Research Interests

Evaluating the safety and quality of FDA regulated products is fundamental to the regulatory and public health function of FDA. Having worked for over 20 years at FDA, as a pharmacology/toxicology reviewer and supervisor (4 years), a clinical pharmacology reviewer (1 year), as the CDER Associate Director for Research Policy and Implementation (12 years), and now as the Director of the Cosmetics Division (3 years), I have a broad, yet fundamental interest and understanding of the type, quality and quantity of scientific data needed, in order to support regulatory decision making. My primary interest is to articulate the relevant regulatory questions, to identify the scientific approaches and data that will support regulatory decision making, and to effectively implement FDA’s mandate, which is to support public health, through appropriate regulation of FDA-regulated products (and ingredients). Ensuring the safety and quality of FDA-regulated products is of utmost interest to me, as well as identifying and documenting the scientific process used to achieve the intended goal of product safety and quality.

Proposed Research Project for FDA Commissioner's Fellow

The use of talcum powder in cosmetic body powders has been associated in the literature, with ovarian cancer outcomes in humans. However, the epidemiology data has remained inconclusive, with respect to direct correlation between talc exposure from cosmetics, and the etiology of ovarian oncogenesis. The Office of Women’s Health (OWH) at FDA awarded in 2016, a two-year research grant to the Office of Cosmetics and Colors (OCAC), in order to better understand the possible mechanistic link between talc exposure from body powder use, and ovarian cancer outcomes. However, OCAC feels that a commissioner’s fellow would contribute greatly to the success of this important regulatory research project, by bringing specialized expertise, as well as the increased visibility that comes from the commissioner’s fellowship program, in order to ensure a positive outcome for this project.

The objective of the proposed project is identify and conduct studies that will lead to a better understanding of the mechanisms by which talc may pose an ovarian cancer risk to women, given the equivocal nature of epidemiological studies which do not directly implicate talc exposure and ovarian cancer risk. Some of the specific questions that we hope to address include the following:

1. Identify whether, and characterize how, talc may be translocated from the vaginal area to the ovaries, in an appropriate animal model. This would be done via the detection of talc in the ovaries, and the characterization of a time course for such events to happen.
2. Identify what might be the initial transcriptional events that would be indicative of possible toxicologically relevant endpoints.
3. Propose possible mechanisms that would indicate whether talc may or may not be involved in ovarian oncogenesis, from cosmetic body powder use in the perineal area.

The project is expected to be done partly in collaboration with laboratory researchers at various FDA laboratories, however under the direction of the preceptor within the Cosmetics Division in OCAC. 

Applicant Requirements

Ph.D. in Toxicology/Molecular Toxicology or related field, with experience in the design, conduct, analysis and interpretation of toxicology data, both from experimental studies as well as from published literature. Excellent writing skills and oral communication skills. Interest generating and using scientific data to support decision making and regulatory policy development.

Selected Recent Publications

1. Antoni Valencia1, Josep Prous1, Oscar Mora1, Nakissa Sadrieh2, Luis G. Valerio, Jr.2†; A novel QSAR model of Salmonella mutagenicity and its application in the safety assessment of drug impurities; Toxicol Appl Pharmacol. 2013 Dec 15;273(3):427-34
2. Chen M-L, Sadrieh N, Yu L. Impact of Osmotically Active Excipients on Bioavailability and Bioequivalence of BCS Class III Drugs. The AAPS Journal, 2013;15(4):1043-1050.
3. Laurenson J, Bloom R, Page S and Sadrieh N; Ethinyl Estradiol and Other Human Pharmaceutical Estrogens in the Aquatic Environment: A Review of Recent Risk Assessment Data; AAPS J. 2014 Mar;16(2):299-310
4. Zolnik B, Bancos S, Kim JS and Sadrieh N; Biological requirements and safety assessment of nanomedicines; Frontiers of Nanobiomedical Research Vol IV; World Scientific Publishing; 2014
5. Kumar S, Shen J, Zolnik B, Sadrieh N, Burgess DJ., Optimization and dissolution performance of naproxen spray-dried nano-crystals; Int J Pharm. 2015;486(1-2):159-66