@AppleHelix Here in Aus, there is an exemption for FIH Ph1 trials relating to TGA manufacturing licence/inspection. GMP is not ignored & most align to PIC/S. A CMC advisory says all his Phase 1 clients made FIH batch under GMP. As for GLP tox, it’s same as US, but no SEND or IND, just IB
@learnbiotech@McKinsey In 2011, precision medicine in oncology meant sales force almost obsolete https://t.co/QMIeqjopcm Rare disease is also high for precision med & has patient advocacy (investment not req’d for some). Are launches more successful for precision medicines in well defined populations?
Queensland Life Science Sector Survey - Closes 1 March 2023! LSQ has teamed up with @KnightFrank who are specialists in this real estate sector and are developing a tool that will assist the sector to bridge this gap. Read more https://t.co/nZm1llCrrI
New #JITC article: Phase Ib open-label, multicenter study of pixatimod, an activator of TLR9, in combination with nivolumab in subjects with MSS metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma and other solid tumors https://t.co/80YzKxKa6C @KeithDredge
Phase Ib open-label, multicenter study of pixatimod, an activator of TLR9, in combination with nivolumab in subjects with microsatellite-stable metastatic colorectal cancer, metastatic pancreatic ductal adenocarcinoma and other solid tumors https://t.co/TPa3Hx1k1d
"Never let a good crisis go to waste" Churchill. As quoted by Dr. Feltquate. Did you know the fastest time to trial activation is #Australia? Proud of those Aussies! And let's figure out how to improve efficiency here! https://t.co/9MtJx0fMrU
@ProfPaulYoung Had ‘razor blade’ throat too a few months ago. So painful. Ended up in ED and had CT scan of throat, given dexamethasone and was much better 48 h later. Also no lower respiratory issues which kept me calm as vaccine was doing it job but that throat😫 get well soon
A tremendous national and international effort to publish our exciting data on #pixatimod as a potential therapeutic for #COVID19 thanks to all our collaborators!
@whereisdaz As someone developing a heparan sulfate mimetic, it was not a “crazy idea” to test heparin’s anti-viral properties. Very obvious. But some referenced preclinical data (& PK data!) would be nice to see in order to support the claims in a news piece! (Then there’s GLP tox)
I’ve seen this play out in the most distressing way. Disease is rarely determinant, bad luck has a lot to with it and implying otherwise to unwell people (deliberatley or accidentally) is un helpful and upsetting. Don't do it.
Big wellness has a lot to answer for...
Everyone is obsessed with “translational” and applied research, which have an important role. But without the discovery science, there’s nothing to translate or apply!