Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉

Professor @Pennmedicine We create #CellTherapy #Genetherapy - @TmunityTx & @CapstanTx CoFounder, Past President @ISCTGlobal, @PNASNexus AE

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

🎙️Excited to announce the website for Ring That Bell 🔔 which I co-wrote w internationally acclaimed Irish country music artist @mags__mccarthy. It tells the emotional story of a cancer patient facing relapse and the fierce advocacy, support, and groundbreaking science that offer new hope.
#cancer #cancerresearch #immunotherapy #hope
https://t.co/K1SYmoiqHV

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

Historic. Daraxonrasib did not come from nowhere. It stands on decades of #NIH & #NCI supported work on RAS biology to tackle one of cancer’s most stubborn “undruggable” targets.
Credit Revolution Medicines for execution and clinical development. We should also credit the public federally funded research ecosystem that made the target, tools, and translational path possible.

[Mark Lewis, MD, FASCO @marklewismd]

Cheers, chills, and a standing ovation when RASolute 302 showed unprecedented survival on daraxonrasib for patients with progressive pancreatic cancer

Seldom do you sense you’re witnessing a historic moment in cancer care but this feels like ras targeting has arrived

#ASCO26

[Fyodor Urnov @UrnovFyodor]

Every journalist who interviews this vile charlatan is doing one thing: giving her a platform to continue spewing ignorant self-serving garbage.
SHE DOES NOT KNOW ABOUT ZOLGENSMA.
Just think about what that means.
Why, @jennykleeman? WHY did you choose to write this piece?

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

Kudos @JMaraganore! Where are the other voices? Pharma CEO silence is complicity in the destruction of U.S. science

[John Maraganore 🇺🇸🇬🇷🇺🇦 @JMaraganore]

Agree with ⁦@steveusdin1⁩ here! This is bad policy!

“The OMB’s proposal…. would explicitly subordinate expert peer review to political gatekeepers and make ideological alignment with the administration a prerequisite for funding.”

https://t.co/3PyRC3xdYh

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

🚨NEW #celltherapy in @NEJM #2 - The power of T cell immune augmentation and stem cell transplantation as therapy. Virus-specific T cells and durable control of devastating opportunistic infections such as JC virus in PML https://t.co/dnUIHu0qJ5

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

🚨NEW #celltherapy in @NEJM #1 - Proof of concept: iPSC-derived engineered heart muscle may remuscularize failing myocardium & improve function. Translation will hinge on durability, immune suppression, surgical delivery, arrthymia risk, scalable manufacturing, and if benefit holds in randomized trials. https://t.co/qgDeuAD7TV

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

@ISCTGlobal Clinical Applications Program for Fellows
Forty fellows. Two days. One community that lasts a career. #celltherapy #genetherapy #careerdevelopment
https://t.co/ngSY7d3hhd

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

One and done gene therapy for high cholesterol? More data needed but IMHO this is the type of paper that will be taught for years to come. In Vivo Base Editing of PCSK9 with VERVE-102 for Hypercholesterolemia | New England Journal of Medicine https://t.co/e7QGFH1EtI

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

Broad bans on China-originated biotech assets or clinical data won’t stop Chinese biotech. They will reroute value to Europe, slow U.S. companies, reduce patient access, and weaken American competitiveness.

[Peter Kolchinsky @PeterKolchinsky]

The paradox of biotech protectionism: Why walling off China biotech weakens America

US ban on Chinese biotech/trials would return pharma leadership to Europe, slow US patient access to new meds, & lead to US dependency protectionism claims to prevent.

https://t.co/DJAkWQfd5X

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

China is uplifting scientists, investing hundreds of billions in R&D, and accelerating clinical trials. The USA is not and must reverse the current path.

[Rep. Jake Auchincloss 🟧 @RepAuchincloss]

Asked mid-season about the Yankees, former Red Sox General Manager Theo Epstein once said that he had looked at their roster at the start of the season, realized that they'd win 100 games, and now ignored their weekly standings in order to focus on his own roster's ability to compete.

