6th Annual

C R O W NCONGRESSClinical Research & Operations Worldwide Networking

March 7-9, 2017The Westin Philadelphia | Philadelphia, PA

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

www.crownclinical.com

Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILESIMS

Conference Chair

3 Days, 3 Tracks, 4 Workshops, 30+ Sessions, 40+ Speakers

Session Themes

› Patient Engagement

› Technology Innovation

› Outsourcing Strategies

› Process Efficiency

› Risk Management

› Relationship Building

› Risk-Based Monitoring

Sponsors and Exhibitors

#crownclinical

Clinical Research & Operations Worldwide Networking (CROWN)

c

Craig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS

Ed Miseta, Chief Editor, CLINICAL LEADER

Tanya Momtahen, Vice President, Global Scientific and Clinical Procurement, SANOFI

Mitchell Katz, Ph.D., Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA

Deirdre BeVard, Vice President, Development Operations, NEKTAR THERAPEUTICS

Ratan Ratnesh, Director and Head, Clinical Outsourcing, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

Adrian McKemey, Senior Vice President and Managing Director, QUINTILESIMS

Judith K. Murphy, Ph.D., Senior Director, Head of External Partners, Clinical Development Operations, SHIRE

Adrian Otte, Vice President, Global Development Operations, AMGEN

Christine Pierre, President, SOCIETY FOR CLINICAL RESEARCH SITES (SCRS)

KEYNOTE: CLINICAL OPERATIONAL SHIFTS NAVIGATING CLINICAL TRIALS FROM THE PATIENT PERSPECTIVE

HOW TECHNOLOGY IS DRIVING PATIENT CENTRICITY

Federico A. Feldstein, J.D., Vice President, Global Head of BioResearch Quality and Compliance, THE JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON

T.J. Sharpe, Cancer Survivor, Blogger and Advocate

Nora Belcher, Executive Director, TEXAS e-HEALTH ALLIANCE

Examining How Evolving Regulations, Quality Expectations and Risk Assessments Are Driving Changes in Clinical Operations

Experiencing the Successes and Challenges of the Clinical Trial Journey Through the Eyes of the Patient

Examining Innovative Technology Trends and How They Are Driving a More Patient-Centric Trial

MODERATOR PANELISTS

PANEL: FIND THE RIGHT PARTNER AND OUTSOURCING STRATEGY Weighing Critical Factors to Determine an Appropriate Outsourcing Strategy and Identifying the Optimal Partner for Effective Execution

SENIOR LEADERS PANEL: THE CHANGING STATE OF CLINICAL RESEARCH Examining the Drivers Evolving Clinical Trials and the Resulting Impact on Operations MODERATOR PANELISTS

Association Partner

www.crownclinical.com

C R O W NCONGRESS

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

› Clinical Operations› Clinical Research› Clinical Development› Clinical Outsourcing/Vendor Selection and Management› 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/Procurement› Patient Recruitment/Engagement/Enrollment

SPONSORING AND EXHIBITING OPPORTUNITIES Do you want to spread the word about your organization’s solutions 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 Sinetar at 212-400-6237 or asinetar@exlevents.com.

Dear Colleague, What makes CROWN unique is the seniority and influence of the audience. The industry’s clinical visionaries and leaders come ready to share, engage and listen. The audience possesses the power to initiate change, so the best practices discussed are implemented and result in industrywide clinical process optimization.

Join leaders, change-makers and influencers and be part of the discussion that establishes tomorrow’s strategies for improving clinical operations. I look forward to seeing you in March.

Sincerely, Kristen Hunter Kristen Hunter, Senior Event DirectorExL Events, a Division of Questex, LLC212-400-6241 | khunter@exlevents.com

Who You Will Meet2016 Audience Breakdown

COMPANY TYPE

FUNCTION OF TRIAL SPONSOR PARTICIPANTS

SENIORITY LEVEL

● 45% Pharma, Biotech and Medical Device Companies

● 40% Service Providers

● 5% Associations/Nonprofits

● 10% Other

● 45% Clinical Operations/Process/Management

● 30% Clinical Quality/Compliance/Risk

● 25% Outsourcing/Vendor Management/Procurement

● 40% C-Levels and Vice Presidents

● 40% Directors

● 10% Managers

● 10% Other

80% of the Audience Represented Director-Level and Above

45%

30%

25%

40%

40%

10%

10%

45%

40%

5%10%

Agenda at a Glance

Tuesday, March 7 / Workshops7:45 Registration and Continental Breakfast for Morning Workshop Participants

