We are looking for a biomedical engineer or materials scientist who can help us develop new minimally invasive cancer therapies, such as new materials or devices for tumor targeting and local drug delivery (percutaneous or intra-arterial).

We are one of the few interventional oncology groups in the United States with a basic science lab, large animal tumor model, and several active clinical trials, which enables us to translate new discoveries from bench to animal to bedside.

You have a PhD, master’s, or work experience in a relevant field, and are interested in inventing new medical therapies, and turning them into a reality. If you would like to apply, please email your CV and cover letter to Ed Boas (fboas@coh.org).

More information about our lab

Hello, I'm a med student and new to this subreddit. I just bought my first stethoscope (3M Littmann Classic III) and I'm looking for a good sphygmomanometer as well. Was browsing through Amazon but most didn't seem like they'd last. Will appreciate any recommendations!!

I'm currently based in Israel although I'm originally from Ireland. Both countries with relatively small populations.

I'm also asking this for a personal reason because I'm trying to track the approval process of a drug that seems to be undergoing (human) clinical trials in the US (acotiamide). It sounds extremely promising for a condition I struggle with so I have a vested interest in trying to figure out when it might become available in 'the West'.

But I have no idea how the FDA drug approval process works or even that in the country I live in - although I believe that Israel generally goes with whatever the FDA deems safe.

But to generalize this question out a little:

Take your average smaller country. To be less politically contentious, let's say Lebanon. Or Jamaica. Or The Philippines.

I presume that when the healthcare / regulatory authorities of these countries size up whether to approve a drug or not .. they're not duplicating the process every single time. Otherwise, surely each new drug that's being evaluated would have to go through 190 copycat regulatory processes.

Is it generally the case that countries follow the lead of the "big guys" -- who I guess would be the FDA and EMA?

I've also noticed that it's commonplace for drugs to be approved for use in some countries (acotiamide is already being used in Japan and India) before they get approved in more developed ones.

Is there some reason for this? Do these countries have less weightier approval processes? I'm sure this is a really complicated system - but in broad terms, how does it all work?

Hi everyone, I’m a researcher at the University of Bath, UK. Our team is developing a wearable, non-invasive continuous monitoring platform for tracking several biomarkers, including glucose and ketones.

We have already published a proof of concept of the technology for glucose tracking. https://www.nature.com/articles/s41565-018-0112-4 (I know it is academic and quite technical, so I would advise going through it by reading just the abstract and conclusions)

We are now expanding our research towards monitoring other biologically relevant substances (such as ketones). I understand that this could be interesting to track such substances, especially to learn how food and habits alter their levels throughout the day or in the management of diabetes, especially in patients on complex insulin regimes or on SGLT inhibitors.

I’m reaching out to this community because I believe some of you might be interested in such technology, and please feel free to contact me if you want more info or even for an informal discussion!

We would genuinely appreciate it if you could provide some feedback in the comments or even by completing the survey that you can find on the following websites containing general info related to our platform: the first for diabetes and pre-diabetes(https://glucobit.co.uk/ ) and the second one for general use (https://vitalitybit.co.uk ), and please forgive me if the latter appears only sport-oriented!

Does anyone have any thought on how you would use such a device, do you see any benefit at all from its usage?

Ps. As we are a research group, we DO NOT SELL any device or prototype, we are trying to understand if you have any particular requests; so you have the chance to guide future developments of this technology!

I remembered hearing about AT-121as a non-addictive alternative to opiods without any side effects. When I Google it, it is still classified as "experimental". I am not very savvy in pharmaceutical terms and was wondering if anyone could provide links to the status and expected time frame of a commercial product might be.

Hi,

Some research shows it can help with COVID-19 infection, partially because of it's anti-inflammatory effects( and COVID-19 can cause severe inflammation response). Some say it can even protect, to some extend, against getting the infection:

https://www.researchgate.net/publication/343606475_Rationale_for_the_use_of_N_-acetylcysteine_in_both_prevention_and_adjuvant_therapy_of_COVID-19

But my question is since vaccines also can cause inflammatory response is it a good idea to take NAC after getting a shot? Perhaps this inflammatory response is actually what we want from the vaccine and we don't want to minimize it?

True or False: FDA does not work to establish that an existing off-patent drug is effective for an additional indication unless a developer (a manufacturer seeking exclusivity) decides to PAY the FDA to do so, which only happens with drugs for "orphan" diseases.

​

What led me to ask? I was at FDA.gov and read this:

"We work closely with partners throughout the government, academia, and drug and vaccine developers to explore, expedite, and facilitate the development of products, and provide guidance and technical assistance to drug manufacturers to expedite clinical trials."

here and it squares with what I had earlier seen as an apparent gap and am seeking to confirm it.

Hello, I’m not in the pharmaceutical industry myself, but I noticed that there are some drugs that are approved and sold in countries like France, Russia, Turkey, Germany, Egypt, and yet I cannot find any information about them in North America. For example, nifuroxazide is an antibacterial to treat diarrhea, it’s sold by companies such as sanofi, and yet I cannot find anything equivalent in North America.

Does anybody know why that might be the case? I couldn’t find FDA information on the drug, so is it maybe the case that no pharmaceuticals have picked it up in North America?

