7th CROWN Congress - The Westin Philadelphia

7th CROWN Congress
January 23 - 25, 2018
The 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

Agenda – 7th CROWN Congress



Pre-Conference Day — WORKSHOPS

 WORKSHOPS

8:30AM – 10:00AM

WORKSHOP A — EFFECTIVE INDICATORS OF CRO PERFORMANCE
Measuring the Performance of Vendors Utilizing Key Predictive and Ongoing Indicators to Mitigate Risk and Maximize the Value of the Partnership


  • Identifying predictive indicators when selecting a CRO
    • Evaluating which key indicators effectively assess risk and capability and can predict possible performance issues
    • Identifying critical financial, business and quality factors to take into consideration
      • Evaluating any study-specific criteria that should be examined and incorporated into qualification process
    • Developing a qualification audit incorporating these indicators to assess the risk-level of the potential partner
  • Reviewing study indicators to assess ongoing performance of the CRO during the study
    • Identifying the indicators to measure and monitoring during a study
      • Uncovering ongoing indicators that can predict risk areas to allow mitigation prior to a serious issue evolving
    • Executing ongoing audits of CROs to collect meaningful data to ensure compliance and performance

Maryrose Petrizzo, President and Principal Consultant, CLINICAL QUALITY ASSURED, LLC.

10:00AM – 10:30AM

30-Minute Networking Break


10:30AM – 12:00PM

Workshop A Continues


12:30PM – 1:00PM

Registration for Workshop B


1:00PM – 2:30PM

WORKSHOP B — ALIGNING CLINICAL OPERATIONS TO ICH E6 R2
Breaking Down the Critical Elements of ICH E6 R2 and Creating an Action Plan for Your Clinical Operations to Achieve Full Compliance


  • Identifying the aspects of ICH E6 and the addendum that impacts clinical operations
    • Understanding the elements that have changed as a result of the addendum
    • Outlining the critical elements of the guidance
    • Evaluating regional variations
  • Examining current clinical operations to assess where changes must be made to remain compliant
    • Determining what does not need to change
    • Conducting a gap analysis of processes
  • Developing an action plan to remain compliant
    • Assessing and assigning risk levels to prioritize resource allocation based on criticality
    • Constructing a methodological approach to achieve full compliance
  • Executing the necessary changes to operations
    • Evaluating who should be responsible for implementation and adherence
    • Examining possible barriers to implementation and how to overcome
    • Creating metrics to visualize and oversee operations and ensure continual compliance
  • Evaluating other current or expected regulations that can impact clinical operations and how to prepare

Peggy J. Berry, MBA, RAC, President and CEO, SYNERGY CONSULTING

3:00PM – 4:30PM

Workshop B Continues



Main Conference – Day One

 Wednesday, January 24 – Main Conference

8:45AM – 9:15AM

CHAIRPERSON’S WELCOME AND STATE OF THE INDUSTRY


Paul Spreen, Executive Vice President and Chief Customer Officer, QUINTILESIMS

9:15AM – 10:00AM

A CLINICAL TRIAL SAVED MY LIFE
How a World-Renowned Finance Expert on Capitol Hill Has Become a Powerful Advocate for Clinical Trials 


Stan Collender, Executive Vice President, MSLGROUP; Clinical Trial Participant

10:00AM – 10:45AM

CRO MARKET CONSOLIDATION
Evaluating the CRO Industry Consolidation and Predictions for What’s Next


David H. Windley, CFA, CPA, Managing Director, Healthcare Equity Research, JEFFERIES LLC

10:45AM – 11:15AM

Networking Break


11:15AM – 12:45PM

PANEL DISCUSSION: BREAKING THE OUTSOURCING MOLD
Recognizing the Limitations of the Traditional Outsourcing Model and Developing Innovative Approaches to Optimize Clinical Operations and Maximize Resources


Moderator:
Ed Miseta, Chief Editor, CLINICAL LEADER

Panelists:
Kenneth A. Getz, MBA, Chairman, CISCRP; Director of Sponsored Research, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT
Patricia Leuchten, CEO, THE AVOCA GROUP
Michael Martorelli, Emeritus Director, FAIRMOUNT PARTNERS
Fabian Sandoval, M.D., CEO and Research Director, EMERSON CLINICAL RESEARCH INSTITUTE
John Whyte, M.D., MPH, Director, Professional Affairs and Stakeholder Engagement, CDER, FDA

