https://hstalks.com/category/754/pharmaceutical-sciences/?biosci New and updated series & talks on Pharmaceutical Sciences from HSTalks' Biomedical & Life Sciences Collection. daily 1 2006-01-01T12:00+00:00 Henry Stewart Talks en © Copyright Henry Stewart Talks Ltd. The Biomedical & Life Sciences Collection © Copyright Henry Stewart Talks Ltd. https://hstalks.com/playlist/2205/developing-gene-therapies/?biosci Core principles of gene therapy (GTx) product development - Unmet medical needs addressed by GTx - Emerging business models, industry standards and best practices for GTx - Statistical design and analysis aspects of clinical trials of GTx - Case studies of successful development of GTx - Emerging global regulatory pathways for GTx - Benefits of GTx in the coming years from a multi-stakeholder perspective Developing Gene Therapies Dr. Avery McIntosh Dr. Alex Sverdlov Core principles of gene therapy (GTx) product development, Unmet medical needs addressed by GTx, Emerging business models, industry standards and best practices for GTx, Statistical design and analysis aspects of clinical trials of GTx, Case studies of successful development of GTx, Emerging global regulatory pathways for GTx, Benefits of GTx in the coming years from a multi-stakeholder perspective 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27454/toxicology-in-drug-development/?biosci Toxicological safety assessment - Chemical properties in toxicity - Regulatory standards and guidelines - Dose-response relationships - Organ-specific toxicity mechanisms - In vitro and in vivo methods - Risk assessment and safe doses - Good Laboratory Practice compliance - Ethics and three Rs principles Toxicology in drug development Toxicological safety assessment, Chemical properties in toxicity, Regulatory standards and guidelines, Dose-response relationships, Organ-specific toxicity mechanisms, In vitro and in vivo methods, Risk assessment and safe doses, Good Laboratory Practice compliance, Ethics and three Rs principles 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27455/pharmacovigilance/?biosci Pharmacovigilance definition and scope - Ongoing safety monitoring importance - Regulatory agencies and monitoring systems - Adverse event reporting processes - Managing new safety risks - Safety signal detection methods - Impact on patient safety and trust Pharmacovigilance Pharmacovigilance definition and scope, Ongoing safety monitoring importance, Regulatory agencies and monitoring systems, Adverse event reporting processes, Managing new safety risks, Safety signal detection methods, Impact on patient safety and trust 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27461/drug-shortages/?biosci Drug shortages overview - Global trends & affected medicines - Manufacturing failures & supply chain issues - Demand changes & regulatory challenges - Impact on patient care & healthcare systems - Prevention & mitigation strategies Drug shortages Drug shortages overview, Global trends & affected medicines, Manufacturing failures & supply chain issues, Demand changes & regulatory challenges, Impact on patient care & healthcare systems, Prevention & mitigation strategies 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27453/subcutaneous-vs-iv-formulations/?biosci Subcutaneous vs IV formulations - Administration methods - Pharmacokinetic differences - Patient experience & compliance - Formulation development challenges - Clinical outcomes & advances - Route selection factors Subcutaneous vs IV formulations Subcutaneous vs IV formulations, Administration methods, Pharmacokinetic differences, Patient experience & compliance, Formulation development challenges, Clinical outcomes & advances, Route selection factors 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27449/real-world-evidence/?biosci Definition of real-world evidence - Primary data sources for RWE - RWE vs traditional clinical evidence - Importance of RWE in research and regulation - Opportunities and limitations of RWE - Regulatory agency role in RWE adoption - Examples of RWE impact Real-world evidence Definition of real-world evidence, Primary data sources for RWE, RWE vs traditional clinical evidence, Importance of RWE in research and regulation, Opportunities and limitations of RWE, Regulatory agency role in RWE adoption, Examples of RWE impact 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27415/protein-purification/?biosci Protein purification basics - Recombinant expression systems - Protein recovery steps - Purification chromatography methods - Analytical yield and purity methods - Scale-up challenges and strategies Protein purification Protein purification basics, Recombinant expression systems, Protein recovery steps, Purification chromatography methods, Analytical yield and purity methods, Scale-up challenges and strategies 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27460/pharmaceutical-supply-chain/?biosci Supply chain structure and actors - Handling and transport for medicines - Vulnerabilities and global disruptions - Regulatory oversight and compliance - Supply chain impact on patient health - Need for resilience and transparency Pharmaceutical supply chain Supply