Dr. Tom Frieden is the former Director of the CDC and New York City Health Commissioner, president and CEO of Resolve to Save Lives, and author of The Formula for Better Health: How to Save Millions of Lives, Including Your Own.

In this episode, he traces his path from CDC disease detective to cracking New York City’s drug-resistant tuberculosis outbreak and scaling India’s national TB program. He takes us inside the Bloomberg-era fights over tobacco taxes, smoke-free bars, trans fat and soda, including the battles he lost. He explains his See, Believe, Create framework and the “Cassandra curse” that makes public health so hard to win support for. And he shares what Resolve to Save Lives is doing worldwide, from the 7-1-7 outbreak target to his prediction that heart attacks and strokes will one day be rare.

Breaking the Cassandra Curse | Former CDC Director Dr. Tom Frieden

Today's guest, Dr. Sandra Kweder, spent 35 years at the FDA, from a young medical officer during the AIDS epidemic to over a decade as deputy director of the Office of New Drugs and FDA’s liaison to the European Medicines Agency.

In this episode, we use her career to explore how and why the FDA changes as an institution. She takes us back to the AIDS crisis, when activists called her at home and the agency learned that patients with everything to lose think about risk differently. We dig into how user fees transformed a drug review process where applications once sat untouched for years, and how FDA and Europe reach the same decisions about 97% of the time despite completely different systems. Finally, she offers a candid look at today’s FDA and why, even in an age of AI, good regulation still comes down to judgment.

The Ship Turns Slowly: How the FDA Changes | Former FDA Deputy Director Dr. Sandra Kweder

Today’s guest is Gadi Saarony, the CEO of Advarra, the independent review board that makes sure clinical trials are safe and ethical for the people who take part in them. Before Advarra, he spent nearly 17 years at Parexel, one of the world’s largest CROs, where he rose from leading strategy to running the company’s entire clinical operation across 53 countries.

In this episode, Gadi explains why drug development still struggles with the same problems it had 20 years ago: slow study startup, missed enrollment targets and a deeply fragmented system. That’s true even as CROs have grown into an essential part of the industry. He walks through how outsourcing has swung like a pendulum between pharma and CROs, and why he thinks CROs should run the process while sponsors stay accountable for the science. He also shares why ethics boards are more than a checkbox, how he led Advarra through COVID weeks after becoming CEO, and how he decides what the company should and shouldn’t build. Finally, we discuss whether AI can close the widening gap between how fast science moves and how fast drugs get developed, and why it has to “move at the speed of trust.”

Moving at the Speed of Trust | Advarra CEO Gadi Saarony

Kevin Bitterman is a partner at Atlas Venture and has helped found and scale multiple biotechs. These include Visterra (acquired for $430m), Editas Medicine ($6B market cap), and Mariana Oncology (acquired for $1B+).

In this episode, Kevin walks through his path from a borrowed lab bench at Harvard to building biotech companies at Atlas Venture. He explains the scrappy playbook behind Atlas’s model, where about two-thirds of the firm’s capital goes into companies it creates in-house. He shares the stories behind spotting CRISPR early, pivoting Visterra from bird flu to kidney disease, and selling Mariana Oncology before it ever dosed a patient. Kevin also discusses why he sees China as the biggest shift in biotech in decades, and why AI’s real near-term impact may be in clinical trials rather than drug discovery.

The Company Creation Playbook | Atlas Venture Partner Dr. Kevin Bitterman

Today's guest is, Dr. Michael Gold, the Chief R&D Officer at Compass Pathways, which is developing a psilocybin treatment for treatment-resistant depression. A neurologist by training, he has spent nearly 30 years developing brain drugs at companies including Bristol-Myers Squibb, GSK and AbbVie.

In this episode, Dr. Gold explains why brain drugs fail so often, even with hundreds of millions of dollars and top scientists behind them. He walks through the structural challenges of neuroscience: limited animal models, subjective outcome measures, and diseases that begin decades before symptoms appear. He also shares why rigorous, high-quality data is an ethical obligation to the patients who volunteer for trials, and how better biomarkers are changing the field’s odds. Finally, he discusses Compass Pathways’ path toward potential FDA approval and how psychedelics could reshape the way psychiatry defines mental illness.

Why High Quality Data Is the Best Medicine | $1.6b Compass Pathways CRO Dr. Michael Gold

Today's guest is Dr. Jim Min, the founder and CEO of Cleerly, a cardiovascular imaging company using coronary CT and AI to help clinicians detect and understand heart disease earlier.

