As someone who works on human heritable gene editing (HHGE), I find this post overly optimistic. The safety concerns are real and complex, the clinical utility and validity of polygenic risk is still unproven, and the regulatory barriers at least in the U.S., are huge (no NIH funding, no clear FDA path). More than likely embryo selection using pre-implantation genetic testing for polygenic disease (PGT-P) will continue to expand before HHHE becomes a reality. Even then, requiring IVF will limit utilization due to cost and risk. The one thing that might be a game-changer though is in-vitro gametogenesis (IVG). But that’s still 10-20 years off.
Thanks, Paula! I agree with everything you’re saying! And at the same time, I think we’re in a moment where the trajectory of this field is shifting faster than most realize. You certainly know better than me that the safety concerns are complex, the clinical utility of polygenic risk scores remains unproven in many contexts, and the U.S. regulatory barriers are steep. But I also see that what once felt like insurmountable obstacles in gene editing—whether technical, regulatory, or social—have a tendency to erode when breakthroughs accelerate.
I completely agree that embryo selection via PGT-P is the most immediate and likely near-term application, but that doesn’t preclude heritable gene editing (HGE) from following sooner than expected. Multiplex editing technologies are advancing at an astonishing rate—what we’re seeing with CRISPR-based precision, efficiency, and delivery today is vastly different than what was possible even five years ago. The transition from “we can edit a gene” to “we can edit hundreds in parallel with precision” is not just an incremental step—it’s a paradigm shift.
Regulatory and societal hurdles are massive, but they aren’t static, and recent years have shown us that first hand for better and for worse. The lack of an FDA pathway today doesn’t mean one won’t emerge, especially as international efforts push forward. We’ve seen time and again that once technologies prove their utility—particularly in reducing severe disease burden—policy frameworks adapt (even if slowly). It wasn’t long ago that mRNA vaccines faced skepticism, and now they’re a cornerstone of modern medicine.
IVG is absolutely a game-changer in this equation, and I agree it’s still 10-20 years out for clinical application. But if we’re talking about when HHGE reaches widespread adoption, we should consider how quickly IVG could lower barriers to entry by eliminating the need for traditional IVF, making the entire process more accessible. The confluence of these technologies—multiplex editing, improved embryo selection, IVG, and AI-driven genetic prediction models—suggests that while the future may not be evenly distributed, it’s arriving at an accelerating pace. AI in the last two years has shown us that technology can surprise us, and my broader point is always that policy has a hard time keeping up.
So, while I fully acknowledge the major challenges ahead, I still believe that we’re underestimating the speed at which HGE will transition from theoretical to practical. The history of biotech has repeatedly shown that the distance between “that’s impossible” and “we’re piloting it” is often shorter than expected.
Thanks for such a thoughtful comment—it’s exactly this kind of conversation that makes TCIP worth writing! I appreciate you sharing your expertise to keep me honest.
As someone who works on human heritable gene editing (HHGE), I find this post overly optimistic. The safety concerns are real and complex, the clinical utility and validity of polygenic risk is still unproven, and the regulatory barriers at least in the U.S., are huge (no NIH funding, no clear FDA path). More than likely embryo selection using pre-implantation genetic testing for polygenic disease (PGT-P) will continue to expand before HHHE becomes a reality. Even then, requiring IVF will limit utilization due to cost and risk. The one thing that might be a game-changer though is in-vitro gametogenesis (IVG). But that’s still 10-20 years off.
Thanks, Paula! I agree with everything you’re saying! And at the same time, I think we’re in a moment where the trajectory of this field is shifting faster than most realize. You certainly know better than me that the safety concerns are complex, the clinical utility of polygenic risk scores remains unproven in many contexts, and the U.S. regulatory barriers are steep. But I also see that what once felt like insurmountable obstacles in gene editing—whether technical, regulatory, or social—have a tendency to erode when breakthroughs accelerate.
I completely agree that embryo selection via PGT-P is the most immediate and likely near-term application, but that doesn’t preclude heritable gene editing (HGE) from following sooner than expected. Multiplex editing technologies are advancing at an astonishing rate—what we’re seeing with CRISPR-based precision, efficiency, and delivery today is vastly different than what was possible even five years ago. The transition from “we can edit a gene” to “we can edit hundreds in parallel with precision” is not just an incremental step—it’s a paradigm shift.
Regulatory and societal hurdles are massive, but they aren’t static, and recent years have shown us that first hand for better and for worse. The lack of an FDA pathway today doesn’t mean one won’t emerge, especially as international efforts push forward. We’ve seen time and again that once technologies prove their utility—particularly in reducing severe disease burden—policy frameworks adapt (even if slowly). It wasn’t long ago that mRNA vaccines faced skepticism, and now they’re a cornerstone of modern medicine.
IVG is absolutely a game-changer in this equation, and I agree it’s still 10-20 years out for clinical application. But if we’re talking about when HHGE reaches widespread adoption, we should consider how quickly IVG could lower barriers to entry by eliminating the need for traditional IVF, making the entire process more accessible. The confluence of these technologies—multiplex editing, improved embryo selection, IVG, and AI-driven genetic prediction models—suggests that while the future may not be evenly distributed, it’s arriving at an accelerating pace. AI in the last two years has shown us that technology can surprise us, and my broader point is always that policy has a hard time keeping up.
So, while I fully acknowledge the major challenges ahead, I still believe that we’re underestimating the speed at which HGE will transition from theoretical to practical. The history of biotech has repeatedly shown that the distance between “that’s impossible” and “we’re piloting it” is often shorter than expected.
Thanks for such a thoughtful comment—it’s exactly this kind of conversation that makes TCIP worth writing! I appreciate you sharing your expertise to keep me honest.