DPHARM - The Conference Forum

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DPHARM Disruptive Innovations to Advance Clinical Trials

Innovating for PatientsCelebrating 10 Years Virtually

September 22 -23, 2020 Virtual

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KEYNOTE WITH FDA9:45 amModernizing Clinical Trials Keynote: Q&A with FDAWe are honored to welcome Dr Amy Abernethy to do a keynote FDA Q&A on such topics as:• FDA culture, especially post COVID-19• Decentralized trials• Managing digital across different review divisions• Collection of real world data• Working with FDA in collaboration towards the modernization

of clinical trials• What’s holding back industry?

Amy P. Abernethy, MD, PhD, Principal Deputy Commissioner & Acting CIO, FDA

Hosted with: Tammy Guld, Janssen Clinical Innovation, Global Team Lead, Janssen

KEYNOTE10:30 amKeynote Guest Fireside Chat on Incentives for InnovationStephen Dubner is a journalist, most famous for co-authoring Freakonomics: A Rogue Economist Explores the Hidden Side of Everything. This book has been challenging conventional economic thinking for over 15 years now. Stephen will share his interesting view on incentives that reward innovation and more.

Stephen Dubner, Co-Author, Freakonomics

Hosted with: Craig Lipset, MBA, Advisor and Founder, Clinical Innovation Partners

11:10 amMeet the Technology & Service Companies in One Convenient PlaceOn the left side of the virtual platform, you will see an icon called Meet the Sponsors.A great opportunity to easily explore a number of different companies providing essential solutions to advance clinical trials for the benefit of patients. Check out the raffles and giveaways! This is also where you can get the DPHARM Idol judging grid, information about the daily survey and customer service information. It’s informative and fun!

11:20 amTen Minute Break

DAY ONE - Tuesday, September 22, 2020* All session times are in Eastern Standard Time.

8:30 amOpening Remarks & WelcomeValerie Bowling, Executive Director, DPHARM

PATIENT ADVOCATE KEYNOTE8:45 amThe Immortal Life of Henrietta LacksThe international success of Rebecca Skloot’s New York Times bestseller, The Immortal Life of Henrietta Lacks, has left people keenly interested in the Lacks family and Henrietta’s legacy. Members of the Lacks family have enthralled audiences across the country by talking about their mother, grandmother, and great-grandmother, Henrietta Lacks, and her transcendentally important contributions to science. What has it meant for decades after the fact—that Henrietta’s cells were being used in laboratories around the world, bought and sold by the billions? They put a personal face on such issues as the dark history of medical experimentation on African-Americans, the birth of bioethics, and the legal battles over informed consent. We are honored to welcome the Lacks family to talk about Henrietta Lacks, complicated questions about whether we control the stuff we’re made of, and whether we should share in the profits and discuss, transparency, inclusivity and diversity.

David Lacks, Jr, Henrietta Lacks’ Grandson and Patient Advocate

Veronica Robinson, Henrietta Lacks’ Great Granddaughter and Patient Advocate

Hosted with: Craig Lipset, MBA, Advisor and Founder, Clinical Innovation Partners

9:15 amA Vision for Clinical Trials in 2030 – Top 5 CountdownThese two speakers bring together vision, leadership and passion for doing everything we can to get therapeutics to patients faster. Together they will present a vision for clinical trials 2030.Karlin Schroeder, MA , Senior Director, Community Engagement, Parkinson’s FoundationPamela Tenaerts, MD, MBA, Executive Director, CTTI

Innovative Sources & Solutions Especially in Decentralized Trials, 3 Track Choices:

Track 1: AL/ML, EHRs, e-consent, e-regulatory New Healthcare Consumer

11:30 am We have seen a really nice evolution in companies that are enabling many new capabilities that can radically improve and disrupt the future of clinical trials and the patient experience. The companies listed below have been invited to present on what they are specifically solving to advance clinical trials, increase efficiencies and reduce the burden to patients and investigators. Attendees are free to choose among the following presenting companies.

Track 2: Innovative Digital Solutions Track 3: Innovative Solutions for Patient Diversity

Agenda

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Track 1Track 1: AL/ML, EHRs, e-consent, e-regulatory New Healthcare Consumer

11:30 am - Oracle Health SciencesUsing Machine Learning to Mitigate Failures and Reduce Costs in Clinical Operations• Understand the importance of defining leading indicators based on real-time, high quality, activity specific, standardized data• See how machine learning provides critical operational insights, allowing organizations to learn and adapt• Learn how to transition away from subjective decision making to data-driven decisions with predictive modelsElvin Thalund, Director, Industry Strategy, Oracle Health Sciences

Moderated by:Mark Travers, PhD, MBA, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co.

