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6/2014
Patti E. Dawson
San Antonio, TX dawsonpattie@bellsouth.net Cell: 210-262-2265
SUMMARY
Research/Clinical Research ∙ Medical Product Development ∙ Product Support
Proficient in both pre-clinical (bench and animal) and human clinical project design and management.
Proven success with clinical study execution, data collection, analysis, and reporting to FDA. Managed
the activities of individual projects in a manner that ensured that the studies were conducted within
GCP and FDA regulations and requirements. Developed strong professional relationships with site
Principal Investigators. Extensive medical research and development expertise with understanding
across multiple therapeutic areas including cardiac, vascular, orthopedic, and general surgical grafts,
organ transport solutions, and hemorrhage control devices. Developed, tested and implemented
methods for decontamination, processing and cryopreservation of numerous allografts and xenografts.
Strong scientific writing skills including grants, technical reports and more than 60 publications in
medical/scientific journals. Strong project management skills. Significant presentation experience,
including frequent presentations to surgeons and other health care staff, and presentations at
national/international meetings. Worked closely with sales/marketing in preparing marketing materials,
assisting with site sales analyses, and in technical support of multiple product lines. Have favorable
NACI background clearance and CITI training.
PROFESSIONAL POSITIONS
BRAIN SENTINEL™ Nov 2012 – May 2014
Director of Clinical Research
Summary: Managed multiple clinical research projects for a seizure detection device. Planned and
conducted a multicenter study with nine hospitals sites in the US. Wrote all study protocols, case
report forms, and other clinical study related documents. Performed study start up activities and
ongoing study monitoring to ensure ongoing compliance to study protocol and applicable regulations.
Managed the staff of regional Clinical Research Associates. Coordinated database creation, data
management and statistical analysis for study. Interacted with FDA regarding regulatory submissions
and ensured compliance with FDA regulations, IRB and/or ethics committee requirements, and overall
clinical objectives.
BROOKE ARMY MEDICAL CENTER Mar 2012 – Aug 2012
Research Project Manager (contract position)
Summary: Responsible for providing project management for a Department of the Army simulation and
animal/live tissue study to explore the optimal techniques and procedures to evaluate training and
Patti Dawson dawsonpattie@bellsouth.net 210-262-2265
develop models in invasive lifesaving medical procedures. Responsible for day-to-day conduct of the
study, record keeping, documentation, report and manuscript preparation, and regulatory compliance
including preparation of IRB and IACUC submissions. Was successful in completing project and all
required reporting in allotted time.
CRYOLIFE, INC. 1987-2009
Leading processor of human tissue allografts worldwide
Director of Clinical Research (2006 - 2009)
Summary: Managed all aspects of clinical research involving company’s tissue products across
multiple therapeutic areas for allograft and xenograft products. Product lines included cardiac,
vascular, general surgical and orthopedic grafts. Manage supporting staff of clinical project specialists
and managers. Proficient with multiple clinical project management, budget administration (1.5 M per
year), coordinating/monitoring data collection, analyzing data, and supporting regulatory submissions.
Skilled in investigation and assessment of adverse events and complaints associated with marketed
products. Maintained thorough and current knowledge of competitive products and surgical trends in all
therapeutic areas. Led or participated in numerous multi-departmental project teams.
Primary Accomplishments:
• Conducted retrospective clinical study collecting data for 342 human subjects receiving the
decellularized CryoValve SG pulmonary valve at 7 study sites. Compiled, analyzed and
submitted data within project timeline to FDA resulting in successful receipt of 510(k) clearance.
Spearheaded preparation of manuscript for publication.
• Prepared submission for marketing claim of reduced antigenicity of the decellularized pulmonary
valve resulting in successful receipt of special 510(k).
• Planned and implemented FDA required post-clearance study for decellularized pulmonary
valve. Successfully recruited all desired study sites.
• Prepared and received HUD (humanitarian use device) designation for CryoValve SG aortic
valve; HDE (humanitarian device exemption) study currently underway.
• Planned and conducted animal studies for a xenograft patch product to be utilized in hernia
repair. Submitted and received 510(k) clearance for the product.
• Travel to customer sites to support clinical research studies and to provide sales/marketing
support for tissue products, including attending cases in the OR. Present clinical and pre-
clinical data to surgeons and hospital staff to provide clinical information and promote use of
products.
• Assist with training and education of marketing/sales staff for all tissue products. Assist
marketing with preparation of sales/marketing materials.
Director Allograft Tissues Research CryoLife, Inc. (1997-2006)
Manager, Research and Development CryoLife, Inc. (1987-1997)
Patti Dawson dawsonpattie@bellsouth.net 210-262-2265
Summary: Recognized as being responsible for the successful research and development efforts of all
the company’s allograft tissue processes. Planned and executed all allograft tissue research projects
including development of new methods for collection, decontamination, long-term storage, and in-vitro
and in-vivo testing methods. Coordinated transfer of new methods to manufacturing laboratory and
served as team leader for project teams. Hired and managed research technical staff, planned and
managed budgets for all projects. Assisted with preparation of grant proposals and manuscripts.
Primary Accomplishments:
• Developed and implemented methods for collection, decontamination, preservation and
reconstitution of at least 10 allograft tissues not previously processed for transplant.
Responsibilities included research strategy, oversight of study execution, data analysis,
preparation of study reports, and providing recommendations to upper management. These
developments allowed for the commercial availability of numerous allograft products (cardiac,
vascular, and orthopedic) which now save or enhance patient’s lives every day.
• Developed, tested and implemented a patented decellularization process for human cardiac
(CryoValve SG) and vascular grafts resulting in the successful commercial use of these grafts.
• Investigated and assessed adverse events and product complaints. Coordinated and performed
collection, histological analysis, and assessment of tissue samples.
