RealPharma: Conversations with Pharma Pathfinders

Bridging the Gap: Market Access From Three Sides of the Table - with Vidhya Segar

Real Pharma, hosted by Na-Ri Oh and Ian Wendt, with intern Amos Fung

Episode Summary

Health technology assessment is usually described as a system. Vidhya Segar describes it as a negotiation between people who are each asking a different question. When she worked in government, the question was always why: why this drug, why now, why this population. In industry, it became why not. In this episode, Na-Ri, Ian, and Amos talk with Vidhya, a pharmacist who has worked as a hospital clinician, as an evaluator at Singapore's national HTA agency, and now in market access at Ipsen. Using Singapore as the working example, the conversation covers how a drug gets from approval to reimbursement, what the US most favored nation (MFN) policy looks like from Southeast Asia, how agencies handle rare disease evidence, and what each side of the table could do to make the other's job easier.

About Vidhya Segar

Vidhya Segar is a pharmacist turned national health policy expert turned market access strategist. She began as a hospital pharmacist in Singapore's public health system, working across inpatient and outpatient settings and designing training programs for early career pharmacists. She then moved to the Agency for Care Effectiveness (ACE), Singapore's national health technology assessment body, where she was Senior Assistant Director in the Technology Access Division and led the national rollout of medical device subsidies. Today she is Market Access Manager for Singapore and Malaysia at Ipsen. She is also a regular speaker and moderator at regional pharmacy and health policy conferences and an active voice on LinkedIn on health economics, HTA, and the evolving role of the pharmacist.

What We Cover

[00:00] Intro: The show open and the guest introduction, read in alternating paragraphs by Na-Ri and Ian.

[02:05] Three chairs, one problem: Amos opens with Vidhya's path from acute care pharmacist to national HTA agency to industry. Her version: it was not a grand plan, but sitting on three sides of the access problem changed how she sees it, including the discomfort of realizing that funding one thing means not funding another.

[05:06] There are no bad guys: Why Vidhya thinks most access fights get adversarial, and why people who spend an entire career on one side of the fence tend to lose the ability to see the other side's constraints.

[06:23] A day in the life of a market access manager: What the job actually involves, from dossier submissions to patient access programs to securing tenders, and why the role looks different in a fully reimbursed market than in a partially reimbursed one like Singapore.

[09:30] Why versus why not: The double agent question. What it is like to carry a payer mindset into a business, and why Vidhya thinks the space between "why" and "why not" is where negotiation, and growth, happens.

[10:34] How Singapore's system works: Ian sets the scene with Singapore's reputation for efficient care, then Vidhya walks through the path from regulatory approval to reimbursement: the Health Sciences Authority, the self-pay option inside the government channel, the advisory committees that make the funding decision, and why there is no such thing as 100% reimbursement when everyone is means tested.

[14:04] Real-world evidence and what HTA actually is: ACE's new guidelines on real-world data, why randomized trials remain the gold standard, and Vidhya's argument that people confuse an assessment with a funding decision. Na-Ri adds the US parallel: an FDA approval that cannot find its way onto the market.

[16:25] ACE compared with NICE and ICER: Is ACE stricter than its peers? Vidhya says no, but Singapore's tight link between assessment, funding, and a defined go-live window changes what "access" means in practice.

[18:23] Price, reference baskets, and MFN: How reference pricing works in Singapore, what MFN looks like from Southeast Asia, and Vidhya's concern that industry could overcorrect and underprice drugs for lower-affordability markets. Ian's follow-up: what happens when MFN pressure pushes up the prices Singapore references.

[22:18] Rare disease, cell and gene therapy, and thin evidence: How ACE has approached therapies where robust data is hard to generate, why Vidhya expects case-by-case decisions to continue for the foreseeable future, and what a company can do when reimbursement may not be the answer.

[25:02] Living with uncertainty: Ian asks how a company decides between more randomized trials and a real-world evidence package when the agency's reception is unclear. Vidhya's reframe: both sides want certainty, and certainty is itself a negotiation.

[28:42] What would you change? Vidhya's wish for industry (bring access voices into trial design, because you cannot retrofit evidence) and for agencies (a way to revisit reimbursement decisions as new evidence arrives), plus the resource reality that keeps agencies from doing it.

[32:03] What ACE wished industry understood: Three things: know how the health system you are working in actually funds care, build both a sponsor-friendly and a realistic payer case, and remember it is a long partnership. The elephant hiding behind a pole makes an appearance.

[34:29] Advice for pharmacists thinking about industry: Access work is meaningful even on the industry side, and the best access professionals are corporate polyglots who can speak sales, marketing, medical, and policy. Ian and Na-Ri add their own take on moving from clinical roles into pharma and translating technical work for cross-functional teams.

[38:54] Why she is still in healthcare: Amos closes with the question of what inspires her. Vidhya shares two stories: a clinician's reply to a thank-you email about a rare disease patient group in Singapore, and her grandmother's experience of Parkinson's, which is how she first became curious about drugs.

[42:07] Wrap: Thank yous, and Ian's note that the show is usually very US focused, with some requests to widen the aperture.

Notable Moments

On the premise of the whole conversation: "There are no bad guys in this problem. We're all just operating from different constraints with different motivations and different incentives."

On the two questions that frame the negotiation: "When I was in the government, we were always trained to ask why. Why this drug? Why now? Why this population? Why, why, why? On the business side of things, I'm asking, why not?"

On what HTA is and is not: "It is a rigorous assessment. It is a noble assessment, but it is an assessment."

On designing trials with access in mind: "You cannot retrofit evidence."

On keeping the relationship healthy: "Any reimbursement decision that's won with more tension than is required is a Pyrrhic victory, because we're all humans at the end of the day. We remember things."

On communicating across the business: "If you are not accessible to your business partners, you are of no use."

Mentioned in This Episode

• Agency for Care Effectiveness (ACE), Singapore's national HTA body
• Health Sciences Authority (HSA), Singapore's regulator
• NICE and ICER, as points of comparison for ACE
• Singapore's Drug Advisory Committee and Medical Technology Advisory Committee
• ACE's guidelines on real-world evidence and real-world data
• The US most favored nation (MFN) pricing policy
• Living HTA
• Bloomberg Health-Efficiency Index
• Ipsen

The Mold Blind Spot: Ariana Thacker on Building the First Scalable Model of Care for CIRS

Real Pharma, hosted by Na-Ri Oh and Ian Wendt

Episode Summary

Somewhere between one in four Americans carries a genetic profile that makes it hard to clear biotoxins from the body, and there is still no dedicated ICD-10 code for the illness that can follow. In this episode, Na-Ri and Ian talk with Ariana Thacker, founder and CEO of MoldCo, about how a mystery illness and a mold inspection turned a venture capitalist into the person building a scalable care model for a condition mainstream medicine still mostly misses. Ariana walks through her own diagnostic odyssey, the case for treating mold exposure as a public health issue rather than a niche one, and the treatment philosophy that has put MoldCo at odds with some other providers in the space.

About Ariana Thacker

Ariana Thacker is the founder and CEO of MoldCo, a digital health company building a scalable, evidence based virtual clinic for mold related illness and Chronic Inflammatory Response Syndrome (CIRS). She trained as a chemical engineer with a focus on biology and spent years in early stage and deep tech investing, building a portfolio of more than 70 companies through her venture firm, Conscience VC. In 2022, an unexplained health crisis, chronic fatigue, brain fog, night sweats, and a cluster of symptoms that resisted diagnosis across a dozen physicians, led her to discover toxic mold in her Miami apartment. She founded MoldCo in 2023. The company has raised $11 million to date, including an $8 million seed round co-led by Cantos and Collaborative Fund, and is now live in 48 states.

