ICPM 2008AMSTERDAM

The 15th InternationalConference on Pharmaceutical

Medicine inAmsterdam, The Netherlands

7–10 September 2008

ICPM 20081st announcement

Developing Pharmaceutical

CareMedicines after the

Blockbuster Era

www.icpm2008.org

Dear Colleagues,

Pharmaceutical R&D and medical affairs are the initial concepts behind pharmaceutical medicine. But how can we get a very efficient and accurate update of all the latest scientific developments in this fast moving field? Do we still need a blockbuster mindset? Where can we share with each other our best practices in fields such as risk assessment or pharmaceutical crisis management? Where can we

learn from each other the latest trends in clinical development or the new scientific drivers behind our new pharmaceuticals? How can we meet our international medical business colleagues in a non-competitive atmosphere?

We have selected for you a faculty of more than 40 industrial, academic and governmental executives discussing the real highlights on all the key topics of their and our daily work. You

will get expert-to-expert briefings on the critical issues of our pharmaceutical business. The venue will bring the right atmosphere to meet your colleague delegates and speakers.

In addition to the state-of-the-art scientific program we will have the opportunity to follow different executive classes on medical statistics about non-interventional studies and risk-benefit analyses, and there will be a short course covering all you want to know about media interactions. Spend two and a half days in Amsterdam to boost your knowledge on pharmaceutical medicine to the proper professional level.

The International Conference on Pharmaceutical Medicine is organized every two years by the International Federation of Associations of Pharmaceutical Physicians. The venue is open to all professionals working in the field of new drug development and medical affairs in a pharmaceutical industrial environment.

Don’t miss this opportunity and register today! We will be happy to welcome you to Amsterdam!

Rudolf W. van Olden, M.D., Ph.D.ChairpersonICPM 2008 Organizing Committee

ICPM 2008

The 15th International Conference on Pharmaceutical Medicine in Amsterdam The Netherlands2

Welcome to the ICPM 2008

in Amsterdam

Morning

plenary programEvening

Afternoonparallel program

EveningM

orningparallel short

course program

State of the Art in Translational MedicineChairs: Gustavo Kesselring, Joop van Gerven• Physiology based modelling - Meindert Danhof - Leiden Amsterdam Center of Drug Research• From bedside to bench - Andreas Wallnöfer - F. Hoffmann-La Roche Ltd • New translational models - Philip Scheltens - VU University Medical Center

State of the Art in Trial Design TechnologyChairs: Gerfried Nell, Paul de Koning• Validity of biomarkers and surrogate endpoints - Paul Rolan - University of Adelaide • Pharmacogenomics in trial design - Kevin Cheeseman - AstraZeneca• Adaptive clinical trial design: pro’s and con’s - Kit Roes - Organon

• Statistics for non-interventional studies - Richard Kay - RK Statistics• Update in Risk-Benefit Analyses - Graham Ladds - PharSafer• Media Training - Hill & Knowlton

Lunch Symposia

Medical Research after Marketing AuthorisationChairs: Kurt Bestehorn, Martijn Torreman• Non-interventional studies - Giovanni Fiori - Medi Data• Anticipating reimbursement issues - Hubertus Rosery - Principal• US-EU Regulations & safety registries - Gaby Danan -

Sanofi Aventis

Off-Label PharmacotherapyChairs: Jane Barret, Eric Hoedemaker• Off-label pharmacotherapy: when evidence without label - tbd• Off-label Rx: cheap evidence, payers perspective - tbd• Off-label-comparator through the eyes of FDA and EMEA - tbd

Happy Hour

Presidents ReceptionOkura Hotel

Welcome ReceptionRijksmuseum Amsterdam

Modern Clinical Development 1Outsourcing StrategiesChairs: Domenico Criscuolo, Philippa Smit• Models for Outsourcing in Clinical research - Jeffrey McMullen -

PharmaNet Development Group • Partnering with CROs, trends and opportunities - Rene Sluijter -

Solvay Pharmaceuticals• Outsourcing needs of Biotech vs those of Pharma - Roger

Hickling - Alizyme

Risk Assessment in Clinical Trials and Quality IssuesChairs: Montse Barceló, Cees Ketelaars• Risk Assessment in Clinical Trials - Holger Liebig - Parexel • Striving for Quality - tbd• Quality at any Cost - Rita Hattemer-Apostel - Verdandi AG

