Thomas Serena

Arati Bhosale (Dr.B)-Global Director of Regulatory Affairs, Serena Groups Inc.
Arati Bhosale is a globally recognized healthcare innovator and the Global Director of Regulatory Affairs at Serena Groups Inc., bringing over 17 years of expertise at the intersection of clinical research, regulatory strategy, and health technology. Her career has been defined by a singular mission-transforming rigorous science into real-world patient impact, at scale.
Arati has led and optimized clinical trial operations across multiple phases and international markets, navigating complex regulatory frameworks including FDA, EMA/MDR, and ICH guidelines with both precision and agility. In the wound care space, her regulatory acumen and operational discipline translate directly into accelerating therapy development, ensuring compliance, and improving patient outcomes without sacrificing speed or quality.
A visionary in HealthTech, Arati has built AI-driven platforms designed to streamline clinical workflows and turn complex datasets into confident, actionable decisions. She is equally at home in regulatory discussions, product strategy sessions, and clinical education forums-a communicator who bridges science, technology, and human behavior with clarity.
At this conference, Arati presents as a leading regulatory voice on the evolving landscape of CAMP wound products; offering expert perspective on the strategic pivot, compliance pathways, and regulatory future that will define how these therapies reach, and transform patient care.

Zwelithini "Zweli" Tunyiswa is the founder and CEO of Open Wound Research, where he leads Bayesian statistics, randomized controlled trials, and real-world evidence studies in chronic wound care. His research spans advanced wound-care modalities, wound-associated pain, and nutrition in healing, and includes a Bayesian hierarchical meta-analysis of the trials underpinning Medicare's 2024 Local Coverage Determinations and statistical analyses of multicenter trials in diabetic foot, venous leg, and pressure ulcers. He and his team at Open Wound Research built the LiftOff and BaseCamp registries to advance real-world evidence in wound care. His scholarship covers wound-care research methodology, Bayesian methods for economic and lifetime analyses, and real-world evidence for regulatory and reimbursement decisions.

Mr. Tunyiswa serves on the Editorial Board of Chronic Wound Care Management and Research, on the Research Board of the Association for the Advancement of Wound Care (AAWC), and chairs the Clinical Trial Standards & Reporting Workstream of the Wound Care Collaborative Community (WCCC). He hosts the Open Wound Research Podcast and is the co-architect of the CONSORT 2025 Flowchart Generator and the WoundStats community forum. He speaks regularly at major wound-care meetings. Through the Bexia project, he has built an international research network linking U.S. clinicians with leading South African wound-care specialists. He holds a degree from the University of Pennsylvania.

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. Alvarez obtained a Bachelor of Science in Pre-Med and Chemistry from the University of Dayton, Ohio (1974). He received his doctorate in Biochemistry from Rutgers University in 1979. He was an NIH Postdoctoral fellow and a Wound Healing Fellow at the Department of Dermatology, University of Miami School of Medicine from 1979-1980. Dr. Alvarez is the recipient of the 21st Annual John Boswick Award for lifelong achievement and dedication in the field of wound care. Dr. Alvarez has been awarded 90 research grants. Dr. Alvarez served as a member of the Agency Health Care Policy and Research, a panel for guideline development in the prevention and management of pressure ulcers. Dr. Alvarez was Director of the Curative and Palliative Wound Care Center at Calvary Hospital, Bronx, NY from 2004-2016, and as Program Director of the Vascular and Wound Care Center at University Hospital, Newark, NJ from 2017-2020. Dr. Alvarez is a founding editor of the journal WOUNDS and is Senior Editor of Wound Repair and Regeneration. He has authored over 200 peer- reviewed publications relating to wound care. Dr. Alvarez has also been principal investigator in more than 60 major clinical trials.

Currently, Dr. Alvarez is Program Director (Emeritus), Vascular and Wound Care Center and Professor (Adjunct) in the Department of Surgery at Rutgers, New Jersey Medical School. He is also a Voluntary Associate Professor, Phillip Frost Department of Dermatology and Cutaneous Surgery, University of Miami Miller School of Medicine, Miami, FL

Christie Bergerson, PhD, is a biomedical engineer and AI subject matter expert at ECRI, where she evaluates AI-enabled medical devices and advises healthcare organizations on AI risk, governance, and patient safety. Previously, she held engineering and leadership roles at Abbott Laboratories and Exponent, supporting medical device development, failure analysis, and regulatory strategy. Her research and professional work spans three core areas—software in medical devices, orthopedics, and in vitro diagnostics—with artificial intelligence serving as a common thread across all three. She formerly held a role as an ISO committee member on AI standardization and is the lead author of ECRI guidance on AI.

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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