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  • Day 1
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  • Day 3
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  • Biologics - Innovation in Drug Delivery
  • Biologics - Optimising Drug Formulations
  • Small Molecules
  • Technology & Innovation

 

Day 1
Registration & Light Refreshments

08:20-08:30
Chair’s Opening Remarks

08:30-09:10
Keynote
In What Direction is the Drug Delivery Technology Space Moving?
  • Evaluating how fast the delivery technology field has evolved until now – are there limiting factors to its continued development?
  • What is the potential of less-traditional delivery routes such as nasal and ocular delivery?
  • Discussing the future of evolving areas including polymer technologies, auto injectors, microneedles etc.
  • Looking retrospectively, has the industry done all it can until now to maintain the R&D paradigm?

Anand Subromony
Vice President Drug Delivery & Device Development
MedImmune

09:10-09:15

Please move to your next session

09:15-09:50
Case Study
Small Molecules
Biopharmaceutics as Catalyst for Quality by Design
  1. Definition of Biopharmaceutics & relationship with QbD.
  2. Biopharmaceutical tools (Classifications, IVIVC / IVIVR, PBPK modelling).
  3. Overall impact of Biopharmaceutics:
    • CQAs understanding.
    • Prediction in anticipation of clinical studies.
    • Clinically Relevant Control.
    • Virtual evaluation of Life Cycle Management scenarios.
  4. Case studies / examples of applications

Jérôme Mantanus
Head of Formulation and Process Characterization
UCB Pharma

Case Study
Biologics – Optimising Drug Formulations
Fixed Dose mAb Combinations: A recent case study highlighting CMC development challenges and strategies
  • A recent surge in clinical trials using more than a single mAb has brought interest to CMC strategies to make patient administration less burdensome
  • Co-administration and co-formulation of multiple mAbs is now a hot topic for CMC development
  • Developing fixed dose combinations is not straightforward and requires balancing multiple factors
  • Analytical control strategies require significant more effort to resolve product quality attributes

Tarik Khan
Group Leader / Scientist
Roche

Case Study
Technology & Innovation
Manufacturing the Future: a strategic approach to Product and Process development by Continuous Manufacturing
  • J&J deployment strategy in continuous manufacturing
  • CM in development – strategic approach
  • Minimization of API consumption
  • Case study of a J&J compound in development

Giustino Di Pretoro
Associate Director
Johnson & Johnson

09:50-10:45
iSolve Meetings, Meet the Speakers & Refreshment Break
 iSolve-Logo-resized
10:45-10:50
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10:50-11:25
Case Study
Small Molecules
Microenvironmental pH Modulation – An Effective Tool in Enhancing
• Pros and cons of using high-energy solids (salts, co-crystals, or amorphous solid dispersions) to generate supersaturation and enhance drug bioavailability
• Dissolution from solid and diffusion layer model
• Microenvironmental pH modulation to control dissolution behaviour of solid dosage forms
• Case study in enhancing oral absorption of the salt of a weakly acidic BCS Class II compound

Helen Hao Hou
Scientist
Genentech

Case Study
Biologics – Optimising Drug Formulations
A Thermodynamic Approach to Explore Excipient Mixtures and Novel Excipients in High Concentration Protein Formulations
    • How to identify synergic effects in excipient selection?
    • Do we need novel excipients or can we determine the “sweet spot” for formulation development using classical excipients?
    • How many experimental data-points do we need?
    • How far can modelling approaches guide us?
    • Why consider thermodynamics in formulation development

Those results will be presented and discussed.

Dr. Christoph Brandenbusch
Group Leader
TU Dortmund

Case Study
Technology & Innovation
Continuous Granulation at UCB Pharma – A Case Study
11:25-11:30
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11:30-12:05
Technology Spotlight
Small Molecules

Technology Spotlight
Technology & Innovation
Technology Spotlight
Technology & Innovation
12:05-12:10
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12:10-12:45
Case Study
Small Molecules
The unmet need of biodegradable parenteral controlled release DDS: concept, performance and perspectives
  • Parenteral CR is dominated by PLA and PLGA based DDS
  • Many clinically used DDS have undesired release profiles (very high burst release or lag times, complex release profiles)
  • Problems are associated with high acidity of PLA / PLGA monomers
  • Alternatives are needed to increase selection portfolio
  • Promising alternatives will be presented (lipid and polymer based)

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

Case Study
Biologics – Optimising Drug Formulations
Protein aggregation in multidose parenteral formulations: challenges during formulation development
    • Overview: Root causes for protein aggregation
    • Challenges in formulation development of multidose formulations
    • Primary packaging components and impact on protein aggregation
    • Case studies

Dr. Kathrin Spielberger
Senior Scientist
Product & Process Development Sanofi

Case Study
Technology & Innovation
Molecular Dynamics Simulations of Amorphous Systems

• MD simulations reveal molecular interactions that may facilitate interpretation of experimental data
• Energy calculations enable estimates of amorphous miscibility
• Water uptake and the influence of water on drug-excipient interactions can be explored
• Water clustering leads to domains having enhanced mobility

12:45-13:40
Networking Lunch
Lunch
13:40-13:45
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13:45-14:20
Case Study
Small Molecules
Differentiating Itraconazole Formulations Based on the Flux through Artificial Lipophilic Membrane

• Different itraconazole formulations were evaluated using a miniaturized dissolution-permeation apparatus
• Flux values obtained correlated well with published in-vivo data in rodentsFor the solid dispersions, a decrease in flux was observed over time
• The latter observation could be explained by crystallization, as supported by DSC and XRPD results

