There is a continual demand for knowledge and understanding of industry standards and best practices in pharmaceutical clinical development. Pharmaceutical professionals are tasked to evaluate the various aspects of the clinical development process within their firms so they can implement improvement measures. This conference provides professionals with the right knowledge and tools to help drive improved performance and efficiency throughout the course of their clinical development process.
At ExL Pharma’s 6th Annual Clinical Performance Metrics & Benchmarking Summit, leading industry experts discuss how the implementation and application of performance metrics can improve your clinical trials, expedite development and enhance quality. Sessions offer both large and small pharmaceutical companies the opportunity to discuss and learn the different types of metrics used in clinical development, how to manage and successfully gain internal buy-in of a metrics program, discuss lessons learned on choosing the right benchmarking company, and the techniques on deriving meaningful conclusions from this benchmarking data to measure productivity. This year’s summit also provides attendees the opportunity to gain first hand knowledge when selecting available technologies for efficient data collection and analysis, and a detailed case study example on the use of metrics to help prioritize the impact efforts when managing timelines and deliverables. This is a must attend educational summit and an excellent networking opportunity.
We look forward to greeting you in September!
1. Register by august 6, 2010 for maximized savings
6th Annual Clinical
PROUDLY PRESENTS Performance Metrics &
Benchmarking Summit
measuring and improving Clinical performance to
maximize efficiency and Reduce operational Costs
SePteMBer 20-21, 2010,
Featured Sessions include: HyAtt At tHe Bellevue,
IDENTIFYING CLINICAL METRICS PHilAdelPHiA, PA
strategies for selecting Clinical Development metrics
and analyses to ensure optimal performance Industry PartIcIPants Include:
Nancy dynes, Consultant, Portfolio Management Systems, ELI LILLY
· Astellas
INTERNAL PERFORMANCE · AstraZeneca
gaining internal Buy-in of Your Clinical metrics
program to improve an organization’s processes · Bristol-Myers Squibb
randy Krauss, Associate Director, Therapeutic Portfolio Management, GENzYME · Eli Lilly
· Genentech
METRICS IMPLEMENTATION
Finding value in Data acquired through previously · Genzyme
implemented Clinical performance measurement and · GlaxoSmithKline
assessments, to avoid unnecessary and Costly New · Merck & Co
initiatives · sanofi-aventis
Karen Brooks, MS, CCRA, Associate Director, Therapeutic Operations,
SANOFI-AVENTIS · And More!
CRO METRICS
identifying metrics and Tools to measure CRo and post-Conference workshop on
sponsor performance and Continuous improvement BalaNCeD sCoReCaRDs
in Clinical outsourcing Collaborations
Jan Matsson, Director Clinical Outsourcing,ASTRAzENECA utilizing the Balanced
Scorecard Method to
Convert value drivers
into Metrics and Align
Performance Goals with
Overall Business Strategy
To RegisTeR Call 866-207-6528 oR visiT us aT www.exlphaRma.Com
2. 6th Annual Clinical Performance
Metrics & Benchmarking Summit
september 20-21, 2010, hyatt at The Bellevue, philadelphia, pa
who shoulD aTTeND
There is a continual demand for knowledge and understanding of indus- Professionals from pharmaceutical,
try standards and best practices in pharmaceutical clinical development. biotechnology and medical device
Pharmaceutical professionals are tasked to evaluate the various aspects of companies with responsibilities
the clinical development process within their firms so they can implement in the following departments:
improvement measures. This conference provides professionals with the
right knowledge and tools to help drive improved performance and effi- • Process Improvement/Enhancement
ciency throughout the course of their clinical development process. • Metrics and Benchmarking Development
• Performance Management
At ExL Pharma’s 6th Annual Clinical Performance Metrics & Benchmarking • Clinical Operations
Summit, leading industry experts discuss how the implementation and • Clinical Development & Planning
application of performance metrics can improve your clinical trials, ex-
• Clinical Trials & Studies
pedite development and enhance quality. Sessions offer both large and
• Resource Management
small pharmaceutical companies the opportunity to discuss and learn
the different types of metrics used in clinical development, how to man- • Research & Development/R&D Operations
age and successfully gain internal buy-in of a metrics program, discuss • Data Management
lessons learned on choosing the right benchmarking company, and the • Project Management & Planning
techniques on deriving meaningful conclusions from this benchmarking • Process Planning
data to measure productivity. This year’s summit also provides attend- • Medical Affairs
ees the opportunity to gain first hand knowledge when selecting available • Business Development/Operations
technologies for efficient data collection and analysis, and a detailed case • Technology Development
study example on the use of metrics to help prioritize the impact efforts • Capacity Planning/Management
when managing timelines and deliverables. This is a must attend educa- • Drug Development and Safety Management
tional summit and an excellent networking opportunity.