What We Cover

[00:00] Intro — Framing the episode: a condition Thacker says affects tens of millions of Americans, with almost no infrastructure in mainstream medicine built to catch it.

[02:03] Ariana's origin story — An unexplained illness, months of inconclusive testing, and the mold inspection that finally connected the dots.

[08:42] From patient to founder — Why Ariana spent time trying to recruit someone else to be CEO before deciding to take the job herself, and the biobank findings that convinced her the opportunity was bigger than her own case.

[09:33] The scale of the problem — Water damage data, the genetic susceptibility angle, and Ariana's estimate of how many Americans are affected.

[11:02] Why mold related illness slips through the cracks — No dedicated ICD-10 code, and a set of biomarkers most primary care and specialist panels never run.

[12:09] The diagnostic odyssey — A dozen specialists, a friend's tip, and the Shoemaker-certified physician who finally confirmed a diagnosis.

[16:20] Three policy fixes — An HHS-level mold commission, an environmental screening question at the annual physical, and a new ICD-10 code for the inflammatory response to mold.

[18:37] Inside the Shoemaker Protocol — How MoldCo built its clinical model in collaboration with Dr. Ritchie Shoemaker, and what "90% of patients get 70 to 90% better" looks like in practice.

[21:17] Why access is so limited — Roughly 30 Shoemaker-certified providers nationwide, wait lists, and a pricing landscape Ariana calls inconsistent to the point of price gouging.

[23:08] The policy case — MoldCo's economic impact report, and early conversations with HHS, CMS, and ARPA-H.

[27:02] How MoldCo actually works — The three questions behind the model (am I being exposed, is mold making me sick, how do I get better), and how a $150 to $300 a month price point pencils out.

[31:50] Clinical quality control — Full-time staff physicians, weekly clinical huddles, and why Ariana says the price point doesn't mean corners get cut.

[33:09] Treating patients still in the environment — What happens when remediation or relocation isn't realistic, and why re-exposure doesn't always mean starting over.

[39:31] Where MoldCo draws the line — Why the team advises against antifungal treatment for CIRS, the research behind that position, and how it differs from the antifungal and naturopathic camps elsewhere in the field.

[44:54] The HLA haplotype connection — Why some patients get hit much harder than others, and what having the genetic marker does and doesn't predict.

[47:14] What's next — A forever chemicals program targeting PFAS, and the research behind it.

[52:50] Closing — The middle school teacher who put Ariana on a path toward science, and where to find MoldCo.

Notable Moments

On not wanting the job she ended up taking: "I actually did not want to be CEO. I was interviewing multiple CEOs for this role. I just wanted to make sure that this was built and created, whether that was through me or, even more ideally at the time, someone else."

On the hair loss that came with her diagnosis: "I actually had the most gratitude for the hair loss, because it anchored me in reality. There is something wrong here. There's an actual physical sign that something is wrong, versus a lot of the gaslighting and doubt I was getting through mainstream medicine."

On why MoldCo won't budge on antifungals: "We're not a Shoemaker company, we're MoldCo. In light of new data and evidence, we're happy to change our opinion and our approach. But for now, what we're doing is working, and it's working great."

On pricing: "There's no reason this can't be affordable and accessible for patients... there's no reason it should include a $13,000 price tag. I just think that's absurd."

Mentioned in This Episode

The Shoemaker Protocol, and the work of Dr. Ritchie Shoemaker and Dr. Scott McMahon

MoldCo's economic impact report on the healthcare cost burden of mold related illness

LabCorp, where MoldCo's lab panel is processed

Conscience VC, Ariana's venture firm prior to founding MoldCo

MoldCo's free environmental exposure guide and self-assessment

From Patient Involvement to Patient Leadership: A Conversation with Donna Cryer, JD

Real Pharma, hosted by Na-Ri Oh and Ian Wendt

Episode Summary

As AI moves deeper into drug development, from trial design to evidence generation, the more pressing question isn't what the technology can do. It's who has the authority to decide how it's used. In this episode, Na-Ri and Ian sit down with Donna Cryer, JD, founder of the Global Liver Institute, longtime FDA patient representative, and the person credited with creating the Chief Patient Officer role in Pharma. Donna draws a hard line between patient involvement and patient leadership and makes the case that one changes outcomes while the other is often just theater.

About Donna Cryer

Donna Cryer is a lawyer, patient advocate, and two-time (arguably four-time, counting interim roles) CEO who has spent decades pushing patients from the margins of drug development into governance roles with real authority. She was diagnosed with inflammatory bowel disease at 13, which led to a rare autoimmune liver disease and a liver transplant in her twenties. She founded and led the Global Liver Institute for a decade, serves as an FDA patient representative on advisory committees, sits on the board of PathAI, and built the framework that became the pharmaceutical industry's Chief Patient Officer role.

What We Cover

[00:00] Intro — Framing the episode: patient leadership in a moment when pharma is becoming more data-driven and AI-enabled, and why the real question is one of authority, not just capability.

[02:19] What shaped Donna's philosophy — How a decade building the Global Liver Institute, and a career of being one of the only people in the room who knows where the liver actually is, shaped her approach to patient leadership.

[05:33] Liver disease and stigma — Why most of what people think they know about liver disease is wrong, how stigma shows up differently across hepatitis B, hepatitis C, and cirrhosis, and how Donna worked to change CPT coding so mash patients weren't buried under cardiovascular or diabetes diagnoses.

[07:34] Donna's own story — Diagnosed with IBD at 13, an autoimmune liver disease in her twenties, and a transplant that gave her a kind of authority no amount of professional training can substitute for.

[11:22] Defining patient centricity — Donna's litmus test: did something actually change because a patient was in the room? If nothing changed, it wasn't patient engagement, no matter what the meeting deck says.

[17:47] From involvement to leadership — Why one patient out of twenty on a P&T committee isn't leadership, and what it actually takes for patient input to carry weight in a decision rather than just being collected.

[23:14] Building the Chief Patient Officer role — The origin story, why nearly every CPO hire ended up being a physician despite Donna's original intent, and the trust gap she thinks still needs to close: can a patient leader be trusted with fiduciary and business responsibility, not just advocacy.

[30:09] FDA patient representative: voice vs. vote — What it's actually like sitting on an FDA advisory committee with a vote, not just a comment period, and how that changed the outcome of specific drug approval decisions.

[36:50] Culture and acceptance — The uneven reception patient reps still get in rooms full of physicians and biostatisticians, and Donna's approach to turning skepticism into buy-in, plus her case for clinician training on working with patients as peers rather than problems.

[44:24] AI in pharma — Donna's board role at PathAI, and a guiding principle she credits to a colleague: if a task doesn't require your judgment, your license, or your network, AI can probably do it. Where that leaves the parts of the job that still require a human.

[50:06] Where AI helps, and where it doesn't yet — The problem of patient data missing from the sources most models are trained on, and why patient registries, patient communities, and even patient co-authorship on publications matter for closing that gap.

[51:51] Patient skepticism about AI and health data — Why concerns about data governance and security are real, but patients in genuine medical need are often more willing to adopt AI tools than the industry assumes.