12:00 pm - Target HealthLearnings From a COVID-19 Study that Used E-Informed Consent and Realtime Direct Data CaptureDoing research in the time of COVID-19 is like doing a study in a war zone. Patient encounters are limited and the use of paper informed consent documents (eICD’s) and paper source records for initial data capture in the ICU or COVID-19 unit are not allowed. Tablets secured in a sterile environment connected to the internet are acceptable which allows for electronic signatures and remote data capture. In this case example, while these paperless tools were not universally accepted in an ongoing COVID-19 study, there was clear adoption by some of the sites. Of the 12 study sites, 3 used eInformed Consent with 25% of patients signing electronically, with one site 22/23 subjects signing electronically. In terms of direct data capture, all sites did direct data capture with 1,292/11,464 (11.3%) forms entered in real time. One site entered all 270 forms in real time while many sites entered around 10% of forms in real time. Dr Mitchel shares the initial results of the use of eInformed Consent and direct data capture in a COVID-19 study on the use of these paperless tools and what this means for patients.Jules Mitchel, PhD, MBA, CEO, Target Health

11:55 am - Florence HealthcareHow to Ensure Your Remote Site Monitoring Strategy Does Not FailFlorence’s platform is enabling remote site access at over 7,200 study sites in 27 countries. Sponsors and CROs can harness the platform for remote monitoring, management, and SDV. This talk will cover how Florence leverages its experience as a major Electronic Investigator Solution in clinical research to guarantee remote site monitoring success for organizations around the globe.Ryan Jones, CEO, Florence Healthcare

11:45 am - BBK WorldwideInnovation for the New Healthcare ConsumerBBK’s Aaron Fleishman will leverage patient and physician voices in shedding light on the new healthcare consumer and the innovation needed to engage them in clinical research. He will provide insight into how dynamic new tools and technologies can be used to meet them on their terms to not only create study-life balance but to drive enrollment success.Aaron Fleishman, Director, Market Development, BBK Worldwide

12:15 pm - SaamaAccelerate Clinical Development with Game-Changing AI and Analytics In this short, 10-minute presentation, Jonathan Burr, Saama’s Senior VP of Clinical Platform Strategy, will highlight innovations that are fundamentally transforming the way in which clinical data is collected, analyzed, and submitted. These include:• Intelligent Clinical Data Mapping — Moving away from complicated data standards to automatically mapping to usable data models, both

for submitting data (SDTM) and reviewing data.• Smart Data Queries —Taking time and effort out of the data management processes with Machine Learning and AI.• Talking to Your Data — Get instant answers to all of your clinical operations questions, without having to track down an expert or

understand the data model.Jonathan Burr, Senior Vice President, Clinical Platform Strategy, Saama

12:25 pm - PRA Health SciencesPRA’s Advances and Progress in Deploying New Technologies for EHR IntegrationsKent Thoelke, EVP, CSO, PRA Health Sciences

12:35 pm - ComplionBridging Sites and Sponsors with Innovations in Site RegulatoryComplion, an eRegulatory solutions company focuses on an innovation that makes regulatory compliance in remote clinical research possible. In their session, Complion’s CEO addresses:• New problems uncovered in site binder completeness• Key learnings from conversations with pharma companies and CROs• Remote monitoring realities during a pandemic, what’s possible and progressRick Arlow, Founder and CEO, Complion

Agenda

12:50 pm - - Track 1 Concludes

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Track 2Track 2: Innovative Digital SolutionsModerated by:Judith Reece, PhD, MBA, VP, Digital Development, GSK

11:30 am - InterSystemsUtilizing Real-Time, Real-world Data to Accelerate Clinical Trials and Enhance Market AccessThe speakers will discuss an approach to rapid site selection, cohort identification, and patient recruitment, leveraging comprehensive, longitudinal patient health records updated in real time. Drawing on a set of use cases, the team will explore ways to accelerate clinical trials and enhance market access.Matthew Stannard, Life Sciences Advisor, InterSystemsQi Li, MD, Physician Executive, InterSystems

12:15 pm - Clinical InkDirect Data Capture and BYOD: Tools and Techniques to Make Your Virtual Trial a Reality • Why DDC is uniquely able to support virtual trials• How BYOD supports patient engagement and encourages compliance• Why technology must be able to support a wide range of deployment options and adapt as trial progressEd Seguine, CEO, Clinical Ink

12:25 pm - Philips HealthcareThe Sensor to Endpoint Journey This session will discuss wearable sensor innovation and the endpoints which provide support for remote patient monitoring in clinical trials.Krishna Jhaveri, MD, PhD, Sr. Clinical Scientist, Philips Healthcare

11:45 am - MedidataPatient Impact From Rapidly Evolving Virtual Technologies Join this session to learn the impact of new digital technologies on the patient and how incorporating multiple point solutions may not always be the best.Alicia Staley, Sr. Director Patient Engagement, Medidata

12:35 pm - BoxAccelerate Clinical Operations Remotely with Digital OrchestrationBox has an innovative solution that provides R&D organizations a seamless and secure way to access, verify, and share source data or patient documents alike without in-person clinical site visits. More specifically learn how to: • Accelerate the verification process of documents and patient records at clinical sites with cloud technologies• Increase control of your clinical sites and reduce margin of error with real time access to regulated and non regulated content• Boost productivity while ensuring GxP compliance on regulated and non regulated contentManu Vohra, Managing Director, Life Sciences, Box

11:55 am - Datacubed HealthDetecting Adverse Events in Vaccine Trials with Geofencing This session begins by briefly exploring the challenges faced by vaccine study teams – reporting errors, data delays and missed adverse events – and those specific to COVID-19 – reducing physical touchpoints while ensuring ongoing patient engagement. It then focuses on solutions with unique geofencing technology and behavioral science that can make the clinical trial process easier for patients while improving data collection.Brett Kleger, President & CEO, Datacubed Health

