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Saros posted:I'm kinda curious who you guys work for. I also have been out of the lab for over three years and after quitting my last job (pharma patents) and moving across the world I considered trying to get back into the practical side of science/pharma but ultimately gave up because holy poo poo is the pay all sorts of terrible and the job security is a joke. I would very much like to hear about this.
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# ¿ Dec 9, 2014 09:27 |
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# ¿ May 12, 2024 03:53 |
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Saros posted:Anything specific? It's a pretty broad job. Sorry, I'm specifically interested in the ways folks are planning to undermine the registration process via the ebola crisis.
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# ¿ Dec 10, 2014 14:51 |
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Sundae posted:We got a team of people who had never been in a solids pharma facility before. They gave us a few 483s for bullshit that was easily explained, but since they had all biologics experience, they missed all the REAL fruit and just picked up the low-hanging bullshit. Like, we got a 483 for not following our protocol for a validation, but not for a systemic failure we ignored that could have (potentially -- highly unlikely, but we don't know and never checked) implicated somewhere in the vicinity of 5,000 batches. Well, that's not terrifying or anything. How did this happen, and who was on the audit team?
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# ¿ May 20, 2015 22:31 |
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None of this is remotely in my work area, but that really shouldn't be happening-biologics inspections is a whole different office from drugs inspections, has different oversight offices and are governed under an entirely different ruleset (Chapter 5.5 versus 5.7 in the manual), and different CP docs for the details of the inspection. These people should have undergone a separate prep regime and been up to par before they arrived, even for normal compliance inspection. Cripes.
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# ¿ May 21, 2015 00:25 |
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Sundae posted:Yeah... I got called in during the audit to explain the functionality of a tablet press and what basic components of the press did. At least one of them had never seen a tablet press, which is unbelievable for someone who is supposed to be providing oversight for a solids facility. There are ways to notify the FDA about this sort of thing. The systemic failure you mentioned wouldn't have to be a part of it- you and your firm could remain fully anonymous. I'm less worried about your company than the next ten that team audited- and whatever screwup caused an improperly trained audit team to be in the field in the first place.
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# ¿ May 21, 2015 02:19 |
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Sundae posted:Could you PM me details about the reporting approach, if you know? I'm all game for doing that. Done and sent. I look forward to seeing your photo in the papers: standing outside a burning factory in Bangladesh, surrounded by men in Hazmat suits holding geiger counters. edit: and rifles, they'll also be holding rifles. Discendo Vox fucked around with this message at 21:49 on May 21, 2015 |
# ¿ May 21, 2015 05:41 |
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Stan Lee Jeans posted:I'm just finishing up a Ph.D. and just got a nice-looking job offer for research at a biotech startup (~30 employees). Everything's looking good, but on the offer the one red flag I noticed was complete transfer of intellectual property rights to the company. Is that sort of clause standard for industry or is it negotiable? Dik Hz posted:That clause is standard across all of R&D everywhere. No matter how it's written, the courts have protected your rights to your own IP that is unrelated to your work. So it's not like they can just claim anything you invent off hours if it doesn't relate to the business. Please note IANAL, though. Normally I'm one for negotiating everything always, but I wouldn't recommend negotiating in this case. IANAL as well, but be aware that the standard I've frequently encountered is if you use pretty much even the slightest amount of on--the-clock time, or company resources, in inventing the thing, they may be able to claim it. Sometimes conceptual similarity can be enough for them to make it seem like you were developing it on their time-it varies. That said, it's also a policy of pretty much every research university, too- it really is close to boilerplate for entities that do research. If they didn't have something along those lines, you could claim ownership of your work product, and potentially even sell it to competitors.
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# ¿ May 23, 2015 00:14 |
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gninjagnome posted:I always wondered why they bothered with those clauses, but then we had to fire a guy that actually independently filed (and received!) a patent for work he did on at my company. He got caught when legal did a patent search as part of the due diligence work as we were getting ready to apply for a our own patent,. Apparently he was trying to start a consulting, and was going to say he was a paid consultant at my company, and his work resulted in the patent. Not sure how he thought he'd get away with it. It's a common issue when someone who's been involved with the creation of a thing realizes how much the creation is worth- there's a whole second tier of this involving foreign companies and governments as well. A ring of people working for the PRC were arrested or placed under warrant just last week.
