Critical Path Institute: Leveraging Tech, AI for Future Drugs

Looking ahead, Critical Path Institute CEO Dr. Klaus Romero sees the drug development industry at an inflection point.

“We’re needing to develop therapies that are leveraging technologies…that are at the true cutting edge of the intersection of science and people’s needs,” he said. “Gene-based therapies, cell-based therapies, anti-sense oligonucleotides–those types of products have the potential to be really transformative, but there are also innovative small molecules that can have major impact too.”

Yet, those possibilities reinforce the need to make sure potential risks and harms are equally as understood as the potential benefits, Romero said. C-Path’s core competencies are well-positioned to provide that analysis. 

Take artificial intelligence, or AI, which C-Path has actually been utilizing since 2016. 

“We recognized then that this was something that could have a transformative power and we started working on building the first foundation for us to start integrating artificial intelligence into the development of our drug development solutions,” he said. “Now, we have an advanced approach that keeps evolving.”

Moving forward, Romero noted AI’s vast potential in drug development will require proper checks, which C-Path, as a trusted neutral party, can offer. “More specifically, how can we be sure that a given AI solution is actually doing what it’s supposed to do to inform a drug development decision.”

The increased usage of digital health technologies, such as smart watches and phones, and other wearable sensors, will help elevate patient data, as long as they consistently capture meaningful information.  The algorithms that process such data also must be reliable. The FDA and EMA have already issued guidance on their usage in clinical trials.

For example, C-Path VP of Neurology Dr. Diane Stephenson noted these tools’ utility for Parkinson’s patients to track their experience. “Their experience with the disease changes, not only each day, but within the day. It’s highly variable. So, if you expect that a doctor visit every six months or a year is going to be able to accurately predict a patient experience? How would you know if a drug worked?”

“This is just the beginning of those devices,” Stephenson said. “I can only imagine they’re going to get more and more sophisticated.”

Added Romero, “As we advance in those areas that will have a bearing in unlocking the potential of all drugs to be used for new kinds of indications, that’s where I see the future in advancing the science.”

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