Programme 2022

21st – 23rd March 2022, All Timings in CET

7:40 AM - 8:40 AM

Registration & Refreshments

8:40 AM - 8:50 AM

Chair's Opening Remarks

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

Technology & Innovation

How Will AI and Machine-Learning Technologies Change our Industry?

Sune Andersen, Principal Scientist in Particle Engineering , Janssen

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

10:15 AM - 10:45 AM - Solution Spotlights

Small Molecules

Session Title TBC (Adare)

Biologics

Session Title TBC (Pfanstiehl)

Technology & Innovation

Session Title TBC (Nanoform)

Device Development

Session Title TBC (Gerresheimer)

10:45 AM - 11:35 AM

1-2-1 Pre-Scheduled Meetings & Networking Break

11:35 AM - 12:05 PM - Case Studies

Small Molecules

New Insights in the Endothelial Transport of Orally Administered PEGylated Mixed Micelles

Rene Van Nostrum, Associate Professor, Pharmaceutical sciences , Utrecht University

Biologics

Modelling Rheology of Highly Concentrated Proteins

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

Technology & Innovation

Novel Nanotechnologies for Mucosal Delivery of Small Molecules and Biologics: Old Problems but New Solutions

Dr. Andreas Bernkop-Schnürch, Head of the Department Center for Chemistry and Biomedicine , Innsbruck University

Device Development

MDR Article 117 Effects on Developing New Combination Products

  • Growth of medical devices and combination products
  • Current regulations on medical devices and combination products
  • Impact and challenges of the Notified Body Opinion requirement (Article 117)

12:10 PM - 12:55 PM - Panel Discussion

Device Development

Improving Care Quality Through Connected Drug Delivery Devices

  • Reducing dosage complexity through improved delivery
  • Connected devices and apps as digital devices, the role played in care at home
  • Challenges and opportunities

12:55 PM - 1:55 PM

Networking Lunch

1:55 PM - 2:25 PM - Solution Spotlights

Small Molecules

Session Title TBC (Hovione)

Biologics

Session Title TBC (Roquette)

Technology & Innovation

Solution Spotlight by Ashland

Device Development

Session Title TBC

2:30 PM - 3:15 PM - Panel Discussion

Device Development

Moving care to the Patient Home and the Role of Microneedle Drug Delivery Systems

  • What is the Value to the Patient in Home Administration of Injected Medicines?
  • Can at home delivery assist health systems without diminishing quality care?
  • Challenges and opportunities of microneedle drug delivery
  • Formulating drugs for microneedle delivery

3:15 PM - 4:05 PM

1-2-1 Pre-Scheduled Meetings & Networking Break

4:05 PM - 4:35 PM - Case Studies

Small Molecules

Strategic Selection for Development Candidate Targeting Oropharyngeal Administration

Philippe Lienard, Early Development Coordinator , Sanofi

  • Research candidate properties to master for maximizing probability of success
  • Design of the formulation for intended clinical studies
  • Device selection for fit-4-purpose oral application in clinical studies

Biologics

Biopharmaceutics of mAbs: Challenges in Subcutaneous Bioavailability Prediction

Mikolaj Milewski, Principal Scientist , MSD

Reliable prediction of clinical subcutaneous bioavailability of monoclonal antibodies (mAbs) remains challenging. Only limited success was reported in use of preclinical-to-clinical translation, ex vivo methods, or in silico methods. This gap has a direct impact on human subcutaneous dose selection and cost of goods in development of a new drug product.

This presentation will review the biopharmaceutics of mAbs with special emphasis on the subcutaneous absorption process and hypotheses behind incomplete systemic absorption. These are related to formulation-related events (e.g. precipitation at the site of injection or strong nonionic interaction of mAbs with SC tissue) and physiological events (e.g. nonspecific metabolic degradation at the site of injection or during transit in the lymphatic system). A deeper understanding of these processes may facilitate developing better predictive tools, streamlined development, and cost savings.

