In this episode of RealPharma, Ian Wendt and Na-Ri Oh sit down with Dara Katcher Levy, a regulatory attorney at Hyman, Phelps & McNamara, P.C.—widely regarded as one of the nation’s top firms in food and drug law. Dara brings decades of expertise in promotional review, labeling negotiations, and post-market compliance, helping life sciences companies navigate the complex world of FDA regulations.

Together, they unpack the most pressing regulatory questions facing biopharma in 2025:

DTC Advertising Under Fire: Why the U.S. remains one of only two countries allowing direct-to-consumer (DTC) prescription drug ads, and the political push to restrict them.

AI in Pharma Marketing: How AI is being adopted to streamline promotional reviews, where it adds efficiency, and where compliance risks still demand human oversight.

FDA Enforcement Trends: Why the Office of Prescription Drug Promotion (OPDP) has shifted its focus from celebrity DTC ads (think Serena Williams and Brittany Mahomes) to healthcare professional materials, and what that means for manufacturers.

Telehealth & Influencers: The murky legal ground when platforms like Hims & Hers Health, Inc. or paid content creators promote prescription drugs. Should they be held to the same standards as manufacturers?

First Amendment vs. FDA: A deep dive into recent enforcement controversies—like the warning letter to Sprout Pharmaceuticals over its CEO’s personal Instagram post—and whether FDA is overreaching in regulating speech.

Dara also shares how she advises clients to balance responsible communication with compliance, and why she believes patients benefit from more information, not less, so long as it’s presented transparently and fairly.

Hyman, Phelps & McNamara, P.C. – Dara’s firm, specializing in FDA law.

FDA OPDP Enforcement Letters Database – Track recent untitled and warning letters.

Food, Drug, and Cosmetic Act (FDCA) – The foundation of FDA authority.

FDORA (Food and Drug Omnibus Reform Act of 2022) – Recent legislation impacting drug development and promotion.

Addyi (flibanserin) – Sprout Pharmaceuticals – Case study mentioned in FDA’s 2024 enforcement actions.

Episode Title: From Rock Star to Rare Disease Revolutionary: Casey McPherson’s Fight for His Daughter’s Life

In this deeply personal and inspiring conversation, hosts Na-Ri Oh and Ian Wendt sit down with Casey McPherson, founder and CEO of AlphaRose Therapeutics—and acclaimed recording artist—to explore how one father’s determination to save his daughter’s life is shaking up the rare disease drug development model.

Casey shares his journey from fronting rock bands to founding a biotech company, sparked by his daughter Rose’s diagnosis with an ultra-rare genetic disorder. He discusses why the current rare disease model is broken, how Alpha Rose is reimagining the path from diagnosis to treatment, and the emotional and ethical complexities of innovating in this space.

What You’ll Learn in This Episode:

How Casey’s music career prepared him to run a biotech startup.

Why rare disease families face a “diagnostic odyssey” and what needs to change.

The gap between available technology and systemic barriers to treatment.

How AlphaRose Therapeutics is creating scalable models for ultra-rare diseases.

The promise—and challenges—of engaging with regulators like the FDA in new ways.

Why the Leonard Cohen classic Hallelujah has become a personal anthem for Casey.

Links & Resources:

AlphaRose Therapeutics

StartEngine – Invest in Alpha Rose (crowdfunding equity round open until August)

Leonard Cohen – Hallelujah (Jeff Buckley cover)

People Magazine feature on Casey McPherson

Follow Casey on Instagram

Episode Title: Behind the PBM Curtain: Antonio Ciaccia Exposes the Game

Show Notes:

PBMs remain one of the most opaque and influential forces in healthcare—shaping drug prices, patient access, and payer negotiations—often under the guise of cost savings. Antonio, widely recognized as one of the most outspoken voices for transparency in the pharmaceutical supply chain, takes us deep inside the systemic problems that have led to distorted pricing models, misaligned incentives, and challenges for manufacturers, payers, and patients alike.

Key Topics Covered:

The Gross-to-Net Bubble: How rebates, discounts, and government distortions drive higher list prices and undermine value-based formulary design.

PBM Consolidation & Vertical Integration: The impact of PBMs owning wholesalers, specialty pharmacies, and even repackaging themselves as drug companies.

The 340B Program & Market Distortions: Why hospitals and covered entities are often incentivized to favor higher-priced drugs over clinically superior, cost-effective alternatives.

Policy and Reform: What’s being done at the state and federal levels, including the FTC investigations, Medicaid reforms, and disruptive models like Mark Cuban’s Cost Plus Drugs.

Burn It Down or Fix It? Antonio’s candid take on whether incremental improvements can save the current system or if structural overhaul is the only way forward.

What Manufacturers Should Know: Strategies for navigating PBM-driven formularies, access barriers, and rebate-driven contracting.

Antonio also shares actionable insights for payers, manufacturers, and policymakers on how to realign incentives and reduce inefficiencies that inflate costs without adding value.

Why Listen:

Resources & Links:

46brooklyn Research – Data-driven analysis on drug pricing.

