VIBpharma
OUTSOURCING IN WEST
CLINICAL TRIALS COAST
Wednesday 27 and Thursday 28 January 2010, San Francisco, USA
Supplier selection strategies and vendor management processes
to maximize the return on your outsourcing investment
HEAR FROM KEY INDUSTRY SPEAKERS: KEY REASONS TO ATTEND:
Gavin Choy, Vice President, Timothy McNamara,  Improve your long-term outsourcing strategies
Clinical Operations, SUPERGEN Vice President, to overcome clinical trial challenges in the
Clinical Research current economic climate
Nancy Havrilla, Senior Director, and Medical Affairs,
Clinical Operations, ACHAOGEN  Take away ideas on CRO selection and
ISTA PHARMACEUTICAlS techniques to maximize the return on your
lorna Dean, Director, outsourcing investment from proven methods
Rafael Escandon,
SPM-Supplier Performance that demonstrate value for money
Vice President, Clinical
Management, AMGEN Develop more robust project management
Operations, CYTOKINETICS 
Raymond Starling, Senior processes through case studies highlighting
Director, Clinical Development Jacqueline Mardell, strategies to ensure smooth, cost effective and
Senior Director, Clinical successful trials
and Operations, ATHERSYS
Operations, METABOlEx  Discover ways you can improve your offshoring
Christina DiArcangelo, strategy and make the most of opportunities for
Associate Director, Francie Kivel,
conducting trials in emerging countries
Clinical Contracts and Senior Director, Clinical Trials,
Outsourcing, FIBROGEN AASTROM BIOSCIENCES
Susan Iovino, Director, Elizabeth Shewell, TOP COMPANIES REPRESENTED:
Clinical Operations, Director, Outsourcing,
INCYTE CORPORATION ● BAYER ● ISTA
NOVABAY PHARMACEUTICAlS PHARMACEUTICALS PHARMACEUTICALS
Todd Reul, Associate Director, Maria Madison, Director, AMGEN
●
● ATHERSYS
Clinical Outsourcing, Clinical Operations, ● FIBROGEN
ENANTA PHARMACEUTICAlS ● AASTROM
FACET BIOTECH ● FACET BIOTECH
BIOSCIENCES
Henry Brandon, ● NOVABAY
PHARMACEUTICALS ● ACHAOGEN
Regional Head North America,
Global Strategic Outsourcing, ● METABOLEX ● INCYTE
BAYER PHARMACEUTICAlS ● CYTOKINETICS CORPORATION
Gold sponsor: Silver sponsors:
, INC.
REGISTER NOW:
Online: www.vibpharma.com/outsourcing/west Tel: +44 (0)20 7753 4268
Email: book@arena-international.com Fax: +44 (0)20 7915 9773

Program Day One Wednesday 27 January 2010
8:30 Registration 11:40 Risk management for small pharma and biotechs:
making the right decision on how much to outsource
9:00 Opening remarks from the Chair ● Avoiding costly and critical mistakes that can cripple small biotechs
Maria Madison, Director, Clinical Operations,
● Compare full service versus functional outsourcing models and the
ENANTA PHARMACEUTICAlS
implications for small scale trials
● Finding CROs with the right level of expertise and experience in
Sustainable strategies to safeguard the return on similar sized trials
your outsourcing investment ● Ensuring that your trial is given the resources and time it needs
when competing with large scale trials
9:10 Keynote presentation: Christina DiArcangelo, Associate Director, Clinical Contracts and
Outsourcing in uncertain times: asset management Outsourcing, FIBROGEN
strategies for long term survival
Getting the balance right between retaining in-house capacity and
●
12:10 The CRO selection process: how it can hinder or help
relying on CROs
● Making the most of the opportunities for cost savings and cheaper identifying the best possible partner
trials in the current economic climate ● Operating a preferred provider list versus a competitive tender
● Strategies for leveraging CROs on cost in a competitive market process: over-reliance versus a lengthy inefficient selection process?
