1. Arena International’s 5th Annual Outsourcing in Clinical Trials East Coast
Conference, Philadelphia
Program Day One – May 13th
2014
08:30 Registration and refreshments
08:45 Chair’s opening remarks
Vendor Selection and Relationship Management
09:00 Keynote Presentation: Considering the benefits of forming a true partnership rather than a
‘client-service provider’ relationship to reduce risk of trial failure, financial loss and
damage to reputation
 Highlighting the importance of taking due time and care to select the appropriate vendor
for the trial to avoid costly delays at the start of the trial
 Exploring incorporating ‘flexsourcing’, and considering the service provider team as an
internal division of the sponsor company will improve communication and therefore
success rates of clinical studies
 Developing strategies to create long-term partnerships to maximize RoI for the sponsor
and improve team alignment of sponsor and service provider
 Incorporating multi-trial contracts with service providers to reduce costs and difficulties
associated with the vendor selection process
 Reviewing how best to form a strong partnership when working with multiple vendors to
ensure a successful functional outsourcing model
 Enhancing the benefits for a service provider to work in this sort of relationship to
encourage the formation of these kind of partnerships
Speaker: David Freschi, Director and Head, Clinical Outsourcing, Otsuka Pharma
09:30 Revealing the True Value of Patient Recruitment
 Discussing the steady decline of enrolment rates by evaluating industry trends
 Determining innovative patient recruitment options for enrolment shortfalls
 Comparing options in terms of cost efficiency to ensure that you are securing the best
system for your company
 Analyzing the costs and value of different patient recruitment strategies
 Maximizing leverage through the use of data and making the business case
Speaker: Joe O’Rourke, Director, Business Development, Acurian
10:00 Exploring strategies for enhanced vendor selection which avoid the costs associated with
a breakdown in sponsor-vendor relationship midway through a trial
 Considering how best to validate a potential vendor’s expertise in a certain geographical
or therapeutic area to ensure they have the required knowledge to effectively work on the

2. trial
 Evaluating the key factors to look for when selecting a vendor to establish a cost-
effective selection process
 Reviewing the pros and cons of working with niche, specialty vendors to elucidate when
best to work with these sorts of companies
 Conducting interviews with vendor staff members to establish if their experiences and
capabilities will fit those needed for a specific study
 Emphasizing the importance of focusing on a specific vendors’ experience and skill set,
rather than size to ensure the most suitable provider is identified
Speaker: Richard O’Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals
10:30 Morning refreshment break and networking
11.00
Panel Discussion –Developing and maintaining relationships with vendors throughout the
trial
 Emphasizing the importance of preparation when moving into larger phase III trials to
promote an easier transition into this stage
 Implementing RBM strategies in large scale trials to improve efficiency and reduce cost
 Identifying if your partner has the relevant experience when growing your trial to an
international scale to ensure successful growth
 Appreciating the increased effect change orders will have on larger trials to highlight the
importance of keeping to budgets and timelines
 Considering the ‘big pharma’ approach to clinical outsourcing to identify best practice
strategies of undertaking large-scale trials
Panellists:
Brigid Siegel, Executive Director & Global Head, Clinical Category & Outsourcing Management,
Novartis
Christine Buben, Director, Clinical Operations, BTG
11:45 Using technology to implement a data-driven approach to monitoring
 Definition and description of key terms related to risk-based monitoring
 Background to industry changes around site monitoring
 How these varying approaches can be used together to form a holistic and cohesive
approach to site monitoring.
 Explanation of how those terms work together to describe the end-to-end process of site
monitoring and site management, including oversight by regulatory authorities
Speaker: David Kiger, VP Product Strategy, PAREXEL Informatics
12.15 Lunch break and networking
Small-Medium Sized Companies Big Pharma
1:45 Developing strategies for smaller
companies to ensure their trial is given the
necessary focus by your provider
 Considering how smaller companies
Overcoming challenges, and building
solutions within effective vendor
qualification
Speaker: Kevin O’Brien, Vendor Qualification
Manager, Merck

