Yu-Chieh Chiu

Dr Vickie R. Driver is System Wide Medical Director of the Wound Care and Hyperbaric Centers at INOVA Healthcare in the DC Metropolitan area and is Professor, University of Virginia, School of Medicine. She is also Fellow, Royal College of Physicians and Surgeons-Glasgow, PM and Inaugural Fellow, Assoc for the Advancement of Wound Care, FAAWC. Dr Driver has accepted the position as Chair, Board of Directors for the Wound Care Collaborative Community, an important collaboration with the FDA, CMS and the NIH and received a prestigious honor of receiving The Robert A. Warriner III, MD Memorial Award. She is Board Certified with American Board of Podiatric Surgeons and is a Fellow at the American College of Foot and Ankle Surgeons, licensed in VA, MA, and RI. Her career has a special emphasis on wound healing and limb preservation, and she is proud to be an outspoken ambassador for improving care to patients that face

Joseph Rolley is Principal at JTR Business Consulting, LLC located in Doylestown, Pennsylvania providing market access and business consulting services to the medical technology industry. Joe has over 40 years of experience in the medical device industry spanning sales, marketing, business development, reimbursement, government affairs and health policy. Prior to his current consulting role, he was Vice President, Market Access and Professional Education at Integra Life Sciences in Princeton, New Jersey. At Integra, he led teams that created and implemented market access and health economic strategies that opened government and commercial payer access for new and in-licensed regenerative technologies. He also led the company’s surgeon education and cadaver lab program. Prior to Integra, he served for 30 years in business roles of increasing responsibility at Bristol-Myers Squibb and Convatec.

He has been actively involved in industry and professional associations throughout his career. He currently serves the Wound Care Collaborative Community as Treasurer and Board Member. He represented the wound care industry at the AdvaMed trade association where he co-led the establishment of the Wound Healing & Tissue Regeneration Sector and served as working group chair for over 15 years. He also chaired the Corporate Advisory Council of the National Pressure Injury Advisory Panel (NPIAP) and was the 2009 recipient of the Thomas Stewart Founder’s Award for his public policy support.

Mr. Rolley holds a B.S. degree in Biochemistry and a M.S. degree in Industrial Administration, both from Purdue University. He and his wife, Theresa, reside in Doylestown, Pennsylvania, USA.

Dr Yu-Chieh Chiu is an assistant director at the FDA's Center for Devices and Radiological Health (CDRH). Joining the agency in 2016, he has served in CDRH/OPEQ/OHT4 since August 2023. Dr Chiu oversees medical device reviews with a focus on wound care products, having reviewed and signed off on over 500 premarket and postmarket submissions while leading the development of wound device guidance documents and participating in interagency projects. He serves as the Wound Care Collaborative Community liaison, where he contributes his expertise to advance wound care device regulation and foster cross-functional collaboration across stakeholders. His roles at FDA have included Team Lead for OHT1/THT1A2 (October 2021 - August 2023) and Lead Reviewer for OHT4/TH4B4 (January 2018 - October 2021), as well as several acting leadership positions across different offices. 

Throughout his FDA career, Dr Chiu has reviewed over 700 submissions across diverse device categories, including wound care devices, plastic surgery devices (dermal fillers and microneedling devices), ophthalmic devices (contact lenses and dry eye devices), and orthopedic devices. He is recognized as a biocompatibility expert across CDRH, providing consultation on biocompatibility issues for various device types and training reviewers to conduct independent assessments. Dr Chiu has contributed to regulatory policy development, leading the drafting of negative pressure wound therapy guidance and participating in FRO preamble preparation/finalization, while also serving as a technical expert for ASTM F04.43 Cells and Tissue Engineering Constructs. Dr Chiu is knowledgeable about FDA regulations, including the FD&C Act, 21st Century Cures Act, and device-specific guidance documents. His combination of scientific expertise, regulatory knowledge, and proven leadership in supervising review teams and mentoring staff has made him an invaluable contributor to FDA's mission of protecting public health through effective medical device regulation. 

Dheerendra Kommala, MD, is chief medical officer at ECRI, responsible for ECRI’s Medical Office. He joined ECRI in 2019 as Chief Strategy Officer responsible for setting the organization’s strategic direction. 

