Outsourcing - 2023 Archive

2023 Archived Content

Relationship and Alliance Management in Outsourced Clinical Trials

How pharma and biotech sponsors approach their outsourcing strategy continues to adapt as the industry responds to the pandemic, inflation, and world events. Outsourcing models, exploring new technologies and needs, as well as CRO and third-party provider relationships are being re-examined with an eye towards efficiency and adaptability. SCOPE Summit’s Outsourcing stream will address the tangibles of outsourcing strategy as well as the soft skills required for strong relationships. CHI’s 7th Annual Mastering an Outsourcing Strategy track will dive into agile outsourcing models, working with technology vendors, and exploring the nuances of outsourcing for decentralized clinical trials. CHI’s 9th Annual Relationship and Alliance Management for Clinical Trials track is dedicated to exploring the health of partner relationships, strategies for becoming a partner of choice, and how to overcome challenges in these partnerships.

Part 1: Mastering an Outsourcing Strategy

Part 2: Relationship and Alliance Management in Outsourced Clinical Trials

Monday, February 6

SCOPE’s 2nd Annual Masters of Clinical Research Golf Tournament* (Sponsorship Opportunities Available)8:00 am

Connect with your peers and colleagues at SCOPE's 2nd Annual 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.
*Limited space available. Separate registration and fee required for Golf.

Conference Registration Open (Gatlin Foyer)9:00 am

Open Workshop: Introducing ClinEco, the New B2B Clnical Trial Community and Marketplace1:00 pm

Sit down with a small cross-industry group for a 45-minute hands-on session to learn about, share feedback, and register for free for the new B2B clinical trial community and marketplace. ClinEco unites sponsors, CRO's, 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. Join the ClinEco community now for free at: https://clineco.io/register. Let us know if you are joining us at: bgallant@clineco.io. Walk-ins welcome. Open to all SCOPE attendees.

User Group Meetings2:00 pm

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.

Part 1: Mastering an Outsourcing Strategy

5:00 pm

Organizer's Welcome Remarks and 2nd Annual Masters of Clinical Research Golf Tournament Awards

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

5:05 pm Plenary Keynote Introduction

Tarra Shingler, Chief Commercial Officer, StudyKIK

5:10 pm INTERACTIVE PANEL:

Lighting a “Beacon of Hope” to Address Racial Inequity in Clinical Trials, Health, and Education

PANEL MODERATOR:

Vicky DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi

Launched in July 2021 as a $33.7M commitment from Novartis and the Novartis US Foundation, Beacon of Hope began as a 10-year collaboration to increase diversity among clinical trial participants and investigators; improve access to high-quality education and promising jobs; address inherent bias in the data standards; and find actionable solutions to environmental and climate issues that disproportionately affect health among communities of color. This session brings together leaders from collaborating partner companies Novartis, Sanofi, Merck, and four of the participating HBCUs to discuss how Beacon of Hope aims to improve the quality and inclusivity of clinical trials.

PANELISTS:

Adrelia Allen, PharmD, PMP, Director, Clinical Trial Patient Diversity, Merck

Rajbir Singh, MD, Executive Director of Precision Medicine and Health Equity Trials Design, Meharry Medical College

Priscilla Pemu, Doctorate, MBBS MS FACP, Associate Dean Clinical Research at Morehouse School of Medicine

Kimberly Fookes, Global Head, Diversity & Inclusion in Clinical Trials, Novartis

Celia J. Maxwell, MD, Associate Dean for Research, Howard University College of Medicine, Medicine & Health Affairs, Howard University Hospital

Beacon of Hope and the Center of Excellence for Clinical Studies at Charles R. Drew University of Medicine and Science (CDU)

Jay Vadgama, PhD, Professor & Executive Vice President Research & Health Affairs & Chief, Cancer Research & Training & Internal Medicine, Charles R. Drew University of Medicine & Science

This presentation describes the importance of creating a Center of Excellence for Clinical for Clinical Studies in South Los Angeles which has one of the highest rates of health disparities in the nation. It provides important information on social determinants of health and how they impact health disparities. We provide a road-map on how CDU plans to address health disparities with partnership with Novartis and the Beacon of Hope.

