31 May Learning to Design with Diversity and Inclusion in Mind. A Fireside Chat with Leading Experts Transforming Healthcare Across MedTech Part 2
The MedTech Color Collaborative Community on Diversity and Inclusion presents:
Product Development and Clinical Research – Learning to Design with Diversity and Inclusion in Mind
A Fireside Chat with Leading Experts Transforming Healthcare Across MedTech
Produced by the Product Development and Clinical Research Committee
You're invited! The second of a webinar series to foster a dialogue on best practices to ground product design considerations around the unique needs of the end users, while elevating awareness and understanding regarding the importance of including diverse, and often underrepresented, participants in clinical studies.
Hear from these principle experts driving change in their respective companies – J&J, Edwards, AppliedVR and ResMed.
Join the MedTech Color Collaborative Community and the Product Development and Clinical Research subcommittee to engage in conversation from leading experts transforming healthcare across MedTech.
Check out the first discussion in this series here: https://youtu.be/fRiJwTERXwk
Anthony is Vice President of Preclinical, Clinical, and Medical Affairs for Cardiovascular & Specialty Solutions for J&J Medical Devices. Tony is currently responsible for leading global teams involved in product development, product lifecycle management, clinical evidence generation strategy, trial development and execution, strategic collaborations with external physicians, publications, and evidence dissemination to support the claims and value proposition of key products throughout the development process and post-launch lifecycle. Through strong alignment with colleagues globally and with cross-functional partners in R&D, Global Strategic Marketing, HEMA, Regulatory, and others, Tony ensures that the global strategy and local execution is aligned with the product development, portfolio strategies, quality management, and product marketing strategies to bring solutions that add value to physicians and patients
Dr. Charisse Sparks
Charisse Y. Sparks, MD, has deep experience in medical device use and development, and is also a passionate advocate for DEI&B (Diversity, Equity, Inclusion and Belonging.) As the third Black female fellowship trained Orthopaedic Trauma Surgeon in the country, she has driven meaningful innovation for patients in both clinical practice and industry. While at Johnson & Johnson’s DePuy Synthes Companies, Dr. Sparks influenced the future of medical devices for trauma, extremities, craniomaxillofacial, and animal health (TECA) across the development process – pre-clinical, clinical, and medical. As the Chief Medical Officer of AppliedVR Dr. Sparks continues to accelerate innovation, monitor patient safety, and drive solutions to reduce disparities in access to healthcare solutions. AppliedVR is the proven pioneer in immersive therapeutics where her skills and passions are thriving. Dr. Sparks’ career stands on two pillars of success: 1. Clinical & Medical Expertise – Accelerating innovation while championing value, quality, patient safety, clinical research, and regulatory compliance. 2. Cross-Functional Collaborations – Partnering with all stakeholders to develop global strategies that generate evidence and drive product safety and efficacy. Fostering inclusive environments that encourage idea sharing.
Jaime Wheeler, MBA, CPhT is the Vice President of Clinical Affairs for Transcatheter Heart Valves at Edwards Lifesciences. She has worked in both medical device and pharmaceutical research for over 25 years focusing on the strategy, design, and conduct of clinical research across various therapeutic areas including: Cardiology, Rheumatology, Pain Management, Peripheral Vascular/Embolic Protection and Structural Heart. She has managed multiple divisions and regions including an expatriate assignment in Tokyo, Japan. She was the Clinical lead on three successful Merger and Acquisition deals, the largest worth $1.5B. Ms. Wheeler holds two Bachelor of Science degrees, a Master of Business Administration degree, she was a prior Virginia State Emergency Medical Technician (EMT-B) and is a Certified Pharmacy Technician (CPhT). She currently sits on the AdvaMed Working Group for Women in Cardiovascular Device Trials, is a founding member of the MedTech Color Collaborative Community on Diversity and Inclusion in Medical Device Product Development and Clinical Research, and is a Board Member for OneOC in Santa Ana, California.
Kimberly L. Sterling, Pharm.D., M.S. is the Vice President of Health Economics & Outcomes Research (HEOR) at ResMed. Kimberly serves as a key leader within the Medical Affairs organization, responsible for the development of scientific evidence that demonstrates the value of ResMed device and digital solutions, with a significant focus on research that supports gaining, maintaining, and expanding patient and provider access. Additionally, she engages as an influential thought leader with external industry organizations that are working to empower diverse communities and eliminate health inequities. Prior to joining ResMed in 2019, Kimberly held a variety of positions at Eli Lilly & Company and Sanofi, focused on HEOR strategy & implementation, scientific communication to payers and engagement with health technology assessment organizations. She has 20 years of HEOR experience within the pharmaceutical and medical device industries. Kimberly received her Doctor of Pharmacy degree from Butler University then went on to receive her Master of Science degree in Pharmaceutical Economics and Policy at the University of Southern California. In addition to her current sleep and respiratory medicine research at ResMed, she has published HEOR studies for multiple other diseases including bipolar disorder, cardiovascular diseases, diabetes, and autoimmune diseases in peer-reviewed journals.
Nada joined Experien Group (now Veranex LLC) in 2017 after working 12 years at FDA’s Center for Devices and Radiological Health (CDRH). Since 2010, she had been a CDRH Senior Science Health Advisor, serving as an expert consultant and senior advisor in the Center Director’s office. Nada combines her deep institutional knowledge with innovative approaches to help companies successfully communicate product information to 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 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 Experien Group, Nada helps medical device and combination product manufacturers generate regulatory/clinical roadmaps 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.
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