Program 2019

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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

Please Move to your Next Session

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

More Than Just Down-Scaling – Miniaturization of Methods in a High-Throughput Setting Requires Creative Concepts and Holistic Thinking

Dr. Martin Hüelsmeyer, Head of HTS Operations & Analytics NBE Formulation Sciences, Principal Research Scientist, AbbVie

  • Formulation screening
  • Biotherapeutics
  • Robotics
  • Analytics & stress assays

Device Development

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

  • 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

Please Move to your Next Session

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

Parenteral Sustained Release of Peptides – Getting It Right

Simon Bjerregaard, Senior Research Scientist, Ferring

 

  • Abstract TBC

Technology & Innovation

Device Development

Drug Delivery Devices for Innovative Parenterals and Biosimilars: Patient-Centered Technical and Business Opportunities

Corinna Sonderegger, Head Portfolio Management Device Development & Commercialization, Novartis

  • Innovative Biologics versus Biosimilars - understanding and delivering on emerging customer needs
  • Smart devices – who is the customer
  • Changing biologics portfolios inline with new device technologies
  • Intravitreal injections as special challenge with recent advancements

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

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

Please Move to your Next Session

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

Lunch & Learn Round Table with ADM SIO

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

Show more

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

Please Move to your Next Session

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

Small Molecules

Solution Spotlight By Hovione

Biologics

Solution Spotlight

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

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

Please Move to your Next Session

4:45 PM - 5:20 PM - 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

Please Move to your Next Session

5:25 PM - 6:00 PM - Keynote

Biologics

Challenges and Opportunities for the next Generation of Oral Peptide Delivery

Alan S Harris, Senior VP, Global R&D Life Cycle Management, Ferring

  • A patient-centric approach and the patient benefits of oral drug delivery of peptides
  • Current development challenges
  • Outcome of current oral drug delivery technologies
  • Why have so few technologies reached the market?
  • Science based selection process of drug delivery technology
  • What the future holds?

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

Please Move to your Next Session

9:20 AM - 9:55 AM - Case Studies

Small Molecules

Challenges and Opportunities to Include Patient Centred Design in Industrial Drug Development

Dr. Carsten Timpe, Expert Scientist, Roche

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

9:55 AM - 10:55 AM

iSolve & Networking Break

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

Small Molecules

3D Printing as an Investigative Tool in Particle Detachment

Tim Rouse, Senior Scientist, Chiesi

  • Abstract TBC

Biologics

Challenging Transfer of a Fill & Finish Process for a Highly Fragile Bispecific mAb

Stephanie Greco, Head of laboratory in Pharmaceutical Engineering, Sanofi

  • Utility of extensive comprehension of the mAb aggregation law
  • Set-up of a temperature control process to prevent aggregation
  • Impact of temperature variations on fill weights during Time-pressure filling

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

Please Move to your Next Session

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

Small Molecules

Solution Spotlight By Foster Delivery Science

Session TBC

Biologics

Hydroxylpropyl ß-cyclodextrin: A Promising Excipient for Protein Stabilization

Show more

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

Application of New Drying Techniques for OSD

Sune Andersen, Principal Scientist Spray Drying , Janssen

  • Abstract TBC

 

Biologics

Session TBC (Novo Nordisk)

Stephen Buckley, Head of the Discovery ADME Department in Global Research, Novo Nordisk

Case Study on the first example of a peptide drug to be administered orally.

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

Session TBC (Novartis)

Daniel Latham, Head – Device Development & LCM Device Development & Commercialisation, Novartis

  • 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

Lunch & Learn Round Table with Cydex Pharmaceuticals

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

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

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

9:10 AM - 9:15 AM

Please Move to your Next Session

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

Small Molecules

Session TBC (Polyphor)

Mario Maio, Head CMC Development, Polyphor

  • Abstract TBC

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

Mind the Gap - How to Assure Data Integrity in a High-Throughput Formulation Screening for Biotherapeutics

Sabine Eichling, Senior Scientist II, NBE High Throughput and Advanced Formulation Sciences Drug Product Development, AbbVie

  • 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

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

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

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

Dr. Matthias G. Wacker, Head of Department, Pharmaceutical Technology and Nanosciences, Fraunhofer-Institute for Molecular Biology and Applied Ecology

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

Device Development

Future Potential for Wearables

  • Key drivers for adopting wearables
  • Using data to design better treatments
  • Wearable drug delivery

2:25 PM - 2:30 PM

Please Move to your Next Session

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

Small Molecules

Biologics

Characterization of Subvisible Particles: Old Challenges and Newest Improvements

Anacelia Ríos Quiroz, Scientist - Group Leader Particle Lab Biologics, Roche

Show more

Technology & Innovation

Ultra-high Drug Loaded Micellar Drug Formulation and Solid Dispersions

Prof. Dr. Robert Luxenhofer, Chair of Chemical Technology of Materials Synthesis, Wuerzburg University

  • Small differences with a big impact: Structure-property relationships in micellar drug formulations
  • Injectable drug formulation depots with sustained 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 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

Nanoparticle Based Formulations: Special Emphasis on Bioavailability Improvement and Delayed Release upon Parenteral Administration

Dr. Yogeshwar Bachhav, Associate Director Pharmaceutical Development , AiCuris Anti-infective Cures

  • Abstract TBC

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 - 4:15 PM

Networking break

4:15 PM - 4:50 PM - Case Studies

Small Molecules

Smart Delivery of Actives by Polyrotaxanes Providing New Options for the Treatment of Niemann-Pick Typ C Disease

Gerhard Wenz, Professor, Saarland University

Show more

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

Session TBC (early formulation tech innovation)

Dr. Elisabeth Kersten, Lab Head Early Formulation Development, Bayer

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.

4:50 PM - 4:55 PM

Please Move to your Next Session

4:55 PM - 5:30 PM - Panel Discussion

Technology & Innovation

Are We Prepared for the Regulations on Patient-Focused/Patient-Centric Drug Development?

Sven Stegemann, Director, Pharmaceutical Business Development, Lonza

Dr. Carsten Timpe, Expert Scientist, Roche

Louise Place, Head Of Regulatory Affairs and Senior Quality Assurance Consultant, Cambridge Design Partnership

  • With the recent first FDA draft Guideline on Patient-Focused Drug Development (PFDD) and three additional guidelines to follow as well as the finalization of the EMA Reflection on pharmaceutical development of medicines for use in the older population”, patient centric drug product development is becoming mandatory for the pharmaceutical industry
  • What does it mean to the pharmaceutical industry, how do we build a framework of patient centric/focused drug product development
  • Take an opportunistic view how this can help to create a competitive advantage by adding real value to patients and payers
  • Debate on how to best take advantage of the emerging regulation and influence its implement

5:25 PM - 5:30 PM

Poster Presentation Award

5:30 PM - 5:35 PM