Program 2019

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

  • Comparing two dated lyophilized products (60’s) with historical cycles that exhibit distinct complications
  • Development and optimization of manufacturing processes to overcome the lack of physical chemistry data from dated products
  • Applying product knowledge, new freeze dryer knowledge, simulation and process modelling

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

Parenteral depot formulations are often characterized by a relatively high degree of complexity. Hence, getting formulation and device as well as manufacturing processes right is far from trivial despite the long history in this field dating almost 90 years back to the first protacted insulin protamine formulations. 
  • Technology landscape for parenteral depot formulations of peptides and proteins
  • Driving and blocking factors for making the perfect match between active and sustained release technology
  • Strategies for developing parenteral sustained release formulations (drug delivery by design)
  • Examples of studies from formulation development
  • Future directions within parenteral sustained release of peptides and proteins

Device Development

Facilitating Meaningful Differentiation of Products by Establishing a Culture of Innovation

Dr. Stefan Holzner, Senior Director, Head of Device Development, Takeda

Facilitating meaningful differentiation of products by establishing a culture of innovation:
  • Challenges specific to the area of rare diseases
  • Case study on fostering a culture of innovation
  • Approach & Guiding Principles
  • Selected examples of how building on existing platforms allows to differentiate existing products and deliver value to the patient
  • Observations  & take aways

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

  • Nanoparticle formulation for drugs with poor aqueous solubility
  • Comparison of polymer nanoparticle fabrication methods and composition
  • Effect of nanoparticle fabrication method and composition on nanoparticle physical properties

Biologics

More Than Just Down-Scaling – Miniaturization of Methods in a High-Throughput Setting Requires Creative Concepts and Holistic Thinking

Dr. Martin Hüelsmeyer, Head of HTS Operations & Analytics NBE Formulation Sciences, Principal Research Scientist, AbbVie

  • Formulation screening
  • Biotherapeutics
  • Robotics
  • Analytics & stress assays

Technology & Innovation

2D Inkjet Printing for Patient Centric and Translational Drug Delivery

Dr. Amrit Paudel, Assistant Professor & Principal Scientist, Graz University of Technology, Research Center Pharmaceutical Engineering (RCPE)

  • Inkjet printing of drug formulation for oro-mucosal and gastro-intestinal drug delivery
  • Flexibility and technological limitations of inkjet-printed formulations
  • Solvent selection and ink development approach integrating formulation and jettability considerations for printing amorphous solid dispersion on to the edible substrate
  • Demonstration of dose escalation by tailoring process parameters and substrate properties for film-foldability
  • Hyperspectral imaging as an exploratory tool for non-destructive drug content and homogeneity analysis of the inkjet-printed formulations

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

  • Innovative Biologics versus Biosimilars - understanding and delivering on emerging customer needs
  • Smart devices – who is the customer
  • Changing biologics portfolios inline with new device technologies
  • Intravitreal injections as special challenge with recent advancements

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

Prof Rainer Jordan, Chair of Macromolecular Chemistry, School of Science, TU Dresden, Germany and Vice-President of DelAqua Pharmaceuticals Inc, TU Dresden

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Biologics

Mind the Gap - How to Assure Data Integrity in a High-Throughput Formulation Screening for Biotherapeutics

Sabine Eichling, Senior Scientist II, NBE High Throughput and Advanced Formulation Sciences Drug Product Development, AbbVie

  • Data handling
  • Data evaluation
  • Formulation screening
  • Biotherapeutics

Technology & Innovation

Development of Polymeric Nanoparticles for Intravenous Administration

Dr Rebecca Booth, Senior Scientist, AstraZeneca

  • Formulation optimisation, physical & chemical composition analysis
  • Developing a robust manufacturing process
  • Biopharmaceutics & critical quality attributes

Device Development

A Self Anchoring Microneedle Patch (StAMP) Offering Precise and Sustained Transdermal Drug Delivery

Manita Dangol, Senior Research Fellow , University College Dublin

  • Development of StAMP which offers precise skin penetration and sustained mechanical adhesion
  • Comparison of conventional microneedle with StAMP
  • Formulation assessment of drug coatings on StAMP
  • Exemplary delivery of high molecular weight, protein drugs using StAMP

