About
With nearly 20 years of experience in the biotech industry, I am a seasoned executive and…
Articles by Stacy
Activity
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The University of Florida Human Neuromechanics Laboratory represented today at BME Outreach!!! Thank you to all the fabulous students and staff that…
The University of Florida Human Neuromechanics Laboratory represented today at BME Outreach!!! Thank you to all the fabulous students and staff that…
Liked by Stacy Arnold
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Mercer alumnus William Mark McCullough has been working his way up the ladder in his acting career, and you can catch him now in Marvel Studios'…
Mercer alumnus William Mark McCullough has been working his way up the ladder in his acting career, and you can catch him now in Marvel Studios'…
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Experience
Education
Licenses & Certifications
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Interpretation and Application of ICH E6(R2)
Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center)
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SolidWorks
ModernTech Corporation
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Project Managament Professional (PMP)
Project Management Institute
Issued ExpiresCredential ID 1866242
Volunteer Experience
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Board Member - BME External Advisory Board
University of Florida
- Present 1 year 3 months
Education
The BME External Advisory Board (EAB) comprises nationally distinguished leaders from industry, academia and government who provide advice on the department’s academic, research, outreach and other programs.
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Founding Member
Life Science Women's Network
- 3 years 4 months
The LSWN’s mission is to provide our global network of life science professionals the environment in which to share, support, mentor, grow, and collaborate. The LSWN is comprised of its members and two exceptional founding women from each region. Specialization varies across all the life science fields.
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Volunteer
American Heart Association | American Stroke Association
- Present 18 years 6 months
Health
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Mercer University School Liaison
Habitat for Humanity International
- 6 years 7 months
Disaster and Humanitarian Relief
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Publications
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BioGlue® is not associated with polypropylene suture breakage after aortic surgery
Frontiers in Surgery
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Optimizing tissue cryopreservation techniques for cryopreservation solution modifications
CryoBiology
The purpose of this study was to observe how minor changes to cryopreservation solutions affect the success of cryopreservation controlled-rate freeze cycles.
Other authorsSee publication -
Functional Performance and Biomechanics of Decellularized Human Aortic Valves
QScience
Allograft decellularization based on detergents and/or enzymes to reduce antigenicity has been reported to damage tissue structure.
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(729) In Vitro Hemodynamic and Duability Results for SynerGraft® Treated Pediatric Aortic Allografts1
AATB American Association of Tissue Banks
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CryoValve® SG Human Aortic Valve: The Next Generation Allograft Heart Valve
AATB American Association of Tissue Banks
A combination of in vitro bench data, in vivo animal data and human clinical data demonstrate the benefits of SynerGraft technology when applied to allograft aortic heart valves. SynerGraft technology was developed to decellularize allograft tissue without negatively impacting the structural integrity of the tissue. The CryoValve SG Human Aortic Valve (CryoValve SGAV) has received a Humanitarian Use Device designation from the US FDA. Review for a Humanitarian Device Exemption by FDA is…
A combination of in vitro bench data, in vivo animal data and human clinical data demonstrate the benefits of SynerGraft technology when applied to allograft aortic heart valves. SynerGraft technology was developed to decellularize allograft tissue without negatively impacting the structural integrity of the tissue. The CryoValve SG Human Aortic Valve (CryoValve SGAV) has received a Humanitarian Use Device designation from the US FDA. Review for a Humanitarian Device Exemption by FDA is pending
Other authorsSee publication -
Long-Term Cryogenic Storage Impact on Heart Valve Performance
AATB American Association of Tissue Banks
Cryogenic preservation is the recommended technique for long-term storage of allograft heart valves. Analyses of the probability of tissue degradation during cryopreservation and predictions of long-term tissue stability using theoretical models have shown that ultra-low temperatures in cryogenic storage cause the movement of the molecular tissue constituents to be arrested and cease deleterious chemical reactions. A theoretical examination of worst case phenomenon such as water partitioning…
Cryogenic preservation is the recommended technique for long-term storage of allograft heart valves. Analyses of the probability of tissue degradation during cryopreservation and predictions of long-term tissue stability using theoretical models have shown that ultra-low temperatures in cryogenic storage cause the movement of the molecular tissue constituents to be arrested and cease deleterious chemical reactions. A theoretical examination of worst case phenomenon such as water partitioning and temperature excursions show that below -165oC, valves remain sufficiently far below their glass transition temperature preventing any storage degradation (Karlsson, 2009). The present study evaluates and compares the performance of human heart valves held in long-term liquid nitrogen storage (liquid phase) to valves stored less than one year. This study provided experimental data that long-term cryogenic storage does not impact heart valve performance and durability confirming the aforementioned theoretical models.
Other authorsSee publication
Patents
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Vascular Access System With a Reinforcement Member
Filed US 15/035,626
A system for providing a continuous flow of blood between two locations in a cardiovascular system of a patient is provided. The system includes a blood conduit having a proximal portion configured to be attached to an artery. The system also includes a distal portion configured to be inserted into a blood vessel at an insertion site and to be advanced there through to a location spaced apart from the insertion site. Moreover, the system includes a reinforcement member positioned at least…
A system for providing a continuous flow of blood between two locations in a cardiovascular system of a patient is provided. The system includes a blood conduit having a proximal portion configured to be attached to an artery. The system also includes a distal portion configured to be inserted into a blood vessel at an insertion site and to be advanced there through to a location spaced apart from the insertion site. Moreover, the system includes a reinforcement member positioned at least partially about the blood conduit in at least one of the distal portion, the proximal portion, or a combination thereof.
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Systems And Methods For A Fluid Carrying Conduit Of A Vascular Access System
Filed US 20150051532
Projects
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Tampa Headquarters Construction Project
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Executive Sponsor for this multi-million dollar construction initiative to build Axogen's Tampa Headquarters.