This conference is also of interest to:
We look forward to greeting you in September!
• CROs
• Technology Providers
Mary Ruggiero Kristen Hunter • Consultants
Conference Director Team Leader, Production
mruggiero@exlpharma.com ExL Pharma
Hotel information Discover true grandeur, unrivaled style and service at our iconic downtown Philadel-
phia hotel. Situated on the famous Avenue of the Arts, Hyatt at The Bellevue (formerly
Park Hyatt Philadelphia at the Bellevue) blends old-world architecture with modern
amenities. Unwind in our luxuriously oversized guestrooms with posh amenities.
Allow our European-style, Concierge to personally recommend and make arrange-
ments at top restaurants, shows and events. Dine at XIX (NINETEEN) atop our Phila-
delphia luxury hotel, with sweeping city views. Peruse world-class shops within our
landmark building. Work out in our remarkable 93,000 square foot health club. See
why this elite Center City Philadelphia hotel has earned the Hyatt distinction.
rOOM reServAtiONS:
If you require overnight accommodations, please contact the hotel and state that you
are with ExL Pharma’s Annual Clinical Performance Metrics & Benchmarking Sum-
mit conference by Sunday, August 29, 2010. We encourage conference participants
Hyatt at the Bellevue, to make reservations with our designated venue to take advantage of ExL Pharma’s
Philadelphia, PA discounted room rate by the aforementioned date.
200 South Broad Street
Philadelphia, Pennsylvania 19102 USA
Tel: (215) 982-4900 · Fax: (215) 982-4922 To RegisTeR Call 866-207-6528 oR visiT us aT www.exlphaRma.Com
Email: conciergephlph@hyatt.com
3. Conference Agenda
Day One · September 20th
8:00 Continental Breakfast & Conference Registration 2:00 BENCHMARKING
How to Obtain and Utilize Benchmarking Data to Predict and As-
9:00 Chairperson’s Welcome & Opening Remarks sess Clinical Trial Performance
David Zuckerman, president, CusTomiZeD impRovemeNT • Overview of benchmarking and activities undertaken to participate
sTRaTegies in benchmarking surveys
• Where to go for the information to benchmark against
9:15 IDENTIFYING CLINICAL METRICS • How to interpret benchmarking data and determine relevance to
Strategies for Selecting Clinical Development Metrics your business
and Analyses to Ensure Optimal Performance • Incorporating benchmarking into clinical trial execution decisions
• Gaining knowledge of the different types of metrics used in clinical • Deriving meaningful conclusions from this data to measure pro-
development ductivity
• Understanding specific performance evaluations: trial metrics, otis Johnson, manager, global Clinical Trial operations, meRCK & Co
country metrics, site metrics Nancy Trewhella, Business performance management, meRCK & Co
• Methods for ensuring the metrics chosen are both valid and rel-
evant 3:00 Networking & Refreshment Break
• Evaluating their impact on clinical development performance
• Discussion on special metrics to improve processes: quality met- 3:30 CASE STUDY- INDUSTRY PERSPECTIVE
rics, financial metrics Understanding and Applying New Metrics for Measuring R&D
Nancy Dynes, Consultant, portfolio management systems, eli lillY Performance to Optimize Efficiency and Cost - a GSK Approach
• Examination of the current R&D practices
10:00 INTERNAL PERFORMANCE • Discussion of new metrics/ approaches used for optimum clinical
Gaining Internal Buy-in of Your Clinical Metrics performance
Program to Improve an Organization’s Processes • The impact this has on cost optimization
• Learn how to teach people what they need to do as an organization Dongzhou (Jeffery) liu, phD, ms, mBa, medical lead/principle Clinical
