Programme 2022

21st – 23rd March 2022, Berlin & Online, 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?

Sebastian Kube, Senior Data Scientist, Boehringer Ingelheim

Sune Andersen, Principal Scientist in Particle Engineering, Janssen

Lorenzo Gentiluomo, Associate Principal Scientist, Lonza

  • Digitalization starts in the labs where the data is produced – better invest in tablets for technicians than invest in the next big AI promise on the horizon?
  • The carrot: Try-out and implement advanced data analytics in very limited but easily overseeable use cases first
  • The stick: Proper data management is key to any digitalization effort!
  • Making the data FAIR creates already a first business value for data-driven drug product development
  • Big application use case for AI in drug product development?
  • Data wrangling: the 80-20 data science dilemma

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

Small Molecules

Optimal Self-Assembly of Liquid Nanoparticles (LNP) in a Ring Micromixer

Mostafa Nakach, Head of formulation and Process Development, Sanofi

Technology & Innovation

Device Development

Impact of the EU MDR on the Risk Management Process for Drug-Device Combination Products

Dr. Fatima Bennai-Sanfourche, Director Medical Device Safety, Medical Device Safety Officer, Bayer

  • Regulatory landscape changes
  • EU MDR requirements on device risk management process
  • Impact of the EU MDR on drug-device risk management process
  • Usability engineering/Human Factors (HF)
  • Benefit -risk assessment of drug-device combination product

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

Small Molecules

Session Title TBC (Adare)

Biologics

Trehalose and Sucrose: Essential components of Platform Biopharma Formulations and Covid 19 Applications

Christian Lotz, General Manager EMEA, Pfanstiehl GmbH

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

  • Mixed micelles from bile acids and phospholipids are currently used as oral formulations for poorly soluble drugs including vitamin K. 
  • PEGylation improves the gastrointestinal colloidal stability and mucus penetration of mixed micelles. 
  • PEGylated mixed micelles interact with Scavenger Receptor B1, imposing a mechanism for intestinal transport that may be used for other poorly soluble drugs. 
  • Animal studies indicate that PEGylated mixed micelles may especially be useful to improve oral bioavailability in patients suffering from cholestasis. 

Biologics

Novel Nanosystems for Oral Delivery of Biologics

Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London

Oral administration is the most convenient and preferred way of taking drugs. However, apart from a few exceptions, oral administration is currently not an option for biologics. The use of absorption enhancers has limitations, including safety issues and its applicability to a narrow range of biologics. Different delivery strategies are therefore urgently needed. Nanomedicine-based approaches have promising potential for oral biologics, though one has to apply a deep understanding of the gastrointestinal tract physiology and barriers in the design of nanosystems for oral delivery of biologics. In this talk, I will summarise the latest findings from my lab on nanomedicine-based approaches, including bovine milk exosomes, and their potential for oral delivery of biologics.

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

Parenteral Drug-Device Combination Products – Data Package, Integrated Control Strategy, and Platform Approach for Successful Submissions

Corinna Sonderegger, Executive Director Competence Center, Global Device & Packaging Development (GDPD), Novartis

Health Authority expectations in USA, Europe, China and around the world have risen strongly. Extensive data requirements and statistics on product robustness and user capability even under worst-case conditions require a change in mindset from the very start of product design, applying thorough scientific and engineering principles, true cross-functional collaboration, an integrated drug-device control strategy, and smart platforming, to enable successful market registrations, competitive products, and reasonable use of resources. Examples will be provided mainly for prefilled syringes with needle-safety systems and autoinjectors, the principles apply across all combination products.

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

Small Molecules

Continuous Manufacturing Cost Reduction and Challenges

  • Designing processes for continuous manufacturing programs
  • What are the main bottlenecks towards implementing continuous manufacturing?
  • How can CM bring costs down?

Biologics

Latest Advances in the Oral Delivery of Biologics

Patrick Garidel, Head of Process, Purification and Pharma Development, Boehringer Ingelheim

Dr. Stefan Bracht, Vice President Head of Drug Delivery Innovation, Bayer

Driton Vllasaliu, Senior Lecturer in Pharmaceutics, King’s College London

  • Current research areas for the oral delivery of biologics, what is most promising
  • New materials and technologies that can enable oral delivery
  • Importance of oral delivery to patients

Technology & Innovation

Latest Trends in CNS Drug Delivery

  • Overview of modelling brain barriers methods
  • Recent developments in CNS drug delivery
  • Overcoming brain barrier

12:55 PM - 1:55 PM

Networking Lunch

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

Small Molecules

Session Title TBC (Hovione)

