K. Dev Verma

Dr. Fife completed a Family Medicine residency at the University of Texas, Southwestern in Dallas followed by a two-year Fellowship in Undersea and Hyperbaric Medicine at Duke University. Until 2013 she was a Professor of Medicine at the University of Texas Health Science Center, Houston where she initiated the Memorial Hermann Center for Wound Healing and Hyperbaric Medicine and the Lymphedema Center. She is now a Professor of Geriatrics at Baylor College of Medicine in Houston. She serves as the Chief Medical Officer of Intellicure, LLC, a health information technology company, and the Executive Director of the U.S. Wound Registry, a non-profit organization recognized by CMS as a qualified clinical data registry (QCDR). The USWR develops wound relevant quality measures and helps wound care practitioners meet the requirements of Medicare’s Quality Payment Program. She currently serves on the boards of the Alliance of Wound Care Stakeholders (past co-chair), and CLI Global Society, and she is on the American Diabetes Association's Amputation Prevention Coalition. She is co-chair of the Real World Evidence Work Group for the Wound Care Collaborative Community. Past board activities include the American Academy of Wound Management, the Association for the Advancement of Wound Care, and the American Professional Wound Care Association. She has authored more than 100 peer reviewed articles and book chapters as well as editing 3 textbooks.Her current focus is the use of real world data to find what works in the treatment of chronic wounds.

Dr. Lucian Vlad is an Associate Professor and Director of the Wound Care and Hyperbaric Fellowship at Atrium Health Wake Forest Baptist in Winston-Salem, NC. He is board-certified in Family Medicine, faculty in the Plastic & Reconstructive Surgery Department and has practiced full time in a tertiary wound care and hyperbaric center since 2012, with a clinical focus on limb salvage and complex chronic wounds, including diabetic foot ulcers, venous leg ulcers, and pressure injuries. His academic interests span compression therapy, negative pressure wound therapy, collagen scaffolds and other advanced biologics, low-intensity laser and hyperbaric oxygen therapy, and clinical nutrition in wound care, and he is an active educator and frequent national and international lecturer.
Outside clinical work his advocay work includes ABWMS (American Board of Wound Medicine & Surgery) as member of the Board of Directors, WCCC (Wound Care Collaborative Community) as Chair of the Real Word Evidence Workstream, AAWC (Association for the Advancement of Wound Care) as Co-Chair of the Education Commitee and WHS (Wound Healing Society) member of Edducation Commitee.

Dr. Dove is the Director of Clinical Research at the Department of Orthopaedics, Division of Podiatry at UT Health Science San Antonio. Dr. Dove has served as a Principal Investigator in over 50 clinical trials, over the past twenty years. She is currently establishing a research program, in which her colleagues, residents and students will be actively engaged.

She earned the Degree of Doctor of Podiatric Medicine at California College of Podiatric Medicine in San Francisco, CA, She also completed her Post Graduate Training at The University of Texas, Health Science Center in San Antonio, Texas under the tutelage of Dr. Lawrence Harkless. She completed a surgical fellowship at North General Hospital, in New York, NY.

Dr. Dove was previously in private practice in Las Vegas. Her private practice combined industry sponsored research and general podiatry, with a focus on wound care. Before opening her practice, Dr. Dove was the director of podiatry at the Diabetic foot and Ankle Center - Hospital for Joint Disease - NYU. Concurrently, she served as the sub-investigator for multiple Phase I-IV clinical trials.

Dr. Dove has multiple publications, including the Lancet and other peer-reviewed journals.

Dr. Teresa L.Z. Jones is the Program Director for Diabetes Complications at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health in Bethesda, Maryland. Her research program at NIDDK is focused on basic science, translational and clinical studies on the diabetic lower extremity to improve our understanding of diabetic neuropathy and wound healing and the prevention and treatment of diabetic foot ulcers. She is the Project Scientist for the NIDDK Diabetic Foot Consortium whose initial goal is to validate prognostic, monitoring and diagnostic biomarkers for diabetic foot ulcers that can be used for clinical decision-making and therapy development. She is a board-certified endocrinologist who received her medical degree from Northwestern University Feinberg School of Medicine, completed her Internal Medicine residency at the University of Minnesota and her Endocrinology and Metabolism fellowship at the National Institutes of Health. She is the endocrine consultant for Whitman-Walker Health in Washington, DC.

John C. Lantis II, MD, is currently the site chief and professor of Surgery at Mount Sinai West Hospital and the Icahn School of Medicine in mid-town Manhattan, where he practices as a senior vascular surgeon. On January 1, 2024, he was named the director of advanced wound care, Department of Surgery, Mount Sinai Healthcare System. 
In 2023, he became the editor in chief of the journal WOUNDS; a Clinical Compendium. He is the past president of the New York Vascular Surgery Society, a founding member of the American Board of Wound Medicine and Surgery, and the Vascular Study Group of New York. 

Dr Painter-Hanson is a passionate, strategic leader and global operating executive with comprehensive expertise in transforming clinical research programs into data-driven commercial opportunities with impactful scientific output. Extensive experience in leading global medical and clinical affairs divisions for both industry and non-profit organizations, and management of and within clinical research organizations. Dr Painter-Hanson is a strong and effective collaborator with business partners, regulatory affairs, clinical operations, quality assurance, and R&D. 

Dr Painter-Hanson is an experienced leader of high-performing teams to achieve impactful evidence generation plans and successful global implementation in complex matrix environments. 

