Cambridge Healthtech Institute's 10th Annual

Clinical Data Strategy and Analytics:
( 臨床データに関する戦略と分析法 )
 

Enabling Data-Driven Clinical Trials
データ重視の臨床試験の実現

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

 

臨床データに関する戦略と分析法をテーマにしたこのカンファレンスプログラムでは、臨床研究に対応するインフォマティクスの専門家が一堂に会し、急速に変わりつつある環境のなかでこの技術を発展させていくうえでの課題について議論し、必要な解決策について考えます。

 

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

INTEGRATED TECHNOLOGY PLATFORMS

10:45 Chairperson's Remarks

Jaydev Thakkar, IS Director, R&D Informatics, Amgen

10:50 SPECIAL OPENING PRESENTATION: Integrated Technology Platforms and the Implications to Our Clinical Organizations

Rehbar_TayyabkhanRehbar Tayyabkhan, Vice President, Global Data Strategies & Solutions, Global Clinical Operations, Bristol-Myers Squibb

As capabilities emerge with e-clinical technology platforms, esource, analytics, etc., clinical operations organizations have no choice but to adapt and realign our capabilities. This presentation will provide some context for some high-impact emerging changes and share some practical approaches taken to realize the value from these technological advancements.

11:15 CO-PRESENTATION: Technology Innovations Transforming Clinical Research, Are We There Yet?

Jaydev_ThakkarJaydev Thakkar, IS Director, R&D Informatics, Amgen

Yan Chow, M.D., MBA, Medical Director, Digital Health, Amgen

Innovative digital technologies are starting to disrupt the highly regulated and conservative biopharmaceutical industry. We will examine the clinical and business drivers of this revolution, as well as its impact on how and why we conduct research studies and clinical trials.

11:40 Implementing Large Change in a Large Organization

Christine_BuesnelChristine Buesnel, Director, Product Development, Biometrics, Roche

This talk will inform the audience of a large system, process and people change for management of the medical data that Roche/Genentech undertook over a 3-year timeframe. I will discuss the scope of the change, the impact on the organization, and the impact on the people. I will also address the lessons we learned and think are applicable to any large scale change in an organization.

12:05 pm CO-PRESENTATION: New Tufts Research: EDC Trends, Insights, and Opportunities

Ken_GetzKen Getz, MBA, Director, Sponsored Research Programs, Research Associate Professor, Tufts Center for the Study of Drug Development


Richard_YoungRichard Young, Vice President, Veeva Vault EDC, Veeva Systems

Hear new research from Tufts Center for the Study of Drug Development on current and evolving EDC practices across the drug development enterprise. Learn how seemingly minor decisions in one functional group can significantly impact overall clinical trial timelines. We'll also share where the industry is headed and ways to overcome key clinical data management challenges including protocol changes, source data verification, and more.

12:30 Session Break

12:40 Luncheon Presentation to be Announced

John Fontenault, COO, Omnicomm


1:20 Coffee and Dessert Break in the Exhibit Hall

BIOMETRICS TO FACILITATE INNOVATION IN CLINICAL DEVELOPMENT

2:00 Chairperson's Remarks

Christine Buesnel, Director, Product Development, Biometrics, Roche

2:05 Analytics to Drive Better Decisions in Clinical Development

Angelique_HopkinsAngelique Hopkins, MPH, Associate Director, Clinical Trial Analytics, Business Insights and Analytics, Bristol-Myers Squibb Company

Integrated, predictive analytics can help drive R&D strategy and execution, with clear benefits to operational costs and long-term financial success. Analytics in trial planning and execution are often viewed as drivers of delay rather than acceleration and analytics is rarely used effectively to drive decisions in planning. This presentation will discuss how embedding analytics into clinical development process can alleviate challenges and build trust with stakeholders for faster, better decisions.

2:30 From the Trenches: Technical Strategies for Start-Up and Virtual Pharma/BioTech Companies

Steve_SweeneySteven Sweeney, Vice President, Clinical Development Operations, Quartet

This presentation will focus on the technology stack utilized for clinical development in the start-up and virtual pharma/biotech sector. It will include a review of popular start-up models and overlay considerations for the use of technology to improve efficiency and vendor oversight and obtain scientific and medical insights.

2:55 Clinical Data Integration from Translational Modeling Using Machine Learning Approach

Raj_BandaruRaj Bandaru, Senior Director, Data Sciences Strategy, Translational Medicine, Sanofi

Use of clinical data for translational modeling and trial simulation is key capability to transform the pharma industry to more data and model-driven drug development. At Sanofi, we have developed some elegant machine learning approaches to integrate clinical study data and make it available for clinical research. This approach reduces the manual effort and thus enabling real time analytics and simulation of trial results.