Monday, September 8D eve l o p i n g P h a r m a c e u t i c a l C a re

Sunday, September 7

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Lunch Sym

posia

ICPM 2008

The 15th International Conference on Pharmaceutical Medicine in Amsterdam The Netherlands4

Morning

plenary programAfternoon

parallel programEvening

Morning

parallel short course

program

Lunch Sym

posia

Highly Specialized Indications in ResearchPaediatric researchChairs: Martin Offringa, Gerard van Leijenhorst• Essentials of pediatric drug development - John van den Anker - Georgetown University Center• Regulatory aspects of paediatric drug development - Agnès Saint-Raymond - EMEA• The role of paediatric networks - Rosalind Smyth - Alder Hey Children’s Hospital

Orphan WorldChairs: Norbert Clemens, Ad Sitsen• Ethical issues in funding orphan research - Maria Wästfelt - Karolinska Institute• 25 yrs orphan drug development in US - Marlene Haffner - Amgen• Hurdles in orphan drug development - Bruno Giannetti - Pharming Group NV

• Statistics for non-interventional studies - Richard Kay - RK Statistics• Update in Risk-Benefit Analyses - Graham Ladds - PharSafer• Media Training - Hill & Knowlton

Lunch Symposia

Pharmaceutical Crisis ManagementFailures in Phase III-IVChairs: Chris Allen, Rudolf van Olden• Role of Drug Safety Monitoring Boards - tbd• Case report: Pre-Approval - torcetrabip - tbd• Case Report: Post Approval - glitazonen -

Alistair Benbow - GlaxoSmithKline

Getting new therapeutic modalities to the marketChairs: Luis Collia, Ed Schook• Regulatory hurdle, need for change? - Bert Leufkens -

CBG-MEB NL • Reimbursement hurdle, need for change? - Sir Michael Rawlins -

NICE UK • Breaking News

Happy Hour

Gala Dinner and ICPM 2008 lectureBeurs van Berlage

Modern Clinical Development 2Trends in Clinical DevelopmentChairs: Johanna Schenk, Cees Ketelaars• Stimulating Innovation: conditional and accelerated approach

- Richard Tiner - Association of the British Pharmaceutical Industry

• Patient Recruitment Strategies: Differences between Ph II/III - IV - Jane Eisner - Quintiles

• Post marketing surveillance: Registries and other techniques - Nancy Dreyer - Outcome

Managing Cost Aspects in Clinical DevelopmentChairs: Jean-Paul Deslypèere, Philippa Smit• Cost management and Performance Metrics - David Sexton -

Pfizer Global Research and Development• e-Clinical processes in improving cost efficiencies -

Kenneth Getz - CISCRP• Improved efficiencies: Globalisation of Clinical Trials -

Brian O’Keeffe - Malaysian Biotechnology Corporation

Tuesday, September 9M e d i c i n e s a f t e r B l o c k bu s t e r E r a

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Morning

plenary program

Any end of the Blockbuster MindsetChairs: Stuart Geary, Henk-Jan Out• R&D philosophy: private-public partnerships - Daan Crommelin - Dutch Top Institute Pharma• Targeted therapies: nichebusters - Genzyme• Drivers behind science: role of financial investor - Martin Eigenhuijzen - ABP Investments

New Scientific Drivers behind Pharmaceutical MedicineChairs: Gerfried Nell, Philip Salden• Stem cell Research; New Panacea? - tbd• Latest Developments in Pharmaceutical Nanotechnology - tbd• New Insights from System Biology - Hans Westerhoff - Biocentrum Amsterdam

Closing Ceremony• ICPM 2010 at a glance

FARE WELL LUNCH

Wednesday, September 10P h a r m a c e u t i c a l F u t u re

VenueHotel Okura AmsterdamFerdinand Bolstraat 3331072 LH AmsterdamThe NetherlandsPhone: +31 20 6787111Fax: +31 20 6712344

Who will attendThe program will be of interest to anyone who is working within the field of pharmaceutical medicine or clinical pharmacology, drug regulation, teaching pharmacotherapy and application of pharmacotherapy in daily clinical practice. In addition, especially those who are in training for these specialties, should attend the meeting.

ICPM 2008

The 15th International Conference on Pharmaceutical Medicine in Amsterdam The Netherlands6

General Information VenueAmsterdam is living history, a city where you will feel immediately at home. Built around a network of stunning canals, you can admire centuries old houses, as well as the most contemporary architectural designs. In this bustling cosmopolitan metropolis, you won’t find a warmer welcome than at Hotel Okura Amsterdam. Hotel Okura Amsterdam is located on the banks of the Amstel Canal, close to the financial, cultural and entertainment district of Amsterdam. The city’s motorways are easy accessible and Schiphol International Airport is only a 15 minutes drive away.

