Tuesday, April 15, 2014

No-response rejections from major university graduate programs?

I've heard anecdotal reports about major graduate programs accepting application fees and not sending any communications or rejections -- have you heard anything about this? 

(NB, it wasn't in chemistry, but it was a science/engineering field.) 

Monday, April 14, 2014

Thursday, April 10, 2014

A friendly note from the FDA

Via Pharma Manufacturing, Reuters has some tough news about GSK's API manufacturing facility (emphasis mine):
The U.S. FDA issued a warning letter to GlaxoSmithKline after determining that GSK did not take sufficient action to resolve problems after contaminated APIs were found at the drugmaker's Ireland manufacturing plant. 
The contaminated ingredient, paroxetine, is used to make antidepressant drugs Paxil and Seroxat. During an October inspection, an FDA investigator reported that paroxetine was contaminated with material from the Cork plant's pharmaceutical waste tank. According to the FDA, some batches of drugs using the contaminated ingredient were later shipped and GSK failed to notify its customers about the lapse. 
The most strongly worded portion of the March 18 FDA warning letter stated, "We are concerned that your firm does not consider the entry of pharmaceutical waste streams into your manufacturing process a significant deviation with a potential quality impact. In your response to the Form FDA-483, you acknowledged that you should have informed your customers of this incident; however, you did not describe any recent or future communication with your customers regarding the incident to rectify the prior lapse." 
GSK has responded by stating its plans to recall certain batches of Paxil from wholesalers.
From the FDA warning letter itself [I've changed the "(b)(4)" from the letter to "[redacted]"]:
...Your firm discovered that the [redacted] used to manufacture [redacted] batches of [redacted] and [redacted] batches of [redacted] was contaminated with material from your pharmaceutical waste tank, which contained APIs, intermediates, and solvents. (emphasis CJ's) Examples of chemicals that are collected in the waste tank include [redacted]. Your firm became aware of this contamination in January 2012 and completed risk assessments to determine the impact on the quality of [redacted] manufactured using the contaminated solvents on April 19, 2013. Your firm distributed [redacted] shipments of [redacted] potentially contaminated [redacted] batches after becoming aware of this significant deviation. In contrast, [redacted] batches made with the contaminated [redacted] were rejected. 
Quality impact assessments were made for both [redacted] and [redacted], but we note that the approach taken in the two assessments was different. For instance, the [redacted] assessment noted that the standard release testing did not detect significant quantities of contaminants in the potentially impacted [redacted] batches, but that additional testing on [redacted] from [redacted] showed the impacted batches were exposed to significant amounts of [redacted]. The assessment states that the sample preparation used in the [redacted] sample release testing appears to be incapable of complete extraction of the potential contaminants, and it therefore relied on results obtained from the additional testing from the [redacted] of [redacted] product to demonstrate that the [redacted] batches were impacted by the pharmaceutical waste contamination event. Your firm’s assessment for [redacted] included no such additional testing and relied on the [redacted] samples’ passing test results, concluding that there was no quality impact to the [redacted] batches....
...Please also describe why the quality assessments appear to assume uniform distribution of contaminants following addition of [redacted] to the waste stream and before the backflow of contaminants into the [redacted] tank. Provide a revised quality assessment for [redacted] that clearly describes all calculations used to support the conclusions, and clearly describe any altered conclusions after addressing the issues described in this letter. For each analytical method used to support your conclusions, provide method qualification information, including the limit of detection for each potential contaminant. Also, provide a quality impact assessment for your [redacted] product, which was also manufactured using [redacted] around the time of the initial contamination in the [redacted] tank. Describe any contact you have had with the customers of the potentially affected products and your plans with respect to the disposition of any potentially affected batches that remain within expiry.  
(You have to love a letter that is addressed directly to the CEO. Wow.)

It's difficult to tell exactly what happened from this warning letter, but I am wondering if there was a tank that was somehow connected to a waste tank and something burped over? Or the wrong valve got opened for just a second? I'm confused. There's a hell of a story around here somewhere.

Ultimately, what is really bad is that rather than trashing the batches, they decided that they could continue processing. While it may have saved them a batch or two of product, it sure seems like it has made much worse headaches later.  

The dumbest thing you will read all day

Via John Spevacek, this WSJ op-ed on the lack of petroleum engineering departments in elite universities contains an absolutely ahistorical statement (emphasis mine): 
The oil and gas industry has been historically volatile and marked by boom-and-bust cycles caused by fluctuating commodity prices, with company prospects often tied to hit-or-miss exploratory drilling. Not surprisingly, the industry has struggled with periodic brain drain since the 1980s as students looking for steady employment and career growth have been turned off by such uncertainty. 
Technological advances such as seismic imaging, horizontal drilling and hydraulic fracturing—all developed by private companies—have removed much of this volatility and changed the nature of the industry to more of a manufacturing operation. But now another source of even greater uncertainty has been injected into the mix: political and regulatory risk. This is one energy lesson that undergraduates are hearing loud and clear from their professors.
Relax, all you wildcatters, the oil and gas industry's more like making license plates* these days. Ho hum.