[55:05] Closing advice for pharma CEOs — Donna's ask: don't just bring a patient in to solve "a patient problem." Bring a patient in to help solve the biggest problem facing the company.

Notable Moments

On what patient centricity actually requires: "My favorite definition of patient centeredness, and certainly patient engagement, is: did something change because a patient was there? If nothing changed, then it wasn't patient... it certainly wasn't patient engagement."

On the difference a vote makes: "The difference between a voice and a vote. A vote is so much better."

On AI and professional judgment: "If it doesn't need my judgment, my license, or my network, I shouldn't be doing it. AI can probably do it."

Mentioned in This Episode

• Global Liver Institute
• PathAI
• Advanced Advocacy Academy
• Cutting for Stone by Abraham Verghese
• PatientsLikeMe

When Healthcare Policy Incentives Backfire: 340B, Hospital Pricing, MFN, and Drug Affordability with Deborah Williams

Healthcare policies are often evaluated by what they are intended to accomplish. But what happens when the incentives created by those policies produce very different results?

In this episode of RealPharma, Ian Wendt and Dr. Na-Ri Oh speak with longtime health policy expert Deborah Williams about the unintended consequences embedded in the U.S. healthcare system—from hospital reimbursement and industry consolidation to the 340B Drug Pricing Program, biosimilars, most-favored-nation pricing, and pharmaceutical innovation.

Deborah argues that healthcare policy must be judged not by its stated purpose, but by the behaviors, financial incentives, and measurable outcomes it creates. The discussion examines why transparency alone may not lower healthcare costs, how hospital systems use their political and economic influence, and why policies designed to improve affordability can sometimes contribute to higher prices.

The conversation also explores the practical and constitutional uncertainties surrounding most-favored-nation drug pricing, the Trump administration’s GARD, GLOBE, and GENEROUS models, and the potential downstream effects of pricing reform on research, development, manufacturing, and patient access.

Topics Discussed

• Why healthcare policy should be evaluated by results rather than intentions
• The history and limitations of diagnosis-related groups, or DRGs
• Why MACRA has failed to create an effective physician payment system
• Whether healthcare price transparency can meaningfully reduce costs
• The effects of hospital consolidation and certificate-of-need laws
• Why hospital systems have become so politically difficult to challenge
• Indiana’s effort to cap hospital prices relative to Medicare rates
• The widening divide between large health systems and rural hospitals
• How nonprofit hospitals deploy capital and justify tax-exempt status
• The role of hospital employment in local political influence
• Why 340B purchasing incentives can favor higher-priced branded products
• How 340B spreads may undermine biosimilar adoption
• Whether 340B savings are reaching vulnerable patients
• Alternatives to funding safety-net and uncompensated-care services through drug discounts
• Why policymakers may need to separate hospital support from pharmaceutical pricing
• The rationale behind most-favored-nation drug pricing
• Whether European countries are likely to pay more for pharmaceuticals
• How Medicaid best-price rules affect commercial contracting
• The relationship between direct-to-consumer pricing and 340B exposure
• GARD, GLOBE, and GENEROUS drug-pricing models
• The legal and constitutional questions surrounding mandatory drug rebates
• Pharmaceutical manufacturing reshoring and national economic policy
• How interest rates and global reimbursement policies affect drug development
• The need to measure the quality—not merely the quantity—of pharmaceutical innovation
• Why every healthcare payment system has both intended and unintended consequences

Key Takeaways Policy intentions do not guarantee beneficial outcomes

Even carefully designed reimbursement systems can produce distortions once stakeholders respond to the incentives. Deborah emphasizes that policymakers must continuously measure what happens after implementation rather than assuming a program is working because its goals are admirable.

Transparency is necessary, but not sufficient

Publishing hospital prices may help patients and purchasers compare costs, but transparency has limited value when every available option is still unaffordable. Meaningful reform may also require addressing hospital concentration, market power, and state certificate-of-need restrictions.

Hospitals possess considerable economic and political power

Large health systems are often among the biggest employers in a congressional district or state. That employment base, combined with campaign contributions and community influence, makes hospital payment reform politically difficult—even when prices and capital spending appear difficult to justify.

The 340B program can create incentives that conflict with affordability

The discussion examines how hospitals may earn substantial spreads between the discounted acquisition cost of a drug and the amount ultimately reimbursed. Those spreads can influence product selection, encourage use of higher-priced brands, and weaken the competitive position of lower-cost biosimilars.

Safety-net funding should be tied to services society wants to support

Rather than indirectly subsidizing hospitals through drug-pricing spreads, Deborah suggests that policymakers consider more direct support for uncompensated care, emergency services, obstetrics, psychiatric care, and other socially valuable services.

Most-favored-nation pricing remains highly uncertain

MFN policies may be politically attractive because Americans pay more for many medicines than patients in other developed countries. However, other countries may be unwilling or unable to increase their spending, leaving manufacturers to absorb much of the financial impact in the United States.

Drug-pricing rules interact in complicated ways

Best-price requirements, 340B discounts, Medicare reimbursement, direct-to-consumer models, and international reference pricing cannot be evaluated in isolation. A change in one area can cascade through the rest of the pharmaceutical pricing system.

Innovation should be measured by scientific and clinical value

Deborah argues that policy analysis should move beyond simply estimating how many drugs might be lost under a pricing reform. The more important question is whether policies reduce the development of first-in-class therapies, novel mechanisms, and clinically meaningful advances.

Episode Summary
In this episode of Real Pharma, hosts Na-Ri Oh and Ian Wendt sit down with Kristiaan Rawlings, Executive Director at EPM Scientific, to unpack what is really happening in the biopharma talent market right now. From the surprising resurgence of market access hiring to the growing influence of AI in recruiting and candidate preparation, this conversation explores the forces reshaping commercial talent strategy in 2026. The group also digs into salary inflation, title compression, M&A-driven hiring shifts, hybrid work expectations, and why communication skills and executive presence may matter more than ever.

What We Cover

• Why market access has re-emerged as one of the hottest hiring areas in biopharma
• How companies are responding to policy shifts, competition, and launch pressure
• What the current K-shaped hiring market means for candidates in high-demand vs. lower-demand functions
• Why specialists in forecasting, analytics, and insights may need to broaden their skill sets
• How AI is affecting interviews, candidate prep, and recruiting workflows
• The continued importance of presentation skills, executive presence, and storytelling
• How M&A activity is influencing hiring, retention packages, and future job movement
• What’s happening with salary growth, especially at the director, senior director, and VP levels
• Why hybrid work is still the norm and fully remote roles remain limited
• What candidates should know before making a move in 2026

Key Takeaways
Biopharma hiring is not following a single trend. Some functions are seeing intense demand and rising compensation, while others are consolidating under broader roles. Kristiaan explains that market access, select commercial operations roles, and experience in competitive therapeutic areas are commanding a premium right now. At the same time, he notes that professionals who can combine technical skill with strong communication and leadership presence are consistently outperforming others in the interview process.

The episode also highlights a more nuanced view of AI: it is not simply replacing jobs, but it is changing how work gets done. Used well, AI can improve recruiting efficiency, candidate prep, and search precision. Used poorly, it can make candidates sound generic, underprepared, or overly scripted.

🧠 Episode Summary

What if we’ve been thinking about cancer all wrong?

In this deeply personal and paradigm-shifting episode of RealPharma, hosts Dr. Na-Ri Oh and Ian Wendt sit down with Dr. Christopher Gregg—neuroscientist, entrepreneur, and stage 4 cancer patient—to explore a bold new vision for cancer care.

