Curriculum Vitae

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Professional Experience

2007-2009
Senior Pharmacovigilance / Regulatory Affairs Consultant
Chattem, Inc., Chattanooga, TN
Department of Product Safety & Regulatory Affairs, David Grob, MS, RAC - Director

• Responsible for all pharmacovigilance (PV) activities relating to adverse events (AE), drug safety, and post-marketing surveillance to ensure regulatory compliance. Primary international PV contract liaison (ARISg).

• Chaired the AE Committee Review meetings and prepared Food & Drug Administration (FDA) Medwatch 3500A forms for over-the-counter (OTC) drugs, devices and dietary supplements.

• Conducted InfoMed tracking system database queries, data mining and literature searches to generate trending analyses, establish product histories and detect safety signals.

• Provided technical/scientific support as well as statistical/data analysis for the Department of Product Safety & Regulatory Affairs, Marketing and Product Development to reduce outside consulting costs.

• Wrote and edited standard operating procedures (SOPs), promotional material for health professionals, white papers and technical documents. Primary author and preparer of New Drug Application (NDA) Periodic Safety Update Reports (PSURs). Assembled and maintained safety and efficacy references.

• Reviewed incident data to develop medical terminology, causality and chronologies for AEs to determine if investigations are warranted and initiated in compliance with FDA and Code of Federal Regulations (CFR).

• Implemented the customized versioning and coding of the InfoMed database program to improve efficiency for Consumer Affairs, Quality Control and the Department of Product Safety & Regulatory Affairs.

• Team member for non-clinical/clinical studies including protocol design, monitoring and management.

• Experience in reviewing and preparing 510(K) pre-market notification and NDA submissions. Experience interpreting Pre-Investigational New Drug (IND) processes as well as assessing Chemistry, Manufacturing, and Control (CMC) and current Good Manufacturing Practice (cGMP) requirements.

• Conducted reviews of labeling, artwork and advertising materials for claim support justification, appropriate language and compliance with federal and state regulatory agencies. Reviewed ingredient listings and formulations for safety issues as well as active and inactive ingredient regulatory permissions.

• Drafted responses to Corrective and Preventive Action (CAPA) investigations, FDA 483 Observations/Warning Letters, internal audits and provided product recall support.

• Conducted drug regulation reviews, CFR and OTC drug monograph interpretation and risk analyses. Gave guidance to six consumer affairs representatives on technical inquiries and disposition of complaints. Provided input to Consumer Healthcare Products Association (CHPA) letters addressing industry draft guidances.

• Utilized effective communication and proficient computer skills such as Excel, Word, and PowerPoint daily. • Member of Drug Information Association and attended 2008 Annual DIA Meeting in Boston, MA.

2004-2007
Postdoctoral Fellow
Johns Hopkins University School of Medicine, Baltimore, MD
Department of Oncology - Division of Immunology & Hematopoiesis
Laboratory of T cell Activation and Tolerance, Jonathan Powell M.D., Ph.D.

• Managed multiple independent and collaborative research projects.

• Established in vivo models of T cell tolerance/activation and analyzed anergic signaling pathways.

• Characterized transgenic and knockout mouse phenotypes. Performed high-dimensional microarray data analysis studies and mouse colony management.

• Communicated research and ideas through seminars, posters, peer-reviewed journals and continuous appraisal scientific literature. Provided guidance for graduate students and technicians.

1998-2003
Graduate Student / Teaching Assistant
The Pennsylvania State University, University Park, PA
Department of Veterinary & Biomedical Sciences,
Pamela (Correll) Hankey Ph.D.

Thesis Project: The role of the MSP/RON signaling pathway in CR3 activation and the regulation of inflammation in vitro and in vivo. (click here for full publication)

• Analyzed a receptor tyrosine kinase pathway in vitro and in vivo within models of infection and inflammation.

• Characterized knockout mouse phenotype. Performed equipment repair and trouble shooting.

• Presented independent research through seminars, posters and peer-reviewed journals.

• Designed and taught two semesters of molecular, cellular and developmental biology.

1997
Research Assistant
Centocor (Johnson & Johnson), Malvern, PA
Immunology and Pharmacology & Toxicology Departments

• Assisted in • Assisted in experiments validating the efficacy of a monoclonal antibody against TNF-alpha (Infliximab/Remicade) within in vivo models of arthritis. Carried out toxicology experiments and ascites production.
• Analyzed clinical chemistries of serum samples. Performed ELISA assays and animal cell culture.

• Dosed laboratory animal and collected samples. Provided animal care and husbandry.

• Conducted information searches and complied with Good Laboratory Practice (GLP) procedures. .

Education

1998-2003
Doctor of Philosophy in Pathobiology
The Pennsylvania State University, University Park, PA

1993-1997,
Bachelor of Science in Animal Bioscience
The Pennsylvania State University, University Park, PA

Capabilities & Technical Skills

Pharmacovigilance/Drug Safety Data Analysis – Adverse event reviews, investigations and reporting; Signal detection and trending; Data mining; Post-marketing surveillance; Medical causalities.

Regulatory Affairs – Labeling reviews; Claim support justification; Ingredient listings and drug regulation reviews; CFR and OTC drug monograph interpretation; Risk analyses.

Technical & Scientific writing/Communication – SOPs; NDA PSURs; Peer-reviewed journal articles; Promotional material for health professionals; White papers; Medwatch 3500A forms; Responses to CAPA investigations, FDA 483 Observations/Warning Letters, internal audits; 510(K) pre-market notification and NDA submissions; Communication of research/ideas through presentations, seminars, email, posters, and meetings; Strong interpersonal skills.