12:00 pm - IQVIAHow IQVIA Identifies High-Volume Qualified Patients Through Data Science, Innovative Technologies, and Unmatched Clinical Expertise for Greater Precision, Providing Qualified Referrals to Sites for any Therapeutic Area, in any Country, to Scale• Selecting and optimizing sites based on data-driven approaches using the IQVIA CORE• Direct-to-patient recruitment – Not just fast recruitment but quality recruitment• Allowing sites to focus on high-quality patient care, maximizing patient flow for increased efficiency, and continually monitoring

staff needs.Erica Prowiser, Global Head Recruitment & Retention, IQVIA

Agenda

12:50 pm - Track 2 Concludes

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Track 3Track 3: Innovative Solutions for Patient Diversity Moderated by:Jessica Scott, MD, JD, Head of R&D Patient Engagement Office, Takeda

11:30 am - Quest DiagnosticsHow Quest Diagnostics Innovative Solutions are Helping the R&D Industry Transition from Traditional to Hybrid to Decentralized Trial OperationsQuest Diagnostics goes through how they’re able to support clinical trial operations including patient recruitment and site selection in this critical era of transitioning to decentralized and hybrid models to support patient and physician research needs. More specifically areas of focus will be:• Patient-friendly data and infrastructure-based clinical trial solutions that leverage an end-to-end analytical platform that supports

innovation across the clinical trials lifecycle • Quest PSC and mobile collection partnership options which allow for patient flexibility to comply with trial visits/procedures• Profiling approach to non-traditional site location and recommended approaches to site identification• Quest approach to data-enriched trial planning and multi-faceted analyses for an adaptive patient recruitment outreach approach• Insights in outcomes for the R&D industryDavid Freeman, GM, Information Ventures, Quest Diagnostics

11:45 am - ElligoHow an Innovative Model Delivering Clinical Care Addresses Patient-Centric Rights and Increases Trial ParticipationCurrent regulations that specify study participant rights are necessary but insufficient. Rights based on patient-centric principles are not recognized. In this session, learn how Elligo’s innovative model of delivering clinical trials within clinical care can address patient-centric rights to help increase participation and improve the patient experience by:• Enabling patients to participate in research with their primary physician: research as a care option• Expanding patient access by navigating across the spectrum of clinical operations models• Offering data collection flexibility to meet patients at the right point of careEli Alford, COO, Elligo

12:25 pm - Science 37Enabling Access and Enhancing Diversity in Clinical ResearchWith the world thrust into the COVID-19 era—and the pandemic disproportionately affecting communities of color—these disparities are amplified and need attention. During this session, we’ll explore ways to eliminate participant burdens—enabling access and engaging more diverse people to build a more inclusive way forward.Jonathan Cotliar, MD, CMO, Science 37

12:15 pm - InatoIncreasing Clinical Trial Diversity with a Marketplace ApproachGiven the recent FDA guidance to have patients in clinical trials reflect the patient population that will take the medication once approved, clinical trial diversity is a scientific imperative. Inato will discuss how a marketplace approach, which has worked to revolutionize other industries such as insurance and banking loans, can similarly transform the traditional site selection approach to create greater visibility across a more diverse population of doctors and patients.Liz Beatty, Chief Strategy Officer, Inato

12:35 pm - THREAD Research10 Insights From Our First 100 Decentralized StudiesThis session will provide key insights from lessons learned by THREAD supporting their customers’ global decentralized studies. Insights will include flexible patient options, global considerations, site training, participant kits, home health, sensors, virtual visits and more.John Reites, President, THREAD Research

12:00 pm - ParexelHow Decentalized Clinial Trials (DCT) are Addressing Disparities in Health OutcomesParexel’s Rosamund Round will address:• Industry assumptions about DCTs improving participant diversity• Direct feedback from patients and physicians of differing racial, ethnic, cultural and linguistic backgrounds challenging assumptions• Conclusions about ways to optimize DCTs and improve access to research for patients from diverse groupsRosamund Round, VP, Patient Innovation Center, Parexel

11:55 am - Life Line ScreeningDisrupting Traditional Research in a Community SettingLife Line Screening is uniquely positioned in the healthcare continuum to disrupt traditional clinical trial recruitment models and can help speed the delivery of new medications to market. More specifically, get:• An understanding how Life Line Screening conducts decentralized research in Life Line’s mobile community setting• An introduction to Life Line’s unique operating model, processes, solutions, and select case studies.Kelly Daubach, RD,VP, Business Development, Life Line Screening

Agenda


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3 Afternoon Track Choices:Pharma Innovation Flexible/Decentralized Clinical Trials Reporting from the Trenches

Track 1

12:50 pmLunch Break

1:20 pmQuick Fire Presentations on Solutions that Support Flexible and Remote Care/ResearchPresenting companies:PreventiceShimmer Sensing

1:25 pm

DPHARM AnnouncementsValerie Bowling, Executive Director, DPHARM

1:30 pm- 2:40 pm

Pharma Innovation on Flexible/ Decentralized Clinical Trials Reporting from the TrenchesThis is a great opportunity to hear from several different pharma companies reporting on a specific example of innovation applied to advance clinical trials within the last 12 months. Each session addresses the milestones, challenges and problems with adoption. Attendees are free to choose among the following presenting companies.

