2022 Agenda


  • 8:00 am

  • Registration, Morning Coffee / Tea

    Graciously hosted by 

  • 8:25 am

  • DPHARM Opening

  • 8:30 am

  • Extraordinary Patient Advocate Maimah Karmo

    Escaping war-torn Liberia, becoming a refugee, being diagnosed with breast cancer, and surviving it inspired our patient advocate speaker, Maimah Karmo to build a foundation that educates, empowers, and advocates for young women affected by breast cancer. We are proud to open DPHARM 2022 with Maimah’s incredible story.


    Maimah Karmo, MBA
    Founder/CEO, Tigerlily Foundation

    Moderated with:


    Peyton Howell, MHA
    Chief Commercial and Strategy Officer, Parexel

  • 9:00 am

  •  

    OPENING KEYNOTE

    Reverse Innovation So More Patients Benefit from More Therapeutics

    Renowned author and thought leader on Reverse Innovation, Vijay Govindarajan reviews critical elements within organizational culture that make the shift to a reverse innovation mindset possible. Specifically, he will discuss:

    • What is the definition of reverse innovation and why does it have such a tremendous impact on fueling greater advances in innovation?
    • Audience exploration on what are the true barriers to innovation in getting new therapies to patients faster
    • How do you build a culture that allows for a mindset shift where reverse innovation can flourish?
    • Why is it critical to strive to become a truly inclusive, human-centric organization?
    • Case study and call to action


    Vijay Govindarajan, PhD
    Coxe Distinguished Professor, Tuck School of Business,
    Dartmouth College

     


  •  
    Big Topic Leadership Panel

  • 9:30 am

  • Informed Consent. Can We Achieve Radical Change for More Patients?

    Radical thinkers come together in this leadership panel to challenge how we can finally make real changes to informed consent that reduces the burden to patients.  More specifically, they address:

    • Right sizing 
    • Content/technology 
    • Barriers
    • Vision of real change and how to get there and sustain it

    Moderated by:


    Conor Kane, MBA

    Senior Director, Janssen Clinical Innovation, Janssen Research & Development, LLC

    Panelists:

     

    Ezekiel J. Emanuel, MD, PhD
    Vice Provost for Global Initiatives and the Diane v.S. Levy and Robert M. Levy University Professor, Co-Director of the Health Transformation Institute, University of Pennsylvania


    Peter Ronco
    Head of Global Development, Janssen Research & Development, LLC


    Craig Tendler, MD
    VP, Oncology Clinical Development and Global Medical Affairs, Janssen Research & Development, LLC


    William (Bill) Terry, MD, MPH
    Medical Director Clinical Research, Janssen Research & Development, LLC

  • 10:05 am

  •  

    VISIONARY KEYNOTE

    Next Generation Innovation and Learning from the Fringes with Malcolm Gladwell

    Malcolm Gladwell is the author of six New York Times bestsellers — The Tipping Point, Blink, Outliers, What the Dog Saw, David and Goliath, and Talking to Strangers. He has been named one of the 100 most influential people by TIME magazine and one of the Foreign Policy’s Top Global Thinkers. He has explored how ideas spread in the Tipping Point, decision making in Blink, and the roots of success in Outliers. With his book, David and Goliath, he examines our understanding of the advantages of disadvantages, arguing that we have underestimated the value of adversity and over-estimated the value of privilege. Malcolm is the host of the popular 10-part podcast, Revisionist History where he re-examined an overlooked or misunderstood aspect of past events. He has been a staff writer for The New Yorker since 1996 and speaks globally to a wide range of industries.

  • 10:40 am

  • Followed by Q&A

    Moderated with:


    Najat Khan, PhD

    Chief Data Science Officer, Global Head, Strategy and Operations, Janssen Research & Development, LLC

  • 10:50 am
    - 11:35 am

  • DPHARM Cafe & Networking Exhibit Hall

    • Breakfast, coffee and tea
    • Meet the Exhibitors solving today’s challenges in clinical trials
    • Meet the Patient Therapy Dogs
    • Enjoy the DPHARM Foundation Treasure Hunt – where you can win 2 tickets to a Broadway show of your choice, 1 night hotel stay in NYC plus a $500 donation to a patient foundation of your choice
    • Chocolate turtles by Boston’s oldest chocolatier, Phillips Chocolates
    • DPHARM swag & Charging Station
    • Networking!!

    Graciously hosted by 

     

  • 11:35 am

  • Innovative Patient-Centric Sources & Solutions


  • Track A: Patient-Centric Clinical Trials for All

    Chaired by:

    Judith Reece
    Judith Reece, PhD

    VP, Digital Development, GSK


    11:35 am – 11:45 am

    Overcoming Patient Engagement Challenges in a Fully Decentralized Clinical Trial

    • Supporting the patient throughout the clinical trial journey
    • Applied technology to support sites and patients
    • Strategies for increasing diversity


    Brian Greene

    VP, Business Development, Decentralized Clinical Trials (DCT), ICONplc.com/PRA


    11:45 am – 11:55 am

    Feasibility: A Case for Never Asking More Than 10 Questions Ever Again

    Traditional feasibility solutions continue to under-deliver and cause frustration for sponsors and sites alike, while concurrently hurting relationships. During this session, we will discuss 3 components:

    • Leveraging Site Intelligence
    • Reducing Site Burden
    • Increasing Response Rates


    Suzanne Caruso
    SVP, Clinical Solutions – Insights and Analytics, WCG


    11:55 am – 12:05 pm

    Leapfrog Clinical Trial Acceleration with ZAIDYN Clinical Development

    • Discover a new approach to help you improve the clinical trial design process
    • Explore how to create a standards-based, data driven interconnected eco-system to accelerate clinical trial design


    Sid Shah
    Associate Principal, ZS Associates 


    Amit Mudgal
    Associate Principal, ZS Associates 


    12:05 pm – 12:15 pm

    How to Use an AI Data Platform to Ease Site & Patient Burden Participation Clinical Research

    • Addressing low accuracy and difficulty in locating trial participant medical history
    • Examine how manual chart review is untenable given the need for pragmatic designs with large patient numbers
    • Discuss the value of deploying an AI data platform to solve chart review using OCR/NLP and algorithms for scalable search, and address the challenges of data privacy and data provenance


    Michael A. Ibara, PharmD
    Chief Data Officer, Elligo Health Research®

     


    12:15 pm – 12:25 pm

    Building the Right “Molecule” by Combining Clinical & Digital Decentralized Elements

    • Explore how patient centric services supported by digital technologies can improve data quality and the clinical trial journey for patients and their families.
    • Review of combining clinical and digital elements can improve quality and efficiency in patient treatments and in clinical assessments that can be successfully accomplished in patients’ homes
    • Discuss how bringing the human element to decentralized visits and the use of e-clinical services can significantly reduce patient burden and maintain the patient’s relationship with their healthcare team


    Edward Triebell
    Executive Director, Digital Health, MRN


    12:25 pm – 12:35 pm

    Optimizing the Patient Experience in the Community Setting

    • Identify the top common friction points in patient research for patients (and their providers)
    • Consider how research tethered to the point-of-care benefits patient access to treatments (demonstrated by a case study)
    • Examine how small research team amplification can help reach more patients faster


    Colleen Hoke
    Co-founder and CEO, Objective Health


    12:35 pm – 12:45 pm

    Patient-focused Clinical Trial Technologies and Meeting Patients Where They Are

    • When it comes to technology – what do patients prefer?
    • How and when do patients want sponsors to engage with them?
    • What are patient preferences post pandemic?


