Paediatric Clinical Trials 2015: 2 Exclusive Interviews with Lundbeck USA and klausrose Consulting

LONDON - March 10, 2015 - PRLog -- SMi will open its doors to the 9th annual Paediatric Clinical Trials conference in just over 2 weeks’ time on the 25^th – 26^th March 2015 at the Holiday Inn, Regents Park Hotel in London UK. The industry leading conference on the formulation of medicines for children, has once again attracted a global audience of market leaders and scientific pioneers to review the latest developments in paediatric therapeutics.

In the run up to the show, SMi spoke to some key presenters including Dr Deborah Lee from Lundbeck USA and Klaus Rose from klausrose Consulting.

Dr Lee will be providing this year’s attendees with strategic guidance on conducting clinical trials in a presentation entitled: Strategies for Maximising Pediatric studies. Unique insight will be given on the use of PK modelling for established pediatric dosing. The challenges of conducting pediatric trials and the use of patient advocates in pediatric orphan indications will also be discussed.

When asked about the strengths of this year’s Paediatric Clinical Trials, she said:

‘There will be a wide variety of topics discussed with a very varied list of presenters. This conference will be a single source to learn about all aspects of paediatric drug development from developing formulations to clinical programs. I am looking forward to presenting a US perspective.’

On what she thought attendees would take away from the talk, Dr Lee commented,

‘I am hoping that attendees will learn how careful design and incorporation of certain factors at the beginning may be critical to eventual success, especially in orphan indications. I hope also to encourage companies to use patient advocates from the beginning as equal members of the program development team.b. In addition, their success relies on how many bacterial strains the vaccine is efficient on. You know that some bacterial species may be highly diverse and finding a vaccine which valences are efficient on most of them may be challenging.’

This year’s Paediatric Clinical Trials conference will be chaired by Klaus Rose. ‘The conference is an excellent networking opportunity.’ Klaus will be hosting an interactive pre-conference workshop on Paediatric Drug Development and opening the event with a keynote address discussing regulatory framework in a presentation entitled: From the origin US and EU paediatric legislation to today’s PIP challenges. Delegates will hear about strategy to limit the number of PIP modifications, operational challenges, and US and EU paediatric legislations.

On what he thinks the biggest challenges are in the industry he said,

‘The pediatric committee (PDCO) of the European Medical Agency (EMA) is very enthusiastic in the wish to promote pediatric clinical trials. Unfortunately, there are areas where this enthusiasm has began to damage pediatric research and individual patients, specifically in diseases that are rare and ultra-rare in children. A committee that is composed of generalists cannot have the necessary in-depth expertise in these complex areas. In rare and very rare diseases a one-size-fits-all attitude of the European regulatory authorities is not differentiated enough to design a reasonable approach how to allow the use of new break-through medications in children. Studies that will never recruit enough patients for a meaningful result do not help anybody. And for those few unfortunate young patients that are recruited into such a study it is a personal tragedy. After some years they and their parents will be told that the study was terminated because not enough patients could be recruited. What they will not learn is that the studies were wrongly designed even before they started. For pharmaceutical companies this is a daring challenge. They want to stay on good terms with the EMA, but they also know that they will not be able to recruit the patients for many clinical trials they have been forced to commit to by the PDCO.’

For the full interview visit the downloads page at http://www.smi-online.co.uk/goto/2015paediatric-trials54.asp

Paediatric Clinical Trials
25th - 26th March 2015
Holiday Inn Regents Park Hotel, London, UK.
http://www.smi-online.co.uk/goto/2015paediatric-trials54.asp

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Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk