7:40 AM - 8:40 AM
Registration & Refreshments.
8:40 AM - 8:50 AM
8:50 AM - 9:25 AM - Keynote
Biologics
How Next-Generation Biotherapeutics will Influence Formulation and Device Development
Kerstin Walke, Head of Pharmaceutical Development Biologicals, Boehringer Ingelheim
In the last couple of years the development of Biotherapeutics moved away from standard monoclonal antibodies to more complex formats, which led to the need of miniaturized and high throughput screening systems in the early stage of formulation development. Also the need for predictive tools like in-silico today plays an important role in the formulation development. At the same time the need for patient self-administration got to play a very important role, not necessary limited anymore to a few indication areas. Based on novel constructs the probability for high concentrated formulations might be limited and therefore high volume devices are taking a more important role. Also co-formulations of multiple monoclonal antibodies into a single drug product brings certainly convenience to the patients, however brings also the need for new analytical methods. At the same time it can also be observed a trend to advanced therapy medicinal product (ATMPs), which is a new area and the pharmaceutical development of such compounds is challenge.
9:30 AM - 10:05 AM - Case Studies
Small Molecules
Optimisation of Industrial Freeze Drying Cycle - Two Real Life Examples
Mostafa Nakach, Head of Pharmaceutical Engineering, Sanofi
Biologics
In-Silico Modelling to Support Protein Formulation Development
Patrick Garidel, Associate Director Protein Science, Boehringer Ingelheim
• Challenges with protein therapeutics
• In-silico modelling and molecule design
• Current approaches to support developability
• Some real cases
Technology & Innovation
Parenteral Sustained Release of Peptides – Getting It Right
Simon Bjerregaard, Senior Research Scientist, Ferring
Device Development
Facilitating Meaningful Differentiation of Products by Establishing a Culture of Innovation
Dr. Stefan Holzner, Senior Director, Head of Device Development, Takeda
10:10 AM - 10:45 AM - Case Studies
Small Molecules
Nanoparticle Formulation Development: A Closer look at Pharmaceutical Fabrication Methods
Ben Van Hove, Associate Director Drug Product Development, Oral Solid Dosage Forms, Janssen
Biologics
More Than Just Down-Scaling – Miniaturization of Methods in a High-Throughput Setting Requires Creative Concepts and Holistic Thinking
Technology & Innovation
2D Inkjet Printing for Patient Centric and Translational Drug Delivery
Device Development
Drug Delivery Devices for Innovative Parenterals and Biosimilars: Patient-Centered Technical and Business Opportunities
Corinna Sonderegger, Head Portfolio Management Device Development & Commercialization, Novartis
10:45 AM - 11:45 AM
iSolve & Networking Break
11:45 AM - 12:20 PM - Case Studies
Small Molecules
Polyoxazoline: A Potent Alternative to PEG-based Formulations of Hydrophobic Drugs
Biologics
Mind the Gap - How to Assure Data Integrity in a High-Throughput Formulation Screening for Biotherapeutics
Technology & Innovation
Development of Polymeric Nanoparticles for Intravenous Administration
Dr Rebecca Booth, Senior Scientist, AstraZeneca
Device Development
A Self Anchoring Microneedle Patch (StAMP) Offering Precise and Sustained Transdermal Drug Delivery
Manita Dangol, Senior Research Fellow , University College Dublin
12:25 PM - 1:00 PM - Solution Spotlights
Small Molecules
New Surfactants in Wet Ball Milling and an Innovative Embedding of Nanocrystals into a Granulate Matrix
Dr. Matthias Rischer, Director Drug Delivery & Innovation Projects, Losan
Key words: screening methods, DoE, wet ball milling, nanosuspensions, granulation, dissolution
The Nanocrystal Technology by wet ball milling is getting more and more interest and importance for experts in formulation screening, tox study and clinical trial sample supply for low soluble API´s with a problem in bioavailability. The reason is a fast set-up and scale-up of the manufacturing process, the easy application of the liquid Nanocrystal formulations in such studies and the available down-processing possibilities to come to the final dosage form (capsules, tablets, stickpacks). Losan Pharma has invented in a cooperation a new and fast screening system for nano-milling which has meanwhile reached commercialisation (Zentrimix 380R® from Hettich Labs, Germany). In order to widen the application of the Nanocrystal system new surfactants with improved toxic and hemolytic properties in comparison to the reference sodium dodecyl sulfate (SDS) have been used with a model drug substance to evaluate their potential as stabilisers in the Nanocrystal suspensions. As SDS is very limited in use due to its toxicity especially for tox studies or parenteral applications new surfactants need to be developed to improve this situation. In addition a new down-processing approach is presented to embed the obtained Nanocrystal suspensions via a extrusion like process into a granulate (with the possibility of a continuous granulation) and a comparison has been made to the conventional fluid bed spray drying process which has been implemented before.