• Co-authored numerous research papers, book chapters, and patents.
• Assisted sales/marketing with technical presentations to surgeons, donor services professionals
and other hospital staff.
• Assisted with training of marketing staff in various scientific aspects of tissue product lines.
Served as resource for technical and scientific questions from customers.
Emory UniversityAtlanta, GA
Research Assistant, Department of Endocrinology (1985-1987)
Research focus involved growth hormones and detection of growth inhibitors. Duties included
maintenance of animal colony, performance of established study methods, and creation of novel
methods for assessment of animal health status and detection of enzyme levels.
Universityof Texas Graduate School of Biomedical Sciences/ M.D Anderson Hospital and
Tumor Institute Houston, TX (1977-1985)
Research Associate Division of Hematology (1984-1985)
Research on creation of immunomagnetic fluids for use in removing cancer cells from patient
blood/bone marrow. Maintained and manipulated nude mouse colony for departmental usage.
Research Associate Immunogenetics (1977-1984)
Gene mapping of mouse and rat genome with emphasis on immunologically related genes. Primary
methods utilized were HPLC, electrophoresis (numerous methods), plate diffusion. Managed large
mouse, rat, and rabbit colony. Highly proficient with laboratory animal manipulations. Performed
human gene mapping in specific populations.
Patti Dawson dawsonpattie@bellsouth.net 210-262-2265
EDUCATION
University of South Alabama, Mobile, Alabama. Bachelor of Science, Biology
PROFESSIONAL AFFILIATIONS
Member of Association of Clinical Research Professionals (ACRP)
PUBLICATION LIST
JOURNAL PUBLICATIONS
1. Douglas, T.C. and P.E. Dawson. The position of the gene for glyoxalase I on chromosome 17 of
the mouse. Immunogenetics,1979; 8:367-371.
2. Douglas, T.C. and P.E. Dawson. Location of the gene for theta antigen in the Mouse. III. The
position of Thy-1 relative to Lap-1 and Mpi-1. J. Heredity, 1979;70:250-254.
3. Douglas, T.C., K.A. Kimmel, and P.E. Dawson. Genetically controlled variation of "acid" beta-
galactosidase detected in Rattus Norvegicus by isoelectric focusing. Genetics, 1982;100:455-473.
4. Carpenter, J.F. and P.E. Dawson. Quantitation of dimethyl sulfoxide in solutions and tissues by
high-performance liquid chromatography. Cryobiology,1991;28:210-215.
5. Brockbank, K.G.M., C. McCaa, P.E. Dawson, J.L. Milton. Warm Ischemia Limits: Protein
synthesis/viability of cryopreserved menisci. J. Transplant Coordination, 1991;1:121-123.
6. Brockbank, K.G.M., J.F. Carpenter, P.E. Dawson. Effects of storage temperature on viable
bioprosthetic heart valves. Cryobiology, 1992;29: 537-542.
7. Brockbank, K.G.M., P.E. Dawson. Cytotoxicity of amphotericin B for fibroblasts in human heart
valve leaflets. Cryobiology, 1993;30: 19-24.
8. Brockbank, K.G.M., P.E. Dawson, J.F. Carpenter. Heart valve leaflet revitalization. Tissue and Cell
Report, 1993;Vol.1, No.2.
9. Brockbank, K.G.M., P.E. Dawson. Influence of whole heart post-procurement cold ischemia time
upon cryopreserved heart valve viability. Transplantation Proceedings, 1993;25: 3188-3189.
10. Hansen, T.N., P.E. Dawson, K.G.M Brockbank. Effects of hypothermia upon endothelial cells:
mechanisms and clinical importance. Cryobiology 1994;31: 101-106.
11. Eskew, T., J.D.Ollerenshaw, J.M. Philpott, K.Dennis, P.Dawson, Y.S. Sun, W.R. Chitwood, and
R.M. Lust. Successful small diameter arterial grafting using cryopreserved allograft arteries. ASAIO
Journal,1997; 43:M522-M526.
12. Elkins, R.C., P.E. Dawson, S. Goldstein, S.P. Walsh, and K.S. Black. Decellularized human valve
allografts. Ann Thorac Surg, 2001;71:S428-32.
Patti Dawson dawsonpattie@bellsouth.net 210-262-2265
13. Elkins, R.C., S. Goldstein, C.W. Hewitt, S.P. Walsh, P.E. Dawson, et al. Recellularization of heart
valve grafts by a process of adaptive remodeling. Sem in Thorac and Cardiovasc Surg,2001; 13,
No.4, Suppl 1:87-92
14. Elkins, R.C., M.M. Lane, S.B. Capps, C. McCue, and P.E. Dawson. Humoral immune response to
allograft valve tissue pretreated with an antigen reduction process. Sem in Thorac and Cardiovasc
Surg, 2001; 13, No.4, Suppl 1: 82-86.
15. Giglia JS, Ollerenshaw JD, Dawson PE, Black, KS, and Abbott WM. Cryopreservation prevents
arterial allograft dilation. Annals of Vascular Surg, 2002;16:762-767.
16. Davidson PA, Rivenburgh DW, Dawson PE, and Rozin R. Clinical, histologic, and radiographic
outcomes of distal femoral resurfacing with hypothermically stored osteoarticular allografts. Am
Journal of Sports Med,2007;35, No. 7:1082-90.
BOOK CHAPTERS
1. Douglas, T.C., Lake P, Skarvall H and Dawson P. Genetic Factors Influencing the Immunogenicity
of Thy-1 Cell Surface Antigens. In Frontiers in Immunogenitics, W.H. Hildemann, ed., Elsevier-
North Holland,1981: pp 91-105.