John has an interesting assertion about the salary direction of petroleum engineers, which is a slight bit different than the predictions of some Texas A&M professors -- hard to say who's right, though.

I vaguely agree with the author that there is a lot of ideological-not-quite-fully-economically-incentivized push for educating students in green technology. But it's easier to say "we need to train more researchers in innovative new green nanofemtoyottotechnologies" to Congresscritters than it is to say "it sure would be helpful to have some more electrochemists around here", even as they might be the same thing. 

Also, I feel the author doesn't look very closely at why some universities might have departments of petroleum engineering and some might not. It's not ideology, so much as economics and history. 

*Reference from Neal Stephenson's "Cryptonomicon", explained here

Job postings from all around

From the inbox, lots of job postings:

Pleasanton, CA: CooperVision is looking for an experienced M.S./Ph.D. chemist to be a senior scientist working new materials for contact lenses. (5+ years for Ph.D. candidate, 12+ years for M.S.)

South San Francisco and Markham, ON, CA: A variety of sales and technical positions at Fluidigm, in the United States and around the world (including a number of chemistry positions in Canada.) Sounds really interesting.

Boston, MA: Looks like Ensemble Therapeutics is looking for an experienced Ph.D. medicinal chemist.

Daily Pump Trap: 4/10/14 edition

Good morning. For now, a smattering of postings from C&EN Jobs that are interesting and/or relevant: 

Synthetic biochemistry?: GSK has a very interesting posting for organic chemists of a certain bent:
We are investing heavily in new technologies for the manufacture of our drugs under an initiative termed Advanced Manufacturing Technologies (AMT). Among these technologies the Synthetic Biochemistry team (a cross-divisional, cross-scientific function, global team) is seeking to develop industrial biotechnology and synthetic biology approaches to create new routes for manufacture of drugs. We’re also looking to enable better chemocatalytic solutions through application of smart automation and catalyst design. We are seeking people across a variety of skillsets at sites in the US (Upper Merion, PA and Research Triangle Park, NC). These new AMT roles will be embedded within the current Global API Chemistry teams at these sites with the intention of growing current capabilities or introducing new skills to the team... 
...If you are interested in a career in either chemical catalysis or synthetic biochemistry, there can be few better environments in which to pursue your ambitions than GSK. The positions will involve working within a multidisciplinary environment where you will be encouraged to expand your technical knowledge through a combination of courses, conferences and on-the-job experience. 
Sounds pretty interesting. 5 positions,  M.S./Ph.D. Having 5 people spread out over a number of sites doesn't exactly sound like the most concentrated of efforts, though.

La Jolla, CA: Calibr (the California Institute for Biomedical Research) is looking for a synthetic chemist to do a postdoc; sounds intriguing. "Profound literature search skills" is a nice one. (Sooooooooo, does anyone get the feeling that you're a molecular sherpa for the biologists in this postdoc?)

East Providence, RI: NuLabel Technologies is a polymer research company that's looking for a M.S./Ph.D. coating formulation chemist:
...NuLabel is actively searching for Coating Formulation Chemist and/or Polymer Scientist with a strong background in polymer chemistry to fill a Senior Scientist role. 
Key Activities:
  • Lead laboratory in formulation and synthesis of new material technologies to support business objectives
  • Design application-specific and client-driven polymeric coatings and plastic products
Requirements:
  • Must be an independent self-starter working at the leading edge of innovation of polymeric coatings and adhesives
  • Must have a MS or PhD in Chemistry, Organic Chemistry, Polymer Chemistry, Material Science or comparable engineering field with emphasis in polymers and their manufacture
  • Must have at least 10 years of research and development experience (preferably 5+ years in industry)
  • Good product knowledge of widely used commercial resin and emulsion systems and additives
  • Polymeric coating experience specific to emulsion technologies
  • Effective communication and social skills are imperative
  • Must be passionate, creative, independent, have initiative and be a problem solver
How much are they willing to pay this experienced dynamo? "Starting at 75,000.00" Wooooo!

(Readers, please correct me if I'm wrong in thinking that the salary is a touch (say, 10k?) low. I'm spitballin' here.)

Washington, D.C.: Technology Sciences Group is looking for a M.S./Ph.D. chemist to be a TSCA specialist.

Wednesday, April 9, 2014

Conference board: US real GDP was 1.9% for 2013

Last year, I offered cash stakes ($10) for anyone who would take the over on a over/under bet for US real GDP for 2013. Well, the US Conference Board finally (today) put the magic "actual value" asterisk on Q4:
That means that, likelier than not, real GDP for 2013 was up 1.9%, which means that I lost the cash bet to @Brandon_Vara. Brandon, e-mail me your address and I'll get you that ten-spot -- don't spend it all at once.

It should be noted that See Arr Oh, @Lewis_Lab and @UnstableIsotope all took the over, and were correct. In this particular case, I am happy to be wrong. 

We're right on schedule


Want to see chemical entrepreneurs in action?

