BEGIN:VCALENDAR
VERSION:2.0
PRODID:-//California Life Sciences - ECPv6.17.1//NONSGML v1.0//EN
CALSCALE:GREGORIAN
METHOD:PUBLISH
X-WR-CALNAME:California Life Sciences
X-ORIGINAL-URL:https://www.califesciences.org
X-WR-CALDESC:Events for California Life Sciences
REFRESH-INTERVAL;VALUE=DURATION:PT1H
X-Robots-Tag:noindex
X-PUBLISHED-TTL:PT1H
BEGIN:VTIMEZONE
TZID:America/Los_Angeles
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20250309T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20251102T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20260308T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20261101T090000
END:STANDARD
BEGIN:DAYLIGHT
TZOFFSETFROM:-0800
TZOFFSETTO:-0700
TZNAME:PDT
DTSTART:20270314T100000
END:DAYLIGHT
BEGIN:STANDARD
TZOFFSETFROM:-0700
TZOFFSETTO:-0800
TZNAME:PST
DTSTART:20271107T090000
END:STANDARD
END:VTIMEZONE
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20260514T080000
DTEND;TZID=America/Los_Angeles:20260514T173000
DTSTAMP:20260407T200853Z
CREATED:20260407T200853Z
LAST-MODIFIED:20260407T200853Z
UID:10001056-1778745600-1778779800@www.califesciences.org
SUMMARY:Small Molecule Preclinical Development and IND Filing: Nuts\, Bolts and Best Practices
DESCRIPTION:Investigational new drug (IND) application is an important milestone that marks the entry of a molecule into clinical development. Knowing the objectives\, expectations\, and processes of assembling and filing an IND is the key to not only a successful filing but also a promising clinical development path forward. Often\, there are cases where too many nice-to-have studies crowd in the package but critical studies/issues are not addressed\, and this can lead to significant delays in clinical development. Additionally\, the regulatory environment is changing as rapidly as the industry. Therefore\, keeping up to date on the regulatory requirements and the industry’s best practices in different aspects including non-clinical safety\, PK\, CMC\, and clinical plan is paramount. \nBelow are the topics to be covered: \n\n\n\nOverview of preclinical development and IND filing for small molecules\nKey preclinical studies required (Safety\, DMPK & CMC)\nClinical Development plans\n\n\n\n\nRegulatory strategie\nInteracting with regulatory agencies\n\nREGISTER» \nHosted by:
URL:https://www.califesciences.org/event/small-molecule-preclinical-development-2/
LOCATION:Hilton San Diego/Del Mar\, 15575 Jimmy Durante Blvd\, Del Mar\, CA\, 92014\, United States
CATEGORIES:Industry Events,Industry Supported
ATTACH;FMTTYPE=image/png:https://www.califesciences.org/wp-content/uploads/2025/11/SoCal-Industry-Event-1.png
END:VEVENT
END:VCALENDAR