An ELITE Gathering of Clinical Decision-Makers Learn, Network...

The 4th Annual

January 27-29, 2015 | Hyatt Regency Philadelphia at Penn’s Landing

C R O W NC l inical Research & Operations Worldwide Networking

An ELITE Gathering of Clinical Decision-Makers Learn, Network and Engage on Topics Critical to the Effective Design, Development and Execution of Clinical Trials

FEATURED PRESENTATIONS

CONGRESS

SESSION

TRACKS RISK-BASED MONITORING

EFFECTIVE PARTNERSHIPS

QUALITY ASSESSMENT

DATA OPTIMIZATION

SITE PERFORMANCE MAXIMIZATION

THE VOICE OF TODAY’S PATIENT

Meet Today’s Clinical Trial Participant: Hear Her Story, Learn from Her Experiences and Understand

How She Engages with the Patient Community

Wendy Ramsey, Active Clinical Trial Participant and Cancer Survivor

Start the New Year Armed with the Latest Approaches, Tools and Technologies for Effective Risk-Based Monitoring, Building Partnerships, Quality Assessment,

Maximizing Site Performance, Data Optimization and Engaging the Patient

REVOLUTIONIZING CLINICAL TRIALS WITH BIG DATA

Optimizing Innovation and Improving Efficiency through the Better Informed

Decision-Making Power of Big Data

Les Jordan, Director, Quintiles Technology Solutions, QUINTILES

SPONSORS & EXHIBITORS

SENIOR LEADERS PANEL DISCUSSION – CLINICAL INNOVATION Identifying the New Value Networks in Clinical Trials and Their Potential Impact on Operations

Moderator: Craig Lipset, Head of Clinical Innovation, Worldwide R&D, PFIZER

Panelists: John Barry, Head, Vendor Strategy & Management, MERCK

Jay Kaminski, Corporate Vice President, Global Clinical Research and Development Operations, CELGENE CORPORATION

John Orloff, Global Head, R&D, BAXTER BIOSCIENCES

QUALITY CULTURE IN VENDOR ENGAGEMENTS

Developing a Quality Culture that Fosters Effective Clinical Partnerships

Christopher Hilton, Vice President, Vendor Quality Management, PFIZER

Diane Ryan, Executive Director, Clinical Trial Process & Quality, PFIZER

Deirdre Hall, Vendor Quality Management & Process Lead, PFIZER

For more information visit www.crownclinical.com CLICK HERE TO LEARN MORE

Pharma Biotech & Med Device

Service Providers

Sites/Investigators

Other

63%

24%

8%

5%

C-Level and Vice President

Director

Manager

Other

26%

52%

15%

7%

Who Should Attend?This conference is designed for professionals from pharmaceutical, biotechnology and medical device companies; CROs; and other service providers involved in designing, developing, executing and managing clinical trials. Attendees’ job responsibilities include:

• Clinical Operations

• Clinical Research

• Clinical Development

• Clinical Management/Oversight

• Clinical Quality Assurance/Control

• Clinical Compliance

• Good Clinical Practice/ GCP

• Clinical Monitoring

• Clinical Data Management

• Clinical Trial Design

• Study Management/ Clinical Project Management

• Clinical Site Selection/ Contracting/ Management

• Clinical Sourcing/ Strategic Sourcing/ Vendor Management

• Patient Recruitment/ Engagement/ Enrollment

SPONSORSHIP AND EXHIBITING OPPORTUNITIES Do you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL works closely with you to customize a package that aligns with your specific thought leadership, education, business development and brand awareness goals.To learn more about these opportunities, contact Business Development Manager Andrew Ferguson at 917-258-5150 or [email protected].

AUDIENCE PROFILE COMPANY TYPE

HOTEL INFORMATION

Hyatt Regency Philadelphia at Penn’s Landing 201 South Columbus BoulevardPhiladelphia, PA 19106Phone: 1-888-421-1442 To make reservations please call 1-888-421-1442 and request the negotiated rate for ExL’s 4th CROWN 2015 Summit.. You may also use the following weblink to make reservations online: https://resweb.passkey.com/go/exlpharma2015. The group rate is available until January 6, 2015. Please book your room early as rooms available at this rate are limited.

SENIORITY

* Based on previous years' attendance

Dear Colleague, It's a critical time in clinical research as so many aspects of trials are evolving and the focus is shifting.

• Collaborative efforts to standardize processes and pool information are advancing research and streamlining development.

• Patient-centered approaches to trial design, recruitment and retention are shortening timelines and cutting costs.

• Innovative technologies are changing data collection, visualization and interpretation.

• New partnership models encourage collaboration and expedite execution.

• Risk-based approaches optimize resources and maximize data quality.

The 4th CROWN Congress attracts an elite group of clinical professionals, including many early adopters of industry changes who continue to spearhead the innovative initiatives advancing clinical research and development. Join us in January and gain a comprehensive education regarding how clinical trials evolve and the approaches your company needs to take to effectively design, develop and execute clinical trials in 2015 and beyond.

I look forward to seeing you in the New Year.

Sincerely,

Kristen Hunter CROWN Event Director, ExL Events, [email protected]

63%

24%

8%5%

26%

52%

15%

7%

C R O W N

For more information visit www.crownclinical.com For more information visit www.crownclinical.com CLICK HERE TO LEARN MORE

Agenda at a Glance

WEDNESDAY, JANUARY 28 – MAIN CONFERENCE DAY ONE7:45 Registration and Continental Breakfast for Conference Participants

8:45 Chairperson’s Welcome and State of the Industry

9:15 Senior Leaders Panel Discussion - Clinical Innovation: Identifying the New Value Networks in Clinical Trials and their Potential Impact on Operations

10:15 Networking and Refreshment Break

10:45 Revolutionizing Clinical Trials with Big Data: Optimizing Innovation and Improving Efficiency Through the Better Informed Decision-Making Power

11:30 Interactive Session: Quality Culture In Vendor Engagements

12:30 Lunch

Track A QUALITY ASSESSMENT

Track B EFFECTIVE PARTNERSHIPS

Track C RISK-BASED MONITORING

1:30 Chair Introduction Chair Introduction Chair Introduction

1:45 Case Study: Metrics Strategy Outsourcing Trends Why Risk-Based Monitoring?

