Navigating Global Regulatory Pathways for Rare Disease Oncology with Paul Romness

  Paul Romness, Chair, Chief Executive Officer & President of OS Therapies, a clinical-stage oncology company and leader in gene-edited, Listeria-based cancer immunotherapies developing targeted treatments for osteosarcoma and other solid tumors joins eHealth Radio and the Cancer Information & Health News Channels. Listen to interview with host Eric Michaels & guest Paul Romness discuss the following: To start, you bring a wealth of leadership experience to the table, and you are now guiding OS Therapies through an incredibly pivotal regulatory chapter. Could you share what personally drew you to this mission, and how your background shaped the company's laser-focus on tackling devastating, hard-to-treat solid tumors like osteosarcoma?OS Therapies is described as a leader in gene-edited, Listeria-based cancer immunotherapies. For our audience, how do you harness Listeria bacteria to trigger an immune response against solid tumors?Traditional therapies usually look for just one specific marker to target a cancer cell, but cancers can mutate to hide from them. OST-HER2 goes after three different markers instead. How does this triple-target approach prevent the cancer from escaping, and why is that such a game-changer?Osteosarcoma is a devastating disease that often affects children and young adults. How does OST-HER2 work to prevent or delay the recurrence of these tumors after surgical resection?The company recently reported positive Phase 2b data for OST-HER2 in patients with recurrent, fully resected lung metastatic osteosarcoma. What were the key takeaways regarding event-free and overall survival from that study?

Looking at your broader pipeline, you are also developing next-generation Tunable Antibody Drug Conjugates (tADCs) using a proprietary silicone linker. How does this complement your immunotherapy platform?If you achieve U.S. approval in 2026, OS Therapies would become eligible for a Priority Review Voucher. How does that voucher factor into your long-term commercialization or capitalization strategy?
As both CEO and Chairman, navigating three major regulatory bodies (FDA, EMA, MHRA) simultaneously is a massive undertaking. What advice do you have for other biotech leaders attempting to harmonize global regulatory pathways for rare diseases?If everything aligns as you hope with the FDA, EMA, and MHRA, what will this mean for the families and young patients facing osteosarcoma, and what is your ultimate vision for how OS Therapies will reshape the landscape of cancer treatment over the next few years? Paul Romness is the chair, CEO, and President of OS Therapies. He leads the company with over 25 years of experience in the biopharmaceutical industry, having served in multiple functions at Johnson & Johnson, Amgen, and Boehringer Ingelheim. He has been directly involved in the launch of nine major products spanning oncology, surgery, HIV, pulmonary disease, cardiovascular disease, and diabetes, and has been a consistent advocate for addressing unmet medical need and getting treatments to patients. Website: https://ostherapies.com Social Media Links: Facebook: facebook.com/OSTherapies  Instagram: instagram.com/ostherapies  Linkedin: linkedin.com/company/os-therapies   X: x.com/OSTherapies  People also listened to this: From Farm to Face: Why Olea Essence Olive Oil-Based Skincare Products are Perfect for the Whole Family