AAPS 2024 PHARMSCI 360
Symposium: Translating the Translational Sciences – Different Understanding, Common Aim 2
Moderator: Sibylle Neuhoff, PhD
|Sr. Principal Scientist & Deputy Head of Translational Sciences (DMPK)
Special Presentation: Summarizing the Most Promising Biomarkers to Inform on DDI Magnitude
Sibylle Neuhoff, PhD
|Sr. Principal Scientist & Deputy Head of Translational Sciences (DMPK)
Physiologically-Based Pharmacokinetics Meets Protein Mass Spectrometry for Modelling of TMDD
Armin Sepp, PhD
|Sr. Principal Consultant
Derisking drug development – Leveraging the power of key CMC activities and PBPK modeling approaches in early development programs
Deven S Shah, BPharm, PhD, Head of Chemistry, Manufacturing & Controls (CMC), Certara Drug Development Solutions
David Turner, MsC, PhD, Senior Scientific Advisor, Modelling and Simulation, Certara
Drug development is complex, and high rates of attrition stem from a variety of factors. Chemistry, Manufacturing, and Controls (CMC) issues account for a significant attrition of the molecules during clinical development. Hence it is paramount that proper attention is given at an early stage to the physicochemical properties to identify robust candidate molecules and formulations which could reduce the probability of attrition and enhance the strength of the pipeline. These early characterization studies are aimed at identifying a molecule and formulation(s) which are stable, bioavailable, and manufacturable. Basic solid state and solution state characterization studies can help identify the key challenges earlier on with respect to solid state form, lipophilicity, solubility, stability etc. In parallel, biopharmaceutics evaluation can shed light on the BCS (Biopharmaceutics Classification System)/DCS (Developability Classification System) class and the rate limiting properties for oral absorption. Recently, there has been advances in development of PBPK models in the early discovery space which offers capabilities to further strengthen work in early formulation screening. 您可以进行敏感性分析,以确定改进配方所需的条件,如使用喷雾干燥分散配方提高溶解度,或通过微粉化降低粒度。This talk will focus on combining the experimental developability evaluation and PBPK modeling for a tailored approach to identifying suitable formulations which are able to maximize the oral exposures in a dose linear manner, are innocuous/tolerable, and have suitable processability/stability to support both toxicology studies and eventual identification of a clinical dosage form.
Presentation Objectives:
- Early Identification of Robust Candidate Molecules and Formulations
- Integration of Biopharmaceutics Evaluation and PBPK Modeling
- Tailored Formulation Optimization Approaches
Poster: (M1030-02-08) Mechanistic Mathematical Modeling of In Vitro Drug Release from PLGA-Based Dexamethasone Solid Implants
Naresh Mittapelly, Ph.D.
|Research Scientist II
Poster: (M1030-02-11) Demonstration of Virtual Bioequivalence (VBE) Between Progesterone Vaginal Rings Using Mechanistic Vaginal Absorption and Metabolism Model (MechVAM) Within Simcyp Simulator
Sebastian Polak, Ph.D.
|Senior Scientific Advisor & Head Mechanistic Dermal Modeling
Keynote: Takeaways from Translational Science Sharpshooters: Simple Strategies for Accuracy, Efficiency, and Impact
Moderator: Sebastian Polak, PhD
|Senior Scientific Advisor Head Mechanistic Dermal Modeling
Poster: (M1430-07-40) Mechanistic PBPK Modelling of Itraconazole Oral Solutions: Evaluating HP-β-CD Impact on Solubility and Drug-Drug Interactions
David B. Turner, Ph.D.
|Senior Scientific Advisor, Modelling and Simulation
Virtual Bioequivalence – New Developments, Applications and Pitfalls
David B. Turner, PhD
|Senior Scientific Advisor, Modelling and Simulation
Lunch and Learn – Biosimulation at Scale: Industrializing Quantitative Systems Pharmacology (QSP) to Guide Drug-Development Decision Making
Piet van der Graaf, Pharm.D., Ph.D., SVP and Head of Quantitative Systems Pharmacology and Fei Hua, PhD, Executive Director, QSP
Poster: (T1230-02-08) Physiologically Based Pharmacokinetic Modelling of Risperidone and Its Metabolite Paliperidone PLGA Based In Situ Gel Forming Long-Acting Injectable Formulations In Vivo
Naresh Mittapelly, Ph.D.
