Cambridge Healthtech Institute's 12th Annual

Clinical Trial Forecasting, Budgeting and Contracting

Innovative Strategies for Cost-Efficient Trials

February 8 - 9, 2022 ALL TIMES EST

Responding to COVID-19, the move towards decentralized clinical trials, and the unpredictability of the future are all changing the game in clinical trial forecasting, budgeting, and contracting. As trials become more nuanced and more risk is introduced, so must internal budgets and the negotiations and contracts with CROs, sites, and other partners. Cambridge Healthtech Institute’s 12th Annual Clinical Trial Forecasting, Budgeting and Contracting conference shares case studies and best practices on developing forecasts and budgets, as well as negotiating and writing contracts for CROs, sites, and partners.

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: Gatlin A3

    CLINICAL TRIAL MANAGEMENT: EXPLORING STRATEGIES IN FORECASTING, BUDGETING, AND CROSS-DEPARTMENT COLLABORATION

    10:55 am

    Chairperson's Remarks

    Christopher Chan, Vice President, FP&A, IGM Biosciences, Inc.
    11:00 am

    A Large Pharma's Approach to Clinical Trial Cost Forecasting and Management

    Piet Theisohn, Vice President, Resource Management, Clinical Operations, R&D Clinical Operations, Bayer AG – Pharma

    Bayer implemented an integrated system to manage the finances of all interventional clinical trials. This covers the early planning five years down the road and the operational management of ongoing trials, including forecasting on annual, quarterly, and monthly level, whole study and per country. We'll give an intro to our approach and integration with different systems and discuss strength and development areas and give an outlook.

    11:30 am

    Outsourcing Decision-Making Strategies and Partnership Models

    Michelle Everill, Senior Director, Head, Clinical Business Operations, Bristol Myers Squibb Co.
    12:00 pm

    Leveraging Operational Data in Clinical Trial Forecasting

    Keith Jones, Senior Director, Financial Planning & Analysis, Ovid Therapeutics, Inc.

    Biopharmacetical sponsors with little institutional clinical history are often at the mercy of large clinical datasets. Benchmark comparisons are often not relevant when studies are in rare or ultra-rare diseases. Leveraging internal clinical metrics, even when the data is sparse, can help immensely to hone clinical trial forecasts. This session will look at CTA contracting timelines, feasibility, patient recruitment, and other clinical data as forecasting sources.

    Kyle Cunningham, Chief Product Officer, Greenphire

    The ability to accurately forecast and predict is critical to clinical trial outcomes, yet this remains a top challenge in study planning and execution. We turn to data for guidance but how do we ensure the data we are referencing is reliable? This session will touch on key use cases for better, industry-indicative data points and how technology can help to ensure data integrity for better decision making and smarter trials.

    1:00 pm Transition to Lunch
    Meghan Harrington, Vice President, Clinical Financial Management, Medidata, a Dassault Systèmes Company

    Budgeting and payments are always hot topics. But why do we always seem to talk about the same strategies? While the fundamentals of these processes still ring true, technology is now enabling novel approaches to operationalize clinical finance strategies. Join this session with Medidata’s VP of Product to learn how to optimize what we know already works well, and hear industry examples of fresh approaches to managing budget and payment processes.

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

    STRATEGIES FOR ROI AND COST SAVINGS

    Anca Copaescu, CEO, Strategikon Pharma
    2:35 pm

    Case Study: Building the Financial Rationale for a Program Level Continuation Protocol

    Kenneth Wilson, Outsourcing Lead, Global Product Development Center of Excellence, Pfizer Inc.

    Patients often benefit through continued treatment by investigational products, so it is important to develop a plan for allowing patients to continue receiving such treatments that maximize return on investment (ROI).  Historically, when a submission is complete, or development of a product is discontinued, we allow patients to remain on study through the parent protocol.  In this presentation, we will examine the cost savings for moving 9 parent protocols into a master continuation protocol, allowing us to consolidate 9 studies into one and reduce ongoing costs and global footprint of providing patients with treatment.

    3:05 pm

    Forecasting Investigator Site Costs in Your Overall Clinical Trial Budget: Common Challenges and How to Mitigate Them as Painlessly as Possible

    Christopher Chan, Vice President, FP&A, IGM Biosciences, Inc.

    Unfortunately, budgeting for investigator site costs is not as simple as composing a site budget and multiplying by projected number of sites and patients. Trials may have multiple complex variables, including out-of-scope procedures, unscheduled visits, mid-study protocol changes, SOC reimbursements, inconsistent screen failure time-points, patient expense, and more. This presentation will discuss relatively painless ways to budget for site costs and how to deal with confounding variables reasonably and effectively.

    3:35 pm

    Short Staffed? Forecasting and Budgeting the Cost of Your Clinical Trial Portfolio: Many Trials. One Financial Analyst

    Jennifer Sydney Goldman, Director, Clinical Business Operations, Deciphera Pharmaceuticals, Inc.

    Small companies with limited cash need to accurately budget and forecast the cost of their clinical trial portfolio, but also cannot afford a team of clinical financial analysts to do so. Join me in this presentation to hear about techniques that expand the capacity of one person to efficiently budget and forecast a portfolio of trials, without losing their mind!

    Anca Copaescu, CEO, Strategikon Pharma

    In this session learn: What are the key oversight elements in the financial management of clinical service providers; Evaluation of cost drivers for different clinical study models: classic, remote, decentralized; Considerations for milestone tracking and payment schedules; Importance of analyzing different clinical study scenarios to determine the impact on execution strategy; How to leverage technology to expedite decision making and improve transparency in vendor financial oversight.

    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: Gatlin A3

    STREAMLINING THE CONTRACTING PHASE

    Mike Martin, Principal, ZS
    8:25 am

    Contracting & Budgeting Module in a New Study Start-up Tool: Initial Learnings

    Donna Libretti Cooke, JD, Director, Contracting & Budgeting & Sustainability Champion, Bayer

    Hear about Bayer's preparation for rolling out a new study start-up tool, specifically related to the Contracting & Budgeting module. Development of an ideal "wish list" for the module, sprint workshops, critically assessing processes, and garnering a new working group to champion the new way of working have all been part of the overall strategy. There will be more to share, perhaps even overcoming identified pain points. Stay tuned!

    8:55 am

    Model Contract Clauses on a National Level: Overview on Current Status

    Thorsten Ruppert, PhD, Senior Manager, R&D & Innovation, Verband Forschender Arzneimittelhersteller eV

    Industry-sponsored clinical trials benefit from favorable research infrastructures and streamlined study start-up processes. Currently, clinical trials worldwide face challenges regarding study start-up due to the time needed to finalize the contracting for a specific trial between the sites involved and the sponsor. This process currently in many countries is difficult and time-consuming. The talk should provide an overview of examples from different trial locations to address this problem.

    Bryan Clayton, M.S., Senior Vice President, Strategic Solutions, YPrime

    Ancillary technologies and services can be a headache for the most seasoned clinical operations veterans.  Often times the contract process drags on; and as a result, those same services end up on the critical path to the first-patient-in milestone. 

    This practical presentation will present ideas on how to leverage a predefined rate card to generate an easy to execute startup agreement, all while finding the potential for additional discounts.

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

    ROOM CHANGE: Gatlin E5

    CONTRACT LANGUAGE AND CYBERSECURITY

    11:20 am Talk Title to be Announced
    Glenda Guest, Vice President, NCRA; President, Assured of Quality Consulting & Training
    11:25 am

    Cybersecurity in CTAs and Vendor Agreements: Proactive Management vs. Cleaning Up the Mess

    Katherine Leibowitz, JD, Lawyer, Leibowitz LLC

    While cyber risk is not new, cybersecurity language in CTAs and remote monitoring agreements is.  Security incidents can impact multiple parties, creating mutuality of risk. This session will discuss sample cybersecurity language from research institutions and pitfalls for sponsors.   Hear about lessons learned from sponsor audits of their vendor agreements for compliance with CTA cybersecurity obligations.  Common gaps make sponsor CTA obligations heavier.  Learn about contract provisions that mitigate risk.

    12:00 pm Bridging Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
    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.

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





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