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

Technology & Innovation

Leveraging New Therapeutic Modalities to expand the Druggable Target Space

Shalini Andersson, Chief Scientist New Therapeutic Modalities, AstraZeneca

  • Innovation through new therapeutic modalities
  • Current landscape of oligonucleotide therapeutics, opportunities and the challenges
  • The promise of mRNA therapeutics and delivery hurdles
  • Future outlook

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

Data Sciences meet Formulation Development: Workflow in Vaccine Formulation Development using Integrative High Throughput/High Content Approaches

Joao Miguel Freire, Scientist Formulation Science & Technology (FST), Janssen

  • Full session abstract TBC

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

Trehalose and Sucrose: Essential components of Platform Biopharma Formulations

Dr. Christian Lotz, General Manager, EMEA, Pfanstiehl

  • Commercial Biotherapeutics Stabilized with Trehalose
  • Commercial Biotherapeutics Stabilized with Sucrose
  • Key Issues in Biopharma Formulation Development
  • Essential components of a “Platform Biopharma Formulation”
  • Understanding important physicochemical properties of Trehalose and Sucrose
    • Instability of sucrose at low pH – free glucose, protein glycation
    • Phase transition and crystallization of trehalose
    • Importance of Control of Glucose levels in Sucrose as well as Trehalose
  • Purity, Quality, Consistency in Pfanstiehl’s Trehalose and Sucrose
    • β-glucans in sucrose – interference with endotoxins
    • Trace metal specifications for Sucrose and Trehalose
  • Advantages of Trehalose over Sucrose
  • Pfanstiehl’s Biopharma Stabilization Portfolio incld. newly launched L-Arginine  and L-Histidine
  • Conclusions

Technology & Innovation

Solution Spotlight By LTS Lohman

Device Development

Emergo by UL: Topic 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

Nanoparticles and Medicines Design

Professor Ijeoma Uchegbu, Chair in Pharmaceutical Nanoscience, UCL School of Pharmacy

Show more

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

Roundtable led by Halo Labs

Topic: Fast, Low Volume Subvisible Particle Analysis with HORIZON

Moderated by:
Renee Tobias, Director of Marketing, Halo Labs

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

Small Molecules

Cristal Therapeutics: Topic TBC

Rachel Hu, Senior Formulation Scientist, Cristal Therapeutics

  • 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

BioTED: an Innovation Portfolio for Biologics

Gregoire Schwach, Head Drug Delivery, Roche

  • TBC

Device Development

Interchangeability of Combination Products

Mike Tate, Human Factors Manager, Boehringer Ingelheim

  • 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

An Integrated Approach to Rapidly Advancing Poorly Bioavailable Compounds to the Clinic

David Lyon, Senior Fellow, Research, Lonza

  • Integration of active pharmaceutical ingredient synthesis and drug product development activities
  • Technology selection for poorly soluble molecules based on physical-chemical properties
  • Rapid advancement of poorly soluble compounds to the clinic
  • Case studies
 
Currently it is estimated that over 70% of compounds in development are poorly soluble and require solubility enhancement to orally absorbed.  Furthermore, a significant fraction of these assets are held by small-to-medium sized biotechnology companies that often lack resources and “bricks and mortar” to independently drive the compounds to the clinic and beyond.  In this talk we will discuss an integrated offering that has been developed to help biopharma rapidly advance poorly soluble assets to the clinic using an integrated approach that leverages in silico predictions and bulk sparing laboratory tests to develop clinically-ready formulations with a line of sight to commercial production.

Biologics

New Silicone-Free Option for Delivery of Sensitive Biologics in Pre-Filled Syringes

Russ Hornung, Business Development- Drug Delivery and Packaging , W.L. Gore & Associates

  • Within the biologics market, there has been a significant advancements with molecule complexity and advanced delivery. With these advancements and market growth, the industry has seen a greater number of formulations sensitive to stability.
  • The trend toward higher viscosities and higher concentrations also create an environment for particle challenges and consistent injection time over the full course of 2-year aging.
  • In this presentation, discussion will be on the GORE IMPROJECTâ Syringe Plunger and its ability to enable bare glass syringes for a silicone-free delivery option.

Technology & Innovation

Improving Compliance and Accuracy of Dosing in Paediatrics and Patients with Dysphagia.