|Research Scientist II
Keynote: Using AI/ML – What is Lacking to Make AI/ML Really Successful in the Drug Discovery/Development Processes
Moderator: Sebastian Polak, PhD
|Senior Scientific Advisor & Head Mechanistic Dermal Modeling
Newer Quantitative Modeling Approaches for Preclinical-to-Clinical Translation of T-Cell Engaging Bispecifics
Hot Topic Speaker: Fei Hua, PhD
|Executive Director, QSP
Virtual Bioequivalence Frameworks and Workflows
Frederic Y. Bois, PhD
|Sr. Scientific Advisor & Head of Mechanistic Modeling
Speaker Spotlight: Omics-Driven Drug Delivery: Pioneering Precision Medicine
Moderator: Sibylle Neuhoff, Ph.D.
|Sr. Principal Scientist & Deputy Head of Translational Sciences (DMPK)
Poster: (W1130-02-12) Virtual Bioequivalence (VBE) Outcome May Depend on Choice of Dissolution Inputs in Physiologically Based Pharmacokinetic Modelling
David B. Turner, Ph.D.
|Senior Scientific Advisor, Modelling and Simulation
Poster: (W1130-02-07) Development and Verification of a Physiologically-Based Pharmacokinetic (PBPK) Model for Vaginal Administration of Progesterone Ring and Gel Formulations”
Sebastian Polak, Ph.D.
|Senior Scientific Advisor & Head Mechanistic Dermal Modeling
Closing Plenary: AI and AI-Assisted Approaches in Pharmaceutical Discovery and Development
Piet van der Graaf, Pharm.D., Ph.D.
|Senior Vice President and Head of Quantitative Systems Pharmacology
On-Demand Presentation: Biomarkers as Linkers Between Preclinical, Clinical, and Patient Outcome
Matt Harwood, MSc, Ph.D.
|Principal Scientist
Join us at Booth #2310 for a Demo!
Phoenix: (PK/PD Analysis & Pharmacometric Modeling)
Day 1: Monday, October 21
- 11:45am – 12:15pm
- 3:15pm – 3:45pm
Day 2: Tuesday, October 22
- 11:15am – 11:45pm
- 4:00pm – 4:30pm
Day 3: Wednesday, October 23
- 11:30am – 12:15pm
- 2:15pm – 2:45pm
Simcyp PBPK Simulator: (Modeling and Simulation Platform)
Day 2: Tuesday, October 22
- 10:30am – 11:00am
- 3:15pm – 3:45pm
Day 3: Wednesday, October 23
- 10:45am – 11:15am
- 1:30pm – 2:00pm
AAPS Resources
Before or after your visit to our booth, explore our “molecule to market” solution ecosystem through the resources below.
Translational and Preclinical
Mechanistic Modeling – PBPK
- Simcyp™ PBPK Simulator Brochure
- What’s New in the Simcyp™ Simulator – from Regulatory Advances to New Modalities [On-Demand Webinar]
- Simcyp™ PBPK Simulator Software
- Simcyp™ PBPK 技术服务
Mechanistic Modeling – QSP
- [Webinar] Adding Quality Control & Validation to Drug Discovery with AI
- [Webinar] QSP Modeling for FIH Starting Dose in Oncology
- [Blog] Four Ways that Mechanistic Modeling Accelerates Bispecific (and Multispecific) Antibody Drug Development
- [Publication with Ichnos Glenmark Innovation] ISB 2011 trispecific T cell engager shows strong tumor cytotoxicity and overcomes immune escape mechanisms of multiple myeloma cells
- [Customer Success Story with CDR-Life] Systems Modeling Delivers Efficiencies and Savings in Clinical Development
PK/PD Analysis and Pharmacometrics
- The Phoenix Platform for PK/PD Analysis and PMX Modeling
- Phoenix WinNonlin for non-compartmental analysis and PK, PD, and TK modeling
- Phoenix NLME for popPK
- Integral Data Repository for source data to CDISC report pipelines
- Phoenix Hosted for high performance, low cost operations at scale
- Pirana 建模工作平台
Clinical Data Management and Biometrics
- Streamline Clinical Trials with Automated Metadata Management
- 临床试验自动化:为什么它是成功的关键
- Dreaming Big with Standardization in Clinical Trial Design
- 临床研究中使用的 CDISC 标准指南
- Implementing a Clinical MDR | Downloadable Guide
- Overcoming the challenges of CDISC compliance in academia
- CDISC SDTM Mapping | Best Practice Guide
Clinical and Pre-clinical Data
Early Development Solutions
Cell & Gene Therapy
Targeted Radiation Therapies
监管写作
Certara.AI – GPTs specialized for the life sciences
Certara for Academia