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.

1. VIBpharma
Wednesday 17 and Thursday 18 March 2010, New Brunswick, New Jersey
Optimizing your outsourcing strategies to maximize the quality
and cost efficiency of your clinical trials
HEAR FROM KEY INDuSTRY SPEAKERS: KEY REASONS TO ATTEND:
● Great new case studies from key biotech
• Molly Rosano, Director
• oss Pettit,
R and pharmaceuticals companies
Clinical Research, Vice President, Clinical
Learn the latest new approaches that can help
Operations, ARIAD
●
PulMATRIx INC you increase the efficiency of your outsourcing
PHARMACEuTICAlS program
• onathan Guerriero,
J
• ashieda Gluck,
R Participate in expert led panel discussions to
Program Director, ●
Head of Clinical get your questions answered
RADIuS
Operations,
• Katie Wood,
VIFOR PHARMA
Clinical Trial Head TOP COMPANIES REPRESENTED:
Translational Medicine • isa Kaufman MS,
l ● PFIZER ● RADIUS
Oncology, NOVARTIS Director, Clinical ● NOVARTIS ● CELTIC PHARMA
Operations,
PHARMACEuTICAlS ● SOLACE ● EISAI
STROMEDIx
● ROCHE ● ASTRAZENECA
• Maureen Hynes,
• ary- Callahan-Squire,
M
Director, Strategic
Executive Director,
Sourcing, MIllENNIuM
Clinical Programs,
PHARMACEuTICAlS
ASTRAZENECA FREE* for vice presidents
• hris Houchins,
C and directors from biotech
VP Clinical Operations,
ARNO THERAPEuTICS and pharma companies
Silver sponsors:
europe
REGISTER NOW:
Online: www.vibpharma.com/outsourcing/nj Tel: +44 (0)20 7753 4268
Email: book@arena-international.com Fax: +44 (0)20 7915 9773

2. Program day one Wednesday 17 March 2010
08:30 Registration 11:30 Developing an effective strategy to maintain multiple
contracts successfully and improve time and cost
09:00 Opening remarks from the Chair efficiency
● Establishing an optimal model for your clinical trial department to
09:10 Evaluating recent and ongoing changes in the world of ensure that your protocol produces the best possible partnership every
outsourcing in order to plan for future partnerships time
● Assessing developments taking place in the CRO marketplace in order ● Achieving a balance between over dependence on too few providers,
to establish a more effective decision making strategy and an unmanageable number of vendors
● Understanding the implications for sponsors and the opportunities ● Incorporating offshore CROs into your global strategy in order to
that have been created by a more integrated CRO/Sponsor climate promote good interaction and reduce the likelihood of error
● Overcoming the challenges presented by a more CRO reliant ● Reviewing supervisory strategy to improve your working relationships
environment to exploit potential advantages without sacrificing and increase efficiency
autonomy Jonathan Guerriero, Program Director, RADIuS
● Uncovering developing trends and what they mean for the future of
clinical trials outsourcing 12:00 Panel Discussion: The tender process: how can you
Mitchell Katz, Vice President Clinical Operations, EISAI GlOBAl ensure that the proposal you receive is realistic and
ClINICAl DEVElOPMENT informative in order to avoid unnecessary change orders
● The Request For Information: ensuring that your request is sufficiently
Identifying the optimum vendor for your business to specific to allow the CRO to provide a comprehensive and informative
response
ensure a successful partnership ● Understanding the optimal level of detail in order to make efficient use
09:30 Achieving clarity on how to identify the type of CRO that of time without compromising the bid process
best meets the needs of your company profile to help ● The Request For Proposal: analyzing key questions to maximize the
accuracy and relevance of the proposals you receive
you maximize ROI ● Developing best practice reviewing the bids to identify the CRO who
● Establishing the needs of your trial in order to more effectively
best meets your needs
streamline the selection process
● Re-evaluating bid-grids and the need for negotiations to be based on a
● Assessing the capabilities and specialities you require of your CRO
common language: avoiding all barriers to communication
● Understanding whether a full service or function service model will
● Comparing ‘apples to apples’ to make sure that the cheapest bid really
offer the best return on the investment of your time and financial outlay
is the best value
● Achieving a balance between price and quality by involving both the
Katie Wood, Clinical Trial Head Translational Medicine Oncology,
clinical and outsourcing teams in the selection protocol
NOVARTIS PHARMACEuTICAlS
● Revealing key strategies to make the right choices first time, every time
lisa Kaufman MS, Director, Clinical Operations, STROMEDIx Maureen Hynes, Director, Strategic Sourcing, MIllENNIuM
