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Developing a cancer drug without Big Pharma: this hospital shows it can be done

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Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#51

Post by ramraj07 »

prox wrote: post #48
ramraj07 wrote: post #41

Earlier quoted context omitted.

Got my PhD from a lab that works on antibody drugs, they eventually even released one to the market. I’d argue that our current system is broken. There’s no reliable metric of drug effectiveness in any of our pre-clinical models, and thus we end up going into clinical trials quite blind indeed. And more often than not, what drug gets into trials has more to do with ego and politics than actual scientific merit. And t…

Is this a market that can be disrupted? It sounds if you know how to save a few billion and introduce more science based drugs, it’s ripe for an overtake.

Absolutely, and if you recall, even YC tried to get in on this idea.

Except they did the same mistake anyone who comes up with this disruption plan commits (including Google with Calico, or Zuck with CZI) - they recruit existing academics to do the disruption. Unfortunately this just fails miserably because they’re culturally corrupted to think of standard dogmas (like there can never be a single cure for cancer). I remember a time when other such dogmas existed (remember how it was considered impossible to de-differentiate somatic cells?).

The other mistake tech bros make in biology is they think they can make any cool idea work if they are smart enough. Because this is actually true in tech. But biology is restricted by laws of nature. If a drug doesn’t work, it can’t be made to work. There’s no room for wishful thinking.

Third mistake I see often is individual bias towards fields that they come from. Someone who has an RNA background will only try to use RNA to solve everything, likewise with antibodies, or imaging, etc. The current research funding system incentivizes such thinking and it becomes entrenched in anyone already in this field. There’s never a thought of “which is the exact technology and approach I should use to solve this problem independent of what I’m an expert at?” So a lot of projects are doomed from the start.

As long as you’re cognizant of these three facts, I think it’s very possible to disrupt this field.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#52

Post by yread »

refurb wrote: post #46
EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

Exactly. I work in this field. Doing phase 3 clinical trials costs between $5,000 to $20,000 per patient per year. This particular drug did a phase 3 with 423 patients for 2 years, so you're looking at a cost of $4M to $16M just for this one trial alone. Then add on top all the CMC (manufacturing) research that needs to happen, the regulatory filing work, etc, etc. Unless someone has a few hundreds of millions sittin…

When hospitals are contracted to do work in a clinical trial setting they take their costs and multiply it by 10 (at least). This was done in house with in house resources. This hospital has its own pharmacy that can synthesize drugs and give it to the patients. The pharmacy probably charged just the material costs internally and not for the time.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#53

Post by raxxorraxor »

DrScientist wrote: post #49
ramraj07 wrote: post #41

Earlier quoted context omitted.

Got my PhD from a lab that works on antibody drugs, they eventually even released one to the market. I’d argue that our current system is broken. There’s no reliable metric of drug effectiveness in any of our pre-clinical models, and thus we end up going into clinical trials quite blind indeed. And more often than not, what drug gets into trials has more to do with ego and politics than actual scientific merit. And t…

I'd agree with a lot of that in terms of both many drugs being 'discovered' in clinical trials as oppose to earlier ( a lot of it it about choosing the right patients and dose ), and the differences in mindsets between researchers and those often involved in the clinical trial side. One of the things you've missed is the strong restrictions put on pharma in terms of promoting use of existing drugs beyond the existing…

I think the restrictions on pharma, while doctors have more freedom is quite helpful. There are some problems here as well where this freedom has been abused, but overall that isn't a problem in my opinion.

Clinical trials are long and expensive, the medical advisory board wants compensation as well. But even startups can theoretically fund new therapies if they and their medial advisory boards get subsidies. It is a lot of risk though because for most drugs or medical devices, the real effectiveness can only be determined later in the trial itself.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#55

Post by llamaimperative »

DrScientist wrote: post #50
prox wrote: post #48

Earlier quoted context omitted.

Is this a market that can be disrupted? It sounds if you know how to save a few billion and introduce more science based drugs, it’s ripe for an overtake.

In the same way Uber disrupted licensed taxis - or the big internet firms disrupted ad supported media. ie totally ignoring existing regulations, pretending they don't apply to you and just hoping you can push through. In a lot of the 'problems' are the regulations ( which are double edged and tricky to get right ) - and pharma companies are just following the rules. I think governments might be less lax in letting t…

Pointing the finger at regulation is misleading IMO. The regulations for bringing a drug to market are essentially quite simple: prove that it’s better than what currently exists.