Technology & Innovation

Device Development

Improving Health Outcomes Through Digital Devices and Combination Products

  • Current status of connected devices. What impact have they made?
  • Benefits vs the hype of connected devices
  • Challenges and opportunities

4:40 PM - 5:10 PM - Case Studies

Biologics

High Concentration/SC Delivery of Antibodies

Naila El-kechai, Formulation and Drug Product Team Leader, Sanofi

Technology & Innovation

Biopredictive Tools for the Development of Injectable Drug Products

Matthias  Gerhard Wacker, Associate Professor, National University of Singapore

Today, biopredictive performance assays play a key role in the development of peroral drug products. They enable the early prediction of the bioavailability of drugs in animals or humans. Most injectables are developed for smaller patient populations and require a technologically more advanced formulation design. In this area, biopredictive tools are at the infant stage and only few methods are applicable these advanced therapeutics. With more biopharmaceuticals entering the global healthcare market, a growing number of niche busters are developed for the intravenous or subcutaneous route of administration. The talk will showcase recent advances in the development of biopredictive performance assays for intravenous nanomedicines and subcutaneous depot formulations. Current challenges and knowledge gaps will be highlighted.

Device Development

Combination Products Biologics Delivery

  • Challenges with biologics subcutaneous delivery
  • Can devices move biologics delivery to the patient home
  • Challenges and opportunities

5:15 PM - 6:00 PM - Panel Discussion

Device Development

Improving Patient Experience Through Digital and Combination Products

6:00 PM - 6:05 PM

Chair’s Closing Remarks

6:05 PM - 7:05 PM

Evening Networking Reception

8:00 AM - 9:00 AM

Registration & Refreshments

9:00 AM - 9:05 AM

Chair's Opening Remarks

9:05 AM - 9:50 AM - Panel Discussion

9:55 AM - 10:25 AM - Solution Spotlights

Small Molecules

Session Title TBC (Quotient Sciences)

Biologics

Session Title TBC (BASF)

Technology & Innovation

Session Title TBC (ShinEtsu)

Device Development

Solution Spotlight By TBC

10:25 AM - 11:15 AM

1-2-1 Pre-Scheduled Meetings & Networking Break

11:15 AM - 11:45 AM - Case Studies

Biologics

Device Development

Inhalation Combination Products for Non-Pulmonary Conditions

  • Current status of inhalation combination products
  • Inhalation products UX
  • Future research opportunities

11:50 AM - 12:20 PM - Solution Spotlights

Small Molecules

Session Title TBC (Foster Delivery Science)

Biologics

Session Title TBC (Croda)

Technology & Innovation

Session Title TBC (Schrodinger)

John C. Shelley, Fellow, Schrödinger

Device Development

Session Title TBC

12:25 PM - 12:55 PM - Case Studies

Small Molecules

Bringing QbD Principles to Formulation Development: Insights from a Multivariate Dataset Generated on a High-Throughput Automation Line

Martin Huelsmeyer, Head of HTS Operations & Analytics , AbbVie

Technology & Innovation

Utilising Nano-Carriers to Target the Brain

  • DMPK challenges with brain targeting nanodrugs
  • Crossing the BBB
  • Opportunities in nanodrug development for brain targeting.

Device Development

Challenges and Opportunities in Developing Combination Products and Medical Devices

  • Necessary steps in development
  • Common barriers to combination product development
  • Project and people related issues

12:55 PM - 1:55 PM

Networking Lunch

1:55 PM - 2:25 PM - Solution Spotlights

Small Molecules

Session Title TBC (STA WuXi AppTec)

Biologics

Session Title TBC

Technology & Innovation

Session Title TBC (Lubrizol)

Device Development

Session Title TBC

2:30 PM - 3:15 PM - Panel Discussion

Device Development

Future Outlooks for Medical Devices and Combination Products

  • How far have we come with medical devices, combination products and connected devices?
  • Considerations for improving UX and patient centric design
  • Future outlooks

3:15 PM - 4:05 PM

1-2-1 Pre-Scheduled Meetings & Networking Break

4:05 PM - 4:35 PM - Case Studies

Biologics

Polymers and Peptides  for Stabilization and Targeted Delivery of Nucleic Acids in Vivo

Dr. Manfred Ogris, Professor Department of Pharmaceutical Sciences, University of Vienna

  • Molecular conjugates
  • Gene therapy
  • Virus coating

Technology & Innovation

Using Nanotechnology to Better Target Therapies

  • Biological properties of nanoparticles
  • Use of nanoparticles to cross biological barriers

Device Development

Microneedle Use for Vaccine Delivery

  • Microneedle design and construction
  • Vaccine drying and stabilisation
  • Future outlooks

4:40 PM - 5:10 PM - Keynote

Technology & Innovation

Accelerating Drug Development

  • Obstacles to proof-of-concept between discovery and development
  • Gaps in pre-formulation, formulation, drug delivery as well as CMC regulatory strategies
  • Rapid human assessment, speed to POC and transition to registrational studies

