CONFIDENTIAL Presentation to Erin K. Bennett July 10, 2012 Central Laboratory Services.

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Presentation transcript:

CONFIDENTIAL Presentation to Erin K. Bennett July 10, 2012 Central Laboratory Services

CONFIDENTIAL 2 Growing Challenges in Our Industry Meeting Enrollment Milestones Step 1: Warmer

CONFIDENTIAL 3 The Traditional Enrollment Model Perceptions About Central Lab’s Influence: Sponsor Select Vendors CRO Pick Sites Central Lab Central Lab Process Samples Sites Enroll Patients Data Quality & Reportable Test Metrics Logistics, Stability & Turn-Around Time Data Delivery Enrollment Milestones

CONFIDENTIAL 4 The New Normal: Sites Play Central Roll Growing Influences in the Roll of Sites: Trial Competition: Choice of Sponsors Time Pressures Patient Scarcity Kit IssuesData Quality Communications Sites High-performing sites are in demand Their concerns impact trial participation Responsiveness to site concerns is key to maximizing enrollment. Step 2: Reframe

CONFIDENTIAL 5 Insights Into Investigator Motivation Recent Market Research Report ►Independent study by LSSG ►Global coverage of investigators ►Focus on site motivations & engagement ►Conclusion: Satisfied Sites Perform Better Step 3: Rational Drowning

6 Ninety-four percent (94%) of investigators state the central laboratory selected by the Sponsor impacts their (and their staffs’) success, day-to-day activities and willingness to work with a particular sponsor on future studies. Source: Life Science Strategy Group, LLC Q. To what degree does the central laboratory that is selected by the Sponsor impact: IMPACT OF THE CENTRAL LABORATORY ON CLINICAL TRIAL INVESTIGATORS © 2011 Life Science Strategy Group, LLC Unauthorized photocopying or distribution is prohibited Mean = 5.2 N=374 Your nursing and support staff's day-to-day activities in support of the clinical trial? Your success as a clinical trial investigator? Your willingness to continue to work with a particular Sponsor on future clinical trials? Mean = 5.2 N=374 Mean = 5.0 N=374 94%

7 Increasing Importance Unaided, investigators state effective, timely communication, reliable, quality results and easy-to-use kits are top factors leading to a strong relationship with a central laboratory. Source: Life Science Strategy Group, LLC Q. What do you consider to be the three most important factors leading to a strong relationship between an investigator site and a central laboratory services provider? FACTORS LEADING TO A STRONG RELATIONSHIP WITH A CENTRAL LABORATORY © 2011 Life Science Strategy Group, LLC Unauthorized photocopying or distribution is prohibited “Easy access over phone and , fast and reliable response.” “Fluid communication, day by day or week by week with the monitor and central lab for screening and follow up.” “Simple. Fast, high quality, reliable results.” “Meeting time limits, assuring delivery of data, clarity in reporting.” “Readiness and willingness to listen if there is an unexpected or wrong result as perceived by the site.” Factor Fast, easy access to and effective communication with the lab / customer service Quality of lab results Ease of lab kit use Reliability of the lab Adherence to timelines/speed “ and call on regular basis regarding any update related to the study.” “Well-prepared patient kits and shipping materials that are easy to use.” N=552 COMMUNICATIONS DATA QUALITY EASY TO USE KITS The Big Three Erin won’t present this one. She’ll use slide 8.

8 In general, Investigators’ most preferred lab provides organized, user-friendly kits and lab instructions, they are familiar with the company and its reputation/reliability, and it has strong customer service and professionalism and timely reporting. Source: Life Science Strategy Group, LLC Q. Which central laboratory services provider do you MOST PREFER to work with? Q. What factors contributed to this response? RATIONALE FOR MOST PREFERRED LAB (unaided) © 2011 Life Science Strategy Group, LLC Unauthorized photocopying or distribution is prohibited Familiarity with the company, well-known, reputable and reliable company Organized and easy-to- use kits; clear instructions Increasing # of mentions “Familiarity and having worked with them before and knowing that they are really good at what they do. I know they are very reliable.” “The ease and clarity of their lab instructions. The packing supplies and lab kits are self explanatory. Covance has always been very prompt with the lab results.” “Their results are reliable, they communicate with investigators fast, if abnormal exam, we receive supplies fast and before the expiration date.” “Accurate, timely reporting and quick turn-around. Easy to access assistance when required.” N=514 Great customer service and professionalism; provides assistance in a timely manner Accurate; timely reporting; quick turn-around

9 More than 85% of investigators agree that they are more satisfied and willing to work with a Sponsor on future trials when they have selected their preferred central laboratory from past clinical trials. Source: Life Science Strategy Group, LLC Q. To what degree to you agree or disagree with the following statement? I am more satisfied and willing to work with a pharmaceutical Sponsor on future clinical trials when they have selected my preferred central laboratory to support clinical trials that I have been an investigator for in the past. IMPACT OF THE CENTRAL LABORATORY ON INVESTIGATOR WILLINGNESS TO WORK WITH A SPONSOR ON FUTURE TRIALS © 2011 Life Science Strategy Group, LLC Unauthorized photocopying or distribution is prohibited Mean=4.7 N=370 I am more satisfied and willing to work with a pharmaceutical Sponsor on future clinical trials when they have selected my preferred central laboratory to support clinical trials that I have been an investigator for in the past. 87% Satisfied Sites Higher Engagement with Sponsor Better Enrollment Performance

CONFIDENTIAL 10 Goals for Investigator Meeting Answer QuestionsProtocol Review and TrainingDevelop Strong Relationships GET THEM EXCITED ABOUT YOUR STUDY!! Step 4: Emotional Impact

CONFIDENTIAL 11 Optimized Solution Engages Sites Consistent, easy to use kits delivered on timeSite startup training that minimizes wasted time Dependable high-quality data Rapid time to resultCall center at their service Step 5: Value Proposition

CONFIDENTIAL 12 Investigator Sites Prefer Covance CLS I am more satisfied and willing to work with a pharmaceutical Sponsor on future clinical trials when they have selected my preferred central laboratory to support clinical trials that I have been an investigator for in the past. “” Sponsor Choice of Central Lab: Drives investigator site satisfaction Impacts site willingness to work on future studies with that sponsor Covance: Most preferred central laboratory Top Attributes: Data Source: 2011 Survey by Life Science Strategy Group, LLC Step 6: Our Solution

13 Customized Training & Support Solutions Study-Specific Investigator Training Manual ►Provides step-by-step instructions for sites Investigator Training Capabilities ►Live presence with site representatives ►eLearning solutions now available Investigator Call Center ►Global presence & multiple languages Kit Inventory Monitoring ►Efficiency & dependability

14 Kits Designed for Site Efficiency Global Automated Kit Production Rigorous Quality Controls Scalable Capacity Extensive Automation Promotes Efficiency & Consistency >20,000 kits / day capacity High-Quality Data Starts with Consistent Kits

15  Additional slides can be added if needed