● Identifying solutions to project management resource obstacles to ● Avoiding path dependency on the selection processes without
ensure a smooth trial process reinventing the wheel
Gavin Choy, Vice President, Clinical Operations, SUPERGEN ● Assessing strengths and weaknesses of potential partners using
case study data and like for like comparison tools
● Saving time through developing your own bid grid for CROs to
9:40 Making the right outsourcing decision first time: submit proposals
avoiding a chop and change approach to reduce ● Ensuring consistent understanding and interpretation amongst
costly errors vendors of sponsor expectations, timelines and budgets
● Understanding and setting manageable expectations of your Maria Madison, Director, Clinical Operations, ENANTA
trial partner PHARMACEUTICAlS
● Taking the time to get the contract right to save time during trials
● Making decisions on the basis of evidence and sustained 12:40 Lunch
trial output
● Managing the pressure to get results quickly without compromising
your trial 2:00 Implementing optimal outsourcing strategies to
● Knowing when to end a relationship and preventing rushed safeguard the future of the virtual pharma model
decisions on the effectiveness of a CRO ● Outlining the present trends for virtual pharma companies and
Nancy Havrilla, Senior Director, Clinical Operations, ACHAOGEN implications for the outsourcing model
● Solutions for cutting costs without compromising drug
development activities in the current funding crisis
10:10 Managing costs and expenditure in outsourced ● Identifying expertise and guidance on cost effective alternatives to
clinical trials outsourced functions
● Understanding how trial costs are calculated to enable better ● Finding the right trial partner to fit your business model and size, is
decision making bigger always better?
● Addressing the cost implications of outsourcing different functions ● Managing delays due to unexpected factors controlled by suppliers
● Getting value for money from CRO partners to ensure timelines are kept on track
● Evaluating inconsistencies between CRO pricing models and how to ● Avoiding common time and cost overruns and ensuring the best
interpret them service from your CRO
● Measuring ROI on outsourced trials A panel of speakers from the two days will discuss and take
● Quantifying the value of a partnership for quicker decision making questions on this important issue
on future trials
lorna Dean, Director, SPM-Supplier Performance Management,
AMGEN 2:30 Offshoring to emerging countries: reducing costs and
achieving consistency in uncertain trial environments
● Understanding the nuances of the changing regulatory
10:40 Morning Refreshments environments in offshore clinical trials to better manage trial risks
● Know your environment: an up-to-date picture of standards in the
EU, India and China
Improving selection processes to minimize risk and ● Matching trials to the right country: evaluating trial requirements
maximize time and cost savings with different regulatory and environmental factors
● Choosing CROs that have credible and substantiated experience in
11:10 Ensuring trial partners are fit for purpose by trials with key groups
implementing an efficient and thorough Jacqueline Mardell, Senior Director, Clinical Operations, METABOlEx
selection process
● Determining your selection criteria for seeking out the right
quality partner
3:00 Panel Discussion:
● Gathering information on potential partners to ascertain capabilities Metrics and KPIs for improving trial processes
and strengths ● Standardization of trial functions and use of metrics to measure
● Measuring track records and expertise: using case studies to gauge desired outcomes
competencies ● Identifying CROs that can operate within the framework of your KPIs
● Mitigating inherent risks in outsourcing: ensuring your contract ● Ensuring compliance with in-house processes and protocols
covers all areas of the timeline, service and budget during the ● Improving the sponsor’s ability to control and monitor studies
negotiation stage in order to significantly reduce trial times
