Stacking Exclusivity: How Regulatory Incentives Power Drug Innovation
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Stacking Exclusivity: How Regulatory Incentives Power Drug Innovation
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About this listen
A pharmacist–turned–regulatory strategist and a 25-year patent attorney walk into a podcast… and blow up the myth that “no composition of matter means no value.”
- Ray and Nicole break down how regulatory exclusivity actually drives drug innovation, often more powerfully than patents.
- Hear how NCE, orphan drug, pediatric, and GAIN Act exclusivity can turn an old or overlooked molecule into a fundable, defensible asset.
- Discover why biologics play by completely different rules, why there’s no Orange Book, and what the mysterious “patent dance” really is.
- Learn how exclusivities can stack (and when they absolutely don’t), including real examples of companies turning five years into ten—or more.
- Get a preview of skinny labeling, the loophole that stops perpetual exclusivity and deserves its own episode.
- Plus: a rapid tour of EU, China, and Japan exclusivity systems and how global rights shape investment strategy.
A fast, clear, myth-busting guide to one of the most misunderstood forces in the life sciences industry.
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