Dr Kommala brings more than 25 years of experience as an academic clinician, researcher, and chief medical officer. He successfully introduced new products and services to markets throughout the world by working collaboratively with major health systems, industry leaders, clinicians, and patients. Throughout his career, he has been a vocal advocate for patient safety and a visionary leader managing large teams. 

Prior to joining ECRI, Dr Kommala was global vice president of medical affairs for Baxter Healthcare. Previous experience included working as chief medical officer/global vice president of medical affairs for ConvaTec and as associate medical director of Global Pharmaceutical Research for Renal Care, Abbott Laboratories. 

Dr Kommala received his initial medical training in India and completed a fellowship in nephrology at the University of Missouri, Columbia School of Medicine.

Cristin Taylor is a senior medical affairs leader with extensive experience advancing innovation, clinical strategy, and evidence generation in advanced wound care. She is currently the senior director of Medical Affairs for Advanced Wound Care at Convatec, where she supports the development and clinical integration of technologies addressing complex and chronic wounds. 

Dr Taylor brings a multidisciplinary background spanning industry, clinical science, and translational research, with prior leadership roles in clinical and medical affairs at Gelmetix and as founder of Alclinix LLC. Her experience also includes senior clinical science and advisory positions at PathAI, Beckman Coulter Diagnostics, and Smith & Nephew as well as earlier clinical and academic appointments at leading health care institutions. 

She holds a Doctor of Physical Therapy from the University of Miami, a Master of Science in Health Sciences from The George Washington University, and a Certificate in Finance for Senior Executives from Harvard Business School Executive Education. Her work focuses on bridging clinical evidence, regulatory strategy, and commercialization to accelerate meaningful innovation in wound care. 

Dev is a plastic and reconstructive surgeon with 5+ years of FDA regulatory experience and specialized expertise in wound healing product development, combining clinical wound care expertise with comprehensive regulatory oversight of chronic wound therapeutics across the complete development lifecycle.

As FDA Medical Officer in CDER Division of Dermatology from 2020 - 2025 and Chair of the FDA Inter-Center Wound Healing Working Group, Dev led cross-agency regulatory strategy for wound healing products and organized a landmark 2022 FDA Wound Healing Scientific Workshop with 330+ stakeholders. He provided scientific oversight for innovative wound therapeutics from Pre-IND through NDA/BLA approval, with expertise in clinical trial design, endpoint validation, real-world evidence integration, and regulatory pathways for wound healing therapeutic indications. In addition, he served as CDER representative to the Wound Care Collaborative Community (WCCC). His clinical background includes managing patients with nonhealing chronic wounds and performing complex wound reconstruction surgeries, providing real-world understanding of treatment challenges and unmet medical needs.

In his new role as Senior Medical Director, Clinical Development at Oruka Therapeutics he is responsible for execution and operational oversight of clinical trials for psoriasis and hidradenitis suppurativa, ensuring high-quality data generation to support the safety and efficacy of pipeline products.

Dr Rachana Visaria is the Acting Director of the Division of Plastic and Reconstructive Surgery Devices within the Office of Surgical and Infection Control Devices (OHT4) at the FDA's Center for Devices and Radiological Health (CDRH). She holds a PhD in Bioengineering and is a Regulatory Affairs Certified (RAC) professional with over 10 years of experience in regulatory science, policy development, and total product lifecycle (TPLC) oversight. Her regulatory expertise spans diagnostic, monitoring, screening, and therapeutic products, including wound care devices, surgical implants, respiratory devices, digital health technologies, and neurostimulators. She has directed the review and evaluation of complex regulatory submissions including PMAs, De Novos, breakthrough device designations, and Medical Device Development Tool (MDDT) requests. She has authored numerous peer-reviewed publications and book chapters, including recent work on digital health regulation, and serves as FDA's primary liaison to several international standards working groups. Her commitment to regulatory excellence, stakeholder collaboration, and patient-centered innovation has been recognized through multiple CDRH awards. 