2:30 Key Performance and Quality Indicators Selecting a Vendor Case Study: Restructuring Monitoring


3:45 Inspections and Audits Panel Discussion: Developing an Effective Partnership

Risk-Based Monitoring Survey Results

4:30 Clinical Quality Management Systems Building and Maintaining the Relationship Panel Discussion: Communication and Change Management

5:15 Cocktail Reception

THURSDAY, JANUARY 29 – MAIN CONFERENCE DAY TWO

Track A MAXIMIZE SITE PERFORMANCE

Track B DATA OPTIMIZATION

Track C RISK-BASED MONITORING

8:15 Chair Introduction Chair Introduction Chair Introduction

8:30 Site Selection Common Protocol Template Operational Execution

9:15 Case Study: Leveraging Technology Clinical Data Analytics Case Study: Risk-Based ManagementPlanning, Execution And Results

10:00 Networking & Refreshment Break

10:30 SITE PERSPECTIVE Transcelerate Shared Investigator Platform Mid-Sized Biotech Case Study: RBM In A Rare Disease Trial

11:15 Pilot Case Study: Group Recruitment Technology Showcase Centralized Monitoring

12:00 Lunch

1:00 The Voice Of Today’s Patient: Hear Her Story, Learn from Her Experiences and Understand How She Engages with the Patient Community

1:45 Panel Discussion: Patient Engagement: Strategic Approaches and Innovative Technologies for Engaging the Patient to Optimize and AdvanceClinical Development

2:45 Chairperson’s Concluding Remarks

3:00 Conference Concludes

TUESDAY, JANUARY 27 – WORKSHOPS7:30 Registration and Continental Breakfast for Morning Workshop Participants

8:30 Workshop A OPERATIONALIZING RISK-BASED MONITORING

Workshop B VENDOR MANAGEMENT

10:00 30-Minute Networking Break

12:00 Morning Workshops Conclude/ Lunch for Morning Workshop Participants

12:30 Registration for Afternoon Workshops

1:00 Workshop D PROACTIVE CLINICAL QUALITY MANAGEMENT

Workshop E GLOBAL TRIAL MANAGEMENT


C R O W N


TUESDAY, JANUARY 27 – WORKSHOPS

7:30 Registration and Continental Breakfast for Morning Workshop Participants

8:30WORKSHOP A

OPERATIONALIZING RISK-BASED MONITORING IN CLINICAL TRIALS

WORKSHOP B

VENDOR MANAGEMENT

Theory to Practice: Building Blocks to Support Maturing Risk Management PracticesPenny Bristow, President, CORE CLINICAL SOLUTIONS, LLC Betsy Fallen, Independent Consultant, BAFALLEN CONSULTING, LLCLinda Sullivan, Co-Founder & President, METRICS CHAMPION CONSORTIUM (MCC)

» Defining Risk-Based Monitoring for Your Organization• Systems Level: One size does not fit all

• Strategic planning and key components• Gap analysis of current monitoring systems• Cross-functional components, including vendors • Partnering and strategic alliances• Procedures: updates and new, and the importance of governance• Quality Risk Management master plans • Key risk indicators, risk assessment, and trending • Design selection and planning

• FAQs Round-Table• Project Level

• Key considerations and project prioritization• Quality risk management project plan• Mapping to project plans, e.g., monitoring plan• Project and site risk assessment• Prioritization, risk mitigation, to risk control • Evaluation and continuous improvement• Vendor and site management • New skills needed for trending and escalation; evaluation and oversight

» Case Study: Systems and Project Level QRM Application

Effective Strategies for Maximizing the Productivity of Clinical Vendors Meryl Wiernik, Principal, BIOPHARMA QA & OUTSOURCING CONSULTANTS Marisa Bower, Former Director, Global Procurement, TEVA

» Identifying the “Right” Supplier • Assessing internal requirements against supplier capabilities • Knowing what to look for in a supplier • Strategies for pre-qualifying a new supplier when working with limited resources • Assessing the risks• How important are ‘preferred suppliers’?

» Developing a Mutual Understanding• The importance of a mutual understanding and how to build it • Developing the requirements for the relationship • The pros and cons of a quality agreement and when it’s necessary • Ensuring the requirements are understood and maintaining this understanding

» Effective Oversight• Building an effective oversight plan • Executing effective oversight with limited resources • Handling and resolving issues • Developing a vendor management model • Recognizing the importance of audits




1:00WORKSHOP D

PROACTIVE CLINICAL QUALITY MANAGEMENT WORKSHOP E

GLOBAL TRIAL MANAGEMENT

Proactive Approaches for Implementing Quality by Design Principles and Executing Clinical Trials for Quality Liz Wool, CCRA, CMT, President & CEO, QD-QUALITY AND TRAINING SOLUTIONS, INC Eva DeMartin, Director, R&D Compliance Management Services, ALLERGAN

» Overview• Defining and demystifying Quality by Design (QbD) principles and methods

• How do you define quality? • Identifying and implanting quality standards • Determining and developing quality checks • Assigning roles and responsibilities • Feedback loop for continuous improvement; Designing your Knowledge Management System

» Benchmarking Current Practices • Strategies for benchmarking current trial management practices to QbD principles and

methods • Interactive exercise: What is quality for the trial and vendors? • Assessing the gaps in current practices for QbD

» Critical to Quality Factors • Identifying those ‘critical to quality’ factors that pose a risk to trial quality and human subject

protection • Defining key topics related to ‘critical to quality’• Review of industry think tank tools

• FDA-CTTI Risk Assessment Tool• TransCelerate Risk Assessment Categorization Tool (RACT) • Determining applicability to organization’s clinical trials

» Group Activities • Applying QbD to trial scenarios and risks

Effectively Managing Operations, Mitigating Risk and Overcoming Common Barriers to Success when Conducting International Trials Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, NEKTAR THERAPEUTICSDeven V. Parmar, MD, FCP, Director, Clinical Development, PROLONG PHARMACEUTICALS

» Managing Operations • Streamlining clinical processes and effectively managing global project teams• Developing an effective communication plan when working globally • Best practices for selecting sites • Translation considerations and concerns • Challenges specific to emerging regions and how to overcome them

» Mitigating Risk • Implementing risk-based study management when functioning on a global scale • Simplifying the protocol to ensure understanding and compliance • Effectively executing risk-based monitoring when working internationally

» Common Barriers to Success • Ensuring necessary infrastructure is available • Identifying oversight practices to ensure vendors and sites are compliant and effective• Cultural differences that can greatly impact trial execution and data quality


4:30 Afternoon Workshops Conclude

C R O W N

7:30 Registration and Continental Breakfast for Morning Workshop Participants

8:30WORKSHOP A

OPERATIONALIZING RISK-BASED MONITORING IN CLINICAL TRIALS

WORKSHOP B

VENDOR MANAGEMENT

Theory to Practice: Building Blocks to Support Maturing Risk Management PracticesPenny Bristow, President, CORE CLINICAL SOLUTIONS, LLC Betsy Fallen, Independent Consultant, BAFALLEN CONSULTING, LLCLinda Sullivan, Co-Founder & President, METRICS CHAMPION CONSORTIUM (MCC)

