HEAR FROM KEY INDuSTRY SPEAKERS:

• Molly Rosano, Director Clinical Research, PulMATRIx INC

• Jonathan Guerriero, Program Director, RADIuS

• Katie Wood, Clinical Trial Head Translational Medicine Oncology, NOVARTIS PHARMACEuTICAlS

• Maureen Hynes, Director, Strategic Sourcing, MIllENNIuM PHARMACEuTICAlS

• Chris Houchins, VP Clinical Operations, ARNO THERAPEuTICS

• Ross Pettit, Vice President, Clinical Operations, ARIAD PHARMACEuTICAlS

• Rashieda Gluck, Head of Clinical Operations, VIFOR PHARMA

• lisa Kaufman MS, Director, Clinical Operations, STROMEDIx

• Mary- Callahan-Squire, Executive Director, Clinical Programs, ASTRAZENECA

KEY REASONS TO ATTEND: Great ● new case studies from key biotech and pharmaceuticals companies

Learn ● the latest new approaches that can help you increase the effi ciency of your outsourcing program

Participate ● in expert led panel discussions to get your questions answered

FREE* for vice presidents and directors from biotech and pharma companies

Optimizing your outsourcing strategies to maximize the quality and cost effi ciency of your clinical trials

REGISTER NOW: Online: www.vibpharma.com/outsourcing/nj Tel: +44 (0)20 7753 4268Email: book@arena-international.com Fax: +44 (0)20 7915 9773

Wednesday 17 and Thursday 18 March 2010, New Brunswick, New Jersey

VIBpharma

PFIZER ●

NOVARTIS ●

SOLACE ●

ROCHE ●

RADIUS ●

CELTIC ● PHARMAEISAI ●

ASTRAZENECA ●

TOP COMPANIES REPRESENTED:

Silver sponsors:

europe

Program day one Wednesday 17 March 2010

11:30 Developing an effective strategy to maintain multiple contracts successfully and improve time and cost efficiencyEstablishing an optimal model for your clinical trial department to ●

ensure that your protocol produces the best possible partnership every timeAchieving a balance between over dependence on too few providers, ●

and an unmanageable number of vendorsIncorporating offshore CROs into your global strategy in order to ●

promote good interaction and reduce the likelihood of errorReviewing supervisory strategy to improve your working relationships ●

and increase efficiencyJonathan Guerriero, Program Director, RADIuS

12:00 Panel Discussion: The tender process: how can you ensure that the proposal you receive is realistic and informative in order to avoid unnecessary change orders The Request For Information: ensuring that your request is sufficiently ●

specific to allow the CRO to provide a comprehensive and informative response Understanding the optimal level of detail in order to make efficient use ●

of time without compromising the bid process The Request For Proposal: analyzing key questions to maximize the ●

accuracy and relevance of the proposals you receive Developing best practice reviewing the bids to identify the CRO who ●

best meets your needs Re-evaluating bid-grids and the need for negotiations to be based on a ●

common language: avoiding all barriers to communication Comparing ‘apples to apples’ to make sure that the cheapest bid really ●

is the best valueKatie Wood, Clinical Trial Head Translational Medicine Oncology, NOVARTIS PHARMACEuTICAlSMaureen Hynes, Director, Strategic Sourcing, MIllENNIuM PHARMACEuTICAlSJonathan Guerriero, Program Director, RADIuS

01:00 Lunch

Optimizing the bid process to streamline procedure and expedite trial start-up 02:30 Employing comprehensive and well researched

contracts to reduce the risk of change orders and missed milestonesAchieving maximum CRO buy-in in order to share risks and benefits ●

and reduce the likelihood of vendor-led over-runIdentifying potential areas of risk to better prepare for them ●

Reducing the need for time-consuming and financially draining ●

change-orders by establishing a water-tight contract Understanding whether a one-off contract or a long term partnership ●

will be most effective for your trial Using a long-term partnership to reduce the likelihood of costly ●

mistakes and develop a sense of shared responsibilityMary- Callahan-Squire, Executive Director, Clinical Programs, ASTRAZENECA