Dr. Gregg shares how his own diagnosis sparked a radical rethink of oncology: moving away from the “war on cancer” mindset toward managing it as a chronic, controllable condition. Drawing inspiration from agriculture, AI, and evolutionary biology, he introduces the concept of “algorithms as drugs”—dynamic, data-driven treatment strategies designed to outmaneuver resistance.

This conversation blends cutting-edge science with raw human experience, offering a hopeful and pragmatic roadmap for the future of precision medicine.

🔑 Key Topics Covered

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Why curing cancer may not always be the best goal—and what to aim for instead

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The concept of adaptive therapy and managing cancer like a chronic disease

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What elephants, farmers, and pests can teach us about treatment resistance

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The limitations of today’s drug development and clinical trial systems

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“Algorithms as drugs” and the future of programmable medicine

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How AI, smartphones, and behavioral data can unlock scalable precision care

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The role of value-based care models in accelerating innovation

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Dr. Gregg’s personal journey living 7+ years with stage 4 cancer

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Building Storyline Health, Primordial AI, and Uncharted Health

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The importance of patient agency—and the risks of unguided experimentation

🚀 Why This Episode Matters

Cancer care is at an inflection point. While billions are spent developing new drugs, Dr. Gregg argues that the real breakthrough may come from how we use the drugs we already have.

By combining AI, real-time patient data, and systems thinking, this approach could dramatically extend lives, reduce costs, and make care more human-centered.

🔗 Learn More

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Explore Dr. Gregg’s free masterclass: Uncharted Health

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Follow developments from Storyline Health and Primordial AI

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Stay tuned for upcoming clinical applications of algorithm-driven care

🎧 About the Guest

Dr. Christopher Gregg is a Professor of Neurobiology and Human Genetics at the University of Utah, a leading researcher in genomics and brain science, and a biotech entrepreneur. His work spans neuroscience, AI, and precision medicine—and is deeply informed by his personal experience living with metastatic cancer.

The Opioid Reckoning (Part 2): Litigation, Accountability, and the Fight for Justice with Paul T. Farrell Jr.

In Part 2 of our deep dive into the opioid crisis, hosts Dr. Na-Ri Oh and Ian Wendt continue their conversation with Paul T. Farrell Jr., the West Virginia attorney who helped lead the historic national opioid litigation.

This episode moves beyond the legal strategy discussed in Part 1 and explores the human toll, the documentary that captured the battle, the controversial trial outcome, and the surprising legal reversal years later. It’s a story of perseverance, public health accountability, and the long arc of justice.

🎬 From Courtroom to Documentary

Paul shares the unexpected origin story behind the PBS documentary The Bitter Pill, directed by Clay Tweel. What began as a filmmaker casually attending a hearing soon turned into a seven-year chronicle of the opioid litigation, capturing the rise of a local lawsuit in Huntington, West Virginia into a nationwide legal movement.

The documentary highlights not only the legal fight but also the devastating real-world impact of the opioid epidemic on families, healthcare workers, and communities.

⚖️ The Trial That Shook the Case

A major focus of the episode is the Cabell County trial, the first major test of the legal strategy that ultimately helped drive national settlements.

Paul explains how:

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The case became the bellwether trial for thousands of similar lawsuits.

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A national settlement framework complicated the ability to settle locally.

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The federal judge ultimately ruled against the plaintiffs on legal grounds—even as similar arguments succeeded in other jurisdictions.

For Paul and his team, the ruling felt like a devastating setback after years of work.

💰 The $50 Billion National Settlement

Despite the loss in the bellwether trial, the broader litigation resulted in nearly $50 billion in settlements with pharmaceutical manufacturers, distributors, and pharmacies.

Paul explains the goals behind the settlement:

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Transparency around how opioid pills were distributed across the U.S.

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Accountability for the systemic failures that fueled the epidemic

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Funding for opioid abatement programs, rather than compensation for individual claims

In West Virginia, settlement funds were allocated through a unique structure that created the West Virginia First Foundation, a statewide public-private trust designed to ensure funds are used specifically to combat addiction and support recovery programs.

🔄 A Stunning Legal Reversal

The documentary originally ends on a bleak note after the Cabell County loss. But the story didn’t end there.

In October 2025, the Fourth Circuit Court of Appeals reversed the trial court’s decision, reopening the case and giving Cabell County another opportunity to argue its claims.

For Paul, the decision brought a sense of vindication after years of uncertainty and reignited the fight for accountability.

🧠 Has the System Changed?

The episode closes with a broader discussion about whether the opioid crisis could happen again.

Paul reflects on changes across the healthcare ecosystem:

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Greater scrutiny and transparency in medical research and publishing

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Stronger safeguards for pharmacists and prescription monitoring

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Increased attention to controlled substance distribution practices

But he also warns that the incentives in healthcare and pharmaceuticals remain powerful—and vigilance will be essential.

💡 Final Reflections

When asked what sustains him through years of litigation, setbacks, and public scrutiny, Paul points to faith, community, and the people who show up along the journey at the right moments.

It’s a fitting close to a story that began with one lawsuit in a small Appalachian city—and grew into one of the largest public health litigations in U.S. history.

🎧 In This Episode

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The origin and filming of The Bitter Pill documentary

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Inside the Cabell County bellwether trial

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Why the national opioid settlement unfolded the way it did

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The structure and purpose of opioid abatement funding

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The 2025 appellate reversal that revived the case

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Whether the healthcare system has truly changed

👥 Guest

Paul T. Farrell Jr.
Attorney and lead counsel in the Cabell County opioid litigation, which helped catalyze the nationwide opioid settlements.

The Opioid Reckoning (Part 1): Paul Farrell Jr. on Litigation, Accountability, and the System That Failed

West Virginia has had the highest drug overdose death rate in the United States for over a decade. In a state with fewer than 2 million people, 780 million prescription opioids were distributed in just six years.

For Paul Farrell Jr., a Huntington, West Virginia native and mass tort attorney, those numbers weren’t abstract statistics. They were neighbors. Friends. Family members.

In Part 1 of this two-part episode, hosts Na-Ri Oh and Ian Wendt sit down with Paul to unpack how the largest civil litigation in American history — the opioid multidistrict litigation (MDL 2804) — came together, and how it reshaped the conversation around corporate accountability in the pharmaceutical supply chain.

This is not just a legal story. It’s a story about systems failure — across manufacturers, distributors, regulators, policymakers, and healthcare stakeholders — and what happens when transparency finally forces a reckoning.

In This Episode

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Growing up in Huntington, WV as the opioid crisis escalated

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The investigative journalism that exposed 780 million pills — and the moment Paul decided to act

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What “public nuisance” law is — and why it became the legal breakthrough strategy

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The role of distributors as the “choke point” in the opioid supply chain

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How 3,000+ cases consolidated into the largest MDL in U.S. history

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Why abatement — not just financial damages — became central to the settlement strategy

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Internal company communications that revealed troubling attitudes toward affected communities

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The intersection of regulation, enforcement, and corporate responsibility

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How transparency and subpoena power changed the trajectory of the crisis

Why This Conversation Matters

For those working in pharma, healthcare, commercialization, policy, compliance, or distribution, this episode challenges us to examine difficult questions:

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Where does responsibility truly lie in a complex healthcare ecosystem?

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What happens when financial incentives distort oversight?

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And how do we prevent the next Pandora’s box from opening?

