Program 2019

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  • Biologics

  • Small Molecules

  • Technology & Innovation

  • Device Development

7:30 AM - 8:20 AM

Registration & Refreshments

8:20 AM - 8:30 AM

8:30 AM - 9:10 AM - Keynote

Biologics

How Next-Generation Biotherapeutics will Influence Formulation and Device Development

Kerstin Walke, Head of Pharmaceutical Development Biologicals, Boehringer Ingelheim

In the last couple of years the development of Biotherapeutics moved away from standard monoclonal antibodies to more complex formats, which led to the need of miniaturized and high throughput screening systems in the early stage of formulation development. Also the need for predictive tools like in-silico today plays an important role in the formulation development. At the same time the need for patient self-administration got to play a very important role, not necessary limited anymore to a few indication areas. Based on novel constructs the probability for high concentrated formulations might be limited and therefore high volume devices are taking a more important role.  Also co-formulations of multiple monoclonal antibodies into a single drug product brings certainly convenience to the patients, however brings also the need for new analytical methods. At the same time it can also be observed a trend to advanced therapy medicinal product (ATMPs), which is a new area and the pharmaceutical development of such compounds is challenge.

9:10 AM - 9:15 AM

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9:15 AM - 9:50 AM - Case Studies

Small Molecules

Right Time, Right Place; Exploiting Micro and Nano Particulates for Drug Delivery

  • Development of sustained release of small molecule and peptide APIs to shift treatment from daily to monthly or longer
  • Delivery of hard-to-formulate actives for complex and novel applications
  • Poly-lactide microspheres for the treatment of eye diseases
  • Organ-selective delivery of cytotoxic payloads
  • Targeting of tumour cells

Biologics

Analytical Techniques for Biopharmaceutical Evaluation

Marc-Antoine Fabre, Global Head Biopharmacy, Sanofi

  • Understanding site structure-activity dynamic for novel ADC development
  • New techniques to better understand molecule stability

Technology & Innovation

Innovations in Creating Drugs for CNS Diseases

  • Potential routes to crossing the BBB (Blood Brain Barrier)
  • S1P1inhibitors as a potential companion drug
  • Formulating CNS drugs with built in S1P1 inhibitors

Device Development

Case Study: Roadmap of Lifecycle Management for a Rare Disease Designated Combination Product

Steve Bowman, Device Program Lead, Shire

  • Product life cycle management from vial to PFS and beyond
  • Specific requirements and considerations for combination product development
  • When connectivity becomes part of lifecycle management
  • Importance of user research to maximize device lifespan

9:50 AM - 9:55 AM

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9:55 AM - 10:30 AM - Case Studies

Small Molecules

Nanoparticle Formulation Development: A Closer look at Pharmaceutical Fabrication Methods

Ben Van Hove, Associate Director Drug Product Development, Oral Solid Dosage Forms, Janssen

  • Nanoparticle formulation for drugs with poor aqueous solubility
  • Comparison of polymer nanoparticle fabrication methods and composition
  • Effect of nanoparticle fabrication method and composition on nanoparticle physical properties

Biologics

QbD and Process Scale Up Considerations

 

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

Technology & Innovation

Ultra-High Drug Loading in Micelles

  • Drug release timing, uniformity of colloidal dispersions, drug stability colloidal uniformity and formulation stability
  • Triggering drug release based on oxygen levels in cancerous cells

Device Development

In What Direction is the Drug Delivery Technology Space Moving?

  • Evaluating how fast the delivery technology field has evolved until now – are there limiting factors to its continued development?
  • What is the potential of less-traditional delivery routes such as nasal and ocular delivery?
  • Discussing the future of evolving areas including polymer technologies, auto injectors, microneedles etc.
  • Looking retrospectively, has the industry done all it can until now to maintain the R&D paradigm?