8:30 WORKSHOP A

MAKING PATIENT CENTRICITY A REALITY TODAYWORKSHOP B

EFFECTIVE PLANNING IN CLINICAL TRIALS

12:00 Lunch for Morning Workshop Participants

12:30 Registration for Afternoon Workshop Participants

1:00 WORKSHOP C

RISK-BASED MONITORING OPTIMIZATIONWORKSHOP D

RESCUING A CLINICAL TRIAL

4:30 Workshops Conclude

Wednesday, March 8 / Main Conference Day One8:15 Registration and Continental Breakfast

9:00 CHAIRPERSON’S WELCOME AND STATE OF THE INDUSTRY

9:30 NAVIGATING CLINICAL TRIALS FROM THE PATIENT PERSPECTIVE

10:15 Networking Break

10:45 SENIOR LEADERS PANEL: THE CHANGING STATE OF CLINICAL RESEARCH

12:15 Lunch

1:00 KEYNOTE: CLINICAL OPERATIONAL SHIFTS

1:45 VISIONARY LEADERS PANEL: WHERE’S THE INNOVATION?

2:45 CHAIRPERSON’S CONCLUDING REMARKS

3:00 Conference Concludes

TRACK APATIENT AND SITE ENGAGEMENT

TRACK BOUTSOURCING STRATEGIES

TRACK CRISK-BASED MONITORING

1:15 Track Chair Introduction Track Chair Introduction Track Chair Introduction

1:30 CASE STUDY: Engaging the Patient Shifting Partner Models The State of Risk-Based Monitoring (RBM)

2:15 Patient Recruitment and Retention Optimization

Digital Outsourcing Strategy CASE STUDY: RBM at a Mid-Sized Company

3:00 Networking and Refreshment Break

3:30 Optimize Site Contract Negotiations EXTENDED PANEL DISCUSSION: Find the Right Partner and Outsourcing Strategy

RBM and the Centralized Monitoring Model

4:15 CASE STUDY: Streamline Site Start-Up RBM Analytics

5:00 Networking Reception

Thursday, March 9 / Main Conference Day TwoTRACK A

PROCESS EFFICIENCY AND INNOVATIONTRACK B

RELATIONSHIP BUILDINGTRACK C

RISK MANAGEMENT

8:15 Track Chair Introduction Track Chair Introduction Track Chair Introduction

8:30 How Technology Is Driving Patient Centricity

Vendor Performance Indicators Changing Regulations

9:15 Key Performance Indicators INTERACTIVE SESSION: The Role of CROs

Proactive Risk Management

10:00 Networking and Refreshment Break

10:30 Artificial Intelligence TECHNOLOGY SHOWCASE Quality Management Systems

11:15 CASE STUDY: Drug to Device Trials CASE STUDY: Predicting Audit Findings at Sites

12:00 Lunch

www.crownclinical.com

C R O W NCONGRESS

Why Attend CROWN?

1 Be part of a unique and intimate forum of senior-level decision-makers able to influence industry change.

2 Achieve a comprehensive education on the latest strategies, trends, tools and technologies for advancing clinical trials.

3 Make the necessary connections to position your company for success with the highest ratio of industry representatives to suppliers.

4 Leverage the knowledge of this senior-level group by engaging with an audience where more than 80% hold Director-level and above titles.

Venue The Westin Philadelphia99 South 17th Street at Liberty Place / Philadelphia, PA 19103To make reservations please call 1-888-627-8153 and request the negotiated rate for ExL’s 6th CROWN Congress. You may also make reservations online at https://www.starwoodmeeting.com/Book/exl6crown. The group rate is available until February 13, 2017. Please book your room early as rooms available at this rate are limited.*ExL Events is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, bureaus or travel companies. ExL Events is affiliated with event company Questex, LLC. In the event that an outside party contacts you for any type of hotel or travel arrangements, please disregard these solicitations and kindly email us at info@exlevents.com. ExL has not authorized these companies to contact you and we do not verify the legitimacy of the services or rates offered. Please book your guest rooms through ExL’s reserved guest room block using the details provided.

Questions? Comments? • Do you have questions or comments on the agenda?

• Is there a specific topic missing that you would like to see addressed?

• Would you like to get involved as a speaker, panelist or roundtable moderator?

Please contact Event Director Kristen Hunter at 212-400-6241 or khunter@exlevents.com. She’d be happy to discuss any of the above with you, or any other questions that you have about this program.

