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  • small moleculess
  • biologics
  • technology and partnerships

FOCUS DAY, 17 February 2014

12:40-13:20
13:20-13:30
13:30-14:10
interactive workshop


  • Latest innovations in desiccant moisture management
  • Time to market reduction by mastering primary packaging atmosphere 

Valère Logel
Head of Development
Clariant Healthcare Packaging
France

interactive workshop

Expediting First-in-Human (FIH) and Proof-of-Concept (PoC) programs through the integration of real time manufacture and immediate clinical testing

Quotient Clinical Logo

 

  • Translational Pharmaceutics – a proven paradigm reducing time, cost and risk in early development
  • Drawbacks of conventional CMC approaches for FIH studies
  • Enabled FIH programs – risk-based formulation design and screening within SAD/MAD studies
  • Rapid access to PoC patient groups within integrated protocol designs
  • Identification of scaleable, developable drug products

Dr. Peter Scholes
Chief Scientific Officer
Quotient Clinical

14:10-14:50
interactive workshop

  • Optimising the productivity of spray dried dispersion production
  • Development of an extrudable grade of  HPMC for solubility enhancement 
  • Tailoring the spray performance and deposition location of liquid nasal formulations  

Amina Faham
Sr. Pharmaceutical Application Manager
The Dow Chemical Company

interactive workshop


  • Lipid formulations - Investigating the progress of digestion and release of API via lipolysis titrations
  • Solid dispersions - Examining how long the drug can be preserved in supersaturated form in the presence of polymers and excipients
  • Oral drugs - biphasic dissolution experiments supplying data regarding potential bioavailability as a function of gastric pH, transit time and passive diffusion into a lipid layer

John Comer
Chief Scientific Officer
Sirius Analytical

14:50-15:30
interactive workshop

Utility of Super-API Technology in delivering drugs with clinically significant pharmacological improvements

  • Transformational improvement in drug solubility, permeability, bioavailability and kinetics associated with robust new IP, that is applicable across a wide range of poorly soluble compounds and compound classes
  • Approaches to deliver Super-API compounds with earlier tmax, higher Cmax and higher exposure leading to clinically meaningful benefits
  • Converting parenteral drugs into orally available high-value pharmaceutical Super-API products
  • Assessing potential opportunity of pH independent absorption significantly reducing the disadvantageous food effect and overall variability of compounds assocoated with it
  • Validated, scalable, GMP compliant distruptive continuous scalable approach applicable from early discovery phase to cGMP production scale

Gabor Heltovics
CEO
Druggability Technology Holdings

interactive workshop

Understanding the needs in developing release tests for special delivery systems 

  • Devices for long term drug delivery for: inserts/implants; parenterals; and medical devices
  • Application of USP apparatus 7
  • Accelerated release testing

Sandra Klein
Professor of Pharmaceutical Technology
University of Greifswald

15:30-16:00
16:00-16:40
interactive workshop

Intec Pharma's Accordion Pill™, a novel, proprietary gastric retentive dosage form, is a proven solution for:

  • Low bioavailability and non-linear pharmacokinetics of BCS class II and IV drugs
  • Poor efficacy of narrow absorption window drugs
  • A detailed description of the technology and recent data obtained in various clinical programs will be presented   

Nadav Navon
Vice President R&D and Operations
Intec Pharma

interactive workshop

  • Amorphous spray-dried particles for improved oral pharmacokinetics
  • Solid lipid particles for improved oral pharmacokinetics
  • Spray-dried particles for improved lung  and nasal pharmacokinetics and dynamics
  • Case studies for each technology and delivery route

Dr David K Lyon
Sr. Vice President–Research
Bend Research Inc.

