1. SMi Presents their 3rd Annual Conference on…
PLUS TWO HALF-DAY POST-CONFERENCE WORKSHOPS
Wednesday 1st July 2015, Holiday Inn Regents Park Hotel, London, UK
A: Spray Dry and Formulation
Workshop leaders: Jim Bullock, Director, iFormulate Ltd
David York, School of Chemical and Process Engineering,
University of Leeds
8.30am - 12.30pm
B: Defining and implementing QbD
in the design space for Scale up
Workshop leader: Pierre Lebrun, Experienced Statistician
- Project Leader, Arlenda
1.30pm - 5.30pm
29-30
JUNE
2015Holiday Inn Regents Park Hotel, London, UK
Lyophilisation -
Europe
www.lyophilisationconference.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
ACADEMIC & GROUP DISCOUNTS AVAILABLE
BOOK BY 31ST MARCH AND SAVE £400
BOOK BY 30TH APRIL AND SAVE £200
BOOK BY 29TH MAY AND SAVE £100
CONFERENCE CHAIR:
Poul Bertelsen,
Principal Scientist, Takeda
KEY SPEAKERS INCLUDE:
• Yves Mayeresse, Director Primary and Secondary
Expertise, GSK
• Patrick Garidel, Head of Pharmaceutical Basic
Development, Boehringer-Ingelheim
• Eunice Costa, Process Development Engineer, Hovione
• Sune Klint Andersen, Principal Scientist, Novo Nordisk A/S
• Michael Dekner, Innovation Manager, Baxter Bioscience
• Edith Lecomte-Norrant, GPS Innovation & Technology &
Sciences Director, UCB BioPharma
WHY ATTEND THIS EVENT:
• Understand the fundamentals of freeze drying and
methods to optimise the process development
• Learn how to integrate risk-based approaches into QbD
principles
• Discuss strategies for improvement and areas of unmet
needs in our roundtable breakout session
• Gain new insight of spray-drying methodologies to
achieving continues –processing
• Strengthen understanding of how PAT can be applied in
lyophilisation.
@SMIPHARM
Protecting drug stability and optimising formulation
development through robust PAT and QbD principles

2. Register online at: www.lyophilisationconference.com • Alternatively
Lyophilisation - Europe
Day One I Monday 29th June 2015
Supported by
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Poul Bertelsen, Principal Scientist, Takeda
QUALITY BY DESIGN PRINCIPLES (QBD)
AND SCALING UP OF LYOPHILISATION
OPENING ADDRESS
9.10 Applying Quality by Design Principles (QbD) and risk
assessment
• ICH guidelines
• The QbD process
• QRM management including examples
Poul Bertelsen, Principal Scientist, Takeda
9.50 The basics of freeze drying
Patrick Garidel, Head of Pharmaceutical Basic
Development, Boehringer-Ingelheim
10.30 Morning Coffee
11.00 Keynote address: Implementation of
QbD in lyophilisation
• Improving flexibility and robustness of
the process design
• Quantitative performance measures to ensure product
quality
• Identifying stabilising excipients to ensure drug stability
• Evaluating risk factor of material attributes
Yves Mayeresse, Director Primary and Secondary Expertise,
GSK
11.40 Important considerations for scale-up
• From lab to large scale
• A generic approach to scale-up
• Challenges of scale up
Michael Dekner, Innovation Manager, Baxter Biosciences
12.20 Networking Lunch
1.30 Round table breakout session:
• Group introductions and discussion
of challenges met
• Examine opportunities to implement and
optimise the application of QbD principles
in process development.
• Share concerns, success stories and major areas for
improvement
MODELLING PROCESS DEVELOPMENT
2.10 Spray-drying process development and scale-up for
complex dosage forms: an alternative to lyophilisation
• A viable alternative for achieving continuous production
• Benchmarking lyophilisation with spray drying
• Challenges in spray drying process and formulation
development for complex dosage forms
• Maintaining product critical quality attributes across scales
• Case study: Scale-up of spray dried formulations
Eunice Costa, Process Development Engineer, Hovione
2.50 Crystal nucleation: Theory and modelling
• Classical nucleation theory
• Multi-step nucleation
• Molecular simulation of crystal nucleation
• Modulation of crystal nucleation using additives
Jamshed Anwar, Associate Dean for Research & Professor
of Computational Chemistry, Lancaster University
3.30 Afternoon Tea
4.00 The mechanical properties of lyophilised cakes
• The properties of mechanical properties of lyophilised
cakes are a potential QbD property
• Discussion: The mechanical properties of protein-based
lyophilized cakes
Daryl Williams, Reader in Particle Science, Imperial College
London
4.40 Panel discussion:
• Review PAT and QbD principles and discuss
current challenges facing scale up and
quality control
• Discuss opportunities for continuous lyophilisation
• Identify ways to bridge the gap between commercial and
laboratory lyophilisation
Panel leader: Yves Mayeresse, Director Primary and
Secondary Expertise, GSK
Panellists:
Eunice Costa, Process Development Engineer, Hovione
Michael Dekner, Innovation Manager, Baxter Biosciences
5.20 Chair's Closing Remarks and Close of Day One
Official media partner Leading media partner
Keynote
Presentation

3. fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Lyophilisation - Europe
Day Two I Tuesday 30th June 2015
8.30 Registration & Coffee
9.00 Chair’s Opening Remarks
Poul Bertelsen, Principal Scientist, Takeda
PROCESS ANALYTICAL TECHNOLOGIES (PAT)
OPENING ADDRESS
9.10 Scale up methodologies for spray drying processes
• A viable alternative to achieving continuous production
• Optimising solution/suspension properties to maintain
critical quality attributes
• Challenges with atomization
• Case study: Spray drying of nanoparticles
Sune Andersen, Principal Scientist, Novo Nordisk A/S
9.50 Morning round table discussion
• How does PAT support scale up processes
and to what degree has it been successful?
• Discuss critical issues and major cost drivers
currently faced in scale up
• Discuss experiences with filing QbD reports and fulfilling
the requirements of PAT
10.30 Morning Coffee
11.00 The value of modelling in spray dried product development
• Understanding process influence and scale
• Predicting product structure and product quality
• Efficient approaches with models and experiments
Andrew Bayly, Chair in Chemical Engineering, Institute of
Particle Science and Engineering, University of Leeds
11.40 Engineering a continuous process to ensure
end product quality
• Controlling product structure and
homogeneity during freezing
• Process intensification and economic factors in scale up
• Integration with upstream and downstream operations
• Design for scalability and robust technology transfer
Bruce Williams, Managing Director, Williams Process Ltd
12.20 Networking Lunch
1.30 Enabling technologies in lyophilisation processes
• New approaches and robust technology transfer
• Recognising the need for and challenges of continuous
production in industry
• Case study
Andrew Tait, Postgraduate Research Engineer, Newcastle
University
CONTINUOUS IMPROVEMENT TO ENSURE PRODUCT QUALITY
2.10 Implementing QbD tools to optimise
product quality
• Integrating risk-based approaches
into QbD principles
• Maintaining continuous process
validation and control of process parameters.
• Case study on material flow
Pierre Lebrun, Experienced Statistician - Project Leader,
Arlenda
2.50 PAT on Pharmaceutical Processes
• Benefits of PAT in process development
• Implementing new technology in for PAT
Edith Norrant, GPS Innovation & Technology & Sciences
Director, UCB BioPharma
3.30 Afternoon Tea
4.00 Panel discussion:
• Application of Quality-by-Design to process
development
- Which steps are it most often applied to?
Is it relevant to apply it to all steps?
- How often is it used in IMPDs/CTAs?
- Experience with filing equations?
• Discuss the unique challenges facing design of experiments
• Future prospects for continuous production processes
• Critical issues and major cost drivers with technology
transfer in scale up
Panel leader: Sune Klint Andersen, Principal Scientist Novo
Nordisk A/S
Panellists:
Edith Norrant, GPS Innovation & Technology & Sciences
Director, UCB BioPharma
Bruce Williams, Managing Director, Williams Process Ltd
Andrew Tait, Postgraduate Research Engineer, Newcastle
University
4.40 Chair’s Closing Remarks and Close of Day Two
Want to know how you can get
involved? Interested in promoting
your services to this market?
Contact Teri Arri, SMi Marketing
on +44 (0) 20 7827 6162, or
email: tarri@smi-online.co.uk
Engineering
Spotlight
Keynote
Address:
Critical validation
processes and
risk-based QbD

