everylife foundation talk - evaluating early access models for patients

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Access for Good A 21 st Century Approach to Expedite Responsible Expanded Access 1

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Access for Good

A 21st Century Approach to Expedite Responsible Expanded Access

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…born from personal

experience

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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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