Experimental Design/Management – Statistical and data analysis; Non-clinical/clinical protocol design; Establishment of in vivo murine disease models; Project management; Guidance for consumer affairs representatives, graduate students, technicians.

Computer Skills – Excel; Word; PowerPoint; Outlook; Dreamweaver; Photoshop; CellQuest; InfoMed.

Laboratory Techniques – ELISA; Flow cytometry; Primary cell isolation and tissue collection; Immunohistochemistry; PCR genotyping; Western blots/SDS-PAGE; Real-time RT-PCR; Tissue culture; In vitro kinase, proliferation, enzymatic and cellular-based assays; Knockout and transgenic mouse characterization; Animal handling and dosing.

Publications

Wilson C.B., Ray M., Lutz M.A., Sharda D., Xu J., Hankey P.A. The RON receptor tyrosine kinase regulates IFN-gamma production and responses in innate immunity. J Immunol. 2008 Aug 15;181(4):2303-10.

Huang G.N., Huso D.L., Bouyain S., Tu J., McCorkell K.A., May M.J., Zhu Y., Lutz M.A., Collins S., Dehoff M., Kang S., Whartenby K., Powell J., Leahy D., Worley P.F. NFAT binding and regulation of T cell activation by the cytoplasmic scaffolding Homer proteins. Science. 2008 Jan 25; 319(5862): 476-81.

Collins S., Lutz M.A., Zarek P.E., Anders R.A., Kersh G.J., Powell J.D. Opposing regulation of T cell function by Egr-1/NAB2 and Egr-2/Egr-3. Eur J Immunol. 2008 Feb; 38(2): 528-36.

Zheng Y., Collins S., Lutz M.A., Allen A., Kole T., Zarek P., Powell J.D. A role for mammalian target of rapamycin in regulating T cell activation versus anergy. J Immunol. 2007 Feb; 178(4): 2163-70.

Scheibner K.A., Lutz M.A., Boodoo S., Fenton J.D. and Horton M.R. Hyaluronan fragments act as an endogenous danger signal by engaging TLR2. J Immunol. 2006 Jul; 177(2): 1272-81.

Safford M., Collins S., Lutz M.A.*, Allen A., Huang C.T., Kowalski J., Blackford A., Horton M.R., Drake C., Schwartz R.H. and Powell J.D. Egr-2 and Egr-3 are negative regulators of T cell activation. Nat Immunol. 2005 May; 6(5): 472-80. (* co-first author)

Correll P.H., Morrison A.C. and M.A. Lutz. Receptor tyrosine kinases and the regulation of macrophage activation. J Leuko Biol. 2004 May; 75(5): 731-7.

Lutz M.A., Liu Q-P. and P.H. Correll. Activation of CR3-mediated phagocytosis by MSP requires the RON receptor, tyrosine kinase activity, phosphatidylinositol 3-kinase and protein kinase C zeta . J Leuko Biol. 2003 Jun; 73(6): 802-14. (+ cover figure)

Lutz M.A., (2003) The role of the MSP/RON signaling pathway in CR3 activation and the regulation of inflammation in vitro and in vivo. Ph.D. Thesis. Pennsylvania State University, University Park. 146 p.

Lutz M.A., Gervais F., Berstein A., Hattel A.L. and P.H. Correll. STK receptor tyrosine kinase regulates susceptibility to infection with Listeria monocytogenes. Infect Immun. 2002 Jan; 70(1): 416-8.

Abstracts / Presentations

Lutz M.A., Collins S. and Powell J.D. (2006) The roles of Egr-2/3, mTOR and Cbl-b during anergy induction. Keystone Symposia - Lymphocyte Activation and Signaling, Steamboat Springs, CO.

Wilson C.B., Morrison A.C., Lutz M.A. and P.H. Correll. (2004) Activation of the RON receptor tyrosine kinase by MSP induces the phosphorylation of STAT3 and the upregulation of SOCS 1 & 3 in primary peritoneal macrophages. Experimental Biology 2004 (The American Association of Immunologists), Washington D.C.

Lutz M.A., Morrison A.C. and P.H. Correll. (2003) The STK receptor tyrosine kinase is expressed on tissue-resident macrophages and protects tissues from inflammatory damage. 36th annual meeting of the Society for Leukocyte Biology, Philadelphia, PA.

Lutz M.A., Takakura N., Suda T. and P.H. Correll. (2003) The STK receptor tyrosine kinase is expressed on Kupffer cells and protects the liver from inflammatory damage. Keystone Symposia, Taos, NM.

Lutz M.A., Liu Q-P. and P.H. Correll. (2002) Downstream signaling events from the RON receptor tyrosine kinase related to MSP activation of CR3-mediated phagocytosis in primary peritoneal macrophages. Experimental Biology 2002 (The American Association of Immunologists), New Orleans, LA.

Lutz M.A. and P.H. Correll. (2000) Activation of complement-mediated phagocytosis by MSP through the RON receptor. The American Association of Immunologists and the Clinical Immunology Society Joint Annual Meeting, Seattle, WA.

Lutz M.A. and P.H. Correll. (2000) Activation of complement-mediated phagocytosis by MSP through the RON receptor. 28th annual Mid-Atlantic Immunobiology Conference, State College, PA.

Teaching Experience

Spring 2001
Teaching Assistant - Biology: Function and Development of Organisms (BIOL 240W)
A study of development and physiological processes at the organismic level.

Fall 2000
Teaching Assistant - Biology: Molecules and Cells (BIOL 230W)
A study of cellular phenomena including molecular genetics and metabolic interactions.