Biomarkers and Experimental Human Models in Clinical Development and Practice
|
Maria Burian, MD, MBA |
Webinar Recording |
Biomarkers & Translational Tools |
| Considerations in the Design and Development of T-cell Dependent Bispecific Antibodies for Cancer Immunotherapy |
Saileta Prabhu, PhD |
Webinar Recording |
Biologics Community |
| Amino Acid Transporters as Potential Targets in Cancer Therapy |
Vadivel Ganapathy, PhD |
Webinar Recording |
Membrane Transporter |
Breaking Down Barriers for Acceleration of Development of New Anti-Infectives
|
Major Jeffrey W. Froude, II
Steven E. Kern, PhD
|
|
Infectious Diseases
Global Health |
Quantitative Systems Pharmacology (QSP) Modeling of Drug-Induced Nephrotoxicity – Bridging the Link Between Drug Exposure, Urinary Biomarkers and Renal Dysfunction
|
Yeshitila Gebremichael, PhD
|
Webinar Recording |
Systems Pharmacology
Biomarkers & Translational Tools |
Mechanistic Models of the Immune System for Quantitative Prediction and Simulation of Biotherapeutic Immunogenicity
|
Xiaoying Chen, PhD
Craig Thalhauser, PhD
Piet van der Graad, PhD |
Webinar Recording |
Biologics |
Overcoming Adoption Barriers of Model-Based Precision Dosing in Healthcare
|
Sirj Goswami, PhD
|
Webinar Recording |
Translational & Precision Medicine |
| Model Evaluation of Continuous Data Pharmacometric Models: Metrics and Graphics |
France Mentré
|
Webinar Recording |
PSP Webinar |
| FDA's Sentinel System and the Regulatory Process |
Michael Nguyen |
Webinar Recording |
Development, Regulation & Outcomes |
| Precision Health for All: The All of Us Research Project |
Eric Dishman |
Webinar Recording |
CTS Webinar |
Drug-Drug Interactions of Gene-Drug Interactions
|
Stephan Schmidt, PhD
|
Webinar Recording |
Pharmacogenomics |
Understanding the Impact of Quantitative Pharmacology (QP) in Drug Development Through Real-Life Examples
|
Sophie Peigné
Marylore Chenel
Chunze Li
Sandhya Girish
Ulrika Simonsson
|
Webinar Recording |
Quantitative Pharmacology |
Safety Assessment in Phase 1 Healthy Volunteer Trials
|
|
Webinar Recording |
Early Development & Drug Safety |
| Modernization of Eligibility Criteria Initiative: Focus on Organ Impairment and Pediatrics Working Groups |
Atiqur Nam Rahman, PhD and Ruby Leong, PhD |
Presentation Slides |
Special Populations |
Clinical Outcome After Therapy for MDD
|
Arjun Athreya and Drew Neavin |
Webinar Recording |
Biomarkers and Translational Tools |
SPO Community Webinar:
"Age-Dependent Developmental Changes in Hepatic Organic Cation Transporter 1 (OCT1) Protein Expression in Neonates and Small Infants"
"UGT1A9 rs3832043 Influences Acetaminophen Glucuronidation in Neonates"
"Maturation of Human Hepatic Membrane Transporter Proteins in the First Four Months of Life"
|
David Hahn
Matthew Linakis
Bianca van Groen |
Webinar Recording |
Special Populations
|
| PBPK Modeling and Clinical Evaluation of a Natural Product-Drug Interaction |
Mary Paine, RPh, PhD
|
Presentation Slides
|
Regulatory Science
|
Trends in Biologics and Biosimilar Development and Approval in the US
|
Hae-Young Ahn, PhD
|
Presentation Slides |
Biologics
|
Driving Patient-Centered Translational Medicine
|
Christopher P. Austin, MD
|
Webinar Recording
|
Clinical and Translational Science (CTS)
|
Clinical Pharmacological and Pharmacodynamic Perspectives on the Adverse Events of Cancer Immunotherapy
|
Imke H. Bartelink, PharmD, PhD
David Y. Oh, MD, PhD
|
Webinar Recording
|
Oncology
|
Standardizing Terms for Clinical Pharmacogenetic Test Results
|
Kelly E. Caudle, PharmD, PhD
|
Webinar Recording
Presentation Slides
|
Pharmacogenomics
|
FDA’s Expectations on Presentation and Communication of Clinical Pharmacology Modeling & Simulation in Submission Documents
|
Yu-Nien “Tom” Sun, PhD
Sriram Krishnaswami, PhD
|
Presentation Slides
|
Pharmacometrics and Pharmacokinetics
|
Considerations for Evaluating Body Size and Body Composition
|
Catherine M.T. Sherwin, PhD, MSc, FCP
|
Webinar Recording
|
Special Populations
|
Implementing Pharmacogenetic Tests for Patient Care Using Clinical Pharmacogenetics Implementation Consortium (CPIC®) Guidelines
|
Mary V. Relling, PharmD
|
Webinar Recording
|
Clinical Pharmacology & Therapeutics (CPT)
|
Journal Club "Comparison of Genome Sequencing and Clinical Genotyping for Pharmacogenes"
|
Wenjian Yang |
Webinar Recording
*presentation only, no audio
Presentation Slides
|
Pharmacogenomics
|
A Six-Stage Workflow for Robust Application of Systems Pharmacology: A Conceptual Strategy and Case Study
|
Daniel Kirouac, PhD
|
Webinar Recording
|
Systems Pharmacology
|
When are Transporters Important in Drug Disposition Including Tissue
Distribution of Drugs?
|
Jashvant (Jash) Unadkat, PhD
|
Webinar Recording |
Regulatory Science
|
Pharmacokinetics and Dose Adjustments for Monoclonal Antibodies in IBD - Considerations and Applications in Clinical Practice
|
Diane Mould, PhD
Anne Strik, MD
|
Webinar Recording
Presenters' responses to attendee questions |
CPT:Pharmacometrics and Systems Pharmacology (CPT:PSP)
|
Translational PK/PD Modeling: Strategies and Insights Provided from Modeling Preclinical Data
|
Harvey Wong, PhD
|
Webinar Recording
|
Translational PK/PD
|
A genetic algorithm based global search strategy for population pharmacokinetic/pharmacodynamic model selection
|
Eric A. Sherer, PhD
|
Webinar Recording
|
Pharmacometrics and Pharmacokinetics
|
Precision Medicine:
"Incorporating Pharmacogenetic Testing into Graduate Pharmacy Curriculum Significantly Enhances Students Knowledge and Attitude towards Personalized and Precision Medicine"
"Integration of Precision Medicine Initiative into Clinical Practice" |
Esteban Burchard, MD, MPH
|
Webinar Recording
|
Pharmacogenomics |
Role of PK/PD Assessments at the Site of Action in Decision Making during the Development of Monoclonal Antibodies: Examples and Case Studies
|
Rong Deng, PhD
|
Webinar Recording
Presentation Slides |
Biologics
|