Cambridge Healthtech Institute's 3rd Annual

Data Technology for End-to-End Clinical Supply Management

Controlling the Complexity of Clinical Supply Chain Forecasting and Contingency Planning

February 8 - 9, 2022 ALL TIMES EST

Digitalization is leveraging new relationship models throughout the entire clinical trial supply chain network. The transformative capability of incorporating valuable insights from multiple sources of data while increasing the amount/quality of data collected/analyzed saves time, money and increases productivity. So why aren’t more organizations incorporating data technology-enabled capabilities into their clinical supply chain? Cambridge Healthtech Institute’s 3rd Annual Data Technology for End-to-End Clinical Supply Management convenes stakeholders who are adopting and applying digital technologies for agile response in our complex world.

Monday, February 7

8:00 am SCOPE’s Inaugural Masters of Clinical Research Golf Tournament

Connect with your peers and colleagues at SCOPE's Inaugural Masters of Clinical Research Golf Tournament. For more information on participating or how you can get involved as a sponsor, please visit the SCOPE Summit website for further details.

9:00 am Conference Registration Open (Gatlin Foyer)
2:00 pm User Group Meetings (ROOM LOCATIONS: St. John's 30 & 31 & St. John's 32)

Co-locate your User Group, a Workshop or even your company's Annual Meeting with SCOPE Summit. CHI will help market the event and manage logistical operations. We will co-market prospective attendees and extend your users a discount to attend the entire SCOPE conference. We are here to work with you. Use SCOPE as your gathering point! Learn more on the SCOPE Summit website.

KEYNOTE LOCATION: Gatlin A1 & A2

EVENING KICK-OFF PLENARY KEYNOTE & PARTICIPANT ENGAGEMENT AWARDS

5:00 pm KEYNOTE PRESENTATION:

Organizer's Welcome Remarks

Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)
Tarra Shingler, MS, Senior Vice President, Global Business Solutions, StudyKIK
5:10 pm KEYNOTE PRESENTATION: Engaging and Understanding Patient Behavior to Improve Accessibility, Retention and Outcomes
Panel Moderator:
Dana Edwards, Chief Commercial Officer, Circuit Clinical

Patient-centric drug development that incorporates patient experience coupled with behavioral science and real-world evidence is evolving the way in which sponsors and regulators bring new medicines to the patients. This executive panel will discuss emerging trends along with case studies that demonstrate how understanding patient need, beliefs and their healthcare journeys influences participation in clinical trials and impacts outcomes.

Panelists:
Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi
Brendan O'Neill, Senior Director Patient Recruitment Programs, Clinical Development & Operations & Global Product Development, Pfizer Inc.
Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.
Thad Wolfram, President, Matrix Clinical Trials, Matrix Clinical Trials
5:45 pm KEYNOTE PRESENTATION:

SCOPE's 2022 Participant Engagement Awards Introduction

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC
5:50 pm KEYNOTE PRESENTATION:

SCOPE's 6th Annual Participant Engagement Awards

Panel Moderator:
David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 6th year, the Participant Engagement Award (PEA) recognizes innovation and change in how the industry communicates with participants in the fields of recruitment and retention in clinical trials. 

Participant Engagement Awards Judges

Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.

Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata

Irfan Khan, CEO, Circuit Clinical

Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.

Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata


Participant Engagement Awards Contestants: 

Angie Caprise, Senior Scientist, Global Trial Optimization, Merck & Co., Inc.

Melissa Jane Bime, CoFounder & CEO, Infiuss Health

Melissa Gebhardt, Senior Director Business Development & CDx, Guardant Health

Fabio Gratton, Co Founder & CEO, CureClick LLC

Gwenn Oakes, Program Director, Global Trial Optimization, Merck

Adam Kleger, InVibe

Ian Greenfield, Tryl

Jeff Smith, Tryl

    Panelists:
    Michelle Crouthamel, PhD, Head, Digital Sciences, AbbVie, Inc.
    Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata
    Irfan Khan, CEO, Circuit Clinical
    Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.
    Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative
    Alicia Staley, MBA, Trial Volunteer & Cancer Survivor; Vice President, Patient Engagement, Medidata
    Angie Caprise, Senior Scientist, Global Trial Optimization, Merck & Co., Inc.
    Melissa Jane Bime, CoFounder & CEO, Infiuss Health
    Melissa Gebhardt, Senior Director Business Development & CDx, Guardant Health
    Fabio Gatton, Co-Founder & CEO, THREAD Research (formerly inVine Labs)
    Adam Kleger, Head, Client Solutions, inVibe Labs
    Gwenn Oakes, Director, Global Trial Optimization, Merck & Co., Inc.
    Jeff Smith
    Ian Greenfield, CEO, Tryl
    6:35 pm SCOPE's Kick-Off Networking Happy Hour (Gatlin Terrace)
    7:45 pm Close of Day

