10 Feb Altruism is Not Enough: The Black Community’s Participation in Clinical Research and Medical Device Product Development
Presented by the MedTechColor Collaborative Community's Product Development and Clinical Research Subcommittee, this virtual panel discussion will address the importance of participant diversity in clinical trials and medical device product development. The webinar will focus on the recruitment and retention of these diverse patient populations, the importance of diverse participation at all levels of the product development lifecycle, and will address the historical injustices in clinical research and medical device product development specific to the Black community. Our panelists will also discuss how the industry aims to address challenges to diverse participation and what solutions are needed to increase Black participation in clinical research.
Registration Link: https://us06web.zoom.us/webinar/register/WN_0sC9q7TYTGG9nU56gSfgaA
Dr. Chris Gibbons
Dr. Gibbons is a digital health innovator, entrepreneur, physician and scientist. His career has been dedicated to solving some of life’s most challenging health problems. These include improving health among racial and ethnic minorities and using digital technologies to improve health beyond the walls of the hospital. He is the Founder and CEO of The Greystone Group, a digital health innovation and transformation firm. The firm works with healthcare clients from the federal government, to large and small healthcare systems as well as silicon valley technology companies to help them understand and thrive in the emerging world of digital and virtual healthcare. Dr. Gibbons is also the Chief Health Innovation Adviser for the Federal Communications Commission’s Connect2Health Task Force, a Visiting Professor, Duke University School of Medicine, a Board Member of Reach Thought Leadership Forum and an Advisory Board member at MetroHealth DC and an adviser to the American Medical Association's Center for Health Equity. Dr. Gibbons is a published author and international speaker. Previously Dr. Gibbons was the Associate Director of the Urban Health Institute at Johns Hopkins and an Assistant Professor of Medicine, Public Health and Health Informatics at Johns Hopkins schools of Medicine and Public Health. Dr. Gibbons attended medical school at the University of Alabama School of Medicine. He then trained in Preventive Medicine and Public Health, completed basic science research training in molecular neuro-oncology and fellowship training in General Surgery all at Johns Hopkins University in Baltimore.
Dr. Michelle Tarver
Dr. Michelle Tarver is the Deputy Director of the Office of Strategic Partnerships and Technology Innovation where she provides co-leadership for all scientific collaborative and emerging technology- related activities at the Center for Devices and Radiological Health (CDRH). This leadership and oversight at CDRH include but are not limited to public health emergency preparedness and response activities, digital health, cybersecurity, conformity standards development and implementation, partnerships, and patient science and engagement. Under her leadership, CDRH is advancing efforts to include underserved and underrepresented populations in the evaluation of medical devices, including people of diverse age, gender, racial, and ethnic backgrounds; those living with rare diseases; and those in rural areas. Dr. Tarver received a B.S. in Biochemistry from Spelman College in Atlanta, GA and completed the M.D./Ph.D. program at The Johns Hopkins University School of Medicine and Bloomberg School of Public Health. Following her internal medicine internship, she completed a residency in ophthalmology with fellowship training in ocular inflammation (uveitis) both at the Wilmer Eye Institute (Johns Hopkins). Board-certified in ophthalmology with an epidemiology doctorate, she has worked on laboratory-based and epidemiological studies, clinical trials, registries, developing patient-reported outcome measures as well as surveys to capture patient preferences. As a dedicated clinician, she continues to care for patients living with uveitis (a rare disease) in Bowie, MD.
Kendal Whitlock is the Head of Digital Optimization, RWE Clinical Trials, with Walgreens Co. This role leverages data assets and partnerships to advance culturally responsive approaches to clinical research. In her role, Ms. Whitlock focuses on digital solutions to drive access and opportunities that are both flexible and convenient for all participants. Ms. Whitlock brings extensive pharmaceutical industry experience to this new role. She holds a Master of Public Health from Columbia University and is working toward her doctorate. She earned a BA with honors from Spelman College. Ms. Whitlock has published in professional/peer-reviewed journals (including requests for translation in multiple languages to serve broader market segments), has worked and been a speaker internationally, is a Co-Lead of the 3C Decentralized Clinical Trials (DCT) Research Curriculum Initiative for the Decentralized Trials Research Alliance (DTRA), is the Chair of the Product Development and Clinical Research Sub-committee for the Med Tech Color Collaborative Community (an FDA-contributing stakeholder network), is an active member of the Personalized Medicine Coalition (PMC) Health Equity Task Force, and is a member of the recently launched NIH (ORWH)-BMGF (WHI) Innovation Equity Forum Steering Committee
Nada joined Experien Group (now Veranex, Inc.) in 2017 after working 12 years at the FDA’s Center for Devices and Radiological Health (CDRH). Since 2010 she had been a CDRH senior science health advisor in the Center Director’s office. Nada combines her deep institutional knowledge with innovative approaches to help companies successfully communicate product information to the FDA throughout the total product life cycle. Leveraging her years of reviewer experience and broad FDA exposure, she develops actionable premarket strategies to guide programs through successful submission. She also orchestrates compliance activity. While at the FDA, Nada led postmarket investigations for OB-GYN devices, wrinkle fillers, tanning devices, breast implants, negative pressure wound therapy (NPWT) devices, and metal-on-metal hip implants, and she applies this knowledge to help companies effectively manage postmarket requirements. At Veranex, Nada helps medical device and combination product manufacturers generate regulatory/clinical road maps for success. Building upon her strong engineering background, she helps companies devise and position product performance testing and/or clinical studies to achieve major milestones.
Victoria Baptiste, BSN, RN, is a nurse living in Baltimore County, Maryland, committed to educating, empowering, and mobilizing patient advocates, healthcare providers, clinicians, researchers, community leaders, and policymakers to increase access to high-quality care for all people. From clinical trial participation and management to serving on the frontlines of the pandemic to increase vaccine confidence and equity, she works to reach her patients in community settings as a traveling nurse. Victoria also serves as Senior Advisor to the Lacks family-led HELA100: Henrietta Lacks Initiative, is honored to serve as a World Health Organization Goodwill Ambassador for Cervical Cancer Elimination, and was humbled to be named to the BBC 100 Women 2022 list recognizing inspiring and influential women from around the world.
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