Centric`s second annual ultra orphan conference, with Pharmaceutical Executive Magazine serving as media partner for 2009 event, offers industry guidance CHESTERFIELD, Mo.
–(Business Wire)–Highlighting the role of specialty pharmaceuticals as the fastest growing segment of the prescription drug market in the United States, the recent Secon 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. 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, the conference drew a capacity-audience of representatives from biotech and pharmaceutical companies, patient advocacy organizations, venture capital groups, and consulting firms. Issues impacting stakeholders — ranging from legal concerns, regulatory requirements, managed care reimbursement and patient advocacy – were addressed by some of the most distinguished leaders in the industry.
Setting the tone, Craig Kephart, president and CEO 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) 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
* 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, and Diane Edquist Dorman, vice president, Public Policy, National Organization for Rare Disorders (NORD), examined how the new administration`s healthcare policies will impact orphan drug development, as well as recent healthcare plan developments and NORD
* Dennis Matheis, president, Anthem Blue Cross and Blue Shield of Missouri, addressed reimbursement, pay-for-performance, value-based benefit design, and comparative effectiveness.
Additional conference speakers included:
* William Sullivan, principal consultant, Specialty Pharmacy Solutions, LLC
* 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 & Pemphigoid Foundation
* Warwick Charlton, M.D., M.B.A., chief medical officer, Centric Health
* Douglas Paul, vice president and partner, MME 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 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.
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