to help them understand how metrics will be used investigator, medical affairs/Clinical Research, glaxosmiThKliNe
• How to communicate metrics results effectively throughout the
organization 4:15 ROUNDTABLE DISCUSSIONS
Randy Krauss, associate Director, Therapeutic portfolio management, Choose from one of the following tables discussing a specific clinical
geNZYme performance metric, and how they can indicate strong performance
10:45 Networking & Refreshment Break 1) Site Performance & Patient Recruitment Metrics: Identifying,
applying and utilizing metrics to optimize site performance,
11:15 METRICS IMPLEMENTATION productivity and quality
Finding Value in Data Acquired through Previously 2) Protocol Metrics: Learn how to objectively score a protocol.
Implemented Clinical Performance Measurements and How good is this document? How likely will people enroll in this?
Assessments, to Avoid Unnecessary and Costly New Initiatives How is it written?
• Identify appropriate metrics for study performance 3) Quality Metrics: How to successfully define quality metrics,
• Utilize metrics to accelerate timelines by decreasing bottlenecks understanding what they are, and if the results of the quality
• Analyze metrics continuously for guiding future performance metrics can be effectively used
Karen Brooks, ms, CCRa, associate Director, Therapeutic operations, 4) M&A Metrics: How to manage setting metrics targets in
saNoFi-aveNTis operations during and after a merger and acquisition, what to
anticipate, avoid, and expect
12:00 Lunch 5)
Outsourcing Benefits and Challenges: Understanding the role of
outsourcing in improving the sponsor-vendor relationship and
1:15 best practices used in managing cost & increasing supplier
Understanding How Performance Metrics can Contribute to productivity
Improved Business Processes
• The use of metrics to help prioritize impact efforts when managing moDeRaToRs:
timelines and deliverables maggie ayers, B.sc., Director, Clinical studies, asTellas
• Comparing different metrics to identify which areas of improve-
ment would garner the greatest revenue impact Nancy Dynes, Consultant, portfolio management systems, eli lillY
sean gharpurey, principal project manager- product Development Cheryl Fiedler, pharmD, executive Director, study strategy & planning,
operations, geNeNTeCh BRisTol-mYeRs sQuiBB
gretchen e. goller, msw, patient Recruitment/Compliance
strategist-operations, saNoFi-aveNTis
Jan matsson, Director Clinical outsourcing, asTRaZeNeCa R&D
5:15 Day One Concludes
4. Conference Agenda
Day Two · September 21st
paNelisT:
8:00 Continental Breakfast alex lancksweert, Business lead, simplifying Clinical information en-
vironment (sCie), glaxosmiThKliNe
Cheryl Fiedler, pharmD, executive Director, study strategy & planning,
9:00 Chairperson’s Introduction of Day Two BRisTol-mYeRs sQuiBB
David Zuckerman, president, CusTomiZeD impRovemeNT
sTRaTegies edward mannello, Director, study Recruitment, asTRaZeNeCa
9:05 Moderator’s Summary of Roundtable Discussions 12:15 Main Conference Concludes
Brief overview and key points from roundtable discussions
Lunch for Workshop Participants
9:30 CRO METRICS
Identifying Metrics and Tools to Measure CRO and Sponsor Per-
formance and Continuous Improvement in Clinical Outsourcing
Collaborations
POST-CONFERENCE WORKSHOP
• Identifying metrics and tools to measure the partnership and col- 1:15 Utilizing the Balanced Scorecard Method to Convert
laboration between pharmaceutical companies and CROs Value Drivers into Metrics and Align Performance
• The importance of relationship governance Goals with Overall Business Strategy
• Case study: The AstraZeneca/Quintiles Clinical Pharmacology Al-
liance • What is the balanced scorecard method?
