Program Manager Team Leader
Resume:
Diego Rua, Ph.D., M.B.A.
E-mail: ********@*****.***
Phone # 845-***-****
SCIENTIFIC SKILLS & EXPERTISE
Perform safety and toxicological assessments. Review toxicological risk assessments and biocompatibility evaluations in medical device pre-market regulatory submissions. Review and conduct pre-clinical and clinical safety/efficacy/in-use studies for cosmetic products, OTC drugs and dietary supplements. Liaise with supporting research labs and act as technical representative in government contracts. Evaluate post-market surveillance adverse event reports and safety trends associated with FDA regulated products. Active in the area of alternatives to animal testing in hazard and risk assessments. HIGHLIGHTS OF PROFESSIONAL EXPERIENCE
’18 – 25 Research Biologist/Reviewer – CDRH, FDA (Government)
’15 – 17 Interdisciplinary Scientist – CDER, FDA (Government)
’08 – 15 Biologist/Team Leader - CFSAN, FDA (Government)
’06 – 08 Program Manager – Avon Products R&D (Retail/Personal products industry)
’03 – 06 Senior Scientist – Alticor/Amway (Retail/Consumer goods industry)
’02 – 03 Research Scientist/Group Leader – Fibrogenex, Inc. (Start-up Biotech)
’99 – 03 Postdoctoral fellow – University of Chicago (Academia)
’94 – 98 Research & Teaching Assistant – Wayne State University (Academia)
’91 – 93 Scientist – Strohtech, Inc (Biotech)
EDUCATION
’06 – 09 Master in Business Administration (MBA), with a concentration in Strategic Management. Davenport University.
’94 – 99 Doctor of Philosophy (PhD) in Biological Sciences, with a concentration in Molecular & Cellular Biology. Wayne State University.
’90 – 91 Master of Science in Biological Sciences. Wayne State University.
’86 – 90 Bachelor of Arts in Physics. Kalamazoo College. ACHIEVEMENTS
28 peer-reviewed publications, 1 patent, invited guest speaker Rua, page 2 of 7
LAST APPOINTMENT
’18 - 25 Research Biologist/Reviewer – Center for Devices and Radiological Health. Food & Drug Administration (FDA). White Oak, Maryland. (Government) Review scientific information to determine the biocompatibility and safety of FDA regulated products/medical devices. Member of the Skin Sensitization Working Group in the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). PREVIOUS PROFESSIONAL EXPERIENCE
’15 – 17 Interdisciplinary Scientist – Center for Drug Evaluation & Research. FDA (Government) Review scientific information to determine the safety and efficacy of FDA regulated products/OTC drug products such as sunscreens. Member of the Skin Sensitization Working Group in the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).
’08 – 15 Biologist/Team Leader - Center for Food Safety & Applied Nutrition, FDA (Government) Produce safety assessments on the use of ingredients in FDA regulated products/cosmetic products and color additives. Respond to citizen’s petitions. Evaluate post-market surveillance adverse event reports. Develop guidelines. Design and supervise FDA-sponsored research on botanical extracts with associated adverse event reports. Center representative to ICCVAM and member of its Skin Sensitization Working Group. Review validation data in support of alternative (non-animal) testing methods.
’06 – 08 Program Manager – Clinical Evaluations. Avon Products R&D. Suffern, New York.
(Public company; AVP; 40,300 employees; Personal products industry) Supervised in-house and external clinical safety and/or efficacy studies that supported product development and advertising claims with science, having responsibility over all aspects of study design including: budget, protocol, adherence to GLP/GCPs, and data analysis. Studies involved anti- aging skin care technologies and UVB/UVA sunscreens, as well as medical/cosmetic devices which produced data for 510K submissions. Ensured gathering of proper claim support documentation and reviewed labeling, promotional, and advertising materials. Defended claims through internal and/or external challenges. Managed three supporting scientists and multiple projects in a fast-paced, highly matrixed environment. Initiated and managed relationships with outside contract research organizations (CROs) as well as institutional review boards (IRBs).