Naikia Byrd-Atkinson, Director, US Clinical Trials Diversity and Inclusion, Sanofi

SCOPE's 7th Annual Participant Engagement Awards Introduction5:40 pm

5:45 pm

SCOPE's 7th Annual Participant Engagement Awards

PANEL MODERATOR:

Kelly McKee, Vice President, Decentralized Clinical Trials (DCT), Medidata

David Sall, President & CEO, Marketing, Patient Enrollment Advisors LLC

Now in its 7th 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 2023 Participant Engagement Award program is brought to you by Cambridge Healthtech Institute (CHI)’s SCOPE and is accepting submissions at: https://www.scopesummit.com/participant-engagement-award

PANELISTS:

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

Anne Marie Mercurio, Clinical Trial Volunteer and Patient Advocate

Marisa Rackley, Vice President, Clinical Site Start Up, Site Engagement, Trial Optimization, Takeda

Irena Webster, Vice President, Head of Development Operations, Forma Therapeutics

Kelly White, Senior Director, Head, Global Trial Optimization, Oncology, Merck & Co.

Kendal Whitlock, Head, Digital Optimization, RWE Clinical Trials, Walgreens Co.

SCOPE's Kick-Off Happy Hour6:30 pm

Close of Day7:45 pm

Tuesday, February 7

Registration Open (Gatlin Foyer)7:00 am

Morning Brew & Pastries to Jumpstart Your Day (Sponsorship Opportunities Available) or Morning Coffee7:30 am

8:30 am

Chairperson's Remarks

Marina Filshtinsky, MD, Executive Director, Conferences, Cambridge Healthtech Institute

Micah Lieberman, Executive Director, Cambridge Healthtech Institute

8:35 am Chairperson'sPlenary Keynote Introduction

Jim Reilly, Vice President, Development Cloud Strategy, Veeva Systems

8:40 am

Would I Want My Mother to Be Part of a Clinical Trial?

Virginia Nido, Global Head, Product Development Industry Collaborations, Genentech, a member of the Roche Group

Have the quality and efficiency of trials improved in the past 20 years? Have biopharma industry collaborations changed the landscape of clinical trials? Would you want YOUR mother to be part of one of your clinical trials? Learn about the breadth and scope of solutions that have come out of industry collaborations and how YOU, as a biopharma executive, have the power to adopt changes that impact the entire industry.

9:05 am INTERACTIVE PANEL:

Navigating a Global Crisis: Pandemic, War, Hyperinflation, Supply Chain Disruptions…You Name It

PANEL MODERATOR:

Balazs Flink, Senior Director, Clinical Development Operations, Daiichi Sankyo, Inc.

Running a complex clinical trial involves a lot of moving pieces, forward planning, modeling, allocation of resources, and a neverending ability to adjust while maintaining the highest standards. It has never been easy, but many of us in the clinical research profession know how to do our part. The advent of DCTs, novel tech and data sources, and then the pandemic put us all to the test. However, we are now facing supply chain disruptions and other human/material resource challenges that make everything even more complicated. What is a clinical ops leader to do?

PANELISTS:

Gaurav Sawhney, Vice President, Head, Clinical Partner Management, Takeda Pharmaceuticals, Inc.

Bryan O'Neill, Global Head, Clinical Supply Operations, Daiichi Sankyo, Inc.

Deborah Profit, PhD, Vice President, Clinical Management & Applied Innovation, Otsuka America Pharmaceutical, Inc.

Ken Getz, Executive Director, Tufts Center for the Study of Drug Development

Help Us Set a Guinness World Record: Join Everyone for a Group Photo at 9:25 Sharp in the Keynote to Make History!9:30 am

Grand Opening Coffee and Refreshment Break in the Exhibit Hall9:35 am

10:35 am Chairperson's Remarks

Neil Berger, VP, FSP Commercial and Operational Strategy, Parexel

10:40 am

Key Considerations for Evaluating and Selecting Technology Suppliers for Digital Health Technologies (DHT)

Sonali Bhatnagar, Associate Director, Clinical Innovation & Digital Health, R&D Sourcing & Procurement, Merck

This talk will discuss challenges associated with evaluating, selecting, and onboarding new suppliers and the key questions cross-departmental teams should consider. We will discuss digital health technologies as they apply to decentralized clinical trials in particular, and how this strategy can apply across therapeutic areas.