10:30 AM - 11:30 AM

iSolve & Networking Break

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

Small Molecules

Advances in Supersaturating Drug Delivery Systems

Prof Rainer Jordan, Professor of Macromolecular Chemistry, TU Dresden

 

  • What are Supersaturating Drug Delivery Systems (SDDS)?
  • Advances in developing and characterizing SDDS?
  • Complexity in in-vitro and in-silico characterization of SDDS?
  • Benefits and limitations of SDDS characterization tools and methods

Biologics

Solid Lipid Solution Formulations

 

 

Abstract TBC

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

Compatibility studies for administration devices materials: A long journey

  • How do compatibility studies fit into the formulation journey?
  • Selecting the correct plastics: infusion systems vs syringes
  • Thinking about shelf stability

12:10 PM - 12:15 PM

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

Small Molecules

Session TBC

 

 

 

 

Biologics

Solution Spotlight By Pfanstiehl

Technology & Innovation

Session TBC

Device Development

Session TBC

12:50 PM - 1:50 PM

Networking Lunch

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

Small Molecules

Evaluation of Dry Powder Formulation Approaches for the Improvement of Lung Pharmacokinetics of Poorly Water-Soluble NCEs in Preclinical in-vivo Experiments

Alessandro Fioni, DMPK Senior Scientist, Chiesi

In brief, the crystalline powder of the test Compound A, characterized by very low solubility in water and therefore not suitable for inhalation administration during in vivo preclinical experiments, was converted in different powders, using different techniques and combining different excipients, with the aim to increase the solubility of the powder and improve the lung pharmacokinetics of the compound. The obtained formulations were tested in vivo to evaluate the effect of the formulation on the PK profile of the Compound A.

Biologics

Novels Tool for Peptide and Protein Conjugations

Thomas Hoeg-Jensen, Scientific Director, Novo Nordisk

Abstract TBC

Technology & Innovation

Optimizing 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-centered design: Practical guidance for combination products

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

2:25 PM - 2:30 PM

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

Small Molecules

Solution Spotlight By Hovione

Biologics

Solution Spotlight By Unchained Labs

Technology & Innovation

Solution Spotlight By Dow

Device Development

Solution Spotlight By Confinis

3:05 PM - 4:05 PM

iSolve & Break

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

Small Molecules

Understanding Material Properties for HME Process Optimization in ASD Formulations

Samuel Kyeremateng, NCE Formulation Sciences Senior Scientist, Abbvie

  • Demonstrate connection between ASD thermodynamic properties and HME manufacturing process
  • Application drug/polymer phase diagram as a tool for HME risk assessment
  • Demonstrate correlation between drug/polymer phase diagram, drug load, rheology, and HME process.
  • Correlating drug product CQA (residual crystallinity, chemical/thermal stability) to drug/polymer phase diagram and HME process parameters

Biologics

Oral delivery of hydrophobic drugs using mixed micelles

  • Improving bioavailability through mixed micelle formulations
  • PEGylation stabilisation of mixed micelles
  • Mucus penetration through endothelial cells by PEGylated mixed micelles

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

Foundational research on subcutaneous injection physiology to improve biologics delivery systems 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

4:40 PM - 4:45 PM

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4:45 PM - 5:20 PM - Case Studies

Biologics

Can biosimilars and generics be treated as if they are one and the same?

  • Can biosimilars be used the same way generics are
  • Switching patients from originator to biosimilar
  • NOR-SWITCH and similar case studies

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

Dealing with the Changing Regulatory Landscape around Combination and Medical Devices

  • Challenges of developing combination products through a changing regulatory landscape.
  • Working across boundaries to achieve common goals.
  • Case study on the review of human factors protocols by regulators.

5:20 PM - 5:25 PM

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5:25 PM - 6:00 PM - Keynote

6:00 PM - 6:05 PM

6:05 PM - 7:05 PM

Drinks Reception

8:00 AM - 8:30 AM

Registration & Refreshments

8:30 AM - 8:40 AM

Chair's Opening Remarks

8:40 AM - 9:15 AM - Keynote

Small Molecules

Future Trends in Pharmaceutical Development

Olaf Queckenberg, Head of Chemical & Pharmaceutical Development, Bayer

Abstract TBC

9:15 AM - 9:20 AM

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9:20 AM - 9:55 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

Current Research on GLP-1 with a Special Focus on Semaglutide Oral Delivery

Jesper Lau, Vice President, Protein and Peptide Chemistry, Novo Nordisk

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

Ophthalmic Drug Delivery

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

9:55 AM - 10:55 AM

iSolve & Networking Break

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

Small Molecules

Improving Absorption of Poorly Soluble Compounds

  • Highlighting the main obstacles to oral delivery
  • Formulating drugs with solutions to identified obstacles in mind

