The 5th Annual JANUARY 26-28, 2016 | SONESTA HOTEL PHILADELPHIA CROWN C linical R esearch & O perations W orldwide N etworking 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 FEATURED SESSIONS CONGRESS 3 Days, 3 Tracks, 4 Workshops, 30+ Sessions, 50+ Speakers Paulo Moreira, Vice President, Global Clinical Operations – External Innovation, EMD SERONO SPONSORS & EXHIBITORS PANEL: NEW APPROACHES TO COMMON OUTSOURCING PROBLEMS Leveraging Cross-Organization Expertise to Form Flexible and Innovative Partnerships that Drive Operational Efficiency Moderator: Kenneth A. Getz, MBA, Chairman, CISCRP; Director of Sponsored Research, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT PATIENT PERSPECTIVE: A LIFESAVING TRIAL Understanding Today’s Patient and Their Need for Trial Information Jamie Goldfarb, Cancer Survivor and Patient Advocate CLINICAL OUTSOURCING TRENDS Examining the Changes in Outsourcing, Evaluating the Drivers and Understanding the Impact on Clinical Operations Mitchell Katz, Ph.D., Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA VISIONARY LEADERS PANEL: IDENTIFYING THE DISRUPT Exploring Innovative Approaches, Trends and Technologies That Have the Potential to Revolutionize Clinical Research Operations Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM CLINICAL INNOVATION RISK MANAGEMENT OUTSOURCING STRATEGIES OPERATIONAL METRICS RISK-BASED MONITORING RELATIONSHIP BUILDING PATIENT AND SITE ENGAGEMENT DATA OPTIMIZATION SESSION THEMES Moderator: Elizabeth Mascherino, Advisor, Clinical Innovation, ELI LILLY AND COMPANY Al Altomari, President and CEO, AGILE THERAPEUTICS, INC. Mark Travers, Global Head of Monitoring Excellence and Interim Head of North America Clinical Trial Operations, MERCK To Register Contact Adriana Murillo [email protected] or 917-258-5142
Transcript
The 5th Annual
JANUARY 26-28, 2016 | SONESTA HOTEL PHILADELPHIA
C R O W NC l inical Research & Operations Worldwide Networking
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
Paulo Moreira, Vice President, Global Clinical Operations – External Innovation, EMD SERONO
SPONSORS & EXHIBITORS
PANEL: NEW APPROACHES TO COMMON OUTSOURCING PROBLEMS Leveraging Cross-Organization Expertise to Form Flexible and Innovative Partnerships that Drive Operational Efficiency Moderator:
Kenneth A. Getz, MBA, Chairman, CISCRP; Director of Sponsored Research, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
PATIENT PERSPECTIVE: A LIFESAVING TRIALUnderstanding Today’s Patient and Their Need for Trial Information
Jamie Goldfarb, Cancer Survivor and Patient Advocate
CLINICAL OUTSOURCING TRENDS Examining the Changes in Outsourcing, Evaluating the Drivers and Understanding the Impact on Clinical Operations
Mitchell Katz, Ph.D., Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA
VISIONARY LEADERS PANEL: IDENTIFYING THE DISRUPTExploring Innovative Approaches, Trends and Technologies That Have the Potential to Revolutionize Clinical Research Operations
Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM
CLINICAL INNOVATION
RISK MANAGEMENT
OUTSOURCING STRATEGIES
OPERATIONAL METRICS
RISK-BASED MONITORING
RELATIONSHIP BUILDING
PATIENT AND SITE ENGAGEMENT
DATA OPTIMIZATION
SESSION
THEMES
Moderator: Elizabeth Mascherino, Advisor, Clinical Innovation, ELI LILLY AND COMPANY
Al Altomari, President and CEO, AGILE THERAPEUTICS, INC.
Mark Travers, Global Head of Monitoring Excellence and Interim Head of North America Clinical Trial Operations, MERCK
To Register Contact Adriana Murillo [email protected] or 917-258-5142
AUDIENCE PROFILE*
COMPANY TYPE
SENIORITY LEVEL
55% - Pharma, Biotech and Med Device Cos
30% - Service Providers
5% - Sites/Investigators
5% - Associations/Nonprofits
5% - Other
55%
30%
5%5%
5%
30% - C-Levels and Vice Presidents
45% - Directors
20% - Managers
5% - Other
30%
45%
20%
5%
75% of the Audience Represents Director-Level and Above
*Anticipated audience based on previous years.
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:
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 [email protected].
HOTEL INFORMATION
SONESTA HOTEL PHILADELPHIA1800 Market StreetPhiladelphia, PA 19103 To make reservations please call 1-800-SONESTA (766-3782) and request the negotiated rate for ExL’s 5th CROWN Summit. For more information and to book online visit http://exlevents.com/5th-crown-congress/venue/. The group rate is available until January 4, 2016. Please book your room early as rooms available at this rate are limited. *ExL Events, Inc. is not affiliated with Exhibition Housing Management (EHM)/Exhibitors Housing Services (EHS) or any third-party booking agencies, housing bureaus, or travel and events companies. 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 [email protected]. 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.
Dear Colleague,
CROWN stands for Clinical Research & Operations Worldwide Networking, and this event attracts an elite group of clinical decision-makers ready to learn, network and engage on topics critical to the effective development, execution and management of clinical trials.
What makes this event unique is the seniority and influence of the audience. The industry’s clinical visionaries and leaders come ready to share and listen. The audience possesses the power to initiate change, so the best practices discussed are implemented and result in industry-wide clinical process optimization.
Don’t miss this opportunity to learn innovative strategies for improving clinical operations before they become the industry standard.
I look forward to seeing you in January.