03:00 Establishing a workable contract that delivers on promises Optimizing the speed of your trial by identifying potential problems at ●

the outset Asking the revealing questions: pinpointing unrealistic promises ●

Defining effective due diligence procedure to ensure that your vendor ●

is offers what you need Ensuring that the bid is realistic and all-inclusive to minimize the ●

chance of over-spendingClearly defining responsibilities and expectations in order to minimize ●

oversight and achieve key milestonesKatie Wood, Clinical Trial Head, Translational Medicine Oncology, NOVARTIS PHARMACEuTICAlS

03:30 Afternoon refreshments and networking

08:30 Registration

09:00 Opening remarks from the Chair

09:10 Evaluating recent and ongoing changes in the world of outsourcing in order to plan for future partnershipsAssessing developments taking place in the CRO marketplace in order ●

to establish a more effective decision making strategyUnderstanding the implications for sponsors and the opportunities ●

that have been created by a more integrated CRO/Sponsor climate Overcoming the challenges presented by a more CRO reliant ●

environment to exploit potential advantages without sacrificing autonomy Uncovering developing trends and what they mean for the future of ●

clinical trials outsourcingMitchell Katz, Vice President Clinical Operations, EISAI GlOBAl ClINICAl DEVElOPMENT

Identifying the optimum vendor for your business to ensure a successful partnership09:30 Achieving clarity on how to identify the type of CRO that

best meets the needs of your company profile to help you maximize ROI Establishing the needs of your trial in order to more effectively ●

streamline the selection process Assessing the capabilities and specialities you require of your CRO ●

Understanding whether a full service or function service model will ●

offer the best return on the investment of your time and financial outlay Achieving a balance between price and quality by involving both the ●

clinical and outsourcing teams in the selection protocol Revealing key strategies to make the right choices first time, every time ●

lisa Kaufman MS, Director, Clinical Operations, STROMEDIx

10:00 Size matters: matching your CRO to the phase, drug, location and business model in question to maximize efficiencyFinding a CRO that can offer both the security of a large corporation, ●

and the personal partnership of a smaller providerAssessing the true benefits of using a large CRO: can it save you time ●

and money?Developing a strategy that incorporates specialist, smaller vendors ●

in order to take advantage of a closer working relationship and the resulting efficiencyOptimizing results in early phase trials by selecting a well suited ●

vendorEvaluating small and large CROs to establish the most price-efficient ●

approachRoss Pettit, Vice President, Clinical Operations, ARIAD PHARMACEuTICAlS

10:30 Morning Refreshments and Networking

Putting in place the best possible vendor and in-house team to ensure a successful, timely, and cost efficient trial 11:00 Case Study: learning what virtuals require of CROs and

the lessons that more traditional business models can take from a fully outsourced formatWhat does the ideal CRO offer the virtual biopharma? ●

Establishing a self managing format which reduces the need for ●

constant oversight from the sponsorSuccessfully ensuring that your project is given adequate resource and ●

attention so that quality is maintainedSecuring excellent the vendor staff your trials require to enable you to ●

focus on core competenciesOvercoming challenges specific to virtual pharma and identifying ●

tailored strategies to maximize efficiencyChris Houchins, Vice President, Clinical Operations, ARNO THERAPEuTICS

08:45 Registration and refreshments

09:10 Chairman’s opening remarks

Developing effective CMC outsourcing strategy09:40 The Role of CMC in Early and late Phase Clinical Trials

CMC strategies for early-phase clinical studies ●

Risk-managed CMC regulatory compliance strategies ●

Effective collaborations with CMOs for CMC development activities ●

of external partner and clinical trial supplies Coordination of clinical operations, quality and regulatory functions ●

to ensure adherence to standards and on time clinical trial supplies Effective interactions with international regulatory bodies to gain ●

timely approval of regulatory submissions Angelos Dovletoglou, Director, Small Molecules, CMC, BIOGEN IDEC