Alisha Oropallo, MD FACS, FSVS, FABWMS is a Professor of Surgery at the Donald and Barbara Zucker School of Medicine at Hofstra University/Northwell and the Feinstein Institutes for Medical Research. She practices as the Director of the Comprehensive Wound Healing Center at Northwell Health and Program Director of the Wound and Burn Fellowship program at Northwell Health. Dr. Oropallo completed her residency in Vascular Surgery at Boston University Medical Center and her General Surgery residency at Maimonides Medical Center, NY. She has been the lead investigator on multiple clinical trials, published papers, and has been invited to present lectures in wound healing globally. She is interested in education, research, and quality measures in tissue regeneration to help improve patient outcomes.

Dr. Robert Snyder is Dean at Barry University School of Podiatric Medicine. He also serves as Director of Clinical Research at the University. He is certified in foot and ankle surgery by the American Board of Podiatric Surgery and is also a board certified wound specialist physician. Dr Snyder is past-president of the Association for the Advancement of Wound Care and past-president of the American Board of Wound Management, the certifying body for Wound Care Specialists. In addition to his doctorate, he holds an MSc in Wound Healing and Tissue Science from Cardiff University School of Medicine. His expertise at Cardiff, Wales, was further acknowledged by appointment as Honorary Visiting Professor. Dr. Snyder has completed an MBA in Health Management. He is a key opinion leader and sought after speaker, lecturing extensively throughout the United States and abroad. He has been recognized with many awards for his contribution to the profession. Dr. Snyder has published several book chapters and over 165 papers in peer reviewed and trade journals on wound care. He serves as Associate Editor for JAPMA and is on the editorial advisory boards of Wound Management & Prevention, Wounds and Podiatry Management. He is also a periodic reviewer for the Lancet and NEJM. He has been a Principal Investigator on more than 50 randomized controlled trials for innovative wound healing modalities and therapies. In 2018, Dr. Snyder was inducted as a Faculty Fellow of the Royal College of Physicians & Surgeons (Glasgow).

Dr Yu-Chieh Chiu is an assistant director at the FDA's Center for Devices and Radiological Health (CDRH). Joining the agency in 2016, he has served in CDRH/OPEQ/OHT4 since August 2023. Dr Chiu oversees medical device reviews with a focus on wound care products, having reviewed and signed off on over 500 premarket and postmarket submissions while leading the development of wound device guidance documents and participating in interagency projects. He serves as the Wound Care Collaborative Community liaison, where he contributes his expertise to advance wound care device regulation and foster cross-functional collaboration across stakeholders. His roles at FDA have included Team Lead for OHT1/THT1A2 (October 2021 - August 2023) and Lead Reviewer for OHT4/TH4B4 (January 2018 - October 2021), as well as several acting leadership positions across different offices. 

Throughout his FDA career, Dr Chiu has reviewed over 700 submissions across diverse device categories, including wound care devices, plastic surgery devices (dermal fillers and microneedling devices), ophthalmic devices (contact lenses and dry eye devices), and orthopedic devices. He is recognized as a biocompatibility expert across CDRH, providing consultation on biocompatibility issues for various device types and training reviewers to conduct independent assessments. Dr Chiu has contributed to regulatory policy development, leading the drafting of negative pressure wound therapy guidance and participating in FRO preamble preparation/finalization, while also serving as a technical expert for ASTM F04.43 Cells and Tissue Engineering Constructs. Dr Chiu is knowledgeable about FDA regulations, including the FD&C Act, 21st Century Cures Act, and device-specific guidance documents. His combination of scientific expertise, regulatory knowledge, and proven leadership in supervising review teams and mentoring staff has made him an invaluable contributor to FDA's mission of protecting public health through effective medical device regulation. 

Brian Gillette, PhD, is a biomedical engineer specializing in clinical and translational research in advanced therapy modalities, clinical data science, and machine learning/artificial intelligence, with extensive experience working with health systems, pharma, biotech, and medical device companies on clinical trials and real-world evidence. At Droice Labs, he helps biopharma teams drive highly efficient evidence generation for FDA, CMS, EMA, and other regulatory approvals by combining modern clinical trial study designs with regulatory-grade AI middleware. Prior to Droice, Brian was an Assistant Professor at NYU Long Island School of Medicine in the Departments of Surgery and Foundations of Medicine, where he led research in regenerative medicine and wound healing.

