3 ms·

If they’re at mice this is, at best, 10 years away from getting approved for humans. Immuno-Oncology is the hot new shit, a huge wave of biotech startups is be

If they’re at mice this is, at best, 10 years away from getting approved for humans. Immuno-Oncology is the hot new shit, a huge wave of biotech startups is betting everything on it. Celgene bought Juno for 11bn recently, Gilead bought Kite for 12bn. Puts tech startups into perspective :) Tres commas...

josu 9y ago
>10 years away from getting approved for humans. Isn't there a fast-track for experimental treatments for late stage cancer?
- matte_black 9y ago
  Not sure, but in the United States there may soon be easier access for any person with a terminal illness to get access to any experimental treatment if they so desire, even treatments that are in early stages with no human trials yet.
  - epmaybe 9y ago
    Yeah there's a lot of talk about "right to try" laws doing what you have described. Personally? It had better be an airtight law accounting for the edge cases that could allow certain populations to be taken advantage of. For example, if anyone with a terminal illness can try an experimental drug, could a pharmaceutical company charge for said treatment? Or use the data from trying this treatment on the patient to further their own research? I guess it just doesn't sit well with me since researchers in the US have had a history of taking advantage of certain populations in furthering progress (Tuskeegee, prison populations, mental institutions).
    - Udik 9y ago
      > Or use the data from trying this treatment on the patient to further their own research? What would be the problem with it, provided that the treatment is given for free and the patient has no other options?
      - epmaybe 9y ago
        My gut tells me that if the treatment is given for free (my original comment mentioned I was concerned if the company was charging for said treatments) then there's far less of a problem. However, there's still this incentive for a company to take advantage of this situation. Giving the treatment for free could technically be cheaper than providing the drug in a trial while also paying a participant.
        matte_black 9y ago
        So? Earlier human trials means faster to market drugs means competitive advantage.
        epmaybe 9y ago
        Without being as vague, my main concern is that a pharmaceutical company could find value in business practices that put patients, even those with terminal illnesses, at an unacceptable risk of harm that the patient may not be cognizant of. If the company begins a campaign of fraudulent kickbacks to healthcare professionals we end up with a corrupt system in which we take advantage of patients and their families. Medicine and medical research goes slowly and cautiously because we wish to protect people. To end this comment, I wish to go back to my statement that if this country goes in the direction of right to try, I sincerely hope lawmakers ensure protection of the patients that could benefit.
        epmaybe 9y ago
        I wanted to update you with some new information I remembered. There is already legislation that allows for this, called the Compassionate Use Act. The difference being that the FDA is required to be involved, giving final say on if the doctor and pharmaceutical company can administer the mtreatment to the patient.
- cryoshon 9y ago
  there is, but making the jump from mouse to humans with a therapy isn't always successful. sometimes subsequent mouse studies don't pan out, or sometimes the FDA sees something they don't like and you need more research before moving to preclinical development and then phase 1. i'd put it far sooner than 10 years assuming their concept works in humans, though.
- randcraw 9y ago
  Yes there is. The FDA calls it "breakthrough therapy". For breakthroughs, 10 years before widespread availability would be a maximum. In late stage cancer, especially where options for treatment are few, rollout could be very fast, like 2-5 years.
mft_ 9y ago
1) These drugs are already being tested in humans 2) The pathway from first-in-man to approval can be a lot shorter than 10 years for promising drugs or combinations. Pembrolizumab, for example, took roughly four years: https://en.wikipedia.org/wiki/Pembrolizumab#History https://en.wikipedia.org/wiki/Pembrolizumab#History

josu 9y ago

>10 years away from getting approved for humans. Isn't there a fast-track for experimental treatments for late stage cancer?

matte_black 9y ago
Not sure, but in the United States there may soon be easier access for any person with a terminal illness to get access to any experimental treatment if they so desire, even treatments that are in early stages with no human trials yet.
- epmaybe 9y ago
  Yeah there's a lot of talk about "right to try" laws doing what you have described. Personally? It had better be an airtight law accounting for the edge cases that could allow certain populations to be taken advantage of. For example, if anyone with a terminal illness can try an experimental drug, could a pharmaceutical company charge for said treatment? Or use the data from trying this treatment on the patient to further their own research? I guess it just doesn't sit well with me since researchers in the US have had a history of taking advantage of certain populations in furthering progress (Tuskeegee, prison populations, mental institutions).
  - Udik 9y ago
    > Or use the data from trying this treatment on the patient to further their own research? What would be the problem with it, provided that the treatment is given for free and the patient has no other options?
    - epmaybe 9y ago
      My gut tells me that if the treatment is given for free (my original comment mentioned I was concerned if the company was charging for said treatments) then there's far less of a problem. However, there's still this incentive for a company to take advantage of this situation. Giving the treatment for free could technically be cheaper than providing the drug in a trial while also paying a participant.
      - matte_black 9y ago
        So? Earlier human trials means faster to market drugs means competitive advantage.
        epmaybe 9y ago
        Without being as vague, my main concern is that a pharmaceutical company could find value in business practices that put patients, even those with terminal illnesses, at an unacceptable risk of harm that the patient may not be cognizant of. If the company begins a campaign of fraudulent kickbacks to healthcare professionals we end up with a corrupt system in which we take advantage of patients and their families. Medicine and medical research goes slowly and cautiously because we wish to protect people. To end this comment, I wish to go back to my statement that if this country goes in the direction of right to try, I sincerely hope lawmakers ensure protection of the patients that could benefit.
        epmaybe 9y ago
        I wanted to update you with some new information I remembered. There is already legislation that allows for this, called the Compassionate Use Act. The difference being that the FDA is required to be involved, giving final say on if the doctor and pharmaceutical company can administer the mtreatment to the patient.
cryoshon 9y ago
there is, but making the jump from mouse to humans with a therapy isn't always successful. sometimes subsequent mouse studies don't pan out, or sometimes the FDA sees something they don't like and you need more research before moving to preclinical development and then phase 1. i'd put it far sooner than 10 years assuming their concept works in humans, though.
randcraw 9y ago
Yes there is. The FDA calls it "breakthrough therapy". For breakthroughs, 10 years before widespread availability would be a maximum. In late stage cancer, especially where options for treatment are few, rollout could be very fast, like 2-5 years.

mft_ 9y ago

1) These drugs are already being tested in humans 2) The pathway from first-in-man to approval can be a lot shorter than 10 years for promising drugs or combinations. Pembrolizumab, for example, took roughly four years: https://en.wikipedia.org/wiki/Pembrolizumab#History https://en.wikipedia.org/wiki/Pembrolizumab#History