Development Data

Mary Kish

508-***-**** ***************@*****.*** LinkedIn URL: Mary Kish

PROFILE

Scientist: Impacting through innovation with solution driven ideas. MS degree in Molecular Biology a BS Physio-Neuro Biology and over 15 years of industry experience from research supporting small molecule drug discovery efforts, to enzyme assay development to UPLC protein characterization/method development. This includes the ability to perform Design of Experiment studies and generate information to optimize for best conditions through statistical analysis to understand what causes the greatest change and what variables have the greatest impact. Substantiated record of increasing effectiveness by combining innovative science in a team based environment.

PROFESSIONAL EXPERIENCE

Charles River Laboratories, Biologics Testing Solutions, Shrewsbury, MA 8/2016 – present

Scientist II

Conduct UPLC and HPLC method development, DOE and process improvement as needed

Perform SEC, RP and WCX Analysis of protein samples to support the Biosimilars project

Troubleshoot analytical instrumentation to solve technical problems

Serve as a Research Scientist responsible for the development and execution of studies related to the characterization and analysis of biotherapeutics

Manage projects, interpret and report data and ensure regulatory compliance

Interpret experimental data in JMP statistical analysis software for generating frequency distribution information, analysis of variance and correlation techniques and write reports

Biogen, Technical Development, Cambridge, MA 7/2014 – 12/2015

Associate Scientist III (contract position)

Investigated formulations evaluating alternate excipients for greatest biosimilar stability through novel formulation development and characterization evaluation.

Performed analytical characterization of study samples using various protein biochemical or biophysical methods.

Executed formulation and process development study protocols, stability, and product characterization studies.

Pfizer, Inc., Pharmaco-Dynamics and Metabolism Group, Groton, CT 2/2007 – 7/2011

Senior Associate Scientist

Influenced change in the FDA guidelines for better understanding of drug metabolism by the use of mRNA as a necessary tool for prediction of CYP-3A4 induction. (see publications)

Increased the productivity of key metabolism induction assays by 400% while dramatically decreasing costs and time associated with key ‘go/no go’ support of novel compounds by expanding a 24-well to a 96-well-plate platform through modification, analysis, validation and rewriting of the standard operating procedure.

Through independent research and collaboration I spearheaded an effort to reduce assay development cycle time by 98% by developing a 20 minute method using RapidFire®/MS technology to characterize enzymatic data. This involved the improvement of the current 40 hour HPLC method which resulted in increased assay efficiency, cost effectiveness and reproducibility of data.

Advanced in-vitro understanding of bio-therapeutics and their effect on induction through design and development of assays in mammalian hepatocytes.

Ensured all analyzed in-vitro drug-drug interaction and metabolism study data for all required development projects were accurate and ready for FDA reports.

University of Albany, School of Public Health, Dept of Biomedical 12/2004 – 6/2005

Sciences at Gen*NY*Sis Center for Excellence in Cancer Genomics, Rensselaer, NY

Research Scientist

Contributed to the understanding of DNA repair after exposure to an alkylating agent through recombinant DNA technology.

Pfizer Inc., Research Pharmacology, San Diego, CA 9/2003 – 5/2004

Research Associate Scientist (contract position)

Collaborated on a new innovative concept: 2-gene expression of recombinant proteins in mammalian cells for effect on PPAR regulation

Developed novel therapeutics by evaluating the efficacy of small molecules in reporter gene assays on mammalian cells

Improved group morale by volunteering to take over weekend dosing schedule in order to gain experience with small animals including handling, dosing, dissection and tissue collection/harvesting for in-vivo assays.

MiraCosta Community College, San Diego, CA 1/2004 – 5/2004

Associate Faculty: Course: Biology 206 “Principles of Separation and HPLC”

Engaged students in separation and purification techniques through lecture and lab.

Provided future scientists with insight into the R&D industry with trouble shooting ideas when using analytical tools.

Ontogen Corporation, Drug Discovery - Biology, Carlsbad, CA 1/2001 – 1/2003

Senior Research Associate I

Developed, optimized, and validated HTS screens, secondary screens and counter-screen measures for identifying small molecules ability to inhibit kinases and phosphatases. This included PK values, IC50, Km, and Vmax determination.