2. Dawson.P.E. Brockbank., K.G.M. Human Heart Cold Ischemia and its Effect on Post-
cryopreservation Viability of Heart Valves. In: Cardiac Valve Allografts: science and practice, A.C.
Yankah, M.H. Yacoub and R.Hetzer Eds.,Springer,1997:pp 23-28.
3. Black KS, Dawson PE. Allografts. In Encyclopedia of Biomaterials and Biomedical Engineering, GE
Wnek and Bowlin GL, Eds.,Dekker,2004:pp 11-18.
ABSTRACTS AND PRESENTATIONS
1. Coleman, P.E. and T.C. Douglas. 1979.Linkage data regarding the location of Thy-1 on
chromosome 9 and Glo-1 on Chromosome 17. Mouse News Letter, 60:58.
2. Dawson, P.E., T.C. Douglas and K.A. Kimmel. 1979.B-galactosidase. Rat News Letter. 5:45.
3. Douglas, T.C., K. Kimmel and P.E. Dawson. 1980. Genetically controlled electrophoretic variation of
"acid" B-galactosidase in Rattus Norvegicus. Isozyme Bulletin, 13:61.
4. Dawson, P.E. and T.C. Douglas. 1980. Donor’s sex can influence Thy-1 immunogenicity. Mouse
News Letter, 63:18.
5. Dawson, P.E. and T.C. Douglas. 1981.Linkage data regarding the position of Bgl-e on chromosome
Patti Dawson dawsonpattie@bellsouth.net 210-262-2265
9. Mouse News Letter, 65:23.
6. Douglas, T.C. and P.E. Dawson. 1982. Genetic factors influencing the immunogenicity of Thy-1
Antigens. Fed. Proc., 41: 293.
7. Douglas, T.C., P.E. Dawson, and R. Chakraborty. 1982. Genetic control of beta-galactosidase
levels in Rattus Norvegicus by factor(s) linked to Glb-1. Isozyme Bulletin 15 supp.:26 (4th Intl.
Congress on Isozymes).
8. Dawson, P.E. and T.C. Douglas. 1982. Biochemical genetic markers which differentiate subline
AKR/Cum from AKR/J and congenic strain B6.Pl-Thy-1a from C57BL/6J. Mouse News Letter,
67:20.
9. Brockbank, K.G.M., P.E. Dawson. 1989. Cell viability in fresh, refrigerated, and cryopreserved
human heart valve leaflets. Presented at the 13th Annual Meeting of the American Association of
Tissue Banks.
10. Brockbank, K.G.M., P.E. Dawson. 1990. Cell viability in fresh and stored human heart valve leaflets.
Presented at the 27th annual meeting of the Society for Cryobiology, Cryobiology 27:182.
11. Brockbank, K.G.M., J.F. Carpenter, P.E. Dawson. 1990. Comparison of human heart valve leaflets
stored at -196ºC and -80ºC. Presented at the 14th annual meeting of the American Association of
Tissue Banks.
12. Brockbank, K.G.M., C. McCaa, P.E. Dawson, J.L. Milton. 1990. Warm ischemia limits use of
orthopaedic soft tissues. Presented at the 14th annual meeting of the American Association of
Tissue Banks.
13. Brockbank, K.G.M., J.F. Carpenter, P.E. Dawson. 1991. Effects of storage temperature on viable
bioprosthetic heart valves. Presented at the 5th International Symposium on Cardiac Bioprosthe-
ses.
14. Brockbank, K.G.M., P.E. Dawson, R.T. McNally. 1991. Cytotoxicity of amphotericin B for fibroblasts
in human heart valve leaflets. Presented at the 5th International Symposium on Cardiac Bioprost-
heses.
15. Brockbank, K.G.M., C. McCaa, P.E. Dawson, J.L. Milton. 1991. Warm ischemia limits use of
orthopaedic soft tissues. Presented at the 28th meeting of the Society for Cryobiology.
16. McCaa, C., P. Shealy, J. Milton, P.E. Dawson, R. McNally, K.G.M. Brockbank. 1992. A comparison
of fresh autograft, cryopreserved allograft and fresh frozen allograft medial menisci in the canine
stifle at one year. Presented at the 29th Annual Meeting of the Society for Cryobiology.
17. Brockbank, K.G.M., P.E. Dawson, L.J. Brossolet. 1993. Cryopreservation of allogeneic tissue for
anterior cruciate ligament replacement. Presented at the 2nd Congress of the European Associa-
tion of Tissue Banks.
18. Brockbank, K.G.M., P.E. Dawson, J.F. Carpenter. 1993. Incubation of heart valve leaflets at 37ºC in
culture medium prior to cryopreservation enhances 2-deoxyglucose phosphorylation. Presented at
the 30th annual meeting of the Society for Cryobiology.
Patti Dawson dawsonpattie@bellsouth.net 210-262-2265
19. Brockbank, K.G.M., P.E. Dawson. 1993. Influence of whole heart post-procurement cold ischemia
time upon cryopreserved heart valve viability. Presented at the 2nd International Congress of the
Society for Organ Sharing.
20. McNally, R.T., Fronk, D.M., Capps, S.B., Clarke, K.A., Hall, M.T., and Dawson, P.E. 1996.The
clinical status of cryopreserved tissue for transplant. Presented at the 33rd annual meeting of the
Society for Cryobiology.
21. Ollerenshaw, J., P.E. Dawson, R. Metz, K. Black, 1997. Viability of endothelial cells present on vein
conduit and valve leaflet pre and post cryopreservation measured using fluorescent probes.
Presented at the 21st annual meeting of the American Association of Tissue Banks.
22. Dawson, P.E., Ollerenshaw, J.D., 1998.Viability and coverage of endothelial cells on human
femoral arteries before and after cryopreservaton. Presented at the 22nd annual meeting of the
American Association of Tissue Banks.
