Location: Stage

Defining Digital Biomarkers & Digital Measurements

Conference Platform Opens

The conference platform opens before the agenda starts, giving you time to plug the presentations, panels and discussions into your agenda for the rest of the day. This also gives you plenty of time to get familiar with the platform.

Chair’s Opening Remarks & Presentation – Clearing The Cloud and Clarifying The Space: Defining Digital Biomarkers, Digital Measurements and Digital Endpoints

Jennifer Goldsack, Executive Director, Digital Medicine Society

Wellness Break

Get-up and have a stretch before the next session begins.

Presentation – Digital Biomarkers in Psychiatry: Monitoring Fluctuations in Real-Time

Francesca Cormack, Director of Research and Innovation, Cambridge Cognition

Wellness Break

Get-up and have a stretch before the next session begins.

Location: Sessions

Panel Discussion: Will the Impact of Covid-19 Give Rise to the Golden Age of Digital Biomarkers & Digital Measurements?

As companies across healthcare scramble to figure out how to “go digital” in Covid-19-impacted healthcare systems, the need to figure out how and where digital biomarkers/measurements fit in with this is now more critical than ever. Hear from the pioneers in the field and their thoughts on questions such as: 

• How is the impact of Covid-19 changing how we view the potential of digital biomarkers/measurements?
• With Telehealth on the rise, how can digital biomarkers/measurements change how patients are managed and treated?
• With the impact of Covid-19 on in-person clinical trials, how can digital biomarkers/measurements become the new gold standard in virtual trials?
• As this industry rapidly emerges, how can we encourage standardization of definitions across this field? 
• What barriers need to be removed for digital biomarkers/measurements to deliver on their potential?

Ray Dorsey, Professor of Neurology, Director, CHET, University of Rochester

Kimon Angelides, Founder, Early Bird Pharma

Peter Bergethon, Vice President, Head of Digital & Quantitative Medicine, Biogen

Rhoda Au, Professor, Anatomy & Neurobiology, Boston University

Joe Kvedar, Senior Advisor, Virtual Care / Professor, Dermatology, Partners Healthcare / Harvard Medical School

Location: Networking Area

Speed Networking

In the purpose-built Networking area, get ready to expand your network through randomly assigned 1 on 1 quick-fire video meetings. You can choose who you want to “connect” with and then set-up 1-2-1 in-depth catch-up’s throughout the rest of the event. 

This function also ensures that you don’t meet the same person more than once, allowing you to meet as many fellow attendees as you desire.

Your future collaborators or partners could be just one click away!

Location: Stage

Presentation: Standardizing Digital Measurement in Movement Disorders

• BrainBaseline founder Joan Severson will discuss their history and approach to translating clinical assessments into digital, self-administered, mobile formats
• Collaborator Dr. Josh Cosman will share insight on movement disorder study design using digital measurements, as well as the choice to deploy using consumer-grade hardware
• The duo will reveal future plans and work on furthering the development of digital biomarkers for movement disorders

Joan Severson, Chief Executive Officer, BrainBaseline 

Josh Cosman, Director, Digital Health Strategy, AbbVie 

Wellness Break

Get-up and have a stretch before the next session begins.

Storm Session – Lightning Talks

Addressing the levels of evidence needed for digital measures is crucial to ensure their success and implementation in both clinical trials and routine care. Through lightning talks and a lively panel discussion, this ‘storm session’ unpacks the evidentiary framework, regulatory pathways and performance considerations for digital biomarkers and measures.

11:40am
Lightning Talk: What Are the Regulatory Pathways Available?

Andy Coravos, Co-Founder & Chief Executive Officer, Elektra Labs 

11:50am
Lightning Talk: What Are The Considerations Beyond Measurement Performance?

Beau Woods, Deputy Director, Cyber Safety Innovation Fellow, Atlantic Council

Wellness Break

Get-up and have a stretch before the next session begins.

Location: Sessions

Panel Discussion: What Level of Evidence is Needed to Evaluate Biomarkers and Measurements?

• Why do we need medical evidence in order to calibrate digital biomarkers/measurements?
• What impact would standardizing levels of evidence have on this industry?
• What exactly should we be evaluating before deciding to use a digital measure? The sensor, the software, and/or its clinical application? 
• Individuals are able to buy many of the technologies being considered for use in clinical trials directly. What impact does this have on technology selection, regulatory considerations, and deployment of these technologies in clinical trials? 
• How should we think about consent and data governance in this era of digital data?

Andy Coravos, Co-Founder & Chief Executive Officer, Elektra Labs 

Beau Woods, Deputy Director, Cyber Safety Innovation Fellow, Atlantic Council

Ninad Gujar, Vice President, Regulatory & Quality, NeuroLogica Corporation

Jeremy Wyatt, Chief Executive Officer, ActiGraph

Open Q&A with Speakers

This is your chance to pose your burning questions to the expert speakers from the previous panel. 