3. can use the more competitive vendor
landscape to their benefit to get the
most out of their providers
 Ensuring the most suitable vendor is
selected to ensure their skill set is
complementary to the needs of the trial
 Outlining strategies for smaller
companies to outsource their trials on
a larger, global scale
 Identifying the need to establish
enthusiasm from the vendor team to
ensure they are invested in your trial
 Evaluating advantages to vendors of
working with a smaller company to
maximize on these sorts of
relationships
Speaker: Ruth Ann Subach, Director, Clinical
Operations, Trevena
2.15 Achieving a Key Milestone: Site Activation
 Establishing the Study Start Up team
 Identifying steps for activating a site
 Timeline Management – setting
realistic expectations
 Start up considerations for different
kinds of trials
 Effective tracking, proactive
management and site communication
 Site Activation: the foundation for
meeting future milestones
Speaker: Cheryl Johnson, Project Director.
SynteractHCR
Investigating Clinical Trial Cost-cutting
Innovations
 The challenges associated with
conducting and managing today’s
larger, multinational clinical trials have
never been greater. There has been a
dramatic increase in costs and trial
complexity over the last several years
resulting in significant delays caused
by lengthy trial startup and clinician
enrollment processes
 Primary cost drivers include trial site
startup (i.e., training, systems setup
and access, regulatory process and
documentation); site payments; and
site monitoring
 New cost-cutting technological and
operational methods have been
developed and implemented to
challenge cost drivers
 Learn how techniques such as risk-
based monitoring, remote data
collection, and pre-enrollment can
drastically reduce the overall cost of
your trial
Speaker: Mary James, Senior Manager,
Patient and Physician Services, UBC
2.45 Afternoon refreshment break and networking

4. 3:15 Ensuring you fully benefit from your
partners expertise for support to ensure
success in trial compliance and patient
recruitment; a small company perspective
 Considering which outsourcing model
is the most suitable for your company
to ensure the most is made from the
sponsor- vendor relationship
 Evaluating how to effectively research
your vendor to fully comprehend your
vendor’s expertise
 Ensuring all relevant information is
communicated in an accurate and
timely manner to avoid wrong steps
being taken
 Utilizing a vendor’s patient recruitment
expertise to promote the smooth
running of trials on a global scale
 Exploring how best to manage multiple
vendors to create smooth processes
incorporating a number of teams
Speaker: Joseph Pastore, Vice
President, Product Development,
Juventas Therapeutics
Aligning processes between the internal
clinical operations team and the CRO team
to facilitate the smooth running of the trial
 Encouraging strong preparation as a
whole team from the outset to promote
a unified approach to the trial
 Promoting a strong level of
communication and honesty
throughout the trial to ensure all issues
are brought to attention as early as
possible
 Sharing both vendor and sponsor
expertise and resources effectively to
resolve any disruptions in the trial
 Ensuring all parties’ processes are in-
line to avoid any repetition of action
from vendor or sponsor
 Detailing metrics and service level
language to ensure the expectations
and targets of the trial are met by the
vendor
 Benefiting from preferred partners by
implementing very early pre-trial
preparation
Speakers: Kristian Hubbard, Manager,
Outsourcing, Robert Adamczyk, Associate
Director, Clinical Pharmacology, Analysis,
Reporting & Outsourcing, & Susan Lubin,
Associate Director, Outsourcing Operations,
Bristol-Myers Squibb
3:45 The Patient is waiting!- Innovation in global
labs, enhance study performance &
maximize your R&D budgets?
 The Central Lab Model is over 25 years
old, now often seen as a commodity,
what “added value” can be leveraged
by embracing and utilizing new
technology & disruptive innovations
o Review current and future
innovations in lab technology,
service, that are changing the
face of clinical research
 Enhancing the patient and site
experience, tangible benefits of
Integrated smarter lab data
o Faster smarter patient
How to determine the feasibility of a
proposed alternative clinical monitoring
strategy
 Standardization of terms –
Demystifying & Defining the three ‘R”s
o Risk based monitoring
o Remote monitoring
o Reduced monitoring
 When is Risk Based monitoring
appropriate? When is it not?
 Assigning complexity level and
associated risk for a trial
 Considerations include geography,
study phase, safety profile of
compound, patient population,
therapeutic area, data collection
methods
 Risk category examples

