Contact
Michelle DeSimone, Ph.D.,
www.linkedin.com/in/michelle-
desimone-ph-d-dabt-16768625
(LinkedIn)
Top Skills
Communication
Relationship Building
Sparring
Languages
English
Italian
Certifications
DABT
Regression and Analysis of Variance
Methods in Quantitative Genetics
QTL Mapping
Diplomate of the American Board of
Toxicology (D.A.B.T.)
Honors-Awards
2014 Occupational and Public Health
Best Manuscript Award
2013 Carcinogenesis Postdoctoral
Fellowship
2013 ELSI Postdoctoral Award
2012 Postdoctoral Fellowship
2012 New Investigator Travel Award
Publications
Pleiotropic Effects of the
Trichloroethylene-Associated P81S
VHL Mutation on Metabolism,
Apoptosis, and ATM-Mediated DNA
Damage Response.
Regulation of KLF4 turnover reveals
an unexpected tissue-specific role of
pVHL in tumorigenesis.
DABT
Chief of Staff at Regeneron Pharmaceuticals
New York, New York, United States
Experience
Regeneron
4 years
Director, Chief of Staff
January 2022 - Present (1 year 10 months)
Associate Director, Chief of Staff
2019 - December 2021 (2 years)
Noven Pharmaceuticals
Principal Scientist, Clinical Pharmacology & Translational Sciences
2017 - 2019 (2 years)
Greater New York City Area
• Served on Program Teams as Subject Matter Expert for translational
research strategies to identify and advance candidates from discovery to
clinical phase.
• Responsible for the design and oversight of nonclinical and bioanalytical
studies (GLP and non-GLP); Identification of CROs to request bids/proposals,
generation of CDA/MSA, POs/invoices; Manage budgets, timelines, and data
review; Review and revision of study protocols and final reports for regulatory
submissions; Liaise with bioanalytical vendors for method development
• Author and review relevant sections of regulatory documentation: NDA,
IND, Investigator's Brochure, FDA briefing package, orphan drug applications,
and other justification documents; Participate in FDA meetings
• Participate on due diligence teams to identify key risks and opportunities for
candidate development; Responsible for reviewing the messaging of clinical
and nonclinical data including toxicology, ADME, PK, and pharmacology;
Ensured harmonization through regulatory document preparation.
• Communicate study results to cross-functional project teams, including
the interpretation of results from a translational perspective; Provide
recommendations for de-risking in a step-wise approach
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• Partner with commercial and business development teams to identify new
assets with characteristics favorable for transdermal drug delivery, including
ADME, PK, or clinical safety

Regeneron Pharmaceuticals, Inc.

Scientist, Program Operations, Development Sciences (re-org of
Strategic Program Direction
2016 - 2017 (1 year)
Tarrytown, NY

• Served on the Strategic Program Team (SPT) in partnership with the Global
Program Head (GPH) to align the pre-IND data package to the strategic vision
for development candidates.
• Responsible for leading due diligence on internal data sets with cross-
functional teams to prepare for IND/CTA; Authored and prepared the Opt-
in document for partnered decision-making; Aligned the messaging of data
supporting the clinical plan and indication; Worked directly with Subject Matter
Experts on Opt-in sections and visualization needs.
• Served on late stage development teams to support the commercial launch
of product candidates including, Kevzara® (sarilumab) for rheumatoid arthritis
and Dupixent®(dupilumab) for atopic dermatitis by editing clinical manuscripts
from CRO partners to align scientific content and brand strategy with Global
Program Head and Medical Affairs team.

Roche
Translational Scientist, pRED External Development Group
2014 - 2016 (2 years)
Greater New York City Area

• Translational Scientist for the External Development Group, a cross-

functional drug development team that partnered with external biotechnology
companies for the joint clinical development of assets through Phase 2 clinical
proof of concept with the goal of de-risking potential programs prior to in-
license.
• Partnered with Global Business Development to identify potential assets
within the strategic vision of Roche's Disease Therapeutic Areas; Performed
disease-area landscapes using competitive intelligence resources and served
on internal due diligence teams to review asset profiles; Leveraged expertise
in toxicology and translational biology for strategic ranking of assets against
success criteria; Presented the rationale for Go/No-go recommendations to
Executive Management.

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• With Subject Matter Experts, proposed preclinical de-risking strategies
to internal and external teams across several therapeutic areas including
oncology, CNS, pain, inflammation, and rare disease indications.
• Partnered with Data Science to analyze clinical molecular and genetic
datasets obtained to inform strategies; Communicate and present findings to
Sr Leadership team.
• Authorship of the clinical trial protocol, IND/CTA, ICF, IB, site training
materials; Reviewed dose escalation safety data with medical monitor;
Partnered with Biomarker Lead to develop proof of mechanism/pharmacology
assessments as exploratory endpoints; Collaborate with colleagues both
internally (e.g. Translational Medicine) and externally (CROs, key opinion
leaders) to execute strategy.