23. Dawson, P.E., Schorr, A.J., Howell, S.M., Hull, M.L., Haut, T. 1998.Strength comparison of the
anterior and posterior tibialis tendons to semitendinosus and gracilis tendons. Presented at the
22nd annual meeting of the American Association of Tissue Banks.
24. Dawson, P.E., Schorr, A.J. 1998.Demonstration of superior cellular viability in cryopreserved
meniscus. Presented at the 22nd annual meeting of the American Association of Tissue Banks.
25. Schorr, A.J., Dawson, P.E., 1998.Optimization of harvesting, cryopreservation, and PTFE graft
seeding protocols for use with vascular endothelial cells.
26. Dawson, P.E., 1999. Science and application of acquiring allografts. Presented at the 6th annual
Wisconsin Perfusion Society Spring Conference.
27. Ollerenshaw, J.D., Matsuura, J.H., Yuksel, U., Dawson, P.E., Trygstad, A., Cameron, A., Goodman,
C.L., Davenport, C.K., Rosenthal, D., and Black, K.S. 1999. Biolasticä, a novel vascular graft matrix
which supports growth and attachment of human vascular endothelial cells. Presented at the
International Society for Cardiovascular Surgery 24th World congress.
28. Dawson, P.E., S. Goldstein, S.P. Walsh, and K.S. Black, 2000. Synergraft treatment of valve
allografts. Presented at the 24th Annual Meeting of the American Association of Tissue Banks, Bal
Harbour; FL 2000.
29. Elkins, R.C. K.S. Black, P.E. Dawson, S. Goldstein, and S. Walsh, 2000. Decellularized human
valve allografts. Presented at the VIII International Symposium on Cardiac Bioprostheses, Cancun,
Mexico; Nov. 2000.
30. Elkins, R., M. Lane, S. Capps, C. McCue, P.E. Dawson, 2001. Humoral immune response to
allograft valve tissue pretreated with an antigen reduction process. Presented at the Stentless
Bioprostheses 4th Annual Symposium, San Diego, CA; May 2001.
31. Matsuura, JH, D Rosenthal, E. D. Wellons, K.D. Anastasiades, D.L. Hubbard, P.E. Dawson, and
J.D. Ollerenshaw, 2002. Venous plaque: A new pathologic lesion? Presented at the 26th Annual
Meeting of the Southern Association for Vascular Surgery, Miami, FL; Jan 2002.
32. Dawson PE, Carter TR, Cameron AJ, Black, KS. 2002. Intact chondrocytes in human osteoarticular
Patti Dawson dawsonpattie@bellsouth.net 210-262-2265
cartilage during long term maintenance. Presented at Arthroscopy Association of North America
21st Annual Meeting, Washington, DC; April 2002.
33. Dawson PE, Black KS, Cameron AJ, Kurz AC, Carlson C, and LaPrade R. 2002. Intact
chondrocytes in human osteoarticular cartilage during long-term maintenance. Presented at the
26th Annual Meeting of the American Association of Tissue Banks, Boston, MA Aug 2002.
34. Dawson PE, Cameron AJ, Kite-Powell K, Black KS. 2002. Human explant review: Cellularity of
explanted cryopreserved heart valve allografts. Presented at the 26th Annual Meeting of the
American Association of Tissue Banks, Boston, MA; Aug 2002.
35. Walsh SP, Dawson PE, Black KS. Biomechanical properties of SynerGraft treated human heart
valves and vascular grafts. Presented at Advances in Tissue Engineering and Biology of Heart
Valves, Florence, Italy; 2004.
36. Dawson, PE, Black KS, Fronk DM. Effect of ischemic time on cellular viability of vascular tissues.
Presented at the 28th Annual Meeting of the American Association of Tissue Banks, Chicago, IL;
Aug 2004.
37. Dawson, PE. Preservation methods for osteochondral allografts – Maximizing safety and viability.
Presented at the Florida Orthopaedic Society Annual Meeting, Sarasota, FL;May 2005.
38. Goldstein, S, Dawson, P, Walsh S, Heacox A. Engineering connective tissue grafts via antigen
reduction technologies. Presented at the In Vitro Biology Meeting, Baltimore, MD. June, 2005.
39. Dawson, PE, Davidson PA, Rivenburgh DW, Cameron AM, Walsh S, Heacox A. Clinical success of
hypothermically stored human osteoarticular cartilage grafting and implications for cryopreserved
cartilage. Presented at the 42nd Annual Meeting for the Society of Cryobiology; July 2005.
40. Davidson, PA, Dawson PE, Walsh SP. Effect of cryopreservation on human osteoarticular cartilage
grafts. Presented at the 6th Symposium of the International Cartilage Repair Society, Dan Diego,
CA, Jan. 2006.
41. Dawson, PE, Schrock GE, Takkenberg JJM. Mid-term outcomes after pulmonary valve replacement
with CryoValve SG decellularized allograft pulmonary valves. Presented at the 17th International
Congress of the European Association of Tissue Banks and 17th Annual meeting of British
Association for Tissue Banking, Edinburgh, UK, Nov. 2008.
42. Goldstein S, Dawson P, Ray G, and Heacox A. Immunohistochemical evidence for antigen
reduction in decellularized human aortic and pulmonary valves. Presented at the World Society for
Pediatric and Congenital Heart Surgery, Montreal, Canada, June 2008.
43. Ward J, De Lorenzo R, Husaini S, Kragh J, White C, Morgan T, and Dawson P. A Perfused
Cadaver Training Model for Invasive Lifesaving Procedures: Uncontrolled Hemorrhage. Presented
at NextMed/MMVR20 July 2012.