4. HALF-DAY POST-CONFERENCE WORKSHOP A:
Wednesday 1st July 2015
8.30am - 12.30pm
Holiday Inn Regents Park Hotel, London, UK
Spray Dry and Formulation
Workshop leaders:
Jim Bullock, Director, iFormulate Ltd
David York, School of Chemical and Process
Engineering, University of Leeds
Overview of workshop:
Spray drying is an important manufacturing process for
pharmaceuticals and other formulated products. The
workshop will cover:
• What properties are needed in a spray-dried
formulated product?
• How are these properties measured?
• How can the formulation and process conditions be
designed to create the desired properties?
The workshop will include an overview of the science
behind spray drying, some relevant industrial examples as
well as an interactive group session.
Why should delegates attend this workshop:
Attendees will receive a valuable grounding in the
science and technology of spray drying and how this can
be used in designing formulations and using formulation
processes.
Programme
8.30 Registration and coffee
9.00 Opening Remarks
9.15 Spray drying principles
10.15 Modelling for spray drying
10.45 Coffee Break
11.15 Spray drying and formulated product properties
11.45 Interactive group session
12.15 Closing remarks
12.30 End of workshop
About the workshop leaders:
Dr Jim Bullock is co-founder and director of iFormulate
Ltd. Previously he was CEO of Intelligent Formulation Ltd
which promoted formulation technology in the UK.
After a D.Phil from Oxford, Jim led R&D projects in
imaging at Ilford Ltd and activities on crystal engineering
and dye formulation and chemistry at ICI/Zeneca. At
BASF, in UK and Germany, he headed formulation
development for colours and held marketing, strategy,
R&D and regulatory affairs functions for BASF’s global
biocides business and was also a board director of Agion
Technologies, USA.
Jim is co-director of the CPD course “Spray Drying and
Atomisation of Formulations”, run by the University of
Leeds.
David York holds the chair of Structured Particulate
Products in the department of Chemical Engineering and
is also Director of the High Value Chemical Manufacturing
hub which is focussed on increasing the interactions
between the university academics and industry to drive
research and impact. Part of this work included setting up
and managing the Strategic Partnership with P&G. He is
currently working with the KTN to help develop proposals
for a National Centre for Formulation and also sits on the
I ChemE Research Committee developing a strategy for
chemical engineering research in the UK.
David is a chemical engineer with 35 years’ experience in
industrial R&D inside P&G, has sat on the EPSRC Strategic
Advisory Network and chairs the Industrial advisory team
for UCL’s IMRC in Macro molecules. He is a visiting
professor at the Universities of Birmingham and Bristol and
is both a Fellow of the IChemE and the Royal Academy
of Engineering.
About the organisation:
iFormulate Ltd was founded to provide customised R&D
and innovation services to companies working in the field
of Formulation Science and Technology. We offer
consultancy, project management, idea generation and
development, assistance with commercialisation, market
and business development, training andevents.
www.iformulate.biz

5. HALF-DAY POST-CONFERENCE WORKSHOP B:
Wednesday 1st July 2015
1.30pm - 5.30pm
Holiday Inn Regents Park Hotel, London, UK
Defining and implementing QbD in
the design space for Scale up
Workshop leader: Pierre Lebrun, Experienced
Statistician - Project Leader, Arlenda
Overview of workshop:
• QbD –define, design, characterize, validate,
and monitor to meet the quality attributes
necessary for clinical performance
• Design Space, a (predictive) risk-based
approach
• Working in Phase I-III process validation
• Case studies, group - problem solving exercises
and interactive discussion
The workshop will include an overview of the
science behind spray drying, some relevant
industrial examples as well as an interactive group
session.
Programme
1.30 Registration and coffee
2.00 Opening Remarks
2.10 Session1: QbD applied to pharmaceutical
process
2.50 Session 2: linking CPP to clinical relevance
through process understanding
3.30 Coffee Break
4.00 Session 3: Case studies: beginning a QbD
analysis from development to process
valdiation
4.40 Session 4: Q/A + discussions
5.20 Closing remarks
5.30 End of workshop
About the workshop leader:
Pierre Lebrun has a master degree in computer
sciences and economy, followed by a master in
statistics at the university of Louvain-la-Neuve in
Belgium. Next, he completed his PhD in statistics in
2012 at the university of Liege (Belgium), in the
topic of Bayesien models and Design Space
applied to Pharmaceutical industry. Pierre is now
working for Arlenda, a Belgian company
specialized in biostatistics for pharmaceutical
development. Topics of interest include Quality by
Design, (bio) assay development, validation and
general statistics for the manufacturing and
release of drugs and vaccines, using effective
Design Space strategies.
About the organisation:
Arlenda is a company
specialized in advanced
clinical and non-clinical
statistics for the Pharma industry. Arlenda aims at
implementing QbD thinking, Bayesian thinking,
and modeling and simulations in perfect
accordance with the latest guidelines and
regulatory requirements. Arlenda also develops
softwares for the validation, transfer, and routine
of analytical and bio analytical assays, and for
stability studies.

6. FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
LYOPHILISATION - EUROPE
Conference: Monday 29th & Tuesday 30th June 2015, Holiday Inn Regents Park Hotel, London, UK Workshops: Wednesday 1st July 2015, London
4 WAYS TO REGISTER
www.lyophilisationconference.com
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
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