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DTSTART;TZID=America/Los_Angeles:20260611T084500
DTEND;TZID=America/Los_Angeles:20260611T173000
DTSTAMP:20260506T221126Z
CREATED:20260506T221126Z
LAST-MODIFIED:20260506T221126Z
UID:10001084-1781167500-1781199000@www.califesciences.org
SUMMARY:Antibody Preclinical Development & IND Filing: Nuts\, Bolts\, Best Practices and Regulatory Strategies
DESCRIPTION:The investigational new drug application (IND) application is an important step in a drug development program\, and understanding the requirements for a successful IND filing is utmost important to ensure fast and efficient development. While the principles and basics are similar across different modalities for an IND filing such as safety studies\, there are important aspects that need to be considered for antibody-based therapeutics (antibodies\, antibody-drug conjugates and multispecific antibodies). In this workshop\, our highly experienced speakers from industry and the FDA will discuss the necessary preclinical studies for an antibody candidate and the best practices and regulatory strategies for a successful IND package of an antibody candidate. \nOutline: \n\nOverview of antibody-based therapeutics: structure\, generation\, design\, and optimization\nOverview of preclinical development and IND filing requirements for antibody-based therapeutics\nNon-clinical pharmacology considerations antibodies and in vivo disease modeling\nPharmacokinetic/Pharmacodynamic and bioanalytical considerations for successful IND filings\nHuman dose projection through clinpharm quantitative modeling\nPreclinical toxicology studies\nIND-enabling CMC activities\nClinical Development Plan\nRegulatory strategies and interactions with FDA: Industry perspective & how to prepare for FDA meetings\nThe regulatory perspective: the do’s and don’ts and avoiding a clinical hold\n\nREGISTER» \nHosted by:
URL:https://www.califesciences.org/event/antibody-preclinical-development-ind-filing/
LOCATION:Hilton San Francisco Airport Bayfront\, 600 Airport Blvd\, Burlingame\, CA\, 94010\, United States
CATEGORIES:Industry Events,Professional Development
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DTSTART;TZID=America/Los_Angeles:20260417T084500
DTEND;TZID=America/Los_Angeles:20260417T173000
DTSTAMP:20260401T221451Z
CREATED:20260401T221451Z
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UID:10001050-1776415500-1776447000@www.califesciences.org
SUMMARY:Small Molecule Preclinical Development and IND Filing: Nuts and Bolts
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. In this workshop\, our speakers highly experienced with IND filings will discuss systemically the preclinical studies required for small molecule IND filings and the nuts\, bolts\, and best practices for putting together a high-quality IND package\, as well as how to interact with various regulatory agencies. \nTopics:\n\nOverview of preclinical development and IND filing for small molecules\nKey preclinical studies required (Safety\, DMPK & CMC)\nClinical Development plans\nRegulatory strategies\nInteracting with regulatory agencies\n\nREGISTER» \nHosted by:
URL:https://www.califesciences.org/event/small-molecule-preclinical-development/
LOCATION:Hilton San Francisco Airport Bayfront\, 600 Airport Blvd\, Burlingame\, CA\, 94010\, United States
CATEGORIES:Industry Events,Industry Supported
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BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20251202T084500
DTEND;TZID=America/Los_Angeles:20251202T173000
DTSTAMP:20251126T204807Z
CREATED:20251125T170956Z
LAST-MODIFIED:20251126T204807Z
UID:10000955-1764665100-1764696600@www.califesciences.org
SUMMARY:Enhancing Bioavailability and Manufacturability with Enabling Formulation Technologies for Oral Small Molecule Drug Product Development
DESCRIPTION:From Lead Optimization and Candidate Nomination Through Clinical Development \nIt is well known that a majority of small molecule late discovery and development pipelines are populated by compounds that are poorly soluble\, and/or permeable. This has resulted in increasing use of established and emerging technologies to address these limitations. There are multiple ways that enabling technologies are impactful on the overall drug development effort\, among them: \n\nRendering poorly soluble molecules into tractable entities\, with respect to: Solubility\, Supersaturation on dissolution\, Absorption and PK profile\nEnhancing the ability to efficiently modify and optimize the performance of drug products in response to pre-preclinical\, preclinical and early clinical in vivo data\nHelping to ensure that the dosage form(s) used in clinical development are appropriate to the target\, with respect to pharmacokinetic (PK) and pharmacodynamic (PD) profiles\n\nThe workshop will describe and discuss approaches\, with case studies\, that address the iterative\, interdependent\, multidisciplinary nature of effective drug product development\, with focus on small molecules that require enabling technologies. \nREGISTER» \nHosted by:
URL:https://www.califesciences.org/event/enhancing-bioavailability-and-manufacturability/
LOCATION:Hilton San Francisco Airport Bayfront\, 600 Airport Blvd\, Burlingame\, CA\, 94010\, United States
CATEGORIES:Industry Events,Professional Development
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