PHARMACEuTICAlS
Jonathan Guerriero, Program Director, RADIuS
10:00 Size matters: matching your CRO to the phase, drug,
location and business model in question to maximize 01:00 Lunch
efficiency
● Finding a CRO that can offer both the security of a large corporation, Optimizing the bid process to streamline procedure and
and the personal partnership of a smaller provider
● Assessing the true benefits of using a large CRO: can it save you time expedite trial start-up
and money? 02:30 Employing comprehensive and well researched
● Developing a strategy that incorporates specialist, smaller vendors
in order to take advantage of a closer working relationship and the
contracts to reduce the risk of change orders and
resulting efficiency missed milestones
● Optimizing results in early phase trials by selecting a well suited ● Achieving maximum CRO buy-in in order to share risks and benefits
vendor and reduce the likelihood of vendor-led over-run
● Evaluating small and large CROs to establish the most price-efficient ● Identifying potential areas of risk to better prepare for them
approach ● Reducing the need for time-consuming and financially draining
Ross Pettit, Vice President, Clinical Operations, change-orders by establishing a water-tight contract
ARIAD PHARMACEuTICAlS ● Understanding whether a one-off contract or a long term partnership
will be most effective for your trial
10:30 Morning Refreshments and Networking ● Using a long-term partnership to reduce the likelihood of costly
mistakes and develop a sense of shared responsibility
Mary- Callahan-Squire, Executive Director, Clinical Programs,
Putting in place the best possible vendor and ASTRAZENECA
in-house team to ensure a successful, timely, and
cost efficient trial 03:00 Establishing a workable contract that delivers on
promises
11:00 Case Study: learning what virtuals require of CROs and ● Optimizing the speed of your trial by identifying potential problems at
the lessons that more traditional business models can the outset
take from a fully outsourced format ● Asking the revealing questions: pinpointing unrealistic promises
● What does the ideal CRO offer the virtual biopharma? ● Defining effective due diligence procedure to ensure that your vendor
● Establishing a self managing format which reduces the need for is offers what you need
constant oversight from the sponsor ● Ensuring that the bid is realistic and all-inclusive to minimize the
● Successfully ensuring that your project is given adequate resource and chance of over-spending
attention so that quality is maintained ● Clearly defining responsibilities and expectations in order to minimize
● Securing excellent the vendor staff your trials require to enable you to oversight and achieve key milestones
focus on core competencies Katie Wood, Clinical Trial Head, Translational Medicine Oncology,
● Overcoming challenges specific to virtual pharma and identifying NOVARTIS PHARMACEuTICAlS
tailored strategies to maximize efficiency
Chris Houchins, Vice President, Clinical Operations, 03:30 Afternoon refreshments and networking
ARNO THERAPEuTICS

3. day one Wednesday 17 March 2010 Program day two
Establishing a relationship which optimizes quality 08:45 Registration and refreshments
and reduces error 09:10 Chairman’s opening remarks
04:00 Maximising transparency and reliability through metrics
and SlAs to develop an efficient and reliable working Developing effective CMC outsourcing strategy
relationship
● Enhancing the quality and reliability of your trial through the
09:40 The Role of CMC in Early and late Phase Clinical Trials
● CMC strategies for early-phase clinical studies
deployment of effective metrics
● Risk-managed CMC regulatory compliance strategies
● Matching the CRO to your KPI requirements in order to create a
● Effective collaborations with CMOs for CMC development activities
harmonious partnership that meets your needs
of external partner and clinical trial supplies
● Measuring and bench-marking your pre-agreed metrics: how to
● Coordination of clinical operations, quality and regulatory functions
effectively assess your progress against key goals
to ensure adherence to standards and on time clinical trial supplies
● Minimizing trial duration through the use of an effective monitoring
● Effective interactions with international regulatory bodies to gain
protocol
timely approval of regulatory submissions
● Adapting your strategy to take account of offshore trials: factoring in
Angelos Dovletoglou, Director, Small Molecules, CMC, BIOGEN IDEC
potential obstacles
04:30 Chairman’s summation and close of day 1 Developing an offshore strategy that minimizes risk
