This document provides a summary of Patricia Grutkoski's professional experience and qualifications. She has over 20 years of experience in research and diagnostic laboratories, including launching laboratory developed tests and implementing new FDA-approved assays. Her areas of expertise include clinical studies using animal and human subjects under various regulatory guidelines. She has a Ph.D. in molecular biology and has held several leadership roles supervising staff and projects at various research institutions and companies.

1. Patricia S. Grutkoski, Ph.D.
1497 Wynne Ave.
St. Paul, MN 55108
Email: pgrutkoski@msn.com
(612) 863-5805 (work)
(651) 485-6072 (cell)
Ph.D. scientist in cellular and molecular biology with 20 years of post-
doctoral experience in research and diagnostic labs. Phi Beta Kappa since 1990.
Areas of expertise include:
 GCP/GLP/GMP, ISO, USP, FDA, CLIA, CAP and OECD guidelines
 In vivo and in vitro testing
 Small and large animal models
 Clinical studies using human subjects
 Project management including multi-department projects and teams
PROFESSIONAL EXPERIENCE
6/07-present Allina Health, Molecular Diagnostics Laboratory
Technical Specialist, 1/2011- present
Technical Consultant, 6/2007-12/2010
 Launched >10 Laboratory Developed Tests (LDT)
 Research and optimization of method
 Organization of validation study
 Created necessary documents including SOPs, QC records
 Performed all training of lab staff
 Worked with Information Systems to build test into electronic medical record.
 Led implementation of 7 IVD assays (performance verification, SOP and QC
development).
 Worked with marketing to develop and maintain client education pieces and all new
test marketing material.
 Implemented and maintained QA/QC programs that led to five flawless inspections
by CAP.
 Performed DNA mutation analysis in clinical research studies resulting in two
publications.
 Participated as a member of the Drug Preparation Laboratory for stem cell clinical
trials
 Supervision and training of technical staff
1/06-5/07 Toxikon Corp., Toxicology
Study Director, 2/2006-5/2007
 Oversaw studies of in vitro cellular and hematological toxicology of medical
devices and products. Finalized protocols and reports.
 Developed protocols for in vitro assays that support in vivo studies or provide
possible alternatives to animal testing.
 Oversaw in vivo studies of small (rodent) and large (dog and monkey) animals.
Included development of protocols, study coordination, and all reports.
 Oversaw special projects in microbiology.
 Worked under GLP/GMP, ISO, USP, FDA, and OECD guidelines (among others)

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 Supervision and training of technical staff (4).
Technical Resources Manager, 1/2006-3/2006
 Worked with clients to develop studies that are scientifically sound and meet the
requirements of regulatory guidelines
 Served as technical liaison between Sales/Marketing and Study Directors
7/03-11/05 Repromedix, Corp., Research & Development
ResearchInvestigator, 8/2005 -11/2005
ResearchScientist II, 7/2003 -7/2005
 Study coordinator and research lead for “Th1/Th2 Cytokine Expression in Recurrent
Pregnancy Loss”. Clinical study in conjunction with Boston Medical Center,
Reproductive Science Center, and My Physician Associates.
 Technical supervisor for the manufacture and performance of Anti-Phospholipid
Antibody ELISA assays.
 Technical supervisor for lymphocyte phenotyping by FACS
 Project team leader for establishment of diagnostic tests for hemostasis proteins
 Supervised technical staff in R&D department (Research Associate level)
 Scientific liaison to Sales & Marketing Department
 Wrote Immunology chapter of Sales Training Manual
 Trained sales personnel in Immunology and Hemostasis
 Scientific input into marketing literature and positioning of tests
 Work with physician experts in fields of immunology and hematology
 Present scientific lectures to prospective clients
6/01-7/03 Rhode Island Hospital, Division of Surgical Research
Instructor, 7/2002-7/2003
ResearchFellow, 6/2001-6/2002
Academic research and collaborations resulting in 15 publications using small animal
models of sepsis and shock.