Biologics

“Lycagel® : Soft Capsule Performance/ Stability vs Gelatin”

Steve Amoussou-Guenou, Global Technical Developer, Roquette

Technology & Innovation

Solution Spotlight by Ashland

Device Development

Session Title TBC

2:30 PM - 3:15 PM - Keynote

Poster presentations

Oxidative Degradation of Polysorbate
Johanna Weber, Martin Luther University Halle

Poloxamer 188 as Stabilizer in Biological Formulations: Present State of Research and Application
Lukas Bollenbach, Martin Luther University Halle

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

Combination products under MDR (article 117)

Heinrich Martens, Vice President Regulatory Affairs - BU Devices Pharmaceuticals and Devices Division, Fresenius Kabi

  • What is a combination product
  • The meaning of Article 117
  • The role and task of the Notified Body
  • Manufacturer responsibilities
  • Evidence and fulfilment of the GSPRs
  • Notified Body opinion

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 - 8:30 AM

Registration & Refreshments

8:30 AM - 9:15 AM - Keynote

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

9:00 AM - 9:05 AM

Chair's Opening Remarks

9:20 AM - 9:50 AM - Case Studies

Small Molecules

Process Optimisation in ASD Formulation

  • Hot melt extrusion
  • Drying techniques
  • Process optimisation best practices

Biologics

QbD Best Practices as part of Biologics Production

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

Technology & Innovation

Best Strategies for Reducing the Cost of 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

Device Development

Opportunities for Ingestible Medical Devices

  • Current status of orally ingestible devices engineering
  • Opportunities and challenges with ingestible devices

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

Small Molecules

Session Title TBC (Quotient Sciences)

Biologics

Session Title TBC (BASF)

Technology & Innovation

Continuous Manufacturing: Rheological Powder Characterisation of Excipients to Understand Their Behaving During the Feeding Step

Vanessa Havenith, Technical Sales Manager, SE Tylose GmbH & Co. KG

  • Powder rheology analysis of excipients with FT4
  • Influence of moisture on excipients flow behaviour
  • Correlation with feeding trials
  • L-HPC a multi-functional excipient: case study (twin screw wet granulation)

Device Development

Dissolvable Microneedles – From Product Development to Commercial Manufacturing

Dr. Sebastian Braun, Head of Formulation Development 1 and Head of Manufacturing MAP, LTS Lohmann Therapie-Systeme AG

For the past decade, innovation in microneedles has been a focus within the pharmaceutical world. Today, microneedles are seen as a viable option for the delivery of drugs such as biologicals, vaccines and difficult-to-deliver small molecules through the skin, in both immediate-release and long-acting products. The widely recognized benefits of transdermal administration in terms of pain-free delivery, convenience and patient compliance, make microneedles an ideal platform for an increasing number of therapeutic areas.

In the first half of the presentation, you will get an insight into the options of transdermal applications. A brief comparison of a variety of transdermal application including injection systems will provide a better understanding of problems faced while using such system. In the second half of the presentation, we will take a deep look into the field of microneedle systems. In addition to current designs and compositions we will look into the development, manufacturing and analytical testing of microneedle system. The final topic will be the commercial manufacturing of microneedle systems. What are the challenges for CDMOs and how to develop suitable manufacturing equipment in a still shifting microneedle technology environment?

This will give you the complete picture from product development to commercial manufacturing.

10:25 AM - 11:15 AM

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

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

Biologics

Technology & Innovation

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

Technology & Innovation

Session Title TBC (Foster Delivery Science)

Biologics

Understanding Biopharmaceutical Detergents

James Humphrey, Research & Technology Specialist, Croda

  • The role of detergents in biopharmaceutical formulations
  • Discussing the stability of detergents in biopharmaceutical formulations
  • Exploring formulation effects on detergents

Small Molecules

Molecular Modelling to Support Drug Formulation for Small Molecule and Biologic Drugs

John C. Shelley, Fellow, Schrödinger

Show more

Device Development

Session Title TBC

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

Biologics

Thermokinetic Modelling of Biologics as a Tool for Accelerating Development

Martin Huelsmeyer, Head of Science Affairs & Strategic Initiatives, NBE Formulation Sciences, Senior Principal Research Scientist, AbbVie

Stability studies are an integral part of all development activities. Usually, stability must be assessed at the recommended storage temperature, what is typically 2-8°C for biologics. To securely claim a shelf life of two years the stability needs to be observed over long periods of time, what is often challenging due to increasingly aggressive project timelines. In addition, if CQAs run out of specification this often becomes clear at late stages of a stability study, exacerbating the situation even more as time for new studies is lacking.