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

  • Commercial Biotherapeutics Stabilized with Trehalose
  • Commercial Biotherapeutics Stabilized with Sucrose
  • Key Issues in Biopharma Formulation Development
  • Essential components of a “Platform Biopharma Formulation”
  • Understanding important physicochemical properties of Trehalose and Sucrose
    • Instability of sucrose at low pH – free glucose, protein glycation
    • Phase transition and crystallization of trehalose
  • Purity, Quality, Consistency in Pfanstiehl’s Trehalose and Sucros
    • β-glucans in sucrose – interference with endotoxins
    • Trace metal specifications for Sucrose and Trehalose
  • Advantages of Trehalose over Sucrose
  • Pfanstiehl’s Biopharma Stabilization Portfolio

Technology & Innovation

Oral Thin Films – Tailoring Therapy Need

Dr. Marco Emgenbroich, Corporate Senior Director , Head of Pharmaceutical Development I R&D, LTS Lohmann Therapy Systems

Oral drug delivery technologies form an important part of the pharmaceutical industry representing the largest share of the overall market. In particular oral transmucosal drug delivery systems have recently gained a lot of attention. One of the key driving factors is the preference for non- invasive routes of drug delivery. Although oral thin films have been available in the forms of breath freshening strips, vitamin strips and other over-the-counter products for the past two decades, pharmaceutical companies have recently directed their focus towards formulating prescription products into oral thin films.

Oral mucosal drug delivery provide several advantages over traditional oral drug delivery methods such as the ease of self-administration, increased bioavailability, rapid onset of action, no water required and improved patient compliance. Oral thin films provide fast accurate dosing and are expected to increase compliance, especially among elders and children. Given the specific advantages offered by these films and their ability to overcome the current unmet needs, the future holds significant potential.

This presentation will show the components and science of OTFs and how it can be used to provide a genuine alternative to current drug delivery methods – and be considered as a genuine alternative dosage form.

Features and benefits of using OTFs to address disease areas will be discussed, highlighting the market potential and increased market share associated with the development of the product.

Device Development

Rubber Components Selection for Optimal Drug Packaging

Simon Kervyn, Manager Materials Development, Datwyler

  • Composition of rubber components
  • Extractables and leachables from rubber
  • Fine tuning of rubber composition to adapt to the rubber use

When a drug packaging is selected a particular attention is needed for the selection of rubber products. Indeed, a wrong choice of such products can lead to the compounds not performing according to the expectations, high amount of leachables or even incompatibility with the drug resulting in failed stability study.

Several topics will be discussed, starting from the rubber composition and its impact on extractables. Over the years, rubber formulation have changed to reduce the amount of products leaching from the rubber. This phenomenon can be further reduced by applying a coating on the rubber.

Finally, the rubber composition can be further tuned depending on the intentional used. For examples, rubber products for lyophilized drugs have been optimized for fast drying. Whereas rubber products for needle shield need to be permeable to EtO gas to ensure a sterilization of the drug packaging.

1:00 PM - 2:00 PM

Networking Lunch

Lunch & Learn Round Table with ADM SIO

Management of Contaminants in Plant based Excipients 

  • Example of vegetable oils
  • Composition of vegetable oils
  • Undesirable compounds : Contaminants from culture origin & Process Origin

    Special focus on the contaminants generated by the process : Glycidyl fatty acid esters

    Management of these contaminants by process control (importance of GMP)


Moderated by: Stephanie Bureau, R&D Director, ADM SIO

Hervé Limouzin, Sales & Marketing Manager, ADM SIO

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

Show more

Biologics

Long Recombinant Homogeneous Linkers for Dual Protein Conjugations, to Replace Heterogeneous PEG

Thomas Hoeg-Jensen, Scientific Director, Novo Nordisk

Show more

Technology & Innovation

DNA-Based Nanoassays for Biomarker Detection in Liquid Biopsy and Therapeutic Drug Monitoring

Loredana Casalis, Head of Nanoinnovation Laboratory, Elettra

Show more

Device Development

Predicting the Future: Learning about Challenges with Injectable Formulations to select better Primary Packaging

James K. Mellman, Device Manager, Novartis

  • When the packaging becomes more than just a container closure system
  • Selection of primary packaging platforms from various options available in the market
  • Case studies of challenging formulations with primary packaging
  • Current directions for understanding drug container interactions

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

Close to 90% of drugs coming out of the drug discovery pipeline, have solubility limitations translating to poor bioavailability, which may ultimately result in clinical failures. Amorphous solid dispersions (ASDs) are an established platform to address bioavailability challenges due to low aqueous solubility. The complexity of ASD development, added to the concerns on physical stability, pose as perceived risks, however, the clinical and commercial success of ASD-based formulations stands as driving force: to date, 24 FDA-approved therapies are commercially available

This presentation will address the main challenges in the formulation of ASDs, and highlighting the importance of integrated development and the synergies between pre-formulation and commercial manufacturing expertise. The science-based development platform for ASDs will be presented. This platform relies on the integration between formulation and analytical development, from API to drug product, coupled with the use of computational models, formulation databases and miniaturized high-throughput in vitro techniques.

