Discovery is a complex and high-risk process in drug development, as researchers strive to identify and advance promising therapeutic candidates. It requires scientific prowess, advanced technologies, and strategic vision to navigate through potential obstacles with agility. With this episode, Big4Bio is kicking off an occasional series on discovery sciences with Charles River Labs, which, over the past five years, has contributed to more than 80 percent of novel FDA-approved drugs. We spoke with Charles River Labs' chief scientific officer of discovery Justin Bryans, and Charles River Labs' vice president and chief scientific officer for discovery and safety assessments, Steve Bulera, about the challenges of drug discovery, why every moment matters, and the benefits of the collaborative approach Charles River takes in working with its partners.
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Discovery is a complex and high-risk process in drug development, as researchers strive to identify and advance promising therapeutic candidates. It requires scientific prowess, advanced technologies, and strategic vision to navigate through potential obstacles with agility. With this episode, Big4Bio is kicking off an occasional series on discovery sciences with Charles River Labs, which, over the past five years, has contributed to more than 80 percent of novel FDA-approved drugs. We spoke with Charles River Labs' chief scientific officer of discovery Justin Bryans, and Charles River Labs' vice president and chief scientific officer for discovery and safety assessments, Steve Bulera, about the challenges of drug discovery, why every moment matters, and the benefits of the collaborative approach Charles River takes in working with its partners.
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
Discovery is a complex and high-risk process in drug development, as researchers strive to identify and advance promising therapeutic candidates. It requires scientific prowess, advanced technologies, and strategic vision to navigate through potential obstacles with agility. With this episode, Big4Bio is kicking off an occasional series on discovery sciences with Charles River Labs, which, over the past five years, has contributed to more than 80 percent of novel FDA-approved drugs. We spoke with Charles River Labs' chief scientific officer of discovery Justin Bryans, and Charles River Labs' vice president and chief scientific officer for discovery and safety assessments, Steve Bulera, about the challenges of drug discovery, why every moment matters, and the benefits of the collaborative approach Charles River takes in working with its partners.