Biologics
Trehalose and Sucrose: Essential Components of Platform Biopharma Formulations
Dr. Christian Lotz, General Manager EMEA, Pfanstiehl GMBH
Technology & Innovation
Oral Thin Films – Tailoring Therapy Need
Device Development
Rubber Components Selection for Optimal Drug Packaging
Simon Kervyn, Manager Materials Development, Datwyler
1:00 PM - 2:00 PM
Networking Lunch
2:00 PM - 2:35 PM - Case Studies
Small Molecules
Inhalable Dry Powders for the Improvement of Lung Pharmacokinetics in Preclinical in-vivo Experiments
Alessandro Fioni, DMPK Senior Scientist, Chiesi
The pharmacokinetic profile of NCEs administered by the inhalation route depends on multiple factors, including the physico-chemical properties of the formulation, especially when the NCE is delivered as a powder. In this case, solubility of the compound may influence its bioavailability, efficacy and safety. Compound A reported in this study is a NCE designed for inhalation for the treatment of respiratory diseases. Good in vitro pharmacological and ADME profile supported the progression of the compound to in vivo evaluation. Intratracheal administration to rodents as a blend of crystalline micronized API resulted in a lung half-life longer than 120 hours and limited systemic exposure, suggesting that the lack of reproducibility observed during the in vivo PD tests was mainly due to the low solubility of the powder. In light of these data, two different formulations were investigated in order to increase the solubility of Compound A: 1) conversion of the crystalline API in amorphous powder by a lyophilization process, and 2) formulation of composite particles including Compound A with mannitol and DPPC by spray-drying of a solution. The crystalline micronized material, the amorphous powder and the spray-dried formulation were administered intratracheally to rats using the innovative PreciseInhale system.
The formulation of Compound A with mannitol and DPPC showed shorter lung t1/2 (19 hours), compared to amorphous (t1/2 = 44 hours) and crystalline API (t1/2 > 120 hours). Systemic exposure was comparable between the amorphous-based formulations and 10-fold lower for the crystalline powder. Moreover, a good correlation was found between lung PK parameters (lung t1/2, lung MRT) of the administered powders and their dissolution profile determined in simulated lung fluid.
The results obtained suggested that the spray-dried formulation with DPPC and mannitol represents a useful platform to overcome solubility issues of poorly water-soluble compounds during in vivo PD experiments and it could be extended to other poorly water-soluble molecules, in order to investigate their real efficacy in vivo and avoid discarding promising compounds due to sub-optimal powder characteristics.
Biologics
Long Recombinant Homogeneous Linkers for Dual Protein Conjugations, to Replace Heterogeneous PEG
Thomas Hoeg-Jensen, Scientific Director, Novo Nordisk
Technology & Innovation
DNA-Based Nanoassays for Biomarker Detection in Liquid Biopsy and Therapeutic Drug Monitoring
Loredana Casalis, Head of Nanoinnovation Laboratory, Elettra
Device Development
Predicting the Future: Learning about Challenges with Injectable Formulations to select better Primary Packaging
James K. Mellman, Device Manager, Novartis
2:40 PM - 3:15 PM - Solution Spotlights
Small Molecules
The Perks of a One Stop Shop: From Low Solubility APIs to High Performance Formulations
Mafalda Paiva, Analytical Scientist, Team Leader Physical and Performance Characterization , Hovione
Small Molecules
How do I Quickly Develop First-in-Human (FIH) Dosage Forms and Bridge to Drug Products for Proof-of-Concept (POC)?