North Carolina State University

Postdoctoral Toxicologist, Toxicogenomics
2011 - 2013 (2 years)
Department of Genetics

• Principal Investigator responsible for the design, execution, and interpretation

of novel population-based mouse models to elucidate environmental and
genetic factors that predispose to inter-individual variations in susceptibility to
xenobiotics.
• Experimentally modeled chronic disease in mice using low dose dietary
exposure to environmental carcinogens; Expertise in the application of
genetic mouse model resources (i.e. recombinant inbred lines, knock-outs,
transgenics, humanized knock-ins, and cre-lox systems), as well as in vitro cell
systems (i.e. ES cells, primary cell lines, iPSC generation, cancer derived cell
lines, and reporter lines) for investigative toxicology and pharmacology studies.
• Developed novel strategies (i.e. in vivo and in vitro models) to identify and
understand differences and congruence across mammalian species, especially
as they relate to humans.

University of North Carolina at Chapel Hill

Toxicologist (Ph.D. program), Translational Clinical Research
2006 - 2011 (5 years)
Curriculum in Toxicology

• Conducted original translational research to elucidate the relationship

between sporadic mutations in the VHL tumor suppressor gene and exposure
to environmental carcinogens using transgenic embryonic stem cell models,
transgenic mouse models, and clinical renal cell carcinoma samples.

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• Designed and independently conducted a 1,200 rodent carcinogenesis
bioassay; Served as project leader for working groups including: selection of
endpoints, writing of SOPs, collection of GLP data, analysis of budgets and
funding support, and maintaining external collaborations.
• Developed and validated a novel xenograft model of renal cell carcinoma
using transgenic embryonic stem cells to investigate the molecular and cellular
consequences of gene mutations on normal cell biology, radiation response,
and tumor microenvironment. Published study data in leading national cancer
journal.
• Developed a transgenic mouse population model to evaluate the role
of nutritional status and genetic background on injury-susceptibility using
Affymetrix gene expression arrays.
• Designed a pharmacogenetic study utilizing human renal cell carcinoma
biopsy samples to identify chemical-exposure signatures using arrays and
mutation assays. Responsible for external funding and collaborations with
hospital surgical teams. HIPAA certification.

Massachussetts Institute of Technology

Research Specialist, Mechanisms of DNA Repair
August 2004 - July 2006 (2 years)
Center for Environmental Health Sciences

• Performed in vitro evaluations to assess the repair of DNA damage by

human 3-methyladenine DNA glycosylase (AAG) enzyme, and the mechanism
by which mutations in AAG increase the potential for genomic instability;
Implemented a biochemical assay approach by purifying FPLC proteins to
assess the protein-protein interactions involved in coordinating the mammalian
base excision repair pathway

Pacific Northwest National Laboratory - PNNL

Research Fellow, Systems Biology Group
January 2004 - June 2004 (6 months)
Richland, WA

• In vitro immunology studies investigating the transcriptional and post-

transcriptional regulation of oxidative stress mechanisms in murine
macrophage cell lines; Investigated the activation of LPS-induced tumor
necrosis factor-α signaling pathways, nitric oxide production, gene expression
and post-translational modifications.

Berkeley Lab
ORISE Fellow, Risk Analysis Group
2001 - 2002 (1 year)
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Department of Energy, Berkeley, CA

• Environmental Risk Assessment Toxicologist; Worked with CalTOX, a

computational model, to assess the application of a chemical’s Characteristic
Travel Distance in population exposure assessments; Integrated Human
Toxicity Potentials into population risk assessments and prepared predictive
calculations for case study evaluation

Tufts University
Research Assistant, Biochemistry
January 2000 - April 2000 (4 months)
Boston, MA

• Isolated recombinant human E6 protein from the high-risk strain of Human

papillomavirus (HPV-16) to develop an understanding of its active binding site
using NMR; Developed an ELISA-based colorimetric assay to assess in vitro
binding characteristics of purified E6 protein

Education
University of North Carolina at Chapel Hill School of Medicine
Ph.D., Toxicology with Certificate in Translational Medicine from Howard
Hughes Medical Institute · (2006 - 2011)

North Carolina State University

Postdoctoral Scholar, Toxicology and Toxicogenomics · (2011 - 2013)

Northeastern University
B.S., Toxicology · (1999 - 2003)

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