EveryLife Foundation Talk - Evaluating Early Access Models for Patients
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Transcript of EveryLife Foundation Talk - Evaluating Early Access Models for Patients
Access for Good
A 21st Century Approach to Expedite Responsible Expanded Access
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...while drugs are locked away in development...
…millions of patients left without treatment
options every year…
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..but mechanisms are too cumbersome.
…hence all countries have compassionate use
laws in place to (try to) relieve this…
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• Eroom’s law
• Drug centric models unfit for today’s challenges?
• Rare disease drug development needs patient engagement and input.
• Off-label use and/or drug—repurposing - only partial solutions.
• Real-time data gathering - continuous risk-assessment of drugs.
• Patients and doctors want access to drugs sooner.
• Information asymmetry, ROI considerations and lack of reimbursement.
• Patient centric drug development models and real world data under-deployed.
Paradise Lost
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Source: Nature
2012
Recognizable trends?
• Social media has impacted the policy debate.
• Continued calls for earlier access are likely to continue.
• Focus is shifting to the private sector.
• Consensus that technology can help provide a solution.
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Our Solution Platform bridging Doctors/Patients with new drugs
• All countries have expanded access laws, we make use of existing laws.
• We connect doctors and their patients with treatment options on our platform.
• Serving patients who cannot get into clinical trials.
• Automating the most cumbersome processes (submission to regulatory authorities).
• More data. Earlier access.
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myTomorrows provides web-based
navigation tools to match patients and
doctors to clinical trials and early access
programs for drugs in development.
myTomorrows.com Information / enabling / curated & controlled access
Search databases for Clinical Trials
and Early Access Programs
Find treatments options using filters
Physician & Patient specific content
Submission to regulatory authorities &
feedback loop
Engagement funnel & fulfillment
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Global early access provision
myTomorrows experiences:
• Ensuring compliance with healthcare laws on a global & national basis is
complex but important – compliance filters are essential to our approach
• Quality and data are key to success
• Transparency of data means that HCPs able to draw own conclusions on EAP appropriateness for individual patient situation
• Fair pricing addresses many stakeholder issues.
• Reimbursement important to enable equitable early access for all
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How to get to Multiple treatment options for rare disease patients?
Requires a novel approach to rare disease drug development:
• Collaboration between all stakeholders
• Physician/patient-centric approach
• Tech solutions and new business models
• Working within regulatory requirements
myTomorrows platform connects –
patients, regulator, doctors and innovators.
Paradise regained?
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Open database
• “Open” API
• We want to collaborate with you to use our database
• To help patients and physicians confronted with unmet medical needs
• Please use our database to stimulate innovation
• Contact us on [email protected] to get access.
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