2020 Archived Content

2020 Keynote Speakers

Join these keynote presentations, co-presentations, panels and live Q&A sessions listed below. There are multiple options listed at the same time: choose one option and then watch the others on-demand later. On-demand presentations will be available for one year. You will have access to all of these impressive presentations to view at a time convenient to you. Time zones on the agenda are in CET (Central European Time: +6 hours Eastern Standard Time, +9 hours Pacific Standard Time). Presentations will become available to watch at the scheduled CET time. We are proud to feature a variety of topics and people that we hope can help you and the industry take clinical research into the future.

TUESDAY, 10 NOVEMBER

11:55 Event Kick-off

12:00 Option 1: Design as the Ultimate Expression of Strategy: How to Empower the Execution of Bold Ideas

Majid Iqbal, Special Advisor, Strategy and Design, Ministerie van Defensie; Author, Thinking in Services
Strategic design is the process of translating game-changing decisions into clear, concise, and complete instructions for execution: the who, why, how, what, when, and where of operations. Encoding them into the designs of systems and services allows us to “take more risk while avoiding it.” Having it both ways requires dexterity in switching between the abstract and the concrete. It requires thinking and tooling that is at once simple and sophisticated, advanced and primitive. This talk gives two examples of strategic design in practice: within a government agency and a major healthcare initiative.

12:00 PANEL PRESENTATION: Option 2: Expanding the Boundaries of Patient-Centric Trials & Understanding the Implications of Virtual Trials

PANEL MODERATOR:
Gareth Powell, Patient Engagement & Clinical Development Project Lead, Business Development & Marketing, NIHR Clinical Research Network
The clinical research landscape in the UK is rapidly evolving to become more patient-centric in how we identify, engage, and enroll participants. For example, we know that there is greater inclusivity from reaching out to a community population to participate in research, as compared to waiting for the right patient to come to the right research unit at the right hospital where a trial happens to be taking place. This presentation will describe a number of patient-centric initiatives that are being implemented which span primary and secondary care, and the community in the UK to boost recruitment and retention to later-phase commercial trials. It is an opportunity to hear some of the current thinking and new ideas about how the next generation of clinical trials will be delivered, and what the impact of these changes will be. The multi-stakeholder panel will discuss how these initiatives will benefit the patient, industry, and other key stakeholders.

Understand new patient-centric initiatives spanning primary, secondary, and community care in the UK that boost recruitment
Delivering the first virtual trials in the UK: Understand what is involved and the implications of the virtual trial
Discover the benefits of a multiple modality approach to patient recruitment
Identify where the PIC model will derive the most benefit for your trial
Learn about best practices: Challenges, successes, and solutions in patient engagement in clinical research design

PANELISTS:
Sophie Evett, PhD, Feasibility Lead, Feasibility Center of Excellence & Study Optimization, Pfizer Ltd.
Marta Garcia, PharmD, MPH, Director, Patient Involvement in R&D, Clinical Development, Servier
Yan Yiannakou, MBChB, Professor of Neurogastroenterology, NIHR National Patient Recruitment Centre - Newcastle, Newcastle Hospitals NHS Trust

15:00 Option 1: A Clinical Trial Moonshot?

Jacob 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.

15:00 Option 2: CO-PRESENTATION: Sustainable Patient Engagement for an Impactful Patient-Centric Clinical Development Program
While many companies support patient centricity in principle, few successfully engage patient perspectives and integrate learnings cross-functionally, impacting and improving patient experiences and outcomes. At Ipsen, we believe a combination of company-wide collaboration and actively integrating patient perspectives in every new program leads to better results for everyone. To this end, we propose to share a case study, four years in the making, that highlights how patient insights have impacted our Phase II to Phase III programs.