PATENTS
1. Brockbank, K.G.M., Goldstein, S., Adoma, C., Sheldon, J.K., and Dawson, P.E.,U.S. Patent #
5,741,782. Antibiotic Cocktail and Method of Use. Issue date 4/21/98.

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P Dawson CV_6-14

  • 1. 6/2014 Patti E. Dawson San Antonio, TX dawsonpattie@bellsouth.net Cell: 210-262-2265 SUMMARY Research/Clinical Research ∙ Medical Product Development ∙ Product Support Proficient in both pre-clinical (bench and animal) and human clinical project design and management. Proven success with clinical study execution, data collection, analysis, and reporting to FDA. Managed the activities of individual projects in a manner that ensured that the studies were conducted within GCP and FDA regulations and requirements. Developed strong professional relationships with site Principal Investigators. Extensive medical research and development expertise with understanding across multiple therapeutic areas including cardiac, vascular, orthopedic, and general surgical grafts, organ transport solutions, and hemorrhage control devices. Developed, tested and implemented methods for decontamination, processing and cryopreservation of numerous allografts and xenografts. Strong scientific writing skills including grants, technical reports and more than 60 publications in medical/scientific journals. Strong project management skills. Significant presentation experience, including frequent presentations to surgeons and other health care staff, and presentations at national/international meetings. Worked closely with sales/marketing in preparing marketing materials, assisting with site sales analyses, and in technical support of multiple product lines. Have favorable NACI background clearance and CITI training. PROFESSIONAL POSITIONS BRAIN SENTINEL™ Nov 2012 – May 2014 Director of Clinical Research Summary: Managed multiple clinical research projects for a seizure detection device. Planned and conducted a multicenter study with nine hospitals sites in the US. Wrote all study protocols, case report forms, and other clinical study related documents. Performed study start up activities and ongoing study monitoring to ensure ongoing compliance to study protocol and applicable regulations. Managed the staff of regional Clinical Research Associates. Coordinated database creation, data management and statistical analysis for study. Interacted with FDA regarding regulatory submissions and ensured compliance with FDA regulations, IRB and/or ethics committee requirements, and overall clinical objectives. BROOKE ARMY MEDICAL CENTER Mar 2012 – Aug 2012 Research Project Manager (contract position) Summary: Responsible for providing project management for a Department of the Army simulation and animal/live tissue study to explore the optimal techniques and procedures to evaluate training and
  • 2. Patti Dawson dawsonpattie@bellsouth.net 210-262-2265 develop models in invasive lifesaving medical procedures. Responsible for day-to-day conduct of the study, record keeping, documentation, report and manuscript preparation, and regulatory compliance including preparation of IRB and IACUC submissions. Was successful in completing project and all required reporting in allotted time. CRYOLIFE, INC. 1987-2009 Leading processor of human tissue allografts worldwide Director of Clinical Research (2006 - 2009) Summary: Managed all aspects of clinical research involving company’s tissue products across multiple therapeutic areas for allograft and xenograft products. Product lines included cardiac, vascular, general surgical and orthopedic grafts. Manage supporting staff of clinical project specialists and managers. Proficient with multiple clinical project management, budget administration (1.5 M per year), coordinating/monitoring data collection, analyzing data, and supporting regulatory submissions. Skilled in investigation and assessment of adverse events and complaints associated with marketed products. Maintained thorough and current knowledge of competitive products and surgical trends in all therapeutic areas. Led or participated in numerous multi-departmental project teams. Primary Accomplishments: • Conducted retrospective clinical study collecting data for 342 human subjects receiving the decellularized CryoValve SG pulmonary valve at 7 study sites. Compiled, analyzed and submitted data within project timeline to FDA resulting in successful receipt of 510(k) clearance. Spearheaded preparation of manuscript for publication. • Prepared submission for marketing claim of reduced antigenicity of the decellularized pulmonary valve resulting in successful receipt of special 510(k). • Planned and implemented FDA required post-clearance study for decellularized pulmonary valve. Successfully recruited all desired study sites. • Prepared and received HUD (humanitarian use device) designation for CryoValve SG aortic valve; HDE (humanitarian device exemption) study currently underway. • Planned and conducted animal studies for a xenograft patch product to be utilized in hernia repair. Submitted and received 510(k) clearance for the product. • Travel to customer sites to support clinical research studies and to provide sales/marketing support for tissue products, including attending cases in the OR. Present clinical and pre- clinical data to surgeons and hospital staff to provide clinical information and promote use of products. • Assist with training and education of marketing/sales staff for all tissue products. Assist marketing with preparation of sales/marketing materials. Director Allograft Tissues Research CryoLife, Inc. (1997-2006) Manager, Research and Development CryoLife, Inc. (1987-1997)
  • 3. Patti Dawson dawsonpattie@bellsouth.net 210-262-2265 Summary: Recognized as being responsible for the successful research and development efforts of all the company’s allograft tissue processes. Planned and executed all allograft tissue research projects including development of new methods for collection, decontamination, long-term storage, and in-vitro and in-vivo testing methods. Coordinated transfer of new methods to manufacturing laboratory and served as team leader for project teams. Hired and managed research technical staff, planned and managed budgets for all projects. Assisted with preparation of grant proposals and manuscripts. Primary Accomplishments: • Developed and implemented methods for collection, decontamination, preservation and reconstitution of at least 10 allograft tissues not previously processed for transplant. Responsibilities included research strategy, oversight of study execution, data analysis, preparation of study reports, and providing recommendations to upper management. These developments allowed for the commercial availability of numerous allograft products (cardiac, vascular, and orthopedic) which now save or enhance patient’s lives every day. • Developed, tested and implemented a patented decellularization process for human cardiac (CryoValve SG) and vascular grafts resulting in the successful commercial use of these grafts. • Investigated and assessed adverse events and product complaints. Coordinated and performed collection, histological analysis, and assessment of tissue samples. • Co-authored numerous research papers, book chapters, and patents. • Assisted sales/marketing with technical presentations to surgeons, donor services professionals and other hospital staff. • Assisted with training of marketing staff in various scientific aspects of tissue product lines. Served as resource for technical and scientific questions from customers. Emory UniversityAtlanta, GA Research Assistant, Department of Endocrinology (1985-1987) Research focus involved growth hormones and detection of growth inhibitors. Duties included maintenance of animal colony, performance of established study methods, and creation of novel methods for assessment of animal health status and detection of enzyme levels. Universityof Texas Graduate School of Biomedical Sciences/ M.D Anderson Hospital and Tumor Institute Houston, TX (1977-1985) Research Associate Division of Hematology (1984-1985) Research on creation of immunomagnetic fluids for use in removing cancer cells from patient blood/bone marrow. Maintained and manipulated nude mouse colony for departmental usage. Research Associate Immunogenetics (1977-1984) Gene mapping of mouse and rat genome with emphasis on immunologically related genes. Primary methods utilized were HPLC, electrophoresis (numerous methods), plate diffusion. Managed large mouse, rat, and rabbit colony. Highly proficient with laboratory animal manipulations. Performed human gene mapping in specific populations.