5. stratification, enrolment,
recruitment and retention
o Increased value for safety and
efficacy monitoring
 Managing costs- How innovation in
Labs can significantly maximize your
R&D budgets, review and discuss real
life case studies
Speaker: Paul Travis, Executive Director,
Global Business Strategy & Development,
MRL, MedPace
o Low risk - Phase 3/3b, IV or post
marketing
o Medium risk – Phase 2/2B
o High risk – Proof of concept, first
trial in man
 What are the limits of Risk Based
monitoring, even in trials where it is
appropriate to use?
Speaker: Joanne Hollenbach, Chief
Operating Officer (US), Cmed Clinical
Services
4.15 Establishing specific needs in trial
management to develop effective strategies
with limited resources
 Outlining the importance of planning
ahead to think about outsourcing on a
holistic and continuous level
 Pooling all internal team’s knowledge
together to benefit from past
experiences and avoid delays to the
trial
 Considering unique ways to incentivise
a vendor team in ways which fit with
the capabilities of the company size
 Assessing how best to use the limited
staff available in small companies to
ensure quality assurance throughout
the trials
 Improving efficiency of in-house
activities to rise to the challenge of
minimal staff numbers
 Emphasizing the need for a flexible
approach to outsourcing from both
sponsor and vendor to accommodate
and manage any unexpected change
orders that may occur
Speaker: Sri Srivastava, Director, Preclinical
and Early Clinical Development, Aestus
Therapeutics
Pinpointing obstacles within a preferred
partnership model to ensure strategies are
in place to overcome them and improve the
quality of data and efficiency of the trial
 Relationship management between the
sponsor and vendor as a foundation to
a valuable partnership.
 Managing projects using transparent
metrics and clear escalation criteria to
enhance delivery within a partnership
 Implementing contracting models that
avoid zero-sum-game interactions
 Requirements and approaches for
managing performance of delivery
within a partnership using contractual
incentives and penalties
Speaker: Thomas Lawler, Senior Director,
Global Project Management, AstraZeneca
4:45 Chair’s summation and close of day one

6. Arena International’s 5th Annual Outsourcing in Clinical Trials East Coast
Conference, Philadelphia
Program Day Two – May 14th
2014
08:30 Registration and refreshments
08:50 Chair’s opening remarks Chair’s opening remarks
Biopharmaceuticals Medical Devices
09:00
Balancing the need for high quality results
whilst meeting budget requirements to
avoid unnecessary overspend
 Addressing the advantages of taking
more time at the outset to accurately
predict budgets and avoid surprises
during the trial
 Considering the impact of change
orders on the trial costs to highlight
why their effects must be minimized
 Evaluating the effectiveness of fixed
price contracts against monthly
payment models to elucidate if this a
cost-effective model
 Utilizing fixed price contracts as a way
of incentivizing the vendor to develop
more in-depth trial design strategies
 Highlighting the ‘danger-zones’ in
typical trials for change orders to
occur to ensure more attention is paid
to these issues
 Exploring how realistic price caps are
as a potential method to limit
spending and keep budgets under
control
Speaker: John Barry, Head, Vendor Strategy
and Management, Merck
Assessing available outsourcing models to
investigate which model will be most
effective to meet the needs of the trial
 Introducing different outsourcing
models to highlight the benefits and
disadvantages of each and
understand what sort of trials best fit
which model
 Highlighting the importance of
reliability and trust between sponsor
and vendor when working with a full
outsourcing model versus the risk of
total reliance on one vendor
 Assessing the need for a really strong
chain of communication to fully
consider the impact of a functional
outsourcing model
 Analyzing cost advantages of each
model to see how the size of the trial
should impact the choice of model
 Emphasizing the importance of
building long term relationships with
service providers to capitalize on
strong foundations and save on costs
and time
 Evaluating how clinical trial oversight
processes need to change depending
on the model in place to ensure the
trial is running on budget and without
delay
Speaker: Elizabeth Somers, Associate
Director, Diagnostic Development, Morphotek
09:30 Visual Analytics Tools and Techniques to
Simplify Complex Trials
Exploring and overcoming challenges
associated with a medical device company
conducting pharmaceutical clinical trials