I raised this anecdote at a recent roundtable of experts discussing China's rise in biotechnology. China is uplifting scientists, investing hundreds of billions in R&D, and accelerating clinical trials. It's going to win 100 games. The center of biomedical gravity is moving to China from America, just like it moved from Europe to America at the close of last century.

Unless America decides to win 110 games.

https://t.co/8H4eCKOzb8

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

@endpts The China question is tearing biotech apart
IMHO the US needs to run faster, trying to stop China is not the way to go https://t.co/YLja1rCtK5

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

The US is about to be overtaken by China in innovation. China R&D investments increased almost 6X from 2007 to 2023, overtaking the EU’s and coming close to US figures. Chart at https://t.co/Uqoppn85dW and @Statnews series America Science Shattered below

[Helen Branswell 🇨🇦 @HelenBranswell]

The destruction of the enterprise of US academic science has been one of the most confounding aspects of a hugely confounding year. My @statnews colleagues are writing about the consequences for individuals & the country.
You want to read this series.
https://t.co/XOJ8eiiVCC

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

US congressional commission is escalating its warning that the US could soon be eclipsed by China in biotech. The window is closing faster than anticipated, especially through faster clinical trial infrastructure. #FDA https://t.co/TINixdpnLU

[Prof Peter Hotez MD PhD DSc(hon) @PeterHotez]

America is eating its young. We’re a nation built on the greatness of our research universities, it’s what gave us the Manhattan Project, victory in the Cold War, over HIV/AIDS. Our future depends on a robust NextGen of scientists. But we traded it for wellness influencers, climate denialists, and phony MAHA ideologies that more resemble a twisted Lysenko version of Stalinist Russia in the 1930s and 40s

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

My China vs. US innovation thread https://t.co/8uM1RO9WO7

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

The US is about to be overtaken by China in innovation. China R&D investments increased almost 6X from 2007 to 2023, overtaking the EU’s and coming close to US figures. Chart at https://t.co/Uqoppn85dW and @Statnews series America Science Shattered below

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

Every word👇 is true. Plus #NIH funding. Plus H-1B for foreign born scientists. China is overtaking the US #innovation #celltherapy #genetherapy

[Houman David Hemmati, MD, PhD @houmanhemmati]

🇺🇸 🇨🇳 I was on @foxnewsnight tonight discussing something that should concern every American in the context of the U.S.-China summit.

For decades, the United States has led the world in biotechnology. Cell & gene therapies & advanced biologics — the medicines of the future — are finally delivering real hope to patients with diseases that were once untreatable or incurable. These are not incremental improvements. They are transformative.

But here’s the reality we can no longer ignore: roughly half of the global investment capital in advanced biotechnology is now flowing to China.
This isn’t just about money or market share. It’s about who will control the next generation of life-saving treatments. When capital, talent, & manufacturing shift overseas, American patients lose access, American innovation slows, and our strategic position in one of the most important industries of the 21st century erodes.

China is not playing by the same rules. They are moving aggressively to dominate cell and gene therapy, while we continue to tie ourselves in regulatory knots and send mixed signals to the companies trying to develop these therapies here at home.
We cannot afford to watch this happen. The patients who are waiting — children with rare genetic diseases, adults facing terminal conditions, families desperate for options — don’t care about bureaucracy or politics. They care about whether these treatments reach them in time.

The FDA has an essential role to play in this moment. We must modernize our approach so that we can accelerate safe and effective innovation here in America, while maintaining the rigorous standards that have made our system the global gold standard. If we fail to do this, we will not only lose our leadership — we will fail the very patients we are supposed to serve.
In my career, I’ve seen what’s possible when regulation keeps pace with science, and I’ve seen what happens when it doesn’t.

The video of my appearance is below 👇 . I’d love to hear your thoughts.

