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Paediatric Clinical Trials

SAE Media Group is proud to present the return of their 11th annual Paediatric Clinical Trials Conference, 20th – 21st March 2016, London.
 

The field of paediatric medicines is advancing and the push has been to make medicines child size, however approximately two thirds of medicinal products that are prescribed for children have not been adequately studied and recommended for paediatric use*
 

Strengthening strategies in paediatric investigation plans remains paramount and with the EMA 10 year review of paediatric regulation a call has been made for greater guidance with the goal of increasing the number of safe paediatric therapeutics on the market.
 

Join us as we discuss current clinical trials, implementation and paediatric drug development in a series of interactive conference sessions, roundtables and workshops led by leading industry experts. Gain information on methods to improve clinical recruitment, appreciate ethical issues and navigate regulations when planning and executing a paediatric clinical trial. We will be exploring the complexities of paediatric drug formulation and helping you determine clinical endpoints.
 

*http://www.gsk.com/media/280875/paediatric-medicines-policy.pdf?

FEATURED SPEAKERS

Andy Kenwright

Andy Kenwright

Senior Statistical Scientist, Hoffmann-La Roche Limited
Bianca  McDade

Bianca McDade

Director, Regulatory Affairs, GSK
Deborah Lee

Deborah Lee

VP, Clinical Development, Insys Therapeutics, Inc.
Hernando  Patino

Hernando Patino

Senior Medical Director, Johnson & Johnson
Karl-Heinz Huemer

Karl-Heinz Huemer

Scientific Office, Austrian Agency for Health and Food Safety
Philippe  Auby

Philippe Auby

CEO & President, OEDC, Otsuka Europe Development and Commercialisation Ltd
Robert Kahn

Robert Kahn

Former Senior Safety Science Leader, Global Pediatric Oncology, Genentech
Tom Willgoss

Tom Willgoss

Senior Outcomes Research Scientist , Roche Products

Andy Kenwright

Senior Statistical Scientist, Hoffmann-La Roche Limited
Andy Kenwright

Andy has been a Statistician through both preclinical, early phase and late phase clinical development for decades, mostly as Head of Statistics at small CROs. In the past 9 years at Roche he has spent around half his time trying to make medicines for children, and medicines made for adults be better suited to children. Before clinical trials Andy studied at Liverpool, Sheffield and Leeds – everything from termites to dairy cows, physiology and nutrition to medical statistics.
Being part of the Paediatric strategy group at Roche/Genentech, working to build on Roche’s reputation within Paediatric medicines, Andy has some lessons learned and hopefully good advice on how to plan, analyse and report paediatric clinical trials.
 
 

Bianca McDade

Director, Regulatory Affairs, GSK
Bianca  McDade

Cecile De Coster

Associate Director, Regulatory Affairs, Alexion Pharmaceuticals
Cecile  De Coster

Deborah Lee

VP, Clinical Development, Insys Therapeutics, Inc.
Deborah Lee

Floriane Sequier

Senior Scientist, Astrazeneca
Floriane  Sequier

Genevieve Michaux

Member of the Brussels and Paris Bar, Partner, mayer brown llp
Genevieve Michaux

Hernando Patino

Senior Medical Director, Johnson & Johnson
Hernando  Patino

Jane Lamprill

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

Jesus Garcia-Segovia

VP & Head of Clinical Development, Orchard Therapeutics
Jesus Garcia-Segovia

Karl-Heinz Huemer

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

Kerry Leeson-Beevers

Patient Representative, Paediatric Committee, EURODIS
Kerry  Leeson-Beevers

Klaus Rose

CEO, klausrose Consulting
Klaus Rose

Larissa Kerecuk

Rare Disease Lead for BCH, The Birmingham Childrens Hospital
Larissa Kerecuk

Philippe Auby

CEO & President, OEDC, Otsuka Europe Development and Commercialisation Ltd
Philippe  Auby

Robert Kahn

Former Senior Safety Science Leader, Global Pediatric Oncology, Genentech
Robert Kahn

Tom Willgoss

Senior Outcomes Research Scientist , Roche Products
Tom Willgoss

Conference agenda

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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

Session 1: Physiology of the child’s body and the differences to the adult body

Klaus Rose

Klaus Rose, CEO, klausrose Consulting

  • Absorption, distribution, metabolisation and excretion in children
  • The different age groups as per ICH E 11
  • Clinical trials in children
  • clock

