7:45 AM - 8:35 AM
Registration & Refreshments
8:35 AM - 8:40 AM
8:40 AM - 9:20 AM - Panel Discussion
The Golden Age of Drug Delivery
John D. Higgins, Distinguished Scientist, MSD
Philippe Lienard, Preclinical leader, Institut Pasteur
9:25 AM - 9:55 AM - Case Studies
Small Molecules
Polymeric Prodrugs Platform For Long-Acting Injectable Depots and Parenteral Therapeutics
Biologics
Epithelial Permeation Enhancement by Cationic Peptide Enhancers Investigated for Oral Peptide Delivery
Technology & Innovation
Oral Macromolecule Delivery by High-Throughput GI Absorption Screening
Thomas von Erlach, Chief Scientific Officer , Vivtex
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
Application-Specific Poloxamers for Biologics
Dr. Meike Roskamp, R&D Lab Leader, 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
Direct-to-Organ Drug Delivery – Opportunities, Challenges, and Ideas
Harshal Shah, BioPharma Sector Head, 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
Formulation & Process Challenges in the Drug Product Development of Biopharmaceuticals
Dhananjay Jere, Director Drug Product Research & Development, Manufacturing & Supply, Fresenius Kabi
Technology & Innovation
Bioavailability of Actives with a Case Study of CBD
Alexandru Zabara, Innovation Manager Pharma, dsm-firmenich
Device Development
Human Factors in Labelling Development for Drug-Device Combination Products (DDCPs)
Florian Schauderna, Senior Manager Human Factors / Usability Engineering, Bayer Pharmaceuticals
12:00 PM - 12:30 PM - Case Studies
Technology & Innovation
Targeting Drugs in Vascular System
Biologics
Biocompatible Polymer Systems for Efficient Systemic and Cellular Delivery of 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
Leveraging Rapid Clinical Assessments to Accelerate Pediatric Formulation Development
Nazim Kanji, Executive Director, Pediatric Services Drug Development Consulting, Quotient Sciences
Biologics
Trehalose, Sucrose and Amino Acids: Essential Components of Platform Biopharma Formulations
Christian Lotz, General Manager EMEA, Pfanstiehl GmbH
Technology & Innovation
Nanoparticle Engineering, Stabilization, and Formulation Development: A Patient and Planet Centric Approach for Formulation of Poorly Soluble Molecules
Martti Kaasalainen, Senior scientist, Nanoform Finland
Device Development
Simulating Injection Back Pressure for Drug Delivery to Subcutaneous Tissue, Cerebral Ventricles and Beyond
Scott Ariagno, Vice President Development & Engineering Services, EdgeOne Medical Inc.
1:05 PM - 2:05 PM
Networking Lunch
2:05 PM - 2:35 PM - Case Studies
Small Molecules
Amorphous Solid Dispersions: Current Perspectives, Challenges & Opportunities
Samuel Kyeremateng, Principal Scientist , AbbVie
Biologics
Formulation Development For A Human Plasma Protein – Use of DoE and Statistical Evaluation
Joris Höfinghoff, Head of Formulation Development for Plasma-derived Therapies, Takeda
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
Connected Injection Devices - Improving Real-World Outcomes
Kasper Bayer Frøhling, R&D Programme Manager, Medical Device Development, Novo Nordisk
2:40 PM - 3:10 PM - Solution Spotlights
Small Molecules
The Perfect Match Between Patient Needs and Optimized Manufacturing: MMTS™ Minitabs
Giuseppe De Franza, Senior Manager, Pharmaceutical Development and Technical Service, Adare
Biologics
More than a Theory - Successful Delivery of Biologics and Vaccines by Microarray Patch
Anna Schlüter, Head of Formulation and Process Development MAP Innovator, LTS
Technology & Innovation
ASD-Based Oral Drug Product Development: The Role of Biopredictive Tools
Mafalda Paiva, Senior Manager, R&D Analytical Development, Hovione
Technology & Innovation
Scalable Lipid Nanoparticle Formulation Using Impingement Jets Mixing Systems
Paul Pietsch, Global Engineering Solutions Manager, Knauer Wissenschaftliche Geräte GmbH
3:10 PM - 4:00 PM
1-2-1 Pre-Scheduled Meetings & Networking Break
4:00 PM - 4:30 PM - Case Studies
Small Molecules
Formulation Environmental Decision Tool (FEDT)/How to Add Environmental Dimension in Selection of a Drug Product Formulation - Spray Drying or Hot Melt Extrusion, a Case Study Application
Emilie Belissa, Drug Product Expert Product Design & Performance (PD&P), UCB
Biologics
Development Strategy for Ultra-High Concentrated Biotherapeutics.