11:10 am

Outsourcing to Technology Vendors: Contracts, Metrics, and Challenges

Nick Lewis, Head, Clinical Vendor Management, Bayer

With decentralized clinical trials and patient centricity being accelerated in the light of the COVID-19 pandemic, there are a plethora of suppliers offering wearable, biosensors, devices, and app services. With the shift from traditional suppliers to technology vendors, how do we ensure the solution is fit for purpose, the supplier can meet sponsor expectations, and the clinical trial proceeds as per the plan?

11:10 am

Outsourcing to Technology Vendors: Contracts, Metrics, and Challenges

Nick Lewis, Head, Clinical Vendor Management, Bayer

11:40 am

Top 10 Things to Consider When Managing IRT Audit Data

Cat Hall, VP of Data & Quality, G&A - Product, Endpoint Clinical

The speaker will discuss the challenges in reviewing the IRT audit log and the innovation in process and technology that helps to support oversight of IRT audit data as well as audit data archiving.

Learn –

What is the difference between an IRT Audit log and Audit Trail

How to overcome unblinding risk in your IRT audit Review Plan

Steps you can take to demonstrate compliance with the regulatory guidelines.

12:10 pm

Global Oversight Monitoring - Partnering for Success

Christine Burhoe, R.Ph., Director, Global Clinical Operations, KPS Life

This interactive presentation will review the reasons to conduct oversight monitoring and the keys to collaboration of a successful oversight monitoring plan. In demonstrating how each program can vary from Sponsor to Sponsor, it will discuss the activities at the visit, the types of issues that are identified, the challenges and the successes, and case studies that highlight the value of oversight monitoring through a global outsourced partner.

Transition to Lunch12:40 pm

12:45 pm

LUNCHEON PRESENTATION:Avoiding Outsourcing Strategies that No Longer Work

Neil Berger, Vice President, FSP Commercial and Operational Strategy, Parexel

Don’t change your outsourcing model for the wrong reason. This talk will explore outsourcing models and trends, as well as emerging models and metrics to consider.

Coffee & Dessert Break in the Exhibit Hall (Sponsorship Opportunities Available)1:15 pm

2:10 pm Chairperson's Remarks

Kevin D. Duffy, MBA, Chief Commercial Officer, KPS Life

2:15 pm

Growing Pains: Anticipating the Impact of a Biotech’s Evolution on Outsourcing Strategy

Richard Scaife, Vice President, Strategic Outsourcing & Vendor Management, VectivBio AG, PCMG Committee Member

This talk will cover how to go from fully outsourced to functional breakouts. We'll discuss hands off to hands on at site level, as well as CRO subcontracting lessons learned and when essential becomes comprehensive contracting.

2:45 pm

When CULTURE and STRATEGY Sit Down to Breakfast: Exploring Outsourcing Models through a Partnership Lens

Debbie Gilmore, Vice President, Strategic Alliance Management, ICON

Kelly Simcox, Global Head, Clinical Operations R&D, Sanofi

Sponsors continue to evolve both outsourcing strategies and operating models to improve clinical trial performance. In this session, Sanofi and ICON discuss how they created a shared partnership/alliance culture, which evolved both the outsourcing strategy and operating model. The result leverages the best of both organizations and aims at shaping a more efficient environment.

3:15 pm CO-PRESENTATION:

From Pharma to Biotech: Differences in Sourcing Approaches

Jennifer Henrick, Vice President, Clinical Operations, Homology Medicines

Richard L Polgar, Sr Advisor, Danforth Advisors

Big pharma and biotech each have their unique attributes that play out quite differently during sourcing events. Learn the differences and similarities while capturing skills to improve your sourcing event and supplier governance. Walk away with the knowledge to be more successful, plan better and think about the long-term value that can be captured. Learn from veterans in the industry while having fun.

3:45 pm

Ecosystem Collaboration: Partnering for More Accessible Clinical Trials that Support Sponsors, Patients, and Providers

Samantha Eells, Co-Founder, Lightship

Clinical trial design and conduct are multifaceted with collaboration across organizations, supply chains, and health systems. Ensuring patient safety, quality, and data integrity across programs is key for success. To create clinical trials that offer more access and choice, seamless integration of processes and patient and provider preferences are required. We’ll discuss best practices for clinical trials that incorporate the spectrum of decentralized to in-person approaches for a successful study.

