Programme 2020

9th-11th March 2020, Berlin

7:40 AM - 8:40 AM

Registration & Refreshments

8:40 AM - 8:50 AM

Chair's Opening Remarks

8:50 AM - 9:25 AM - Keynote

Small Molecules

New Modalities, Opportunities and Challenges

Shalini Andersson, Chief Scientist New Therapeutic Modalities, AstraZeneca

  • Full session abstract TBC

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

Small Molecules

Drug Delivery Approaches for Small Molecule Sterile Injectables

Richard Green, Senior Director, Pharmaceutical Sciences, Pfizer

  • Portfolio and therapeutic drivers for parenteral technologies
  • Parenteral drug delivery technology strategy
  • Case studies for complex sterile injectable programs

Biologics

Personalised Therapies Based on mRNA Drugs

Heinrich Haas, Vice President RNA Formulation & Drug Delivery , BioNTEch RNA Pharmaceuticals

  • 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

Clinically Relevant Drug Product Specifications

Andreas Abend, Director Analytical Sciences, Merck

Device Development

10:10 AM - 10:45 AM - Case Studies

Small Molecules

Multivariate Analysis in the Pharmaceutical Industry

Mike Tobyn, Research Fellow, Bristol-Myers Squibb

  • Big data
  • Multivariate analysis
  • Validated techniques

Biologics

Freeze Dryer's Characterization for the Purpose of scale-up Activities

Mostafa Nakach, Head of formulation and process development Biologics Drug Product Development, Sanofi

  • Biological continuous manufacturing
  • Making sense of regulatory guidelines
  • Formulating drugs with manufacturing in mind

Technology & Innovation

Device Development

First-time-use experience

Rémy Kohler, Human Factors Engineer, Device and Packaging Development, PTDE-D , Roche

  • Affordance
  • Signifier
  • Expectations and drug delivery devices

10:45 AM - 11:35 AM

iSolve & Networking Break

11:35 AM - 12:10 PM - Solution Spotlights

Small Molecules

Solution Spotlight By bdd

Biologics

Solution Spotlight By Pfanstiehl

Technology & Innovation

Solution Spotlight By LTS Lohman

Device Development

Solution Spotlight By TBC

12:15 PM - 12:50 PM - Case Studies

Small Molecules

Targeting small molecules to lymph: Methods and Applications

Daniel Bonner, Vice President, PureTech Health

Biology of Oral Absorption via Lymph - how dietary lipids are processed 
Current/Past Approaches
Lipid-based formulations
Lipid prodrugs
  • Targeting an immunomodulator to the gut-draining lymphatics
  • Creating an oral candidate from a compound with high first-pass metabolism

Biologics

Summary of six years of progress in the Oral Biopharmaceutics area – the EU/IMI project OrBiTo

Bertil Abrahamsson, Senior Principal Scientist , AstraZeneca

OrBiTo is a project in the area of oral biopharmaceutics tools that included world leading scientist from nine universities, one regulatory agency, one non-profit research organisation, three small/medium sized specialist technology companies together with twelve pharmaceutical companies. The OrBiTo project aimed to deliver a framework for rational application of predictive biopharmaceutics tools for oral drug delivery. 

This was achieved through novel prospective investigations to define new methodologies or refinement of existing tool. Extensive validation has been performed of novel and existing biopharmaceutics tools by using historical datasets from industry partners. A combination of high quality in vitro and in silico characterizations of active drugs and formulations have been integrated into physiologically based in silico biopharmaceutics models capturing the full complexity of gastrointestinal drug absorption. This approach has given an unparalleled opportunity to deliver transformational change in European industrial research and development towards model based pharmaceutical product development in accordance with visions model-informed drug development.

Technology & Innovation

Challenges and Opportunities in Combination Product Design, Development and Use

  • Importance of coupling device design with drug formulation
  • Main challenges of designing user friendly devices

Device Development

Injectability Modelling for Arbitrary Drug Delivery Devices

Nima Aghajari, Senior Simulation Engineer, Sanofi

The Injectability of a drug delivery device is a key performance parameter that refers to the force required to inject a given solution at a given amount of time. The development of drug formulations with higher viscosities on the one hand and the desire of patients to employ smaller needles on the one hand pose great challenges for current and future device developments. Conventionally, a series of experimental tests is performed to ensure adequate injectability, which is usually associated with substantial time and costs. Experimental testing furthermore requires components to be physically available in order to be analyzed, which is often not the case in early development phases.  In this talk, an approach to virtually predict the injectability of an arbitrary drug delivery device by using a customizable simulation model is presented.

