7:40 AM - 8:40 AM
Registration & Refreshments
8:40 AM - 8:50 AM
8:50 AM - 9:25 AM - Keynote
Small Molecules
Understanding Developability Assessment of Small Molecules
9:30 AM - 10:05 AM - Case Studies
Small Molecules
Current Trends in Technology and Regulatory Landscapes for Developing and Bringing Generics and Innovative Medicines to Market
Rosario LoBrutto, Head of Scientific Affairs, Sandoz
Biologics
Ultrasmall Targeted Nanoparticles with Engineered Antibody Fragments for Imaging of HER2-overexpressing Breast Cancer
Marcello Marelli, Senior Scientist Antibody Discovery and Protein Engineering, AstraZeneca
Device Development
Biopharm Combination product development: Container Closure selections/criteria and Injection force modelling
Aarti Gidh, Technology Development Team Lead, GSK
10:10 AM - 10:45 AM - Solution Spotlights
Small Molecules
Unlocking Full Formulation Performance through Advanced Excipients
Dr. Kathryn Hewlett, Application Development & Innovation Scientist , DuPont Nutrition & Biosciences
Biologics
Hard-to-Stabilize Proteins and Peptides: Can Recombinant Human Albumin be an Effective Approach?
Eleonora Cerasoli, Ph.D., Science Manager, Technology Group, Albumedix
Device Development
A QbD Approach Towards Manufacturing of Parenteral Packaging Components with First Line USA
Rahul Thakar, Technical Key Account Manager, Datwyler Pharma Packaging, Inc.
10:45 AM - 11:35 AM
iSolve & Networking Break
11:35 AM - 12:10 PM - Case Studies
Small Molecules
Solubility Strategies at the Interface of Drug Discovery and Development
Dr. Philippe Lienard, CMC Pre-Development Science Leader, Sanofi
Biologics
Machine Learning Models for Predicting P-gp and BCRP Mediated Efflux
Istvan Enyedy, Principal Scientist, Biogen
Device Development
Incorporating Behaviour Design into Digital Health Tools
Paul Upham, Head, Smart Devices, Genentech
12:15 PM - 12:50 PM - Solution Spotlights
Small Molecules
Continuous Melt Granulation of Thermally Labile Drug
Tony Listro, Vice President of Technical and Quality , Foster Delivery Science
Technology & Innovation
Bridging the Drug Substance to Drug Product Continuum for Poorly Soluble Molecules
David Lyon, Senior Fellow, Research, Lonza Pharma & Biotech
Device Development
The Sorrel Wearable Drug Delivery Platform for Your Primary Container
Dr. Andrei Yosef, CEO, Sorrel Medical
12:50 PM - 1:50 PM
Networking Lunch
1:50 PM - 2:25 PM - Case Studies
Small Molecules
Building a Chemical Space Map for in- silico Prediction of Supersaturation by Mesoporous Silica
Suman Luthra, Senior Principal Scientist, Pfizer
Biologics
Quest for Quality Drug – Use of First Principle Based Biophysical Assays to select Manufacturable Molecule
Sathya Venkataramani, Associate Director, Janssen Biotherapeutics
Device Development
Harnessing the Power of the Digital Exhaust to Improve Patient Outcomes
Graham Jones, Director of Innovation, Novartis
2:30 PM - 3:05 PM - Solution Spotlights
Small Molecules
How do I quickly develop first-in-human (FIH) dosage forms and avoid CMC delays while achieving proof-of-concept (POC)?
