December 01, 2022

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Bringing compelling science to your vial-to-PFS migration project


Pharmaceutical and biotech companies are increasingly asking their CDMO partners to provide options for moving a drug product from a vial into a pre-filled syringe (PFS).


The decision to switch from a vial to a PFS is often being driven by a desire to innovate to retain market presence or strengthen market share for an indication and reduce market costs. There is also a desire to create more convenient drug products for patients, easing or tailoring administration to the therapeutic need. 


In our whitepaper, Martin Gonzalez, Ph.D., Sr. Manager Formulation and Process Development at Pfizer CentreOne discusses some of the most relevant engineering activities that are necessary to successfully deliver this kind of project.


Download the paper here:

Considerations for Migrating a Drug Product Presentation from Vial to Pre-Filled Syringe 

BioPharmGuy


Hope this extended, 9-day break from BioPharmGuy News wasn't too much for y' all to handle. The extra couple days before the weekly deadline was a pleasant experience here, and I look forward to it again next November.


Saw a bumper sticker on a parked minivan while out for a run this week. It said "Artwork IS Work". And that really got me thinking. Regardless how everyone is talking about an impending recession, unaffordable home prices and crime running rampant, it's pretty inspiring that we live in a country where unemployed people can still afford a minivan.


Speaking of America, how about that USA soccer team? Onward they go! (Condolences to our Iranian subscriber)


-BPG


Scientist Leads

As you may know, BioPharmGuy is the top source for biotech, pharma & life science company data, such as decision maker emails, drug pipelines, and so much more. However, we do not list many end users like scientists and engineers. We also do not cover the academic and non-profit sectors.


Since we've definitely gotten many requests for that sort of information in the past, we wanted to recommend checking out SciLeads.


If you're doing any marketing that targets scientists or other end users, SciLeads specializes in contact information for those types of people so may be worth a look.


Companies Added & Removed

None. Because it's the week after Thanksgiving week and we are still lazy.


Just kidding.


Over the past two weeks we added 21 companies and removed 11.


Best New Name:

Rezo Therapeutics


Worst New Name:

Aquyre Biosciences


You Will be Missed:

Dharma Biomedical


Summary file available on our downloads page.


Industry

Tevogen Bio

In 2009, when Barack Obama won the Nobel peace prize, we learned you don't actually have to have done anything to receive this award. (Nominations for that 2009 prize closed 11 days after he was inaugurated).


So we shouldn't be too surprised that the bar for simply being nominated is laying on the ground. Thus Tevogen Bio has inexplicably been nominated for the Nobel peace prize for its “work towards alleviating health inequality”.


What big ideas are they pursuing exactly? Same thing about 2,000 other companies in our directory are doing - standard drug discovery.


Weirdly, the person that nominated them is a professor who works on microbial diseases, yet medical/life sciences are not one of the academic disciplines from which professors can make nominations.


So who knows if this nomination is even formally accepted. Conveniently, none of us can know if this was a real nomination until 50 years from now, per the Nobel committee's rules. That's the earliest they will release the list of nominees.


BioPharmGuy 'bout to be “nominated” in 2024. 


PEP Therapy

How bored is your communications person when they decide hiring an intern qualifies as company news?


If you know someone who has 5-6 months to kill in France starting March 2023, let ‘em know about this gem.  


Wealthy People – Still Winning

Convicted former CEO of Theranos, Elizabeth Holmes, received an 11+ year sentence for her transgressions. She will be excused from reporting to prison until April, as she is currently pregnant. 


Not to be totally cynical, but her first pregnancy enabled her to get a trial delay, and now her second is getting her prison sentence pushed forward. 


Only a total sociopath would decide to have a baby just as she was facing 15 years in the clink. But accidents do happen, so even though she’s proven to be a liar and a generally pretty terrible person, we can’t know for sure if this pregnancy was a sentence-reducing gambit. Buuuuuut…


Anyways, 11 years seem a bit harsh considering she wasn’t convicted on any counts related to misleading customers and doctors on health-related tests. She was only convicted of ripping off wealthy people. Meanwhile, no one has seen any jail time over knowingly poisoning the drinking water in Flint, Michigan. 


And that's how American justice works.


Your Money or Your Life

The record for world's most expensive drug just keeps getting broken. The new champion is Hemgenix, a product from CSL Behring & Uniqure. It is a one-time gene therapy treatment for Hemophilia B and the magic number they slapped on this bad boy is $3.5 million. 


Get a side gig, make dinners at home for the next 456 years and you'll be good to go.

Health & Science

Covid in China

People are really lashing out against the latest lockdowns in China. This despite the government recently making restrictions a little less extreme. It seems three years is just too long to keep people cooped up, even in an authoritarian dictatorship.


And you might think a government like that would force their citizens to get vaccinated so that an orderly transition out of Zero Covid could take place. Unfortunately, only 40% of the elderly have gotten three Covid shots and China still has far fewer intensive care beds per person than developed countries. Plus fewer than 0.1% of residents have ever had Covid, so a large wave of Omicron will almost certainly lead to many deaths.


The Communist party has kept this lockdown going a lot longer than many outsiders expected to be possible, but the end may be a lot closer than it was a couple weeks ago.


Interesting fact: China is currently projected to spend about $240 billion on Covid testing this year (1.5% of GDP), never mind manpower enforcing lockdowns, etc. Dystopianly, Covid mitigation is a pretty important part of the Chinese economy at the moment.


The Disease fka Monkeypox

The WHO has finally caved to indignant Mandrills everywhere and made an official name change recommendation from Monkeypox to MPox, which is, admittedly, a pretty cool name.


Of course, British parliament members are known as MPs, so we will sit back and wait for them to demand a re-rebrand.


Jackpot

A reproductive cell bank has released a small analysis indicating an increase in sperm quality when donors use the available virtual reality headsets during the donation process.


There is no clear theory why that might be, but Mark Zuckerberg may have finally found a use case for his $36 billion Metaverse.


Panacea Peddler

A longtime reader has reported an Instagram spammer is hawking micro-doses of psychedelics alleging the following benefits: 


“helps fight cancer, focus, good for your heart & bones, helps anemia, anxiety, depression, PTSD, PMS, inflammation, immunity, weight loss, physical energy, stamina, emotional balance, problem solving skills, focus, emotional openness, spiritual awareness, creativity, trauma, neuro movement problems and many more”


The last part may be the hardest to believe - many more than every possible ailment?


We long for those simpler times back when drug dealers just sold stuff to get people high.


Liver Let Live

A large study investigated data from 2005 to 2021 and concluded there was a 21% increase in organ donors and a 26% increase in transplant surgeries when motorcycle rallies are held nearby. Not that anyone needs to be told a motorcycle is a dangerous mode of transportation, but putting numbers like this on it should be unsettling to all.


And yes, the study controlled for the fact that motorcycle rallies are held in motorcycle country. The increase was shown relative to the numbers in the region both four weeks prior and four weeks following the rally.


So if you need a kidney, guess you could do worse than moving to Sturgis.


Pace Maker

A cardiologist runs a half marathon, and on the way encounters not one, but two people having cardiac arrest and proceeds to save both their lives in the process. It’s a Twitter thread of bad and good luck


Chin (Slightly) Up

Christmas is coming and, as ever, consumer medical devices are all the rage at Sharper Image. This year treat your loved one to a massager that may or may not reduce their double chin while sparing them the trouble of actually working for that outcome.


And look, Sharper Image helpfully only shows us the skinny "After" model, who seems to be falling asleep in her chin sling. Soooo relaxing.

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