16:40-17:20
interactive workshop

  • Importance of data standardisation
  • Advantages of cross-departmental application
  • Document, content and process management in one solution - formulation example
  • Integrated reporting
  • Interactive discussion

Sinisa Belina
Senior Life Sciences Consultant
INFOTEHNA

interactive workshop

  • What is a compaction simulator
  • The compression process
  • Experimentation
  • Synergy of MCC with DC lactose

Gary Norman
Technical Manager EMEA
DFE Pharma

17:20-18:00
interactive workshop

Correlating in-vitro profiles with in-vivo studies to accurately predict the performance of pharmaceutical dosage forms

  • Dissolution and release fundamentals
  • Principles of flow through cell (USP4)
  • Case study 1: oral tablet formulation
  • Case study 2: injectable suspension formulation
  • Case study 3: liposome formulation

Samir Haddouchi
Managing Director
SPS Pharma Services

interactive workshop

18:00-18:10

DAY 1, 18 February 2014

07:20-08:05
08:10-08:15
08:15-08:55
keynote

Creating an essential regulatory check list for new formulations

  • Understanding fundamental requirements on the use of new and experimental dosage forms
  • Evaluating what excipients should be used and which ones should be avoided on safety and toxicology basis
  • Successfully meeting  assessors expectations when submitting dossier for formulation development
  • Identifying the easiest way to seek guidance from regulators
  • Keeping up to date with emerging EMEA legislations

Dr. Keith Horspool
VP, Pharmaceutical Development USA
Boehringer Ingelheim
USA

Gabor Heltovics
CEO
Druggability Technology Holdings

Stephan Buchmann
Head Preformulation & Preclinical Galenics
Actelion
Switzerland

08:55-09:35
keynote

What's my motivation? - Partnering as a key to success for addressing healthcare R&D challenges

  • There's no one size fits all - Tailoring partnering models to meet different collaboration goals
  • Iceberg ahead- The role of alliance management in managing open innovation
  • Examples from the Bayer HealthCare R&D collaboration portfolio

Christoph Huwe
Global External Innovation & Alliances
Bayer
Germany

09:35-11:20
11:20-12:00
conference room a
small molecules

Using novel and known technologies that are available in the market to improve the solubility of new compounds

  • Using past case studies to identify what crucial lessons have been learnt and how it can be applied for future projects
  • Understanding how to enhance solubility and bioavailability for both emerging and existing therapies
  • Improving solubility and bioavailability by setting out clear strategies from the onset
  • Evaluating challenges that new technologies can present to both existing therapies and future therapies

Stephan Buchmann
Head Preformulation & Preclinical Galenics
Actelion
Switzerland

conference room b
biologics

  • Improving stability and preventing aggregation using novel excipients and technologies
  • Tackling high viscosity using simple approaches
  • Technologies for half life extension and role of devices

Anand Subramony
Principle Fellow and Head at Novartis Institutes for BioMedical Research
Novartis
US

conference room c
technology and partnerships

Collaborating with partners and sharing risk by eradicating traditional frame works

  • Successfully generating a solid framework to bridge gaps between two different companies by eliminating different working practices
  • Communicating with your partners efficiently in order to have clear business objectives
  • Aligning the productivity strategy to address developmental challenges and to meet business imperatives

 

Tomas Landh
Director
Novo Nordisk
Denmark

12:00-12:40
interactive workshop


  • Overcome limitations of direct compression
  • Shorten development time
  • Reduce time to market

Dr. Leonhard Ohrem
Portfolio Manager, Pharma Raw Materials
Merck Millipore

interactive workshop

Bringing the digital drug delivery platform of the future into practice today

  • Benefits of electronic oral drug delivery
  • Medimetrics IntelliCap® system
  • Faster development through reliable in-vivo absorption data
  • New therapies and business models for pharma 

Jeff Shimizu
CTO
Medimetrics Personalized Drug Delivery, Inc.

interactive workshop

Using the power of automation to improve repeatability, data quality and knowledge retention

An introduction to automation followed by case studies in:

  • Polymorph and salt screening
  • Lipotropic nanoparticle dispersions
  • Hot melt extrusion