’03 - 06 Senior Scientist. Bioassay/Analytical Services. Alticor/Amway. Ada, Michigan (Private company; worldwide retail sales of US$6.4 billion in 2005; 13,000 employees; nutritional supplements/beverages/personal care/cosmetics/home care products) Developed and performed in vitro cell-based assays to support R&D’s characterization and formulation of foods, nutritional supplements, beverages and cosmetic products. Implemented new technologies to facilitate the documentation of functional biological activity in natural raw ingredients as well as their safety and the substantiation of claims made in finished products. Managed three supporting scientists and worked regularly in cross-functional teams.
’02 - 03 Research Scientist- Group Leader. Fibrogenex, Inc. Chicago, IL. (Private company; currently Chifyx http://chifyx.com/; Start-up Biotech) Used conditioned media from large-scale culture of mammalian cells to purify native proteins, such as growth factors and morphogens, which have great potential for therapeutic use. Assayed purified samples for biological activity. Managed two supporting scientists.
’99 - 03 Postdoctoral fellow. Center for Molecular Oncology. University of Chicago. Mentor: Dr Stephen J. Kron. Project: “Establishment and maintenance of polarity states in yeast cells”. Discovered a nuclear export signal (NES) in the mitotic cyclin Clb2p by sequence alignments and structural modeling.
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’98 - 99 Research Assistant. Wayne State University. Detroit, Michigan. Wrote several NIH grant renewals and proposals for my PhD thesis advisor.
’94 - 97 Teaching Assistant. Wayne State University. Detroit, Michigan. Taught students and prepared experiments for laboratory sections of Microbiology, Genetics and Histology courses. Wrote lab examinations for each course and generated lab grades.
’91 - 93 Scientist. Strohtech, Inc. Detroit, Michigan. Contributed in a team effort to express the human hemoglobin gene in yeast cells and purify the recombinant gene product from endogenous proteins.
’87 - 88 Internship Technician. The Upjohn Company. Kalamazoo, Michigan. Set up an Automated Microbiology Identification System (AMBIS) and built up a pathogenic bacteria databank. Trained permanent employees to use the system.
’86 - 90 Undergraduate Teaching Assistant. Kalamazoo College. Kalamazoo, Michigan. Taught and lead conversation sections of Spanish courses EDUCATION COMPLETED
’06 - 09 Master in Business Administration (MBA) with distinction in Strategic Management. Davenport University. Grand Rapids, Michigan.
’94 - 99 Doctor of Philosophy (PhD) in Biological Sciences, with a concentration in Molecular & Cellular Biology. Wayne State University. Detroit, Michigan. Thesis: "Regulation of Cardiolipin synthesis and the role of this phospholipid in Adriamycin- induced Cardiotoxicity". Thesis advisor: Dr Miriam L. Greenberg. Contributed to purify the mitochondrial membrane protein cardiolipin (CL) synthase. Developed a novel screen for isolating yeast mutants in biosynthesis of the phospholipid CL. Showed that CL-devoid yeast mutant cells have lower sensitivity to the chemotherapeutic drug adriamycin, which supports a role for CL in the cardiotoxicity of adriamycin. Used this model system to find analogues of adriamycin that are less toxic to mitochondria.
’90 - 91 Master of Science in Biological Sciences. Wayne State University. Detroit, Michigan.
’86 - 90 Bachelor of Arts in Physics. Kalamazoo College. Kalamazoo, Michigan. SELECTED PRESENTATIONS (total number of presentations: 5)
'13 12th Annual International Conference on the Science of Botanicals, Oxford, MS
“Regulation of cosmetic products in the United States”.
'12 OECD Methods in In Vitro Toxicology, IIVS, Gaithersburg MD “Regulation of the manufacture and safety testing of cosmetics products”
'02 The Cell Cycle Meeting, Cold Spring Harbor Laboratory, Cold Spring Harbor NY and Yeast Genetics and Molecular Biology Meeting, Madison, WI "Blocking Clb2p nuclear export delays mitotic exit and the isotropic switch to promote filamentous growth
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PUBLICATIONS (total number of publications: 28)
Le Y, Ren B, Muskhelishvili L, Davis K, Wang Y, Gwinn W, Rua D, Heflich RH, Cao X. (2025) Characterizing the Pulmonary Toxicity and Potential Mutagenicity of Formaldehyde Fumes in a Human Bronchial Epithelial Tissue Model. Environ Mol Mutagen. in press. Patlewicz G, Nelms M, Rua D. (2022) Evaluating the utility of the Threshold of Toxicological Concern (TTC) and its exclusions in the biocompatibility assessment of extractable chemical substances from medical devices. Comput Toxicol 24:1-11. Wang, Y., Wu, Q., Ren, B., Muskhelishvili, L., Davis, K., Wynne, R., Rua, D., Cao, X (2022) Subacute Pulmonary Toxicity of Glutaraldehyde Aerosols in a Human In Vitro Airway Tissue Model. Int J Mol Sci 23(20):121**-*****.