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# ¿ May 24, 2015 03:29 |
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outlier posted:Never again. Not even once. Laboratory Chat - Never again. Not even once. Are you folks getting some nice schadenfreude from the LaCour scandal? Front page of the new york times today! One thing the article doesn't entirely spell out, probably out of fear of liability, is that at this point, it looks like data was never collected. I've been discussing it with a colleague, and both of us were shocked at what a bad job the guy did at falsifying data. Disappointing- we'd expect better of someone published in Science. Discendo Vox fucked around with this message at 16:41 on May 26, 2015 |
# ¿ May 26, 2015 16:38 |
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My favorite quote, from Dr. Green, the supervising, field-leader PhD who seems to have done no actual supervising:quote:I thought [his initial results] were so astonishing that the findings would only be credible if the study were replicated. (I also had some technical concerns about the “thermometer” measures used in the surveys.) Thermometer measures. And here I am trying to find a single journal that will look at my mildly new theorywork. Thermometer measures. In Science. One of the better sources is, of course, Retraction Watch.
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# ¿ May 26, 2015 23:56 |
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Dik Hz posted:I heard the piece on This American Life, and thought it sounded like bullshit. Good to know I was right. It turns out the dude just took the national average and added a perfect bell curve to it, shifting it a bit. FFS. Half of the frustration in our office wasn't with the fact that he was falsifying data (we're a good enough department that such a practice is outside our scope of consideration), but rather how incompetently the data was faked. Jeez, dude, toss some secondary systemic error terms on there or something. The other half are still trying to figure out who his faculty supervisor was (onsite), or how it would be possible in any universe for him not to have one. All of us are enjoying further publicity of how worthless the Big Two are. None of us are enjoying the negative publicity for social sciences generally.
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# ¿ May 29, 2015 13:25 |
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Dik Hz posted:What is amazing to me is that nobody checked his data. Extraordinary claims require heightened scrutiny. He was so hamfisted in faking his data that it is obvious to anyone with a basic understanding of statistics. Nature and Science, the most prestigious garbage dumps in all of academia, and my field is communication science. vvvv I said prestigious. Discendo Vox fucked around with this message at 15:29 on May 30, 2015 |
# ¿ May 30, 2015 06:47 |
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At a workshop on a particular method, the top workshop on this method in the country. At a mini-session, the speaker is a brand-new hire for the department running the workshop: he has few publications, but they're in major journals, and he's received a lot of major lay press publication coverage. In his methods talk, he discusses abusing a blanket method approval for the Turk to use forced response materials so that the IRB doesn't know about it. He tells this to an audience of about 35. At a methods workshop. At a place that's just hired him.
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# ¿ Jun 3, 2015 01:55 |
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outlier posted:Now I read that lab mice suffer a similar problem. A good fraction of them may be mislabelled: http://buff.ly/1KrY8YA Yup. There also seem to be similar systemic undocumented strain pollution problems in plant science- Retraction Watch ran a bit about it awhile ago.
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# ¿ Jun 12, 2015 19:26 |
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Sundae posted:I absolutely agree with this. Not that I had much say in the matter, but moving from laboratory roles into "expert consultant" roles where I'm stuck in phone conferences and writing reports/project plans/updates all day was a terrible satisfaction decision even if the monetary gains were nifty. I don't think it was worth it. My experience in a social science field is that who you're stuck in the conference room with makes all the difference in the world.
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# ¿ Jul 2, 2015 19:01 |
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Sundae posted:Oh, um... guys? I blew up my company again today. You're really gunning for that promotion to the board of directors, aren't you?
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# ¿ Jul 2, 2015 20:24 |
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If the system is validated, was it certified by an outside entity that might have liability?(I don't know this area, sorry) Have you identified the source of the error so you have someone to point a finger at? ...Do you still have that contact info I gave you?