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

Case Study
Biologics – Optimising Drug Formulations
Protein-based nanoparticles for drug delivery purposes
Topical delivery of therapeutic proteins
– Polyglycerol-based nanocarriers
– Stimuli-triggered drug release
– New approaches for severe genetic skin diseases

Sarah Hedtrich
Assistant Professor for Pharmacology
Freie Universität Berlin

Case Study
Technology & Innovation
Solvent-induced phase separation in amorphous solid dispersions

amorphous solid dispersions
amorphous-amorphous phase separation
solvent selection for ASD preparation
thermodynamic phase behavior

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

14:20-14:25
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14:25-15:00
Technology Spotlight
Small Molecules
Technology Spotlight
Technology & Innovation

Technology Spotlight
Small Molecules
15:00-15:05
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15:05-15:40
Case Study
Small Molecules
Left to Our Own Devices: Design Control and Risk Management Strategies for Combination Products.
Case Study
Biologics – Optimising Drug Formulations
Introduction on “Next Generation Biologics”

CAR T cells
– CRISPR-CAS9
– Gene Therapy
– ATMPs

Carsten Olbrich
Quality Product Steward Bayer AG
Pharmaceuticals

Case Study
Technology & Innovation
Enhancing Open Innovation to Promote Sustainable Development
  • Encourage outside thinking by breaking down silos to create brainstorming teams
  • Implementing a transparent attitude to the development arena
  • What path is the development industry expected to move in?
  • Adapting to the evolving development and drug targeting space by sourcing distinctive technologies
  • Enhancing creativity in the development space
  • Allocating total product knowledge to promote successful, shared development
  • Allotting external innovation from non-pharma industries

Robert Meyer
PhD Director Pharmaceutical Commercialization
MSD

15:40-16:40
iSolve Meetings, Meet the Speakers & Refreshment Break
iSolve-Logo-resized
16:40-17:15
Case Study
Small Molecules
An Inter-Company Perspective on Biopharmaceutical Drug Product Robustness Studies
DP robustness studies are essential in developing a commercial product that:
• is not on the edge of stability failure
• meets quality standards when formulation and process parameters are within allowed ranges.Through the use of DOE, relationships between formulation attributes and manufacturing process parameters are established, ensuring DP production consistently meets CQAs.
BPOG survey and manuscript reviews and discusses the current industry status with regard to the scope, design and execution of biopharmaceutical DP robustness studies.
Common themes and alignment opportunities were identified with regard to the use of DP robustness studies.
Recommendations for best practices and harmonization are integrated in the case studies.

Anette Mullertz
Professor, Department of Pharmacy, Faculty of Health and Medical Sciences
University of Copenhagen

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

Formulation and Process development of ADC Drug Products -A Case Study
• Importance of non-invasive routes of administration for peptides
• Focus on oral peptide delivery: marketed products and expectations from the market
• Main challenges for oral peptide delivery: stability and permeability through the intestinal epithelium
• Key formulation components in oral peptide technologies progressed in the clinic
• Lessons learnt from oral peptide clinical studies
• Anticipating challenges to switch from injection to the oral route
• Innovative approaches to address the remaining hurdle of low oral peptide absorption

Joel Richard
SVP CMC Development

Ipsen

Case Study
Technology & Innovation
Oral delivery of hydrophobic drugs using mixed micelles/strong>

• Hydrophobic drugs having low bioavailability can be formulated in bile-salt containing mixed micelles
• Those mixed micelles can be stabilized in gastric conditions by a few different ways, including PEGylation
• PEGylated mixed micelles show good mucus penetration and transport through endothelial cells
• PEGylated mixed micelles are designed to provide proper bioavailability even under cholestatic conditions

Cornelus F. van Nostrum
Associate professor
Utrecht University

17:15-17:50
Case Study
Small Molecules
A Two-Phase Dissolution-Partition Test for Characterization of BCS II/IV Drugs and Formulations
  • Characterize the aqueous super-saturation resulting from dissolution of amorphous solid dispersions
  • Use the aqueous media with pH alteration for ionic drugs
  • Assess the interplay among three kinetic processes: dissolution, precipitation and partition
  • Facilitate evaluation of key formulation variables and functional excipients
  • Demonstrate IVIVC for several BCS II and IV products
Case Study
Biologics – Innovation in Drug Delivery
Session Title TBC

• General overview on technologies that enable controlled targeted drug delivery and drug release at the site of action.
• The role of HER2 in cancer therapy and targeted drug delivery.
• Linking controlled release technologies to antibody-directed systems.
• Presentation of two case studies about controlled targeted drug delivery.
• Comparison, challenges and outlook on targeted drug delivery technologies.

Case Study
Technology & Innovation
Microneedles: From Basic Research to a Drug Product

Minimally invasive delivery holds advantages over similar invasive delivery techniques. To that end, ease of application and reducing phobia of needle delivery can improve compliance and health worldwide.

  • As we see a global shift towards mid-size and larger modalities, New drug delivery technologies provide benefits which justify a need To invest and develop these technologies
  • Cold-chain burden needs To be intelligently addressed in the ever increasing energy demands that future holds.
  • The bottlenecks facing the microneedle technology development need To be understood and addressed smartly

Yash Kapoor
Associate Principal Scientist
MSD

17:50-17:55
Please Move To Your Next Session

17:55-18:30
Keynote
Technology & Innovation

Combination treatment of multidrug resistant tumors with stimuli-sensitive nanocarriers co-loaded with siRNA and drugs
18:30-18:35
Chairman Closing Remarks
18:40-20:00
Evening Reception

Day 2
The full agenda on this day will be released soon

Day 3
The full agenda on this day will be released soon