7.  Understanding why advanced
analytics technologies are seemingly
playing a bigger role in our business
along with the engagement,
deployment and expanded use of
visual analytics software and tools
 To provide an overview of the
different visual analytics tools, the
capabilities they support and
identifying the appropriate tools
specific to a given company’s needs
 In light of these tools reviewed – how
do we balance and focus on what the
end user requires versus the
temptation to create flashy
dashboards with all the bells and
whistles which distract from that end
goal?
Speaker: Mark Penniston, Senior Vice
President and General Manager, Clinical
Analytics, Theorem Clinical Research
Speaker: George Omburo, VP, Product and
Clinical Development. Derma Sciences
10:00
Panel Discussion: Designing in-depth
contracts incorporating legal aspects to
provide a plan of action and clear
responsibilities for all eventualities
 Ensuring any service level language
utilized in the contract is pre-agreed to
align expectations with all parties
 Exploring the benefits of incorporating
risk-sharing partnerships to conclude
how this strategy is effective
 Identifying how to divide risk and
benefits with vendors to facilitate the
risk-sharing process
 Implementing strategies within
contract writing in order to avoid major
breaches in contract
 Adapting negotiation strategies to
ensure contingency plans are in place
in your contract
 Working with a legal team to develop
a mitigation plan in case of issues
during the trial
Panellists: Marisa Bower, Director, Global
Procurement, R&D, Teva Pharmaceuticals &
Michael Cox, Senior Manager, Outsourcing,
MedImmune
Panel Discussion- Considering how best
to run trials in emerging markets to
maximize on the advantages this region
offers
 Ensuring due preparation is taken to
finalize all documentation and meet
required timelines
 Considering the cost effects of
entering different regions to recognize
which area will be most beneficial
 Exploring different regulatory
processes to conclude how a service
provider can be best used to facilitate
approval
 Underlining the advantages of running
trials in emerging markets to
recognize the potential benefits to
your company
 Developing patient recruitment
strategies to benefit of increase
enrolment rates whilst ensuring high
quality data
Panellists: Thomas Miller, Director, Clinical
Research and Education, Vapotherm & Eric
Eastman, Chief Scientific Officer, DioGenix
10:45 Morning refreshment break and networking

8. 11:15 Developing best practice strategies in
vendor monitoring to ensure effective
vendor management
 Exploring options for smaller
companies to identify how to monitor
trial activities to make the most of
limited staff and resources
 Defining performance metrics to
promote quality assurance from the
vendor and identify any low
performing teams
 Encouraging regular meetings
between vendor and sponsor to
ensure protocol adherence by the
clinical team
 Considering strategies for monitoring
studies on a global scale to effectively
manage an international trial
 Investigating available technologies to
generate a more effective and
efficient monitoring process
Speaker: Lori Carman, Senior Director,
Clinical Research and Operations, Insmed
Developing strategies for qualifying
vendors to ensure they have the industry
and product expertise to take on the study
 Evaluating the value of medical-
device specific vendors to utilize their
knowledge and experience
 Investigating vendors’ experiences
and reputation to reveal how they
work and if they have any contacts
that may be useful to the trial
 Utilizing a vendor’s knowledge to
navigate the regulatory medical
device minefield
 Ensuring the needs and expectations
of the trial are explained explicitly to
provide an accurate response
 Examining vendor staff to uncover if
they have the required knowledge
and experience to run a medical
device trial
Speaker: Denise Weber, Vice President,
Clinical Affairs, Maquet Cardiovascular

9. 11.45 Next Generation of Functional Outsourcing
Models
 Discuss the evolution of functional
outsourcing models from insourcing to
functional strategic partnership
 Evaluating how biopharma can build a
best in class FSP partnership model
to gain efficiencies, produce
innovation, reduce cost and deliver
high quality data
Speaker: Elizabeth Carter, Worldwide Senior
Director Functional Services, PAREXEL
International Corporation
Ensuring continuous collaboration
throughout the trial to achieve effective
trial oversight and management
 Outlining how strong communication
links are imperative to maintaining
trial budgets and deadlines
 Encouraging openness from both
sides so any potential problem areas
can be addressed as early as
possible to minimize impact on cost or
time
 Emphasizing the importance of low
staff turnover to maintain strong
communication links on a personal
level
 Considering how vendors can
communicate with each other
efficiently to avoid unnecessary
involvement of the sponsor
 Engaging one point of contact at the
vendor company to make
communication as simple as possible
 a control centre for the trial
Speaker: John Minier, Director, Regulatory
and Clinical Affairs, Small Bone Innovations
12.15 Optimizing Study design to Drive Development Performance
 Characterizing trends in study design practices
 Assessing the impact of protocol complexity on study performance and efficiency
 Exploring adaptive designs and improved feasibility approaches to optimize study
design
Speaker: Kenneth Getz, Director of Sponsored Research Programs & Research Associate
Professor, Tufts Centre for the Study of Drug Development
12:55 Lunch break and networking