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# ¿ Jul 2, 2015 21:03 |
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OK, now I'm more confused. But identifying another guilty party would help a lot, I would think.
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# ¿ Jul 3, 2015 00:38 |
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gninjagnome posted:You're confusing being responsible and being blamed. Two totally different things. Nah, I'm very familiar with that distinction- it was that I got two responses that contradicted each other on how the validation was structured. Sundae's post cleared things up.
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# ¿ Jul 3, 2015 16:32 |
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Zerstorung posted:I've been stuck as an autoclave bitch for a year and a half now. The company I work for seems to be outright opposed to training me for career advancement despite getting really good performance reviews and being way ahead of the promotion curve for my position. Usually the line I get is "those jobs are really tough, are you sure you aren't happy staying here?" Zerstorung posted:being way ahead of the promotion curve for my position
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# ¿ Aug 20, 2015 16:33 |
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Sundae posted:On a different note, I just received a call from an HR recruiter at Genentech asking me to apply for a certain position at their main HQ in South San Francisco. Gyahahaha, it's happening! Let me know when you're in town to give the PhRMA annual keynote, we'll do lunch.
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# ¿ Sep 1, 2015 00:22 |
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outlier posted:Ah, thanks. I adopted it years ago when I joked that a colleagues child should be christened "statistical outlier". Been worried that the Gladwell book makes it look pretentious. Give him a rundown on multiple comparisons problems- the drive to apply control conditions is noble, but doing so without theoretical reasons is a fishing expedition for errors with a pre-stocked ice chest.
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# ¿ Sep 19, 2015 19:09 |
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outlier posted:In my previous job at Governmental Scientific Agency, we were reorganised about once a year so that we could "the best <governmental scientific agency> in the world". Of course, it was important to involve the staff and allow feedback, so we were given a steady stream of surveys asking "What do you think about our proposal to rename the Division of Foo to Foo Division, to make it more dynamic, responsive and help us become the best <governmental scientific agency> in the world?". When we answered in the negative, the reply was alway, "No, you're wrong. The Foo Division will be more dynamic, responsive and help us become the best <governmental scientific agency> in the world." It sounds like my dream jorb (well, I'm interested in the policy side of things, so I want to be the one renaming divisions).
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# ¿ Oct 5, 2015 13:47 |
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To be more serious, I am actually planning to head to some division of federal research administration, so information on how to make that suck less would be helpful. You guys like narrow RFPs, right?
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# ¿ Oct 5, 2015 18:13 |
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Epitope posted:Yes when they include my interest/expertise, no when they don't Well, I guess you'd better meet me at a cocktail party in Georgetown! ...the research funding system needs reform, but I'm still a number of years from having any leverage in that area. Someday.
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# ¿ Oct 5, 2015 20:31 |
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outlier posted:* Government or public health type gives a talk that is greeted with absolute silence from the audience Tell me about the cause of this one- I'm genuinely curious.
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# ¿ Oct 22, 2015 17:37 |
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Epitope posted:When I've seen that it was that the entire audience was focused on research research research, and then here's this guy talking about something, and ya ya ok i get it, when is he going to get to the results, show me the data, wait its over. There was no data, nothing to grapple with, so I don't have anything to say about that. Cuz I'm just in the research mode. Also this sounds suspiciously like service, giving my time for- sure something that is important, but taking precious time from research research research. If I speak up that means I am volunteering. Eugh, tragedy of the commons. Thanks, that's helpful (my career will partially involve having to give similar talks).
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# ¿ Oct 22, 2015 23:30 |
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Dik Hz posted:I got to help build a lab about that size two years ago. My contribution was the 3000 sq ft analytical lab. If you have any questions, go ahead and shoot. I'm not an expert, but I did learn a lot. My biggest success was putting all the analytical equipment on center aisles on adjustable height tables. I left a 2 foot walkway between the tables so servicing the equipment is really easy. I then dropped utilities on posts from the ceiling to hook them up. Extremely functional. You guys really ought to have a contracted specialist be doing that design work. There are default best practices for this sort of thing.
