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Meet to Focus on
Rare Diseases & Orphan Product Research, Development, and Access
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to download today.
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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
Overview:
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)
FDA
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 Future • Research
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.
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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
PatientsLikeMe
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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