In this discussion, our guests give their observations and recommendations on how companies can navigate within the United States market and beyond. Watch now.
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Drug development is already complex, but in this regulatory landscape, risks lurk at every turn. Funding decreases, manufacturing uncertainties, loss of regulatory expertise, legal challenges, and the threats of tariffs have elevated risks to both investors and drug and device developers in the United States market. The effects, however, go beyond the United States, as the global market pivots and tries to adapt to each move the United States makes. While many of these changes are new, our guests give their observations and recommendations on how to move forward.
Key Takeaways
- Understanding the global impact on the United States market’s reduced funding.
- International funding and investment opportunities beyond U.S. markets
- The complications surrounding current manufacturing initiatives.
- Other countries’ efforts to establish themselves as viable clinical trial locations.
- How companies are navigating the environment.
Panelists
Ali Pashazadeh
CEO | Treehill Partners
Ali Pashazadeh is founder and CEO of Treehill Partners. He has 20 years experience at Goldman Sachs, UBS and Blackstone as a healthcare investment banker, advising companies on large, complex, global strategic transactions. He also has 30 years ongoing experience as a trauma and reconstructive surgeon, and as a biotech CEO.
Dr. Khanh Courtney
Biologics Technical Strategy Leader | Element Materials Technology
Dr. Khanh Courtney specializes in solving complex analytical challenges for biopharmaceutical products through expert method development and stage-appropriate validation. Drawing on her Ph.D. in biochemistry from the University of Wisconsin-Madison, she excels at designing characterization studies that address critical regulatory requirements and creating robust documentation for IND/BLA applications. Her technical expertise bridges the gap between R&D innovation and CMC compliance, enabling smoother regulatory pathways for biological therapeutics.
Mike Walker
VP for Life Sciences Advisory | Microsoft
Mike J. Walker is a VP for Life Sciences Advisory at Microsoft that is known as an industry authority on emerging technologies & digital innovation. He’s a 30-year digital-transformation expert that inspires leaders in areas like agentic AI, IoT, digital twins, cybersecurity, and more.