● Establishing a relationship prior to selection to get the trial off to the A panel of speakers from the two days will discuss and take
best start questions on this important issue
Raymond Starling, Senior Director, Clinical Development and
Operations, ATHERSYS

Day One Wednesday 27 January 2010 Program Day Two
3:30 Afternoon refreshments 8:30 Registration
9:00 Opening remarks from the Chair
A step-by-step approach to selecting trial partners to Rafael Escandon, Vice President, Clinical Operations,
avoid costly errors CYTOKINETICS
4:00 Identifying and selecting your short-list and
preferred CRO partners Offshore clinical trials: keeping complex projects
● Looking at your organization and the specific areas that you are
trying to enhance when selecting providers on time and within budget
Breaking down functional areas during selection: therapeutic
●
9:10 Keynote presentation:
expertise, geographic reach, clinical service areas, lab, imaging
from one provider or multiple providers Ethical responsibilities of developed world sponsors
● Managing the process of canvassing the marketplace of all the conducting clinical trials in developing countries
providers that offer required services and submitting Request for ● Key decision drivers supporting the conduct of your trial abroad
Information (RFI) ● Appreciating cultural differences and minimizing risks of errors
● Evaluation of RFI responses and face-to-face meetings with a ● Assessment of partner’s ability to meet trial expectations
subset of suppliers ● Analyzing history of ethical and GCP compliance and regulatory
● Identifying the right number of partners - how many is reasonable track record
and the advantages and disadvantages of more or less ● Appropriate site selection and other resource allocation, planning
● MSA process and terms and conditions to consider while going and logistics
through this process ● Patient recruitment considerations in new trial localities
Henry Brandon, Regional Head, North America Global Strategic ● Site and vendor contract strategies
Outsourcing, BAYER PHARMACEUTICAlS ● Sustaining local access to treatments
Rafael Escandon, Vice President, Clinical Operations, CYTOKINETICS
4:30 An outcome-based approach to outsourcing:
balancing cost and quality considerations for 9:40 Keynote presentation:
optimal results Conducting strategic clinical trials in China: 2010
● Focusing clinical trial processes and outsourcing decisions on ● The current status of the Chinese regulatory environment for
desired outcomes conducting clinical trials
● Conducting a study-specific analysis using key factors such as the ● Clinical facilities accredited by China SFDA to conduct trials
ideal patient profile, technological and expertise needs for the trial ● Advantages and disadvantages of conducting trials in China
when determining whether to outsource ● Recent outcomes regarding US FDA site inspections in China
● Identifying the best opportunities for strategic partnerships ● Strategic practices to conduct successful trials: planning,
● Knowing your partner’s capabilities to determine agreed training and partnership
outcomes prior to a trial Dr xiaxiong Wei, Director, Clinical Pharmacology, MEDPACE
● Determining the right level of support and monitoring for
optimal results 10:10 Panel discussion:
Timothy McNamara, Vice President, Clinical Research and
Developing effective supply chain planning for
Medical Affairs, ISTA PHARMACEUTICAlS
shipping to offshore trial sites
● Planning how much supply is needed and coordinating with
5:00 Closing remarks from the Chair and end of day one trial partners
● Blinding techniques for various phases and purposes in clinical trials
● Pharmaceutical and biotech aspects of blinding comparators
● Understanding the role and responsibilities of clinical supply
chain planners and managers
● Clinical supply management team structure and effectiveness
● Collaborating and working with clinical groups: challenges
and opportunities
A panel of speakers will discuss these issues and take questions
on project management processes.