4:15 pmFind Your Table and Meet Your Moderator

4:20 pmInteractive Breakout Discussion Groups

Concurrent breakout discussion groups are interactive, guided discussions hosted by a facilitator or set of co-facilitators to discuss some of the key issues presented earlier in the day’s sessions. Delegates will join a table of interest and become an active part of the discussion at hand. Bring your pharma, biotech, CRO, site, hospital or patient perspective to each of the discussions below. To get the most out of this interactive session and format please come prepared to share examples from your work, vet some ideas with your peers, be a part of group interrogation and problem solving, and, most importantly, participate in active idea sharing. Please visit the Interactive Breakout Discussion Groups Page for more information.

Welcome Reception in the Exhibit Hall5:00 pm

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle*6:30 pm

*Courtesy shuttles will be available Tuesday and Wednesday 6:30-10:30pm (last pick up), bringing you to and from Pointe Orlando.

The Pointe Orlando is an open air-entertainment destination, featuring local and brand names restaurants, bars, nightclubs, 20-screen movie theater, comedy club and family attractions.

Shuttles will run a continuous loop 6:30-10:30pm (last pick up) between Rosen Shingle Creek, Hilton Orlando, DoubleTree Orlando at SeaWorld, and Pointe Orlando.
On-site look for our courtesy shuttle signage directing you to pick up locations within the hotels.

Wednesday, February 8

8:00 amRegistration Open

8:30 am

Breakfast Presentation Option #1:Achieving the Impossible: Maximizing Patient Experience and Data Quality in a Complex Rare Disease Program

Caroline Jackson, Executive Vice President, Patient Services, mdgroup

Mobile health has a significant impact on patient retention and experience in clinical trials. However,it’s still under-utilized as there is a perception that more complex assessments and procedures cannot be conducted effectively in the home. This case study highlights how mdgroup worked with a client to implement complex sample collections in the homes of patients suffering from a rare disease, resulting in reduced travel burden and low dropout rates.

8:30 am

Breakfast Presentation Option #2:Strategies for Biopharma Companies to Boost Clinical Trial Enrollment

Dennis Akkaya, Chief Commercial Officer, myTomorrows

We would like to invite you to join us for an informative event about overcoming obstacles in recruiting patients for BioPharma clinical trials. During this event, we will delve into barriers such as lack of awareness and financial considerations that can impede clinical trial recruitment success. Additionally, impactful strategies to increase clinical trial participation and recruitment success will be shared.

9:00 amSession Break

9:10 am Chairperson's Remarks

David MacMurchy, CEO, Lightship

9:15 am CO-PRESENTATION:

Building a Relationship Health Program and the Impact on Partnerships

Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.

Dennis Salotti, Senior Director & Head, Strategic Outsourcing & Clinical Innovation, Jazz Pharmaceuticals

This presentation will focus on the key elements of clinical vendor governance and oversight from the perspective of a mid-size pharma; and using holistic vendor relationship management as a vehicle to support effective partnership. The presentation will cover the following key points: overall framework for effective governance; performance management and differentiating relationship vs. delivery metrics; and implementing a relationship health program within a partnership.

9:45 am PANEL DISCUSSION:

Approaches and Best Practices for Assessing CRO Performance

PANEL MODERATOR:

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

With many companies in some form of CRO outsourcing model, including FSP arrangements, it is increasingly important to have effective performance measures that help assess the overall relationship and performance not only at an individual study level but also at a portfolio level. This panel will discuss what approaches have worked well, and what haven’t worked well including incentive models (bonus, earn-backs, etc.).

PANELISTS:

Debbie Gilmore, Vice President, Strategic Alliance Management, ICON

Randy Krauss, Executive Director, Metrics, Analytics, & Performance, Merck

Dennis Salotti, Senior Director & Head, Strategic Outsourcing & Clinical Innovation, Jazz Pharmaceuticals

Keith Dorricott, Director, Dorricott Metrics & Process Improvement Ltd.

10:15 am

Why expert partners and staff matter, what metrics don’t tell

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

Getting IRT wrong can have big ramifications for your clinical trial. Even an IRT that works but is not optimized can have time, resource, and budget implications. As with other disciplines in clinical development IRT must be recognized as something that requires dedicated experts with both a deep and broad knowledge of the technology and its application. This presentation will describe what expertise looks like, why it is important, why built for purpose matters, and the benefits of in-house experts.

Coffee Break in the Exhibit Hall (Sponsorship Opportunities Available)10:45 am

11:40 am

Chairperson's Remarks

Marina Malikova, PhD, Executive Director, Surgical Translational Research, Operations and Compliance, Boston University School of Medicine

11:45 am CO-PRESENTATION:

Promoting/Working/Accelerating Climate Mitigation in Trial Design

Jason Lanier, Global Program Leader, Director, Janssen Clinical Innovation

Jason LaRoche, Director and Focus Area Leader, Janssen Clinical Innovation

Governments, healthcare providers, and other stakeholders are calling for action on climate change. We’ll discuss the climate footprint of clinical research and propose an activity-based approach for future measurement. We will discuss how this approach can be applied to estimating the climate footprint of future trials and co-inform trial design as well as how we as an industry can come together to collectively measure and reduce the emissions from clinical research.

12:15 pm PANEL DISCUSSION:

Managing the Downstream Impact of World Events in Clinical Trials from a Clinical Sourcing and Operations Perspective

PANEL MODERATOR:

Scott Sawicki, MA, Senior Director, Strategic Sourcing & Vendor Management, ADC Therapeutics

In this panel, we will discuss short- vs. long-term impacts of world events, including COVID-19 and the war in Ukraine (e.g. supply chain, patient recruitment/retention, patient care, inflation, resources, etc.). We'll explore lessons learned from dealing with these challenges, how big and small pharma can adapt in financially uncertain times, and strategies for pivoting resources and the impact on timelines and budgets.

PANELISTS:

Daniella Ajib, Executive Director, Vendor Outsourcing, Gilead Global

Hansu Dong, Executive Director, Clinical Outsourcing & Business Operations, Clinical Operations, Novavax

Rene Stephens, MSHS, Independent Consultant

Mary Frances Sassaman, Vice President, Project Delivery, ICON

Transition to Lunch12:45 pm

Part 2: Relationship and Alliance Management in Outsourced Clinical Trials

12:50 pm

LUNCHEON PRESENTATION:The New Age of R&D Procurement: Strengthen Vendor Performance Management & Oversight with Technology

Anca Copaescu, CEO, Strategikon Pharma

Over $50B are spent annually in R&D outsourcing across multiple service categories, supporting increasingly more complex studies with fewer resources. Core activities (RFP management, strategic partner governance and category sourcing) are painfully manual and lacking data driven analytics. Learn how technology increases business scalability in a resource-constrained environment, strengthening vendor oversight, minimizing compliance risks and reducing the overall cost of outsourcing execution.

Coffee & Dessert Break in the Exhibit Hall with "Best of Show Award" Winner Announcement (Gatlin BCD)1:20 pm

2:20 pm Plenary Keynote Introduction

Ivor Clarke, CEO, SubjectWell

2:25 pm

Faster, Better, Cheaper: The Increasing Role and Opportunities for Real-World Evidence in Informing Regulatory Pathways

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

An open dialogue on the facilitators, barriers, and open opportunities to effectively utilize RWE for informing regulatory pathways from a biopharma company perspective. Additionally, we will highlight some of the novel use cases and key lessons learned by biopharma companies in utilizing RWE for discovery and development purposes.

2:35 pm

Advancing Evidence Generation of the Future

Amy Abernethy, MD, PhD, President of Product Development and Chief Medical Officer at Verily; Former Principal Deputy Commissioner, FDA

Clinical research is undergoing a major shift, as we move towards continuous evidence generation to support accelerated drug development and approvals. In this talk, Dr. Abernethy will share her firsthand experience with the evolving use of real-world data and evidence at FDA during COVID. She'll speak to the need for quality longitudinal data sets, the role of technology, and how new approaches are transforming the clinical research field.

2:45 pm

Fireside Chat: Next-Generation Data Sources

Amy Abernethy, MD, PhD, President of Product Development and Chief Medical Officer at Verily; Former Principal Deputy Commissioner, FDA

Christopher Boone, PhD, Global Head, Health Economics & Outcomes Research, AbbVie, Inc.