» Defining Risk-Based Monitoring for Your Organization• Systems Level: One size does not fit all

• Strategic planning and key components• Gap analysis of current monitoring systems• Cross-functional components, including vendors • Partnering and strategic alliances• Procedures: updates and new, and the importance of governance• Quality Risk Management master plans • Key risk indicators, risk assessment, and trending • Design selection and planning

• FAQs Round-Table• Project Level

• Key considerations and project prioritization• Quality risk management project plan• Mapping to project plans, e.g., monitoring plan• Project and site risk assessment• Prioritization, risk mitigation, to risk control • Evaluation and continuous improvement• Vendor and site management • New skills needed for trending and escalation; evaluation and oversight

» Case Study: Systems and Project Level QRM Application

Effective Strategies for Maximizing the Productivity of Clinical Vendors Meryl Wiernik, Principal, BIOPHARMA QA & OUTSOURCING CONSULTANTS Marisa Bower, Former Director, Global Procurement, TEVA

» Identifying the “Right” Supplier • Assessing internal requirements against supplier capabilities • Knowing what to look for in a supplier • Strategies for pre-qualifying a new supplier when working with limited resources • Assessing the risks• How important are ‘preferred suppliers’?

» Developing a Mutual Understanding• The importance of a mutual understanding and how to build it • Developing the requirements for the relationship • The pros and cons of a quality agreement and when it’s necessary • Ensuring the requirements are understood and maintaining this understanding

» Effective Oversight• Building an effective oversight plan • Executing effective oversight with limited resources • Handling and resolving issues • Developing a vendor management model • Recognizing the importance of audits




1:00WORKSHOP D

PROACTIVE CLINICAL QUALITY MANAGEMENT WORKSHOP E

GLOBAL TRIAL MANAGEMENT

Proactive Approaches for Implementing Quality by Design Principles and Executing Clinical Trials for Quality Liz Wool, CCRA, CMT, President & CEO, QD-QUALITY AND TRAINING SOLUTIONS, INC Eva DeMartin, Director, R&D Compliance Management Services, ALLERGAN

» Overview• Defining and demystifying Quality by Design (QbD) principles and methods

• How do you define quality? • Identifying and implanting quality standards • Determining and developing quality checks • Assigning roles and responsibilities • Feedback loop for continuous improvement; Designing your Knowledge Management System

» Benchmarking Current Practices • Strategies for benchmarking current trial management practices to QbD principles and

methods • Interactive exercise: What is quality for the trial and vendors? • Assessing the gaps in current practices for QbD

» Critical to Quality Factors • Identifying those ‘critical to quality’ factors that pose a risk to trial quality and human subject

protection • Defining key topics related to ‘critical to quality’• Review of industry think tank tools

• FDA-CTTI Risk Assessment Tool• TransCelerate Risk Assessment Categorization Tool (RACT) • Determining applicability to organization’s clinical trials

» Group Activities • Applying QbD to trial scenarios and risks

Effectively Managing Operations, Mitigating Risk and Overcoming Common Barriers to Success when Conducting International Trials Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, NEKTAR THERAPEUTICSDeven V. Parmar, MD, FCP, Director, Clinical Development, PROLONG PHARMACEUTICALS

» Managing Operations • Streamlining clinical processes and effectively managing global project teams• Developing an effective communication plan when working globally • Best practices for selecting sites • Translation considerations and concerns • Challenges specific to emerging regions and how to overcome them

» Mitigating Risk • Implementing risk-based study management when functioning on a global scale • Simplifying the protocol to ensure understanding and compliance • Effectively executing risk-based monitoring when working internationally

» Common Barriers to Success • Ensuring necessary infrastructure is available • Identifying oversight practices to ensure vendors and sites are compliant and effective• Cultural differences that can greatly impact trial execution and data quality


4:30 Afternoon Workshops Conclude

TUESDAY, JANUARY 27 – WORKSHOPS C R O W N


7:45 Registration and Continental Breakfast for Conference Participants

8:45 CHAIRPERSON’S WELCOME AND STATE OF THE INDUSTRY

Craig Lipset, Head of Clinical Innovation, Worldwide R&D, PFIZER

9:15 SENIOR LEADERS PANEL DISCUSSION – CLINICAL INNOVATION Identifying the New Value Networks in Clinical Trials and Their Potential Impact on Operations Moderator:Craig Lipset, Head of Clinical Innovation, Worldwide R&D, PFIZER Panelists:John Barry, Head, Vendor Strategy & Management, MERCKJay Kaminski, Corporate Vice President, Global Clinical Research and Development Operations, CELGENE CORPORATIONJohn Orloff, Global Head, R&D, BAXTER BIOSCIENCES » Open innovation: Collaborating in a non-competitive environment to advance clinical research and development » Data disclosure: How does publicly available clinical data impact the industry and trial operations? » Patient-centricity: Optimizing the engagement and involvement of the patient to improve clinical research » Social media: Strategies for harnessing and leveraging the power of social media and weighing the risks and benefits


10:45 REVOLUTIONIZING CLINICAL TRIALS WITH BIG DATA Optimizing Innovation and Improving Efficiency through the Better Informed Decision-Making Power of Big Data Les Jordan, Director, Quintiles Technology Solutions, QUINTILES » What is the big data opportunity? » Harnessing big data analytical capabilities to:

• Advance predictive modeling to identify candidates with highest probable success rates • Optimize patient identification based on genetic information • Real-time trial monitoring to increase safety and minimize risk • Maximum data transparency among all stakeholders to improve efficiency and value

» Making it happen, breaking down the silos, and the timeline for impact

11:30 INTERACTIVE SESSION: QUALITY CULTURE IN VENDOR ENGAGEMENTS Developing a Quality Culture that Fosters Effective Clinical Partnerships Christopher Hilton, Vice President, Vendor Quality Management, PFIZER Diane Ryan, Executive Director, Clinical Trial Process & Quality, PFIZER Deirdre Hall, Vendor Quality Management & Process Lead, PFIZER » Defining ‘partnership’ and initiating a cultural/behavioral shift to align expectations of all stakeholders » Examining the industry’s constantly evolving approach to vendor quality optimization » Identifying the key areas where sponsors may need more or less control » Developing an effective quality culture - technology, tools, approach, culture shift » Overview of Pfizer’s Quality Initiatives and their impact

12:30 Lunch

TRACK A

QUALITY ASSESSMENT TRACK B

EFFECTIVE PARTNERSHIPS TRACK C

RISK-BASED MONITORING

1:30 Track Chair Introduction Steven Talerico, Associate Director, Clinical QualityManagement, Inspections Lead, MERCK