Developing an offshore strategy that minimizes risk while taking advantage of potential efficiencies10:10 Case Study: Outsourcing clinical trials to India Overcoming cultural and language differences in order

to optimize the reliability of your clinics Successfully conducting essential initial research to establish the ●

requirements of your location of choice Developing protocol that enables you to select a vendor that can ●

fulfil those requirements Ensuring that your CRO has sufficient in-country support from a ●

local vendor in order to reduce the likelihood of time-consuming misunderstandings Assessing the availability of qualified investigators who can deliver ●

your data on time and to an FDA compliant standard Understanding India’s regional languages and their implications ●

your you trial: avoiding surprises

10:40 Working effectively with CROs in the uK to increase the efficiency of Phase I clinical trials Highlighting the UK regulatory landscape to better understand the ●

necessary process and maximize efficiency Clarifying REC and CA submission to guarantee regulatory ●

expectations are met Explaining the MHRA accreditation system for Phase I CROs to ●

ensure the selection of an appropriate facility Moira Burke, Managing Director, BIO-KINETIC EuROPE

11:10 Morning refreshments and networking

11:40 Running a high quality trial through careful management of international partnerships Identifying the technology required to ‘watch’ an off-shore trial ●

Overcoming key challenges when monitoring the progress of a ●

geographically distant trial Taking account of the hidden costs of managing your relationship in ●

order to create a more realistic budget Minimizing the likelihood of misunderstandings by creating effective ●

and clearly defined chain of command

12:10 Evaluating the role of China in the future of clinical trialsAssessing the business challenges of operating in China today: ●

determining the political and economic landscapeAnalyzing the potential benefits to patient recruitment and time ●

savingsDelving deeper into the challenges: uncovering the current status ●

of infrastructure, personnel and supply systems in order to gauge whether developing operations in China would benefit your businessEnsuring patient care and safety standards through careful ●

evaluation of likely obstaclesEstablishing the true financial efficiencies over a more traditional ●

locationSourcing a CRO with specialist skills in this geographical area the ●

challenges associated with it01:10 Lunch

Establishing a relationship which optimizes quality and reduces error04:00 Maximising transparency and reliability through metrics

and SlAs to develop an efficient and reliable working relationshipEnhancing the quality and reliability of your trial through the ●

deployment of effective metricsMatching the CRO to your KPI requirements in order to create a ●

harmonious partnership that meets your needs Measuring and bench-marking your pre-agreed metrics: how to ●

effectively assess your progress against key goals Minimizing trial duration through the use of an effective monitoring ●

protocol Adapting your strategy to take account of offshore trials: factoring in ●

potential obstacles

04:30 Chairman’s summation and close of day 1

day one Wednesday 17 March 2010

register online now! www.vibpharma.com/outsourcing/nj

Program day two day two Thursday 18 March 2010

02:40 Keynote Presentation: How to ensure that your trials comply with both local and FDA regulationsExploring the progress of key global clinical trial locations against ●

FDA requirements to identify the most proficient Pinpointing key challenges as the FDA become increasingly ●

demanding on safety data and patient numbersUsing local knowledge to ascertain in advance what is required ●

of your trial and how best to satisfy in-country regulations and guidelinesReviewing the requirements and the implications for your key ●

milestones and budget targetsAcquiring sufficient local expertise and guidance to ensure that your ●

trial runs smoothlyIdentifying common pitfalls and how they can be overcome going ●

forward

Maintaining a partnership that reduces your exposure to risk and maximizes efficiency03:10 Optimizing communication in order to expedite the

delivery of product to marketEnsuring that communication is part of your protocol: building it ●

into your strategy Overcoming language and cultural barriers to achieve effective ●

communication in an increasingly global market Developing a communication strategy that avoids the possibility of ●

misinterpretation and time-consuming errors Ensuring that your relationship does not suffer as a result of the ●

pressure to cut costs Learning from past mistakes: analyzing errors and their solutions to ●

help build a fool-proof systemRashieda Gluck, Head of Clinical Operations, VIFOR PHARMA

03:40 Afternoon refreshments and networking

04:10 learn what steps to take to improve communication and performance with your existing CRO and when and how to move part or all of your project to a new CRO What are the warning signs that a project needs to be rescued? ●