As a clinical assistant professor for the Department of Health at the University of Washington, Dr Painter-Hanson lectures, publishes internationally, and is a guest speaker on clinical epidemiology, clinical studies, and related topics at international scientific conferences. With a passion for clinical research, having published widely on topics related to clinical investigations in orthopedics and trauma, Dr Painter-Hanson is a medical doctor with 6 years of practicing experience in different specialties and health care systems. 

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. 

Dr. Windy Cole, DPM, CWSP, FACCWS, FFPM RCPS (Glasg)

Dr. Windy Cole is a double board-certified podiatric physician and internationally recognized wound care expert with more than 24 years of clinical experience in limb preservation and advanced wound management. She serves as Adjunct Professor and Director of Wound Care Research at Kent State University College of Podiatric Medicine and is Chief Research Officer for Capsicure Clinical Research Organization.
As the founder of Cole Collaborative Consulting, Dr. Cole partners with biotech and medical device companies to develop evidence generation strategies, strengthen market access pathways, and deliver high-quality scientific and medical communications.
A leader in the integration of emerging technologies into wound care, Dr. Cole has directed numerous clinical trials and contributes her expertise to advisory boards across the biotech and device sectors, providing insight on FDA strategy, clinical trial oversight, medical monitoring and protocol development with real world implementation.
A sought-after speaker at national and international symposia, she is dedicated to advancing patient outcomes through evidence-based practice, interdisciplinary collaboration, and innovation in the management of complex, hard-to-heal wounds.

Dr Holly Franzen-Korzendorfer is a clinical assistant professor of Physical Therapy at Marist University in Poughkeepsie, NY. She holds a PhD in Physical Therapy from Nova Southeastern University, a Master of Physical Therapy from Chapman University, and a BA from Iowa State University. She is also a Certified Wound Specialist credentialed by the American Board of Wound Management (ABWM).  

Dr Korzendorfer’s experience in wound management includes work in various care settings across the United States, along with executive roles in the durable medical equipment and wound care industries, where her responsibilities included education, research, regulatory, and product development. At Marist, she teaches critical inquiry, clinical medicine, and integumentary content. In addition to her teaching responsibilities, Dr Korzendorfer is both the coordinator of and a mentor for the DPT doctoral projects and is the recipient of two Education Innovator Awards from the Physical Therapy Learning Institute (PTLI).   

Dr Korzendorfer has published original research and review articles, presented nationally, and serves as a peer reviewer. In addition to her involvement with the Wound Care Collaborative Community (WCCC) Tools Workgroup, she is a member of the American Physical Therapy Association’s (APTA’s) Specialization Academy of Content Experts (SACE) for wound management and of the Academy of Clinical Electrophysiology and Wound Management’s (ACEWM) Wound Management Residency Task Force.   

Robyn Bent, MS, RN, is the director of the Patient-Focused Drug Development (PFDD) Program in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). The PFDD program is an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Ms. Bent also serves as an FDA representative to the Management Committee of the International Council for Harmonisation. 

Prior to joining the FDA, Ms. Bent held several positions at the National Institutes of Health. She has a background in pediatric oncology nursing, extensive experience in clinical trial design and oversight, and continues to practice as a registered nurse. Ms. Bent earned her Bachelor of Science in Nursing from The Catholic University of America and her Master of Science degree from the George Washington University.

Gabriele Brambilla, MBA, is Alira Health’s Chief Executive Officer and Co-Founder. As CEO, Gabriele evangelizes Alira Heath’s mission—humanizing healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance.  

In 2018, he co-founded the MetroWest Life Sciences Network, a regional collaboration of healthcare and life science-based organizations, municipalities, and economic and business development organizations in Boston’s MetroWest, where Alira Health is headquartered. As the network’s current chairman, Gabriele fosters collaboration, innovation, and entrepreneurship in this critical life sciences ecosystem.  

He is also on the Board of Directors of MassMedic, EnlightenVue, WoundForce, Firefly Innovations, X-Cor Therapeutics, and SMOC and is the co-founder of Inter Academy MetroWest Boston soccer program.  

Gabriele began his career in pharmaceuticals, working for an Italian firm based in Shanghai, and developed his deep industry expertise through roles with medical device and digital health technology practices.  

He holds a BA in Political Science from the University of Pavia, a master’s degree in International Affairs from the I.S.P.I., and an MBA from Post Graduate SDA Bocconi in Milan, Italy. 

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

Dr. Alison J. Garten is a Board-Certified Podiatric Surgeon, Certified Wound Care Physician and a Certified Pedorthist.
She received her Bachelor of Science in Biology at East Carolina University and then went on to complete her Doctorate of Podiatric Medicine at Temple University School of Podiatric Medicine in Philadelphia, PA. Dr. Garten completed her residency at Washington Hospital Center/Georgetown University in Washington, DC.
She currently lives in Charlotte, NC and is a wound care panel physician at a Tenet Hospital at Piedmont Medical Center. She is past director of medical services at Charlotte Limb Preservation and Diabetic Foot Center. Dr Garten is also a professional speaker who often is traveling educating others on topics such as limb salvage and wound care management. Lastly, she serves as a consultant/advisor for several wound care companies and serves as a chief medical advisor for an international wound care company providing education and guidance on best practices for the industry.
She is past President of the American Association for Women Podiatrists along with serving on the American Podiatric Medical Education Task Force for the National Board of Podiatric Medical Examiners. She is a past board member of the District of Columbia Board of Podiatry which was an appointed position by the Mayor. Dr. Garten was recently named one of the most influential podiatrists by podiatry management magazine.

Her motto is “Your Health is Your Wealth”. This is what drives her daily to be a compassionate physician.

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 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.