10. 2:00 Developing effective clinical trial
agreements to ensure shared
responsibility throughout the study
 Evaluating sponsor and site
perspectives to ensure all needs are
taken into account
 Explore how best to put together
clinical trial agreements to ensure all
factors are clear and agreed by all
parties
 Considering how to effectively
outsource investigator site contracting
to ensure working with a suitable site
Speakers: Albine Martin, COO, Precision
Biologics & Hee Smith, Contracts Associate,
John Hopkins University
Considering the differences between USA
and European regulations, develop
strategies to conduct US trials
internationally by adopting processes to
optimize both US and international
regulations
 Analysing the differences between
FDA and EU legislation to identify the
different documentation required for
approval
 Focusing on the changes on EU
legislation to investigate how similar
they will become to the FDA
legislation
 Considering to what extent a CRO
can be relied upon to have the
regulatory knowledge to comply with
regulations on an international scale
 Evaluating which regions are most
appropriate for your trial to simplify
the approval process
 Implementing flexible regulatory
pathways to accommodate
international changes to regulations
Speaker: Karen Fraser, Senior Director,
Clinical, Veniti
2:30 Overcoming issues with an ever-changing
CRO team to ensure the needs of the trial
are consistently being met
 Underlining the importance of
reviewing a potential vendor’s staff
turnover in the selection stage to keep
this issue to a minimum
 Exploring strategies to incorporate
staff turnover requirements within the
contract to encourage the vendor to
keep staff
 Ensuring the sponsor is informed of
any upcoming changes to the trial
team as early as possible to enable
them to accommodate to these
changes
 Considering being involved with the
recruitment process to ensure high
quality replacements are found
 Minimizing time lags created through
information handovers by pushing
responsibility for smooth transition
onto the vendor
Considering the importance of developing
good sponsor-vendor relationships for
biomarker clinical trials
 Highlighting the key challenges
specific to biomarker trials to ensure
the most appropriate vendor is found
 Sourcing vendors with the appropriate
staff experience to increase the
chance of a successful trial
 Exploring how best to manage these
sorts of vendors throughout the trial t
ensure long term partnerships
 Considering differences for biomarker
study patient recruitment to reveal
how these patients should be targeted
Speaker: Eric Eastman, Chief Scientific
Officer, DioGenix

11.  Utilizing individual staff incentives to
encourage staff members to stay on a
particular study
Speaker: Diane Rudisill, Senior Clinical
Project Manager, Galderma
3:00 Afternoon refreshment break and networking
3:30
Speaker Hosted Roundtables
Interactive roundtable sessions offer a unique opportunity to come together with your peers to
share best practice and develop solutions to critical challenges facing the industry as a whole.
Hosted by industry experts and each focused on a single issue, roundtables are an exciting,
interactive way to build your personal network and learn from the experience and expertise of
others.
Each roundtable session lasts for 30 minutes, and delegates may attend up to 3 roundtables
Roundtable
1
Considering how best to manage multiple trials to facilitate study success
Facilitator: Christine Buben, Director, Clinical Operations, BTG
Roundtable
2
Determining strategies to accurately predict clinical trial budgets
Facilitator: Kristian Hubbard, Manager Outsourcing, ECTR, Bristol-Myers Squibb
Roundtable
3
Identifying the pros and cons that using ‘flexsourcing’ throughout a trial can present
Facilitator to be confirmed
Roundtable
4
Developing source data verification costs to reduce costs whilst maintain accuracy
Facilitator to be confirmed
5:00 Chair’s summation and close of conference