2:55 pm

Fireside Chat: Future-Ready Operations: Building a Multi-Year Roadmap

Lynne M. Cesario, Executive Director, Global Lead Risk Based Monitoring Program, Pfizer Global R&D Groton Labs

Jane Hiatt, Executive Director, Site Management and Monitoring, Early-Stage Development, Merck

Ward Lemaire, Head of Data Management, Integrated Data Analytics & Reporting, Janssen, J&J

With increases in complexity and new trial modalities, organizations need to constantly assess what the future needs. This chat will focus on the strategic choices and approaches to be considered, and how to plan out such a multi-year roadmap.

Booth Crawl & Refreshment Break in the Exhibit Hall (Sponsorship Opportunities Available). Last Chance for Viewing. (Gatlin BCD)3:25 pm

4:25 pm

Chairperson's Remarks

Rosalie Filling, Vice President, Senior Global Head, R&D Operations, Endo Pharmaceuticals

4:30 pm

Alliance Management in the Clinical Space: Strategies for Becoming a Partner of Choice

Brigid McTague, Vice President, Global Head, Planning, Resourcing and Partnerships Management, Janssen R&D

5:00 pm

Throwing out the Alliance Playbook: Exploring a Site-Centric Approach

Noelle Gaskill, Head, Clinical Research Operations, Mirati Therapeutics

In a competitive landscape, what does a successful site organization alliance/collaboration look like? What is the latest in these models and how do you actually measure success? I look forward to covering at a high-level how the alliance space has evolved over my tenure in working with CROs and sponsors in a competitive landscape and how I use that knowledge to make a difference today.

5:30 pm

User Support: The Intersection Between eClinical Software and a Site Centric Mindset

Bob Weney, Director, Global Client Services, Clinical Project Services, Almac Group

The success of your clinical trial in part relies on a positive experience for your sites and patients. As clinical trials become more intricate and run longer, sites are experiencing higher turnover rates than ever before. Join us as we discuss evolving trends in daily user support needs/requests.

6:00 pm CO-PRESENTATION:Partnering for Success, a Modern Solution to Outsourcing

Laurie Callen, Senior Director, Clinical Data Management, Moderna Therapeutics

David Geismer, Senior Vice President, Professional Services, Medidata

Sponsors rely on technology companies to support their clinical trials. So how do Sponsors get the most value out of their vendors in order to effectively and efficiently run their trials? In this session, Moderna and Medidata discuss how they moved from the traditional sponsor/vendor relationship into a partnership that drove the successful completion of their COVID trials in record time. They will also showcase how this partnership is changing the way both companies operate today and into the future.

Close of Day6:30 pm

SCOPE out Pointe Orlando for an entertaining night out via our Courtesy Shuttle*6:30 pm

Thursday, February 9

Registration Open (Gatlin Foyer)7:15 am

7:45 am

Breakfast Presentation: Impacting Timelines vs Impacting Resources — It's Not Either / Or Anymore

Lisa Moneymaker, Chief Technology & Product Officer, Saama

Our industry is challenged to find the right resources to drive operational best practice. There is also an expectation to move at the “speed of Covid” for every trial. It feels like an either/or. However, you can have both. You can accelerate timelines with fewer resources. Join this exciting session to learn about: The biggest time and resource drains on clinical trials; Applying AI/ML to improve efficiency; Challenging your own internal processes to get to market faster.

Transition to Sessions8:15 am

8:25 am

Chairperson's Remarks

Chuck Bradley, Senior Vice President, Global Development Operations, Annexon Biosciences

8:30 am FEATURED PRESENTATION:

Trends & Challenges in Pharma Sourcing and Procurement – Managing Relationships with the Modern Supplier

Luiz A. Barberini, CQE, CSCP, CPIM, Head, External Manufacturing Operations, Bayer SA

This presentation covers how Bayer's External Relationship Governance model adds value to the business ensuring a reliable partnership and complements the Sourcing & Procurement Functions, sharing current trends on procurement roles and the necessity to have an operational perspective in sight, with different approaches from different business necessities and how to best manage CMOs, 3PLs and Clinical Trials partners.