1:30 pm - 1:50 pmBMS – Adapting a Long Term Follow Up Oncology Study into the Decentralized Clinical Trial ModelThis presentation will demonstrate how to adapt the decentralized model for oncology patients. Key takeaways include:• Explore opportunities for decentralized trials in oncology• Understand the nuances for oncology patients compared to other TA patientsHassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, Bristol Myers Squibb

1:50 pm - 2:05 pmEMD Serono: Flexible Trials are the New NormalIn this session, Dr Garcia shares the lessons learned from understanding, embracing and implementing solutions to meet patients’ needs where patients are in clinical trials. Dr Garcia also shares his experience in working with study teams to get them on board with vital changes to support flexible clinical trials.Rodrigo Garcia, MD, Head of Clinical Innovation, EMD Serono

Track 1: Case StudiesModerated by:Monique Adams, PhD, Director, Clinical Innovation Lead, Janssen

Agenda

2:05 pm - 2:20 pmSanofi – Decentralization of Clinical TrialsFor the past 12 months Sanofi has been working on a pivotal trial design that includes remote visits. Sanofi is now bringing much of that insight into their plans to ‘pandemic-proof’ protocols for upcoming trials. In this session, you will hear an update and lessons learned.Laura Kling, Director, Digital Innovation, Sanofi

2:20 pm Track 1 Concludes

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Track 2

1:50 pm - 2:05 pmReporting on Unusual Partners as Enablers of Pharma InnovationMagda Schoeneich reports on the learnings she’s gathered over several years on partnerships from leaders representing Apple, Google, Facebook, futurist such as Sir Kenneth Robinson, academics from Harvard, MIT Center for Collective Intelligence, Cambridge University, the Santa Fe Institute along with strategic partners such as IDEO and the US Airforce. More specifically:• How these learnings have impacted partnerships and diverse team building• Internal and external partners• The outcome of a more diverse team with unexpected partners• The ripple effect on innovation• How patients and other stakeholders are benefitingMagdalena Schoeneich, Head Center for Scientific Leadership & Innovation, Takeda

1:30 pm - 1:50 pmNovartis – Partnering Effectively with the Digital Ecosystem: A Guide for Big PharmaNovartis Biome has been on a journey for the past two years to find new and effective ways to partner with the entire digital ecosystem (big and small). This session covers:• Identifying critical differences when working with a tech (large or small) company• Cultural change is key to ensuring engagements are fruitful and lead to long lasting partnerships• Differences between a vendor and a partner• Getting to a fruitful and mutually beneficial relationship between big pharma companies and startup health tech companies Robin Roberts, Co-founder, Managing Director, Global Head of Strategy, Novartis Biome

Track 2: New Partnerships and CollaborationsModerated by:Chandra Ramanathan, MBA, PhD, Global Head, Pharma R&D Open Innovation, Bayer Healthcare

2:20 pm - 2:40 pm How UCB Embraced Decentralized Clinical Trials as a Mindset and Not a Platform to Innovate for PatientsUCB has embraced a mindful approach with DCT to evaluate the entire clinical lifecycle, beyond the operations to creatively reduce study design complexity; number of visits and to courageously evolve and adopt remote assessments for use in our clinical research protocols as alternatives to traditional in-clinic physical assessments. In this session, UCB’s Shelly Barnes shares the progress.Shelly Barnes, Global Clinical Innovations Lead, UCB

2:05 pm - 2:20 pmHow to Generate Meaningful Insights for Clinical Development through an ML-Enabled, Q&A-based Knowledge Automation Platform Boeringer Ingelheim and Huma.ai together discuss how Huma.ai’s Q&A platform on top of clinicaltrials.gov can quickly generate insights for clinical development and the benefit to R&D and patients. Also covered is how an ML platform can allow subject matter experts to ask questions of their data and instantly get answers. The platform is self-service, works with both structured and unstructured data, and connects multiple data sources (both internal and external) through natural language.Lana Feng, PhD, Co-founder and CEO, Huma.aiMohammed Ali, Global Head Digital Trials & Clinical Operations, Boehringer Ingelheim


Agenda

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Track 3

1:50 pm - 2:05 pmRoche on their Progress in Pushing the Boundaries in Digital BiomarkersRoche has been busy pushing the boundaries to advance their Digital Biomarker portfolio. They have made substantial progress with their Digital programs. In this session, attendees get an update on breaking news from their Parkinson’s program and learn how COVID-19 has impacted their digital efforts.Christian Gossens, PhD, MBA, Global Area Head Digital Biomarkers, pRED Informatics, Roche Pharmaceutical Research and Early Development

1:30 pm - 1:50 pmJohnson & Johnson Case Study: The Collaboration that Built the Data-driven Platform to Benefit PatientsThis case study tells the story about the collaboration that was formed to build a data-driven platform that:

• Enables data source in one place• Identifies burden scores for sites and patients• Gets to the primary endpoint• Improves streamline work-study team and patient experience• Holds teams accountableMonica Teall, Associate Director, JanssenMiruna Sasu, Clinical Operations and Data Science, Johnson & Johnson

Track 3: Advances in Data Driven EffortsModerated by:Yusuf Ghadiali, Senior Director, Global Clinical Operations, Biogen

2:05 pm - 2:20 pmTakeda’s Collaboration with Be the Partner to Innovate for PatientsThis session highlights a patient portal case study.Thomas Klein, Founder and CEO, Be the PartnerJessica Scott, MD, JD, Head of R&D Patient Engagement Office, Takeda

2:20 pm - 2:40 pmSanofi Case Study: Remote Spirometry in COPD: Foundations for Wearables in Clinical TrialsSanofi conducted a trial to validate at-home spirometry using a Bluetooth connected device with a companion app to track to time the user and to track the reading, with a goal to collect data for validation. This presentation will focus on the process, approach and lessons learned in comparing in-clinic spirometery readings to the home device where patients were enrolled in a couple of different drug trials in COPD. More specifically:

