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Business Of Biotech

BoB@JPM: Marc Salzberg, M.D., Airway Therapeutics

36 min episode · 2 min read
·
Marc Salzberg

Episode

36 min

Read time

2 min

Topics

Productivity, Relationships, Investing

AI-Generated Summary

Key Takeaways

  • BPD Incidence by Gestational Age: Bronchopulmonary dysplasia affects over 90% of infants born at 22–23 weeks, dropping to 30–50% near 28 weeks. Airway Therapeutics targets the 22–27 week and six day population for its pivotal trial, with plans to expand the addressable market to include babies born at 29–30 weeks post-approval.
  • Private Funding Strategy for Clinical-Stage Biotechs: Airway Therapeutics raised nearly $100 million without institutional investors, relying on family offices, high-net-worth individuals, and a private equity arm of an insurance company. Salzberg now identifies institutional capital as essential for completing the pivotal trial and scaling manufacturing, making JPM a deliberate fundraising target.
  • Regulatory Incentives for Rare Pediatric Indications: Zelpultide alfa holds orphan designation in both the US and Europe and qualifies for the FDA pediatric priority review voucher program. Salzberg used this designation to justify moving directly from phase 1b into a combined phase 2b/3 pivotal trial, compressing the development timeline and reducing capital requirements.
  • Manufacturing Process Development as the Core IP Barrier: The difficulty with zelpultide alfa was not the manufacturing itself but developing the upstream process, purification workflow, and accompanying analytics. Once that process was established, a limited number of capable CDMOs in the US and internationally were identified. Securing financing, not technical readiness, is now the bottleneck to scaling.
  • Bridging Academia and Industry in Drug Development: Salzberg's founding of PharmaBrains addressed a structural gap: academia lacks regulatory expertise and commercial focus, while industry lacks clinical feasibility knowledge. His model brought all three stakeholders — academic, industry, and regulatory — onto a shared platform to run studies that were both scientifically rigorous and commercially viable.

What It Covers

Marc Salzberg, CEO and CMO of Airway Therapeutics, discusses building a privately funded clinical-stage biotech developing zelpultide alfa, a recombinant surfactant protein D targeting bronchopulmonary dysplasia in preterm infants born at 22–28 weeks, now entering a multinational phase 2b/3 pivotal trial across Europe, the US, and Israel.

Key Questions Answered

  • BPD Incidence by Gestational Age: Bronchopulmonary dysplasia affects over 90% of infants born at 22–23 weeks, dropping to 30–50% near 28 weeks. Airway Therapeutics targets the 22–27 week and six day population for its pivotal trial, with plans to expand the addressable market to include babies born at 29–30 weeks post-approval.
  • Private Funding Strategy for Clinical-Stage Biotechs: Airway Therapeutics raised nearly $100 million without institutional investors, relying on family offices, high-net-worth individuals, and a private equity arm of an insurance company. Salzberg now identifies institutional capital as essential for completing the pivotal trial and scaling manufacturing, making JPM a deliberate fundraising target.
  • Regulatory Incentives for Rare Pediatric Indications: Zelpultide alfa holds orphan designation in both the US and Europe and qualifies for the FDA pediatric priority review voucher program. Salzberg used this designation to justify moving directly from phase 1b into a combined phase 2b/3 pivotal trial, compressing the development timeline and reducing capital requirements.
  • Manufacturing Process Development as the Core IP Barrier: The difficulty with zelpultide alfa was not the manufacturing itself but developing the upstream process, purification workflow, and accompanying analytics. Once that process was established, a limited number of capable CDMOs in the US and internationally were identified. Securing financing, not technical readiness, is now the bottleneck to scaling.
  • Bridging Academia and Industry in Drug Development: Salzberg's founding of PharmaBrains addressed a structural gap: academia lacks regulatory expertise and commercial focus, while industry lacks clinical feasibility knowledge. His model brought all three stakeholders — academic, industry, and regulatory — onto a shared platform to run studies that were both scientifically rigorous and commercially viable.

Notable Moment

Airway Therapeutics enrolled its first patient in the pivotal BPD trial at one hour and 51 minutes before midnight on December 31, meeting a self-imposed 2025 enrollment commitment with no margin to spare — a detail Salzberg recounted without apparent irony.

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Episode Transcript

Welcome back to the business of biotech. I'm your host, Ben Comer, chief editor at Life Science Leader. And today, I'm speaking with doctor Mark Salzberg MD, CEO, chief medical officer, and board chair at Airway Therapeutics, a clinical stage biopharmaceutical company developing zelpultide alpha, a recombinant version of human surfact surfactant protein d for severe respiratory, inflammatory and infectious diseases, including, bronchopulmonary dysplasia, which is currently in phase two b three trials. Does that sound sound alright so far, Anthony? That's true. Yeah. Thank you. Mark joined Airway Therapeutics as president and CEO in 2013. And before that, he held leadership roles at several CROs, including Dynotechs and Medpace, the latter of which acquired PharmaBrains, a European CRO where Mark was founder and CEO. Before that, he worked in academic medicine as a director at the Clinical Cancer Research Center in Switzerland and at University Hospital Basel, and he began his career at Roche, working in global operations. Excited to chat with Mark about the company building process and clinical strategy at Airway, what he learned during his time in academic research and leading CROs, and what his priorities are for 2026. Thank you so much for being here, Mark. Thank you for having me, Ben. It's the, the JPM, day one session of the business of biotech. We're here in San Francisco, and I I wanted to start out, and we'll we'll talk a little bit about, JPM, and I'll get your thoughts, you know, and and your maybe your goals for the conference, Mark. But I I wanted to start out with your background. You went to, I think, medical school and law school concurrently, at the University of Basel. Is is that correct? That's right, that's right. I started with medical school and, in Switzerland, you have to write a thesis, a dissertation to get your doctor's degree. And, I wrote about the ethical and medical issues with high risk clinical studies in human beings. Interesting. And so I became interested in the legal aspects of medicine and research. So enrolled in law school as well. Did you sleep at all during that time? I slept. I slept. Your career in life sciences began at Roche. Could you talk a little bit about those initial experiences and maybe what you worked on, at Roche? Yeah. At Roche, I have the possibility to enroll in a training program for young physicians, which was extremely helpful for me to understand the drug development process. I later then specialized in pharmaceutical medicine, which was my goal, so Roche helped me a lot in that respect. I worked in the CNS, in section first, and then moved over to virology and oncology. And that exposure in virology to HIV disease and cytomegalovirus disease, CME disease, for AIDS patients and transplantation, helped me a lot of in terms of understanding for deeper immunology, and then the translation from bench to bedside, from research into clinical, development. On one hand, and oncology, …

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