Thanks

Is it acceptable to obtain tier 2, 3, and 4 publications in advance and then maybe 1 tier 1 publication at the end, upon full approval? It's really expensive and time consuming to aim at only tier 1 publications for our first major therapeutic, so I want to make sure we're getting published in good places even if they aren't the super elite Nature, New England Journal of Medicine, JAMA Dermatology, British Medical Journal, etc. types of the world. We recently got one paper accepted into Dermatology Online Journal, which has a high h-factor and a good reputation. We have a tight budget so paying professors to publish in top journals on our behalf is an unrealistic option at this time. We sent out a few feeler emails to some professors and they're eager to help us for free, but obviously we can't provide the same perks a big for-profit company can give them.

Context: sole founder of a nonprofit in the pharma space. We're giving away our two treatments 100% free of charge post-FDA phase 4; everything is funded by donations at this point, so we have to be really careful re spending.

Moscow-based "R-Pharm" will become a leading manufacturer of Russia's Sputnik V covid-19 vaccine.

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https://preview.redd.it/9aiell09cn661.jpg?width=800&format=pjpg&auto=webp&s=1664b05709b81d547c8b5c8d651af0dc9c750e5a

On December 11, 2020, Moscow Mayor Sergei Sobyanin and R-Pharm Chairman Alexey Repik checked the progress of the production of the vaccine against Covid-19 in the Moscow plant. The project is being developed by R-Pharm. Wiskind provided more than 40,000 square meters of rock wool cleanroom panels, cleanroom doors and other cleanroom enclosure products for the project.

The production base will produce the flagship home vaccine "Sputnik V" developed by the Epidemiology and Microbiology Center. According to this project, when the factory reaches full capacity, it will produce up to 20 million doses of vaccine every month. The total investment in the project amounts to 8.6 billion rubles. The R-Pharm enterprise plans to start at the end of December 2020, and the first batch of Sputnik V vaccines are planned to be produced in Moscow Technopolis in January 2021. The construction of the complex located on the territory of the special economic zone "Technopolis "Moscow" took place in record time, which is necessary for the implementation of national and urban vaccination programs. The area of the new factory will exceed 20,000 square meters.

www.flashfreeze.com

https://preview.redd.it/ymwm0iiq6z361.jpg?width=2400&format=pjpg&auto=webp&s=33cb3583e4a96a1c22be296616d29522619dcefe

I’m entering a ph3 trial later this month as a patient and it has a placebo group. The trial goes for 2 years, but would this mean the placebo group can’t get an actual vaccine until after that? And that everyone in the study would be unaware of their immunity status? Or would the studies likely change to have a comparator at some point? Planning to ask the actual study rep, of course, but I’m not sure he’d know or be able to say.

Has anyone with the had any experience transitioning from pharma to medical devices?

What are the significant differences within the field as far as your role within Regulatory? Did you find one to be more challenging or lucrative? Pros/Cons? Thanks!

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Would like to ask you about what group of antidepressants (SSRI and SNRI) has less sexual side effects like decreased libido or erectile disfunction. Sertraline has a lot of them, whatever people say.
I'm interested especially in Venlafaxine.
Don't suggets any other groups of AD, I know about possible options.

View Poll

And many of them are almost unpronounceable.

What do the bits of the words in drug names mean? Examples- antihistamines and acid reducers used to generally end in -mine: diphenhydramine, chlorpheniramine, ranitidine, famotidine, etc, proton-pump inhibitors, -zole: pantoprazole, omeprazole, lansoprazole, Etc; anti-fungals, -ole: miconazole, clotrimazole, etc; pain relievers: -en: naproxen, acetaminophen, ibuprofen..;to name a few.

Now, the names seem so random, it’s hard to even know what a drug is for from the generic...

I was wondering if anyone knew of any resources for finding a list of all drug launch dates, either in the US or global? I know I can get the FDA/EMA approval dates, but a launch does not necessarily come shortly after approval. I'm also not necessarily interested in purely the US market.

What I mean by on-demand: any healthcare location using saline that was compounded on-site/at a partner pharmacy, and then packaged for particular use-cases. This is instead of getting pre-filled bags from the manufacturers.

I imagine that this is rare, given the stringent sterilization regulations from the FDA and other bodies & high cost to produce. I'm just curious if this idea has ever been floated around, even in times of crisis (e.g. national shortage, military, whatever). Or even if there is budding interest from pharma companies.

Hello all!

I am fairly new to the regulatory affairs (RA) world. I am a recent PharmD grad with no industry experience (no rotations, no internships). However, I got an amazing opportunity to pursue a masters in Regulatory Affairs and Heath Policy starting January 2021. In the meantime, I have accepted a position at a retail pharmacy to pay the bills and such.

Being that this is a new chapter in my life, I moved to the wonderful state of Colorado with no connections/network. Considering I'm starting my RA journey from scratch, I will be doing some research on the opportunities in this state. I'm originally from the east coast and am aware of the head honchos in pharmaceutical industry there. However, I am unaware of the companies here and was hoping someone can give me a taste as to what Colorado has to offer and what may be some great companies to look into considering I'll be working here for quite a while.

Thank you in advance!