Selling in a Competitive Ultra-Orphan Disease Market
Bill Zabel, Vice President, U.S. Sales, Talecris Biotherapeutics tells us about leveraging distribution to maximize outcomes by using patient advocates to raise disease awareness and managed care strategies to gain buy-in and support.
Patient Centered Health Management/REMS 2.0
David Sirois, DMD, PhD, President of the Board of Directors, International Pemphigus & Pemphigoid Foundation (IPPF) discusses outcomes of a model for improving Ultra-Orphan illness through an individualized Health Management Program.
Big or Small: Drug Development Post-Health Care Reform
Michael McCaughan, Editor in Chief, Prevision Policy, LLC, explains what Health Care Reform does (and doesn’t) change about drug development, how FDA regulation is evolving at the same time and where we are headed next.
Manufacturer Viewpoints and Initiatives
Roger Garceau, M.D., FAAP, Senior Vice President, R&D and Chief Medical Officer, NPS Pharmaceuticals, Inc. explains why and how investing in the orphan drug marketplace makes sense with predictions on how innovation will take place in the rare disease market going forward.
Pfizer, Inc.
Ed Mascioli, M.D., Vice President, BioTherapeutics R&D, Orphan and Genetic Diseases, Pfizer, Inc. reviews Pfizer’s past experience in discovering, developing, and commercializing therapies for rare diseases and how Pfizer is restructuring to position itself to compete in this marketplace.
Reimbursement Implications and Strategies for Distribution Model Options
Dean Erhardt, Principal, D2Pharma Consulting, LLC presents reimbursement care updates and trends related to orphan drugs and strategies for exclusive, limited, and open distribution models
The Effect of REMS on Product Commercialization
David A. Galardi, Pharm.D., Commercialization, Apogenics Inc. gives a REMS overview with emphasis on commercialization and the fallacy of standardization.
New Complexities in Pricing Orphan and Ultra-Orphan Drugs
Doug Paul, Partner, MME LLC elaborates how increased competition and changes in markets are pushing ultra-orphan drug prices downward.
The New Administration & the Impact on Orphan Drug Development: the Good, Bad and Ugly - Dorman
Diane Edquist Dorman, Vice President, Public Policy, National Organization for Rare Disorders (NORD), tackled the subject of the new Administration and the impact on orphan drug development, and how NORD is responding.
Why Smaller Is Better: The Triumph of the Biotech Model
Michael McCaughan, Editor-In-Chief, F-D-C Reports, Inc., Elsevier Business Intelligence, gave an eye-opening overview of the new FDA, with its tougher enforcement tools; the new reality of the marketplace, where the traditional sponsor-centric world is ending and tighter ties to the patient are crucial for commercial success; and how the new regulatory model favors the smaller, more nimble "biotech" organization, one that can grasp and implement a culture of risk management.
Regulatory/REMS/Health Intelligence
David Galardi, Pharm.D, Apogenics, examined the "nuts and bolts" of REMS, including history, resources, definitions, and techniques for meeting REMS obligations and maintaining commerce.
The New Administration and the Impact on Orphan Drug Development: the Good, Bad and Ugly - Slotnick
Jayson Slotnik, Attorney at Law, Hogan & Hartson, LLP, and Diane Edquist Dorman, Vice President, Public Policy, National Organization for Rare Disorders (NORD), tackled the subject of the new Administration and the impact on orphan drug development.
Reimbursement and Benefit Trends
Dennis Matheis, President, Anthem Blue Cross and Blue Shield of Missouri, provided an overview of current reimbursement trends and demonstrated how payers are approaching pay for performance, value based benefit design (VBBD) and comparative effectiveness.
The Power of Health Management
Dr. Warwick Charlton, M.D., MBA, Chief Medical Officer, Centric Health Resources, Inc. explained how a well-run health management program can result in a positive ROI for sponsors in higher compliance and higher patient loyalty rates.
High Touch via Telephone
Dr. Robert Sandhaus - Medical Director, AlphaNet explained how the ADMAP program for patients with Alpha-1 Antitrypsin Deficiency was designed to supplement medical care by helping patients and families better understand their disease and treatment.
The IPPF + Centric Health Management Program
Dr. David Sirois, DMD, PhD, Chairman of the Board of Directors, The International Pemphigus & Pemphigoid Foundation (IPPF), provided outcomes to date from a program that launched in May, 2008 to provide peer health coaching and health management to patients with pemphigus and pemphigoid.
Advocacy Involvement
John Walsh, Chairman of the Board of Centric Health Resources; President, CEO, and co-founder, The Alpha-1 Foundation, explained that there are ways to work with consumer groups that benefits patients, benefits industry, and strengthens service and brand.
Integrate Risk Evaluation & Mitigation Strategies (REMS) with Health Management & Distribution
Craig Kephart, President & CEO, Centric Health Resources, Inc., presented the benefits of integrating REMS requirements with distribution. Companies that are willing to put the right structure in place to monitor patients, collect data, and measure outcomes should find that REMS can work to their advantage.
Health 2.0: How Empowering Patients can Lead to Increased Patient Acquisition
Wendy White, Founder & President, Siren Interactive, presented the popular subject of social networking and how to use it to reach patients. There is a conversation going on, and you have an opportunity to influence the dialogue.
Including Distribution and Patient Services in Ultra-Orphan Pricing
Doug Paul, Vice President and Partner, MME Consultants, presented an enlightening lecture titled, "Including Distribution and Patient Services in Ultra-Orphan Pricing: The intersection of the forgotten P's of the marketing mix." What is the Missing P? Patients!
What We Do
Centric provides distribution, specialty pharmacy, and health management services to the ultra orphan and unique disorder marketplace. Manufacturers benefit from the advantages of a fully integrated distribution and patient services model, complete with 3PL, intake and reimbursement hub, specialty pharmacy, nursing, and health management and/or compliance program, patient registry services, training, and co-marketing, with a dedicated focus on ultra orphan disorders. Services are also offered on an individualized basis to meet the unique needs of a particular therapy, executed with the same high-touch, dedicated focus that is characteristic of all Centric services.
Integrating Risk Evaluation & Mitigation Strategies (REMS), Health Management and Distribution to Streamline the Approval Process and Maximize Sales
Proactively preparing the REMS in conjunction with a health management program and integrating the program with distribution may help to avoid delays in the FDA approval process and facilitate a manufacturer's ongoing reporting relationship with the FDA. It can also help monitor drug safety, reduce the cost of multiple vendor relationships and redundant tracking activities and provide valuable patient outcomes data. Presented by Craig Kephart, President and CEO of Centric Health Resources at the CBI 4th Annual Rare Disease Summit, Alexandria, VA.
Orphan Product Development and Post-Marketing Commitments, Meeting the Current Challenges of Rare Disease Product Development.
A Webinar presented by ExL Pharma on May 6, 2009, 2:00 – 4:00 p.m EDT. Craig Kephart, President & CEO of Centric Health Resources, joined industry experts from BioMarin, the FDA, and the HPS Group to review current challenges faced by participants in the rare disease marketplace. Craig’s segment, posted here, discusses pressure from increases in cost, pricing implications, and launch considerations.
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