Overcoming patient recruitment challenges and
building flexibility into your clinical trials
10:40 Boosting patient participation and compliance using
an in-home clinical service model
● Increasing patient comfort and convenience to maximize patient
recruitment, compliance and retention
● Increasing efficiency by understanding what a centrally managed in-
home clinical service model is and what services can be provided
to study patients at their home or other convenient locations
● Effectively implementing these services and addressing the
regulatory issues to optimize patient recruitment strategies
● Practical case studies: trials that effectively utilized homecare
services to speed recruitment, enhance compliance and increase
patient satisfaction
REGISTER ONLINE NOW! Gail Adinamis, President and CEO, ClINICAl RESOURCE NETWORK
www.vibpharma.com/outsourcing/west 11:10 Morning refreshments

Day Two Thursday 28 January 2010
11:40 Investigational medicinal products for the EU: Successful trial management: reducing change orders
rules, regulations, solutions and support and keeping to budget
Framework and context of EU legislation including the CTD Directive
●
3:00 Building flexibility into processes to incorporate
2001/20/EC and annex 13 to the EU GMPs under 2003/94/EC
● Practical requirements and preferences in operational GMPs changes to the scope of your trial
● Product specification files ● Negotiating budgets and agreements to ensure visibility on all sides
● Investigational medicinal product dossiers ● Understanding internal budgetary implications of change orders
● What do Qualified Persons do? ● How to determine the limits of your budgets and agreeing these
● Conducting QP audits of non EU facilities and QP declarations with your CRO
for import ● Strategies to reduce the likelihood of change orders
● Provision of comparators and ‘NIMPs’ Elizabeth Shewell, Director, Outsourcing, INCYTE CORPORATION
● Answering the ten key questions for outsourcing IMP supply to the EU
Paul Thomas, Chief Scientific Officer, PENN PHARMA 3:30 Afternoon refreshments
Building flexibility into your processes for smoother Successful vendor management frameworks for
clinical trials clinical trials
12:10 Panel discussion: 4:00 Establishing a sustainable governance relationship
The impact of internal processes and diverse ● What is governance and why is it important?
project teams on CRO management ● Getting internal buy-in and commitment for governance
● How to overcome internal differences in communication and ● Navigating levels of governance (executive, operational and
monitoring of CROs business management)
● Developing a preferred list of providers to speed up the trial set ● Establishing metrics and identifying CROs that can operate within
up process an agreed performance framework
● Using hybrid project teams to improve the relationship ● Deciding on the content to be covered by each level of governance
management process ● Keeping momentum going during a trial to ensure desired
● Learning from success and failure to improve project management outcomes
of outsourced trials Henry Brandon, Regional head North America, Global Strategic
● Dealing with the challenge of maintaining control and decision Outsourcing, BAYER PHARMACEUTICAlS
making speed while managing internal growth
A panel of speakers from the two days will discuss and take
4:30 Relationship management and partnership working
questions on this important issue. Panel will also include Susan
Iovino, Director, Clinical operations, NOVABAY PHARMACEUTICAlS across multi-site trials
● Giving CROs flexibility while ensuring best use of resources and
minimal delays
12:40 Lunch ● Maintaining ongoing communication to ensure key deliverables
and timelines are met
● Relationship management across multiple trial sites: balancing
Innovation in project management to better cost decisions with the practicalities of monitoring and
communication
trial monitoring
● Making the right decision: keeping project management in-house
2:00 Precontract audits of CROs to reduce outsourcing risks or outsourcing to a service provider?
● Assessing the capabilities and free capacity of CROs to achieve Jason lindow, Associate Director, Clinical Operations, OxIGENE
project goals
● Identifying CRO standard operating procedures to ensure ideal fit
with sponsor processes
5:00 Closing remarks from the Chair and end of conference
● Quantifying impact on resource availability of subcontracted
functions to third parties
● Continuous development and training of staff to keep up to date
with technologies and standards
● Matching hardware and software capabilities to trial needs to
ensure quick and cost efficient data analysis
Francie Kivel, Senior Director, Clinical Trials, AASTROM BIOSCIENCES
2:30 Agreeing the parameters of communication and
reporting by CROs during the trial process
● Ensuring that everyone knows their responsibility at the outset
of a trial
● Keeping track of progress to address issues early without
jeopardising outcomes
● Developing a strategic process to achieve agreed outcomes on time
and on budget
● Reducing the amount of necessary oversight to increase trial
efficiency and ease the burden on sponsors
● Identifying vendors with good reporting tools and transparent
communication processes
Todd Reul, Associate Director, Clinical Outsourcing,
FACET BIOTECH

Sponsors and Media Partners
Gold Sponsor Exhibitors
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
a division of
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
Media partners
Silver Sponsor Pharmaceutical Technology is used daily
Penn Pharma is a leading provider of as a means of creating partnerships and
integrated product development and as a point of reference by professionals
custom manufacturing services to within the pharmaceutical industry. This comprehensive resource
the international healthcare industry supplies the latest news releases, detailed information on industry
including formulation and analytical projects, white papers, event information and a thorough breakdown
development, clinical trial supply, custom manufacture, high of products and services. www.pharmaceutical-technology.com
containment processing, CMC consultancy and QP release
services. Penn manufactures to GMP and is MHRA licensed and World Pharmaceutical Frontiers:
FDA inspected. www.pennpharm.co.uk The pharmaceutical industry is changing fast.