  • 4. Patti Dawson dawsonpattie@bellsouth.net 210-262-2265 EDUCATION University of South Alabama, Mobile, Alabama. Bachelor of Science, Biology PROFESSIONAL AFFILIATIONS Member of Association of Clinical Research Professionals (ACRP) PUBLICATION LIST JOURNAL PUBLICATIONS 1. Douglas, T.C. and P.E. Dawson. The position of the gene for glyoxalase I on chromosome 17 of the mouse. Immunogenetics,1979; 8:367-371. 2. Douglas, T.C. and P.E. Dawson. Location of the gene for theta antigen in the Mouse. III. The position of Thy-1 relative to Lap-1 and Mpi-1. J. Heredity, 1979;70:250-254. 3. Douglas, T.C., K.A. Kimmel, and P.E. Dawson. Genetically controlled variation of "acid" beta- galactosidase detected in Rattus Norvegicus by isoelectric focusing. Genetics, 1982;100:455-473. 4. Carpenter, J.F. and P.E. Dawson. Quantitation of dimethyl sulfoxide in solutions and tissues by high-performance liquid chromatography. Cryobiology,1991;28:210-215. 5. Brockbank, K.G.M., C. McCaa, P.E. Dawson, J.L. Milton. Warm Ischemia Limits: Protein synthesis/viability of cryopreserved menisci. J. Transplant Coordination, 1991;1:121-123. 6. Brockbank, K.G.M., J.F. Carpenter, P.E. Dawson. Effects of storage temperature on viable bioprosthetic heart valves. Cryobiology, 1992;29: 537-542. 7. Brockbank, K.G.M., P.E. Dawson. Cytotoxicity of amphotericin B for fibroblasts in human heart valve leaflets. Cryobiology, 1993;30: 19-24. 8. Brockbank, K.G.M., P.E. Dawson, J.F. Carpenter. Heart valve leaflet revitalization. Tissue and Cell Report, 1993;Vol.1, No.2. 9. Brockbank, K.G.M., P.E. Dawson. Influence of whole heart post-procurement cold ischemia time upon cryopreserved heart valve viability. Transplantation Proceedings, 1993;25: 3188-3189. 10. Hansen, T.N., P.E. Dawson, K.G.M Brockbank. Effects of hypothermia upon endothelial cells: mechanisms and clinical importance. Cryobiology 1994;31: 101-106. 11. Eskew, T., J.D.Ollerenshaw, J.M. Philpott, K.Dennis, P.Dawson, Y.S. Sun, W.R. Chitwood, and R.M. Lust. Successful small diameter arterial grafting using cryopreserved allograft arteries. ASAIO Journal,1997; 43:M522-M526. 12. Elkins, R.C., P.E. Dawson, S. Goldstein, S.P. Walsh, and K.S. Black. Decellularized human valve allografts. Ann Thorac Surg, 2001;71:S428-32.