A look back on lessons learned from two years of testing at-home spirometers in COPD patientsThe remaining hurdles to clear so we can translate wearables data collection into value for patients, providers, and pharmaNikita Bakhru, Digital Initiative Leader, Sanofi


Agenda

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2:40 pmBreak

2:50 pmFireside Leadership Chat: The Future of Clinical Research and the Innovation Coming Out of this PandemicBen Liu welcomes two pioneering researchers. Together they share insights on the future of clinical research and the innovation coming out of this pandemic.Moderated by:

Ben Liu, DPhil, CEO and Co-founder, TrialSpark

Panelists: Mark Fishman, MD ,Professor, Harvard Dept of Stem Cell and Regenerative Biology, Mass General

Michael Mina, MD, PhD, Asst Professor, Harvard School of Public Health and Brigham and Women’s Hospital, Harvard Medical School

Agenda

Now in its 9th year, DPHARM Idol Disrupt is a live show featuring a select group of innovators who present what they believe is a disruptive technology or service that could be a changing force for clinical trials. Each of the pre-approved presenting companies gives a quick-fire session followed by questions from the DPHARM Idol Disrupt judges.

The questions from the judges provide great examples of how to assess technologies/services for their disruptive quality, especially for the benefit of patients. Past DPHARM Idol Disrupt winners include Medidata, Spaulding Clinical, ePharma Solutions, Science 37, Florence Healthcare, PhysIQ, Medable and Tasso. Who will be the DPHARM Idol Disrupt 2020 winner?

2019 Winner: Tasso, Where are They Now?Ben Casavant, PhD, Co-Founder and CEO, Tasso

Presenting Companies:

ProofPilotProofPilot will demonstrate how they are democratizing clinical trials by making it as easy to design, manage and participate in trials as it is to manage a blog.Matt Amsden, CEO & Founder

Obvio HealthObvioHealth will share two case studies illustrating how innovative capture of unstructured patient data improves data accuracy and quality.Susan Dallabrida, PhD, VP, Consultancy

King-DevickKing-Devick will present on how they developed remote and self-administration options for their solutions as a reaction to the biggest disrupter… COVID-19Steve Devick, Founder and CEO

Root HealthRoot Health will present on their breakthrough AI-Driven platform for clinical research enrollment and retentionRaj Sharma, President & CEO

TrialScopeTrialScope will present on how they reinvent recruitment for clinical trials, applying crowdsourcing through a vetted collective of over 65 recruitment partners – combined with innovative technology – for better patient matching at scale.Mike Wenger, VP, Patient Engagement

DPHARM Idol Disrupt Judges:Esther Dyson, Executive Founder, WellvilleCindy Geoghegan, Patient AdvocateYusuf Ghadiali, Senior Director, Global Clinical Operations, BiogenHassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Bristol Myers SquibbJoe Kim, MBA, Senior Advisor, Clinical Operations and Digital Registry, Digital Health Office, Translational Technology & Innovation, Eli Lilly & CompanyÜlo Palm, MD, PhD, Former SVP, Head, Digital Science, AllerganChandra Ramanathan, MBA, PhD, Global Head, Pharma R&D Open Innovation, Bayer HealthcareDouglas Schantz, VP, Clinical Operations, AlexionJessica Scott, MD, JD, Head of R&D Patient Engagement Office, Takeda PharmaceuticalsMark Travers, PhD, MBA, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co.

3:10 pm

DPHARM Idol Disrupt

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4:30 pm

10 Minute Break

4:40 pm

Zoom Small Group Interactive DiscussionThe concluding afternoon of day one will be dedicated to 30 minute small group discussion choices. These interactive discussions are first come first serve and have limited capacity. Registration is required in advance.

To register for the discussion topic of your choice please email [email protected] with the Subject Line: DPHARM Group Discussion Choice.Topics to date include:

How Technologies are Disrupting Patient Enablement and Changing the Way We Engage Patients in Clinical Trials Today and in the Future.MaryAnne Rizk, PhD, SVP Digital R&D Strategy, IQVIA

The Future of Pharma will Require Us to Look Outside Of It: A Discussion on Novel PartnershipsKent Thoelke, EVP, CSO, PRA Health Sciences

How is the COVID Crisis Driving Innovation? How Will We Live, Work, Conduct Science, and Develop Drugs in the Post-COVID WorldÜlo Palm, MD, PhD, Co-Founder/Chief Medical Officer and Co-Founder, APANDEMIC/Ordaos Bio

If You Build It, Will They Come? Striking a Balance Between Innovation, Sustainability and What Matters Most to Patients and Care/Support PartnersSarah Krüg, CEO/Founder, Cancer101/Health Collaboratory

5:15 pmPartnering Meetings Through Meeting Mojo Platform Continues to 9:00 pm ET

Agenda

DAY TWO - Wednesday, September 23, 2020* All session times are in Eastern Standard Time.

