Drug Development and Approval

One of the challenges we identified in The Future of Longevity Impact Roadmap is that it developing new drugs and treatments, and getting them approved by regulators, is expensive and usually takes a long time. This applies not just to the field of longevity but medicine in general.

I think drug development and approval should be one of the subdomains we focus on in health.

I agree with your assessment. And I may add: I’ve noticed that you’ve been part of the team that created the Future of Longevity Impact Roadmap, and it is a fantastic piece of work. Kudos!

In any case, the drug approval phase is indeed a serious bottleneck in the drug development process. What’s more, our recent experience with the rapid SARS-CoV-2 vaccine development has demonstrated that it’s entirely possible to accelerate the approval process by an order of magnitude. And that’s without even mentioning the Chinese and Russian vaccines which seem to be very safe and efficient, even though they have not undergone the usual FDA / EMA drug approval process.

So yeah - it’s definitely time to transform and disrupt this field, and XPRIZE is in a fine position to do so.

I like this @NickOttens , but I think it is very focused. How would we approach it from a broader sense? Translational Medicine is coming to mind

Should we consider that a subdomain or a breakthrough?

@Lemar, @iraspastor, @efoehr, @TSeoh, @Lodder545, can I ask your thoughts on this as a potential “subdomain” for our Global Visioneering program?

We’re asking the Community to advise on areas of focus before crowdsourcing the major challenges in those areas, breakthroughs to overcome those challenges, and ideas for prize competitions to incentivize those breakthroughs.

Given your expertise in pharma and drug development, I wonder if you think this is a topic XPRIZE should focus on or not?

Click here to learn more about our Global Visioneering program, which kicked off this month.

Yes - Without a doubt - and not just for single agents, but for the eventual requirements for the combination approaches, integrating many of these therapies for rejuvenation.

FDA has thought about combinations over the years and revised their guidance (https://www.fda.gov/combination-products/about-combination-products/frequently-asked-questions-about-combination-products) but for the most part the typical modus operandi remains “study combinations AFTER single interventions” - following this model, many of us will not “survive” to see the future

We need a lot of new, creative thinking here …

Thanks, @iraspastor! If this subdomain receives enough votes, we can move it forward in the Global Visioneering process to study the problems you mention, and others, in more depth and eventually come up with breakthrough solutions. So please give it an up-vote, and keep an eye on this thread for developments!

If clinical trials can be simulated in silico, it could help a lot, I guess. So a breakthrough in the process of drug development and approval may rely on a breakthrough of such computational technologies.

That’s a good point. There are some breakthroughs in the simulation of human bodies and tissues that may enable limited in-silico trials.

See for example -

General question for the experts on this discussion thread: are current in-silico models generally considered to be quite accurate, or is the technology still pretty nascent?

From drug leads to clinical trials, many in-silico technologies involve in this field with different levels of maturity. Should we focus on the clinical trials stage which people spend most of time and money on?

I am a huge fan of the work of XCures (https://www.xcures.com/). They are both digitizing the clinical trial process AND connecting it seamlessly to the broader healthcare system to quickly get actionable insights on treatments to oncology patients.

"The xCures platform captures Real World Evidence (RWE) from patients being treated in clinical trials, compassionate use and managed access programs, virtual and decentralized studies, investigator-initiated studies, and even N-of-1 clinical studies. The platform integrates data from all these sources, effectively creating a ‘perpetual trial’ that continuously refines treatments and improves outcomes. "

The data is then shared with a sister organization, Cancer Commons, that runs virtual tumor boards to provide any patient with a second opinion or to collaborate with their doctor.

They are also running many other projects that tackle pain points. For example, they just released a new AI system to seamlessly enroll patients in clinical trials and they run crowdsourcing sessions open to the medical community and public to help individual patients that seem to have run out of options.

All of that said, it makes me think that a potential way of framing a prize could be: Any patient in the world could instantly access the data (or knowledge gained) from any other patient’s treatment in the world.

This is a little different from the challenge of speeding up new drugs and their approval, but I am thinking it might be also very useful to create awareness about the treatments that are already out there being developed all over the world.

Or, if it is important to stick with new drug development, I guess the challenge might be: Create a new regulatory approval process that is just as safe as the current process, but 80 percent faster?

I’m afraid we don’t go into regulatory issues too deeply in our competitions. For better or worse, XPRIZE is mainly concerned with technology and technological developments.

I like this idea, though -

“All of that said, it makes me think that a potential way of framing a prize could be: Any patient in the world could instantly access the data (or knowledge gained) from any other patient’s treatment in the world.”

But don’t we just want the insights from the other patient’s treatment? As the prize is phrased right now, it sounds like patients would just share information with each other about their diseases, and that’s already happening on some forums.

Thank you. Roey.

We are on the same page. All my suggestions were related to technology development.

In terms of your second point, we have insight about treatments for well-understood diseases, but not for disease like cancer. Over the last ten years, with the falling cost of technology, we have also seen many new players, startups, companies, countries try new treatments (often with publications in different languages.) If you look up clinical trial treatments for a specific cancer, there are often hundreds of trials. It’s really hard to keep up! On top of this, as we move, into personalized medicine, the data and variables get even more complex. For example, people will respond differently to a treatment based on their genetics, gender, ethnicity, microbiome and more. There are people trying to work on this problem, but a lot of work still needs to happen. Thank you!

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Thank you for the illuminating answer!

I feel like your suggestion is only one of several breakthroughs that can be used to accelerate drug development and approval. I’ll post a new one and tag you on it. Would love to hear what you think :slight_smile:

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Yes, thank you Roey! I agree there are many good options to move forward.

This is an idea that I haven’t thought through very much, but I wonder about the possibility of creating low-cost safe medical scans and images and, if we could take images more frequently, if that would speed up clinical trials results and research. For example, I believe Mary Lou Jepson is working on low-cost ($1.00 per scan/image) using ultrsound and software. From what I understand, most clinical trials runs scans every few months, but what if we could run them everyday? Would this help us identify drugs solutions that are working more quickly?

Maybe we can expect some kind of devices that can be installed at home or on mobile phones, and scan our bodies everyday or real-time, if it can be done passively.

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Actually, from my limited knowledge about clinical trials, just getting the participants to attend the monthly meetings is difficult enough. I don’t think we can ask them to get to the hospital every day just to have themselves scanned.

But maybe we can use some kind of wearable, or a home scanning device, to do that?

I just saw your answer, after I wrote exactly the same to @darlenedamm :smiley:

Exactly… :grinning:

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