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"I always kept my lab at NCI, so I was always doing my research. But I was asked by him to lead the oncology critical path at the FDA, and I did that. I was doing that while also helping the King of Jordan develop the biotechnology strategy of Jordan and what it would take to move it forward."
In this episode of The Biotech Startups Podcast, Samir Khleif shares pivotal moments from his career at the crossroads of government, research, and entrepreneurship—reflecting on being chosen by FDA commissioner Andy von Eschenbach to lead oncology reform at the FDA, while simultaneously running his NCI research lab and advising Jordan’s national biotech strategy. 
He highlights the power of academic freedom, assembling a task force of over 120 top experts to advance regulatory change, and the leadership lessons gained building world-class teams—all culminating in a breakthrough that sparked the founding of Georgiamune.
Key topics covered:

• Leading National Reform: Spearheading FDA oncology reform with 120+ experts.
• Balancing Multiple Roles: Navigating government, research, and global biotech.
• The Value of Academic Freedom: Leveraging flexibility to drive innovation.
• Building Top-Performing Teams: Attracting and motivating elite talent.
• From Breakthrough to Startup: Turning discovery into Georgiamune.

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Subscribe to the Podcast:Apple: https://podcasts.apple.com/us/podcast/the-biotech-startups-podcast/id1679591994Spotify: https://open.spotify.com/show/2PSL162R2s0zOwU5913Zv4Youtube: https://www.youtube.com/@thebiotechstartupspodcast Website: https://www.thebiotechstartupspodcast.com/ 
Find our guest, Samir Khleif, at these links: LinkedIn: https://www.linkedin.com/in/samir-khleif-4280b29/Website: http://www.georgiamune.com/ Find our host, Jon Chee, at these links: LinkedIn: https://www.linkedin.com/in/jonchee
Learn more about Excedr:LinkedIn: https://www.linkedin.com/company/excedr/ Website: https://www.excedr.com
Intro & Outro Songs Created by OkKyojin, Owned by Excedr:Website: https://flow.page/kyojin 
Resources & Articles:Oncology Critical Path Initiative at the FDA: https://www.fda.gov/science-research/science-and-research-special-topics/critical-path-initiativeBuilding a World-Class Cancer Center: https://www.ncbi.nlm.nih.gov/books/NBK584196/2025 Trends in Biotech Venture Capital Funding https://www.excedr.com/blog/trends-in-biotech-venture-capital-fundingImpact of Regulatory Environment on Life Sciences VC https://www.excedr.com/blog/impact-of-regulatory-environment-on-life-sciences-vc 
Companies, Universities, & People mentioned:NCI: https://www.cancer.gov/FDA: https://www.fda.gov/
Andy von Eschenbach, MD: https://www.linkedin.com/in/andrew-von-eschenbach-m-d-9439ab10/
Timestamps:00:00 Intro01:43 Transition: From Building a Cancer Center to the Next Phase01:56 Leading National Reform at the FDA03:01 Balancing Research, Government, and Global Biotech Advisory03:36 Innovating Drug Development: The FDA’s Critical Path Initiative05:31 Identifying Challenges and Building Solutions07:11 Engaging the Community and Assembling Expert Teams09:11 Recruiting Talent: Bringing Experts Back to Jordan11:01 From Scientific Discovery to Entrepreneurial Action12:31 Launching Georgiamune: Taking Control of Innovation22:43 OutroThe Biotech Startups Podcast gives you a front-row seat to the business and science of building a biotech. Hosted by Jon Chee, CEO of Excedr, the show features honest conversations with founders, execs, and investors about their work, their companies, and how they got there. From scientific breakthroughs to startup lessons, each episode explores what it really takes to grow a life science company—from pre-seed to IPO.