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Understanding and Mitigating the Consequences of Loper Bright, Corner Post & Judicial Activities on Drug Development, Commercialization, and Investment

June 16, 2025
Breakout Session
Intellectual Property and Legal Landscape
While the industry is moving forward with the blending of technology and science, the legal landscape is quite different in one of the largest markets: the United States. The Loper Bright ruling this year removes Chevron deference, which historically deferred to agencies, such as the FDA, for guidance when judiciary challenges are presented. Combined with the Corner Post ruling, which removes statute of limitations, the rulings have now expanded judiciary power to be able to both review and reject federal agency interpretations of previously adopted statutes. Consequently, the industry has already seen the filing of a legal challenge to the FDA’s regulation of laboratory developed tests. Additionally, the FDA’s exclusivity recommendations and drug approvals are expected to be challenged. Panelists will discuss the current movement as it contradicts the industry's initiatives for diverse clinical trial patient population and the evolving legal landscape, drug and MedTech developers must understand to navigate the US market.
Moderator
Lori Ellis
Head of Insights
BioSpace
Speakers
Chris Hart, JD
Partner
Foley Hoag
Konstantina Katcheves
Senior Vice President, Innovative Medicines Business Development
Teva Pharmaceuticals
Michelle Longmire, MD
CEO & Co-founder
Medable
Edie Stringfellow
SVP, Global Health Strategy and Biomedical Commercialization
Precia Group

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