Hotel Shuttle service by Canal Boat Amsterdam is the City of canals. Getting to your destination by public transport is as efficient as taking a canal boat. Therefore we organized on September 7th, 8th,9th and 10th the early morning and late afternoon hotel shuttle boats. These boats will pick you up in front or close to your hotel and will go directly to the Okura Hotel and vice versa. Convenient, efficient en comfortable with coffee/tea on board.

IFAPP Meetings during ICPMSunday September 7th12.00 - 3.00 pm EC Meeting3.00 - 4.00 pm House of Delegates

Exhibitor Packages We will have 18 booths available sized from 2.00 x 2.00 meter up to 6.00 x 2.00 meter. For further information about sponsoring or exhibiting during ICPM 2008 please contact: secretariat@icpm2008.org We will send you our Sponsorship & Exhibition Prospectus upon your request.

How to registerAccompanying persons who want to attend the scientific program do need to register separately.

Please note that the organizers are obliged by the Dutch Tax Authorities to charge 19% VAT The amount will be specified on the invoice. Supplementary of 3,5 - 4,4 % service charge (depending on your credit card) will be added to the total amount.

Registration fee includes: access to all ICPM scientific sessions, including the morning short course program for early birds. Access to the exhibition / posters. Final Congress Program, List of participants, Congress Bag, Name badge, 3 x lunch in exhibition hall, canal shuttle.Registration fees are quoted in EURO

€ 875,00 before May 1st 2008 excl. 19 % VAT€ 975,00 after May 1st 2008 excl. 19 % VAT€ 1075,00 on site excl. 19 % VAT

Monday September 8th7.00 pm President’s Reception (by invitation only)

Wednesday September 10th12.00 pm General Assembly (all IFAPP members)

Registration only via

www.icpm2008.org

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Social events:Welcome Reception at Rijksmuseum € 25,00 incl. 6% VATGala dinner at Beurs van Berlage € 75,00 incl. 6% VAT

PaymentRegistration fees are to be paid in Euro by Credit Card, VISA, MASTERCARD or AMERICAN EXPRESS. Instructions for payment are included in the online registration form after submitting.

Hotel classification We cannot take any responsibility for the hotel * classification as it is announced on our website.

Terms of CancellationCancellation of registration must be sent in writing to the secretariat’s address from Travel Congress Management (see address above). In case of cancellation on or before June 1st 2008, the registration fee will be refunded, less a € 100,00 administration fee. (as per committee policy) Cancellations received after June 1st 2008 will not be accepted or refunded. Please note that the terms of cancellation are applicable in all circumstances. Also if a visa is officially refused to the participant.

KENDLE CAREERS Real people. Real results.®

Kendle is a leading clinical research organization, the third-largest provider of Phase II-IV clinical development services. We deliver innovative and robust clinical development solutions. Kendle's European Clinical Pharmacology Unit is based in Utrecht and providesthe opportunity for early human administration of compounds. The unit is strategically located on the campus of the University Hospital. Both the highly favorable regulatory environment and unique collaboration with many academic departments provide an optimal platform for accelerated drug development. We place a strong emphasis on the growth and development of each of our associates, and our project teams have the autonomy and authority to run global trials. We also provide a progressive work-life environment and offer novel programs to encourage loyalty and ownership in our company. Please visit Kendle at the International Conference on Pharmaceutical Medicineon 7-10 September 2008 at the Hotel Okura Amsterdam. Information about this congress can be found on www.icpm2008.org. For more information about Kendle or an overview of our open positions please visit www.kendle.com.

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ICPM 2008

The 15th International Conference on Pharmaceutical Medicine in Amsterdam The Netherlands8

Changes of Registration and NamesChanges of names are in all circumstances considered as cancellations and will be treated as new registrations.

BadgesAll delegates will receive a personal badge upon registration at the entrance of the venue as of Sunday September 7th. All participants are kindly requested to wear their badges throughout the conference. Only participants wearing their name badge will be admitted to the sessions, exhibition hall and canal boats.

IMPORTANT: Accompanying persons who want to attend the Scientific Program do need to register separately. Accompanying persons who do not attend the Scientific Program do only receive a badge when the first registrant booked welcome reception and / or Gala Dinner for both.

