Programme 2021

15th – 17th March 2021

SUBMIT A POSTER

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

Today, in times of increasing pressure on global healthcare systems and in light of the COVID-19 pandemic, the value of improved drug delivery to reduce dosing complexity is broadly recognized. Especially for biotherapeutics that need to be dosed parenterally, product optimizations that facilitate a flexible care setting in which patients can choose the place of drug administration are increasingly in the focus of manufacturers, regulators, payers, and healthcare providers. In this context, subcutaneous dosing alternatives to intravenous infusions and ready-to-use device technologies have been demonstrated to reduce administration related costs and resources.

A key requirement when it comes to parenteral administration outside of a controlled healthcare setting is that patients and lay caregivers understand the administration procedure and still adhere to the treatment regimen. So-called connected devices and accompanying health apps may play a pivotal role in ensuring drug administration outside of a clinic and in enabling early treatment decisions by ensuring an ongoing dialogue between the patient and healthcare provider.

The presentation will discuss the evolution of drug delivery technologies that facilitate administration of biotherapeutics. The opportunities and challenges of connected drug delivery devices in supporting a flexible care setting will be discussed.

9:40 AM - 10:15 AM - Case Studies

Small Molecules

Understanding and Designing Manufacturing Operations and Product Behavior with Coupled CFD-DEM Modeling

Andrea Benassi, CMC – Chemistry Manufacturing & Controls, Drug Product manufacturing & Innovation, New Technology & Innovation Scientist, Chiesi

In our activity of DPI process and product design we daily deal with complex, non-linear, multi-phase flows involving powders and gasses, e.g. the dose entrainment in the swirling air flow inside inhalers, the fine API particles deposition in the deep airways, the air/nitrogen borne particles colliding during API or excipient micronization in jet mills. Standard techniques of computational engineering, such as computational fluid dynamics (CFD), discrete element modeling (DEM) and their coupling, proved to be ideal tools to tackle the above-mentioned phenomena. Applications of the coupled CFD-DEM approach to both process and product design will be shown highlighting their potential and describing their current limitations.

Biologics

Delivery Technologies for mRNA Nanotherapeutics

Heinrich Haas, Vice President, Formulation, BioNTech

  • mRNA technology offers various new opportunities for therapeutic intervention  in fields including cancer infectious disease or protein substitution therapy
  • Delivery plays a paramount role for successful development of clinical product on this basis
  • Tailored delivery systems  are required for  different RNA formats and application routes
  • Thorough understanding of molecular coherencies inside these systems is helpful for rational development of clinical candidates
  • Meanwhile several mRNA based products have been successfully developed up to clinical stage

Technology & Innovation

Bringing Drugs to Market Sooner

  • Advanced screening to reduce the number of compounds wasted in discovery phases
  • Advanced predictive modelling to reduce costs per drug brought to market
  • Saving most time and money can happen at pre-clinical and clinical tests

Device Development

Microneedles for Drug and Vaccine Delivery

Ryan F. Donnelly, Chair in Pharmaceutical Technology , Queen's University Belfast

This presentation will look at advanced microneedle delivery systems, their utility in a pandemic situation and their progression to the clinic

10:20 AM - 10:55 AM - Solution Spotlights

Small Molecules

Solution Spotlight by Nanoform

Biologics

Protein or Not? Advanced High Throughput Aggregate Analysis with the Aura

Dan Lund, Director of Sales, Halo Labs

In protein-based formulations, distinguishing aggregated API from other particle types is important for understanding the root cause of instability. Until now, existing methods have been either unreliable or too cumbersome and difficult to use in many workflows. Here we introduce the Aura, a 96-well low-volume aggregate and particle imaging system that can rapidly size, count, and characterize particles and identify them as proteins, non-proteins, hydrophobic, or other types of molecules.

Technology & Innovation

Solution Spotlight By LTS Lohman

Device Development

Solution Spotlight By TBC

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

Processability issues in development of oral solid dosage forms are often triggered by drug substance variability or scale-up effects. In this context, we need predictive and discriminating analytical methods to select both the right formulation and the right process. Powder rheological and as well as mechanical properties are not assessed at all or at least standardized methods are missing. Therefore, we need to characterize the drug substances, excipients and powder blends in an appropriate manner to better understand how we can use the data to optimize particle morphology and predict processability.

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

  • Abstract TBC

Technology & Innovation

How to Anticipate Formulation and Stability with Modeling?