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

  • Choosing the appropriate dosage form for first-in-human/Phase I trials – fit for purpose, fit for phase?
  • Compounding or GMP manufacturing – how to balance cost, time and dose flexibility?
  • Challenges with poorly soluble molecules in early development – what technologies can we deploy?
  • Bridging to robust and scalable Phase II drug products – how to avoid losing time in development?
  • Highly flexible and adaptive clinical manufacturing strategies for patient trials – how can real-time manufacturing be used?

Small Molecules

Simplifying Tablet Formulation Strategies with Avicel® SMCC and METHOCEL™ DC2

Dr. Carsten Huettermann, Senior Application Scientist, Leader Pharma SAFI Innovation EMEA, DuPont

  • Excipients play an important role for the development of streamlined and improved production processes like direct compression and continuous manufacturing of tablets.
  • Avicel® SMCC is a silicified microcrystalline cellulose derived from co-processing MCC and colloidal silicon dioxide (SiO2). The co-processing yields in a high-functional excipient that exhibits performance attributes unmatched by a simple blend of MCC and SiO2 like optimum flow, superior compactability, and excellent binding properties. It is therefore the binder of choice for direct compression and continuous manufacturing.
  • METHOCEL™ DC2 is a pure Hypromellose for sustained release matrix tablets which was engineered by designing the particles morphology to improve flow without the use of additives or additional granulation steps.
  • In case studies the benefits of Avicel® SMCC and METHOCEL™ DC2 for enhanced productive processes for immediate and sustained release oral solid dosage forms are shown.

Device Development

Combination Products – Global Regulatory Landscape

Viky Gilles Daniel Verna, Co-Founder and VP, confinis

This presentation will introduce the global concept of “combination Product” and it’s understanding per different regions’ regulatory perspectives. It also covers the latest status of the evolving combination product regulatory landscape of relevant regions. Challenges resulting from global regulatory divergence are highlighted as well as risk mitigation strategies.

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

  • Demonstrate connection between ASD thermodynamic properties and HME manufacturing process
  • Application drug/polymer phase diagram as a tool for HME risk assessment
  • Demonstrate correlation between drug/polymer phase diagram, drug load, rheology, and HME process.
  • Correlating drug product CQA (residual crystallinity, chemical/thermal stability) to drug/polymer phase diagram and HME process parameters

Biologics

Root Cause Investigations for Visible Particles and Aggregation in Drug Containers – Case Studies

Andreas Seidl, Head Global Analytical Characterization & Bioanalytics , Hexal (Novartis)

  • The first case study will describe root cause investigations to identify a novel cause for visible particles in polysorbate containing formulations
  • For root cause investigations unconventional approaches may be more successful than the beaten path
  • Broad unbiased screening may be necessary to identify novel causes for unexpected results
  • In a second case study inorganic leachables from a sterile filter were identified as cause for aggregation/particle formation
  • This highlights the importance of a broad method portfolio for characterization of dimers/aggregates/particles and to successfully investigate the root cause of aggregate formation
  • The described findings might be relevant in general for biologics drug product development and will contribute to the improved quality of biopharmaceuticals

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

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Small Molecules

Solid Lipid Solutions as Formulation Platform for Poorly Soluble Drugs

Ruzica Kolakovic, Senior Scientist, Pharmaceutical Sciences, Drug Product Development , Janssen

Vast majority of new active pharmaceutical ingredients (APIs) entering development pipeline from discovery possess insufficient water solubility and/or low dissolution rate. These cause challenges in achieving desired bioavailability.

