Providing clinical trial support

Roey

We want to fully understand the tradeoffs of supporting competing teams in their clinical trials or not.

Such support would involve:

• Milestone awards for qualifying teams, covering the expense of submitting a clinical trial proposal to the FDA or equivalent regulatory body.
• Partnering qualifying teams with a contract research organization (CRO).
• Connecting teams with investors.
• Second milestone awards to cover teams' expenses during Phase 2 clinical trials.

The main upside is that this would allow many more teams to compete. If we don't provide support for clinical trials, the competition would likely be limited to existing start-ups and established firms.

The downside is that it would make the competition way more expensive, which would make it more difficult to fundraise for the prize, and - if we are able to raise the funds - reduce the final prize purse for the winner(s).

Are there other tradeoffs we should consider?

NickOttens

@Lodder545, @MFossel, @Jozef, I remember you weighed in on the clinical trial discussion before, so I would like to ask your feedback again. We want to understand the tradeoffs of providing teams with support to carry out their clinical trials or not.

The main upside is that it would democratize innovation and allow (many) more teams to compete. But there is a significant downside: it would make the competition far more expensive, which would also possibility reduce the prize for the winner(s).

MFossel

@NickOttens,
Thank you for asking, Nick. From our perspective, we strongly feel that the Xprize for longevity is based on flawed assumptions. Essentially, the impetus focuses upon biomarkers without attention to fundamental and effective points of intervention. Moreover, and ironically, we find that almost no one involved believes that aging can be reversed, while the data firmly support the reality of such an intervention. With that in mind, our feedback is that the choice between supporting such teams or providing larger Xprize awards is a flawed choice, one that will ultimately make little difference. As Indiana Jones said, "they're digging in the wrong place" and it matters very little whether we support such digging or provide a large prize for such digging: it's still digging in the wrong place.

Michael.

Jozef

Hello @Roey, @NickOttens,
I have something off topic, but somehow still related. Could You please make separate competition about building computer simulation as substitute or complement of clinical trials? Or at least to have it as optional milestone part for current competition.

NickOttens

Thank you for your comment, @MFossel! I think this speaks to the need to legitimize the science in this field, which is still fairly new and not well-known. Providing that age reversal can be achieved would be a huge breakthrough that unlocks investment, innovation, and hopefully regulatory changes.

@Jozef, I don't think proving age reversal in a simulation would accomplish that goal. I think we need to demonstrate biological age reversal in human beings (or perhaps pets?) to really drive this field forward.

NickOttens

@ynevies, @abartke, @james7, @MSK, @conboymj, what is your take on the tradeoffs of providing support for clinical trials in an age reversal competition or not? Are there any up- or downsides we've missed?

Jozef

Once you can achieve age reversal in simulation, then there is certain probability , that it will work in real world. Imagine to try many builds with different conditions and one of them will work. This can go to clinical trial then. Complexity of such simulation is beyond the scope of anything that humans created so far.

MFossel

Age reversal was accomplished in human cells in vitro 22 years ago, in human tissue in vitro and ex vivo 20 years ago, and has been partially (within current limits of gene transfection) accomplished in animals 9 years ago and again 8 years ago. This is not in silico, but in the lab. We intend to take it to human trials within 2 years, based on a unified systems model as detailed in the January issue of Alzheimer's & Dementia, an article that generated more than 600 global reprint requests and summarizes both the model and the technique.

Lodder545

It would be nice to democratize innovation and allow more teams to compete by funding them before the prize, but it might not be financially realistic. The average Newco would do well to take a New Molecular Entity to Phase 2 for $8-10 million. For many, it will cost more. Instead, consider sticking with existing start-ups and established firms. Winning the prize would help them attract big pharma partners.

NickOttens

Thank you so much for the feedback! This is very valuable.

I think we're leaning toward not providing teams with support to register and conduct clinical trials, in order to keep the competition simpler and more affordable, and hopefully to keep the prize for the winner(s) bigger.

@Navonica, @aaroncp1an0, @eli, what is your opinion on this?