. Every day thousands of individuals with arthritis seek answers to a myriad of questions about this chronic, debilitating and incurable disease.
 
And they will seek those answers tomorrow, next week, next month and next year and beyond. As a 24/7 resource, the Arthritis Foundation is ready to provide answers.
 
In response to PhRMA report – Medicines in Development: Arthritis – we reached out to some Arthritis Foundation advocates to get their response to this question about how PhRMA can continue to be a leader in improving the lives of patients. 
 
One of these advocates tells us that “early recognition of the disease and early treatment are keys to improving the lives of patients with arthritis and related diseases… We need to continue to advocate for more rheumatologists and health care providers trained in rheumatology and affordable access to treatments such as biologics (drugs),” said Pat M. - Loveland, OH.
 
Years ago arthritis treatments reduced joint inflammation but not disease progression that could ultimately lead to disability. Today disease-modifying anti-rheumatic drugs (DMARDs) are enabling disease remission.
 
And the future seems brighter.
 
With the biopharmaceutical research companies engaged in the development of 92 medicines to help the millions of Americans affected by arthritis, an improved quality of life is within reach.
 
We know 155 active clinical trials are underway in the United States. Nearly two-thirds of those trials have not yet started to recruit patients or have just begun to seek volunteers to participate.  And 58 trials are on-going but not recruiting new patients.
 
“The lives of patients with arthritis and related diseases will continue to improve with the ongoing research for a cure…development of new treatments provides children (with juvenile arthritis) and their families with many more options to find that course of treatment to which the patient responds and that will lead to remission and, hopefully, one day, an ultimate cure…,” said advocate Megan F. - Hudson, OH.
 
As the Foundation embarks on this project with PhRMA it keeps top of mind that raising the volume on the national discussion about arthritis remains critical in efforts to improve lives and keep people in the workforce.  “We continue to make headway in improving the lives of people with arthritis by speaking out about this disease and letting people know how it affects not only adults, but children. If we prevent, diagnose and treat early, people with arthritis can lead productive lives,” advocate Amy B. of Cincinnati, OH, said.
 
“For those of us suffering today, we need options for managing the pain and stopping the progression of the disease so that we can remain contributing members of our society and not a drain on the system,” said advocate Cheryl S. - Louisville, KY. 
 
These advocates have observed amazing strides in the diagnosis and treatment of arthritis. They speak for so many when they say that it is their hope that the medicines in development for gout, juvenile arthritis, osteoarthritis, psoriatic arthritis, rheumatoid arthritis and spondylitis included in the PhRMA report will pave the way for a cure.  
 
We are working tirelessly toward that end.
 

Christopher F. Smith
CEO, Arthritis Foundation, GLR

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Christopher F. Smith
CEO, Arthritis Foundation, GLR

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Christopher Smith was appointed Chief Executive Officer of the Arthritis Foundation’s newly-formed Great Lakes Region in December, 2010.  The Region - one of 10 in the country – is comprised of six former Chapters covering five states.  They are:  Michigan, Ohio, Kentucky Pennsylvania & West Virginia. Today the Great Lakes Region carries out the mission of the Arthritis Foundation by advocating for people who have arthritis, offering programs and services that improve the lives of millions of people of all ages diagnosed with arthritis as well as investing in cutting-edge research.  The Arthritis Foundation is the leading nationwide, non-profit health organization committed to helping people take greater control of arthritis. The Great Lakes Region is an $11 million organization with 59 employees.  
 
This is the second time that Mr. Smith has been employed by the Arthritis Foundation having served as President (Executive Director) for the former Delaware Chapter from 1991-1994. Having built his career in non-profit management, Mr. Smith is in his 30th year working for volunteer health agencies.  Beginning as a field representative for the American Cancer Society in Massachusetts, Mr. Smith quickly moved to senior positions for ACS in North Carolina;  the Arthritis Foundation in Delaware; the American Diabetes Associations in New York and in the Northeast;  and Special Olympics in New York before assuming the duties of Great Lakes Region CEO in 2010.
 
As CEO, Mr. Smith serves on the Executive Cabinet for the national Arthritis Foundation with shared responsibility for setting policy, creating strategies and making recommendations on how best to carry out the strategic plan for the Foundation.  He is the cabinet representative on the national Research Advisory Committee and has served on the national Budget & Finance Committee as well as served on multiple task forces and committees related to fund development, operations and technology.
 
A 1982 graduate of Northeastern University with a Bachelor of Science in Criminal Justice, Mr. Smith received his Master’s in Business Administration from Elon College, now Elon University in 1991.  Married with three children and two grandchildren, Chris is married to Dale Scalise-Smith, PhD, Vice President for On-Line Learning & External Partners at Utica College in Upstate New York.
 
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We’ve seen great strides to treat arthritis and related diseases. How do we continue to make headway to improve the lives of patients?

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
AVP, Scientific Affairs , PhRMA

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Gabriela Lavezzari
AVP, Scientific Affairs , PhRMA

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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 few 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 his experience in the industry, Dr. Lavezzari spent almost 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).

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We’ve seen great strides to treat arthritis and related diseases. How do we continue to make headway to improve the lives of patients?

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:

  • Decreasing the average time of diagnosis of psoriatic arthritis from four years to one year;
  • Helping people with PsA better manage their disease;
  • Reducing barriers to health care and treatments;
  • Improving understanding of PsA symptoms, disease management and impact on patient quality of life among health care providers. 

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.

NPF
Partner, Arthritis Contributor

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NPF
Partner, Arthritis Contributor

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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

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