Pascale Cavillon, Director, Global Patient Centricity, Global Medical Affairs, IPSEN Pharma

Christine Seymour, Senior Director, Head, Global Clinical Operations Oncology & Rare Disease, Ipsen

15:20 OPTION 1 LIVE: Speaker Q&A

PANEL MODERATOR:
Jacob Laporte, PhD, Patient; Co-Founder & Vice President, Global Head of BIOME - The Digital Innovation Lab, Novartis

15:20 OPTION 2 LIVE: Speaker Q&A

PANEL MODERATORS:
Pascale Cavillon, Director, Global Patient Centricity, Global Medical Affairs, IPSEN Pharma
Christine Seymour, Senior Director, Head, Global Clinical Operations Oncology & Rare Disease, Ipsen

15:30 Option 1: IMITrials@Home – Building a Framework for Remote Decentralized Trials in Europe

PANEL MODERATOR:
Duane Schulthess, Managing Dir, Vital Transformation BVBA
This interactive panel discussion will introduce the https://trialsathome.com/ project and a broader story about building a framework for remote decentralized trials across Europe.

What are Remote Decentralized Trials (RDCTs) and why do we need them?
Best practices based on industry experience to date
Technology recommendations and considerations
Mapping the compliance landscape in Europe for RDCTs and addressing bottlenecks
Stakeholder engagement: What do participants and HCPs think of this model and what can be done to support them?
Practical application: Running a large pan-European RDCT

PANELISTS:
Mira Zuidgeest, PhD, University Medical Center Utrecht, Julius Center, Global Health; IMI Trials@Home project lead and WP PILOT co-lead
Kai Langel, Director, Clinical Innovation, Janssen Cilag SA
Philippe Bordes, Alliance Manager, Public Private Partnerships, Sanofi Group

15:30 Option 2: Precision Medicines Need Precision Enrollment

Patrick Short, Dr, CEO, Sano Genetics

Liam Eves, Director, Sano Genetics

Billy Boyle, Founder and CEO, Owlstone Medical

Precision medicine requires access to high-quality medical history and genomic data for screening. Sano has developed a framework called Precision Enrolment. The key pillars to our approach are a rich digital experience, long-term relationships with patients, deep medical and genomic data, and a data-driven process that integrates with sites.

16:00 Session Break - View Our Virtual Exhibit Hall

16:30 Problem-Solving Breakout Discussions - View Our Virtual Exhibit Hall
Join your colleagues and fellow delegates for a focused, informal discussion moderated by a member of our speaking faculty. A small group format allows participants to meet potential collaborators, share examples from their own work and discuss ideas with peers.

17:10 Session Break - View Our Virtual Exhibit Hall

17:35 Option 1: The Journey from Patient to Advocate to Leader: Changing the Clinical Research Game & Impact of Rare Disease Research on COVID-19

Rob Long, Executive Director, Uplifting Athletes
I will talk about my journey from Division I football and top NFL prospect to cancer patient. My experience of undergoing chemo and radiation and fighting through a battle with brain cancer has enabled me to leverage my story to make a difference in the lives of those affected by rare diseases. The attendees will gain insights into what it means to be a volunteer at the front lines of oncology research and clinical trials. New approaches to partnering with advocates, disease communities and young researchers will be shared. In addition, we will discuss the future of rare disease research and the impact that this research is having in the world of COVID-19.

17:35 Option 2: KEYNOTE PANEL: Impact of the COVID-19 Pandemic on ClinicalTrials and Monitoring: Challenges and Solutions

PANEL MODERATOR:
Laurie Halloran, President & CEO, Halloran Consulting Group Inc
Discuss the impacts of COVID-19 on clinical trials, including delays in patient enrollment and study initiation, inability of patients or sites to comply with scheduled visits, impacts of limited staffing and study materials due to reprioritization, and more. Discuss how best to address statistical implications from missed patient visits, tests, and increased protocol deviations; strategies to advance decentralized trials and remote monitoring; and near-term and longer-term strategies to mitigate the impacts of COVID-19 on clinical trials.

PANELISTS:
Marissa Volpe, Vice President, Head of Global Clinical Development Operations, Sarepta Therapeutics
Kevin Douglass, Associate Director, Process Excellence & Risk Management, Daiichi Sankyo Inc
Carrie Melvin, Senior Vice President, Development Operations, X4 Pharmaceuticals