Luigi Boltri, Director, Technology Development, Adare Pharmaceuticals

Parvulet - A Novel Semi-Solid Oral Patient Centric Dosing Solution
  • Eliminates the need for food compatibility studies in clinical development.
  • Uses standard manufacturing and packaging processes.
  • Reconstituted immediately prior to dosing > no special storage required

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

Designer Nanomedicines for Cancer Immunotherapy

Professor Khuloud Al-Jamal, Chair of Drug Delivery & Nanomedicine, King’s College London

Immunotherapy is a revolutionary approach in the treatment of cancer that, over the past decades, has transformed the landscape of cancer care. Immunotherapy is based on the premise that it is possible to mobilise the patient’s own immune system to destroy cancerous cells. Clinically, while the success has been miraculous and durable in positive responders, there are many cases where checkpoint blockade has failed leaving significant room for improvement. For instance, rationally targeting multiple check points, both stimulatory and inhibitory, within the tumour microenvironment may improve on the current response rate. However, the use of monoclonal antibodies precludes or seriously limits this possibility as they cannot be specifically targeted to the tumour and as such are linked to significant off target effects. Recent work from our lab seeks to develop a rationally formulated ‘genetic immunotherapy’ regime based on the co- delivery of siRNA to remove inhibitory check point molecules while simultaneously delivering pDNA/mRNA expressing stimulatory checkpoint molecules to the tumour environment. We have explored options to co-deliver immunogenic cell death drugs in combination with the aim of producing more potent cancer cell therapeutics and vaccination strategies.

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 - Panel Discussion

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

Small Molecules

Understanding Developability Assessment of Small Molecules

Sudhakar Garad, Global Head of Chemical and Pharmaceutical Profiling , Novartis Institutes for BioMedical Research

  • Why solubility, stability and delivery is imp during lead optimization and its impact of selection of dev candidates
  • Impact of strong interface/collaboration with chemist and pharmacokinetics during NCE selection
  • Speed to clinic with right biopharm properties

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

Small Molecules

Biologics

CMC aspect of Oligonucleotide Therapeutics

Sonoko Kanai, Associate Director, AstraZeneca

  • Full session abstract TBC

Technology & Innovation

In Vitro Models of the Blood Brain Barrier and their use in Drug Delivery Studies

Birger Brodin, Professor, University of Copenhagen

  • Modelling the neurovascular unit/BBB
  • Brain efflux mechanisms
  • Brain uptake mechanisms
  • Biologics and the BBB

Device Development

Drug product challenges with Closed System Transfer Devices

Twinkle Christian, Process Development Scientist, Drug Product Technologies department, Amgen

  • Closed System Transfer Devices (CSTDs) are meant to offer protection to healthcare professionals against harmful exposure of hazardous drugs during compounding and administration. Although there has been much focus on CSTDs in the context of drug contamination and safety, there has not been much discussion around the compatibility of CSTDs with biological products and patient safety. This talk will address the major challenges with the use of CSTDs including drug product incompatibility and hold up volume to name a few. These aspects are crucial given the impending USP <800>, in 2020 which will mandate healthcare professional to use CSTD for compounding and administration of all biologics as per the National Institute of Occupational Safety and Health (NIOSH) list of antineoplastic and hazardous drugs.

10:05 AM - 10:55 AM

iSolve & Networking Break

10:55 AM - 11:30 AM - Solution Spotlights

Small Molecules

Analysis from the Tufts Center for the Study of Drug Development to Assess the Financial Benefits from Translational Pharmaceutics®: A Platform for Accelerating Product Development

Andy Lewis, Vice President, Pharmaceutical Sciences, Quotient Sciences

  • Discover the difference between Translational Pharmaceutics and traditional approaches to drug development. 
  • Realise the multi-million dollar benefits of Translational Pharmaceutics, as demonstrated in the Tufts CSDD study.
  • Learn how much time and budget you could save on your drug development timeline.
  • Uncover the findings of the Tufts CSDD study including a review of the methodology, results and key conclusions.
  • Hear from real case studies which demonstrate how Translational Pharmaceutics can be utilised during drug development.

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

How to Unlock the Potential of Digital to Design Products for the Benefit of all Stakeholders

  • To be or not to be…digital? Inclusive user insights to determine why, how, what and who?
  • Why digital for drug delivery products? Some potential benefits
  • What do we mean by ‘digital’ and how do we get there? Let’s learn some top tips from other sectors
  • Now let’s implement it with all stakeholders in mind – digital toolkits for product design

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

Small Molecules

Process Material Compatibility Study Concepts

Thomas Schmidt, Principal Scientist, Novartis

  • Considerations for process material compatibility with biologic drug product
  • Performance of material compatibility studies
  • Case studies on compatibility issues

