7:45 AM - 8:45 AM
Registration & Refreshments
8:45 AM - 8:50 AM
Chair's Opening Remarks
8:50 AM - 9:20 AM - Keynote
Technology & Innovation
Regulatory Strategy Lifecycle Management Considerations for Complex Drug Delivery Devices - How Safe Are My Combination Products?
9:25 AM - 9:55 AM - Case Studies
Small Molecules
Engineering Prodrug Therapies For Infectious Disease and Cancer Therapy
Biologics
Development of a Controlled Nucleation Protocol and Transfer to a Clinical Supply Facility
Stefan Schneid, Scientific Lead Parenterals, Bayer Science Fellow, Bayer
Technology & Innovation
Artificial Intelligence & Machine Learning Applications in Drug Formulation and Delivery
Olivier Brass, Principal Scientist– Vaccines, Sanofi
Device Development
Device Regulatory Strategies for Drug Device Combination Products
Louise Place, Director, CMC RA Devices, GSK
10:00 AM - 10:30 AM - Solution Spotlights
Small Molecules
Fully Automated and DoE-Based Development of a Oral Solid Dosage Form
Dr. Thomas Brinz, Director Engineering Pharma Services, Syntegon Technology GmbH
Biologics
Solution Spotlight by BASF
Technology & Innovation
Apisolex™ and Apinovex™ Polymers: Efficient New Tools for Solubility Enhancement and Lifecycle Management
Nick DiFranco, Global Market Segment Manager for Oral Treatments, Lubrizol Life Science Health
Device Development
Solution Spotlight by Cambridge Consultants
10:30 AM - 11:25 AM
1-2-1 Pre-Scheduled Meetings & Networking Break
11:25 AM - 11:55 AM - Case Studies
Small Molecules
Drug Bioavailability Challenge: How to Make New Drug Candidate Available on the Market
Philippe Lienard, Preclinical leader, Institut Pasteur
Biologics
Concept of Drug Product Manufacturing Process Characterization
Technology & Innovation
Delivery of Poorly Soluble Drugs to Pediatric Populations - Opportunities and Challenges
Carsten Timpe, Technical R&D Expert Scientist, Fmr. Roche
Device Development
Topic TBC (human factors engineering in device/combo product development)
Florian Schauderna, Senior Manager Usability/Human Factors Engineering, Bayer
12:00 PM - 12:30 PM - Case Studies
Small Molecules
Inflammation-Responsive Supramolecular Gels for Controlled Drug Delivery
Nitin Joshi, Assistant Professor Brigham and Women’s Hospital, Harvard Medical School
Biologics
Novel Developments in the Nucleic Acid-Based Drugs
Manfred Ogris, Professor for Pharmaceutical Sciences, University of Vienna
Technology & Innovation
Automating MS-based Biotherapeutic Characterization Workflows for the Developability Assessment of Therapeutic Proteins
Christian Hug, Senior Scientist, Novartis Institutes for Biomedical Research
Device Development
Implantable Devices for Long-Acting Drug Delivery
Eneko Larrañeta, Senior Lecturer in Pharmaceutical Sciences, Queen’s University Belfast
12:35 PM - 1:05 PM - Solution Spotlights
Small Molecules
Solution Spotlight by Quotient Sciences
Biologics
Trehalose, Sucrose and Amino Acids: Essential Components of Platform Biopharma Formulations
Christian Lotz, General Manager EMEA, Pfanstiehl GmbH
Technology & Innovation
Solution Spotlight by Nanoform
Device Development
Solution Spotlight by EdgeOne Medical
1:05 PM - 2:05 PM
Networking Lunch
2:05 PM - 2:35 PM - Case Studies
Small Molecules
Biologics
Topic TBC (lipid nanoparticles for RNA/DNA)
Rene van Nostrum, Associate Professor, Pharmaceutical Sciences, Utrecht University
Technology & Innovation
Continuous Direct Compression (CDC) Technology Implemented Using a Semi-Continuous Blending Step: a case study
Yunfei Li Song, Senior Scientist (Process Engineering and Analytics), GSK
Device Development
Digital Inhalers Case Study & Lessons from Aircraft Crashes!