Thermokinetic modeling is providing a solution for this dilemma. With an appropriate short-term stability study of only 12 weeks the stability behavior of a given product can be reliably predicted. A case study using a standard mAb confirms that such thermokinetic models accurately describe the stability behavior for the entire shelf-life of the product using historic QC data for comparison.

In addition, thermokinetics can be used to model stability in time-consuming temperature excursion experiments, deliver estimates for hold-times during manufacturing or compare degradation in different packaging containers. Thermokinetic modelling is a versatile and reliable tool for early knowledge of stability outcomes, boosts the probability of project success and is therefore routinely used in development.

Small Molecules

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

An End-to-End Pharmaceutical Development Pathway to Rapidly Bring Poorly Soluble New Chemical Entities to the Market

Jinling Chen, SVP, Pharmaceutical Development Services, STA Pharmaceutical

  • Pharmaceutical development pathway integrating patient needs, development considerations and physico-chemical/biopharmaceutical compound profile
  • Integrated CMC platform from developability assessment, formulation design and process optimization leading to a robust commercial dosage form
  • Case studies showcasing how an integrated CMC platform can accelerate timelines

Biologics

Session Title TBC (Celanese)

Technology & Innovation

Session Title TBC (Lubrizol)

Device Development

Session Title TBC

2:30 PM - 3:15 PM - Case Studies

Small Molecules

Printing of Non-Printable: 3D Printing of Pharmaceutical Oral Solid Dosage Forms by a Fused Deposition Method

Valentyn Mohylyuk, Pharmaceutical Scientist (research fellow), Queen's University Belfast

Show more

Biologics

Modelling Rheology of Highly Concentrated Proteins

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

Technology & Innovation

Gene Therapy Development and Delivery, Present and Future

  • The current state of gene therapies
  • Overcoming common challenges in developing gene therapies
  • Challenges and opportunities

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

Handling and Stabilisation of Viral Products

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

Formulation & Device Lifecycle Management for Biotherapeutics - The Value of Platform Technologies

Beate Bittner, Senior Portfolio Strategy Director, Roche

  • Abstract TBC

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

CMC Considerations for Cell Therapy Formulations

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

Biologics

A Photostability Testing Strategy for High Throughput Formulation Screenings

Paulina Luisa Fischer, PhD Student, AbbVie

Technology & Innovation

Opportunities for Personalised Immunotherapies Based on mRNA Drugs

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

Device Development

Overcoming Common Challenges in Software Medical Devices

  • Discussing everything from new device business case to post-launch considerations, how can you best set yourself up for success?
  • What are the common challenges on the journey to market? How to approach and overcome them?
  • Building and implementing a strategic plan from the start to eliminate uncertainty at different stages

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

Small Molecules

galenIQ™ for Continuous Manufacturing

Michael Black, Head of Sales Pharma, Beneo

Biologics

Session Title TBC (Precision Nanosystems)

Technology & Innovation

A Transition from Batch to Continuous Mixing

Pauline Janssen, Product Application Specialist, DFE Pharma

Show more

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

Technology & Innovation

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

Particle Size Control Through Micronization: Challenges and Solutions

Salvatore Mercuri, Associate Director, NPI & MSAT, Monteggio, Lonza

Micronization is an important technique in drug formulation, but not all substances are simple to process.
This presentation will give an insight into how micronization processes can be developed for challenging inhalation materials.
What technical issues need to be addressed if an API is to be successfully micronized?
A robust process development strategy will be presented that ensures all attributes critical for quality are maintained, even for the most challenging.
A case study on the micronization of a highly potent inhalation API with a tendency to undergo surface amorphization will also be presented.
Key findings, including solid-state characterization and post-micronization conditioning, will be disclosed

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

Device Development

Signal Management Devices Life Cycle Management

  • The need for better signal detection, new EU regulations
  • Post-market surveillance and feeding back to device engineers
  • Challenges

Small Molecules

Pushing Small Molecules Development Further

  • What are the areas where small molecules can still be innovative when so much focus is on biotech?
  • New modalities and drugging the traditionally undruggable
  • How can technology push small molecules innovation?

Biologics

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

  • Current status of biosimilar development, regulations updates
  • Can biosimilars be used the same way as generics
  • Switching patients from originator to biosimilar

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

Small Molecules

Session Title TBC (Improving Oral Bioavailability)

Anette Müllertz, Professor, Head of Center, University of Copenhagen

  • Abstract TBC

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