Biologics

Selecting Compound for Long Acting Injections and Available Technologies

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

  • Why is long acting injectable formulation relevant from a clinical perspective?
  • Pharmacokinetic and physical chemical considerations when initiating a formulation program for a long acting injectible product
  • Formulation strategies available for long acting injecting release – including some examples

Technology & Innovation

Staying Ahead of the Game: Formulation Development Strategies for Biologics and Biosimilars

Sachin Dubey, Deputy Director - Process Sciences I, Ichnos Sciences

  • Abstract TBC

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

Small Molecules

Solution Spotlight By Foster Delivery Science

Feng Zhang, Assistant Professor, University of Texas at Austin

Biologics

Stable Liquid Formulations for Viral Vaccines and Gene Therapy Viral Vectors: Reality or Fantasy

Dr. Andreas Seidl, Chief Operating Officer, LEUKOCARE AG

  • Current pain points and hurdles in vaccine / viral vector DS/DP development
  • Applying a database-driven and algorithm-based formulation development for vaccine & viral vector formulations
  • Formulation case studies on stabilizing vaccines & viral vectors               
  • Future directions for vaccines & viral vectors formulation development

Technology & Innovation

Fine Powder Methyl Cellulose and its Dry Binder Application

Dr. Andreas Sauer, Technical Sales Director, SE Tylose GmbH & Co. KG

  • New grade of methyl cellulose
  • Investigation of methyl cellulose compactibility
  • Application of methyl cellulose as dry binder in direct compression and roller compaction processes

Device Development

Computer Simulations for Subcutaneous Injections

Joel Gresham, Simulation Expert & Life Sciences Lead, Crux Product Design Ltd.

  • Attempting to predict injectability of novel formulations (particle suspensions and high viscosity biologics)
  • Quickly assessing risks (backpressure, leakage, pain) with virtual “in-silico” methods
  • Optimising device and formulation parameters with minimal physical testing


Developing novel formulations incurs significant risk, and recent trends in high viscosity, large volume injection pose much uncertainty around appropriate delivery methods. It is highly beneficial to predict the behaviour of formulations and devices at the earliest possible stage to avoid expensive failures later in the development process. Computer simulations are now more powerful than ever and can offer great advantages in the medical sector but have not yet seen the same level of uptake as other safety-critical industries such as aerospace and automotive, in part due to the highly complex nature of biological systems. Crux have partnered with Gilead Sciences to develop models to investigate needle occlusion, human tissue backpressure, leakage risk and pain. These models show good agreement with physical experiments, and reveal important relationships relating device & formulation parameters to injectability metrics.

12:50 PM - 1:50 PM

Networking Lunch

Lunch and Learn roundtable:

Roundtable led by Captisol, a Ligand company

Topic: Captisol a globally accepted modified cyclodextrin in 11 approved products. Come and learn what’s new.

Moderated by:
Vince Antle, Senior Vice President, Technical Operations

JD Pipkin, Vice President, New Product Development

1:50 PM - 2:25 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

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

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

2:55 PM - 3:45 PM

Networking Break

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

Small Molecules

Advances in Dermal Drug Development – The Formulation and The Model

Charles Evans, VP of Pharmaceutical Development, MedPharm

  • The importance of preformulation – drug characterisation
  • The medicine is drug and formulation
  • Testing performance to de-risk your programs
  • Criticality of process development – assess the risk
  • Using unique models to aid with marketing claims

Biologics

Extending Shelf Life of Therapeutic Proteins with Hydroxylpropyl ß-Cyclodextrins - Mechanistic Understanding of Bevacizumab Stabilization

Shiqi Hong, Senior biopharma scientist, Roquette

  • Case study of KLEPTOSE® as an effective excipient in bevacizumab formulation
  • Does surface properties of surfactants and protein properties affect aggregation?
  • Mechanistic understanding of bevacizumab stabilization with KLEPTOSE®
  • Thermal and oxidative stability of KLEPTOSE® under stress conditions

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

Technology & Innovation

5:00 PM - 5:10 PM

Poster Presentation Award

11th Global Drug Delivery & Formulation Summit 2020 Poster Competition Awards

5:10 PM - 5:15 PM

Chair’s Closing Remarks

5:15 PM - 6:15 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

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.

9:40 AM - 10:15 AM - Keynote

Device Development

Creating a Digital Ecosystem that Improves Outcomes: The Do’s and Don’ts to Navigate Hype vs Hope

Matthew Clemente, Vice President, Device Development, 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.

