EUROMEET INGMonaco 2010

March 8-10, 2010Grimaldi Forum

Monaco

2 2 n d A n n u a l

Call for Abstracts

Dear Colleagues,

It is our pleasure to invite you to participate in three days of discussion,sharing of experience, moving the debate forward and networking at the22nd Annual EuroMeeting in Monaco, March 8 - 10, 2010. Whether yourinvolvement will be as a session chair, speaker, tutorial instructor, orattendee, and whether you are a representative of a regulatory agency,academia, industry or patient group, or a student or emergingprofessional, we believe you can play a key role in building the success ofthe EuroMeeting and ensuring its place as one of the most importantEuropean conferences for professionals involved in the development ofmedicines.

When deciding on the themes, we have chosen the integrated,multidisciplinary approach, aiming to generate interest from as manydisciplines as possible. We hope we have identified interesting andthought-provoking topics for the themes. With this approach we wish tocreate a lively platform for a debate on development and market accessof medicines in Europe.

Programme development is well on its ways and you can see the directionwe wish the themes to take in the following pages. We do hope that thiswill stimulate you to contribute with a presentation or tutorial abstract.These abstracts are essential for the dynamics of the meeting.

Monaco is an exciting venue, well known to most people. Despitebeing a small country, it has a lot to offer and is very hospitable andculturally interesting. No doubt there are numerous challengesaround but we strongly believe you should not miss thisopportunity to bring your contribution to the necessary debateon drug development. Make your plans to come to Monaconext year!

Welcome from the EuroMeeting 2010 Co-Chairs Bruno Flamion and Kerstin Franzén

Bruno FlamionProfessor, Clinical Pharmacology, University of Namur, Belgium andChair, Scientific Advice Working Party, EMEA

Bruno Flamion is an MD who practised internal medicine andnephrology in Belgium. He was a Research Fellow at the NIH (1988-1992) and with the Belgian National Fund for Scientific Research (1992-

1996) and later got a PhD in physiological sciences from the University of Brussels. Heis now Full Professor of Physiology and Pharmacology at the University of Namur,Belgium, where he heads a molecular physiology lab. He has been involved as amedical expert for the Belgian Federal Agency for Medicines and Health Products(FAMHP) since 1999 and for the EMEA: CHMP, PK group, Pharmacogenomics, andmore recently CAT (Committee for Advanced Therapies). His favourite activity ischairing the Scientific Advice Working Party.

Kerstin FranzénSenior Director, Regulatory Policy & Intelligence, Pfizer, Sweden

Kerstin Franzén has a background in Regulatory Affairs covering 29years. After an academic degree at Uppsala University, M Pharm Sci,she joined the pharmaceutical industry, first for a short period in themarketing area, and then went into the regulatory arena. The first

seven years were spent with the Roche affiliate in Sweden, followed by a move to theSwiss headquarters where she stayed for four years, still in Regulatory Affairs. In 1990 shedecided to join Kabi Pharmacia and go back to Sweden. This company went through anumber of mergers and acquisitions, which eventually led to her current position withPfizer in Regulatory Policy & Intelligence, an area she has been involved in since 1998.

Speak at the EuroMeeting 2010 – Submit an Abstract

The Drug Information Association invites you to submitpresentation abstracts and/or tutorial abstracts for the 22ndAnnual EuroMeeting in Monaco, March 8-10, 2010. You maysubmit more than one abstract.

Presentation AbstractsYou are invited to submit abstracts for presentations that fallwithin the themes detailed on the following pages. If selected,your presentation will be a single presentation which will fit withina session.

Please note:• Only one presenter per presentation will be allowed.• A presentation abstract should be for a 20-minute

non-commercial presentation. Only presentation abstracts willbe considered. Session abstracts will not be accepted.

Tutorial AbstractsPre-conference tutorials will take place before the EuroMeeting onthe morning of Monday, March 8, 2010. A tutorial is a ‘hands-on,’interactive learning experience which takes a different format thana session. They are led by up to two instructors, are attended by asmaller number of participants and are more interactive. Tutorialsconsist of three hours of instruction with a 30-minute break in themiddle.