    Kelly Franchetti
    SVP and Global Head, Patient Insights and Strategy, Yprime


    12:45 pm – 12:50 pm

    Efficient Patient-Centric Strategy: Reducing Patient Burden and Sponsor Costs Simultaneously

    • No two patient voices are the same: building flexibility and personalization into clinical trial design and execution
    • Increasing study engagement in diverse populations
    • …what about the budget? Informed, strategic trial planning for optimized ROI


    Sarah Val, MPH
    Regional Sales Director, Americas, mdgroup


    Track B: New Frontiers in Digital Technology Solutions

    Chaired by:


    Stephen Lutsch
    Director, Head of Revolutionize Clinical Trials, LEO Pharma

    11:35 am – 11:50 am

    Patient Centricity: The Key to Building Better Research Communities

    So often in science, we are confronted by a chasm dividing the key stakeholders of research: sponsors, scientists, sites, caregivers, and patients. We do ourselves, our data, and ultimately our patients a disservice by operating in a fractured environment of isolated technologies, independent workflows, and disconnected communications. Learn how technology can be used to:

    • Engage the entire research community beyond traditional boundaries
    • Create interdependent workflows that holistically address each stakeholder’s needs
    • Enable cohesive, thoughtful communication to align and manage expectations

    Patricia “Savi” Glowe
    Chief Research Operations Officer, ProofPilot


    11:50 am – 12:00 pm

    Improving the Patient eCOA Experience

    Examining technology strategies that can provide a flexible and reliable eCOA collection experience for study patients, such as: Support for multiple devices and device types; Passive study updates and data synchronization (it just gets done); Reminder support


    Anthony Mikulaschek
    VP, IQVIA eCOA


    12:00 pm – 12:10 pm

    Preparing for FDA’s Diversity in Clinical Trials Initiative

    The FDA’s draft guidance on Diversity in Clinical Trials is a welcome initiative to bring underrepresented patient populations to the forefront of clinical research.

    • Understand how this guidance, coupled with increasing enrollment criteria means trial sponsors and CROs must expand their site selections to include “Frontier Sites” and clinics who can recruit and enroll underserved patients
    • Discuss how many of these sites are inexperienced with trial conduct procedures & regulatory demands
    • Examine practical solutions to empower and activate ‘Frontier Sites’
    • Explore how compliance automation could be the key to bringing new treatments to more patients


    Denise Janus
    Chief Clinical Research Officer, Complion


    12:10 pm – 12:20 pm

    Augment Medical Writing with Artificial Intelligence (AI)

    • Explore the future of work for life sciences teams and ways in which humans and technology can work together to create more efficient workforces
    • Understand the potential of pharmaceutical document augmentation and how AI is paving the way for a fully automated document landscape
    • Case study review on using AI to augment regulatory submissions and other reporting


    Emmanuel Walckenaer
    CEO, Yseop


    Marjo Gazak
    Sr. Director, Global Scientific Communications; Sr. Director, Knowledge Management & Content Delivery Innovation, Eli Lilly and Company


    12:20 pm – 12:30 pm

    The Challenge and Importance of Quality Data Capture in Remote Patient Monitoring

    • Validate digital biomarkers against clinical gold standard
    • Continuously and remotely collect data throughout the clinical trial with minimal interruptions in data capture
    • Transfer data securely and in real time for immediate patient intervention and prompt data interpretation and analysis


    Catherine Oglevee
    Program Manager, Empatica


    12:30 pm – 12:40 pm

    OpenSite: Frictionless Connections Between Sites and Sponsors

    • Introducing a networking platform for clinical research
    • Frictionless connections between sites and sponsors that is free, open, secure, and trusted


    Bill Cooney
    President & CEO, MedPoint Digital


    12:40 pm – 12:50 pm

    Shaping the Next Generation Participant Experience

    • Examine practical considerations for enhancing the participant experience through technology
    • Discuss the role of digital technology in reducing patient burden
    • Using technology to ensure that patients are always well informed


    Clay Williams
    VP, Mobile Applications, IT , Greenphire


    Track C: Making DCT’s a Realistic Option for More Patients

    Chaired by:

    Douglas Schantz
    Doug Schantz

    SVP, Clinical Operations, Asklepios BioPharm

    11:35 am – 11:50 am

    Innovating to Navigate Escalating Study Costs, Timelines, and an Uncertain Economic Future

    Some advances are innovative, and some just do things the old, inefficient way
    online. There are four tests you can use to determine if a technology or approach you
    are adopting is truly innovative. As we enter troubled economic times, now is the time to improve efficiency and drive ROI in clinical research.

    • Explore an actionable definition of innovation in the context of clinical research
    • Understand the need for performance management technology; examine the risks associated with traditional training and the learning management system approach vs. emerging technologies in adult learning
    • Review of data from pivotal studies demonstrating the scope of the opportunity to drive efficiency


    David Hadden

    President & Founder, Pro-ficiency


    11:50 am – 12:00 pm

    Three Key Tactics to Design a Patient-Centric DCT

    • Conveying the value of patient-centric tactics to secure stakeholder buy-in (i.e., internal sponsor buy-in)
    • Gathering feedback from patients to understand what’s feasible and important to them (i.e., Ask the patient)
    • Designing the protocol with fit for purpose DCT tactics appropriate to the patient population (i.e., follow through where possible)


    Lyn Agostinelli

    Principal Consultant, Clinical Operation, Halloran Consulting


    12:00 pm – 12:10 pm

    End-to-End Digital Patient Journey: Insights into Patients Before, During, and After a Clinical Trial Through Tokenization

    • Understand the increasing value of RWD as part of evidence generation for clinical programs in supporting both post-approval activities as well as approval-related regulatory filings
    • Examine the importance of streamlining the research process to accelerate recruitment, maintain engagement, and reduce patient loss during a study
    • Transition to evidence and treatment plans that take into account the entire patient journey (before diagnosis, during the initial phases of treatment, and beyond) for optimal patient and financial outcomes


    Bob Zambon

    VP, Solution Design, Syneos Health


    12:10 pm – 12:20 pm

    Design Studies Your Patients Want to Join: Co-creation to Launch Optimized Clinical Trials

    • How Patient-Centered study design approaches help researchers create the experiences that participants need and expect
    • How patient co-creation can lead to better endpoint selection, more inclusive study experiences, stronger regulatory compliance, and ultimately, better data
    • Specific strategies to consider for creating patient-centric studies that address the root causes of challenges in recruitment and retention


    John Reites

    CEO, Thread


    12:20 pm – 12:30 pm

    Solving for the Crisis in Clinical Research: Research in the Post-Pandemic Era

    • The industry has the largest pipeline that we have ever seen, yet, we are challenged with a global healthcare staffing crisis
    • The number of Investigators participating in research is rapidly declining, and research is far more complex
    • Ninety-five percent of patients are not currently participating in research. Now is the time to innovate and find new options for how we conduct research and increase the pool of stable investigators


    Kushal Gohil

    SVP, Corporate Strategy and Innovation, Parexel


    12:30 pm – 12:40 pm

    How a Decentralized Model Offers Fresh Hope for Patients

    Peripartum Depression (PPD) is an under-recognized disease that can have a debilitating effect on patients and their families. Conventional, clinic-based treatment requires a continuous, 60-hour visit to an infusion center, during which patients must be monitored throughout for serious side effects. Such requirements severely limit patient access to existing PPD treatment. In this session, Dr. Reist will discuss:

    • Examine results from a study that attempts to bring PPD treatment out of infusion centers and into patients’ homes by adopting DCT approaches
    • Discuss how numerous moving parts of this complex study—including mobile nurses, the pharmacy, and a sensory device provider all work together in a truly patient-centric fashion, with patient safety remaining the number-one priority.