5:10 PM - 5:15 PM

Chair’s Closing Remarks

5:15 PM - 6:15 PM

Evening Networking Reception

8:30 AM - 9:00 AM

Registration & Refreshments

9:00 AM - 9:05 AM

Chair’s Opening Remarks

9:05 AM - 9:50 AM - Panel Discussion

Technology & Innovation

Reducing the Cost of Developing Medical Devices

  • Blending multiple ideas with streamlined management to innovate more effectively
  • How efficient is current device and combination products R&D
  • Accelerating product design and testing to reduce R+D cost of devices and combination products

9:55 AM - 10:25 AM - Case Studies

Small Molecules

A Photostability Testing Strategy for High Throughput Formulation Screenings

Paulina Luisa Fischer, PhD Student, AbbVie

Biologics

CMC Considerations for Cell Therapy Formulations

  • CAR-T therapies processing best practices
  • Maintaining stability testing standards in tight timeframes

Technology & Innovation

Opportunities for Personalised Immunotherapies Based on mRNA Drugs

  • Current challenges of RNA degradation
  • RNA therapy stabilisation and delivery

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

10:30 AM - 11:00 AM - Solution Spotlights

Small Molecules

Solution Spotlight by BENEO

Biologics

Session Title TBC

Technology & Innovation

Solution Spotlight by DFE Pharma

Device Development

Session Title TBC

11:00 AM - 11:50 AM

1-2-1 Pre-Scheduled Meetings & Networking Break

11:50 AM - 12:20 PM - Case Studies

Biologics

Making QbD a Regular Step in Biologics Production

  • Current QbD guidelines and best practices
  • Control strategies for QbD
  • QbD methodology

Technology & Innovation

CNS Drug Delivery and Barrier Modelling

  • Overview of modelling brain barriers methods
  • Understanding brain endothelium
  • Overcoming brain barrier

Device Development

Wearable Insulin Delivery Devices

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

12:25 PM - 12:55 PM - Solution Spotlights

Small Molecules

Session Title TBC (PMC Isochem)

Biologics

Session Title TBC

Technology & Innovation

Session Title TBC

Device Development

Session Title TBC

12:55 PM - 1:55 PM

Networking Lunch

1:55 PM - 2:40 PM - Panel Discussion

Technology & Innovation

Preparing for Patient-Centric Drug Development Regulations

  • What guidelines exist on Patient-Focused Drug Development (PFDD)?
  • Why do we need more patient focussed thinking and design of drug products, medical devices and combination products?
  • How will become more patient focussed shake up the industry and make us more competitive

2:45 PM - 3:15 PM - Case Studies

Small Molecules

Process Optimisation in ASD Formulation

  • Hot Melt Extrusion
  • Spray Drying
  • Excipient selection

Biologics

Tumour Targeting Through Novel CART Cell Therapies

• Challenges and opportunities to finding the right antigens
• Overcoming hostile environments found with tumours

Technology & Innovation

Injectables Formulation for Sustained Release

• Reducing relapse rates
• Physiochemical alteration

Device Development

Development of Inhalers That Guide Patient Technique

  • Current issues with improper use
  • Medication loss
  • Programming smart inhalers to inform patients of medication adherence

3:15 PM - 4:05 PM

1-2-1 Pre-Scheduled Meetings & Networking Break

4:05 PM - 4:35 PM - Case Studies

Small Molecules

Biologics

QbD and Process Scale Up

  • Opportunities for continuous manufacturing of biologics
  • Current regulatory guidelines
  • Formulating drugs with manufacturing in mind

Technology & Innovation

Artificial Intelligence Opportunities and Challenges In Drug Formulation Process Optimisation

  • Improving engineering processes
  • Opportunities for using AI in predictions and modelling

Device Development

Challenges and Opportunities in Combination Product Design, Development and Use (1)

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

4:40 PM - 5:10 PM - Keynote

Technology & Innovation

Future Opportunities for New Modalities

  • Innovation through new modalities
  • Antibody drug conjugates, Nucleic acid delivery, AAV, Cell therapy, Immune targeting Nanomedicine
  • mRNA therapeutics and delivery hurdles
  • Future outlooks

5:10 PM - 5:25 PM

Poster Presentation Award

5:25 PM - 5:30 PM

Chair’s Closing Remarks