Jake Grace
Workflow Architect
Chemspeed Technologies
UK

12:40-13:40
13:40-14:20
conference room a
biologics

Vaccines are complex products of particulate nature, consisting of e.g. viruses, virosomes, virus-like particles, or adjuvanted proteins

  • Vaccine formulation development aims to preserve physical, chemical and biological integrity and efficacy, ideally in liquid form and without a cold chain
  • High-throughput techniques can accelerate and improve the difficult and time-consuming task of vaccine formulation development
  • Automated liquid handling is used for fast preparation of a multitude of formulations in microplates and vials.
  • A variety of high throughput analytical methods are used: absorbance and fluorescence spectroscopy, dynamic light scattering, imaging, microscopy and potency 
  • The various formulations are characterised before and after accelerated stress.
  • Automated data analysis is applied to select the most promising formulation candidates

Renske Hesselink
Scientist Formulation & Fill/Finish Development
Crucell
Netherlands

conference room b
biologics

Successfully predicting protein-protein interactions by using the latest computerised technology

  • Four in silico tools and their practical application to the prediction and characterisation of protein-protein-interaction are demonstrated: SAP (Spatial Aggregation Propensity) identifies hydrophobic patches and is applied to engineer mAbs and ADCs with increased stability.
  • DI (Developability Index) predicts aggregation propensities based on SAP and net charge. SCM (Spatial Charge Map) ranks mAbs according to viscosity. SIM (Spatial Interaction Map) predicts hot spot residues for specific protein-protein-interaction sites

Bernhard Helk
Head New Technologies
Novartis
Switzerland

conference room c
technology and partnerships

Understanding the history and current status of transdermal delivery   

  • Exploring the future of transdermal technology including active delivery        
  • Knowing the benefits, challenges and limitations of passive transdermal
  • Understanding physicochemical requirements on formulation and APIs for transdermal systems   
  • Successfully overcoming regulatory hurdles of transdermal delivery
  • Identifying the key market drivers for transdermal patches

Dr. Hans Michael Wolff
Director
UCB Biosciences
Germany

14:20-15:00
interactive workshop

Focus on Suspensions Formulations

  • Introduction to ion exchange excipients: History, solutions and strengths
  • Drug delivery systems that use ion exchange excipients
  • Focus on suspension formulations using ion exchange technology
  • Processing using ion exchange excipients
  • Case studies using ion exchange and coating technologies

Amie Gehris
Technical Service Manager - Healthcare and Specialty Nutrition
The Dow Chemical Company

interactive workshop


  • Drug delivery customisation can address the needs of patient subpopulations such as pediatrics, geriatrics, dysphagia patients, adolescents, and patients with mental illness
  • How a proprietary formulation with a novel technology satisfies patient centric needs and improves patient compliance/ adherence to therapy
  • Aptalis has proven expertise in providing innovative/effective therapies for unmet medical needs

Mauro Serratoni, PhD
Group Leader and Formulation Scientist
Aptalis Pharmaceutical Technologies

Nadine Maalouf, PharmD
Director, Licensing Pharmaceutical Technologies
Aptalis Pharmaceutical Technologies

interactive workshop

Challenges in Drug Development

  • Opportunities of nano scale API presented to pharma companies
  • Fundamentals of agitator bead mills for micronisation
  • Real comminution vs. dispersing
  • Machine characteristics of agitator bead mills
    • Design criteria
    • Materials of construction
  • Case Study – Janssen Pharmaceuticals
  • Nano-enabled drugs on the market

Markus Maier
Technical Support Pharma
NETZSCH Feinmahltechnik GmbH

15:00-16:00
16:00-16:40
conference room a
small molecules

Drastically improving efficacy and quality of compounds by using HME

  • Improving both the quality and the efficacy of manufactured products by using HME
  • Enhancing therapeutic efficacy, improving absorption and increasing dissolution
  • Overcoming solubility challenges by dispersing APIs in a matrix at a molecular level to form a solid solution