Olivier Brass, Senior scientist, lead of research unit, research department , Sanofi

  • Combine modelling approaches for formulation and stability description and prediction
  • Molecular understanding of excipient formulation through molecular dynamic
  • Accelerated stability as a good prediction way for long-term and thermal excursion prediction
  • Case studies

Device Development

Creating New Solutions for Needle-free Drug Delivery Devices

  • Reviewing the top historic problems with needle free devices
  • Generating high pressures inside the devices and maintaining flexibility
  • Delivering biologics via needle-free devices

12:25 PM - 1:00 PM - Solution Spotlights

Small Molecules

Solution Spotlight By Adare

Biologics

Solution Spotlight By DelSiTech

Technology & Innovation

Solution Spotlight By Schrödinger GmbH

Device Development

Solution Spotlight By Sensile Medical

1:00 PM - 2:00 PM

Networking Lunch

2:00 PM - 2:35 PM - Case Studies

Small Molecules

Technology & Innovation

Lyophilization Cycle Transfer and Scale-Up Case Study: Impact of Freeze Dryer Configuration

Stefan Schneid, Laboratory Head Formulation Development Parenterals, Bayer

  • Introduction and critical factors for process transfer
  • Influence of freeze dryer configuration and vial loading
  • Case studies for project transfers
  • Recommendations for risk mitigation

Device Development

Human Factors Engineering and Patient Centric Design Considerations

  • Human factors engineering consideration
  • Patient centric design considerations
  • Best practice for meeting human factors regulations

2:40 PM - 3:15 PM - Case Studies

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

  • Formulation to maintain safe, stable, low concentration dosing
  • Overcoming adsorption to ensure concentration consistency during DP manufacturing process
  • Ensuring safety and dose accuracy during preparation and clinical administration

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

Technology & Innovation

Nano-structured Films for Ocular Drug Delivery

  • Typical patient non-compliance
  • Sustained release of drug via intraocular devices
  • Monitoring drug release kinetics

3:15 PM - 4:05 PM

iSolve & Networking Break

4:05 PM - 4:40 PM - Case Studies

Small Molecules

Biologics

Challenges and Opportunities in Cell Therapy Formulation and Delivery

Bharathi Vellalore, Scientist, Drug Product Development Discovery, Product Development and Supply, Janssen

  • Formulation of autologous and allogeneic cell therapy products
  • Cold supply chain: Freezing, storage, transport, thawing and administration
  • Novel drug delivery approaches for solid tumor CAR-T therapy

Technology & Innovation

Device Development

How to use Smart Devices Intelligently to Deliver Outcomes

Jace Blackburn, Smart Device Engineer, Genentech

  • Introduction to Smart DevicesTypes of Smart Devices & data they generate
    • Current Smart Device applications on the market
  • How to evaluate the fit of Smart Devices with a brand team’s digital strategyStrategies to dig into with your marketing colleagues
    • Strategies that should raise red flags
  • How to execute a make vs buy decision for companion applications to support your digital strategy
  • Delivering on the prioritized outcomes through the implementation of behavior design
    • Intro on behavior design
    • Analyzing reasons for medication non-adherence or non-persistence with a behavior design lens

4:45 PM - 5:20 PM - Keynote

Technology & Innovation

Topic TBC: Innovations in Ocular Delivery

Kenneth J. Mandell, Founder and CEO, LayerBio

5:20 PM - 5:30 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

9:30 AM - 10:05 AM - Case Studies

Small Molecules

Targeting Cancers with Nano Drug Delivery Systems

  • Understanding passive and active targeting strategies
  • Main problems with nanoparticle formulations
  • Instability of nanoparticles

Biologics

Device Development

Topic TBC

10:10 AM - 10:45 AM - Solution Spotlights

Small Molecules

Solution Spotlight By Foster Delivery Science

Biologics

Solution Spotlight By Pfanstiehl

Technology & Innovation

Solution Spotlight By ShinEtsu

Device Development

Solution Spotlight By TBC

10:45 AM - 11:35 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Case Studies

Small Molecules

In-Silico Excipient Screening for Pharmaceutical Formulations

Gabriele Sadowski, Professor for Thermodynamics, TU Dortmund

  • Reliable excipient selection based on thermodynamic modeling
  • Predicting long-term stability and influence of humidity  
  • Amorphous solid dispersions
  • Lipid-based formulations
  • Self-amorphous systems

Technology & Innovation

Formulation Development Strategies for Monoclonal and Bispecific Antibodies

Sachin Dubey, Senior Associate Director, Drug product and Analytical Development, Ichnos Sciences SA

Last couple of decades have witnessed significant growth of biopharmaceuticals; they are now playing pivotal role in the management of several diseases. Currently, they constitute around 30% of all the novel drugs approved each year; majority of biopharmaceuticals are proteins and monoclonal antibodies. Formulation development is an integral part of product development and is often used as a differentiating attribute. Multiple drug product presentations are employed during clinical development and commercial launch. Strategy of their development and timing of their launch are critical and defines product development efficiency. Increased importance of bispecifics/trispecifics have further made the formulation and drug product development   very important from strategic point of view.

