Medical Writer

Rohit Singhal, PhD, DABT

** ******** ******, **** ***, Framingham, MA 01702 Phone: 501-***-****

Green Card – authorized to work in the US without requiring visa Email: *********@*****.***

Ø Core Competencies:

• Research Scientist with 6 years post-PhD experience in pharmaceutical industry and academia applicable to non-

clinical R&D program and clinical biomarker analysis

• Skilled in scientific writing – 12 publications, writing and editing protocols, and meeting presentations

Ø Team/Leadership Responsibilities:

• Part of US-EU cross-functional project teams, early safety core team and external collaborations

• Project management – Strategized, implemented, and successfully managed projects with CRO and internally

Professional Experience

Freelancer Medical Writer March 2014 – Current

Write, review, and edit scientific publications, study reports, due diligence and literature review.

Sanofi, Framingham, MA, Research Scientist (contract) March 2012 – March 2014

• Part of ‘Non-clinical Early Safety’ team of 8 members and interacted with 2 cross-functional US-EU project teams

• Strategized, conducted, and analyzed pre-clinical IND-enabeling toxicology projects applicable to small

molecules safety assessment

• Drafted study reports and responses for regulatory submission to FDA/EMA

• Complex data analysis and unambiguous interpretation of critical results to senior management

• Project management – Identified CROs, and outsourced projects for complex problems in pre-clinical and

clinical phases I/IV – liver toxicity issues

o Preclinical Study Monitor - ensured resources, study report and timeline for outsourced projects

o Data presentation and report writing; consultation with project teams and management (MS Office Suite)

• Translational Biomarker - Identified and validated new biomarkers of drug-induced liver injury from clinical

phase-I study for investigation of liver tox issues (publication)

• Performed due diligence and safety assessment for Oncology and Immunotherapy drug targets

o Recommended on go/no-go decision

• Working knowledge of GLP, GCP, and ICH regulatory guidelines and eCTD structure

Michigan State University, Lansing, MI, Postdoctoral Fellow May 2008 – February 2012

• Demonstrated – Immunomodulation by complement depletion in rodents alleviates Acetaminophen (Tylenol™)-

liver toxicity by 40%

• Investigated mechanisms of potentiation of TLR4 signal transduction in hepatotoxicity

• External collaboration with Bristol-Myers Squibb on genomic signature analysis of 2 marketed drugs

University of Arkansas for Medical Sciences (UAMS) and US-FDA NCTR August 2003 – April 2008

Graduate Assistant/PhD

• Demonstrated using cellular and molecular biology tools and rodent models – mechanisms of soy-mediated

chemoprevention

• Evaluated estrogenicity of dietary soy in rat and pig models: a paradigm of infants consuming soy formula

All India Institute of Medical Science (AIIMS), New Delhi, India May 2001 – July 2003

Research Fellow

• Pharmacovigilance – reported adverse drug events and reviewed medical information

• Retrospective epidemiological study on 240 patients linking reduced breast cancer relapse and better prognosis

with NSAIDs consumption

Professional Certification – Diplomate of American Board of Toxicology (DABT), 2011

Education

Ph.D. in Toxicology (2003 – 2008), University of Arkansas for Medical Sciences, Arkansas

Dissertation: Modulation of aryl hydrocarbon receptor-mediated signaling by soy consumption and endogenous estrogens

M.S. in Toxicology (1999 – 2001), Jamia Hamdard University, India

B.S. in Chemistry (1996 – 1999), Merrut University, India

Selected Publications (12 Publications in Peer-reviewed journals, 13 Posters, and 2 Conference talks)

Clinical Biomarkers - Singhal R, Harrill A, Menguy F, Jayyosi Z, Watkins P. Elevations in serum biomarkers of

hepatotoxicity after cholestyramine administration in human subjects. BMC Pharmacol Toxicol. 2014 Aug 3;15(1):42.

Drug-Induced Liver Injury - Singhal R, Ganey P, Roth R. Complement activation in acetaminophen-induced liver

injury in mice. Journal of Pharmacology and Experimental Therapeutics. 2012 May;341(2):377-85.

Soy and Gene Expression - Ronis MJ, Shankar K, Singhal R, Badger TM. Mammary Gland Morphology and Gene

Expression Differ in Female Rats Treated with 17β-Estradiol or Fed Soy Protein Isolate. Endocrinology. 2012 Oct 1.

Is Soy Estrogenic? - Singhal R, Shankar K, Ronis MJ. Hepatic Gene Expression Following Consumption of Soy Protein

Isolate in Female Sprague-Dawley Rats Differs from that Produced by 17β-Estradiol Treatment. J Endocrinol. 2009

Jul;202(1):141-52.

Women at Higher Risk to Smoking (PAH)-Mediated Cancer - Singhal R, Shankar K, Badger TM, Ronis MJ.

Estrogenic Status Modulates DMBA-Mediated Hepatic Gene Expression and Carcinogenicity. Carcinogenesis. 2008

Feb;29(2):227.

Soy-Chemoprevention (2) - Singhal R, Badger TM, Ronis MJ. Rats fed soy protein isolate (SPI) have impaired hepatic

CYP1A1 induction by polycyclic aromatic hydrocarbons as a result of interference with aryl hydrocarbon receptor

signaling. Toxicol Applied Pharmacol. 2008 Mar 1;227(2):275-83.

Soy-Chemoprevention (1) - Singhal R, Badger TM, Ronis MJ. Reduction in 7, 12-dimethylbenz[a]anthracene-Induced

Hepatic Cytochrome-P450 1A1 Expression Following Soy Consumption in Female Rats is Mediated by Degradation of

the Aryl Hydrocarbon Receptor. J Nutr. 2007 Jan; 137(1):19-24.

Oncology - Kumar VL, Srivastava A, Singhal R, Kumar V. Immunoreactive Estrogen Receptor in Breast Tumor and

Adjacent Tissue: Association with Clinicopathological Characteristics in Indian Population. J Surg Oncol. 2005 Mar 15;

89(4):251-5.

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