Bringing Access into the Drug Development Process, The 2017 Expanded Access Summit (September 15, 2017)

3 Aug

By Jess Rabourn, President, WideTrial

2017 may go down as the “Year of Expanded Access”. Expanded Access Programs (EAPs) are FDA authorized clinical trials for patients who cannot get into regular clinical trials.  The mechanism was created in 1987 to permit seriously ill patients and their doctors to explore new possible treatments that are in clinical development but not yet approved for market. And now, after 30 years of practice, there are major opportunities to use relatively inexpensive EAPs to strengthen clinical drug development in the toughest diseases.

This year, the Trump administration -including HHS and FDA leadership-  plus several elected officials on Capitol Hill, have called for greater power for gravely ill Americans and their doctors to consider pre-approval therapeutics. Drug and device makers around the country are already scrambling to comply with special measures in the new 21stst Century Cures Act which require companies to publicize their early-access policies. Additional early-access legislation may find its way into the FDA Reauthorization Act before Summer’s end.

At the same time, big initiatives for real world evidence, precision diagnostics, and adaptive clinical trial design are captivating product development teams in the same companies that face demands for early product access. Could these two disparate opportunities be addressed by the same solution?  In the U.S., well-designed Expanded Access programs are finding their way into the drug development process for new products in unsolved, life-threatening diseases. Treating wider sets of patients in a target indication opens the door to vast collection of consented treatment-outcomes data, which are vital for understanding a patient population and the differential response patients may have to an investigational drug, device, or diagnostic.  So how can EAPs be integrated into clinical development, and what needs to change to marry the benefits of access and research?

On September 15, 2017, in Cambridge, Massachusetts, leaders from pharma and biotherapeutics companies, FDA, NIH, and leading advocacy organizations will be brought together to answer these questions.

The 2017 Expanded Access Summit is designed to be a groundbreaking event for drug development. It is produced by WideTrial, a longstanding policy advisor and innovation leader in pre-approval access. WideTrial has tasked its speakers and attendees with establishing new best-practices for modern Expanded Access. Audience participation will be a critical component of the Summit outcomes, which will be compiled, edited, and submitted for publication after the event.

To learn more and take part in this event, register now on the conference website:  http://widetrial.com/

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