Deciding whether you should work with your current CRO to make ●

changes and if so what you need to do Pinpointing how best to change CROS once the decision has been ●

made What do you look for in a new CRO? ●

Evaluating whether you should have the new CRO take over all of ●

the study or just certain functionsKate Didio, Sr. Director, Clinical Operations, SuRFACE lOGIxMolly Rosano, Director Clinical Research, PulMATRIx INC

04:40 Closing remarks from the Chair

05:00 End of conference

Program day two day two Thursday 18 March 2010

Who should attendThe audience will be made up of Vice Presidents, Directors and Managers within pharmaceutical and biotech manufactures from the following areas:

Outsourcing ●

Clinical Operations ●

Procurement ●

External Alliances ●

Clinical Trials ●

Clinical Research ●

R&D ●

Project Management ●

Contracts ●

Legal Counsel ●

About the ConferenceOptimizing your outsourcing strategies to maximize the quality and cost efficiency of your clinical trials.

Following the enormous success of our San Francisco and Boston. Outsourcing in Clinical Trials events earlier this year, VIBpharma is proud to announce the launch of Outsourcing in Clinical Trials New Jersey.

The New Jersey conference comes at a crucial time for outsourcing clinical trials as pharma and biotech companies pursue cost-reduction strategies. Outsourcing to a specialized provider is an effective and highly popular method for minimizing financial outlay and maximizingtime-efficiency.

VIBpharma's Outsourcing in Clinical Trials New Jersey will bring major pharma and biotech manufacturers together to debate potential solutions to these complex challenges. Located in New Brunswick this event will cover topics such as the vendor selection, the effect of merger and acquisition on the outsourcing marketplace, offshoring, and relationship management. By debating and discussing the latest solutions to shared challenges, the conference will help you get the most out of your outsourcing strategy for the coming year.

This event is FREE* to attend for a limited number of biotech and pharma manufacturers.

Register your place today!

How you will benefit from attending Outsourcing in Clinical Trials New Jersey • Participate in cutting edge debate on how to choose the

perfect vendor

• Maximize your productivity by learning new technique to manage your contracts and relationships

• Analyze the impact of merger and acquisition activity in the market place and how it may affect your trials

• Develop a deeper understanding of how to overcome the challenges presented by offshore outsourcing

• Hear the latest case studies and learn from their outcomes

• Minimizing costs by benchmarking your metrics and SLAs with industry best practice

Do you wish to exhibit your products and services at this exclusive event? Contact details: Jack Dacombe, Sponsorship Manager +44(0) 207 753 4259jackdacombe@arena-international.com

Silver SponsorMedpace is a full-service, global contract research organization (CRO) that partners with biopharmaceutical companies to

bring innovative drugs to market. Medpace, based in Cincinnati, Ohio, manages global studies and regulatory submissions, providing clinical trial support in all phases of development up to and including submissions to regulatory agencies. In addition to full-service CRO functionality, Medpace has international operations that include bioanalytical and pharmacology capabilities, central laboratory, and core imaging services.

Medpace physicians have extensive experience conducting clinical trials and understand the issues from the perspective of the clinical investigator, the scientific leader, and the reviewer at the regulatory agencies. Medpace brings these perspectives to each clinical trial that we conduct. www.medpace.com

Bio-Kinetic Europe – Consistency in Clinical Excellence. An independent Phase I-II Clinical Pharmacology Unit based in Belfast, Northern Ireland, we have experience in 400+ clinical

trials across all therapeutic areas and trial designs. We have a GCP & GMP accredited 40-bed clinic, a 11,500 volunteer database and a Phase I CTA approval timeline of 14 days that provides further incentive for our clients. www.biokineticeurope.com

BioClinica is a leading global provider of integrated, technology-enhanced clinical

trial services. BioClinica supports pharmaceutical and medical device innovation with imaging core lab services, internet image transport, electronic data capture, interactive voice and web response, and clinical supply chain design and optimization solutions. www.bioclinica.com

