6th CROWN Congress -

6th CROWN Congress
March 7 - 9, 2017
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

Agenda – 6th CROWN Congress



Workshops

 Tuesday, March 7, 2017 – Workshops

 

WORKSHOP A

8:30AM – 12:00PM
MAKING PATIENT CENTRICITY A REALITY TODAY
Embracing the Empowered Patient to Optimize Clinical Trial Operations

Dennis Salotti, M.S., MBA, CCRA, Vice President, Operations, THE AVOCA GROUP
Lakshmi Sundar, Vice President, Strategy and Development, THE AVOCA GROUP
Caryn Laermer, Associate Director, AVOCA QUALITY CONSORTIUM

WORKSHOP B

 

 

WORKSHOP C

WORKSHOP D

 


Conference Day One

 Wednesday, March 8, 2017 – Main Conference Day One

9:00AM – 9:30AM

CHAIRPERSON’S WELCOME AND STATE OF THE INDUSTRY


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

10:15AM – 10:45AM

Networking Break


10:45AM – 12:15PM

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 LEADER

Panelists:
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)

12:15PM – 1:15PM

Lunch


 

TRACK A
PATIENT AND SITE ENGAGEMENT

1:15PM – 1:30PM
Track Chair Introduction

Arti Bajpai, President, COMPLIANCE AND QUALITY INTEGRATION (CQI) CONSULTING

1:30PM – 2:15PM
CASE STUDY: ENGAGING THE PATIENT
Leveraging Patient Input to Optimize Clinical Trial Operations

Beth Zaharoff, Director, Patient Focused Drug Development, TESARO

TRACK B
OUTSOURCING STRATEGIES

1:15PM – 1:30PM
Track Chair Introduction

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

1:30PM – 2:15PM
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

2:15PM – 3:00PM
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, ISG
Jon Lightman, Partner and Practice Lead, Life Sciences, ISG

TRACK C
RISK-BASED MONITORING

1:15PM – 1:30PM
Track Chair Introduction

Sina Djali, Head, Risk Management – Central Monitoring, Integrated Data Analytics and Reporting, Global Clinical Development Operations, JANSSEN R&D

1:30PM – 2:15PM
THE STATE OF RISK-BASED MONITORING
Analyzing the Results from Trials that Utilized Risk-Based Monitoring (RBM) to Assess the Impact

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

 

 

TRACK A
PATIENT AND SITE ENGAGEMENT

4:15PM – 5:00PM
CASE STUDY: STREAMLINE SITE START-UP
Leveraging Patient Data to Optimize Enrollment and Increase the Efficiency of Site Start-Up

Kimberly Ray, Vice President, Site and Patient Network, QUINTILESIMS

TRACK B
OUTSOURCING STRATEGIES

3:30PM – 5:00PM
EXTENDED PANEL DISCUSSION: FIND THE RIGHT PARTNER AND OUTSOURCING STRATEGY
Weighing 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.

TRACK C
RISK-BASED MONITORING

4:15PM – 5:00PM
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.

 

5:00PM – 6:00PM

Networking Reception



Conference Day Two

 Thursday, March 9, 2017 – Main Conference Day Two

7:45AM – 8:15AM

Continental Breakfast


 

TRACK A
PROCESS EFFICIENCY AND INNOVATION

8:15AM – 8:30AM
Track Chair Introduction

Lakshmi Sundar, Vice President, Strategy and Development, THE AVOCA GROUP

9:15AM – 10:00AM
KEY PERFORMANCE INDICATORS
Leveraging Programmatic Metrics to Build Operational Efficiencies in Clinical Trials

Andrea Falkoff, MBA, Vice President Operations, WORLDCARE CLINICAL

TRACK B
RELATIONSHIP BUILDING

8:15AM – 8:30AM
Track Chair Introduction

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

8:30AM – 9:15AM
VENDOR PERFORMANCE INDICATORS
Measuring the Performance of Vendors Utilizing Key Predictive and Ongoing Indicators to Mitigate Risk and Maximize the Value of the Partnership

Kristy Galante, M.S., Director/External Alliances, Global Clinical Development Operations, JANSSEN RESEARCH & DEVELOPMENT, LLC

9:15AM – 10:00AM
INTERACTIVE SESSION: THE ROLE OF CROs
Learning How Sponsors Actually View the Role of CROs in Clinical Development

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

TRACK C
RISK MANAGEMENT

8:15AM – 8:30AM
Track Chair Introduction

Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

8:30AM – 9:15AM
CHANGING REGULATIONS
Evaluating the Changing Global Regulatory Environment and the Impact on Clinical Risk Management

Doreen McGirl, North America Lead, Global Quality Business Operations, OTSUKA PHARMACEUTICAL DEVELOPMENT & COMMERCIALIZATION, INC.

9:15AM – 10:00AM
PROACTIVE RISK MANAGEMENT
Proactively Planning for Risk Realization and Managing Response

Stephen Potter, Director, Clinical Development Quality, PFIZER

 

 

TRACK A
PROCESS EFFICIENCY AND INNOVATION

10:30AM – 11:15AM
ARTIFICIAL INTELLIGENCE
Discussing the Use of Artificial Intelligence (AI) in Clinical Trials to Optimize Patient Compliance and Data Quality

Moe Alsumidaie, MBA, MSF, Industry Expert and Content Contributor, APPLIED CLINICAL TRIALS

TRACK B
TECHNOLOGY SHOWCASE

11:30AM – 12:00PM
TECHNOLOGY SHOWCASE
Exposing the Real Value of Data Through Advanced Visualizations

Dimitris Agrafiotis, Ph.D., FRSC, Chief Data Officer, Head of Technology Products, COVANCE

TRACK C
RISK MANAGEMENT

10:30AM – 11:15AM
QUALITY MANAGEMENT SYSTEMS
Leveraging a Quality Management System (QMS) to Optimize Clinical Operations and Mitigate Risk

Grace Crawford, Vice President, Clinical Quality and Compliance, MEDIMMUNE
Alfred L. Chester, Director, Clinical Quality and Compliance, MEDIMMUNE

11:15AM – 12:00PM
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, CQ, Director, Quality Performance and Risk Management, PFIZER

 

12:00PM – 1:00PM

Lunch


1:00PM – 1:45PM

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

1:45PM – 2:45PM

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 SQUIBB

Panelists:
Nora Belcher, Executive Director, TEXAS e-HEALTH ALLIANCE
Paulo Moreira, Vice President, Global Clinical Operations – External Innovation, EMD SERONO
Jonathan Rowe, Ph.D., M.S., M.A., Executive Director, Head of Clinical Development Quality Performance and Risk Management, PFIZER

2:45PM – 3:00PM

CHAIRPERSON’S CONCLUDING REMARKS


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


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