Sincerely,
Kristen Hunter Event Director ExL Events 212-400-6241 [email protected]
C R O W N
To Register Contact Adriana Murillo [email protected] or 917-258-5142
8:30 Phase II Oncology Case Study: Improving Patient Enrollment
Effective Oversight Strategy Case Study: Quality Risk Framework
9:15 Case Study: Evolving Patient Recruitment Case Study: Collaborative Outsourcing Approach
Quality by Design
10:00 Networking and Refreshment Break
10:30 Site and Patient Engagement Case Study: Issue Management TransCelerate’s QMS Initiative
11:15 Case Study: Optimizing Site Engagement Clinical Data and Technology Inspection Preparation
12:00 Lunch
1:00 Patient Perspective: A Lifesaving Trial
1:45 Panel: Learning Patient Engagement from Rare Disease Trials
2:45 Chairperson’s Concluding Remarks
3:00 Conference Concludes
TUESDAY, JANUARY 26 – WORKSHOPS7:45 Registration and Continental Breakfast for Morning Workshop Participants
8:30Workshop A
EVOLVING RISK INDICATORSWorkshop B
CRO OVERSIGHT
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 C ESTABLISHING AN OPERATIONAL METRICS FRAMEWORK
Workshop D STRATEGIC SITE ENGAGEMENT
2:30 30-Minute Networking Break
4:30 Afternoon Workshops Conclude
C R O W N
To Register Contact Adriana Murillo [email protected] or 917-258-5142
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S7:45 Registration and Continental Breakfast for Morning Workshop Participants
8:30 WORKSHOP A EVOLVING RISK INDICATORS
WORKSHOP B
CRO OVERSIGHT Identifying Relevant Risk Indicators for Each Stage of the Trial to Optimize Operations by Mitigating Risk Early and Cost EffectivelyCeleste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC » Recognizing the value in a set of risk indicators that changes as the trial evolves to optimize and adjust as data becomes available » Identifying, weighing and evaluating risk factors through the effective use of metrics so mitigation can be brought in early in the process, thereby reducing cost • Streamlining site start-up, monitoring and data cleaning to reduce
clinical costs » Conducting proactive risk analysis using a flexible risk indicator set as a cost-effective tool to identify risk earlier • Ensuring your platform can support changing indicators
» Identifying effective risk indicators at varying stages of trial development and execution • Utilizing the eTMF as an early risk indicator for site conduct
» Learning practical applications and electronic tools for implementing workshop principles
Creating and Implementing an Effective CRO Oversight Plan to Achieve Your Clinical Operations Goals Marlene Byard, BSN, MBA, Director, Clinical Quality and Compliance, MEDIMMUNEJanis L. Hall, MBA, COP, Senior Consultant, THE AVOCA GROUPJanice Hutt, Chief Operating Officer, THE AVOCA GROUP Caryn Laermer, MBA, Associate Director, Avoca Quality Consortium, THE AVOCA GROUP
» Defining CRO oversight • Recognizing the importance of oversight • Discussing the key industry challenges and opportunities from the
perspectives of sponsors and CROs
» Achieving effective CRO oversight • Outlining the specific elements of effective oversight • Identifying the critical questions and decisions to enable oversight • Examining the Avoca Third Party Oversight Plan and Quality
Agreement
» Implementing effective CRO oversight • Defining the leading practices for oversight implementation • Operationalizing oversight using a CRO oversight plan and quality
agreement • Incorporating effective oversight practices into daily operations
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 C
ESTABLISHING AN OPERATIONAL METRICS FRAMEWORK
WORKSHOP D STRATEGIC SITE ENGAGEMENT
Developing a Basic Metrics Framework Using Limited Resources to Assess and Track the Performance and Quality of Clinical Operations Linda Sullivan, Co-Founder and President, METRICS CHAMPION CONSORTIUM (MCC) » Identifying the critical success factors
• Defining what has to go well to achieve the desired outcome » Developing a metrics framework
• Addressing the role of metrics in clinical performance • Structuring operations to track performance and quality• Initiating a scorecard strategy to effectively visualize and evaluate the
data » Using the measurements
• Understanding the metrics and utilizing them to assess performance and quality
• Designing a metric definition template, parameters and thresholds to easily identify opportunities for improvement
• Sharing the MCC’s small to mid-sized company survey results• Comparing your company’s metrics strategy to others in the industry • Evaluating how your risk management practices compare to similarly
sized companies• Learning how smaller companies are using technology to track and
measure performance and quality • Identifying common challenges when working with limited resources
Developing and Implementing an Investigator and Site Engagement Plan to Differentiate Your Trial and Deliver Results on Time Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC. » Examining the need for a strategic site engagement plan
• Identifying drivers and understanding why a plan is necessary • Defining the purpose
» Developing the plan • Outlining the critical elements of a site engagement plan
» Executing the plan • Setting expectations and effectively managing principal investigators • Reviewing proven techniques for engaging and educating study
coordinators • Assigning roles and resources for effective execution of the plan
» Evaluating the benefits and results through real-life case studies
2:30 30-Minute Networking Break
4:30 Afternoon Workshops Conclude
WHY CROWN?
• First major clinical event of the year
• Highest ratio of industry to supplier
• Most senior-level audience
• Large enough to attract a diverse gathering of clinical decision-makers, but small enough to maintain an intimate feel ideal for quality networking and learning
• Research-based session topics on today’s critical issues
• Customizable agenda to hear only the topics relevant to you
• Fresh speaking faculty of new and relevant clinical executives spearheading industry advancements and driving innovation
“Congratulations on a wonderful congress, the intimate and still-vibrant atmosphere was great.” —Director, Clinical Compliance, Process and Procedures, REGENERON PHARMACEUTICALS, INC.
“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
TESTIMONIALS FROM OUR 2015 EVENT
“Risk-based monitoring sessions exceeded expectations. Good span of foundational discussion to [a] more advanced take with case studies.” —Clinical Monitoring, Clinical Operations, COVIDIEN/MEDTRONIC
“I enjoyed the conference very much and look forward to future ones.” —Quality Assurance, DR. REDDY’S LABORATORIES
Start the New Year Armed with the Latest Strategies, Trends, Tools and Technologies for Advancing Clinical Trials, and Make the Connections
to Position Your Company for Success in 2016 and Beyond
To Register Contact Adriana Murillo [email protected] or 917-258-5142
7:45 Registration and Continental Breakfast for Morning Workshop Participants
8:30 WORKSHOP A EVOLVING RISK INDICATORS
WORKSHOP B
CRO OVERSIGHT Identifying Relevant Risk Indicators for Each Stage of the Trial to Optimize Operations by Mitigating Risk Early and Cost EffectivelyCeleste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC » Recognizing the value in a set of risk indicators that changes as the trial evolves to optimize and adjust as data becomes available » Identifying, weighing and evaluating risk factors through the effective use of metrics so mitigation can be brought in early in the process, thereby reducing cost • Streamlining site start-up, monitoring and data cleaning to reduce
clinical costs » Conducting proactive risk analysis using a flexible risk indicator set as a cost-effective tool to identify risk earlier • Ensuring your platform can support changing indicators