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

Biologics

SynBiosys Microparticles for the Development of Long-Acting Injectable Formulations for Biological Therapeutics

Rob Steendam, Chief Technology Officer, InnoCore Pharmaceuticals

There is an increasing need for patient-friendly delivery of biological therapeutics to treat chronic and site-specific diseases. Demonstrating excellent control over release kinetics and well preserved bioactivity of protein therapeutics, InnoCore’s SynBiosys biodegradable polymeric microparticle technology combines all the features required for long-acting injectable (LAI) formulations for biologics. This talk will address the typical challenges in development of LAI formulations for biologics and give an update on InnoCore’s SynBiosys microparticle technology. Examples showcasing the development and manufacturing of LAI SynBiosys microparticle formulations for various peptide and protein therapeutics and their application in the treatment of chronic and site-specific diseases will be provided.

Technology & Innovation

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

Thomas Kipping, Head of Drug Carriers, Merck

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Device Development

Solution Spotlight TBC

Small Molecules

A Convenient Formulation of Orodispersible mini-tablets for Pediatric Administration

Dr. Michael Black, Head of Sales Pharma, BENEO-Palatinit GmbH

Orodispersible mini-tablets (ODMT) are a beneficial dosage form for pediatric medicines. A recent study to develop a convenient direct compression formulation for ODMT with hydrochlorothiazide (HCT) and with enalapril maleate (EM), as model commonly prescribed pediatric drugs, is described. Additionally the mechanical properties, disintegration behaviour and dissolution profiles of the example ODMTs are presented.

About the content:
  • What is isomalt?, how is it manufactured and what are its physical properties?
  • Making tablets with isomalt
  • The sensory properties of isomalt and how this makes medicine taste better

10:55 AM - 11:45 AM

Networking break

11:45 AM - 12:20 PM - Case Studies

Small Molecules

Processing Strategies to Prepare Poorly Soluble Drug Compounds by Nanotechnological and Amorphous Formulation Approaches

Werner Hoheisel, Group Lead Formulation Technologies, Invite

Identifying the most appropriate formulation and processing strategy of poorly soluble drugs is a challenging task for most pharmaceutical companies. It involves deep knowledge about the interaction of drug compound and added excipients and their respective physico-chemical properties. In most cases, the preparation process of stable compounds is initiated by modelling the interaction of drug and excipient as well as by experimental screening procedures in order to determine the most promising drug-excipient combinations. Besides selecting the right materials, the employed process technology is essential as well in order to produce stable and safe amorphous or nanotechnological drug formulations.

Invite GmbH, located in Cologne, Germany, and the Drug Delivery Innovation Center (DDIC), a consortium of pharmaceutical companies as well as material and equipment manufacturers, are addressing challenges as described above in order to develop new routes for producing solid dosage forms of poorly soluble drugs.

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

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Technology & Innovation

In progress, Unique Identifiers on Dosage Forms to Prevent Counterfeits and Falsified Medicines

Sven Stegemann, Professor for Patient Centric Drug Development and Manufacturing, Graz University of Technology

  • Introduction into the issue of counterfeiting
  • Review of different available technologies
  • Future perspectives of emerging technologies

12:25 PM - 1:00 PM - Case Studies

Small Molecules

Amorphous Solid Dispersion: Strategies in Early Stage Development and Technology Choice

Philippe Lienard, Pre-Development Science Project Manager, Sanofi

When a new chemical entity is close to enter development, research teams initiate discussions with development teams and one of the first questions which could be raised is “can we do an Amorphous Solid Dispersion because our compound is insoluble?” Whilst this is a very pertinent question, the answer is not a simple one.
 
As many ASD technologies are available at the industrial scale, selection of the right technology is strategic for the future development pre-clinical and clinical and may be driven by one or more of the following considerations:

  • Quantity of API available for early development studies
  • Stage of development (feasibility studies, formulation/process development)
  • Formulation selection
  • CMC prerequisite (physical and chemical stability, solubility and dissolution improvement)
  • Biological performance enhancements.

This talk will describe how to make early formulation strategic choices for these complex ASD formulations, exemplified with tangible case studies.

Technology & Innovation

Characterization of Protein Based Medicines using Drop Coat Deposition Raman spectroscopy

Anna Luczak, Senior Scientist, Bristol-Myers Squibb

Biologics drugs are substantially more challenging to characterize than small molecule based pharmaceuticals due to complexity of the molecule and analytical ability to accurately determine its protein secondary structure. Drop Coat Deposition Raman (DCDR) spectroscopy has been utilized for fingerprinting of BMS biologics and has been successfully used in differentiating counterfeit biologics from their authentic counterpart. DCDR spectroscopy is also being further explored for other applications such as degradation studies of biologics to understand how some of the stress conditions affect the secondary structure of the protein in the formulation. This talk focuses on the DCDR spectroscopy and its capabilities for effective characterization of changes in secondary structure of protein that can be applicable for upstream and downstream in manufacturing.