9:00 am PANEL DISCUSSION:

How Small Biotechs Develop, Manage, and Maintain Relationships with CROs

PANEL MODERATOR:

Chuck Bradley, Senior Vice President, Global Development Operations, Annexon Biosciences

This panel will discuss:

Key considerations for smaller biotechs in selecting CROs to work with
How small biotechs can position themselves as valuable partners to CROs
Strategies for managing and maintaining relationships with CROs

PANELISTS:

Hansu Dong, Executive Director, Clinical Outsourcing & Business Operations, Clinical Operations, Novavax

Erin O'Boyle, Vice President, Clinical Operations, Rezolute, Inc.

Ratan Ratnesh, Senior Director, Outsourcing & Vendor Management, Taiho Oncology, Inc.

10:00 am

Build a Strategic Budget to Invest in Supporting your Clinical Trial Sites

Daniel Perlman, CEO, Transformative Pharmaceutical Solutions

An in-depth discussion on how Pharmaceutical companies have historically used clinical trial budgets and exploring new opportunities that can provide a better return on their investments.

10:15 am

CO-PRESENTATION:A Thought-Provoking Conversation about Diversity and Inclusion: Are Race and Ethnicity the Only Dimensions?

Sean Kennedy, MPH, Executive Director, Therapeutic Strategy Lead, Real World Evidence, Worldwide Clinical Trials

Aman Khera, MBA, FRAPS, FTOPRA, Vice President, Global Head of Regulatory Strategy, Scientific Solutions, Worldwide Clinical Trials

Daniel Perez, CCRP, Director and Global Head of Patient Experience, Patient Experience, Diversity & Inclusion, Worldwide Clinical Trials

•Join us in a lively conversation about different dimensions of diversity that should be included in your clinical trial strategy. Significant progress has been made elevating this discussion to the forefront of drug development, however, there continue to be unaddressed gaps. This will be an interactive discussion with the audience where we explore these questions and challenge their impact. Our three panel members will share their personal expertise, perspectives, and experiences.

Networking Coffee Break (Gatlin Foyer)10:45 am

11:05 am

Chairperson's Remarks

Josephine Stacey, Director, Strategic Business Operations, Global Development, R&D, Johnson & Johnson

11:10 am PANEL DISCUSSION:

Strategies to Attract, Engage, and Retain Talent during Times of Change

PANEL MODERATOR:

Josephine Stacey, Director, Strategic Business Operations, Global Development, R&D, Johnson & Johnson

This panel will discuss:

The impact staff turnover has on clinical trial operations and outsourcing
Working with CROs and sites to mitigate staffing changes
Insights on returning to the office, DE&I efforts, and meaningful changes that impact employees
How to develop talent and grow people into careers

PANELISTS:

Eileen Doherty, Vice President, Enabling Business Information Solutions (EBIS), The Janssen Pharmaceutical Companies of Johnson & Johnson

Rosalie Filling, Vice President, Senior Global Head, R&D Operations, Endo Pharmaceuticals

Valerie Balosso, Director, Data Management, Infectious Diseases, GSK

12:10 pm

The Tempus TIME Network

Matthew Cooney, Vice President, Therapeutic Development, Oncology, Medical Science, Tempus Labs

The TIME Network screens 1 million patients daily using technology and nursing review to find trials. Once a patient is identified, the site is rapidly opened using a pre-approved trials agreement, central IRB, and uniform contracting. This process empowers the TIME Network to activate hundreds of trials in an average of 10 days. The TIME program has enabled patients to stay within their own community practices to participate in clinical research.

Transition to Lunch12:40 pm

12:45 pm

LUNCHEON PRESENTATION:Redefining CRO Sourcing Model Terminology to Optimize Outsourcing Strategies

Ann Pongracz, Vice President of Business Development, Strategic Solutions, ICON

Historical terms such as ‘Full Service’ or ‘FSP’ struggle to reflect the reality of industry sourcing trends. ICON, partnering with Tufts CSDD and Pharmaceutical partners have established a taxonomy for categorizing sourcing models. This session addresses, the evolution of sourcing model definitions, the process of aligning the industry to a new taxonomy, and insights from ICON’s Partner of Choice outsourcing model survey.

Closing Remarks1:15 pm

Scope Summit 2023 Adjourns1:20 pm