Cambridge Healthtech Institute's 8th Annual

Protocol Development, Global Site Selection, Feasibility and Site Management:
( 治験実施計画書の作成、世界各地での治験実施施設選定、実現可能性、施設管理 )

Improving Outcomes through Strategy, Relationships, Data and Execution

2018年2月13-14日 | Hyatt Regency Orlando | フロリダ州オーランド


臨床試験の計画立案、運営、施設管理の問題を解決するには、他社のベストプラクティスに学び、意思決定を支援するためのデータと技術を活用しながら、治験実施施設や開発業務受託機関 (CRO) 、治験依頼者の間の意思疎通と関係を改善していく必要があります。治験実施計画書の作成、世界各地での治験実施施設選定、実現可能性、施設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、臨床試験の計画を立案し、実施する際に考慮すべき問題などをめぐって議論が展開されます。


Monday, February 12

9:00 am - 7:30 pm Registration Open

5:00 - 6:15 pm Pre-Conference Plenary Keynote Panel

6:30 - 8:30 pm SCOPE's Kick-Off Networking Happy Hour on the Garden Terrace Hosted by CHI, DrugDev, & Praxis

8:30 Close of Day

Tuesday, February 13

7:15 am Registration Open and Morning Coffee

8:20 Opening Plenary Keynotes

9:45 Grand Opening Coffee Break in the Exhibit Hall


10:45 Chairperson's Remarks

Christopher Conklin, Director, Feasibility Center of Excellence, Pfizer

10:50 Trends in Protocol Design Practice and Its Impact on Performance

Ken_GetzKen Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP

The scientific and operating demands of protocol designs have increased rapidly during the past decade due to numerous factors. This talk characterizes trends in, and the forces driving, protocol design practices. The impact of these practices on clinical trial performance and economics will be discussed.

11:15 Maximizing Site Contributions in a Competitive Landscape

Dawn_FureyDawn Furey, Head, Global Clinical Trial Operations, Merck & Co.

Sites submit trial proposals for participation and are selected (or not selected) without much insight into the protocol or rationale for why they have been allocated a particular number of patients. Sponsors create competitive recruitment strategies that don't allow sites to plan or manage their resources, so even when sites have the ability to enroll more patients, they often don't have the resources. I will set forth some proposals for how we might "stop the insanity" of peppering the world with sites and focus on a collaborative model where sites and sponsors plan their recruitment and resources synergistically with the goal of making both of them successful.

11:40 Feasibility... Decisions, Decisions, Decisions: Early Planning and Internal-External Models

John_OidtmanJohn Oidtman, Ph.D., Senior Vice President, Head of Global Clinical Operations, EMD Serono

This presentation will focus on the steps that sponsors must consider when planning clinical trial conduct. It will provide insights into approaches to optimize the early planning process and will also provide perspectives on the pros and cons of internal vs. external business models.

12:05 pm CO-PRESENTATION: Strengths and Limitations of Data in Clinical Trial Feasibility

Martin_LeeMartin Lee, M.D., Vice President, Scientific Services, Scientific Affairs, PRA Health Sciences

Jacqui_WhitewayJacqui Whiteway, Ph.D., Senior Director, Feasibility, Scientific Affairs, PRA Health Sciences

There is an increasing emphasis on the use of data in clinical trial planning, especially in projecting enrollment rates and in selecting countries and sites for participation. Our presenters will identify the strengths, limitations and optimal use of existing and emerging data sources; discuss the importance of direct site interactions in the planning process; and recommend a systematic approach to optimal clinical trial planning.

12:30 Session Break

12:40 Luncheon Presentation to be Announced

1:20 Coffee and Dessert Break in the Exhibit Hall


2:00 Chairperson's Remarks

Dawn Furey, Head, Global Clinical Trial Operations, Merck & Co.

2:05 Accelerating Drug Development through Protocol Harmonization: TransCelerate's Common Protocol Template

Robert_DiCiccoRobert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline

Increasing complexity in protocols makes implementation and reporting difficult and the lack of consistency compounds the issue. A significant opportunity exists for an improvement in quality and simplification through protocol harmonization, as all protocols rely on the same health care and regulatory infrastructure for design, review and implementation. This session will explore the collaboration between TransCelerate, FDA, and NIH to achieve alignment on a common protocol structure. It will also describe how TransCelerate's CPT enables use of clinical data standards, as well as next steps towards automation and data traceability from protocol through to downstream processes.

2:30 CASE STUDY CO-PRESENTATION: How the Business Embedded the Tech-Enabled CPT in Our Business Process and Extended It to Extract Data for Downstream Processes

Bina_RathodBina Rathod, Associate Director & Business Lead, MRL IT Global Clinical Development, Merck & Co.

Mitzi_AllredMitzi Allred, Director, Clinical Research, Clinical Content Standards, Merck & Co.

This presentation will cover how our business partners leverage the tech enabled CPT to make protocol data and metadata available to downstream clinical processes, tools and applications to optimize reusability with minimum manual intervention. We will cover from protocol creation and downstream process to clinical study report finalization.