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

Agree. Bring back the experts, both in advisory committees and as FDA staff scientists and reviewers

[Houman David Hemmati, MD, PhD @houmanhemmati]

The FDA Commissioner role is open. This is a pivotal moment for American medicine — & for American patients.

Here’s what I believe the next Commissioner should stand for. Not as a wish list. As a baseline.

🔬 1. BRING BACK THE ADCOMS — AND MAKE THEM COUNT.
Advisory Committee meetings are one of the FDA’s most powerful tools for transparency. They should return in full force. Open. Public. And real.

Patients, doctors, scientists, advocates, & skeptics should all be able to speak. But if you want to speak, you fill out a financial conflict-of-interest form under penalty of perjury — & you read it out loud at the podium before you say another word. Every single person.

And if the issues are complex and the science requires more than one day, then take the time. Don’t cut people off because the schedule says so. The public deserves to see exactly how these decisions are made. Real transparency builds real trust.

⚖️ 2. STOP ASKING ONLY “IS IT SAFE ENOUGH TO APPROVE?” — START ASKING “WHAT HAPPENS IF WE DON’T?”
For rare diseases. For serious conditions with no good options. For patients who don’t have ten years to wait for traditional trials that may never be feasible.

Every regulatory decision carries two risks: the risk of approving something, and the risk of not approving it. Both are real. Both affect real people.

When traditional gold-standard trials aren’t practical, we should still be able to move with urgency — but only when paired with strong post-approval commitments and rigorous safety monitoring. We can give desperate patients a chance without abandoning scientific integrity.

🇺🇸 3. THE FDA’S ONLY CLIENT IS THE AMERICAN PATIENT. FULL STOP.
The FDA exists to serve patients — not outside interests or external pressures of any kind.

It must continue protecting the public from products that carry real, known risks but offer no meaningful clinical benefit.

At the same time, when there is credible evidence that a treatment can help patients with serious conditions, Americans and their physicians should be trusted to make informed decisions once they have complete and honest information about the risks, benefits, and alternatives.

The FDA’s job is to make sure the science is sound and the information is clear. Then let patients and doctors do what’s best for them.

These principles matter because the FDA’s decisions affect every family in this country.

Note: This is a simple social media post and not a massive policy document. The issues are FAR more nuanced, there are challenges and risks with each of the things I said above, and I recognize that. But it's intended to serve as a discussion starter. We must always strive to improve, and we can when we have open debate and dialogue.

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

The Misinformation industry - a standing network of influencers, conspiracy accounts, partisan personalities, and monetized outrage pages . . . spread misinformation, it goes viral, and then they monetize whatever potions they are selling at the link in their bio. https://t.co/1rDCnrTjHh

[Will Saletan @saletan]

Brutal numbers here from @ScottGottliebMD on how thoroughly DOGE has gutted the FDA teams that are supposed to review drugs for serious diseases.

On the bright side, it's not like there's a new viral outbreak or anything. 😬
https://t.co/iXoOvmqqKx

[Dr. Catharine Young @DrCatharineY]

RFK Jr. has called the HPV vaccine “the most dangerous vaccine ever invented.”

A staggering new review covering 274 studies found the opposite (again).

HPV vaccines, without a doubt, remain one of the greatest cancer prevention tools in modern medicine.

[Bruce Levine, Ph.D. 🇺🇦🥼🔬🧬🧪💉 @BLLPHD]

The babies’ deaths could have been prevented with a long-standard vitamin K shot. https://t.co/2f5vrFsG5q

[Ruella Lab @RuellaLab]

Great job to our PhD candidate Audrey for the wonderful presentation at @ISCTglobal! Read more about this work in our @ScienceTM publication.

Also great presentation by Dr. Bruce Levine (@BLLPHD), thank you for featuring our work from @CellCellPress

@MarcoRuella @PennMedicine

[NBC News @NBCNews]

New results published in the New England Journal of Medicine finds Moderna’s mRNA flu vaccine gave more protection against illness than the standard flu shot in a Phase 3 clinical trial. https://t.co/vEIcJExeFP