    Tuesday, February 8

    7:15 am Registration Open (Gatlin Foyer)
    7:15 am Morning Coffee (Sponsorship Opportunity Available)

    KEYNOTE LOCATION: Gatlin A1 & A2

    NEW NORMAL IN PERI-PANDEMIC CLINICAL TRIALS & CONNECTED HEALTH AT SCALE

    8:05 am KEYNOTE PRESENTATION:

    Organizer's Welcome Remarks

    Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)
    Peyton Howell, Chief Commercial & Strategy Officer & President, Consulting, Parexel
    8:15 am KEYNOTE PRESENTATION:

    Fireside Chat: Fit-for-Future Data Operations in a Post-Pandemic World

    Demetris Zambas, Vice President & Global Head, Data Monitoring & Management, Pfizer Inc.
    Darren Weston, Senior Vice President, Integrated Data Analytics and Reporting (IDAR)and Janssen Clinical Innovation (JCI), Janssen Pharmaceuticals, Inc.
    Cynthia Pan, RPh, Senior Director, Therapeutic Area Operations Leader, Global Clinical Operations, Regeneron

    The COVID-19 pandemic continues to reshape our world and our approaches to clinical trials. During the last 20 months, the risk-benefit ratios of many innovative methodologies and technologies have inversed. Risk-averse organizations have grasped the realities that these new innovative methods are now the only means to efficiently execute clinical trials.  This new reality and the ongoing need for real-time data collection and consumption require new creative and live data flows. An additional ramification of this evolution has been a significant improvement in the level of collaboration required and realized within our organizations and with our external partners and technology providers. Let us discuss how we can cement this “New Normal” to not only maintain the momentum but to ensure these valuable innovations are sustainable.

    9:10 am KEYNOTE PRESENTATION:

    Case Study: Moving Beyond the Promise of Connected Health, Learning from Implementation at Scale

    Adama Ibrahim, Director, Digital Solutions, Technology, Platforms, Data & Digital Global Drug Development, Novartis Pharma AG
    Justin Wright, MD, Vice President, Global Head Connected Health, Novartis

    At Novartis Global Drug Development, we have a vision to accelerate digital products by developing one or more “connected health” solutions (connected device, wearable, software as medical devices) into our drug programs over the next 5 years. This showcase of the Connected Health group, formed to deliver the vision, will focus on presenting the real work that has been done as a collaboration to bring these digital health tools to clinicians, patients, and to pharma research that improve the overall health care experience and improve access to trials. How does an integrated patient experience deliver more value to patients, providers, and payers? How do you give patients their own digital data so they can be more engaged in their treatment plans? How can Connected Health improve clinical workflow, communication, data exchange, and clinical research? How do you do this at scale, beyond a pilot?

    9:55 am Grand Opening Coffee Break in the Exhibit Hall (Gatlin Ballroom BCD)

    ROOM LOCATION: St. John's 26 & 27

    BIOGEN CASE STUDY: BRINGING REAL-TIME 360° TRANSPARENCY TO CLINICAL SUPPLY

    10:55 am

    Chairperson's Remarks

    Ben Taylor, CEO, LedgerDomain
    11:00 am

    How Barcodes and Blockchain Unlock Supply Chain Collaboration

    Imran M. Shakur, Associate Director, Clinical Supply Capabilities, Biogen

    Digital transformation in clinical supply has the potential to reduce site burden and eliminate errors, but has often been stalled by workflow complexity and lack of interoperable standards. This session will highlight how barcodes and blockchain together provide a real-time picture of clinical supply inventory for all stakeholders – unlocking greater operational efficiencies and supporting the common effort to bring groundbreaking new drugs to market.

    11:30 am

    Real-World, Real-Time: Bridging Study Sites & Study Leadership

    Michael Keech, Senior Principal Commercial Compliance & Quality, IQVIA
    Greg Plante, Principal, Digital Transformation, IQVIA

    Blockchain is well-suited to supply chains where numerous organizations handle sensitive information and require a real-time "single version of the truth." But for busy clinicians, study coordinators, and executive leadership, blockchain-backed mobile apps and dashboards are only half the picture – intuitive workflows and comprehensive data science are critical to successful adoption. Learn how IQVIA has navigated a fragmented data landscape and aligned stakeholder requirements towards greater collaboration in clinical supply.

    12:00 pm PANEL DISCUSSION:

    Clinical Collaboration in a Personalized World

    Panel Moderator:
    Ben Taylor, CEO, LedgerDomain

    The clinical supply world is heating up, as the number and complexity of clinical trials continues to accelerate. Personalized medicine places new demands on patient data management. The most advanced cell and gene studies are stalled by the lack of real-time collaboration, even as the clock is ticking on short-lived samples that expire in a matter of days. In this panel discussion, we will discuss how new decentralized technologies like blockchain bridge gaps between stakeholders and accelerate personalized treatments to patients.

    Panelists:
    Michael Keech, Senior Principal Commercial Compliance & Quality, IQVIA
    Greg Plante, Principal, Digital Transformation, IQVIA
    Imran M. Shakur, Associate Director, Clinical Supply Capabilities, Biogen
    Cheryl Kole, Head of Solutions Strategy and Commercialization, Almac Clinical Technologies, Almac Group

    In the increasingly complex world of clinical trials, utilizing modern technology redefines the supply chain. Learn how to optimize your supply chain strategy and overcome the challenges associated with complex study designs using advanced technology solutions.

    1:00 pm Transition to Lunch
    Andy Hinks, Senior Business Analyst, Signant Health

    Signant Health will give a brief overview and demonstration of the new DRP functionality enhancement to their SmartSignals Supplies Forecasting and Planning applications; the industry’s only fully integrated solution that puts you in full control of your clinical supply chain.

    1:35 pm Coffee and Dessert Break in the Exhibit Hall (Gatlin Ballroom BCD)

    SUPPLY CHAIN 4.0 – DIGITALIZATION AND ANALYTICS

    2:30 pm

    Chairperson's Remarks

    Maria N. Humagain, Senior Manager, IRT Systems, BeiGene
    2:35 pm

    How Digital Technologies Can Accelerate the Translation of Clinical Supply to Large-Scale Commercial Supply

    Prashant Yadav, PhD, Senior Fellow, Center for Global Development; Lecturer, Global Health & Social Medicine, Harvard Medical School

    Biopharmaceutical companies face increasing pressure to accelerate the timelines for development, and the need for rapid post approval capacity ramp-up. This requires a much faster and streamlined transition from the clinical supply chain to the commercial supply chain. The fast scaleup of COVID-19 vaccine and therapeutics from clinical to commercial have accelerated the expectations. This talk will focus on opportunities to design the clinical supply chain in ways that can enable more rapid transition to commercial supply, especially using digital technologies.

    3:05 pm

    Block Chain: Patient Safety & Supply Chain Security 

    Aaron Graham, Executive Director, Brand Safety & Security, Boehringer Ingelheim Pharmaceuticals Inc
    3:35 pm

    How Interactive Response Technology (IRT) can Simplify your Overall Study Management and Costs

    Maria N. Humagain, Senior Manager, IRT Systems, BeiGene

    This presentation discusses how Supply Chain and Clinical Trial Teams can utilize Interactive Response Technology for Clinical Trials in the face of high speed timelines and reduced budgets, includes a look at what IRT can do for your study and Supply Chain Management, how to choose the right vendor, how to contract with preferred providers, how to set up basic standards, and how to ensure quality systems every time.

    4:05 pm PANEL DISCUSSION:

    Leveraging Data to Cut Waste, Minimize Risk, Improve Resilience & Speed Decision Making in the Clinical Supply Chain 

    Panel Moderator:
    Neeraj Shah, Director, Global Clinical Supply Chain Excellence, Bristol Myers Squibb Co

    Digitalization is leveraging new relationship models throughout the entire clinical trial supply chain network. The transformative capability of incorporating valuable insights from multiple sources of data while increasing the amount/quality of data collected/analyzed saves time, money and increases productivity.   Learn from this panel of experts as they share their insights on how data is transforming supply chain management. 

    Panelists:
    Aaron Graham, Executive Director, Brand Safety & Security, Boehringer Ingelheim Pharmaceuticals Inc
    Maria N. Humagain, Senior Manager, IRT Systems, BeiGene
    Prashant Yadav, PhD, Senior Fellow, Center for Global Development; Lecturer, Global Health & Social Medicine, Harvard Medical School

    INTERACTIVE BREAKOUT DISCUSSIONS

    4:35 pm Find Your Table and Meet Your Moderators
    4:40 pm Interactive Discussions

    Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. For in-person events, the facilitator will lead from the front of the room while attendees remain seated to promote social distancing. For virtual attendees, the format will be in a Zoom room. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussion page on the conference website for a complete listing of topics and descriptions.

    5:25 pm Welcome Reception in the Exhibit Hall (Gatlin Ballroom BCD)
    6:40 pm Close of Day

    Wednesday, February 9

    7:15 am Registration Open (Gatlin Foyer)
    BREAKFAST PRESENTATIONS

    Come enjoy a breakfast with your peers while listening to your choice of two compelling industry presentations.

    Kyle Hogan, President, Datacubed Health

    Sponsors and CROs need more than change management to operationalize decentralized trials. In this session, Kyle Hogan will outline the approaches sponsors and CROs can take to build value in the decentralized trial participant journey, from pre-implementation to study launch and monitoring. 

    Andrea Valencia Dremelj, Director BioPharma Business Operations, Biopharma, SOPHiA GENETICS

    Delays in clinical trial patient enrollment are significant challenges for sponsors, especially for biomarker-targeted investigational therapies associated with rare genomic variants. Join us and discover the solutions offered by SOPHiA GENETICS, leveraging insights from multimodal datasets - including 770’000 genomic profiles - curated across 780+ healthcare institutions. We can better enable biomarker-driven clinical trials in oncology and inherited rare disorders to meet recruitment goals by identifying potential sites worldwide.

    8:15 am Session Break

    ROOM LOCATION: St. John's 26 & 27

    APPLYING BLOCKCHAIN FOR END-TO-END CLINICAL SUPPLY MANAGEMENT

    8:20 am

    Chairperson's Remarks

    Hernando C. Giraldo, Digital Laboratory, Scouting and Innovation, Boehringer Ingelheim Pharmaceuticals, Inc.
    8:25 am

    Optimizing and Accelerating Clinical Trials and Health Data Marketplace with Blockchain

    Disa Lee Choun, Head, ICOA, Janssen UK

    Distributed Ledger Technology has been widely adopted in the Financial sector, unlike the Pharmaceutical and Healthcare industries.  With the rise of digital health, e-patients, and patient empowerment, could blockchain be the game changer?  Could we optimize and accelerate the drug development process and access to better care?  Learn more about PharmaLedger project and the Clinical Trial and Health Data Use Cases using IoT and machine learning.

    9:00 am

    PharmaLedger's Journey through the eConsent Use Case

    Baldwin C. Mak, Leader Strategic Feasibility & Manager, Clinical Trial Portfolio, Boehringer Ingelheim Canada

    The global pandemic has accelerated changes in the way patients, physicians and other stakeholders conduct clinical trials through the use of digital technologies and remote interactions.  Yet trust, transparency and security of data remains a concern which impacts patient engagement and confidence in the results.  The e-consent use case aims to leverage the informed consent on blockchain technology to increase patient empowerment and to transform the future conduct of clinical trials by improving trust, transparency, and security.

    9:25 am

    Powering Trust in Internet of Things (IoT) Trial Ecosystems

    Maria Eugenia (Xenia) Beltran, PharmaLedger Project Coordinator, Universidad Politécnica de Madrid

    Architectures for the IoT medical devices typically rely on transmitting data to centralized cloud servers which often generate isolated data silos in different medical devices platforms and concerns of trust and lack transparency in data processing, manipulation and concealment of IoT data. To overcome these downsides, the PharmaLedger IoT and Personalized Medicine use case provides data sharing schemas supporting data integrity and provenance, under consenting and domain-specific privacy principles. 

    Craig Mooney, Vice President, Scientific E-tech Enabled Services, Calyx

    This presentaton will be a case study where usual site stock management is not efficient enough, aiming to understand how fractional prediction works and how it can be applied, and provide insight into how it addresses protocol-specific challenges, resulting in a more efficient clinical supply chain.

    10:25 am Coffee Break in the Exhibit Hall (Gatlin Ballroom BCD)
    11:25 am PANEL DISCUSSION:

    Blockchain Consortium – The IMI PharmaLedger Project

    Panel Moderator:
    Disa Lee Choun, Head, ICOA, Janssen UK
    Panelists:
    Maria Eugenia (Xenia) Beltran, PharmaLedger Project Coordinator, Universidad Politécnica de Madrid
    Baldwin C. Mak, Leader Strategic Feasibility & Manager, Clinical Trial Portfolio, Boehringer Ingelheim Canada
    Hernando C. Giraldo, Digital Laboratory, Scouting and Innovation, Boehringer Ingelheim Pharmaceuticals, Inc.
    Lynn H Wang, Director, Product Management, Supply Chain Visibility, Johnson & Johnson
    11:55 am Transition to Lunch
    Ian Davison, Subject Matter Expert, Medrio

    Clinical trials often require the careful management of products that may be very precious due to scarcity or expense.  Learn how RTSM can be used to optimize the supply chain, as well as optimize the use of products at site to ensure as much of your IP as possible ends up in subjects and not in the returns or destruction process.

    12:30 pm Coffee and Dessert Break in the Exhibit Hall(Gatlin Ballroom BCD)
    1:30 pm Close of Part A Conference. Join Plenary Keynotes and stay on for Part B of SCOPE Summit!*

    KEYNOTE LOCATION: Gatlin A1 & A2

    DIVERSITY, EQUITY & INCLUSION (DE&I) AND SPEAKING THE LANGUAGE OF BUSINESS AND LEADERSHIP

    1:30 pm KEYNOTE PRESENTATION:

    Welcome Remarks from CHI and the SCOPE Team

    Micah Lieberman, Executive Director, Cambridge Healthtech Institute (CHI)

    Thank you all for being here from the SCOPE team: Micah Lieberman, Dr. Marina Filshtinsky, Kaitlin Kelleher, Bridget Kotelly, Mary Ann Brown, Ilana Quigley, Patty Rose, Julie Kostas, and Tricia Michalovicz

    1:35 pm KEYNOTE PRESENTATION:

    Why Advancing Inclusive Research is a Moral, Scientific, and Business Imperative

    Meghan McKenzie, Principal, Inclusion, Patient Insights and Health Equity, Chief Diversity Office, Genentech

    Our industry is rightfully focused on the importance of diversity, equity, and inclusion in clinical trials. Many of us have been focused on this in our work and/or in our advocacy, both inside and outside of our organizations for some time. Why is inclusivity so important to PIs and patients? Why is it both a moral and a business imperative? Learn why representation in clinical research matters for your patients and how it shapes good science. The face of the world is changing and your success is tied to reaching ethnic minorities.

    2:45 pm Booth Crawl & Refreshment Break in the Exhibit Hall (Gatlin Ballroom BCD)
    2:00 pm KEYNOTE PRESENTATION:

    Implicit Bias Around Advocacy and Decision Making: Metrics of DE&I and Speaking the Language of Business and Leadership

    Panel Moderator:
    Kimberly Richardson, Research Advocate, Founder, Black Cancer Collaborative

    What is the perspective of Black professionals and patient advocates as the medical and scientific industries grapple with effective ways to engage minority population?  Where are their voices being heard and what can we learn from the cultural experiences they weave into their research methodologies and daily practices? Panelists will share their perspectives on how the Black voice should be included in advocacy and public and private aspects of clinical research. 

    Panelists:
    Karriem Watson, PhD, Chief Engagement Officer, NIH
    Monique Phillips, Global Diversity and Inclusion Lead, Bristol Myers Squibb Co.
    Nikhil Wagle, MD, Assistant Professor, Harvard Medical School, Dana-Farber Cancer Institute





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