Programme 2021

15th – 17th March 2021 | Berlin

7:40 AM - 8:40 AM

Registration & Refreshments

8:40 AM - 8:50 AM

Chair's Opening Remarks

8:50 AM - 9:35 AM - Panel Discussion

Technology & Innovation

Overcoming the Main Challenges with Freeze Drying under Aseptic Conditions

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

Small Molecules

Drug Delivery Approaches for Small Molecule Delivery

  • Parenteral drug delivery technologies
  • Small molecule drug delivery case studies

Biologics

Personalised Immunotherapies Based on mRNA Drugs

  • Overview of the obstacles created by RNA degradation and the effects on stability and delivery
  • Potential for better drugs by modifying RNA structure to promote self-amplification

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

Challenges and Opportunities in Combination Product Design

  • Coupling device design with drug formulation best practice
  • Common challenges in UX design- case studies

10:20 AM - 10:55 AM - Case Studies

Small Molecules

Formulating to Improve Tissue Distribution and Toxicity

  • Problems with nanoparticle inadequate tissue distribution
  • Avoiding toxicity from drug build up in targeted cells

Biologics

Powder Characterization for Small Molecule Formulation – understanding the Particle-Powder-Processability Interface

Carolin Auch, 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.

Technology & Innovation

Nanotechnology Uses for Advanced Drug Delivery and Targeting

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

  • Case studies for cancer delivery
  • Crossing the blood-brain barrier
  • Intracellular delivery

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

10:55 AM - 11:45 AM

iSolve & Networking Break

11:45 AM - 12:20 PM - Solution Spotlights

Small Molecules

Solution Spotlight by BENEO

Biologics

Solution Spotlight By Halo Labs

Technology & Innovation

Solution Spotlight By LTS Lohman

Device Development

Solution Spotlight By TBC

12:25 PM - 1:00 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

1:00 PM - 2:00 PM

Networking Lunch

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

Small Molecules

QbD for Small Molecules Scale Up Process

  • Continuous manufacturing techniques
  • Regulatory guidelines
  • Formulating drugs with manufacturing

Biologics

Designing Formulations for Enhanced Bio-availability

  • Lipid-based delivery systems for poorly water-soluble drugs
  • Applicability of lipid-based excipients

Technology & Innovation

Optimising Formulations for Continuous Manufacturing

  • Improving material science, API and process robustness for continuous manufacturing
  • Ensuring you have fully automated controls to realize true end-to-end pharma production
  • Breakthrough technologies poised to revolutionize formulation and manufacturing

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 - 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 TBC

3:15 PM - 4:05 PM

iSolve & Networking Break

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

Small Molecules

Process Optimisation in ASD Formulations

  • Hot Melt Extrusion
  • Spray Drying
  • Excipient selection

Biologics

Oral Delivery through Mixed Micelles

Gabriele Sadowski, Professor for Thermodynamics, TU Dortmond

  • Higher stability and greater cargo capacity
  • Opportunities for controlled release therapies
  • Improving Stability

Technology & Innovation

Device Development

Improving Biologics Delivery and Patient Experience

  • Developing better delivery technology for biologics based therapies
  • Factors affecting drug absorption after SC injection
  • Improved knowledge of SQ anatomy, physiology and the biomechanics of injection to better inform formulation

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

Stabilising Techniques for Antibody-Drug Conjugates

  • Formulating monoclonal antibody and the payload in unison
  • Improving characterisation and control of newer ADCs
  • Potential for hydrophobic drugs

Technology & Innovation

Nanotechnology Application in Drug Design and Delivery

  • Nanobiotechnology for drug discovery
  • Minimising adverse effects on healthy cells

Device Development

Topic TBC

10:05 AM - 10:55 AM

iSolve & Networking Break

10:55 AM - 11:30 AM - Case Studies

Small Molecules

In-Silico Excipient Screening for Pharmaceutical Formulations

Gabriele Sadowski, Professor for Thermodynamics, TU Dortmond

  • 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

Carbon Nanotube Composites use in Novel Drug Delivery

  • Overcoming biological barriers
  • Nanotube interactions with subcellular structures

Device Development

Wearable Insulin Delivery Devices

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

11:35 AM - 12:10 PM - 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

12:10 PM - 1:10 PM

Networking Lunch

1:10 PM - 1:45 PM - Solution Spotlights

Small Molecules

Solution Spotlight By Quotient Sciences

Biologics

Solution Spotlight By Roquette

Technology & Innovation

Solution Spotlight By BASF

Device Development

Solution Spotlight TBC

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

Small Molecules

Accelerated Stability Testing of Biopharmaceutical Excipients

  • Accelerated vs Real-Time testing techniques
  • Humidity and pH accelerated effects prediction
  • Current regulations for accelerated shelf life assessments

Biologics

Practical Lessons on Making QbD an Essential Step in Biologics Production

  • Exploiting prior knowledge about similar products
  • Critical Quality Attributes
  • Designing a CMC strategy

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

Solution Spotlight By Lonza Pharma & Biotech

Biologics

Solution Spotlight By TBC

Technology & Innovation

Solution Spotlight by MedPharm

Device Development

Solution Spotlight by TBC (1)

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

Small Molecules

Topic TBC

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

Topic TBC

  • Blending multiple ideas with streamlined management to innovate more effectively
  • How much is pharma losing today through R&D that does not result in product?
  • Accelerating product design and testing to reduce R+D cost of devices and combination products

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

Small Molecules

Topic TBC

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

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

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 Catalent

Biologics

Solution Spotlight By TBC

Technology & Innovation

Solution Spotlight By DFE Pharma

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 by Arcinova

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

Preparing for the Nanomedicines Market?

  • Nanocarrier production and scale-up
  • Process parameters
  • IVIVC

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

Emerging Opportunities in Biologics Delivery

  • Changing regulatory landscape
  • Demand in the market
  • Challenges in the industry to be addressed
  • The changing landscape of collaboration

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

Topic TBC

5:35 PM - 5:40 PM

Chair’s Closing Remarks