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
In Vitro Release Characterization of Oral Modified-Release (MR) Tablet & Pellets Formulations
Yushi Sunazuka, Scientist in Analytical Science Group, Nippon Boehringer Ingelheim
Biologics
High-Throughput Formulation Screening Approach to Develop Ultra-High Concentrated Bioproducts.
Isabelle Deimel, Scientist, Abbvie
Technology & Innovation
Inflammation-Responsive Supramolecular Gels for Controlled Drug Delivery
Nitin Joshi, Assistant Professor Brigham and Women’s Hospital, Harvard Medical School
Device Development
Drug Device Combination Development for Large Volume Therapeutic Proteins
Claus Geiger, Global Device Leader , Sanofi
5:05 PM - 5:35 PM - Keynote
Device Development
Recent Experiences and Challenges with Medical Device and Single Integration Combination Products for CE Mark
Biologics
Engineering of Delivery Systems for RNA at the Nanoscale
Heinrich Haas, Vice President Formulation & Drug Delivery Formulation & Drug Delivery, BioNTech
5:35 PM - 6:15 PM - Keynote
Device Development
Regulatory Strategy Lifecycle Management Considerations for Complex Drug Delivery Devices - How Safe Are My Combination Products?
6:15 PM - 6:20 PM
6:20 PM - 7:10 PM
Evening Networking Reception
8:00 AM - 8:45 AM
Registration & Refreshments
8:45 AM - 8:50 AM
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
Concept of Drug Product Manufacturing Process Characterization
Technology & Innovation
Development of a Controlled Nucleation Protocol and Transfer to a Clinical Supply Facility
Stefan Schneid, Scientific Lead Parenterals, Bayer Science Fellow, Bayer
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
Biodegradable Polymer-Based Drug Delivery Technologies for Development of Tomorrow’s Long-Acting Injectable Medicine
Rob Steendam, Chief Technology Officer, InnoCore Pharmaceuticals
Technology & Innovation
Challenges Associated with In-Use Administration of Biologics
Device Development
Patient-Relevant Features of an On-Body Drug Delivery Device for Large Volumes and High Viscosity Drugs
10:30 AM - 11:20 AM
1-2-1 Pre-Scheduled Meetings & Networking Break
11:20 AM - 11:50 AM - Case Studies
Small Molecules
The Potential of Lipid Based Formulations for Brick Dust Molecules
Rene Holm, Prof. Drug formulation and delivery, University of Southern Denmark
Biologics
Spray Drying of Lipid Nanoparticles Enables Intratracheal Delivery of mRNA
Kristina Friis, Associate Principal Scientist in Advanced Drug Delivery, Astrazeneca
Technology & Innovation
Nature-Inspired Systems for Oral Delivery of Biologics
Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London
Device Development
Liquid Inhalers – Evolution Towards a New and Diverse Technology Landscape
Dr. Gunilla Petersson, Former Science and Innovation Director Inhaled Drug Delivery, AstraZeneca
11:55 AM - 12:25 PM - Case Studies
Small Molecules
Leveraging Predictive Tools for Improved Film Coating Processes
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
The Relationship Between Liquid-Liquid Phase Separation and Protein-Protein Interactions for mAbs
Device Development
Are Sustainability, Reusability & Green Manufacturing major trends? - A case study of Respimat®
Felix Weiland, Head of Device Technology, Boehringer Ingelheim
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
DEVELOPICK™: Rapid and Accurate Evaluation Tool for Molecular Stability
Heonchang Lim, Group Lead, Formulation Development, Samsung Biologics
Technology & Innovation
Availability of Vaccine Delivery Systems, Immunostimulators and Combined Adjuvant Systems in the Next Decade
Peter Tygesen, Managing Director, Adjuvant Systems , Croda Pharma
Device Development
Avoiding Autoinjector Misfires by Bypassing the Spring Release Mechanism - is a pressurized cartridge the solution?