Testimonials “ As a writer who covers the clinical space, access to executives at pharma companies is vital to my job. The quality of the topics and speakers at the CROWN Congress makes this a must-attend event for me. The networking that takes place here is very valuable.”

—Ed Miseta, Chief Editor, Clinical Leader

“ We enjoyed the CROWN Congress very much and gathered lots of new contacts and education. We will definitely join you again next year!”

—Sales Leader, Gray Consulting

“ Usually I’m bored at conferences and don’t learn anything new, but almost every session provided me with new knowledge!”

—Principal, Biopharma QA and Outsourcing Consultants

“ Congratulations on a wonderful congress, the intimate and still vibrant atmosphere was great.”—Director, Clinical Compliance, Process and

Procedures, Regeneron Pharmaceuticals, Inc.

“ I enjoyed the conference very much and look forward to future ones.”—Quality Assurance, Dr. Reddy’s Laboratories

Tuesday, March 7 / Workshops

7:45 Registration and Continental Breakfast for Morning Workshop Participants

8:30 WORKSHOP AMAKING PATIENT CENTRICITY A REALITY TODAY

WORKSHOP BEFFECTIVE PLANNING IN CLINICAL TRIALS

Embracing the Empowered Patient to Optimize Clinical Trial OperationsDennis Salotti, M.S., MBA, CCRA, Vice President, Operations, THE AVOCA GROUPLakshmi Sundar, Vice President, Strategy and Development, THE AVOCA GROUPCaryn Laermer, Associate Director, AVOCA QUALITY CONSORTIUM• Defining patient centricity within the context of healthcare and research

and where they intersect - Discussing what patient centricity means to you and how you define it - Examining Avoca patient data and other resources to understand the

voice of the patient • Assessing the impact of the empowered patient on trial sponsors, CROs

and sites, and their relationship with each other - Evaluating industry research outlining the CRO versus sponsor

perspectives on innovation and patient centricity - Establishing strategies for involving the CRO in patient engagement

and the design of patient-centric trials• Engaging the patient to improve quality and outcomes

- Sharing Avoca’s Quality Consortium’s efforts around developing strategies for patient engagement

- Analyzing viable strategies for soliciting feedback from the patient and incorporating patient feedback into trial designs

• Measuring the ROI of a patient-centric approach to clinical trial development and execution- Understanding return on investment (ROI) versus return on engagement (ROE)

- Studying a collection of ROI and ROE measures and strategies to identify how they can be captured

Optimizing Your Resource Allocation, Site Selection and Risk Mitigation Strategy Utilizing Decision Science Methodology Vladimir Shnaydman, President, ORBEE CONSULTING• Optimizing resource allocation, outsourcing strategy and scheduling

for a clinical trials portfolio with limited manpower and budget for trial sponsors and CROs- Effectively allocating money and manpower across clinical trials,

employee roles and cost centers/business groups- Scheduling for new trials to minimize delays in starting- Maximizing resource utilization - Optimizing outsourcing strategy, hiring trend and budgeting

projections- Identifying and analyzing resource bottlenecks - Developing effective contingency planning

• Selecting sites of the highest value - Assigning a qualitative site value based on multiple attributes- Maximizing the value of your portfolio of selected sites- Aligning site selection with your budget, enrollment target, site

capacity and trial power • Considering risk in clinical trials planning: identification, assessment

and mitigation - Determining potential risks- Conducting risk assessment- Assessing risk mitigation options and mitigation costs - Cultivating a risk mitigation strategy under limited contingency

resources

12:00 Lunch for Morning Workshop Participants

12:30 Registration for Afternoon Workshop Participants

1:00 WORKSHOP C RISK-BASED MONITORING OPTIMIZATION

WORKSHOP D RESCUING A CLINICAL TRIAL

Driving Quality in Clinical Operations by Identifying and Mitigating Clinical Risk Through a Continuous Quality Improvement ApproachArti Bajpai, President, COMPLIANCE AND QUALITY INTEGRATION (CQI) CONSULTING• Examining the regulatory drivers to adopt an effective risk-based

monitoring strategy • Comparing how different companies are defining and assessing risks in

clinical research - Determining how risk is defined, when to assess risk and how to

mitigate identified risks• Effectively assessing risk at the protocol stage

- Walking through a sample protocol to discuss weaknesses and possible risk areas

