Time's Up: Truly Servicing Diverse Populations in Clinical Trials

Luther T Clark, MD, FACC, FACP is Deputy Chief Patient Officer and Global Director, Scientific Medical and Patient Perspective (SMPP) in the Office of the Chief Patient Officer (OCPO) at Merck. In this role, he is responsible for (1) gathering internal and external scientific and medical information to assist with decision-making at the highest levels; (2) collaborating across Merck to increase the voice of patients, directly and indirectly in decision-making; (3) collaborating with key internal and external stakeholders in development of a systematized approach for collecting and incorporating patient insights across the patient journey and product lifecycle; and (4) representing Merck externally, expanding bi-directional exchange with key patient and professional leaders and organizations.Dr Clark leads Merck’s Patient Insights Team, is co-leader of the team that champions Health Care Equities (including promotion of health literacy and research diversity) and chairs the Patient Engagement, Health Literacy & Clinical Trials Diversity Investigator Initiated Studies Research Committee.Prior to joining Merck, Dr Clark was Chief of the Division of Cardiovascular Medicine at the State University of New York Downstate Medical Center (SUNY Downstate) and founding Director of the National Institutes of Health (NIH) funded Brooklyn Health Disparities Research Center.Dr Clark earned his Bachelor of Arts degree from Harvard College and his Medical degree from Harvard Medical School. He is a Fellow of the American College of Cardiology (FACC) and the American College of Physicians (FACP), and a past member of the Board of Directors of the Founders Affiliate of the American Heart Association. He is a nationally and internationally recognized leader in cardiovascular education, clinical investigation, cardiovascular disease prevention, and health equity. He has authored more than 100 publications and edited and was principal contributor to the textbook Cardiovascular Disease and Diabetes (McGraw-Hill).Dr Clark has received numerous awards and honors, including the Harvard University Alumni Lifetime Achievement Award for Excellence in Medicine. He is the current President of the Health Science Center at Brooklyn Foundation (HSCB Foundation), SUNY Downstate Medical Center.

Fernanda Copeland, MS, RD, CDE, CSN is a global patient affairs leader with extensive experience in clinical patient care, patient and group education, nonprofit and biotech industries. She was previously at Intarcia Therapeutics where she was responsible for creating the patient advocacy function and instrumental in expanding the professional and clinician engagement functions. While at Intarcia, Ms Copeland also built the disease state and product curriculum and training for the medical and commercial pre-launch teams.Prior to joining the biotechnology industry, Ms Copeland dedicated the first ten years of her career working as an inpatient and outpatient clinical dietitian, working with patients and families to help educate and manage serious medical conditions. Ms Copeland holds a Bachelor of Science in dietetics in nutrition from Florida International University, a master’s degree in community nutrition from Simmons’ University and is a PhD candidate in Health Services at Walden University. Ms Copeland leads the Global Patient Advocacy & Engagement function at AVROBIO and is responsible for patient inclusion from pre-clinical development to commercialization of AVROBIO’s investigational gene therapies. She serves on the diversity and inclusion subcommittee at MassBio and is a member of the patient advocacy in life sciences advocacy leaders’ sub-committee. She is the founder and president of the Friends of North Scituate Village, a non-profit organization that has its goal to support small businesses in her community. On her spare time, she enjoys spending time with her westie Finn, kayaking, playing volleyball and being outdoors.

