7:40 AM - 8:40 AM
Registration & Refreshments
8:40 AM - 8:50 AM
Chair's Opening Remarks
8:50 AM - 9:35 AM - Keynote
Technology & Innovation
Connected Drug Delivery Devices and their Role in Enabling a Flexible Care Setting
Beate Bittner, Product Optimization Franchise Leader, Roche
9:40 AM - 10:15 AM - Case Studies
Small Molecules
Understanding and Designing Manufacturing Operations and Product Behavior with Coupled CFD-DEM Modeling
Biologics
Topic TBC: Vaccine design and delivery
Camilla Foged, Professor Vaccine Design and Delivery Group, University of Copenhagen
Technology & Innovation
How to Utilize Transporters for Brain-Targeting
Device Development
Microneedles for Drug and Vaccine Delivery
Ryan F. Donnelly, Chair in Pharmaceutical Technology , Queen's University Belfast
10:20 AM - 10:55 AM - Solution Spotlights
Small Molecules
Unique Nanoforming Technology for Poorly Soluble APIs by Nanoform
Satu Lakio, Pharmaceutical Development Director, Nanoform
Biologics
Protein or Not? Advanced High Throughput Aggregate Analysis with the Aura
Bernardo Cordovez, Chief Science Officer and Founder, Halo Labs
Technology & Innovation
Dissolvable Microarray Patch Systems – Microneedles That Are Able to Meet The Content Uniformity Requirements
10:55 AM - 11:45 AM
iSolve & Networking Break
11:45 AM - 12:20 PM - Case Studies
Small Molecules
Powder Characterization for Small Molecule Formulation – understanding the Particle-Powder-Processability Interface
Carolin Riehl, Principal Scientist | Lab Head Drug Delivery & Innovation, Merck
Biologics
Disruptive Technologies for Formulation, Manufacturing and/or Delivery: Enabling Advancements for Biologics and Vaccines Products into the Future
Jeffrey T. Blue, Executive Director, Vaccine Drug Product Development PR&D, MSD
Technology & Innovation
How to Anticipate Formulation and Stability with Modeling?
Olivier Brass, Senior scientist, lead of research unit, research department , Sanofi
Device Development
A Unique Needle-Free Delivery System for Injectable, Precision Engineered, Thermally Stable, Unit Solid Dose Vaccines
David Grant, Head of Device Development , Enesi Pharma
12:25 PM - 1:00 PM - Solution Spotlights
Small Molecules
Minitablets – a Patient Centric Dosage Form
Biologics
Parenteral Delivery of Therapeutic Proteins and Peptides using Biodegradable Silica Matrix
Frederic Dargelas, Director, Head of Business Development and Alliance Management, DelSiTech
Technology & Innovation
Using Computer Modelling to Inform Formulation Development for Small Molecule Drugs and Biologics
John C. Shelley, Fellow, Schrödinger
Device Development
Enabling a Flexible Autoinjector Platform for the Delivery of High Viscosity or High-Volume Parenteral Formulations
Alex Vasiev, Manager of Device Development , Oval Medical Technologies
1:00 PM - 2:00 PM
Networking Lunch
2:00 PM - 2:35 PM - Case Studies
Small Molecules
New Insights into Developing Enabling Formulations for Problem Drugs
Anette Müllertz, Professor, Head of Center, University of Copenhagen
Biologics
Using Gene Therapy approaches to address Global Pandemics
Technology & Innovation
Lyophilization Cycle Transfer and Scale-Up Case Study: Impact of Freeze Dryer Configuration
Stefan Schneid, Laboratory Head Formulation Development Parenterals, Bayer
2:40 PM - 3:15 PM - Case Studies
Small Molecules
Drug Delivery Across Biological Barriers in the Context of Infectious Diseases
Biologics
Challenges in the Pharmaceutical Development of Very Low Concentration Dosage Forms for Highly Potent Immunotherapy Molecules
Naila El Kechai, Formulation and Drug Product Team Leader, Sanofi
Device Development
Impact of article 117 on the Development of New Combination Products
Dr. Fatima Bennai-Sanfourche, Director Medical device Safety, Medical Device Safety Officer, Bayer
3:15 PM - 4:05 PM
iSolve & Networking Break
4:05 PM - 4:15 PM
Poster Presentation - Prediction Model of Drug Release from Long-Acting Implantable Dosage Forms Obtained by 3D Printing
Giuseppe Manini, PhD student, ULB
Poster Presentation - Characterisation and Delivery of Ultra-Viscous and Non-Newtonian Formulations
James Hance, Senior Device Development Engineer, Oval Medical Technologies Ltd
Poster Presentation - Novel Nanomedicines with the DELOS Platform: Nanoformulation of an Enzyme in Peptide Targeted Nanovesicles to Treat Fabry Disease
Alba Córdoba Insensé, Technology Transfer & BD Director, Nanomol Technologies S.L.