Track Chair IntroductionElizabeth Shewell, Senior Director, Outsourcing, INCYTE CORPORATION

Track Chair Introduction Martin Giblin, Vice President, Global Data Management, QUINTILES

1:45 CASE STUDY: METRICS STRATEGYClinical Trial Process Quality Metrics; Aligning Strategy with ExecutionJonathan Rowe, PhD, MS, MA, Head, Quality Performance Management, PFIZER » Defining the customer and the drivers for collecting and interpreting metrics » Beyond quality what are we measuring and why? » Evaluating different levels of perspectives and value when visualizing overall performance » Developing a strategy map to understand how different operations, goals and initiatives connect and relate » Continual testing of strategies as a hypotheses to ensure effectiveness from operational, customer, value and growth perspectives

OUTSOURCING TRENDS Evaluating Outsourcing Trends and Varying Partnership Models and Assessing the Impact on Clinical R&D Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, NEKTAR THERAPEUTICS » Discussing the outsourcing landscape - past, present and future » Comparing the different types of outsourcing models and their value » Identifying new and innovative partnership models to minimize risk » The pros and cons of utilizing third parties to manage vendor relationships

WHY RISK-BASED MONITORING?Understanding the Drivers Behind the RBM Initiative and the Intended Impact Ann Meeker-O’Connell, MS, Senior Director, QA Clinical Strategy Team Lead, JANSSEN PHARMACEUTICALS, INC., former Acting Director, Division of GCP, FDA » The origins of the FDA’s risk-based initiatives » Overview of basic principles of FDA’s drive towards optimizing clinical quality through risk-based approaches » Evaluating the mission of this initiative and its intended impact on the industry » Assessing adoption of risk-based principles – gaps and opportunities

2:30 KEY PERFORMANCE AND QUALITY INDICATORS Improving Accuracy of Clinical Performance Measurement by Identifying the Metrics that Actually Drive Clinical Quality Michael J. Howley, PhD, Associate Clinical Professor, Business, LEBOW COLLEGE OF BUSINESS, DREXEL UNIVERSITY » Recognizing that not all operational measurements are linked to quality » Understanding the ‘Metrics Trap’ and why benchmarking may not the best tool for measuring performance » Learn which specific metrics actually drive quality from the results of an academic-industry collaboration study to improve measurement of clinical trial performance » Identifying which performance measurements are not significant or demonstrated a negative impact on quality

SELECTING A VENDOR Defining Vendor Selection Criteria and Conducting Effective Qualification Audits to Ensure Capability and Compatibility Bernadette Donohue, Manager, Clinical Outsourcing, MALLINCRODT » Determining what processes should be in place for selecting a CRO or other clinical service provider and assigning responsibilities » Identifying and prioritizing criteria and metrics to determine capability • Executing vendor comparisons

» Defining what elements are necessary in a partner to be compatible with your processes/systems » Best practices for conducting qualification audits and what this entails

CASE STUDY: RESTRUCTURING MONITORING Restructuring Clinical Monitoring to a Risk-Based Approach Resulting in Cost Savings and Improved QualityM. Peggy Fay, PhD, RN, CCRC, CRA, Director, Global Clinical Monitoring, MEDTRONIC, INC. » Defining the RBM approach and outlining the critical elements for success » Initiating the organizational restructuring across 10 therapeutic business units » Identifying system requirements and necessary integration capabilities » Execution roadblocks and how they were overcome » Achieving significant cost avoidance while improving quality, efficiency and response time


WEDNESDAY, JANUARY 28 – MAIN CONFERENCE DAY ONE


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C R O W N

7:45 Registration and Continental Breakfast for Conference Participants

8:45 CHAIRPERSON’S WELCOME AND STATE OF THE INDUSTRY

Craig Lipset, Head of Clinical Innovation, Worldwide R&D, PFIZER

9:15 SENIOR LEADERS PANEL DISCUSSION – CLINICAL INNOVATION Identifying the New Value Networks in Clinical Trials and Their Potential Impact on Operations Moderator:Craig Lipset, Head of Clinical Innovation, Worldwide R&D, PFIZER Panelists:John Barry, Head, Vendor Strategy & Management, MERCKJay Kaminski, Corporate Vice President, Global Clinical Research and Development Operations, CELGENE CORPORATIONJohn Orloff, Global Head, R&D, BAXTER BIOSCIENCES » Open innovation: Collaborating in a non-competitive environment to advance clinical research and development » Data disclosure: How does publicly available clinical data impact the industry and trial operations? » Patient-centricity: Optimizing the engagement and involvement of the patient to improve clinical research » Social media: Strategies for harnessing and leveraging the power of social media and weighing the risks and benefits


10:45 REVOLUTIONIZING CLINICAL TRIALS WITH BIG DATA Optimizing Innovation and Improving Efficiency through the Better Informed Decision-Making Power of Big Data Les Jordan, Director, Quintiles Technology Solutions, QUINTILES » What is the big data opportunity? » Harnessing big data analytical capabilities to:

• Advance predictive modeling to identify candidates with highest probable success rates • Optimize patient identification based on genetic information • Real-time trial monitoring to increase safety and minimize risk • Maximum data transparency among all stakeholders to improve efficiency and value

» Making it happen, breaking down the silos, and the timeline for impact

11:30 INTERACTIVE SESSION: QUALITY CULTURE IN VENDOR ENGAGEMENTS Developing a Quality Culture that Fosters Effective Clinical Partnerships Christopher Hilton, Vice President, Vendor Quality Management, PFIZER Diane Ryan, Executive Director, Clinical Trial Process & Quality, PFIZER Deirdre Hall, Vendor Quality Management & Process Lead, PFIZER » Defining ‘partnership’ and initiating a cultural/behavioral shift to align expectations of all stakeholders » Examining the industry’s constantly evolving approach to vendor quality optimization » Identifying the key areas where sponsors may need more or less control » Developing an effective quality culture - technology, tools, approach, culture shift » Overview of Pfizer’s Quality Initiatives and their impact

12:30 Lunch

TRACK A




1:30 Track Chair Introduction Steven Talerico, Associate Director, Clinical QualityManagement, Inspections Lead, MERCK

Track Chair IntroductionElizabeth Shewell, Senior Director, Outsourcing, INCYTE CORPORATION

Track Chair Introduction Martin Giblin, Vice President, Global Data Management, QUINTILES