Nikki Whitfield, Vice-President, CDMO Services, Quotient Sciences
Small Molecules
Simplifying Tablet Formulation Strategies with Avicel® SMCC and METHOCEL™ DC2
Dr. Carsten Huettermann, Senior Application Scientist, Leader Pharma SAFI Innovation EMEA, DuPont
Device Development
Combination Products – Global Regulatory Landscape
Viky Gilles Daniel Verna, Co-Founder and VP, confinis
3:15 PM - 4:15 PM
iSolve & Networking Break
4:15 PM - 4:50 PM - Case Studies
Small Molecules
Understanding Material Properties for HME Process Optimization in ASD Formulations
Samuel Kyeremateng, NCE Formulation Sciences Senior Scientist, Abbvie
Biologics
Root Cause Investigations for Visible Particles and Aggregation in Drug Containers – Case Studies
Andreas Seidl, Head Global Analytical Characterization & Bioanalytics , Hexal (Novartis)
Technology & Innovation
New Generation of Safer Drug-Eluting Mesh Implants by Electrospinning and 3D Printing
Dr Dimitrios A. Lamprou, Reader in Pharmaceutical Engineering , Queen’s University Belfast
Small Molecules
Solid Lipid Solutions as Formulation Platform for Poorly Soluble Drugs
Ruzica Kolakovic, Senior Scientist, Pharmaceutical Sciences, Drug Product Development , Janssen
4:55 PM - 5:30 PM - Keynote
Biologics
Challenges and Opportunities for the next Generation of Oral Peptide Delivery
Alan S. Harris, Senior VP, Global R&D Life Cycle Management, Ferring
5:30 PM - 5:35 PM
5:35 PM - 6:35 PM
Drinks Reception
8:00 AM - 8:45 AM
Registration & Refreshments
8:45 AM - 8:50 AM
Chair's Opening Remarks
8:50 AM - 9:25 AM - Keynote
Small Molecules
Drug Delivery – Recent Technology Trends and Solutions
Dr. Stefan Bracht, Vice President Head of Disruptive Technologies, Bayer
9:30 AM - 10:05 AM - Case Studies
Small Molecules
Modelling and Control of Fluid Bed Granulation Processes
Sophie Martin, Process Engineer in Pharmaceutical Development, Sanofi
Biologics
Design of Long-acting GLP-1 Analogs Applicable for Once Weekly and Oral Dosing
Jesper Lau, Vice President, Protein and Peptide Chemistry, Novo Nordisk
Technology & Innovation
Insights in Protein-Protein Interactions at High Protein Concentrations: The Relevance of Surrogate Parameters
Josef Hartl, Scientist, Boehringer Ingelheim
Device Development
MDR – Notified Body Opinion – Article 117
April Kent, M.Sc., B.Sc. Regulatory Affairs Manager, Combination products and IVDs, Amgen
10:05 AM - 11:05 AM
iSolve & Networking Break
11:05 AM - 11:40 AM - Solution Spotlights
Small Molecules
Reactive Twin-Screw Melt Extrusion in Drug Delivery
Feng Zhang, Assistant Professor , University of Texas at Austin
Two case studies to illustrate the reactive between drug and excipients during twin-screw melt extrusion to improve the quality attributes of melt extruded amorphous solid dispersions. In the case of meloxicam, the presence of meglumine improves the chemical stability of meloxicam and enhances its dissolution rate. In the case of naproxen, the presence of meglumine enhances its physical stability of naproxen and enhances its dissolution rate.
Biologics
Hydroxylpropyl ß-cyclodextrin: A Promising Excipient for Protein Stabilization
Rajeev Gokhale, Head Global Pharmaceutical Sciences R&D, Head Asia R&D , Roquette
Protein stability is a major challenge to overcome during manufacturing, upstream and downstream processes, formulation, transportation and storage of biopharmaceuticals. Proteins may aggregate during these activities in addition to chemical changes. Aggregation is often irreversible leading to inactive and potentially immunogenic species, resulting in to reduced efficacy and toxicity to patients. Formulation development involves selection of appropriate excipients to stabilize the protein drugs throughout its recommended shelf life against potential excursions in its life cycle and aid in the delivery of therapeutics into the patient. While role of many excipients in the stability of formulation is well documented, scares information is available on role of Cyclodextrins in stabilization of therapeutic proteins such mAbs. Cyclodextrins play a vital role in reduction of interfacial tension with the environment and hydrophobic interactions among the protein molecules. In the present study stabilizing effects of novel Cyclodextrins, KLEPTOSE® HPB and HP in various therapeutics protein formulations have been investigated. Physical-chemical stability was influenced under different stress conditions such as thermal and agitation for monoclonal antibodies and human growth hormone. We employed a two-prong approach, high throughput screening and conventional chromatographic methods to establish validation. This study provides insight in to both methodologies to understand interplay between protein and surrounding environments. We attempt to provide role of novel Cyclodextrins to reduce aggregation and develop therapeutically effective and safe protein formulations.
