Research Instructor of Dermatology
Boston University School of Medicine
Boston University School of Medicine, Dept of Dermatology
609 Albany Street, J-605, Boston, MA 02118
- Douglas School of Business, Monessen, PA – A.D., Business Law (1973-1975)
- American Academy of Wound Management, North Bay Village, FL – C.W.S., Board Certified Wound Specialist (1998)
- CRC Training, Clinical Research Administration (2000)
- Regulatory Affairs and Compliance, Clinical and Pre-Clinical Trials, GMP, IND, and FDA interactions. This includes the Design of protocols, Manual of Operating Procedures, Case Report Forms as required by NIH/DoD.
My interests and achievements have been in Regulatory Affairs and Compliance as it relates to clinical and pre-clinical research. Indeed, I have actively participated in protocol development and formulation of Design Studies. I have over 20 years of experience in the coordination and management of research and clinical trials, including NIH sponsored research. I have been in charge of managing over 100 clinical research projects, both industry and government sponsored. The majority of clinical trials have been related to wound healing, particularly chronic wounds. Several of the clinical trials that I have been involved with have also led to FDA approval (topical mupirocin and bioengineered skin). The only proven treatments for human chronic wounds and skin infection, as per FDA approval and Cochran analysis, had my direct involvement (mupirocin, bioengineered skin, high dose pentoxifylline). I was part of the research team that was the first in the world to successfully use bone marrow-derived cultured mesenchymal stem cells in human chronic wounds. Because of my experience and interest in clinical research, I published an article detailing the steps involved in starting a clinical trial. This experience also includes patient recruitment, coordination of regulatory approvals, Investigational New Drug (IND) applications, case report form development, and more recently development of a Good Manufacturing Practice (GMP) facility.
Other Research Interests:
- Acute and Chronic wounds and their treatment
- Teaching of trainees about the processes involved in obtaining IRB approval.
- Pre-clinical wounding, in mouse and domestic pig models.
- Stem cells, including bone marrow-derived (with or without GCSF mobilization) cells.
- Pre-clinical and patient-based use of multipotent bone marrow-derived mesenchymal stem cells (MSCs) and pluripotent very small embryonic-like stem cells (VSELs).
In addition to the above achievements, I have published 22 peer-reviewed articles, 34 peer-reviewed abstracts and co-authored 1 textbook.
- Phillips TJ, Manzoor J, Rojas A, Isaacs C, Carson P, Sabolinski M, Young J, Falanga V: The longevity of a bilayered skin substitute after application to venous ulcer. Arch Dermatol 138:1079-1081, 2002.
- Falanga, V, Shrayer D, Cha J, Butmarc J, Carson P, Roberts AB, Kim S-J: Full-thickness wounding of the mouse tail as a model for delayed wound healing. Wound Rep Regen 12:320-326, 2004.
- Carson, PA: Clinical Research in Dermatology –10 Steps to Getting Started. Dermatologic Therapy. Vol 19, 377-382, 2006.
- Falanga V, Iwamoto S, Chartier M, Yufit T, Butmarc J, Kouttab N, Shrayer D, Carson P: Autologous bone marrow-derived cultured mesenchymal stem cells delivered in a fibrin spray accelerate healing in murine and human cutaneous wounds. Tissue Engineering 13:1299-1312, 2007.
- Panuncialman J, Hammerman S, Carson P, Falanga V: Wound edge biopsy sites in chronic wounds heal rapidly and do not result in delayed overall wound healing. Wound Repair and Regeneration. Wound Rep Regen 18:21-25, 201.
- Yufit T, Carson P*, Falanga V: Topical Delivery of cultured stem cells to human non-healing wounds: GMP facility development in an academic setting and FDA requirements for an IND for human testing. *Carson P and Yufit T are equal first authors on this manuscript and contributed equally. Current Drug Delivery, March 18, 2013. Epub ahead of print.
- Falanga V, Lindholm C, Carson P, Panuncialman J, Mamakos L, Lotti T, Falanga J. Text Atlas of Wound Healing. 2nd Edition. Informa HealthCare, 2012, pp. 222.