Biomarker Scientist

SHERRI E. BOLDT

** ******* **** ****

North Stonington, CT 06359

860-***-**** (home)

860-***-**** (cell)

*******@****.***

http://www.linkedin.com/pub/sherri-boldt/9/632/358

SUMMARY

Hardworking, dedicated, highly experienced in vitro biologist with expertise in GLP environments, cell biology, immunology and molecular biology. Skilled in cell culture (primary culture and multiple cell lines), immunoassays, CYP450 enzyme assays, RT-PCR, HPLC, CE, ELISAs, SDS-PAGE, gene cloning and plasmid preparation, vector construction, DNA/RNA sequencing, and DNA/RNA isolation/purification from cells. Adept at mentoring and training of new personnel and interns. Works well independently and in a team environment; excellent communication skills. Contributing author to scientific journals and reports; strong writing/editing skills. Talented in quickly mastering and adapting multiple methods for assay development.

PROFESSIONAL EXPERIENCE

PFIZER GLOBAL RESEARCH AND DEVELOPMENT, GROTON, CT

Biomarker Scientist, DSRD Department, BDT and BAT Laboratories (initially a 50/50 split position; became full-time in BDT in June 2015)

2014 – present

Supports the BDT (Biomarker Development Translation) laboratory by utilizing a variety of immunology-based platforms (MSD, Millipore Bioplex, Molecular Devices Spectramax) to provide analysis of preclinical study samples. Serves as POC for studies (coordination of sample collection and sample ordering in Cerner, collection and final QC of data). Performs validations of new assays as needed and generates validation reports.

Also supported the BAT (Bioanalytical Toxicology) laboratory, in accordance with GLP/GMP requirements, by utilizing HPLC assays/Empower software to provide homogeneity and dose concentration analysis for study formulations. Generated CSRs (Contributing Scientist Reports) for summation of results.

LANCASTER LABORATORIES, LANCASTER, PA

Senior Scientist 2012 - 2014

In support of a client located in RI, and in accordance with GLP/GMP requirements, performed analytical testing for process development/process characterization studies for recombinant biopharmaceutical drug substances. Utilizing HPLC (Titer, SEC, Glycan Map) and CE assays; was granted assay reviewer/approver privileges by client. Has mastered use of Empower for analysis of HPLC data, LIMS for entry of assay data, and ELN (Electronic Laboratory Notebook, Waters).

2012

PFIZER GLOBAL RESEARCH AND DEVELOPMENT, GROTON, CT

Senior Associate Scientist, PDM Department, Induction CoE Laboratory

2006 - 2011

Supported PDM (Pharmacokinetics, Dynamics, and Metabolism) Induction CoE (Center of Excellence) global needs by evaluating compounds for their potential to cause cytochrome P450 (CYP450) induction using the immortalized human hepatocyte cell line (Fa2N-4), and cryopreserved human hepatocytes.

Duties included isolation of mRNA from cells, cDNA amplification, and RT-PCR to assess CYP3A4 induction; as well as generation of reports summarizing data for 100 clients and project teams.

• Increased productivity and awareness of Induction CoE by 50% by analyzing and delivering induction data for 600 compounds to internal clients.

• Cited as a co-author on 4 publications (contributed both writing and data).

• Recognized for timely deliverance of data to clients during an increased time of submissions, as well as investigation of how structural changes affected induction, with 2 individual performance awards.

• Led several projects, including an investigation of cytokines on CYP450 enzymes/transporters, investigation of luminescent assay to evaluate induction, and the evaluation, selection and recommendation of 12 new hepatocyte lots. Based on recommendation, 3 lots were purchased.

• Trained over 5 laboratory personnel in cell culture, RNA isolation from cells, and RT-PCR.

• Volunteered for the department’s Safety Committee, conducted laboratory safety inspections.

Associate Scientist/Senior Associate Scientist, DSRD Department,

Investigative Toxicology Laboratory

1998 - 2006

• Strengthened ties with the University of Connecticut by successfully mentoring student intern in successful completion of project to predict mitochondrial toxicity of compounds by measuring mitochondrial membrane potential; recognized with a Pfizer Achievement Award for this work.

• Conducted DSRD (Drug Safety Research and Development) GLP cytochrome P450 analysis on liver tissue from animal preclinical studies for 50 compounds; aided in generating reports.

