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

08:30 - 09:10 - Keynote

Small Molecules

Transforming the Small Molecule to Medicine Product Design Process?

Brian Henry , Vice President, Drug Product Design, Pfizer

09:15 - 09:50 - Case studies

Small Molecules

Solvent-Induced Phase Separation in Amorphous Solid Dispersions

Gabriele Sadowski , Faculty Head, Univ. of Dortmund

Biologics

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

Tarik Khan, Group Leader / Scientist, Roche

Technology & Innovation

Control Strategies in Continuous Manufacturing at Novartis - Case Studies

Markus Krumme, Head of Continuous Manufacturing, Novartis

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

Combination Treatment of Multidrug Resistant Tumours with Stimuli-Sensitive Nanocarriers Co-Loaded with siRNA and Drugs

Biologics

Biopharmaceutics as Catalyst for Quality by Design

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

Facilitating meaningful differentiation of products by establishing a culture of innovation

Dr. Stefan Holzner, Senior Director Device Development, Shire

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 Adare Pharmaceuticals

Biologics

Technology Spotlight with Pfanstiehl

Technology & Innovation

Technology Spotlight with Losan Pharma

Device Development

Technology Spotlight with Datwyler

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

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, Abbvie

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

Tech Spotlight with Enable Injections

Mike Hooven, President and CEO, Enable Injections, Inc.

15:05 - 16:00

Meetings

iSolve & Networking Refreshments

16:05 - 16:35 - 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

Biopharmaceutics Risk Assessment During Formulation and Clinical Development

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

Technology & Innovation

Novel Developments in the Formulation of Amorphous Solid Dispersions

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

Device Development

Risk Management and Formative Human Factor

Muriel Didier, Human Factors Team Head, Novartis

16:40 - 17:15 - case studies

Small Molecules

Absorption Modelling in Regulatory Context – from IVIVC to PBPK

Bertil Abrahamsson, Senior Principal Scientist, Astrazeneca

Biologics

Protein-based nanoparticles for drug delivery purposes

Juan M. Irache, Professor, University of Navarra

Technology & Innovation

Manufacturing Innovation – Bringing New Technologies from the Lab to the Shop Floor

Robert Meyer, Principal Scientist, Innovation and New Technology Development , MSD

Device Development

Bridging Between Device Types during Clinical Development

Chris Muenzer, Senior Device Engineer, Roche Switzerland

17:15 - 17:50 - keynote

Technology & Innovation

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

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

Next Day Book Now
08:05 - 08:35

Registration & Refreshments

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

08:40 - 09:15 - Keynote

Technology & Innovation

In What Direction is the Drug Delivery Technology Space Moving?

Anand Subromony, Vice President New Product Technologies, MedImmune

09:20 - 09:50 - Case studies

Small Molecules

Leveraging prediction tools to accelerate product development

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

Biologics

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

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

Technology & Innovation

Fill and Finish processing of Biotech products

Jean-René Authelin , Global director of Pharmaceutical Engineering, Sanofi

Device Development

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

09:50 - 10:50

iSolve & Break

10:50 - 11:25 - Case studies

Small Molecules

Strategies for developing value-added complex injectable generics

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

Biologics

Formulation Design of Amaller 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

Professor Duncan Craig , Director Pharmaceutics, UCL

Device Development

Trends and challenges in inhaled drug delivery transforming respiratory drug portfolios

Gunilla Petersson, Science & Innovation Director, Astrazeneca Sweden

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

Tissue Specific Delivery Using Caveolae Technology Improves Drug Efficacy

Ruchi Gupta, Scientist I, MedImmune

12:45 - 13:45

Networking Lunch

13:45 - 14:20 - case studies

Small Molecules

Early “Developability” Assessment, Key to Success in Development Phases

Philippe Lienard , CMC Discovery Coordinator, Sanofi

Biologics

Mucoadhesive polymers: product developments and future trends

Andreas Bernkop-Schnürch, Prof. Institute of Pharmacy University of Innsbruck

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

Tech Spotlight Revox Sterilization Solutions

Technology & Innovation

Technology Spotlight with Capsugel

Device Development

TBC

15:00 - 15:50

Break

15:50 - 16:25 - case studies

Small Molecules

User Friendly Medicines

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

Technology & Innovation

Panel Discussion: How big data and artificial intelligence can revolutionize pharmaceutical R&D

Panel Chair:

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

Panel Chair:

Brian Henry, Vice President, Drug Product Design, Pfizer

Sven Schreder, Vice President, Boehringer Ingelheim (Invited)

Anand Subramony, Vice President New Product Technologies, MedImmune (invited)

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

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

Registration & Refreshments

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

08:30 - 09:05 - Keynote

Technology & Innovation

Smart Drug Delivery Systems: Going Inside Cells and to Individual Organelles

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

09:10 - 09:45 - Case studies

Small Molecules

Challenges and Opportunities of Developing Paediatric Drug Formulations

Terry Ernest, Product Development Team Leader, GSK (Invited)

Biologics

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

Stephen Buckley, Head of Department Absorption and Biological MS, Novo Nordisk

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

09:50 - 10:25 - Technology Spotlights

Small Molecules

Technology Spotlight with Quotient Clinical

Biologics

Tech Spotlight TBC

Technology & Innovation

Tech Spotlight with Merck KGaA

A Closer Look Into Hot Melt Extrusion Formulations: Impact on the Molecular Level

Dr. Finn Bauer, Head of Solid Formulations R&D, Merck KGaA

10:25 - 10:45

Break

10:45 - 11:20 - 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

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

11:20 - 11:55 - Case studies

Small Molecules

Suspendilicious: unveiling the marvels of lipid suspensions

Kristof Kimpe, Principal Scientist, Janssen Pharmaceutica (a division of Johnson & Johnson)

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

11:55 - 12:30 - Technology Spotlights

Small Molecules

Technology Spotlight with Roquette

Biologics

TBC

Technology & Innovation

Technology Spotlight with Foster Delivery Science

12:30 - 13:40

Networking Lunch

13:40 - 14:15 - Case studies

Small Molecules

Biologics

Bioinspired drug delivery systems

Lorenz Meinel, Director and Chair, University of Würzburg

Technology & Innovation

Cryopreservation of ex vivo Cell and Gene Therapies

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

14:15 - 14:50 - case studies

Small Molecules

Challenges and Opportunities of Developing Pediatric Drug Formulations

Biologics

Scalable Manufacturing of the Next Generation of Liposomal Vaccines

Yvonne Perrie , Prof in Drug Deliver, University of Strathclyde

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

14:55 - 15:35

Keynote

Applying biopharmaceutics in global public health – Deworming children more safely

Christophe Tistaert , Senior Scientist, Janssen Belgium

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