12:45PM – 1:45PM

Lunch


 

TRACK A
SMALL TO MID-SIZED COMPANIES

1:45PM – 2:00PM
Track Chair Introduction

Evan L. Tzanis, Senior Vice President, Clinical Development and Medical Affairs, PARATEK PHARMACEUTICALS

2:00PM – 2:45PM
PANEL: MAXIMIZING RESOURCES FOR CLINICAL SUCCESS
Discussing Best Practices at Small and Mid-Sized Companies for Successfully Optimizing and Prioritizing Clinical Operations to Position Trials for Success

Panelists:
Atul Mahableshwarkar, M.D., DFAPA, Vice President, Clinical Development, BLACKTHORN THERAPEUTICS
Jean Mastrangelo, Senior Manager, Clinical Operations, HENGRUI THERAPEUTICS, INC.
Eileen M. Daniel, Executive Director, Clinical Operations, NEKTAR THERAPEUTICS

2:45PM – 3:30PM
ARTICULATING CLINICAL RISKS
Qualifying Clinical Risks to Senior Management, Boards and VCs so They Understand the Trial’s Needs

Evan L. Tzanis, Senior Vice President, Clinical Development and Medical Affairs, PARATEK PHARMACEUTICALS







TRACK B
OUTSOURCING

1:45PM – 2:00PM
Track Chair Introduction

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

2:45PM – 3:30PM
COMMUNICATION PLANNING
Establishing an Effective Communication Plan to Increase Transparency and Mitigate Risk Between Partners

Kristy Galante, M.S., Director/External Alliances, Global Clinical Development Operations, JANSSEN RESEARCH & DEVELOPMENT, LLC
Joe Pollarine, Senior Director, GxP Systems Strategy, BioResearch Quality and Compliance, JANSSEN RESEARCH & DEVELOPMENT, LLC


TRACK C
PATIENT ENGAGEMENT

1:45PM – 2:00PM
Track Chair Introduction

Kelly McKee, Advisor, Clinical Innovation, ELI LILLY & CO.

2:45PM – 3:30PM
PANEL: MAKING PATIENT CENTRICITY A PRIORITY
Driving a Patient-Centered Culture in Clinical Trials to Make the Needs of the Patient the Priority

Moderator:
Beth Zaharoff, Director, Patient Focused Clinical Trial Engagement, TESARO

Panelists:
Gail Adinamis, Founder and CEO, GLOBALCARE CLINICAL TRIALS, LLC
Alan Kott, MUDr., Clinical Vice President and Practice Lead, Data Analytics, BRACKET
MarlaJan Wexler, Creator/Author, LUCK FUPUS; Patient Leader

 

 

TRACK A
SMALL TO MID-SIZED COMPANIES
(cont.)

4:00PM – 4:45PM
INOVIO CASE STUDY: CLINICAL QUALITY RISK MANAGEMENT SYSTEM
Examining How a Small Pharma Developed and Implemented a Clinical Quality Risk Management System (CQRMS) to Achieve ICH E6 R2 Compliance 

Linda Peterson, Associate Director, Clinical Operation and Global Integration, INOVIO PHARMACEUTICALS
Karen Roycroft, Director, Clinical Quality Assurance, INOVIO PHARMACEUTICALS
Steve Whittaker, Senior Consultant, THE AVOCA GROUP; Executive Director, THE AVOCA QUALITY CONSORTIUM

TRACK B
OUTSOURCING
(cont.)

4:00PM – 4:45PM
PANEL: ASSESSING OUTSOURCING OPTIONS
Exploring Different Outsourcing Approaches to Determine the Best Fit for Your Needs and Where to Look for Them



Panelists:
Craig A. Coffman, Executive Director, Clinical Business Operations and Outsourcing, NEKTAR THERAPEUTICS
Scott Rauscher, Director, Global Procurement R&D, BRISTOL-MYERS SQUIBB

TRACK C
PATIENT ENGAGEMENT
(cont.)