In this episode, we explore why traditional cardiology has been so symptom-driven and what changes when physicians can directly visualize the plaque causing coronary artery disease. Jim explains why cholesterol levels, stress tests, and calcium scores can miss important aspects of risk, and how Cleerly is trying to move heart care toward a more personalized, disease-based model. We also discuss the company’s clinical trials, the challenge of building reimbursement and adoption around a new standard of care, and what it took for Jim to move from academic research into entrepreneurship. Finally, we talk about the role AI could play in bringing together imaging, biomarkers, genetics, and other data to make cardiovascular prevention more precise.

The End of Symptom-Based Cardiology | $750m Cleerly CEO Dr. James Min

Today's guest is Paul Brient, Chief Product Officer at Athenaheallth, a $17 billion EHR with more than 170,000 clinicians on its network. Paul has spent his entire career getting doctors to actually love the technology they use, from running PatientKeeper for 17 years, to now leading Athena's push to build an AI native EHR.

We start with the origins of the physician friction problem, why doctors adopted robotic surgery overnight but fought the EHR for two decades, and how Meaningful Use turned the highest paid people in the hospital into data entry clerks. From there, Paul walks through the structural misalignment in healthcare software, where the person who builds the product, pays for it, and uses it are three different people, and why Athena's practice level model works differently. We also get into payers, which Paul argues are the most misunderstood players in the system, and how Athena's Moment of Care product brings payer intelligence to the point of care in real time. And finally, the AI native EHR itself, why Paul believes the original EHR was a mistake of metaphor built around a paper chart, and why he thinks this is finally the moment doctors will actually love their software.

How Doctors Became Unit Secretaries | $18B Athenahealth Chief Product Officer Paul Brient

Cardiovascular disease remains the world's leading killer, yet cardiovascular drug development has declined dramatically when compared to other therapeutic areas.

Today, we sit down with Dr. Howard Surks, a cardiologist turned bench scientist turned big pharma leader who left Merck and Sanofi to help build Cardurion Pharmaceuticals from the ground up around a first-in-class heart failure drug. 

In the episode, Howard's discusses journey from studying blood vessel biology at Tufts to running translational medicine programs at two of the world's largest pharma companies: the real tradeoffs between big pharma and biotech, why cardiovascular trials have become so expensive that most companies walked away. We dig into what it actually takes to move a molecule from the lab into patients, and how decades of basic science research became the foundation for Cardurion's PDE9 inhibitor program. 

When Big Pharma Abandoned the Heart | $750m Carduion CSO Dr. Howard Surks

Today's guest, Rachel Werner, is a physician, health economist, and Executive Director of Penn’s Institute of Health Economics whose work explores how healthcare policy can improve care without creating harmful unintended consequences.

In this episode, we discuss why public quality report cards can push providers to avoid high-risk patients. We examine why pay-for-performance often improves the metric being rewarded without meaningfully improving patient outcomes. We also explore the debate over nursing home staffing mandates and the evidence that stronger staffing requirements could save thousands of lives each year. Finally, we discuss why rigorous research does not always translate into policy, and what it takes to build a more evidence-informed healthcare system.

Why Is Good Healthcare Policy So Hard? | UPenn LDI Director Dr. Rachel Werner

Today's guest is Mark Frank is the founder and CEO of SonderMind, one of the largest mental health platforms in the country that helps providers help patients and manage their practices.

In this episode, we unpack why the mental health care system has lacked the basic infrastructure that exists in nearly every other healthcare vertical. Mark walks through the provider side, where therapists are forced to become small business operators just to deliver care, and the patient side, where insurance directories are functionally broken and subjective screening tools like the PHQ-9 leave massive gaps in understanding. We explore how SonderMind is building an integrated system of care that captures what happens between sessions to give therapists better information and patients better outcomes. T

An Operating System for Mental Healthcare | $1B+ SonderMind CEO Mark Frank

Nikhil Reddy (@nikhilrxddy) · Zencastr

Nikhil Reddy (@nikhilrxddy)

Discover where healthcare is headed with The Healthcare Theory. Through recurring mini-series, we unpack everything from health policy to life sciences and digital health. Tune in every week for insightful conversations with founders, researchers, and industry experts that are shaping the future of healthcare.

The Healthcare Theory Podcast