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Paediatric Clinical Trials

SAE Media Group is proud to present the 10th Paediatric Clinical Trials Conference, 16th – 17th March 2016, London. This event will look at the paediatric therapeutic developments, directives and procedures which have been put in place to protect children taking part in clinical trials.

Many treatments of today are the result of past clinical trials. The need for improving strategies in conducting paediatric clinical trials has never been greater. Even if the costs linked trials are not always affordable, pharmaceutical industries continue to expand their research.

A series of interactive conference sessions, roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to develop analgesics in paediatric population, implement a strategy regulatory partnership through collaboration, explore innovations in drug formulation, monitor and audit issues specific to paediatric research and utilize clinical pharmacology to model adult data to paediatrics.
 

FEATURED SPEAKERS

Daniel Bar-Shalom

Daniel Bar-Shalom

Associate Professor, University of Copenhagen
Philippe Auby

Philippe Auby

Vice President of Clinical Development – Paediatrics, Lundbeck

Albert Allen

Medical Director, Eli Lilly And Company
Albert Allen

Daniel Bar-Shalom

Associate Professor, University of Copenhagen
Daniel Bar-Shalom

David McIntosh

Head, Global Scientific Affairs, Novartis Vaccines
David McIntosh

David McIntosh

Honorary Clinical Senior Lecturer - Imperial College London, Imperial College
David McIntosh

Ellen Bolotin

Global Clinical Leader in Paediatrics , Bayer Corporation
Ellen Bolotin

Esther Van Duijn

Scientist, TNO
Esther Van Duijn

Jane Lamprill

Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy
Jane Lamprill

Johan Vande Walle

Professor in Paediatric Nephrology, University Hospital Ghent
Johan Vande Walle

Karl-Heinz Huemer

Scientific Office, Austrian Agency for Health and Food Safety
Karl-Heinz Huemer

Klaus Rose

CEO, klausrose Consulting
Klaus Rose

Martine Gehin

Clinical Pharmacologist, Actelion
Martine Gehin

Philippe Auby

Vice President of Clinical Development – Paediatrics, Lundbeck
Philippe Auby

Robert Kahn

Senior Safety Science Leader, Genentech
Robert Kahn

Ronald Rosenburg

Head Global Clinical Development Strategy, Grunenthal GmbH
Ronald Rosenburg

Sabine Fuerst-Recktenwald

Senior Medical Director Paediatric Oncology, Roche Pharma Schweiz AG
Sabine Fuerst-Recktenwald

Sangeeta Sedani

Clinical Investigation Lead, GlaxoSmithKline R&D
Sangeeta Sedani

Xavier Liogier

Clinical Scientist, Hoffmann La Roche Ltd
Xavier Liogier

Conference agenda

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10:30

Registration and Coffee

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11:00

Opening remarks

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11:15

Session 1 Historical Regulatory and Clinical Background

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12:00

Session 2 Child Physiology and Clinical Pharmacology

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13:00

Break

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14:30

Session 3 Pediatric Clinical Trials

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15:30

Session 4 The PIP Challenge: Operational Considerations

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16:30

Closing remarks

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16:45

End of workshop

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

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9:10

Update of the frameworks of US and EU paediatric legislation

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

  • Paediatric legislation US and UE
  • Challenges in paediatric negotiations with FDA and UE 
  • Scientific and operational challenges of the UE PIPs
  • clock

    9:50

    Challenges in paediatric drug development - developing new oncology drugs for children

    Sabine Fuerst-Recktenwald

    Sabine Fuerst-Recktenwald, Senior Medical Director Paediatric Oncology, Roche Pharma Schweiz AG

  • The 'optimal' timing
  • A more sustainable and more actionable based drug development model
  • Historical adult centric vs. integrated paediatric development at Roche
  • Long-term safety considerations
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    10:30

    Morning Coffee

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    11:00

    Panel Discussion: Paediatric microdosing

  • Microtracer technology in early clinical development, of added value in PIP
  • Alternative pharmacokinetic phenotyping in children
  •  Monitoring Phase II drug metabolism
  • Esther Van Duijn

    Esther Van Duijn, Scientist, TNO

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor, University of Copenhagen

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

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    11:40

    Towards a better understanding of bioethics and paediatric drug development and clinical trials

    Albert Allen

    Albert Allen, Medical Director, Eli Lilly And Company

  • How bioethics is a fundamental justification for the need for paediatric drug development efforts
  • Differences between bioethics in paediatric vs. adult research, differences in the US vs. EU approaches
  • Bioethics and the design and implementation of a well-conceived paediatric drug development plan
  • Bioethics and the design and implementation of individual paediatric clinical trials at different phases of development
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    12:20

    Networking Lunch

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    14:00

    Prelicensing strategies to support paediatric development

    Karl-Heinz Huemer

    Karl-Heinz Huemer, Scientific Office, Austrian Agency for Health and Food Safety

  • Paediatric Investigation Plans (PIP)
  • Scientific advice, orphan Drugs, advanced therapies
  • Global development
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    14:40