This episode sets the foundation for a deeper conversation about accountability, culture, regulation, and reform.

Coming Next Week: Part 2

There was simply too much to cover in one episode.

In Part 2, we’ll explore:

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The evolution of the litigation and key tipping points

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The role of state attorneys general and settlement frameworks

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The ongoing PBM litigation

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The documentary The Bitter Pill

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And what lasting change should look like for the industry

Make sure to subscribe so you don’t miss it.

Ending the Diagnostic Odyssey: Rare Disease, Employers & Reimagining Health Plans

Hosts: Na-Ri Oh & Ian Wendt
Guest: Joshua Resnikoff, Founder & CEO, Sunstone Health

Episode Overview

What if the biggest innovation in rare disease wasn’t a new drug—but a new way to navigate the system?

In this episode, Na-Ri and Ian sit down with Joshua Resnikoff, biomedical engineer turned founder of Sunstone Health, to explore how employers can fundamentally rethink healthcare spending—while dramatically improving outcomes for families facing rare diseases.

Josh’s journey into healthcare reform wasn’t academic—it was personal. After years navigating the healthcare system to diagnose his son’s rare periodic fever syndrome, Josh experienced firsthand the emotional, financial, and systemic toll of what’s known as the diagnostic odyssey. That experience sparked a mission: compress a seven-year diagnostic journey into just 12 weeks.

This conversation dives into rare disease, employer-sponsored health plans, insurance mechanics, and why aligning incentives might be the key to transforming care.

🔬 From Scientist to System Builder

•

Josh’s background as a biomedical engineer at Harvard’s Wyss Institute

•

The rare disease journey that reshaped his career

•

Why getting a diagnosis—even without treatment—changes everything

•

The emotional and economic cost of delayed diagnosis

🧬 The 7-Year Diagnostic Odyssey

On average, it takes:

•

7 years from first symptom to effective treatment for rare disease patients

•

Countless ER visits, specialist referrals, medication trials, and escalating costs

•

Significant emotional strain—rare disease families face dramatically higher stress and divorce rates

Sunstone’s model reduces that timeline to approximately 12 weeks using:

•

Whole genome sequencing

•

AI-powered clinical interpretation

•

Expert clinician review (human-in-the-loop model)

•

Direct coordination with local care teams

The result?
Earlier intervention. Reduced healthcare utilization. Better outcomes.

💼 Why Employers Are the Key

Josh explains why self-funded employers—not traditional commercial insurers—are uniquely positioned to drive change.

Key insights:

•

~2/3 of Americans receive insurance through employers

•

Many large employers are self-funded, meaning they pay claims directly

•

Employers think in long-term employee retention (not 12-month insurance cycles)

•

Better healthcare = healthier employees = higher retention & productivity

Sunstone’s innovative model:

•

No per-employee-per-month subscription fees

•

Employers only pay when a family receives actionable results

•

High ROI through reduced ER visits, unnecessary treatments, and delayed care

🛡 Insurance 101 (Made Understandable)

The episode breaks down:

•

Fully insured vs. self-funded plans

•

Third-party administrators (TPAs)

•

Stop-loss / reinsurance

•

How high-cost cases (like $2M gene therapies) are financially managed

The takeaway:
When diagnoses happen earlier, total system costs often decrease—even when advanced therapies are involved.

🤝 Mission-Driven Innovation

A powerful theme throughout the conversation:

Many leaders in the rare disease ecosystem—including Josh—entered the field because of their own children.

That lived experience shapes:

•

Sunstone’s patient-first data ownership model

•

Continuous reanalysis of patient data

•

Clinical trial matching

•

Ethical alignment with families

As Josh says:

“Even if this whole thing went belly up, we will have helped hundreds of families—and I’d feel good about that for the rest of my life.”

🚀 Recent Milestones

•

Successfully raised Series A funding

•

800+ community investors via WeFunder

•

Integration with Broad Clinical Labs

•

Expanded epilepsy and autism-focused programs

•

Rapidly growing employer pipeline

🔗 Learn More

•

🌐 Sunstone Health: https://www.sunstonehealth.com/

•

💼 Connect with Josh on LinkedIn

🎙️ Beyond Survival: Why Empathy Is the Missing Prescription in Pharma

Episode Summary:

In this no-holds-barred conversation, Na-Ri Oh and Ian Wendt sit down with Matthew Zachary—brain cancer survivor, founder of Stupid Cancer, host of Out of Patients, and a relentless disruptor in patient advocacy.

At 21, Matthew was diagnosed with brain cancer and faced a life-altering decision: take chemotherapy and lose his identity as a musician, or reject treatment and risk everything. That decision became the first of many moments where he saw the cracks in the healthcare system—specifically, the glaring absence of empathy.

Now, nearly three decades later, Matthew shares how his experience transformed into a mission to fix what’s broken: in pharma, in media, in patient engagement—and in how we talk about what matters most.

This isn’t your typical Pharma Podcast. It’s a masterclass in calling out BS, rethinking metrics that matter, and re-centering real human lives in healthcare strategy.

What You’ll Hear in This Episode:

•

🎹 The life-defining decision Matthew made at 21—and why he turned down chemo

•

💊 How a lack of empathy almost cost him everything

•

🧠 The problem with patient engagement that’s all talk and no trust

•

🎤 The rise of Stupid Cancer and the “Howard Stern of Healthcare” era

•

📺 Why DTC ads may be a $28 billion distraction

•

🧵 The missing link between pharma marketers and patient communities

•

🔥 How compliance is killing creativity—and what to do about it

•

🗳️ Why Matthew is building a voter movement out of patient voices

Memorable Quote:

“If there is no empathy, there is no conversation.” – Matthew Zachary

Mentioned in the Episode:

•

Stupid Cancer

•

Out of Patients Podcast

•

Matthew’s upcoming book: We the Patients: How to Understand, Navigate, and Survive America’s Healthcare Nightmare

•

https://wethepatients.org/

Guest:

•

Matthew Zachary (@MatthewZachary)

Let me know if you'd like a shorter version for Spotify/Apple Podcast platforms or suggested social media captions to promote the episode.

🎙️ Real Pharma – Episode Title: Breaking the Silence: Why Pharma Needs to Speak Up
Hosts: Na-Ri Oh & Ian Wendt
Guest: Brian Reid, Founder & Principal at Reid Strategic

🔍 Episode Summary:

In this episode of Real Pharma, Na-Ri and Ian sit down with Brian Reid—a healthcare communicator, strategist, and former journalist who's worked across government, pharma, and media—to explore a provocative question: Why is the pharmaceutical industry so quiet when it comes to telling its own story?

Together, they unpack the communication failures shaping drug pricing, PBMs, the Inflation Reduction Act (IRA), biosimilars, and the broader healthcare system. Brian argues that the problem isn’t a lack of data or platforms—it’s a lack of courage, clarity, and commitment to narrative.

From the importance of speaking up in a noisy media environment to the myth of reputational risk, this conversation is a must-listen for anyone in life sciences, policy, or healthcare storytelling.