» Identifying effective risk indicators at varying stages of trial development and execution • Utilizing the eTMF as an early risk indicator for site conduct
» Learning practical applications and electronic tools for implementing workshop principles
Creating and Implementing an Effective CRO Oversight Plan to Achieve Your Clinical Operations Goals Marlene Byard, BSN, MBA, Director, Clinical Quality and Compliance, MEDIMMUNEJanis L. Hall, MBA, COP, Senior Consultant, THE AVOCA GROUPJanice Hutt, Chief Operating Officer, THE AVOCA GROUP Caryn Laermer, MBA, Associate Director, Avoca Quality Consortium, THE AVOCA GROUP
» Defining CRO oversight • Recognizing the importance of oversight • Discussing the key industry challenges and opportunities from the
perspectives of sponsors and CROs
» Achieving effective CRO oversight • Outlining the specific elements of effective oversight • Identifying the critical questions and decisions to enable oversight • Examining the Avoca Third Party Oversight Plan and Quality
Agreement
» Implementing effective CRO oversight • Defining the leading practices for oversight implementation • Operationalizing oversight using a CRO oversight plan and quality
agreement • Incorporating effective oversight practices into daily operations
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 C
ESTABLISHING AN OPERATIONAL METRICS FRAMEWORK
WORKSHOP D STRATEGIC SITE ENGAGEMENT
Developing a Basic Metrics Framework Using Limited Resources to Assess and Track the Performance and Quality of Clinical Operations Linda Sullivan, Co-Founder and President, METRICS CHAMPION CONSORTIUM (MCC) » Identifying the critical success factors
• Defining what has to go well to achieve the desired outcome » Developing a metrics framework
• Addressing the role of metrics in clinical performance • Structuring operations to track performance and quality• Initiating a scorecard strategy to effectively visualize and evaluate the
data » Using the measurements
• Understanding the metrics and utilizing them to assess performance and quality
• Designing a metric definition template, parameters and thresholds to easily identify opportunities for improvement
• Sharing the MCC’s small to mid-sized company survey results• Comparing your company’s metrics strategy to others in the industry • Evaluating how your risk management practices compare to similarly
sized companies• Learning how smaller companies are using technology to track and
measure performance and quality • Identifying common challenges when working with limited resources
Developing and Implementing an Investigator and Site Engagement Plan to Differentiate Your Trial and Deliver Results on Time Beth Harper, President, CLINICAL PERFORMANCE PARTNERS, INC. » Examining the need for a strategic site engagement plan
• Identifying drivers and understanding why a plan is necessary • Defining the purpose
» Developing the plan • Outlining the critical elements of a site engagement plan
» Executing the plan • Setting expectations and effectively managing principal investigators • Reviewing proven techniques for engaging and educating study
coordinators • Assigning roles and resources for effective execution of the plan
» Evaluating the benefits and results through real-life case studies
2:30 30-Minute Networking Break
4:30 Afternoon Workshops Conclude
TUESDAY, JANUARY 26 – WORKSHOPS
“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
“I enjoyed the conference very much and look forward to future ones.” —Quality Assurance, DR. REDDY’S LABORATORIES
C R O W N
To Register Contact Adriana Murillo [email protected] or 917-258-5142
7:15 Registration and Continental Breakfast for Conference Participants
8:00 CHAIRPERSON’S WELCOME AND STATE OF THE INDUSTRY Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILES
8:30 VISIONARY LEADERS PANEL: IDENTIFYING THE DISRUPT Exploring Innovative Approaches, Trends and Technologies that Have the Potential to Revolutionize Clinical Research Operations Moderator:Elizabeth Mascherino, Advisor, Clinical Innovation, ELI LILLY AND COMPANY Panelists:Al Altomari, President and CEO, AGILE THERAPEUTICS, INC.Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM Paulo Moreira, Vice President, Global Clinical Operations – External Innovation, EMD SERONOMark Travers, Global Head of Monitoring Excellence and Interim Head of North America Clinical Trial Operations, MERCK » Assessing the impact of the shared economy on clinical research through the repurposement of research, patient sharing and innovative partnerships » Increasing clinical data transparency and accessibility as a driver for open innovation and collaboration » Recognizing the changing consumer and how the evolution of the customer influences recruitment and patient engagement » Leveraging mobile apps and online communities to help patients find trials and solicit their feedback to improve trials » Harnessing big data and how that translates to clinical research
9:30 THE VALUE IN DATA Integrating and Leveraging Data Across Trials to Transform Clinical Research Malcolm Postings, Global Chief Technology Officer (CTO), QUINTILES » Unlocking innovation and generating efficiencies through the visualization of data across all trials » Breaking down the walls and moving away from data in silos » Developing integration platforms to standardize the data and allow integration » Storing and accessing information in a centralized and efficient way to be able to manipulate and learn from the data » Examining what resources are available to learn from and building processes to achieve data integration and process optimization
10:15 Networking and Refreshment Break
10:45 CLINICAL OUTSOURCING TRENDS Examining the Changes in Outsourcing, Evaluating the Drivers and Understanding the Impact on Clinical Operations Mitchell Katz, Ph.D., Head of Clinical and Drug Safety Operations, PURDUE PHARMA » Identifying outsourcing trends and partnership models for companies of varying sizes
• Evaluating the impact of CRO consolidation » Examining how partnerships and outsourcing strategies are evolving and the drivers for this change » Discussing the impact of off-shoring on clinical operations » Predicting future changes in outsourcing and their impact on the industry
11:30 NEW APPROACHES TO COMMON OUTSOURCING PROBLEMS Leveraging Cross-Organization Expertise to Form Flexible and Innovative Partnerships that Drive Operational Efficiency Moderator: Kenneth A. Getz, MBA, Chairman, CISCRP; Director of Sponsored Research, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT Panelists:Scott Gray, Co-Founder and CEO, CLINCIERGEXin Ke, Ph.D., President, FMD K&L INC. Tracy Rockney, J.D., Co-Founder and Managing Partner, ONESOURCE REGULATORY, LLCLynn Sutton, Vice President Clinical Operations, INSEPTION GROUP, LLC Michael Swalina, Partner, PYXA SOLUTIONS, LLC » Dissecting common outsourcing problems and their root causes » Recognizing the growing gap between operational excellence and financial performance » Characterizing new and flexible open outsourcing approaches » Identifying and leveraging multi-functional expertise across organizations to operate in a services consortium
12:30 Lunch
TRACK A
OPERATIONAL METRICS TRACK B
OUTSOURCING STRATEGIES TRACK C
RISK-BASED MONITORING
1:30 Track Chair Introduction Janis L. Hall, MBA, COP, Senior Consultant, THE AVOCA GROUP
Track Chair IntroductionCraig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS
Track Chair Introduction Sina Djali, Head, Risk Management – Central Monitoring, Integrated Data Analytics and Reporting, Global Clinical Development Operations, JANSSEN R&D