• Developing an effective mitigation plan through risk-based monitoring to minimize current and future risks - Defining what makes an effective mitigation plan and how that

translates into a risk-based monitoring strategy • Recognizing clinical risk management as a collective responsibility

and working across teams to effectively execute for continuous improvement - Outlining who is responsible for developing, executing and overseeing

the risk mitigation and risk-based monitoring plan - Reviewing how lessons learned from one trial should impact future

projects to proactively mitigate risk for a continuous improvement approach

Repositioning a Trial for Success When Targets Are Not Being Met and Taking Proactive Measures to Avoid a Rescue Situation Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC.• Discussing the conditions that define a rescue situation

- Showcasing common rescue and rejuvenation scenarios- Understanding the signs, symptoms and early warning signals that

indicate a study is on the path for needing rescue• Classifying the root causes for a rescue situation

- Exploring why sites fail to enroll or perform as expected- Using diagnostic methods and processes to uncover the true

root causes- Avoiding the temptation to treat symptoms when everyone is in

panic mode• Establishing rescue and rejuvenation actions and priorities

- Identifying interventions and the importance of creative thinking- Analyzing which actions are most likely to have an impact

• Walking through case examples of rescue situations step-by-step and defining an action plan to get back on track

• Taking proactive measures and performing preventative maintenance - Measuring the “right” things: Having clearly defined key performance indicators (KPIs) to assess the progress of the study

- Recognizing why upfront investments are critical in site and CRO relationship management

- Rethinking the role, value, purpose and types of communication plans to avoid rescue

4:30 Workshops Conclude

C R O W NCONGRESS

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Wednesday, March 8 / Main Conference Day One

www.crownclinical.com

Sponsors and Exhibitors

Stay Connected

8:15 Registration and Continental Breakfast

9:00 CHAIRPERSON’S WELCOME AND STATE OF THE INDUSTRY Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILESIMS

9:30 NAVIGATING CLINICAL TRIALS FROM THE PATIENT PERSPECTIVE Experiencing the Successes and Challenges of the Clinical Trial Journey Through the Eyes of the Patient

T.J. Sharpe, Cancer Survivor, Blogger and Advocate• Describing the background, the story and the diagnosis • Analyzing the suggested treatment plan and finding other options • Understanding clinical trials from the patient’s perspective

› Identifying the challenges, difficulties and inefficiencies in clinical trials from a patient’s perspective and addressing what can be done to improve the process

• Documenting and sharing this experience with other patients, including lessons learned • Changing the clinical trials process to be more patient-centric by being an advocate

10:15 Networking Break

10:45 SENIOR LEADERS PANEL: THE CHANGING STATE OF CLINICAL RESEARCH Examining the Drivers Evolving Clinical Trials and the Resulting Impact on Operations

Moderator: Ed Miseta, Chief Editor, CLINICAL LEADERPanelists: Deirdre BeVard, Vice President, Development Operations, NEKTAR THERAPEUTICS Mitchell Katz, Ph.D., Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA Adrian McKemey, Senior Vice President and Managing Director, QUINTILESIMS Adrian Otte, Vice President, Global Development Operations, AMGEN Christine Pierre, President, SOCIETY FOR CLINICAL RESEARCH SITES (SCRS)• Determining the most critical regulation shifts and how clinical operations need to change to remain compliant • Evaluating shifts in outsourcing models and what this means for clinical operations • Examining increasingly complex protocols and the resulting impact on trial timelines, budgets and overall success • Defining “The Empowered Patient” and how this concept is revolutionizing clinical research and trial operations • Predicting which clinical technologies will innovate clinical trials and drive the most change

12:15 Lunch#crownclinical

Clinical Research & Operations Worldwide Networking (CROWN)

C R O W NCONGRESSWednesday, March 8 / Main Conference Day One

TRACK APATIENT AND SITE ENGAGEMENT

TRACK BOUTSOURCING STRATEGIES

TRACK CRISK-BASED MONITORING

1:15 TRACK CHAIR INTRODUCTION Arti Bajpai, President, COMPLIANCE AND QUALITY INTEGRATION (CQI) CONSULTING

TRACK CHAIR INTRODUCTION Mitchell Katz, Ph.D., Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA

TRACK CHAIR INTRODUCTION David Hilfiker, Senior Director, Strategic QA - Clinical Development Team Leader, JOHNSON & JOHNSON

1:30 CASE STUDY: ENGAGING THE PATIENT Leveraging Patient Input to Optimize Clinical Trial Operations Beth Zaharoff, Director, Patient Focused Drug Development, TESARO• Identifying the drivers behind developing a strategy for

increasing patient engagement • Learning from patient focus groups to understand their

likes and dislikes, as well as the perceived pros and cons of their trial participation experiences