🧠 What You’ll Learn:

•

Why pharma’s “default to silence” is damaging public trust—and what the industry can do instead

•

The communications trap around complex topics like PBMs, pricing, and benefit design

•

How public perception problems could have been avoided with smarter storytelling (hello, Hep C)

•

Why simplicity is power—and how “pharm-to-table” and Mark Cuban are reframing the narrative

•

The case for overcommunication in the face of misinformation and AI-driven “slop”

•

Why the Medicare Prescription Payment Plan was a missed communication opportunity—and how to fix it

🔊 Quotable Moments:

“We're in a 30-year experiment of what happens when pharma steps back from the policy debate—and the results are in.” – Brian Reid

“I just want pharma to beat Bigfoot in public trust. That’s my goal.” – Brian Reid

“When in doubt, just shout. Say something. Do something.” – Na-Ri Oh

“It’s not always about having the perfect message—it’s about showing up and making the case.” – Ian Wendt

🧭 Resources Mentioned:

•

Cost Curve – Brian Reid’s daily newsletter on healthcare policy: https://reidstrategic.com/

•

KFF’s piece on complexity as a barrier to affordability

•

Examples from Mark Cuban’s Cost Plus Drugs and Eli Lilly CEO Dave Ricks’ public podcast appearances

👥 Connect with Brian Reid:

•

💼 Website: https://reidstrategic.com/

•

📬 Newsletter: Cost Curve

•

💬 LinkedIn: Brian Reid

Episode Title: Formulation as Strategy: Why CDMOs Matter More Than Ever

Guest: Elizabeth Hickman, President & CEO, Austin Pharmaceutics

Episode Overview

In this episode of RealPharma, hosts Nari Oh and Ian Wendt sit down with Elizabeth Hickman, President and CEO of Austin Pharmaceutics, to unpack one of the most critical—and often misunderstood—elements of drug development: formulation and the evolving role of CDMOs.

As drug molecules become more complex and solubility challenges grow, CDMOs are no longer just manufacturing vendors. They are strategic partners helping biotech and pharma companies bridge the gap between discovery and commercialization. Elizabeth shares her journey from commercial pharma leadership to running a science-driven CDMO, and explains why formulation decisions made early can determine whether a promising molecule ever reaches patients.

🔍 Key Topics Covered

•

The expanding role of CDMOs
Why CDMOs are shifting from executional partners to strategic extensions of pharma and biotech teams.

•

Why formulation is make-or-break
How solubility and bioavailability challenges derail up to 80% of modern drug candidates—and why these issues must be addressed early.

•

From “undruggable” to developable
How AI-driven discovery and structure-based drug design are unlocking new targets while creating new development hurdles.

•

Inside Austin Pharmaceuticals’ approach
A look at Austin’s proprietary Kinetisol® technology and how amorphous solid dispersion can improve bioavailability, scalability, manufacturability, and sustainability.

•

Small biotech vs. big pharma dynamics
What early-stage companies should look for in a CDMO partner—and the most common mistakes teams make when selecting one.

•

Patient impact starts with formulation
How pill burden, dosing frequency, and manufacturability directly affect adherence, cost, and competitiveness.

•

The future of CDMOs
Reshoring, cost pressures, AI adoption, and the growing need for talent with both scientific depth and entrepreneurial mindset.

💡 Memorable Takeaways

•

“Formulation is where promising molecules either become viable drugs—or stall out.”

•

Solving in-vivo performance alone isn’t enough; scalability and manufacturability must be designed in from day one.

•

The best CDMO relationships are built on transparency, urgency, and shared long-term vision.

•

Advanced formulation isn’t just a technical advantage—it’s a competitive and economic one.

👤 About the Guest

Elizabeth Hickman is President and CEO of Austin Pharmaceutics, a U.S.-based early-phase CDMO specializing in formulation development for challenging small-molecule drugs. With a background spanning commercial strategy, drug launches, and executive leadership, Elizabeth brings a sponsor-centric mindset to CDMO partnerships—helping clients accelerate innovation while reducing risk.

🎧 Hosts: Na-Ri Oh & Ian Wendt
🎓 Special Guests: Emma Cousin (PhD Candidate, Choice Institute – UW), Amos Fung (RealPharma Intern & Student Pharmacist)

🔍 Episode Summary:

In this thought-provoking episode, hosts Na-Ri Oh and Ian Wendt sit down with Emma Cousin, a PhD candidate at the Choice Institute, University of Washington, to unpack the real-world implications of the Inflation Reduction Act (IRA)—particularly the Medicare Drug Price Negotiation Program.

Joining them is Amos Fung, a RealPharma intern who brings a front-line pharmacy perspective to the policy conversation.

Together, they discuss:

•

📜 A primer on the IRA’s healthcare provisions—what it is, how it came to be, and why it matters now.

•

💊 How CMS selects drugs for Medicare negotiation and whether this process constitutes true “negotiation.”

•

👩‍⚕️ The ripple effects on pharmacists, pharmacies, and patient care.

•

💸 The looming concerns around cashflow, operational readiness, and access as the 2026 implementation date approaches.

•

🧠 How researchers like Emma are modeling long-term effects—and what metrics we’ll need to track to assess the IRA’s success.

•

🔄 Unintended consequences and who might be left behind—especially independent pharmacies and vulnerable communities.

•

📈 A candid discussion on myths around drug pricing and why “good intentions” in policy still need strong evidence and thoughtful execution.

🎯 Key Takeaways:

•

The IRA marks the first time Medicare can directly negotiate drug prices—albeit in a tightly structured format that raises questions about the fairness of “negotiation.”

•

Pharmacies face operational and financial strain, particularly smaller or independent ones, due to rebate lags and implementation complexities.

•

Patients will benefit from caps on out-of-pocket costs, but awareness and education are lacking—many don’t realize what the law offers.

•

Stakeholders like pharmacists, researchers, and policy influencers need better communication and clearer technical standards from CMS.

•

Evidence-based policy should be the north star for drug pricing reforms, but real-world implementation remains messy and evolving.

🧠 Resources & Mentions:

•

Brian Reid & Adam Fein – Top newsletters to follow for updates on drug pricing policy.

•

CMS Guidance Documents – Frequently updated, but often inaccessible to non-policy experts.

•

National Pharmaceutical Council, Milliman, Portal (Harvard) – Organizations doing forward-looking modeling and policy impact research.

Reinventing Cell Therapy with Acoustics, Microfluidics & High-Throughput Engineering

In this episode, hosts Na-Ri Oh and Ian Wendt sit down with Dr. Andrew Gray — immune cell engineer, biotech founder, venture capitalist, and CEO of CellEcho — to explore how a new acoustic-powered gene-delivery platform may redefine the boundaries of cell therapy.

The conversation spans the current state of the cell therapy landscape, the persistent barriers to scalability, and why CellEcho’s ASOP platform (Acoustically Stabilized Oscillatory Pockets) could unlock a new era of faster, cheaper, and more effective cell engineering.

🔬 Episode Highlights 1. The State of Cell Therapy: Breakthroughs & Bottlenecks

•

Despite scientific success, many pharma companies are exiting cell therapy due to cost, complexity, and manufacturing burdens.

•

Conversely, major players like BMS continue doubling down, acquiring companies such as Orbital Therapeutics.

•

Autologous therapies remain logistically overwhelming and expensive—often ~$400k per dose.

2. Why Cell Therapy Is So Hard to Scale

•

“Vein-to-vein” timelines are still measured in weeks, not days.

•

Manufacturing is bespoke: each patient’s cells must be extracted, engineered, expanded, frozen, shipped, and reinfused.

•

Viral vectors and current non-viral delivery methods introduce cost, complexity, and biological limits.

3. The Next Frontier: In Vivo, Allogeneic & Beyond

•

Allogeneic CAR-Ts remain challenging due to immune rejection and complex engineering.

