State University Professional Experience

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Malathi Banda PhD

201-***-**** Greenfield

************@*****.*** Indiana, 46140

https://www.linkedin.com/in/malathi-banda/

Scientist with early drug discovery/ development expertise in industry, government and academia. Expertise in in-vitro and in-vivo Toxicology studies, Project and Client management. Managed GLP client-sponsored studies with applicable regulatory requirements. Have working knowledge of safety and risk assessment, Food and Drug Administration (FDA) regulations, current Good Laboratory, Clinical and Manufacturing Practices (GLP GCP and GMP). Primary responsibilities include: designing studies, performing experiments, analyzing data, writing reports, manuscripts and presenting data at various national and international meetings. EDUCATION:

Ph.D: Biological Sciences, GPA: 3.97. Wayne State University, Detroit, MI, USA. 2003 -2009 Certificate in Regulatory Sciences, GPA: 4. University of Arkansas Medical School, Little Rock, AR, USA. 2013-2015.

M.Sc: Biotechnology, University of Hyderabad / Hyderabad Central University, Hyderabad, India. 1999-2001.

B.Sc:Triple major in Genetics, Microbiology and Chemistry, Osmania University, Hyderabad,India.1996-1999.

PROFESSIONAL EXPERIENCE

Covance Laboratories Inc (CRO) January 2017- April 2017 Early Development; Genetic Toxicology

Study Director

• Provided leadership and study direction during the conduct of client-sponsored early development, Genetic Toxicology studies with applicable regulatory requirement in a GLP-compliant environment.

• Responsible for the study design, protocol development, oversee of scientific and technical conduct, data interpretation, review, documentation and report writing.

• Maintained continuous client interaction throughout the development and conduct of studies

• Coordinated efforts of the internal and external study team to ensure study objectives are met and timelines are adhered to.

• Early development • Risk Assessment • Regulatory Science

• Toxicology • GLP • Project Management

• Safety Assessment • Invitro preclinical models • Client Management 2

• Maintained knowledge of the latest regulatory standards, requirements, and guidelines

(OECD, ICH, VICH, ISO, etc) on chemicals, small molecule pharmaceuticals, biologics, veterinary drugs, and medical devices.

• Developed expertise in a variety of in-vitro and in-vivo genetic toxicology assays (ICH battery, Ames, chromosome aberration, micronucleus test, comet assay, and other screening assays).

• Reviewed 50+ study reports and gained deep understanding of pre-clinical safety assessment and development of small molecule pharmaceuticals, biologics, medical devices, and consumer products.

• Maintained knowledge of the latest regulatory guidelines and current trends on test methods, analysis, and interpretation of data.

US Food and Drug Administration

National Center for Toxicological Research

Lead Scientist / Staff Fellow 2016

An Oak Ridge Institute for Science and Education (ORISE) Fellow/ Research Scientist 2013 -2016

• Conducted toxicological research and safety assessment studies.

• Developed toxicology testing strategies, established in-vitro toxicology model, and provided mechanistic toxicity data on FDA regulated chemicals for risk assessment.

• Reviewed regulatory submission to FDA (pharmacology, Pharmacokinetics / toxicokinetic / ADME, general toxicology studies, developmental and reproductive toxicology studies).

• Managed six different research projects by strategic timeline management planning, providing technical direction, data analysis and interpretation.

• Led efforts to troubleshoot and solve assay development and validation problems.

• Established an in-vitro/ ex-vivo preclinical 3D tissue culture model to assess molecular- targeted combination therapies for personalized cancer treatments.

• Developed and validated a quantitative PCR based assay that can measure a target mutation when present 1 in 100,000 wild-type alleles.

• Measured specific cancer driver mutations as biomarkers to improve cancer risk assessment and public health.

• Collaborated with CDER/FDA, and EPA projects.

• Reviewed and provided input on the project proposals related to health disparities. Barbara Ann Karmanos Cancer Institute 2009-2012

Wayne State University, Department of Surgery

Postdoctoral Researcher

• Worked in the translational Medicine group and provided leadership and scientific guidance to perform a variety of drug discovery studies.

• Responsible for proposal and protocol development, study design, study conduct, data analysis and interpretation, quality review, reporting, and timeline management.

• Established the role Metabotropic glutamate receptor-1 in breast oncogenesis.

• Determined that ZEB2 serve as a molecular target for the antiangiogenic therapy of cancer and other angiogenesis-driven diseases.

• Mentored research scientists in their associated projects. Wayne State University 2003 - 2009

Department of Biological Sciences

Graduate Research Assistant

3

• Discovered novel transcripts of BAX mRNA and determined their functional roles.

• Conducted an effective evaluation of the “housekeeping” control genes for radiation exposure.

• Developed a microfluidic chip that can bind mRNA from a small volume of human blood.

• Managed and trained undergraduate students in their thesis research projects. PUBLICATION PROFILE:

Authored several manuscripts published in high impact peer-reviewed journals. https://scholar.google.com/citations?user=I2ccUVsAAAAJ&hl=en SKILLS DEVELOPED:

• Cytotoxic T Lymphocyte Assays

• In-vitro and in-vivo toxicology assays

• Flow Cytometry

• Cytotoxicity assays

• High-content microscopy and confocal microscopy including 3 D Zstack imaging

• In vitro 3D preclinical model

• Mouse Xenograft model

• Statistical variations and regression analyses using SAS, JMP and PRIZM software AWARDS:

• FDA-NCTR Directors Special Citation Award, “For creativity and dedication in the development of methods for the culture of ex-vivo lung tumor spheroids.” (2016)

• FDA-NCTR Outstanding Service Award, “For excellence in methods development for the quantification of the human HRAS codon 12 GGC to GAC mutation” (2015)

• FDA-NCTR Group Recognition Award, “For dedication and outstanding performance combining neutral reporter gene mutational analyses with ACB-PCR measurement of cancer driver mutations to understand carcinogen mode-of-action.” (2015)

• Thomas C Rumble Fellowship awarded to the outstanding freshman by Wayne State University, Detroit, MI (2003-2004).

HONORS

• Hold Leadership roles (Program co-chair, elected Councilor, committee member) for Environmental Mutagenesis and Genomics Society.

• Editorial Board Member of International Journal of Genetics and Genomics.

• Editorial Board Member of Scholars Academic and Scientific Society Journal

• Serving as a Peer-Reviewer for various international scientific journals in the fields of genetic toxicology and cancer biomarkers.

• Selected for FDA Fellows Experiential Rotation Program with FDA’s Office of Minority Health.

• Co-chaired a session on Case studies in in-vitro Genetoxic assays session at 2015 Environmental Mutagenesis and Genomics Society annual meeting. MEMBERSHIPS/AFFLIATIONS

• Member of American Association for Cancer research.

• Member of the Environmental Mutagenesis and Genomics Society.

• Member of Society of Toxicology.

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