    9:50

    Session 2: US & EU paediatric legislation

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

  • US & EU Paediatric Legislation
  • The EU paediatric Investigation Plan (PIP) and the Paediatric Committee
  • Logic of the PIP system
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    10:30

    Morning Coffee

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    11:00

    Session 3: Impact of paediatric legislation in US and EU

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

  • PIP decisions: examples
  • Resources consumed from pharmaceutical industry
  • Impact on child health 
     
  • clock

    11:40

    Session 4: The way forward

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

  • Does the EU paediatric legislation need revision?
  • Who are the main drivers in the discussion?
  • Industry’s and companies’ way forward
  • clock

    12:30

    Closing remarks

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

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    12:50

    Close of workshop

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Robert Kahn

    Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, Genentech

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

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    9:10

    Paediatric clinical trials in the EU: 10 year report on paediatric procedures

    Karl-Heinz Huemer

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

  • How EU Paediatric regulation is helping to facilitate early dialogue between applicants and the European Medicines Agency submitting paediatric investigation plans
  • Explore opportunities to open a dialogue with HTA organisations for parallel discussion on paediatric clinical trials
  • The benefits of parallel Scientific Advice Working Party (SAWP)/ HTA (health technology assessment) scientific advice- what effect is this having on drug development?
  • Discussion on future changes to the regulatory framework
  • clock

    9:50

    Strategies to optimise and strengthen PIPs and ensure a consistent scientific approach within therapeutic areas

    Bianca  McDade

    Bianca McDade, Director, Regulatory Affairs, GSK

  • Scientific advice on paediatric medicines
  • How to prevent hurdles in compliance
  • How to minimise the number of PIP modifi cations made for paediatric therapeutics
     
  • clock

    10:30

    Morning Coffee

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    11:00

    Paediatric Clinical Trials: FDA Perspective

    Deborah Lee

    Deborah Lee, VP, Clinical Development, Insys Therapeutics, Inc.

  • PSPs: they are not the same as PIPs
  • FDA: successful negotiation tactics
  • Use your patient advocates
  • Approval process: Ad Coms
  • clock

    11:40

    EU Paediatric Legislation (EUPL): A Ten Years Assessment

    Klaus Rose

    Klaus Rose, CEO, klausrose Consulting

  • Key elements of the EUPL
  • EMA/EU Commission Report to the EU Parliament January 2017
  • EUPL assessment by industry, clinicians, patient associations and politicians
  • EUPL revision?
  • The global way forward in paediatric research and improving child health
     
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    12:20

    Networking Lunch

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    13:30

    Necessary safety considerations to optimise paediatric clinical trials

    Robert Kahn

    Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, Genentech

  • Emphasising the continuum from preclinical to clinical studies
  • Exploring concerns of paediatric growth and development through translational safety
  • Importance of drug safety strategy throughout clinical drug development
  • Considerations for long term effects of drugs for paediatric cancer survivors
     
  • clock

    14:10

    "who has deviant children ? (We all do – in our trials – but how hard can analysing the data from these ‘tomorrow adults’ be?)”

    Andy Kenwright, Senior Statistical Scientist, Hoffmann-La Roche Limited

  • To deviate is “to depart from the norm”  Ignoring any negative connotation to the word, our kids often fall outside of expected study behaviours and standards
  • Simply applying standards you apply to adults may well not work – from lab ranges to dosing regimens to summary graphs and physiological or PK/PD assumptions
  • A fundamental paradigm is… that the small people (you’re right! they are not just small people) grow and change (then change and grow) but we want stability during our trial periods. How do we track this - how do we allow for this?
  • In developing a paediatric toolkit at Roche, what are the broad stroke highlights of some of the most “current” topics


     

  • clock

    14:50

    Afternoon Tea

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    15:20

    Paediatric rare disease research: challenges & opportunities

    Larissa Kerecuk

    Larissa Kerecuk, Rare Disease Lead for BCH, The Birmingham Childrens Hospital

  • What are rare diseases, how is care organised and why is it important
  • Challenges in rare disease research
  • Opportunities in rare disease research: personalised medicine & working with children, young people and families
  • Why should research into rare disease be integral part of care & how personalised medicine will help us understand common diseases
  • clock

