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DTSTART;TZID=America/New_York:20260617T083000
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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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DTSTART;TZID=America/New_York:20260617T173000
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CREATED:20260519T135325Z
LAST-MODIFIED:20260601T204427Z
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SUMMARY:Executive Dinner 2026 (Invite-Only)
DESCRIPTION:Join us on Wednesday\, June 17\, 2026 at the Energy Innovation Center in Pittsburgh for a relaxed evening to meet new colleagues\, reconnect with those familiar\, and hear from our guest speaker\, Ryan Haney\, Managing Director\, Healthcare Equity Capital Markets / Origination\, Wells Fargo. \n*This event is reserved for individuals serving in executive leadership roles\, including CEO\, CFO\, CSO\, President\, Founder\, CMO\, COO\, CBO\, CIO\, CTO\, or Vice President of Life Sciences PA Core Member companies. A Life Sciences PA Core Member is an organization involved in biotech\, pharmaceutical\, medical device\, diagnostics\, and digital health research and development\, patient groups\, research institutions\, and funding & investment groups. Service providers are not eligible to attend this event. If you are not sure of your eligibility\, please contact Emily Boring\, Membership Director\, eboring@lifesciencespa.org. \n*There is no registration fee. The cost for this event is fully underwritten by our generous sponsors. However\, space is limited and you must register for this event if you plan to attend \nIf you have any questions about the program\, please contact Natalie George\, Programs Manager\, ngeorge@lifesciencespa.org. \n			\n				Click Here to Register
URL:https://lifesciencespa.org/event/executive-dinner-2026/
LOCATION:Energy Innovation Center\, 1435 Bedford Avenue\, Pittsburgh\, PA\, 15219
CATEGORIES:Life Sciences PA Events
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