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Ph.D. in Molecular Biology with over 15 years of industry experience, including a proven track record as an effective leader of diverse teams. Extensive expertise in advancing five PCR-based molecular in vitro diagnostic (IVD) platforms from early development through to global commercialization. Led product lines comprising more than 30 FDA-approved 510(k) test kits, generating over $700 million in revenue, including $120 million from non-COVID-19 products. Core Competencies:• Lead research teams from early discovery through verification studies, 510(k) submissions, and product launch.• Develop and implement actionable plans for efficient execution in fast-paced environments, with a strong ability to communicate complex concepts clearly.• Strong decision-maker skilled in analyzing and interpreting complex data to optimize and troubleshoot assay performance.• Develop strategies to identify and address critical assay and system parameters. • Direct cross-functional teams, collaborating with engineering, manufacturing, clinical, and quality assurance groups.• Proficient in managing product transfer from R&D to production, including process validation and documentation. • Expertise in developing, verifying, and validating assays, QC reagents, and workflows.• Experienced in instrument integration, from early prototypes to commercial platform launches.• Author documentation for internal and external reviews, including 510(k) submissions and CE marking.• Proven experience in managing multi-site operations and overseeing multiple shifts.• Oversee, mentor, and train scientists, junior staff, production, engineering, and QC personnel, fostering a collaborative team environment.• R&D software, database tools, and graphical user interface development.• Interface with upper management to communicate project status, issues and resource needs.• Design control, ISO 15189 and ISO13485
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Molecular Diagnostics
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Director Of Research DevelopmentQuidel Mar 2022 - PresentSan Diego, Ca, UsLed the R&D team that developed the Savanna platform and Respiratory Virus Panel 4 (RVP4), the first Savanna product sold in Europe. Oversaw FDA submissions for RVP4+ emergency use and 510(k) applications, with 510(k) approval of the Savanna platform in December 2023. Key contributor to the development of lab software and database tools.
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Associate Director, R&DQuidel Sep 2015 - Mar 2022San Diego, Ca, UsLed the development of the Solana (real-time HDA assay) and early-stage Savanna (PCR-based, sample-to-result) platforms, managing process transfer to production and QC. Directed research teams in the creation of assay content, while overseeing hardware and software development. Led COVID-19 assay development for the Lyra and Lyra Direct platforms, achieving EUA clearance and CE marking in under 7 months.
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Manager, Molecular R&DQuidel Feb 2013 - Sep 2015San Diego, Ca, UsProject lead for the development of Lyra Direct and two AmpliVue assays (Group B Streptococcus and Bordetella). The AmpliVue tests combine simple sample processing from Lyra Direct with isothermal helicase-dependent amplification (HDA) and a self-contained, disposable ELISA-based detection device. Both AmpliVue assays and multiple Lyra Direct products received 510(k) clearance, CE marking, and are sold worldwide.
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Senior ScientistQuidel Apr 2010 - Feb 2013San Diego, Ca, UsKey contributor to the development of the first Lyra test kits for detecting Influenza A+B and C. difficile, including a novel, cost-effective sample preparation kit for the C. difficile Lyra Direct test. Both tests received CE marking and FDA approval. Led the development of five additional Lyra test kits, all achieving FDA approval and CE marking, with assays approved on multiple platforms. Evaluated external assay technologies for Business Development initiatives.
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ScientistQuidel Feb 2009 - Apr 2010San Diego, Ca, UsLed the development of a microfluidic PCR device with electric potential detection for Molecular Diagnostics at the Point of Care.
