Things may be different now, but worth noting that this approach was proposed for LSD research about 20 years ago and FDA was not supportive.
To me, this doesn't sound like a good use of money for a start up. But, with adjustments, it could be a good basic science project for an academic lab.
I think it would be much simpler in terms of ethics and regulatory red tape for a group not doing drug development (like the Hopkins or UChicago teams) to fundraise for study based on the RDoC framework. A study designed with this framework could look at general therapeutic effects that cut across diagnostic categories.
Having participants pay would be ethically perilous, but this should be relatively easy to raise money for. Arguably, the dubious work Fadiman and Stolaroff and crew were doing in the 60s can be read as an example of how having participants pay distorts incentives.
And using an investigator-initiated vs drug-company-initiated application emphasizes that this designed as basic research, which, given the statistics of heterogeneous samples, more likely to yield new hypothesises than conclusions.
"To me, this doesn't sound like a good use of money for a start-up. But, with adjustments, it could be a good basic science project for an academic lab.
I think it would be much simpler in terms of ethics and regulatory red tape for a group not doing drug development (like the Hopkins or UChicago teams) to fundraise for study based on the RDoC framework."
I agree it is challenging and expensive enough for companies to navigate drug approval, this would need NIH/philanthropic funding. On the other hand couldn't Pragmatic research be something that Psychedelic companies contribute to the psychedelic community? (https://chacruna.net/what-do-psychedelic-medicine-companies-owe-to-the-community/) Some form of industry-academia partnership?
I could see this working with the right people involved. A caveat is you'd want to have a real smart and efficient design to maximize learnings, maybe like a Bayesian basket trial.
It might still be hard to make it make financial sense for a for-profit. Since Phase I trials are typically around $4.5 million, which is a lot for any startup, the company's founders would want to minimize their dilution if they could. For example, the company might want to see how much of the money their funders could directly contribute to the University without it passing through the company.
Because of the cost issues, the project might work best if the company is bringing a lot of non-financial resources and isn't footing the whole bill. So maybe the company partners with an academic group that specializes in, say, anxiety disorders but which hasn't done work with controlled substances before. Then the company's access to drug and FDA IND become more compelling to the academic partner vs partnering with, say, Hopkins, who could already do the study without the company.
Things may be different now, but worth noting that this approach was proposed for LSD research about 20 years ago and FDA was not supportive.
To me, this doesn't sound like a good use of money for a start up. But, with adjustments, it could be a good basic science project for an academic lab.
I think it would be much simpler in terms of ethics and regulatory red tape for a group not doing drug development (like the Hopkins or UChicago teams) to fundraise for study based on the RDoC framework. A study designed with this framework could look at general therapeutic effects that cut across diagnostic categories.
Having participants pay would be ethically perilous, but this should be relatively easy to raise money for. Arguably, the dubious work Fadiman and Stolaroff and crew were doing in the 60s can be read as an example of how having participants pay distorts incentives.
And using an investigator-initiated vs drug-company-initiated application emphasizes that this designed as basic research, which, given the statistics of heterogeneous samples, more likely to yield new hypothesises than conclusions.
Link to RDoC framework: https://www.nimh.nih.gov/research/research-funded-by-nimh/rdoc/about-rdoc.shtml
Thanks for the awesome contribution, Matt!
"To me, this doesn't sound like a good use of money for a start-up. But, with adjustments, it could be a good basic science project for an academic lab.
I think it would be much simpler in terms of ethics and regulatory red tape for a group not doing drug development (like the Hopkins or UChicago teams) to fundraise for study based on the RDoC framework."
I agree it is challenging and expensive enough for companies to navigate drug approval, this would need NIH/philanthropic funding. On the other hand couldn't Pragmatic research be something that Psychedelic companies contribute to the psychedelic community? (https://chacruna.net/what-do-psychedelic-medicine-companies-owe-to-the-community/) Some form of industry-academia partnership?
I could see this working with the right people involved. A caveat is you'd want to have a real smart and efficient design to maximize learnings, maybe like a Bayesian basket trial.
It might still be hard to make it make financial sense for a for-profit. Since Phase I trials are typically around $4.5 million, which is a lot for any startup, the company's founders would want to minimize their dilution if they could. For example, the company might want to see how much of the money their funders could directly contribute to the University without it passing through the company.
Because of the cost issues, the project might work best if the company is bringing a lot of non-financial resources and isn't footing the whole bill. So maybe the company partners with an academic group that specializes in, say, anxiety disorders but which hasn't done work with controlled substances before. Then the company's access to drug and FDA IND become more compelling to the academic partner vs partnering with, say, Hopkins, who could already do the study without the company.
(Thanks for the signal boost in my article!)