    16:00

    Overcoming ethical challenges for companies, parents and children

    Jane Lamprill

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

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    16:40

    Chairman’s Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Philippe  Auby

    Philippe Auby, CEO & President, OEDC, Otsuka Europe Development and Commercialisation Ltd

    clock

    9:10

    Introducing the paediatric matrix trial: A novel concept in accelerating paediatric drug development

    Robert Kahn

    Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, Genentech

    clock

    9:50

    What can we learn from paediatric drug development? Psychopharmacology as a paradigm

    Philippe  Auby

    Philippe Auby, CEO & President, OEDC, Otsuka Europe Development and Commercialisation Ltd

  • Paediatric needs using psychiatry and psychopharmacology as a paradigm
  • Challenges: Is paediatric drug development still dependent on adult development?
  • Key ethical and scientific considerations
  • Concrete examples 
     
  • clock

    10:30

    Morning Coffee

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    11:00

    Challenges when formulating paediatric medicines

    Floriane  Sequier

    Floriane Sequier, Senior Scientist, Astrazeneca

    clock

    11:40

    Strategies to gaining rewards and incentives for paediatric medicines

    Genevieve Michaux

    Genevieve Michaux, Member of the Brussels and Paris Bar, Partner, mayer brown llp

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    12:20

    Networking Lunch

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    13:30

    Clinical outcome assessments in paediatric clinical trials

    Tom Willgoss

    Tom Willgoss, Senior Outcomes Research Scientist , Roche Products

  • Importance of patient-centred measurement in paediatric clinical trials
  • Identifying the appropriate informant - self-report, caregiver-report or clinician-report?(developmental/age-related differences)
  • Regulatory considerations
  • Operational factors- optimising paediatric clinical trials while preventing common pitfalls
     
  • clock

    14:10

    Challenges of conducting paediatric trials in oncology: The case for external contemporaneous control Studies

    Hernando  Patino

    Hernando Patino, Senior Medical Director, Johnson & Johnson

    clock

    14:50

    Afternoon Tea

    clock

    15:20

    Ex-vivo autologous haematopoietic stem cell gene therapy for paediatric monogenic disorders

    Jesus Garcia-Segovia

    Jesus Garcia-Segovia, VP & Head of Clinical Development, Orchard Therapeutics

    clock

    16:00

    Positive engagement, a parent and patient representative perspective

    Kerry  Leeson-Beevers

    Kerry Leeson-Beevers, Patient Representative, Paediatric Committee, EURODIS

  • Living with a rare disease - A parents perspective
  • ASUK’s journey from developing a charity to being actively involved in the delivery of our first clinical trial
  • Advocacy & Training Requirements
  • Positive engagement with children, young people and parents
     
  • clock

    16:40

    Chairman’s Closing Remarks and Close of Day Two


    Senior Statistical Scientist
    Hoffmann-La Roche Limited
    Director, Regulatory Affairs
    GSK
    Associate Director, Regulatory Affairs
    Alexion Pharmaceuticals
    VP, Clinical Development
    Insys Therapeutics, Inc.
    Senior Scientist
    Astrazeneca
    Member of the Brussels and Paris Bar, Partner
    mayer brown llp
    Senior Medical Director
    Johnson & Johnson
    Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel
    Paediatric Research Consultancy
    VP & Head of Clinical Development
    Orchard Therapeutics
    Scientific Office
    Austrian Agency for Health and Food Safety
    Patient Representative, Paediatric Committee
    EURODIS
    CEO
    klausrose Consulting
    Rare Disease Lead for BCH
    The Birmingham Childrens Hospital
    CEO & President, OEDC
    Otsuka Europe Development and Commercialisation Ltd
    Former Senior Safety Science Leader, Global Pediatric Oncology
    Genentech
    Senior Outcomes Research Scientist
    Roche Products

    Supporters

    Preliminary List of Attending Organisations 2017

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    Speaker Interview Series: Jane Lamprill, European Research Council Ethics Panels, Paediatric Research Consultancy

    Download

    Speaker Interview Series: Larissa Kerecuk, Rare Disease Lead, The Birmingham Children’s Hospital

    Download

    Speaker Interview Series: Klaus Rose, CEO, Klausrose Consulting

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    Speaker Interview Series: Andy Kenwright, Senior Statistical Scientist, Roche Limited

    Download

    Speaker Interview Series: Deborah Lee, VP Clinical Development, Insys Therapeutics

    Download

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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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    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
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