New York Professional Events List


The 7th Annual CROWN Congress - Clinical Research & Operations Worldwide N...


Date
Jan 23, 2018 - 08:00 AM - Jan 25, 05:30 PM
Organizer
New York Media Technologies LLC in association with EXL Events Inc.
Location
The Westin Philadelphia 99 South 17th St,

Philadelphia,
PA,
USA,
ZIP: 19103
Phone:

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
  • Clinical Compliance
  • Patient Recruitment/ Engagement/Enrollment
  • Study Management/Clinical Project Management
  • Good Clinical Practice/GCP
  • Clinical Monitoring
  • Clinical Data Management
  • Clinical Trial Design
  • Clinical Site Selection/Contracting/Management
  • Clinical Sourcing/Strategic Sourcing/Procurement


Agenda


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Agenda
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Pre-Conference Day — WORKSHOPS

WORKSHOPS

7:45AM – 8:30AM
Registration and Continental Breakfast for Morning Workshop Participants

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

12:00PM – 12:30PM
Lunch for Workshop A Participants

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

2:30PM – 3:00PM
30-Minute Networking Break

3:00PM – 4:30PM
Workshop B Continues

4:30PM –
Workshop B Concludes

 

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. WindleyCFA, 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. GetzMBA, 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


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


OUTSOURCING

1:45PM – 2:00PM
Track Chair Introduction
Mitchell Katz, Ph.D., Head of Clinical Research and Drug Safety Operations, PURDUE PHARMA

2:00PM – 2:45PM
EFFECTIVE OVERSIGHT STRATEGY
Developing Effective Strategies for Overseeing and Managing the Quality of Clinical Partners to Ensure Performance and Mitigate Risk

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

PATIENT ENGAGEMENT

1:45PM – 2:00PM
Track Chair Introduction
Kelly McKee, Advisor, Clinical Innovation, ELI LILLY & CO.

2:00PM – 2:45PM
PATIENT-CENTERED DIGITAL RECRUITMENT
Creating a Digital Patient Recruitment Ecosystem Focused on Patients to Optimize Engagement
Kevin Hudziak, Emerging Strategy Consultant, 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
Panelists:
Gail Adinamis, Founder and CEO, GLOBALCARE CLINICAL TRIALS, LLC
Alan Kott, MUDr., Clinical Vice President and Practice Lead, Data Analytics, BRACKET
Beth Zaharoff, Director, Patient Focused Clinical Trial Engagement, TESARO

3:30PM – 4:00PM
Networking and Refreshment Break

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

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

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


4:45PM –
Networking Reception

 

Main Conference – Day Two

Thursday, January 25 – Main Conference

8:15AM – 9:00AM

Registration and Continental Breakfast

 

SMALL TO MID-SIZED COMPANIES

9:00AM – 9:15AM

Track Chair Introduction

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

 

9:15AM – 10:00AM

REDUCING RISKS THROUGH OUTSOURCING

Balancing Risks and Resources at Emerging BioPharma by Leveraging Modeling and Simulations to Inform Planning and Design Decisions

Laura Marquis, Enterprise Segment Head Mid-Size and Emerging Biopharma, QUINTILESIMS

 

10:00AM – 10:45AM

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

 

INNOVATIVE TECHNOLOGIES AND PROCESSES

9:00AM – 9:15AM

Track Chair Introduction

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

 

9:15AM – 10:00AM

WORKFORCE INNOVATION

Driving Innovation and Implementing Change by Defining and Assessing the Competencies Needed to Effectively Utilize New Tools and Technologies

Jim Kremidas, Executive Director, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS

 

10:00AM – 10:45AM

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

 

RISK MANAGEMENT

9:00AM – 9:15AM

Track Chair Introduction

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

 

9:15AM – 10:00AM

ICH E6 R2 COMPLIANCE

Interpreting ICH E6 R2 and Aligning Clinical Operations to Be Compliant

Speaker TBD, CLUEPOINTS

 

10:00AM – 10:45AM

PROACTIVE RISK MANAGEMENT

Leveraging Analytics to Predict Site Performance and Reduce Risk

Rajneesh Patil, Senior Director, RBM and Analytics, QUINTILESIMS

 

10:45AM – 11:15AM

Networking and Refreshment Break

 

SMALL TO MID-SIZED COMPANIES (cont.)

11:15AM – 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

 

INNOVATIVE TECHNOLOGIES AND PROCESSES (cont.)

11:15AM – 12:00PM

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

 

RISK MANAGEMENT (cont.)