12:50 PM - 1:50 PM

Networking Lunch

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

Small Molecules

Reviewing our internal CMC innovation set-up

Gregoire Schwach, Head Drug Delivery, Roche

Abstract TBC

Biologics

Lipid-based Excipients with Advanced Functionality

Dr. Sharareh Salar-Behzadi, Principal Scientist, Research Center Pharmaceutical Engineering (RCPE)

  • Lipid-based excipients are developed belonging to a certain chemical group with outstanding stable solid state and a broad range of hydrophilicity- lipophilicity balance (HLB) value, melting point, viscosity, and solubility
  • Due to this manifoldness in properties, these compounds are attractive candidates as solubility-enhancer and for development of modified release formulations for oral and carrier-free pulmonary application.
  • The stable solid state and the lack of monotropic polymorphism of these compounds is the guarantee for stable performance of pharmaceutical product

Technology & Innovation

Optimising Conventional 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

Implementing Human Factors Engineering and User-Centred Design: Practical Guidance for Combination Products

  • Introduction to human factors engineering and user-centred design
  • Suggestions for involving users throughout the development process
  • Tips for planning and implementing a human factors engineering approach optimised for combination products
  • Best practices for meeting regulatory expectations for human factors engineering

2:30 PM - 3:05 PM - Solution Spotlights

Small Molecules

Solution Spotlight By TBC

Biologics

Solution Spotlight By Gore

Technology & Innovation

Solution Spotlight By Adare

Device Development

Solution Spotlight By Datwyler

3:05 PM - 3:55 PM

iSolve & Networking Break

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

Small Molecules

Delivery to market: Application of Multivariate Analysis to production processes

Paolo Avalle, Associate Principal Scientist, MSD

  • Introduction: the promise of digitalization in pharmaceutical manufacturing.
  • Modeling production processes for biotech and small molecules
  • Leveraging multivariate analysis with data integration, discrete and time dependent models.
  • From drug substance to drug product, connecting unit operations.
  • Regulatory considerations to multivariate modeling; the case for AI in pharmaceutical manufacturing

Biologics

Polysorbate Degradation: Implications and Control

Satya Kishore Ravuri, Senior Group Leader, Early-Stage Pharmaceutical and Processing Development, Roche

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

Technology & Innovation

Enhancing Drug Formulation of Challenging Compounds Using Supercritical Fluid (SCF) Technologies

  • SCF technologies to streamline development
  • RightSize Particle technology – Improving dissolution rates for poorly soluble compounds
  • Processing conditions
  • Using a broad range of excipients
  • Particle and crystal property selection
  • Amorphous, crystalline and co-crystals

Device Development

Microneedle Vaccine Delivery

Anne Moore, Professor, University College Cork

Abstract TBC

4:35 PM - 5:10 PM - Case Studies

Small Molecules

Application of Thermodynamic and Kinetic Modeling in ASD Development for Primary Packaging Assessment

Kristin Lehmkemper, Senior Scientist, AbbVie

  • The preparation of amorphous solid dispersions (ASDs) is an established technique to increase the bioavailability of poorly water-soluble active pharmaceutical ingredients (APIs) by embedding them in polymeric excipients matrices.
  • Thermodynamic modeling can be used to understand the physical stability of ASD formulations in terms of API recrystallization and mechanical deformation of the solid drug product as well as the impact of relative humidity.
  • By combining the thermodynamic modeling with well-established kinetic models, primary packaging containers and moisture uptake modeling for physically stable ASD drug products can be assessed.

Biologics

Should I mix for additional 5 min or not? Setting up the mixing parameters for protein drug manufacturing with computational fluid dynamics

Omar Naneh, Senior scientist BPD DPD Operational Sciences, Lek d d. (Novartis)

  • Mixing step of a drug product (DP) or drug substance (DS) during the manufacturing should enable sufficient homogenization of the material at desired time but, on the other hand, should not influence its quality. Mixing is known to cause particle generation in biological drugs.
  • The mixing process is usually assessed during process development on smaller scales and is then confirmed in a production. However, development usually takes place in models that lack sufficient power for accurate scalability. This leads to challenges, since designs do not predict actual situation on a large scale.
  • An appropriate design can be obtained by considering computational fluid dynamics (CFD) simulations. The calculated fluid velocities along the streamlines in CFD models provide a description that is specific for a given large scale vessel. The selected SDM is then used to assess the influence of mixing on DP or DS quality in laboratory.