Technology & Innovation
Solid Dosage Forms for Heterogeneous Patient Groups: Challenges and Solutions
Véronique Henner-Kulkarni, Technical Sales Manager , ShinEtsu
In the frame of patient centric approach, formulators are dealing with different solid dosages forms like mini-tablets or oral dispersible tablets. For those forms the standard manufacturing or analytical processes aren’t always suitable.
The presentation will review common challenges and provide solutions based on cellulose derivatives for administrating medicines to heterogeneous population in terms of:
- Mini-tablets:
o Coating of mini-tablets
o Taste masking formulations and analysis
- ODT:
o Content of uniformity with low dosage API
o Analysis of ODMT
-Bi-layer tablets formulation
Device Development
Platform for Change and Improved Patient Experience
Mike Hooven, President and CEO, Enable Injections, Inc.
The enFuseTM platform, an on-body drug delivery system, is a unique technology being developed for patient self-administration of high-volume biologic drugs from 5 - 50mL. The system is designed with novel features to provide comfort, convenience and simplicity for the patient. Some of these unique features will be discussed in terms of their impact on patients, drug development and the overall healthcare landscape.
11:45 AM - 12:20 PM - Case Studies
Small Molecules
Small is the New Big: Case Studies of two Nanotech Products from Lab to Market
Biologics
Challenging Transfer of a Fill & Finish Process for a Highly Fragile Bispecific mAb
Stephanie Greco, Head of laboratory in Formulation & Process Development, Sanofi
Technology & Innovation
Challenges and Opportunities to Include Patient Centered Design in Industrial Drug Development
Leonie Wagner-Hattler, Formulation Scientist, F. Hoffmann-La Roche
Device Development
Micro Array Patches: Delivering High Drug Doses Transdermally
Professor Ryan F. Donnelly, Chair in Pharmaceutical Technology, Queen's University Belfast
12:25 PM - 1:00 PM - Solution Spotlights
Small Molecules
How-to Use Oral Drug Delivery Technology Innovatively
Luigi Boltri, R&D Director, Innovation and Technology Liaison, Adare Pharmaceuticals
Biologics
Hard-to-Stabilize Proteins and Peptides: Can Recombinant Human Albumin be an Effective Approach?
Eleonora Cerasoli, Senior Research Scientist, Albumedix
The expanding field of peptide and protein therapeutics gives promise for improvement of treatments against several diseases. Many of the biopharmaceuticals found to be efficacious continue to face ex vivo instability challenges despite advancements in protein and peptide engineering. In this respect a lot of the drug development efforts are devoted to pre-formulation and formulation studies aiming at maximizing the stability of the biopharmaceutical. This is not an easy task and therefore, they form a critical objective of any drug development program.
It is well-known that recombinant human serum albumin can stabilize proteins in solution preventing adsorption, aggregation and oxidation. The stabilizing ability stems from some of the roles albumin performs in blood, such as a carrier of small hydrophobic entities, participation in the control of pH and osmotic pressure and affording the majority of the antioxidant capabilities present in blood. Recombinant human albumin is therefore a promising stabilizer for hard-to-formulate biopharmaceuticals.
In this talk we will illustrate the use of Albumedix® Recombumin®, a recombinant albumin product, as a stabilizing agent for model biopharmaceuticals. We will present data on the use of Recombumin showing its versatility as an advanced excipient.
Technology & Innovation
Reimagining your Orally Dispersible Tablets Formulation Excipients, Introducing a New Lactose Product (SuperTab® 50ODT)
Mara van Haandel, Innovation Manager , DFE Pharma
An orally disintegrating tablet or orally dissolving tablet (ODT) is a drug dosage form available for a limited range of over-the-counter (OTC) and prescription medications. ODTs differ from traditional tablets in that they are designed to be dissolved on the tongue rather than swallowed as a whole. The regulatory condition for meeting the definition of an orally disintegrating tablet is that ODT drugs should disintegrate in less than 30 seconds for US ODT products and less than 3 minutes for European ODT products. ODT’s are a novel way for product line extensions and a new manner helping to deliver medication to pediatrics and geriatric patients, or to those who suffer from Dysphagia.
