QPS is a GLP/GCP-compliant contract research organization (CRO) delivering the highest grade of discovery, preclinical, and clinical drug development services. Since 1995, it has rapidly expanded into a full-service CRO with 1100+ employees in the US, Europe, India and Asia. Today, QPS offers expanded pharmaceutical contract R&D services with special expertise in Neuropharmacology, DMPK, Toxicology, Bioanalysis, Translational Medicine and all Phases of Clinical Development.
QPS has CLIA-certified and GLP-compliant laboratories ready fast track novel coronavirus and COVID-19 RT-qPCR/QPCR and Serological Assays, and vaccine or therapy development programs. We're known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. For more information, visit www.qps.com or email info@qps.com
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BioPharmGuy
I picked up my third mRNA dose on Tuesday. Switched it up and went with Pfizer/BioNTech this time – felt inspired to sample all the biotech company offerings. Then yesterday Spotify told me I was in the top 0.5% of users in minutes streamed this year. What a week!
-BPG
Addition & Attrition
Busy catching up on some stuff from Thanksgiving week and only did a bit of data work. Three companies added, 14 removed. Got rid of a chunk of consultants who only do marketing stuff. Summary file available on our downloads page.
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Merck/Ridgeback
The FDA advisory committee of outside experts voted 13-10 to recommend approval for molnupiravir. Not exactly a resounding vote of confidence. Efficacy was about 50%, provided the recipient started taking the drug within five days of showing symptoms. (That’s a bit better than Tamiflu, which only helps with flu if the patient takes it within two days of symptoms.)
But wait a minute - last Friday, as you were busy ignoring that mountain of dirty dishes, Merck sent out some PR that said the 50% efficacy was no longer accurate and it was more like 30%. Woof.
It’s likely the FDA will approve this product, but the Pfizer antiviral is right around the corner with a much higher efficacy (for now), so it's not likely this Merck/Ridgeback product will get much traction.
Name Game
New company launched out of Cambridge, UK last week. They decided to call themselves LoQus23 Therapeutics instead of the more obvious (and better) Loqus Therapeutics. They didn’t bother to activate their website prior to sending out the press release, so we can’t do much research on what was going through their heads when they came up with that moniker. Our best guess is one of the founders decided to use their old AOL instant messenger screen name for simplicity. 2/10
Then we have Vaccibody who decided to rebrand, which was probably a good idea. Not the worst name, but it makes you think they’re working on a vaccine that is an antibody, except their product is actually a fusion protein. They will now be known as Nykode Therapeutics. They’re from Norway and they say Nykode roughly translates to ‘new code’. Ok, guess that’s not too bad. Not much we can do but simultaneously shrug/blink/slightly frown in response to this one. 5/10
Website Roast
Where to start on this amazing piece of internet real estate Dren Bio has created. How about click on 'Leadership' to see the captain and his crew all posing in front of a marina. Why a marina as a backdrop? No way of telling - the company is not named after anything marine/aquatic. But two guys do have vests on, which is great dockside garb.
Next click on 'Contact' to find out where Dren Bio is located. They’ve drawn their own map, which makes a lot of sense these days since no one's driving all over the world mapping streets for us for free or anything. As you can see, if you feel like visiting Dren, it’s easy to get there – what you do is fly into the middle of an extranuclear DNA helix, hop on that DNA highway 101 heading south until you pass a nucleus or two, take a left at the ribosome then a right at the second mitochondria – follow the actin strand and you can’t miss it!
But if that’s not enough, scroll down a bit more to get a view of that logo in all its full-sized, difficult-to-read glory. It has a huge, lowercase ‘d’ & ‘b’ with concentric circles inside them instead of actual holes. What do those concentric circles have to do with the company name or product? Nothing. Nothing at all. The company works on antibodies, which are famously Y-shaped. Bleh. 3/10
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Qosina, a global supplier of single-use components, offers a comprehensive portfolio of more than 1,000 stock components for the design, development and manufacture of single-use systems. Leveraging over 40 years of experience as a trusted supplier of OEM medical components, Qosina provides a much-needed resource for bioprocess, vaccine production, and cell and gene therapy.
Our mission is to ensure security of supply and the best customer experience possible by helping our customers find, order and receive their required components quickly and accurately. We provide practical solutions to meet the changing needs of the bioprocess industry through innovation, technology and continuous improvement.