Formulating API as a lipid-based formulation is often taken as approach to achieve desired bioavailability. This is achieved mainly by enhancements in drug solubilization and dissolution rate. In addition, LBF can stimulate intestinal lymphatic drug transport (thereby reducing first-pass metabolism), and merging evidence suggests a potential role for components of LBF (primarily surfactants) in the inhibition of intestinal efflux and metabolism. Most common way to formulate the LBFs is soft capsule approach where API is dissolved or suspended in liquid vehicle. However, using a semi-solid or solid carrier to form solid lipid solution (SLS) can offer many advantages such as possibility for manual filling at small scale in lab environment for purpose of pre-clinical and early clinical studies. Selection of excipients for SLS is made based on automated solubility screening of API in solid lipid excipients. Combination of these two techniques significantly reducing time and cost for development and manufacturing of pre-clinical and early clinical formulation of ‘difficult-to-formulate’ compounds.

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

  • A patient-centric approach and the patient benefits of oral drug delivery of peptides
  • Current development challenges
  • Outcome of current oral drug delivery technologies
  • Why have so few technologies reached the market?
  • Science based selection process of drug delivery technology
  • What the future holds?

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

  • What is new – recent market entries of drug delivery products incl. generics
  • Patient centric development with focus on children and the elderly e.g. mini tablet dispenser
  • Unmet need in parenteral drug targeting (focus on brain, solid tumors)
  • Progress in continuous manufacturing technologies (tablets & lyo)
  • Oral delivery of peptides and beyond
  • Data as an asset from F.A.I.R. data format to augmented intelligence

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

Fluidized bed processes are a complex equilibrium between thermodynamics, hydrodynamics and atomization.

A simple model based on mass and heat balances on the equipment is proposed to find the perfect alchemy to control granulation, coating and drying processes in Fluidized bed.

3 cases studies:

  • Application to a granulation process
  • Application to a coating process
  • Application to a drying process

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

  • The discovery journey towards once week semaglutide
  • Preclinical and clinical data
  • The ambitious challenge to oral delivery of semaglutide

Technology & Innovation

Insights in Protein-Protein Interactions at High Protein Concentrations: The Relevance of Surrogate Parameters

Josef Hartl, Scientist, Boehringer Ingelheim

  • The differences with crowded solutions
  • Protein-protein interaction and colloidal properties
  • The significance of surrogate parameters
  • Relevance for drug product development

Device Development

MDR – Notified Body Opinion – Article 117

April Kent, M.Sc., B.Sc. Regulatory Affairs Manager, Combination products and IVDs, Amgen

Show more

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

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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

Dr. Ajay J. Khopade, Vice President-R&D, Formulation Development (Non-Orals), Sun Pharma Advanced Research Co. Ltd.

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Biologics

Challenging Transfer of a Fill & Finish Process for a Highly Fragile Bispecific mAb

Stephanie Greco, Head of laboratory in Formulation & Process Development, Sanofi

  • Utility of extensive comprehension of the mAb aggregation law
  • Set-up of a temperature control process to prevent aggregation
  • Impact of temperature variations on fill weights during Time-pressure filling

Technology & Innovation

Challenges and Opportunities to Include Patient Centered Design in Industrial Drug Development

Leonie Wagner-Hattler, Formulation Scientist, F. Hoffmann-La Roche

  • Challenges and opportunities: An industry in transition
  • Patient focus: The needs to get to the future state
  • Roadblocks in drug development
  • Patient centricity: Impact on drug product development
  • Lessons learnt from pediatric drug product development
  • Examples, Conclusion and Outlook

Device Development

Micro Array Patches: Delivering High Drug Doses Transdermally

Professor Ryan F. Donnelly, Chair in Pharmaceutical Technology, Queen's University Belfast

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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

Pulsatile drug delivery for desired biopharmaceutical performance: Insights to achieve ideal pharmacokinetics, encourage patient compliance and generate new intellectual property.

  • Focus on the use of oral pulsatile release design as a way to leverage chronotherapy, mimic bid or tid dosing, create a challenge to generic competition
  • Timed delivery of two different active ingredients and provide both quick onset of action and quick termination of action
  • Target delivery to a specific GI site of action
  • Adare Proprietary Pulsatile Release Technology featured case studies to be presented

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

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Device Development

Human Factors - Trends, Optimization, ROI and the Future

Matthew Gottschalk, Director of Programme Development, Worrell

  • Trends in drug delivery and the impact on HF
  • Optimizing HF activities to go beyond risk
  • Combining HF studies with Market Research (User Acceptance) Studies
  • Presenting the ROI of HF activities
  • New technologies and perspectives on the evolution of HF

1:00 PM - 2:00 PM

Networking Lunch

Lunch & Learn Round Table with Capitsol a Ligand Technology

What’s New with Captisol?

