Manager Engineering

Michelle D. Kofron, Ph.D.

Allentown area, Pennsylvania

Email: *********@*****.***

Mobile Phone: 434-***-****

EXECUTIVE SUMMARY

Highly motivated and business-minded leader with 4+ years of experience as a Clinical Department leader; 5+ years of experience with clinical trial development, execution, and management; 3+ years of experience in Research and Product Development. Strong proficiency in project planning and management and developing internal and external collaborations specific to each project. Willingness to adopt a “hands on” approach to ensure planned deliverables are on-time. As department manager and director, experience in the business aspect of trial execution, including forecasting and managing project and departmental budgets and involvement in development of a medical society-based registry.

EMPLOYMENT HISTORY

Consultant

Vera Tech Medical Consulting (September 2015 – Present)

Expert consultation for established and start-up medical device companies, tissue banks (HCT/Ps), and laboratories. Specifically, clinical trial development, study documentation, site selection, initiation, monitoring and close-out activities. Involvement with regulatory submissions IDE and postmarket surveillance.

Director of Clinical Research (July 2014 – July 2015)

ACell, Inc., Columbia, MD

Responsible for the organization and operation of ACell’s Clinical Affairs Department. Provide a compliant infrastructure for the management, implementation, and monitoring of ACell Sponsored and Investigator-Initiated Clinical Trials. Maintained relationships with principal investigators and key thought leaders. Conduct site visits: pre-study selection, study initiation, monitoring, and closeout. Serves as clinical representative during interactions with regulatory authorities. Responsible for the creation and management of the clinical department budget ($3.4M), hiring of direct reports (5), project timelines, planning, and execution. Lead for ACell’s Postmarket Surveillance Plan (FDA mandated 522 order) and development and participation in the American Urogynecologic Society Pelvic Floor Disorders Registry. ACell Industry Partner representative on the AUGS PFD Registry Strategic Advisory Board. Serve as the clinical representative on cross-functional product development teams. Oversee the development and execution of clinical trials in a variety of therapeutic areas, including gastroenterology, urogynecology, wound healing, trauma, plastic surgery, general surgery, musculoskeletal, and orthopaedics.

Clinical Affairs Manager (Sept 2011 – July 2014)

ACell, Inc., Columbia, MD

Responsible for the organization and operation of ACell’s Clinical Affairs Department. Provide oversight and input for all clinical trials sponsored by ACell. Lead ACell’s involvement with the development and participation in the American Urogynecology Society’s Pelvic Floor Disorders Registry, ACell representative on the AUGS PFD Registry Strategic Advisory Board and oversee the postmarket surveillance. Writing of SOPs, clinical protocols and other study-related documents, data monitoring, and data analysis. Responsible for clinical department budget ($2.5M), hiring of direct reports (2), and project execution, including CRO assignments. Successful completion of the Dale Carnegie “Communications” and “Leadership” Courses.

Project Manager, Clinical Research (Aug 2010 – Sept 2011)

Globus Medical, Inc., Audubon, PA

Coordinate GCPs to design and manage 16 clinical trials. Design and prepare clinical trial plans, protocols, IRB submissions, ICF, CRFs, and other study-related documentation, negotiate clinical trial budget and ensure completion within budget. Research scientific evidence and guidance documents to ensure compliance with regulatory requirements. Monitor clinical studies to ensure protocol compliance, communicate regularly with study investigators on all phases of the study. Manage incoming clinical site data and perform statistical analysis where appropriate. Prepare and review performance with team members, clinical investigators, and the Globus Medical Research Steering Committee.

Research Scientist (Dec 2007 – Aug 2010)

Globus Medical, Inc., Audubon, PA

Conduct all aspects of research and development under cGLP principles, including experiment design, protocol and report writing, coordinating with CROs to run animal studies for in vivo testing of implants, data analysis, and writing of validations, SOPs, and regulatory reports. Serve as a scientific resource for PD teams and marketing. Interface with management and the product engineers, providing technical training as needed. Evaluate new technologies and products for potential acquisition. Maintain current laboratory instruments (DSC, GC, SEM, EDXA) and provide recommendations for future equipment purchases. Investigate potential new product developments through a regular review of the scientific literature, identification of unmet clinical needs, and exploration of external opportunities for new developments. Completed the AMA Project Management Course in March 2008.

UVa Graduated Graduate Student (May 2007 – Aug 2007)

Dept of Orthopaedic Surgery, UVA

Basic science and translational research in musculoskeletal tissue engineering and stem cell biology. Included work in stem cell biology, cell culture, molecular biology, gene transfections (viral and non-viral), and animal studies.

Research Scientist (Aug 2005 – Dec 2005)

Tissue Genesis, Inc., Honolulu, HI

Paid internship completed to satisfy a requirement of the UVa Biotechnology Training Program. Responsible for the fabrication, test methodology, and benchtop evaluation of tissue engineered ligament and blood vessel constructs. Results are presented in a journal publication.

