Natasha Griffin, PhD

• Support the strategic direction and business development of the In Vitro Diagnostics Regulatory team • Develop and execute regulatory services to meet the unique and specific needs of each client • Facilitate FDA interactions with clients by preparing regulatory submissions and/or providing review of supportive information • Support premarket efforts of clients by informing on regulatory strategy and development of medical devices through design and review of analytical and clinical testing protocols • Specialization in premarket review of microbiology-related in vitro diagnostic devices • Collaborate and interact with other groups within MCRA to ensure that clients receive comprehensive guidance regarding all aspects of the commercialization of their products

CDRH/OPEQ/OHT7/DMD/BAC1 General Description: Manage and coordinate scientific reviewers to perform premarket reviews of molecular microbiology diagnostics by critically analyzing and summarizing scientific data to assess safety and effectiveness while ensuring compliance with established scientific methods as well as FDA policies and federal regulations. Collaborate with internal and external stakeholders to develop and implement sustainable, least burdensome approaches to resolve complex issues by maximizing efficiencies and shaping new policies without compromising standards. Establish professional relationships to promote future collaborations and efficient communication. Represent the FDA at internal and external forums to effectively communicate recommendations and policies via oral presentations and discussions, as well as written documents and responses. Areas of Expertise: -Antimicrobial susceptibility test devices -Devices for the detection of antimicrobial resistance -Devices for the detection of intestinal pathogens -Devices for the detection of colonization -Devices for culture-dependent and culture-independent testing of pathogens -Devices integrated within total laboratory automation systems

FDA Regulatory Review • Provide technical expertise to perform scientific reviews in molecular microbiology; critically analyze and summarize analytical and clinical scientific data of microbiology medical devices to assess safety and effectiveness. • Provide scientifically-supported recommendations for medical device clearance while ensuring compliance with established scientific methods as well as FDA policies and regulations, according to the laws described in the Federal Food, Drug and Cosmetic Act. • Effectively communicate recommendations and policy to internal and external stakeholders via oral presentations and discussions, as well as written documents and responses. • Serve as a lead reviewer individually or in a team to synthesize perspectives to provide comprehensive and informed recommendations, as well as serve as a consultant to provide my expertise in the review of a product. • Use of excellent written and oral communication skills when providing FDA feedback through written reviews and interactive discussions as well as in-person meetings and teleconferences. • Provide concise and relevant feedback to facilitate streamlined and least burdensome approaches. Guidance and Policy Development • Developed and executed guidance documents and new policies related to AST devices. • Effectively communicate updated policy to both internal and external stakeholders. • Collaborate with reviewers and managers to shape new policies and guidance as it relates to the issuance of EUAs in response to the public health emergency. • Serve as the FDA/CDRH representative for Standards organization activities related to AST

Brief Description: Investigate production and novel release of Shiga toxin from a recently emerged, traditionally non-Shiga toxin producing Shigella flexneri clinical isolate. Elucidate mechanisms of Shigella antivirulence. Adaptation of genetic tools for DNA recombineering in Chlamydia trachomatis. (PI: Anthony Maurelli, PhD) Research Activities • Use genetic and biochemical approaches to investigate the regulation, production and release of Shiga toxin from recently emerged, historically non-Shiga toxin producing Shigella flexneri clinical isolates using traditional bacteriological and cell culture methods. o Standard bacteriological methods such as bacterial survival and growth curve assays. o Genetic tools such as plasmid-based cloning, polymerase chain reaction (PCR), DNA mutagenesis, DNA recombineering, generalized transduction, transformation, RNA isolation and analysis. o Biochemical approaches using -galactosidase reporter assays and Western blot analysis. o Use of cell culture for in vivo analyses. • Elucidate mechanisms of Shigella anti-virulence using bacteriological and bioinformatic tools. o Screening and characterizing spontaneous mutants. o Next generation sequencing and analysis. o Use of bacteriological, genetic, biochemical, and cell culture tools previously described. • Adapt genetic tools for DNA recombineering in Chlamydia trachomatis using modified genetic and biochemical approaches, cell culture, and fluorescence microscopy. o Use of bacteriological, genetic, biochemical, and cell culture tools previously described. • Use software packages such as Clone Manager, Snap Gene, File Maker, Vision Works (UVP), Microsoft Office Suite (Word, Excel, Power Point) to maintain, analyze and present data.

Brief Description: Elucidate genetic mechanisms in which virulence factors of Shigella flexneri are regulated in response to various environmental cues. (PI: Helen J. Wing, PhD) Postdoctoral Research Activities: • Investigated the unique ability of the VirB transcriptional regulator to influence virulence gene expression in Shigella flexneri using in vivo and in vitro genetic and biochemical approaches. o Used bacteriological, genetic, and biochemical tools previously described, as well as 32P-labeled DNA methods (i.e., DNaseI Footprint, EMSA, Primer extension) and Chromatin Immunoprecipitation analysis. • Developed independent research project characterizing the role of the SlyA transcriptional regulator in acid resistance, an essential component of S. flexneri pathogenesis. o Used bacteriological, genetic, and biochemical tools previously described and developed novel protocols. Instructor: • BIOL 251: Introduction to Microbiology (lecture) o Re-designed course syllabus and prepared lectures to engage non-microbiology majors. o Maintained on-line course tools (via WebCampus). o Provided regular in-person office hours. Guest Lecturer: • BIOL 464/664: Bacterial Pathogenesis (lecture) • BIOL 351: Microbiology (lecture) o Lectured and led group discussions for microbiology majors.

Study gene regulation in enteric bacterium Salmonella typhimurium, specifically two-component regulatory systems which respond to environmental cues and confer resistance to bactericidal agents. (PI: Yixin Shi, PhD)

Study of various fungal pathogens that cause soybean sudden death syndrome and their effects on different soybean cultivars. (PI: Shuxian Li, PhD)