1:45 CASE STUDY: METRICS STRATEGYClinical Trial Process Quality Metrics; Aligning Strategy with ExecutionJonathan Rowe, PhD, MS, MA, Head, Quality Performance Management, PFIZER » Defining the customer and the drivers for collecting and interpreting metrics » Beyond quality what are we measuring and why? » Evaluating different levels of perspectives and value when visualizing overall performance » Developing a strategy map to understand how different operations, goals and initiatives connect and relate » Continual testing of strategies as a hypotheses to ensure effectiveness from operational, customer, value and growth perspectives

OUTSOURCING TRENDS Evaluating Outsourcing Trends and Varying Partnership Models and Assessing the Impact on Clinical R&D Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, NEKTAR THERAPEUTICS » Discussing the outsourcing landscape - past, present and future » Comparing the different types of outsourcing models and their value » Identifying new and innovative partnership models to minimize risk » The pros and cons of utilizing third parties to manage vendor relationships

WHY RISK-BASED MONITORING?Understanding the Drivers Behind the RBM Initiative and the Intended Impact Ann Meeker-O’Connell, MS, Senior Director, QA Clinical Strategy Team Lead, JANSSEN PHARMACEUTICALS, INC., former Acting Director, Division of GCP, FDA » The origins of the FDA’s risk-based initiatives » Overview of basic principles of FDA’s drive towards optimizing clinical quality through risk-based approaches » Evaluating the mission of this initiative and its intended impact on the industry » Assessing adoption of risk-based principles – gaps and opportunities

2:30 KEY PERFORMANCE AND QUALITY INDICATORS Improving Accuracy of Clinical Performance Measurement by Identifying the Metrics that Actually Drive Clinical Quality Michael J. Howley, PhD, Associate Clinical Professor, Business, LEBOW COLLEGE OF BUSINESS, DREXEL UNIVERSITY » Recognizing that not all operational measurements are linked to quality » Understanding the ‘Metrics Trap’ and why benchmarking may not the best tool for measuring performance » Learn which specific metrics actually drive quality from the results of an academic-industry collaboration study to improve measurement of clinical trial performance » Identifying which performance measurements are not significant or demonstrated a negative impact on quality

SELECTING A VENDOR Defining Vendor Selection Criteria and Conducting Effective Qualification Audits to Ensure Capability and Compatibility Bernadette Donohue, Manager, Clinical Outsourcing, MALLINCRODT » Determining what processes should be in place for selecting a CRO or other clinical service provider and assigning responsibilities » Identifying and prioritizing criteria and metrics to determine capability • Executing vendor comparisons

» Defining what elements are necessary in a partner to be compatible with your processes/systems » Best practices for conducting qualification audits and what this entails

CASE STUDY: RESTRUCTURING MONITORING Restructuring Clinical Monitoring to a Risk-Based Approach Resulting in Cost Savings and Improved QualityM. Peggy Fay, PhD, RN, CCRC, CRA, Director, Global Clinical Monitoring, MEDTRONIC, INC. » Defining the RBM approach and outlining the critical elements for success » Initiating the organizational restructuring across 10 therapeutic business units » Identifying system requirements and necessary integration capabilities » Execution roadblocks and how they were overcome » Achieving significant cost avoidance while improving quality, efficiency and response time



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CASE STUDY

CASE STUDY

C R O W N


TRACK A




3:45 INSPECTIONS AND AUDITSProven Strategies for Utilizing Mock Inspections and Internal Audits as Effective Tools to Assess Performance, Compliance and QualitySteven Talerico, Associate Director, Clinical Quality Management, Inspections Lead, MERCK » Effectively executing a mock inspection to gain valuable insight into potential risk areas » Best practices and lessons learned for conducting effective internal audits » Case study examples of major potential problem areas uncovered through proactive internal process examination » What to look for when assessing internal audit data and identifying common problem areas » Understanding what data is important and how to categorize it

PANEL DISCUSSION: DEVELOPING ANEFFECTIVE PARTNERSHIP Identifying the Critical Components for Building and Maintaining a Strategic Partnership Moderator:John Rafa, Executive Director, Research Services, THE AVOCA GROUPPanelists:Klaus Goodwin, Director Clinical Compliance, Process & Procedures, REGENERON Rich Polgar, Director, Global Procurement, R&D, BRISTOL-MYERS SQUIBBElizabeth Shewell, Senior Director, Outsourcing, INCYTE CORPORATION » Defining the importance of strategic partnerships » Effectively recognizing and leveraging the expertise and knowledge of your partner » Best practices for aligning business objectives and improving collaboration » Redesigning processes to optimize delegation and oversight » Strategies for maintaining a productive, trustworthy and long-term partnership

RISK-BASED MONITORING SURVEY RESULTS Results from The MCC’s Recent Survey on their Member’s Experiences with Risk-Based Monitoring Linda Sullivan, Co-Founder & President, METRICS CHAMPION CONSORTIUM (MCC) » Identifying the primary drivers for adopting risk-based monitoring » Evaluating the adoption of the six RBM approaches/ models » Utilization of central data analytic approaches and data sources » Defining what performance metrics are being used to trigger onsite monitoring visits

4:30 CLINICAL QUALITY MANAGEMENT SYSTEMSLeveraging Clinical Quality Management Systems to Accurately Assess and Manage Quality and RisksSharon Reinhard, Former Director, Clinical Operations & Compliance, iCEUTICA, INC. » Defining the purpose of a clinical quality management system » Identifying the critical elements » Effectively utilizing a quality management system to monitor organizational and study performance » Gaining internal buy-in and overcoming implementation challenges » Integrating with vendor and site processes and systems » Documenting the clinical & CQA QMS elements in your Corporate Quality Manual » Best practices and lessons learned

BUILDING AND MAINTAINING THE RELATIONSHIPContinuous Process Improvement Strategies and Transformation Within the Strategic Partnership to Optimize ValueFrances Grote, Senior Director, Clinical Operations Vendor Oversight, BIOGEN IDEC » Establishing clear expectations at the onset of the partnership » Determining appropriate levels of transparency » Utilizing key metrics to continually ensure quality expectations are met » Conducting audits to assess performance » Having a plan to address and escalate potential issues

PANEL DISCUSSION: COMMUNICATION ANDCHANGE MANAGEMENT Strategies for Initiating the Necessary Shift Towards Risk-Based Approaches and RBM Adoption Moderator:Lori Convy, RN, Associate Director, SME, Monitoring, Global CSU, SANOFIPanelists: Brooke Geibel, Associate Clinical Program Director, Clinical Development Operations and Biometrics, SHIRESusan Mullin, Associate Director, Global Clinical Operations & Strategy, BRISTOL-MYERS SQUIBBRon Taylor, Director, Clinical Trial Management, SEATTLE GENETICS » Effectively articulating the message to stakeholders and decision-makers » Best practices for gaining internal support and buy-in » Identifying the risk-management framework that needs to be in place to effectively execute RBM » How to achieve cross-functional collaboration for implementation » Managing the reaction from sites and strategies for easing the transition at the site level