 Examined the expression of SOCS (suppressor of cytokine signaling) proteins in
inflammatory cells in response to septic challenge and/or shock.
 Established that MCL-1 overexpression has no effect on the apoptosis of immune
cells in response to sepsis.
 Performed study “IDN-6556 in a Mouse Model of Polymicrobial Sepsis: Effects on
Immune Function, Immune Cell Apoptosis, and Septic Mortality” in conjunction
with IDUN Pharmaceuticals, Inc.
 Training and supervision of junior research technician.
4/97-6/01 Rhode Island Hospital, Division of Surgical Research
Post-doctoral Fellow
Academic research and collaborations resulting in 11 publications.
 Research lead for the clinical study “Evaluation of the Impact of Antipyretics in the
Critically Ill”. Clinical investigator: Mitchell M. Levy, M.D.
 Examined effect of hypoxia ± reoxygenation of whole blood on receptor expression
and binding capacity on PMN.
 Examined cytokine regulation of PMN apoptosis, migration, and bactericidal
capacity in vitro in normal and hypoxic conditions.
 Established a role for HNP-1 (-defensin 1) as an inhibitor of PMN migration.

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 Supervised Ph.D. candidate examining the effects of hypoxia and extracellular
matrix proteins on PMN apoptosis.
 Managed two senior technicians.
EDUCATION AND TRAINING
2014 University of St. Thomas, Minneapolis, MN
Mini MBA Program, May 2014
2009 Emergency Management Institute, U.S. Department of Homeland Security
FEMA Training
2006 Middlesex Community College, Bedford, MA.
Management Training: Business and Industry, February 2006
Project Management: Business and Industry, October 2006
2004 Beckman/Coulter, Miami Lakes, FL
System II FACS Training Course
1997 Ph.D., Molecular Biology, Loyola University of Chicago, Chicago, IL.
Advisor: Gary L. Engelmann, Ph.D.
Ph.D. Dissertation: Role of TGF-ß in Heart Development: Analysis of
the Type II TGF-ß Receptor.
1990 B.A., Chemistry, St. Catherine University, St. Paul, MN.
ACS Certified, Concentration: Biochemistry
PUBLICATIONS
1. Carrado, K.A., K.B. Anderson, and P.S. Grutkoski. Thermal analysis of porphyrin-clay
complexes. In: ACS Symposium Series No. 499 Supramolecular Architecture: Synthetic
Control in Thin Films and Solids. 1992; Ed. T.Bein, ACS, New York: Chap.12, pp155-165.
2. Engelmann, G.L., and P.S. Grutkoski. Coordinate TGF-ß receptor gene expression during rat
heart development. Cellular and Molecular Biology Research. 40(2):93-104, 1994.
3. Schluns, K.S., P.S. Grutkoski, J.E. Cook, G.L. Engelmann, and P.T. Lee. Human thymic
epithelial cells produce TGF-ß3 and express TGF-ß receptors. International Immunology.
7(10):1681-1690, 1995.
4. Wakim, B.T., P.S. Grutkoski, A.T.M. Vaughan, and G.L. Engelmann. Stimulation of a Ca2+-
calmodulin-activated histone 3 arginine kinase in quiescent rat heart endothelial cells compared
to actively dividing cells. J. Biol. Chem. 270(39):23155-23158, 1995.
5. Engelmann, G.L., R.A. Worrell, R.A. Duff, P.S. Grutkoski, and R.P. Harvey. Expression of
cardiac muscle-specific markers in rat myocyte cell lines. Mol. and Cell. Biochem. 157:87-91,
1996.
6. Grutkoski, P.S., and G.L. Engelmann. TGF-ß ligand and receptors: Expression and function in
heart development. The Developing Heart ; Eds. B. Ostadal, M. Nagano, N. Takeda, and
N.S. Dhalla, Lippincott-Raven Publishers, New York, 1997.