11:15AM – 12:00PM

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

 

12:00PM – 1:00PM

Lunch

 

1:00PM – 1:45PM

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

 

1:45PM – 2:45PM

INTERACTIVE SESSION: TOMORROW’S CLINICAL TRIAL

Evaluating the Forces Changing Clinical Operations and What Clinical Trials Look Like Five, Ten and 25 Years From Now

2:45PM – 3:00PM

CHAIRPERSON’S CONCLUDING REMARKS

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

3:00PM – Conference Concludes



Speaker Details


----------
Faculty
----------

Gail Adinamis
Founder and CEO, GLOBALCARE CLINICAL TRIALS, LLC

 

Gail Adinamis, Founder and CEO, GLOBALCARE CLINICAL TRIALS, LTD.

 

Munther Baara
Head of New Clinical Paradigm, PFIZER

 

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

 

Stephen Brannan, M.D.
Chief Medical Officer, KARUNA PHARMACEUTICALS

 

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

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

Stan Collender
Executive Vice President, MSLGROUP

Clinical Trial Participant

view speaker profile

Eileen M. Daniel
Executive Director, Clinical Operations, NEKTAR THERAPEUTICS

view speaker profile

Dany DeGrave
Senior Director Innovation Programs & External Networks, SANOFI

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

view speaker profile

Kenneth A. Getz, MBA
Chairman, CISCRP

Director of Sponsored Research, TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT

 

Kevin Hudziak
Emerging Strategy Consultant, ELI LILLY & CO.

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

 

Alan Kott, MUDr.
Clinical Vice President and Practice Lead, Data Analytics, BRACKET

Jim Kremidas
Executive Director, ASSOCIATION OF CLINICAL RESEARCH PROFESSIONALS

 

Patricia Leuchten
CEO, THE AVOCA GROUP

 

Maryann Livolsi, MSN, RN, RQAP-GCP
Senior Director, R&D Quality Assurance, ACADIA PHARMACEUTICALS

 

Maryann Livolsi, Head of Clinical QA and Compliance Programs, R&D Quality Assurance and Compliance, SHIRE

Atul Mahableshwarkar, M.D., DFAPA
Vice President, Clinical Development, BLACKTHORN THERAPEUTICS

Laura Marquis
Enterprise Segment Head Mid-Size and Emerging Biopharma , QUINTILESIMS

 

 

Michael Martorelli
Emeritus Director, FAIRMOUNT PARTNERS

 

Jean Mastrangelo
Senior Manager, Clinical Operations, HENGRUI THERAPEUTICS, INC.

 

 

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

Ed Miseta
Chief Editor, CLINICAL LEADER

 

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

 

Dawn Niccum, Quality Manager, ENDOCYTE, INC.

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

 

Rajneesh Patil
Senior Director, RBM and Analytics, QUINTILESIMS

 

Linda Peterson
Associate Director, Clinical Operation and Global Integration, INOVIO PHARMACEUTICALS

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

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

view speaker profile

Joe Pollarine
Senior Director, GxP Systems Strategy, BioResearch Quality and Compliance, JANSSEN RESEARCH & DEVELOPMENT, LLC

view speaker profile

Holly Posner, M.D., M.S.
Senior Director, Clinical Development, Global Product Development Group, PFIZER

view speaker profile

Scott Rauscher
Director, Global Procurement R&D, BRISTOL-MYERS SQUIBB

view speaker profile

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

view speaker profile

Karen Roycroft
Director, Clinical Quality Assurance, INOVIO PHARMACEUTICALS

view speaker profile

Karen Roycroft, Associate Director, Clinical Quality Management, OTSUKA

Fabian Sandoval, M.D.
CEO and Research Director, EMERSON CLINICAL RESEARCH INSTITUTE

view speaker profile

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

Paul Spreen
Executive Vice President and Chief Customer Officer, QUINTILESIMS

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

Steve Whittaker
Senior Consultant, THE AVOCA GROUP

Executive Director, THE AVOCA QUALITY CONSORTIUM

view speaker profile

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

view speaker profile

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

Beth Zaharoff
Director, Patient Focused Clinical Trial Engagement, TESARO

view speaker profile

 

 

 

Please contact the event manager Marilyn below for the following: 
- Discounts for registering 5 or more participants.
- If you company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase. 
We can also provide a certificate of completion for this event if required.

NO REFUNDS OR TRANSFER ALLOWED ON REGISTRATIONS 
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Event Categories
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Keywords: Clinical , conference , design , developing, development , Management , managing, pharmaceutical , professional, research




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