Daniel Primavessy, Project Manager Innovation Pharmaceuticals, Midas Pharma GmbH
1:00 PM - 2:00 PM
Networking Lunch
2:00 PM - 2:30 PM - Case Studies
Small Molecules
Accelerated Stability for Small Molecules Drug Product
Jean-Rene Authelin, Senior Scientific Advisor Global CMC , Sanofi
Technology & Innovation
How to Achieve a Productive and Efficient R&D
Deepak Murpani, CSO & COO, Andersen Pharma Global
Device Development
Designing for Change: Behaviour Design for (Connected) Medical Devices
Soren Skov, Senior Human Factors Engineer, Roche
2:35 PM - 3:05 PM - Solution Spotlights
Small Molecules
Lactide / Glycolide Polymers for Long-Acting Injectables (LAI’s): Key Chemistry and Processing Considerations for Success
Patrick Duffy, R&D Team Leader, Manufacturing Manager for Bioresorbable Polymers, Ashland
Biologics
Controlled Release of mAbs and RNA Through a new Parenteral Dosage Form
Christina Schmid, Business Development, Celanese Pharma & Medical
Technology & Innovation
Overcome Capping Challenges and Increase Tableting Speed in Direct Compression
Dr. Olaf Häusler, Global Pharma Technical Application Specialist, Roquette Pharma Solutions
Technology & Innovation
Improving the Odds of Success in Developing Oral Protein Degraders: A CMC Perspective
Steven Winling, Scientific Advisor, Science & Technology, Catalent
3:05 PM - 3:55 PM
1-2-1 Pre-Scheduled Meetings & Networking Break
3:55 PM - 4:25 PM - Case Studies
Small Molecules
Use of surrogates as API sparing approach for assessing feeding performance in continuous drug product manufacturing
Ko Cattoor, Senior Scientist, Oral Solids Development, Drug Product Development, Johnson & Johnson
Biologics
Protein–Protein Interactions in High-Concentration Monoclonal Antibody Solutions Probed by Quartz Crystal Microbalance?
Tim Diederichs, Post Doc, Boehringer Ingelheim
Technology & Innovation
Novel Techniques to Manufacture Tailor-Made Pharmaceutical Microparticles
Martin Spörk, Scientific Area Leader, Research Center Pharmaceutical Engineering GmbH
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
4:30 PM - 5:00 PM - Case Studies
Small Molecules
Gastrointestinal drug targeting and characterization of a novel esophageal drug delivery system in humans
Biologics
Developability assessment of biologics and formulation of novel molecules
Shahid Uddin, Senior Director Formulation/ Stability and Drug product design, Immunocore
Technology & Innovation
The Role of Data Quality in the Computational Prediction of Stability Studies
Christos Dimitrakopoulos, Data Scientist, Roche
Technology & Innovation
Sudden build up of sub-visible particles over the shelf-life, an early signal of potential Polysorbate degradation issues – Case Study from the industry
Janez Jancar, Senior Expert, Novartis
5:00 PM - 5:45 PM - Panel Discussion
Device Development
Connected Care: Overcoming Roadblocks and Identifying Opportunities
Kasper Bayer Frøhling, R&D Programme Manager, Medical Device Development, Novo Nordisk
Tonio Hoche, Device Engineer, Roche
Soren Skov, Senior Human Factors Engineer, Roche
Harshal Shah, BioPharma Sector Head, Cambridge Consultants
5:45 PM - 5:55 PM
Poster Award: DDF Poster Competition 2023
5:55 PM - 6:00 PM
6:00 PM - 7:00 PM
Evening Drinks Reception
8:00 AM - 8:35 AM
Registration & Refreshments
8:35 AM - 8:40 AM
8:40 AM - 9:10 AM - Keynote
Technology & Innovation
In Silico and Risk Based Approaches to Choice of Formulation- What Works and What Does Not
Kishore Ravuri, Chapter Leader, Drug Product Pharmaceutical Development, Roche
9:15 AM - 9:45 AM - Keynote
Biologics
Advances in Strategies Towards Improving Oral Bioavailability of Peptides and Proteins
Stephen Buckley, Director and Head of Oral Delivery Technology, Novo Nordisk
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
Oxidative Degradation of Polysorbate
Johanna Weber, Pharmacist, Martin-Luther-University in Halle
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 Device Engineer, F. Hoffmann-La Roche
10:25 AM - 10:55 AM - Solution Spotlights
Small Molecules
Furosemide- How to Make a Leading Drug Better and Its Use Wider
Pieter Muntendam, President & CEO, SQ Innovation Inc.