•

In vivo CAR-T offers promise but is limited by the small genetic “payload capacity” of lipid nanoparticles.

•

Solid tumors remain particularly difficult: only ~9% response rates in some indications.

4. Introducing CellEcho & the ASOP Platform

CellEcho’s technology emerged from UC Irvine’s microfluidics program. By applying precision acoustic energy, the platform can:

•

Hold cells in place using thousands of stable micro-eddies

•

Open controlled, programmable “portals” in cell membranes

•

Sequentially deliver multiple genetic payloads with high efficiency

•

Achieve 1 billion cells/hour processing rates

•

Reduce dose production costs by ~100×

•

Enable high-throughput engineering, not just manufacturing

This unlocks the ability to test dozens to hundreds of engineered CAR-T variants in days—rather than the years needed today.

One academic lab spent 6 years evaluating 11 CAR-T variants.
CellEcho tested 8 variants in under 48 hours — and aims for 100+ per week.

5. From Better Manufacturing to Better Medicines

While CellEcho originally targeted faster manufacturing, Andrew shares that the bigger opportunity is designing entirely better therapies, not simply making today’s ones faster.

This includes:

•

Engineering CAR-Ts with multiple CAR constructs

•

Arming cells with resistance to tumor suppression signals

•

Precise control over expression levels (avoiding under- or over-expression)

•

Unlocking new indications: autoimmunity, neurodegeneration, regenerative medicine

6. Personal Motivation & Mission

Andrew shares how his mother's struggle with myasthenia gravis sparked his lifelong journey in immunology. His 20-year career investigating immune evasion, Tregs, and tumor microenvironments culminated in his conviction that next-generation cell engineering is essential.

7. What’s Next for CellEcho

•

Currently initiating pre-seed fundraising

•

Supported by multiple federal grants (including NSF SBIR)

•

Expanding early partnerships with Stanford, Mass General Brigham, and industry collaborators

•

Building a fully automated, AI-augmented cell therapy design platform

•

Dual strategy:

•

Cell-therapy-development-as-a-service

•

Proprietary therapeutic pipeline in select indications

💡 Key Takeaways

•

Cell therapy works — but not broadly or efficiently enough.

•

Engineering complexity, not biology alone, is the rate-limiting step.

•

Acoustic microfluidics enables a scalable, programmable, non-viral way to engineer living cells.

•

High-throughput screening for cell therapies could transform discovery the way combinatorial chemistry transformed small molecules.

•

The real revolution isn’t just faster production — it’s better, more sophisticated therapies.

🔗 Learn More About CellEcho

Visit: https://cellechobio.com
Contact: Via the Info link on the website (messages route directly to Dr. Gray).

👩‍🔬👨‍⚕️ Hosts:

Na-Ri Oh & Ian Wendt

🎧 Guest:

Dr. Ron Shigeta – Biotech visionary, co-founder of IndieBio, and food innovation expert.

🧬 Episode Summary:

In this deeply insightful and refreshingly candid episode, Ian and Nari welcome back biotech veteran Dr. Ron Shigeta to explore the evolving landscape where food, health, and biotech collide. From the collapse of the lab-grown meat hype cycle to the challenges of democratizing access to functional food, Ron brings hard truths, historical context, and cautious optimism to the table.

As the U.S. federal government embraces its Make America Healthy Again (MAHA) agenda—reforming food policy to prioritize public health—the conversation asks:
👉 Can we finally treat food as medicine, and make it scalable, credible, and affordable?
👉 What went wrong with cultured meat—and what comes next?
👉 Why does Ron really hate the term “food tech”?

If you’ve ever wondered whether the future of wellness lies in your fridge, your pharmacy, or your feed, this one’s for you.

🔑 Key Topics Covered:

•

MAHA & Food Policy Shifts:
What the government’s new approach to food says about public health—and why it matters.

•

Cultured Meat's Cautionary Tale:
Why the dream of lab-grown meat stumbled—and how the next wave of companies might succeed.

•

Ultra-Processed vs. Ultra-Useful:
A frank conversation on consumer trust, marketing blunders, and what “processed” really means.

•

Food as Preventative Medicine:
From diabetes to GLP-1s to micronutrients—why we’re ignoring the obvious.

•

Pharma’s Cost Spiral & Innovation Trap:
$2M gene therapies, $500K cancer cures, and why food might be the only scalable solution left.

•

The Neuroscience of Eating:
Food isn’t just fuel—it’s identity, emotion, and the deepest form of human behavior.

•

Why “Food Tech” is Bad Branding:
Ron’s passionate take on why the tech world misunderstands how people eat.

🧠 Memorable Quotes:

“Technology for the public will always win—because once people use it, they can’t let it go.” – Ron Shigeta

“We’ve invented healthcare Americans can’t afford.” – Ron Shigeta

“Nobody buys food because it’s high-tech. Nobody. That’s not how trust is built.” – Ron Shigeta

📚 Mentioned in This Episode:

•

MAHA (Make America Healthy Again) policy initiative

•

GLP-1s and the rise of preventative obesity drugs

•

Blue zones and the elusive science of longevity

•

Golden rice and biotech’s public trust problem

•

OneSkin and peptide-based functional cosmetics

•

Ron’s upcoming book on food, neuroscience, and the future of health

🎙 Episode Title: From Job Search to Power Move: How Top Talent’s Playing 2025
🧠 Guests: Kristiaan Rawlings, Executive Director at EPM Scientific
🎧 Hosts: Na-Ri Oh & Ian Wendt

Episode Summary
Layoffs. AI. Resume black holes. The biopharma hiring market feels noisy—and not in a good way. But beneath the doomscrolling, there’s a more nuanced story unfolding.

In this episode, Kristiaan Rawlings returns to RealPharma to deliver a data-backed pulse check on the state of hiring across the industry. Drawing from hundreds of hours of direct conversations with execs, talent leaders, and hiring managers, Kristiaan unpacks:

•

📈 Which therapy areas and functions are hiring (and which are not)

•

🧠 How AI is actually being used in recruitment—and where it falls short

•

👀 Why 70% of senior roles are now confidential

•

🤝 The traits that are getting candidates hired in 2025

•

💸 Sign-on bonuses: who’s getting them, how to ask, and what to watch out for

Whether you're job hunting, hiring, or just trying to read the market right—this conversation brings the clarity.

Resources & Links
🔗 Connect with Kristiaan Rawlings on LinkedIn
🌐 Explore non-confidential roles at EPM Scientific

Where Policy Meets the Pharmacy Counter

Featuring Congressman Jake Auchincloss

Episode Summary
In this episode of RealPharma, hosts Na-Ri Oh and Ian Wendt sit down with Congressman Jake Auchincloss (MA-04) to dissect the tangled web of policy, profit, and politics driving America’s drug pricing system. From pharmacy benefit managers (PBMs) to the politics of tariffs, this discussion explores the push for transparency, fair competition, and sustainable reform in healthcare.

Auchincloss, a Marine veteran and member of the House Energy and Commerce Committee, brings a rare combination of policy depth and industry fluency. Together, they unpack how entrenched middlemen have distorted the system—and what bipartisan solutions could finally restore balance between innovation and access.