7. Leuenroth, S., C. Lee, P. Grutkoski, H. Keeping, and H.H. Simms. Interleukin-8-induced
suppression of polymorphonuclear leukocyte apoptosis is mediated by suppressing CD95
(Fas/Apo-1) Fas-L interactions. Surgery 124(2):409-417, 1998.

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8. Grutkoski, P.S., C.T. Graeber, R. D’Amico, H. Keeping, and H.H. Simms. Regulation of IL-
8RA (CXCR1) expression in PMN by hypoxia and reoxygenation. J. Leukoc. Biol. 65(2):171-
178, 1999.
9. Grutkoski, P.S., R. D’Amico, A. Ayala, and H.H. Simms. IL-1ß stimulation induces paracrine
regulation of PMN function and apoptosis. Shock 12(5):373-381, 1999.
10. Dunican, A., P. Grutkoski, S. Leuenroth, A. Ayala, and H.H. Simms. Neutrophils regulate their
own apoptosis via preservation of CXC receptors. J. Surg. Res. 90(1):32-38, 2000.
11. Leuenroth, S.J., P.S. Grutkoski, A. Ayala, and H.H. Simms. The loss of Mcl-1 expression in
human polymorphonuclear leukocytes promotes apoptosis. J. Leukoc. Biol. 68(1):158-166,
2000.
12. Leuenroth, S.J., P.S. Grutkoski, A. Ayala, and H.H. Simms. Suppression of PMN apoptosis by
hypoxia is dependent upon Mcl-1 and MAPK activity. Surgery 128(2):171-177, 2000.
13. Dunican, A.L., S.J. Leuenroth, P. Grutkoski, A. Ayala, and H.H. Simms. TNF- induced
suppression of PMN apoptosis is mediated through IL-8 production. Shock 14(3):284-288,
2000.
14. Grutkoski, P.S., C.T. Graeber, A. Ayala, and H.H. Simms. Paracrine suppression of apoptosis
by cytokine-stimulated neutrophils involves divergent regulation of NF-B, Bcl-XL, and Bak.
Shock 17(1):47-54, 2002.
15. Grutkoski, P.S., R. D’Amico, A. Ayala, and H.H. Simms. TNF- stimulated PMN suppress
migration and bactericidal activity of PMN in a paracrine manner. Crit. Care Med. 30(3):591-
597, 2002.
16. Grutkoski, P.S., C.S. Chung, and A. Ayala. PMN and lymphocyte apoptosis in the critically ill:
Different means, similar outcome (review). Critical Care and Shock 5(3):155-164, 2002.
17. Ayala, A., C.S. Chung, J.L. Lomas, G.Y. Song, L.A. Doughty, S. Gregory, W.G. Cioffi, J.
Reichner, H.H. Simms, and P.S. Grutkoski. Shock-induced neutrophil mediated priming for
acute lung injury in mice: Divergent effects of TLR-4 and TLR-4/FasL deficiency. Am. J.
Path. 161(6):2283-2294, 2002.
18. Ayala, A., J.L. Lomas, P.S. Grutkoski, and C.S. Chung. Pathological aspects of apoptosis in
severe sepsis and shock. Int. J. Biochem. & Cell Biol. 35(1):7-15, 2003.
19. Ayala, A., C.S. Chung, G.Y. Song, P.S. Grutkoski, and H.H. Simms. Down-regulation of the
immune response. In: Molecular & Cellular Biology of Critical Care Medicine. Eds. P.
Linden and L.A. Doughty, L.A. Kluwer Academic Publishers, Norwell, MA: Chapter 3,
pp41-78, 2003.
20. Lomas, J.L., C.S. Chung, P.S. Grutkoski, B.W. LeBlanc, L. Lavigne, J. Reichner, S.H.
Gregory, L.A. Doughty, W.G. Cioffi, and A. Ayala. Differential effects of MIP-2 and KC on
hemorrhage induced neutrophil priming for lung inflammation: Assessment by adoptive cell
transfer in mice. Shock 19(4):358-365, 2003.