ACADEMIC TRAINING

Ph.D., Biomedical Engineering University of Virginia, Charlottesville, VA

Dissertation: “Bone Tissue Engineering Using an Ex Vivo Gene Therapy Approach”

Primary Advisor: Cato T. Laurencin, M.D., Ph.D.

My thesis research investigated the use of scaffold, cells, and bioactive factors delivered using an ex vivo gene therapy as a tissue engineering approach for bone healing.

1.Scaffold: Development of a novel tubular sintered microsphere matrix using biodegradable poly(lactide-co-glycolide). Optimization studies were based on desired porosity and mechanical properties.

2.Cells: Isolation of primary rabbit bone marrow stromal cells (BMSCs) and use of Fluorescent Activated Cell Sorting (FACS), biomarker identification and cellular differentiation studies to characterize the stem cell population

3.Bioactive Factor: Construction of an adenoviral vector encoding human bone morphogenetic protein-2 for genetic modification of BMSCs

4.In Vitro and In Vivo Studies: In vitro scaffold characterization and degradation; Cellular studies to monitor in vitro bone regeneration by expression of specific bone biomarkers; In vivo critical size ulnar defect model in rabbit including surgical performance, mechanical, histologic, and microcomputed tomography assessment.

M.S., Biomedical Engineering Drexel University, Philadelphia, PA

Research: “Cryopreservation of Tissue Engineered Constructs for Bone”

Completion of undergraduate engineering requirements (9/97 – 9/00)

B.A. Biology Bucknell University, Lewisburg, PA

ACHIEVEMENTS

UVa Engineering Graduate Student Travel Grant - 2007

The National Dean’s List – 2006 - 2007

UVa Excellence in Scholarship in Science and Engineering Award - 2006

L. William Ballard Fellowship Recipient - 2005

Jill E. Hungerford Outstanding Graduate Student Award - 2005

UVa School of Medicine - Outstanding Biomedical Engineering Graduate Student

Award - 2005

Invited Speaker, International Conference on Bioengineering & Bioinformatics: “Issues and Opportunity” Delta Academy of Science, Mansoura Egypt - 2004

Conference Committee Member for the Biotechnology Training Program Biennial Symposium - 2004

Tissue Engineering – Special Interest Group Award, Society for Biomaterials - 2003

UVa Biotechnology Training Program/Fellowship Recipient (sponsored by

National Institutes of Health) - 2003- 2005

Conference Committee Co-Chair (Student) for the 28th Annual Northeast

Bioengineering Conference Award, IEEE, EMBS, and Drexel’s School of Biomedical Engineering, Science and Health Systems - 2002

Robert E. Davies Student Travel Award, American Women in Science –

Philadelphia Branch - 2002

Calhoun Fellowship Recipient – 2000 - 2003

Invited Speaker, Northeastern Montgomery County Branch of the American

Association of University Women, Jenkinstown, PA - 1999

American Assoc. of University Women Career Development Grant – 1998 - 1999

Drexel Graduate Biomedical Assoc. Vice-President – 1998 - 1999

Drexel Graduate Biomedical Assoc. First Year Rep. for Biomedical Sciences – 1997 - 1998

Starmaker Softball Pitching Award - 1991

Womens Softball Varsity Athlete, Bucknell University – 1989 - 1993

Marsden Scholarship Recipient – 1989 – 1993

MEMBERSHIPS:

American Association of University Women (2000-present)

Society for Biomaterials (2001-2007)

Board of Directors, Helen I. Moorehead, MD, Foundation (2003-2007)

Orthopaedic Research Society (2007-2011)

Connecticut Academy of Science and Engineering Review Board (2010-2011)

Society of Clinical Research Associates (2011-2014)

Association of Clinical Research Professionals (2012-2013)

Regulatory Affairs Professional Society (2012-2013)

GRANTS

1.Spiral structured nanofibrous scaffolds for bone tissue engineering

Wallace H. Coulter Foundation

P.I. = Xiaojun Yu, Ph.D. (Stevens Institute of Technology)

Co-P.I. = Cato T. Laurencin M.D., Ph.D. (University of Virginia)

8/1/2007 – 8/1/2009 Amount $240,000

Role: Consultant Time devoted: 15%

BOOK CHAPTERS

1.Kumbar SG, Kofron MD, Nair LS, Laurencin CT: Importance of Nanoscale on Cell Behavior In Biomedical Nanostructures, Gonsalves KE, Laurencin CT, Halberstadt C, Nair LS (eds.) John Wiley & Sons, Inc. 2007.

2.Kofron MD, Laurencin CT: Genetic Modification of Stem Cells for Orthopaedic Applications In CRC Handbook on Stem Cells and Engineering, (Submitted).

JOURNAL PUBLICATIONS: (14) - details posted on Linked In

SCIENTIFIC & MEDICAL SOCIETY PRESENTATIONS –

Podium (10) and Poster (17) – details posted on Linked In

Detailed resume available on request.

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