Cambridge Healthtech Institute’s 9th Annual

Clinical Technology and Innovation

Disruptive Technologies for Data and Trial Management

February 20-21, 2020


Digital technology, mobile solutions, novel data collection modalities, and integrative systems are becoming game-changing features of modern clinical trials. However, the adoption of novel technology solutions to improve overall outcomes and garner operational efficiencies has been slower than expected. CHI's 9th Annual Clinical Technology and Innovation conference will be featuring a broad array of topics, such as digitalization of clinical trials, machine learning, implementation and adoption strategies, and more.

Arrive early and attend Part 1 (Wed - Thurs): Sensors, Wearables and Digital Biomarkers in Clinical Trials

Final Agenda

Thursday, February 20

11:30 am Registration Open (Regency Rotunda)

PRA_New 12:30 pm BRIDGING LUNCHEON PRESENTATION: Navigating the Inclusion of Wearables in Clinical Trials: Considerations with Different Patient Populations

Christina Fawcett, Senior Director, Operations, PRA Health Sciences

What types of studies do wearables seamlessly integrate and when do the complications outweigh the benefits? Are all types of patients ready to embrace wearables and are we ready to support the change?

1:00 Coffee and Dessert Break in the Exhibit Hall (Windermere Ballroom)

BioTelResearch

 

2:00 Afternoon Plenary Keynotes (Regency Ballroom S)

3:10 Booth Crawl & Refreshment Break in the Exhibit Hall. Last Chance for Exhibit Viewing (Windermere Ballroom)

DIGITAL HEALTHCARE TO RESHAPE CLINICAL TRIALS
Barrel Spring

4:10 Chairperson’s Remarks

Craig Lipset, Independent Advisor, Former Head of Clinical Innovation, Pfizer

4:15 Predictive Medicine: Artificial Intelligence and Its Impact on the Future of Healthcare

Fombu_EmmanuelEmmanuel Fombu, MD, MBA, Vice President, Locust Walk

The true benefits of artificial intelligence, machine learning, natural language processing, robotics and data will be seen when we move away from our current fee-for-service model of healthcare and towards preventative medicine. The idea is simple: instead of waiting for people to get sick and then trying to treat their symptoms (reactive medicine), we can head illnesses off at the pass, intercept and stop them from becoming a problem in the first place. Artificial Intelligence is making the art and science of predictive medicine cheap and realistic.

4:30 NEW: A Clinical Trial Moonshot?

LaPorte_JacobJacob LaPorte, PhD, Patient; Co-Founder & Vice President, Global Head of BIOME – The Digital Innovation Lab, Novartis

Implementing digital solutions is harder than it looks. One of the key reasons for that is lack of global regulatory standards. The digital challenge can overwhelm the sites and it requires investment to test & validate the technology. Digital technologies will lead to data explosion and more targeted clinical studies.

4:45 Brief Summary of SCOPE Scientific Symposium

Michelle Crouthamel, PhD, Director, Digital Health & Innovation, AbbVie

4:55 Digital Health Dreams vs. Digital Health Reality: Realities of Building Innovative Patient-Centric Capabilities for Clinical Trials

Simmonds_AlexAlex Simmonds, Head, Clinical Trial Solutions, Varian Medical Systems 

The hyped-up potential of digital health technology to transform pharma shouts from every industry news source and at every crowded conference. But, the truth is that technology invention and innovation have always preceded technology adoption by many years, in every industry. This is especially true in life sciences R&D, where the frictions to innovation adoption – powerful regulatory constraints, long timelines to execute trials and the misaligned incentives of the healthcare system itself – have resulted in especially slow progress bringing new technologies into clinical trial conduct.

5:15 CO-PRESENTATION: Leveraging the Low-Code Platform to Streamline the Processes for Advisory Boards and Learning Events

choudhri shurjeelShurjeel Choudhri, Senior Vice President, Head, Medical & Scientific Affairs, Bayer Inc.
cohen eviEvi Cohen, Vice President, Global Life Sciences & Healthcare, Appian


In this session, you will hear and learn how Bayer Canada is leveraging a leading low-code intelligent automation platform to streamline the processes for planning and conducting Advisory Boards and Learning events. The innovative approach to managing the overall processes will allow Bayer to plan and conduct these activities more efficiently while reducing overall process complexity.  