PANEL

PANEL

FIRST TIME PRESENTED

C R O W N

TRACK A




3:45 INSPECTIONS AND AUDITSProven Strategies for Utilizing Mock Inspections and Internal Audits as Effective Tools to Assess Performance, Compliance and QualitySteven Talerico, Associate Director, Clinical Quality Management, Inspections Lead, MERCK » Effectively executing a mock inspection to gain valuable insight into potential risk areas » Best practices and lessons learned for conducting effective internal audits » Case study examples of major potential problem areas uncovered through proactive internal process examination » What to look for when assessing internal audit data and identifying common problem areas » Understanding what data is important and how to categorize it

PANEL DISCUSSION: DEVELOPING ANEFFECTIVE PARTNERSHIP Identifying the Critical Components for Building and Maintaining a Strategic Partnership Moderator:John Rafa, Executive Director, Research Services, THE AVOCA GROUPPanelists:Klaus Goodwin, Director Clinical Compliance, Process & Procedures, REGENERON Rich Polgar, Director, Global Procurement, R&D, BRISTOL-MYERS SQUIBBElizabeth Shewell, Senior Director, Outsourcing, INCYTE CORPORATION » Defining the importance of strategic partnerships » Effectively recognizing and leveraging the expertise and knowledge of your partner » Best practices for aligning business objectives and improving collaboration » Redesigning processes to optimize delegation and oversight » Strategies for maintaining a productive, trustworthy and long-term partnership

RISK-BASED MONITORING SURVEY RESULTS Results from The MCC’s Recent Survey on their Member’s Experiences with Risk-Based Monitoring Linda Sullivan, Co-Founder & President, METRICS CHAMPION CONSORTIUM (MCC) » Identifying the primary drivers for adopting risk-based monitoring » Evaluating the adoption of the six RBM approaches/ models » Utilization of central data analytic approaches and data sources » Defining what performance metrics are being used to trigger onsite monitoring visits

4:30 CLINICAL QUALITY MANAGEMENT SYSTEMSLeveraging Clinical Quality Management Systems to Accurately Assess and Manage Quality and RisksSharon Reinhard, Former Director, Clinical Operations & Compliance, iCEUTICA, INC. » Defining the purpose of a clinical quality management system » Identifying the critical elements » Effectively utilizing a quality management system to monitor organizational and study performance » Gaining internal buy-in and overcoming implementation challenges » Integrating with vendor and site processes and systems » Documenting the clinical & CQA QMS elements in your Corporate Quality Manual » Best practices and lessons learned

BUILDING AND MAINTAINING THE RELATIONSHIPContinuous Process Improvement Strategies and Transformation Within the Strategic Partnership to Optimize ValueFrances Grote, Senior Director, Clinical Operations Vendor Oversight, BIOGEN IDEC » Establishing clear expectations at the onset of the partnership » Determining appropriate levels of transparency » Utilizing key metrics to continually ensure quality expectations are met » Conducting audits to assess performance » Having a plan to address and escalate potential issues

PANEL DISCUSSION: COMMUNICATION ANDCHANGE MANAGEMENT Strategies for Initiating the Necessary Shift Towards Risk-Based Approaches and RBM Adoption Moderator:Lori Convy, RN, Associate Director, SME, Monitoring, Global CSU, SANOFIPanelists: Brooke Geibel, Associate Clinical Program Director, Clinical Development Operations and Biometrics, SHIRESusan Mullin, Associate Director, Global Clinical Operations & Strategy, BRISTOL-MYERS SQUIBBRon Taylor, Director, Clinical Trial Management, SEATTLE GENETICS » Effectively articulating the message to stakeholders and decision-makers » Best practices for gaining internal support and buy-in » Identifying the risk-management framework that needs to be in place to effectively execute RBM » How to achieve cross-functional collaboration for implementation » Managing the reaction from sites and strategies for easing the transition at the site level


TRACK AMAXIMIZE SITE PERFORMANCE

TRACK BDATA OPTIMIZATION

TRACK C


8:15 Track Chair Introduction Scott Rauscher, Associate Director, Global Procurement, R&D, BRISTOL-MYERS SQUIBB

Track Chair Introduction Track Chair IntroductionMartin Giblin, Vice President, Global Data Management, QUINTILES

8:30 SITE SELECTIONData-Driven Site Selection Methodologies to Effectively Assess Adequacy and Feasibility Deven V. Parmar, MD, FCP, Director, Clinical Development, PROLONG PHARMACEUTICALS » Identifying the qualities of a high-potential site » Examining the unique characteristics of the trial and translating that into site requirements to optimize enrollment and performance • Common characteristics that can act as barriers to

enrollment » Best practices for conducting site feasibility studies to determine recruitment capability » Overseeing site selection when working with a CRO

COMMON PROTOCOL TEMPLATE Developing a Common Protocol as a Platform to Streamline the Clinical Development Process Rob DiCicco, Vice President, Clinical Pharmacology Sciences and Study Operations, GLAXOSMITHKLINE » The impact of aligning protocol content with data standards: The importance of traceability » Opportunities to reuse protocol content from study planning to reporting and disclosure » Moving from documents to eProtocols: strategies to support patient, investigator, regulator and sponsor needs

OPERATIONAL EXECUTION Proven Strategies for Building an Effective Site Management and Monitoring Team to Seamlessly Execute a Risk-Based Monitoring Approach Alexandra Massoud, Director, Clinical Site Monitoring, QUINTILES » Assessing the impact of RBM on site monitoring and management practices• What changes need to be made to ensure effective execution

at the site and management level? • The impact of technology when executing RBM

» Developing a communication plan to ensure effective and compliant execution enterprise-wide » Interpreting recent regulatory and audit findings to identify and overcome potential operational obstacles » How do evolving onsite monitoring practices, as a result of RBM, translate into new required skill sets for CRAs and monitors? • Can these new required skills be learned through training?