Expressed, purified, and characterized cloned proteins and performed routine cytotoxicity assays in support of several different projects

Contributed to the better understanding of diabetes that identified chemicals acting as inhibitors of HSL, an enzyme of lipid metabolism that affects glucose control. Research lead to a publication.

Genetics Institute, Drug Substance Development, Andover, MA 9/1999 – 6/2000

Research Associate (contract position)

Increased the rate of drug development by providing a team of twelve scientists with quick and accurate ELISA data sets every week..

Analyzed assay data and designed EXCEL spreadsheets for data.

Maintained CHO (mammalian) cell cultures in spinner flasks.

EDUCATION:

MS Molecular Biology, Southern Connecticut State University, New Haven, CT, 1996

BS Physio-Neuro-Biology, University of Connecticut, Storrs, CT, 1993

Graduate Certificate in Biotechnology and Bioprocessing, University of Massachusetts Lowell,

Lowell, MA, 1999

Post Baccalaureate Program, University of Hartford, Hartford, CT 2012-2013

MEMBERSHIPS/AFFILIATIONS

Sigma Alpha Pi – National Leadership Honor Society, inducted May 2013

AWARDS

The Achieving Customer Excellence Award, Charles River Laboratories, 2017

Excellence Award, Sigma Alpha Pi 2013

Individual Performance Award, Pfizer July, 2010

Individual Performance Award, Pfizer Feb, 2010

Individual Performance Award, Pfizer 2009

Technical Achievement Award, Uniroyal Chemical 1996

Author’s Award, Uniroyal Chemical 1996

PUBLICATIONS

Fahmi, Odette A; Kish, M; Boldt, Sherri; Obach, Scott. “Cytochrome P450 3A4 messenger RNA is a more reliable marker than CYP3A4 activity for detecting PXR-activated induction of drug metabolizing enzymes.” Department of Pharmacokinetics, Dynamics and Metabolism (OAF, MK, SB and RSO) Pfizer Inc. Global Research & Development, Groton, Connecticut. Published June 21, 2010. DMD.110.033126

Fahmi O.A., Boldt S, Kish M, Obach RS, Tremaine. L. “Prediction of drug-drug interactions from in-vitro induction data: application of the relative induction score approach using cryopreserved human hepatocytes. “Drug Metab Dispos. 2008 Jun 2;PMID: 18519654

Odette A. Fahmi, Tristan Scott Maurer, Mary Kish, Edwin Cardenas, Sherri Boldt, and David O Nettleton. “A combined model for predicting CYP3A4 clinical net drug-drug interaction based on CYP3A4 inhibition inactivation, and induction determined in-vitro.” Drug Metab Dispos. May 19, 2008; DMD. 107.018663

Deborah H. Slee, Abhijit S. Bhat, Truc N. Nguyen, Mary Kish, Katy Lundeen, Hui-Ling Wang, Michael J.Newman, Peter Pallai, Kevin M. Short, Stephen J. McConnell.“Pyrrolopyrazinedione Based Inhibitors of Human Hormone-Sensitive Lipase (HSL).” Journal of Medicinal Chemistry.2003, Vol. 46. p.1120-1122.

McDonald, P.T., Kish, M.K., King, P.A. Dunagan, F.J., and Weiland, R.T. Field Persistence of Several Insecticides on Cotton Foliage as Determined by Beet Armyworm (Spodoptera Exigua) Bioassay. p.1164-1167. 1998 Proceedings Beltwide Cotton Conferences. Product Resistance Conference, National Cotton Council, Memphis, Tennessee.

SKILLS

In-vitro assay In-vivo assay Dosing Oral gavage

Cell Culture Aseptic Technique ELISA SDS-PAGE Western Blot Cloning & Expression LIMS HTS

DNA/RNA isolation Transfection Fermentation DOE

Protein purification RT-PCR GLP/cGMP Immunoassays Liquid handling Teaching/mentoring 32 Karat SoftMax

Electronic notebook JMP EMPOWER MS Office

INSTRUMENTATION

HPLC/UPLC SoloVPE PA-800 Plus TAQMAN

plate readers GXII/LabChip ICE3:Protein Simple

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