Program 2018

12th March – 14th March, Berlin

07:30 - 08:20

Registration & Refreshments

Register, get yourself some refreshments and say hello to your fellow attendees

08:20 - 08:30

Chair’s Opening Remarks

Chair's Opening Remarks Olaf Queckenberg Head of Global Chemical & Pharmaceutical Development Bayer AG Germany

08:30 - 09:10 - Keynote

Small Molecules

In What Direction is the Drug Delivery Technology Space Moving?

Anand Subromony, Vice President Drug Delivery & Device Development, MedImmune

09:15 - 09:50 - Case studies

Small Molecules

Biopharmaceutics Risk Assessment During Formulation and Clinical Development

Filippos Kesisoglou, Senior Principal, Scientist,Biopharmaceutics, Pharmaceutical Sciences and Clinical Supply MSD

Biologics

Fixed Dose mAb Combinations: A recent case study highlighting CMC development challenges and strategies

Tarik Khan, Group Leader / Scientist, Roche

Technology & Innovation

Manufacturing the Future: a strategic approach to Product and Process development by Continuous Manufacturing

Giustino Di Pretoro, Associate Director, Johnson & Johnson

Device Development

Global Regulatory Strategies for Combination Product Registration and Change Management

Martin McLoughlin , Head of Device Development, Bristol-Myers Squibb

09:50 - 10:25 - Case studies

Small Molecules

Biopharmaceutics as Catalyst for Quality by Design

Jérôme Mantanus, Head of Formulation and Process Characterization, UCB Pharma

Biologics

End of the platform formulation era? Limitations and ways out

Ahmed Basheer , Principal Scientist, Novartis

Technology & Innovation

Manufacturing the Future: a strategic approach to Product and Process development by Continuous Manufacturing

Giustino Di Pretoro, Associate Director, Johnson & Johnson

Device Development

Left to Our Own Devices: Design Control and Risk Management Strategies for Combination Products

Richard Wedge, Director Design Control Implementation, Pfizer

10:25 - 11:25

iSolve & Break

11:30 - 12:05 - Case studies

Small Molecules

Microenvironmental pH Modulation – An Effective Tool in Enhancing Dissolution and Oral Absorption of Solid Dosage Forms

Helen Hao Hou, Scientist, Genentech

Biologics

A Thermodynamic Approach to Explore Excipient Mixtures and Novel Excipients in High Concentration Protein Formulations

Dr. Christoph Brandenbusch, Group Leader, TU Dortmund

Technology & Innovation

Device Development

The continually evolving Biologics field and the inherent effect on drug delivery device design - a strategic approach to designing platform devices for operational efficiency

Brian Holt, Principal Engineer, Operations Site Head, Device & Final Drug Product Technologies, Amgen

12:10 - 12:45 - technology spotlights

Small Molecules

Technology Spotlight with REVOX Sterilization Solutions

Biologics

Technology Spotlight with Pfanstiehl

Technology & Innovation

Technology Spotlight with Losan Pharma

Device Development

TBC

12:45 - 13:45

Networking Lunch

13:45 - 14:20 - case studies

Small Molecules

Differentiating Itraconazole Formulations Based on the Flux through Artificial Lipophilic Membrane

Bernard Van Eerdenbrugh, Fellow, Chemical and Pharmaceutical Profiling, Novartis Pharma AG

Biologics

Protein aggregation in multidose parenteral formulations: challenges during formulation development

Dr. Kathrin Spielberger, Senior Scientist, Product & Process Development Sanofi

Technology & Innovation

Solvent-induced phase separation in amorphous solid dispersions

Prof. Gabriele Sadowski, Professor Thermodynamics, Department of Biochemical and Chemical Engineering, TU Dortmund

Device Development

Who moved my Device?” – a talk on working within the changing regulatory landscape around combination and medical devices.

Bjørg Kaae Hunter, Device Engineering Manager, GlaxoSmithKline

14:25 - 15:00 - Technology Spotlights

Small Molecules

Technology Spotlight with Grace

Biologics

Technology Spotlight with Unchained Labs

Technology & Innovation

Technology Spotlight with LTS Lohman

Device Development

TBC

15:05 - 15:40 - case studies

Small Molecules

The unmet need of biodegradable parenteral controlled release DDS: concept, performance and perspectives

Karsten Mäder, Professor of Pharmaceutics, Martin-Luther-University Halle Wittenberg

Biologics

Combining the best of two worlds: Using High Throughput physico-chemical testing & biorelevance assays in biotherapeutics development

Sabine Eichling, Senior Scientist II, NBE High-Throughput and Advanced Formulation Sciences

Technology & Innovation

Molecular Dynamics Simulations of Amorphous Systems

Prof. Thomas Rades, Chair Pharmaceutical Sciences, Univ of Copenhagen

Device Development

Risk Management and Formative Human Factor

Muriel Didier, Human Factors Team Head, Novartis

15:40 - 16:40

iSolve & Break

16:40 - 17:15 - case studies

Small Molecules

Enhancing Open Innovation to Promote Sustainable Development

Robert Meyer, PhD Director Pharmaceutical Commercialization, MSD

Biologics

Protein-based nanoparticles for drug delivery purposes

Juan M. Irache, Professor, University of Navarra

Technology & Innovation

An Inter-Company Perspective on Biopharmaceutical Drug Product Robustness Studies

