Welcome and Introduction

Day 1 Topic: Patient Engagement

KEYNOTE: Dr. David Fajgenbaum – A Patient’s Journey in Developing His Own Cure

When Dr. David Fajgenbaum was diagnosed with Castleman Disease, it had no cure. Not giving up hope, he decided to focus all his efforts on researching how to cure himself and others alongside him. Based on his laboratory research findings, he tried an experimental treatment on himself as a last resort. The treatment has been successful, and he has been in remission ever since. Dr. Fajgenbaum will share the patient journey – the ups, downs, and reliance on family, his colleagues, and the scientific community. He will also discuss the use of innovation in his research.

Presented in collaboration with the WCG Patient Forum

PANEL AND Q&A: Driving Progress for Patients through Collaboration

For years, the barrier to rapid drug development has been in finding patients to complete clinical trials. To make clinical trials a standard care option, the industry has to ensure that it is meeting the needs of patients during the clinical trial design process. This panel will discuss how patient engagement activities have evolved through the years and share new and innovative ways of incorporating the patient voice into clinical trials.

Facilitator:

• Patricia Leuchten, Founder, WCG Avoca; Chief Change Officer, WCG Clinical

Panelists:

• Jonathan Corle, Caregiver & Patient Advocate
• Dr. David Fajgenbaum, National Bestselling Author of Chasing My Cure and Co‑founder and President of the Castleman Disease Collaborative Network
• Naziah Lasi-Tejani, Group Director, Global Patient Partnership, Roche
• Hope Wohl, Chief Executive Officer, Breastcancer.org

Day 1 Closing

Welcome and Introduction

Day 2 Topic: Innovation

Measuring Innovation Adoption: Tufts-Avoca Research Overview

What is holding the industry back from moving forward with critical innovations? In this session, Ken Getz and Denise Calaprice will share research conducted by WCG Avoca partnered with Tufts on the innovation adoption process within the pharmaceutical industry.

• Denise Calaprice, PhD, Senior Consultant, WCG Avoca
• Ken Getz, Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine; Founder and Board Chair, CISCRP

Innovation for Impact: Sweet Farm’s Model for Driving Systemic Change

Sweet Farm’s founder, Nate Salpeter, will share how a 20-acre farm is using innovation to drive change towards a more sustainable world. By linking regenerative agriculture, farm-animal rescue, education, and technology, Sweet Farm is revolutionizing food and agriculture production – and other industries can benefit from their learnings.

• Nate Salpeter, PhD, Co-Founder, Sweet Farm; General Partner, SNØCAP

PANEL AND Q&A: Enabling Innovation across the Clinical Trial Landscape

This panel will explore industry approaches and critical success factors in the adoption of innovation. Representative Members of the Avoca Quality Consortium and the Avoca Innovation Alliance will discuss how their organizations evaluate and operationalize innovations and overcome barriers in the push toward next-generation clinical trial execution.

Facilitator:

• Steve Whittaker, Senior Consultant, WCG Avoca

Panelists:

• Leslie Addy, Director, Innovation and Decentralized Clinical Trials, Amgen
• Patrick Floody, Head of Global Clinical Trial Services, Regeneron
• Rasmus Hogreffe, MSc.Med, eMBA, Vice President, Decentralized Clinical Trial Innovation, Medable
• Jonathan Rowe, Principal, Head of R&D Quality and Operations Risk Management, ZS
• Doug Schantz, Vice President, Clinical Operations, Alexion Pharmaceuticals

Day 2 Closing

Welcome and Introduction

Day 3 Topic: Diversity & Inclusion

INTERVIEW: A Patient Perspective on Clinical Trial Equity and Diversity

Kimberly Richardson was diagnosed with a rare ovarian cancer 10 years ago. This past year, she has fought breast cancer. In this interview, Ms. Richardson discusses what, if anything, has changed in the diagnosis, care, and access to biomarker testing and clinical trials in the past decade. She has also become a powerful patient advocate on the local and national stage and will describe obstacles and solutions to meeting the needs of under-served communities participating in clinical trials.

