EMPOWERING THE RARE DISEASE COMMUNITY CONNECT VOICE RESEARCH INNOVATE
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1 EMPOWERING THE RARE DISEASE COMMUNITY CONNECT VOICE RESEARCH INNOVATE
2 OCTOBER 2012 A report to our costituets
3 NORD is the recogized atioal leader drivig progress o behalf of the etire rare disease commuity. It provides a uified voice for patiets ad other stakeholders, promotes research ad state-of-the-art regulatory practices, educates medical professioals to ecourage earlier diagosis ad appropriate treatmet, ad raises public awareess of the challeges experieced by patiets ad their families. Established by patiet advocates who led the campaig for the Orpha Drug Act i 1983, NORD is a oprofit orgaizatio represetig: Everyoe who lives with a rare disease Everyoe who cares about someoe livig with a rare disease Everyoe seekig to improve the lives of people with rare diseases NORD s advocacy iitiatives are based upo the followig visio ad guidig priciples: A atioal awareess ad recogitio of the challeges faced by people livig with rare diseases ad the associated costs to society A atioal commitmet to assurig that people with rare diseases ca secure access to diagostics ad therapies that exted ad improve their lives A social, political, ad fiacial culture of iovatio that supports both the basic ad traslatioal research ecessary to create diagostic tests ad therapies for all rare disorders A regulatory eviromet that ecourages developmet ad timely approval of safe ad effective diagostics ad treatmets for patiets with rare diseases.
4 NORD provides strog ad cosistet leadership i advocacy, awareess, educatio, patiet services, ad research. Specific recet accomplishmets iclude: Leadership ad Patiet Represetatio i Public Policy NORD was istrumetal i developig ad shapig the FDA Safety ad Iovatio Act of Provisios i this law of critical importace to the rare disease commuity will accelerate research o orpha drugs ad medical devices, ecourage implemetatio of iovative regulatory practices, ad improve commuicatio amog all ivolved. A Voice for the Rare Disease Commuity i Federal Agecies NORD works closely with the Natioal Istitutes of Health (NIH), Food ad Drug Admiistratio (FDA), Social Security Admiistratio (SSA) ad other federal agecies to icrease awareess ad uderstadig of the cocers of the rare disease commuity. For istace, NORD provided key iput to FDA about patiet eeds i preparatio for the 2012 reauthorizatio of the Prescriptio Drug User Fee Act (PDUFA). NORD has also assisted SSA with its Compassioate Allowaces Program to assure timely review of applicatios from patiets with extremely disablig diseases. Assurig Patiet Access to Treatmets NORD pioeered the cocept of Patiet Assistace Programs ad, sice 1987, has helped more tha 1.3 millio patiets obtai eeded medicatios. Today, its high-touch, patiet-cetric programs provide a complete suite of services to compaies seekig to streamlie ad stregthe their patiet assistace programs.
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6 Uifyig the Rare Disease Commuity With early 200 member orgaizatios ad a vast umber of additioal parterships ad collaborative relatioships, NORD serves as the hub of the rare disease commuity, uitig patiets, govermet parters, researchers, idustry, ad ivestors i a focused commuity-wide effort to achieve the ed goal we all share improvig the lives of people affected by rare diseases. Global Coectio Through a strategic partership with the Europea Orgaisatio for Rare Diseases (EURORDIS), NORD serves as the U.S. sposor for the aual global Rare Disease Day i February ad hosts olie disease-specific global patiet commuities (RareCoect.org). NORD ad EURORDIS also collaborate o globalizatio of policies, ad ecourage FDA ad the Europea Medicies Agecy to seek ways to elimiate ay uecessary duplicatio of effort. Promotig ad Facilitatig Research NORD parters with other patiet orgaizatios to provide grats for the study of rare diseases. I at least oe case, this has resulted i a FDA-approved product. Numerous articles resultig from NORD-fuded studies have bee published i medical jourals. Through its Corporate Coucil, NORD provides a forum for the discussio of timely topics ad iteractio with federal officials ad thought leaders. I additio, NORD icreases awareess amog patiets of opportuities to participate i cliical trials.