• Discussing what patients wish they had known at a trial’s onset

• Outlining the resulting clinical operational changes based on patient feedback

• Bringing the patient voice to protocol development • Facilitating better communication with advocacy

groups • Making the patients feel appreciated

• Evaluating the overall improvements from these changes

SHIFTING PARTNER MODELS Moving Away from Strategic Alliances and Bringing Previously Outsourced Work Back Internally to Ensure Data Integrity and Compliance Mitchell Katz, Ph.D., Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA • Identifying the drivers to move away from the strategic

alliance partnership model• Determining what is and has been lacking in the

strategic alliance partnership model • Shifting work back within internal processes and

systems from those of the selected alliance partners• Identifying what efficiencies are hoped to be gained

by bringing work back internally • Assessing and overcoming the challenges of

transitioning partnership models • Reviewing lessons learned and advice on how to choose

a partnership model

THE STATE OF RISK-BASED MONITORING Analyzing the Results from Trials that Utilized Risk-Based Monitoring (RBM) to Assess the ImpactMartin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILESIMS • Gauging the impact of RBM on different phases of

clinical trials as well as therapeutic areas • Assessing the change in trial quality, patient safety and

costs as a result of RBM implementation • Determining if trends are being identified earlier to

mitigate overall risk• Exploring situations when RBM is not being utilized• Comparing the industry’s utility and perspective of RBM

today versus five years ago• Exploring whether RBM is the new standard or the

default, and whether the industry is confident RBM can improve outcomes

2:15 PATIENT RECRUITMENT AND RETENTION OPTIMIZATION Leveraging Ambulant Care Services In Support of Clinical Trials to Significantly Increase Patient Recruitment and Retention Rates Gail Adinamis, Founder and CEO, GLOBALCARE CLINICAL TRIALS • Listening to the frustrations from patients and offering

home or alternate-site services to make participation in clinical trials easier and more convenient

• Understanding how ambulant care services work in the clinical trial setting and the benefits to recruitment, retention and data quality

• Examining case study results demonstrating significant increases in recruitment and retention rates as well as rescuing trials from failure

DIGITAL OUTSOURCING STRATEGY Customizing a Strategy for Implementing Digital Solutions to Optimize Clinical Operations Effectiveness Frances Grote, Director and Practice Lead, Clinical Sourcing Advisory Services, ISGJon Lightman, Partner and Practice Lead, Life Sciences, ISG• Finding the right-sized digital solution to best fit your

needs by examining different digital operating models and evaluating their benefits

• Engaging internal stakeholders to clearly determine digital solution needs, avoid redundant efforts and optimize opportunities

• Choosing the right strategy to integrate digital solutions into clinical operations and achieve process efficiency

• Building an effective business case to ensure leadership buy-in, predict costs, evaluate the impact on internal resources, and ensure delivery on time and on budget

CASE STUDY: RISK-BASED MONITORING AT A MID-SIZED COMPANYImplementing Risk-Based Monitoring at a Mid-Sized Company in Collaboration with CRO PartnersJustin Stark, Head/Director, Risk Based Monitoring and Standards, UCB• Evaluating the implications of the recent ICH E6 GCP

revisions• Walking through the implementation of a risk-based

monitoring approach in collaboration with CRO partners• Developing the road map for implementation• Analyzing lessons learned and opportunities for

improvement

3:00 Networking and Refreshment Break

CASE STUDY

Clinical Research & Operations Worldwide Networking (CROWN)

CASE STUDY

C R O W NCONGRESS

www.crownclinical.com

EXTENDED PANEL DISCUSSION

3:30 OPTIMIZE SITE CONTRACT NEGOTIATIONSAccelerating and Streamlining Site Contract Negotiations Through Common Language Evaluation and Reconciliation (CLEAR) Contract Clauses for Clinical ResearchChristine Pierre, President, SOCIETY FOR CLINICAL RESEARCH SITES (SCRS)• Understanding patients as the drivers for CLEAR • Executing effective collaboration between SCRS,