Device Development

Wearable Insulin Delivery Devices

  • Sweat based glucose monitoring
  • Closed loop systems for glucose measurement and dosage setting
  • Data collection and deep learning

12:15 PM - 12:50 PM - Solution Spotlights

Small Molecules

Solution Spotlight By Quotient Sciences

Biologics

Hydroxypropyl-β-cyclodextrin as a Versatile Excipient in Biologics Processes – Application in Ultrafiltration/Diafiltration

Shiqi Hong, Senior biopharma scientist , Roquette

  • Biologics undergo various stresses during manufacturing, transport and storage.
  • HPβCD has been successfully used to mitigate aggregation in biologic formulations.
  • HPβCD is surface active and can potentially protect protein from interfacial stress during ultrafiltration/diafiltration (UF/DF) process.
  • Case study: Application of HPβCD in protein formulation during UF/DF process 
    • Concentration of HPβCD was maintained throughout UF/DF process
    • HPβCD showed improved protein recovery and reduction in particle formation
  • Potential application of HPβCD in protein UF/DF process and formulation

Technology & Innovation

Solution Spotlight By BASF

Device Development

Solution Spotlight TBC

12:50 PM - 1:50 PM

Networking Lunch

1:50 PM - 2:25 PM - Case Studies

Small Molecules

Dry granulation process development

Ranjit Dhenge, Investigator R&D, GlaxoSmithKline

This presentation will cover dry granulation (roller compaction) process development enabled by modelling and prediction tools. Key points in presentation will be:
  • Development and Application of Small-scale tools in roller compaction
  • Brief overview of system modelling approach and its application
  • Model based roller compaction operating space- case study.

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

Mesoporous silica is a versatile carrier for biomolecules due to its stability, low toxicity, and ability to be functionalized with a variety of molecules and polymers. The porous structure with hundreds of void channels can absorb/ encapsulate reasonably large amounts of biomolecules and the distinctive properties, such as high surface area, large pore volume, and tuneable pore size with a narrow distribution make them readily suitable for various controlled release applications. The adsorption of protein on solid surfaces is a common yet complicated phenomenon due to the complex behaviour of the macromolecules during this process. Hence, it is important to understand; why and how these biomolecules adsorb, the behaviour of adsorbed proteins either as individual molecules or in an ensemble, the influence of adsorption on the protein’s biological function and, if there is a general mechanistic rule for the adsorption process.

In general, the immobilisation of biomolecules onto solid surfaces is often considered irreversible, which can be addressed by the use of surface-active substances or large polymers as displacers as long as they do not affect the protein conformation during or after desorption. Displacer molecules such as surfactants encourage desorption of the macromolecules by an exchange mechanism where the attached protein is competitively substituted from the adsorbent surface in the favour of immobilisation of the smaller molecules.

This presentation discusses the possible use of mesoporous silica as a drug delivery carrier for macromolecules without compromising their biological activity by establishing the required ‘ideal parameters’ for surface immobilisation. Along with this, the optimal parameters to allow maximum desorption, especially the role of displacer will also be discussed.

Technology & Innovation

Overcoming Barriers of Acetylcholinesterase Inhibitors for Alzheimer’s Disease

  • Success of Acetylcholinesterase inhibitors as NCE
  • Common issues with solubility and low bioavailability
  • Crossing the Blood Brain Barrier

Device Development

Ophthalmic Drug Delivery

  • Avoiding drug loss through thermoresponsive polymer formulation
  • in-vitro evaluation of ophthalmic drug release
  • Performance characteristics of ophthalmic drug delivery

2:25 PM - 3:15 PM

iSolve & Networking Break

3:15 PM - 3:50 PM - Solution Spotlights

Small Molecules

Formulating Amorphous Solid Dispersions: Key Challenges and Considerations for a Streamlined Approach