5:45 PANEL DISCUSSION: Scaling Innovation

Lipset_CraigModerator: Craig Lipset, Independent Advisor, Former Head of Clinical Innovation, Pfizer


Panelists: Tammy Guld, Global Lead, Janssen Clinical Innovation

Emmanuel Fombu, MD, MBA, Vice President, Locust Walk

Jacob LaPorte, PhD, Patient; Co-Founder & Vice President, Global Head of BIOME – The Digital Innovation Lab, Novartis

Alex Simmonds, Head, Clinical Trial Solutions, Varian Medical Systems

Digital tools can generate a great deal of buzz and attention, but most companies today are exploring and experimenting with similar digital solutions. What will set companies apart is not whether they can find digital tools or pilot solutions, but which companies are able to implement and scale digital solutions across their development organization.

  • Explore how companies are organizing themselves to scout, pilot and scale digital solutions
  • Identify strengths across various models -- from centralized digital and innovation teams to capabilities being embedded with business owners
  • Share best practices to move innovation “beyond the pilot”

6:15 Networking Reception (Manatee and Spring Foyer)

7:15 Close of Day

Friday, February 21

7:15 am Registration Open (Regency Rotunda)

7:45 BREAKFAST PRESENTATION: Breaking Down the Roadblocks to Site Activation (Regency Ballroom T)

Johnston_JillJill Johnston President, Study Planning & Site Optimization, WCG


8:15 Session Break

PRACTICAL APPLICATIONS OF AI
Barrel Spring

8:20 Chairperson’s Remarks

Jeff Kozloff, CEO, TrialScope

8:25 Quantifying the Value of Enrollment Acceleration Strategies

David SwankDavid Swank, Technical Director, Strategic Options and Assessments, R&D, Bristol-Myers Squibb Co.

How do you deploy your limited resources (head count and cash) to maximize the value of your portfolio? This presentation will discuss how to quantify the overall time to launch for event driven studies, and how potential acceleration efforts can be valued. The key drivers of study value will be discussed along with helpful rules of thumbs and questions you should be asking so your organization make informed resourcing decisions.

8:55 AI in Clinical Trials: From Big Sky to Practical Application

Reilly_JimJim Reilly, Vice President, Clinical Market Strategy, Veeva Systems

Artificial Intelligence (AI) has made its way into the realm of clinical trials and is reshaping how studies are conducted. This presentation looks at the practical ways AI and process automation are being used effectively today to optimize trial design and execution. Join this presentation for a look into how technology is revolutionizing the clinical operations landscape – from the smallest biotech to big pharma.

VIRTUAL AND HYBRID TRIALS

9:25 CO-PRESENTATION: Understanding the Data Journey in Virtual Trials

Ibrahim_AdamaAdama Ibrahim, Associate Director, Clinical Operations, Biogen


Kornberg_AndrewAndrew Kornberg, Associate Professor & Senior Neurologist, The Royal Children's Hospital Melbourne

Virtual trials promise to improve clinical research. New methods of data collection and usage also bring new challenges. This forum will model the journey of data in a virtual trial, identify key challenges and offer solutions for sponsors and CROs.

9:55 CO-PRESENTATION: Decentralized Trials Have Arrived: How to Successfully Implement Global Virtual TrialsIQVIA_NoTagline_NEW

Josh RoseJosh Rose, Vice President, R&DS Global Strategy, Head, Virtual Trial Solutions, IQVIA
MaryAnne RizkMaryAnne Rizk, PhD, Senior Vice President, Digital R&D Strategy,Research & Development Solutions,  IQVIA Technologies


Virtual trial models bring clinical research directly to patients, reducing the burden of participation and improving engagement. These innovative models offer operational flexibility to better meet the needs of all clinical trials stakeholders while curbing costs and shortening timelines. Speakers will share lessons learned and best practices planning and implementing different decentralized trial models: from hybrid trials, to long-term follow-up studies, and trials for specialty areas like digital therapeutics. Session includes a live technology demo.