ODT manufacturing can be split into two distinct areas. The initial technology used involved lyophilization. The first ODT form of a drug to get approval from the U.S. Food and Drug Administration (FDA) was a Zydis ODT formation of Claritin (loratadine) in December 1996. The second technology and most cost effective technology uses the standard tableting process equipment.
SuperTab® 50ODT is a specifically designed spray dried lactose which has characteristics that facilitate the production of ODT’s . Utilizing proprietary spray drying techniques a lactose monohydrate product has been developed with a typical porous nature due to which a fast disintegration time can be established in combination with a smooth tablet perception. The balance is to have a formulation that produces tablets with low friability, to aid packaging / transportation and the desired fast oral disintegration time coupled with a pleasant mouth feel and texture.
New in the development of excipients is the usage of large trained sensory tests panels evaluating product from prototypes to final products with CATA (Check All That Apply) and RATA (Rate All That Apply) testing protocols and use of MVA (Multi Variant Analysis) to monitor, evaluate the sensory and physical behavior of tablets. The study shows that using these CATA & RATA screening techniques the Organoleptic properties of commonly used pharmaceutical excipient such as lactose can be modified to suit ODT application.
Historically, these type of formulations have used polyols such as Mannitol etc. Unlike polyols, lactose does not decrease the small intestinal transit time[1].
[1] Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility, Drug Substances - 2018
Device Development
Human Factors - Trends, Optimization, ROI and the Future
Matthew Gottschalk, Director of Programme Development, Worrell
1:00 PM - 2:00 PM
Networking Lunch
2:00 PM - 2:35 PM - Case Studies
Biologics
Electrospinning of Biopharmaceuticals
Sune Andersen, Principal Scientist in Particle Engineering, Janssen
Biologics
Oral Semaglutide: Realising the Potential of Oral Peptide Delivery
Stephen Buckley, Head of the Discovery ADME Department in Global Research, Novo Nordisk
Technology & Innovation
Fill and Finish Process Development for Biologic Products : Derisking Approach
Marie Wacquet, Drug Product Process Development Unit Manager, Biologics, Sanofi
Device Development
MDR Impact on Pharma Companies
Bjorg K. Hunter, Regulatory Manager, Devices, GSK
2:40 PM - 3:15 PM - Solution Spotlights
Small Molecules
Mesoporous Silica: An Option for Liquisolid Systems
Fred Monsuur, Excipient Development & TCS Manager, W.R. GRACE & Co.
Adsorption on solid adsorbent carriers is one of the emerging techniques for delivery of oils, solubilisers and lipids. Carriers should display high surface area, strong adsorption capacity, ease of processing and generation of liquid loaded free flowing powder which can easily be processed to solid dosage forms like tablets, capsules and sachets. Hence, solid adsorbents are increasingly gaining the attention of formulators for design of oil & lipid based oral drug delivery system. The ideal carrier is one which demonstrates maximum release of adsorbed component in GI tract to initiate drug dissolution and absorption process. In a direction to ensure the same there was a need to develop a new Mesoporous silica gel (MSG) carrier. We evaluated towards different carriers like Granulated fumed silica(GFS) and Magnesium aluminum silicate (MAS) for its adsorption, desorption and release property. Also the effect of humidity and silanol groups on oil adsorption and desorption was studied. SYLOID® XDP silicas are engineered with specific pore size, adsorption, and desorptive capacity that creates the ideal carrier for lipids and converts liquid ingredients into free flowing powder
Biologics
End to End Solutions in Freeze Drying: From Cycle Audit through Formulation, Process Optimisation and Scale up
Dr Mattia Cassanelli, International Technical Sales Executive, Biopharma
Technology & Innovation
New Silicone-Free Plunger Option for Delivery of Sensitive Biologics in Bare Glass Pre-Filled Syringes
Russ Hornung, Business Development – Drug Delivery, W.L. Gore & Associates, Inc.