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Startup ContributorCrinetics Pharmaceuticals Sep 2008 - Feb 2009San Diego, California, UsCo-authored the first grant application for Crinetics Pharmaceuticals. -
Research ScientistAcadia Pharmaceuticals Jul 2004 - Aug 2008San Diego, California, UsMy work primarily focused on advancing early GPCR hits from HTS screens to drug candidates by developing assays in appropriate cell backgrounds to identify compounds suitable for animal testing and potential clinical development. This process involved cloning and mutating genes for expression in eukaryotic cell lines and harvesting tissues to characterize lead compounds in vitro.I researched M1 ligand characteristics, including off-rates and coupling efficiencies, and mutated the orthosteric binding site to investigate ligand-receptor interactions, including ERK phosphorylation assays.In early work, I identified and cloned MrgX receptors from multiple species and developed assays to measure GTP-γS exchange in response to low-affinity ligands.Findings from these studies were reported in the following publications:Bradley S.R., et al. (2010) Neuropharmacology. 58(2): pp. 365-73.Pettersson H., et al.(2009) J Med Chem. 52(7): pp. 1975-82.Spalding T.A., et al.(2006) Mol Pharmacol. 70(6): pp. 1974-83Vanover et al. (2006) J Pharmacol Exp Ther. 317(2): pp. 910-8Ott T.R., et al. (2006) Receptors. Br J Pharmacol 147(1): pp. 73-82. -
Postdoctoral ScientistNeurocrine Biosciences Jul 2001 - Jul 2004San Diego, California, UsIdentified residues on CC chemokine receptor 7 and its agonists involved in high-affinity ligand binding and receptor activation. This required developing assay systems, including cAMP and various reporter assays. I optimized an electroporation protocol for large-scale transient transfections of mammalian cell lines to perform GTP-γS and radioligand binding assays, while FACS was used to assess receptor surface expression. I set up a high-throughput chemotaxis assay and used Western blotting to identify key residues in the N-terminal domain of CCL-19 that activate proteins in the MAP kinase pathway. Later, my research focused on residues in the CCL-19 N-terminus important for β-arrestin recruitment using BRET, desensitization, and dimerization. I also contributed to optimizing protocols for high-throughput adaptation.Findings from these studies were reported in the following publications:Ott T.R., et al. (2006) Biochem Biophys Res Comm 348(3): pp1089-93Ott T.R., et al. (2005) J Pharmacol Toxicol Methods 51(2): pp. 105-14. Epub 2004 Nov 5Ott T.R., et al. (2004) J Biol Chem 279(41): pp. 42383-92. Epub 2004 Jul 28Ott T.R., et al. (2004) Biochemistry 43(12): pp. 3670-78 -
Postdoctoral FellowHrsu Medical Research Council Jun 2000 - May 2001Identified key ligand residues crucial for activity at the GnRH II receptor using radioligand binding, desensitization, and internalization assays. Investigated GnRH II receptor expression in various tissues through RNA protection assays, quantitative PCR, and Western blotting.Findings from these studies were reported in two publications:Millar R.P., Lowe S., Conklin D., Pawson A., Maudsley S., Troskie B., Ott T., Millar M., Lincoln G., Sellar R., Faurholm B., Scobie G., Kuestner R., Teresawa E. and Katz A. (2001) A novel mammalian receptor for the evolutionarily conserved type II GnRH. Proc Natl Acad Sci U S A 98: pp. 9636-41Morgan K., Conklin D., Pawson A. J., Sellar R., Ott T.R. and Millar R.P. (2003) A human type II gonadotropin releasing hormone receptor gene homologue overlaps two genes in the antisense orientation on chromosome 1.q11. Endocrinology 144(2): pp. 423-36
Thomas Ott Skills
Thomas Ott Education Details
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University Of Cape TownChemical Pathology Specializing In Molecular Biology -
Deutsche Höhere Privatschule Windhoek, NamibiaMatrik And Abitur
Frequently Asked Questions about Thomas Ott
What company does Thomas Ott work for?
Thomas Ott works for Molecular Diagnostics
What is Thomas Ott's role at the current company?
Thomas Ott's current role is Director of Research and Development | IVD | Assay V&V.
What is Thomas Ott's email address?
Thomas Ott's email address is th****@****ail.com
What schools did Thomas Ott attend?
Thomas Ott attended University Of Cape Town, Deutsche Höhere Privatschule Windhoek, Namibia.
What skills is Thomas Ott known for?
Thomas Ott has skills like Assay Development, Biotechnology, Molecular Biology, In Vitro, Drug Discovery, Cell Culture, Life Sciences, Pcr, Tissue Culture, Molecular Diagnostics, Cell Biology, Infectious Diseases.
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