chain structure and actors, Handling and transport for medicines, Vulnerabilities and global disruptions, Regulatory oversight and compliance, Supply chain impact on patient health, Need for resilience and transparency 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27451/drug-stability/?biosci Drug stability for efficacy and safety - Chemical and physical degradation - Regulatory and stability testing - Drug instability and patient health - Formulation for stability - Mechanisms of drug degradation - Types of stability studies - Packaging and storage for stability Drug stability Drug stability for efficacy and safety, Chemical and physical degradation, Regulatory and stability testing, Drug instability and patient health, Formulation for stability, Mechanisms of drug degradation, Types of stability studies, Packaging and storage for stability 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27462/clinical-trial-operations/?biosci Clinical trial planning and design - Team roles and collaboration - Site management and patient recruitment - Regulatory compliance and documentation - Data collection and quality management - Oversight, monitoring, and trial closure Clinical trial operations Clinical trial planning and design, Team roles and collaboration, Site management and patient recruitment, Regulatory compliance and documentation, Data collection and quality management, Oversight, monitoring, and trial closure 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27456/regulatory-affairs-in-pharma/?biosci Regulatory Affairs in Pharma - Preparation of Regulatory Documentation - Early Engagement with Agencies - Global vs Regional Requirements - Importance of Documentation Strategy - Ensuring Compliance and Ethics - Cross-functional Communication - Adherence to International Guidelines - Post-marketing Responsibilities - Development and Use of SOPs Regulatory affairs in pharma Regulatory Affairs in Pharma, Preparation of Regulatory Documentation, Early Engagement with Agencies, Global vs Regional Requirements, Importance of Documentation Strategy, Ensuring Compliance and Ethics, Cross-functional Communication, Adherence to International Guidelines, Post-marketing Responsibilities, Development and Use of SOPs 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27448/confidence-intervals/?biosci Confidence interval definition - Importance of confidence intervals - Confidence intervals vs p-values - Confidence intervals in clinical decisions - Best practices for statistical analysis Confidence intervals Confidence interval definition, Importance of confidence intervals, Confidence intervals vs p-values, Confidence intervals in clinical decisions, Best practices for statistical analysis 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/22762/regulatory-considerations-in-the-development-of-ge/?biosci Introduction to regulatory considerations in the development of gene therapy products - Regulatory definitions of gene therapy - Designations and expedited pathways - Unique regulatory considerations for gene therapy - Emerging regulatory trends Regulatory considerations in the development of gene therapy products Dr. Seoan Huh Introduction to regulatory considerations in the development of gene therapy products, Regulatory definitions of gene therapy, Designations and expedited pathways, Unique regulatory considerations for gene therapy, Emerging regulatory trends 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27382/in-vitro-vs-in-vivo-vs-in-silico-models/?biosci In vitro, in vivo, in silico models - Applications of model types - Strengths and limitations of each model - Challenges in translating preclinical findings - Integrating multiple models in research - Criteria for selecting research models In vitro vs in vivo vs in silico models In vitro, in vivo, in silico models, Applications of model types, Strengths and limitations of each model, Challenges in translating preclinical findings, Integrating multiple models in research, Criteria for selecting research models 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27416/biostatistics-in-clinical-trials/?biosci Foundational role of biostatistics - Study design and randomisation - Hypothesis testing and significance - Addressing bias and reliability - Regulatory decisions and approval Biostatistics in clinical trials Foundational role of biostatistics, Study design and randomisation, Hypothesis testing and significance, Addressing bias and reliability, Regulatory decisions and approval 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27418/p-values-in-clinical-research/?biosci Basics of p values - Interpreting p values - Misconceptions about p values - Statistical vs clinical significance - Limitations of p values - P values in regulatory decisions - Study design, effect size, and context P values in clinical research Basics of p values, Interpreting p values, Misconceptions about p values, Statistical vs clinical significance, Limitations of p values, P values in regulatory decisions, Study design, effect size, and context 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27383/high-throughput-screening/?biosci HTS principles and workflow - Automation