What makes it difficult is the word “prove”

It turns out it’s obscenely hard to make a drug that’s good, and even harder to prove that it’s good.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#56

Post by llamaimperative »

InDubioProRubio wrote: post #30
EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

Does it? There is a billion people on this planet without adequate medical system - whose health is not considered worth investing into. If they get auto-diagnosed by app (zero-cost), they could volunteer for a free chemical trial (delivery of package), a application of said package (local nurse - not free) and a series of follow up scans + analysis. The office behemoths involved are optional. Whats missing is tools…

Lovely: so just give tons of people an experimental drug and collect garbage data by doing so!

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#57

Post by quietbritishjim »

JPLeRouzic wrote: post #38
quantumwoke wrote: post #29

Earlier quoted context omitted.

My wife (MD) tells me that vaccine refers to anything that induces an immune response against a pathogen or disease. In this case the vaccine causes anti-EGFR antibody production

> In this case the vaccine causes anti-EGFR antibody production English is not my native tongue so I have some problem to parse your sentence. I prefer the writing in the publication cited above [0] even if it's probably the same meaning: " CIMAvax-EGF is a therapeutic cancer vaccine composed of human recombinant EGF " [0] https://aacrjournals.org/clincancerres/article/22/15/3782/79...

It parses fine to me, but then I'm a native English speaker (and I don't claim to know whether its content is actually true). Strictly speaking, there should be a comma after "case", which may have helped you but is unusual unless you're writing something really formal.

Here's the sentence restructured:

... vaccine refers to anything that induces an immune response against a pathogen or disease. Here is how that definition applies in this case: the vaccine causes the immune system to produce anti-EGFR antibodies.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#58

Post by JPLeRouzic »

ramraj07 wrote: post #41
EternalFury wrote: post #14

Anyone can mix chemicals in a test tube and claim it’s the cure for something. That’s the easy part. Proving it’s safe and effective, that’s what requires a lot of capital expenditure. This statement is a drastic characterization, but you could say “half a dozen PhDs can form reasons to believe they may have found a cure for something”, and the paragraph would end the same.

Got my PhD from a lab that works on antibody drugs, they eventually even released one to the market. I’d argue that our current system is broken. There’s no reliable metric of drug effectiveness in any of our pre-clinical models, and thus we end up going into clinical trials quite blind indeed. And more often than not, what drug gets into trials has more to do with ego and politics than actual scientific merit. And t…

Many thanks for saying what I suspected when looking at the research publications and clinical trials on neurodegenerative diseases. I was starting to think I was an unproductive perpetual malcontent.

For example, memantine has been tested 5 times in ALS. There even no pre-clinical studies that show any positive effect of memantine in animal models. This seems so bizarre to me.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#59

Post by DrScientist »

llamaimperative wrote: post #55
DrScientist wrote: post #50

Earlier quoted context omitted.

In the same way Uber disrupted licensed taxis - or the big internet firms disrupted ad supported media. ie totally ignoring existing regulations, pretending they don't apply to you and just hoping you can push through. In a lot of the 'problems' are the regulations ( which are double edged and tricky to get right ) - and pharma companies are just following the rules. I think governments might be less lax in letting t…

Pointing the finger at regulation is misleading IMO. The regulations for bringing a drug to market are essentially quite simple: prove that it’s better than what currently exists. What makes it difficult is the word “ prove ” It turns out it’s obscenely hard to make a drug that’s good, and even harder to prove that it’s good.

> prove that it’s better than what currently exists.

So how do you do that ethically? How do you justify taking off something that you know works to some extent and try something completely new or worse placebo? ie don't you have to construct the trial in the context of existing treatments etc?

These are the kind of challenges that makes drug development slow - in the end you don't do one trial, but a series of trials, slowly building confidence and making the case.

Often that's what takes the time during the clinical phase.

Of course it would be much faster to go straight to a big trial that would show how well your treatment works in conditions optimal to it - however that kind of 'move-fast break-things' approach involves potentially breaking things which happen to be people.

Regulation just reflects the cautious 'first do no harm' philosophy.

Now let's be honest - big pharma will simultaneous complain about regulation and the cost of development, and at the same time know it creates barriers to entry - there is always some frustration about the slowest of regulatory authorities to adopt new methods - however you wouldn't want your regulatory to be gungho.

Re: Developing a cancer drug without Big Pharma: this hospital shows it can be done

#60

Post by bilbo0s »

llamaimperative wrote: post #56
InDubioProRubio wrote: post #30

Earlier quoted context omitted.

Does it? There is a billion people on this planet without adequate medical system - whose health is not considered worth investing into. If they get auto-diagnosed by app (zero-cost), they could volunteer for a free chemical trial (delivery of package), a application of said package (local nurse - not free) and a series of follow up scans + analysis. The office behemoths involved are optional. Whats missing is tools…

Lovely: so just give tons of people an experimental drug and collect garbage data by doing so!

I'm not sure people fully understand the scientific method.

All data is not reliable data.

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