How to Submit an Abstract

The deadline for submitting abstracts is Friday, April 24, 2009.

All abstracts have to be submitted onlineYour abstract can be up to approximately 300 words. You will be also asked toprovide a short summary (2-3 sentences) and two learning objectives forparticipants. You will increase the probability of your abstract being accepted byproviding as much specific information as possible.

Please submit your abstracts online at www.diahome.org (see screenschot on next page)

Go the drop-down menu at the top “Get Involved”, then click on “Submit Abstracts”

Speak at the EuroMeeting 2010 – Submit an Abstract

The Innovative Medicines InitiativeCurrent statusLessons learnedHow can patients and other stakeholdersbecome more involvedComparisons with other public-privatepartnerships

Is an open innovation paradigm the wayforward for pharma?Experience from other related industriesWhat examples already exist in pharma?

The importance of pre-competitive datasharing to accelerate drug developmentissues around data sharingSuccessful examples– clinical and preclinicalCan biomarkers facilitate innovative drugdevelopment?What is required for validation andquantification?Regulatory view on biomarkersHow to incorporate into the developmentdecision-making process?

What is an innovative medicine?How measure innovationHow will payers reimburse innovationWhat does innovation look like from thepatient perspectiveWhere are the incentives for developingnovel anti-infectious agents

Innovation in early and late phase clinicaltrialsImpact of adaptive designs on timelines andcost

Can innovative trial design reduce risk

Have the benefits of translational medicinebeen realised?SuccessesWhich therapeutic areas have benefitedmost?Gaps

Theme 2: Staying in Business: How to MakeSure You Comply with All Rules andRegulationsTheme Leader:Beat Widler, Global Head, Clinical Quality Assurance,F. Hoffman-La Roche AG, Switzerland

The Pharmaceutical Package has created new obligations:How to deal with them

Consequences of moving development andmanufacturing to China and India

Counterfeit: Who owns the problem? Who is in control?

Drug abuse and doping

Theme 1: Innovation Theme Leader:Jackie Hunter, Senior Vice President, Science Environment Development, GlaxoSmithKline, UK

2010 Themes: Topics

Theme 3: Paediatrics Theme Leader:Angelika Joos, Director, Regulatory Policy Europe,Merck Sharp & Dohme (Europe) Inc., Belgium

Pre-clinical aspects, juvenile testing

Paediatric formulations and quality aspects, combination products

Set-up and conduct of paediatric clinical trials, ethical challenges,trial designs, modelling

Regulatory challenges and PIP case studies

Paediatric Clinical Research Networks: Expectations

Pharmacovigilance and safety aspects with paediatric trials

Process for SPC extension

Theme 4: Decision-MakingTheme Leader:Craig Johnson, Principal Regulatory Scientist, Regulatory Information & External Affairs,Eli Lilly, UK

Should regulatory processes become more transparent and, if so, how?

Conditional approvals. How to strike the right balance between early access, patientsafety and commercial reality

Evolving the benefit/risk concept and the use of quantitative models. Where are we nowand where are we going?

What is the true value of risk management for decision making and for post-approval commitments?

HTA (Health Technology Assessment) bodies' influence on regulatory decision making:reality? An opportunity? A threat?

Patient influence on regulatory decisions. How much do they and should they have?

2010 Themes: Topics

Theme 5: Biotherapeutics and Advanced TherapiesTheme Leader:Catarina Edfjäll, Head of Regulatory Affairs Europe, Celgene International SARL,Switzerland

Advanced Therapies: A diverse landscape with one regulatory framework.

Functioning of the CAT to date?

The EU is leading the world in regulating this new class of products - how is it seenfrom other regions?

Pre-clinical issues – are there any? Towards ICH S10?

Clinical development – can current clinical trial rules cope with cell and genetreatments? What are the ethical aspects of clinical development?

Cells-, genes, devices, combinations: Is this the future for pharmaceutical industryand how close are we to seeing the first products available?

Pricing, reimbursement and HTA considerations for advanced therapies. How willpayers react? Health Technology Assessments – are they possible for advancedtherapies?

Pharmacovigilance and Risk Management plans – do Advanced Therapies createspecific challenges? The benefit/risk balance: Is it manageable? Or should we behappy with risk control?