1:45 CLINICAL OPERATIONS PERFORMANCEMEASUREMENT Establishing Metrics to Assess and Track Performance Ross Weaver, PharmD, MBA, Chairman, CLINICAL SCORE LLC Joshua Schoppe, MPH, CCRP, Senior Outreach Coordinator, SIDNEY KIMMEL CANCER NETWORK AT JEFFERSON » Recognizing metrics as a critical element to accelerate completion of clinical trials » Utilizing metrics as a benchmark to assess performance » Identifying unanticipated factors that slow study completion » Developing improvement strategies based on comparisons between findings and norms
IDENTIFYING THE RIGHT PARTNER Outlining the Benefits and Limitations of Different Types of Partners and Defining Vendor Selection Criteria Elizabeth I. O. Garner, MD, MPH, Chief Medical Officer, Senior Vice President, Clinical Development, AGILE THERAPEUTICS » Determining what processes should be in place for selecting a CRO or other clinical service providerDefining what elements you require in a partner to ensure compatibility with your teams, processes, and systems » Identifying and prioritizing criteria and metrics to determine capability • Executing vendor comparisons
» Comparing the benefits and limitations of partnering with larger versus smaller CROs • Examining the varying levels of flexibility and control with
CROs of different sizes
RBM RESULTS Evaluating the Results of Risk-Based Monitoring and Comparing Them to Initial Expectations Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM » Benchmarking the initial predicted outcomes and expectations for RBM » Examining the raw data on global RBM implementation and execution and its impact on the following areas:• Patient safety • Cost • Resource efficiency
» Addressing how the results align with expectations » Identifying areas for improvement and developing action plans
2:30 LEVERAGING KEY INDICATORS Identifying and Utilizing Key Performance, Risk and Quality Indicators to Maintain Data and Process Integrity and Compliance Courtney L. Bryant, Clinical Process Optimization Director, SHIRE PHARMACEUTICALS » Defining which critical key performance, quality and risk indicators to continually monitor in order to accurately assess study status » Establishing tolerance levels and trend alerts for these indicators to proactively identify any problem areas » Crafting effective strategies for visualizing and monitoring this data on an ongoing basis » Determining roles, responsibilities and management duties for tracking indicators and addressing potential problems
CREATIVE OUTSOURCING FOR SMALLERCOMPANIES Evaluating Innovative Outsourcing Strategies that Maximize Value when Working with Limited Resources Craig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS » Understanding the outsourcing challenges unique to smaller companies • Competing with large pharma for CRO resources • Dealing with limitations, such as being unable to guarantee
large projects over a long period of time » Recognizing the flexibility of small companies and their ability to continually innovate, develop and change outsourcing strategies » Executing a transactional approach for selecting vendors to simplify and streamline the process » Taking advantage of economics and leveraging the buying power of your vendor to secure cost-effective services from third parties » Developing study initiation meetings that articulate your strategy and needs » Evaluating innovative technologies and processes and deciding whether they can make a positive impact on outsourcing » Effectively balancing time, budget and quality when working at a small company
MONITORING DEFICIENCIES Outlining the Most Common Deficiencies in Monitoring Activities Identified Through Mock Inspections and Internal Audits Amer Alghabban, Vice President, GxP Quality Assurance, Compliance and Training, KARYOPHARM THERAPEUTICS, INC. » Proactively assessing monitoring effectiveness through auditing » Identifying the most common monitoring deficiencies found in the following areas:• Site monitoring• Data management• Statistics oversight• CRO management• Oversight of technical service providers
» Evaluating why these issues continue to occur and what preventive measures can be taken
3:15 Networking and Refreshment Break
WEDNESDAY, JANUARY 27 – MAIN CONFERENCE DAY ONE
SPONSORS & EXHIBITORS
Stay engaged and join our LinkedIn Group – Clinical Research & Operations
7:15 Registration and Continental Breakfast for Conference Participants
8:00 CHAIRPERSON’S WELCOME AND STATE OF THE INDUSTRY Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILES
8:30 VISIONARY LEADERS PANEL: IDENTIFYING THE DISRUPT Exploring Innovative Approaches, Trends and Technologies that Have the Potential to Revolutionize Clinical Research Operations Moderator:Elizabeth Mascherino, Advisor, Clinical Innovation, ELI LILLY AND COMPANY Panelists:Al Altomari, President and CEO, AGILE THERAPEUTICS, INC.Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM Paulo Moreira, Vice President, Global Clinical Operations – External Innovation, EMD SERONOMark Travers, Global Head of Monitoring Excellence and Interim Head of North America Clinical Trial Operations, MERCK » Assessing the impact of the shared economy on clinical research through the repurposement of research, patient sharing and innovative partnerships » Increasing clinical data transparency and accessibility as a driver for open innovation and collaboration » Recognizing the changing consumer and how the evolution of the customer influences recruitment and patient engagement » Leveraging mobile apps and online communities to help patients find trials and solicit their feedback to improve trials » Harnessing big data and how that translates to clinical research
9:30 THE VALUE IN DATA Integrating and Leveraging Data Across Trials to Transform Clinical Research Malcolm Postings, Global Chief Technology Officer (CTO), QUINTILES » Unlocking innovation and generating efficiencies through the visualization of data across all trials » Breaking down the walls and moving away from data in silos » Developing integration platforms to standardize the data and allow integration » Storing and accessing information in a centralized and efficient way to be able to manipulate and learn from the data » Examining what resources are available to learn from and building processes to achieve data integration and process optimization
10:15 Networking and Refreshment Break
10:45 CLINICAL OUTSOURCING TRENDS Examining the Changes in Outsourcing, Evaluating the Drivers and Understanding the Impact on Clinical Operations Mitchell Katz, Ph.D., Head of Clinical and Drug Safety Operations, PURDUE PHARMA » Identifying outsourcing trends and partnership models for companies of varying sizes
• Evaluating the impact of CRO consolidation » Examining how partnerships and outsourcing strategies are evolving and the drivers for this change » Discussing the impact of off-shoring on clinical operations » Predicting future changes in outsourcing and their impact on the industry
11:30 NEW APPROACHES TO COMMON OUTSOURCING PROBLEMS Leveraging Cross-Organization Expertise to Form Flexible and Innovative Partnerships that Drive Operational Efficiency Moderator: Kenneth A. Getz, MBA, Chairman, CISCRP; Director of Sponsored Research, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT Panelists:Scott Gray, Co-Founder and CEO, CLINCIERGEXin Ke, Ph.D., President, FMD K&L INC. Tracy Rockney, J.D., Co-Founder and Managing Partner, ONESOURCE REGULATORY, LLCLynn Sutton, Vice President Clinical Operations, INSEPTION GROUP, LLC Michael Swalina, Partner, PYXA SOLUTIONS, LLC » Dissecting common outsourcing problems and their root causes » Recognizing the growing gap between operational excellence and financial performance » Characterizing new and flexible open outsourcing approaches » Identifying and leveraging multi-functional expertise across organizations to operate in a services consortium
12:30 Lunch
TRACK A
OPERATIONAL METRICS TRACK B
OUTSOURCING STRATEGIES TRACK C