Aaron Stewart, Associate Principal Scientist, Lonza

A large and increasing fraction of orally administered small molecules in pharma company pipelines have poor oral absorption due to low aqueous solubility or dissolution rate. To overcome these limitations, formulation approaches for increasing oral bioavailability are needed. Amorphous solid dispersions (ASDs) are a prevalent technology for addressing oral bioavailability challenges, given the applicability and scalability of the technology across a diverse compound physicochemical space. Developing ASDs requires an integrated approach, where bioperformance, physical and chemical stability as well as manufacturability are all considered. Combining knowledge of key drug, polymer and gastrointestinal properties together with an in vitro and in silico toolkit is critical for achieving optimal in vivo performance while reducing development timelines and drug substance requirements. This presentation covers some general strategies for developing a successful amorphous solid dispersion formulation, from formulation intermediates to final dosage forms.

Biologics

Silicone-Free Prefilled Syringe Packages for Sensitive Biologics and Ophthalmic injections

Rob Gelissen, Business Development for Drug Delivery and Packaging, W. L. Gore & Associates – PharmBIO Division

  • Injection volumes of 2 mL are becoming more common, but, USP standards limit particle counts to a quantity per injection
  • Impact of Higher concentrations biologics and concern for aggregation in presence of silicone
  • Floaters, inflammation, interocular pressure increases and silicone presence in injections
  • Impact of Aging and changing injection profiles, resulting in slower or stalled autoinjector injections

Technology & Innovation

Device Development

Solution Spotlight by TBC (1)

3:55 PM - 4:30 PM - Case Studies

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

Show more

Device Development

4:35 PM - 5:20 PM - Panel Discussion

Small Molecules

5:20 PM - 5:35 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, Vice President, Device Development, Device R&D, Novo Nordisk

Significant investments have been made across industry in the areas of connected devices and digital health, yet few have resulted in real world improvements to patient outcomes. While many of the value propositions are substantial and self evident, navigating the technical, clinical, regulatory and commercial landscapes have created both phenomenal success stories and dismal failures.

We will review some of these case studies and discuss strategies in navigating the hype versus hope of these promising systems. The development of highly reliable, usable, relevant and broadly adopted systems that truly improve outcomes is found at the intersection of rigorous engineering competencies and robust commercial strategies.

9:45 AM - 10:20 AM - Case Studies

Small Molecules

Local Delivery for Enteric Coated Drugs

  • Advances in Colonic delivery
  • Enteric coating for sustained release
  • Enteric coating targeting

Biologics

Topic TBC

Technology & Innovation

Material Properties of Amorphous Solid Dispersions – Influence of Incorporated Drugs

Karsten Fluegel, Postdoctoral Researcher | Drug Delivery & Innovation, Merck

  • Formulation development of amorphous solid dispersions (ASD) still is challenging although the technology is established and several poorly water-soluble drugs have been marketed using this technique
  • Selection of excipients for ASDs needed for tablet compression is often performed on a case-by-case basis according to the formulator’s experience and eventually trial and error
  • As the polymer is the main component in the ASD, it predominantly determines material properties and thus systematically investigating the impact of the incorporated drug on these properties (e.g. mechanical properties and wetting behavior) helps rationalizing and facilitating excipient selection

Device Development

Development of Inhalers That Guide Patient Technique

  • Setting out the problem with improper inhaler use
  • Can we reduce the amount of medication lost from inhalers?
  • Programming smart inhalers to inform patients of medication adherence
  • Integrated sensors to warn patients of environmental asthma triggers

10:25 AM - 11:00 AM - Solution Spotlights

Small Molecules

Solution Spotlight By BDD

Biologics

Solution Spotlight By Hovione

Technology & Innovation

3D Powder Bed Printing with Lactose: a showcase

Korinde van den Heuvel, Senior Product Developer , DFE pharma

3D powder bed printing offers huge potential benefits in pharmaceutical manufacturing, but limited information is available on excipient selection in relationship to functionality in the dosage form in literature.

In this presentation we investigate the benefits of powder based 3D printing by utilizing a base formulation of lactose monohydrate and pregelatinized starch. Both powder characterization as well as the impact of print settings and formulations on tablet properties will be discussed.