Navnit Shah
Former Head of Oral Formualtion
Roche
US

conference room b
biologics

A prototype for the sustained release of pharmaceutically relevant monoclonal antibodies was developed using silk lyo-gels

  • Silk antibody hydrophobic/hydrophilic interactions are the primary driving force controlling the sustained release. Hydration resistant offers a secondary means through which antibody release could be controlled by inducing high density β-sheet
  • The process for preparing the lyo-gels does not expose the antibody to manufacture stresses (organic solvents, temperature, shear, etc.)
  • Improved long term release of antibodies from lyo-gels when compared to hydrogels was obtained.
  • The therapeutic molecule could be selected or engineered with different hydrophobicity or surface charge to aid in the optimisation of the sustained local delivery profile

Bernardo Perez-Ramirez
Senior Scientific Director, BioFormulations Development
Genzyme
US

conference room c
technology and partnerships

Using nanomaterials and oral bioavailability of poorly soluble drugs

  • Understanding how nanomaterials can be used for drug targeting
  • Assessing how nanomaterials and sustained-release can be used for self-assembling nanosystems and polymer nanogels

Dr Joël Richard
VP, Peptides
Ipsen
France

16:40-17:20
keynote

Reducing risk and cost in delivery and formulation investigations by using the latest simulations

  • Using developmental models to improve decision making and creating leaner and faster developmental processes
  • Reducing delivery and formulation timelines to bring products to market faster
  • Understanding how to streamline complex formulation processes and to maximise delivery and formulation efficiency
  • Identifying winning strategies to cut cost in delivery and formulation whilst promoting the growth and success of R&D

Anand Subramony
Principle Fellow and Head at Novartis Institutes for BioMedical Research
Novartis
US

Andreas Bhagwani
CEO
Nanologica

Dr Joël Richard
VP, Peptides
Ipsen
France

Dr. Hanshermann Franke
Head of Research & Development
LTS Lohmann Therapie-Systeme AG

PJ Anand
Founder, President & CEO
Alycone Lifesciences Inc

Tomas Landh
Director
Novo Nordisk
Denmark

17:20-17:30
17:30-18:30

DAY 2, 19 February 2014

07:35-08:20
08:20-08:30
08:30-09:10
keynote

Effectively managing formulation and delivery pipelines by using QbD

 

  • Successfully using data management and information to support knowledge management in delivery and formulation
  • Utilising technical tools, software to gain knowledge out of data and identifying the gaps in knowledge management
  • Implementing QbD on individual steps of development from formulation and delivery
  • Setting out clear CQP and CPP from the onset to aid QbD implementation
  • Applying DoE and PAT from early stage development to manufacturing
  • Using knowledge in unit operations to aid quality risk assessment by using ICH guidelines (Q7-Q11)

Chetan Pujara
Senior Director, Product Formulation Development
Allergan
US

09:10-09:50
conference room a
small molecules

Non-adherence to therapy has a huge impact on society and is an increasing burden to healthcare systems

  • Understanding the drivers of non-adherence
  • Opportunities to improve patient adherence in drug delivery

Olaf Queckenberg
Global Drug Discovery - Global Chemical & Pharmaceutical Development
Bayer
Germany

conference room b
technology and partnerships

Microcatheter platform for highly targeted and controlled direct delivery to the brain

Most advanced delivery platform for direct intraparenchymal delivery of therapeutics

Best-in-class delivery system for acute or chronic delivery of therapeutics irrespective of size, shape and charge

Management team with significant experience executing on successful biopharma collaborations

PJ Anand
Founder, President & CEO
Alycone Lifesciences Inc

09:50-11:10
11:10-11:50
conference room a
small molecules

Employing HME as a cost effective method of increasing solubility of water insoluble APIs

  • Identifying the appropriate excipients for HME processing of water insoluble drugs by using molecular modeling
  • Using novel inorganic excipients to achieve increased dissolution rates (continuous granulation)
  • Extrusion with polymeric carriers for the development of solid dispersions
  • Continuous co-crystallisation of water insoluble drugs 

