Cambridge Healthtech Institute's 4th Annual

Managing Outsourced Clinical Trials
( アウトソーシングされた臨床試験の管理 )

Building Successful Partnerships with Effective Oversight

2018年2月14-15日 | Hyatt Regency Orlando | フロリダ州オーランド


アウトソーシングされた臨床試験の管理をテーマにしたこのカンファレンスプログラムでは、ベンダーの質や実績に関するケーススタディや教訓が紹介され、治験依頼者や開発業務受託機関 (CRO) の視点から治験実施の国際基準であるICH-E6 R2の最新の改訂版を踏まえた議論が展開されるほか、アウトソーシングのための提携やサードパーティプロバイダーとの協力を通じて効率的な臨床試験を実現するための方策も明らかにされます。


Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Plenary Keynotes

3:00 Valentine's Day Celebration in the Exhibit Hall, Last Chance for Exhibit Viewing


4:00 Chairperson's Remarks

Walter Young, External Partner Engagement & Governance Lead, CSL Behring

4:05 Sponsor Oversight of Service Providers: Thoughts from a Quality Perspective

Joanne_SpalloneJoanne Spallone, Global Development Quality Audit Head, Franchise Operations and Strategy, Novartis

Within our industry, every clinical trial employs third party services to some extent. Everyone knows that the trial sponsor must provide appropriate oversight for the external service providers. But how do we define "appropriate oversight"? What is "effective oversight"? This talk will provide a QA perspective, having observed examples from Sponsors' and Health Authorities' perspectives.

4:30 Sponsored Presentation (Opportunity Available)

4:55 PANEL DISCUSSION: Vendor Quality and Oversight in Light of the New ICH E6 R2 Changes

Joanne_SpalloneJoanne Spallone, Global Development Quality Audit Head, Franchise Operations and Strategy, Novartis

Diane_MillerDiane Miller, Director, Vendor Management, AbbVie

Richard O'Hara, Associate Director, Clinical Outsourcing, Endo Pharmaceuticals

With increased pressure of the ICH E6 R2 addendum changes on quality and oversight in clinical trials, Sponsors and CROs are concerned with ensuring quality partnerships. This panel will discuss KPIs for vendor quality, quality metrics, and how Sponsors and CROs are approaching their relationships with quality in mind.

5:50 Close of Day

5:50-7:00 pm Track Reception (Sponsorship Opportunity Available)

Thursday, February 15

7:15 am Registration Open

Accenture7:45 Breakfast Presentation to be Announced


8:30 Chairperson's Remarks

8:35 Governance, Oversight and Quality Management with Key Vendors

Sagarika_BolliniSagarika Bollini, Director, Head of Clinical Partner Management, Central Clinical Planning and Solutions, Global Clinical Operations, Bristol-Myers Squibb

Discuss key components to CRO/sponsor relationship management and building a framework of trust within the partnership. Can we create a culture of engagement, ownership that drives performance driven culture within the partnership? This talk will focus on governance best practices including diagnosing issues/risk and quality management frameworks for oversight.

9:00 CO-PRESENTATION: Optimizing External Service Provider Relationships

Walter Young, External Partner Engagement & Governance Lead, CSL Behring

Brian Dudt, Senior Director, Study and Business Operations, CSL Behring


9:25 Supplier Segmentation and Classification: How to Make It Meaningful

Marija Nikolic, Associate Director, Vendor Management, Contracts & Outsourcing, Astellas Pharma Global Development

This presentation will focus on how to go about understanding the true business levers and drivers to make meaningful supplier segmentation. Careful consideration should be given to levers that encompass inherent business risk as well as those that drive value. The segmentation or classification process should be made distinct to clearly drive the message as to the oversight and management of the classification. Meaningful classification translates into recognizable benefits to internal stakeholders.

9:50 Sponsored Presentation (Opportunity Available)

10:15 Networking Coffee Break

10:30 Chairperson's Remarks

10:35 Establishing a Common Process for the Management and Escalation of Supplier Performance: From Manufacturing to Drug Development

Marisa Bower, Director, Global Supplier Management & Supply Business Development, Merck

The session will highlight implementation of an end-to-end supplier performance management process that ensures reliable and compliant supply and service delivery. It will outline the commercial importance of deploying consistent methodology, developed by the direct side of our business, to align all categories across a large, global procurement organization. The methodology results in creation of a framework that ensures optimal performance from key suppliers, scorecards to enable consistent supplier evaluation, and supports a common way of working across categories, suppliers and stakeholders. Criteria for segmentation must be established and agreed by all impacted stakeholders. The management of all suppliers in a specific segment must be consistent in terms of governance, corrective action planning, VOC data collection and frequency of segmentation. The process for managing suppliers who support multiple areas of business must be well-constructed in order for data to be meaningful and can have benefit to procurement colleagues and stakeholders through the business.

11:00 Sponsored Presentation (Opportunity Available)

11:25 Brief Session Break


11:35 Contracting Dilemmas - Should the Sponsor or CRO Contract with Third Parties?

Lan Bandara, Director, Pharmaceutical Contract Management Group (PCMG); Director, Clinical Outsourcing, Medicines Development Centre, Coordination Department, Eisai Limited

The talk covers 1. Different contract models, 2. Pros and cons of each model with reference to new ICH E6 R2 guidelines, 3. Lessons learned from recent case studies.

12:00 pm PANEL DISCUSSION: Where Is the Industry Headed with 3rd Party Suppliers?

Chris_RullChristopher Rull, Principle Consultant, CR Consulting, LLC; Former Vice President, Head of Business Development & Account Management, UBC

Charlotte_FrenchCharlotte French, Executive Director, Outsourcing & Contracts, Medical and Development, Astellas

Craig Coffman, Executive Director, Clinical Business Operations & Outsourcing, Nektar Therapeutics

As CROs are tasked with outsourcing more services on behalf of Sponsor companies, where is the industry headed with this practice? This panel will address the following questions: Are CROs equipped to effectively outsource for additional service providers? When Sponsors outsource to CROs, is the CRO's capability to outsource additional services a factor in deciding to partner with a particular CRO? How is oversight and accountability of deliverables being handled? What are some best practices and lessons learned when CROs are outsourcing multiple services?

12:50 Closing Remarks

1:00 SCOPE Summit 2018 Adjourns

2018 SCOPE Conference at a Glance

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In Memory of Gerald "Jerry" Matczak
Matczak Jerry

Gerald "Jerry" Matczak, lead consultant in clinical innovation at Eli Lilly & Co., was a rare breed in the pharmaceutical world, someone who not only embraced social media, but also listened to activist patients. He has been a part of the SCOPE conference since its inception and won the Patient Engagement Award on Wednesday, the day before his passing. Matczak died suddenly on Feb. 2 at age 54. We will all miss him.

- Cambridge Healthtech Institute (CHI)