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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
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
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
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
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
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                 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
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                 	         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
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                 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


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                  To RegisTeR visiT us aT www.exlphaRma.Com
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




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                                                                                                                                                                                                                                                                                                                                                                                                                                                    City
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ExL Pharma's 6th Pharmaceutical Performance Metrics Conference Brochure, September, Philadelphia, PA

  • 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