7:30 AM - 8:25 AM
Registration & Refreshments
8:25 AM - 8:35 AM
Chair’s Opening Remarks
8:35 AM - 9:05 AM - Keynote
Technology & Innovation
Current and Future Perspectives for Drug Delivery and Formulation
Donna French, Vice President Pharma Development , AstraZeneca
9:10 AM - 9:40 AM - Keynote
Technology & Innovation
Continuous Manufacturing Platform for Complex Parenterals
9:40 AM - 10:15 AM - Case Studies
Small Molecules
Engineering Prodrug Therapies For Infectious Disease and Cancer Therapy
Biologics
Formulation Strategies and Stability Characterization of siRNA Drug Products
Sathya Venkataramani, Director Pre-Pivotal Drug Product Technologies - Biologics, Amgen
Device Development
Large Volume Patch Pumps, Challenges and Opportunities
Charles Rampersaud, VP, Head of Devices and Packaging, Genentech
10:15 AM - 10:45 AM - Solution Spotlights
Small Molecules
New Insights in the Endothelial Transport of Orally Administered PEGylated Mixed Micelles
Biologics
Inhaled Delivery of Biologics: Why it’s a Good Solution
Device Development
Improving Care Quality Through Connected Drug Delivery Devices
10:45 AM - 11:35 AM
Networking & 1-2-1 Meetings
11:35 AM - 12:10 PM - Case Studies
Small Molecules
Amorphous Solid Dispersions – A Development Overview
Raman Iyer, Associate Director and Senior Fellow, Novartis
Biologics
Predictive high-throughput screening of oligonucleotide lipid nanoparticle for gene silencing
Chun-Wan Yen, Principal Scientist, Genentech
Device Development
The evolving paradigm of post-market safety reporting (PMSR) for combination products
12:15 PM - 12:50 PM - Solution Spotlights
Small Molecules
Scratching the Surface – Surface Characterization of Pharmaceutical Powders for Oral Solid Dosage Forms
Biologics
Surfactants in Bioformulation: Are We at the End or the Beginning of a Journey?
Technology & Innovation
Rapid Development of Amorphous Solid Dispersions (ASDs) for Improved Bioavailability
David Lyon, Sr. Fellow, Global Research, Lonza, Small Molecules
12:50 PM - 1:50 PM
Networking Lunch
1:50 PM - 2:25 PM - Case Studies
Small Molecules
Enabling Bioperformance Prediction Through Data Analytics
Pierre Daublain, Principal Scientist, Merck
Device Development
The Port Delivery System With Ranibizumab: A New Paradigm for Long-Acting Retinal Drug Delivery
Shrirang Ranade, Sr. Technical Development (CMC) Team Leader, Genentech
Technology & Innovation
The dynamic, motile and deformative properties of RNA nanoparticles lead to efficient tumor vasculature targeting , fast renal excretion and rapid body clearance
2:30 PM - 3:00 PM - Case Studies
Small Molecules
Discovery and Translation of Cellular Nanoparticle Technology
Biologics
Cell Penetrating Peptide Enhancing the Intracellular Delivery of Proteins
Device Development
Current Challenges and Opportunities in Developing Combination Products Biologics Delivery and Medical Devices
James Leamon, Director, Biologics Device Development , Jazz Pharmaceuticals
3:05 PM - 3:55 PM
Networking & 1-2-1 Meetings
3:55 PM - 4:25 PM - Solution Spotlights
Small Molecules
Enabling Efficient Oral and Injectable Solubility Enhancement with Apinovex™ and Apisolex™ Polymers
Nick DiFranco, Global Market Segment Manager, Oral Treatments, Lubrizol Life Science Health
Joey Glassco, Global Market Segment Manager, Parenteral Drug Delivery, Lubrizol Life Science Health
Biologics
Essential components of Platform Biopharma Formulations and Covid 19 Applications
Device Development
Combination Products Biologics Delivery
4:30 PM - 5:00 PM - Case Studies
Small Molecules
Overcoming Bioavailability Challenges of Very Weak Acid for Oral Delivery – A Case Study of HCV Drug Dasabuvir
Shuang Chen, Ph.D., Sr. Principal Research Scientist Solid State Chemistry, Process R&D, AbbVie
Biologics
Long acting biologics: A steep climb
Technology & Innovation
mRNA delivery with acid degradable lipid nanoparticles
Professor Niren Murthy, Professor of Bioengineering, University of California at Berkeley
5:00 PM - 5:30 PM - Case Studies
Small Molecules
Spray-Dry Process Application in the Pre-Clinical Stage of Drug Development
Marika Nespi, Senior Principal Scientific Researcher , Genentech
Biologics
Liquid pre-formulation assessment for monoclonal antibodies and new modalities
Shwetha Iyer, Principal Scientist, Novartis
Device Development
