Disruptive Innovations to Advance Clinical Trials · 2019-09-11 · Disruptive Innovations to Advance Clinical Trials 9 Annual th ... Increasing Patient Recruitment to Trials:

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September 17-18, 2019 Renaissance Boston Waterfront Hotel, Boston, MA

Disruptive Innovations to Advance Clinical Trials

Annual9th

Innovating for Patients

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DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS AGENDA

DAY ONE - TUESDAY, SEPTEMBER 17, 2019

7:45 am Registration & Coffee/Tea hosted by

8:25 am DPharm Begins!

PATIENT ADVOCATE KEYNOTE 8:30 am Patient Advocate Opening Presentation Fewer than 1% of the women who audition for the famed Radio City Rockettes make the roster and ironically, fewer than 5% of women under 40 get breast cancer. Our patient advocate keynote, Alyssa Epstein has experienced both. This veteran professional dancer will share her patient story, what mattered to her most as a patient and what it took to get back on stage.

Alyssa Epstein Patient Advocate, Radio City Rockette & Inspiration

9:00 am Chairs' Opening Remarks Tammy Guld Janssen Clinical Innovation, Global Team Lead, Johnson & Johnson

KEYNOTE 9:05 am

Modernizing Clinical Trials, Frameworks and Priorities Scott Gottlieb, MD23rd Commissioner of the FDA

KEYNOTE 9:45 am Collaborating to Transform R&D

Rod MacKenzie, PhD EVP, Chief Development Officer, Pfizer, Inc

with

Benjamine Liu, DPhilCEO and Founder, TrialSpark

10:05 am DPharm Café & Networking Exhibit Rooms • Breakfast• Partnering Tables• Meet the Exhibitors• Networking

DISRUPTIVE RESTORATION CORNERSTONE SPEAKER 10:45 am Good, Better…Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines Merck is walking the walk in disrupting how to restore best practices for people, product and productivity. With a clear vision on output, their remarkable team mapped a plan to an enterprise to change operational delivery. In this R&D Leadership session hear the story on how they are delivering what they promise:• How to plan upfront once and do it properly• Getting the basics right and what do you need to disrupt to get

there• Significant changes on greatly improving monitoring• The use of iPad technology to monetize CRA visits• How monitoring reports got reduced from 8 to 2• Building a stable workforce with strong employee engagement• Behavior, structure, systems and tools• Scaling it

Mark Travers, PhD, MBAVP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co

11:10 am Actions to Embrace and Support Innovation for the Benefit of Patients Shwen Gwee, PhDCo-Founder, Novartis Biome, and General Manager, Head of Open Innovation, Novartis

GUEST KEYNOTE 11:20 am The World’s 50 Most Innovative Companies 2019 Fast 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 the Deputy Editor of Fast Company to tell us about:• Defining Innovation• The process for selecting companies as the World’s 50 Most

Innovative• Interesting examples of Fast Companies top 50 most innovative

companies• Common elements in the identified 50 companies? Any major

themes?• Thoughts based on the top 50 list over the years on what the

key enablers are of sustaining innovation over a longer period of time

• Established companies that have either re-invented themselves or surprised Fast Company with something innovative for their customers

• Favorites to highlight and biggest surprises• Thoughts on which companies can change the world and why• Advice for pharma R&D developersDavid Lidsky, JD, Deputy Editor, Fast Company with Shwen Gwee, PhD, Co-Founder, Novartis Biome, and General Manager, Head of Open Innovation, Novartis

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11:45 am - Innovative Sources & Solutions 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 (see pg 13).

Track A: Innovative Digital Solutions Moderator: Nikhil Kavimandan, PhDDirector of Innovation & Strategy, Global Development Operations, Novartis

Track B: Innovative Patient Solutions Moderator: Sandra Freeman, GCO U.S. Director, MAO Supported Studies, Johnson & Johnson

Track C: Where Are They Now? Moderator: Ülo Palm, MD, PhD, SVP and Head, Digital Science, Allergan

11:50 am - 12:05 pm: Oracle Health Sciences Learning to Fish in an Industry Filled with Data Lakes Jae Chung, MBA, VP, Product Management / Strategy Helen Yeardley, PhD, SVP, Global Head of Feasibility, Site ID and Study Start-up, Clinical Research Service, ICON plc

11:50 am - 12:05 pm: PA Consulting Clinical Trial 2030: Pragmatic Predictions for the Next Evolution of Trials and What We Can Do Now to Prepare Kelsey Jakee, Life Sciences Expert

11:50 am - 12:00 pm: Elligo Health Research True Electronic Source: Why Elligo’s Approach Attains Real Source Data Collection in our Healthcare-Enabling Research Organization Jacylyn Bodmer, MBA, Chief Information & Technology Officer