in screening - Assay development and validation - Data analysis and hit ID - Managing false results - Limitations and challenges of HTS - Technological advances in HTS High-throughput screening HTS principles and workflow, Automation in screening, Assay development and validation, Data analysis and hit ID, Managing false results, Limitations and challenges of HTS, Technological advances in HTS 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27417/statistics-in-drug-development/?biosci Statistics in Drug Development - Experimental Design & Variability - Decision-Making in Clinical Trials - Clinical Outcomes Analysis - Statistical Literacy in Drug Development - Statistics in Drug Discovery & Preclinical - Personalized Medicine & Big Data Impact Statistics in drug development Statistics in Drug Development, Experimental Design & Variability, Decision-Making in Clinical Trials, Clinical Outcomes Analysis, Statistical Literacy in Drug Development, Statistics in Drug Discovery & Preclinical, Personalized Medicine & Big Data Impact 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/23851/long-term-follow-up-of-gene-therapy-trial-particip/?biosci Long-term follow-up of gene therapy (LTFU) - History of LTFU - Gene therapy registries - Platform trials - Bespoke Gene Therapy Consortium (BGTC) - Mock schedule of assessments - Bayesian hierarchical modelling - EXNEX Long-term follow-up of gene therapy trial participants: practical and statistical considerations Dr. Avery McIntosh Long-term follow-up of gene therapy (LTFU), History of LTFU, Gene therapy registries, Platform trials, Bespoke Gene Therapy Consortium (BGTC), Mock schedule of assessments, Bayesian hierarchical modelling, EXNEX 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/23026/gene-therapies-economics-access-barriers-commercia/?biosci Gene therapy - Rare diseases - Economic challenges of gene therapies - Patient access - Real world evidences - Health technology assessment - Patient advocacy groups - Clinical development plan - Market development plant Gene therapies: economics, access barriers & commercial models Dr. Kasem S. Akhras Gene therapy, Rare diseases, Economic challenges of gene therapies, Patient access, Real world evidences, Health technology assessment, Patient advocacy groups, Clinical development plan, Market development plant 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27459/small-molecules-vs-biologics/?biosci Small molecule vs biologic drugs - Molecular structure differences - Mechanisms of action - Pharmacokinetics and manufacturing - Clinical applications and outcomes - Class advantages and challenges - Emerging combination strategies Small molecules vs biologics Small molecule vs biologic drugs, Molecular structure differences, Mechanisms of action, Pharmacokinetics and manufacturing, Clinical applications and outcomes, Class advantages and challenges, Emerging combination strategies 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27452/excipients-in-drug-formulation/?biosci Excipients in drug formulation - Types and functions of excipients - Excipients in drug stability and effectiveness - Selection criteria for excipients - Impact of excipients on manufacturing and delivery - Regulatory considerations for excipients - Advances in excipient science Excipients in drug formulation Excipients in drug formulation, Types and functions of excipients, Excipients in drug stability and effectiveness, Selection criteria for excipients, Impact of excipients on manufacturing and delivery, Regulatory considerations for excipients, Advances in excipient science 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27450/formulation-development/?biosci Formulation development stages - Drug stability & bioavailability - Excipients & delivery systems - Solubility enhancement & taste masking - Regulatory & quality assurance - Stability & bioequivalence testing - Quality by Design & risk management Formulation development Formulation development stages, Drug stability & bioavailability, Excipients & delivery systems, Solubility enhancement & taste masking, Regulatory & quality assurance, Stability & bioequivalence testing, Quality by Design & risk management 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27457/biomarkers-in-drug-development/?biosci Biomarker definition and importance - Types of biomarkers - Biomarkers in clinical decision-making - Clinical and drug development biomarkers - Analytical methods for biomarkers - Quality control in biomarker analysis - Advances in biomarker technology - Biomarkers in precision medicine Biomarkers in drug development Biomarker definition and importance, Types of biomarkers, Biomarkers in clinical decision-making, Clinical and drug development biomarkers, Analytical methods for biomarkers, Quality control in biomarker analysis, Advances in biomarker technology, Biomarkers in precision medicine 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/27458/precision-medicine/?biosci Precision Medicine Foundations - Genomic & Molecular Profiling - Biomarkers & Pharmacogenomics - Applications in Oncology & Cardiology - Variant Interpretation Challenges - AI & Multi-Omics Integration Precision