  • 5. Patti Dawson dawsonpattie@bellsouth.net 210-262-2265 13. Elkins, R.C., S. Goldstein, C.W. Hewitt, S.P. Walsh, P.E. Dawson, et al. Recellularization of heart valve grafts by a process of adaptive remodeling. Sem in Thorac and Cardiovasc Surg,2001; 13, No.4, Suppl 1:87-92 14. Elkins, R.C., M.M. Lane, S.B. Capps, C. McCue, and P.E. Dawson. Humoral immune response to allograft valve tissue pretreated with an antigen reduction process. Sem in Thorac and Cardiovasc Surg, 2001; 13, No.4, Suppl 1: 82-86. 15. Giglia JS, Ollerenshaw JD, Dawson PE, Black, KS, and Abbott WM. Cryopreservation prevents arterial allograft dilation. Annals of Vascular Surg, 2002;16:762-767. 16. Davidson PA, Rivenburgh DW, Dawson PE, and Rozin R. Clinical, histologic, and radiographic outcomes of distal femoral resurfacing with hypothermically stored osteoarticular allografts. Am Journal of Sports Med,2007;35, No. 7:1082-90. BOOK CHAPTERS 1. Douglas, T.C., Lake P, Skarvall H and Dawson P. Genetic Factors Influencing the Immunogenicity of Thy-1 Cell Surface Antigens. In Frontiers in Immunogenitics, W.H. Hildemann, ed., Elsevier- North Holland,1981: pp 91-105. 2. Dawson.P.E. Brockbank., K.G.M. Human Heart Cold Ischemia and its Effect on Post- cryopreservation Viability of Heart Valves. In: Cardiac Valve Allografts: science and practice, A.C. Yankah, M.H. Yacoub and R.Hetzer Eds.,Springer,1997:pp 23-28. 3. Black KS, Dawson PE. Allografts. In Encyclopedia of Biomaterials and Biomedical Engineering, GE Wnek and Bowlin GL, Eds.,Dekker,2004:pp 11-18. ABSTRACTS AND PRESENTATIONS 1. Coleman, P.E. and T.C. Douglas. 1979.Linkage data regarding the location of Thy-1 on chromosome 9 and Glo-1 on Chromosome 17. Mouse News Letter, 60:58. 2. Dawson, P.E., T.C. Douglas and K.A. Kimmel. 1979.B-galactosidase. Rat News Letter. 5:45. 3. Douglas, T.C., K. Kimmel and P.E. Dawson. 1980. Genetically controlled electrophoretic variation of "acid" B-galactosidase in Rattus Norvegicus. Isozyme Bulletin, 13:61. 4. Dawson, P.E. and T.C. Douglas. 1980. Donor’s sex can influence Thy-1 immunogenicity. Mouse News Letter, 63:18. 5. Dawson, P.E. and T.C. Douglas. 1981.Linkage data regarding the position of Bgl-e on chromosome
  • 6. Patti Dawson dawsonpattie@bellsouth.net 210-262-2265 9. Mouse News Letter, 65:23. 6. Douglas, T.C. and P.E. Dawson. 1982. Genetic factors influencing the immunogenicity of Thy-1 Antigens. Fed. Proc., 41: 293. 7. Douglas, T.C., P.E. Dawson, and R. Chakraborty. 1982. Genetic control of beta-galactosidase levels in Rattus Norvegicus by factor(s) linked to Glb-1. Isozyme Bulletin 15 supp.:26 (4th Intl. Congress on Isozymes). 8. Dawson, P.E. and T.C. Douglas. 1982. Biochemical genetic markers which differentiate subline AKR/Cum from AKR/J and congenic strain B6.Pl-Thy-1a from C57BL/6J. Mouse News Letter, 67:20. 9. Brockbank, K.G.M., P.E. Dawson. 1989. Cell viability in fresh, refrigerated, and cryopreserved human heart valve leaflets. Presented at the 13th Annual Meeting of the American Association of Tissue Banks. 10. Brockbank, K.G.M., P.E. Dawson. 1990. Cell viability in fresh and stored human heart valve leaflets. Presented at the 27th annual meeting of the Society for Cryobiology, Cryobiology 27:182. 11. Brockbank, K.G.M., J.F. Carpenter, P.E. Dawson. 1990. Comparison of human heart valve leaflets stored at -196ºC and -80ºC. Presented at the 14th annual meeting of the American Association of Tissue Banks. 12. Brockbank, K.G.M., C. McCaa, P.E. Dawson, J.L. Milton. 1990. Warm ischemia limits use of orthopaedic soft tissues. Presented at the 14th annual meeting of the American Association of Tissue Banks. 13. Brockbank, K.G.M., J.F. Carpenter, P.E. Dawson. 1991. Effects of storage temperature on viable bioprosthetic heart valves. Presented at the 5th International Symposium on Cardiac Bioprosthe- ses. 14. Brockbank, K.G.M., P.E. Dawson, R.T. McNally. 1991. Cytotoxicity of amphotericin B for fibroblasts in human heart valve leaflets. Presented at the 5th International Symposium on Cardiac Bioprost- heses. 15. Brockbank, K.G.M., C. McCaa, P.E. Dawson, J.L. Milton. 1991. Warm ischemia limits use of orthopaedic soft tissues. Presented at the 28th meeting of the Society for Cryobiology. 16. McCaa, C., P. Shealy, J. Milton, P.E. Dawson, R. McNally, K.G.M. Brockbank. 1992. A comparison of fresh autograft, cryopreserved allograft and fresh frozen allograft medial menisci in the canine stifle at one year. Presented at the 29th Annual Meeting of the Society for Cryobiology. 17. Brockbank, K.G.M., P.E. Dawson, L.J. Brossolet. 1993. Cryopreservation of allogeneic tissue for anterior cruciate ligament replacement. Presented at the 2nd Congress of the European Associa- tion of Tissue Banks. 18. Brockbank, K.G.M., P.E. Dawson, J.F. Carpenter. 1993. Incubation of heart valve leaflets at 37ºC in culture medium prior to cryopreservation enhances 2-deoxyglucose phosphorylation. Presented at the 30th annual meeting of the Society for Cryobiology.
