Join us in London next March for our 9th annual Paediatric Clinical Trials conference

1. REGISTER BY 19TH DECEMBER AND RECEIVE A £300 DISCOUNT
REGISTER BY 30TH JANUARY AND RECEIVE A £100 DISCOUNT
25 - 26
MAR
2015 Holiday Inn Regents Park Hotel, London, UK
@SMIPHARM
SMi presents the 9th annual...
Paediatric Clinical Trials
Reviewing latest developments in the
formulation of medicines for children
Klaus Rose, CEO, klausrose Consulting
KEY SPEAKERS INCLUDE:
• Susan Cole, Senior Pharmacokinetics Assessor, MHRA
• Dr Koenraad Norga, Head of Clinic Paediatric Oncology,
Universitair Ziekenhuis Antwerpen, Vice Chairman, Paediatric
Commitee (PDCO)
• Dr Mette Due Theilade, Principal Scientist, Paediatric
Investigation Plan (PIP), Regulatory Affairs, Novo Nordisk A/S
• Dr Cristina De Min, Chief Medical Officer, Novimmune
• Terry Ernest, Formulation Team Manager, Global Formulation,
Product Development, GlaxoSmithKline R&D
• Dr Philippe Auby, Vice President of Global Clinical Research,
Paediatric Neuro-Psychiatry, Lundbeck
BENEFITS OF ATTENDING:
• New for 2015 – Join us and hear the MHRA discuss guidelines
for pharmacokinetic modelling in paediatric regulatory
submissions
• New for 2015 – Listen to GlaxoSmithKline discussing
considerations associated with the use of foods and
beverages to assist the administration of medicines to children
• The PDCO will review Paediatric clinical trials in the EU; what
you should know
• Case studies showcasing breakthroughs in paediatric clinical
trials
• Hear key pharmaceutical, biotechnology, regulatory and
academic experts share their knowledge to ensure your
clinical trials have optimal outcomes
• An overview of the current practices and challenges in
designing and preparing for paediatric clinical trials and how
to get yours right!
PLUS INTERACTIVE PRE-CONFERENCE WORKSHOP
CHAIR FOR 2015:
Tuesday 24th March 2015, Holiday Inn Regents Park Hotel, London, UK
Paediatric Drug Development – Vision, Challenges, Strategy
Workshop Leader: Klaus Rose, CEO, klausrose Consulting
10.30am - 4.45pm
www.paediatric-trials.co.uk
BOOK BY 19TH DECEMBER AND RECEIVE £300 DISCOUNT
BOOK BY 30TH JANUARY AND RECEIVE A £100 DISCOUNT
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