RISK-BASED MONITORING
1:30 Track Chair Introduction Janis L. Hall, MBA, COP, Senior Consultant, THE AVOCA GROUP
Track Chair IntroductionCraig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS
Track Chair Introduction Sina Djali, Head, Risk Management – Central Monitoring, Integrated Data Analytics and Reporting, Global Clinical Development Operations, JANSSEN R&D
1:45 CLINICAL OPERATIONS PERFORMANCEMEASUREMENT Establishing Metrics to Assess and Track Performance Ross Weaver, PharmD, MBA, Chairman, CLINICAL SCORE LLC Joshua Schoppe, MPH, CCRP, Senior Outreach Coordinator, SIDNEY KIMMEL CANCER NETWORK AT JEFFERSON » Recognizing metrics as a critical element to accelerate completion of clinical trials » Utilizing metrics as a benchmark to assess performance » Identifying unanticipated factors that slow study completion » Developing improvement strategies based on comparisons between findings and norms
IDENTIFYING THE RIGHT PARTNER Outlining the Benefits and Limitations of Different Types of Partners and Defining Vendor Selection Criteria Elizabeth I. O. Garner, MD, MPH, Chief Medical Officer, Senior Vice President, Clinical Development, AGILE THERAPEUTICS » Determining what processes should be in place for selecting a CRO or other clinical service providerDefining what elements you require in a partner to ensure compatibility with your teams, processes, and systems » Identifying and prioritizing criteria and metrics to determine capability • Executing vendor comparisons
» Comparing the benefits and limitations of partnering with larger versus smaller CROs • Examining the varying levels of flexibility and control with
CROs of different sizes
RBM RESULTS Evaluating the Results of Risk-Based Monitoring and Comparing Them to Initial Expectations Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM » Benchmarking the initial predicted outcomes and expectations for RBM » Examining the raw data on global RBM implementation and execution and its impact on the following areas:• Patient safety • Cost • Resource efficiency
» Addressing how the results align with expectations » Identifying areas for improvement and developing action plans
2:30 LEVERAGING KEY INDICATORS Identifying and Utilizing Key Performance, Risk and Quality Indicators to Maintain Data and Process Integrity and Compliance Courtney L. Bryant, Clinical Process Optimization Director, SHIRE PHARMACEUTICALS » Defining which critical key performance, quality and risk indicators to continually monitor in order to accurately assess study status » Establishing tolerance levels and trend alerts for these indicators to proactively identify any problem areas » Crafting effective strategies for visualizing and monitoring this data on an ongoing basis » Determining roles, responsibilities and management duties for tracking indicators and addressing potential problems
CREATIVE OUTSOURCING FOR SMALLERCOMPANIES Evaluating Innovative Outsourcing Strategies that Maximize Value when Working with Limited Resources Craig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS » Understanding the outsourcing challenges unique to smaller companies • Competing with large pharma for CRO resources • Dealing with limitations, such as being unable to guarantee
large projects over a long period of time » Recognizing the flexibility of small companies and their ability to continually innovate, develop and change outsourcing strategies » Executing a transactional approach for selecting vendors to simplify and streamline the process » Taking advantage of economics and leveraging the buying power of your vendor to secure cost-effective services from third parties » Developing study initiation meetings that articulate your strategy and needs » Evaluating innovative technologies and processes and deciding whether they can make a positive impact on outsourcing » Effectively balancing time, budget and quality when working at a small company
MONITORING DEFICIENCIES Outlining the Most Common Deficiencies in Monitoring Activities Identified Through Mock Inspections and Internal Audits Amer Alghabban, Vice President, GxP Quality Assurance, Compliance and Training, KARYOPHARM THERAPEUTICS, INC. » Proactively assessing monitoring effectiveness through auditing » Identifying the most common monitoring deficiencies found in the following areas:• Site monitoring• Data management• Statistics oversight• CRO management• Oversight of technical service providers
» Evaluating why these issues continue to occur and what preventive measures can be taken
3:45 PROACTIVE MANAGEMENT OF CLINICAL SITEPRODUCTIVITY Optimizing Operations and Compliance at the Site Level Through Effective Performance Monitoring Matt McKinney, Continuous Quality Expert, COMPREHEND » Examining a case study with only three CRAs and a full service CRO facing increasing protocol deviations, low enrollment levels and high site staff turnover » Utilizing key metrics to access capability and select sites for success » Collaborating with your CRO to monitor ongoing site performance by tracking critical variables • Proactively identifying protocol deviations
» Utilizing scorecards to visualize key performance metrics (enrollment, data quality and compliance) and prioritize actions » Maximizing transparency and collaboration with your extended team through centralized and risk monitoring to improve study conduct
INTERACTIVE DISCUSSION: EFFECTIVE OUTSOURCING MODELSExamining Which Outsourcing Models Are Working and How Partnerships Have and Continue to Evolve Moderator:Craig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS Panelists:John Barry, Head, Portfolio Sourcing and Relationship Management, MERCK Mitchell Katz, Ph.D., Head of Clinical and Drug Safety Operations, PURDUE PHARMA Richard Polgar, Director, Global Procurement, BRISTOL-MYERS SQUIBBRéne A. Stephens, Executive Director/Head Contracts & Outsourcing, ASTELLAS PHARMA DEVELOPMENT OPERATIONS » Assessing the one-size-fits-all outsourcing strategy versus managing a portfolio of specialized providers » Reviewing the preferred provider/partnerships model and what that offers » Defining programmatic versus functional outsourcing strategies and analyzing the pros and cons for different company types » Examining resources and other necessary criteria when determining an appropriate outsourcing strategy » Quantifying and executing an outsourcing model shift » Discussing how clinical partnerships and outsourcing have changed over the past decade » Exploring outsourcing’s continued evolution and what the model may look like 10 years from now
CENTRALIZED MONITORING Developing a Centralized Monitoring Approach to Increase Efficiency and Cut Costs Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILES » Defining centralized monitoring and the difference between remote monitoring » Evaluating the benefits of centralized monitoring » Understanding the necessary technology requirements to execute centralized monitoring » Building the approach and developing a strategy and execution plan that demonstrates long-term cost savings » Identifying common implementation obstacles and strategies for overcoming them » Examining case studies of data quality improvement and collective risk reduction through centralized monitoring
4:30 MEASURING PATIENT CENTRICITY Defining a Valid and Reliable Method for Measuring Patient Centricity to Establish a Foundation for Improvement Michael J. Howley, Ph.D., Associate Clinical Professor, Business, LEBOW COLLEGE OF BUSINESS, DREXEL UNIVERSITY » Preventing patient centricity from becoming a fad by measuring its impact » Outlining a valid and reliable three-step program to measure patient centricity by determining:• What you should measure • How you should measure it • When you should gather the measurements