21. Ayala, A., P.S. Grutkoski, Y. Ding, and C.S. Chung. Mechanisms of immune resolution
(review). Crit. Care Med. 31(8 Suppl):S558-S571, 2003.
22. Grutkoski, P.S., C.T. Graeber, Y.P. Lim, A. Ayala, and H.H. Simms. Alpha-defensin 1 (human
neutrophil protein-1) as an anti-chemotactic agent for human polymorphonuclear leukocytes.
Antimicrobial Agents & Chemother. 47(8):2666-2668, 2003.
23. Ayala, A., Y. Ding, R.J. Rhee, L.A. Doughty, P.S. Grutkoski, and C.S. Chung. Pathological
aspects of the anti-inflammatory/immune suppressive response to sepsis and shock. Recent
Res. Devel. Immunol. 5:13-35, 2003.
24. Grutkoski, P.S., Y. Chen, C.S. Chung, and A. Ayala. Sepsis-induced SOCS-3 expression is
immunologically restricted to phagocytes. J. Leukoc. Biol. 74(5):916-922, 2003.
25. Ayala, A., J.L. Lomas, P.S. Grutkoski, and C.S. Chung. Fas-ligand mediated apoptosis in
severe sepsis and shock (review). Scand. J. Infect. Dis. 35(9):593-600, 2003.

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26. Grutkoski, P.S., Y. Chen, C.S. Chung, W.G. Cioffi, and A. Ayala. Putative mechanism of
hemorrhage-induced leukocyte hyporesponsiveness: Induction of suppressor of cytokine
signaling (SOCS) -3. J. Trauma 56(4):742-747, 2004.
27. Lomas-Neira, J.L., C.S. Chung, P.S. Grutkoski, E.J. Miller, and A. Ayala. CXCR2 inhibition
suppresses hemorrhage-induced priming for acute lung injury in mice. J. Leukoc. Biol.
76(1):58-64, 2004.
28. Ding, Y., C.S. Chung, S. Bray, Y. Chen, P.S. Grutkoski, S. Carlton, J.E. Albina, and A. Ayala.
Polymicrobial sepsis induces divergent effects on splenic and peritoneal dendritic cell function
in mice. Shock 22:137-144, 2004.
29. Grutkoski, P.S., C.S. Chung, J. Albina, W. Biffl, and A. Ayala. Apoptosis in the critically ill.
In: Textbook of Critical Care, 5th edition. Eds. M.P. Fink, E. Abraham, J.L. Vincent, and
P.M. Kochanek, Elsevier Saunders Publishers Inc, Philadelphia, PA: Chapter 38, pp195-
202, 2005.
30. Lomas-Neira, J.L., C.S. Chung, P.S. Grutkoski, S. Carlton, A.L. Dunican, H.H. Simms, W.G.
Cioffi, and A. Ayala. Divergent roles of the murine neutrophil chemokines in hemorrhage
induced priming for acute lung injury. Cytokine. 31(3):169-79, 2005
31. Chung, C.S., Y. Chen, P.S. Grutkoski, L. Doughty, and A. Ayala. SOCS-1 is a central
mediator of steroid-increased thymocyte apoptosis and decreased survival following sepsis.
Apoptosis. 12(7):1143-53, 2007.
32. McCormick, S.R., M.J. McCormick, P.S. Grutkoski, et al. FLT3 mutations at diagnosis and
relapse in acute myeloid leukemia: cytogenetic and pathologic correlations, including cuplike
blast morphology. Arch Path Lab Med. 134(8):1143-1151, 2010.
33. McCormick, S.R., R.R. Higgins, P.S. Grutkoski, et al. Myeloid neoplasm with translocation
t(2;11)(p21;q23-24), elevated microRNA 125b-1, and JAK2 exon 12 mutation. Br J Haematol
169(2):290-293, 2015