Aseptic filled concentrated Captisol solution available for development
Approved Chinese Captisol Drug Master File and first approved Captisol enabled product in China
Redundant validated commercial manufacturing sites
Established a new European Captisol distribution site
New Captisol safety white papers on pediatric populations, renal observations and oral use
Own Captisol enabled product development program for CE-Iohexol

  • Vince Antle, PhD, Senior Vice President of Technical Operations
  • JD Pipkin, PhD, Vice President, New Product Development

2:00 PM - 2:35 PM - Case Studies

Biologics

Electrospinning of Biopharmaceuticals

Sune Andersen, Principal Scientist in Particle Engineering, Janssen

Parenteral administration of biopharmaceuticals for intestinal diseases is associated with numerous disadvantages e.g. low patient compliance, and toxicity caused by high systemic bioavailability. One alternative that can potentially overcome these limitations is oral administration of biopharmaceuticals, where the local delivery will reduce the systemic exposure and furthermore the manufacturing costs will be lower.

Electrospinning is a new promising drying technology for biopharmaceuticals as drying takes place at low temperature coupled with a possibility to make nanosized fibers. The technology will be discussed and compared to traditional drying technologies.

 

Biologics

Oral Semaglutide: Realising the Potential of Oral Peptide Delivery

Stephen Buckley, Head of the Discovery ADME Department in Global Research, Novo Nordisk

  • Peptides such as insulin and glucagon-like peptide-1 (GLP-1) receptor agonists are used in the treatment of type 2 diabetes.
  • The inherent physicochemical properties of these peptides (high molecular weight, enzymatically labile, hydrophilicity, and low permeability) have hampered attempts to deliver peptides via the oral route and necessitated that they be administered by injection.
  • Recently, oral semaglutide, a GLP-1 analog, coformulated with the absorption enhancer sodium N-[8-(2-hydroxybenzoyl) aminocaprylate] (SNAC) in a tablet has been developed.
  • This coformulation provides unique, site-directed release and absorption in the stomach and effectively surmounts inherent challenges relating to solubility, molecular size, and proteolytic lability to achieve therapeutically relevant plasma exposure of semaglutide.

Technology & Innovation

Fill and Finish Process Development for Biologic Products : Derisking Approach

Marie Wacquet, Drug Product Process Development Unit Manager, Biologics, Sanofi

Fill and finish step following downstream processing is a critical step of the biopharmaceutical manufacturing. Appropriate development studies based on product and technologies knowledge are essential to ensure successful industrial transfer.

  • Risks associated to fill and finish processing
  • Studies to be performed (lab scale trials and calculations)
  • Case studies

Device Development

MDR Impact on Pharma Companies

Bjorg K. Hunter, Regulatory Manager, Devices, GSK

With the introduction of new EU MDR pharma companies must ensure readiness for the implementation in May 2020. However, specifically for single integral medical products with a device component there is still many unknowns. This talk will include an industry perspective as well as case studies of how MDR Art 117 readiness can be approached in this time of uncertainty.

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

The presentation will describe a case study about the process development of a lyophilised protein product. The different phases from formulation to cycle development and technology transfer will be covered outlining challenges and commercial benefits.

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

  • Solving some of the industry’s most complex device design challenges using In-Silico (virtual) techniques
  • Reporting of computational modelling within an FDA regulatory submission - FDA V&V40
  • Digital evidence and the digital twin
  • Acoustic design and simulation
  • Will modelling and simulation ever be accepted as credible evidence of safety or clinical benefit?

 

 

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

To allow targeting of drugs by nanoparticles and triggered release at the site of action, one must ensure that drugs are stably encapsulated before reaching the target site. Usually change in pharmacokinetics and biodistribution are the prime outcome parameters to indicate stability of drug-loaded nanoparticles. However, to prevent excessive use of animals, reliable in vitro measurements are required that carefully predict in vivo stability. We will show that asymmetric flow-field flow fractionation (AF4) may do the trick. Furthermore, we will show examples of ways to improve stability and enable triggered release of drug-loaded polymer micelles.

Biologics

Biosimilars – Regulatory Primer for Formulation Scientists

Paul Chamberlain, Member, NDA Advisory Board, NDA Advisory Services Limited

The EU regulatory pathway for marketing authorization of biosimilar medicinal products was established in 2005. This presentation will illustrate how the principles have been applied in practice to authorize different products, including implications for product formulation.