Aniket Badkar, ‎Associate Director, Biologics Product Development, Allergan

Device Development

Navigating Global Combination Product Regulations

17:15 - 17:50 - keynote

Small Molecules

Technical integration of device systems and associated business process to accelerate innovation

Vice President, Drug Delivery Innovation, Drug Delivery and Device R&D, Operations Site Head, Eli Lilly and Company

17:50 - 18:00

Chair’s Closing Remarks

Olaf Queckenberg Head of Global Chemical & Pharmaceutical Development Bayer AG Germany

Next Day Book Now
08:30 - 08:35

Registration & Refreshments

Register, get yourself some refreshments and say hello to your fellow attendees

08:35 - 08:40

Chair’s Opening Remarks

Chair's Opening Remarks Olaf Queckenberg Head of Global Chemical & Pharmaceutical Development Bayer AG Germany

08:40 - 09:15 - Keynote

Small Molecules

Utilizing Novel Technology to Accelerate Drug Development, Save Money and Improve the Efficiency of Drug Delivery and Formulation

Olaf Queckenberg, Head of Global Chemical & Pharmaceutical Development, Bayer AG Germany

09:15 - 09:50 - Case studies

Small Molecules

Leveraging prediction tools to accelerate product development

Jatin Patel, Head - Oral Product Design & Development, Bristol-Myers Squibb

Biologics

Foundational research on subcutaneous injection physiology to improve biologics delivery systems and patient experience

Justin M Wright, PhD Vice President, Drug Delivery Innovation Drug Delivery and Device R&D, Eli Lilly and Company

Technology & Innovation

Optimizing Parenteral Delivery of Novel Class of Anticancer Drug Conjugates

Justin M Wright, PhD Vice President, Drug Delivery Innovation Drug Delivery and Device R&D, Eli Lilly and Company

Device Development

Strategies for developing value-added complex injectable generics

Surendera Tyagi, Head, Innovation & Development Center, US Fresenius Kabi USA

09:50 - 10:50

iSolve & Break

10:50 - 11:25 - Case studies

Small Molecules

Quantitative Biopharmaceutics: Use of Modeling and Simulation to Inform API and Formulation Decisions

Filippos Kesisoglou, Senior Principal Scientist, Biopharmaceutics, Pharmaceutical Sciences and Clinical Supply MSD

Biologics

Formulation Design of smaller proteins and insulin for multiple injection dosing and/or infusion

Svend Ludvigsen, Senior Scientific Director, Novo Nordisk A/S

Technology & Innovation

Integration of solid form selection and biopharmaceutical risk assessment into drug product design in the early phase development

Device Development

Digital Health Combination Products: What’s Next?

11:30 - 12:05 - Technology Spotlights

Small Molecules

Technology Spotlight with Hovione

Biologics

Technology Spotlight with Albumedix

Technology & Innovation

Technology Spotlight with DFE Pharma

Device Development

TBC

12:10 - 12:45 - Case studies

Small Molecules

Oral delivery of hydrophobic drugs using mixed micelles

Rene Van Nostrum, Associate Professor, Utrecht University Netherlands

Biologics

Oral Peptide Technologies Progressing in the Clinic: Addressing Challenges to Bring New Products to the Market

Joel Richard, SVP, Operations Site Head, Peptides Ipsen

Technology & Innovation

The next Wave of Innovation in the Parenteral Space - A Stimulus Talk with Voting on Questions

Bernd Riebesehl, Distinguished FellowNovartis, Pharma AG

Device Development

When drug meets device.... new challenges for drug stability and material characterisation of combination products

12:45 - 13:45

Networking Lunch

13:45 - 14:20 - case studies

Small Molecules

A Two-Phase Dissolution-Partition Test for Characterization of BCS II/IV Drugs and Formulations

Biologics

Mucoadhesive polymers: product developments and future trends

Andreas Bernkop-Schnürch, Univ.-Prof. Dr. Institute of Pharmacy

Technology & Innovation

Microneedles: From Basic Research to a Drug Product

Yash Kapoor, Associate Principal Scientist, MSD

Device Development

Implementing human factors engineering and user-centered design: Practical guidance for combination products

14:25 - 15:00 - Technology Spotlights

Small Molecules

Technology Spotlight with Dow

Biologics

TBC

Technology & Innovation

Technology Spotlight with Capsugel

Device Development

TBC

15:00 - 15:50

Break

15:50 - 16:25 - case studies

Small Molecules

Session Abstract TBC

Prof. Clive Wilson, Univ of StrathClyde

Biologics

Thermal Stabilization of Freezing Sensitive Adjuvanted Vaccine Formulations Through Spray Drying

Olivier Brass, Formulation Scientist, Sanofi Pasteur (Invited)