2. Paediatric Clinical Trials
Day One | Wednesday 25th March 2015
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
Klaus Rose, CEO, klausrose Consulting
REGULATORY FRAMEWORK FOR PAEDIATRIC RESEARCH – PART 1
OPENING ADDRESS
9.10 From the origin of US and EU paediatric legislation to today’s
PIP challenges
• The vision of US and EU pediatric legislation
• Has medical treatment of children improved since 1997?
• Operational challenges in the pediatric discussion with the
regulatory authorities
• What can you do if you think pediatric requirements are
exaggerated - tips and pointers
• Processes and procedures to limit the number of PIP
modifications required
Klaus Rose, CEO, klausrose Consulting
9.50 Paediatric clinical trials in the EU: regulatory perspective
• Using the EU Paediatric Regulation to develop better
medicines for children
Dr Koenraad Norga, Head of Clinic Paediatric Oncology,
Universitair Ziekenhuis Antwerpen, Vice Chairman, Paediatric
Commitee (PDCO)
10.30 Morning Coffee
11.00 Revision of the ICH E11 guideline: status and update
• Reviewing & analysing how an addendum to the current
E11 guideline could address new scientific and technical
knowledge advances in pediatric drug development
• Discussing how the ICH E11 currently covers many of the
relevant issues for consideration in pediatric drug
development and reviewing where there are gaps in
contemporary guidance on several topics
• Discussing how to best address key specific topics such as
the type of studies and methodology including the use of
extrapolation of data in pediatric drug development, or
modelling and simulation approaches as they might apply
to pediatric subpopulations
Solange Rohou, Director Regulatory Affairs/Policy Europe,
AstraZeneca
PREPARING FOR CLINICAL TRIALS
11.40 Infectious diseases – outbreaks and crises – how to include
children in clinical trials
• Emerging viral infections – risk and transmission in children
• Therapeutics and vaccines – treatment and prevention
• Bacterial meningitis – and end in sight
Dr David G. McIntosh, Head, Global Scientific Affairs, Novartis
Vaccines and Diagnostics
12.20 Networking Lunch
1.20 Optimising the role of the applicant to facilitate a smoother
paediatric trial ethics review
• Understanding what the EC/IRB look for in your
application and protocol
• Reviewing the aspects of legal and ethical frameworks
relevant to paediatric trials
• Addressing key ethical issues e.g. information provision,
minimising distress etc.
• Realising the benefits of GEP© (Good Ethical Practice) for
successful paediatric trials
Jane Lamprill, Paediatric Research Advisor, Specialist
Medical Writer, Children, Paediatric Research Consultancy
2.00 Formulating for paediatric clinical trials, pitfalls and
opportunities
• Understanding the patient, age specific problems
• Excipients, do and do not (mostly do nots)
• The oral route, organoleptics
• Where to find solutions
Pharmacist Daniel Bar-Shalom, Associate Professor, University
of Copenhagen
2.40 Afternoon Tea
3.10 Dosage form acceptability assessment & paediatric patient
reported outcome instruments
• Paediatric clinical trials provide an opportunity for
formulators to evaluate the acceptability of the dosage
form being developed
• The heterogeneous patient population in paediatric
clinical trials makes acceptability assessment challenging,
since the ability of the patients to provide feedback varies
• Paediatric Patient Reported Outcome Instruments may act
as a useful tool to help obtain accurate data
Dr Roy Turner, Formulation Project Leader, Paediatric &
Geriatric Network Leader, Technical Research &
Development, Novartis
INNOVATIONS AND ADVANCES
3.50 Innovation in paediatrics
• Why we need to develop age-appropriate and disease-specific
outcome measures
• Defining clinically meaningful involvement – why it’s essential
Dr Elin Haf Davies, Director & Founder, Empowering Children/
Enabling Research
PANEL DISCUSSION
4.30 Optimizing patient retention strategies for successful trial
development – how to keep patients on board
• Making sure patients stay on course with all study
requirements to ensure the statistical validity of the clinical
data analysis
• Listening to study volunteers and developing sustainable
relationships throughout the trial
• Knowing what patients want and need in order to
maximize retention
• Working with patients to engage them in the study and
establishing the most effective methods to reach them
Professor Koenraad Norga, Head of Clinic Paediatric
Oncology, Universitair Ziekenhuis Antwerpen, Vice
Chairman, Paediatric Commitee (PDCO)
Dr Deborah Lee, Senior Medical Director, Clinical Affairs,
Lundbeck, USA
Dr David G. McIntosh, Head, Global Scientific Affairs,
Novartis Vaccines and Diagnostics
Dr Philippe Auby, Vice President of Global Clinical
Research, Paediatric Neuro-Psychiatry, Lundbeck
5.10 Chairman's Closing Remarks and Close of Day One
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Register online at: www.paediatric-trials.co.uk • Alternatively fax y

3. Klaus Rose, CEO, klausrose Consulting
REGULATORY FRAMEWORK FOR PAEDIATRIC RESEARCH – PART 2
9.10 Population pharmacokinetic and physiologically
based pharmacokinetic modelling in paediatric
KEYNOTE
regulatory submissions
• Determination of posology in paediatric patients
usually involves an initial extrapolation from adult data.
There is then an iterative process with results from one
study informing the design of further studies
• Pharmacokinetic models are important to inform the
extrapolation and to collate the data
• Physiologically based models offer an opportunity to
mechanistically understand the drug disposition in children
and to use this information to optimise clinical study design
• Population pharmacokinetic analysis affords the
opportunity for sparse sampling in children and optimal use
of the available data
• Pharmacodynamics may also differ in children and should
be adequately described in suitable PKPD models
• It is important that size and maturation functions are
adequately described in the models
• For regulatory submissions qualification and verification of
these models and the input parameters is very important
Susan Cole, Senior Pharmacokinetics Assessor, MHRA
9.50 Transatlantic collaboration on Paediatric Investigation Plans -
recent experiences with Type 2 diabetes PIPs
• EU Paediatric Investigation Plan vs US Paediatric Study Plan
• What to do with divergent regulatory requirements to
paediatric trials
• Challenges with Type 2 Diabetes Mellitus PIPs
Dr Mette Due Theilade, Principal Scientist, Paediatric
Investigation Plan (PIP), Regulatory Affairs, Novo Nordisk A/S,
DESIGNING PAEDIATRIC CLINICAL TRIALS
10.30 Morning Coffee
11.00 The challenges of developing the first drug for a life-threatening
disease for which no approved drug exists
• Creation of alternative ways to determine dose and dose
frequency
• Limitations of conventional study designs in rare diseases
• Challenges in the recruitment of paediatric patients with a
rare disease
• Definition of a regulatory pathway for a disease for which
no drug has ever been approved
Dr Cristina De Min, Chief Medical Officer, Novimmune
11.40 Strategies for maximizing pediatric studies
• Challenges of conducting paediatric trials in orphan
indications and part of life cycle management
• Use of PK modelling for establishing paediatric dosing and
to support efficacy in orphan populations
• Use of patient advocates in protocol development in
paediatric orphan indications
Dr Deborah Lee, Senior Medical Director, Clinical Affairs,
Lundbeck, USA
Supported by
Paediatric Clinical Trials
Day Two | Thursday 26th March 2015
8.30 Registration & Coffee
9.00 Chairman's Opening Remarks
12.20 Networking Lunch
CASE STUDIES
1.20 Considerations associated with the use of foods and
beverages to assist administration of medicines to children
• Why are products mixed with food?
• Current practices of mixing with food
• Summary of recent EMA guidance
• Risks associated with mixing products with food
Terry Ernest, Formulation Team Manager, Global Formulation,
Product Development, GlaxoSmithKline R&D
2.00 NIHR clinical research network: children support and delivery
of clinical research
• Current and emerging Infrastructures
• Delivery frameworks
• NIHR children performance to date with key examples
• Challenges and opportunities
Dr. Sabah Attar, Divisional Head of Portfolio Operations, NIHR
Clinical Research Network: Children
2.40 Afternoon Tea
3.10 Practical application of physiologically based
pharmacokinetic modeling to select starting doses in
children
• Advantages and limitations of a physiologically based PK
modelling approach
• A strategy for applying PBPK in drug development projects
• Several case studies from Roche projects will be shared
Dr Neil Parrott, Modelling & Simulation Scientist,
Pharmaceutical Sciences, Roche Innovation Center Basel,
Roche Pharmaceutical Research and Early Development
3.50 Learning from paediatric psychopharmacology
• Practical guidance for paediatric trials using experience
from paediatric psychopharmacology
• Scientific considerations and ethical challenges
• Case studies
Dr Philippe Auby, Vice President of Global Clinical Research,
Paediatric Neuro-Psychiatry, Lundbeck, France
4.30 Chairman’s Closing Remarks and Close of Day Two
your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711