Advanced therapies and medical devices – living with a new reality? How equippedare the medical device sector and the new framework to work with the each other?

Biosimilars: Will it ever be possible to envisage biosimilar advanced therapies?

Theme 6: Challenges for Switching CentrallyAuthorised Products from Prescription to Non-Prescription Status Theme Leader:Christelle Anquez-Traxler, Regulatory and Scientific AffairsManager AESGP, Belgium

A steep learning curve for both industry and CHMP: What arethe lessons learnt? Who benefits?

What are the trends in central switching? Will this impactswitching at the national level and provoke more (ambitious)switches? Are incentives sufficient to enable innovation?

Benefit/risk assessment and Risk Management Plans formedicines switched

National and central switches: How do they coexist at nationallevel?

2010 Themes: Topics

Theme 7: Personalised MedicineTheme Leader:Wills Hughes-Wilson, Director, HealthPolicy Europe, Genzyme, UK

What does “personalised medicine” mean?How is it used in clinical practice? Benefits topatients? In which therapeutic areas?

What needs to change in thebio/pharmaceutical environment andframework to make personalised medicines areal possibility? Can it become a realbusiness model?

Building on experience to date. What canwe learn from the existing diagnostic andtherapy relationships?

Payers’ views on the promise or potential forpersonalised medicines Can HealthTechnology Assessments be applied topersonalised medicine?

What does the diagnostics sector need tosuccessfully serve personalised medicines?Steps needed to achieve a successfulmarketing authorisation for adiagnostic/drug combination?

Will the benefit/risk balance be assessed inthe same way as for “regular” treatments?

Building the link between discovery andclinical validation of genetic markers(biomarkers)?

Particular aspects of pharmacovigilance andRisk Management Plans for personalisedmedicine?

The EC considers creating a research agendafor integration of genomics into healthservices and conducting studies intotranslational research for genomicsapplications. What recommendationsshould be made?

A very strong IT structure is necessary.What needs to be developed? How toensure international harmonisation ofregulatory regimes and IT standards tosupport the development?

Ongoing education – how to keepphysicians and healthcare providersup to date?

Intellectual property considerations?

Do patients need to be involved inthe research and developmentphase?

How to address patient data privacyconcerns?

Theme 8: Taking the European RegulatoryInfrastructure ForwardTheme Leader:Brenton James, Consultant in Strategic Regulatory Affairsin the European Union, UK

From two to six committees, from 15 to 27 member states,and more to come: How to navigate

EMEA Roadmap to 2010: Are we there?

Is CHMP overloaded? Is it losing its power?

New players in the regulatory process

The growing network of national agencies

Optimal use of limited resources

More inspectors, more inspectorates: Who benefits?

2010 Themes: Topics

Theme 9: Risk ManagementTheme Leader:Trevor Gibbs, Executive Vice President, ii4sm, Switzerland

Experience and challenges to date for RMP (EU) andREMS (US)

US experience from implementing FDAAArequirements

Lifecycle monitoring: Are we there?

Pharmacoepidemiology trials: A novel regulatorytool

Theme 10: The Informed PatientTheme Leader:Nick Sykes, Director, Head, Global Regulatory Intelligence and TA Analysis, Pfizer, UK

Consequences of the ‘Pharmaceutical Package’ proposal

Communication to the patients in a multicultural, multistate environmentThe package leaflet: Is it written for patients or regulators?

What patients really want to know and how

Are informed patients better involved patients?

2010 Themes: Topics

Theme 11: E-HealthTheme Leader:Valdo Arnera, General Manager, Europe, PHT Corporation, Switzerland

What does e-health mean?