Dennis Douroumis
Director of Centre for Innovation in Process Engineering and Research
Greenwich University

conference room b
biologics

Protein aggregates and colloidal stability: How can colloidal protein stability be predicted

  • Assessment of protein aggregates from the nm to mm scale
  • Process parameters during manufacturing influencing the formation of protein aggregates
  • Protein aggregate analytics: current trends to cover the micrometer gap

Patrick Garidel
Associate Director
Boehringer-Ingelheim
Germany

conference room c
technology and partnerships

Different challenges and perspectives of pharmaceutical spray drying (SD) - spanning from the laboratory up to large pharmaceutical commercial scale

 

Three case studies will be presented:

  • SD vs Freeze drying  - Due to the fact SD is a continuous,  gentle drying process with the ability to manipulate powder properties, the number of processes moving from Freeze Drying to SD has increased exponentially. Pharmaceutical development data, including final dosage forms, will be used to compare both technologies
  • Mimicking large scale powder properties with a modified lab scale setup  - In the laboratory scale, powder properties (particle size, density, solvent) are typically poor due to the reduced size of the drying chamber and ability to manipulate droplet size and residence time. In this example both these points will be address by the authors
  • Commercial scale manufacturing challenges – maximizing throughput while maintaining powder properties


Marcio Temtem
Group Leader - Pharmaceutical Development
Hovione

Sune Klint Andersen
Principal Scientist - Drying Processes
Novo Nordisk AS

11:50-12:30
interactive workshop

Presentation of Fresenius Kabi’s QbD approach for developing sterile pharmaceuticals

  • Establishing a systematic toolkit for process optimization for sterile aqueous formulations, emulsions, liposomal formulations, suspensions and lyophilisates

Case studies:

  • Identification of an appropriate container closure system for parenteral drugs
  • Systematic testing of oxygen sensitive drugs
  • Exploiting freeze drying microscopy for lyophilization
  • Multidimensional process optimization by DoE for developing emulsions as drug-carriers for lipophilic APIs

Dr. Franz Kainz
Director Contract Development
Fresenius Kabi Product Partnering

interactive workshop

  • Discussing the industrial processes most commonly used to prepare liposomal products
  • Understanding which process is the most suitable for your liposomal product
  • Addressing the challenges of scaling up liposomal formulations from bench to industrial scale (100-250L)
  • Increasing robustness and controlling critical process parameters of complex processes such as high pressure homogenisation: Insight into scale up strategy using case study and examples

Marie-Andrée Yessine, Ph.D.
Senior Development Scientist
OctoPlus

interactive workshop

Improving encapsulation of APIs in a stabilised form through a tightly controlled internal porous structure using NLAB Silica™ platform technology

  • Presentation of real case studies showing increased solubility of even the most poorly soluble molecules 
  • Superior amorphous stability shown over years
  • Insight into the key determining factors guiding which APIs are applicable to this technology: from API structure to pore size and surface chemistry 
  • Transforming hard to handle molecules into free flowing powder; improving dose uniformity in oral formulations  
  • Proof of Principle in vivo shown: NLAB Silica™ successfully delivers differentiation factors to embryonic stem cells to induce specific differentiation to functional motor neurons 

The presentation concludes with an interactive session on "Pros and cons of the applicability of mesoporous silica based technology".

Dr Adam Feiler
CTO
Nanologica

12:30-13:10
conference room a
small molecules

Using Poly(2-oxazoline)s as a versatile drug delivery platform

  • Identifying the benefits of well-controlled living cationic ring-opening polymerization of 2-oxazolines 
  • Understanding biocompatibility of poly(2-oxazoline)s 
  • Examining the high capacity formulations of paclitaxel and exploring the formulation of other highly hydrophobic drugs
  • Identifying both safety and efficacy in early in vitro and in vivo cases from the onset


Robert Luxenhofer
Professor
Julius-Maximilians-Universität Würzburg

conference room b
biologics

Overview of the role of human albumin in the formulation and delivery of peptide drugs