Actively or passively take part in this session.

Andy Coravos, Co-Founder & Chief Executive Officer, Elektra Labs 

Beau Woods, Deputy Director, Cyber Safety Innovation Fellow, Atlantic Council

Ninad Gujar, Vice President, Regulatory & Quality, NeuroLogica Corporation

Jeremy Wyatt, Chief Executive Officer, ActiGraph

Lunch

Finally, lunch at a conference that is completely your choice!

Use this extended break to have your regular lunch, spend time with your family and give your brain a break. Recharge for the afternoon session.

Day 1 of The Digital Biomarkers & Digital Measurements Summit includes an extended break in the middle to give you ample time for lunch and another chance to catch-up on the day job. Or if you have time, you can use this break for 1-2-1 meetings or open networking.

Location: Expo Area

Tour of Expo

Take a tour of the virtual Expo and interact with partners of The Digital Biomarkers & Digital Measurements Summit to understand more about their services.

Location: Stage

Digital Biomarkers & Measurements in Clinical Trials

Presentation – Trying To Put The “Good” Back With “Night”; Objective Measurements of Night-Time Scratch and Sleep in Atopic Dermatitis

• We will learn how Pfizer’s evaluating and using digital wearables as an objective quantitative measurement of nighttime scratch and sleep to provide unbiased at home assessments of this endpoint.
• Pfizer’s Digital Medicine and Translational Imaging (DMTI) will also share insights and learnings to how they are deploying this technology worldwide.

Carrie Northcott, Director, Pfizer 

Wellness Break

Get-up and have a stretch before the next session begins.

Presentation – The importance of Reproducible Site, Home and Real World Gait 

• Monitoring the patients’ real life allows a continuous and completely objective assessment of daily habits and performance, and a much more clinically relevant and powerful outcome measure for clinical trials when trying to show the impact on patients’ quality of life.
• Get an insight on FeetMe’s objective data collection capabilities and use cases.

Alexis Mathieu, Co-Founder & CEO, FeetMe

Wellness Break

Get-up and have a stretch before the next session begins.

Presentation – How We Know What We Know in Clinical Trials

• We will learn how mobile technologies, novel analytical techniques, the availability of transmission and storage resources have brought us toward the integration of latent and trial data, but have also revealed some limits that need to be addressed.
• The opportunities and obstacles the team have encountered on this journey into a new era of data, information, and knowledge in clinical trials.

Jamileh Jemison, Head of Clinical Development, HealthMode 

Wellness Break

Get-up and have a stretch before the next session begins.

Panel Discussion: Digital Biomarkers/Measurements: The New Normal of Virtual Clinical Trials?

The seismic impact of Covid-19 on traditional, in-person clinical trials sent shockwaves around the drug development industry. As pharma/biotech pivot to more virtual clinical trials, the time is now for digital biomarkers/measurements to be routinely integrated but key questions must be answered, such as:

• What is the new normal for pharmaceutical clinical trials?
• How can digital biomarkers/measurements improve clinical trials for pharma/biotech?
• How should digital biomarkers/measurements integrate into virtual clinical trials?
• Currently, how comfortable are pharma/biotech with executing virtual clinical trials?
• What is the commercial rationale for integrating more digital biomarkers/measurements into clinical trials?

Ashkan Vaziri, Co-Founder & Chief Executive Officer, BioSensics 

Shyamal Patel, Director, Head of Data Science, Pfizer

Lauren Bataille, Director, Digital Strategy Lead, Clinical Trial Innovation, Novartis

Jamileh Jemison, Head of Clinical Development, HealthMode 

Location: Stage

Digital Measurements in Routine Clinical Care

Presentation: The Heartline Study: Measuring Atrial Fibrillation Using Digital Measures.

John Whang, Head of IET, Cardiovascular & Metabolism, Johnson & Johnson

Wellness Break

Get-up and have a stretch before the next session begins.

Panel Discussion: How Can Digital Biomarkers/Measurements Revolutionize Patient Care?

With healthcare systems undergoing a once-in-a-lifetime change, there is a clear opportunity for digital biomarkers/measurements to help ensure patients continue to receive the best care possible. However, crucial questions must be answered from the tech and medical perspectives to make sure that these technologies are integrated in the right way:

• What is the current need for digital biomarkers and measurements in routine care?
• What barriers need to be removed to integrate biomarkers and measurements into routine care?
• What do digital companies need to do in order to work closely with healthcare professionals?
• How do we evaluate the real-world use of digital measurement tools in routine clinical care?
• How can digital biomarkers/measurements improve quality of life for patients? 

