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Don’t miss essential insights from this three-part webinar series.


By registering for the webinar series, you will have the opportunity to join all three fascinating webinar discussions. You will also have access to the OnDemand recordings allowing you to watch back the discussions at any point.

For more information on each session, click the links below:


Tuesday Nov 8, 2022 | 8:00am (PST) 11:00am (EST) 4:00pm (GMT)

Improving Health Equity: Bringing Clinical Trials to the Patients
  • Where the clinical trial industry is and where we hope to go with health equity in clinical trials
  • Why the FDA has new clinical trial guidance that incorporates diversity inclusion plan
  • How a community-centric model can increase awareness, education and access to clinical trials

Representation matters. People want to see themselves when making key health decisions. More inclusive trials support broader treatment effectiveness. That’s why increasing diversity in clinical trials needs to rise.


Speakers

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Dr. Joneigh S. Khaldun

Vice President and Chief Health Equity Officer

CVS Health


Joneigh S. Khaldun, MD, MPH, FACEP is a nationally recognized healthcare executive, health policy and public health expert who currently serves as the Vice President and Chief Health Equity Officer for CVS Health. In this role she advances strategy, programs and policy to achieve health equity across all CVS Health lines of business. Prior to this, she served as Chief Medical Executive for the State of Michigan and Chief Deputy Director for Health in the Michigan Department of Health and Human Services, where she oversaw public health, Medicaid, behavioral health, and aging services. She was the lead strategist guiding Michigan’s COVID-19 response and in 2021, was appointed by President Biden to the COVID-19 Health Equity Task Force.

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Mark McClellan

Robert J. Margolis, M.D., Professor of Business, Medicine and Policy and Director

Duke-Margolis Center for Health Policy


Mark McClellan is the Robert J. Margolis, M.D., Professor of Business, Medicine and Policy and Director of the Duke-Margolis Center for Health Policy. A physician economist focused on advancing quality and value in health care, his COVID-19 response work spans virus containment and testing strategies, resilient care delivery, and accelerating therapeutics and vaccine development. Dr. McClellan is a former leader of the Centers for Medicare & Medicaid Services and the U.S. Food and Drug Administration. An independent director on the boards of Johnson & Johnson, Cigna, Alignment Healthcare, and PrognomIQ, Dr. McClellan co-chairs the Guiding Committee for the Health Care Payment Learning and Action Network and serves as an advisor for Arsenal Capital Partners, Blackstone Life Sciences, and MITRE.

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Owen Garrick, MD

Chief Medical Officer

CVS Health Clinical Trial Services


Owen Garrick, MD is Chief Medical Officer of CVS Health Clinical Trial Services. In this role, Dr. Garrick is responsible for the overall medical strategy across the portfolio, overseeing medical compliance, clinical insights, publications and clinical innovation. He will build out the medical affairs function across CTS. Dr. Garrick will continue to be the Executive Sponsor for the CTS-wide equity efforts, including diversity in clinical trials. Dr. Garrick joined CVS Health as Vice President, Conduct Delivery for Clinical Trial Services, in April 2021. He helped build the nationwide, patient-centric clinical trial delivery model currently in expansion, as well as the Commitment on Diversity and Equity (CODE) in clinical trials initiative. Prior to joining CVS Health, Owen was President of Bridge Clinical Research, where he had responsibility for the Clinical Trials, Research Analytics, Health Services Research and Healthcare Communications business units.

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Paul Burton, M.D., Ph.D., F.A.C.C, M.R.C.S

Chief Medical Officer

Moderna


As Chief Medical Officer, Paul Burton oversees medical affairs and safety. Dr. Burton joined Moderna after spending sixteen years with Johnson & Johnson. Since March 2020, he served as Chief Global Medical Affairs Officer of Janssen Pharmaceuticals where he was responsible for Janssen’s worldwide medical affairs strategy and execution. Previously, he served as Janssen’s Vice President and Head, Cardiovascular and Metabolic Medical Affairs. Dr. Burton also led the Johnson & Johnson collaboration with APPLE for the digital HEARTLINE™ study, and previously led clinical operations for all therapeutic areas across the Americas. Dr. Burton has an M.D. from the University of London, is board certified in surgery and is a Member of the Royal College of Surgeons with specialist training in cardiothoracic surgery. He holds a Ph.D. in cardiovascular molecular and cellular biology from Imperial College in London and is a Fellow of the American College of Cardiology. He has published extensively in peer reviewed journals.