» Understanding the factors that increase/decrease the patient centricity of trials • Evaluating the impact of management initiatives
» Building a foundation on which patient centricity can revolutionize clinical trials
PANEL: THE FUTURE OF MONITORING Evaluating Monitoring Trends and Assessing Their Current and Future Impact on Clinical Operations Moderator: Sina Djali, Head, Risk Management – Central Monitoring, Integrated Data Analytics and Reporting, Global Clinical Development Operations, JANSSEN R&D Panelists:Eileen M. Daniel, Executive Director, Clinical Operations, NEKTAR THERAPEUTICSKyle Given, Managing Principal, Consulting Services, MEDIDATA SOLUTIONS Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Maryann Livolsi, MSN, RN, RQAP GCP, Head of Clinical QA and Compliance Programs, R&D Quality Assurance and Compliance, SHIRE » Discussing industry adoption rates for different types of monitoring » Evaluating industry confidence in risk-based monitoring approaches and concerns for regulatory acceptance » Assessing the drivers for risk-based monitoring approaches and the intended impact on clinical operations » Recognizing changes in monitoring and sources of innovation » Highlighting industry trends that can influence monitoring approaches, such as data transparency and patient engagement » Speculating what monitoring will look like five, 10 and 20 years from now
5:15 Cocktail Reception
PANEL
EXTENDED INTERACTIVE DISCUSSION
“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
C R O W N
C R O W N
TRACK A
OPERATIONAL METRICS TRACK B
OUTSOURCING STRATEGIES TRACK C
RISK-BASED MONITORING
3:45 PROACTIVE MANAGEMENT OF CLINICAL SITEPRODUCTIVITY Optimizing Operations and Compliance at the Site Level Through Effective Performance Monitoring Matt McKinney, Continuous Quality Expert, COMPREHEND » Examining a case study with only three CRAs and a full service CRO facing increasing protocol deviations, low enrollment levels and high site staff turnover » Utilizing key metrics to access capability and select sites for success » Collaborating with your CRO to monitor ongoing site performance by tracking critical variables • Proactively identifying protocol deviations
» Utilizing scorecards to visualize key performance metrics (enrollment, data quality and compliance) and prioritize actions » Maximizing transparency and collaboration with your extended team through centralized and risk monitoring to improve study conduct
INTERACTIVE DISCUSSION: EFFECTIVE OUTSOURCING MODELSExamining Which Outsourcing Models Are Working and How Partnerships Have and Continue to Evolve Moderator:Craig Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS Panelists:John Barry, Head, Portfolio Sourcing and Relationship Management, MERCK Mitchell Katz, Ph.D., Head of Clinical and Drug Safety Operations, PURDUE PHARMA Richard Polgar, Director, Global Procurement, BRISTOL-MYERS SQUIBBRéne A. Stephens, Executive Director/Head Contracts & Outsourcing, ASTELLAS PHARMA DEVELOPMENT OPERATIONS » Assessing the one-size-fits-all outsourcing strategy versus managing a portfolio of specialized providers » Reviewing the preferred provider/partnerships model and what that offers » Defining programmatic versus functional outsourcing strategies and analyzing the pros and cons for different company types » Examining resources and other necessary criteria when determining an appropriate outsourcing strategy » Quantifying and executing an outsourcing model shift » Discussing how clinical partnerships and outsourcing have changed over the past decade » Exploring outsourcing’s continued evolution and what the model may look like 10 years from now
CENTRALIZED MONITORING Developing a Centralized Monitoring Approach to Increase Efficiency and Cut Costs Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILES » Defining centralized monitoring and the difference between remote monitoring » Evaluating the benefits of centralized monitoring » Understanding the necessary technology requirements to execute centralized monitoring » Building the approach and developing a strategy and execution plan that demonstrates long-term cost savings » Identifying common implementation obstacles and strategies for overcoming them » Examining case studies of data quality improvement and collective risk reduction through centralized monitoring
4:30 MEASURING PATIENT CENTRICITY Defining a Valid and Reliable Method for Measuring Patient Centricity to Establish a Foundation for Improvement Michael J. Howley, Ph.D., Associate Clinical Professor, Business, LEBOW COLLEGE OF BUSINESS, DREXEL UNIVERSITY » Preventing patient centricity from becoming a fad by measuring its impact » Outlining a valid and reliable three-step program to measure patient centricity by determining:• What you should measure • How you should measure it • When you should gather the measurements
» Understanding the factors that increase/decrease the patient centricity of trials • Evaluating the impact of management initiatives
» Building a foundation on which patient centricity can revolutionize clinical trials
PANEL: THE FUTURE OF MONITORING Evaluating Monitoring Trends and Assessing Their Current and Future Impact on Clinical Operations Moderator: Sina Djali, Head, Risk Management – Central Monitoring, Integrated Data Analytics and Reporting, Global Clinical Development Operations, JANSSEN R&D Panelists:Eileen M. Daniel, Executive Director, Clinical Operations, NEKTAR THERAPEUTICSKyle Given, Managing Principal, Consulting Services, MEDIDATA SOLUTIONS Celeste M. Gonzalez, B.S., CVT, RQAP-GCP, CCRP, Principal Specialist, Clinical Quality Assurance, BOSTON SCIENTIFIC Maryann Livolsi, MSN, RN, RQAP GCP, Head of Clinical QA and Compliance Programs, R&D Quality Assurance and Compliance, SHIRE » Discussing industry adoption rates for different types of monitoring » Evaluating industry confidence in risk-based monitoring approaches and concerns for regulatory acceptance » Assessing the drivers for risk-based monitoring approaches and the intended impact on clinical operations » Recognizing changes in monitoring and sources of innovation » Highlighting industry trends that can influence monitoring approaches, such as data transparency and patient engagement » Speculating what monitoring will look like five, 10 and 20 years from now
THURSDAY, JANUARY 28 – MAIN CONFERENCE DAY TWOTRACK A
PATIENT AND SITE ENGAGEMENT TRACK B
RELATIONSHIP BUILDING TRACK C
RISK MANAGEMENT
8:15 Track Chair Introduction Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM
Track Chair IntroductionAnn Meeker-O’Connell, Head, Risk Management and External Engagement, BioResearch Quality and Compliance, JOHNSON & JOHNSON
8:30 PHASE II ONCOLOGY CASE STUDY: IMPROVINGPATIENT ENROLLMENT Evaluating the Patient’s Journey to Maximize Interaction and Optimize the Trial Experience Molly Rosano, Vice President, Clinical Development Operations, MOMENTA PHARMACEUTICALS » Establishing the need for and importance of taking ownership of patient and site engagement • Increasing the quality of the engagement through direct
interaction from the sponsor, not through a CRO » Breaking down the patient pathway to identify what influences and drives direction, and finding places to increase interaction • Determining how patients validate the information they’ve
received from their physicians• Intervening in the appropriate places along this pathway in
order to optimize awareness of trial options » Engaging with the trial participants, providing support to the patients and caregivers, and making sure they understand the value they provide to the trial » Ensuring sites have the proper training and knowledge to provide the best care and support » Gauging the resulting increase in enrollment and retention as a result of these efforts