while taking advantage of potential efficiencies
10:10 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 trials
● Assessing the business challenges of operating in China today:
determining the political and economic landscape
● Analyzing the potential benefits to patient recruitment and time
savings
● Delving 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 business
● Ensuring patient care and safety standards through careful
evaluation of likely obstacles
● Establishing the true financial efficiencies over a more traditional
location
register online now! ● Sourcing a CRO with specialist skills in this geographical area the
www.vibpharma.com/outsourcing/nj challenges associated with it
01:10 Lunch

4. day two Thursday 18 March 2010
02:40 Keynote Presentation: How to ensure that your trials
comply with both local and FDA regulations Who should attend
● Exploring the progress of key global clinical trial locations against The audience will be made up of Vice Presidents, Directors
FDA requirements to identify the most proficient and Managers within pharmaceutical and biotech
● Pinpointing key challenges as the FDA become increasingly manufactures from the following areas:
demanding on safety data and patient numbers
● Using local knowledge to ascertain in advance what is required ● Outsourcing ● Clinical Research
of your trial and how best to satisfy in-country regulations and ● Clinical Operations ● R&D
guidelines
● Procurement ● Project Management
● Reviewing the requirements and the implications for your key
milestones and budget targets ● External Alliances ● Contracts
● Acquiring sufficient local expertise and guidance to ensure that your ● Clinical Trials ● Legal Counsel
trial runs smoothly
● Identifying common pitfalls and how they can be overcome going
forward
How you will benefit from attending Outsourcing
Maintaining a partnership that reduces your exposure in Clinical Trials New Jersey
to risk and maximizes efficiency
• articipate in cutting edge debate on how to choose the
P
03:10 Optimizing communication in order to expedite the perfect vendor
delivery of product to market
• aximize your productivity by learning new technique to
M
● Ensuring that communication is part of your protocol: building it
into your strategy manage your contracts and relationships
● Overcoming language and cultural barriers to achieve effective • nalyze the impact of merger and acquisition activity in the
A
communication in an increasingly global market market place and how it may affect your trials
● Developing a communication strategy that avoids the possibility of
misinterpretation and time-consuming errors • evelop a deeper understanding of how to overcome the
D
● Ensuring that your relationship does not suffer as a result of the challenges presented by offshore outsourcing
pressure to cut costs
● Learning from past mistakes: analyzing errors and their solutions to • Hear the latest case studies and learn from their outcomes
help build a fool-proof system • inimizing costs by benchmarking your metrics and SLAs with
M
Rashieda Gluck, Head of Clinical Operations, VIFOR PHARMA
industry best practice
03:40 Afternoon refreshments and networking
04:10 learn what steps to take to improve communication About the Conference
and performance with your existing CRO and when and Optimizing your outsourcing strategies to maximize the
how to move part or all of your project to a new CRO quality and cost efficiency of your clinical trials.
● What are the warning signs that a project needs to be rescued?
● Deciding whether you should work with your current CRO to make Following the enormous success of our San Francisco
changes and if so what you need to do and Boston. Outsourcing in Clinical Trials events earlier
● Pinpointing how best to change CROS once the decision has been this year, VIBpharma is proud to announce the launch of
made Outsourcing in Clinical Trials New Jersey.
● What do you look for in a new CRO?
● Evaluating whether you should have the new CRO take over all of The New Jersey conference comes at a crucial time
the study or just certain functions for outsourcing clinical trials as pharma and biotech
Kate Didio, Sr. Director, Clinical Operations, SuRFACE lOGIx companies pursue cost-reduction strategies. Outsourcing
Molly Rosano, Director Clinical Research, PulMATRIx INC to a specialized provider is an effective and highly popular
method for minimizing financial outlay and maximizing
04:40 Closing remarks from the Chair time-efficiency.
VIBpharma's Outsourcing in Clinical Trials New Jersey will
05:00 End of conference 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!

