Cambridge Healthtech Institute’s 5th Annual

Managing Outsourced Clinical Trials

Building Successful Partnerships with Effective Oversight, Risk Mitigation & Resource Management

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.

Final Agenda

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

Wednesday, February 20

11:30 am Registration Open

12:30 pm BRIDGING LUNCHEON PRESENTATION (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:10 Coffee and Dessert Break in the Exhibit Hall

2:10 Plenary Keynotes

3:20 Booth Crawl & Refreshment Break in the Exhibit Hall, Last Chance for Exhibit Viewing

RBM, VENDOR QUALITY & OVERSIGHT

4:05 Chairperson’s Remarks

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

4:10 INTERACTIVE PANEL:CRO Oversight, RBM and ICH E6 R2

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

Gronen_SusanneSusanne Gronen, Senior Vice President and Head, Data Science, Astellas


Bednarski_SarahSarah Bednarski, Associate Director, Strategic Monitoring, Sunovion


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


Collins_JillJill Collins, Executive Director, Global Operations Management, Syneos Health


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

With the passage of ICH E6 (R2) addendum, the pharma industry is taking a closer look at how they approach clinical trial quality and oversight with their partners. This panel will cover:


  • What does ICH E6 R2 mean for risk-based monitoring?
  • How is the industry approaching the ICH E6 R2 addendum changes: the struggles and challenges they have faced or continue to face
  • What does a sponsor expect the CRO to handle on its behalf?
  • How are sponsors and CROs collaborating to ensure clinical quality risk management?
  • How are sponsors and CROs handling oversight, especially when CROs subcontract to third party vendors?

5:10 Presentation to be Announced

5:40 What Should CROs Do to Protect Sponsors Undertaking RBM Trials

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

This presentation will examine the ICH GCP (E6) requirements for oversight and RBM, including central monitoring. Proposals will be given for a model framework for ensuring sponsor oversight. Using a CRO appears to be the common model in the industry for clinical trials using RBM methods, and so it should be a well established model for CROs to give information to sponsors to ensure oversight. Judging by continued inspection findings, it is an area that deserves more review.

6:107:10 Networking Reception (Sponsorship Opportunity Available) or Close of Day

Thursday, February 21

7:15 am Registration Open

7:45 BREAKFAST PRESENTATION (Sponsorship Opportunity Available) or Morning Coffee

8:15 Session Break

RISK MITIGATION PLANNING & ENSURING THAT TIMELINES ARE MET

8:20 Chairperson’s Remarks

Chairperson to be Announced

8:25 Clinical Analytics Innovation 2.0 - Measurement that Matters

Lodha_AnkitAnkit S. Lodha, MS, MBA, Associate Director, Clinical Analytics & Innovation, Global Development Operations, Shire

Clinical analytics and insight can be leveraged to address a wide range of operational questions in variety of settings. It is often utilized for purposes that are beyond the original intent of these data points. At Shire, we have developed industry best practices in measuring multiple CROs performance consistently i.e. apple to apple comparison for all our CRO partners. We are applying best practices, but also taking a fresh approach to develop a world-class clinical analytics metrics that will enhance our partnerships across our therapeutic areas. The goal of this presentation is to review the capability of several analytical approaches and to demonstrate how these insight can be incorporated into all phases of a clinical development program. This presentation will also share advances from previous analytical solutions and from scaling up our clinical analytics suite of metrics in developing KPIs to measure clinical trial performance.

8:55 INTERACTIVE PANEL: What Can Sponsors and CROs Do When Timelines/Milestones Aren’t Met for Study Start-Up?

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


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

Topics to be discussed:

  • How are CROs responding to missed timelines and milestones around patient enrollment, site selection, and study start-up?
  • How are CROs addressing risks such as site staffing shortages, patient recruitment issues, etc. that may delay clinical trials? What type of risk mitigation planning is happening?
  • How can sponsors proactively ensure timely study start-up? How can sponsors hold CROs more accountable? Do contract incentives work?

9:55 Presentation to be Announced

10:25 Networking Coffee Break (Sponsorship Opportunity Available)

SOURCING MODELS AND IMPLICATIONS FOR RESOURCE MANAGEMENT

11:10 Chairperson’s Remarks

Chairperson to be Announced

11:15 CO-PRESENTATION: Implementing a High-Functioning FSP Model at a Small or Mid-Sized Sponsor

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

OHara_RickRichard O’Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals

This presentation will cover the following: Assessing core competencies and building FSP(s) to complement, portfolio transparency to provide as much lead as possible to all providers, building a meaningful and effective governance with providers, and dynamic resource planning.

11:45 Sponsored Presentation (Opportunity Available)

12:15 pm Transition to Shared Sessions

12:20 CO-PRESENTATION: Sourcing Models and Implications on Resource Management

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


Cohen_JonathanJonathan Cohen, Executive Director, Business Operations, Regeneron

This presentation will provide a review of internal resource needs versus outsourcing. There will be an assessment of needs using resource, performance and budget data that is available.


12:50 INTERACTIVE PANEL: What Does Your Sourcing Model Mean for Your Resource Management Process?

Moderator: Anca Copaescu, CEO, Strategikon Pharma

Rosalie Filling, Vice President, Clinical Operations, Endo Pharmaceuticals

Chan_ChrisChris Chan, Executive Director, R&D Finance, Fibrogen


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


Cohen_JonathanJonathan Cohen, Executive Director, Business Operations, Regeneron


Catherine Deacon, Director, Finance Global Development and CEI, Takeda

Topics to be discussed:

  • How to effectively align resources to meet outsourcing needs
  • Approaches for accurately forecasting resource demands
  • Impact of resourcing on financial forecasting
  • How to quickly get your organization to adapt to changing resource needs

1:20 Transition to Lunch

1:25 LUNCHEON PRESENTATION (Sponsorship Opportunity Available)

1:55 Closing Remarks

2:00 SCOPE Summit 2019 Adjourns

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

Register!

“SCOPE Featured Author”
Emmanuel Fombu, MD,
Director, Digital Health Solutions
Novartis


Signature Sponsors

IQVIA

Medidata


Premier Sponsors

Appian
Axiom

BBK-Worldwide

Bioclinica_new

ClinicalInk

Covance

DrugDev

ERT
Mendel Health
Oracle-Health-Sciences

PRA Health Sciences 
Saama-Technologies

Syneos Health

UBC_new

Veeva