EFFECTIVE OVERSIGHT STRATEGY Developing Effective Strategies for Overseeing and Managing the Quality of Clinical Vendors to Ensure Performance and Mitigate Risk Frances Grote, Practice Director, Clinical Sourcing Advisory Services, ISG » Aligning quality, timeliness and delivery expectations among all stakeholders » Identifying the key elements of an effective oversight plan » Defining the key elements of a sourcing agreement » Crafting strategies and tools for effectively assessing ongoing performance and compliance » Recognizing the importance of transparency and communication
CASE STUDY: QUALITY RISK FRAMEWORK Structuring a Risk-Based Framework for Your Clinical Operations to Proactively Identify and Mitigate Risk Deborah A. Guattery, MJ, BSN, RN, Quality Systems and CAPA Manager, CSL BEHRING Sheri Kuss, Associate Director, Clinical Process Development, TEVA PHARMACEUTICALS » Applying quality by design and risk assessment approaches to a new study and developing a comprehensive risk management plan » Exploring critical to quality elements and performing risk assessments at the protocol development stage with all key stakeholders » Prioritizing risks and identifying key mitigation strategies » Assessing compliance management of identified risks » Monitoring key risk indicators during the conduct of the trial
9:15 CASE STUDY: EVOLVING PATIENT RECRUITMENTExamining the Patient Recruitment Evolution from Paid Media to Earned PlacementElizabeth Mascherino, Advisor, Clinical Innovation, ELI LILLY AND COMPANY » Recognizing the need to evolve patient recruitment tactics » Defining earned and paid media approaches » Developing strategies to promote earned media » Assessing the potential impact of earned placement on our recruitment campaigns » Evaluating the results from these new recruitment tactics
CASE STUDY: COLLABORATIVE OUTSOURCINGAPPROACH Aligning Business Units and Stakeholders to Optimize Supplier Communication and Strategy Richard Polgar, Director, Global Procurement, BRISTOL-MYERS SQUIBB » Examining the drivers behind this internal initiative to align business units and stakeholders » Engaging all stakeholders in an effective way to ensure strategies and communication with suppliers are aligned » Creating a dialogue and forum for change through governance meetings » Realizing a strong and aligned team provides better communication with suppliers, streamlines operations and eliminates redundancies
QUALITY BY DESIGN Utilizing Protocol Design to Facilitate Quality Oversight and Optimize ComplianceDonna Edgerton, Head, Quality Assurance, ONCOGENEX PHARMACEUTICALS » Recognizing the protocol as the primary tool to facilitate and support quality conduct of the trial » Examining elements of the protocol design that can improve or detract from compliance• Assessing the protocol feasibility • Determining the clarity and complexity
» Optimizing site education and compliance through a well-designed protocol » Strategies for reducing the number of amendments » Effectively communicating the importance of protocol design internally to influence change, improve the process and optimize clinical quality
10:00 Networking and Refreshment Break
5:15 Cocktail Reception
CASE STUDY
CASE STUDYCASE STUDY
CASE STUDY
C R O W N
To Register Contact Adriana Murillo [email protected] or 917-258-5142
TRACK APATIENT AND SITE ENGAGEMENT
TRACK B
RELATIONSHIP BUILDING TRACK C
RISK MANAGEMENT
10:30 SITE AND PATIENT ENGAGEMENT Facilitating Engagement with Sites and Patients to Build Relationships that Optimize Clinical TrialsKim Ray, Vice President, Site & Patient Network, QUINTILES » Developing a Clinical Site Engagement Team to advise and provide study teams proactive support to set trials up for success » Executing a team approach to identify and train the right sites the first time and evaluating the resulting impact on recruitment » Facilitating ongoing and meaningful site communications to improve operations, recruitment and retention, and site satisfaction » Demonstrating the positive impact on timelines, costs and enrollment by being a better partner to sites
CASE STUDY: ISSUE MANAGEMENT Establishing an Effective Strategy to Identify, Communicate, Escalate and Resolve Issues that Engage All Stakeholders Cathy Dawson, Director, Clinical Affairs, AESCULAP » Evaluating the importance of transparency in an productive relationship » Defining the critical elements of an effective escalation plan » Developing a communication strategy that informs and engages all necessary stakeholders when an issue is identified » Discussing complications that arise when a CRO applies drug study processes to a device study » Executing the steps to resolve issues quickly and putting processes in place to prevent future occurrences
TRANSCELERATE’S QMS INITIATIVE Developing the Framework for a Clinical Quality Management System to Accurately Assess and Manage Risk Susan Callery D’Amico, Vice President, R&D Quality Assurance, ABBVIE Deb Driscoll, Vice President, Quality Assurance, MERCK » Recognizing the need for a streamlined and proactive guidance that provides the framework for an effective clinical quality management system (QMS) » Developing guidelines that can be customized to fit any organization’s unique circumstances and accommodate variability » Defining the purpose of TransCelerate’s QMS initiative » Identifying the critical elements of a QMS » Effectively utilizing a quality management system to monitor organizational and study performance » Integrating the QMS with vendor and site processes and systems
11:15 CASE STUDY: OPTIMIZING SITE ENGAGEMENT Streamlining Study Activation and Recruitment, Enhancing Clinical Trial Quality and Improving Site Satisfaction through Effective Engagement Bonnie Vlahos, MBA, BSN, RN, Senior Director, Enbrel Program Clinical Lead, GIPB – Clinical Sciences, PFIZER, INC. » Developing a Clinical Site Engagement Team to advise and provide study teams proactive support to set trials up for success » Executing a team approach to identify and train the right sites the first time and evaluating the resulting impact on recruitment » Facilitating ongoing and meaningful site communications to improve operations, recruitment and retention, and site satisfaction » Demonstrating the positive impact on timelines, costs and enrollment by being a better partner to sites
CLINICAL DATA AND TECHNOLOGY Effective Strategies for Capturing, Leveraging and Visualizing Clinical DataKyle Given, Managing Principal, Consulting Services, MEDIDATA SOLUTIONS » - Applying advanced data analytics as the industry embraces disruptive technologies » - Examining the latest technologies, strategies and processes for capturing, leveraging and visualizing clinical data to optimize quality and improve overall trial conduct » - Utilizing objective standardization & industry benchmarks to unlock your data, benchmark it against industry peers, and turn it into actionable insights you can act on » - Describing two specific areas where companies are leveraging data analytics to optimize quality, cost and cycle times within their clinical portfolio; at the study level and at the organizational level
INSPECTION PREPARATIONAdapting Inspection Readiness Procedures when Executing Risk-Based Monitoring and Other Risk Management Approaches Steven Talerico, Associate Director, SRPM, Global Inspections Lead, Global Clinical Trial Operations, MERCK » Shifting from full SDV to RBM and the impact on inspection readiness » Redefining inspection readiness with risk-based operations » Ensuring effective communication regarding risk-based monitoring and audit expectations » Analyzing what the inspector is looking for and common findings
12:00 Lunch