12:05 - 12:15 pm: Clinical Ink The Move From EDC to eSource: Overcoming the Industry’s Data Crisis Ed Seguine, MBA, CEO

12:05 - 12:15 pm: BBK Worldwide The Myth: New Technology Inherently Equals Improved Outcomes Aaron Fleishman, Director of Market Development Matt Kibby, Principal, President

12:00 - 12:10 pm: MRN Successful Integration of In-Home Visits with Mobile Technology Graham Wylie, MBBS, CEO

12:15 - 12:25 pm: 4G Clinical Follow the Science without Technology Limitations • A cultural shift: Changes in people, processes and

technology• Quickly adapt to protocol amendments• Focus on the science and trial outcomesNeta Bendelac, Sr. Director, Strategy Washington Alves, Sr. Director, CMC Operations, Gemini Therapeutics

12:15 - 12:25 pm: ClinEdge The ROI of Providing Patient Travel Options: Exploring Cost Savings & Benefits for Sponsors & CROs Al Peters, VP, Patient Travel Services

12:10 - 12:20 pm: EDETEK EDETEK’s CONFORM™ Clinical Informatics Platform is Revolutionizing How Clinical Data is Being Ingested (from patient monitoring devices, EDCs, Labs, EHRs, Iot, etc.), Standardized, Transformed, Validated, Blinded, and Mapped to Create Near Real Time Access to Decision Makers on Trial Executions Mark Gee, Sr. Director Business Development

12:25 - 12:30 pm: snapIoT Bridging Socio-Economic Barriers in Important Maternal Health Research Christian Knaus, Senior Director, Client Development

12:25 - 12:35 pm: Greenphire From Rideshare to Reservations: Improving the Patient Experience through Travel Innovation Kyle Cunningham, Chief Product Officer

12:20 - 12:30 pm: GlobalCare Clinical Trials Decentralized/Hybrid Trials – Patient-Centric Services Facilitate Recruitment, Compliance and Retention Gail Adinamis, CEO

12:30 - 12:35 pm: Complion Why Respecting Site Agency is the Key to Site Success Rick Arlow, Founder and CEO

12:35 - 12:45 pm: Clincierge Improving Clinical Trial Performance through Effective Management of The Patient Journey Scott Gray, CEO

12:30 - 12:40 pm: Quest Diagnostics Case study: Impact of Lab Data on Phase 3 Study Planning, Site Selection and Recruitment David Freeman, GM, Information Ventures

12:35 - 12:40 pm: Science 37 5 Years of Lessons Learned in Virtual Trials in 5 Minutes Jonathan Cotliar, MD, CMO

12:45 - 12:50 pm: Inteliquet Increasing Patient Recruitment to Trials: Innovation in Predictive Analytics and Digitization Brings Clinical Trials into Clinical Care Debra Kientop, MBA, VP, Life Sciences

12:40 - 12:45 pm: Clinical Pipe First Year into Live Connection of EHR-to-EDC Clinical Pipe Application: Site Buy-in, Sponsor/CRO Adoption, Challenges and Solutions Hugh Levaux, PhD, Founder and CEO

12:40 - 12:45 pm: UBC Accelerating from Site-based to Real World Data-driven Clinical Development Paul Bloom, Sr. Director, Software Engineering

12:50 - 12:55 pm: AiCure AI-Based Digital Endpoints of Clinical Functioning: Increasing Sensitivity and Validity in Evaluating Clinical Efficacy Isaac Galatzer-Levy, VP Clinical and Computational Neuroscience

12:45 - 12:50 pm: Hawthorne Effect Clinical Trials 2.0 The Era of Convenience for Patients, Efficiencies for Sponsors Jodi Akin, Founder and CEO

12:45 - 12:50 pm: IBM Watson Health Observed Best Practices for Patient-Reported Outcomes Walker Bradham, Offering Manager - IBM Clinical Development Platform Danielle Chow, Life Sciences Portfolio Manager for Watson Health

12:50 - 2:00 pm: Lunch & Networking There is a choice of three buffet stations located in each exhibit room.

Seating is available in the session rooms and at networking tables.

Partnering is open and assigned partnering tables are located in the Brewster foyer and Brewster room on the 4th floor. You are welcome to bring your lunch to your assigned partnering meeting.

12:50 - 12:55 pm: Thermo Fisher Scientific Improving Patient Recruitment: Returning Genetic Results Shantanu Kaushikkar, MBA Director Product Marketing, Genotyping


Pharma Innovation 2019 Reporting from the Trenches This 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.

Track A Moderator: Joseph Kim, MBA Sr. Advisor, Clinical Operations and Digital Registry, Digital Health Office Translational Technology & Innovation, Eli Lilly & Co

Track B Moderator: Tammy Guld Janssen Clinical Innovation, Global Team Lead, Johnson & Johnson

Track C Moderator: Paulo Moreira Global Head of Clinical Operations, Agenus

2:05 - 2:20 pm The PD-FIDI: Developing a Digital Endpoint for Parkinson’s Disease Laura Kling, Director, Digital Innovation, Sanofi

2:05 - 2:20 pm The Evolution of Using Real World Data to Create Trial Readiness CohortsMartine Lewi, PhD, MBA, Janssen Clinical Innovation, Scientific Director, Johnson & Johnson

2:05 - 2:20 pm How Bayer Leveraged the Patient Voice in the Redesign of their Clinical Trial FinderMichelle Shogren, Director of Innovation, Pharma R&D Clinical Operations, Bayer

2:20 - 2:35 pm Pfizer: The Validation Study – ePRO and Scrolling Elan Josielewski, VP of Patient Centered Science, ICON Commercialisation & Outcomes, ICON Sachin Karnik, Director of New Clinical Paradigm, Pfizer

2:20 - 2:35 pm Re-Thinking Clinical Development – Using Historical Data to Transform Clinical Trials Aaron Mann, Global Program Lead, Industry Collaborations Data Sharing Initiatives, Genentech, a member of the Roche Group

2:20 - 2:35 pm Eli Lilly: Tracing Patient Recruitment Effectiveness Nicole Sheetz, PharmD, Advisor, Clinical Design, Delivery & Analytics, Eli Lilly & Company

2:35 - 2:50 pm Digital Recruitment and Analog Issues: Goals, Metrics and Challenges in Evaluating Recruitment TacticsSarah Luijpers, Associate VP, Drug Development Operations, Business Operations, Allergan

2:35 - 2:50 pm The Novartis Biome: Helping the Digital Health Ecosystem Truly Impact Drug Development Robin Roberts, Co-Founder, Novartis Biome, Head of Strategy & Innovation, Novartis

2:35 - 3:05 pm Don’t Clinical Trial Participants Have a Right to their Data and Results? What is PDAI Doing About It? Moderator:Jessica Scott, MD, Head of R&D Patient Engagement Office, Takeda Pharmaceuticals

Panelists:David Leventhal, MBA, Senior Director, Clinical Trial Experience, Pfizer

Sara Loud, MBA, Chief Operating Officer, Accelerated Cure Project (ACP) for MS

Megan McBride, MPH, Associate Director, Janssen Clinical Innovation, Janssen

2:50 - 3:05 pm Structured Data and Corporate Structure: How a Centralized Data Platform Within a Decentralized Organization Unlocks Value Daniel Rothman, Chief Information Officer, Roivant Sciences

2:50 - 3:20 pm The Value of Chasing Shiny Objects in Clinical Trials Merck's Laura Gaulchie and Bayer's Michelle Shogren have a game for the DPharm audience to myth bust. This session will use Kahoot to help determine how we chase shiny objects in clinical research. Laura Galuchie, TransCelerate Program Lead, Merck Michelle Shogren, Director of Innovation, Pharma R&D Clinical Operations, Bayer

3:05 - 3:20 pm Clinical Research as a Care Option into Direct to Patient Trials Leveraging Mobile Technologies Kent Thoelke, EVP, Chief Scientific Officer, PRA Health Sciences John Whang, MD, IET Head, Cardiovascular and Metabolism, Johnson & Johnson

3:05 - 3:20 pm Partnering with Patients: Retention and Engagement through Patient Data Return Dana Edwards, Sr. Director, Design and Delivery Innovation, IQVIA Judith Reece, MBA, PhD, VP, Digital Development, GSK

3:30 - 4:00 pm Afternoon Break in the DPharm Café & Networking Exhibit Rooms graciously hosted by:• Refreshments including chocolates by Boston’s oldest chocolatier and ice cream• Partnering Tables• Meet the Exhibitors• Networking and more



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Zeitgeist Talk Choices

Choice A

4:00 - 4:20 pm - Tech-Enabled Direct-to-Patient Return of Trial Results 23andMe and CISCRP are collaborating with industry stakeholders to enable: • Return of trial results directly to patients• Conduct end-to-end patient voice engagement throughout the medicine development life cycle• Provide more dynamic and in-depth conversation with patients that is bigger than their participation in one trial• Enable two-way feedback with patients to improve planning for clinical studies • Empowering the patient to take control of their health - and access novel therapies through clinical trialsIn this session, hear more about how these organizations are innovating in this space and impacts on the future of drug development with the patient at the center and the patient’s voice throughout.Shawn Tedman, MBA, Director, Clinical Trials Business, 23andMe withKen Getz, MBA, Director of Sponsored Research, Tufts CSDD and Founder, CISCRP Paulo Moreira, Global Head of Clinical Operations, Agenus

4:20 - 4:30 pm - Enigmatic Exceptional Responders—What Can We Learn From These Miracle Patients? • Build registry to enable and conduct the systematic study of exceptional responders receiving study drugs• Generate hypotheses with better understanding of the biology with exceptional responder datasetsSunita Badola, Head, External Partnership & Patient Data Strategy, Takeda Pharmaceuticals

Choice B

4:00 - 4:20 pm - The Use of AI and Big Data to Increase Reproducibility and Greater Accuracy in Drug Development Arjun (Raj) Manrai, PhD, Assistant Professor, Harvard Medical School and Faculty Member, Computational Health Informatics Program (CHIP), Boston Children’s Hospital

4:20 - 4:30 pm - How Digital Twins will Revolutionize Clinical TrialsCharles Fisher, PhD, Founder and CEO, Unlearn.AI

4:30 pm DPharm Idol Disrupt 2019 Now in its 8th 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 and Medable.Who will be the DPharm Idol Disrupt 2019 winner?Presenting Companies:TrialScoutIrfan Khan, MD, CEO

xCuresMika Newton, CEO

Shimmer Research Geoff Gill, President

IntelligenciaVangelis Vergetis, PhD, Co-Founder

Trials.aiKim Walpole, Founder and CEO

Tasso Ben Casavant, PhD, Co-Founder and CEO

DPharm Idol Disrupt Winner 2018, Medable’s Dr Michelle Longmire, will kick off DPharm Idol Disrupt 2019 and will give a brief update about their progress over the past year on: Leveraging the Human Digitome in Digital Trials

DPharm Idol MC:Valerie Bowling Executive Director, DPharm

DPharm Idol Judges: Sandra FreemanGCO U.S. Director, MAO Supported Studies, Johnson & Johnson

Cindy Geoghegan Cancer Veteran and Patient Advocate

Hassan KadhimDirector, Head of Clinical Trial Business Capabilities, BMS

Ülo Palm, MD, PhD SVP and Head, Digital Science, Allergan

Douglas Schantz Executive Director, Development Operations, AstraZeneca

Jessica Scott, MD, JD Head of R&D Patient Engagement, Takeda Pharmaceuticals

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

5:45 pm DPharm Annual Networking Reception & Partnering Join us at the reception to fill a gift bag to donate to Boston Children's Hospital.




DAY TWO - WEDNESDAY, SEPTEMBER 18, 2019

8:00 am Morning Coffee & Partnering

8:30 am Chair’s Opening & DPharm Idol Disrupt Winner AnnouncementTammy GuldJanssen Clinical Innovation, Global Team Lead, Johnson & Johnson

ZEITGEIST SPEAKER ON BIG DATA & AI FOR DRUG DEVELOPMENT 8:40 am The Collective Struggle to Evolve a Drug Development Organization’s Data and Analytics Culture and Capabilities Perhaps one of the most inquisitive CDOs in R&D, Milind Kamkolkar joins DPharm for the first time to address:• The theory of going digital in drug development?• Identifying hype from reality• What is the problem we are trying to solve?• Taking a big, complex organization and evolving it to be digitally

modern• What is the intended use of the data?• Priorities, structure, culture and next steps

Milind Kamkolkar Chief Data Officer, Cellarity

HEALTHGRADES KEYNOTE 9:05 am Healthgrades Founder Kerry Hicks on Transparency and the Future of Patient Expectations “Everyone likes progress and no one likes change.” Kerry HicksKerry Hicks is the founder of Healthgrades, which put the power of transparency into millions of patients’ hands on provider visit experiences. In this fireside chat, we will begin with his vision for Healthgrades, what it was like to build it, early fears, and unintended consequences.We will discuss Kerry’s three top principals:1. Transparency 2. Accountability 3. EmpowermentOur conversation will also cover the intersection between patient experience, technology and clinical research. Finally, we will get Kerry’s insights on why you must consider transparency with everything you build going forward, the customer/patient experience, key changes in clinical research and who may come along to disrupt us.

Kerry Hicks, MBAFounder, Healthgradeswith

Craig Lipset, MBAFormer Head of Clinical Innovation, Pfizer

9:25 am Today Show @DPharm Host:Michelle ShogrenDirector of Innovation, Pharma R&D Clinical Operations, Bayer

Guest Companies:IQVIA What Innovative Technologies are Fundamentally Changing the Way Clinical Trials are Run? Dana Edwards Sr. Director, Design and Delivery Innovation

Parexel Putting Innovation into Practice Sy Pretorius, MBChB, MBA Chief Medical and Scientific Officer

ERT Voice and AI plus Additional Support for Clinical Trials Andrea Valente EVP and Chief Development Officer

GUEST DESIGN SPEAKER 10:10 am Starbucks: Innovation for the End User Experience Starbuck’s guest speaker, Robert Mercer sits down with Eli Lilly’s Joe Kim to discuss an out-of-industry example from one of the best companies to cherish the end user experience. We will hear how Starbucks approaches innovation and in particular how they designed their mobile experience with the customer in mind. More specifically:• Barriers and executive buy-in• Rolling out the mobile experience• Balancing the scale of new solutions across stores around the

globe with the need to maintain existing operations and delivery• How Starbucks engages with customers to learn and develop

innovative new solutions

Robert MercerDesign Director, Global Digital Products, StarbuckswithJoseph Kim, MBASr. Advisor, Clinical Operations and Digital Registry, Digital Health Office, Translational Technology & Innovation, Eli Lilly & Co

10:30 am DPharm Café is open with breakfast, a Starbuck's themed break, networking and so much more. See page 16 for details.

11:10 am - 3 Break Out Choices

Track A: EHR eSource, Security, RWD & the Rise of Voice Tech

Track B: MAPs, Virtual Trials, Patient/Investigator Comm & Protocol Toolkit

Track C: Big Data, AI & Machine Learning



Break Out Choices

11:10 am - Track A: EHR eSource, Security, RWD & the Rise of Voice Tech Moderated by: Michele Cherry, Senior Manager, Client Partner, Pfizer

11:15 am - Operationalizing EHR eSource – Ruthless Separation of Hype from Reality DPharm welcomes one of the most credible voices in e-source, Dr Meredith Zozus for the first time to this event. Dr Zozus will begin briefly with why e-source can be truly disruptive to clinical studies from overall cost reduction, the ability to cut down on clinical data monitoring, reducing errors on data collection, site burden to the enormous decrease in manual labor. Joining DPharm for the first time as well is Pfizer’s Michele Cherry who is working with Dr Zozus on operationalizing e-source at Pfizer. Together, they will show the DPharm audience how e-source works and talk about what is required to implement it on a multicenter clinical study. Expect ruthless separation of hype from reality and discussion around the following questions:• What makes a study a good or bad candidate for EHR e-source and why?• How much of the data is really available in the EHR?• How does operationalizing e-source change site selection and start up time-lines?• How to reengineer start up times around e-source?• How to make ends meet from a regulatory perspective to operational perspective?• What are the unknowns and pitfalls?• Is the technology ready? Are the sites ready? Is my organization ready?• How to prompt discussions in your organization about when to jump on the adoption curve?• How do we gain experience with EHR e-source and de-risk it for my company?Meredith Zozus, PhD, Director of Clinical Research Informatics, UT Health Science Center San Antonio with Michele Cherry, Senior Manager, Client Partner, Pfizer

11:35 am - #WeHeartHackers: Why this is Vital to Clinical Trial Data Security Biohacking Village founder Janine Medina will cover a topic that we don’t always think about, but when you get exposed to it, you’re so glad as it makes you think deeper about clinical trial innovation, safety and privacy for patients, especially in this digital era. Janine is joined by former entrepreneur-in-residence at the FDA, Andrea Coravos where they discuss:• What is hacking? And why is it important for your clinical trial?• White Hat vs Black Hat• Security Bill of Materials for Connected Medical Devices / Wearables• Digital tools in trials and their vulnerabilities• Conventional trials and their vulnerabilities• What unexpected things can we learn from hackers when they look at the existing clinical trial process (the less scary things)• Coordinated disclosure• FDA’s CyberMed Safety (Expert) Analysis Board (CYMSAB)• #WeHeartHackers, and FDA-led initiative around cybersecurity research• BHV at DEF CONNina Alli, Executive Director, Biohacking Village with Andy Coravos, CEO and Co-Founder, Elektra Labs

12:00 pm - Using Real World Data to Plan Eligibility Criteria and Enhance Recruitment Sponsors are increasingly using real world data (RWD) to pressure-test assumptions and explore the impact of different eligibility criteria on trial feasibility before the protocol is finalized. In this session from the Clinical Trials Transformation Initiative (CTTI), learn about:• Practical models and operational guidance for using RWD to facilitate RCT planning and execution• Enhancing recruitment and eligibility through new approaches enabled by RWD• Actionable tools and case studies that support the appropriate use of RWD sources in clinical trial planningAt a time when limited best practices exist, CTTI’s multi-stakeholder work provides a much needed framework for using RWD to enhance the quality and efficiency of clinical trials moving innovation forward.CAPT Dianne Paraoan, USPHS, Associate Director for Regulatory Affairs, Office of Medical Policy, Center for Drug Evaluation and Research, FDA Jack Sheehan, RPh, MBA, PhD, Director, Real-World Value and Evidence, Neuroscience, Janssen Scientific Affairs

12:20 pm - The Future Outlook on Voice Technologies and Their Possible Impact on Clinical Trials Sara Holoubek, MBA, CEO, Luminary Labs

12:40 pm - Driving Patient Empowerment in Clinical Trial Recruitment: Case Study on Why Delivering Personalization at Scale is Not Only Necessary, but Possible! Kate Hermans, Chief Business Officer – Pharma, 83bar

12:50 pm - Maximizing the Value of RWD – Technology Challenges and Opportunities Paul Slater, Co-Founder, Clinical Research Innovation Hub, Microsoft Corporation

1:00 pm - LUNCH



Break Out Choices

11:10 am -Track B: MAPs, Virtual Trials, Patient/Investigator Comm & Protocol Toolkit Moderated by: Laura Galuchie, TransCelerate Program Lead, Merck

11:15 am - Master Protocols as the Future of Clinical Research: Patient-Centric R&D and Transformational Efficiencies We know patients, regulators, investigators and drug developers have a common interest in bringing safe and effective therapies quickly to patients needing them, yet the familiar clinical trial process contains built-in inefficiencies leading to delays, redundancies, and escalating costs. Master Protocols enable drug developers to answer questions more quickly, and patients participating in clinical trials to have the best opportunity to access promising therapies while contributing to the scientific understanding of their condition thereby allowing the field to progress as rapidly as possible.In this collaborative session representing both the patient and drug developer perspectives, learn what it takes to make MAPs a reality – the opportunities, challenges, why it’s disruptive and how all stakeholders can contribute.Abby Bronson, SVP of Research Strategy, Parent Project Muscular DystrophyDaniel Millar, MBA, Senior Director, Strategic Business Transformation Quantitative Sciences, Janssen Research & Development

11:35 am - Case Study: The ADAPTABLE Trial and Shared Learnings from a Virtual Trial The ADAPTABLE trial is the largest virtual trial ever run on the Medidata platform. Learn about the rationale around the decision to run the trial as a virtual trial, the impact on patient enrollment, engagement and retention as well as the incorporation of patients to inform the design of the trial and the tools used in the conduct of the study.Michael Tucker, Senior Product Solutions Specialist, Mobile Health, Medidata withHolly Robertson, PhD, Project Leader, Global MegaTrials, Duke Clinical Research Institute

11:50 am - Direct-to-Patient Clinical Trials Next Milestones and Actions to Get There We have called direct-to-patient trials, virtual trials, flexible trials, siteless trials, remote trials, decentralized trials and more. Many of us have done pieces of these types of trials, but as an industry, this is still not the norm by a long shot. In this discussion, we report on our progress, identify what’s missing to close the gaps and next steps and call to actions.Led by: Craig Lipset, MBA, Former Head of Clinical Innovation, Pfizer with Adama Ibrahim, EMBA, Associate Director, Performance Operational Capabilities, Global Clinical Operations, BiogenJacob LaPorte, PhD, Co-founder & VP, Global Head of Novartis Biome, Novartis Kelly McKee, Head, Patient Recruitment, Vertex Pharmaceuticals Jules Mitchel, PhD, President, Target Health

12:20 pm - Enhancing Clinical Trial Communications Between Patients and Investigators As an industry, we must prioritize building rapport with the patients who have instilled their trust and made a commitment to help researchers learn more about a disease and improve healthcare in the future. It’s equally important for healthcare professionals to feel that they have the support they need to build strong relationships with patients in the clinical trial setting. The more clinical trial sponsors do to show empathy and personalize the interaction with patients, healthcare professionals and site staff, the better trials will be. This presentation is a call to action for the audience to invest in high quality conversations between site staff and patients/ study participants.• Understanding patient interest and motivation• Deepening the connection between patients and site staff• Empowering PatientsThe goal is for patients to feel more engaged with the trial, and to equip site staff with tools to drive patient-centered conversations.Suzann Johnson, Associate Director Investigator Patient Engagement, CIE, Janssen

12:40 pm - The Launch of the Patient Protocol Engagement Toolkit (P-PET) The #1 way to make clinical trials patient-centric is to ask patients what they want. We know that patients are empowered by knowledge of their diseases and understanding of how drugs are developed and they want to take an active role in the drug development process to create better experiences for clinical study participants, caregivers, and families, they do not always have the tools for engaging patients in study design and measuring patients’ experiences during a clinical study.

For the first time attendees will preview the Patient Protocol Engagement Toolkit (P-PET). It entails a User and Resource Guide and templates that help teams consider necessary details when engaging patients during protocol development. Patient feedback during protocol development may help identify ways to improve patient experience and reduce patient burden.

The audience will also preview the recently made public Study Participant Feedback Questionnaire (SPFQ) toolkit. It includes the three questionnaires and a User Guide to help study teams consider necessary details to include the questionnaires into the study trial design. Collecting real-time feedback from clinical study patients may help identify burden/impact and inform the steps to take to make the current or future studies less burdensome to patients. These tools support innovation for the benefit of patients and drug development.Michele Teufel, Feasibility and Recruitment Partner, AstraZeneca

1:00 pm - LUNCH



AGENDA DPHARM: DISRUPTIVE INNOVATIONS TO ADVANCE CLINICAL TRIALS

Break Out Choices

11:10 am - Track C: Big Data, AI & Machine Learning Moderated by: Keith Koharski, Senior Director, Analytics, Digital Solutions and Innovation, Global Clinical R&D, Celgene

11:15 am - Is Digital Science, Big Data, Machine Learning, and AI Going to Revolutionize Medical Research and Practice? Implications for Pharmaceutical R&D • What is behind the terms “Digital Science, Big Data, Machine Learning, AI”?• Examples where these new technologies are shifting paradigms in medicine• What are the implications for pharmaceutical R&D? Can we sit it out or do we rapidly need to change?• What can AI do in development and what do we want AI to do in development?• How to separate hype from real opportunities to create value?• Why can’t we successfully implement Digital Science without a Digital Culture? What is a Digital Culture?• How is Allergan creating a Digital Culture to drive the success of Digital ScienceÜlo Palm, MD, PhD, SVP and Head, Digital Science, Allergan

11:35 am - AI in Healthcare: Why Augmented Intelligence Is the Path Toward Success Elizabeth Milkovits, PhD, Director, Global Analytics, IQVIA

11:45 am - An AI Powered Pragmatic Study: Mendel 3800 This session will review a study being conducted by Mendel.ai including the methodologies around automatic extraction of patient data being executed by Artificial Intelligence (AI). The result is a pragmatic study being completed at a fraction of cost and a fraction of time as compared with traditional methods. Karim Galil, MD, CEO, Mendel.ai with Matthew Michela, MBA, President and CEO, Life Image

11:55 am - All the Insight at a Fraction of the Time and Effort: Using Deep Learning to Generate a Wearable Sensor-based Proxy for VO2max There is a long list of “gold standard” clinical assessments that, while accepted by industry and regulators, are far from ideal or practical. They are either too expensive (polysomnography), too inaccurate (6 minute walk), or too burdensome for patient and trial coordinator (VO2max). Multivariate data sets from wearable sensors, when coupled with deep-learning artificial intelligence, represent the opportunity to use continuous, real-world physiology data to replicate these assessments using only the data passively collected throughout activities of daily living. In this presentation physIQ will discuss their latest proprietary deep learning algorithm that they are validating as a potential replacement for VO2max in clinical trials.Chris Economos, MBA, Chief Commercial Officer, physIQ

12:10 pm - Managing Site and Study Performance in Clinical Trials with AI Amit Gulwadi, SVP, Clinical Innovations, Saama

12:25 pm - AI Patterns in the Clinical Value Chain Sudhi Rau, Business Technology Leader, Janssen Pharmaceuticals R&D, IT, Global Clinical Development Operations & Janssen Clinical Innovation, Janssen Laszlo Vasko, Senior Director, R&D IT Clinical, Janssen

12:40 pm - What Needs to be Assembled Among Teams and Infrastructure to Support AI Deployment? • What to assemble to truly be a data driven organization?• Adoption challenges• Barriers• Next steps to AI adoptionModerated by:Michelle Hoiseth, Chief Data Officer, Parexel Panelists:Milind Kamkolkar, Chief Data Officer, Cellarity Ülo Palm, MD, PhD, SVP and Head, Digital Science, Allergan

1:00 pm - LUNCH


http://del.ai/



R&D LEADERSHIP KEYNOTE 2:00 pm KPIs that Support Innovation for Patient-Engagement Dr Plump leads Takeda’s global Research & Development organization, where he provides strategic direction and oversight. He specializes in bringing an unwavering focus on patients and a deep commitment to innovation and positive change in the healthcare industry. Dr Plump is joined by his colleague and DPharm veteran, Dr Jessica Scott in a fireside keynote to share the development of KPIs that support innovation for patient-engagement.

2:30 pm Super Session Choices The concluding section at DPharm offers two compelling tracks addressing upskilling site staff where we are proudly partnering with ACRP and CRAACO, which focuses on the integration of research and care. Attendees are free to “pick and mix”.

Choice #1: Workforce Innovation: Upskilling Site Staff for 21st C Clinical Trials Workforce Innovation Chair: Jim Kremidas, Executive Director, ACRP

This section of DPharm addresses one of the elephants in the room. As an industry, we are not doing a good enough job consistently ensuring the skill levels and training of site staff. The results of this is so costly that not even Tufts CSDD have a number on it. In this section, we are going to address head on the source of this problem and where innovation fits in so we can:• Understand the inequality of the workforce performance in clinical trials at the site level• Establish a definition and alignment on the competencies required for clinical research staff• Establish industry standards for validating the qualifications of site staff• Define a career path for site staff to enhance retention and quality• Improve enrollment, accurate data, operational efficiencies and overall quality in the clinical research ecosystemThis will get achieved through these sessions:

2:35 pm We Have a Problem with Workforce Performance at the Site Level and Here is What We Can Do Now Jeff Kingsley, DO, MBA, CPI, FACRP, CEO, IACT HealthChris Pitcherella, MBA, Director, Clinical Site Management, Pfizer David Vulcano, MBA, VP, Clinical Research Compliance and Integrity, HCA Healthcare

3:05 pm How to Develop Career Paths and Build the Competency of the Clinical Research Workforce / Individuals via Organizational Level Changes Deena Bernstein, Leadership Council, SCRSDenise Snyder, MS, RD, LDN, Associate Dean for Clinical Research, Duke University School of Medicine Mark Travers, PhD, MBA, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co

3:50 pm - 4:50 pm Collaborative Efforts for Workforce Efficiency and Productivity that are Disruptive Jennifer Byrne, CEO, JavaraBeth Harper, Workforce Innovation Officer, ACRP Dave Morin, MD, Director of Research, Holston Medical Group

5:00 pm DPharm Concludes

Andrew Plump, MD, PhD President, Research & Development Takeda Pharmaceuticals with

Jessica Scott, MD, JD Head of R&D Patient Engagement Takeda Pharmaceuticals


Choice #2: CRAACO: Clinical Research as a Care Option CRAACO Chair: Murray Abramson, MD, MPH, VP, Global Clinical Operations, Biogen

Five years ago, DPharm featured a session highlighting an example of research offered as a care option within a health system with positive health outcomes. The interest from both health systems and pharma in learning about the details of how to make this happen continues to grow. DPharm is committed to dedicating this section called CRAACO to highlight examples of bringing research closer to patients and patients closer to research.

2:35 pm Understanding the Goals of Care vs Research • Goals for care vs goals for research• Oversight and governance• Is there an ethical burden of breaking down the line between research and care?• What is the hesitation behind embracing the blurring of this boundary?• In areas like precision medicine, this is already blurring, how to manage?• Hurdles stopping large companies from thinking about this– Is it practical? Ethical?Moderted by: Kent Thoelke, EVP, Chief Scientific Officer, PRA Health Sciences Panelists: Murray Abramson, MD, MPH, VP, Global Clinical Operations, BiogenJennifer Byrne, CEO, JavaraJonathan Jackson, PhD, Director, CARE Research Center, Massachusetts General Hospital Douglas Schantz, Executive Director, Development Operations, AstraZeneca

3:00 pm How a CRAACO Approach Facilitates Diverse Recruitment and Especially Retention to Clinical Trial Jonathan Jackson, PhD, Director, CARE Research Center, Massachusetts General Hospital

3:10 pm Weighing Your Options in Considering Clinical Research from a Patient Perspective • Strategies and ideas to reduce the burden to patients• Understanding of clinical care with their physician?• Communication, consent and data sharingModerated by: Cindy Geoghegan, Cancer Veteran and Patient Advocate Panelists: Dave Bjork, Patient Advocate and Danya Kaye, Patient Advocate

3:35 pm How Sanford Health Systems Integrated Clinical Care and Clinical Research – Going from 3% of Patients in Clinical Trials to 10% in 8 years: Case Study • Creating a system for all providers to work seamlessly• Educational programs and continual training across all areas of care and specialties for trial offerings• Identifying gaps in trial availability• Attracting providers who are interested in clinical research for their patients• NCORP siteJennifer Weiss, Director of Clinical Research, Sanford Research

4:05 pm Pfizer’s Collaborative Approach with Ocshner Healthcare System to Integrate Clinical Research into Clinical Care Tim Joy, Senior Director, Patient Technologies & eSource, Pfizer

4:30 pm The Need for an Internal Advocate: How Can Clinical Research Professionals bring CRAACO into Clinical Operations? In this session, participants will receive an insider’s view of how being an advocate within pharma for patients and sites can benefit clinical trial awareness, participation, and experiences.Kelly McKee, Head, Patient Recruitment, Vertex Pharmaceuticals

4:50 pm Building a Site Network with Clinical Research as a Care Option Deena Bernstein, Leadership Council, SCRS

5:00 pm - DPharm Concludes

Documents

Disruptive Innovations to Advance Clinical Trials · 2019-09-11 · Disruptive Innovations to Advance Clinical Trials 9 Annual th ... Increasing Patient Recruitment to Trials: