The following notes are unofficial, and should not be taken as an accurate record of events, nor as containing accurate medical knowledge.

Alison Jacobs and Garry Daniels - UCB

Biological drugs can cost over one billion dollars to develop. 75% of costs are due to drugs failing. It takes less than 10 years to ‘break even' and cover the costs of development with sales. In 2006, $55 billion was spent on drug development, only 22 new drugs were licensed.

‘Attrition' - drugs in development not making it to the market. Only 9% success. Regulatory authorities are increasing the hurdles.

There are ten defined steps in the drug development process, from discovery of a target to post-approval studies. Pre-clinical testing is usually on animals, before initial trials on humans. Even after delivery to market, research and investigation continues to find further evidence.

Question from EYM: Why do so many drugs fail to reach the market?

Safety and efficacy are the reasons why a drug may not make it to the market.

This pharma company has a timetable which shows the drugs that are planned to be ready in future years. However, it is not known whether any of these drugs will actually succeed.

There are 4 phases of clinical research:

• Phase I studies are with healthy volunteers. This stage tests basic safety.
• Phase II studies are with actual patients. Usually around 100 patients. Safety is again the focus, together with finding correct dosage, and looking for the first signs of efficacy.
• Phase III studies are with thousands of patients, again focussing on safety, but looking to prove the drug works in the wider population. Phase III trials are needed to acquire a licence.
• Phase IV studies are after drug regulation and production. Follow-up studies with patients who use the drug.

Question from EYM:Are there trials for drugs in children?

There are now regulations that specific paediatric trials need to take place to define the dosage and use regulations in children.

Three things to remember in clinical research: safety, safety, and safety. GCP (good clinical practice) ensures that the patient is protected by ethical conduct, and the production of credible data.

Self-regulation and audit from regulatory authorities can take place.

‘Protocol', the precise rules and procedures that a doctor running a trial must abide by,, that defines exactly how a patient in the trial should be managed. Ensures consistency across trial patients.

www.clinicaltrials.gov is a list of all trials currently active by pharma companies, in the US. All trials registered on this site must be reported, positive or negative.

Recruitment of patients is controlled with strict rules to protect the patient. The type of patient eligible is sometimes very specific, it is therefore difficult to find eligible patients. Retaining patients, ensuring they complete the study, is also difficult. Some studies are very long and could be a number of years.

‘Adverse event' anything untoward that happens to a patient when they are subjects in a trial, even if it is seemingly unconnected with the drug. Analysis of trends in other patients will determine if there is any drug-based link at all.

Some patients dislike taking the trial medication, or the follow-up tests are too imposing. Many patients will not be retained because of this.

Safety is ensured through detailed and numerous tests of all kinds.

In the future, pharma companies need to work faster to bring drugs to the market. Gaining confidence in development drugs earlier in the development process needs to take place. Companies need to be bolder in the choice of developments. Companies need to collaborate more with patients.

Patient centricity is important - the focus should be on the disease rather than the drug.

Compaies need to define unmet medical need. Complete packages of care should be developed, not just single drugs.

Better safety, better efficacy.

Pharma companies will achieve this by changing the development cycle, to ensure that feedback is incorporated in iterations, and there are no gaps or pauses in the development cycle. UCB aim to design complete packages of care for all severe diseases.

"By putting patients firsr in everything we do, then the business will take care of itself and the profits will follow" Roch Doliveux, CEO UCB, April 2007

Questions from EYM:

How do companies decide where to target resources, and which diseases to treat?

The CEO makes complex decisions made from information coming from different departments.

Is it true that companies wish to focus on other more common diseases than IBD?

True historically, but CD is now a valid market, top priority.

Why is Remicade so expensive?

To cover costs. Development of generic drugs could reduce the profit margin. This drug was one of the first biological drugs, so its development was complicated. They are very complex. Delicate drugs are expensive to store and distribute.

Do companies research the nature and mechanism of the disease, as well as drug treatment?

Yes, biochemical pathways are identified. Leads to better understanding of potential treatments. Always focuses on disease mechanism.

When lobbying government to make drug treatments affordable, it is often stated that there is a social cost to treatments.

A component of phase III studies includes social costs. Can then lobby for reimbursement.

NICE in the UK make decisions on the basis of the effectiveness and costs of treatments. In the UK, some pharma companies have stated that the health service need only pay for a drug when it is effective.

Drug patent regulations date from the 1920s, is it time to change this process to allow faster development? It is recognised that change is essential to ensure the success of pharma companies. The UK government has capped the amount of profit that a company can make from sales. Patent laws definitely need to change.

Marco introduces the theme for the first EYG workshop. The workshop will generate definitions of the unspoken needs of people with IBD, with examples, so that the EYG know what the priorities are when lobbying for changes and developments. This could lead into a future project to allow us to define priorities for EYG lobbying.

Four seminar groups are created, each led by an EYM member. Each group also includes an EYG member. Arjan and Gillian float between groups to observe overall.

The seminar groups will present their findings to the other participants later tomorrow.

One of the EYG projects has been to create a board game for children with IBD. This project is almost complete. Chayim presents the final design for the board, which features a picture of our mascot, Loekie the Lion, dressed in his white doctors coat and with his stethoscope.

Evelyn presents the delegates with specially made T-shirts, which show this image on the front.

The four seminar groups line-up in the centre of the room, and take turns to roll a giant dice, and answer the questions in order for their team to move forward through the spaces on the board.

Chayim then asks for the delegates help in thinking of new questions, and a way for the players to find out the answers to the questions. The best will be awarded with a prize at the gala dinner. The seminar groups split up to work on this.

Chayim also asks that each country nominates someone to help translate the questions into different languages. Chayim states that the Game will be available to download from the EYG website soon. Denmark have already created a similar game, to great success.

The EYG leaders take turns to update the delegates on the progress made in each project over the last year. Each project is summarised, and the importance of co-operative working is the focus.

Elisabeth, OMCCV

Elisabeth introduces a workshop in which each delegate uses materials and objects provided to represent their past, present and future with regards to IBD. Delegates begin constructing their collages.

Each seminar group then views each others' collages, before summarising their creations for the rest of the EYM delegates.

All delegates then work together to create a large jigsaw in the middle of the room. One object from each collage which represents each delegates feelings is then added to the jigsaw.

The delegates meet at the municipal fire station in Lendplatz, Graz, to use the indoor facilities to play dodge ball. Chayim and Marco organise the seminar groups, and a tournament begins.

Jenny Bickett and Sian Davis - Fleishman-Hillard

A Media relation is the process of building up a professional relationship with print and broadcast media. Furthermore, digital media and online media is growing, like blogs and podcasts.

Relations with the media are important - the bridge between our organisations and the public. Journalists need us to bring stories to them, or to comment on another story.

After politicians, more doctors are interviewed by the media than any other profession.

A journalist may not be a health expert. They will need to write many general stories. They have tight deadlines and search for big stories.

Consumer media is for the general public. The medical media are specialised for healthcare professionals.

A ‘news piece' is time sensitive, and provides an initial reaction. A ‘feature article' is not time sensitive, and can be in more depth.

Online communications are important - 55% of European households have access. Two out of every three retired people use the internet. ‘Blog' a journal style website where people can enter text, resulting in a running conversation.

A Hepatitis B awareness meeting was run in London, with good success. The media were used to raise awareness of the session and the condition hand in hand. Follow-up articles in the media also resulted. An art exhibition called ‘Oncology on Canvas' was used to generate media interest about the effects of Cancer. Over 200 news articles and 150 million ‘audience impressions' resulted. An ‘audience impression' is a measure of how many people come into contact with the story.

Good articles are interesting, relevant, different, supported.

How to write a good article:

• Know your media - which media are interested in IBD?
• Identify your angle - a theme or event to base the article on
• What is your message?
• Understand your audience and tailor the content of the article to them.

Construction:

• Construct a story map
• Beginning, middle, end
• State conclusion first, then follow up with details
• Pitch the story with a headline and intro paragraph
• Choose the right language and style for the article

Pitching the article:

• Identify a contact, discuss ideas, send an outline, agree length, it may be edited.

Success factors:

• Build relationship with the media, read and know the publication, sell your idea to them.

Preparations for an interview are similar. Tips are to:

• Be succinct, give some key facts or statistics which capture what you are trying to say.
• Feel confident and at your best. Be confident and in control, make eye contact with the journalist.
• The public only listen to 7% of what you say. Use gestures and body language to be communicative.
• Avoid jargon, be prepared for new questions, preparation really does help!

