notlob

I would suggest taking a more proactive approach in your relationship with the FDA, perhaps hiring an experienced consultant to either help you work with the FDA (the new "Pre-Cert" program might be worthwhile) or dial back your marketing claims to a safer position.

Right here on this Show HN you've said "Caelum is a digital therapeutic for Irritable Bowel Syndrome." This statement makes clear that you're intending for this to be used in the treatment of a specific disease (so this is a medical device and is subject to FD&C Act).

You're also said you're providing "1-on-1 digital coaching" and more specifically you "personalize each patient’s program based on their eating habits, past food trials, and demographics (age, gender, ethnicity, etc)" (so specific treatment regimens). "Minimal risk" for the FDA generally excludes individualized treatment regimens. There may be sufficient grounds to support oversight.

Can you speak a bit about how this is regulated? Are you working with the FDA Digital Health group?

For someone in the medtech space, it's been interesting to see how loosely (not at all?) marketing is regulated in automotive and tech in general. Were the FDA regulating automotive, there is absolutely no way that Tesla's driving assist package could be marketed with the name "Autopilot", for one. More broadly than just marketing, it's also amazing to me that Tesla could have released a feature (I know they've revised it since) that was designed for human supervision but did not require hands on the wheel for long stretches of time. What did the risk management look like there?

It seems premature to ask the question in the title at this juncture, doesn't it? DoJ is still investigating Holmes.

At UIUC biochemistry is offered through Molecular and Cellular Biology. It's a good program but distinct from Chemistry. Next semester sounds like sophomore fall, which would be on schedule for chemistry majors as well as biochem majors at most programs I know of.

I have no idea what bringing up ChemE has to do with anything: undergrad ChemE has little to do with chemistry and a lot to do with continuum mechanics and steam tables. It's common for engineering students to do their natural sciences classwork (it isn't called "earth sciences", that is something else) together along with major students.

This is a misstatement of what the biochemistry coursework I am familiar with looks like.

Biochem, when offered as an undergrad program, is offered through the biology department and has a number of standard biology department requirements that would be elective at best for chemistry undergrads. Biochem majors also take orgo following gen chem, just like chemistry majors.

I don’t know what “touchy-feely” means in this context, but “chem except you take orgo almost immediately” does not match with my experience at all.

What does “cognitively more demanding“ mean?

That link doesn’t address my question. It says he works at SpaceX and he works at Tesla, not the nature of the work.

He manages engineers, and he would seem to be quite effective at it (a rarity!), but being a highly technical manager isn’t the same as performing engineering work. Do you have a specific example in mind?

It’s a risk/benefits balance. Rhinovirus 39 is very low risk, especially under controlled conditions. Loneliness in the developed Western world is a growing problem, so gaining a better understanding of what impact it will have has clear benefits.

“Then, the researchers gave each participant an intranasal live-virus vaccine against rhinovirus 39...”

Joking aside, what part of this seems improperly managed by the IRB?

Will this be self-hosted? Also, why FDA first instead of CE?

Drug company employee salaries and overhead also keep pace with inflation, better than academic salaries. I don’t understand your point.

A biologic production line requires extensive upkeep: it is a living product. Costs all around are higher. There are also Phase IV activities to consider.

Bottom line, all else being equal, biologics cost more than small-molecule drugs to make and distribute.

I don’t have specific knowledge on Humira or its biosimilars, but $40 is more reasonable.

To be specific, Humira was developed from research by BASF Bioresearch (bought by Abbott) and a research consortium in the UK, so credit to the UK taxpayers is warranted; I’m not sure about the US side.

Nevertheless, government sponsored research largely does not cover the development of the drug, and those costs are somewhere in the hundreds of millions USD range on up.

It’s perhaps analogous to how list prices for college tuition aren’t necessarily reflective of what people actually pay.

It’s a complex system and the price increases are used in part to negotiate with the intermediaries like PBMs.

Biologics are a special case also due to complexities in how they (and biosimilars) are regulated, manufactured, and exclusivity periods they are granted. They certainly are not a few cents a dose to make.

Not a satisfying answer, and apologies for that, but it’s difficult to traverse with anything approaching brevity.

> For a drug that costs literally pennies per dose to manufacture.

Pennies per dose for a biologic?

Your experience is standard practice for engineering senior design (sometimes called capstone).

Perhaps so. It’s difficult to discuss anything adjacent to healthcare when it intersects with our lives in such a personal way. It’s really challenging to bridge the knowledge and experience gap as well. Insiders are the first to declare the system we have now as flawed, but it’s a very complicated machine to change. We are trying!

edit, to speak to the complexity. Up until yesterday, if you asked me if the industry should cease direct to consumer marketing, I’d say “hell yes, I’ll push the big red button myself”. Yesterday however, while watching late night TV (which I rarely do), I happened to pay attention to an ad (which I rarely do) for a biologic that could really help out a friend with a miserable chronic condition. Don’t know if it will work or not until they try, but they are exactly the right population for the treatment. None of their physicians suggested it, I didn’t think of it despite being vaguely familiar with this area of medicine, but the DTC ad was an inspiration. I still think on the balance that DTC marketing is bad, but this personal experience makes me question if the possibility of occasional successes overrides. I have no idea, but I spend a lot of time nursing my beer in the corner the pub trying to figure things out.

I can't say I understand why you selected those two organizations: the CDC doesn't have pharma manufacturing expertise that I am aware of (interested to hear of what you know on that angle); the NSF is non-medical and it's a grant agency, no labs. I should also note that even if they were chartered for this sort of work and were working on it, they would face the same source material supply problems facing commercial groups that result in some supply interruptions, and the basket of problems associated with manufacturing small amounts of drugs.

There are many non-profit and academic institutes that are working on the problem of generic drug costs holistically, including figuring out how to produce APIs (in pharma, API is active pharmaceutical ingredient) from plentiful source materials and how to produce the APIs by flow processes so that small quantities of drugs are more economical to produce. They're doing good work but it's a hard problem, experienced execs and leaders are difficult to come by, and getting funding in biotech is far more difficult than getting funding in IT. They do receive support from NIH, FDA, DARPA (making drugs at a CSH in the middle of Afghanistan is useful), big pharma (being able to make drugs cheaper is generally of interest), and philanthropic groups. Many smart and talented people are "on it!", good progress is being made, but it is a hard problem.

The clinical studies needed to support receiving approval to market the old drug for a new indication, as well as whatever lifecycle management and post-marketing surveillance activities (Phase IV) that are required. The alternate indications may be well-known but marketing for an off label indication is not permitted (as in, they actually jail CEOs and executives for that).

The exclusivity period is intended to incentivize developing old drugs for new indications. What would you suggest instead of the exclusivity window?

Much of large pharma R&D effectively happens through asset acquisition of smaller entities, and I don’t think that is reflected well by budget numbers.

Tufts numbers are generally regarded as high. Booth at Atlas puts the cost ranging from $300M for a drug that can be developed on a lean process (like Eli’s Chorus) to $1.6B for something developed by large pharma. Regardless of where in the range you are, it’s risky and it isn’t cheap.

Which brings me to my original question: if not assisted by the exclusivity provided by IP, how should drug development costs be paid for? And beyond that, how should lifecycle costs be paid for?

Parent is speaking of a different drug than the article, and it sounds like they are speaking of a new drug.

How would you propose recouping the cost of developing a New Chemical Entity into an approved drug without the exclusivity provided by IP?

For annotations and notes I love LiquidText (iOS only, http://liquidtext.net). It’s great for ebooks and longer reviews, has a nice “accordion” feature for comparing between distant pages, and can help produce nice summaries to share with others. File management is a pain, sufficient enough that I don’t use it for manuscripts. For those, I generally print them out and annotate directly. It’s really hard to beat paper.

For organization, I use BibDesk (http://bibdesk.sourceforge.net). I used Papers when it first came out, but for reasons relating to business practices I now forget I went back to BibDesk.

> I wonder if we can get some DNA from it.

From the article: “McKellar said that soft tissue and decayed blood from the tail were found in the amber but no genetic material was preserved.”

Electrical engineers do not wire houses. Electricians (a distinct profession, also licensed) wire houses. Similar to how chemical engineers are distinct from plumbers.

I'm done here, this is not going anywhere productive or enlightening.

> In this scenario, the state has redefined the meaning of "engineer" in a way that is very detrimental.

This is backwards from my perspective. Engineering has long been a licensed profession. It is only recently that a group of people have chosen, for some reason beyond me, to call themselves "software engineers" and avail themselves of the industrial exemption. I'm not a fan but the ship has sailed on that one.

> A Medical Doctor or physician implies with his or her title, authority to practice.

There are many MDs and DOs that are not licensed by their state boards and they too have to take care with misrepresenting themselves as physicians licensed to practice. The same is true of people using the industrial exemption to practice engineering, one cannot use the industrial exemption to practice before the public.

TL;DR from my perspective (PhD in engineering but not an engineer) there is a newer group people who are attempting to redefine what "engineer" means as a profession, and that redefinition relaxes education, experience, and professional conduct standards by quite a bit. I realize that like the Browncoats of Firefly I am on the losing side, and also like the Browncoats I don't like it.

Electrical Engineer is also a licensed profession.

This misses my point. My point is that while I am a "doctor" I am not a physician, and that even though I use the title in other places it's prudent to be very careful about it in a medical setting because it could be misconstrued. Perhaps it would be prudent to demonstrate similar care when addressing the government organization that cares very much about licensing engineers while one is using the industrial exemption.