3:20 Visual Analytics for Medical Data Review: A Physician's Perspective

Anthony Everhart, M.D., FACP, Vice President, Medical Informatics, Chiltern International, Inc.

BREAKOUT DISCUSSION GROUPS

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

DIGITALIZATION OF CLINICAL TRIALS

8:25 Chairperson's Remarks

8:30 Harnessing Digital Technology and Big Data in Clinical Trials and Beyond

Vaibhav_NarayanVaibhav Narayan, Vice President, Research and Therapeutic Area IT, Janssen

Measuring physiological and activity-based parameters remotely and continuously via unobtrusive on/off-body sensors or smartphones has the potential to revolutionise our ability to monitor patients between clinic visits and develop objective markers that track disease trajectory. How can we harness such advances in digital technology and big data analytics to enable more informative and efficient clinical studies and develop patient-centric digital solutions that improve outcomes in the real world?

8:55 Digital Biomarker Implementation, Presentation and Comparability

Amy_CalvinAmy Calvin, BS, MT (ASCP), MBA, Digital Strategy and Implementation, Advisor, Eli Lilly and Company

Over the past few years, data generation is beginning to take a new form. It's moving from subjective to more objective, from episodic to contemporaneous, and is being generated through connected digital tools that can be used to quantitatively explain or predict physiological, behavioral, and functional health measures and outcomes. These digital measures are known as digital biomarkers. This presentation utilizes learnings from pilot examples to examine the implementation, presentation and comparability of digital biomarkers.

9:20 Wearables and Sensors Are Changing the Clinical Trial Process, but What's the Return on Investment for This Dramatic Change in People, Process and Technology?

Debbie_ProfitDeborah Profit, Ph.D., Vice President, Otsuka Information Technology

The advent of wearables and sensors in clinical trials is changing the paradigm of trial designs, clinical teams, outsourcing practices, and ultimately patient engagement. However, what value does sensor/wearable data and these new trial practices bring, and how quick is the return of investment to the various stakeholders? Otsuka Pharmaceutical Development and Commercialization, Inc. is on the cutting edge of the trial and technology reform, and will share some critical learnings from "the road less traveled".

9:45 Presentation to be Announced

Speaker to be Announced, ZS Associates


10:10 Coffee Break in the Exhibit Hall

FROM THE TRENCHES: THE CASE STUDIES

11:10 Chairperson's Remarks

Chairperson to be Announced, ZS Associates

11:15 Data Integration Solutions: A Case Study of CSL Behring's Evolution on Managing Clinical Data

Thomas_VerishThomas Verish, Senior Director, Data Operations & Clinical Infrastructure, CSL Behring

CSL Behring had three new molecular entity approvals in the last two years for rare diseases to treat factor eight and nine deficiencies in hemophilia, along with hereditary angioedema. How does a company go from running small rare disease studies to delivering a Phase III CV mega-trial? We will discuss how we have spent the last two years preparing to start this study in the first half of 2018.

11:40 CO-PRESENTATION: Randomization Authorization Flow (RAF): It's Not Just about Meeting Eligibility Criteria

Jody Goldstein, Senior Clinical Project Manager, Center for Human Experimental Therapeutics, University of Rochester

Susan_BennettSusan Bennett, Senior Clinical Data Manager, Center for Human Experimental Therapeutics, University of Rochester

RAF is a review and approval process of predetermined key data points and eligibility criteria by a single point of contact (medical monitor) prior to randomization. The RAF process helps to ensure enrollment of the appropriate study-specific patient population. This gestalt review takes into account critical elements not necessarily covered by the eligibility criteria. Looking for subtle (subjective) differences between patients upfront ensures meeting the primary outcomes of the study.

12:05 pm Session Break

12:10 Bridging Luncheon Presentation: Centralizing Data to Address Imperatives in Clinical Development

Karim_DamjiKarim Damji, Senior Vice President, Products, Solutions & Marketing, Saama Technologies

With the deluge of structured, unstructured, and syndicated data, the use of varied data for targeted outcomes remains difficult, despite increased industry efforts to address the issue. New technologies are federating the ability to leverage analytic-ready data for innovations in clinical development and drug commercialization. With the application of clinical data-as-a-service and meta-data core, centralized clinical data lakes have the power to improve data quality, evidence generation, and time-to-insights.

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)



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