Technology & Innovation

Device Development

3D printing for the fabrication of transdermal microneedles: In vitro and in vivo evaluation

Dennis Douroumis, Professor in Pharmaceutical Technology and Process Engineering, Director of Centre for Innovation in Process Engineering and Research (CIPER), University of Greenwich

3D printed microneedles have been fabricated using stereolithography (SLA) though a layer – by – layer deposition of a biocompatible photopolymerized resin. SLA allowed the printing of various microneedle geometries with excellent quality and reproducibility.  The technology can be easily adopted for the printing of solid or hollow microneedles for the delivery of drug substance in a solid or liquid form.  Printed structures presented very good piercing capacity with minimal application force and string mechanical properties.  Advanced characterization techniques (e.g. OCT, micro – CT) provided excellent understanding of the microneedles performance.  In vivo animal trials of model drug molecules proved the potential of 3D printed microneedles compared to subcutaneous injections. Clinical findings showed fast onset action and longer duration of the administrated doses. .

5:15 PM - 6:00 PM - Keynote

Device Development

Improving Patient Experience through Digital and Combination Products Harmony

6:00 PM - 6:05 PM

Chair’s Closing Remarks

6:05 PM - 7:05 PM

Drinks Reception

8:00 AM - 8:45 AM

Registration

8:45 AM - 8:50 AM

Chair's Opening Remarks

8:50 AM - 9:25 AM - Keynote

Biologics

Current Status and Opportunities of Cell and Gene Therapies

Otmane Boussif, Global Head Cell & Gene Therapy Technical Development, Novartis

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

CMC aspect of Oligonucleotide Therapeutics

Sonoko Kanai, Associate Director, AstraZeneca

  • Full session abstract TBC

Technology & Innovation

Nanotechnology Application in Drug Design and Delivery

  • Aiding drug discovery through use of nanobiotechnology
  • Limiting effects on healthy cells

Device Development

Closed System Transfer Devices (CSTDs) could become Mandatory for Preparation and Administration of Biologics after USP<800> becomes Mandatory

Twinkle Christian, Principle Scientist, Drug Product Technologies department, Amgen

  • Chemical compatibility of the drug product with the CSTD material of construction during preparation and administration
  • Physical compatibility issues due to the CSTD vial adaptor which may cause stopper coring which may result in immunogenicity if the particles are injected
  • CSTD off label use to extend the drug product expiry
  • Hold up volume due to CSTD vial adaptor geometry which may lead to inaccurate dosing
  • Clinical sites have preferences for a specific brand mostly driven by cost effectiveness but that brand of CSTD may or may not be compatible for the intended drug product

10:05 AM - 10:55 AM

iSolve & Networking Break

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

Small Molecules

Process Material Compatibility Study Concepts

Thomas Schmidt, Principal Scientist, Sandoz

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

Biologics

Selecting Compound for Long Acting Injections and Available Technologies

Rene Holm, Head and Scientific Director, Liquids & Parenterals, Janssen

Technology & Innovation

Carbon Nanotube Composites for 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 Quotient Sciences

Biologics

Polysorbates for Biopharmaceuticals: An unnecessarily complex mixture or synergistic blend?

James Humphrey, Applications Specialist, Croda

Show more

Technology & Innovation

Continuous Manufacturing and Influence of Excipient Variation

Mara van Haandel, Innovation Manager, DFE pharma

Batch-to-batch and vendor-to-vendor excipient variation has been studied commonly, but typically small data sets are used in literature (eg: Gamble, 2010; Doelker, 1993; Williams, 1997). Few researchers have evaluated the use of large data sets to assess the impact of excipient variation on drug product performance. In this presentation DFE Pharma shows the impact of excipient variation on continuous processes like continuous feeding, granulation and tableting.

Device Development

Solution Spotlight By Cambridge Design Partnership

12:15 PM - 12:50 PM - Case Studies

Small Molecules

Spray Flash Evaporation, a Disruptive Eco-efficient process for the Continuous Engineering of Nano-pharmaceutics: from laboratory to industry

Dr. HDR Denis Spitzer, Founding Director of the NS3E laboratory, Mixed Research Unit, UMR ISL/CNRS/UNISTRA

Show more

Biologics

Injection Pain with Biologicals

Jonas Fransson, Director of Drug Product Development, Swedish Orphan Biovitrum AB

  • Issues and factors causing injection pain
  • Specific issues with biologicals
  • New innovations to mitigate injection pain

Technology & Innovation

Design, Translation and Development of Polymeric Nano-Medicines

  • Review the basics of translation and development for polymeric nano-medicines
  • Design of delivery nanocarriers for cancer therapies

Device Development

Creating a Digital Ecosystem Beneficial to the Patient

  • The case for connected devices
  • Do all devices need to be connected?
  • How can a device-app ecosystem aid the patient’s experience

12:50 PM - 1:40 PM

Networking Lunch

1:40 PM - 2:15 PM - Solution Spotlights

Small Molecules

Solution Spotlight By Foster Delivery Science

Biologics

Solution Spotlight By LEUKOCARE

Technology & Innovation

Solution Spotlight By ShinEtsu

Device Development

Solution Spotlight By Crux

2:20 PM - 2:55 PM - Case Studies

Small Molecules

Accelerated Stability Testing of Excipients

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

Biologics

Oligonucleotides, the Small Large Molecules

  • Challenges with formulation
  • Challenges with analytics (methods and stability)
  • What are the expectations of health authorities?

