Wednesday, September 25, 2013

Meet to Focus on Rare Diseases & Orphan Product Research, Development, and Access

Meet to Focus on Rare Diseases & Orphan Product Research, Development, and Access
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US Conference on Rare Diseases & Orphan Products:
The New Era in Health Care

October 7-9 | North Bethesda, MD
Co-sponsored with National Organization for Rare Disorders
At this annual conference, all stakeholders in the rare disease/orphan product community - patients, patient organizations, researchers, drug and device companies, investors, thought leaders and government – meet to focus on rare diseases and orphan product research, development, and access. Search the Online Program.
Keynote Speaker:
Bill Corr
Deputy Secretary
U.S. Department of Health and Human Services
Luncheon Speaker:
FDA Initiatives on Orphan Products
Monday, October 7 | 11:45AM-1:00PM
Janet Woodcock, MD
Director, Center for Drug Evaluation and Research (CDER)
Plenary Sessions:
The Affordable Care Act and the Rare Diseases Community
Plenary Session 2:
- NINDS NeuroNext Program
- NORD Initiative on Natural History Studies
Health Care System of the FutureResearch Frontiers in Rare Diseases: The Next Opportunities
The Next 30 Years Session Topics:
Patients and Industry: Partnership and Collaboration in Research
Funding and FDA Review
The Investment Environment for Orphan Drugs/Devices
FDA's Orphan Grants Program
FDASIA Provision Highlights
Collaboration from Bench to Bedside: How Industry and Patients
Can Partner in Rare Diseases
Hearing the Voice of the Patient
The International Perspective on Orphan Drug/Devices
Assuring Patient Access to Treatments
Paying for Orphan Therapies
Repurposing: FDA and NIH Perspectives
Managing Orphan Drug Recalls and Shortages
NIH Clinical Center-CDER Clinical Trials and Regulatory
Training Collaborative
• Plus More

Just Added: New Tutorial | October 6:
Overview of The Regulatory Frameworks and Opportunities for Orphan Medicinal Products (OMPs)
The tutorial will describe regulatory frameworks from FDA and EMA and incentives for development of Orphan Medicinal Products (OMPs). It will cover details regarding incentives for developments of OMPs, opportunities and challenges. Additionally, this tutorial will give an overview of the different options to gather control data in rare/ultra rare disease settings. Case studies for requests for ODDs and marketing authorizations for OMPs will be presented and discussed.

Move Toward Better Communication and Collaboration Among Patients, Payers, and Product Developers
A Model of Patient, Payer, and Product Developer Collaboration to Support Innovating for ValueOctober 30-31 | Washington, DC

DIA and the Brookings Institution are collaborating to strengthen communication between health care stakeholder communities. This conference will focus on highlighting the perspectives and outcomes most relevant to patient communities, reimbursement requirements and innovative payment models of most interest for payer groups, and how both can help inform product developers as they drive toward novel value-based innovation. Register by October 9 to Save $100!
Keynote Speaker:
James Heywood
Co-Founder, Chairman
Session Topics:
• Aligning Perspectives on Value and Outcomes
• Identifying Stakeholder Needs and Challenges to
Strategic Communication
• Exploring Opportunities for Efficient Engagement
Throughout Discovery, Clinical Development, Regulatory
Review, and Product Use
• Case Studies and Current Initiatives
• Next Steps: Charting a Course Forward
• And More
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