4:20 PM - 4:55 PM - Case Studies
Small Molecules
Biologics
Challenges and Opportunities in Cell Therapy Formulation and Delivery
Technology & Innovation
Pharmaceutical Process Simulation
Robert Hennig, Associate Director Drug Delivery & Innovation, Healthcare R&D, Merck
Device Development
How to use Smart Devices Intelligently to Deliver Outcomes
Jace Blackburn, Smart Device Engineer, Genentech
5:00 PM - 5:45 PM - Panel Discussion
Device Development
The Role of Microneedle Delivery Systems in the COVID age?
Ryan F. Donnelly, Chair in Pharmaceutical Technology , Queen's University Belfast
Twinkle Christian, Process Development Scientist, Drug Product Technologies Group, Amgen
David Hipkiss, Chief Executive Officer, Enesi Pharma
Anne Moore, Professor , University College Cork
Jeffrey T. Blue, Executive Director, Vaccine Drug Product Development PR&D, MSD
5:35 PM - 5:40 PM
Chair’s Closing Remarks
8:00 AM - 8:45 AM
Registration & Refreshments
8:45 AM - 8:50 AM
Chair's Opening Remarks
8:50 AM - 9:25 AM - Keynote
Biologics
The Boon and Bane of Polysorbate
Patrick Garidel, Head of Process, Purification and Pharma Development, Boehringer Ingelheim
9:30 AM - 10:05 AM - Case Studies
Small Molecules
Humidity Induced Collapse in Freeze Dried Cakes
Daryl Williams, Professor of Particle Science , Imperial College
Technology & Innovation
Liquid Formulations for a Combination of Low and High Dose Drugs
Jayne Lawrence, Director, NoWCADD, University of Manchester
Technology & Innovation
BBB Pathophysiology-Independent Drug Delivery in Traumatic Brain Injury
Technology & Innovation
Dry powder pulmonary vaccine delivery: Inducing mucosal immunity at the site of pathogen entry
Camilla Foged, Professor Vaccine Design and Delivery Group, University of Copenhagen
10:10 AM - 10:45 AM - Solution Spotlights
Technology & Innovation
Planar Dosage Forms Advantages Over Classical Dosage Forms
Dr. Timo Taghizadeh, Head of Business Development & Marketing, tesa Labtec GmbH
Biologics
Trehalose and Sucrose: Essential Components of Platform Biopharma Formulations and Covid 19 Applications
Christian Lotz, General Manager EMEA, Pfanstiehl GmbH
Technology & Innovation
Spray Drying Formulations with HPMCAS (Hypromellose Acetate Succinate)
Shogo Warashina, Technical Sales Manager, SE Tylose GmbH & Co.KG
10:45 AM - 11:35 AM
iSolve & Networking Break
10:50 AM - 11:00 AM
Poster presentation - Development and Verification of Analytical Techniques for a Blinded Comparator Drug Productv
Juliet Symonds, Investigator, GSK
Poster Presentation - Adeno-Associated Virus Mediated Gene Delivery: Novel Analytical Tools
Dr. Johanna Simon, Scientific Expert Analytical and Preparative Liquid Chromatography, Merck
Poster Presentation - Study of the long‐term stability of the compactibility of spray‐dried mannitol powders containing α and β crystalline polymorphs
Philippe Leferve, Head of Global CTS Labs, Roquette
Poster Presentation -
11:35 AM - 12:10 PM - Case Studies
Small Molecules
In-Silico Excipient Screening for Pharmaceutical Formulations
Gabriele Sadowski, Professor for Thermodynamics, TU Dortmund
Biologics
Vaccine Drying and High Throughput Screening
Technology & Innovation
Formulation Development Strategies for Monoclonal and Bispecific Antibodies
Sachin Dubey, Senior Associate Director, Drug product and Analytical Development, Ichnos Sciences SA
12:15 PM - 12:50 PM - Solution Spotlights
Small Molecules
Improving Delivery of Poorly Soluble Compounds with Science-led Integrated Programs
Sarah Stevens, Vice President, Drug Development Sciences , Quotient Sciences
Biologics
Hydroxypropyl-β-cyclodextrin as a Versatile Excipient in Biologics Processes – Application in Ultrafiltration/Diafiltration
Shiqi Hong, Senior biopharma scientist , Roquette
Technology & Innovation