TransCelerate and ACRO • Examining the objectives of CLEAR and how they are

accomplished• Accelerating site initiations • Expediting recruitment timelines • Reducing study start-up costs • Improving productivity • Getting new treatments to patients faster without

sacrificing quality

EXTENDED PANEL DISCUSSION: FIND THE RIGHT PARTNER AND OUTSOURCING STRATEGYWeighing Critical Factors to Determine an Appropriate Outsourcing Strategy and Identifying the Optimal Partner for Effective Execution Moderator: Craig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS Panelists:Tanya Momtahen, Vice President, Global Scientific and Clinical Procurement, SANOFI Judith K. Murphy, Ph.D., Senior Director, Head of External Partners, Clinical Development Operations, SHIRE Ratan Ratnesh, Director and Head, Clinical Outsourcing, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC. • Outlining the different types of outsourcing models • Assessing the ideal criteria for each of the different

outsourcing models • Identifying the critical factors that should influence

your outsourcing strategy decision • Determining when the outsourcing model should be

selected • Evaluating the different partner options once an

appropriate outsourcing model has been selected • Defining the “right” partner and developing effective

selection criteria • Discussing common issues and barriers to success

while maintaining an effective outsourcing strategy

RBM AND THE CENTRALIZED MONITORING MODELMapping Out and Executing a Centralized Monitoring Approach to Optimize Operational Quality and EfficiencySteve Young, Senior Vice President, US Operations, CLUEPOINTS• Defining the benefits of a centralized monitoring

approach on a large and small scale • Understanding the technology and methods needed to

ensure effective centralized monitoring • Mapping out the execution plan for a seamless

transition • Identifying common implementation obstacles and

strategies for overcoming them • Examining case studies of data quality improvement and

collective risk reduction through centralized monitoring

4:15 CASE STUDY: STREAMLINE SITE START-UPLeveraging Patient Data to Optimize Enrollment and Increase the Efficiency of Site Start-UpKimberly Ray, Vice President, Site and Patient Networks, QUINTILESIMS• Exploring the inefficiencies of the current study start-up

and enrollment processes• Outlining the process efficiencies gained by enabling

site start-up to be activated after the patients have been identified

• Leveraging informatics-based technology to pre-identify patients who meet the inclusion criteria

• Ensuring patient eligibility by mining electronic medical records to identify patient-protocol matches

• Realizing significant cost and time savings through a more effective site selection and enrollment approach

RBM ANALYTICS Leveraging Advanced RBM Analytics to Predict and Identify Sites With an Increased Probability of Events Bhargava K. Reddy, Associate Director, Advanced Analytics, UCB BIOSCIENCES, INC.• Evaluating the effectiveness of descriptive analytics

and visualizations that are presented as dashboards for RBM.

• Understanding the benefits of advanced analytics as compared to descriptive analytics in the RBM data monitoring landscape.

• Outlining a case study using advanced RBM analytics to allow for proactive risk assessment and the necessary intervention before an event occurs

• Utilizing advanced analytics to increase data integrity by ensuring a timely database lock

5:00 Networking Reception

CASE STUDY

EXTENDED PANEL DISCUSSION

Association Partner

Media Partners

36OPMTHE FULL SPECTRUM OF PRODUCT MANAGEMENT

36O Outsourcing -Pharma.com

CanBiotechR&D Outsourcing

Capital Sourcing

Competitive Intelligence

Wednesday, March 8 / Main Conference Day One

C R O W NCONGRESSThursday, March 9 / Main Conference Day Two

TRACK APROCESS EFFICIENCY AND INNOVATION

TRACK BRELATIONSHIP BUILDING

TRACK CRISK MANAGEMENT

8:15 TRACK CHAIR INTRODUCTION Lakshmi Sundar, Vice President, Strategy and Development, THE AVOCA GROUP

TRACK CHAIR INTRODUCTIONCraig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS

TRACK CHAIR INTRODUCTIONJonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Quality Performance and Risk Management, PFIZER

8:30 HOW TECHNOLOGY IS DRIVING PATIENT CENTRICITYExamining Innovative Technology Trends and How They Are Driving a More Patient-Centric Trial Nora Belcher, Executive Director, TEXAS e-HEALTH ALLIANCE• Exploring the changing role of the patient and how it is

redefining the role of technology in clinical trials • Discussing innovative technology trends and how they

are shaping clinical trials • Evaluating the patient’s role in developing, driving and

adopting technology • Interpreting the data on patient-centric technology and

what this means for future clinical trials

VENDOR PERFORMANCE INDICATORSMeasuring the Performance of Vendors Utilizing Key Predictive and Ongoing Indicators to Mitigate Risk and Maximize the Value of the Partnership Kristy Galante, MS, Director / External Alliances, Global Clinical Development Operations, JANSSEN RESEARCH & DEVELOPMENT, LLC • Identifying predictive indicators when selecting a vendor

