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SMi 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?

• Review and discuss paediatric clinical trial Legislation in the EU and globally
• Explore the practical costs and safety considerations of conducting a paediatric clinical trial
• Review the challenges in paediatric drug development for oncology drugs and vaccines
• Optimise your approach to paediatric formulation to improve clinical success
• Evaluate approaches for recruitment and retention
 

Directors, Chiefs, VPs, Heads, Managers, Principals of:


• Clinical Trials/ Paediatric
• Clinical Research
• Regulatory Affairs
• Clinical Operations
• (Paediatric) Drug Development
• Drug Formulation
 

Ablynx nv; Achillion Pharmaceuticals; Actelion; Actelion Pharmaceuticals; Austrian Agency for Health and Food Safety; Bayer; Bayer Corporation; Capsugel; Celgene International; Eli Lilly And Company; Flamel Ireland; Genencor International; Gilead Sciences Ltd; GlaxoSmithKline R&D; Grunenthal GmbH; Hoffmann La Roche Ltd; Johnson & Johnson; KinderPharm; King Faisal Specilist Hospital & Research Center; klausrose Consulting; Laboratoires SMB S.A; Lundbeck; Medical Research Network www.themrn.co.uk; Novartis Vaccines; Paediatric Research Consultancy; Paion; PharmaLex; Roche Pharma Schweiz AG; Shire Pharmaceuticals; SIRON BV; Takeda ; Tefly Clinic; Teva Pharmaceuticals Industries; TNO; University Hospital Ghent; University of Copenhagen; Vifor (International) Ltd;

Conference programme

8:30 Registration & Coffee

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

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
  • 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
     
  • 10:30 Morning Coffee

    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
  • 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
     
  • 12:20 Networking Lunch

    13:30 Paediatric orphan drug development and the challenges involved

    Cecile  De Coster

    Cecile De Coster, Associate Director, Regulatory Affairs, Alexion Pharmaceuticals

    • Executing a clinical trial for drug development in rare childhood diseases and adapting to changes in your investigation plan
    • Complex Issues in developing drugs and biological products for rare diseases
    • How to accelerate the development of therapies for paediatric rare diseases
    • Methods to overcome the challenges of trial design

    14:10 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
     
  • 14:50 "who has deviant children ? (We all do – in our trials – but how hard can analysing the data from these ‘tomorrow adults’ be?)”

    Andy Kenwright

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

  • 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


     

  • 14:50 Afternoon Tea

    15:40 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
  • 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

  • Key guidance updates for studies with children
  • Revised European Commission ethics considerations document
  • Child and family protocol issues at EC/IRB review
  • Plan and perform good ethical practice – a win-win for all
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Philippe  Auby

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

    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

  • Novel concept based on mechanism-of-action PIPs
  • How this matrix enables early initiation of paediatric phase I clinical studies in order to accelerate drug development time lines
  • The ways in which this supports molecule prioritization both within a single company and between multiple collaborating Companies
     
  • 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 
     
  • 10:30 Morning Coffee

    11:00 Paediatric drug formualtions and the regulation behind excipients

    Floriane  Sequier

    Floriane Sequier, Senior Scientist, Astrazeneca

  • Understanding patient needs, ages and dosages forms
  • Common pitfalls in developing paediatric formulations and tips to manage them
  • Excipients for paediatric use: The journey from selection to approval
  •  

    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

  • How to obtain a supplementary protection certificate (SPC) or extension
  • How are incentives changing the paediatric drugs market and can these incentives work for you?
  • Break- down of revised rewards and incentives for 2017
  • 12:20 Networking Lunch

    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
     
  • 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

  • Addressing challenges of conducting paediatric trials in oncology with observational studies
  • The use of external contemporaneous versus historical controls
  • Addressing generalisability of results coming from these studies
  • Practical operational aspects of this type of studies
  • Can registry databases be used as source for this studies?
  •  

    14:50 Afternoon Tea

    15:20 Gene Therapy for monogenic disorders of the bone marrow

    Bobby Gaspar

    Bobby Gaspar, Head of Paediatrics and Immunology , Ucl Hospitals

  • Ex-vivo bone marrow gene therapy has now shown correction of specific immunological, metabolic and haematological disorders
  • Hear how current lentiviral vector designs show high levels of efficacy and safety
  • One off stem cell treatments have shown robust long term recovery
  • The ways in which commercial interest is increasing with a view to making these licensed gene therapy medicines
     
  • 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
     
  • 16:40 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Andy Kenwright

    Andy Kenwright

    Senior Statistical Scientist, Hoffmann-La Roche Limited
    Bianca  McDade

    Bianca McDade

    Director, Regulatory Affairs, GSK
    Bobby Gaspar

    Bobby Gaspar

    Head of Paediatrics and Immunology , Ucl Hospitals
    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

    Bobby Gaspar

    Head of Paediatrics and Immunology , Ucl Hospitals
    Bobby Gaspar

    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

    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

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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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, SMI 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@smi-online.co.uk

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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
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