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# ¿ Nov 27, 2015 20:31 |
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Bastard Tetris posted:If you have anyone you'd like to recommend, reply or PM and I can check them out. Sorry, the people I know best focus on academic medical centers, and are usually brought in at the institutional level. These guys also have a solid reputation. I'm not sure either group does the granular work you're looking at at this point. If you're running a larger scale (capital) lab project, though, ask for Bob Marriott. He developed most current research space planning practices. Discendo Vox fucked around with this message at 19:40 on Nov 28, 2015 |
# ¿ Nov 28, 2015 19:36 |
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An unrelated question to those involved in the conversation above, from someone working primarily in social sciences: How long did it take you to stop seeing "amine" as "anime"?
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# ¿ Jan 13, 2016 02:04 |
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Anyone have experience with tracking down a medical device approval? A startup's new-ish product is making some rather iffy claims in its spate of paid push pieces online, and I'm having trouble locating them or their product in FDA databases.
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# ¿ Apr 6, 2016 14:19 |
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Sundae posted:I'm finding nothing relevant in the 510(k) or PMA databases. Their e-mail and chat contacts provide auto-responses indicating that it's "outside business hours" in Venice Beach CA (ha). That's exactly what I'm thinking, and what I saw. I'm going to check around a bit more, then nail them to the wall. They're already giving away free samples! ...If I were smart I'd also make this into a publication. Hm. Discendo Vox fucked around with this message at 19:29 on Apr 7, 2016 |
# ¿ Apr 7, 2016 19:11 |
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MickeyFinn posted:What do you do for work? You sound like a lawyer and not a scientist, but your presence in this thread indicates lawyer-scientist? Phil Sci bachelors, law degree, getting a social science and bioethics doctorate, aiming for reg work. My underlying ethos is the maximization of outstanding student debt.
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# ¿ Apr 7, 2016 21:24 |
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ahahahahahahaaahkill me
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# ¿ Oct 19, 2016 16:21 |
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The ban (on chimpanzees) is unfortunate, but the cost intensive nature of maintaining primates for research, plus the development of alternative models, means it hasn't done much harm.
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# ¿ Nov 17, 2016 03:57 |
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Appachai posted:I have to interview someone who has worked in QA QC for theranos for 5 years tomorrow. wtf is this hiring manager thinking They might be a state's witness.
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# ¿ Mar 23, 2017 09:57 |
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vivisectvnv posted:To be fair, the whole theranos story is a combination of actual really bad decisions on the PR/Regulatatory/Transcperancy, but the technology itself is kind of amazing Are you referring to the micro testing technology that turned out to be fake and fraudulent?
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# ¿ Mar 23, 2017 23:21 |
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Why would they feel the need to do this? It's apparently a concern about something after hours...
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# ¿ Mar 29, 2017 21:55 |
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Peter Thiel, noted socipathic monster with a love of pseudoscience, recently funded a clinical trial for a herpes vaccine. By "trial", I mean he paid the academic researcher, William Halford, to send participants to St Kitts in the Caribbean, and did...whatever the trial was without Institutional Review Board oversight. Institutional Review Boards (IRBs) are the backbone of research participant protections and most research ethics in the US, and are required by law several different ways for and FDA drug trial run by a scientist with academic affiliations. I was really worried that this ws to set up a scenario where the FDA, under the control of a Trump appointee, would use the study to justify unraveling IRBs and the decades of research protections they entail. Well it turns out Halford sent the study in for peer-reviewed publication. I'm not so worried anymore. Crossposting from pseudoscience thread because I thought folks would enjoy the most rigorous methods of drug development that money can buy. Discendo Vox fucked around with this message at 06:49 on Aug 30, 2017 |
# ¿ Aug 30, 2017 06:37 |
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# ¿ May 12, 2024 03:53 |
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buglord posted:I mean, they called me when I was in the drive thru of a burger joint, and because my phone was paired to my car a weird way, they heard the music I was playing. But I guess that didn't scare them away either. So here's hoping something positive happens! Post the music.
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# ¿ Sep 11, 2017 07:57 |