VIVEK SHUKLA, Ph.D. Center for Tobacco Products Office of Science, US FDA Beltsville, MD 20705 Office: (301) 796-1277 Cell: (240) 277-5155 email: [email protected] [email protected] SUMMARY EXPERIENCE • More than 28 years of drug development, and mechanistic toxicology research experience in an academic setting and regulatory agency, utilizing comprehensive knowledge in cancer biology, epigenetics, induced pluripotent stem cells, toxicology, immunology, pathology, and regulatory affairs. • More than 3 years of experience in the US FDA, as a Toxicology reviewer for Substantially Equivalent applications at the Center for Tobacco Products. • Identifying, distributing, and balancing workload and tasks among lab members in accordance with established workflow, skill level, and/or occupational specialization. • Mentoring junior members of the group about status and progress of work, discussing work progress, and reviewing completed work to ensure that the instructions on work priorities, methods, deadlines, and quality have been met. • Providing toxicology and nonclinical science expertise related to the toxicological aspects of public health issue. • Gathering information and formulating recommendations based on substantial analysis and evaluation of major issues in the field of environmental science, biology, pharmacology, and/or toxicology. • Serving as a regulatory reviewer with responsibility of providing technical support, clarifications, edits of the rationale and justification of the marketing order for the products under review. • Hands-on experience conducting preclinical toxicity studies and evaluating the toxicological and pathological endpoint results in novel drug discovery and drug development projects from natural products. • Possess extensive leadership and service experience in academia and professional societies. Served as the Chair of various committees at the National Institutes of Health and University levels. • Strong written communication skills. Extensive writing experience including reports, manuscripts, reviews, and grants to both federal and private agencies. Independently managed complex projects from start to completion that involved management, organizational skills, decision-making, delegation, communication, planning, motivating, meeting deadlines, and interpersonal skills. Presented and published numerous research findings at regional and at international meetings. • Effective communication skills through extensive teaching experience. Trained many surgery fellows, postdoctoral trainees, visiting fellows, and summer students throughout my career. • Successful track record of driving independent research. Published research articles as an independent investigator in areas of research including “development of induced pluripotent stem cells from lung epithelial cells” where the goal was to understand the underlying mechanisms involved in differentiation and address the associated toxicological concerns and “molecular mechanisms of small cell lung carcinoma”. Findings from this study is highlighted on the cover page of Journal of Thoracic Oncology. EDUCATION Doctor of Philosophy (Ph.D.) Zoology March 2001 VBS Purvanchal University, Jaunpur, UP, India Graduate research topic: Alcohol induced changes in Albino Rats Major advisor: Dr. R.K.Tiwari Master of Science (M.Sc.) Biochemistry June 1995 University of Allahabad, Prayag Raj, UP, India Bachelor of Science (B.Sc.) Dec 1992 Purvanchal University, Jaunpur, UP, India Honors: College Fellowship (1988-1992). Awarded by the College to top 3 students demonstrating academic excellence. EMPLOYMENT HISTORY / SUMMARY OF JOB RESPONSIBILITIES Food and Drug Administration, Toxicologist, GS-0415-13-7, 40 hours/week Oct 2022-Present Food and Drug Administration (FDA), Center for Tobacco Products (CTP), Office of Science (OS), Division of Non-clinical Science (DNCS), Beltsville, Maryland. Duties: • Primary Toxicology reviewer at OS/DNCS to evaluate the substantially equivalent (SE) applications and ToxRAD reviews. • Evaluate the toxicology study data submitted to support the application including in vitro and in silico studies. • Make recommendations about the safety of tobacco products based on the toxicological data in collaboration with chemistry, microbiology, and environmental sciences teams. • Conduct a comprehensive systematic review of the literature on the toxicity of acrolein in mammalian studies to help characterize the dose-response relationships for toxicity that are not well-defined for acrolein, and tobacco use exposure. • Establish a safety margin by evaluating the toxicology literature and by considering the weight of evidence-based safety interpretation as well as the population, pharmacokinetic and pharmacodynamic properties. • Served as a DNCS Co-Lead in RT-UNC affiliated project, “Identification and validation of a biomarker of electronic cigarette smoker”. • Served as a Co