savvak

5 ms·

1.
by savvak 5y ago
I'm not sure we are supposed to doxx ourselves here, but yes, I did help write the article. No problem and I really appreciate your feedback - it was the intention here to help get an understanding from technically-minded people what a
2.
by savvak 5y ago
I had quoted the section of the article regarding how the outcome payments would be calculated because you mentioned I was sidestepping the issue, but hope it is clearer now in any case! There is also a risk that too much detail might confu
3.
by savvak 5y ago
The analysis in the paper shows that once a drug goes off-patent its chance of being repurposed approaches 0%. There is repurposing of on-patent drugs while a monopoly profit can be enforced. That's not the point. The point is that inf
4.
by savvak 5y ago
Quoting article verbatim in third paragraph under heading "Solution — using pay for success contracts to repurpose off-patent drugs": Outcome payments are disbursed to the fund by payers upon success of a particular clinical tria
5.
by savvak 5y ago
Currently, private pharmaceutical drug development is seen through the patent lens because there is no other way create a scalable business model. What is needed is to convince payers (e.g. health insurers, govt, or philanthropy) to back pa
6.
by savvak 5y ago
If a pay for success model could provide more QALYs at a lower cost than patented drugs, there would be no need to limit patent protections: the model would simply outcompete the patent system. Payers would instead "buy" successfu
7.
by savvak 5y ago
Yes, it may be possible to update standard of care with a robust Phase 2 RCT that convinces doctors, especially for a pilot. Phase 3 trials for a repurposed generic would be more expensive, but a new label indication would provide further i
8.
by savvak 5y ago
Thanks for correction! Yes, it is possible to reformulate a generic but there's only a business model if you can prevent off-label competition (and a compounding pharmacy could also reformulate). This is what I mean by information abou
9.
by savvak 5y ago
Bruce Bloom who was the former CEO of Cures within Reach was one of the first people to propose using pay for success financing (i.e. social impact bonds) to repurpose generic drugs, although their focus was on rare disease (see https:&#x2
10.
by savvak 5y ago
That's the point, under the current system you can't enforce a royalty. You could theoretically use e-medical records to detect infringement, but you can't build a business case on suing individual patients and doctors taking
11.
by savvak 5y ago
As noted above, according to research, the chance of a drug getting a new indication falls to almost zero soon after generic entry - see https://pubmed.ncbi.nlm.nih.gov/33397471/ . This is because you cannot enforce a m
12.
by savvak 5y ago
Yes, this would be a pay for success contract. And a "prize" or outcome payment of $1b would not be necessary. By using a generic drug, you can enter into phase 3 trials immediately, and it can cost less than $10-15m to obtain reg
13.
by savvak 5y ago
According to research of the 197 new FDA approved drugs since 1997, the chance of a generic drug getting approval for a new indication drops to almost zero after it goes off-patent/generic - see https://pubmed.ncbi.nlm.nih.g
14.
“Pay for success” contracts – a model to develop new therapies from old drugs(crowdfundedcures.medium.com)
57 points by savvak 5y ago|30 comments