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JOTEC Integration
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Leading the global integration of JOTEC into CryoLife, Inc including systems, processing, and cross-functional structure.
Included in this effort is collaborating with and overseeing executive leadership in the execution of integration-related tasks to ensure on time completion of critical integration milestones. -
JOTEC Due Diligence & Acquisition
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CryoLife, Inc. ("CryoLife"; NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has entered into a definitive agreement to acquire JOTEC AG ("JOTEC"). JOTEC is a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair. The combination of CryoLife and JOTEC will create a Company with a broad and highly…
CryoLife, Inc. ("CryoLife"; NYSE: CRY), a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has entered into a definitive agreement to acquire JOTEC AG ("JOTEC"). JOTEC is a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair. The combination of CryoLife and JOTEC will create a Company with a broad and highly competitive product portfolio focused on aortic surgery, and will position CryoLife to compete strongly in the important and growing endovascular surgical markets.
My role in this effort was leading the CryoLife executive team in the planning, execution, and completion of due diligence for the $250+ million acquisition of JOTEC. The result was the successful completion of the due diligence and the signing of a definitive agreement. -
Mergers & Acquisitions - PhotoFix
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In 2016, CryoLife acquired the PhotoFix asset from GBI. My role was leading corporate due diligence for the purchase, leading integration of the asset into the CryoLife systems, and leading the manufacturing transfer from GBI (Denver, Colorado) to CryoLife (Kennesaw, GA).
• Establish project governance in accordance with CryoLife NPD procedures
• Manage and track the project team with resource and delivery plans
• Track and control project costs in accordance with the agreed…In 2016, CryoLife acquired the PhotoFix asset from GBI. My role was leading corporate due diligence for the purchase, leading integration of the asset into the CryoLife systems, and leading the manufacturing transfer from GBI (Denver, Colorado) to CryoLife (Kennesaw, GA).
• Establish project governance in accordance with CryoLife NPD procedures
• Manage and track the project team with resource and delivery plans
• Track and control project costs in accordance with the agreed budget
• Track and control project timeline in accordance with agreed timeline
• Ensure on-going risks and issues are recognised, resolved and communicated
• Management and motivation of internal project team and 3rd party stakeholder contracted to the project to ensure a professional and successful delivery
• Responsible for risk planning and issue identification working with the Project Sponsors, Stakeholders, and Business Leaders
• Manage the SharePoint site for the project/work stream. -
New Product Development - NeoPatch DFU
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Project description:
In 2015, R&D completed concept and feasibility of a new product development technology, NeoPatch DFU (human chorioamniotic membrane). My role as project lead was to manage new product development design transfer processes according to FDA design controls. In April 2016, the final stage of Design Control (Design Transfer) was completed and this product launched into commercial production to support the now completed 50 patient clinical trial.
• Establish…Project description:
In 2015, R&D completed concept and feasibility of a new product development technology, NeoPatch DFU (human chorioamniotic membrane). My role as project lead was to manage new product development design transfer processes according to FDA design controls. In April 2016, the final stage of Design Control (Design Transfer) was completed and this product launched into commercial production to support the now completed 50 patient clinical trial.
• Establish project governance in accordance with FDA Design Control and CryoLife procedures
• Manage and track the project team with resource and delivery plans
• Track and control project costs in accordance with the agreed budget
• Track and control project timeline in accordance with the agreed timeline
• Responsible for issue identification working with the Project Sponsors, Stakeholders, Business Leaders, and project team
Honors & Awards
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Top 40 Under 40 Award
Tampa Bay Business Journal
These 40 business people have achieved success in their industries and demonstrate a commitment to bettering Tampa Bay.
Languages
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German
Limited working proficiency
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French
Limited working proficiency
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Dutch
Elementary proficiency
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Axogen continues to grow! Join our team! We're hiring a Director, Regulatory Affairs in the Alachua, FL Headquarters. Here's the link to apply:…
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Medtronic is expanding the market for its Aurora EV-ICD system for treating ventricular #arrhythmias, announcing the system's launch in Japan…
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I am grateful to share that I have been awarded the 2024 STAR Award at axogen. With just under a year in this role, I am honored to be recognized for…
I am grateful to share that I have been awarded the 2024 STAR Award at axogen. With just under a year in this role, I am honored to be recognized for…
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Axogen is excited to see our fellows this weekend in Phoenix for the FULL Best Practices in Upper Extremities course. If you are interested in…
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A big thank you to American Society of Pain and Neuroscience ASPN and Tim Deer, MD Dawood Sayed for always supporting APP education and striving to…
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Proud to share our research on splinting for Dupuytren's contracture after Collagenase injection. Thank you to my co-authors and JHS.…
Proud to share our research on splinting for Dupuytren's contracture after Collagenase injection. Thank you to my co-authors and JHS.…
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Axogen continues to grow! Join our team! We're hiring a Sr. Engineer, Quality in the Vandalia, OH Office. Here's the link to apply:…
Axogen continues to grow! Join our team! We're hiring a Sr. Engineer, Quality in the Vandalia, OH Office. Here's the link to apply:…
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#South #Korean #scientists at KAIST have made a groundbreaking discovery in #cancer #treatment by finding a way to reverse #colon #cancer #cells back…
#South #Korean #scientists at KAIST have made a groundbreaking discovery in #cancer #treatment by finding a way to reverse #colon #cancer #cells back…
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Join Olajompo Moloye-Olabisi, Ph.D, chair of the UF BME Alumni Advisory Board, and the UF community in supporting future biomedical engineers. Your…
Join Olajompo Moloye-Olabisi, Ph.D, chair of the UF BME Alumni Advisory Board, and the UF community in supporting future biomedical engineers. Your…
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