Beasley, J., Korn, D., Popov, K., Dumproff, R., Sessions, Z., Rath, M., Alves, V., Causey, K., Rua, D., Muratov, E., Tropsha, A. (2022) Integrated approach to elucidate metal-implant related adverse outcome pathways. Regul Toxicol Pharmacol. 136:105***-******. Alves, V., Borba, J., Braga, R., Korn, D., Kleinstreuer, N., Causey, K., Tropsha, A., Rua, D., Muratov, E. (2022) PreS/MD: Predictor of Sensitization hazard for chemical substances released from Medical Devices. Toxicol Sci. 189(2):250-259
Ren, B., Wu, Q., Muskhelishvili, L., Davis, K., Wang, Y., Rua, D., Cao, X. (2022) Evaluating the sub-acute toxicity of formaldehyde fumes in an in vitro human airway epithelial tissue model. Int J Mol Sci. 23(5):2593-2616.
Wang, Y., Wu, Q., Muskhelishvili, L., Davis, K., Wynne, R., Tripathi, P., Bryant, M., Rua, D., Cao, X. (2021) Toxicity of ortho-phthalaldehyde aerosols in a human in vitro airway tissue model. Chemical Research in Toxicology 34(3):754-766.
Chen YF, Goodheart C, Rua D. (2020) The Body's Cellular and Molecular Response to Protein- Coated Medical Device Implants: A Review Focused on Fibronectin and BMP Proteins. Int J Mol Sci. 21(22):8853-8869.
Coelho, S.G., Rua, D., Miller, S.A., Agrawal, A. (2020) Suboptimal UVA attenuation by broad spectrum sunscreens under outdoor solar conditions contributes to lifetime UVA burden. Photodermatol Photoimmunol Photomed. 36(1):42-52
Patlewicz, G., Lizarraga, L.E., Rua, D., et al. (2019). Exploring current read-across applications and needs among selected U.S. Federal Agencies. Regul Toxicol Pharmacol. Aug 106:197-209 Rua, D., Liu X, Wokovich A, Guo C, Keire D. (2019) Particle Size Distribution Analysis of OTC Aerosol or Powder Drug Products with Potential for Inadvertent Inhalation Exposure to Consumers. J Pharm Sci. 108(4):1506-1511
Rua, D., Avonto, C., Lasonkar, P., Chittiboyina, A.G., Khan, I.A. (2017) Identification of a compound isolated from German chamomile (Matricaria chamomilla) with dermal sensitization potential. Toxicol Appl Pharmacol. 318:16-22
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Rua, D., Hong, H., Sakkiah, S., Selvaraj, C., Ge, W., Tong, W. (2016) Consensus Modeling for Prediction of Estrogenic Activity of Ingredients Commonly Used in Sunscreen Products. Int J Environ Res Public Health. 29;13(10)
Avonto, C., Chittiboyina, A.G.,Wang, M.,Vasquez, Y., Rua, D., Khan, I.A. (2016) In Chemico Evaluation of Tea Tree Essential Oils as Skin Sensitizers: Impact of the Chemical Composition on Aging and Generation of Reactive Species. Chem Res Toxicol. 18;29(7):1108-17 Zhou, W., Wang, P.G., Wittenberg, J.B., Rua, D., Krynitsky, A.J. (2016) Simultaneous determination of cosmetics ingredients in nail products by fast gas chromatography with tandem mass spectrometry. J Chromatogr A. 1446:134-40
Avonto, C., Chittiboyina, A.G., Rua, D., Khan, I.A. (2015) A fluorescence high throughput screening method for the detection of reactive electrophiles as potential skin sensitizers. Toxicol Appl Pharmacol. 1;289(2):177-84