• Utilized Mitoscan Assay to provide information to project teams about potential mitochondrial toxicity of compounds; received DSRD Team Award for this work. Successfully completed project assessing investigation of Mitoscan assay as a tool to predict toxicity in vivo.

• Mentored and trained 2 summer interns in a formal capacity and 4 others informally.

• Adapted measurement of hemoglobin in liver tissue into P420 assay procedure; developed Nile Red/Oil Red O staining of cells procedure to evaluate steatosis.

• Conducted validation of total binding ELISA for Immunotoxicology laboratory (volunteered to use past skills to aid short-handed group).

• Conducted optimization of β-oxidation assay procedures to measure peroxisomal proliferation in rat/monkey liver, heart, and skeletal muscle.

• Investigated cell lines transfected with CYP450 enzymes as a tool to screen for compounds whose mechanism of toxicity is metabolism by CYPs.

• Served on the department’s SOP (Standard Operating Procedures) Document Committee.

PRIMEDICA, WORCESTER, MA

Scientist

1996 - 1998

Developed and tested a variety of bioassays (ELISAs, cell-based assays) based on client need (contract laboratory).

• Tested various compounds as therapies in HIV-infected cells.

• Successfully adapted myleoperoxidase immunoassay (measure of inflammation) from tube to 96-well plate format.

• Developed and validated reproducible standard curve for cell-based assay.

HYBRIDON, WORCESTER, MA

Associate Scientist

1993 - 1996

• Tested antisense oligonucelotides utilizing a luciferase-based assay, multiple cell lines, and molecular biology techniques including isolation/purification/amplication/sequencing of RNA and DNA, gel electrophoresis, generation of transient and stable transfections, western and Northern blotting.

• Successfully generated multiple HPV target clones via transient and stable transfections in CHO and HepG2 cell lines.

• Demonstrated that Cellfectin was more efficient than Lipofectin in generating stable transfections.

• Work in screening anti-HPV oligos resulted in several candidates being chosen for preclinical study.

HONORS AND AWARDS

Pfizer Individual Performance Awards 2008, 2010, 2014 (2), 2015, 2016 (2)

Pfizer Achievement Award, 2005

Pfizer DSRD Team Award, 2004

Pfizer DSRD Teamwork Ice-T Award, 2016

PROFESSIONAL ASSOCIATIONS

Member, Society of Toxicology, 2005-present

Member, New England Chapter, Society of Toxicology, 2000-present

Member, American Medical Writer's Association, 2011-present

EDUCATION

Master of Arts, Biology

Brown University

Drug-Associated Mitochondrial Toxicity and its Detection In Vitro

Bachelor of Science, Zoology

University of Rhode Island

PUBLICATIONS

• Odette A. Fahmi, Mary Kish, Sherri E. Boldt, and R. Scott Obach. Cytochrome P450 3A4 mRNA is a more reliable marker than CYP3A4 activity for Detecting PXR-Activated Induction of Drug-Metabolizing Enzymes. DMD 38: 1605-1611, 2010.

• Robert Walsky and Sherri E. Boldt. In Vitro Cytochrome P450 Inhibition and Induction. Curr. Drug Metab. 9(9): 928-939, 2008.

•Odette A. Fahmi, Tristan Scott Maurer, Mary Kish, Edwin Cardenas, Sherri E. 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. DMD 36: 1698-1708, 2008.

• Odette A. Fahmi, Sherri E. Boldt, Mary Kish, R. Scott Obach, and Larry M. Tremaine. Predication of Drug-Drug-interactions from In Vitro Induction Data: Application of the Relative Induction Score Approach Using Cryopreserved Human Hepatocytes. DMD 36:1971-1974, 2008.

• David Amacher., Shelli Schomaker, Sherri Boldt, and Michael Mirsky. The relationship among microsomal enzyme Induction, liver weight, and histological change in cynomolgous monkey studies. Food Chem. Toxicol. 44: 528-37, 2006.

• John C. Pettersen, Ingrid Pruimbroom-Brees, Omar L. Francone, David E. Amacher, Sherri E. Boldt, Roy L. Kerlin, and William E. Ballinger The PPARα Agonist Fenofibrate and CP-778,875 Cause Increased β-Oxidation Leading to Oxidative Injury in Skeletal and Cardiac Muscle in the Rat. Toxicol. Pathol. 40:435-447, 2012.

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