17:55 OPTION 1 LIVE: Speaker Q&A

PANEL MODERATOR:
Rob Long, Executive Director, Uplifting Athletes

17:55 OPTION 2 LIVE: Speaker Q&A

PANEL MODERATOR:
Laurie Halloran, President & CEO, Halloran Consulting Group Inc

PANELISTS:
Kevin Douglass, Associate Director, Process Excellence & Risk Management, Daiichi Sankyo Inc
Carrie Melvin, Senior Vice President, Development Operations, X4 Pharmaceuticals
Marissa Volpe, Vice President, Head of Global Clinical Development Operations, Sarepta Therapeutics

18:05 Session Break - View Our Virtual Exhibit Hall

WEDNESDAY, 11 NOVEMBER

12:00 Option 1: Empowering Patients through a Fully Digitalized Experience

Mohanad Fors, Head, Global Commercial Digital Innovation, Almirall LLC
Patients are the center of all our actions and our daily work. Digital solutions are providing unique channels and opportunities when it comes to our patients' interactions. We are experiencing new dimensions in this world of direct-to-patient trials, remote trials, virtual trials, and seamless digital interactions. A special set of technical capabilities and a relationship with patients based on trust is required to lead us through a fully digitalized experience through the whole treatment journey. What is the role of patients in the new treatment regimens and how has this changed in the digital era? What are the key challenges? Digital solutions vary from simple patient support programs to digital therapeutics and complete virtual interactions. In the session, we will be covering the new patient journey now and in the future with new understanding of the patient's role in the management of digital assets and digital panning.

12:00 Option 2: Pragmatic Clinical Trials: Real-World Evidence’s Hidden Gem

Mats Sundgren, PhD, Director, Health Informatics, AstraZeneca R&D
There is a growing interest in the collection of patient data beyond the traditional realm of randomised clinical trials (RCTs), for which costs have steadily ballooned in recent years, prompting pharma to turn to routinely collected data as a means of creating more efficiency in their research. Pragmatic clinical trials (PCTs) are research investigations embedded in health care settings designed to increase the efficiency of research and its relevance to clinical practice. Costs can be reduced by building RCTs upon existing registries and electronic health records (EHR), an approach that is increasingly supported by health authorities. This presentation will discuss and present recent efforts and regulatory aspects of conducting the next phase of PCTs for label inclusion.

12:20 OPTION 1 LIVE: Speaker Q&A

PANEL MODERATOR:
Mohanad Fors, Head, Global Commercial Digital Innovation, Almirall LLC

12:20 OPTION 2 LIVE: Speaker Q&A

PANEL MODERATOR:
Mats Sundgren, PhD, Director, Health Informatics, AstraZeneca R&D

14:20 LIVE CO-PRESENTATION: Evolving from the Pandemic: Moving toward a New Vision for Clinical Trials in 2030

Pamela Tenaerts, MD, MBA, Executive Director, Clinical Trials Transformation Initiative (CTTI)
In the face of the COVID-19 pandemic, the clinical trials ecosystem has moved rapidly to implement a range of innovative approaches – from running virtual visits and using mobile technologies, to streamlining trial designs and running master protocols – in an effort to quickly evaluate promising therapeutics without rebuilding research infrastructure. In this keynote presentation, the executive directors of the Clinical Trials Transformation Initiative (CTTI) and the Innovative Medicines Initiative (IMI) will discuss:

How the COVID-19 pandemic is transforming the clinical trials ecosystem
Emerging best practices for planning and conducting high-quality clinical trials in the current global landscape
A multi-stakeholder vision for sustaining and driving innovation in clinical trial design and execution into the next decade

Pierre Meulien, PhD, Executive Director, Innovative Medicines Initiative (IMI)

14:55 Session Break - View Our Virtual Exhibit Hall

15:05 Problem-Solving Breakout Discussions - View Our Virtual Exhibit Hall
Join your colleagues and fellow delegates for a focused, informal discussion moderated by a member of our speaking faculty. A small group format allows participants to meet potential collaborators, share examples from their own work and discuss ideas with peers.

15:45 Session Break - View Our Virtual Exhibit Hall

16:05 Option 1: Digitalization of Clinical Trials: Breakthroughs in Technologies and Data

Peter Bergethon, Vice President, Head of Digital and Quantitative Medicine, Biogen
Medicine as systems science characterizes the health state by measurable properties. Changes in state over time (dynamics) define trajectories through growth, health and disease. Dynamic transitions define trajectories between health, illness and therapeutic interventions. Capturing time dependence is the power of digital technology. Herein lies the power of digital medicine. We will review specific cases showing how this paradigm is transforming our clinical trial landscape.