Avonto, C., Wang, Y.H., Avula, B., Wang, M., Rua, D., Khan, I.A. (2015) Comparative studies on the chemical and enzymatic stability of alpha- and beta-arbutin. International Journal of Cosmetic Science, Sep 9: 1–7
Chittiboyina, A.G., Avonto, C., Rua, D., Khan, I.A. (2015) Alternative Testing Methods for Skin Sensitization: NMR Spectroscopy for Probing the Reactivity and Classification of Potential Skin Sensitizers. Chem Res Toxicol. 21;28(9):1704-14
Wittenberg, J.B., Canas, B.J., Zhou, W., Wang, P.G., Rua, D., Krynitsky, A.J. (2015) Determination of methylisothiazolinone and methylchloroisothiazolinone in cosmetic products by ultra-high-performance liquid chromatography with tandem mass spectrometry. J Sep Sci. 38(17):2983-8
Wang,Y.H., Avonto, C., Avula, B., Wang, M., Rua, D., Khan, I.A. (2015) Quantitative Determination of α-Arbutin, β-Arbutin, Kojic Acid, Nicotinamide, Hydroquinone, Resorcinol, 4- Methoxyphenol, 4-Ethoxyphenol, and Ascorbic Acid from Skin Whitening Products by HPLC- UV. J AOAC Int. 98(1):5-12
Avula, B., Wang, Y.H., Wang, M., Avonto, C., Zhao, J., Smillie, T.J., Rua, D., Khan, I.A. (2014) Quantitative determination of phenolic compounds by UHPLC-UV-MS and use of partial least- square discriminant analysis to differentiate chemo-types of Chamomile/Chrysanthemum flower heads. J Pharm Biomed Anal. 88:278-88
Brovelli, E.A., Rua, D., Roh-Schmidt, Chandra, A., Lamont E., Noratto G.D. (2005) Human Gene Expression as a Tool to Determine Horticultural Maturity in a Bioactive Plant (Echinacea purpurea L. Moench). J Agric Food Chem. 53(21):8156-61
Williams, F., Cronin, M., Guy, R.H., Rothe, H., Rua, D., Yang, C., Roper, C.S., et al.
(2013) Threshold of toxicological concern (TTC) task force: a strategy to support application of TTC to dermally applied cosmetic ingredients. Toxicology Letters 221:S35 Rua, D., Holzen, T., Glick, B.S., Kron, S.J., Bishop, D.K. (2002) Monitoring changes in the subcellular location of proteins in S cerevisiae. Methods Mol Biol. 241:299-311 Rua, page 6 of 7
Rua, D., Tobe, B.T., Kron, S.J. (2001) Cell cycle control of yeast filamentous growth. Current Opinion in Microbiology 4:720–727
Schlame, M., Rua, D., Greenberg, M.L. (2000) The biosynthesis and functional role of cardiolipin. Progress in Lipid Research 39(3):257-288 Zhao, M., Rua, D., Hajra, Amiya K., Greenberg, M.L. (1998) Enzymatic synthesis of radiolabeled CDP-DG. Analytical Biochemistry 258, 48-52 Zhao, M., Schlame, M., Rua, D., Greenberg, M.L. (1998) Cardiolipin synthase is associated with a large complex in yeast mitochondria. J.Biol.Chem. 273, 2402-2408 Schlame, M., Zhao, M., Rua, D., Haldar, D., Greenberg, M.L. (1995) Kinetic analysis of cardiolipin synthase: a membrane enzyme with two glycerophospholipid substrates. Lipids 30, 633-40 SELECTED ABSTRACTS (total number of abstracts: 16) Evaluation of the Genotoxicity of Ortho-Phthalaldehyde in a Human in vitro Organotypic Airway Tissue Model and Human Lymphoblastoid TK6 Cells (2024). Y. Le, Y. Sun, X. Li, R. Wynne, N. Twaddle, F. A. Beland, D. Rua, W. M. Gwinn, X. Cao, Y. Wang. 63rd Annual Meeting of the Society of Toxicology.