    Christopher Reist, MD

    Medical Director, Psychiatry & Behavioral Sciences, Science 37


    12:40 pm – 12:50 pm

    Partnering with Patients to Design & Execute DCTs: Examples from the Field

    Learn how patients and patient advocacy organizations can serve as powerful partners to facilitate all stages of DCT deployment from protocol design, recruitment and engagement to dissemination of results. Hear examples from the real world including:

    • A Rare disease DCT that went from protocol design to the FDA in 60 days
    • A DCT that leveraged trusted messengers in the community to involve minority and underserved patients during the peak of the COVID-19 pandemic


    Renee Willmon

    Senior Director, Evidence and Outcomes, Self Care Catalysts, An Alira Health Company


    Track D: The Future of Clinical Trials

    Track Chair:

    Monique Adams
    Monique Adams, PhD
    Director, Clinical Innovation Lead, Janssen 


    11:35 am – 11:45 am

    Patient Science, Usability, and the Future of Clinical Trials

    • Understand the value of integrating user experience design principles and practice into every virtual study
    • Discuss how to vastly improve greater inclusivity, access and user experience through in-depth research into patient needs, condition and therapeutic-specific needs, clinical practice, and technology engineering
    • Explore best practices, including integrating user-tested instructions, animation, calibration, and feedback directly into mobile study applications


    Joan Severson

    Chief Innovation Officer, Clinical Ink


    11:45 am – 11:55 am

    How EHR to EDC Solutions Are Changing the Trial Landscape

    • Insights and outcomes that EHR to EDC applications (such as Flatiron Clinical Pipe) enable for site research teams, CROs, and sponsors.
    • How Flatiron is scaling Flatiron Clinical Pipe to academic and community centers to enable more efficient clinical trials wherever patients choose to receive their care.
    • The adoption of EHR to EDC technology, such as Flatiron Clinical Pipe, enables simpler, faster, and cleaner


    Lauren Sutton
    Director, Product Management, Flatiron Health


    11:55 am – 12:05 pm

    How Digital Tools Can Advance Clinical Trials

    • Understand how digital tools address the needs of clinical trial participants, sponsors, and regulatory agencies – from improving clinical-trial compliance to eliminating patient-reported outcomes
    • Examine the potential for tech-based strategies to meet multi-stakeholder needs– including digital biomarkers, ePRO, apps and wearables
    • Discuss the value of digital tools from a patient advocate perspective – for example, gathering and reporting on patient-experience data

    Stephen Zabrecky
    Digital Lead, Cambridge Design Partnership


    12:05 pm – 12:15 pm

    Shift to Simplification: Unifying Experiences for Patients, Sites, and Sponsors with Digital Technologies in Clinical Trials

    With a shift towards DCTs and a move away from the transactional nature of in-office clinic visits, the industry has noted the need for resources that reduce burdens on patients, sponsors, and sites. A unified experience across all stakeholders drives trial efficiencies while enhancing patient engagement.

    • Discuss the value and impact of a single-destination patient portal on reducing stakeholder burdens
    • Consider the impact on study participation if patients use just one login to access and participate in all their trial activities, while sponsors customize the amount of virtual touch points and sites speed up study startup activities.


    Kelly McKee
    VP, Patient Registries and Recruitment, Medidata


    12:15 pm – 12:25 pm

    Prognostic Digital Twins Put Clinical Trial Patients First

    This session explores the impact of TwinRCTs on patient access, safety and more.

    • Examine how TwinRCTs, powered by prognostic digital twins, have smaller control arms and increase patient access to experimental treatments
    • Discuss how TwinRCTs have reduced trial timelines by over a year, helping to bring safe and effective treatments to patients sooner
    • Review Unlearn ‘s draft qualified regulatory framework for implementing TwinRCTs in phase 2 and 3 clinical trials


    Andrew Stelzer, PhD
    Head of Business Development, Unlearn.ai


    12:25 pm – 12:35 pm

    The Case for Empathy in Product Design

    Whether you’re creating a new drug, device or clinical trial IT product, user empathy is a crucial tool for the success of your idea. With increasing focus on AI, DCTs and an associated increase in subject diversity, empathy for the patient experience is more important than ever. In this session, we will examine:

    • How spending a bit of time looking outwardly will improve data quality, reduce costs, and eventually help with the adoption of your end product.
    • A specific case example and identify some activities you can easily fold into your processes that help with listening and perspective-taking


    Paul Boyd
    VP, Experience, Clario


    12:35 pm – 12:45 pm

    Make it Realistic: How to Build Trials for Everyday Life

    With McKinsey’s Industry Standard Research survey finding that 100% of surveyed pharma and 89% of surveyed CROs plan to conduct decentralized trials this year, the era of DCTs is here.
    While these trials are more “patient-centric” by nature, it takes a level of understanding, planning, and preparation to ensure trials are frictionless and engaging for patients. Discover how to build trials that fit within the lives of patients.

    • Design an assessment strategy that is more inclusive and less burdensome
    • Provide a consistent patient experience whether on-site or remote
    • Create trial protocols that are transparent and fit patient needs


    Mohammed Ali
    Chief Domain Expert, Medable


    12:45 pm – 12:55 pm

    Advarra’s Update on Connecting Research Sites and Sponsors Through an Integrated Technology Ecosystem

    • Examine the challenges and present solutions to research stakeholders burdened by disparate research technology
    • Recognize and quantify the burden of manual exchange of regulatory documents and other data between non-integrated site and sponsor systems
    • Discuss Advarra’s Site-Sponsor Consortium launched in early 2022 and summarize key conversations and considerations when leveraging standards and improving workflows to achieve better stakeholder communications
    • Review Advarra’s progress and discuss actionable insights of how this connected ecosystem is empowering sites and sponsors to drive clinical trial lifecycle efficiencies


    Aidan Gannon
    Director of Client Services and Innovation, Advarra


    12:55 pm – 1:00 pm

    AI in Clinical Trials 101: Start by Digitizing your Data

    • The ROI of AI in clinical trials is largely unrealized due to the substantial upfront
      investment needed in data cleansing and standardization
    • We are building a foundational capability to digitize and standardize data from clinical
      trial documents (protocols and SAPs) to support downstream use cases, such as
      optimized protocol design, study planning, and results analysis.
    • Whether it’s historical protocol design data, competitor insights, or RWE – with digitized, standardized, integrated data, you can build countless AI and automation solutionsvacross the trial lifecycle


    Eddie Valaitis, PhD
    Director, Pharma & Life Sciences, R&D Analytics &AI, PwC


    Shefali Jain
    Consultant, Health Industries, Analytics & AI, PwC

  • 12:55 pm
    - 1:55 pm

  • Lunch, Networking and 1:1 Partnering

  • 1:55 pm

  • Pharma Innovation 2022 Reporting from the Trenches
     

    Several different pharmaceutical companies report on a specific example of innovation to drive clinical trial efficiencies, reduce patient burden, increase diversity, inclusion, access, and/or better health outcomes in the last 12 months. Each session addresses the milestones, challenges and problems with adoption. All tracks are chaired by a patient advocate and presenting companies include:

    See below for full Track Descriptions>>


  • Track A: Scaling Remote Trials, Customized Site Monitoring Tech and Performance Management to Drive Productivity

    Chaired by:


    Barry Nelson
    Patient Advocate

    1:55 pm – 2:25 pm

    The Pfizer Pledge: Getting to 60% Remote Clinical Trials Across all Therapeutics Areas in 2022

    • Understand the key steps Pfizer is taking to make remote clinical trials a reality for patients
    • Explore the cross functional team approach to scaling remote clinical trials across all therapeutic areas
    • Examine the impact of adopting the light speed mindset
    • Review the key learnings and what the voice of the patient data reveals to date


    Tim Joy
    Executive Director, Head of Strategic Solutions, Pfizer


    Daniela Graham
    Clinician, Pfizer


    2:25 pm – 2:40 pm

    Merck on Developing a Customized Site Monitoring Technology to Drive Efficiencies and Performance

    How we got SMART. This session tells the story of SMART, an internally developed software that has dramatically simplified and improved the lives of CRAs working at Merck.

