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| --- Day changed Sat Dec 03 2016 | ||
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| kanzure | bloop | 06:25 |
|---|---|---|
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| cluckj | beep | 06:27 |
| kanzure | ah.. | 06:27 |
| cluckj | do you know of any good resources that talk about the FDA's biosimilar drug regulations and policies? | 06:27 |
| cluckj | I'm churning through my research databases already | 06:28 |
| cluckj | I figured I could ask the kanzure database too :) | 06:30 |
| streety | have you asked the FDA? | 06:30 |
| streety | although a response is unlikely during the weekend | 06:30 |
| cluckj | :/ | 06:33 |
| kanzure | no | 06:37 |
| cluckj | k, thanks | 06:38 |
| cluckj | the fda would just point me at their publicly available whitepapers and policy documents, which I am already looking through | 06:38 |
| cluckj | I'm talking with a senator's office on wednesday about insulin and am trying to prepare arguments :P | 06:42 |
| streety | actually I wouldn't assume that is all they will be willing/able to do. Try to set up a phone call with someone and they can probably address any questions you have that aren't covered in their public material | 06:56 |
| streety | depends on getting the right someone but when I've been at meetings with FDA attendance they've always encouraged people making contact | 06:57 |
| cluckj | ah okay | 07:14 |
| cluckj | I can throw credentials around and get a callback, for sure | 07:14 |
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| kanzure | cluckj: i'm sure you follow all the diy insulin stuff much more closely than i do | 07:30 |
| cluckj | yes, as little as they report on publicly...I'm going to have a chat with them soon | 07:34 |
| kanzure | i'm not sure about ideal reforms for fda to propose, it's a hard thing to figure out | 07:35 |
| cluckj | I see their work as a "this is how important it is to diabetics" and not as a solution to systemic problems with pharmaceuticals | 07:35 |
| cluckj | yeah, I think that's what I'm being sourced for | 07:35 |
| kanzure | apparently it's illegal to build diy wheelchairs or something. fda is severe. | 07:36 |
| kanzure | http://diyhpl.us/wiki/fda/ | 07:36 |
| cluckj | haha they were having a weird reaction to the DIY artificial pancreas stuff too afaik | 07:36 |
| cluckj | like "we aren't going to stop you..................................yet" | 07:37 |
| kanzure | our "walking dead" members of society should be allowed to do more insane/risky medical tech stuff, and there should be businesses selling to them prolly | 07:37 |
| kanzure | i dunno if it has to be totally unregulated, maybe a small light amount of regulation at least, but certainly not anything to prevent one-shot one-off attempts at improving quality of life and function | 07:38 |
| cluckj | as one of the walking dead, I kind of want the ability to safely experiment and push companies to experiment more with their tech | 07:39 |
| kanzure | alternatively, if the fda is so worried about unregulated tech screwing people up, then they should allocate a budget for pursuing quality-of-life "points" and the "walking dead" should get to collectively spend hypothetical quality years on pursuing different innovations and research or practical short-term solutions, so e.g. if something is "too risky" then the regulators should be required ... | 07:40 |
| kanzure | ...to make up for the difference in pursuing some other short-term direction for their benefit | 07:40 |
| cluckj | I think it needs to be regulated enough so that it's not insanely risky | 07:40 |
| cluckj | precisely | 07:40 |
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| kanzure | as it is, regulators can just say "lol nope, or we sue the fuck out of you and/or raid you with military strike force" but really it should be about delivering and pursuing quality of life and enhancement overall, rather than simply attacking the diseased | 07:41 |
| kanzure | i get it -- a *lot* of snake oil out there. but preventing snake oil is not quite what everyone is interested in.... people are more interested in pursuing solutions. | 07:41 |
| cluckj | the whole "we are not waiting" group/movement is trying to do incremental change stuff by experimenting together by hacking COTS tech | 07:41 |
| cluckj | but the security in that tech that the FDA regulation requires makes hacking it a little dangerous and not super fruitful | 07:42 |
| kanzure | best way to repurpose the FDA would be to give them a mandate to participate and help the proactive stuff, like e.g. making engineering talent more available, or otherwise spending money on DIY stuff, etc. | 07:42 |
| cluckj | yes, that's how they've been treating #wearenotwaiting so far | 07:43 |
| kanzure | is that a twitter hashtag | 07:43 |
| cluckj | yeah, my bad | 07:43 |
| kanzure | they ain't waiting but they're tweeting..? | 07:43 |
| cluckj | lol, that's just the community building stuff, they're really making artificial pancreas tech | 07:44 |
| cluckj | stuff that works | 07:44 |
| cluckj | interfacing certain insulin pumps with continuous glucose monitors, and running algorithms for closed-loop dosing | 07:45 |
| cluckj | and semi-closed loop dosing | 07:45 |
| cluckj | https://openaps.org/ | 07:47 |
| kanzure | .title | 07:49 |
| yoleaux | OpenAPS.org - #WeAreNotWaiting to reduce the burden of Type 1 diabetes | 07:49 |
| kanzure | are they doing insulin production too? | 07:50 |
| cluckj | not the openaps folks, but open insulin talks about and identifies with #wearenotwaiting | 07:52 |
| cluckj | also holy shit novo nordisk is fucking evil, like old testament evil | 07:54 |
| cluckj | pulling their insulin products out of both greece and germany when they tried to institute price controls, and bribing regulatory officials in china | 07:55 |
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| drethelisk | cluckj how long until someone's pump gets hacked and they get assassinated over wifi | 09:50 |
| kanzure | precautions: don't go to defcon | 09:57 |
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| souljack | blue team goes blue | 10:53 |
| cluckj | drethelisk, who knows | 11:05 |
| cluckj | there's already been vulnerabilities found in wireless-enabled medical devices | 11:05 |
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| kanzure | hrm. | 12:17 |
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| cluckj | ? | 12:27 |
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| kanzure | http://rajlaboratory.blogspot.com/2016/12/some-reluctant-thoughts-on-postdoc-pay.html?spref=tw | 13:41 |
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| kanzure | a39e3a8d37793792f62b85cbd7b74cafe482b5b2014203ca28b8555822ce74f3 public-file-size-md_20150304205357.json.gz | 15:02 |
| kanzure | from https://archive.org/details/ia-bak-census_20150304 | 15:02 |
| kanzure | unfortunately that one had all md5-only hashes | 15:03 |
| kanzure | 8daa7a635d77eddb9fecb000abbe10b19611b623a1242b4a7b4b7881b92ddae6 file_hashes_sha1_20160411221100_public.tsv.gz.ots | 15:12 |
| kanzure | from https://archive.org/details/ia_census_201604 | 15:12 |
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| kanzure | e2bc2f240490e91d52a1eaeb5636664f75795da9bfcbbe7692c07b90ae18244b file_hashes_sha1_20160411221100_private.tsv.gz | 15:30 |
| kanzure | and from https://archive.org/download/archiveteam_census_2016 | 15:41 |
| kanzure | 2840f4e64f4c2bf562e97294714371cfe7beb4122e73c3437d535175d93e53df 2016.10.23-ia_identifiers.txt.gz | 15:42 |
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| kanzure | er, i don't mean ".ots" above obviously. sorry. | 15:50 |
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| kanzure | .wik PTPRS | 16:38 |
| yoleaux | "Receptor-type tyrosine-protein phosphatase S, also known as R-PTP-S, R-PTP-sigma, or PTP?, is an enzyme that in humans is encoded by the PTPRS gene." -- https://en.wikipedia.org/wiki/PTPRS | 16:38 |
| kanzure | "Alzheimer's disease pathogenesis is dependent on neuronal receptor PTPsigma" http://biorxiv.org/content/early/2016/12/01/079806 | 16:38 |
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| kanzure | http://bioviva-science.com/blog/dual-gene-therapy-has-beneficial-effects-on-blood-biomarkers-and-muscle-composition | 17:28 |
| kanzure | <!-- This site was created in Webflow. http://www.webflow.com--><!-- Last Published: Wed Nov 30 2016 22:43:04 GMT+0000 (UTC) --> | 17:30 |
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