Francis James, SOC, co-chair of the WCCC Tools Work Group, brings an interdisciplinary background spanning visual communication, imaging technology, and clinical standards. With over two decades as a filmmaker and cinematographer in the International Cinematographers Guild (ICG) and Society of Camera Operators (SOC), he applied rigorous principles of accuracy, reproducibility, and verification to healthcare after recognizing the risks of inconsistent clinical imagery. He founded TRUE-See Systems, authoring foundational patents for color calibration software to improve consistency and reliability in medical photography, 3D imaging, and video. James now focuses on research with wound care physicians, researchers, and engineers to address image quality and AI deployment, as photographs increasingly serve as clinical data. As a volunteer co-chair, he guides the evaluation of emerging digital tools and contributes to consensus-driven guidance on imaging quality and validation, reflecting his commitment to collaborative standards, clinician education, and advancing patient care through practical innovation.

Randy Schwartz is principal at Med Market Consultants, LLC, a Georgia-based consultancy providing strategic commercialization, market access, and medical affairs support to the medical device, biologics, and pharmaceutical industries, with a specialized focus on advanced wound care. Randy brings more than 40 years of leadership experience spanning marketing, business development, clinical affairs, and global market strategy. Prior to founding Med Market Consultants, he held senior US and Global roles at leading organizations including Mölnlycke Health Care, where he helped establish category leadership across their portfolio and led the introduction of novel wound, biologic, and dermatologic technologies to the U.S. and Global markets. Throughout his career, Mr. Schwartz has successfully launched and scaled products across the United States, Europe, and Asia, leveraging his expertise and substantial network. A recognized thought leader in the wound care community, he has collaborated with global innovators, clinicians, and policymakers to advance science-based solutions that improve patient outcomes and drive sustainable access to care. Randy remains actively involved in professional initiatives supporting education, innovation, and industry collaboration and is a current Board Member of the FDA’s Wound Care Collaborative Community. Randy holds a BA from the University of South Florida and an MBA from the University of Miami. He is a passionate leader dedicated to continuous improvement and to helping individuals achieve their professional ambitions and goals. 

Dr. Thomas E. Serena MD FACS FACHM MAPWCA, Founder and Medical Director of The SerenaGroup®, a physician-owned contract research organization (CRO) that conducts clinical trials in a broad range of diseases related to wound healing. To promote clinical research in the burgeoning field of wound care, SerenaGroup® established a site management organization (SMO) that assists hospitals and clinics in establishing compliant research programs. In addition, SerenaGroup® provides consulting services for advanced wound and hyperbaric centers across the globe. Dr. Serena completed his residency in Surgery at Penn State and maintains board certification in Surgery.

Dr. Serena operates advanced wound care and research centers across the United Sates and globally. He has been the lead or Principal investigator in over 150 clinical trials, including diagnostics, antimicrobial dressings, growth factors, and CAMP therapy. He is one of the world leaders in clinical research, quality improvement, and real-world data collection. He holds numerous patents on wound care devices and dressings.
He is recognized internationally as an expert in the field of wound healing: He has more than 350 published papers and has given more than 2500 invited lectures throughout the world. He has been a member of the Board of Directors of the Wound Healing Society He is a Past President of the Association for the Advancement of Wound Care (AAWC) and American Professional Wound Care Association. He is the Vice-President of the International Surgical Wound Complication Advisory Board (ISWCAP). In 2024, he founded the international Post-Acute Wound Society (iPAWS).
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Dr William H. Tettelbach is a physician leader specializing in wound care, infectious diseases, and hyperbaric medicine, with a career focused on chronic wound management, limb preservation, and the evidence-based use of cellular, acellular, and matrix-like products (CAMPs). He serves as chief medical officer of RestorixHealth, providing clinical oversight across a national network of more than 300 wound care and hyperbaric centers. Dr Tettelbach is president of the American Professional Wound Care Association (APWCA) and president of the Wound and Hyperbaric Association, advancing clinical standards, education, and patient access initiatives. He advises the Centers for Medicare & Medicaid Services (CMS) as a member of the Hospital Outpatient Payment Panel and holds academic appointments at Duke University School of Medicine and Western University of Health Sciences. Recognized nationally and internationally for his work at the intersection of regenerative medicine, outcomes research, and health economics, he contributes to guidelines and policy frameworks that promote high-quality, sustainable wound care.