2:55 Presentation to be Announced

3:20 PRESENTATION & PANEL DISCUSSION: Current and Emerging Protocol Optimization Design Strategies

Introductory Presentation:

Ken_GetzKen Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP

Panel Discussion:

Ken_GetzKen Getz, MBA, Director, Sponsored Research Programs, Tufts CSDD; Chairman, CISCRP

Robert_DiCiccoRobert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline

John_OidtmanJohn Oidtman, Ph.D., Senior Vice President, Head of Global Clinical Operations, EMD Serono

A number of protocol design optimization strategies have been introduced and implemented including protocol authoring tools, feasibility review mechanisms, patient advisory boards, and pre-planning simulations. This talk touches on optimization strategies and provides data on their impact to date where available. Several protocol design optimization strategies will also be discussed including the adoption and use of adaptive designs and patient centric approaches. This introductory talk will be followed by a panel discussion among pharmaceutical and biotechnology company professionals. Panel members will discuss:

  • Optimization strategies that most resonate with their respective organizations and why
  • Experience with various strategies and lessons learned
  • Adoption challenges and impact following implementation


3:50 Find Your Table and Meet Your Moderator

4:00 Interactive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day's sessions. Delegates will join a table of interest and become an active part of the discussion at hand. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing.

5:00 Welcome Reception in the Exhibit Hall

6:30 Close of Day

Wednesday, February 14

7:15 am Registration Open

7:45 Breakfast Presentation: A New Way to Pay: SaaS Technology and Outsourcing How You Need It

Stuart Thiede, President, Payments, DrugDev

8:15 Session Break


8:25 Chairperson's Remarks

8:30 Amgen Development Design Center's New Approach to Feasibility: Driving Operational Strategy and Planning Using Historical Data and Local Experts

Laura_CookeLaura Cooke, Executive Director, Amgen Development Design Center, Global Development Operations, Amgen

Data-driven global site selection, an optimized protocol development and feasibility assessment process, and effective site management are critical to improving clinical trial timelines and outcomes. This presentation will share an approach to trial planning and execution that uses both data/tech as well as experts/relationships to improve feasibility.

8:55 Assessing New Data-Driven Approaches Informing Global Investigative Site Selection

Stella_StergiopoulosStella Stergiopoulos, Project Manager, Tufts Center for the Study of Drug Development, Tufts University

A 2016 Tufts CSDD study has demonstrated that current shifts in the investigative site landscape will increase the need for data-driven approaches to inform global investigative site selection, as the landscape remains highly fragmented, nascent, and unstable. In light of these findings, Tufts CSDD conducted two studies assessing current industry trends and strategies on end-to-end site identification through study start-up as well as assessing the types of data that can be gathered from BMIS and Industry strategies around data-driven solutions will be discussed.

9:20 CASE STUDY: Does Use of Public Data at the Study Level Result in a Different Planning Strategy When Compared to Shared Site-Level Data?

Christopher_ConklinChristopher Conklin, Director, Feasibility Center of Excellence, Pfizer

This case study will compare use of shared CTMS data at the site-level vs. publicly available data at the study level in support of study planning for a Phase III study of 1000 subjects with moderate to severe plaque psoriasis. The analysis focuses on two planning endpoints: number of sites required and expected number of patients enrolled per site. Publicly available data underestimates the number of sites required by 21%, and overestimates the enrolment rate by 53%. The session will conclude with a discussion of the potential impact on the need for rescue studies, projected trial enrolment duration, country/site selection, and the benefits of cross-company sharing of CTMS.

9:45 The "Patient's Voice", Incorporating a Valued Partner to Support Recommendations, Drive Efficiencies and Deliver Results

Peter_KoernerPeter Koerner, Associate Director, Site and Patient Access, INC Research/inVentiv Health

10:10 Coffee Break in the Exhibit Hall


11:10 Chairperson's Remarks

11:15 CO-PRESENTATION: Rolling Feasibility in Competitive Immuno-Oncology Trials

Jane_FangJane Fang, M.D., Head, R&D Information, Clinical Biologics, MedImmune/AstraZeneca

Jill_LoftissJill Loftiss, Head, Clinical Operations, Oncology, MedImmune/AstraZeneca

With the rapid development of cancer immunotherapy drug development, competition in the immuno-oncology (IO) trials is fierce. The precision medicine behind trial design is driving rapid change in the way of traditional feasibility assessment. As a result, the innovative approach of Rolling Precision Feasibility has been developed to provide ongoing comprehensive analyses covering trial competitive landscape, patient population, disease epidemiology, precision recruitment rate, regulatory approval landscape, country and site selection strategy, impact of standard of care change, etc.

11:40 PANEL DISCUSSION: Evidence for Success: Which Data Sources and Data Elements to Use in Study Planning and Site Selection

Elisa_CascadeElisa Cascade, President, Data Solutions, DrugDev


Julie_ArgentoJulie Argento, Senior Manager, Development Data & Analytics, Development Design Center (DDC), Amgen

Shawn_TedmanShawn Tedman, MBA, Head, Product Offerings, Clinical Trial Optimization Solutions (CTOS), QuintilesIMS

When it comes to data to plan clinical trials, drive country selection, predict enrollment, and find sites, more may be better, but each data source often adds cost, time, and complexity to the process. While the published literature cites 4 factors for predicting successful site performance: investigative site focus, experience, past performance, time to randomize first subject, actual best practice doesn't necessarily match the theory published in the literature. In this session, industry experts will review in detail which specific data sources and data elements they use to support evidence-based planning, and the relative importance and sequence in which these sources/elements are used.

  • Understand data sources and elements available to support study planning and site selection
  • Identify strategies for maximizing return while minimizing cost and burden
  • Gain insight into which data sources/elements are most powerful in an evidence-based approach

12:05 pm Session Break

12:10 Bridging Luncheon Presentation to be Announced

12:50 Coffee and Dessert Break in the Exhibit Hall

1:30 Close of Conference

Melissa DolenGroup Discounts Are Available! Special rates are available for multiple attendees from the same organization. For more information on group discounts, contact us.


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)