Guinea pig versus human skin sensitization model comparison via virtual screening of DSSTox
(2024). N. N. Tucker, J. T. Beasley, M. R. Hart, S. Boyer, D. Rua, E. Muratov, and A. Tropsha. 63rd Annual Meeting of the Society of Toxicology.
Gordon, J., Truax, J., Borrel, A., Reinke, E., Adams, V., Rua, D., Petersen, E., Uhl, R., Allen, D., Kleinstreuer, N., Strickland, J. (2022) Validation of the Electrophilic Allergen Screening Assay
(EASA) to Detect Substances that Impact the Initial Key Event in the Adverse Outcome Pathway for Skin Sensitization. 61st Annual Meeting of the Society of Toxicology. Sun, Y. Wang, Y., Wu, Q., Rua, D., Cao, X. (2022) Establishing an In Vitro Aerosol Exposure Method for Evaluating the Respiratory Toxicity of Ortho-phthalaldehyde. 61st Annual Meeting of the Society of Toxicology.
Patlewicz, G., Nelms, M., Rua D. (2021) Evaluating the utility of the Threshold of Toxicological Concern (TTC) and its exclusions in the safety assessment of extractable substances from medical devices. QSAR 2021.
Gordon C, Nahan K, Rua D, Elder R (2020) Exploring the application of informatics tools to visualize the chemical space of compounds released from medical devices. 8th Annual FDA Scientific Computing Days
Wang, Y., Wu, Q., Muskhelishvili, L., Davis, K., Tripathi, P., Xiong, R., Rua, D., et al. (2019) Evaluating a Method for Assessing Respiratory Toxicity In Vitro. 58th Annual Meeting of the Society of Toxicology.
Liu, X., Rua, D., Wokovich, A., Guo, C., Keire, D. (2017) Particle Size Distribution Analysis of OTC Drug Products with Unintended Inhalation Exposure to Consumers. American Association of Pharmaceutical Scientists.
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PATENTED WORK
• Duvel L., Rua D., Chandra A., Fast D., and Missler S. Methods of Using Grape Seed Extract to Stimulate Tyrosinase Expression or Melanin Synthesis. # 2006014 AWARDS
• 2019 CDER Recognition Honor Award as part of the Sunscreen Broad Spectrum Analysis Group (from the Office of New Drugs)
• 2018 FDA Regulatory Science Excellence. For innovative research studies exploring the potential for unintended inhalation of over-the-counter (OTC) aerosol/powder drug products ADDITIONAL TRAINING / SKILLS
Training Courses, 2008 – present
• Reviewer Certification Program, FDA/CDRH - 2018
• Aerosol Technology, The Center for Professional Advancement (CfPA)
• Science, Technology and Product Development, CfPA
• Regulatory Compliance for the Personal Care Industry, CfPA
• Cosmetic GMPs around the world, CfPA
• Ingredients for Cosmetics & Toiletries, CfPA
• Clinical Studies for Claims Substantiation of Cosmetic Products, CfPA
• Quantitative Risk Assessments 1 & 2. University of Maryland, College Park.
• Basic Food & Drug Law course, FDA
• Food, Dietary Supplement, and Cosmetic Law and Regulation course, FDA
• Contracting Officer Technical Representative (COTR) certification, FDA Avon Products R&D, Training Courses, 2006 - 2008
• Monitoring clinical studies in the U.S. under legal [21 CFR 50, 56, 312] and guidance
(ICHGCP) requirements
• Statistics- basic and applied.
• Supervisor Compliance & Manager Mentoring Programs Manuscript reviewer for Toxicology Mechanisms and Methods, Toxicology and Applied Pharmacology, Regulatory Toxicology and Pharmacology, Scientific Reports, and International Journal of Environmental Research and Public Health. Reviewer of grants applications submitted to the Alternatives Research & Development Foundation and the Environmental Protection Agency (EPA) Alternatives to Vertebrate Animal Testing Funding Program.
Toxicology Excellence for Risk Assessment (TERA) – February 2011 Dose-Response Assessment Boot Camp
Other language skills: Able to read, speak and write proficiently in Spanish.
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