California research institutes, universities, and biopharmaceutical companies are a critical source of innovation, contributing to the development of approximately a quarter of new drugs that the U.S. Food and Drug Administration approved last year. But despite the breakthroughs, more mundane issues of tariffs, drug pricing, and access to funding continue to weigh on leaders within the sector. We spoke to Tim Scott, president and CEO of Biocom California, about the current state of the biotech industry, a surge in mergers and acquisitions driven by the looming patent cliff, and what Biocom is doing to support companies through partnerships, advocacy, and policy reform.
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California research institutes, universities, and biopharmaceutical companies are a critical source of innovation, contributing to the development of approximately a quarter of new drugs that the U.S. Food and Drug Administration approved last year. But despite the breakthroughs, more mundane issues of tariffs, drug pricing, and access to funding continue to weigh on leaders within the sector. We spoke to Tim Scott, president and CEO of Biocom California, about the current state of the biotech industry, a surge in mergers and acquisitions driven by the looming patent cliff, and what Biocom is doing to support companies through partnerships, advocacy, and policy reform.
ICH M12: How Will New Regulatory Harmonization Impact Drug Developers?
The Big4Bio Podcast
32 minutes 42 seconds
1 year ago
ICH M12: How Will New Regulatory Harmonization Impact Drug Developers?
The recently released update to the International Council for Harmonisation M12 guidelines provides a consistent approach to drug-drug interaction studies across different regulatory agencies. The new guidelines replace regional and local ones and set a global standard for addressing drug-drug interactions. We spoke to Michael Templin, Senior Principal Scientific Advisor for Charles River Laboratories; and Marko Andric, Senior Business Development Director, Late Discovery, for Charles River Laboratories; about the new guidelines, changes drug developers will need to make in their approach to pre-clinical development, and the tools and technologies that might help them comply. A related webinar on the guidelines can be found at www2.criver.com/l/60962/2024-11-05/n5wj6y
The Big4Bio Podcast
California research institutes, universities, and biopharmaceutical companies are a critical source of innovation, contributing to the development of approximately a quarter of new drugs that the U.S. Food and Drug Administration approved last year. But despite the breakthroughs, more mundane issues of tariffs, drug pricing, and access to funding continue to weigh on leaders within the sector. We spoke to Tim Scott, president and CEO of Biocom California, about the current state of the biotech industry, a surge in mergers and acquisitions driven by the looming patent cliff, and what Biocom is doing to support companies through partnerships, advocacy, and policy reform.