Biologics

Oligonucleotides, the Small Large Molecules

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

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

11:30 AM - 11:35 AM

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

Small Molecules

Solution Spotlight By Foster Delivery Science

Session TBC

Biologics

Solution Spotlight by Roquette

 

 

Technology & Innovation

Solution Spotlight ShinEtsu

 

 

 

Device Development

Solution Spotlight Session TBC

Session TBC

12:10 PM - 12:15 PM

Please Move to your Next Session

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

Small Molecules

Biologics

Practical Lessons on Making QbD an Essential Step in Biologics Production

  • Overview of the latest QbD guidelines and best practices
  • QbD methodology: Quality Target Product Profile

Control strategy for QbD

Technology & Innovation

Design, Translation and Development of Polymeric Nano-Medicines

Harivardhan-Reddy Lakkireddy, Head of Drug Delivery Technologies & Innovation - Nanotechnologies, Sanofi

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

Device Development

Nano-structured Films for Ocular Drug Delivery

  • Patient non-compliance with traditional glaucoma treatment
  • Automatic sustained release of drug via intraocular devices
  • Monitoring drug release kinetics

12:50 PM - 1:50 PM

Networking Lunch

1:50 PM - 2:25 PM - Solution Spotlights

Small Molecules

Solution Spotlight Adare Pharmaceuticals

Abstract TBC

Biologics

Solution Spotlight Albumedix

Session TBC

Technology & Innovation

Solution Spotlight DFE Pharma

Abstract TBC

Device Development

Improving COPD treatment with ‘Smart Inhalers’

  • Adherence interventions categories that can be targeted
  • Measuring cost effectiveness of treatment through smart devices- eg smart inhaler

2:25 PM - 2:30 PM

Please Move to your Next Session

2:30 PM - 3:05 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

Technology & Innovation

Penetrating the Blood Brain Barrier (BBB) Using Novel Nanoplatforms

Johannes Khinast, Director , Research Center Pharmaceutical Engineering

  • Developing nano-delivery vehicles capable of targeting the CNS
  • Comparing formulations using organic vs inorganic nanoparticles, liposomes and micelles

Device Development

Human Factors Engineering for Medical Device Development

Rémy Vomscheid, Director, Device Development & Technologies, Ipsen

  • Human Factors Engineering: overview & regulatory framework
  • Patient-centricity in Device Design and Development
  • Case study

3:05 PM - 4:05 PM

Networking Break

4:05 PM - 4:40 PM - Solution Spotlights

Small Molecules

Solution Spotlight Gore

Abstract TBC

Biologics

Solution Spotlight By biopharma group

Technology & Innovation

Solution Spotlight By Grace (1)

Abstract TBC

Device Development

Solution Spotlight Session TBC

 

 

 

4:40 PM - 4:45 PM

Please Move to your Next Session

4:45 PM - 5:20 PM - Keynote

Biologics

5:20 PM - 5:30 PM

Chair’s Closing Remarks and End of Day 2

Mostafa Nakach, Head of Pharmaceutical Engineering, Sanofi

8:00 AM - 8:30 AM

Registration

8:30 AM - 8:35 AM

8:35 AM - 9:10 AM - Keynote

Device Development

Innovating Medical Devices Cost Effectively

  • 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

9:10 AM - 9:15 AM

Please Move to your Next Session

9:15 AM - 9:50 AM - Case Studies

Small Molecules

Local Delivery for Enteric Coated Drugs

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

Biologics

Polysorbate Degradation: Implications and Control

Satya Krishna 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

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

9:50 AM - 9:55 AM

Please Move to your Next Session

9:55 AM - 10:30 AM - Solution Spotlights

Small Molecules

Solution Spotlight By Merck Group

Abstract TBC

Biologics

Solution Spotlight Session TBC

Technology & Innovation

Solution Spotlight Session TBC

Device Development

Solution Spotlight Session TBC

Session TBC

10:30 AM - 11:30 AM

Networking break

11:30 AM - 12:05 PM - Case Studies

Small Molecules

Control Strategy Approaches in Continuous Manufacturing of Oral Solid Dosage Forms

