Centric Health Resources Identifies Ultra-Orphan Industry Trends, Impact of Risk Evaluation and Mitigation Strategies (REMS).Centric's second annual ultra orphan conference, with Pharmaceutical Executive Magazine serving as media partner for 2009 event, offers industry guidance CHESTERFIELD, Mo. -- Highlighting the role of specialty pharmaceuticals as the fastest growing segment of the prescription drug prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, market in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , the recent Second Annual Ultra Orphan Conference: "Emerging Commercialization Strategies for Addressing the Needs of Ultra Orphan Patients -- Accelerate Product Launch and Profitability by Building Regulatory Requirements into Distribution," offered stakeholders insights into industry trends, explained the impact of healthcare reform, and identified opportunities to turn Risk Evaluation and Mitigation Strategies (REMS) into a competitive advantage. Sponsored by Centric Health Resources, Inc. (www.centrichealthresources.com), a new generation health services health services Managed care The benefits covered under a health contract organization focused on improving the quality of life for people nationwide with rare, orphan, ultra-orphan, and chronic genetic disorders The following is a list of genetic disorders and their origins. Beside most disorders is a code that indicates the type of fertilization and the chromosome involved.
Setting the tone, Craig Kephart, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Centric, articulated the opportunities for manufacturers to transform REMS into a market advantage: "REMS presents a new challenge in the drug approval process, with an average Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) delay of nine months due to an insufficient REMS program. While this poses significant implications for manufacturers in this marketplace, it also presents opportunities to integrate REMS with distribution, improve REMS compliance, impact patient compliance, and provide data to support pay-for-performance." Kephart also identified these key trends: * Consolidation of specialty pharmacy drugs as manufacturers seek focus and patient experiences * Food and Drug Administration (FDA) attention to post-market surveillance * Growth in personalized medicine -- drugs manufactured based upon genetic makeup of patient * Margin pressure on the specialty pharmacy channel, and competition among pharmacy benefits management-based specialty pharmacies * Impact of REMS: input is pervasive, creating challenging issues for pricing, access, monitoring, drug approval, and drug regulations * Specialty pharmacy "Big Box" model is ineffective on small market drugs Keynote speaker Michael McCaughan, editor-in-chief, F-D-C Reports, Inc., Elsevier Business Intelligence, discussed the bright side of biotech, including how the new regulatory model favors highly active medicines for small patient populations, how sponsors who embrace the new model have found it provides a competitive advantage, and how the economics of small markets strongly favor smaller companies over larger entities. Conference presenters included: * Jayson Slotnik, attorney-at-law, Hogan & Hartson, LLP LLP - Lower Layer Protocol , and Diane Edquist Dorman, vice president, Public Policy, National Organization for Rare Disorders (NORD Nord (nôr), department (1990 pop. 2,533,000), N France, bordering on the North Sea and Belgium. Lille is the capital. ), examined how the new administration's healthcare policies will impact orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the development, as well as recent healthcare plan developments and NORD initiatives. * Dennis Matheis, president, Anthem Blue Cross and Blue Shield Blue Shield A US not-for-profit health care insurer that is a reimbursement intermediary for physicians. Cf Blue Cross. of Missouri, addressed reimbursement, pay-for-performance, value-based benefit design, and comparative effectiveness comparative effectiveness, n the assessment of the relative merits of two active therapeutic approaches by direct comparison. . Additional conference speakers included: * William Sullivan, principal consultant, Specialty Pharmacy Solutions, LLC (Logical Link Control) See "LANs" under data link protocol. LLC - Logical Link Control * David A. Galardi, Pharm.D., Apogenics * Jim Long, principal and co-founder, BioSolutia * Dean Erhardt, M.B.A., principal, D2 Pharma Consulting, LLC * Robert (Sandy) Sandhaus, M.D., The Alpha-1 Foundation * John Walsh, chairman of the Board of Centric Health Resources; president, CEO, and co-founder, The Alpha-1 Foundation * David Sirois, M.D., D.M.D., Ph.D., chairman of the Board of Directors, The International Pemphigus pemphigus /pem·phi·gus/ (-gus) 1. a distinctive group of diseases marked by successive crops of bullae. 2. pemphigus vulgaris. & Pemphigoid pemphigoid /pem·phi·goid/ (pem´fi-goid) 1. resembling pemphigus. 2. any of a group of dermatological syndromes similar to but clearly distinguishable from the pemphigus group. Foundation * Warwick Charlton, M.D., M.B.A., chief medical officer, Centric Health Resources, Inc. * Douglas Paul, vice president and partner, MME See Multimedia Extensions. Consultants * Wendy White, founder, president, Siren Interactive "This conference was about answering critical questions during a time of health care transformation," Kephart concluded. "Our main focus was to help organizations plan and prepare for new reforms, a potential overhaul of our health care system, and an era of change. We validated the importance of appropriate preparation, and carefully presented the competitive advantages of building REMS requirements into distribution strategies." About Centric Health Resources Centric Health Resources, Inc. is a nationwide, Patient-Centered Health Management[R] organization, serving patients with rare, orphan, and ultra-orphan disorders. Biotech and pharmaceutical manufacturers maximize value by aligning with Centric for streamlined coordination and flexible service offerings that include reimbursement expertise, delivery of specialty pharmaceuticals, peer health coaching, and clinical support from registered nurses. Centric connects physicians, nurses, health benefit payers, patient advocacy groups, biotech/pharmaceutical companies, and families together in partnership for improved service and health outcomes for these specialized patient populations. Visit www.CentricHealthResources.com. |
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