How to navigate regulatory limbo: a Canadian phage therapy CEO's playbook

Описание: "Phages are not drugs. Every time they say, 'Did you go through regulatory?' I say, 'I can do regulatory, but I'm not a drug.' There's 145 components of the regulatory requirements that I don't fit in."

When your health innovation doesn't fit existing regulatory boxes, how do you build a business? Steven Theriault, CEO of Cytophage, has spent 9 years learning to navigate Canada's regulatory maze for phage therapy. From being told "we don't know" by government officials to raising $24M and treating patients, Steven shares his hard-won playbook for building in uncharted regulatory territory.

In this episode of the Podovirus Podcast, Jessica Sacher and Joe Campbell talk to Steven Theriault about what he's tried, accomplished and learned in the last ~decade building a phage biotech company in Canada:

🎯 The pivot strategy: When hospitals won't buy your innovation, find another market (Steven turned to chicken farmers when Clorox contracts blocked hospital sales)

🏛️ Educating regulators: How to teach government officials about your technology when they've never heard of it (Steven went from 10 officials with no idea what a phage was, to regular advisory calls to shape Canada's approach to regulating phage therapy)

📋 Creating your own framework: Why Steven argues phages need different GMP guidelines than traditional drugs, and how to advocate for biological variability

💰 Funding the unfundable: How Cytophage raised $24M for technology that doesn't fit traditional pharma investment models

🔄 The workaround approach: Building revenue streams (agriculture) to fund your real mission (human health) when direct paths are blocked

🌐 International advantage: Why Steven has more regulatory traction in the US than Canada, and how to leverage global progress domestically

Chapters:
00:00 Introduction to Cytophage and Phage Therapy
03:02 Steven's Journey into Phage Research
05:59 Transition from Agriculture to Human Health
08:46 Current Status of Human Phage Therapy
11:37 Patient Acquisition and Treatment Process
14:42 Regulatory Challenges and Government Interaction
17:47 Phage Treatment in Agriculture
19:42 Evolution of Thinking in Phage Research
22:52 Future Directions and Research Needs
32:02 Navigating Regulatory Challenges in Phage Therapy
37:11 Phage Therapy vs Fecal Microbiome Transplants
40:24 Investor Perspectives on Phage Therapy
44:23 The Future of Phage Therapy in Agriculture
47:41 Long-term Vision: Phage Therapy in Canadian Healthcare

Learn more:

Cytophage website: https://cytophage.com/
Steven's 2024 TEDx talk on the future of phage therapy:    • Bacteriophages: The Silent Cure to Antimic...  
The CBC News story on Cytophage's first patient treatment (Thea's success story): https://www.cbc.ca/news/canada/manito...

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