16:05 Option 2: AI in Human Health – Connecting Data Modules from Discovery Biology to Clinical Development

Rangaprasad Sarangarajan, PhD, Sr VP & CSO, Berg LLC
Drug development programs in companies are predicated on biological insights supporting a hypothesis of target and its role in disease etiology. This presentation will focus on the data modules essential for linking discovery biology to early/late stage clinical development and the leveraging of AI in the integration of the various dataflow to make data-driven informed decisions and ensure success. It will outline how to utilize data, AI analytics with RWD-based support for planning drug development to propel products all the way through the clinic.

16:25 OPTION 1 LIVE: Speaker Q&A
PANEL MODERATOR:
Peter Bergethon, Vice President, Head of Digital and Quantitative Medicine, Biogen

16:25 OPTION 2 LIVE: Speaker Q&A
PANEL MODERATOR:
Rangaprasad Sarangarajan, PhD, Sr VP & CSO, Berg LLC

16:35 Session Break - View Our Virtual Exhibit Hall

18:45 Option 1: What Causes Studies to Fail? Understanding Causal Drivers of Operational Success Using Machine Learning

Marcy Kravet, BS, MBA, Head, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
It is currently unknown what drives successful study enrollment despite extensive analysis conducted across the industry, which largely has focused on correlations. The Operational Design Center at EMD Serono has leveraged causal machine learning to analyze hundreds of variables across thousands of clinical trials with the objective of identifying causal drivers of enrollment success, which can be optimized to conduct faster, less expensive trials. Early insights will be shared.

Sylvia Marecki, PhD, Design Analyst, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

18:45 Option 2: PATIENT CO-PRESENTATION: The Patient’s Point of View: Clinical Trial Perceptions and Experiences
Results from a large-scale global study conducted in 2019 among patients and the public offer robust insights into the latest perceptions of clinical research and enrollment barriers, as well as patient engagement preferences (exploring patient receptivity to virtual trial models and the latest technologies). The 2019 CISCRP Perceptions & Insights study is the largest global study of its kind (over 12,400 responses from around the world, including experiences of 3,600+ prior study participants), offering robust global insights that audience members can directly apply within their own organizations. Learn what information is critical to support the participation decision-making process from the patient’s point of view. Identify key participation elements which matter most to patients and their support network. Determine which convenience-enhancing solutions create the biggest impact on overall experiences
Annick De Bruin, Dir Research Svcs, Research Svcs, Ctr for Information & Study on Clinical Research

Phyllis Kaplan, Trial Volunteer and Patient Advocate; Senior Project Manager, Health Communication Services, Center for Information & Study on Clinical Research Participation (CISCRP)

18:45 Option 3: Learning from Whole Foods and Panera – A Roadmap to the Real Future of Hybrid

Craig Lipset, Founder & Advisor, Clinical Innovation Partners LLC; Individual Consultant
The pandemic drove a violent shift to a fully virtual online world, radically changing how we shop, educate, hold business meetings, and obtain care. There will be a new hybrid normal that lands between the “old world” and fully online. These personal experiences in 2020 provide a roadmap for the future of clinical trials, and it will involve approaches we have not yet realized.

19:05 OPTION 1 LIVE: Speaker Q&A
PANEL MODERATORS:
Marcy Kravet, BS, MBA, Head, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Sylvia Marecki, PhD, Design Analyst, Operational Design Center (ODC), Global Clinical Operations, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

19:05 OPTION 2 LIVE: Speaker Q&A

PANEL MODERATORS:
Annick De Bruin, Dir Research Svcs, Research Svcs, Ctr for Information & Study on Clinical Research
Phyllis Kaplan, Trial Volunteer and Patient Advocate; Senior Project Manager, Health Communication Services, Center for Information & Study on Clinical Research Participation (CISCRP)

19:05 OPTION 3 LIVE: Speaker Q&A

PANEL MODERATOR:
Craig Lipset, Founder & Advisor, Clinical Innovation Partners LLC; Individual Consultant

19:15 Session Break - View Our Virtual Exhibit Hall