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
Perspectives on Advancements in Formulation, Drug Delivery and Devices for Biologics
Donna French, Vice President, Dosage Form Design & Development, AstraZeneca
9:10 AM - 9:40 AM - Keynote
Technology & Innovation
Continuous Manufacturing Platform for Complex Parenterals
9:45 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
10:20 AM - 10:50 AM - Solution Spotlights
Small Molecules
Modified Release Development Strategies to Achieve Your Target Product Profile
Helen Baker, Director, Pharmaceutical Sciences, Quotient Sciences
Biologics
Understanding Biopharmaceutical Detergents
Stephen Rumbelow, PhD., Life Sciences Research Fellow, Croda
Device Development
Patient-Centric Device Solutions for Subcutaneous Biopharmaceutical Delivery
Dr. Ingo Waschulewski, Business Development & Sales Manager, Gerresheimer AG
10:50 AM - 11:40 AM
Networking & 1-2-1 Meetings
11:40 AM - 12:10 PM - Case Studies
Small Molecules
Amorphous Solid Dispersions (ASD) – Considerations in Product Development
Raman Iyer, Associate Director, Technical R&D, Novartis Pharmaceuticals Corp.
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 - 12:45 PM - Solution Spotlights
Small Molecules
Melt-Extruded Dexamethasone Ophthalmic Implants: Process, Structure, and in vitro Drug Release
Technology & Innovation
The Early-Development Journey of a Small Molecule: An Integrated Perspective
Beth Negash, Scientist III in the Solid Oral Formulation Development, Catalent Pharma Solutions
Technology & Innovation
Rapid Development of Amorphous Solid Dispersions (ASDs) for Improved Bioavailability
David Lyon, Sr. Fellow, Global Research, Lonza, Small Molecules
12:45 PM - 1:45 PM
Networking Lunch
1:45 PM - 2:15 PM - Case Studies
Small Molecules
Enabling Bioperformance Prediction Through Data Analytics
Pierre Daublain, Principal Scientist, Merck
Technology & Innovation
The Dynamic, Motile and Deformative Properties of RNA Nanoparticles Lead to Efficient Tumor Vasculature Targeting , Fast Renal Excretion and Rapid Body Clearance
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
2:20 PM - 2:50 PM - Case Studies
Technology & Innovation
Discovery and Translation of Cellular Nanoparticle Technology
Biologics
Approach to Critical Quality Attributes (CQA) Designation of Lipid Nanoparticles Enabling Gene Therapies
Keeth Jain, Associate Director, Drug Product Tech Transfer, Generation Bio
Device Development
Current Challenges and Opportunities in Developing Combination Products Biologics Delivery and Medical Devices
James Leamon, Director, Biologics Device Development , Jazz Pharmaceuticals
2:50 PM - 3:40 PM
Networking & 1-2-1 Meetings
3:40 PM - 4:10 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
Accelerating the Development of RNA-Based Medicines: A Case Study on Developing an mRNA-LNP-based COVID-19 Vaccine
Viet Anh Huu Nguyen, Senior Field Application Scientist, Precision NanoSystems Inc.
Device Development
Effect of Silicone Oil Viscosity on Observed Particle Counts in Parenteral Container Closure Systems
Jeff Smythe, Commercial Development Manager, Datwyler Pharma Packaging
4:15 PM - 4:45 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
4:50 PM - 5:20 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
5:25 PM - 5:55 PM - Keynote
Device Development
How Safe Are My Combination Products? Regulatory Strategy Lifecycle Management Considerations
5:55 PM - 6:05 PM
Poster Presentation
6:05 PM - 6:10 PM
Chair’s Closing Remarks
6:10 PM - 7:10 PM
Evening Drinks Reception
8:00 AM - 8:15 AM
Registration & Refreshments
8:15 AM - 8:20 AM
Chair’s Opening Remarks
8:20 AM - 9:05 AM - 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
9:10 AM - 9:40 AM - Case Studies
Small Molecules
3D Printing in Development of Pharmaceutical Dosage Forms and Personalized Medicine
Fakhrul Ahsan, Ph.D., Distinguished Professor, California Northstate University
Technology & Innovation
Long-Acting Injectables – Biopharmaceutics and Drug Product Design
Pratik Saha, Global Head Biopharmaceutics , GSK
Device Development
Strategies and Approaches for Integrating Multi-Sourced Syringe Components into Combination Product CM&C Development
Pete Sargent, Advisor—Engineering , Eli Lilly and Company
9:45 AM - 10:15 AM - Case Studies
Small Molecules
Pediatric Drug Development (PDD)- Challenges, Formulation & CMC Considerations
Raman Iyer, Associate Director, Technical R&D, Novartis Pharmaceuticals Corp.