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Oh My, Cron
Just as soon as people finished Thanksgiving dinner in America, the world started freaking out about a new Covid variant. Do we have evidence that Omicron transmits better than Delta? Not yet, but it probably does. Do we have evidence that it evades vaccines? No. Do we have evidence that it leads to more deaths and severe illness? No. Do we evidence there is a transformer named Omicron? NO!
But by all means, whip the world into a frenzy, news media.
Here’s the thing about viruses – they do not evolve to kill you, they evolve to avoid anything that prevents their spread, meaning vaccinations/social distancing/acquired immunity. So, while there is a decent chance this one will be more infectious than Delta, there is also a chance that it will be less deadly, which would be the hoped for endgame of Covid – to become endemic and non-lethal like common cold viruses.
To reiterate, we barely know anything yet. In a couple weeks we will probably have a good idea if it’s spreading faster than Delta and if we can expect vaccines to work against it, then another 2-3 weeks after that we should know if it’s making people more or less sick.
Berlin Job Mandate
Existing law in Berlin sets a six-year cap on the length of time a science postdoc may be employed by a university. Berlin’s state government just passed a new law requiring universities to offer postdocs a path to a permanent position. It has faced near universal panning even from strong postdoc proponents, because everyone seems to agree it will lead to one outcome and that isn't more permanent positions, it’s less postdocs being hired in the first place. This was a half-baked law passed by people who don’t know what they’re talking about, so expect to see it modified pretty quickly.
They Want it All
A nonprofit submitted a Freedom of Information Act (FOIA) request to the FDA for all the documentation relating to the approval of the Pfizer/BioNTech Covid vaccine, which would be something like 13,000 documents or 329,000 pages.
The FDA, which has 10 people in their main FOIA department and dozens of requests it is already working on, suggested they had time to release about 500 pages per month putting final delivery somewhere in the year 2076. The nonprofit sued, angrily we presume.
The thing about a government body is if you don’t fund it, they can’t get as many things done. Strange, eh? What did this nonprofit expect 10 people to accomplish? It's not like they can just send files out to anyone who asks for them. Each page of a FOIAed document has to be checked over and redacted before it can be released – there are many trade secrets that cannot be revealed.
So this stuff takes time and like we said, this nonprofit is about 40th in line. They sound like a bunch of whiners, mostly because this is an absurd FOIA request in the first place. 390,000 pages. Come on.
Document Pill-aging
Speaking of Pfizer documents, their former Associate Director of Clinical Statistics allegedly uploaded 12,000 internal company documents to her personal Google Drive before quitting and taking a new job. Pfizer found out and is quite angry. (Hopefully there's a pill for that.)
Indie Vaccine
People can believe all the crazy they want, but what they can’t do, even in Germany, is inject people with a 'vaccine' they invented themselves which they had tested on a whole 100 people. Sadly, that's exactly what happened when some random guy conducted a 'vaccination clinic' at the airport he owns and injected another 50 or so people. Police did not enjoy this. Amazingly there were a couple hundred people still in line when it got busted. How they all got convinced that a random quack doctor/airport owner was a secret vaccine-making genius is a great question.
The Devil's Waiting Room
Health care experts analyzed some data and concluded that a person who visits a primary care doctor just after someone with a respiratory illness has an improved chance of falling ill with that respiratory illness in the near term.
Waaaaaaaait a minute…they’re saying being near someone with a respiratory illness can increase your chances of getting that illness? Minds blown! No one's been telling us that nonstop for the past two years.
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Featured Job
Clinical Research Associate - Premier Research
If you have a few years of experience as a Clinical Research Associate it may be a good time to move up a bit. Premier Research is looking for someone to work remotely (and on the road, of course) as their CRA II/Sr. CRA. Premier is a mid-sized company, so you won’t be totally lost in the shuffle like at the giant ones. The job posting is a bit extensive, but if you have a few years experience it should be a decent fit for you. Take a look.
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ETC.
Sour Grapes
A California vintner was so incensed that his next-day FedEx package from California to New York took two extra days he reached out to his local news station to blow the whistle on this tragedy.
He had already contacted FedEx who responded by letting him know the current terms of overnight delivery, to which he agreed, state it is not guaranteed at this time. That shouldn't be too surprising, what with the whole supply chain falling apart. But in the vintner’s words:
“They said, ‘well, it’s on our website’...who goes into a website and checks all their services?”
Who indeed.
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Featured Event
WEBINAR: A Road to Value - Maximize the Value of Every Dollar You Spend featuring Karuna Therapeutics & Coupa
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If you can't make it to the live webinar, please still register for the event to receive the recording afterwards.
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