4:00PM – 4:45PM
JANSSEN CASE STUDY: INFORMED CONSENT OPTIMIZATION
Revamping the Informed Consent Process and Documentation to Optimize Patient Understanding


Cassandra R. Smith, Associate Director, Investigator and Patient Engagement, JANSSEN





 


Main Conference – Day Two

 Thursday, January 25 – Main Conference

 

TRACK A
SMALL TO MID-SIZED COMPANIES

8:45AM – 9:00AM
Track Chair Introduction

Evan L. Tzanis, Senior Vice President, Clinical Development and Medical Affairs, PARATEK PHARMACEUTICALS

9:00AM – 9:45AM
REDUCING RISKS THROUGH OUTSOURCING
Balancing Risks and Resources at Emerging BioPharma by Leveraging Modeling and Simulations to Inform Planning and Design Decisions

Laura Marquis, Senior Vice President, U.S. and Canada Mid Pharma and Emerging Biopharma Sales, IQVIA

9:45AM – 10:30AM
OPTIMIZING CRO PARTNERSHIPS AT A SMALL COMPANY
Strategic Negotiations and Effective Oversight to Optimize Performance and Mitigate Risk When Working With CROs at a Small Company

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








TRACK B
INNOVATIVE TECHNOLOGIES AND PROCESSES

8:45AM – 9:00AM
Track Chair Introduction

Rich Polgar, Director, Global Procurement, R&D, BRISTOL-MYERS SQUIBB


9:45AM – 10:30AM
PANEL: BLOCKCHAIN TECHNOLOGY
Optimizing the Efficacy of Clinical Trials with Blockchain




Moderator:
Maria Palombini, Director, Communities and Initiatives Development, Emerging Technology, IEEE STANDARDS ASSOCIATION

Panelists:
Munther Baara, Head of New Clinical Paradigm, PFIZER
Dany DeGrave, Senior Director Innovation Programs & External Networks, SANOFI

TRACK C
RISK MANAGEMENT

8:45AM – 9:00AM
Track Chair Introduction

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

9:00AM – 9:45AM
ICH E6 R2 COMPLIANCE
Interpreting ICH E6 R2 and Aligning Clinical Operations to Be Compliant



Steve Young, Chief Operating Officer, CLUEPOINTS

9:45AM – 10:30AM
PROACTIVE RISK MANAGEMENT
Leveraging Analytics to Predict Site Performance and Reduce Risk



Rajneesh Patil, Senior Director, RBM and Analytics, QUINTILESIMS









 

 

TRACK A
SMALL TO MID-SIZED COMPANIES
(cont.)

11:45AM – 12:00PM
RESCUING A CLINICAL TRIAL
Salvaging Your Operations When You’ve Been Burned by an Ineffective Partnership with a Large CRO


Dawn M. Niccum, M.S., RN, PMP, CCRA, RQAP-GCP, Director, Quality Assurance, INSEPTION GROUP



TRACK B
INNOVATIVE TECHNOLOGIES AND PROCESSES
(cont.)

11:00AM – 11:45AM
THE VALUE IN BIG DATA
Evaluating the Role of Big Data in Clinical Trials to Improve Research and Optimize Outcomes


Rich Polgar, Director, Global Procurement, R&D, BRISTOL-MYERS SQUIBB





TRACK C
RISK MANAGEMENT
(cont.)

11:00AM – 11:45AM
PANEL: ACHIEVING RBM SUCCESS
Learning from the Experiences of Effectively Executed Risk-Based Monitoring (RBM) Strategies and Guidance to Achieve Success

Panelists:
Eileen M. Daniel, Executive Director, Clinical Operations, NEKTAR THERAPEUTICS
Maryann Livolsi, MSN, RN, RQAP-GCP, Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICAL

11:45AM – 12:30PM
PFIZER CASE STUDY: VENDOR GCP QUALITY RISK MANAGEMENT FRAMEWORK
Developing a GCP Quality Risk Management Framework for Managing Risk in Vendor Engagements

Jon Godshall, Director, Clinical Development Quality, Vendor Quality Lead, PFIZER
Stephen Potter, Director, Clinical Development Quality, Quality Risk Management Lead, PFIZER

 

12:30PM – 1:30PM

Lunch


1:30PM – 2:15PM

FDA PERSPECTIVE: PATIENT DIVERSITY
Recognizing the Need for Greater Patient Diversity in Clinical Trials and How to Get There


John Whyte, M.D., MPH, Director, Professional Affairs and Stakeholder Engagement, CDER, FDA

3:15PM – 3:30PM

CHAIRPERSON’S CONCLUDING REMARKS


Paul Spreen, Executive Vice President and Chief Customer Officer, QUINTILESIMS


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