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, Sterile & Specialty Products, Merck
10:20 AM - 10:50 AM - Solution Spotlights
Small Molecules
The Developability Classification System as a Guide in Drug Formulation
Dr Daniel Joseph Price, Director – Head of Excipients Solid Application , MilliporeSigma
Technology & Innovation
Streamlining End-to-End Amorphous Formulation Development into a Tablet Suitable for Continuous Direct Compression
Pedro Valente, R&D Director - Oral Drug Product Development , Hovione
Technology & Innovation
An End-to-End Pharmaceutical Development Pathway to Rapidly Bring Poorly Soluble New Chemical Entities to the Market
Santipharp Panmai, Vice President & Head of Early-phase Formulation Development, WuXi STA
10:50 AM - 11:40 AM
Networking Break & 1-2-1 Meetings
11:40 AM - 12:10 PM - Case Studies
Technology & Innovation
Alternative Routes of Administration for ADCs
Stefan Yohe, Director, Delivery & Device , Seagen Inc.
Biologics
Advanced Biomaterials Technologies for Improving Biopharmaceutical Formulation and Delivery
Device Development
Enhancing Patient-Centricity During Product Development
Casey Dean, Manager, Device Development, Tolmar
12:15 PM - 12:45 PM - Solution Spotlights
Small Molecules
Nanoparticle Engineering: The Small Ingredient Enhancing Formulations
Dr Christopher Worrall, VP US Business Development, Nanoform
Technology & Innovation
Innovative Gastro-Retentive Drug Delivery Technologies for Improving Therapeutic Outcomes of Oral Drugs
Pavan Handa, MBA, Senior Vice President, Specialty Portfolio Management, Amneal Pharmaceuticals
Dipen Desai, PhD., MBA, VP Formulation & Analytical, Amneal Pharmaceuticals
Device Development
Using Early Drug Development Decisions to Facilitate and Accelerate Device Development Strategies
Jerzy Wojcik, VP Regulatory and Quality Services, EdgeOne Medical Inc
12:45 PM - 1:45 PM
Networking Lunch
1:45 PM - 2:15 PM - Case Studies
Technology & Innovation
Melting Microneedle Patches: A Novel Approach from the Manufacturing and the Delivering Aspects
Biologics
Targeted Delivery of Pharmacological Agents in the Vascular System
Device Development
Role of Devices and MedTech in Pharmacological Treatment of Chronic Conditions
Karthik Lavakumar, Head, Device and MedTech Development - Plasma Derived Therapies, Takeda
2:20 PM - 2:50 PM - Solution Spotlights
Small Molecules
Target Product Profile-Based Product Development: The Importance of Using a Holistic Approach for Your Program
Lisa Caralli, Senior Director, Scientific Advisory, Catalent
Device Development
Design and Development Challenges in Direct–to–Organ Drug Delivery Platforms
Harshal Shah, Head of Global BioPharma Commercial, Cambridge Consultants
2:50 PM - 3:30 PM
Networking Break
3:30 PM - 4:00 PM - Case Studies
Small Molecules
Developing High Drug Load Re-Dispersible Amorphous Formulations
Mengqi Yu, Ph. D., Sr. Scientist I, Formulation Sciences, AbbVie
Biologics
High-Throughput, Fluorescence-Based Esterase Activity Assay for Assessing Polysorbate Degradation Risk During Biopharmaceutical Development
Adithi Bhargava, Technical Development Scientist, Genentech
Technology & Innovation
Transforming Rectal Therapies for Ulcerative Colitis Using Novel Hydrogel Formulation
Ravi Pamnani, Co-Founder/CEO, Intact Therapeutics Inc.
4:05 PM - 4:35 PM - Case Studies
Small Molecules
Microstructure, Properties, and Drug Release Performance of ASDs Prepared by Different Processes
Helen Hou, Principal Scientist, Small Molecule Pharmaceutical Sciences, Genentech
Technology & Innovation
Development of tumor-targeted-combination therapies on PEGylated gold nanoparticle platform
Giulio F. Paciotti, Ph.D., Chief Science Officer , CytImmune
4:40 PM - 5:10 PM - Keynote
Device Development
Delivery Devices at Lilly – Evolution and Future Trends