World Pharmaceutical Frontiers www.worldpharmaceuticals.net
There are more regulations, technologies,
Clinical Resource Network, LLC is a faster product launches and shorter product life cycles than ever before.
leading provider of specialized in-home World Pharmaceuticals frontiers is, and will continue to be, at the
and alternate-site nursing, pharmacy forefront of these changes, so visit us at www.worldpharmaceuticals.net
and phlebotomy services for phase I-IV and stay up to date with all latest developments.
studies conducted in the US, Canada, UK, Drugdevelopment-technology.com: is
Europe and Israel. These services decrease development time by a procurement and reference resource
accelerating patient recruitment and improving compliance and providing a one-stop-shop for professionals
retention. CRN supports trials in all therapeutic categories and age and decision makers within the drug development and medicines
groups. CRN centrally manages an extensive network of clinicians industry. They provide a comprehensive breakdown of drug development
from over 3,000 agencies with services available 24/7. Services for contractors and suppliers, up-to-date news and press releases, white
taking selected protocol visits to the patient include: papers and detailed information on current industry projects and trends.
• Study drug dispensing and administration (IV, injection, oral) Their recruitment area provides career information and the latest job
• Blood draws (safety labs, serial pK) vacancies in the field. www.drugdevelopment-technology.com
• Patient training, education and assessments
www.clinicalresource.net/ Pharmaceutical Business Review:
The Business Review websites are your number
M2S offers a full range of image one stop for all the latest news, comment and
management services, utilizing cutting- industry information. Each Business Review
edge technologies to provide high-quality website offers content that is produced by a
data at the lowest total delivered cost. dedicated team of journalists and global industry experts.In addition
Our “end-to-end” clinical trial services to the free content made available on the sites an intelligence store
include protocol development, electronic image collection, will provide you with premium market analysis reports from the leading
independent radiological review, archiving and web-based data global suppliers of market research and industry analysis.Pharmaceutical
reporting as well as clinical data registries and post-surveillance Business Review is the world's leading pharma website, being used
data management. www.m2s.com by over 100,000 visitors every month. For further information contact
jsharp@industryreview.com
We offer worldwide comparator drug
sourcing and distribution for clinical
, INC. trials. With GDP licensed facilities in Testimonials from our past event
Switzerland, Germany and New Jersey we “This has been a very informative conference. All the speakers
fulfill needs of single lot, long expiration were interesting and provided a lot of information. I enjoyed the
date, Certificate of Analysis, Material roundtable discussions. It was really nice to talk to all the vendors.
Safety Data Sheet, GMP Certificate, samples, etc. We have the There weren’t too many and there wasn’t too little. Really enjoyed
capacity and experience to supply large amounts fast directly from the two days. The setup with the breaks and lunch with the vendors
the manufacturer. www.multipharmaus.com was good for interactivity.”
Director, Clinical Ops. NOVOBAY
“I am impressed by the quality and experience of the speakers.
Do you wish to exhibit your products
Learning the approaches of other sponsor speakers provides
and services at this exclusive event? valuable information that I can use when dealing with vendors.
Contact details: Nick McCudden, The conference has been excellent and I hope to attend again
Sponsorship Manager +44(0) 207 753 4259 next year.”
nicholasmccudden@arena-international.com Outsourcing and Contracts Manager, SCHWARTZ BIOSCIENCE/UCB

BOOKING FORM Oursourcing in Clinical Trials West Coast,
Wednesday 27 and Thursday 28 January 2010, San Francisco, USA
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/west
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I am unable to attend the conference, but I would like to receive the interactive CD-ROM $650 Venue Details
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