  • EU regulatory framework for biosimilars
  • Practical considerations for choice of Reference Product
  • Case examples to illustrate multidisciplinary weight of evidence for authorization
  • Considerations for justifying differences in drug product formulation

Technology & Innovation

Transporter-Mediated Brain-Targeted Prodrugs

Dr. Kristiina M. Huttunen, Adjunct Professor (Docent) Finnish Academy Research Fellow, University of Eastern Finland

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Device Development

Human Factors Engineering for Medical Device Development

Rémy Vomscheid, Director, Device Development & Technologies, Ipsen

  • Human Factors Engineering: overview & regulatory framework
  • Patient-centricity in Device Design and Development
  • Case study

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

  • Article 117 of EU MDR introduces the need for single integral medicinal products with a device component of class IIa and above to have a Notified Body opinion – what does this mean for combination product manufacturers? And what can manufacturers do to be ready for this change in regulations?
  • Notified Bodies will have to apply for MDR designation – what will the impact on this have on the availability of Notified Bodies to meet growing demands and timelines?
  • What will Rules on up classification mean for development and continued marketisation of Devices which will be up classified from class I to class IIa or b such as Rule 20 for inhalers?

5:40 PM - 5:45 PM

Poster Presentation Award

5:45 PM - 5:50 PM

Chair’s Closing Remarks and End of Day 2

Mostafa Nakach, Head of Pharmaceutical Engineering, Sanofi

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

Globally, the pressure on healthcare costs and resources is increasing and aspects such as limited infusion capacity or complex drug preparation procedures markedly contribute to this challenging situation. Especially with a large number of biologic agents being developed for intravenous infusion and frequently for combination therapy, companies are more and more looking into simplifying drug delivery with the aim to improve access and to reduce healthcare costs and resources. Today, subcutaneous versions are available for a number of biotherapeutics even in oncology there is the desire to explore whether these presentations can be administered in the home setting. Typically, in case a treatment is well tolerated, given in monotherapy, and patients live far from an oncology center, such a flexible care setting would be appreciated in a number of countries. A key requisite for enabling home- or self-administration would be the availability of a suitable injection device that can administer larger dosing volumes exceeding 5 mL or more (i.e., ideally ready-to-use with limited administration steps required). In addition, connected device features, such as dosing reminders, adherence trackers, and electronic patient diaries, that also allow an ongoing dialogue with healthcare professionals can be of value in this context. The keynote presentation will present an update of the current status in the field, discuss related opportunities and challenges, and outline future perspectives.

9:35 AM - 10:10 AM - Case Studies

Small Molecules

3D Printing as an Investigative Tool in Particle Detachment

Tim Rouse, Senior Scientist, Chiesi

  • 3D printing at the micro scale
  • Particle detachment from a 3D printed surface
  • Evidence for Rock and Roll particle detachment
  • Impacts of surface rugosity on entrainment of particles (detachment) using the controlled customised 3D printed surfaces

Biologics

Impact of ABC Transporters at the Blood Brain Barrier

Gert Fricker, Director, Institute of Pharmacy and Molecular Biotechnology, University of Heidelberg

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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

In the early preclinical development pharmaceutical industry, biopharm scientists support project teams at several timepoints in the pre-development and entry in to development stages, helping choosing the right molecule, the right formulation(s) for safety studies and early clinical development, minimizing trails & errors and therefore allowing to keep a fast pace.

In this presentation we will illustrate in particular:

  • The use of Drugability Classification System at precandidate stage
  • How good physicochemical profiling followed by selective drug absorption in Dog studies combined with ACAT & PBPK Dog modelling can allow to refine expectations for a given formulation strategy in Human
  • How dissolution & modelling can provide support during phase I
The presentation will rely on a multi-API analysis to better grasp the presented models strength & limits.

Device Development

Benefits and Challenges from Pharmaceutical Industry Perspective

Torsten Kneuss, QA Manager Combination Products, Bayer

The presentation will provide an overview about Software (e.g., Apps) which is regulated as a medical device or as device-constituent part of a combination product and is either being used in conjunction with drug-delivery devices or as a support tool for patients, HCPs or other users in the course of the use of drug products. Main topics will be an overview of the applicable regulations and practical experience gained from an existing medical software solution.