Mark Milton-Edwards, Head of Digital Health Solutions , TEVA
2:40 PM - 3:10 PM - Solution Spotlights
Small Molecules
Solution Spotlight by Adare
Biologics
Solution Spotlight by LTS
Technology & Innovation
Solution Spotlight by Hovione
Device Development
Solution Spotlight By TBC
3:10 PM - 4:00 PM
1-2-1 Pre-Scheduled Meetings & Networking Break (1)
4:00 PM - 4:30 PM - Case Studies
Small Molecules
Topic TBC (Fresenius Kabi)
Dhananjay Jere, Director Drug Product Research & Development, Manufacturing & Supply, Fresenius Kabi
Biologics
Development of New Methods for Characterization of Antibody Self-Association and Non-Specificity
Nikolai Lorenzen, Principal Scientist, Novo Nordisk
Technology & Innovation
Leveraging Mechanistic Models for Drug Product Development of Small Molecules
Karsten Flügel, Principal Scientist Digital Pharmaceutical Development, Merck Group
Device Development
Development of a Smart Connected Device Solution
Tonio Hoche, Device Engineer, Roche
4:35 PM - 5:05 PM - Case Studies
Small Molecules
Optimization of ASD Formulations for Improved Performance
Tatiana Marcozzi, Drug Product Development Scientist - Oral Solid Dosage , Janssen
Biologics
QbD and Process Scale Up
Technology & Innovation
Exploring the use of the more Advanced Approaches to DSc Analysis
Device Development
Optimising the Interface between Medical Devices and Soft Tissue for Enhanced Therapeutic Delivery
Eoin O’Cearbhaill, Associate Professor of Biomedical Engineering , University College Dublin
5:05 PM - 5:50 PM - Panel Discussion
Technology & Innovation
How will the FDA PRIME Pilot Program Support the Development of “new” Excipients
Patrick Garidel, Head of Process, Purification and Pharma Development, Boehringer Ingelheim
5:50 PM - 6:00 PM
Chair’s Closing Remarks
6:00 PM - 7:00 PM
Evening Networking Reception
8:00 AM - 8:45 AM
Registration & Refreshments
8:45 AM - 8:50 AM
Chair's Opening Remarks
8:50 AM - 9:20 AM - Keynote
Device Development
Medical Devices and In-Vitro Diagnostics Used in Drug Clinical Trials: Principles of Use and Sponsor Responsibilities Under the Medical Device and IVD Regulations Requirements
Dr. Fatima Bennai-Sanfourche, Senior Director of QA & RA Compliance for Medical Devices and eHealth
9:25 AM - 9:55 AM - Case Studies
Small Molecules
PAT-Concept for a Semi-Continuous Fluidized-Bed Granulation Process
Dr. Frank Wolters, Lab Head, Bayer AG
Biologics
Topic TBC (RNA Therapy Formulation)
Heinrich Haas, Vice President Formulation & Drug Delivery Formulation & Drug Delivery, BioNTech
Technology & Innovation
Advances in Supersaturating Drug Delivery Systems
Device Development
Device Development - Improving Patient Experience Through Digital and Combination Products
10:00 AM - 10:30 AM - Solution Spotlights
Small Molecules
Strategies for Reducing Nitrosamines Contamination in Drug Products
Dr. Andreas Sauer, Technical Sales Director, Shin-Etsu
Biologics
Solution Spotlight by InnoCore Pharmaceuticals
Technology & Innovation
Solution Spotlight by Sever Pharma Solutions
Device Development
Solution Spotlight By TBC
10:30 AM - 11:20 AM
1-2-1 Pre-Scheduled Meetings & Networking Break
11:20 AM - 11:50 AM - Case Studies
Small Molecules
Biologics
Spray Drying of Lipid Nanoparticles Enables Intratracheal Delivery of mRNA
Kristina Friis, Associate Principal Scientist in Advanced Drug Delivery, Astrazeneca
Technology & Innovation
Combination Treatment of Multidrug Resistant Tumours with Stimuli-sensitive Nanocarriers Co-Loaded with siRNA and Drugs
Device Development
Implementing Human Factors Engineering and User-Centered Design: Practical Guidance for Combination Products
11:55 AM - 12:25 PM - Case Studies
Small Molecules
Investigation of the Impact of Coating Imperfections on Tablet Performance
Elise Vaes, Scientist OSD, Janssen
Biologics
Viscosity and pH Challenges in Development of High Concentration Injectable Protein Formulations
Camille Dagallier, Senior Formulation Scientist, Sanofi
Technology & Innovation
In What Direction is the Drug Delivery Technology Space Moving?