  • 7. Patti Dawson dawsonpattie@bellsouth.net 210-262-2265 19. Brockbank, K.G.M., P.E. Dawson. 1993. Influence of whole heart post-procurement cold ischemia time upon cryopreserved heart valve viability. Presented at the 2nd International Congress of the Society for Organ Sharing. 20. McNally, R.T., Fronk, D.M., Capps, S.B., Clarke, K.A., Hall, M.T., and Dawson, P.E. 1996.The clinical status of cryopreserved tissue for transplant. Presented at the 33rd annual meeting of the Society for Cryobiology. 21. Ollerenshaw, J., P.E. Dawson, R. Metz, K. Black, 1997. Viability of endothelial cells present on vein conduit and valve leaflet pre and post cryopreservation measured using fluorescent probes. Presented at the 21st annual meeting of the American Association of Tissue Banks. 22. Dawson, P.E., Ollerenshaw, J.D., 1998.Viability and coverage of endothelial cells on human femoral arteries before and after cryopreservaton. Presented at the 22nd annual meeting of the American Association of Tissue Banks. 23. Dawson, P.E., Schorr, A.J., Howell, S.M., Hull, M.L., Haut, T. 1998.Strength comparison of the anterior and posterior tibialis tendons to semitendinosus and gracilis tendons. Presented at the 22nd annual meeting of the American Association of Tissue Banks. 24. Dawson, P.E., Schorr, A.J. 1998.Demonstration of superior cellular viability in cryopreserved meniscus. Presented at the 22nd annual meeting of the American Association of Tissue Banks. 25. Schorr, A.J., Dawson, P.E., 1998.Optimization of harvesting, cryopreservation, and PTFE graft seeding protocols for use with vascular endothelial cells. 26. Dawson, P.E., 1999. Science and application of acquiring allografts. Presented at the 6th annual Wisconsin Perfusion Society Spring Conference. 27. Ollerenshaw, J.D., Matsuura, J.H., Yuksel, U., Dawson, P.E., Trygstad, A., Cameron, A., Goodman, C.L., Davenport, C.K., Rosenthal, D., and Black, K.S. 1999. Biolasticä, a novel vascular graft matrix which supports growth and attachment of human vascular endothelial cells. Presented at the International Society for Cardiovascular Surgery 24th World congress. 28. Dawson, P.E., S. Goldstein, S.P. Walsh, and K.S. Black, 2000. Synergraft treatment of valve allografts. Presented at the 24th Annual Meeting of the American Association of Tissue Banks, Bal Harbour; FL 2000. 29. Elkins, R.C. K.S. Black, P.E. Dawson, S. Goldstein, and S. Walsh, 2000. Decellularized human valve allografts. Presented at the VIII International Symposium on Cardiac Bioprostheses, Cancun, Mexico; Nov. 2000. 30. Elkins, R., M. Lane, S. Capps, C. McCue, P.E. Dawson, 2001. Humoral immune response to allograft valve tissue pretreated with an antigen reduction process. Presented at the Stentless Bioprostheses 4th Annual Symposium, San Diego, CA; May 2001. 31. Matsuura, JH, D Rosenthal, E. D. Wellons, K.D. Anastasiades, D.L. Hubbard, P.E. Dawson, and J.D. Ollerenshaw, 2002. Venous plaque: A new pathologic lesion? Presented at the 26th Annual Meeting of the Southern Association for Vascular Surgery, Miami, FL; Jan 2002. 32. Dawson PE, Carter TR, Cameron AJ, Black, KS. 2002. Intact chondrocytes in human osteoarticular
  • 8. Patti Dawson dawsonpattie@bellsouth.net 210-262-2265 cartilage during long term maintenance. Presented at Arthroscopy Association of North America 21st Annual Meeting, Washington, DC; April 2002. 33. Dawson PE, Black KS, Cameron AJ, Kurz AC, Carlson C, and LaPrade R. 2002. Intact chondrocytes in human osteoarticular cartilage during long-term maintenance. Presented at the 26th Annual Meeting of the American Association of Tissue Banks, Boston, MA Aug 2002. 34. Dawson PE, Cameron AJ, Kite-Powell K, Black KS. 2002. Human explant review: Cellularity of explanted cryopreserved heart valve allografts. Presented at the 26th Annual Meeting of the American Association of Tissue Banks, Boston, MA; Aug 2002. 35. Walsh SP, Dawson PE, Black KS. Biomechanical properties of SynerGraft treated human heart valves and vascular grafts. Presented at Advances in Tissue Engineering and Biology of Heart Valves, Florence, Italy; 2004. 36. Dawson, PE, Black KS, Fronk DM. Effect of ischemic time on cellular viability of vascular tissues. Presented at the 28th Annual Meeting of the American Association of Tissue Banks, Chicago, IL; Aug 2004. 37. Dawson, PE. Preservation methods for osteochondral allografts – Maximizing safety and viability. Presented at the Florida Orthopaedic Society Annual Meeting, Sarasota, FL;May 2005. 38. Goldstein, S, Dawson, P, Walsh S, Heacox A. Engineering connective tissue grafts via antigen reduction technologies. Presented at the In Vitro Biology Meeting, Baltimore, MD. June, 2005. 39. Dawson, PE, Davidson PA, Rivenburgh DW, Cameron AM, Walsh S, Heacox A. Clinical success of hypothermically stored human osteoarticular cartilage grafting and implications for cryopreserved cartilage. Presented at the 42nd Annual Meeting for the Society of Cryobiology; July 2005. 40. Davidson, PA, Dawson PE, Walsh SP. Effect of cryopreservation on human osteoarticular cartilage grafts. Presented at the 6th Symposium of the International Cartilage Repair Society, Dan Diego, CA, Jan. 2006. 41. Dawson, PE, Schrock GE, Takkenberg JJM. Mid-term outcomes after pulmonary valve replacement with CryoValve SG decellularized allograft pulmonary valves. Presented at the 17th International Congress of the European Association of Tissue Banks and 17th Annual meeting of British Association for Tissue Banking, Edinburgh, UK, Nov. 2008. 42. Goldstein S, Dawson P, Ray G, and Heacox A. Immunohistochemical evidence for antigen reduction in decellularized human aortic and pulmonary valves. Presented at the World Society for Pediatric and Congenital Heart Surgery, Montreal, Canada, June 2008. 43. Ward J, De Lorenzo R, Husaini S, Kragh J, White C, Morgan T, and Dawson P. A Perfused Cadaver Training Model for Invasive Lifesaving Procedures: Uncontrolled Hemorrhage. Presented at NextMed/MMVR20 July 2012. PATENTS 1. Brockbank, K.G.M., Goldstein, S., Adoma, C., Sheldon, J.K., and Dawson, P.E.,U.S. Patent # 5,741,782. Antibiotic Cocktail and Method of Use. Issue date 4/21/98.