2024年 基調講演

2024年2月11日（日）

SUNDAY MORNING GOLF TOURNAMENT

8:00 am SCOPE’s 3rd Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)
Connect with your peers and colleagues at SCOPE's 3rd Annual Masters of Clinical Research Golf Tournament.

9:00 am Registration Open

PRE-CONFERENCE WORKSHOPS

1:00-1:45 pm Open Workshop: Introducing ClinEco, the New B2B Clinical Trial Community and Marketplace
Sit down with a small cross-industry group for a 45-minute hands-on session to learn about and register for free for the new B2B clinical trial community and marketplace. ClinEco unites sponsors, CROs, service providers, and sites to streamline partnering and vendor selection. We are currently onboarding leaders in clinical research to: Explore the Ecosystem. Engage Partners. Exchange Capabilities.

1:00-2:30 pm The Path towards Sustainable Trials Workshop: Reducing the Environmental Impact of Global Clinical Trials
Developing frameworks to define and manage sustainability risks, and effective guidelines to reduce the carbon footprint of clinical trial operations is a collaborative effort. Beyond positive environmental impacts, sustainable approaches are expected from stakeholders and can be a deciding factor for customer selection and attracting talent. This workshop will discuss the current hotspots of carbon emissions in clinical research and suggest introductory reduction strategies in relation to each. To register, please opt into this workshop by selecting the checkbox under ‘Conference Selection. Open to all SCOPE attendees.

Sustainable Healthcare Coalition is a Partnering Organization at SCOPE.
Jason Lanier, Environmental Sustainability Focus Area, Director, Janssen Clinical Innovation (JCI)
David Lumby, Executive Director, EHS, Thermo Fisher Scientific

SUNDAY AFTERNOON PLENARY SESSION:
KICK-OFF MULTI-STAKEHOLDER PLENARY KEYNOTE AND PARTICIPANT ENGAGEMENT AWARD

3:00 pm Organizer's Welcome Remarks & 3rd Annual Masters of Clinical Research Golf Tournament Awards
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

3:10 pm Plenary Keynote Introduction
Fareed Melhem, Senior Vice President, Head of Medidata AI, Medidata

3:15 pm CO-PRESENTATION: The Next Horizon of Clinical Research: A Multi-Stakeholder Panel on Integrating Research into the Care Continuum
Uli Broedl, Senior Vice President, Head of Global Clinical Development & Operations, Boehringer Ingelheim
Janice Chang, CEO, TransCelerate BioPharma, Inc.
Christoph Koenen, Head of Clinical Development & Operations, Pharma Research & Development, Bayer
This presentation will foster discussion between a diverse set of biopharma leaders representing health authorities, sponsors, sites, and industry consortia on the current and future opportunities facing global R&D, clinical care, and patient satisfaction. Specific topics discussed will include opportunities and barriers to giving patients access to clinical research as part of the care continuum.

3:45 pm SCOPE's 8th Annual Participant Engagement Awards
Now in its 8th 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.
PEA embodies the values and personal accomplishments of Jerry Matczak, who sadly passed away soon after receiving the inaugural 2017 award. We dedicate this award to Jerry in the hopes that it will serve as a reminder of his ideals and accomplishments. SCOPE’s 2024 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE.

PANEL MODERATORS:
Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata; Co-Creator or the SCOPE Participant Engagement Award
David Sall, President & CEO, Patient Enrollment Advisors; Co-Creator, SCOPE Participant Engagement Award

PANELISTS:
Tricia Buchheit, Associate Director, Patient Recruitment, Alnylam Pharmaceuticals
Gretchen Goller, Senior Director & Head, Patient Recruitment Solutions & Clinical Development Operations, Seagen, Inc.
Otis Johnson, PhD, Chief Diversity, Inclusion & Sustainability Officer, Clario
Sarah Krug, Executive Director, CANCER101; CEO, Health Collaboratory
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
Tarra D. Shingler, Senior Vice President, Global Business Solutions, Commercial, StudyKIK
Jeffrey Zucker, Senior Vice President, Trial Optimization & DCT, Worldwide Clinical Trials

4:35 pm SCOPE's Big Game Tailgate
Everyone who’s been to SCOPE knows that the Kickoff Reception is NOT to be missed! This year, in honor of the Big Game, we’ll host a tailgate party to get you pumped up for the game! Meet your old friends, make some new ones, and soak up the Florida vibes as you get ready for your watch parties and another amazing SCOPE conference experience.

5:50 pm Close of Day

2024年2月12日（月）

7:00 am SCOPE’s Monday Morning Fun Run!
Join SCOPE’s Coordinators on Monday, February 12 for our Fun Run! This is an informal event, and ALL abilities are welcome. You can sprint, run, jog, walk, jog-and-talk, or walk-and-talk - the goal is to get up and get moving! Details will be shared closer to the event...remember to pack your sneakers.

7:30 am Registration Open

7:30 am Morning Coffee
Get Up and Go! Jumpstart your morning with a specialty made-to-order coffee and some delicious treats, courtesy of our sponsors.

MONDAY MORNING PLENARY SESSION:
TRANSFORMING THE DEVELOPMENT PARADIGM & GENERATIVE AI IN CLINICAL TRIALS

8:30 am Organizer's Welcome Remarks
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

8:35 am Chairperson's Remarks
Chris Crucitti, Chief Revenue Officer, Executive, Citeline

8:40 am PLENARY KEYNOTE PRESENTATION: Time is Life: Pfizer’s Approach to Accelerating Clinical Development
Robert Goodwin, Senior Vice President, Clinical Development and Operations, Pfizer Inc.
How do we transform the development paradigm to make trials more accessible, more convenient for the participants, less costly, and most importantly, get us the answers we need faster? Because when you’re a patient waiting for a new treatment, every minute matters. Pfizer recognizes that time is life and has set a bold ambition to reduce three additional years off their development timelines, after successfully cutting down more than two years already since 2016. Hear from Rob Goodwin, SVP and Head of Clinical Development & Operations, on what it takes to accelerate development without compromising quality, compliance, or patient safety.

9:05 am INTERACTIVE PANEL: Use Cases of Generative AI in Clinical Trials: Beyond Can We...Where and When Should We?
Where are we now as an industry with integrating and utilizing AI in clinical research? What is next is an open question and the possibilities are many and the hype is loud, but the more important question to ask is “why should we?” in each and every case. AI is a tool, but not always the right one or the most efficient one. Where are you in the journey of bringing Generative AI into CT? Should teams focus on technology and use cases like Diversity in CT inclusion and other specific applications? Why? How was value measured? What risks exist? Where do we choose not to use AI in clin ops and why? Dive in with our expert panel.

MODERATOR:
Brian Martin, Head of AI, R&D Information Research, Research Fellow, AbbVie, Inc.

PANELISTS:
Neil Garrett, PhD, Head of Regulatory Medical Writing, Johnson & Johnson
Samar Noor, Vice President, Head of Statistical Programming, Global Biometric Sciences, Bristol Myers Squibb Co.
Hoifung Poon, PhD, General Manager, Health Futures, Microsoft Research
Prasanna Rao, Head, AI & Data Science, Data Monitoring and Management, Clinical Sciences and Operations, Global Product Development, Pfizer Inc.

9:35 am Grand Opening Coffee & Refreshment Break in the Exhibit Hall. Best of Show Voting Opens.
SCOPE’s exhibit hall is a one-of-a-kind experience. With 240 leading clinical trial technology and services companies represented, it’s easy to find new, innovative companies to partner with, and don’t forget to visit your existing partners to see their latest and greatest. Take a minute to vote for SCOPE’s Best of Show, grab some refreshments, charge your devices, or ham it up in a photo booth, but above all, wear comfy shoes; you’ve got some miles to cover!

2024年2月13日（火）

1:20 pm Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available). Best of Show Winner to be Announced.
SCOPE’s hall this year is bigger than ever; there’s no way to cover it all in just one break. So, after lunch, grab some dessert and a cup of coffee and visit all those booths that you just couldn’t make it to this morning. Stay to hear our Best of Show Winner announcement and congratulate the winner!

TUESDAY AFTERNOON PLENARY SESSION:
MODERNIZING TRIALS WITH FDA & INTERSECTION OF INNOVATIVE DEVELOPMENT MODELS AND INVESTMENT APPROACHES

2:20 pm Organizer's Welcome Remarks
Marina Flishtinsky, MD, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco
Micah Lieberman, Executive Director, Cambridge Healthtech Institute; Co-Founder, ClinEco

2:25 pm Chairperson’s Remarks
Mike Martin, Principal, ZS

2:30 pm PANEL DISCUSSION: Fireside Chat with FDA on Modernizing Clinical Trials
Prospectively randomized, placebo-controlled clinical trials are often the most powerful tool that we have for answering fundamental questions about the safety and efficacy of new medical products. But greater efficiency is needed, as clinical trials are becoming more costly and complex to administer. Moreover, many of the new products that we’re being asked to evaluate aren’t easily evaluated using these traditional approaches. At the same time, new technologies and sources of data and analysis make better approaches possible. FDA has been engaged in a comprehensive effort to advance new innovations and to enable the modernization of clinical trials, so what does this mean to you and to our industry?

PANEL MODERATOR:
Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine

PANELISTS:
Kevin Bugin, PhD, Deputy Director, Operations, Office of New Drugs (OND), FDA's Center for Drug Evaluation and Research (CDER)
Marsha Samson, PhD, Analyst, Office of Medical Policy, FDA

3:00 pm CROSS-INDUSTRY PANEL: Intersection of Innovative Development Models and Investment Approaches That Move the Needle at the Portfolio Level
New to SCOPE 2024-we bring together for the first time, a business-focused panel of strategics from the pharma, investor, healthcare, CRO, and technology start-up communities, to discuss partnership models, that drive much needed innovation in clinical trials and impact development at the portfolio level. How can Pharma manage risks and investments while continuing to remain at the forefront of drug development, clinical research, and trial technology? What alternative business models and risk-sharing partnerships can support innovation, in a resource-constrained environment? Where are the opportunities and the ROI from such partnerships? What Emerging Technologies are showing growth and investment and are moving the needle in clinical research?

PANEL MODERATOR:
Jacob LaPorte, PhD, Patient; Co-Founder & Vice President, Global Head of BIOME - The Digital Innovation Lab, Novartis

PANELISTS:
Angela DeLuca, Vice President, Head of Oncology & Cell Therapies Clinical Operations, Global Development Office, R&D, Takeda
Michael Greeley, Co-Founder & General Partner, Healthcare Technology, Flare Capital Partners
Michelle Longmire, Co-Founder & CEO, Medable, Inc.
Sam Srivastava, CEO, WCG

3:30 pm Booth Crawl & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available). Last Chance for Exhibit Viewing.
Join your colleagues in the Exhibit Hall for one last visit. Enjoy SCOPE’s “Booth Crawl,” where sponsoring booths have a silent competition to see who can serve the most fun or fancy food and drink. Visit their booths to see for yourself! Take a final lap around the hall and enjoy time with your newfound friends and partners.