• 2021 SLP MIDD+ Scientific Conference Wrap Up Report Over two days speakers worldwide, including representatives from the U.S. FDA Offices of Biopharmaceutics, Clinical Pharmacology, Generic Drugs, New Drug Products, Product Quality, Research and Standards, Translational Sciences, the Center for Drug Evaluation and Research, and the National Center for Toxicological Research, as well as ANVISA and Health Canada, provided hundreds of virtual attendees with case studies, software demonstrations, and engaging Q&A sessions.Topics ranged from building and validating machine-learning models to using population PK/PD approaches to support later phase dose selection, to regulatory perspectives for reliable model-informed drug development. Click the titles of the Top Sessions below.
• Discovery:

• Introduction to the ADMET Predictor® platform

• Designing Novel Compounds with Optimized Target Activity and ADMET Properties Using the AIDD™ Module
• Pre-clinical:
• Confidence in FIH PBPK models – “To Verify, Or Not To Verify, That Is The Question?”
• The role of M&S in regulatory decision making
• Model-based meta-analysis of anti-tuberculosis drug efficacy in relapsing mouse model studies
• FIH/Phase I:
• Using a population PK/PD model developed on phase I to select the dose for Phase II: an example with an IgG1 mAb
• Pharmacometrics in Phase 1: First in Human and Dose Selection for Phase 2
• Quantitative Systems Toxicology Identifies the Mechanism and Data Gaps for Evaluating the Hepatotoxicity of Compound V
• Phase II:
• The impact of MIDD during phase 2 of new drug development – a Regulatory Perspective
• Investigation of the power of a phase III trial for different sample sizes via clinical trial simulations using a phase II population PD model
• Pharmacometrics in Phase 2 – PoC and Dose Selection for Phase 3/Marketing
• Phase III: 
• Regulatory Perspectives for Reliable Model Informed Drug Development (MIDD)
• Pharmacometrics in Phase 3 – Data Integration and Analysis to Support Dose and Labeling for the NDA
• Pregnancy PBPK modeling, a necessary step towards safety and efficacy
• Post Approval/Generics:
• FDA’s Perspective on the Physiologically Based Pharmacokinetic (PBPK) Analyses for Biopharmaceutics Applications
• Using Model Informed Drug Development and Model Integrated Evidence to Support Generic Drug Development and Assessment
• The role of modeling and simulation in the approval of generic drug products
• For Academia:
• Teaching of Biopharmaceutics in a Drug Design Course: Use of GastroPlus® as Educational Software

VIEW ALL SLP 2021 REPLAYS

Congratulations to the Award Winners

Celebrating

Women in Science

REPLAY THE ROUNDTABLE

The Ascent, Current Trends and Predictions

The Impact of MIDD

HEAR EXPERT ADVICE

Thank you to the over 1,000 registered attendees for making the 2021 SLP MIDD+ Scientific Conference a success!

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