AAPS PharmSci 360
Date: October 26 – November 5, 2020
Location: Virtual Conference
Week 1 – Partner Presentation
Director of Science and Technology, Pharmaceutics, Catalent
Session Title: Data-Driven Strategies to Accelerate Your Molecule’s Development Path
Date: Monday, October 26, 2020
Time: 2:00PM – 3:00PM ET
Abstract: From understanding your molecule’s ADME and bioavailability challenges to determining an optimal dose form, drug developers encounter many pitfalls from candidate selection to Phase I that can lead the program to stall, stop, or rework.
Ms. Caralli will introduce a fast and efficient development process that can help deliver the right clinical candidate, best formulation strategy and an optimal dosage form to Phase 1. The presentation will discuss in detail data-driven approaches including PBPK modeling, parallel formulation screening, API sparing techniques and optimal early dosing strategies that will help avoid development pitfalls and de-risk path to clinic.
Week 2 – Partner Presentation
Cornell Stamoran, Ph.D.
Vice President of Corporate Strategy, Catalent
William Chin, Ph.D.
Manager, Global Scientific Affairs, Catalent
Session Title: Patient-Focused Drug Design: A structured approach to dose form design to develop better treatments that address patient needs
Date: Wednesday, November 4, 2020
Time: 9:00AM – 10:00AM ET
Abstract: Pharmaceutical products are made for patients, but traditional drug development is largely driven by API pharmaceutics, cost and timelines. It overlooks the patients’ needs and gaps in existing lines of care, which results in a lack of patient compliance. Plus, it can add time and cost if reformulation is required during late phases.
The OptiDose™ Design Solution is a comprehensive early dose form assessment and a strategic development assessment tool to help drive the dose design decision process. It combines pharmaceutics, dose form design and patient characteristics to provide a clear, optimized roadmap to help drug develops achieve their desired drug development endpoints. This design driven approach combines a scientific data-driven tool with Catalent’s comprehensive assessment and development expertise to craft the ideal dose form to optimize your molecule’s potential to create better treatments and launch successful patient-focused products to market faster.
Topic: Lipid-Based Formulation Development of Poorly Soluble Drug for Fast Access to Animal and Human PK Proof of Concept
Author: Benoit Hilbold, Scientific Development Lead, Catalent
Abstract: Lipid-based drug delivery systems (LBDDS) have demonstrated great potential in overcoming the problem of low bioavailability of poorly soluble drugs by improving their solubility and permeability in-vivo. LBDDS present many advantages (accelerated development pathway, easy handling, scalability, compatibility with multiple dosage forms) to enable fast access to the first set of PK data of both animals and humans. This study described a different accelerated development approach of lipid formulation and the dosage form manufacturing methods for administration in animal and human for early studies.