1:00 PATIENT PERSPECTIVE: A LIFESAVING TRIAL Understanding Today’s Patient and Their Need for Trial InformationJamie Goldfarb, Cancer Survivor and Patient Advocate » Receiving a Stage IV melanoma diagnosis as a new mom » Determining the “right” treatment pathway » Participating in a lifesaving clinical trial, blogging the experience and becoming a patient advocate » Understanding information gaps and patient needs » Recognizing the importance of engaging with potential trial participants directly
1:45 PANEL: LEARNING PATIENT ENGAGEMENT FROM RARE DISEASE TRIALS Adopting Scalable Best Practices to Effectively Identify, Engage and Retain Patients from Rare Disease Trials Moderator:Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM Panelists:Donna Appell, RN, Founder and President, HERMANSKY-PUDLAK SYNDROME NETWORK INC. Jayne C. Gershkowitz, Senior Vice President and Chief Patient Advocate, AMICUS THERAPEUTICS Molly Rosano, Vice President, Clinical Development Operations, MOMENTA PHARMACEUTICALS » Assessing the growing role of patient advocacy groups and how to effectively engage and partner with them » Examining novel site and patient communication tools and their impact on recruitment and patient satisfaction » Creating the complete patient experience through home healthcare options, travel arrangements and service centers » Evaluating the impact of effective patient engagement on clinical trial operations
2:45 CHAIRPERSON’S CONCLUDING REMARKS Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILES
3:00 Conference Concludes
THURSDAY, JANUARY 28 – MAIN CONFERENCE DAY TWO
CASE STUDY
CLINICAL DATA AND TECHNOLOGY CASE STUDYCASE STUDY
C R O W N
To Register Contact Adriana Murillo [email protected] or 917-258-5142
TRACK APATIENT AND SITE ENGAGEMENT
TRACK B
RELATIONSHIP BUILDING TRACK C
RISK MANAGEMENT
10:30 SITE AND PATIENT ENGAGEMENT Facilitating Engagement with Sites and Patients to Build Relationships that Optimize Clinical TrialsKim Ray, Vice President, Site & Patient Network, QUINTILES » Developing a Clinical Site Engagement Team to advise and provide study teams proactive support to set trials up for success » Executing a team approach to identify and train the right sites the first time and evaluating the resulting impact on recruitment » Facilitating ongoing and meaningful site communications to improve operations, recruitment and retention, and site satisfaction » Demonstrating the positive impact on timelines, costs and enrollment by being a better partner to sites
CASE STUDY: ISSUE MANAGEMENT Establishing an Effective Strategy to Identify, Communicate, Escalate and Resolve Issues that Engage All Stakeholders Cathy Dawson, Director, Clinical Affairs, AESCULAP » Evaluating the importance of transparency in an productive relationship » Defining the critical elements of an effective escalation plan » Developing a communication strategy that informs and engages all necessary stakeholders when an issue is identified » Discussing complications that arise when a CRO applies drug study processes to a device study » Executing the steps to resolve issues quickly and putting processes in place to prevent future occurrences
TRANSCELERATE’S QMS INITIATIVE Developing the Framework for a Clinical Quality Management System to Accurately Assess and Manage Risk Susan Callery D’Amico, Vice President, R&D Quality Assurance, ABBVIE Deb Driscoll, Vice President, Quality Assurance, MERCK » Recognizing the need for a streamlined and proactive guidance that provides the framework for an effective clinical quality management system (QMS) » Developing guidelines that can be customized to fit any organization’s unique circumstances and accommodate variability » Defining the purpose of TransCelerate’s QMS initiative » Identifying the critical elements of a QMS » Effectively utilizing a quality management system to monitor organizational and study performance » Integrating the QMS with vendor and site processes and systems
11:15 CASE STUDY: OPTIMIZING SITE ENGAGEMENT Streamlining Study Activation and Recruitment, Enhancing Clinical Trial Quality and Improving Site Satisfaction through Effective Engagement Bonnie Vlahos, MBA, BSN, RN, Senior Director, Enbrel Program Clinical Lead, GIPB – Clinical Sciences, PFIZER, INC. » Developing a Clinical Site Engagement Team to advise and provide study teams proactive support to set trials up for success » Executing a team approach to identify and train the right sites the first time and evaluating the resulting impact on recruitment » Facilitating ongoing and meaningful site communications to improve operations, recruitment and retention, and site satisfaction » Demonstrating the positive impact on timelines, costs and enrollment by being a better partner to sites
CLINICAL DATA AND TECHNOLOGY Effective Strategies for Capturing, Leveraging and Visualizing Clinical DataKyle Given, Managing Principal, Consulting Services, MEDIDATA SOLUTIONS » - Applying advanced data analytics as the industry embraces disruptive technologies » - Examining the latest technologies, strategies and processes for capturing, leveraging and visualizing clinical data to optimize quality and improve overall trial conduct » - Utilizing objective standardization & industry benchmarks to unlock your data, benchmark it against industry peers, and turn it into actionable insights you can act on » - Describing two specific areas where companies are leveraging data analytics to optimize quality, cost and cycle times within their clinical portfolio; at the study level and at the organizational level
INSPECTION PREPARATIONAdapting Inspection Readiness Procedures when Executing Risk-Based Monitoring and Other Risk Management Approaches Steven Talerico, Associate Director, SRPM, Global Inspections Lead, Global Clinical Trial Operations, MERCK » Shifting from full SDV to RBM and the impact on inspection readiness » Redefining inspection readiness with risk-based operations » Ensuring effective communication regarding risk-based monitoring and audit expectations » Analyzing what the inspector is looking for and common findings
12:00 Lunch
1:00 PATIENT PERSPECTIVE: A LIFESAVING TRIAL Understanding Today’s Patient and Their Need for Trial InformationJamie Goldfarb, Cancer Survivor and Patient Advocate » Receiving a Stage IV melanoma diagnosis as a new mom » Determining the “right” treatment pathway » Participating in a lifesaving clinical trial, blogging the experience and becoming a patient advocate » Understanding information gaps and patient needs » Recognizing the importance of engaging with potential trial participants directly
1:45 PANEL: LEARNING PATIENT ENGAGEMENT FROM RARE DISEASE TRIALS Adopting Scalable Best Practices to Effectively Identify, Engage and Retain Patients from Rare Disease Trials Moderator:Andy Lawton, Global Head, Clinical Data Management, BOEHRINGER INGELHEIM Panelists:Donna Appell, RN, Founder and President, HERMANSKY-PUDLAK SYNDROME NETWORK INC. Jayne C. Gershkowitz, Senior Vice President and Chief Patient Advocate, AMICUS THERAPEUTICS Molly Rosano, Vice President, Clinical Development Operations, MOMENTA PHARMACEUTICALS » Assessing the growing role of patient advocacy groups and how to effectively engage and partner with them » Examining novel site and patient communication tools and their impact on recruitment and patient satisfaction » Creating the complete patient experience through home healthcare options, travel arrangements and service centers » Evaluating the impact of effective patient engagement on clinical trial operations
2:45 CHAIRPERSON’S CONCLUDING REMARKS Martin Giblin, Vice President, Data Science, Safety and Regulatory Operations, QUINTILES
3:00 Conference Concludes
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The 5th Annual
JANUARY 26-28, 2016 | SONESTA HOTEL PHILADELPHIA
C R O W NC l inical Research & Operations Worldwide Networking
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