Device Development
Challenges and Opportunities in Combination Product Design, Development and Use
12:30 PM - 1:00 PM - Solution Spotlights
Small Molecules
Nitrosamine Risk Mitigation: The Critical Role of Excipients
Dr. Alberto Berardi, Product Application Specialist, DFE Pharma
Biologics
Solution Spotlight by Samsung Biologics
Technology & Innovation
Solution Spotlight by Croda Pharma
Device Development
Solution Spotlight By TBC
1:00 PM - 2:00 PM
Networking Lunch
2:00 PM - 2:30 PM - Case Studies
Small Molecules
Amorphous Solid Dispersions: Current Perspectives, Challenges and Opportunities
Samuel Kyeremateng, Principal Scientist , AbbVie
Biologics
Development Strategy of Ultra-High Concentrated Biopharma Products
Martin Huelsmeyer, Senior Principal Scientist, Scientific Affairs & Strategic Initiatives
Technology & Innovation
Novel CART Cell Therapy Based Tumour Treatments
Device Development
Injectable Drug Formulation Depots with Sustained Release
2:35 PM - 3:05 PM - Solution Spotlights
Small Molecules
Solution Spotlight by Ashland
Biologics
Controlled Release of mAbs and RNA Through a new Parenteral Dosage Form
Christina Schmid, Business Development, Celanese Pharma & Medical
Technology & Innovation
Solution Spotlight by Roquette
Technology & Innovation
Solution Spotlight By Catalent
3:05 PM - 3:55 PM
Networking Break
3:55 PM - 4:25 PM - Case Studies
Small Molecules
Modelling and Control of Fluid Bed Granulation Processes
Biologics
In Silico Risk Based Pathways to Formulation Choice
Kishore Ravuri, Chapter Leader, Drug Product Pharmaceutical Development, Roche
Technology & Innovation
Using Nanotechnology to Better Target Therapies
Device Development
Microneedle use for Vaccine Delivery
4:30 PM - 5:00 PM - Case Studies
Small Molecules
Trojan Horse Formulations for Tumour Drug Delivery
Biologics
Developability Assessment of Biologics and Formulation of Novel Molecules
Shahid Uddin, Director of Formulation & Stability, Immunocore
Technology & Innovation
Chemistry, Manufacturing and Controls (CMC) Strategies for Cell Therapies
Device Development
Are Sustainability, Reusability and Green Manufacturing major trends? - A case study of Respimat®
Felix Weiland, Head of Device Technology, Boehringer Ingelheim
5:00 PM - 5:30 PM - Keynote
Technology & Innovation
Understanding the unknows in Drug Discovery and Development
Ramesh Panchagnula, Managing Director, Nektar Therapeutics
5:30 PM - 5:40 PM
Poster Award: DDF Poster Competition 2023
5:40 PM - 5:45 PM
Chair’s Closing Remarks
5:45 PM - 6:45 PM
Evening Drinks Reception
7:00 PM - 8:00 PM
Speaker's Dinner
8:30 AM - 8:55 AM
Registration & Refreshments
8:55 AM - 9:00 AM
Chair’s Opening Remarks
9:00 AM - 9:45 AM - Panel Discussion
Device Development
Reducing the Cost of Developing Medical Devices
9:50 AM - 10:20 AM - Case Studies
Small Molecules
Glaucoma Medication Dilemma - Turquoise OD, Yellow BID and Purple TID regimen. Why not all OD?
Ajay J Khopade, Vice President R&D Formulations (Non-Oral), Sun Pharmaceutical Industries Ltd.
Biologics
CMC Considerations for Cell Therapy Formulations
Technology & Innovation
3D & 4D Printing in Drug Delivery and Tissue Engineering: From Bench to Patients
Prof Dimitrios Lamprou, Chair of Biofabrication & Advanced Manufacturing, Queen’s University Belfast
Device Development
Special Requirements and Challenges during Ophthalmic Pre-Fillable Syringe Development
Petrick Schneider, Senior Pre-Fillable Syringe Engineer, Roche
10:25 AM - 10:55 AM - Solution Spotlights
Small Molecules
Solution Spotlight by Ligand
Biologics
Scale Up and Manufacturing of Self-Amplifying RNA-LNPs for a COVID-19 Vaccine using the NanoAssemblr® GMP System
Pierrot Harvie, Clinical Manufacturing Manager, Precision NanoSystems
Technology & Innovation
Molecular Modelling to Assist Drug Formulation for Small Molecule and Biologic Drugs
John Shelley, Fellow, Schrodinger
Device Development
Solution Spotlight by TBC
10:55 AM - 11:45 AM
1-2-1 Pre-Scheduled Meetings & Networking Break
11:50 AM - 12:20 PM - Case Studies
Small Molecules
Application of API Surrogate Approach for Continuous Manufacturing Process Development
Biologics
Nucleotide Delivery through Novel biodegradable and Bioresponsive Polymers (biodynamers)
Technology & Innovation
CNS Drug Delivery and Barrier Modelling
Device Development
Wearable Insulin Delivery Devices
12:25 PM - 12:55 PM - Solution Spotlights
Small Molecules
Solution Spotlight by WuXi STA
Biologics
Solution Spotlight by TBC
Technology & Innovation
Solution Spotlight by Lonza
Device Development
Solution Spotlight by TBC
12:55 PM - 1:55 PM
Networking Lunch
1:55 PM - 2:25 PM - Case Studies
Small Molecules
Oral Drug Delivery Strategies for Development of Poorly Water Soluble Drugs in Paediatric Patient Population
Carsten Timpe, Technical R&D Expert Scientist, Fmr. Roche
Biologics
Tumour Targeting through Novel CART Cell Therapies
Technology & Innovation
Injectables Formulation for Sustained Release
Device Development
Development of Inhalers That Guide Patient Technique
2:30 PM - 3:00 PM - Keynote
Technology & Innovation
Future Opportunities for New Modalities
3:05 PM - 3:10 PM
Chair’s Closing Remarks