Jan matsson, Director Clinical outsourcing, asTRaZeNeCa • Definition – combining measuring and managing
• Case study examples of process improvement
10:15 Networking & Refreshment Break • What other options are out there?
10:45 UPDATE FROM THE MCC • Examining the organization from 4 different perspectives
Understanding How Pharmaceutical, Biotechnology and CROs • Financial
Develop Standardized Metrics to Drive Process Improvement • Learning & Growth
and Boost Partnership Performance in Clinical Trials • Customer
• Developing and implementing standardized performance metrics • Internal Business Processes
with a goal of improving efficiency and delivery of clinical trial op-
erations • Outlining the benefits of utilizing a scorecard to track metrics
• Building an industry benchmarking database for clinical trial metrics • Visibility
• Piloting quality assessment tools for site selection and protocol • Efficiency
development • Communication
linda sullivan, vice president of operations, meTRiCs ChampioN • Accountability
CoNsoRTium
• Case study examples of scorecard success
11:15 PANEL DISCUSSION
Examining Available Technologies for Performance Metrics Data
Collection and Analysis 4:15 Post-Conference Workshop Concludes
• How are pharmaceutical companies deciding and prioritizing
which types of performance data to obtain and analyze?
• Discussing the issues pharmaceutical companies have to address “Well organized summit and great speakers”
such as data standardization and how they are making the build or
ALCON RESEARCH
buy performance measurements technology decisions
• Understanding the challenges for implementation and adoption of
these new systems and processes
“Great discussion! Loved the group involvement. Very
helpful and excellent content. Exactly what I came for!”
moDeRaToR: PDL BIOPHARMA
scott Ballenger, president, TRial aCCeleRaTioN iNsTiTuTe
“Very informative learning experience about metrics
& benchmarking”
SANOTI-AVENTIS
To RegisTeR Call 866-207-6528 oR visiT us aT www.exlphaRma.Com
5. 6th Annual Clinical Performance
Metrics & Benchmarking Summit
Sponsorship and exhibiting Opportunities
Media Partners Do you want to spread the word about your organization’s solutions and services
to potential clients who will be attending this event? Take advantage of the op-
portunity to exhibit, present an educational session, host a networking event, or
distribute promotional items to attendees. exl pharma will work closely with you
to customize a package that will suit all of your needs. To learn more about these
opportunities, please contact:
steve Decker, Business Development manager
212-400-6234, sdecker@exlpharma.com
Five ways to Register
Fax: 888-221-6750 Phone: 866-207-6528
Mail: ExL Events, Inc. Online: www.exlpharma.com
555 8th Ave, Ste 310 Email: register@exlpharma.com
New York, NY 10018
Registration Fees for Attending ExL Pharma’s 6th Annual
Clinical Performance Metrics & Benchmarking Summit
eaRlY BiRD pRiCiNg
Register by Friday, August 6, 2010 to Take Advantage of Early-Bird Pricing:
Corporate Rate: Conference + Workshop $1995
Conference Only $1695
sTaNDaRD pRiCiNg
Register After Friday, August 6, 2010:
Corporate Rate: Conference + Workshop $2195
Conference Only $1895
oNsiTe pRiCiNg
Corporate Rate: Conference + Workshop $2295
Conference Only $1995
group Discount program:
save 25% per person when Registering Four
For every three simultaneous registrations from your company, you will receive a fourth complimentary
registration to the program (must register 4 at one time). This is a savings of 25% per person.
save 15% per person when Registering Three
Can only send three? You can still save 15% off of every registration. To find out more on how you can
take advantage of these group discounts, please call 866-207-6528.
