Top Tweets for #OCEPIP17
@FDAOncology hosted 1st patient education workshop "partners in progress" #OCEPIP17 yesterday. Kudos to FDA's Gini Kwitkowski! Proud to see FDA scientists, @AACR , @ASH_hematology, @ASCO, FDA Center Directors and patients spend a day of dialogue together- more to come!
And that’s a wrap! Thanks for the great workshop, @FDAOncology! #OCEPIP17
New CBER approvals: CAR-T cell therapy #OCEPIP17
Palliative care device approvals: intrathecal pain pumps, stents, dilatation balloons #OCEPIP17
Devices: several new approvals for diagnostic purposes- QuantX: software to aid in breast lesion detection on mammogram, Nevisense: aids non-visual identification fo melanoma #OCEPIP17
New and interesting approvals from @FDAOncology: pembrolizumab tumor site agnostic approval for MSI-high and dMMR tumors (as seen in Lynch syndrome) #OCEPIP17
Right to try cuts the FDA out of the process. Single pt IND is not an onerous process and doesn't unduly slow down treatment but allows FDA to capture more of the data in a potentially meaningful way #OCEPIP17 https://t.co/ykncKB52Pz
Great question @jamienholloway regarding distinctions between “Right to Try” and “Expanded Access Program” #OCEPIP17
FDA partnered with @patientslikeme to attempt to better capture patient generated health data #OCEPIP17
https://t.co/UciXtJZZC8
FDA publication from 2017 found that they could find adverse events in social media in at least one case BEFORE standard FDA adverse events reporting systems. Social media for the win! #OCEPIP17
Medwatch looks to be the easiest way to report adverse events for patients: https://t.co/UscoY6yl0Z
#OCEPIP17
@itsthebunk This is the same problem with expanded access. If the drug company won't give access, the IND never even makes it to the FDA #OCEPIP17
Dr. Joohee Sul on expansed access: It’s like driving...until you actually try it, you don’t know what it’s like. #OCEPIP17
post market drug safety monitoring important as a more diverse population will use the drugs, pts use it for a longer duration, captures food interactions, drug interactions -Carol Pamer #OCEPIP17
Right to try: lets patients have access to drugs that have passed through phase I trials. Allows patients to try drug but doesn't require drug companies to make those drugs available. #OCEPIP17
Single patient IND adverse events won't jeopardize drug approval. there is an understanding that the single pt. IND population is very different. #OCEPIP17
Misconception: FDA rarely grants single patient IND, takes a long time. In fact, they approve 99% of requests, and usually 24-48 hours. #OCEPIP17
Fine tuning my #advocacy platform w/ @FDAOncology to be a voice for those with no choice
#cancersurvivor
#OCEPIP17
#AlongComesHope
How do you apply for expanded access?
*physician/patient discussion
*contact drug maker, request access
*drug maker gives doctor info necessary to make up a treatment plan
*single patient IND
https://t.co/FvZsde7BiH
#OCEPIP17
Dr. Joohee Sul: Access to treatments including Expanded Access @FDAOncology #OCEPIP17
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