Clinical Resource Network, LLC is a leading provider of specialized in-home and alternate-site nursing, pharmacy and phlebotomy services for phase I-IV studies conducted in the US, Canada, UK, Europe and Israel. These services decrease

development time by accelerating patient recruitment and improving compliance and retention. CRN supports trials in all therapeutic categories and age groups. CRN centrally manages an extensive network of clinicians from over 3,000 agencies with services available 24/7. Services for taking selected protocol visits to the patient include: • Studydrugdispensingandadministration(IV,injection,oral) • Blooddraws(safetylabs,serialpK) • Patienttraining,educationandassessments www.clinicalresource.net

europe

Sponsors and Media Partners

a division of

Exhibitors

C0 Sponsor

Media partnersPharmaceutical Technology is used daily as a means of creating partnerships and as a point of reference by professionals within the

pharmaceutical industry. This comprehensive resource supplies the latest news releases, detailed information on industry projects, white papers, event information and a thorough breakdown of products and services. www.pharmaceutical-technology.com

Drugdevelopment-technology.com: is a procurement and reference resource providing a one-stop-shop

for professionals and decision makers within the drug development and medicines industry. They provide a comprehensive breakdown of drug development contractors and suppliers, up-to-date news and press releases, white papers and detailed information on current industry projects and trends. Their recruitment area provides career information and the latest job vacancies in the field. www.drugdevelopment-technology.com

Pharmaceutical Business Review: The Business Review websites are your number one stop for all the latest news, comment and industry information. Each Business Review website offers content that is produced by a dedicated team

of journalists and global industry experts.In addition to the free content made available on the sites an intelligence store will provide you with premium market analysis reports from the leading global suppliers of market research and industry analysis.Pharmaceutical Business Review is the world's leading pharma website, being used by over 100,000 visitors every month. For further information contact jsharp@industryreview.com

Medical eTrack is the new, interactive desktop tool designed for executives

& analysts active in or supplying services to the medical equipment industry. www.medicaletrack.com

PharmiWeb.com is the leading industry-sponsored portal for news and jobs in the pharmaceutical sector. Search thousands of constantly updated jobs. Subscribe to job alerts or RSS feeds. www.pharmiweb.com

Medical eTrack

BOOKING FORM

Venue DetailsThe two day conference will take place on Wednesday 17 and Thursday 18 March 2010. The venue for the two days will be a centrally located hotel in New Jersey, USA. For further information contact our operations department on +44 (0) 20 753 4201.

Are you registered? You will always receive an acknowledgement of your booking. If you do not receive anything, please call us on +44 (0) 20 7753 4268 to make sure we have received your booking.

■ I enclose a cheque drawn on a UK bank (please make cheque payable to SPG Media Ltd and write reference POUT0310 on the reverse)

■ I will transfer payment to your Lloyds TSB account City Branch, London, UK: 01492549, sort code 30-00-02 (using reference POUT0310)

■ I would like to pay with my credit card ■ Visa ■ Mastercard ■ AMEX ■ Maestro ■ Solo

Card Number: Expiry Date: Issue Date: CSV*:

Cardholder's Name:

Cardholder's Address:

*The CSV number is the last 3 digit number on the reverse of the card

■ Yes, I have read and understood the terms and cancellations conditions and am happy to proceed with my registration

Signature Date

Discount code if applicable ______________________________Discounts are at the discretion of Arena International and are not cumulative

Four Easy Ways To Book: Prices & Payment Information (please tick option)

Outsourcing in Clinical Trials: New JerseyWednesday 17 - Thursday 18 March 2010, New Brunswick, New Jersey

Total

■ Register online at www.vibpharma.com/outsourcing/nj■ Email us at book@arena-international.com■ Tel +44 (0)20 7753 4268■ Fax +44 (0)20 7915 9773

Delegate Details please photocopy form for multiple bookings

Mr/Mrs/Ms/Dr: First Name: Surname:

Email: Tel: Job Title:

Fax: Department:

Company Details

Company: Address:

Town: Postcode: Country:

VAT Number: Nature of Business:

Payment Details

Purchase Order No.

Arena International Conference Delegate terms and conditions

1. Scope of Agreement: These are the conditions of the contract between you, the Client (“You” and “your”) and Arena International Events Group (“Arena International Events Group”, “we”, “us” and “our”) governing your use of our services, including the conference registration as set out in your booking form. This agreement constitutes the entire agreement between Arena International Events Group and you. All prior agreements understandings and negotiations and representations (save for fraudulent misrepresentation) whether oral or in writing are cancelled in their entirety. The terms of any other electronic communications will not form part of this agreement.