Formulation Development of Solid Oral Dosage Forms with ZoomLabTM 2.2
Martin Hofsäss, PostDoc Development Pharma Solutions, BASF SE
Device Development
Introducing OLAR® - A novel Oral Long Acting Release Platform
Elijahu Berkovich, Head of Emerging Science and Innovation, Clexio Biosciences
12:50 PM - 1:50 PM
Networking Lunch
1:50 PM - 2:25 PM - Case Studies
Small Molecules
Dry Granulation Process Development- Flexible Manufacturing
Ranjit Dhenge, Investigator R&D, GlaxoSmithKline
Biologics
Mesoporous Silica Particles; Simple yet Powerful Tool for the Delivery of Biomolecules
Vivek Trivedi, Lecturer in Drug Delivery, Medway School of Pharmacy , University of Kent
Technology & Innovation
In-Vitro and In-Vivo Data Confirmation of Thermal Stability and Immune Responses Using a Wide Range of Injectable Unit Solid Dose Vaccine Constructs
David Hipkiss, Chief Executive Officer, Enesi Pharma
2:25 PM - 3:15 PM
iSolve & Networking Break
3:15 PM - 3:25 PM
Poster Presentation - From Powder to Tablet – Material Characterization of Two Mannitol Polymorphs
Lena Mareczek, PhD candidate , Merck
Poster Presentation - An Optimal Design of Experiment Approach to Produce Spray Dried Pseudomonas aeruginosa Podoviridae Bacteriophages
Emilie Tabare, PhD student, ULB
Poster Presentation - Transforming Rectal Therapy for Ulcerative Colitis: Patient Perspectives and Pilot Results of Novel Thermosensitive topical gel formulation
Ravi Pamnani, Founder/CEO, Intact Therapeutics, Inc
Poster Presentation - Analytical Tools for poly(lactide-co-glocolide) (PLGA) Implants and Microparticles: 1) Accelerated Release Testing and 2) Simultaneous Quantification of Residual Solvents
Dr Martin Körber, Director Research & Development, Pensatech Pharma GmbH
3:30 PM - 4:05 PM - Solution Spotlights
Small Molecules
Formulating Amorphous Solid Dispersions: Key Challenges and Considerations for a Streamlined Approach
Aaron Stewart, Associate Principal Scientist, Lonza
Biologics
Silicone-Free Prefilled Syringe Packages for Sensitive Biologics and Ophthalmic injections
Small Molecules
Extrusion: An Enabling Technology to Create Long Acting Implants
Tony Listro, Vice President, Technology, Foster Delivery Science
Device Development
On-Body Infuser for Large Molecules up to 20 mL
Dr. Ines Rüstenberg, Director Development, Sensile Medical, a Gerresheimer company
4:10 PM - 4:45 PM - Case Studies
Small Molecules
Evolving Trends in Technology and Regulatory Landscapes for Developing and Bringing Generics and Innovative Medicines to Market
Rosario LoBrutto, Head of Scientific Affairs, Sandoz
Biologics
Peptide Drug Delivery, Characterization and Product Development
Dr Ana L Gomes dos Santos, Principal Scientist, AstraZeneca
Technology & Innovation
Nanoparticles and Medicines Design
Ijeoma F. Uchegbu, Chair in Pharmaceutical Nanoscience, University College London
Device Development
Common Pitfalls in Developing Combination Products and Medical Devices
Scott Brown, Executive Director Device Development, MSD
4:50 PM - 5:35 PM - Keynote
Small Molecules
OcuRing-K™: The Dropless Cataract Surgery Solution
Kenneth J. Mandell, Founder and CEO, LayerBio
5:35 PM - 6:05 PM
Fireside Chat with Stefan Bracht
Dr. Stefan Bracht, Vice President Head of Disruptive Technologies, Bayer
6:05 PM - 6:10 PM
DDF Poster Competition Award & Chair’s Closing Remarks
8:30 AM - 9:00 AM
Registration & Refreshments
9:00 AM - 9:05 AM
Chair’s Opening Remarks
9:05 AM - 9:40 AM - Keynote
Device Development
Creating Digital Ecosystems that Improve Outcomes
Matthew Clemente, Corporate Vice President Delivery Systems Engineering, Novo Nordisk
9:45 AM - 10:20 AM - Case Studies
Small Molecules
Formulation Development Strategies for Monoclonal and Bispecific Antibodies
Sachin Dubey, Senior Associate Director, Drug product and Analytical Development, Ichnos Sciences SA
