Conference on Paediatric Drug Development

Children make up a large percentage of the patient population, yet they are regularly treated with medicines which are not researched or licensed for their age group. In recent years, new EU regulations in the field of paediatrics

Online PR News – 10-November-2010 – – Conference on Paediatric Drug Development
To be held at 23rd - 25th February 2011, London, UK

Samuel Maldonado, Vice-President and Head of Paediatric Drug Development, Johnson & Johnson
David McIntosh, Global Scientific Affairs Senior Expert, Novartis
Hans-Leonhard Ohrem, Technical Manager, Merck
Deborah Bickmann, Boehringer Ingelheim
Jacek Bedkowski, Senior Regulatory Affairs Associate, Baxter
Sarah Branch, Special Populations Group Manager, MHRA
Klaus Rose, Principal Consultant, Granzer Regulatory Consulting & Services
Philippa Smit-Marshall, Vice President, Medical Affairs, Pharmanet Consultancy
Ian Friedland, Study Director, Cubist Pharmaceuticals
Timo Vesikari, Professor of Virology and Consultant Paediatrician, University of Tampere
Daniel Bar-Shalom, Associate Professor, University of Copenhagen
Steffen Gay, Department of Rheumatology, University Hospital Zόrich

Dear Colleague,

Children make up a large percentage of the patient population, yet they are regularly treated with medicines which are not researched or licensed for their age group. In recent years, new EU regulations in the field of paediatrics have generated significant increase in interest and resources dedicated to paediatric drug development. There is now a worldwide awareness that drug treatment of children differs in its scientific context to the regulatory and scientific framework that define drugs for adults.
Visiongain’s inaugural Paediatric Drug Development conference will feature presentations from leading scientists from pharmaceutical companies and leading academic institutions. This conference will aim to highlight the latest trends in developing paediatric drugs, explore better ways to maximise the successes of trials, and cover important regulations and guidelines.

Why you should attend Conference on Paediatric Drug Development:
• Assess challenges associated with the development of children’s medicine
• Discover successful strategies for patient recruitment
• Review the latest paediatric drug regulations and best practice guidelines
• Explore new innovations in paediatric drug formulations
• Learn how to fulfill all the PIP criteria
• Hear it all from leading industry experts

I look forward to meeting you at the conference
Best regards

Who should attend Conference on Paediatric Drug Development ?

Senior VPs, Chief Scientific Officers, Directors, Managers, Professors, Scientists, and Principal Investigators in:
• Paediatric Medicine
• Research & Development
• Clinical Trials
• Therapeutics
• Drug Delivery
• Drug Discovery
• Formulation Development
• Analytical methods
• Analytical Chemistry
• Clinical Operations
• Medical Affairs
• Regulatory Affairs
• Quality Control
• Scientific Affairs
• Toxicology
• Product Development
• Project Management
• Strategic marketing

Pre-Conference Interactive Workshop
Paediatric Drug Development
Wednesday 23rd February 2011

Led by:

Klaus Rose
Principal Consultant
Granzer Regulatory Consulting & Services
(Former Head of Paediatrics, Roche)

Timings: 09:30 - 10:00 Coffee & Registration
10:00 - 15:00 Workshop
Timing includes lunch and refreshment breaks

Day 1 Conference on Paediatric Drug Development
Thursday 24th February 2011

09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 Impact of the EU & US paediatric legislation on industry, authorities, and academia
• EMA paediatric website
• Electronic forms to fill in. cover letter, CD ROMs to all
PDCO representatives
• PIP strategy, deferrals, waivers
• EMA Validation process
• PDCO negotiation process
• Landmines and how to avoid them
• EMA & FDA paediatric requirements
Klaus
Rose
Principal Consultant
Granzer Regulatory Consulting & Services
(Former Head of Paediatrics, Roche)
10:20 Compliance check: fulfilling all the PIP criteria
• Compliance check procedure
• Who will do it and when?
• What will be checked?
• Not compliant
• PIP modification
• Timeliness and Statystics
Jacek
Bedkowski
Global Regulatory Affairs
Baxter Healthcare
11:00 Morning refreshments
11:20 Challenges in paediatric drug development
• Determining correct dosage
• Disease differences between adults and children and by age
• Paediatric specific indications
Ian
Friedland
Study Director
Cubist Pharmaceuticals
12:00 Timing and pace of paediatric drug development
• Appropriate timing to introduce paediatric drug development in
the overall development of a drug
• Highlighting the importance of a stepwise approach to
multiple indications
Samuel
Maldonado
Vice-President and Head Paediatric Drug Development
Johnson & Johnson

12:40 Networking lunch
13:40 Ethics of performing paediatric clinical trials
• Beneficence, justice, respect
• Willingness, assent and consent
• Emergency and volunteer extremes
• Can pharmacology enhance ethics?
David
McIntosh
Global Scientific Affairs Senior Expert
Novartis
14:20 Risk assessment and contingency planning
• Why clinical studies in children present challenges?
• Impact of the paediatric regulations on the clinical trial environment
• Identifying risk in clinical studies in children
• Feasibility studies
• Contingency planning
Philippa
Smit-Marshall
Vice President, Medical Affairs
Pharmanet Consultancy
15:00 Afternoon Refreshments
15:20 Clinical trials in developing countries
• Practical and ethical considerations
• Conducting trials in the correct locations, where drugs will be
registered and available
• Operational challenges
• Continued medical treatment of subjects
16:00 Drug development in paediatric oncology
• What are the major challenges currently confronting paediatric
drug development?
• What measures are being taken to overcome these challenges?
16:40 Closing remarks from the chair

16:50 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting

Day 2 Conference on Paediatric Drug Development
Paediatric Drug Development
Friday 25th February 2011

09:00 Registration and refreshments
09:30 Opening address from the chair
09:40 ODT-formulations: fast disintegration does not always lead to fast dissolution content
• ODT excipient system
• ODT formulation
• Dissolution profiles
• Tablet hardness and the shelf life of the tablet
Leonhar
d Ohrem
Technical Manager
Merck
10:20 The future of oral paediatric formulations
• A critical review of the (few) children-appropriate formulations
will be presented
• An attempt to define the key parameters of a good formulation
for children will be made
• Non-invasive methods for testing formulations will be outlined
Daniel
Bar-Shalom
Associate Professor
University of Copenhagen
11:00 Morning refreshments
11:20 Presentation to be announced
Deborah
Bickmann
Boehringer Ingelheim
12:00 Novel targets in epigenetics- the master regulator system of gene expression
• Acetylation, methylation, sumoylation and microRNAs
• Targetting epigenetic modifications
• Future challange for the pharmaceutical companies
Stef
fen Gay
Group Leader
University Hospital Zόrich
12:40 Networking lunch

13:40 Successful strategies for subject recruitment
• Designing appropriately informed consent forms
• Flexibility in clinical trials to increase numbers
• Child friendly research facilities
• Demonstrating transparency in communication to gain trust
• Seeking outside expertise
Timo
Vesikari
Professor of Virology and Paediatrics
University of Tampere
14:20 Presentation to be announced
Sarah
Branch
Special Populations Group Manager
MHRA
15:00 Afternoon refreshments
15:20 Challenges with PIPs – Industry perspective
• The major challenges encountered
• Avoiding common mistakes
16:00 Evaluating the impact of cost on strategic
business decisions
• Small market
• High risk associated with testing drugs on children
• Associated costs, such as paediatric sales force maintenance
• Limited therapeutic areas
16:40 Chair’s closing remarks
16:50 End of Conference

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