Biologics
Freeze Drying Proteins Formulation: A Journey from Challenge to Opportunity
Clara Ip, International Sales Executive, Biopharma Group
Device Development
How Platform are you? The Family of Injection Devices that Work from Clinical Trials to Lifecycle Management
Tom Mayer, Business Development Manager, Sonceboz SA
3:05 PM - 3:55 PM
iSolve & Networking Break
3:55 PM - 4:30 PM - Case Studies
Small Molecules
Flexibility in Pharmaceutical Manufacturing
Yash Kapoor, Principal Scientist, Merck
Biologics
Nanoemulsion-Based Therapies: Antimicrobial, Anti-inflammatory and Drug Delivery Properties
Device Development
Intracutaneous Microneedle Patch Delivery System for the Treatment of Acute Migraine
Yi Ao, Associate Director, Zosano Pharma
4:30 PM - 5:05 PM - Keynote
Biologics
RNA Nanotechnology for Drug Delivery and Formulation
5:05 PM - 5:50 PM - Panel Discussion
Preparing for Patient-Centric Drug Development Regulations
Diane Harper, Director Regulatory Affairs-CMC, Merck
Galen Shi, Senior Engineering Advisor, Eli Lilly
Graham Jones, Director of Innovation, Novartis
Paul Upham, Head, Smart Devices, Genentech
5:50 PM - 6:00 PM
6:00 PM - 6:10 PM
Poster Presentation Award
6:10 PM - 7:10 PM
Evening Drinks Reception
8:00 AM - 8:45 AM
Registration & Refreshments
8:45 AM - 8:50 AM
8:50 AM - 9:25 AM - Keynote
Biologics
Formulation Development Gap Assessment for An In-licensed Program: A Case Study
Nazila Miller, Director, Drug Product Development , Takeda
9:30 AM - 10:05 AM - Case Studies
Small Molecules
Formulation Challenges and Strategies for Supporting Toxicology and First in Human Studies
Chris Ho, Senior Director, Head of Early Formulation Development, PDS, U.S., Sanofi Genzyme
Biologics
Evaluating the Impact of Polysorbate 20 Hydrolysis During the Life-time of Protein Formulation: A De-risking Case Study
Keethkumar Jain, Senior Scientist Drug Product Development , Takeda
Device Development
Applying ICH Q12 to Combination Products
Diane Harper, Director Regulatory Affairs-CMC, Merck
10:10 AM - 10:45 AM - Solution Spotlights
Small Molecules
Furosemide- How to make a leading drug better and its use wider
Pieter Muntendam, President and CEO, SQ Innovation AG
Technology & Innovation
Oral Thin Films – Tailoring Therapy Needs
Device Development
A New Micro-Pump for Parkinson’s Disease from Sensile Medical
Dr. Gerhard Mayer, Vice President, Business Development , Sensile Medical AG
10:45 AM - 11:35 AM
iSolve & Networking Break
11:35 AM - 12:10 PM - Case Studies
Small Molecules
Oral Controlled-Release Liquid for a Low Potency Drug
Alfred Liang, Senior Director, Pharmaceutical Sciences, Ferring
Biologics
mRNA delivery: Lipid Nanoparticles and Beyond
Puneet Tyagi, Senior Scientist Dosage Form Design & Development, AstraZeneca
Device Development
Modelling Autoinjector Injection Time Distribution
Jean-René Authelin, Global Head of Pharmaceutical Engineering, Sanofi
12:15 PM - 12:50 PM - Solution Spotlights
Small Molecules
Unleashing the Potential of Poorly Water Soluble Drugs with the Next Generation Nano Technology
Andrea Cusack, Managing Director & Chief Business Officer, Leon-nanodrugs GmbH
Technology & Innovation
Transmucosal Delivery – Using the Mucofilm® Technology to Bypass the First Pass Effect
Dr. Ahmad Ghoniem, Pharmacist - Business Development Manager , tesa Labtec North America
Device Development
enFuseTM, a true Wearable Technology Changing the way Drugs are Delivered
Michael Hooven, President and CEO, Enable Injections, Inc.
12:50 PM - 1:50 PM
Networking Lunch
1:50 PM - 2:25 PM - Case Studies
Small Molecules
Inner Ear Drug Delivery: a case study on the Inner Ear Delivery of Neurotrophin-3
Qi-Ying Hu, Director of Formulation and Drug Delivery, Decibel Therapeutics
Biologics
Challenges and Impact of Formulation on Exposure to Drive PKPD in CNS Drug Discovery
Patrick Trapa, Principal Investigator, DMPK, Biogen
Device Development
Compatibility between Drug Formulation and Syringe / Autoinjector Performance
Galen Shi, Senior Engineering Advisor, Eli Lilly
2:30 PM - 3:05 PM - Solution Spotlights
Small Molecules
Functional Polyamino acids: a Versatile & Biocompatible Drug Delivery Toolbox
Vicent J. Nebot, Chief Technical Officer, Polypeptide Therapeutic Solutions S.L.
Biologics
What's in your formulation?
Renee Tobias, Director of Marketing, Halo Labs
3:05 PM - 3:35 PM
Networking Break
3:35 PM - 4:10 PM - Case Studies
Small Molecules
Quantifying the Value of Flexibility from Continuous Manufacturing of Drug Products
Robert Meyer, Head of Innovation Technology Group, Pharmaceutical Commercialization, Merck
Biologics
Application of Dynamic Mechanical Analyzer (DMA) to Determine the Glass Transition Temperature of Frozen Protein Formulations
Younghoon Kim, Scientist- Biologics Drug Product Development and Manufacturing Group, Sanofi
Small Molecules
Lyospheres: Enabling Flexibility for Lyophilized Products
4:15 PM - 4:50 PM - Keynote
Small Molecules
CMC Strategies to Accelerate Proof-of-Concept for Oral Drugs in the Biotech Industry
Jatin Patel, Executive Director-CMC, Constellation Pharmaceuticals
4:50 PM - 5:00 PM