9:00 amOpening Remarks & Announcement of the 2020 DPHARM Idol Disrupt WinnerValerie Bowling, Executive Director, DPHARM

R&D LEADERSHIP FIRESIDE KEYNOTE CHAT9:15 amNavigating Disruption: Regeneron’s Rapid Response to COVID-19 While Maintaining its High-Science PrinciplesIn this fireside chat, Dr Weinreich addresses the following at Regeneron:

• Leading with Science• Culture of Innovation• Entrepreneurial Spirit• Navigating disruption: Drug development amid a public

health crisis• Kevzara (sarilumab)• REGN-COV2• Maintaining our vast portfolio• What We Learned

David Weinreich, MD, MBA, SVP, Head, Global Clinical Development, Regeneron Pharmaceuticals

Hosted with: Tammy Guld, Janssen Clinical Innovation, Global Team Lead, Janssen

GUEST FIRESIDE CHAT9:45 amFostering Innovation and Service: Lessons from a Veteran Disney ExecutiveWe are honored to welcome Marty Yudkovitz, a veteran Disney executive with more than 30 years of experience. In this fireside chat, we discuss with Marty how Disney approaches innovation and service. In doing so, we explore the realities of building support for innovative projects, overcoming obstacles and getting executive buy-in. We also talk about how Disney maintains excellence in the end-user experience at the parks and what we can take away from this to apply to patients’ experiences.

Marty Yudkovitz, JD, Former Head of Strategic Business Innovation, Disney

Hosted with: Monique Adams, PhD, Director, Clinical Innovation Lead, Janssen

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Prioritizing Innovation to Expand Clinical Research Access to Patients

• Sharing the experience and lessons learned• Innovative uses of Real-world Evidence such as Synthetic

Control Arms (case study)• The role of technology in increasing diversity in clinical trials• First insights on outcomes• Critical next steps to shape and evolve

Peyton Howell, EVP, Chief Commercial & Strategy Officer, Parexel

Microsoft: What Technology in the Pandemic Have Taught UsMicrosoft shares the observations from the many R&D organizations they work with who are asking themselves what should “go back to normal” after the pandemic and what should always remain different. This discussion will cover:

• The evolution of advances in enabling technologies and its impact• Research as a continuum from traditional interventional trials to fully

virtual• The balance of physical and virtual elements and how this mix may

change during the course of a study• Thoughts on fully digital representation of a study (including

operational aspects)• Most important considerations for patient experiences

Paul Slater, Co-Founder and Head of Strategy, Clinical Research Innovation Hub@Microsoft

A Maverick Patient Advocate: How Raising Awareness and Outreach to People of Color Leads to Innovation that Reduces Healthcare DisparitiesA breast cancer survivor who moved to the United States at 15 from war-torn Liberia, Maimah Karmo is the founder of the Tigerlily Foundation. Maimah discusses her journey as a cancer survivor and how raising awareness and outreach to people of color leads to innovation that reduces healthcare disparities.

Maimah Karmo, Founder/CEO, Tigerlily Foundation

12:00 pmHow the Next Level of Patient Engagement is Driving Innovation at TakedaThis leadership talk focuses on how Takeda shifted their organizational culture to further their innovation and collaboration. More specifically, the following will be addressed:

• Identifying the needs of the global program teams and patients – the win-win

• Developing a new capability to help teams think differently• What’s happening next? Patient Engagement 2.0. Patient

engagement plans (PEP’s) and beyond

Jessica Scott, MD, JD, Head of R&D Patient Engagement Office, TakedawithDonna Schwarz, Founder, Schwarz Consultants

12:25 pmLunch

1:25 pmDPHARM AnnouncementsValerie Bowling, Executive Director, DPHARM

1:30 pmDPHARM Afternoon Track Choices

FIRESIDE GUEST KEYNOTE

10:15 amFireside Guest Keynote: Highlights of the 50 Most Innovative CompaniesFast Company magazine publishes an annual innovation report ranking businesses making the most profound impact on both industry and culture demonstrating a range of ways to succeed in a competitive world. In particular, they rank the top 50 companies and we are delighted to welcome back for the 2nd year in a row, the Deputy Editor of Fast Company to tell us about the highlights.

David Lidsky, Deputy Editor, Fast Company

Hosted with: Shwen Gwee, VP and Head of Global Digital Strategy, Bristol Myers Squibb

Jennifer Wulff, Pfizer Strategic Partnerships-Clinical Operations and Global Product Development, Pfizer

10:45 amMeet the Technology & Service Companies in One Convenient PlaceOn the left side of the virtual platform, you will see an icon called Meet the Sponsors.

A great opportunity to easily explore a number of different companies providing essential solutions to advance clinical trials for the benefit of patients. Check out the raffles and giveaways! This is also where you can get information about the daily survey and customer service information. It’s informative and fun!

10:50 amTen Minute Break

11:00 amToday Show @ DPHARM

Hosted by:Michelle Shogren, Senior Director of Innovation, Pharma R&D Clinical Operations, Bayer

Top Innovation in 2020 Observations in Our Respective Organizations in the Areas of Feasibility, Diversity in Clinical Trials and Virtual Clinical Trials

Katie Mazuk, VP, Clinical Insights & Experience, JanssenCynthia Verst, PharmD, President, Design & Delivery Innovation for R&D Solutions, IQVIA

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Moderated by: Amy Cramer, Global Product Development Strategic Partnerships, Pfizer DPHARM welcomes a distinguished group of experts representing pharma, academia and a regulatory agency to provide fresh insights and real world examples that will go way beyond eSource.