4. FULL-DAY PRE-CONFERENCE WORKSHOP
Tuesday 24th March 2015
10.30am - 4.45pm
Holiday Inn Regents Park Hotel, London, UK
Paediatric Drug Development – Vision,
Challenges, Strategy
Workshop Leader:
Klaus Rose, CEO, klausrose Consulting
Overview of the workshop:
This workshop will be an interactive walk through
different aspects of pediatric drug development,
starting with the historical background of the
discussion about on-label and off-label
prescription of drugs for children; ethical &
operational challenges of clinical trials in children;
the different meanings of the term 'pediatric drug
development' as used by different players;
pediatric pharmaceutical legislation in the USA
and the EU, and an assessment to what degree
pediatric legislation has improved child health
and child research over the past 18 years. The
workshop will include an interactive walk through
the EMA pediatric website.
Key benefits of attending:
People working in life science industry, regulatory
affairs, academia, ethics committees and people
with a general interest in the challenge of better
medicines for children.
Programme:
10.30 Registration and Coffee
11.00 Opening Remarks
11.15 Session 1 Historical Regulatory and Clinical
Background
12.00 Session 2 Child Physiology and Clinical
Pharmacology
1.00 Break
2.30 Session 3 Pediatric Clinical Trials
3.30 Session 4 The PIP Challenge: Operational
Considerations
4.30 Closing remarks
4.45 End of workshop
About the workshop host:
Dr. Klaus Rose is CEO of klausrose Consulting,
Switzerland, advising on pediatric drug
development and how to comply with FDA &
EMA pediatric requirements. Mostly his clients
are pharmaceutical companies and academic
insitutions. He first studied Latin languages &
psychology and then medicine. After postgraduate
clinical training in General Medicine in Germany and
England hejoined pharmaceutical industry in 1991. He
joined various positions in R&D and medical affairs,
was Global Head Pediatrics Novartis 2001 - 2005 and
Global Head Pediatrics Roche 2005 - 2009. After a
year with a regulatory consultancy he established his
own business. Dr. Rose is a frequent speaker on
international conferences on pediatric drug
development and publishes on a regular basis. A
textbook on pediatric formulations, co-edited with
Prof. Bar-Shalom, University of Kopenhagen, DK, was
released February 2014. Married with two daughters,
his private interests include Mediterranean cooking,
wine, gardening, Latin languages, and classical guitar.
About the organisation:
klaurose Consulting, Switzerland supports
pharmaceutical companies, CROs and other
health care providers in all aspects of pediatric
drug development.

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6. PAEDIATRIC CLINICAL TRIALS
Conference: Wednesday 25th & Thursday 26th March 2015, Holiday Inn Regents Park Hotel, London, UK Workshop: Tuesday 24th March 2015, London, UK
4 WAYS TO REGISTER
www.paediatric-trials.co.uk
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