3 Axis Advisors – Market intelligence and consulting on drug pricing and PBMs.

Related Episodes:

340B or Bust: Is This Program Failing the Sick

This week on Real Pharma, hosts Dr. Na-Ri Oh and Ian Wendt dive into the tangled world of 340B with returning guest William “Bill” Sarraille—one of the most respected voices in healthcare law, an active patient advocate, and a rare disease patient himself.

The 340B Drug Pricing Program was intended to help vulnerable patients by requiring drug manufacturers to provide discounted medications to covered entities. But as Bill puts it, has the program strayed too far from its patient-first mission? With explosive growth, patchwork state laws, opaque data, and billions on the line, is it still doing what it was designed to do—or are the sick paying the ultimate price?

✅ How 340B ballooned from a modest program to a behemoth that may soon outpace Medicare Part D

Bill also shares candid insights from his own journey as a rare disease patient—and why that makes him both more hopeful and more skeptical than ever.

Bill Sarraille on LinkedIn: https://www.linkedin.com/in/william-sarraille-634a8827/

ADAP Advocacy Association: https://www.adapadvocacy.org/

340B Report (for policy resources & updates): https://340breport.com/

Episode Title:

AI Adoption in Healthcare: Navigating the Present and Shaping the Future with Bryce Sady

Episode Description:

Together, they dive into the fascinating landscape of artificial intelligence in healthcare and pharmaceuticals. From practical applications, barriers, and regulatory hurdles, to how clinicians and pharma professionals are integrating AI into their workflows, Bryce sheds light on current adoption rates and trends across the healthcare ecosystem.

Key Highlights:

How healthcare professionals' AI adoption rates compare to the general public (hint: it might surprise you!)

The real-world, practical AI use-cases currently shaping clinician workflows.

Challenges and opportunities around integrating AI into heavily regulated environments.

Insights on clinician education and how platforms like PSL Group’s "Doogle" are changing the landscape.

Predictions for near-term trends in AI, including the pivotal roles of ambient scribes and patient communication tools.

Ethical considerations and liability discussions as AI becomes essential in clinical decision-making.

Bryce also shares his personal inspirations drawn from Tracy Kidder's powerful book, Mountains Beyond Mountains, reflecting on the importance of patient-centered perseverance in healthcare innovation.

Who should listen?

Episode Title: “Hiring Heat Check: What’s Hot in Biotech + Pharma Talent in Mid-2025”

🎙️ Hosts: Ian Wendt & Na-Ri Oh

Episode Overview:

This week, fan favorite Kristiaan Rawlings returns to RealPharma to give us the raw and real insights on pharma and biotech hiring trends as we hit the midpoint of 2025. From compensation curves and BD boom times to the rise of GLP-1s and the return of oncology, this episode is your ultimate pulse check on where hiring is headed—and how to stand out in a crowded field.

Key Topics Covered:

🔹 BD & Search/Eval Roles in Overdrive

🔹 Therapy Area Hot List

🔹 Career Advice for Every Archetype

🔹 Hiring Manager Intel

🔹 Sales Teams = Prizefighters?

🔹 Show Me the Money

Mentioned in This Episode:

Sadhna Bokhiria's salary benchmark post: Kiria Research LinkedIn Post on Pharma Salary Trends

EPM Scientific (Kristiaan’s firm): https://www.epmscientific.com

Connect with Kristiaan Rawlings:

📩 Kristiaan on LinkedIn

Episode Highlights:

“A 16-year tenure at one company? That’s a marriage. But now you’re dating again—and you need to know your story.”

📢 Subscribe to RealPharma

💬 Liked this episode? Let us know what roles or trends you'd like us to cover next time!

Guest: Andrew Craig, Founder of Plain English Finance | Author of Our Future is Biotech

In this bold and wide-ranging conversation, Ian Wendt and Na-Ri Oh sit down with Andrew Craig—British investor, entrepreneur, and author—to explore how biotechnology is poised to shape the next century in the same way physics and computing shaped the last.

Craig draws on his decades of experience as a London and New York investment banker and as a former partner at WG Partners, where he advised more than 60 biotech companies and worked on marquee deals like the $7.6B sale of Nordia Bank and IPOs for brands like EasyJet and Burberry.

But his latest passion lies at the intersection of finance and innovation: making the case that our future is biotech—without a question mark.

Why biology will define the 21st century: Andrew outlines the structural and technological reasons biotech is primed for exponential impact.

CRISPR, AI, and the "exponential stack": How data storage, ML, and sequencing speed make today's breakthroughs possible.

Fixing Europe's biotech lag: The cultural, capital, and regulatory headwinds slowing biotech innovation in the UK and EU.

Rebuilding trust in pharma: Why good actors in drug development don’t get headlines—and how that hurts innovation.

From Oxford Biomedica to DNA-based storage: Vivid examples of tech cost reductions and where we're headed next.

The case for optimism: How to resist the press's negative bias and invest in human progress—literally.

📘 Andrew’s latest book: Our Future is Biotech on Amazon

📕 His first bestseller: How to Own the World on Amazon

🌐 Plain English Finance: www.plainenglishfinance.com

🔗 Connect with Andrew on LinkedIn: linkedin.com/in/andrewcraigpef

“The last century was about physics and tech. The next one will be about biology—and by extension, biotech.”