• Kimberly Richardson, Clinical Research Patient and Advocate

Interviewer:

• Lori Abrams, Vice President, Patient Advocacy & Clinical Research Diversity, WCG Clinical

PANEL AND Q&A: Expanding Diversity and Inclusion in Clinical Trials

Aside from generating new focus on technology and centering the world’s eyes on our industry, the global pandemic also highlighted how clinical trials are often not conducted in areas where the disease burden is greatest. In this session, experts in diversity and inclusion discuss why diversity is important in clinical trial design and conduct as well as how organizations define diversity, and share proactive steps organizations are taking to plan/measure diversity targets that they put in place.

Presented in collaboration with the WCG Patient Forum

Facilitator:

• Lori Abrams, Vice President, Patient Advocacy & Clinical Research Diversity, WCG Clinical

Panelists:

• Agustín Fuentes, PhD, Professor of Anthropology, Princeton University
• Wenora Johnson, Three-Time Cancer Survivor; Volunteer Research and Patient Advocate
• Allison Kemner, Vice President, Clinical Sciences and Operations, Tyra Biosciences
• Nuala Murphy, PhD, President, Global Specialty Solutions, ICON
• Michael Poku, MD, MBA, Senior Medical Director, Oak Street Health

KEYNOTE: Diversity in Clinical Research – Dr. Agustín Fuentes, Professor, Princeton University

Dr. Agustín Fuentes, a leading biological anthropologist at Princeton University, will share a provocative look at how knowledge of biological diversity relates to improving the quality, and equity, of clinical trials. He will lay out the core answers as to what race is and is not, how genomic diversity is central to improving biomedical studies, and why diversity and inclusion must be much more than a demographic checklist.

Day 3 Closing

Welcome and Introduction

Day 4 Topic: Decreasing Site Burden / Quality & Risk

PANEL AND Q&A: Decreasing Site Burden

The WCG Avoca Quality Consortium set out in 2021 to have open and honest discussions on how the industry can reduce the burden on sites. To date, topics such as varying interpretations of regulatory requirements by Sponsor organizations, safety letter over-reporting, and technology burdens have been covered. Join an expert panel which will address some of the largest burdens placed on sites by Sponsor/CRO organizations that take away from the shared customer – the patient.

Facilitator:

• Sandy Smith, Senior Vice President, Clinical Solutions and Strategic Partnerships, WCG Clinical

Panelists:

• Billy Dirkes, Vice President, PPD and AES Quality Assurance
• Jill Heinz, President, Injury Care Research & Family Care Research
• Dr. Christian Kraus, Head of CDO Quality & Compliance, Bayer AG
• Jennifer Sheller, North America Regional Head, Global Clinical Trial Operations, Merck
• Megan Trost, Vice President, Study Start-Up and Administration, WCG Clinical

PANEL AND Q&A: Quality and Risk Across the Clinical Trial Ecosystem

The growing focus on quality and risk across all stakeholder groups is a positive force in clinical trials but is also creating emerging challenges. Quality Management Systems and policies adopted by Sponsors, CROs, Vendors, and Sites can differ in some regards, as can interpretations of regulations – leading to areas of conflict that impede the realization of the shared goal of running efficient, high-quality clinical trials. Senior industry executives will discuss some of the main areas in which stakeholder-specific processes and perceptions of risk can create tension and zero in on achievable fixes for the current causes of conflict.

Facilitator:

• Cristin MacDonald, PhD, Vice President, Client Delivery, WCG Avoca

Panelists:

• Steve Clemons, Senior Vice President, Client Delivery, Velocity Clinical Research
• Caroline Rosewell, Senior Director, Medicines Quality Organization, Lilly
• Diane Puglia Ryan, Head of Process & Risk Quality Management, Quality Center of Excellence, Global Product Development, Pfizer
• Michelle Webb, Vice President, Avoca Quality Consortium, WCG Avoca

Day 4 Closing