Cambridge Healthtech Institute's 7th Annual

Clinical Technology and Innovation:
( 臨床試験のための技術と革新 )

Disruptive Technologies for Data and Trial Management
データと臨床試験管理のための革新的な技術

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

 

臨床試験のための技術と革新をテーマにしたこのカンファレンスプログラムでは、ブロックチェーン技術、機械学習、デジタル技術のトレンド、臨床研究への導入など、幅広いトピックが議論されることになっており、知識や経験を実践的かつ生産的に交換することができます。

 

Wednesday, February 14

11:30 am Registration Open

12:10 pm Bridging Luncheon Presentation: Streamline Clinical Trials with the Industry's Only Proven Clinical Operations Suite - DrugDev Spark™

Brett Kleger, Chief Commercial Officer, DrugDev


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

BLOCKCHAIN, ML, AI

4:00 Chairperson's Remarks

Balazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb

4:05 Blockchain Disruption: How Blockchain Will Change Our Industry

Munther_BaaraMunther Baara, Senior Director, Development Business Technology, Pfizer

Imagine a solution that makes it easy to aggregate health data in a secure, trusted, automated, and error-free way. A solution which enforces rules, privacy, and regulations in a mutually agreed upon manner, resulting in a smart-contract between patient and healthcare stakeholders. This enables patients to aggregate their data from diverse health sources and share what they choose to with their physicians and researchers. All this puts the patient in control of their health and wellbeing, rather than being along for the ride: How it works; Key benefits; Empowering the patients with control over their data.

4:30 Exploration of Where Machine Learning Will Help in the Product Development Process in the Pharmaceutical Industry

Francis_KendallFrancis Kendall, Technology Evaluation and Implementation Leader, Product Development, Roche

The talk will explore how Machine Learning is and will change how Product Development is carried out in the industry from improving efficiencies, gaining more insights on products, improved surveillance of products, especially safety and its use in IoT devices.

4:55 Leveraging Digital Transformation to Unify Data and Process and Boost Clinical Operations

Evi_CohenEvi Cohen, Vice President, Global Pharma & Life Sciences, Appian

Conducting and managing a successful, safe clinical trial is complicated. With massive data and complex processes at the core, it's no surprise innovation in Business Process Management (BPM) is behind many successful trials.

5:25 Intelligent Clinical Trial Design, Planning and Conduct

Balazs_FinkBalazs Flink, M.D., Clinical Trial Analytics Lead, R&D Business Insights and Analytics, Bristol-Myers Squibb

As technology evolves and AI solutions become more sophisticated, there is a natural demand to test and apply them in areas that were traditionally expert opinion-guided. This presentation is about early experiences and challenges of pharma companies - including BMS - that are starting to apply AI in the R&D space to promote precision oncology, identify targets, design and plan trials and translate strategy to efficient operational execution.

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


REMOTE TRIALS AND DIGITAL TECHNOLOGY

8:30 Chairperson's Remarks

Julie Dietrich, MS, Director, Development Design Center, Amgen

8:35 Remote Data Monitoring: Ideal Model versus Current Practices

Charles_RomanoCharlie Romano, Vice President, Global Clinical Operations, Peachtree Bioresearch Solutions

This presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints. Key findings from a survey of patients in four therapeutic areas will also be presented, focusing on factors important to the design and conduct of clinical trials involving mobile devices.

9:00 CO-PRESENTATION: How Technology Can Enable Patient-Centric Clinical Research

Julie_DietrichJulie Dietrich, MS, Director, Development Design Center, Amgen

Sindhya Govind, Specialist Business Systems Analyst, Amgen

Presentation highlights will include: Opportunities for technology to be part of a patient-centric strategy and improve patients' experience with clinical research.

almac 9:25 Talk Title to be Announced

Theodora_SarverTheodora Sarver, Manager, Product Management, Almac Clinical Technologies



9:50 Real World Innovation and Application in Pipeline Data Approaches

Amelia_Wall_WarnerAmelia Wall Warner, Ph.D., RPh, CEO & Founder, Global Specimen Solutions

Pharmaceutical companies have collected vast amounts of data during a clinical trial, yet only ~20% of the data is used. Disparate data sources, unaligned data, and incomplete data sets prevent in-life interventions, lead to delays in go to market, and can lead to non-compliance with regulations. In this presentation, we will discuss case studies that empowered translational medicine and clinical operations teams to make decisions that advanced drug development.