“If success begets success, then a crop of billion-dollar biotech companies in Europe can kickstart a self-sustaining cycle of innovation and investment.”

“People forget that the smartphone they hold was a $100 million science project in the 1990s. Biotech is heading the same direction.”

“We need to fight the narrative that pharma is inherently bad. There are good actors, and we must do a better job telling those stories.”

Biotech isn't just a sector—it's a structural solution to some of humanity’s greatest problems. From disease treatment to environmental restoration, the converging forces of AI, genetics, and biological engineering make this the most consequential time in science since the industrial revolution.

🎙 Episode Title: Rooted in Results: The Future of Functional Medicine with Dr. Erica Armstrong 

🧬 Episode Summary

Whether you're in biotech, med affairs, or digital health, this conversation offers an eye-opening look into how patient-centric, preventative medicine could transform our approach to chronic disease—and what pharma can learn from it.

🧪 What You'll Learn:

Why traditional medicine may be great at managing symptoms—but not always solving problems

How functional medicine complements pharmaceuticals and improves adherence

The biomarkers we’re missing (hello, fasting insulin!)

Why nutrition might be the most under-prescribed medicine

How Root Functional Medicine is scaling personalized care without sacrificing quality

The role of AI, telehealth, and tech platforms in building the future of functional medicine

🧵 Resources & Links Mentioned:

🔹 Guest Bio & Links

Dr. Erica Armstrong, MD, IFMCP

📘 Publications & Tools

The PCOS Thyroid Connection by Dr. Erica Armstrong

Root’s Blog & White Papers

💊 Related Guests Mentioned

Dr. Grace Magedman — Leadership & functional medicine coach

💡 Topics Mentioned

Institute for Functional Medicine (IFM) training: functionalmedicine.org

GLP-1s and functional complements to pharmaceutical therapies

Personalized lab testing and the Root Cause Panel

📱 Follow the Hosts

Nari Oh – LinkedIn

Ian Wendt – LinkedIn

🧠 Favorite Quotes

🎙️ RealPharma Podcast

Episode Title: Cracking the Code on Patient Engagement: Conversational AI with Dan Fox

🗓️ Release Date: May 5, 2025

In this eye-opening episode, we welcome Dan Fox, a trailblazer in AI-powered patient communication, to explore how proactive outreach and conversational AI are reshaping healthcare engagement. As the Managing Director of Healthcare at Drips, Dan shares how his team is using SMS-based AI to boost patient adherence, improve outcomes, and build trust—even in the face of complex compliance and tech fluency challenges.

From personalized text reminders that get 60–80% response rates to thoughtful strategies for integrating AI without sacrificing patient experience, Dan takes us deep into what’s working (and what’s not) in healthcare communication today. Plus, he shares what excites him most about the future—including AI therapists, ambient scribes, and closing the tech adoption gap in health systems.

Why “attention” is the biggest communication challenge in healthcare

How AI-driven SMS is outperforming traditional channels like email and mail

Real-world outcomes: 4.1% improvement in national medication adherence rates

Navigating regulatory complexity with Drips' proprietary “rules engine”

Why many healthcare orgs use “compliance” as a crutch against innovation

Texting seniors? Yes—it works (and they even say “thank you, sweetie” ❤️)

The future of AI in healthcare: from virtual triage to AI therapists

“We’re not using generative AI in our consumer outreach—because every single word needs to be approved. But we use AI to scale natural conversations.” – Dan Fox

“Trust is everything. We use personalization and omnichannel context to build it—one message at a time.” – Dan Fox

“We don’t want PHI. We just want to start the right conversation.” – Dan Fox

Drips.com – Learn more about their AI-powered engagement solutions

CMS Star Ratings: Why medication adherence matters

Companies like RxAnte mentioned for rules-based healthcare targeting

Website: drips.com

LinkedIn: https://www.linkedin.com/in/dsweeneyfox/

Role: Healthcare Strategy Lead

Available wherever you get your podcasts—Spotify, Apple Podcasts, Amazon Music, and more.

In this powerful and deeply human episode of RealPharma, we’re joined by Grace Magedman, PharmD—former Chief Pharmacy Officer at Children’s Hospital of Orange County, functional medicine practitioner, and founder of The Magidman Group.

Grace takes us inside her 20+ years of hospital pharmacy leadership, where she navigated high-stakes medication decisions, complex implementation of rare disease therapies, and the ethical strain of resource constraints. But her most transformative leadership moment came not in the boardroom—but in her own experience of burnout.

Now a certified high-performance coach, Grace shares how she rebuilt from the inside out, creating the Functional Resilience Framework—a science-based system that blends neuroscience, functional medicine, and leadership development to help others sustain performance without sacrificing purpose.

Whether you’re in pharma, hospital leadership, or simply navigating the demands of high-impact work, Grace’s insights offer a roadmap to lead with clarity, energy, and longevity.

• Learn more about Grace’s work: magedmangroup.com

• Interested in the Functional Resilience Framework? Contact Grace directly for coaching or workshops.