The industry predicts that 10-15% of large molecules (biologics) are sensitive to silicone. With the logarithmic rise in biologic molecules in the pipeline, there is a technical need for alternative packages that are free of silicone. Gore has commercialized a silicone free, PTFE-based fluoropolymer encased plunger that enables BARE glass syringes for sensitive large molecules (biologic and conjugate vaccines). This technology eliminates silicone oil, cross-linked silicone, baked-on silicone from the primary package. Data will be presented to show the logarithmic reduction in particles and more consistent injection time across aging conditions. Eliminating the silicone also removes a significant root cause of protein aggregation and conjugated vaccine precipitation.
Device Development
Device Development Using In-Silico Techniques within an FDA Framework
Stephen Gilmore, Engineering Director, Crux Product Design
3:15 PM - 4:15 PM
Networking Break
4:15 PM - 4:50 PM - Case Studies
Small Molecules
Importance of Establishing the Stability of Drug-Loaded Nanoparticles
Cornelus van Nostrum, Associate Professor , Utrecht University
Biologics
Biosimilars – Regulatory Primer for Formulation Scientists
Paul Chamberlain, Member, NDA Advisory Board, NDA Advisory Services Limited
Technology & Innovation
Transporter-Mediated Brain-Targeted Prodrugs
Device Development
Human Factors Engineering for Medical Device Development
Rémy Vomscheid, Director, Device Development & Technologies, Ipsen
4:55 PM - 5:40 PM - Panel Discussion
Device Development
EU Medical Device Regulations impact on Combination Products – What to be Aware of Across Drug Delivery Development
Bjorg K. Hunter, Regulatory Manager, Devices, GSK
April Kent, M.Sc., B.Sc. Regulatory Affairs Manager, Combination products and IVDs, Amgen
Beat Steffen, Founder and Chief Executive Officer, confinis
James K. Mellman, Device Manager, Novartis
Torsten Kneuss, QA Manager Combination Products, Bayer
5:40 PM - 5:45 PM
Poster Presentation Award
5:45 PM - 5:50 PM
5:50 PM - 6:50 PM
Drinks Reception
8:00 AM - 8:50 AM
Registration & Refreshments
8:50 AM - 8:55 AM
8:55 AM - 9:30 AM - Keynote
Device Development
Formulation & Device Lifecycle Management
Beate Bittner, Senior Portfolio Strategy Director , Roche
9:35 AM - 10:10 AM - Case Studies
Small Molecules
3D Printing as an Investigative Tool in Particle Detachment
Tim Rouse, Senior Scientist, Chiesi
Biologics
Impact of ABC Transporters at the Blood Brain Barrier
Gert Fricker, Director, Institute of Pharmacy and Molecular Biotechnology, University of Heidelberg
Technology & Innovation
Biopharmacy of New Chemical Entities for Oral Route Administration: Contributions of Predictive Tools to Confirm Developpability and Support Proof of Concept Clinical Studies
Guillaume Louit, Biopharmacy Team Leader, Sanofi
Device Development
Benefits and Challenges from Pharmaceutical Industry Perspective
Torsten Kneuss, QA Manager Combination Products, Bayer
10:15 AM - 10:50 AM - Solution Spotlights
Small Molecules
Silica Carrier for Solubility Enhancement – Graduating from Lab to Production Scale
Dr. Gudrun Birk, Lab Head Controlled Release, Merck
The drug carrier technology is a valuable option to address the challenge of low solubility of APIs. At small scale, there are various ways available to load the API onto the carrier surface. However, at larger scale, challenges typically arise in process configuration and scale-up operations. A process has been developed which allows for a stable, reliable one-step loading process and up-scaling to clinical & production scale manufacturing. After the loading process, the API-loaded carrier can finally be formulated as a tablet.