Jacqueline Maximilien, Senior Scientist, Janssen 

Abstract TBC

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

In vitro Models of the Blood Brain Barrier and Their Use in Drug Delivery Studies

Birger Brodin, Faculty of Health and Medical Sciences Department of Pharmacy CNS Drug Delivery and Barrier Modelling, University of Copenhagen

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

Device Development

Micro-Injector for solid micro-dose Injections: Regulatory Considerations for Pharmaceutical and Device Development

12:05 PM - 12:10 PM

Please Move to your Next Session

12:10 PM - 12:45 PM - Solution Spotlights

Small Molecules

Solution Spotlight Session TBC

Session TBC

Biologics

Session TBC

Session TBC

Technology & Innovation

Solution Spotlight Session TBC

Device Development

Solution Spotlight Session TBC

Session TBC

12:50 PM - 1:50 PM

Networking Lunch

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

Biologics

PS80 Oxidation Case Study: Any Impact on mAb Stability

Heloise Audat, Head of Late Stage Formulation Development Unit, Biologics, Sanofi

 

Abstract TBC

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

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

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

2:25 PM - 2:30 PM

Please Move to your Next Session

2:30 PM - 3:05 PM - Case Studies

Small Molecules

Modelling and Control of Fluid Bed Granulation Processes

Fluidized bed processes are a complex equilibrium between thermodynamics, hydrodynamics and atomization.

A simple model based on mass and heat balances on the equipment is proposed to find the perfect alchemy to control granulation, coating and drying processes in Fluidized bed.

3 cases studies:

  • Application to a granulation process
  • Application to a coating process
  • Application to a drying process

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

Ultra-high Drug Loaded Micellar Drug Formulation and Solid Dispersions

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 designers vs medical clinicians

3:05 PM - 3:10 PM

Please Move to your Next Session

3:10 PM - 3:45 PM - Case Studies

Small Molecules

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

Technology & Innovation

Optimising Formulation and Drug Synthesis Using Artificial Intelligence

  • Optimising engineering processes
  • Using AI for non-linear relationship predictions and modelling

Device Development

Combination Products: Design and Patient Experience

  • Start troubleshooting with your end goal (the patient!)
  • Human Factors testing in mock-ups
  • Simplify design to reduce cost and improve syringe reliability

3:45 PM - 4:45 PM

Networking break

4:45 PM - 5:20 PM - Case Studies

Small Molecules

Disproportionation of Salts in Solid Oral Dosage Forms

  • Drug efficacy deterioration as a result of salt dissociation
  • Dissolution changes

Biologics

Regulatory Considerations of Nanomedicines

Show more

Technology & Innovation

Nanomedicines - Are We Ready for The Market?

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

Device Development

Benefits of Early Integration of Human Factors: A BYDUREON® BCise case study

James Meehan, Associate Principal Scientist – Human Factors , AstraZeneca

  • This presentation will provide a case study of a HF program for the development of a combination product used to treat type II diabetes
  • This product was initiated in 2009 and has therefore been developed during a period of evolving HF guidance. The presentation will discuss evaluations that were conducted at multiple design stages with representative users, as well as iterations to the design user interface to mitigate observed performance issues
  • This presentation will include an overview of interactions with regulators as well as the importance of having a dialogue with regulators throughout the development process.

5:20 PM - 5:25 PM

Please Move to your Next Session

5:25 PM - 6:00 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

Bispecifics Drug Product Development; Challenge of Low Concentration Analysis and Formulation

Sachin Dubey, Head of Formulation and Analytical Development, Glenmark

  • Glenmark’s BEAT format – advantages, flexibilities, applicability etc.
  • Formulation and stability aspects of bispecifics.
  • Strategies to overcome analytical and formulation challenges for a highly potent molecule.
  • Preparation for clinical trials for extremely low FIH starting dose.

Technology & Innovation

Novel CART Cell Therapy Based Tumour Treatments

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

Device Development

How Will the Future Look for Next Generation Devices?

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

6:00 PM - 6:05 PM

Please Move to your Next Session

6:05 PM - 6:40 PM - Keynote

Technology & Innovation

Injectable Drug Formulation Depots with Sustained Release

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

6:40 PM - 6:45 PM