Practical work The seminar groups are given the task of creating a headline and opening paragraph of a press release relating to one of two scenarios. Sample press releases were available to use as templates. Each group then reads out its creation. Each group has learned from the principles of the presentation, and presents creative and interesting headlines and stories.

The groups then meet to practice interview techniques, as both interviewers, and interviewees. In particular, the ability to convey the right ideas about IBD in a concise and interesting way was the focus of this task. One of the pairs of delegates then presents their interview to the group, and the workshop leaders help analyse it.

The EYG leaders take turns to explain the future plans for each of the projects running at the moment. Each leader asked the EYM delegates for help in specific ways, and collected contact details. Future projects and the need for collaboration in order to achieve our goals was a key theme.

To help the EYG achieve its goals this year, and to help start new projects to help young people with IBD, please contact This e-mail address is being protected from spam bots, you need JavaScript enabled to view it This e-mail address is being protected from spam bots, you need JavaScript enabled to view it

The EYM delegates vote by a show of hands unanimously to confirm Ben (UK) as a full EYG member.

The EYM delegates vote by a show of hands unanimously to confirm Iva (CRO) as a full EYG member. There were no competing candidates proposed.

EYM delegates begin voting to elect two substitute members. A first and second choice are requested, one vote per country. The proposed candidates are:

• Nicola, UK
• Anne-Cecile, FR
• Andrea, SWZ
• Anna Lind, ICE
• Concetta, ITA

Votes are counted and the elected winners are: Nicola (UK), and Andrea (SWZ).

EYM delegates vote for the best poster on a future project or idea. First, second and third choices are requested, one ballot paper per country. Susanne collects the completed papers and will count the votes. The Loekie plate will be awarded later at the gala dinner.

The existing EYG members meet privately and unanimously elect Chayim as the new Chairperson. Ben is unanimously chosen as the group secretary.

Retiring Chairman Marco announces his successor, Chayim, to the EYM delegates.

Marco retires saying that he holds the EYM in his heart. Chayim takes the floor, and thanks Marco for all his amazing achievements. Chayim confirms that the new EYG secretary will be Ben.

Appointed speakers from the ‘unspoken needs' breakout group held yesterday share their findings with the rest of the EYM delegates.

• Group 2, led by Andrea, but Chayim gives a summary, focus on employment issues. Rod asks for the opinions of EYM delegates on tackling the problem of employment discrimination. Would it be useful for disability discrimination laws to be extended to all people with chronic diseases? The delegates themselves had raised this issue in their discussions.

• Group 3, led by Cecilia, focus on diet, food programmes and eating out. Rod suggests considering an IBD-friendly restaurant list. This group feels that people may avoid eating out altogether because of lack of support. Rod suggests some future projects which could help, such as creating an IBD-friendly "good restaurant" list.

• Group 4, led by Nicola focus on education, self-esteem and counselling, as well as raising better awareness, particularly that IBD isn't contagious. This group feels that IBD is less well known than other chronic illnesses, and also that there are common misunderstandings and misconceptions about IBD. Creating a truthful and powerful voice for IBD was this groups focus.

• Group 1, led by Gabi, focus on improving awareness, destroying the taboo surrounding IBD, and employment issues. ‘ill but not an invalid' was this group's decided motto. This group felt that people with chronic diseases may not want to be classified as ‘disabled' or ‘less able'.

Chayim leads a discussion on possible methods to tackle these issues. Support group activities are discussed, in particular sending specially tailored information and letters to clinics and surgeries, teachers, lecturers, and employers. Another approach is in campaigning. Perhaps a change in EU policy or law could help.

Chayim summarises the discussion by saying that the ‘unspoken needs' identified will provide the EYG with a focus for future projects. The projects themselves could be centred around the two approaches, in support group activities and in campaigning. Chayim thanks the delegates for their input.

It is confimed by Chayim that EYM 2008 will be held in Paris, France. EYM 2009 will be held in the Netherlands.

Chayim and Cecilia introduce a Swedish film about the effects of chronic illness (IBD and some other related conditions) on boyfriend, girlfriends and relationships. The film is in Swedish, and subtitled in English. The film features the thoughts and reflections of people with IBD, and is expertly made.