    • Examine how Merck moved forward in shifting paradigms to challenge the status quo
    • Understand the value of user centric design in achieving speed in user adoption 
    • Review year over year  outcomes on quality and consistency in monitoring


    Merle Schneider
    Senior Director, Monitoring Excellence, Global Clinical Trials Operations, Merck & Co. Inc.


    2:40 pm – 2:55 pm

    GSK on How to Implement a Performance Management Culture to Speed Productivity in Clinical Operations

    GSK’s Control Tower is a one-stop shop for all information on the operations of their clinical studies allowing clinical operations leaders and senior management access to all quantitative data [financial, patient recruitment, etc..] on current trial status across all therapeutic areas. With an end goal of the ability to view all active trial performance, see where changes can be made to address recruitment, costs, and speed. Specifically, this session examines:

    • What it takes to foster a performance culture where employees can see internal value and value to patients
    • The critical importance of ensuring that the tool is a user-centric design
    • Over time, using the Control Tower to capture study trends and lessons learned that can be applied earlier in future studies


    Arlene Derbaix
    Clinical Operations, Performance and Control Tower, GSK


    Francois Van Lede
    Performance Manager, Clinical Operations, GSK


     

    Track B: Modernizing Clinical Trials for Patient Optionality

    Chaired by:


    Maimah Karmo, MBA
    Patient Advocate

    1:55 pm – 2:25 pm

    Regeneron and Novartis on Innovating to Accommodate Growing Pipelines

    • Examining how modernizations like the implementation of AI/ML, RWE, DE&I, DCTs impact the need for more flexibility clinical trial design
    • Building protocols in tandem with study design and re-envisioning methods to execute trials

    Moderated by:


    Bari Kowal
    SVP & Head, Development Operations and Portfolio Management, Regeneron

    Panelists:


    Henry Wei, MD
    Head of Development Innovation, Regeneron


    Rinol Alaj, MBA
    Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, Regeneron

    Bill Illis
    Global Head, Collaboration and Technology Strategy, Clinical Development & Analytics, Novartis


    2:25 pm – 2:40 pm

    LEO Pharma’s Journey to Revolutionize Clinical Trials Via User-Centric Design 

    •  Review the vision and approach to achieve user-centric hybrid clinical trials
    • Discuss key challenges around implementation, scaling across trials and regulatory hurdles
    • Understand the potential impact of user-centric design with patients and sites
    • Action steps for the future


    Stephen Lutsch
    Director, Head of Revolutionize Clinical Trials, LEO Pharma


    2:40 pm – 2:55 pm

    Moderna on Innovating Clinical Trial Partnerships to Expand Access

    Moderna discusses its recent partnership with CVS Health to bring its clinical trial closer to patients and expand patient access into more communities.

    • Review the complexities of forming a new partnership and developing a model for implementation and execution
    • Examine the model in terms of investigator strategy, shipping and logistics approach and overall quality & monitoring
    • Operationalizing each part of the model – key considerations, digital platforms, possibilities for scaling
    • Lessons learned moving forward


    Jessica Perry
    Director, Patient Centricity, Clinical Innovation, Moderna


    Josh Rose
    VP, Head of Decentralized Trials, Site Solutions and Strategy, CVS Health


    Track C: Evolving dBM Research, Model Statistical Methods and Graph Based ML in Clinical Trials

    Chaired by:

    Cindy Geoghegan
    Cindy Geoghegan

    Patient Advocate

    1:55 pm – 2:25 pm

    The Last Mile of Digital Biomarker Research – Behold, The Digital Data Registry of Lilly Digital Health

    While digital health technology promotes the ability to collect wearable sensor data and ePROs, what matters more than that is how some of these most complex digital data can be efficiently visualized, extracted and analyzed for digital measures development. Come learn about the industry’s best example of what a Digital Data Platform should (and can) do to ensure dBM research is done efficiently and rigorously.


    Rich Carter

    VP and Chief Digital Officer, Digital Health, Eli Lilly and Company


    Joseph Kim
    Chief Strategy Officer, ProofPilot


    2:25 pm – 2:40 pm

    Sanofi on Transforming Clinical Trials through Statistical Innovation 

    Sanofi is using model statistical methods and programming technology to implement innovations in quantitative analysis into daily operation. This includes a Dose Escalation Execution Platform (DEEP), Interactive Decision Early Oncology (IDEO) and Continuous Efficacy Assessment with 3-Outcome Decision Making (3ODM). This toolset provides more effective approaches to study design, execution and decision making. The user-friendly graphical user interface (GUI) will enable a broader implementation without requiring intensive training or learning.


    Paul Bassett, BSN, RN

    Project Lead, Early Development Oncology Operations, Sanofi


    2:40 pm – 2:55 pm

    AstraZeneca on Leveraging Graph Based Machine Learning in Clinical Trials

    This session examines the impact of the recent evolution in Graph ML that would enable the use of clinical trial data and questions our traditional thinking about data use and reuse.

    • Brief overview of graph representation of data in drug development
    • Discuss how graph modeling and machine learning could help determine optimal times to look for and report out on adverse effects and how/where we can possibly hone in on making trials safer
    • Examine the potential use of these data sets to determine what factors drive attrition and/or adherence
    • Consider how these graphs can help increase development speed, reduce costs and minimize barriers and burdens to patients
    • Case examples (TrialGraph) and call to action.


    Shameer Khader, PhD

    Senior Director, Machine Learning Research, AstraZeneca


    Track D: Partnering with Community Sites\Solving with Data Science\Protocol Design Optimization + Scaling DCTs

    Track Chair:


    Tina Aswani-Omprakash
    Patient Advocate


    1:55 pm – 2:10 pm

    How Otsuka Collaborates with Community Sites to Increase Trial Access

    In its ongoing efforts to increase trial access, Otsuka successfully identified and collaborated with community-based sites to appropriately reach and enroll new patient pools while also accelerating timelines. By identifying quality sites with the right patient populations to meet trial targets and successfully leveraging trusted provider patient relationships, sponsors can make meaningful strides toward a more inclusive and diverse patient population in its trials.


    Candace T. Saldarini, MD

    Senior Director, Applied Innovation Process Improvement, Otsuka Pharmaceuticals


    Liz Beatty

    Co-Founder and Chief Strategy Officer, Inato


    2:10 pm – 2:25 pm

    How Vertex Right-Sizes Data Science Deployment for Clinical Operations

    Hear Vertex’s approach to rethinking how to deploy data science in clinical operations from a from a strategic, fit for purpose perspective. Learn about the impact that it can have on creating greater net value as well as how to create data-driven actions within the business.

    Taylor Uttley, MBA
    Head of Strategy and Operations, Data Strategy and Solutions, Vertex Pharmaceuticals


    2:25 pm – 2:40 pm

    How Eli Lilly Deployed an AI Enabled Solution to Optimize Protocol Trial Design

    Pharma companies face a universal challenge managing the impact of costly protocol design amendments and of patients dropping out of the trial. With a tri-partnership approach with AWS and PwC, Lilly utilized a cloud native AI/ML solution to incorporate learnings from previous clinical trial protocol designs resulting in:

    • Reduced patient and site burden
    • Acceleration of overall trial timelines resulting from shorter enrollment duration, lower number of avoidable amendments and lower patient withdrawal rates
    • Increased cost efficiencies from reduced procedure costs

    The session will share the Eli Lilly journey on how they leveraged AI enabled analytics & automation to completely change the way clinical trials are designed and executed leading to significant business value.


    Matt W. Maddox

    AVP, Eli Lilly and Company


    Kosmas Kretsos

    Head of Clinical Trials Strategy and Solutions, AWS


    Sidd Bhattacharya

    Director, Cloud & Digital Transformation, PwC


    2:40 pm – 2:55 pm

    BMS on Implementing DCTs at Scale

    As DCTs continue to reduce patient burden and remove barriers to clinical trial access, the drive to implement at scale is escalating. This session examines BMS’s approach and specifically will discuss:

    • Ensuring a consistent definition for DCTs across the organization
    • How to align and engage cross functionally to enable bringing DCTs to scale
    • Engaging in collaborative partnerships with service providers to make DCTs a reality at scale


    Hassan Kadhim
    Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS

  • 2:55 pm

  • DPHARM Cafe Afternoon Networking Break Graciously Hosted by

    • Ice Cream! 
    • Refreshments and Beverages
    • Assorted chocolate station
    • Meet the Exhibiting Companies solving today’s challenges in clinical
    • Ask the Patients (Dedicated area with people who experienced a clinical trial and can speak with you about their experience.)
    • Enjoy the DPHARM Foundation Treasure Hunt – where you can win 2 tickets to a Broadway show of your choice, 1 night hotel stay in NYC plus a $500 donation to a patient foundation of your choice
    • 1:1 Partnering and partnering tables
    • DPHARM swag & Charging Station
    • Networking!!
  • 3:45 pm

  • Choice of Breakout Session

    • Breakout Session A
      3:45 pm – 4:15 pm

      Clinical Trial Experience Keynote

      Fireside Leadership Lessons: Driving Innovation to Support Patients and Sites

      Judy Sewards was one of the top 30 leaders who played a critical role in the success of Pfizer’s Covid-19 vaccine clinical trial program. In her role, she led patient and site communications and engagement. She was responsible for Pfizer’s relationships with the over 150 trial sites who conducted the Covid-19 vaccine clinical trials. She also helped create awareness about the clinical trials and worked with community, and government partners to elevate the importance of participation in the trial by diverse communities and organized services to make clinical trial participation more convenient and sustainable for patients. In this fireside keynote chat, Judy will discuss leadership lessons needed to drive innovation and specifically, how to better support patients and sites.


      Judy Sewards
      VP, Head of Clinical Trial Experience, Pfizer

      with


      Barry Nelson
      Patient Advocate

       

       

    • Breakout Session B
      3:45 pm – 4:15 pm

      NEXT-GEN DIGITAL TRANSFORMATION

      Enabling an End-to-End Digital Transformation Strategy to Drive Better Patient Outcomes

      As clinical operations development groups transition digitally with discovery and commercial groups, they face tough challenges that slow down development. This panel discussion brings discovery, development and commercial together to help attendees break down silos and address fragmented strategies for a more efficient digital transformation that allows for more innovation. In this multi-stakeholder session, we will address the following:

      • Key contributing factors to fragmentation at different phases of drug development
      • Potential solutions to anticipate roadblocks and break down silos across the drug discovery, development and commercial processes
      • Business model innovation to focus on value creation versus ROI alone
      • Payor evaluation perspectives impacting reimbursement and value based pricing
      • Adoption challenges and the impact from new products

      Moderated by:


      Adama Ibrahim
      VP, Digital Strategy and Change Management, Novo Nordisk

      Panelists:


      Bob Bois

      Innovation Program Director, Novartis Institutes for BioMedical Research


      Najat Khan, PhD

      Chief Data Science Officer, Global Head, Strategy and Operations, Janssen Research & Development, LLC


      Nuwan Kurukulasuriya, MS, PhD

      Global VP and Therapeutic Area Head, Medical Affairs, Alexion, AstraZeneca Rare Disease


      Michael S. Sherman, MD, MBA, MS

      Executive VP & Chief Medical Officer, Point32Health


      Katherine Vandebelt

      Global VP Clinical Innovation, Oracle Health Sciences

  • 4:15 pm

  • Assessing the Value of Emerging Technologies and Services for Clinical Trials

    The quest to modernize clinical trials and increase access, inclusivity and diversity continues to fuel the evolution of innovative technology and services solutions. As the influx of emerging technologies and services for clinical operations expands, assessing and vetting the value of them becomes a critical task. This session will discuss potential value assessment approaches, de-risking strategies as well as what defines success when working with such new and untested technologies/services.

    Moderated by:

    Yusuf Ghadiali
    Yusuf Ghadiali
    Executive Director, Head of Clinical Trial Business Operations, Daiichi Sankyo, Inc.

    Panelists:

    Brandon Maggio
    Director, Digital & Process Optimization, GSK

    Julien Kroll
    Clinical Trial Technology Strategist, Bayer

  • 4:40 pm

  •  

    DPHARM Idol Disrupt 2022

    Now in its 11th 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 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 winners include Medidata, Spaulding Clinical, ePharma Solutions, Science 37, Florence Healthcare, physIQ, Medable, Tasso, King-Devick, and Biofourmis. Who will be the DPHARM Idol Disrupt 2022 winner? DPHARM Idol will kick off with the 2021 winner, Biofourmis with where they are a year later.

    DPHARM Idol 2021 Winner Where They Are a Year Later


    Jaydev Thakkar
    COO, Biofourmis

    2022 Presenting Companies:


    Ardy Arianpour
    CEO & Founder, Seqster


    Matthew Kokkonen, MBA
    Director, Strategic Account Management, Captario


    Dominique Demolle
    CEO, Cognivia


    Matt Walz
    CEO, Trialbee


    Del Smith, PhD
    CEO/Cofounder, Acclinate


    Ganesh Padmanabhan, MBA
    CEO and Founder, Autonomize

     

    DPharm Idol Disrupt Judges:


    David Apfel

    Head, Data Science External Innovation, Janssen Research & Development LLC

    Cindy Geoghegan
    Cindy Geoghegan

    Patient Advocate

    Yusuf Ghadiali
    Yusuf Ghadiali

    Executive Director, Head of Clinical Trial Operations, Daiichi Sankyo


    Andrea Jackson

    Managing Director, Northpond Ventures


    Hassan Kadhim
    Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS

    Ülo Palm
    Sarah Krüg

    Executive Director, Cancer101
    CEO, Health Collaboratory


    Matt W. Maddox 

    AVP, Eli Lilly and Company

    Judith Reece
    Judith Reece, PhD

    VP, Digital Development, GSK

    Chandra Ramanathan
    Doug Schantz

    SVP, Clinical Operations, Asklepios BioPharm


    Merle Schneider

    Senior Director, Monitoring Excellence, Global Clinical Trials Operations, Merck & Co. Inc.


    Donna Usiskin

    Chief Strategy Officer, New Enterprise Ventures


    Taylor Uttley
    Head of Strategy and Operations, Data Strategy and Solutions, Vertex Pharmaceuticals

     

  • 5:45 pm
    - 7:00 pm

  • Networking Reception and Birds of a Feather Roundtables

     

    The 2022 DPHARM Networking Reception is graciously hosted by   

    • Network with peers!
    • Meet the exhibiting companies solving today’s challenges in clinical trials
    • Enjoy the DPHARM Foundation Treasure Hunt – where you can win 2 tickets to a Broadway show of your choice, 1 night hotel stay in NYC plus a $500 donation to a patient foundation of your choice
    • Help us fill a gift bag to donate to the Ronald MacDonald House Boston Harbor helping local families going through cancer
    • 1:1 Partnering and Partnering Tables
    • DPHARM Swag
    • Topic choice round tables starting at 6:30pm. See below.

     

    6:30 pm – 7:00 pm  Birds of a Feather Roundtable Choices

    Located in the Staffordshire Ballroom

    Attendees are welcome to join one of the following Birds of a Feather Roundtables
    Round tables are on a first come and first serve basis and choices include:

     

    • Securing C-suite Buy-in for Disruptive Change in Clinical Operations, Roundtable Leader: Terttu Haring, Head of the Clinical Innovation Office, Sanofi

     

    • Feedback for FDA on DE&I in Clinical Trials, Roundtable Leader: Maimah Karmo, Founder/CEO, Tigerlily Foundation

     

    • Leveraging Blockchain to Accelerate the Verification and Sponsor Audit Process, Roundtable Leader: Stephen Lutsch, Director, Head of Revolutionize Clinical Trials, LEO Pharma

     

    • Addressing Data Sharing Challenges to Drive Next-Gen Analytics
    • In order to garner the full, innovative power of AI, ML, and advanced analytics, solution providers require large, diverse data sets. In this roundtable discussion, engage with a multi-stakeholder panel to understand why sponsor companies may struggle to share data for new applications and learn how solution providers can help large organizations overcome internal data sharing challenges.
      Roundtable Leaders: Virginia Nido, Global Head of Product Development Industry Collaborations, Genentech,  Aaron Mann, CEO, Clinical Research Data Sharing Alliance & Stephen Pyke, Chief Digital & Data Officer, EVP, Head Clinical Data & Digital Services, Parexel

     

    • Novo Nordisk on Launching a New Data Science and Innovation Group in Research and Early Development
      Roundtable Leader: Adama Ibrahim, VP Digital Strategy & Change Management, Novo Nordisk

     

2022 Agenda


  • 8:00 am

  • Morning Coffee, Tea and 1:1 Partnering

  • 8:30 am

  • Day Two Morning Welcome


    Tina Aswani-Omprakash

    Patient Advocate


  • DPHARM Day Two Kicks Off and the Winner of DPHARM Idol 2022 Announced

  • 8:45 am

  • Exclusive Disruptive Innovation Panel


  • Sanofi on Disrupting Every Aspect of the Clinical Trial Process to Bring Vaccines and Therapeutics to More Patients Faster

    For the first time, Sanofi will unveil how it is totally redesigning and transforming clinical trials through ACT4Patients, an integrated and holistic patient-centric program based on a comprehensive and innovative strategy strongly supported by senior leadership. The program leverages digital technologies and artificial intelligence to improve the patient experience, cost, efficiency, and speed of clinical development.

    Sanofi leaders will discuss how the company is innovatively employing data, adopting technology to drive trial efficiencies, and operationalizing approaches such as decentralized clinical trials and risk-based-monitoring, while incorporating key insights and inventive approaches from startups and academia.

    They will also address how they identified key metrics and milestones to drive success, to understanding and employing the power of digital technology to drive trial efficiencies and speed access to patients.

    And lastly, they will share their perspectives about the impact of the transformation on all departments across the enterprise and the need to identify the talent required to actualize the vision.


    Terttu Haring

    Head of the Clinical Innovation Office, Sanofi


    Audrey Lhomme

    Head of Digital Clinical Development, Sanofi


    Sylvain Nicolas

    Head, Clinical Sciences & Operations Transformation & Performance Office, Sanofi

  • 9:25 am

  •  

    KEYNOTE

    The Future of Science and Medicine: Access and Inclusivity

    Dr Scott Gottlieb, a strong proponent of innovation for clinical trial operations is back by popular demand. He will address the future of medical innovation and the role clinical trial operation executives should be prepared for.


    Scott Gottlieb, MD
    23rd Commissioner, U.S. Food & Drug Administration

    Followed by Q&A with


    Michelle McMurry-Heath, MD
    President & CEO, Biotechnology Innovation Organization (BIO)

     

  • 10:10 am

  • DPHARM Cafe Morning Networking Break hosted by

    • Breakfast, coffee, tea and refreshments
    • Meet the Exhibiting Companies solving today’s challenges in clinical
    • Enjoy the DPHARM Foundation Treasure Hunt – where you can win 2 tickets to a Broadway show of your choice, 1 night hotel stay in NYC plus a $500 donation to a patient foundation of your choice
    • Meet the Patient Therapy Dogs
    • Assorted chocolate station
    • DPHARM Swag & Charging Station
    • Fast Company free digital one year subscription for the 1st 50 people to drop off their business card at the DPHARM swag table
    • 1:1 Partnering and Partnering Tables
    • Networking!!
  • 10:55 am

  • Choice of Breakout Session

    • Breakout Session A
      10:55 am – 11:20 am

      Zeitgeist Speaker
      The Power of Machine Learning & Radio Signals to Monitor Patient Vitals and Predict Future Diseases

      Dina Katabi, Director, MIT Wireless Center, discusses the potential revolutionary impact of the wireless sensors that she and her team have developed for remote health monitoring.

      • Advancing remote health monitoring from wearables to invisibles
      • Understand the impact continuous remote physiological monitoring can have on diagnosing chronic illnesses sooner, more precisely and providing targeted treatments earlier
      • Discuss technology advancements in radio technology and deep learning that allow for the translation of wireless data into meaningful information about what is happening at home for a patient


      Dina Katabi, PhD
      Director, IT Center for Wireless Technology, MIT

    • Breakout Session B
      10:55 am – 11:20 am

      Addressing the Lack of Structured, Clean Patient Data

      Often the elephant in the room that hinders the advancement of innovation in clinical trials for the benefit of patients in the lack of structured, clean patient data. R&D executives know the ability to garner greater data value from all data sources [clinical trials, EHRs, claims data, etc] is critical to supporting the future of drug development. The continued conundrum is that data is too often unstructured, incompatible, incomplete and unreliable and leads to an output of a research-intensive, operational bottlenecks.

      We have a unique group of panelists who will prioritize the critical issues first, provide potential solutions and address what to do about pending issues to be resolved.

      Moderated by:


      Amy Cramer
      Global Product Development Strategic Partnerships, Pfizer

      Panelists:


      Xiaoying Wu, MD, MS
      VP, Data Science Data Platform & Privacy, The Janssen Pharmaceutical Companies of Johnson & Johnson


      Paul Bleicher, MD, PhD
      Executive Partner, Arden Equity


      Lekan Wang
      Head, Machine Learning Services, Parexel

  • 11:20 am

  • Today Show @DPharm


    In the Today Show@DPHARM, we feature four guests in short, but impactful discussions on transformative themes.

    Hosted by:

    Michelle Shogren
    Former Senior Director of Innovation, Pharma R&D Clinical Operations, Bayer

     

    2022 Presenting Companies:


    Ann Dokus
    Senior Director, Head of Technology, Global Patient & Site Services, IQVIA


    Bryan Spielman, MBA
    Chief Growth Officer, Advarra


    Eli Goldberg, PhD
    VP, Data Science, Current Health


    Jagath Wanninayake
    CEO, Suvoda

     

  • 12:30 pm

  • Luncheon, Networking and 1:1 Partnering

    The DPHARM Foundation Treasure Hunt Winner Announced

  • 1:50 pm

  • Fast Company’s View on The World’s 50 Most Innovative Companies 2022

    Fast Company magazine publishes an annual innovation report ranking organizations making the most profound impact on customers. Guest Speaker, David Lidsky, Deputy Editor, Fast Company discusses some of the top 50 companies in how they are making a meaningful impact—on their industries, and society at large. This session provides a wonderful opportunity for pharma executives to think about how other industries are approaching innovation to help more people. More specifically:

    • Interesting examples of Fast Companies top 50 most innovative companies
    • Innovation that helps more people and provides greater access
    • Established companies that have either re-invented themselves or surprised Fast Company with something innovative for their customers
    • Thoughts on which companies can change the world and why


    David Lidsky
    Deputy Editor, Fast Company

    with 

    Craig Lipset
    Craig Lipset, MBA
    Founder, Clinical Innovation Partners

  • 2:15 pm
    - 4:15 pm

  • DPHARM Afternooon Track Sessions

    The concluding section at DPHARM offers three afternoon track choices. Attendees are free to go back and forth.

    • 2:20 pm

      Track A1:
      Advances in Remote Data Monitoring, V02 Max Data Capture

      Track Chair:


      Tina Aswani-Omprakash

      Patient Advocate

       


       

    • 2:20 pm – 2:45 pm

      Remote Monitoring to Improve the Transition Home from the Hospital and Reduce the Risk of Readmission

      Digital monitoring of patients has the potential to better the delivery of cancer care through improved patient-provider communication, enhanced symptom and toxicity assessment and management, and optimized engagement across the cancer continuum. Remote monitoring is especially crucial when patients are at high risk for experiencing symptoms or toxicities from treatment. During these episodes, patients and clinicians benefit from routine assessments of electronic patient-reported outcomes (ePROs) to identify symptoms early and prevent adverse outcomes. The Connected Care protocol provides remote monitoring to medical oncology patients for 10-days post hospital discharge as this is a high-risk period for patients due to a lingering symptom burden and a need for enhanced patient-clinician communication as symptom management shifts from the inpatient to outpatient team. Specifically, Dr. Daly will discuss:

      • The feasibility and acceptability of remote monitoring in the post discharge setting for patients with cancer
      • Patient perspectives for remote monitoring post hospital discharge
      • ePRO versus device and challenges with implementation
      • Thoughts on the right data to collect and at what intervals


      Robert Daly, MD, MBA
      Assistant Attending Medical Oncologist, Department of Medicine, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center

       

       

       


       

    • 2:45 pm – 3:00 pm

      Replacing Six-Minute Walk Test with Continuous VO2 Max Assessment from Wearable Sensors

      While cardiopulmonary exercise testing (CPET) to derive VO2Max remains the gold standard, it is often too expensive or difficult for the patient. The six-minute walk test is the most commonly used alternative, yet still requires an in-clinic visit. Learn how a new deep neural network tool utilizing wearable sensors estimates VO2Max from every 24 hours of unconstrained free-living vital signs, instead of a single point-in-time measure.
      We will review new clinical evidence demonstrating how a novel digital biomarker yields equivalent or superior VO2Max accuracy compared with the six-minute walk test – as well as delivering a richer and higher-quality dataset.

      • Discover how this new approach eases patient burden and anxiety, increasing participation and significantly expanding the potential patient pool for clinical research
      • Examine the quantified, positive impact of higher-frequency cardiopulmonary functional capacity assessments on trial design and endpoint statistics
      • Explore the potential savings in trial timelines, cost, and site burden by eliminating the requirement for an in-person walk test

      Matt Pipke new
      Matt Pipke
      Chief Technology Officer, PhysIQ

       


       

    • Track A2:
      Evolving Voice Assistants and Chabots/RWD & RCT Risk Management

      3:00 pm – 3:20 pm

      Assessing the Effectiveness of Voice Assistants and Chatbots to Capture PROs

      In this session, Janssen and Orbita review their collaboration on a study to compare how voice and chat modalities stack up to traditional ePRO data capture. The presenters examine the outcomes of this first of its kind study and specifically will discuss:

      • The key design elements of the study and how the voice and chat modalities were deployed
      • A comparative analysis of the PROs garnered from voice and chat versus those from traditional electronic modalities
      • The current effectiveness and usability of conversational channels to interact with trial participants and capture data
      • The broader implications for the use of conversational AI in healthcare


      Stephen Ruhmel
      Associate Director, Janssen


      Hayden Meinero
      Regional VP, Sales, Orbita


       

    • 3:20 pm – 3:40 pm

      Tackling the Challenges of Merging Real World Data (RWD) with RCT Data

      Merging Real World Data(RWD) with RCT data could result in further evidence generation and may improve patient experience, lower drug development costs and help us better understand the disease and patient journey. However, merging these two data sources requires a multi-disciplinary approach to mitigate legal, regulatory, technology and privacy risks. This session examines a framework for managing these risks and will discuss:

      • The mechanics of overcoming hurdles to merge RCT data with RWD and an overview of AbbVie’s framework to address regulatory, legal, technology and privacy risks
      • How the concept of tokenization serves as a trusted data de-identification process
      • Potential benefits for patients and sponsors
      • AbbVie’s case examples and the possibilities for scaling across all of their clinical trials


      Aman Thukral
      Head of Digital Operations and Clinical Systems, AbbVie


      Kapil Gombar
      Director, CDM-Clinical Technology Innovation, AbbVie

       

       

       


       

    • 3:40 pm – 4:00 pm

      Enabling Next-Generation Clinical Data Management and Programming

      The pharmaceutical industry is fast realizing that today’s workflows can’t keep up with tomorrow’s data. As data emanates from more places, clinical researchers need new tools to avoid coordination challenges that can result in costly delays. In this session, attendees will:

      • Examine requirements for truly future-proof clinical data management and programming solutions, and learn how artificial intelligence (AI) can accelerate studies along the path to submission and approval
      • How algorithms can reduce the burdensome work of defining study rules, performing edit checks, raising and answering queries, and generating SDTM specifications to help data managers/programmers
      • Demonstration example


      Srinivasan (Srini) Anandakumar
      VP, Product Management, Saama

    • 2:20 pm

      Track B1:
      Reimagining DCTs/The Rise of the Retail Pharmacy in Clinical Trials

      Track Chair:


      Anand Chokkalingam, PhD
      Executive Director and Head of RWE Virology TA, Gilead Sciences


       

    • 2:20 pm – 2:45 pm

      Evaluating the State of DCTs and the Potential Impact on Patient Experience and Inclusivity

      Moderated by:


      Hassan Kadhim
      Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS

      Panelists:


      Marie Rosenfeld
      SVP and Head of Clinical Science, Astellas


      Sheryl Jacobs
      VP, Global Development Operations, Amgen


      Victoria L. Chiou, MD
      Head of Clinical Excellence and Innovation, AstraZeneca


      Elisa Cascade
      Chief Product Officer, Science 37

       

       

       

       

       


       

    • 2:45 pm – 3:15 pm

      Innovating for Inclusivity in Clinical Trials

      In this moderated Q&A, Dr Owen Garrick provides a practical update on CVS Clinical Trial Services’ journey to bring clinical trial services to patient communities.

      • Review how CVS Clinical Trial Services have evolved over the past year, including increased capabilities, challenges, successes, and lessons learned
      • Examine the evolution of partnerships with sponsors and steps to advance them
      • Understanding PI oversight parameters in a distributed clinical trial model
        Explore next steps for the immediate future and the long-term


      Owen Garrick, MD
      Chief Medical Officer, Clinical Trial Services, CVS Health

      Monique Adams
      Monique Adams, PhD
      Janssen Clinical Innovation Lead, The Janssen Pharmaceutical Companies of Johnson & Johnson

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       


       

    • Track B2
      DCTs, Getting Closer to AI/ML-driven Insights & Benchmarking Digital Maturity

      3:15 pm – 3:25 pm

      Enabling DCTs: How Connecting Data and Analytics Allows for More Accurate Decision-Making

      The volume, variety, and velocity of clinical trial data is outpacing traditional clinical trial processes requiring a new data science paradigm. With more digital solutions in use, getting near real-time AI/ML-driven insights can help research teams cut the time and cost of clinical trials while
      accelerating new drugs to market. Learn how:

      • Near real-time AI/ML driven insights are enabling key workflows in DCTs and risk-based quality management (RBQM)
      • Consider the impact of these insights on improving study quality and patient safety while reducing time and cost.


      Melissa Easy
      VP Clinical Technology Solutions, IQVIA

       

       

       

       

       

       

       

       

       

       


       

    • 3:25 pm – 3:40 pm

      Decentralized Clinical Trials at Scale—The Cost/ Benefit Drivers and Perspectives on Adoption

      The COVID-19 pandemic accelerated a radical change to the traditional clinical trial delivery model, revealing that patient-centric study designs were feasible and delivered benefits related to recruitment velocity, diversity, and participant retention. Moving towards the adoption of hybrid/decentralized trials at scale means understanding financial considerations within a framework of regulatory guidance and senior management buy-in. Specifically, this session will examine:

      • The current status of the delivery of hybrid/decentralized trial designs
      • The cost/benefit drivers of DCT and how management support is important to drive adoption


      Elisa Cascade, MBA
      Chief Product Officer, Science 37

       


       

    • 3:40 pm – 4:15 pm

      Benchmarking Clinical Operations for Digital Maturity

      As the life sciences industry’s focus on digital transformation advances at a rapid pace, the opportunity to understand how well your organization stacks up to the rest of the industry around digital maturity in clinical operations can be highly valuable. This session examines a new benchmarking effort to help pharmaceutical companies rank their digital capabilities in clinical operations, codify specific terms that are used readily and leverage insights to drive strategic priorities. Specifically, this session will:

      • Discuss the study purpose, methodology and areas being ranked for digital readiness
      • Examine the value for companies participating
      • Consider how the study with greater industry participation could evolve into an innovation index and generate industry digital maturity metrics

      Moderated by:

      Craig Lipset
      Craig Lipset, MBA
      Founder, Clinical Innovation Partners

      Panelists:


      Hassan Kadhim
      Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS


      Tim Joy
      Executive Director, Head of Strategic Solutions, Pfizer


      Aman Thukral
      Head of Digital Operations and Clinical Systems, AbbVie


      Brandon Maggio
      Director, Digital & Process Optimization, GSK


       

    • 2:20 pm

      Track C1:
      Novel Trial Designs for Patient Optionality/Driving Efficiencies with DCT Data Foundation

       

      Track Chair:


      Holly John
      Senior Director, Patient Advocacy, Agios Pharmaceuticals

       


       

    • 2:20 pm -2:45 pm

      Rethinking Trial Design: Hybrid-Virtual Interventional Safety DCT in a Rare Population

      When faced with an infrequently episodic disease in a rare patient population that would traditionally require sequestering patients into a Phase 1 unit for 6-12 months for an interventional safety trial, Takeda’s digitally enabled clinical team reimagined what it would take from both a clinical and technology perspective to design a trial that could be brought into the patient’s home.

      • The clinical rationale for why the trial needed to be shifted to the patient’s home
      • An overview of the tools, technologies and processes required to support trial complexity
      • Approaches to addressing clinical, operational, technological, regulatory, and legal hurdles in offering a hybrid-virtual trial across the U. S.
      • Innovative thinking that led to bringing together a complex trial design to ultimately determine if the investigational medicine could positively impact patients’ lives


      Jordan Brayanov
      Senior Director, Digital Strategy, Takeda


      Camilla Richmond, MD, MA
      Senior Medical Director, Clinical Science, Takeda


       

    • 2:45 pm – 2:55 pm

      Preparing the Modern Foundation for DCT Data

       More data chaos comes with the continued adoption of digitization and DCTs. Manual methods of data curation, review and cleaning will not scale as data streams from external data sources multiply.Modern capabilities for automation via AI/ML will only be as good as the data they can access. This session addresses:

      • Interoperable data fabric critical to success within the changes of R&D
      • Considerations for a data foundation that creates efficiency within the overall clinical trials value chain


      Raj Indupuri
      CEO, eClinical Solutions


       

    • 2:55 pm – 3:30 pm

      Innovative Trial Designs Panel

      As the competition to recruit patients for clinical trials increases and sites are burdened by staffing shortages, technology shifts and more, how can innovative trial designs reduce patient, site and investigator burden?

      • Designing for patient centricity – reducing the burden for patients, sites and investigators
      • Addressing organizational implementation challenges
      • Engaging in collaborative partnerships and innovation to operationalize and deliver innovative trials designs

      Moderated by:


      Victoria L. Chiou, MD
      Head of Clinical Excellence and Innovation, AstraZeneca

      Panelists:


      Sheryl Jacobs
      VP, Global Development Operations, Amgen


      Camilla Richmond, MD, MA
      Medical Director, Translational Medicine, Takeda

      Daniel Millar
      Daniel Millar, MBA
      Senior Director, Strategic Business Transformation, Janssen Research & Development, LLC

       

       

       

       

       

       

       

       

       

       

       


       

    • TRACK C2
      Evolving Master Protocols/Improving Transparency with Site Relationships

      3:30 pm – 3:55 pm

      Accelerating Master Protocols and Patient Centric Platform Trials 

      This session examines progress made in the evolution of master protocols/platform trials for patient benefit as well as where and how the clinical research ecosystem could evolve to drive higher levels of adoption.

      • Review recent case examples and key learnings of the impact of master protocols on accelerating COVID therapeutic development
      • Discuss the advantages of industry participation in platform trials and the resultant benefit for patients
      • Examine the barriers for to achieving broader adoption of master protocols, including key industry consideration: intellectual property and competition
      • Explore how academic institutions and site networks can innovate their models for platform trials and bolster the value proposition [speed of trial activation, accessible set of high-quality sites, trial-ready patient ready cohorts]

      Daniel Millar
      Daniel Millar, MBA
      Senior Director, Strategic Business Transformation, Janssen Research & Development, LLC

       

       

       

       

       

       

       

       


       

    • 3:55 pm – 4:15 pm

      Merck on Creating Reports To Increase Transparency with Site Relationships

      Study Sites often give feedback on the lack of transparency around tracking and performance metrics related to their site as well as how they compare to other sites participating in a trial. To bridge this information gap, Merck rolled out several reports.

      • Review of the reports generated to address Study Sites feedback
      • Discuss how the reports are being used
      • Understand the impact on the Study Site/Sponsor relationship


      Randy Krauss, PhD
      Executive Director & Head, Merck & Co, Inc


      Andrew Onikepe
      Director, Monitoring Excellence, North America, Global Clinical Trial Operations, Merck & Co, Inc

  • 4:15 pm

  • DPHARM 2022 Concludes