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Lola Fashoyin-Aje

Deputy Director

FDA


Lola A. Fashoyin-Aje, MD, MPH, is a medical oncologist and Deputy Director in the Division of Oncology 3 (DO3) in the Office of Oncologic Diseases (OOD) at the Center for Drug Evaluation and Research- Food and Drug Administration (FDA). In this role, she provides scientific and policy guidance and oversight to multidisciplinary teams reviewing drugs and biologics under development for the treatment of solid tumor malignancies (gastrointestinal, cutaneous, and sarcoma). Dr. Fashoyin-Aje is also an Associate Director at the FDA Oncology Center of Excellence at the FDA, leading scientific and policy initiatives to address disparities and other regulatory science issues in oncology drug development. Prior to joining the FDA, Dr. Fashoyin-Aje completed her undergraduate and graduate training at Columbia University and Yale University, respectively, and received her M.D. degree from the University of Rochester School of Medicine and Dentistry. She completed her training in internal medicine and medical oncology at Johns Hopkins.

Tuesday November 29, 2022 | 8:00am (PST) 11:00am (EST) 4:00pm (GMT)

  Beyond the Data: Understanding the Patient Behind the Numbers

  • How to humanize the data and how, when data has meaning associated with it, it tells a human story and a story of how decisions are made in the real world
  • How to look at patients from all angles
  • What are some of the impacts of data on RWE

The increasing importance of real-world evidence (RWE) to better understand health, cost, quality of life and safety outcomes, effectiveness, value and efficiency of treatment approaches, and patient and physician behaviors.


Speakers

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Alexa Berk

Chief Scientific Officer for Real World Evidence

CVS Clinical Trial services


Alexa Berk is the Chief Scientific Officer for Real World Evidence at CVS Clinical Trial services. Alexa has worked in health research for nearly 20 years, including health outcomes research design and management positions at Memorial Sloan-Kettering Cancer Center and at top pharmaceutical and medical device companies, managing large-scale global clinical trials. Most recently she was the Medical Affairs Director for Digital Health and Data at Invitae, a leading medical genetics company. She has co-authored several journal articles in research literature including publications in the Journal of Clinical Oncology, Radiology, and the Journal of Cancer Education. She is a frequent panelist on topics around high-quality, patient-centric, and equitable real-world evidence, and has presented her research at annual conferences for the American Psychological Association, the Society of Behavioral Medicine, the International Society for Pharmacoeconomics and Outcomes Research, the Miami Breast Cancer Conference, and the American Psychosocial Oncology Society. Alexa has also taught undergraduate- and graduate-level classes at the New School for Social Research and the Columbia University School of Social Work, with a focus on health disparities, patient-reported outcomes, and research ethics in vulnerable populations.

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Andrew C. von Eschenbach, M.D.

President

Samaritan Health Initiatives, Inc.


Andrew C. von Eschenbach, M.D. currently serves as President of Samaritan Health Initiatives, Inc. and as an Adjunct Professor at University of Texas MD Anderson Cancer Center. From September of 2005 to January 2009 he served as Commissioner of Food and Drugs where he championed an agenda to modernize the FDA by process improvement of the regulatory pathway for drugs and medical devices and by fostering creative projects, including FDA’s Critical Path Initiative (designed to bring modern tools of science to the product development process); work plans like the FDA’s Food Protection Plan; and most especially the nurturing of the workforce through initiatives, such as an Agency-wide fellowship program and development of a new integrated campus for the Agency in White Oak, Maryland. Under his leadership, the FDA experienced dramatic increases in resources enabling implementation of many new programs designed to strengthen the FDA in its mission to protect and promote public health. He has emphasized FDA’s role in working with external partners to assure quality throughout the entire life cycle of the products it regulates.

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Jill Pellegrino

Vice President of Recruitment and Real World Evidence (RWE)

CVS Health Clinical Trial Services


Jill Pellegrino is Vice President of Recruitment and Real World Evidence (RWE), CVS Health Clinical Trial Services. She and her team are responsible for leading the Recruitment and RWE product suite for pharmaceutical manufacturers. Jill has 15 years’ experience in clinical research with expertise in recruitment, study conduct, real world evidence and data analytics. Previously she worked at Accelerated Enrollment Solutions where she served as General Manager. Her responsibilities included overseeing the company's patient recruitment business as well as 160 clinical research sites across 11 countries.

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Henriette Coetzer, M.D.

Chief Medical Officer, Recruitment and RWE

CVS Health Clinical Trial Services


Henriette Coetzer, M.D., serves as the Chief Medical Officer for Recruitment and RWE, CVS Clinical Trial Services. A critical care physician by training, Henriette has practiced medicine on virtually every continent and has worked in the U.S. and the European Union to redesign systems and pathways of care using RWE to maximize value and efficiency and to engage policy-makers, providers and patients. At the start of the Covid pandemic she returned to frontline practice delivering critical care to Covid patients and eventually overseeing and redesigning systems to ensure patient safety in a rapidly changing delivery environment. At Health Dialog in Boston, Henriette worked with Dartmouth’s Institute of Health Policy on RWE frameworks to illuminate and understand variation in real-world practice. As Chief Clinical Risk Officer at Rowdmap she worked on the use of the Centers for Medicare and Medicaid Services (CMS) datasets to identify providers, their case mix and natural groupings that produce consistently superior value and outcomes. In the United Kingdom, she served as the Director for Clinical Transformation for the National Health Service building a new care delivery model for the optimal care of the elderly. She started consulting with CVS Health in 2017 on evidence-based program designs before joining Clinical Trial Services in 2019.