5. Sponsors and Media Partners
Silver Sponsor C0 Sponsor
Medpace 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 Media partners
bioanalytical and pharmacology capabilities, central laboratory,
and core imaging services. Pharmaceutical Technology is
used daily as a means of creating
Medpace physicians have extensive experience conducting clinical partnerships and as a point of
trials and understand the issues from the perspective of the clinical reference by professionals within the
investigator, the scientific leader, and the reviewer at the regulatory pharmaceutical industry. This comprehensive resource supplies the
agencies. Medpace brings these perspectives to each clinical trial that latest news releases, detailed information on industry projects, white
we conduct. www.medpace.com papers, event information and a thorough breakdown of products and
services. www.pharmaceutical-technology.com
Bio-Kinetic Europe – Consistency in Clinical
Excellence. An independent Phase I-II Clinical Drugdevelopment-technology.com:
Pharmacology Unit based in Belfast, Northern is a procurement and reference
europe
Ireland, we have experience in 400+ clinical resource providing a one-stop-shop
trials across all therapeutic areas and trial designs. We have a GCP & for professionals and decision makers within the drug development
GMP accredited 40-bed clinic, a 11,500 volunteer database and a Phase and medicines industry. They provide a comprehensive breakdown
I CTA approval timeline of 14 days that provides further incentive for our of drug development contractors and suppliers, up-to-date news and
clients. www.biokineticeurope.com press releases, white papers and detailed information on current
industry projects and trends. Their recruitment area provides career
BioClinica is a leading global provider of information and the latest job vacancies in the field.
integrated, technology-enhanced clinical www.drugdevelopment-technology.com
trial services. BioClinica supports pharmaceutical and medical device
innovation with imaging core lab services, internet image transport, Pharmaceutical Business Review: The Business
electronic data capture, interactive voice and web response, and clinical Review websites are your number one stop
supply chain design and optimization solutions. www.bioclinica.com for all the latest news, comment and industry
information. Each Business Review website offers
content that is produced by a dedicated team
Clinical Resource Network, LLC is a leading of journalists and global industry experts.In addition to the free content
provider of specialized in-home and alternate-site made available on the sites an intelligence store will provide you with
nursing, pharmacy and phlebotomy services for premium market analysis reports from the leading global suppliers of
phase I-IV studies conducted in the US, Canada, market research and industry analysis.Pharmaceutical Business Review is
UK, Europe and Israel. These services decrease the world's leading pharma website, being used by over 100,000 visitors
development time by accelerating patient recruitment and improving every month. For further information contact jsharp@industryreview.com
compliance and retention. CRN supports trials in all therapeutic categories
and age groups. CRN centrally manages an extensive network of clinicians Medical eTrack is the new, interactive
from over 3,000 agencies with services available 24/7. Services for taking Medical eTrack desktop tool designed for executives
selected protocol visits to the patient include: & analysts active in or supplying services to the medical equipment
• Study drug dispensing and administration (IV, injection, oral) industry. www.medicaletrack.com
• Blood draws (safety labs, serial pK)
• Patient training, education and assessments
www.clinicalresource.net 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
Exhibitors
a division of
Do you wish to exhibit your products
and services at this exclusive event?
Contact details: Jack Dacombe,
Sponsorship Manager +44(0) 207 753 4259
jackdacombe@arena-international.com

6. BOOKING FORM Outsourcing in Clinical Trials: New Jersey
Wednesday 17 - Thursday 18 March 2010, New Brunswick, New Jersey
Prices & Payment Information (please tick option) Four Easy Ways To Book:
■ Register online at
Yes, i would like to register for the event: prices www.vibpharma.com/outsourcing/nj
Biotech/Pharma ■ Email us at
I am a Biotech/Pharma VP/Director, please register my FREE place at the 2-day conference* FREE book@arena-international.com
I am a biotech/pharma attendee, please register my place for the two day conference $499 ■ Tel +44 (0)20 7753 4268
I am unable to attend the conference, but I would like to receive the interactive CD-ROM $650 ■ Fax +44 (0)20 7915 9773
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 Venue Details
All bookings are subject to a 2.5% service charge. The 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
FREE*: This event is strictly by invitation only. There are a limited number of FREE places to the conference
Jersey, USA. For further information contact our
and workshop which are reserved for VP/Directors of pharmaceutical manufacturers and biotechs only.
operations department on +44 (0) 20 753 4201.
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 Are you registered?
once the number of complimentary places have been exceeded. All fees must be paid in advance. You will always receive an acknowledgement of your
Discount code if applicable ______________________________ booking. If you do not receive anything, please call
Discounts are at the discretion of Arena International and are us on +44 (0) 20 7753 4268 to make sure we have
Total not cumulative received your booking.
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