10:25 Networking Coffee Break (Session Room Foyer)

10:55 Chairperson’s Remarks

Craig Lipset, Independent Advisor, Former Head of Clinical Innovation, Pfizer

11:00 PANEL DISCUSSION: 360 Degrees of Insight on the Present and Future of Decentralized Trials: Patient, Site, Sponsor, CRO and Technology

Co-Moderators: Craig Lipset, Independent Advisor, Former Head of Clinical Innovation, Pfizer, Inc.

Anthony Costello, Senior Vice President, mHealth, Medidata, a Dassault Systèmes company 

Panelists: Adama Ibrahim, Associate Director, Clinical Operations, Biogen

Bola Oyegunwa, Vice President, Global Head Virtual Trials, Covance

Kay Scroggins, RN, President & CEO, Clinical Trials of Texas

T.J. Sharpe, Patient Advisor, Starfish Harbor, LLC

  • Where are decentralized trials today?
    • Current state of industry adoption
      Indicators of acceptance or anxiety among key research stakeholders
      Use of "fully virtual" versus "hybrid" trial models
      Experience impacting patient retention and representation
      Data and data science needs and requirements
  • Where are decentralized trials heading tomorrow?
    • Ensuring patient preference is recognized and embraced
      Change management required for scale in the organization
      Understanding and overcoming barriers to meaningful adoption
      Getting beyond variations in jargon
      Opportunities for cross-company collaboration

    12:00 pm Transition to Shared Sessions

    AI TO ENABLE DIGITALIZATION OF CLINICAL TRIALS
    Manatee Spring

    12:00 Chairperson’s Remarks

    Prasanna Rao, Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer Inc.

    12:05 Re-Skilling for AI/ML: Leveraging Your SMEs

    Katan_NechamaNechama Katan, Associate Director, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer

    AI/ML are very powerful tools for clinical trials. However, there is a gap between those that understand what AI/ML can do for the business and the business SME (subject matter experts) who really understand the business problems. Without strong SME engagement in solutions, technical solutions are often at risk. This talk will review successful case studies for developing “lego” employees/teams who help bridge the gaps between AI/ML technologist and the SMEs. We will discuss both the how and what that makes an AI/ML project successful in clinical trials.

    12:25 PANEL DISCUSSION: AI Implementation: Technology, Data, People

    Rao_PrasannaModerator: Prasanna Rao, Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer


    Panelists: Balazs Flink, PhD, Head, Clinical Trial Analytics, R&D Business Insights, Bristol-Myers Squibb

    Abhishek Kadam, Associate Director, Data Operations, Clinical Data Management, Novartis

    Malaikannan Sankarasubbu, Vice President, AI Research, Saama Technologies

    Shameer Khader, PhD, Senior Director, Advanced Analytics, Data Science & Bioinformatics, AstraZeneca

    It was proven that machine learning and AI can aid clinical development in various aspects. With evolving AI technology implementation challenges become more and more noticeable. This panel discussion will brainstorm the key pain points of AI implementation:

    • What is the best technology and how to work with technology providers?
    • How to make all data machine learnable and available for AI applications
    • How to solve “the people puzzle”

    1:05 Transition to Lunch

    WIRB_CopernicusGroup 1:10 SCOPE Send Off Luncheon Presentation: Proven, Pragmatic Applications of Artificial Intelligence in Safety Reporting

    Steven Beales Senior Vice President, Safety Solutions Scientific & Regulatory Review WCG

    1:40 Closing Remarks

    1:45 SCOPE Summit 2020 Adjourns


    PLENARY KEYNOTES

    Tuesday Evening, Wednesday Morning and Thursday Afternoon Plenary Keynotes Featuring:

    SCOPE’s 2020 Participant Engagement Award, in Memory of Jerry Matczak
    Patient Perspectives as an Input to Feasibility and Clinical Trial Design
    Digital Trends that Are Changing Clinical Research
    Health Literacy Throughout Drug Development – Why It Matters to Pharma and to Patients
    Implementing an Innovation Methodology to Accelerate Clinical Trial Innovation within Your Organization

    For more details on the Plenary Keynotes: www.scopesummit.com/keynotes
    For more details on the Participant Engagement Award: www.scopesummit.com/participant-engagement-award

    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. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. 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: www.scopesummit.com/breakouts