Centric Health Resources Presents Second Annual Ultra Orphan Conference 2009, "Emerging Commercialization Strategies for Addressing the Needs of Ultra Orphan Patients"
August 24 - 26, 2009, Ameristar Casino & Hotel, St. Louis, Mo. CHESTERFIELD, Mo.--(Business Wire)-- With specialty pharmaceuticals representing the fastest growing segment of the prescription drug market in the United States, Centric Health Resources, Inc. (www.centrichealthresources.com), presents its 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," August 24-26, 2009, Ameristar Casino & Hotel, St. Louis, Mo. Complimentary registration: (http://www.centrichealthresources.com/2009Conference/) Seating is limited. Centric, a new generation health services organization focused on improving the quality of life for people nationwide with rare, orphan, ultra-orphan, and chronic genetic disorders, will share its experience, insights, and strategic approaches in responding to the recent Risk Evaluation and Mitigation Strategies (REMS) requirements implemented by the Food and Drug Administration Amendments Act (FDAAA). Pharmaceutical Executive Magazine is a media partner for the conference. "REMS is making the drug approval process more challenging than ever, with an average FDA delay of nine months resulting from an insufficient REMS program," says Craig Kephart, president and CEO of Centric. "Today, many of the orphan drugs are biologics, and two-thirds of biologics approved in the past year have had a REMS requirement. REMS requirements pose significant implications for manufacturers in the ultra-orphan marketplace." Conference attendees, including biotech companies, specialty pharmaceutical companies, venture capital companies, patient advocacy groups, health plans, employers, and benefits managers will learn how the new regulatory model can work to their advantage. Presentations will demonstrate the success metrics for putting in place the right structure to monitor patients, collect data, and measure outcomes. "The fewer questions left open, the more thorough the planning and preparation, and the more narrowly defined the REMS plan, the simpler the FDA application process," Kephart states. "The conference will address the execution of this planning process and how it can provide organizations with a competitive advantage over manufacturers who fail to build REMS requirements into their distribution." Conference speakers include: * Keynote speaker Michael McCaughan, editor-in-chief, FDC Reports, Inc., Elsevier Business Intelligence, "The Good News for Biotech" * William Sullivan, principal consultant, Specialty Pharmacy Solutions, LLC * David A. Galardi, Pharm.D., Apogenics * Jayson Slotnik, attorney-at-law, Hogan & Hartson, LLP, Washington, D.C. * Diane Edquist Dorman, vice president, Public Policy, National Organization for Rare Disorders (NORD) * Dennis Matheis, president, Anthem Blue Cross and Blue Shield of Missouri * Craig Kephart, president & CEO, Centric Health Resources, Inc. * 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 & Pemphigoid Foundation * Warwick Charlton, M.D., M.B.A., chief medical officer, Centric Health Resources, Inc. * Douglas Paul, vice president and partner, MME Consultants * Wendy White, founder, president, Siren Interactive About Centric Health Resources Centric Health Resources, Inc. is a nationwide, Patient-Centered Health Management 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. CPR Strategic Marketing Communications Frani DePalo, 201-641-1911 x54 fdepalo@cpronline.com Copyright Business Wire 2009
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