Click here for the ACS ERC 2014 Showcase East, live from Boston, Massachusetts! (livestreamed via YouTube)

or, watch here:



Here's the official program for the day. 

Tuesday, April 8, 2014

Weird thought for the day

There's this trope that Big Pharma doesn't develop "cures" because it will ruin the market or there's not enough incentive to do so (i.e. if they can't sell lots of pills, the market won't be big enough. Here's a good example of that thinking.)

So here's Gilead's Sovaldi, which is as close to "a cure" of Hepatitis C as we've seen in a while; it sure is expensive, running about $84,000 for an entire 12-week course. Isn't this proof positive that Big Pharma will work on cures, and if it finds one, it'll just make sure that the pills are really expensive? 

Monday, April 7, 2014

Mr. Buffett's chemists (not really)

I'm not a member of The Cult Of Warren Buffet, but I enjoy reading Berkshire Hathaway's annual report. It's eminently readable as far as annual reports go -- you can imagine Warren Buffett sitting there, happily typing away on his computer. My favorite quote from Buffett was from the 2010 letter, where he publishes his advice to his managers on potentially questionable business moves (emphasis mine):
If you see anything whose propriety or legality causes you to hesitate, be sure to give me a call.
However, it’s very likely that if a given course of action evokes such hesitation, it’s too close to the line and should be abandoned. There’s plenty of money to be made in the center of the court. If it’s questionable whether some action is close to the line, just assume it is outside and forget it.
I just got done reading this year's report (via this article that talks about Berkshire falling behind the S&P 500 of late) and I was struck by this list of Berkshire's largest stock holdings. Sure seems like they're invested in a lot of chemists:
Of course, of these, only a couple (Proctor and Gamble, Sanofi) can truly have chemists at the center of their business models. (I wonder what it is about Sanofi, of all the pharma companies, that seems to hold Berkshire's interest?)

*I took the title from my mental nickname for the Burlington Northern Santa Fe railroad, which is owned by Berkshire Hathaway. BNSF trains interrupt my sleep and conversations on a regular basis.  

This week's C&EN

A variety of tidbits from this week's C&EN:
It is upsetting that C&EN would feature an image of a burned animal being probed by a spectroscopist as some kind of evidence for progress in health science and diagnostics (C&EN, Jan. 13, page 28). In fact, the decision to include the photo of this shaved, burned, and undoubtedly traumatized mouse, strongly suggests that the magazine is out of touch when it comes to matters of taste and blind with regard to ethical considerations that should surround decisions involving animal research.

I would prefer that the researchers on this team shave and burn their own skin before anesthetizing and probing each other. I am serious. Not only would it be a better story, with more gripping photos, but it might also give such researchers pause as they consider the harm and suffering they inflict on their unfortunate lab animals.

Is it any wonder that much of our citizenry continues to regard animal-based scientific studies with revulsion? I hope that C&EN will adopt changes in its editorial review that considers and rejects coverage (and implied approval) of research invoking such obvious cruelty to animals.

David Cordes
Forest Grove, Ore.
The debate around animals in medical research is a heated one to be sure; interesting to see there is disagreement on the subject amongst chemists as well.

(I have always wondered if certain chemists are more likely to go into bench chemistry because they won't have to deal with the ethical issues of animal research?) 

Saturday, April 5, 2014

A fascinating little Open Access kerfluffle with ACS Publications

I found this short piece from C&EN's Sophie Rovner pretty interesting:
Online Access To ACS Publications Is Restored After Some Customers Were Unintentionally Blocked 
On Wednesday, a blog published information about a security feature that the American Chemical Society uses to protect the stability of its website and prevent unlicensed wide-scale downloading of its content. Curious readers who then clicked on the link provided in the post ended up disabling their institutions’ access to ACS publications, which include more than 40 journals as well as C&EN. The society has already restored access for the sites of approximately 200 affected customers. 
Known as a “spider trap,” the security feature is designed to be triggered not by individual users but by automated website crawling and data extraction. 
The spider trap information was posted by University of Cambridge chemist Peter Murray-Rust after he was told about it by an unnamed source, whom he dubbed Pandora. Murray-Rust reported that Pandora found the link associated with an online ACS journal article and clicked on it thinking it would lead her to another journal paper. She then received an automated message saying her institution’s access to ACS publications had been blocked. 
Those who have clicked on the link and have unresolved issues can e-mail support@services.acs.org with their institution name, and ACS will work to reinstate access as quickly as possible.
The original blog post by Peter Murray-Rust is pretty interesting -- read the comments to see all the people who were clicking the Spider Trap Link of Doom, and then finding out that they had accidentally cut off their institution from access. (Onion headline: "Fog in Channel, ACS cut off")

I don't claim to understand all the software issues going on, but it is indeed interesting that ACS Publications is deploying these sorts of security features and willing to cut off access to an institution's IP addresses to make a point. I would love to know if these sorts of features are special to ACS or if other publishers also use these sorts of traps. From Dr. Murray-Rust's second post, it seems like they're more common than we knew...