Device Development

Biocompatibility Testing of Medical Devices and Drug Device Combination Products

Dr. Clemens Günther, Director Nonclinical Safety CC, Bayer

  • Understanding the complexity of non-clinical safety requirements
  • How to select an appropriate test strategy
  • Overview on biocompatibility testing according to ISO-10993
  • How to avoid potential pitfalls

1:00 PM - 2:00 PM

Networking Lunch

2:00 PM - 2:35 PM - Solution Spotlights

Small Molecules

Computer-aided Formulation Development for Small Molecule Drugs and Biologics

John C. Shelley, Schrödinger Fellow, Schrödinger

  • Practical utilization of molecular modeling to provide theoretical backing and inform decision making in drug formulation that compliments experimental data
  • API and excipient property prediction for small molecule drug formulations
  • Characterization of drug-drug and drug-polymer association in small molecule formulations including amorphous solid dispersions
  • Predict viscosities and provide structural insights into concentrated globular protein and antibody solutions including excipient effects

Biologics

Solution Spotlight TBC

Technology & Innovation

The Accordion Pill®: Unique Oral Delivery to Enhance Pharmacokinetics and Therapeutic benefit of Challenging Drugs

Ronny Reinberg, Vice President Technology Affairs, Intec Pharma

The Accordion Pill® (AP) oral delivery platform is a unique, film-based, gastro-retentive technology, developed by Intec Pharma. The AP technology allows multiple drug release profiles, enables high drug loading of both soluble and poorly soluble drugs, and can contain a fixed-dose combination. The platform was already tested in multiple clinical trials (pharmacokinetic (PK), efficacy and safety) in healthy subjects and patients. The results demonstrated significant PK and efficacy improvements for narrow absorption window drugs and poorly soluble drugs while maintaining a very good long-term safety profile. The presentation will discuss the characteristics of the AP, PK and efficacy data achieved using AP formulations and the unmet needs that the technology can address.

Device Development

Solution Spotlight TBC

2:40 PM - 3:15 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

Nanogels for the Intracellular Delivery of Proteins and Peptides

Rene van Nostrum, Associate professor, Utrecht University

  • Dextran-based nanogels are prepared and quantitatively loaded by making use of electrostatic interactions between the gel and the API.
  • After loading, API is covalently conjugated inside the gel to prevent premature release upon administration.
  • Intracellular release is triggered by reduction of the covalent bond between API and the nanogel.
  • Above concept was successfully applied in cancer immunotherapy in vitro and in vivo (animal models).

Technology & Innovation

Sustained Release Intra-Vaginal Drug Delivery Systems based on Ethylene-Vinyl Acetate: Formulation and Physicochemical Considerations

Amrit Paudel, Assistant Professor & Principal Scientist, Graz University of Technology, Research Center Pharmaceutical Engineering (RCPE)

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

3:15 PM - 3:45 PM

Networking Break

3:45 PM - 4:20 PM - Keynote

Small Molecules

CMC Strategies to Accelerate Proof-of-Concept for Oral Drugs in the Biotech Industry

Jatin Patel, Executive Director-CMC , Constellation Pharmaceuticals

In recent years innovation in the pharmaceutical industry has been fuelled by small and mid-size biotech companies which have the benefit of cutting-edge science, nimble organizational processes and increased capital to fund research with a clear focus.  More recently, regulatory processes like breakthrough designation have provided additional impetus to bringing new medicines forward rapidly.   Despite these catalysts, some biotech’s face significant hurdles as they transition from discovery to development.  This is especially true for small biotech’s that use a virtual model where most if not all the development work is outsourced and there is significant reliance on external partners.  In this approach, one of the most common gaps is in the areas of pharmaceutical development that includes preformulation, formulation, drug delivery as well as CMC regulatory strategies. This could lead to conservative or erroneous strategies for early development studies and a negative impact on expediting transition to registrational studies. This presentation will outline several key areas of CMC focus for the discovery to development transition to establish POC and rapid transition to registrational studies.

 

Case studies highlighting smart risk taking and adoption of phase-appropriate development that enables rapid human assessment, speed to POC and transition to registrational studies will be covered.

4:20 PM - 4:55 PM - Keynote

Biologics

Current Status and Opportunities of Cell and Gene Therapies

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

4:55 PM - 5:05 PM

Chair’s Closing Remarks