Technology & Innovation

Novel approaches for efficient topical delivery of small - and biomacromolecules

Sarah Hedtrich, Assistant Professor for Pharmacology, Freie Universität Berlin

Device Development

'Reviewing the newly introduced Rule 21 on the classification of substance-based devices and how this may impact borderline product cases

16:30 - 17:05 - Technology Spotlights

Small Molecules

Technology Spotlight with Patheon

Biologics

TBC

Technology & Innovation

Technology Spotlight with ADM SIO

Device Development

TBC

17:10 - 17:45 - Keynote

Small Molecules

How big data can revolutionize pharmaceutical R&D

17:45 - 17:50

Chair’s Closing Remarks

Olaf Queckenberg Head of Global Chemical & Pharmaceutical Development Bayer AG Germany

Previous Day Next Day Book Now
08:00 - 08:20

Registration & Refreshments

Register, get yourself some refreshments and say hello to your fellow attendees

08:20 - 08:30

Chair’s Opening Remarks

Chair's Opening Remarks Olaf Queckenberg Head of Global Chemical & Pharmaceutical Development Bayer AG Germany

08:30 - 09:05 - Keynote

Small Molecules

Combination treatment of multidrug resistant tumors with stimuli-sensitive nanocarriers co-loaded with siRNA and drugs

Vladimir Torchilin, University Distinguished Professor, Director, Center for Pharmaceutical Biotechnology and Nanomedicine Northeastern University

09:10 - 09:45 - Case studies

Small Molecules

Ensuring age-appropriate medicines for children

Hannah Batchelor, Senior Lecturer in Pharmaceutics, Formulation and Drug Delivery Director of Research, School of Pharmacy, University of Birmingham

Biologics

New Approaches to Advance Therapeutic Drug Delivery across the Blood-Brain Barrier to Brain and Brain Tumours TTUHSC

Technology & Innovation

Recent Advances in the Development of Ocular Drug Delivery Systems

Gregoire Schwach, Head of Drug Delivery, Pharmaceutical Development and Supplies Biologics, EU F. Hoffmann-La Roche

Device Development

Generics for Combination Products: It’s Complicated

09:50 - 10:25 - Technology Spotlights

Small Molecules

Technology Spotlight with Quotient Clinical

Biologics

TBC

Technology & Innovation

Technology Spotlight with Merck

Device Development

TBC

10:25 - 10:45

Break

10:45 - 11:15 - Case studies

Small Molecules

Is it crystal clear? Stability and performance prediction for amorphous pharmaceuticals

Biologics

Knowledge-Based Selection Strategies Using the QbD Approach to Ensure Syringe Selection Decisions Meet Technical and Business Requirements

Kenneth Graham, Senior Fellow Scientist, Associate Director, Regeneron

Technology & Innovation

Innovative Ocular Drug Delivery Systems

Dr Thakur Raghu Raj Singh, Senior Lecturer in Pharmaceutics, Queens University Belfast

Device Development

Words Matter: Labeling Challenges Unique to Combination Products

11:15 - 11:50 - Case studies

Small Molecules

Nanoparticle Formulation Development: A Closer look at Pharmaceutical Fabrication Methods

Biologics

General overview on technologies that enable controlled targeted drug delivery and drug release at the site of action.

Daniel Schweizer, DP Project Lead, TD NBE’s, Novartis

Technology & Innovation

Introduction on “Next Generation Biologics”

Carsten Olbrich , Product Quality Steward Eylea and Anetumab Ravstantine, Bayer

Device Development

Post-Market Changes for the Combination Product

11:55 - 12:30 - Technology Spotlights

Small Molecules

Technology Spotlight with Roquette

Biologics

TBC

Technology & Innovation

Technology Spotlight with Foster Delivery Science

Device Development

TBC

12:30 - 13:40

Networking Lunch

13:40 - 14:15 - Case studies

Small Molecules

Advances in Supersaturating Drug Delivery Systems

Biologics

Bioinspired drug delivery systems

Lorenz Meinel, Director and Chair, University of Würzburg

Technology & Innovation

Formulation Development of Car T-Cells - A Case Study

Richard Zajicek, Head of Formulation Development, Cell and Gene Therapy Group GSK (Invited)

Device Development

Specific challenges for combination products for ophthalmic drug delivery

14:15 - 14:50 - case studies

Small Molecules

Challenges and Opportunities of Developing Pediatric Drug Formulations

Biologics

Minipiloting Tool: CFD Modelling of Commercial Scale Thawing Time from Small Scale Bags

Technology & Innovation

Nucleic acid based therapeutics for cancer: targeted delivery systems and in vivo bioimaging

Manfred Ogris, Professor, Division of Clinical Pharmacy and Diagnostics, Vienna University

Device Development

Device Design to drive patient adherence and engagement

14:55 - 15:35

Keynote

15:35 - 15:45

Chair’s Closing Remarks

Chair's Closing Remarks Olaf Queckenberg Head of Global Chemical & Pharmaceutical Development Bayer AG Germany

Previous Day Book Now
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