Roger Daglius Dias, Director, Research & Innovation, STRATUS Center for Medical Simulation, Brigham & Women’s Hospital / Harvard Medical School

Manuel Fanarjian, HealthTech Fellow, Harvard Medical School

Kate Papp, Clinical Neuropsychologist / Assistant Professor, Brigham & Women’s Hospital / Harvard Medical School

Justin Williams, Chief Executive Officer & Founder, Noteworth

Paul Dagum, Founder, Vice Chairman & CSO, Mindstrong

Location: Sessions

Commercializing Digital Biomarkers & Digital Measurements 

Conference Platform Opens

The conference platform opens an hour before the sessions begin so that you can plug the presentations, panels and discussions into your calendar for the day ahead.

Chair’s Opening Remarks

Dan Karlin, Chief Executive Officer, HealthMode

Panel Discussion: Pharma and Digital Biomarkers/Measurements: A Match Made in Heaven?

Digital biomarker/measurement companies offer exciting ways to revolutionize healthcare. But some consider the pharma and tech industries worlds apart – so how do we successfully form partnerships to bring these two worlds together? This panel hears from tech and pharma leaders to address successful routes for partnerships. 

• How do Pharma currently view digital biomarkers/measurements?
• How has the need for more virtual clinical trials impacted these views?
• Are pharma really getting comfortable with becoming more “digital”?
• Do tech companies understand the nature of pharma and does this understanding impact potential pharma/tech partnerships? 
• How can we align pharma and tech companies on the time it takes to develop digital measures compared to traditional drug development? 

James Musick, Vice President & Head, Digital Transformation, Neurology, UCB 

Rachel Sha, Vice President, Digital Business Development, Sanofi

Vaibhav Narayan, Vice President, Data Science, Neuroscience Therapeutic Area, Janssen

Lauren Li, Head, Digital Health, Ipsen

Jenny Barnett, Chief Scientific Officer, Cambridge Cognition

Open Q&A with Speakers

This is your chance to pose your burning questions to the expert speakers from the previous panel. 

Actively or passively take part in this session.

James Musick, Vice President & Head, Digital Transformation, Neurology, UCB 

Rachel Sha, Vice President, Digital Business Development, Sanofi

Vaibhav Narayan, Vice President, Data Science, Neuroscience Therapeutic Area, Janssen

Lauren Li, Head, Digital Health, Ipsen

Jenny Barnett, Chief Scientific Officer, Cambridge Cognition

Wellness Break

Get-up and have a stretch before the next session begins.

Panel Discussion & Interactive Q&A: How Can We Ensure the Successful Commercialization of Digital Biomarkers and Measures?

As the digital biomarker & measurement industry begins to grow, establishing the options available to commercialize these products is imperative for successful implementation. This multi-stakeholder panel hears from a range of perspectives to discuss the successful commercialization of digital biomarkers & measurements. 

• What current business models are being pursued to commercialize digital biomarkers/measurements?
• What is the market available for biomarkers and measurements – who is the target buyer and who is going to be selling? 
• When and how do we engage buyers in the commercialization process?
• Where do payers and healthcare providers see the future of digital biomarkers and measures?
• Are tech companies that solely focus on digital biomarkers/measurements going to be commercially viable?

Richie Bavasso, Chief Executive Officer, nQ Medical 

Roozbeh Ghaffari, Co-Founder & Chief Executive Officer, Epicore Biosystems 

Adam Gotlin, Vice President, Technology Partnerships, Kaia Health 

Marcee Chmait, Head, Business Development & Partnerships, Providence Health & Services

Pavan Choksi, Investment Associate, Arkitekt Ventures 

Location: Stage

Data Privacy & Security and Innovation 

Presentation: Defending the Impossible – IOT of Medical Devices.

• How can our industry improve our approach to data privacy and security?
• We hear more about Biohacking village and the opportunities hacking can bring. 

Nina Alli, Executive Director, Biohacking Village

Wellness Break

Get-up and have a stretch before the next session begins.

Presentation: Enhancing Clinical Assessments and Home Monitoring with Wearable Motion Sensors

• We learn more about the science behind highly accurate sensors for clinical assessments and home monitoring.
• An insight into Gait Up’s sensors, algorithm, and data solution for therapists and doctors in various mobility disorders.

Benoît Mariani, Founder & Chief Executive Officer, Gait Up

Wellness Break

Get-up and have a stretch before the next session begins.

Presentation: Producing New Treatments for Patients Living With Neurological and Neuropsychiatric Disorders

Nirmal Keshava, Vice President, Cerevel Therapeutics

Wellness Break

Get-up and have a stretch before the next session begins.

Looking into The Future 

Open Q&A with Speakers

This is your chance to pose your burning questions to the expert speakers from the previous panel. 

Actively or passively take part in this session.

Nina Alli, Executive Director, Biohacking Village 

Nirmal Keshava, Vice President, Cerevel Therapeutics 

Benoît Mariani, Founder & Chief Executive Officer, Gait Up

Close of the Digital Biomarkers & Digital Measurements Summit

Roll straight into the rest of your Wednesday, with no flight to catch!