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X-WR-CALDESC:Events for Life Sciences PA
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DTSTART;TZID=America/New_York:20260617T083000
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CREATED:20260422T130620Z
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UID:10000289-1781685000-1781690400@lifesciencespa.org
SUMMARY:The Road to First in Human Trials (Invite-Only)
DESCRIPTION:This session gives biotech leaders a practical roadmap for moving a new asset from development into first-in-human readiness. Attendees will learn how to align CMC\, toxicology\, regulatory strategy\, and early clinical planning around the target product profile so critical decisions are made earlier\, risks are surfaced sooner\, and resources are deployed more strategically.  \nThe discussion will also highlight the operational and regulatory bottlenecks that most often delay IND and Phase 1 execution\, what phase-appropriate development looks like in practice\, and how a more integrated model can improve speed\, governance\, and execution across both SM and LM programs. \nAttendees will take away from the program: \n\nHow to use the target product profile to guide cross-functional decisions earlier in development.\nThe three essentials of IND readiness: drug supply\, the pharm/tox package\, and the clinical plan .\nThe bottlenecks that most often slow progress\, including manufacturing lead times\, formulation and dose changes\, logistics\, and fragmented vendor handoffs \nWhat “phase-appropriate” development means for speed\, capital efficiency\, and long-term asset value \nWhy early clinical strategy should inform CMC and toxicology planning—not the other way around \nWhere earlier FDA engagement and stronger regulatory planning can reduce rework and lower clinical-hold risk \nWhy integrated development\, clinical supply\, and governance models can improve execution for lean biotech teams\n\nAgenda Items: 8:00 AM – 10:00 AM8:00 AM – 8:30 AM – Registration and light Breakfast8:30 AM – 9:30 AM – Education Program9:30 AM – 10:00 AM – Networking \n			\n				Click Here to Register
URL:https://lifesciencespa.org/event/the-road-to-first-in-human-trials-invite-only/
LOCATION:LSPA Headquarters\, 411 Swedeland Rd\, King of Prussia\, PA\, 19406\, United States
CATEGORIES:Life Sciences PA Events
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