Biologics
Soteria®: Delivery of Antibodies in an Easy to Swallow Oral Pill
Vipul Yadav, Director of R&D, Intract Pharma
Technology & Innovation
Targeting Specific Patient Populations for Distinct Oral Dosing Formulation Challenges – Flexible Technology is Key
Sven Stegemann, Director, Pharmaceutical Business Development, Lonza
10:50 AM - 11:50 AM
Networking break
11:50 AM - 12:25 PM - Case Studies
Small Molecules
Control Strategy Approaches in Continuous Manufacturing of Oral Solid Dosage Forms
Jacqueline Maximilien, Senior Scientist, Drug Product Development-Oral Solid Dosage Forms, Janssen
Technology & Innovation
Bispecifics Drug Product Development; Challenge of Low Concentration Analysis and Formulation
Sachin Dubey, Head of Formulation and Analytical Development, Glenmark
Technology & Innovation
Controlling the Formation API Solvates and Hydrates
Gabriele Sadowski, Professor for Thermodynamics, TU Dortmund University
Device Development
Harnessing the Power of the Digital Exhaust and Digital ATM in Wellness Programs
Graham B Jones, Director of Innovation, Novartis
12:30 PM - 1:05 PM - Solution Spotlights
Small Molecules
Transmucosal Delivery – Using the Mucofilm® Technology to Bypass the First Pass Effect
Dr. Sebastian Braun, Head of Science & Technology, tesa Labtec GmbH
The oral mucosa seems to be the ideal location for delivering large APIs systemically and still avoiding the first pass effect. Certain challenges arise when developing such a dosage form. The product has to adhere on a wet and high mobile surface, needs to resist enzymatic degradation and increased saliva flow and has to simple disappear after a few minutes or a few hours. Challenges that can be overcome to develop the next generation of large molecule application systems.
Technology & Innovation
Early Evaluation of Clinical Performance for Modified Release Products
Dr Carol Thomson, Chief Executive Officer , BDD Pharma
Technology & Innovation
Risk Mitigation in Topical Product Development
Rob Turner, Vice President of Business Development and Innovation, MedPharm
1:05 PM - 2:05 PM
Networking Lunch
2:05 PM - 2:40 PM - Case Studies
Small Molecules
Crystallisation Kinetics in ASDs
Christian Lubbert, Postdoc Pharmaceutical Formulations, TU Dortmund University
Biologics
In-use Studies: Some Case Studies
Héloïse Audat, Head of Late Stage Formulation Development Unit, Biologics, Sanofi
Technology & Innovation
Digital Design of Pharmaceutical Products and Processes
Johannes Khinast, Director , Research Center Pharmaceutical Engineering
Device Development
Benefits of Early Integration of Human Factors: A BYDUREON® BCise case study
James Meehan, Associate Principal Scientist – Human Factors , AstraZeneca
2:45 PM - 3:20 PM - Case Studies
Small Molecules
Smart Delivery of Actives by Polyrotaxanes Providing New Options for the Treatment of Niemann-Pick Typ C Disease
Gerhard Wenz, Professor, Saarland University
Biologics
Characterization of Subvisible Particles: Old Challenges and Newest Improvements
Anacelia Ríos Quiroz, Scientist - Group Leader Particle Lab Biologics, Roche
Technology & Innovation
Polysorbate Degradation: Implications and Control
Dr. Franziska Edelmann, Scientist - Pharma Technical Development Analytics , Roche
Technology & Innovation
Formulation Design and Evaluation of Low Dose Aspirin Loaded Wafers for Oral / Buccal Delivery in Geriatric Patients With Dysphagia
Dr Joshua Boateng, Reader (Associate Professor) , School of Science, University of Greenwich
4:20 PM - 4:55 PM - Case Studies
Small Molecules
Nanoparticle Based Formulations: Special Emphasis on Bioavailability Improvement and Delayed Release upon Parenteral Administration
Dr. Yogeshwar Bachhav, Associate Director Pharmaceutical Development , AiCuris Anti-infective Cures
Biologics
Enhancing the Oral Bioavailability of Peptide and Protein by use of Functionalised Self-Emulsifying Drug Delivery Systems (f-SEDDS)
Anette Müllertz, Professor, Head of Center , University of Copenhagen
Technology & Innovation
Miniaturized Capacitive Devices for the Detection of Circulating Biomarkers, Enabling Real-Time Kinetic Measurements, Integrable with Microfluidic Systems
Dr. Federica Mantovani, Industrial Liaison , Elettra
5:00 PM - 5:45 PM - Panel Discussion
Technology & Innovation
Are We Prepared for the Regulations on Patient-Focused/Patient-Centric Drug Development?
Sven Stegemann, Director, Pharmaceutical Business Development, Lonza
Leonie Wagner-Hattler, Formulation Scientist, F. Hoffmann-La Roche
5:45 PM - 5:50 PM