What You’ll Learn:

•

Why PBM reform has momentum but keeps stalling in Congress

•

How the Pharmacists Fight Back Act could level the playing field for independent pharmacies

•

The purpose of the Patients Before Monopolies Act and how it targets vertical integration

•

Auchincloss’s vision for a “biotech social contract” that links innovation, IP protection, and insurance design

•

The real story behind drug import tariffs and the risks of chaotic trade policy

•

How U.S. innovation compares to China’s rapidly advancing biotech ecosystem

•

The importance of aligning drug pricing reform with patient access and national competitiveness

Memorable Moments:

“PBMs deserve to be bulldozed for their behavior over the last two decades.”
“There’s no moral hazard in getting sick—no one fakes chemotherapy to get free drugs.”
“The most expensive thing in the world is what hasn’t been invented yet.”

Why It Matters:
As drug costs rise and innovation races ahead, the U.S. faces a defining choice: will healthcare policy reward breakthroughs or bureaucracy? Congressman Auchincloss argues that reform is not just about prices—it’s about preserving America’s leadership in biomedical innovation while ensuring patients can actually access the medicines that save lives.

Guest:
Congressman Jake Auchincloss
U.S. Representative for Massachusetts’ 4th District
Member, House Committee on Energy and Commerce

Hosts:
Na-Ri Oh & Ian Wendt

Episode Title:

“Conversations, Not Campaigns: The Art of Authentic Engagement in Healthcare”

🗣️ Episode Summary

In this episode, hosts Dr. Na-Ri Oh and Ian Wendt sit down with Colin Hung — healthcare technologist, marketing strategist, and co-founder of the long-running #HCLDR (Healthcare Leadership) Twitter community. Colin shares his journey from biomedical engineering to becoming one of the most respected community builders in digital health.

Together, they explore what authentic engagement really looks like in the healthcare and pharma industries — from how companies can move beyond broadcasting to truly listening, to how AI can support rather than replace human connection in patient advocacy.

🧭 Key Themes & Takeaways

•

From Engineer to Connector: How Colin’s early career in biomedical engineering shaped his systems-thinking approach to digital health.

•

Building #HCLDR: The story behind one of the most influential online healthcare communities — what made it work, and how it evolved over 13 years.

•

Conversation > Communication: Why genuine listening and empathy are more powerful than any marketing message in healthcare engagement.

•

Pharma’s Challenge: How manufacturers can engage meaningfully online despite regulatory constraints — and why showing up as people first matters most.

•

AI in Healthcare: The promise and pitfalls of AI in patient engagement — and how to use it responsibly to empower, not replace, the human touch.

•

The Future of Digital Communities: What comes next for online healthcare engagement now that #HCLDR has passed the torch to new community creators.

👥 Guest Bio: Colin Hung

Colin Hung is a healthcare technologist, community strategist, and co-founder of the #HCLDR community. With more than 25 years in health IT, Colin has been a driving force in bringing together patients, clinicians, and innovators to discuss the future of care. He’s also a writer, speaker, and advocate for inclusive, patient-centered technology.

🔗 Connect with Colin:

• LinkedIn: https://www.linkedin.com/in/colinhung/
•

Twitter (X): https://twitter.com/Colin_Hung

🏷️ Organizations, Movements & Mentions

•

#HCLDR (Healthcare Leadership) — A global online healthcare leadership community founded in 2012 that brought together patients, providers, and industry leaders for weekly discussions on improving healthcare.
🔗 https://hcldr.wordpress.com/
🔗 https://twitter.com/search?q=%23HCLDR

🎧 Listen & Subscribe

Find The RealPharma Podcast on:

•

Spotify

•

Apple Podcasts

•

Google Podcasts

🎙️ Episode Title:

Building the Highway for AI in Pharma: A Conversation with Ilya Burkov

📍 Episode Summary

In this episode of RealPharma, hosts Na-Ri Oh and Ian Wendt sit down with Dr. Ilya Burkov, Head of AI Cloud at Nebius, to explore the critical infrastructure enabling the AI revolution in drug development.

While the headlines often focus on the promise of AI, Ilya brings us backstage—where the real acceleration happens. From GPU scalability and regulatory compliance to synthetic data and digital twins, this conversation unpacks how the roads, bridges, and power lines of cloud infrastructure are shaping the future of biopharma R&D.

Whether you're a biotech founder, pharma executive, or AI enthusiast, this episode offers a 360° view into the unseen tech powering the next generation of therapies.

🧠 What You’ll Learn

•

Why AI needs more than just models—it needs muscle.

•

The role of GPUs-as-a-service in reducing drug discovery timelines

•

How infrastructure and compliance go hand in hand in regulated industries

•

Why digital twins and synthetic control arms could be the future of clinical trials

•

Challenges biotech startups face—and how AI-first models could level the playing field

•

The ethical promise of fully virtual drug pipelines

🧭 Key Quote

“Think of AI in pharma as the car. What we’re building is the highway—bridges, power, road signs—so researchers can just drive.”
— Dr. Ilya Burkov

🧰 Resources & Mentions

• Ilya Burkov on LinkedIn
•

Nebius AI Cloud

•

FDA Digital Health Initiatives

👥 About the Guest

Dr. Ilya Burkov is Head of AI Cloud at Nebius, where he leads teams building cloud platforms purpose-built for AI workloads in life sciences. With a background in large-scale computing and a deep understanding of compliance in regulated industries, Ilya bridges the gap between bleeding-edge technology and real-world healthcare impact.

🎧 Listen & Subscribe

Find RealPharma on your favorite podcast platform:
Apple Podcasts | Spotify | Amazon Music

👉 Don’t forget to rate and review the show—it helps others discover the future of pharma!

🎙️ Episode Title:

Inside the CMC Black Box: A Deep Dive with Reza Oliyai

🧾 Show Notes:

What exactly is CMC — and why is it behind more FDA rejections than any other category?

In this episode of RealPharma, hosts Na-Ri Oh and Ian Wendt sit down with Dr. Reza Oliyai, former SVP of Pharmaceutical & Biologics Operations at Gilead Sciences, and now Founder & CEO of Oliyai Consulting, to demystify the world of Chemistry, Manufacturing, and Controls (CMC).

With over three decades of experience and a role in advancing 200+ drug candidates and 27 product launches, Reza offers a front-row seat to what goes wrong — and right — in the drug development journey.

🔍 In this episode, we explore:

•

What CMC really means — and why the "controls" part is most overlooked

•

Why 74% of FDA complete response letters involve CMC issues

•

The pitfalls of the “Phase 1 mentality” in late-stage development

•

AI in CMC: helpful tool or overhyped distraction?

•

How to evaluate CDMO partners (and why big pharma’s pick might be your wrong fit)

•

The evolving geopolitical landscape and its impact on global manufacturing

•

What startups, investors, and boards need to understand about CMC before it’s too late

•

Career advice: what it takes to lead in this increasingly complex field

🧠 Key Quote:

“CMC is a black box to most executives. That’s a problem. Because it’s also the number one reason drugs get delayed.” — Dr. Reza Oliyai

Whether you're in manufacturing, regulatory, executive leadership, or just trying to understand what actually gets a drug to market — this episode is a must-listen.

🔗 Resources & Mentions:

•

Oliyai Consulting

• Reza Oliyai on LinkedIn
•

FDA’s recent publication of Complete Response Letters

👤 About Our Guest:

Dr. Reza Oliyai is a globally recognized leader in pharmaceutical operations, with deep expertise across small molecules, biologics, ADCs, peptides, siRNA, and more. After 28 years at Gilead Sciences, he now advises over 100 organizations worldwide through his firm, Oliyai Consulting.