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
Key Considerations for the Selection of a Truly Flexible Large Volume Delivery Device Platform
Thomas Mayer, Business Unit Manager, Sonceboz SA
10:55 AM - 11:45 AM
1-2-1 Pre-Scheduled Meetings & Networking Break
11:50 AM - 12:20 PM - Case Studies
Small Molecules
Looking Through the Magnifying Glass – Advanced Characterization of ASD Tablets
Tatiana Marcozzi, Drug Product Development Scientist - Oral Solid Dosage , Janssen
Biologics
Nucleotide Delivery through Novel Biodegradable and Bioresponsive Polymers (biodynamers)
Technology & Innovation
3D Printing Technologies at the Point of Care
Device Development
Usability Engineering Strategy of developing autoinjector with two different indications
Yu-Ting Lin, Senior Usability Engineer, Merck KGaA
12:25 PM - 12:55 PM - Solution Spotlights
Small Molecules
Accelerate First-in-Human Studies through Integrated CMC Platform and Solid State Development
Dr. Santipharp Panmai, Vice President and Head of Early Phase Formulation R&D, WuXi STA
Biologics
Small Molecules to Large Biological Entities: Biodegradable DelSiTech Silica Matrix Technology for Controlled and Long-Acting Release for Ophthalmic and Sub-Cutaneous Administration
Frederic Dargelas, Head of Business Development and Alliance Management , DelSiTech Ltd.
Technology & Innovation
From Powder to Particles: Engineering Particles for Inhalation via Jet Milling
Beatriz Fernandes, Senior Principal Scientist, R&D, Lonza
Technology & Innovation
The High Drug Load Delivery System Enabling the Next Generation Long-Acting Injectables Through Atomic Layer Precision
Joel Hellrup, Head of Pharmaceutical R&D, Nanexa AB
12:55 PM - 1:55 PM
Networking Lunch
1:55 PM - 2:25 PM - Case Studies
Technology & Innovation
Current Status Upon Polysorbate Degradation
Tamara Phan, Post Doc at Pharmaceutical Development Biologicals, Boehringer Ingelheim
Biologics
Oleogels for the Nose-to-Brain Delivery of Oligonucleotides
Dr Vivek Trivedi, Senior Lecturer in Drug Delivery, University of Kent
Technology & Innovation
Innovative Carrier Design and Engineering for Dry Powder Inhalation
Amrit Paudel, Associate Professor, Graz University of Technology
Biologics
Surface Patches Control Antibody Specificity
Hannes Ausserwöger, Doctoral Student, University of Cambridge
2:30 PM - 3:15 PM - Panel Discussion
Technology & Innovation
How will the FDA PRIME Pilot Program Support Development of “new” Excipients
Patrick Garidel, Head of Process, Purification and Pharma Development, Boehringer Ingelheim
Heinrich Haas, Vice President Formulation & Drug Delivery Formulation & Drug Delivery, BioNTech
Janez Jancar, Senior Expert, Novartis
Nick DiFranco, Global Market Segment Manager for Oral Treatments, Lubrizol Life Science Health
Verena Geiselhart, Pharmacist, BASF
3:15 PM - 3:20 PM