» Case studies of best practices and lessons learned from experiences with RBM implementation

9:15 CASE STUDY: LEVERAGING TECHNOLOGYIncreasing Site Productivity and Maximizing Patient Recruitment Through the Use of Site Focused Technology Brian Mundy, ePharmaOne Product Manager, ePHARMASOLUTIONS » Implementing effective tools to streamline and optimize patient recruitment efforts » Utilizing secure document exchange to streamline site communication and oversight » Leveraging technologies to mitigate risk at the site-level » Overview of case study demonstrating 30% increase in site productivity and 25% increase in patient recruitment by leveraging technology » Evaluating the response at site-level and lessons learned

CLINICAL DATA ANALYTICS Expediting Clinical Development and Optimizing Performance through Effective Clinical, Operational and Safety Data AnalysisRick Morrison, CEO, COMPREHEND » Clinical, operational and safety data analysis leveraging latest technologies » Identifying analytic challenges and solutions when outsourcing trials to CROs » Capturing and aggregating data from systems such as: electronic data capture (EDC), clinical trial management (CTMS), electronic patient reported outcomes (ePro), electronic health records (EHR), electronic trial master files (eTMF) and various other systems » Actionable analytics from aggregated data systems that support centralized analysis, risk-based monitoring and medical review

CASE STUDY: RISK-BASED MANAGEMENTPLANNING, EXECUTION AND RESULTS Developing and Executing a Comprehensive Risk-Based Management Plan Using Targeted SDV and Evaluating the Results Maryann Livolsi, Director of R&D Quality Assurance & Compliance, SHIRE Brooke Geibel, Associate Clinical Program Director, Clinical Development Operations and Biometrics, SHIRE » Assessing the challenges of a unique study design » Evaluating study risks using data review findings » Developing a risk-based management plan that integrates risk identification and mitigation activities » Ongoing oversight strategies to ensure compliance » Analyzing audit findings, data evaluation and impact analysis of targeted SDV approach » Overview of metrics, identified trends and lessons learned from implementation » Best practices for identifying and managing issues



CASE STUDYCASE STUDY

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C R O W N

For more information visit www.crownclinical.com

TRACK A

MAXIMIZE SITE PERFORMANCETRACK B

DATA OPTIMIZATIONTRACK C


10:30 SITE PERSPECTIVE The Top 10 Things Trial Sponsors Can Do to Improve Site Performance Howard Waxman, PhD, Director of Psychiatric Research, INVESTIGATOR SITE » Common protocol design issues that cause challenges for sites

» Misconceptions by trial sponsors that can result in non-

compliance

» Easy actions that can have a significant increase on improving

site performance

TRANSCELERATE SHARED INVESTIGATORPLATFORMSpotlighting a New Industry-Wide Shared Platform Enabling Collaboration Among Investigator Sites and Sponsors to Improve Clinical Research ProductivityJacalyn Kent, Senior Director, Clinical Development Information & Optimization Services / Next Generation Development (NGD) - Trial Execution, ELI LILLY » Defining the purpose of the Shared Investigator Platform » Highlight of key features:

• Seamless user experience with a single point of access for interaction with multiple study sponsors

• Harmonized training content delivery (e.g., GCP) and certification

• Critical notifications, alerts, task lists in an integrated view across sponsors, studies

• Comprehensive site personnel and facility profile that is leveraged across participating sponsors

• Secure document exchange to facilitate communication during study planning and study conduct

» Future release roadmap – highlighting additional functionality

MID-SIZED BIOTECH CASE STUDY: RBM IN A RARE DISEASE TRIAL Developing and Executing an Effective Risk-Based Monitoring Approach with Limited Resources in a Global Oncology Trial Ron Taylor, Director, Clinical Trial Management, SEATTLE GENETICS » Evaluating the drivers and expectations when deciding to develop and implement a “home grown” risk-based monitoring approach at a mid-sized biotech » Identifying the challenges when implementing RBM for a global oncology trial » Understanding the planning and resources required for smooth execution » Execution challenges and how they were overcome » Resulting increased efficiencies and process optimization » Lessons learned and plans for future RBM implementation

11:15 PILOT CASE STUDY: GROUP RECRUITMENT Utilizing Group Recruitment as a New Strategy to Improve and Optimize Enrollment and Retention Steve Kepes, MS, Director, Center for Research and Innovation, Clinical Research, COXHEALTH » Why poor recruitment and retention continue to be a common challenge in clinical trials » Identifying process barriers that impact retention and recruitment » Defining the novel concept of group recruitment as new strategy to optimize enrollment and retention » Demonstrating how group recruitment improves integration of clinical research into clinical care, improves the informed consent process and increases patient awareness and engagement

TECHNOLOGY SHOWCASEEffective Strategies for Capturing, Leveraging and Visualizing Clinical Data Hear a series of mini-presentations showcasing the latest technologies, strategies and processes for capturing, leveraging and visualizing clinical data that optimizes quality and improves overall trial conduct.

Are Participants Taking the Study Drug?AiCure presents its advanced facial recognition and motion sensing platform to confirm medication ingestion. Understand how dosing behavior impacts the safety and efficacy data.Adam Hanina, CEO, AICURE

Discovering eClinical Insights Through a Vendor-Agnostic PlatformIn today’s fragmented eClinical ecosystem, the ability to harmonize and leverage trial data to drive decisions is a challenge facing every organization. ERT presents its cloud-based eClinical Insights platform, which provides turnkey integration with other clinical systems, and demonstrate its ability to deliver real-time insights on integrated trial data. ERT

CENTRALIZED MONITORINGEffectively Executing Remote Monitoring of Trial Activities and Data to Mitigate RiskLori Convy, RN, Associate Director, SME, Monitoring, Global CSU, SANOFI » Defining centralized or remote monitoring » Understanding the necessary technology requirements to execute centralized/remote monitoring » Evaluating various models being piloted by TransCelerate » Identifying the critical factors for success

12:00 Lunch

1:00 THE VOICE OF TODAY’S PATIENT Meet Today’s Clinical Trial Participant: Hear Her Story, Learn from Her Experiences and Understand How She Engages with the Patient Community Wendy Ramsey, Active Clinical Trial Participant and Cancer Survivor » Leveraging technology and social media to learn about the diagnosis » Building a support network as a trusted resource for guidance regarding treatment options » Experiencing clinical trials from a patient’s perspective

• Identifying barriers to participation • Simple changes that can improve the patient experience

» The value of ongoing engagement with online patient communities

1:45 PANEL DISCUSSION: PATIENT ENGAGEMENT Strategic Approaches and Innovative Technologies for Engaging the Patient to Optimize and Advance Clinical Development Moderator:Joseph Kim, Senior Advisor, Clinical Development Innovation, ELI LILLY Panelists:Lori Katz, Research Advocate, PARKINSON’S DISEASE FOUNDATION and Parkinson’s Disease PatientSidney Katz, Research Advocate, PARKINSON’S DISEASE FOUNDATION and Patient CaregiverElizabeth Mascherino, Associate Director, Patient Recruitment & Engagement, SHIRE Kelly McKee, Associate Director, Global Trial Optimization, MERCK » Evaluating the role of the patient and their impact on the development of new treatments » Engaging and partnering with patient communities to increase enrollment and retention » How to incorporate the patient’s voice into key aspects of the trial, such as trial design and site selection » Technologies to attract and engage the patient as well as enhance the experience for optimal retention (i.e. text messaging, mobile apps, payment systems, interactive devices) » Staying connected to the patients post-trial and developing a long-term partnership with the community