7 NORD s Programs ad Services Empowerig the etire rare disease commuity Patiets ad Families Iformatio about diseases i patiet-friedly laguage Patiet Assistace Programs to help patiets access their medicatios Referrals to patiet orgaizatios ad other helpful resources Regioal disease-specific meetigs for etworkig ad learig Represetatio o Capitol Hill ad i federal agecies Patiet Orgaizatios Global coectio through RareCoect.org hosted by NORD ad EURORDIS Metorig ad sharig of best practices Opportuities to parter i advocacy ad educatio Regioal meetigs to share iformatio ad lear from each other Medical Professioals Educatio ad awareess through a ew olie platform: NORDPhysiciaGuides.org NORD educatioal parterships with professioal medical societies Research grats Research support such as patiet awareess of cliical trials Idustry Collaboratio toward the shared goal of safe, effective treatmets for patiets Participatio i NORD s Corporate Coucil Parterig with NORD i Patiet Assistace Programs Supportig Rare Disease Day ad other commuity-wide iitiatives Govermet Parters Assistace i uderstadig the challeges of livig with a rare disease Opportuities to iteract with, ad lear from, the rare disease patiet commuity Participatio i evets that draw together all rare disease ad orpha product stakeholders
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9 1.5 MILLION PHYSICIAN GUIDES DISTRIBUTED TO MEDICAL PROFESSIONALS BY NORD NORD i partership with EURORDIS for GLOBAL REACH NORD NOW DISTRIBUTES ITS RARE DISEASE PHYSICIAN GUIDES ONLINE REACHING AN UNLIMITED AUDIENCE INDUSTRY I 2009, EURORDIS ad NORD formed a trasatlatic, patiet-drive strategic alliace for rare diseases, to brig patiet advocates from Europe ad the Uited States together to promote rare diseases as a iteratioal public health priority. GOVERNMENT Leadership ad Patiet Represetatio i Public Policy MEDICAL NORD coects patiets with other stakeholder groups RESEARCH Orpha Drug Act of 1983 Rare Diseases Act of 2002 NIH Rare Diseases Cliical Research Network Isurace Reforms i Affordable Care Act SSA Compassioate Allowaces Program Faster Access to Specialized Treatmets Act (FAST) Trasformig the Regulatory Eviromet to Accelerate Access to Treatmets Act (TREAT) Humaitaria Use Device Reforms Expasio of Rare Disease Program at FDA FDA Safety ad Iovatio Act 1.3 MILLION Number of rare disease patiets NORD has helped through patiet assistace programs Documetig FDA Flexibility Implemetatio of ACA ad FDASIA Natioal Pediatric Research Cosortium Risk/Beefit Policy eacted pedig
10 RECENT HIGHLIGHTS MAY More tha 500 members of the rare disease commuity atteded the Aual NORD Parters i Progress Evet o May 15, 2012, where pioeers from research, idustry, ad public policy were hoored. Seator Kay Haga (NC) ad Reps. Cliff Stears (FL) ad Ed Tows (NY) were amog the hoorees. NORD has hosted regioal meetigs for rare disease patiet orgaizatios i Chicago, New York, Sa Fracisco ad Philadelphia i 2011 ad 2012 to ecourage sharig of best practices. MAR of five laguages. FEB With its Europea parter, EURORDIS (Rare Diseases Europe), NORD hosts global olie commuities (www. RareCoect.org) where posts may be traslated ito ay I February 2012, NORD lauched a ew website to educate both physicias ad cliicias about rare diseases at NORD worked closely with Members of Cogress ad FDA durig the two-year preparatio for reauthorizatio of the Prescriptio Drug User Fee Act. The resultig FDA Safety ad Iovatio Act bore NORD s imprit i umerous groudbreakig provisios. For Rare Disease Day 2012 (February 29), more tha 700 patiet orgaizatios, compaies, academic istitutios ad govermet agecies siged o with NORD as Rare Disease Day Parters. NORD assisted FDA with the agecy s first-ever FDA Patiet Advocacy Day o March 1, JAN OCT NORD coveed a Risk Task Force i Jauary 2012 that is workig with FDA to ehace patiet iput ito decisios related to risk tolerace. NIH Director Fracis Collis, MD, PhD, ad Social Security Commissioer Michael Astrue were amog the speakers at the U.S. Coferece o Rare Diseases ad Orpha Products hosted by NORD ad DIA i October A study commissioed by NORD showed that FDA applied flexibility i the review of two-thirds of the oocologic orpha drugs approved from 1983 to NORD is ecouragig FDA to documet this flexibility to provide greater trasparecy i orpha drug reviews.
11 RECENT EVENTS Metorig Patiet Advocates Approximately 40 NORD member orgaizatios were represeted at a recet meetig i Philadelphia. This icluded both start-up ad seasoed orgaizatios. These meetigs ecourage metorig ad sharig of best practices. Brigig New Treatmets to Patiets NORD commissioed a major study of FDA flexibility i the review of orpha products to documet curret practices ad how the process may be improved. Coectig Patiets with Govermet Parters NORD helped FDA orgaize its first-ever Rare Disease Patiet Advocacy Day i March 2012, educatig patiet leaders beforehad ad brigig them to the White Oak Campus o a bus. ANNUAL EVENTS NORD is the atioal sposor i the U.S. for Rare Disease Day, which takes place o the last day of February each year. Visit the special website NORD hosts (RareDiseaseDay.us) to lear how to get ivolved. At its Parters i Progress Celebratio each year i May, NORD hoors idividuals, public officials, researchers, patiet orgaizatios ad compaies for outstadig achievemets i policy, research ad service NORD co-hosts, with the Drug Iformatio Associatio (DIA), the aual U.S. Coferece o Rare Diseases ad Orpha Products. Collaborators iclude NIH, FDA, EURORDIS ad Duke Departmet of Pediatrics.
12 NORD MOVING FORWARD GLOBAL RareCoect.org Evolvig ad growig the global coversatio amog patiets RareDiseaseDay.us A aual iteratioal advocacy day to brig widespread recogitio of rare diseases as a global health challege. EDUCATE NordPhysiciaGuides.org Creatig the tools for doctors ad cliicias to diagose rare diseases SUPPORT NORD Patiet Assistace Portal Icreasig access ad solutios for our cuttig-edge programs to advace treatmets for patiets. Natioal Orgaizatio for Rare Disorders Coecticut Office 55 Keosia Aveue Dabury, CT rarediseases.org Washigto DC Office 1779 Massachusetts Aveue NW Suite 500 Washigto, DC Massachusetts Office 1900 Crow Coloy Drive Quicy, MA 02169
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