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

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 HallBioTelResearch

 

2:00 Afternoon Plenary Keynotes

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

DIGITAL HEALTHCARE TO RESHAPE CLINICAL TRIALS

4:10 Chairperson’s Remarks

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

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


Fombu_EmmanuelEmmanuel Fombu, MD, MBA, Physician, Author: The Future of Healthcare

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.

4:35 How Will Digital Transform Clinical Trials: Lessons from the Private Sector

LaPorte_JacobJacob LaPorte, PhD, 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.

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

Simmonds_AlexAlex Simmonds, Head, Clinical Trial Solutions, Noona Healthcare

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 Presentation to be Announced

5:45 PANEL DISCUSSION: Scaling Innovation

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


Panelists: Tammy Guld, Global Lead, Janssen Clinical Innovation

Speakers of the Session

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

7:15 Close of Day

Friday, February 21

7:15 am Registration Open

7:45 Breakfast Presentation to be Announced

8:15 Session Break

VIRTUAL AND REMOTE TRIALS

8:20 Chairperson’s Remarks

Chair to be Announced, TrialScope

 

8:25 Virtual Trials from A to Z: Operations, Technology, Data Analytics

Duffy_PamPam Duffy, Senior Director & Digital Strategic Planning and Demand Lead, Pfizer

Virtual trials bring studies directly to patients, increasing participation and boosting your cycle times. Combining technology, data science and clinical expertise, they speed patient recruitment, heighten retention and enhance data quality--at lower cost.

8:55 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.

9:25 AI in Clinical Trials: From Big Sky to Practical Application

Reilly_JimJim Reilly, Vice President, Vault Clinical, 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.

3DS-MEDIDAT3009:55 Presentation to be Announced

10:25 Networking Coffee Break

10:55 Chairperson’s Remarks

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

11:00 PANEL DISCUSSION: Virtual Trials: State of the Union

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


Panelists: Speakers of the Session

  • Let's discuss terminology: Site-less, de-centralized, virtual?
  • Does it have to be one model, or can we mix (e.g. traditional and remote)?
  • Does digital technology inevitably lead to virtual trials?
  • What are some specific challenges in retaining patients and investigators?
  • What are the data science considerations in de-centralized/virtual trial?

11:30 Presentation to be Announced

12:00 pm Transition to Shared Sessions

AI TO ENABLE DIGITALIZATION OF CLINICAL TRIALS

12:00 Chairperson’s Remarks

12:05 Real World Evidence Generation for Clinical Decision Making: Can AI Solve the Challenges?

Bartels_DorotheeProfessor Dr. Dorothee Bartels, Clinical and Real World Data Strategist, X The Moonshot Factory

Real World Evidence Generation (RWE) is continuously gaining importance, but trust in results, transparency and reproducibility are challenging. The same is true for prediction models based on learning algorithms. Questions are arising: who may be the best expert in big data analysis; who may have the appropriate skill sets; and can clinical decisions be based on real world data analysed by either traditional or artificial intelligence (AI) methods? Complementary approaches using synergies from the epidemiological and AI field may boost the field of RWE.

12:25 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.

12:45 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 Inc.


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

Faisal Khan, PhD, Executive Director, Advanced Analytics and Artificial Intelligence, AstraZeneca

Arun Patnaik, Director, Clinical Data Management, Data Operations, Novartis

Malaikannan Sankarasubbu, Vice President, AI Research, Saama Technologies

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

1:10 SCOPE Send Off Luncheon Presentation (Sponsorship Opportunity Available)

1:40 Closing Remarks

1:45 SCOPE Summit 2020 Adjourns

PLENARY KEYNOTES

Tuesday Evening, Wednesday Morning, Wednesday 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