10:15 Networking Coffee Break

REMOTE TRIALS AND DIGITAL TECHNOLOGY (CONT.)

10:30 Chairperson's Remarks

10:35 Clinical Trial Pilots of Wearable Sensors in Diabetes and Asthma

Martin_KarpeforsMartin Karpefors, Ph.D., Informatics Science Director, CardioRenal, Autoimmune & Neuroscience TA Lead, AstraZeneca

Sensors offer a way to transform clinical trial results from snapshot measurements of physiological parameters to continuous remote monitoring, which will enable disease insight, increase patient engagement and control, as well as give cost savings and operational advantages. However, these promises do not come without challenges. Based on our pilot experiences from (multi-)sensor trials in diabetes and asthma, we present some scientific, analytical and operational perspectives.

11:00 Presentation to be Announced



11:25 Transition to Shared Sessions

M-HEALTH'S POTENTIAL TO IMPROVE PATIENT CENTRICITY AND THE CONDUCT OF CLINICAL TRIALS

11:35 Digital Trends Impacting Recruitment, Engagement and Retention

Shwen Gwee, Head, Digital Strategy, Global Clinical Operations, Biogen

Digital technology is connecting more people to clinical trials than ever before and at the same time the adoption of wearables as data collection devices in clinical trials is rising. The hope of streamlining trial operations, patient recruitment and registration is real. What technolgies and approaches are having the greatest impact on recruitment, engagement and retention?

12:00 pm CASE STUDY: The Art and Science of Patient Engagement in the Digital Era - Learning from GSK PARADE Study

Michelle Crouthamel, Lead, Clinical Innovation & Digital Platforms Unit, GlaxoSmithKline

The ability to efficiently develop new medicines for patients with unmet needs is limited by the current model for clinical development. Although the emerging mHealth technologies have the potential to improve the conduct of clinical trials, the successful implementation requires careful study design and patient engagement. Data and experiences from GSK PARADE study will be summarized, highlighting the learning and opportunities in this new area of clinical development.

12:25 Mobile Clinical Trials: New Findings on Patient and Site Perspectives from the Clinical Trials Transformation Initiative

Hassan Kadhim, Business Consultant for Clinical Operations, Boehringer Ingelheim Pharmaceuticals

This presentation will discuss qualitative and quantitative research conducted by the Clinical Trials Transformation Initiative to understand the perspectives of patients and site investigators of mobile clinical trials. Discussion will include insights and advice from site investigators who have participated in trials that incorporate mobile devices to collect data for study endpoints.

12:50 PANEL DISCUSSION: Why Are There Barriers to the Adoption of Innovative Processes and Technologies at Sites?

Moderator: Jim Kremidas, Executive Director, Association of Clinical Research

Professionals (ACRP)

David Vulcano, Assistant Vice President & Responsible Executive for Clinical

Research, Hospital Corporation of America (HCA)

Sean Walsh, MBA, Chief Development Officer, Raleigh Neurology Associates

Beth Harper, MBA, Workforce Innovation Officer, Association of Clinical

Research Professionals (ACRP)

Many innovative technologies and process improvement initiatives are coming out at a rapid pace, whether from TransCelerate and other industry consortia, or from technology companies themselves. Which of these improvements actually work? How can sites implement these more effectively? Why are there barriers to adoption, and how can the innovators better understand sites' needs?

  • Share sites' perspective on the evolving clinical research landscape
  • Discuss the reasons sites struggle with new processes and technology tools
  • Determine ways to facilitate adoption

1:15 Closing Remarks

1:20 SCOPE Summit 2018 Adjourns

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


* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

Choose your language
Traditional Chinese
Simplified Chinese
Korean
English




Signature Sponsor

Premier Sponsors

CAG

> スポンサー

> メディアパートナー

> 出席者

> 出席者の内訳

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)



メール配信サービス