    Safety considerations of paediatric clinical trial

    Robert Kahn

    Robert Kahn, Senior Safety Science Leader, Genentech

  • Current safety challenges and opportunities in paediatric drug development
  • Understanding unique paediatric safety concerns
  • Novel methods to address short and long-term safety issues in children
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    15:20

    Afternoon Tea

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    15:50

    Children on the move: Travel, trials and tests

    David McIntosh

    David McIntosh , Honorary Clinical Senior Lecturer - Imperial College London, Imperial College

     

    ·         Diseases affecting children who travel and migrate
    ·         Treatment or prevention? Trials in children on the move
    ·         Lab tests, sample transport, data-bases: keeping trak
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    16:30

    Chairman’s Closing Remarks and Close of Day One

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Philippe Auby

    Philippe Auby, Vice President of Clinical Development – Paediatrics, Lundbeck

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    9:10

    Paediatric drug development, a bottom up approach with the SAFEPEDRUg-project

    Johan Vande Walle

    Johan Vande Walle, Professor in Paediatric Nephrology, University Hospital Ghent

  • Understanding the patient, age, disease specific problems
  • Alternative paediatric drug research
  • Need for studies in critical ill children and neonates
    ·                          
  • clock

    9:50

    Development of bosentan in paediatric PAH patients with modeling support

    Martine Gehin

    Martine Gehin, Clinical Pharmacologist, Actelion

  • PBPK modeling and paediatric dose finding
  • PopPK modeling
  • Interactions with health authorities
  • clock

    10:30

    Morning Coffee

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    11:00

    Formulation challenges in paediatric drug development

    Daniel Bar-Shalom

    Daniel Bar-Shalom, Associate Professor, University of Copenhagen

  • Understanding the patient, age specific problems
  • Excipients, do and do not (mostly do nots)
  • Organoleptic in the oral route
  • Where to find solutions and inspiration
  • clock

    11:40

    Why paediatric development does really matter? Psychopharmacology as a paradigm

    Philippe Auby

    Philippe Auby, Vice President of Clinical Development – Paediatrics, Lundbeck

  • Considerations for dosing frequency, stability and storage requirements
  • Impact on the progress and success of clinical trials
  • Improving formulation on the safety profile and efficacy of medicines for children
  • Decreasing the risks of adverse drug reactions
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    12:20

    Networking Lunch

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    13:30

    Challenges of drug development in rare diseases - inhalation anthrax

    Sangeeta Sedani

    Sangeeta Sedani, Clinical Investigation Lead, GlaxoSmithKline R&D

  • Background to raxibacumab as a recently developed drug for treatment of inhalation anthrax
  • Regulatory challenges for developing a PIP
  • Study design of field studies
  • Logistical challenges of implementing clinical studies during a public health emergency
  • clock

    14:10

    Networking in paediatric oncology

    Ellen Bolotin

    Ellen Bolotin, Global Clinical Leader in Paediatrics , Bayer Corporation

     

    • Improving drug formulation

    • Facilitating paediatric formulation development through existing data

    • Using innovative technologies in adults that can be used to develop new paediatric formulations

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    14:50

    Afternoon Tea

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    15:20

    How to write clinical trial information for parent and children ?

    Jane Lamprill

    Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy

     

     

     

     

     

  • Introduction to consent and dissent
  • Brief overview ethical and regulatory requirements
  • Information needs for different age children and their parents
  • Tips to ensure clear communication
  • Information and respect for cultural differences
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    16:00

    Challenges in paediatric drug development, example with Down syndrome

    Xavier Liogier

    Xavier Liogier, Clinical Scientist, Hoffmann La Roche Ltd

  • Global development strategy
  • Operational aspects
  • Selection of endpoints
  • clock

    16:40

    Chairman’s Closing Remarks and Close of Day Two

    Philippe Auby

    Philippe Auby, Vice President of Clinical Development – Paediatrics, Lundbeck


    Medical Director
    Eli Lilly And Company
    Associate Professor
    University of Copenhagen
    Head, Global Scientific Affairs
    Novartis Vaccines
    Honorary Clinical Senior Lecturer - Imperial College London
    Imperial College
    Global Clinical Leader in Paediatrics
    Bayer Corporation
    Scientist
    TNO
    Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel
    Paediatric Research Consultancy
    Professor in Paediatric Nephrology
    University Hospital Ghent
    Scientific Office
    Austrian Agency for Health and Food Safety
    CEO
    klausrose Consulting
    Clinical Pharmacologist
    Actelion
    Vice President of Clinical Development – Paediatrics
    Lundbeck
    Senior Safety Science Leader
    Genentech
    Head Global Clinical Development Strategy
    Grunenthal GmbH
    Senior Medical Director Paediatric Oncology
    Roche Pharma Schweiz AG
    Clinical Investigation Lead
    GlaxoSmithKline R&D
    Clinical Scientist
    Hoffmann La Roche Ltd

    Supporting Media Partners

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    Workshops

    Drug Development in the Paediatric Population

    Drug Development in the Paediatric Population

    Holiday Inn Kensington Forum
    15 March 2016
    London, United Kingdom

    Preliminary list of 2016 attendees

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    Speaker interview - Deborah Lee, VP of Clinical Development, INSYS Therapeutics, Inc.

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    Holiday Inn Kensington Forum

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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