Device Development

Solution Spotlight By TBC

11:50 AM - 12:25 PM - Case Studies

Small Molecules

Challenges and Opportunities of Development of Salts of Weak Bases

  • Effect of physicochemical properties of API and excipients
  • Implications of disproportionation on oral bioavailability
  • Alternative formulation approaches

Biologics

Molecular Modelling Techniques to Aid Drug Stability Studies

  • Understand the mechanism of drug delivery
  • Receptor site geometric modelling
  • Data analysis case study using advanced computing

Technology & Innovation

CNS Drug Delivery and Barrier Modelling

  • Modelling brain barriers
  • Understanding brain endothelium
  • Overcoming brain barriers

Device Development

How Will the Future Look for Next Generation Devices?

  • New materials
  • Improved human factor engineering
  • Connectivity and integration into wider healthcare system

12:30 PM - 1:05 PM - Solution Spotlights

Small Molecules

Solution Spotlight By pmc isochem

Biologics

Solution Spotlight By TBC

Technology & Innovation

Solution Spotlight Catalent

Device Development

Solution Spotlight By TBC

1:05 PM - 2:05 PM

Networking Lunch

2:05 PM - 2:40 PM - Case Studies

Small Molecules

Challenges with Oxidation Sensitive Drug Substances

  • How to control antioxidant levels throughout drug shelf life?
  • Oxygen scavengers and new technologies 

Biologics

Chemistry, Manufacturing and controls (CMC) strategies for Cell Therapies

  • Efficient and safe T-Cell Processing for CAR-T therapies
  • Maintaining stability testing standards in compressed development timeframes

Technology & Innovation

Release Testing of Nanoformulations

  • Review of real-time test methods for nanoparticulate drug release
  • Advances in voltammetry and turbidimetry
  • Mathematical modelling for drug release

Device Development

Software Applications (Apps), the New Medical Devices?

  • When do mobile apps become devices? The regulations.
  • Allowing apps to make recommendations on treatments or medical consultations
  • Role of AI and responsibility of app designer’s vs medical clinicians

2:45 PM - 3:20 PM - Case Studies

Small Molecules

Limitations and Problem Solving of Polysorbate

  • Polysorbate degradation
  • Impact of polysorbate degradation on drug stability
  • Improving stability of polysorbate

Biologics

Combination Treatment of Tumours with Stimuli-Sensitive Nanocarriers

  • Combination of siRNA and drug can be used to treat multidrug resistant tumours
  • Drug and siRNA can be loaded on the same delivery nanosystem
  • Such co-loaded nanopreparation could be made stimuli-sensitive
  • Nanopreparations can also target intracellular organelles

Technology & Innovation

Device Development

Combination Products Design for User Experience

  • Designing for device user experience
  • Human Factors testing 
  • Simplify design to reduce cost and device syringe reliability

3:20 PM - 4:10 PM

Networking Break

4:10 PM - 4:45 PM - Case Studies

Small Molecules

Trojan Horse Formulations for Tumour Drug Delivery

  • Improving stability of microparticle internalised chemotherapy
  • Potential to minimise systemic toxicity with new formulations

Biologics

Development, Manufacturing and Supply of Ebola Vaccine

Lynne A. Isopi, Principal Scientist, Vaccine Drug Product Development, MSD

A historic Ebola outbreak occurred in March 2014 in three Western African countries, Guinea, Liberia, and Sierra Leone.  Over 28,000 cases were reported and led to more than 11,000 deaths, more than ten times the amount of cases compared to all past outbreaks combined.  On August 8, 2014, the World Health Organization declared a Public Health Emergency of International Concern (PHEIC).  MSD, partnering with NewLink Genetics, entered into an exclusive worldwide licensing agreement to research, develop, manufacture, and distribute an investigational Ebola vaccine candidate based on recombinant Vesicular Stomatitis Virus (rVSV) technology. Working with multiple partners, MSD has brought forward an efficacious vaccine candidate from Phase I trials in October 2014 to Phase III consistency studies by August 2015.  This presentation will provide background into MSD’s strategy to bring the vaccine to licensure, product development activities to scale-up the process from clinical to commercial, and the challenges faced during product development.

Technology & Innovation

Novel CART Cell Therapy Based Tumour Treatments

  • Challenges and solutions to finding correct antigens
  • Overcoming hostile environment associated with tumours

Device Development

Industry effects of EU MDR and IVDR regulations

  • Independent testing prior to EU marketing: Criteria to test
  • What are the extra responsibilities to be taken by ‘Notified Bodies’
  • Timeline to conform to EU MDR
  • What is covered by EU MDR 117

4:50 PM - 5:35 PM - Panel Discussion

Technology & Innovation

5:35 PM - 5:40 PM

Chair’s Closing Remarks