• Establishing which key indicators effectively assess risk and capability and can predict possible performance issues

• Recognizing critical financial, business and quality factors to take into consideration

• Monitoring during study indicators to assess ongoing performance of vendors

• Identifying the indicators to measure and monitor during a study

• Executing ongoing audits of vendors to collect meaningful data to ensure compliance and performance

CHANGING REGULATIONSEvaluating the Changing Global Regulatory Environment and the Impact on Clinical Risk ManagementDoreen McGirl, North America Lead, Global Quality BusinessOperations, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.• Examining the big picture of the evolving regulatory

landscape and understanding the drivers behind these changes

• Outlining the critical elements of the ICH E6 addendum and what it means for clinical compliance

• Discussing the new EU Clinical Trial Regulation 536/2014

• Assessing the new BIMO requirements• Navigating the impact of these changing regulations

9:15 KEY PERFORMANCE INDICATORSLeveraging Programmatic Metrics to Build Operational Efficiencies in Clinical TrialsAndrea Falkoff, MBA, Vice President Operations, WORLDCARE CLINICAL• Identifying critical key performance indicators (KPIs)• Assessing when and how to apply KPIs to improve

operational and cost efficiencies • Defining common challenges when implementing KPIs

and proactive strategies to overcome them • Examining real-world examples of how KPIs have driven

change

INTERACTIVE SESSION: THE ROLE OF CROsLearning How Sponsors Actually View the Role of CROs in Clinical DevelopmentFacilitated by: Craig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS• Assessing the sponsor’s comfort level regarding

outsourcing more and more of trial operations to CROs • Identifying the top concerns when selecting a CRO • Determining at what stage in the trial is optimal to bring

on a new CRO partner • Examining how the role of CROs is changing

PROACTIVE RISK MANAGEMENT Proactively Planning for Risk Realization and Managing Response Stephen Potter, Director, Clinical Development Quality, PFIZER • Examining the relationship and progression from risk

assessment, through mitigation and potential issue management

• Determining what criteria and thresholds define risk realization and trigger issue management

• Generating an action plan to incorporate risk mitigation, risk monitoring and issue management

10:00 Networking and Refreshment Break

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INTERACTIVE SESSION

C R O W NCONGRESS

10:30 ARTIFICIAL INTELLIGENCE Discussing the Use of Artificial Intelligence (AI) in Clinical Trials to Optimize Patient Compliance and Data QualityMoe Alsumidaie, MBA, MSF, Industry Expert and Content Contributor, APPLIED CLINICAL TRIALS • Defining artificial intelligence and cognitive computing

• Accounting for the fact that patients are more honest with their phones than their doctors

• Discussing the role of AI in clinical trials through virtual health assistants

• Utilizing AI to reduce the burden on sponsors, CROs and sites

• Studying proper patient centricity, engagement and the role of AI

• Demonstrating patients’ reactions to AI through a case study on cognitive intelligence in clinical trials

TECHNOLOGY SHOWCASEEffective Strategies for Capturing, Leveraging and Visualizing Clinical Data

Improving Patient Safety and Compliance, Reducing the Cost and Complexity of Clinical Trials With encapsia™Sammie Rivera, Senior Client Services Manager, CMED• Revising the way clinical trials can be conducted with a

‘smarter’ way• Saving resources, removing work, cutting time, and

improving data quality

Leveraging Data Analytics and a Cutting-Edge CTMS to Provide Better Visibility and Collaboration Across All Trial StakeholdersDrew Bustos, Director, Strategy and Research, ERT• Examining case studies that demonstrate how sponsors

and CROs can leverage data analytics and CTMS to• Access near real-time visibility into critical study

trends • Enable proactive operations • Automate repetitive manual tasks

Exposing the Real Value of Data Through Advanced VisualizationsDimitris Agrafiotis, Ph.D., FRSC, Chief Data Officer, Head of Technology Products, COVANCE• As volumes of trial data increase exponentially, more

sophisticated methods need to be adopted to derive optimal value. The Covance Xcellerate suite employs the most advanced data visualizations on the market with a focus on the specific needs of each team involved in the trial. Using a small sample of data visualizations to illustrate, this session will provide practical insights into how big data can benefit all aspects of trial execution, enabling the study team to:

• Work more efficiently and increase patient safety• Gain insights that are hidden using conventional

models

QUALITY MANAGEMENT SYSTEMS Leveraging a Quality Management System (QMS) to Optimize Clinical Operations and Mitigate RiskGrace Crawford, Vice President, Clinical Quality and Compliance, MEDIMMUNEAlfred L. Chester, Director, Clinical Quality and Compliance, MEDIMMUNE