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Christopher P. Boone, PhD

Vice President, Global Head of Health Economics and Outcomes Research

AbbVie


Christopher P. Boone, PhD is an accomplished global executive, strategist, social scientist, and data technologist with a passion for reinventing and transforming healthcare and life sciences companies utilizing enterprise data & analytics capabilities to drive value creation. Chris has a career-long history as a dynamic, innovative thought leader and a public voice on the power of real-world evidence, health informatics, and enterprise data & analytics, and its ability to radically transform the global health care system into a learning health care system. Currently, Chris serves as the Vice President, Global Head of Health Economics and Outcomes Research at AbbVie. He is also an adjunct assistant professor of health administration at the New York University's Robert F. Wagner Graduate School of Public Service, an active board member of several influential organizations, and a co-founder of a few start-up companies. Prior to AbbVie, he served in two different roles at Pfizer: (1) the Vice President and Head of Global Medical Epidemiology and Big Data Analysis, and (2) the Vice President and Global Head of Real-World Data and Analytics. Chris has been recognized as a Top Diverse Leaders by the Illinois Diversity and Leadership Council (2021), a Global Top 100 Innovator in Data & Analytics (2020, 2019), an Emerging Pharma Leader by Pharmaceutical Executive (2018), and a Top 40 Under 40 Leaders in Health (2017) by the National Minority Quality Forum (NMQF).

Tuesday December 13, 2022 | 8:00am (PST) 11:00am (EST) 4:00pm (GMT)

The Evolving Space of Clinical Trials: A Closer Look at New Delivery Models
 
  • What is new and upcoming with patient-centric clinical trial models
  • What locations are transforming the landscape of clinical trials 
  • What are stakeholder viewpoints on the evolving landscape
  • What are some lessons learned from engaging in these new approaches and at these different locations


The traditional dedicated clinical trial site approach has been the gold standard for a long time; however, there is now a growing need to evolve how and where studies are conducted. The delivery models for clinical trials have evolved, including a greater reliance on decentralized trials (DCT) and conducting studies in community settings, to improve the focus on patient access and to increase patient participation. Such an evolution expands the clinical trial to include a more diverse patient population and embrace more effective data collection.


Speakers

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Craig Lipset

Founder

Clinical Innovation Partners


Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance, Vice Chair of the MedStar Health Research Institute, and Vice President of the Foundation for Sarcoidosis. He is Adjunct Assistant Professor in Health Informatics at Rutgers University. Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

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Josh Rose

Vice President

CVS Health Clinical Trial Services


Josh Rose, Vice President, CVS Health Clinical Trial Services (CTS), is a clinical research industry veteran with more than 20 years of experience. He leads the CTS clinical trial delivery business providing patient-first research within designated HealthHUB locations, the home and virtually. Josh is also responsible for CTS strategy and partnerships. Prior to joining CVS Health, Josh was Vice President and Global Head of Strategy for the Research and Development Solutions Business at IQVIA, while also launching and leading its decentralized clinical trial (DCT) and home research nursing service businesses. Josh has an MBA from Duke University and a Bachelor of Science in chemical engineering from the University of Illinois. He lives in Chapel Hill, NC.

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Rosamund Round

Vice President, Patient Innovation Center

Parexel


Roz leads Parexel’s Patient Innovation Center, dedicated to improving patient access to and experiences in clinical trials. In this role she has led the creation of many exciting and successful services, including decentralized clinical trials (DCT), Patient insights, the Community Alliance Network and building a Patient Advisory Council and Parexel Patient Community. As executive sponsor of Parexel’s DEI activities and member of both the PRIDE Committee and ParAbility (focused on reducing barriers to research for patients from the LGBTQ+ community and those with disabilities respectively), Roz is dedicated to pursuing health equity in clinical research.

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Timothy Joy

Executive Director and Head of Strategic Solutions

Pfizer


Executive Director and head of Strategic Solutions at Pfizer. Tim is responsible for leading a global team tasked to identify and develop creative, scalable, technical and process related solutions for unmet global clinical trial needs. Tim has been at Pfizer since 2001, when he joined Development Informatics. In Development Informatics Tim was responsible for implementation and support of Pfizer Electronic Data Capture systems. Since joining Global Product Development in 2006 Tim has held multiple positions with increasing responsibility. Tim represented Pfizer on an Industry council to redesign and implement enhanced versions of Electronic Data Capture, implement clinical and operational data warehouse, and most recently developing Pfizer’s Decentralized Clinical Trial strategy. Tim has been involved in numerous innovative projects and initiatives to redesign Investigator Site Support, implementation and usage of novel Patient Technologies, and creation of Pfizer’s eSource strategy.

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