Advantages for the health care profession, for the patients

Monitoring of e-prescription

e-CTD

Theme 12: Pharmaceutical Sciences in 2020Theme Leader:Geoff Tucker, Emeritus Professor of Clinical Pharmacology, UK, Chairman ofSimcyp Ltd., University of Sheffield, UK

What major research activities will drive drug discovery and development?. Forexample, disease models, systems biology, in silico/in vitro prediction of PK/PD,bioengineering

What will the enabling technologies be? For example, tissue engineering, stemcells, non-invasive imaging, on demand delivery, miniaturisation

What paradigm/geographical shifts will there be in drug discovery/development?For example, small/large company interfaces/outsourcing, public-private/academic-industrial partnerships, global vs Asian vs Western focus

How will changes in education meet the demands of industry and regulation? Forexample, undergraduate/graduate programmes, interdisciplinary education,transnational programmes

Stand-Alone Topics

If your presentation does not have a fit with any of the abovethemes, you may submit it for consideration as a stand-alonetopic.

2010 Themes: Topics

The deadline for submitting abstractsis Friday, April 24, 2009.

The Principality of Monaco may be one ofthe smallest countries in the world but ithas an incredible amount to offer.Accessible, glamorous, and with DIA’sspecially negotiated hotel rates, veryaffordable, Monaco is one of the world’smost attractive destinations. For threedays in March 2010, Monaco’s 33,000inhabitants will be joined by 3,000

EuroMeeting participants. As all hotels are within walking distance of theConvention Centre, the 2010 EuroMeeting will have an intimate feel thatmaximises networking opportunities. With picturesque places to discover, sitesto visit, museums, leisure facilities, shops and boutiques, and over 150restaurants, you may be very tempted to extend your trip.

An international hub, easily accessible by air, road and rail, the Nice-Côte d’AzurInternational Airport is a 30-minute drive away, providing flights to more than80 destinations throughout the world, and the new TGV railway centre iscompletely underground and links the town centre to the whole European railnetwork.

Quick facts:

Area: Approximately 2 square km (1 square mile)

Location: Between the French and Italian Rivieras

Climate: Sunny weather all-year round

Languages: The official language of Monaco is French but English, Italian, aswell as Monégasque (local language) are also spoken.

Currency: the Euro

Government: Constitutional monarchy. The Grimaldi family has ruled overMonaco since 1297.

Discovering Monaco

La Condamine is the port area. MonteCarlo is the main centre for businessand entertainment where the famousMonte Carlo Casino is located.Monaco-Ville, the old city built on arocky promontory extending into theMediterranean, known as the Rock ofMonaco, or simply Le Rocher (theRock) is where the palace is located

The Convention Centre

The EuroMeeting will take place at thestate-of-the-art Grimaldi Forum on thewaterfront. This daylight-filled buildingwith its stunning glass entrance is built onland reclaimed from the sea. It opened forconferences in September 2000.

Join us in Monaco: Welcome to the EuroMeeting 2010 Global Village

Exhibit at the EuroMeeting 2010

Showcase your company’sproduct or service to over3,000 drug developmentprofessionals at theEuroMeeting 2010 inMonaco.

Join over 200 exhibitors tointeract with professionalsfrom the pharmaceutical,biotechnology, devices,government, academia,healthcare delivery andrelated industries, fromover 50 countries.

For further information, please contact Phyllis Suter atthe Drug Information Association in Europe:phyllis.suter@diaeurope.org or call +41 61 225 5154

About the EuroMeetingThe Drug Information Association’s Annual EuroMeeting is global in scope, attracting wellover 3,000 professionals from over 50 countries. It brings together professionals from thebiopharmaceutical industry, contract service organisations, academic research centres,regulatory agencies and health ministries. This convergence affords attendees the opportunityto network with professional colleagues from around the world.

The DIA is a professional association of approximately 18,000 members worldwide who areinvolved in the discovery, development, regulation, surveillance or marketing ofpharmaceuticals or related products. We are committed to the broad dissemination ofinformation on the development of new medicines or generics and biosimilars, withcontinuously improved professional practice as the goal. The DIA is a financially independentnon-profit organisation that funds itself from meeting and membership fees. The voluntaryefforts of DIA members and speakers allow the DIA to organise conferences, workshops andtraining courses and provide publications at a reasonable, competitive cost.

Do you have a question about the EuroMeeting? Contact Dermot Ryan, Senior EventManager (EuroMeeting): dermot.ryan@diaeurope.org or call +41 61 225 5132

Cover Image: Roger Broders, “La Corne d’Or Nice Villefranche Monaco”© 2009 ProLitterus, Zurich