Dress Informal dress is acceptable for all sessions. Business attire is recommended for the Welcome Reception and the Gala Dinner.

InsuranceThe Organizing Committee accepts no liability for personal injuries sustained, sickness or for loss or damage to property belonging to conference participants and/or accompanying persons, incurred either during or as a result of the conference. It is recommended that each participant takes out a personal insurance.

Visa Participants from EU countries do not need a visa to enter The Netherlands. Participants from all other countries should check if it is necessary to apply for a visa. Official invitations are available upon request by sending an e-mail to: secretariat@icpm2008.org

NewsletterA montly newsletter will be provided via the ICPM 2008 website. When you are interested please fill in your e-mail address at the home page of this website www.icpm2008.org

Hotel Accommodation Information is available on www.icpm2008.org

Hotel Okura, Mercure Aan de Amstel, Golden Tulip Apollo, Hotel Beethoven, NH Grand Hotel Krasnapolsky, NH Barbizon Palace, NH Amsterdam Centre, NH City North, NH Museum Quarter, NH Doelen, NH Caransa, NH Schiller, NH City Centre, Hampshire

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Tour Programs CITYTOUR COACH Including a visit of a diamond factory and Rijksmuseum

GRAND HOLLAND TOURDelft, Rotterdam & The Hague, let’s meet the royals

SHOPPING NIGHT AMSTERDAM WINDMILLS & CHEESE Zaanse Schans and Edam

Visit our website www.icpm2008.org for details of these programs

1-14-08_ICPM_21x14.85cm_c_OL.ind1 1 1/17/08 9:13:53 AM

Call for AbstractsSubjects

Please accept the following guidelines when you are planning to send in your abstract. We offer only 3 choices. All abstracts will give the possibility to participate in the poster sessions.

• Call for Abstract pharmaceutical medicine; only for poster session; all aspects of pharmaceutical medicine; molecular development; clinical development; regulatory; pharmaco-vigilance; medical affairs; health outcomes

• Call for Abstract products in development phase 1-2. ‘The new NCE industrial market’. • Call for Abstract posters to members of the IFAPP with developments of their Associations.

Deadline for submitting an abstract is 1st June 2008

ICPM 2008

10 The 15th International Conference on Pharmaceutical Medicine in Amsterdam The Netherlands

Please visit

www.icpm2008.org to submit your abstract.

• Pharmacological knowledge you need for Pharmaceutical Care

• New possibilities in the development process • Decreasing the costs of development • Direct to patient information, the do’s and

don’ts • Biomarker strategy • Ethics of drug development as seen by

patients • Future indication areas that need exploration,

unmet needs • Lessons from virtual development companies

for a better R&D process

• Pharmacovigilance data for improvement of patient care.

• Access to market; the regulatory hurdle • Pharmaceutical support programmes, better

marketing or better drugs? • Pricing strategies for faster reimbursement • IT systems that improve the development

process • Options for faster patient recruitment • Which laws improve drug development • Crisis management for the medical

department, what to do when a Tsunami hits

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Scientific CommitteeJoop van Gerven CHDRMarleen Hoynck van Papendrecht Centocor Cees Ketelaars Quintiles Paul de Koning Astellas Gerard van Leijenhorst Merck Sharp & Dohme Paul van Meurs Bio-Imaging TechnologiesRudolf van Olden GlaxoSmithKlineHenk-Jan Out Organon InternationalPhilip Salden NVFG Ad Sitsen ClinPharMedEd Schook ALTANA Pharma Ron Suijkerbuijk Amgen Martijn Torreman Janssen-Cilag Philippa Smit-Marshall PharmaNetEric Hoedemaker Sanofi-Aventis Sponsorship

Exhibitors

ICPM 2008

ICPM 2008 secretariatMrs. Caroline van Bruggen

Mrs. Miranda Meulstee

Rendementsweg 24 E-I

3641 SL Mijdrecht

The Netherlands

Phone: +31 (0) 297 285144

Fax: +31 (0) 297 256046

scientific@icpm2008.org

Conference organizerTravel Congress Management

George J. Brouwer

Jeroen Hof

PO Box 103

1170 AC Badhoevedorp

Phone: +31 (0) 20 6597970

Fax: +31 (0) 20 6597762

secretariat@icpm2008.org

housing@icpm2008.org

registrar@icpm2008.org