1:30 pm - Evaluating Patient Claims as Real World EvidenceThe 21st Century Cures Act requires the US FDA to develop a Real-World Evidence (RWE) program to fill knowledge gaps in the use of Real-World Data (RWD) to generate RWE of product effectiveness. Patient claims frequently are used to identify follow-up period events in RWE studies. However, endpoint measurement differences between patient claims and the EHR may be significant. This presentation from Eric Eisenstein will highlight results from an antiplatelet trial simulation. Results will demonstrate differences between patient claims and EHR endpoint estimates, measurement errors and sample size requirements.Eric Eisenstein, Associate Professor in Medicine, Duke Clinical Research Institute

1:50 pm - Perspective on the Evolving Role of RegulatorsThe Danish Medicines Agency (DKMA) has established a data and analytics center (DAC) that is unique in the world. DAC is using a secure supercomputer shared between academia, the health sector and national agencies to pull in registry data that exists in the country (covering entire lifespan). They are able to access anonymized medical records of their citizens in real-time and apply analytics and machine learning to better understand the effect of treatments. They are also able to provide scientific advice to the industry in leveraging analytics using AI and ML based on real-world data. This presentation will highlight a step-wide approach to e-source in regulatory agencies with examples from DKMA DAC.Jesper Kjaer, Head of Data Analytics, The Danish Medicines Agency

2:15 pm - It’s Time to Stop Talking and Start DoingeSource is more than re-use of EHR data. In this presentation, Rob Goodwin will:• Review the integration of all eSource modalities as defined by TransCelerate• Highlight lessons learned from Pfizer’s eSource program• Speak to the goals, scope and current state of Vulcan, a HL7 FHIR accelerator dedicated to Translational and Clinical Research

and convened by the US FDA, NLM, NIH, CTSA Sites, Patient Representative, TransCelerate Biopharma, Society for Clinical data management, and Standards Organizations. Vulcan encourages all interested parties to join.

Rob Goodwin, VP and Head, Pfizer Global Product Development Operations Center of ExcellencewithAmy Cramer, Global Product Development Strategic Partnerships, Pfizer

2:45 pm - The Future of Clinical Research is NowPfizer, EDETEK, and PatientLink are excited to reveal a new approach to clinical research that enables real-time, 360-degree patient engagement and data sharing between patients, sites and researchers to improve clinical research and data return through eSource. More specifically they address:• How the fluid flow of compliant and permissioned data before, during, and after clinical research permits sites and sponsors a

more real-time view of data, enables proactive decision making, transparency, and potentially helps retain both sites and patients• Highlight the strengths and benefits of using HL7 FHIR interoperability standards now and in the future (which will impact

patients, sites, researchers, payers, sponsors and health systems)Munther Baara, Vice President Of Product Strategy and Innovation, EDETEK, Inc.withDebi Willis, CEO / Founder, PatientLink

3:15 pm - How ‘Transformative eSource and EHR2EDC’ Solutions are Enabling the Growing Convergence between Care and Research: Where are We Now?There is a growing convergence between care and research, enabled through ‘transformative eSource and EHR2EDC’ solutions. This trend has an impact on the global healthcare research setting, with breakthrough initiatives both in North America and Europe. Today, we can leverage mature technologies in Natural Language Processing and Machine Learning / Artificial Intelligence which allows us to take major steps in creating connected, augmented real-world data.patients, sites, researchers, payers, sponsors and health systems)Dipak Kalra, President, The European Institute for Innovation through Health DataMartine Lewi, PhD, Scientific Director, Clinical Innovation, Janssen

4:00 pm - - Track A Concludes

Track A: Way Beyond eSource: Progressing Clinical Research through e-Source from the Pharma, Patients, Academia & Regulatory Perspectives

1:30 pm Breakout Choices A, B & C

Agenda

Track Choice A

DPHARM AGENDA


Track Choice B

1:30 pm - Fireside Chat: Creating a Data Driven Culture that Can Absorb AI/ML CapabilitiesVipin Gopal, Chief Data & Analytics Officer, Eli Lilly

1:50 pm - Monitoring in the Digital Age: Advances in Intelligent Monitoring Capabilities that Drive Improved Outcomes for Patients, Sites and Sponsors• AI ML capabilities to power intelligent monitoring are empowering sponsors and sites to predict risk before it happens, thereby increasing

patient safety on trials.• Additional modernization of improve access to data with remote capabilities can now expand remote monitoring capabilities. This has

triggered an evolution of analytical roles re-shaping our industry across sites, sponsors and even patients.• Hear about how CRAs are leveraging digital and data to providing the highest level of patient centricity and improving quality standards.MaryAnne Rizk, PhD, SVP, Clinical & Commercial Technology Strategy, IQVIA

2:15 pm - Conversational AI: How Voice Technology is used in Clinical StudiesThis multi-stakeholder panel will share how voice technology has been used in a research study to efficiently provide patient input and improve patient experiences in clinical research and trials. Key talking points include:• How did we get there?• What did we learn?• What do the patients tell us?• How did nurses respond?• How did the physicians think about it?Moderator:Bert Hartog, PhD, Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen-Pharmaceutica NV Panelists:Emma Richard, Manager, Data Science Insights, Janssen Daniel H Solomon, MD, MPH, Associate Physician & Chief, Section of Clinical Sciences, Division of Rheumatology, Brigham and Women’s HospitalNathan Treloar, President and Co-Founder, Orbita

2:45 pm - Panel: How AI/Machine Learning is being Utilized to Accelerate Clinical Trial Design and DevelopmentThis panel addresses how AI/Machine learning is now being utilized beyond the discovery phase in clinical development. Key areas include advancements in AI/ML for the following applications:• Trial design and execution• Patient identification and trial matching• Patient recruitment and enrollment• Optimizing protocols (ie: inclusion/exclusion criteria)• Site selection• FDA approvalModerator:Prasanna Rao, Head, AI and Data Science, Data Monitoring and Management, GPD, Pfizer Panelists:Alex Aronov, Senior Director & Head of Data Science, Data Strategy & Solutions, Vertex Pharmaceuticals Vipin Gopal, Chief Data & Analytics Officer, Eli LillyNagaraja Srivatsan, Chief Digital Officer, RD&S Technologies, IQVIA