IMPORTANT! Offers may not be combined. Discount only derived from the Start Date of the event:
applies to standard rate. Make checks payable to ExL Events, Four weeks or more: A full refund (minus a $95 processing
Inc. and write code P1702 on your check. You may also use fee), or a voucher to another ExL event valid for two years
Visa, MasterCard, Discover or American Express. Payments from the voucher issue date.
must be received in full prior to the commencement of the Four weeks or Less: A voucher to another ExL event valid
conference. for two years from the voucher issue date.
Conference registrations may be transferred to other
colleagues in the event you are unable to attend. Please To receive a refund or voucher, please fax your request to
notify ExL Pharma, info@exlpharma.com, prior to the event 888-221-6750.
with the name and contact information of the replacement
attendee. There will be an administrative charge of $300 Please Note: Speakers and agenda are subject to change
to substitute, exchange, and/or replace attendance badge without notice. In the event of a speaker cancellation, every
with a colleague occurring within five business days of the effort to find a suitable replacement will be made.
conference. *The opinions of this faculty do not necessarily reflect those
Cancellations: If you need to cancel your registration for an of the companies they represent or ExL Events, Inc.*
upcoming ExL conference, please note the following policies
To RegisTeR visiT us aT www.exlphaRma.Com
6. Register by august 6, 2010 for maximized savings
6th Annual Clinical
PROUDLY PRESENTS Performance Metrics &
PLEASE MENTION PRIORITY CODE: P1702
Benchmarking Summit
Exp. Date:
555 8th Avenue, Suite 310
measuring and improving Clinical performance to
maximize efficiency and Reduce operational Costs
New York, NY 10018
SePteMBer 20-21, 2010,
Featured Sessions include: HyAtt At tHe Bellevue,
PHilAdelPHiA, PA
IDENTIFYING CLINICAL METRICS
strategies for selecting Clinical Industry PartIcIPants Include:
Development metrics and analyses to · Astellas
ensure optimal performance
· AstraZeneca
Name on Card
Nancy dynes, Consultant, Portfolio Management
Card Number
Systems, ELI LILLY · Bristol-Myers Squibb
Signature
INTERNAL PERFORMANCE · Eli Lilly
gaining internal Buy-in of Your Clinical · Genentech
metrics program to improve an
· Genzyme
organization’s processes
Please contact me: I’m interested in marketing opportunities at this event
randy Krauss, Associate Director, Therapeutic · GlaxoSmithKline
Portfolio Management, GENzYME
· Merck & Co
register@exlpharma.com
I wish to receive email updates on ExL Pharma’s upcoming events
www.exlpharma.com
Zip
METRICS IMPLEMENTATION · sanofi-aventis
Finding value in Data acquired · And More!
888-221-6750
through previously implemented
Clinical performance measurement and
post-Conference workshop on
assessments, to avoid unnecessary and
State
Title
BalaNCeD sCoReCaRDs
Fax
Yes! Register me for the conference:
Costly New initiatives
Karen Brooks, MS, CCRA, Associate Director, utilizing the Balanced
Therapeutic Operations, SANOFI-AVENTIS Scorecard Method to
Corporate Rate: Main Conference
Convert value drivers
Corporate Rate: Plus Workshop
CRO METRICS
into Metrics and Align
identifying metrics and Tools to measure
Performance Goals
New York, NY 10018
CRo and sponsor performance and
TO R E G I S T E R
with Overall Business
Continuous improvement in Clinical
555 8th Avenue,
ExL Events, Inc.
Strategy
866-207-6528
outsourcing Collaborations
Suite 310
Jan Matsson, Director Clinical Outsourcing,
ASTRAzENECA
Telephone
Company
Address
Name
Email
Dept.
City
To RegisTeR Call 866-207-6528 oR visiT us aT www.exlphaRma.Com