  • Use of recombinant albumin formulations in delivering enhanced stability of peptide formulations
  • The role of engineered albumins in delivering tuneable half-life extension of peptides and proteins

Mark Perkins
Customer Technical Manager
Novozymes

conference room c
technology and partnerships

Combining the resources of both small and large pharma to obtain the best clinical outcome

  • Efficiently tapping into external drug delivery resources to aid formulation studies
  • Sharing risk in studies by dividing equal responsibilities between internal and external resources

Amer Alghabban
Director, Global Quality Assurance Audting
Acino Pharma
Switzerland

13:10-14:10

Recent advances in biorelevant dissolution methodology

Paul Whittles
Director of Sales & Marketing
Sirius Analytical

Addressing challenges in the formulation development of biopharmaceuticals

Russell Burge, Ph.D.
Application Scientist, Life Sciences
Freeslate, Inc.

14:10-14:50
conference room a
small molecules

Exploring the benefits of using Crystalline Nanosuspension

 

  • New chemical entities are invariably poorly soluble, which presents a challenge for intravenous drug delivery

  • Various technologies such as co-solvents, emulsions, liposomes, cyclodextrins and “pro-drugging” have been used enable delivery, however each generates significant complications

  • The opportunity to use a crystalline IV nanosuspension will be described together with API selection, formulation excipient, process and regulatory considerations

  • Nanosuspension characterisation will be discussed and a “case-study’ of a prototype crystalline IV nanosuspension will be outlined

     

Nick Barker
VP
Cubist
US

conference room b
biologics

Accelerating development and formulation of biologics by using high-throughput methodologies

  • Successfully using high throughput research systems in a strategic manner to understand the effect of pH, stability of compounds to create improved formulations
  • Improving decision making processes by building array based formulations, managing data assessing stability of compounds, integrated analytics and stressing formulations

Xavier Lesaout
Lead Preformulation activities
Merck Serono
Switzerland

conference room c
technology and partnerships

Overcoming the challenges of resources and high attrition rate associated with the development of new antibodies

  • Historically, the pharmaceutical development of antibodies was a tailor-fitted-molecule-dependent approach for each new molecule
  • With an increased amount of antibodies generated by research, a new strategy to enable a fast early phase development based on the extensive experience gained with previously developed molecules was developed
  • Significantly reducing the development efforts needed to initiate phase I clinical trials

Benoit Nossuge
Senior Scientist
Novartis
Switzerland

14:50-15:30
interactive workshop

Polymer micelles for anticancer drug delivery
  • Utilising a novel water soluble polymer, an innovative polymer micelle-based drug delivery platform has been developed to improve performance over the conventional ones
  • The platform is applicable to most hydrophobic drugs for overcoming dose-limiting toxicity and patient intolerability especially for anticancer therapeutics
  • The enormous potential and prospective of these micelle nanoparticles as potent anticancer nanotherapeutics are discussed
  • It is reasonable to believe that these nanotherapeutics would achieve clinical success to an extent even greater than Abraxane

Dr. Wenbin Ying
Vice President
Nitto Denko Technical Corporation

interactive workshop

 Freeslate

  • Demonstration of how automated systems can solve key challenges in development laboratories, including through-put and data management
  • Enhancement of productivity and reproducibility of your current activities using Freeslate automation
  • Automation of previously laborious or manual methods and procedures using proprietary instruments
  • Findings from a case study performed using 2R (2 mL) serum vials

Russell G. Burge, Ph.D.
Application Scientist
Freeslate Inc.

15:30-16:10

Understanding how to implement priority based resourcing of projects in CMC functions

  • Activities which need to be done for high priority projects
  • Minimal paradigm and success triggered resourcing for medium priority projects
  • How to measure compliance with this guidance?
  • How to overcome resistance in the project teams?

Dr. Petra Wicklandt
Vice President Global Chemical & Pharmaceutical Development
Merck Serono
Germany

16:10-16:20