2:45 CHAIRPERSON’S CONCLUDING REMARKS Craig Lipset, Head of Clinical Innovation, Worldwide R&D, PFIZER



FIRST TIME PRESENTED

CASE STUDY

TECHNOLOGY SHOWCASE

C R O W N

TRACK A

MAXIMIZE SITE PERFORMANCETRACK B

DATA OPTIMIZATIONTRACK C


10:30 SITE PERSPECTIVE The Top 10 Things Trial Sponsors Can Do to Improve Site Performance Howard Waxman, PhD, Director of Psychiatric Research, INVESTIGATOR SITE » Common protocol design issues that cause challenges for sites

» Misconceptions by trial sponsors that can result in non-

compliance

» Easy actions that can have a significant increase on improving

site performance

TRANSCELERATE SHARED INVESTIGATORPLATFORMSpotlighting a New Industry-Wide Shared Platform Enabling Collaboration Among Investigator Sites and Sponsors to Improve Clinical Research ProductivityJacalyn Kent, Senior Director, Clinical Development Information & Optimization Services / Next Generation Development (NGD) - Trial Execution, ELI LILLY » Defining the purpose of the Shared Investigator Platform » Highlight of key features:

• Seamless user experience with a single point of access for interaction with multiple study sponsors

• Harmonized training content delivery (e.g., GCP) and certification

• Critical notifications, alerts, task lists in an integrated view across sponsors, studies

• Comprehensive site personnel and facility profile that is leveraged across participating sponsors

• Secure document exchange to facilitate communication during study planning and study conduct

» Future release roadmap – highlighting additional functionality

MID-SIZED BIOTECH CASE STUDY: RBM IN A RARE DISEASE TRIAL Developing and Executing an Effective Risk-Based Monitoring Approach with Limited Resources in a Global Oncology Trial Ron Taylor, Director, Clinical Trial Management, SEATTLE GENETICS » Evaluating the drivers and expectations when deciding to develop and implement a “home grown” risk-based monitoring approach at a mid-sized biotech » Identifying the challenges when implementing RBM for a global oncology trial » Understanding the planning and resources required for smooth execution » Execution challenges and how they were overcome » Resulting increased efficiencies and process optimization » Lessons learned and plans for future RBM implementation

11:15 PILOT CASE STUDY: GROUP RECRUITMENT Utilizing Group Recruitment as a New Strategy to Improve and Optimize Enrollment and Retention Steve Kepes, MS, Director, Center for Research and Innovation, Clinical Research, COXHEALTH » Why poor recruitment and retention continue to be a common challenge in clinical trials » Identifying process barriers that impact retention and recruitment » Defining the novel concept of group recruitment as new strategy to optimize enrollment and retention » Demonstrating how group recruitment improves integration of clinical research into clinical care, improves the informed consent process and increases patient awareness and engagement

TECHNOLOGY SHOWCASEEffective Strategies for Capturing, Leveraging and Visualizing Clinical Data Hear a series of mini-presentations showcasing the latest technologies, strategies and processes for capturing, leveraging and visualizing clinical data that optimizes quality and improves overall trial conduct.

Are Participants Taking the Study Drug?AiCure presents its advanced facial recognition and motion sensing platform to confirm medication ingestion. Understand how dosing behavior impacts the safety and efficacy data.Adam Hanina, CEO, AICURE

Discovering eClinical Insights Through a Vendor-Agnostic PlatformIn today’s fragmented eClinical ecosystem, the ability to harmonize and leverage trial data to drive decisions is a challenge facing every organization. ERT presents its cloud-based eClinical Insights platform, which provides turnkey integration with other clinical systems, and demonstrate its ability to deliver real-time insights on integrated trial data. ERT

CENTRALIZED MONITORINGEffectively Executing Remote Monitoring of Trial Activities and Data to Mitigate RiskLori Convy, RN, Associate Director, SME, Monitoring, Global CSU, SANOFI » Defining centralized or remote monitoring » Understanding the necessary technology requirements to execute centralized/remote monitoring » Evaluating various models being piloted by TransCelerate » Identifying the critical factors for success

12:00 Lunch

1:00 THE VOICE OF TODAY’S PATIENT Meet Today’s Clinical Trial Participant: Hear Her Story, Learn from Her Experiences and Understand How She Engages with the Patient Community Wendy Ramsey, Active Clinical Trial Participant and Cancer Survivor » Leveraging technology and social media to learn about the diagnosis » Building a support network as a trusted resource for guidance regarding treatment options » Experiencing clinical trials from a patient’s perspective

• Identifying barriers to participation • Simple changes that can improve the patient experience

» The value of ongoing engagement with online patient communities

1:45 PANEL DISCUSSION: PATIENT ENGAGEMENT Strategic Approaches and Innovative Technologies for Engaging the Patient to Optimize and Advance Clinical Development Moderator:Joseph Kim, Senior Advisor, Clinical Development Innovation, ELI LILLY Panelists:Lori Katz, Research Advocate, PARKINSON’S DISEASE FOUNDATION and Parkinson’s Disease PatientSidney Katz, Research Advocate, PARKINSON’S DISEASE FOUNDATION and Patient CaregiverElizabeth Mascherino, Associate Director, Patient Recruitment & Engagement, SHIRE Kelly McKee, Associate Director, Global Trial Optimization, MERCK » Evaluating the role of the patient and their impact on the development of new treatments » Engaging and partnering with patient communities to increase enrollment and retention » How to incorporate the patient’s voice into key aspects of the trial, such as trial design and site selection » Technologies to attract and engage the patient as well as enhance the experience for optimal retention (i.e. text messaging, mobile apps, payment systems, interactive devices) » Staying connected to the patients post-trial and developing a long-term partnership with the community

2:45 CHAIRPERSON’S CONCLUDING REMARKS Craig Lipset, Head of Clinical Innovation, Worldwide R&D, PFIZER


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The 4th Annual

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C R O W NC l inical Research & Operations Worldwide Networking

An ELITE Gathering of Clinical Decision-Makers Learn, Network and Engage on Topics Critical to the Effective Design, Development and Execution of Clinical Trials

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An ELITE Gathering of Clinical Decision-Makers Learn, Network...

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