Opportunity and Challenges with Large Volume Subcutaneous Drug Delivery
Ning Yu, Director & Head of Device Development, Biogen
5:30 PM - 6:15 PM - Keynote
Small Molecules
Understanding Polymer Properties to Ensure Product Quality in Developing Extended-Release and Amorphous Solid Dispersion Formulations
Yihong Qiu, Ph.D., Senior Research Fellow Formulation Sciences, AbbVie
6:15 PM - 6:45 PM - Keynote
Device Development
How Safe Are My Combination Products? Regulatory Strategy Lifecycle Management Considerations
6:45 PM - 6:50 PM
Chair’s Closing Remarks
6:50 PM - 7:40 PM
Evening Drinks Reception
8:00 AM - 8:30 AM
Registration & Refreshments
8:30 AM - 8:35 AM
Chair’s Opening Remarks
8:35 AM - 9:05 AM - Keynote
Small Molecules
Molecular Modelling to Support Drug Formulation for Small Molecule and Biologic Drugs
9:10 AM - 9:40 AM - Keynote
Technology & Innovation
Future Opportunities for New Modalities
9:40 AM - 10:15 AM - Case Studies
Small Molecules
Targeted delivery of pharmacological agents in the vascular system
Biologics
A single injection of a recombinant fusion loaded with rapamycin delivers effective zero-order absorption for one month
Device Development
Formulation and Device Considerations for Subcutaneous Delivery
Steven Persak, Director, Device Development, Merck
William Forrest, Principal Scientist I Sterile Formulation Sciences, Merck
10:15 AM - 10:45 AM - Solution Spotlights
Small Molecules
Impact of Bile Salts on Solubilization and Membrane Transport of Supersaturated Drug Formulations
Biologics
Thermokinetic Modelling of Biologics as a Tool for Accelerating Development
Technology & Innovation
Particle Size Control Through Micronization: Challenges and Solutions
10:45 AM - 11:35 AM
Networking Break & 1-2-1 Meetings
11:40 AM - 12:15 PM - Case Studies
Small Molecules
Pediatric Drug Development (PDD)- Challenges, Formulation & CMC considerations
Raman Iyer, Associate Director and Senior Fellow, Novartis
Device Development
Alternative routes of administration for ADCs
Stefan Yohe, Director, Delivery & Device , Seagen Inc.
Technology & Innovation
Advanced Biomaterials Technologies for Improving Biopharmaceutical Formulation and Delivery
12:15 PM - 12:50 PM - Solution Spotlights
Small Molecules
Preparation and evaluation of charge reversal solid lipid nanoparticles
Technology & Innovation
A Novel Approach to Justify Dissolution Differences in an Extended-Release Drug Product using Physiologically Based Biopharmaceutics Modeling and Simulation
Device Development
Combination products under MDR (article 117)
12:50 PM - 1:50 PM
Networking Lunch
1:50 PM - 2:25 PM - Case Studies
Technology & Innovation
Long-Acting Injectables – Biopharmaceutics and Drug Product Design
Pratik Saha, Global Head Biopharmaceutics , GSK
Biologics
High-throughput, fluorescence-based esterase activity assay for assessing polysorbate degradation risk during biopharmaceutical development
Adithi Bhargava, Technical Development Scientist, Genentech
Device Development
Role of Devices and MedTech in pharmacological treatment of chronic conditions
Karthik Lavakumar, Head, Device and MedTech Development, Takeda
2:25 PM - 3:00 PM - Case Studies
Small Molecules
Developing high drug load re-dispersible amorphous formulations
Mengqi Yu, Ph. D., Sr. Scientist I, Formulation Sciences, AbbVie
Device Development
Enhancing Patient-Centricity During Product Development
Casey Dean, Manager, Device Development, Tolmar
Technology & Innovation
Transforming rectal therapies for ulcerative colitis using novel hydrogel formulation
Ravi Pamnani, Co-Founder/CEO, Intact Therapeutics Inc.
3:00 PM - 3:30 PM - Case Studies
Small Molecules
Platform Strategy to Rapidly Bring Poorly Soluble Small Molecules to the Clinic
Helen Hou, Principal Scientist, Small Molecule Pharmaceutical Sciences, Genentech
Biologics
Biopharmaceutics of mAbs: Challenges in Subcutaneous Bioavailability Prediction
Technology & Innovation
Melting microneedle patches: A novel approach from the manufacturing and the delivering aspects
3:30 PM - 4:00 PM - Keynote
Device Development
Formulation & Device Lifecycle Management for Biotherapeutics - The Value of Platform Technologies
Andrew Ratz, Vice President, Drug Delivery and Device Development, Eli Lilly
4:00 PM - 4:35 PM - Panel Discussion
Technology & Innovation
How Will AI and Machine-Learning Technologies Change our Industry?