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Repurposing Off-Patent Drugs: Research & Regulatory Challenges

Finding a new therapeutic use for an existing drug seems like a simple way to get more treatments to more patients more quickly. However, finding new uses for drugs that are off-patent is like navigating through a sea of icebergs without an icebreaker. No single entity owns the territory the icebergs are in. It is difficult to see the full scope of individual challenges, to prioritize which challenges are addressable, and to choose the most effective vehicle to navigate the challenges.

Join us for a free workshop on December 5-6, 2019. First, we will map out the challenges to repurposing drugs that are already on the market but lack commercial and regulatory incentives for research and development. Then, we will host interactive work sessions focused on capturing possible solutions to core questions:

Which problems impede progress the most?
What are the possible solutions?
Are there unanticipated problems with the proposed solutions?
Which solutions can be implemented in the short term?
Who owns the individual challenges?
What challenges are shared space, and how do we establish a collaboration to address challenges faster?

Hilton Rockville Hotel & Executive Meeting Center
1750 Rockville Pike
Rockville, MD 20852

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Deadline to reserve hotel rooms: November 16, 2019

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Potential discussion topics

Accessing existing data
Identifying appropriate comparators
Regulatory approval
Drug labeling
Health economics
Payor perspectives
Real world evidence & real world data challenges
Historical attempts to fix similar problems

Who should attend

Patients
Philanthropists
Non-governmental organizations
Academics
Pharmaceutical developers & manufacturers
Healthcare economists
Patent/intellectual property lawyers
Regulatory policy experts
Computational scientists
Payors & funders

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Repurposing Off-Patent Drugs: Research & Regulatory Challenges
Thursday, December 5, 2019 - Friday, December 6, 2019
8:00 am - 5:00 pm | 8:30 am - 5:00 pm

Hilton Rockville Hotel & Executive Meeting Center
1750 Rockville Pike Rockville, MD

Get in touch! or

Repurposing Off-Patent Drugs: Research & Regulatory Challenges

Who should attend

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