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DTSTART;TZID=America/Los_Angeles:20251020T084500
DTEND;TZID=America/Los_Angeles:20251020T173000
DTSTAMP:20250808T173905Z
CREATED:20250808T173739Z
LAST-MODIFIED:20250808T173905Z
UID:10000861-1760949900-1760981400@www.califesciences.org
SUMMARY:Organoids\, Tissue Bioengineering and AI/ML Tools: Minimizing Animal Studies for Pharmacology / ADME / Tox in the Context of the FDA Roadmap
DESCRIPTION:With the recent FDA memo on phasing out preclinical animal testing requirements for certain drugs and promoting the use of New Approach Methodologies (NAMs)\, the shift in broader strategy has brought new technologies to the forefront. This symposium covers a broad spectrum of NAMs\, including organ-on-a-chip and AI/ML computation modeling\, to reduce traditional animal studies in pharmacological safety and efficacy assessments. These future technologies and discoveries are essential to faster drug development and deeper understanding of human disease\, ultimately resulting in better and safer novel treatments. \nTopics covered: \n\nFDA stance on future preclinical data packages required for biologics investigational new drug (IND) applications\nInnovative approaches to Tissue Bioengineering in invitro organ systems\nImmune incorporation in modelling human tissues\nTissue-on-a-chip advances in preclinical pharmacological and efficacy studies\nAI/ML computation modeling of real-world human data\n\nREGISTER» \n 
URL:https://www.califesciences.org/event/pharmacokinetics-in-drug-discovery-and-development-fundamentals-applications-and-case-studies-location-in-person-event-url/
LOCATION:Crowne Plaza Hotel – Foster City\, 1221 Chess Dr\, Foster City\, CA\, 94404
CATEGORIES:Industry Events
ATTACH;FMTTYPE=image/jpeg:https://www.califesciences.org/wp-content/uploads/2025/01/Industry-Event.jpg
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DTSTART;TZID=America/Los_Angeles:20251009T084500
DTEND;TZID=America/Los_Angeles:20251009T173000
DTSTAMP:20250808T174041Z
CREATED:20250808T174041Z
LAST-MODIFIED:20250808T174041Z
UID:10000862-1759999500-1760031000@www.califesciences.org
SUMMARY:Pharmacokinetics in Drug Discovery and Development: Fundamentals\, Applications and Case Studies
DESCRIPTION:Pharmacokinetic (PK) studies are essential in drug development to understand how a drug is absorbed\, distributed\, metabolized\, and excreted in the body. This information guides dose selection\, optimizes efficacy\, minimizes toxicity\, and supports regulatory approval. Join this full day workshop led by industry experts\, the panel will cover the latest advances and practical strategies on this topic. Designed for scientists and professionals in DMPK\, clinical pharmacology for small molecules and biologics. \nTopics: \n\nIntroduction to PK & Foundational Principles\nStrategies to Overcome High Clearance and Low Bioavailability\nProjecting Human PK from Preclinical DMPK Data\nClinical Pharmacology Studies of Biologics\nUtilizing Population PK in Drug Development\n\nREGISTER» \n 
URL:https://www.califesciences.org/event/pharmacokinetics-in-drug-discovery-and-development-fundamentals-applications-and-case-studies/
LOCATION:Crowne Plaza Hotel – Foster City\, 1221 Chess Dr\, Foster City\, CA\, 94404
CATEGORIES:Industry Events
ATTACH;FMTTYPE=image/jpeg:https://www.califesciences.org/wp-content/uploads/2025/01/Industry-Event.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250926T084500
DTEND;TZID=America/Los_Angeles:20250926T173000
DTSTAMP:20250808T173609Z
CREATED:20250808T173609Z
LAST-MODIFIED:20250808T173609Z
UID:10000860-1758876300-1758907800@www.califesciences.org
SUMMARY:Gene Therapy Challenges and Best Practices: From Discovery to IND and Beyond
DESCRIPTION:This workshop provides a comprehensive overview of AAV gene therapy\, from foundational principles and the discovery of novel therapeutics using NanoCas and Zinc Finger Proteins\, to critical nonclinical and clinical development considerations. Strategies for Bioanalytical method and companion diagnostic development\, as well as genotoxicity and carcinogenicity concerns will be explored. In addition\, the speakers will delve into the intricate CMC\, Process development and scale up\, analytical and Quality Control\, and formulation challenges. The workshop will also cover essential regulatory aspects\, including interactions with the FDA\, ensuring a holistic understanding of bringing AAV-derived genomic medicines to patients. \nREGISTER» \n 
URL:https://www.califesciences.org/event/gene-therapy-challenges-and-best-practices-from-discovery-to-ind-and-beyond/
LOCATION:Crowne Plaza Hotel – Foster City\, 1221 Chess Dr\, Foster City\, CA\, 94404
CATEGORIES:Industry Events
ATTACH;FMTTYPE=image/jpeg:https://www.califesciences.org/wp-content/uploads/2025/01/Industry-Event.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Los_Angeles:20250916T084500
DTEND;TZID=America/Los_Angeles:20250916T173000
DTSTAMP:20250815T172127Z
CREATED:20250815T172127Z
LAST-MODIFIED:20250815T172127Z
UID:10000864-1758012300-1758043800@www.califesciences.org
SUMMARY:Toxicological Aspects for Product Quality\, Occupational Safety\, and Pharmaceuticals in the Environment During the Lifecycle of a Drug
DESCRIPTION:This PBSS workshop will cover strategies\, best practices\, and regulatory guidance for toxicological assessments to assess workplace safety\, product quality / patient safety\, and environmental toxicology. These assessments are critical for manufacturing\, and essential for successful drug development. Included will be a discussion on occupational safety\, toxicological risk assessment\, impurities\, cleaning validation\, and will cover different modalities such as biologics or small molecules. \nREGISTER» \n 
URL:https://www.califesciences.org/event/toxicological-aspects-for-product-quality-occupational-safety-and-pharmaceuticals-in-the-environment-during-the-lifecycle-of-a-drug/
LOCATION:Crowne Plaza Hotel – Foster City\, 1221 Chess Dr\, Foster City\, CA\, 94404
CATEGORIES:Industry Events
ATTACH;FMTTYPE=image/jpeg:https://www.califesciences.org/wp-content/uploads/2025/01/Industry-Event.jpg
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