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

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Technology & Innovation

Targeting Specific Patient Populations for Distinct Oral Dosing Formulation Challenges – Flexible Technology is Key

Sven Stegemann, Director, Pharmaceutical Business Development, Lonza

  • Review of the key trends in regulatory guidance driving patient-centric drug development
  • Key requirements for oral solid patient-centric product
  • Insights into the evidence of patient-centric formulation for the pediatric populations
  • Formulation approaches and technology platforms available for meeting target product profiles factoring in clinical targets, special populations and weight based dosing
  • Formulation and technology considerations for ensuring viable and scalable manufacturing for specialized dosage formats. 
  • Case studies demonstrating technology and formulation approaches and rationale for meeting target product profiles with two different problem statements

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 

  • General introduction to continuous manufacturing
  • Introduction to principles of control strategy elements
  • Insight to building a robust control strategy

Technology & Innovation

Bispecifics Drug Product Development; Challenge of Low Concentration Analysis and Formulation

Sachin Dubey, Head of Formulation and Analytical Development, Glenmark

  • Glenmark’s BEAT format – advantages, flexibilities, applicability etc.
  • Formulation and stability aspects of bispecifics.
  • Strategies to overcome analytical and formulation challenges for a highly potent molecule.
  • Preparation for clinical trials for extremely low FIH starting dose.

Technology & Innovation

Controlling the Formation API Solvates and Hydrates

Gabriele Sadowski, Professor for Thermodynamics, TU Dortmund University

  • Drying of solvate-forming APIs
  • Influence of hydrate and solvate formation on API solubility
  • Water sorption in hydrate-forming ASDs
  • Hydrate formation in ASDs during long-term storage at humid conditions

Device Development

Harnessing the Power of the Digital Exhaust and Digital ATM in Wellness Programs

Graham B Jones, Director of Innovation, Novartis

Clinical decision-making using diagnostic, prognostic, and monitoring biomarkers requires coordination between the healthcare and technology industries and careful design of longitudinal efficacy studies. Community health providers and pharmacies are poised to play a pivotal point‑of‑care role by helping capture prodromal diagnostic data and incorporating biomarker monitoring into wellness programs.  A model for the pharmaceutical in­dustry to embrace these patient engagement opportunities is outlined together with recent advances in connected care and digital enabled treatment solutions.

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

  • Rapid assessment of absorption characteristics through the GI tract
  • Early stage testing of variations of candidate formulations
  • Solutions to overcome formulation challenges

12:30 PM - 1:05 PM - Solution Spotlights

Technology & Innovation

Risk Mitigation in Topical Product Development

Rob Turner, Vice President of Business Development and Innovation, MedPharm

  • Understanding the differences in semi-solid and solid dosage form development
  • The risks associated with topical formulation development
  • The use of performance testing to optimise product safety, efficacy and quality

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

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Biologics

In-use Studies: Some Case Studies

Héloïse Audat, Head of Late Stage Formulation Development Unit, Biologics, Sanofi

  • Challenges of in-use studies: how to well design them.
  • Several adsorption case studies (mAb, ADC and highly potent product)

Technology & Innovation

Digital Design of Pharmaceutical Products and Processes

Johannes Khinast, Director , Research Center Pharmaceutical Engineering

  • In silico API design
  • Continuous manufacturing
  • Pharmaceutical formulation design
  • Large-scale process simulations
  • Artificial intelligence and machine learning

Pharmaceutical companies have started to embrace digital design of products, and especially “big pharma” is leading the way in using advanced computational methods for a wide variety of objectives, including target identification, in silico API design and prediction of API properties, as well as biopharmaceutics. Formulated product design and the effect of processing have received less attention, yet are increasingly becoming embedded in modern product development pathways. In my talk I will present state-of-the-art methods for the design of pharmaceutical formulations (e.g., with respect to stability or biopharmaceutics) and for the analysis and control of pharmaceutical manufacturing operations, with a focus on continuous manufacturing.

These methods combine molecular design approaches with large-scale process simulation methods (e.g., high-fidelity discrete element methods coupled to advanced CFD, including smoothed particle hydrodynamics of Lattice-Boltzmann methods), as well as state-of-the-art control methods. Examples are given (e.g., hot-melt extrusion, fluid bed operations, blending, bioreactor technology) and open challenges are highlighted. Also the promises of AI are critically reviewed.

