Past Event
日にち
October 20-23, 2024
Location
Salt Lake City, UT
Booth #2310
AAPS 2024 PHARMSCI 360
Speakers & Posters
Monday, October 21, 9:00 AM – 11:00 AM MT
Symposium: Translating the Translational Sciences – Different Understanding, Common Aim 2
Moderator: Sibylle Neuhoff, PhD
|Sr. Principal Scientist & Deputy Head of Translational Sciences (DMPK)
Monday, October 21, 9:30 AM – 10:00 AM MT
Special Presentation: Summarizing the Most Promising Biomarkers to Inform on DDI Magnitude
Sibylle Neuhoff, PhD
|Sr. Principal Scientist & Deputy Head of Translational Sciences (DMPK)
Monday, October 21, 9:30 AM – 10:00 AM MT
Physiologically-Based Pharmacokinetics Meets Protein Mass Spectrometry for Modelling of TMDD
Armin Sepp, PhD
|Sr. Principal Consultant
Monday, October 21st | 9:30am-10:15am
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. 臨床開発中の分子の多くが失敗に終わるのは、化学、製造、管理（CMC）に関する問題が原因です。したがって、物理化学的特性に早期の段階で適切な注意を払うことが極めて重要です。これにより、失敗の確率を低減し、パイプラインの強度を高めることができる堅牢な候補分子と製剤を特定することができます。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. 感度分析を実施し、スプレードライ分散製剤を使用して溶解性を高めたり、微粒化によって粒子径を小さくするなど、製剤を改善するために何が必要かを判断できます。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
Monday, October 21, 10:30 AM – 11:30 AM MT
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
Monday, October 21, 10:30 AM – 11:30 AM MT
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
Monday, October 21, 1:30 PM – 2:30 PM MT
Keynote: Takeaways from Translational Science Sharpshooters: Simple Strategies for Accuracy, Efficiency, and Impact
Moderator: Sebastian Polak, PhD
|Senior Scientific Advisor Head Mechanistic Dermal Modeling
Monday, October 21, 2:30 PM – 3:30 PM MT
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
Tuesday, October 22, 9:00 AM – 9:30 AM MT
Virtual Bioequivalence – New Developments, Applications and Pitfalls
David B. Turner, PhD
|Senior Scientific Advisor, Modelling and Simulation
Tuesday, October 22, 12 PM – 1 PM MT
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
Tuesday, October 22,12:30 PM – 1:30 PM MT
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
Tuesday, October 22, 1:30 PM – 2:30 PM MT
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
Tuesday, October 22, 2:50 PM – 3:10 PM MT
Newer Quantitative Modeling Approaches for Preclinical-to-Clinical Translation of T-Cell Engaging Bispecifics
Hot Topic Speaker: Fei Hua, PhD
|Executive Director, QSP
Wednesday, October 23, 10:00 AM – 10:30 AM MT
Virtual Bioequivalence Frameworks and Workflows
Frederic Y. Bois, PhD
|Sr. Scientific Advisor & Head of Mechanistic Modeling
Wednesday, October 23, 11:30 AM – 12:30 PM MT
Speaker Spotlight: Omics-Driven Drug Delivery: Pioneering Precision Medicine
Moderator: Sibylle Neuhoff, Ph.D.
|Sr. Principal Scientist & Deputy Head of Translational Sciences (DMPK)
Wednesday, October 23, 11:30 AM – 12:30 PM MT
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
Wednesday, October 23, 11:30 AM – 12:30 PM MT
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
Wednesday, October 23, 4:15 PM – 5:30 PM MT
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.
|主任科学者
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技術主導サービス
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モデリング・ワークベンチ
Clinical Data Management and Biometrics
- Streamline Clinical Trials with Automated Metadata Management
- Automation in clinical trials: Why it’s essential for success
- Dreaming Big with Standardization in Clinical Trial Design
- A Guide to CDISC Standards Used in Clinical Research
- 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
- 臨床薬理学とモデルを活かした医薬品開発 (MIDD) による 放射線療法の洞察
- Dose Optimization Considerations for Targeted Radiation Therapies
レギュラトリーライティング
Certara.AI – GPTs specialized for the life sciences
Certara for Academia