4:00 pm - Track B Concludes

3:15 pm - Strategic Partnership and Approach to Risk-Based Study Execution and Planning with an Advanced AI-Driven PlatformLokavant and Parexel have partnered to enhance clinical development by more effectively and efficiently leveraging data and predictive analytics. The discussion will include:• The scope of the collaboration• Features of the remote trial oversight application• The interweaving of human-centric and AI-based risk analytics• Using data to adaptively benchmark in a COVID-19 world• How Parexel and Lokavant intend to provide innovation across the clinical development landscapeJamie Macdonald, CEO, Parexel Rohit Nambisan, President, Lokavant, Inc.3:45 pm -Enriching Digital Biomarkers in Heart Failure with Vital Signs: We Can Do Better Than MovementThe measurement of Quality-of-Life (QoL) effects of drugs has inspired the adoption of wearable sensors that measure movement: Steps, Activity counts and Sleep. But movement (as exertion) is only half the picture in diseases of the cardiopulmonary system like Heart Failure. Vital signs like heart rate and respiration rate represent the physiological response to exertion, and are representative of the functional capacity that impacts QoL in these patients. These vital signs can now be measured as easily as actigraphy with wearable sensors. In this talk, we will examine how digital biomarkers of patient QoL is enriched by vital sign data from wearable sensors for conditions that afflict the cardiopulmonary system. We make the case that any deployment of wearable sensors in drug trials for these conditions needs to include vital signs.Matt Pipke, JD, CTO and Co-Founder, PhysIQ

Moderated by: Joseph Kim, MBA, Senior Advisor, Clinical Operations & Digital Registry, Digital Health Office, Translational Technology & Innovation, Eli Lilly & Co

Track B: Data, AI and Machine Learning

Agenda

DPHARM AGENDA


1:50 pm - PfIRe it Up! Using the PfIRe Lab to Develop Digital EndpointsPfizer built an Innovation Research Lab (PfiRe) to evaluate wearable devices before deploying them into clinical studies. In this session, you’ll hear about the innovative way they test these devices to determine which are fit-for-purpose, a critical step in developing a novel digital endpoint, and how they develop their own algorithms to use in clinical trials. Pfizer will also share insights from the STRYDE study, which was developed in the PfiRe lab. David Caouette, Executive Director, Early Clinical Development, PfizerMar Santamaria, Director, Early Clinical Development Pfizer

1:30 pm - A New R&D Paradigm to Apply in a Time of Deadly PandemicsThe rising death toll due to SARS-CoV-2 and the limited availability of effective treatments painfully highlights opportunities for faster and more efficient drug development paradigms.In this presentation, a trio of talent collaborated to present a new R&D paradigm. More specifically, this session will address how integrated Research Platforms and Adaptive Master Protocols can expedite robust evidence generation and more specifcially:• Where current research paradigms pose challenges in efficiency and ethics• How novel concepts of evidence generation through master protocols and digital technology is addressing those challenges• A working example of an Integrated Research Platform for Adaptive Master Protocols Thomas Bock, MD, Co-Founder, APANDEMIC Jamie Macdonald, CEO, Parexel InternationalÜlo Palm, MD, PhD, Co-Founder, APANDEMIC/ Chief Medical Officer and Co-Founder, Ordaos Bio

2:15 pm - The Pitfalls of Validating Novel Digital Endpoints: What You Need to KnowDeveloping and validating Digital outcomes for use in a real world setting is fraught with complications not typically observed in a controlled setting as a clinic or lab. This presentation will cover examples of failed validations as well as computational means for controlling confounders. It will also highlight collaborative bench-marking efforts to better inform validity of outcomes in different settings.Larsson Omberg, VP Systems Biology, Sage Bionetworks

2:45 pm - SMART Markers: A New Framework for Capturing Patient-Generated Digital EndpointsComputational Health Informatics Program at Boston Children’s’ Hospital leveraged the newly regulated SMART on FHIR (Fast Health Interoperability Resources) API to build a software framework– SMART Markers, to capture patient-generated health data, including patient-reported outcomes, and their seamless electronic submission to the health system. Learn how app innovators can use SMART Markers to create their own custom version of practitioner and patient apps and readily leverage an interoperable PGHD functionality out of the box for research or care, at scale- without having to reinvent the wheel.Raheel Sayeed, Chief Fellow in Pediatrics, Boston Children’s Hospital and Harvard Medical School

3:15 pm - ICON’s Experience with Decentralized Clinical Trials During Covid• Methods used to gather patient perspectives • Fresh approaches to using patient insights for decision making• Example/case study: Decentralized trials survey • Applied innovation to ease burden and engage patients – what is helping to recruit and retain patientsE.B. McLindon, Senior VP, Site & Patient Solutions, Icon plc

Moderated by: Carrie Northcott, PhD, Director, Early Clinical Development (ECD) Digital Medicine and Translational Imaging, Pfizer, Inc. Track C: Digital Endpoints

Track Choice C

4:00 pmDPHARM Concludes

4:00 pmPartnering Meetings Through Meeting Mojo Platform Continues to 7:00 pm ET

3:30 pm - Track C Concludes

Agenda

Registration:

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Documents

DPHARM - The Conference Forum