Top Tweets for #expandedaccesssummit
Christina Hartman’s work at @AssistanceFund is personal, as her daughter has a rare disease. TAF provides average assistance of $500-$5k/yr to patients. This is the difference between affording tx and food for many patients. @macroptero #EA3 #ExpandedAccessSummit
Always great to see innovation from the #RareDisease community such as @Jeevatrials founded by @Harsharajasimha to provide a decentralized #Clinicaltrial process for patients, sponsors, & investigators. #ExpandedAccessSummit #EA3
Dr Janet Woodcock notes that despite recent #FDA innovation for #EAP challenges remain. Business reasons, equitable EAP access, and supply are among these challenges. #ExpandedAccessSummit #EA3
FDA’s Dr Janet Woodcock pointed out that she could probably count on both hands manufacturers that sought to recover R&D costs. She indicated there are other issues small biotechs face as barriers to #EAP. #ExpandedAccessSummit #EA3
Marjorie Speers noted that a major issue in #EAP is that we’re applying provisions meant for research to treatment. #ExpandedAccessSummit #EA3
Peter Barton Hutt provided a description of the 22 golden years of #EAP when manufacturers could include costs of TX, running EAP, & tx R&D. Now, manufacturers can no longer include tx R&D, the largest cost. Why did we go backward? #EA3 #ExpandedAccessSummit
From his groundbreaking work in #HIV to today, Tony Fauci intimately knows the evolution of #EAP from parallel track to where we are today. I’m grateful for how far we’ve come, but the evolution must continue. #ExpandedAccessSummit #EA3
Jess Rabourn noted that innovation is bring treatments to patients. I agree & believe every #EAP is a chance to exercise the innovation Jess envisions. @Expanded_Access #EA3 #ExpandedAccessSummit
Karen Frascello of @Alnylam explained the fundamentals of #ExpandedAccess is to allow access of an unapproved or unlicensed treatment in a patient’s country. #EA3 #ExpandedAccessSummit
David Schwicker’s tongue in cheek comment that a 5min brief of the national criteria for EAPs in the EU would take 2.5hrs shows how difficult it is for our industry partners to navigate. #ExpandedAccessSummit #EA3
Amy Barone, MD discussed FDA’s Project Facilitate. She stated that 99.9% approval of SPI is great, but what about the patients who didn’t know they could request access. That’s one of the areas the project will address. #ExpandedAccessSummit #EA3
Richard Klein explained the FDA runs a 24/7 expanded access hotline and takes requests very seriously. #ExpandedAccessSummit #EA3
. @marjorie_speers kicked off the #ExpandedAccessSummit stating in a perfect world there would be no need for expanded access, but the world is not perfect. I’m grateful to our industry partners who participate in EAPs in this imperfect world. #EA3
This letter explains the current situation. Funding for the treatment #NurOwn is one of the most important issue for Brainstorm to be able to consider #ExpandedAccess - as they replied from the #ExpandedAccessSummit
Let's be clear Lance. Brainstorm has repeatedly been denied financial support since prior to it's Phase 2 trial in 2012 to the present.
Attached letter from Brainstorm to Calaneet explains.
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