Cambridge Healthtech Institute’s 5th Annual

Managing Outsourced Clinical Trials

February 20-21, 2019


As more clinical trial activities are outsourced to contract research organizations (CROs) and other third-party vendors, sponsors and their partners must form effective and quality partnerships. Cambridge Healthtech Institute’s 5th Annual “ Managing Outsourced Clinical Trials” conference features case studies and lessons learned from sponsors and CROs on vendor quality and performance in light of the new ICHE6 R2 changes, as well as how to build beneficial partnerships that effectively mitigate and manage risks and resources. 


Arrive early and attend Part 1 (Tues-Wed): Mastering an Outsourcing Strategy


Wednesday, February 20 – Thursday, February 21 (Part 2 of SCOPE)

Bridging Luncheon Presentation (Sponsorship Opportunity Available)

RBM, VENDOR QUALITY, & OVERSIGHT

What Should CROs Do to Protect Sponsors Undertaking RBM Trials?

Andy Lawton, Director & Consultant, Risk Based Approach Ltd.

PANEL DISCUSSION: CRO Oversight, RBM and ICH E6 R2

Panelists:

Sarah Bednarski, Associate Director, Strategic Monitoring, Sunovion

Ann Hegarty, Executive Director, GSMO, Head PLs, CRO Oversight & Ph I Site Management, Allergan

Jill Collins, Executive Director, Global Operations Management, Syneos

David Nickerson, Head, Clinical Quality Management, Global Clinical Operations, EMD Serono

RISK MITIGATION PLANNING & ENSURING THAT TIMELINES ARE MET

PANEL DISCUSSION: What Can Sponsors and CROs Do When Timelines/Milestones Aren’t Met for Study Start-Up?

Moderator: Chuck Bradley, Vice President, Clinical Development, FibroGen, Inc.

Panelists:

Erin O’Boyle, Senior Director, Clinical Contracts and Outsourcing, FibroGen, Inc.

Ian Wyglendowski, Head, Outsourcing, Contracts, and Strategic Partnering, UCB Biosciences, Inc.

Holger Liebig, Senior Director, Strategic Partnerships, PAREXEL International

RESOURCE MANAGEMENT & SOURCING MODELS

CO-PRESENTATION: Talk Title to be Announced

Bari Kowal, Vice President, Global Head of Clinical Project Management and Operations, Regeneron

Jonathan Cohen, Executive Director, Business Operations, Regeneron

PANEL DISCUSSION: What Does Your Sourcing Model Mean for Your Resource Management Process?

Moderator: Ken Walsh, Operations Planning and Analysis Lead, R&D Clinical Development, CSL Behring

Panelists:

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

Chris Chan, Senior Director, R&D Finance, FibroGen, Inc.

Bari Kowal, Vice President, Global Head of Clinical Project Management and Operations, Regeneron

Jonathan Cohen, Executive Director, Business Operations, Regeneron

Luncheon Presentation (Sponsorship Opportunity Available)

PLENARY KEYNOTES

Monday Evening, Tuesday Morning, Wednesday Afternoon Plenary Keynotes Featuring:
 
SCOPE’s 2019 Participant Engagement Award, in Memory of Jerry Matczak
Empowering Humans to Own Their Own Data
Digital Trends That Are Changing the Healthcare Experience
Why Do We Need Caregivers in Clinical Trials; Exploring Real-life Applications in Engagement and Retention
Welcome, Pharma, to AI. Here’s What You Have Been Missing.
 
For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

Arrive early and attend Part 1 (Tues-Wed): Mastering an Outsourcing Strategy


For more details on the conference, please contact:
Lee Yuan

Conference Director

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5404
Email: lyuan@cambridgeinnovationinstitute.com


For partnering and sponsorship information, please contact:

Companies A-O

Ilana Quigley

Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.5457

Email: iquigley@healthtech.com


Companies P-Z

Patty Rose
Senior Manager, Business Development

Cambridge Healthtech Institute (CHI)

Phone: 781.972.1349
Email: prose@healthtech.com 


Signature Sponsor

IQVIA


Premier Sponsors

Appian

Bioclinica_new

ClinicalInk

Covance

DrugDev

ERT

PRA Health Sciences

Praxis

Syneos Health

UBC

Veeva