Technology & Innovation

Overcoming Barriers of Acetylcholinesterase Inhibitors for Alzheimer’s Disease

  • Reasons for the continued success of Acetylcholinesterase inhibitors as NCE
  • Most 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

2:55 PM - 3:45 PM

Networking Break

3:45 PM - 4:20 PM - Solution Spotlights

Small Molecules

Solution Spotlight By MedPharm

Biologics

Solution Spotlight TBC

Technology & Innovation

Digital Assistant to Support Drug Product Development

Ferdinand Brandl, Head of Laboratory, BASF SE, Nutrition and Health, Development Pharma Solutions

  • Drug product development is currently based on empirical methods; the process can be time-intensive, costly, and has a high risk of failure
  • BASF has developed a science-based formulation prediction system that enables formulators to develop robust drug formulations
  • The assistant identifies the most promising drug-excipient combinations and calculates a starting formulation
  • The number of time-consuming and costly lab experiments is significantly reduced; the risk of failure is reduced at early stages

Device Development

Solution Spotlight TBC

4:25 PM - 5:00 PM - Keynote

Small Molecules

Session Title TBC (Sanofi)

Jean-René Authelin, Global Head of Pharmaceutical Engineering, Sanofi

Pharmaceutical engineering is the way to understand and design the Pharmaceutical processes, based on first principles, in order to make them simple, safe, robust, compliant with GMPs and economically performant.  It requires the description and the integration in a relevant model of phenomena at the various scales, from the microscopic scale (molecule, particle) to the largest scale (equipment, plant). It is based on a mix of careful experimental work and theoretical modeling work.

In this talk we will show, based on concrete examples from various domains (oral & parenteral forms, liquid or solid presentation), how Pharmaceutical Engineering can help to move successfully product from research to commercial manufacturing in a context of Quality by Design and digitalization.

5:00 PM - 5:10 PM

Chair’s Closing Remarks

5:10 PM - 6:10 PM

Drinks Reception

8:30 AM - 9:00 AM

Registration

9:00 AM - 9:05 AM

Chair’s Opening Remarks

9:05 AM - 9:40 AM - Keynote

Technology & Innovation

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

Mesoporous Silica Particles; Simple yet Powerful Tool for the Delivery of Biomolecules

Dr Vivek Trivedi, Lecturer, Formulation Science Department of Pharmaceutical, Chemical and Environmental Sciences, University of Kent

Show more

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 PMC isochem

Biologics

Solution Spotlight TBC

Technology & Innovation

Novel screening tools for hot melt extrusion - Early prediction of formulation performance

Thomas Kipping, Head of Drug Carriers, Merck

Show more

Device Development

Solution Spotlight TBC

11:00 AM - 11:50 AM

Networking break

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 Beneo

Biologics

Solution Spotlight TBC

Technology & Innovation

Solution Spotlight TBC

Device Development

Solution Spotlight 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

  • Which antioxidants, acceptability by authorities, how to control their level throughout shelf life?
  • Available packaging solutions: oxygen scavengers and new technologies (e.g. bottles coated with oxygen scavengers
  • In addition: use of desiccant in blisters for moisture sensitive drug products

Biologics

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

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 Multidrug Resistant Tumours with Stimuli-Sensitive Nanocarriers Co-loaded with siRNA and Drugs

  • 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

Nanomedicines - Are We Ready for The Market?

  • Nanocarrier production
  • Scale-up
  • Critical quality attributes
  • Process parameters
  • IVIVC

Device Development

Combination Products: Design and Patient Experience

  • Putting patient needs first
  • Human Factors and UX simulations
  • Simplify design to reduce cost and improve syringe reliability

3:20 PM - 3:50 PM

Networking Break

3:50 PM - 4:25 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 (include Paediatrics)
  • 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

Serge Mathonet, Global Regulatory Affairs Biologics Center CMC Interface , Sanofi

  • 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

4:30 PM - 5:05 PM - Keynote

Small Molecules

Injectable Drug Formulation Depots with Sustained Release

  • Reducing relapse rates amongst all patients including non-complying patients
  • Achieving sustained release drugs through physiochemical alteration

5:05 PM - 5:10 PM

Poster Presentation Award

5:10 PM - 5:15 PM

Chair’s Closing Remarks