2. Our commitment to you: Should the Event be cancelled or the location be changed for reasons or circumstances beyond our control, we reserve the right to reschedule the Event, including changing the location, upon written notice to you. Should the event fail to be rescheduled for any reason your refund shall not exceed the total charge received by us from you.

3. Payment Terms: The Total Fees specified on the booking form are subject to an additional service charge of 2.5% (“Service Charge”) applied to cover administration costs, and are exclusive of VAT and any other applicable sales tax which shall be payable in addition.• Following completion and return of the booking form, full payment including Service Charge is required within five days from the invoice date or prior to the event if this is sooner. All registrants must provide a credit card number as a guarantee at the time of booking. We reserve the right to charge your card in full if payment is not received in accordance with these payment terms. We reserve the right to refuse admission if full payment is not received in accordance with these terms.

4. Cancellations: In the event of cancellation, 100% of the event fee is payable and non-refundable. All cancellation requests must be submitted to us in writing. If we agree to your cancellation then all cancellation fees are payable immediately after the acceptance of your cancellation in writing by us.

• If you are a Biotech/Pharma Manufacturer and have signed up as a free of charge delegate, you will incur a charge of $499 if you cancel your registration.

5. General: You, your executive/s or your agents may not transfer or assign any of the rights or obligations of this Agreement (in whole or part) without our prior consent. Any attempt to resell, assign or transfer rights without our consent will entitle us to cancel the contract without liability to you.• This agreement is governed by and will be construed in accordance with English law and each party irrevocably agrees that the courts of England will have the non-exclusive jurisdiction to deal with any disputes arising out of or in connection with this agreement.• Grant of Licence: If your booking includes the CD-ROM, you warrant that you will only use the CD-ROM for your business purposes and shall not, without our prior written consent, make available, copy, reproduce, transmit, disseminate, sell, licence, distribute, publish, broadcast or otherwise circulate the CD-ROM (or any part of it) to any other person other than in accordance with these terms and conditions.• Arena International Events Group is subject to the UK Data Protection Act 1998 and is registered in the UK with the Information Commissioner to process your personal information. Our primary goal in collecting personal information from you is to give you an enjoyable customised experience whilst allowing us to provide services and features that most likely meet your needs. We collect certain personal information from you, which you give to us when using our Sites and/or registering or subscribing for our products and services. We also collect certain personal data from other group companies to whom you have given information through their websites. If you do not want us to continue using this information please notify us at unsubscribe@arena-international.com. Any personal information supplied to SPG Media Ltd as part of this registration process and/or any other interaction with SPG Media Ltd will be collected, stored and used by SPG Media Ltd its subsidiaries, related companies or affiliates in accordance with the SPG Media Ltd Privacy Policy. Please email privacypolicy@arena-international.com for a copy of the SPG Media Ltd Privacy Policy.• The working language of the Event is English. Executives requiring an interpretation service must make their own arrangements at their own expense.

Arena International Events Group, a trading division of SPG Media Ltd. Registered Office: John Carpenter House, John Carpenter Street, London, EC4Y 0AN. Registered in England No. 01155599. www.arena-international.com

Yes, i would like to register for the event: pricesBiotech/Pharma

I am a Biotech/Pharma VP/Director, please register my FREE place at the 2-day conference* FREE

I am a biotech/pharma attendee, please register my place for the two day conference $499

I am unable to attend the conference, but I would like to receive the interactive CD-ROM $650

Fees For other ParticiPants (non-Biotech/Pharma) The two-day conference $2295

I am unable to attend the conference, but I would like to receive the interactive CD-ROM $650

FREE*: This event is strictly by invitation only. There are a limited number of FREE places to the conference and workshop which are reserved for VP/Directors of pharmaceutical manufacturers and biotechs only. Arena International Events reserves the right to allocate places, refuse applications, or to charge a nominal attendance fee for pharmaceutical manufacturers and biotechs of $499 for the conference once the number of complimentary places have been exceeded. All fees must be paid in advance.

All bookings are subject to a 2.5% service charge.