Biologics
A Self-Assembly Multifunctional Platform for Therapeutic Delivery of Nucleic Acid Medicines to the Brain
Moein Moghimi, Professor of Nanomedicine, Newcastle University
Technology & Innovation
Material Properties of Amorphous Solid Dispersions – Influence of Incorporated Drugs
Karsten Fluegel, Postdoctoral Researcher | Drug Delivery & Innovation, Merck
10:25 AM - 11:00 AM - Solution Spotlights
Small Molecules
Intelligent Formulation Design and Evaluation for SWIFT Product Development
Dr Fiona MacDougall, Director of Biopharmaceutics, BDD
Technology & Innovation
Performance Enhancement Strategies for Low Solubility APIs – do more with less
Mafalda Paiva, Group Leader, R&D Analytical Development, Hovione
João Henriques, Group Leader, R&D Drug Product Development, Hovione
Technology & Innovation
3D Powder Bed Printing with Lactose: a showcase
Korinde van den Heuvel, Senior Product Developer , DFE pharma
11:00 AM - 11:50 AM
Networking Break
11:50 AM - 12:25 PM - Case Studies
Small Molecules
Continuous Manufacturing of Pharmaceutical Nanoparticles (CM-NANO)
Luis Padrela, Lecturer SSPC, Bernal Institute, University of Limerick
Biologics
Oral Delivery of Peptides Using a Core-Shell Silica Construct
David Brayden, Full Professor (Advanced Drug Delivery), University College Dublin
Technology & Innovation
Peptide Nanomaterials: The Future of Biomaterials and Drug Delivery
Dr Garry Laverty, Senior Lecturer in Pharmaceutical Sciences, Queen’s University Belfast
Technology & Innovation
Bespoke Dosing for Pediatric Patients
Rick Panicucci, Senior Vice President CMC, QED Therapeutics
12:30 PM - 1:05 PM - Solution Spotlights
Small Molecules
Development and Continuous Manufacturing of SMART Nano-Particles, Meeting Bottleneck Challenges
Andrea Cusack, Chief Executive Officer, LEON-NANODRUGS GMBH
Technology & Innovation
BEPO® - a Clinically Advanced Long Acting Injectable Technology that Enables Controlled, Systemic or Local Delivery to Address a Broad Range of Therapeutic Needs
Christophe Roberge, Senior Technology Advisor, MedinCell
Technology & Innovation
Maximizing Formulator’s Tools to Enhance Bioavailability of Poorly Soluble Oral Drugs
Stephen Tindal, Director of Science & Technology, Catalent
1:05 PM - 2:05 PM
Networking Lunch
2:05 PM - 2:40 PM - Case Studies
Small Molecules
Amorphous Solid Dispersion: Strategies in Early Stage Development and Technology Choice
Philippe Lienard, Pre-Development Science Leader, Sanofi
Biologics
Understanding and Overcoming of LER (low endotoxin recovery) in Pharmaceutical Formulations.
Klaus Brandenburg, CSO of Brandenburg Antiinfektiva, , Forschungszentrum Borstel
Technology & Innovation
Nano-structured Films for Ocular Drug Delivery
Murty Vyakarnam, Co-founder & Chief Executive Officer , Oculinea Inc
Biologics
Delivery Technologies for mRNA Nanotherapeutics
Heinrich Haas, Vice President, Formulation, BioNTech
2:45 PM - 3:20 PM - Case Studies
Small Molecules
Recent Advances in Modified and Controlled Release Formulations
Biologics
Development, Manufacturing and Supply of Ebola Vaccine
Lynne A. Isopi, Principal Scientist, Vaccine Drug Product Development, MSD
Technology & Innovation
The Confluence of Innovation in Therapeutics, Drug Delivery and Regulation
Twinkle Christian, Process Development Scientist, Drug Product Technologies Group, Amgen
Device Development
Considerations with the Development of Inhaled Combination Products
David Cipolla, Vice President of Research, Insmed Inc.
3:25 PM - 4:10 PM - Panel Discussion
Technology & Innovation
The Future of Novel Biologics, Cell and Gene Therapy Products
Naila El Kechai, Formulation and Drug Product Team Leader, Sanofi
Vishal Nashine, Director Pipeline & Product Lifecycle Strategy (PPLS), BMS
4:10 PM - 4:15 PM
Chair’s Closing Remarks