• Identifying what QMS means to you and within your company

• Determining whether there is a need for industry standardization regarding clinical QMS

• Implementing a top-down approach when developing a QMS

• Mitigating and troubleshooting data integrity issues and identifying common problem areas

• Utilizing the QMS to ensure quality and leveraging the QMS as a risk management tool

11:15 CASE STUDY: DRUG TO DEVICE TRIALS Executing a Cross-Functional Initiative to Establish the Infrastructure and Processes for a BioPharma Company to Successfully Execute a Device Trial Sarah Bilali, Associate Director, Clinical QA, UCB PHARMA • Understanding the complexities of device trials and

determining what expertise and processes are needed that differ from drug trials

• Building a steering committee and network across the organization to have governance and control

• Examining the operational perspective and what needs to change

• Ensuring protocol, templates and systems are appropriate and can capture and track the right information

CASE STUDY: PREDICTING AUDIT FINDINGS AT SITES Building a Proactive Model to Predict the Likelihood of Audit Findings at the Site Level Alex (Wen-Yaw) Hsieh, PStat®, CMBB, CQE, Director, Quality Performance and Risk Management, PFIZER• Identifying variables from previous site audits that

correlate to risk• Outlining what specific factors and measures

contribute to an audit finding • Building a statistical model to predict which sites will

have a critical or major audit finding• Evaluating the impact of using this model on clinical

operations and monitoring

12:00 Lunch

1:00 KEYNOTE: CLINICAL OPERATIONAL SHIFTS Examining How Evolving Regulations, Quality Expectations and Risk Assessments Are Driving Changes in Clinical Operations

Federico A. Feldstein, J.D., Vice President, Global Head of BioResearch Quality and Compliance, THE JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON• Evaluating the current regulatory environment and its impact on clinical operations and vendor relationships • Redefining clinical quality and how it continues to evolve clinical operations • Examining effective clinical risk management practices to assess performance and compliance internally and externally• Identifying the role of clinical operations to ensure compliance and mitigate risk

www.crownclinical.com

CASE STUDY

TECHNOLOGY SHOWCASE

CASE STUDY

Thursday, March 9 / Main Conference Day Two

C R O W NCONGRESS

1:45 VISIONARY LEADERS PANEL: WHERE’S THE INNOVATION? Discussing Industry Experts’ Visions for the Future of Clinical Trials and Which Innovative Solutions

Are Getting Us There Moderator:Richard Polgar, Director, Global Procurement, BRISTOL-MYERS SQUIBBPanelists:Nora Belcher, Executive Director, TEXAS E-HEALTH ALLIANCEPaulo Moreira, Vice President, Global Clinical Operations – External Innovation, EMD SERONOJonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER• Examining how clinical trials will evolve and what the trial of the future will look like

› Determining what elements of clinical trials will undergo the most change to evolve into the trial of the future • Identifying the drivers that will innovate clinical trials to bring them to this future state

› Establishing which technologies will have the most impact • Discussing current innovative initiatives that are evolving clinical

operations and optimizing research

2:45 CHAIRPERSON’S CONCLUDING REMARKS Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILESIMS

3:00 Conference Concludes

VISI

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CONFERENCE CODE: C846

6th Annual

C R O W NCONGRESSClinical Research & Operations Worldwide Networking

March 7-9, 2017The Westin Philadelphia | Philadelphia, PA

3 Days, 3 Tracks, 4 Workshops, 30+ Sessions, 40+ Speakers

www.crownclinical.com

FEATURED SPEAKERS

Paulo Moreira, EMD SERONO

Richard Polgar, BRISTOL-MYERS SQUIBB

Deirdre BeVard, NEKTAR THERAPEUTICS

Ed Miseta, CLINICAL LEADER

Federico A. Feldstein, J.D.,JANSSEN

Tanya Momtahen, SANOFI

Mitchell Katz, Ph.D., PURDUE PHARMA

Grace Crawford, MEDIMMUNE

Christine Pierre, SCRS

Jonathan Rowe, Ph.D., M.S., M.A., PFIZER

Ratan Ratnesh, OTSUKA

Adrian Otte,AMGEN

T.J. Sharpe, BLOGGER AND ADVOCATE

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

#crownclinical Clinical Research & Operations Worldwide Networking (CROWN)

Sponsors and Exhibitors

Association Partner