2:05 PM - 2:40 PM - Case Studies

Device Development

Benefits of Early Integration of Human Factors: A BYDUREON® BCise case study

James Meehan, Associate Principal Scientist – Human Factors , AstraZeneca

  • This presentation will provide a case study of a HF program for the development of a combination product used to treat type II diabetes
  • This product was initiated in 2009 and has therefore been developed during a period of evolving HF guidance. The presentation will discuss evaluations that were conducted at multiple design stages with representative users, as well as iterations to the design user interface to mitigate observed performance issues
  • This presentation will include an overview of interactions with regulators as well as the importance of having a dialogue with regulators throughout the development process.

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

Kerstin Egele, Doctoral researcher, Institute of Organic Macromolecular Chemistry, Saarland University

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Biologics

Characterization of Subvisible Particles: Old Challenges and Newest Improvements

Anacelia Ríos Quiroz, Scientist - Group Leader Particle Lab Biologics, Roche

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2:45 PM - 3:20 PM - Case Studies

Technology & Innovation

Polysorbate Degradation: Implications and Control

Dr. Franziska Edelmann, Scientist - Pharma Technical Development Analytics , Roche

  • Polysorbate degradation
  • Impact of polysorbate degradation on drug stability
  • Improving stability of polysorbate

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

Recent studies have reported that dysphagia is an increasing problem among ageing population who are a growing demographic. Therefore alternative solutions specifically tailored to the special needs of older populations, are required by enhancing the development of novel delivery systems and doses. Composite freeze-dried wafers comprising combinations of metolose (MET), carrageenan (CAR), and low molecular weight chitosan (CS) have been developed for potential delivery of low dose aspirin via the oral route and buccal mucosa. Optimised wafers have been functionally characterised using scanning electron microscopy, X-ray diffraction, mechanical strength, in vitro mucoadhesion, swelling capacity, drug dissolution and release, in vivo taste masking, permeation of aspirin released from wafers using three different models (ex-vivo and in-vitro).  Overall the optimised lyophilised DL wafers seems to be a very promising system for the administration of low dose aspirin for older patients with dysphagia.

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

Nanosuspension based formulations
  • What do we know about nanosuspensions and preparation thereof
  • If one method is suited to formulate Nano suspension all the drugs
  • How efficiently nanosuspensions could be used enhance bioavailability of the poorly soluble drugs
  • Is it possible to use nanosuspensions for delayed release upon parenteral administration

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

  • Self-emulsifying drug delivery systems (SEDDS) can inherently contain permeation enhancers, which are needed for facilitating peptide and protein absorption across the gastro-intestinal epithelium.
  • Incorporating a hydrophilic protein into a lipophilic matric represents a challenged, but is achievable by complexing the protein with a lipophilic emulsifier.
  • Functionalising the SEDDS with protease inhibitors, lipase inhibitors and mucus enhancing/permeating molecules has shown feasible and will incorporate the desired functionality into the SEDDS (f-SEDDS)

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

A label-free device has been developed, based on differential double-layer capacitance readout at micro-fabricated gold electrodes, to detect biomarkers in serum or other bio-sample volumes. By means of electrochemical impedance spectroscopy (EIS) measurements in a three electrodes set-up, the device functionalized with self-assembled monolayers of DNA has been calibrated, by measuring in real time the differential capacitance changes at variable concentrations of DNA in a saline buffer, obtaining a dynamic range extended over few orders of magnitude. Micro-RNAs has then been quantified in human plasma of patients with heart disease, demonstrating a limit of detection (LOD) of 1 pM and the possibility to detect single base mismatch in the target sequence. The same platform was successfully used to detect Her2 in serum, by means of a Her2 directed nanobodies (single domain antibodies) conjugated with the DNA strand complementary to that immobilized on the microelectrode. A further device development towards multiplexing read-out, integrated with a paper-based microfluidic set-up is in progress

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

Louise Place, Head Of Regulatory Affairs and Senior Quality Assurance Consultant, Cambridge Design Partnership

  • With the recent first FDA draft Guideline on Patient-Focused Drug Development (PFDD) and three additional guidelines to follow as well as the finalization of the EMA Reflection on pharmaceutical development of medicines for use in the older population”, patient centric drug product development is becoming mandatory for the pharmaceutical industry
  • What does it mean to the pharmaceutical industry, how do we build a framework of patient centric/focused drug product development
  • Take an opportunistic view how this can help to create a competitive advantage by adding real value to patients and payers
  • Debate on how to best take advantage of the emerging regulation and influence its implement

5:45 PM - 5:50 PM