medicine Precision Medicine Foundations, Genomic & Molecular Profiling, Biomarkers & Pharmacogenomics, Applications in Oncology & Cardiology, Variant Interpretation Challenges, AI & Multi-Omics Integration 2026-10-29 2026-10-29 The Biomedical & Life Sciences Collection https://hstalks.com/t/25666/complex-in-vitro-models-and-the-future-of-drug-saf/?biosci Definition and role of complex In vitro models - Growing importance in drug development - Key messages for the pharmaceutical industry - Challenges to wider industry adoption - Impact on drug safety and efficacy assessment - Future outlook and potential to reduce animal use Complex in vitro models and the future of drug safety and efficacy assessment Dr. Nadine Stokar-Regenscheit Definition and role of complex In vitro models, Growing importance in drug development, Key messages for the pharmaceutical industry, Challenges to wider industry adoption, Impact on drug safety and efficacy assessment, Future outlook and potential to reduce animal use 2026-10-15 2026-10-15 The Biomedical & Life Sciences Collection https://hstalks.com/t/27023/drug-target-landscape/?biosci Drug target classification - Drug-target interaction mechanisms - Druggability assessment - Drug-target engagement examples - Advances in drug target discovery Drug target landscape Drug target classification, Drug-target interaction mechanisms, Druggability assessment, Drug-target engagement examples, Advances in drug target discovery 2026-09-30 2026-09-30 The Biomedical & Life Sciences Collection https://hstalks.com/t/27022/target-identification-in-practice/?biosci Target ID principles & importance - Omics & computational advances - Data-driven disease profiling - Functional validation: RNAi & CRISPR - Pathway & systems biology integration - Rigorous target validation strategies Target identification in practice Target ID principles & importance, Omics & computational advances, Data-driven disease profiling, Functional validation: RNAi & CRISPR, Pathway & systems biology integration, Rigorous target validation strategies 2026-09-30 2026-09-30 The Biomedical & Life Sciences Collection https://hstalks.com/t/27027/pharmacodynamics-vs-pharmacokinetics/?biosci Pharmacokinetics vs Pharmacodynamics - ADME processes - Drug interactions with targets - Dose-response relationships - Integration of PK/PD in therapy - PK/PD modeling - Individualized and evidence-based prescribing Pharmacodynamics vs pharmacokinetics Pharmacokinetics vs Pharmacodynamics, ADME processes, Drug interactions with targets, Dose-response relationships, Integration of PK/PD in therapy, PK/PD modeling, Individualized and evidence-based prescribing 2026-09-30 2026-09-30 The Biomedical & Life Sciences Collection https://hstalks.com/t/22333/ich-s12-nonclinical-biodistribution-considerations/?biosci Chapters of ICHS12 - Introduction (Objective and scope) - Definition of non-clinical (NC) biodistribution (BD) studies - Timing of BD studies - Design of BD studies - ICHS12: Specific considerations - Applications of BD studies ICH S12: nonclinical biodistribution considerations for gene therapy products Dr. Tineke van den Hoorn Chapters of ICHS12, Introduction (Objective and scope), Definition of non-clinical (NC) biodistribution (BD) studies, Timing of BD studies, Design of BD studies, ICHS12: Specific considerations, Applications of BD studies 2026-09-30 2026-09-30 The Biomedical & Life Sciences Collection https://hstalks.com/t/27024/hit-to-lead-process/?biosci Hit-to-Lead stages - Screening and hit ID - Hit triage and criteria - SAR studies - Early ADMET - Scientific disciplines and risk - Technologies in hit-to-lead Hit-to-lead process Hit-to-Lead stages, Screening and hit ID, Hit triage and criteria, SAR studies, Early ADMET, Scientific disciplines and risk, Technologies in hit-to-lead 2026-09-30 2026-09-30 The Biomedical & Life Sciences Collection https://hstalks.com/t/27021/patient-recruitment-and-retention/?biosci Patient recruitment and retention - Barriers to recruitment - Inclusion and exclusion criteria - Strategies for retention and engagement - Diversity and equity in research - Ethical considerations in recruitment - Decentralized and patient-centric trials Patient recruitment and retention Patient recruitment and retention, Barriers to recruitment, Inclusion and exclusion criteria, Strategies for retention and engagement, Diversity and equity in research, Ethical considerations in recruitment, Decentralized and patient-centric trials 2026-09-30 2026-09-30 The Biomedical & Life Sciences Collection https://hstalks.com/t/22729/biomedicines-extraordinary-opportunities-amidst-un/?biosci Evolution of the FDA - Eroom’s law - Blockbuster and me-too drugs - Eli Lilly as an innovator - Impact of mergers on biomedicine research - Industry consolidation and its impact - Impact of academia on biomedicines Biomedicines: extraordinary opportunities amidst uncertain times Prof. Michael Kinch Evolution of the FDA, Eroom’s law, Blockbuster and me-too drugs, Eli Lilly as an innovator, Impact of mergers on biomedicine research, Industry consolidation and its impact, Impact of academia on biomedicines 2026-09-30 2026-09-30 The Biomedical & Life Sciences Collection