跳转到主要内容
主页 / 资源 / 会议 / AAPS 2024 PHARMSCI 360

AAPS 2024 PHARMSCI 360

AAPS 2024 PHARMSCI 360
Speakers & Posters

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

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

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

Mechanistic Modeling – QSP

PK/PD Analysis and Pharmacometrics

Clinical Data Management and Biometrics

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

沪ICP备2022021526号

Powered by Translations.com GlobalLink Web Software