Quita Highsmith is Vice President and Chief Diversity Officer at Genentech, a member of the Roche Group. Ms Highsmith is a leader with almost three decades of experience in the biotech industry. She has co-authored several publications regarding health disparities including the Journal of Oncology Practice and Contemporary Clinical Trials. She frequently presents at national and international forums and has co-authored abstracts at peer-reviewed conferences, including the American Association of Cancer Research’s conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved. She is responsible for leading Genentech’s Diversity and Inclusion strategy, including recruiting, retaining, and developing diverse talent, investing in initiatives to support science education, and addressing barriers in clinical trial participation via Advancing Inclusive Research™. Ms Highsmith is well-known in the biotech industry for being an award-winning visionary and promoting patient inclusion. In 2021, she received the Trailblazer Award from Lead360 and was named Top 100 Diversity Officers by The National Diversity Council. In 2020, was recognized as one of the 100 Most Influential Women in Business by the San Francisco Business Times. Quita is committed to community service and serves on several local non-profit boards including, The Delta San Francisco-Peninsula Foundation Board and Leadership Council San Mateo County. Before her role as Chief Diversity Officer, Ms Highsmith held leadership roles in Government Affairs and the Commercial organizations at Genentech and Sanofi-Aventis. Ms Highsmith received her Master of Business Administration from the Johnson School at Cornell University and her undergraduate degree from the University of Kentucky. 

Jeanne Regnante is a National Expert, Health Equity and Inclusion & Founder of Patient 3i, LLC. Most recently, she was the Chief Health Equity and Diversity Officer at the LUNGevity Foundation. In this role, Ms Regnante’s primary objective was to secure the sustainable engagement of vulnerable lung cancer communities by working with trusted community-based organizations and health care professionals to achieve health equity and equalize disparities for all. Ms Regnante oversaw the strategic design, development and communication of key diversity, equity and inclusivity related policies programs and partnerships as well as led initiatives focusing on the social determinants of health. Previous to this position, Ms Regnante was Senior Vice President of Community Engagement for National Minority Quality Forum where she chaired the Diverse Cancer Communities Working Group (CWG) who worked together to optimize cancer care, treatment and inclusion to clinical trials for racial and ethnic minorities and medically underserved cancer populations. She has enjoyed her 30+ work experience at Merck & Co. which includes Head of Global Patient Engagement, Chief of Staff to Merck’s Chief Medical Officer, Head of Scientific Affairs Operations and led the company wide strategy focused on diversity and inclusion in clinical research. Ms Regnante’s experience includes: Founding member of Patient Focused Medicines Development (PFMD), Co-leader for two EU Innovative Medicines Initiative (IMI)focused on global standards for patient engagement in medicines development. Ms Regnante is currently a contributor to the American Cancer Society-Cancer Action Network (CAN) Roundtable on Barriers to Clinical Trials, a member of the American Cancer Society’s Patient Navigation Roundtable and contributes to the steering committee for IVI’s (Innovation and Value Initiative) Patient Advisory Council. Jeanne is CEO and Co-Founder of Patient3i, LLC a novel and quality approach to ensuring patient insights get to innovators in healthcare. Ms Regnante has been invited to partner on research grants with academic partners and has authored several peer reviewed publications with leaders in the field of health equity.

Ash Rishi is founder and CEO of COUCH Health, a global creative health engagement agency that serves to make health research inclusive. Its focus covers a range of solutions, including patient insights and engagement through to recruitment and retention within health research. Mr Rishi has over 15 years of experience in the industry, navigating the diverse needs of big pharma through to smaller biotech companies. With experience that covers the full medicine lifecycle, from pre-clinical to lifecycle management, his passions lay in working to make research more inclusive and has founded Demand Diversity a non-profit in 2023.

Angela Rochelle, Account Director, Head of Diversity Initiative in Clinical Trials, is the leading advocate for diversifying patient representation in Clinical Trial Experience (CTE) at Langland, where she brings her considerable expertise to the agency’s established legacy of excellence in clinical trial recruitment and experience. Prior to joining Langland, Angela spent time at some of the country’s leading multicultural advertising agencies working with high-profile clients such as Unilever, General Motors, Walmart, and Proctor & Gamble. Her 20+ years of industry experience also involved successful roles in healthcare advertising account management, including recent clinical research and patient advocacy work with Bristol Myers Squibb and Merck. As part of her work at Langland, Angela collaborates with the agency’s established clinical trial inclusivity taskforce—a team committed to designing and deploying clinical trial communications that proactively address common barriers experienced by underrepresented communities, and advising on best practices throughout the agency’s US, UK, and Australia offices.