Just Another T1d

Perspective

FDA Commissioner Marty Makary

How Dr. Marty Makary’s FDA Leadership and Frontline Experience Could Accelerate a Cure for Type 1 Diabetes

When Dr. Marty Makary was confirmed as Commissioner of the U.S. Food and Drug Administration on March 25, 2025, many in the diabetes community took notice—and for good reason.

Makary isn’t just a health policy reformer or a critic of medical bureaucracy. He’s a surgeon who has performed islet transplants himself, having served as Director of the Islet Transplantation Program at Johns Hopkins University.

Now, as the head of the FDA, he has both the insight and the authority to reshape the future of islet cell therapies—and possibly deliver the most meaningful advances toward a cure for Type 1 diabetes.

🔬 What Is Islet Cell Therapy?

Islet cell transplantation involves implanting insulin-producing beta cells into people with T1D, restoring their ability to produce insulin naturally. After decades of small trials and setbacks, several major breakthroughs have changed the game:

• Lantidra (CellTrans): The first FDA-approved islet transplant, approved in 2023, but still requires immunosuppressive drugs.

• Vertex Pharmaceuticals (VX-880 & VX-264): Stem-cell derived islet therapies with VX-264 using an encapsulated device to avoid immune suppression.

• Sana Biotechnology: Their Hypoimmune (HIP) islets survived in humans for over 6 months without immunosuppressants—a major leap forward.

• Sernova’s Cell Pouch: A novel, implantable delivery system for islet cells.

Yet despite this momentum, regulatory red tape, access limitations, and high costs have kept most of these innovations out of reach.

👨‍⚕️ Makary’s Unique Advantage: Clinician + Regulator

Dr. Makary brings something rare to the FDA: he has both performed islet cell transplants and navigated the regulatory hurdles that block progress. This gives him an unparalleled perspective on the need to modernize approval pathways for therapies that could meaningfully transform life with T1D.

He understands what patients go through—and what science is capable of delivering.

🔑 5 Ways Makary Could Help Deliver a Cure

1. 🚀 Fast-Tracking Curative Therapies

Makary has spoken out in favor of breakthrough and regenerative therapies that aim not just to manage—but to cure—chronic disease. Under his leadership:

• Therapies like VX-264 and SC451 (Sana’s stem cell–derived HIP therapy) could be granted accelerated review.

• The FDA may encourage real-world evidence and adaptive trial designs to speed up approvals without compromising safety.

2. 🔓 Expanding Access for Those in Need Now

With Makary’s understanding of patient needs, expect:

• Simplified expanded access for people with brittle diabetes or severe hypoglycemia unawareness.

• Greater use of Right-to-Try programs, offering earlier access to transformative cell therapies.

  
  

3. 🧫 Supporting Immunosuppression-Free Innovation

Makary’s clinical background makes him particularly well-suited to evaluate and support innovations like Sana Biotechnology’s HIP islet cells, which:

• Avoid detection by the immune system,

• Require no lifelong immunosuppressive drugs, and

• Have already shown insulin production in humans for 6+ months.

Sana’s upcoming SC451 trial may be one of the first stem-cell derived, immune-evading cell therapies in human history—with the FDA’s full attention.

4. 💰 Ensuring Fair Pricing and Public Access

Makary is a vocal advocate for price transparency and value-based models. He is likely to:

• Discourage "million-dollar cure" scenarios,

• Encourage affordable access via CMS collaboration and insurer partnerships,

• Promote equitable commercialization of therapies like Lantidra and SC451.

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5. 🏛️ Supporting Public-Interest and Academic Innovation

Having led research at Johns Hopkins, Makary knows the barriers faced by university and nonprofit teams. His FDA may:

• Reduce burdens for investigator-led trials,

• Foster partnerships between academic centers and the FDA,

• Empower publicly funded innovation—not just private-sector giants.

📊 What to Watch Next

Milestone	Organization	Why It Matters
SC451 IND submission	Sana Biotechnology	First hypoimmune stem cell–derived therapy
VX-264 Phase 2 results	Vertex	A scalable, device-based cure pathway
FDA regenerative guidance	FDA (Makary)	Could transform trial standards and endpoints
Expanded Lantidra access	CellTrans	Real-world evidence + coverage decisions
NIH/FDA collaboration	Public research centers	A push toward affordable, scalable cures

🧠 Final Word

Marty Makary is not your typical FDA Commissioner.

He has seen what’s possible with islet cell therapy—and what stands in the way. Now, with the authority of the FDA behind him, he can reshape policy, reduce bureaucracy, and create a path where functional cures for T1D are not just possible, but accessible.

With leadership from scientists, companies like Sana, Vertex, and CellTrans, and now, with a clinician-advocate at the helm of the FDA, we are much closer to a cure than ever.

📢 Want to Help Us Get There?

• Share this blog with your community

• Advocate for clinical trial participation and equitable research funding

• Keep the pressure on for FDA accountability and patient-centered policy

Written by someone who lives with Type 1 diabetes—and believes our best days await.

Just Another T1d

Mike Sommer

Mike@JustAnotherT1d.com