Bio
GMP Regulatory Specialist Jamie Singer joined ORNL in November 2023, after 28 years in the pharmaceutical industry working on investigational drugs for cancer, Alzheimer's disease, other neurological disorders and inflammation. Her specialty in current good manufacturing practices (CGMP) and the associated regulations for the manufacture and licensing of investigational new drugs make her a great fit to work with the ORNL teams generating radioisotopes as drug substance intermediates.
Jamie previously served as a Quality and Regulatory project management consultant for start up pharmaceutical companies, with experience in small molecule, mRNA-lipid nanoparticles and radiopharmaceutical investigational drug manufacturing.
She holds Bachelor of Arts degrees in Chemistry and German from the University of North Carolina at Chapel Hill and a Master of Science degree in Regulatory Affairs and Quality Assurance from the Temple University School of Pharmacy.
She is a member of the Regulatory Affairs Professional Society; the American Chemical Society; and the Project Management Institute.
Trademarks and Patents
US 11974980 Issued May 7, 2024: In vitro and xenograft anti-tumor activity of a halogenated-xanthene against refractory pediatric solid tumors
US 11426379 · Issued Aug 30, 2022: Combination of Local and Systemic Therapies for the Advanced treatment of Dermatologic Conditions
US 11058664 · Issued Jul 13, 2021: In vitro and xenograft anti-tumor activity of a halogenated-xanthene
US US10471144 · Issued Nov 11, 2019: Combination of local rose bengal and systemic immunomodulative therapies for enhanced treatment of cancer
US US10130658B2 · Issued Nov 20, 2018: Method of ex vivo enhancement of immune cell activity for cancer immunotherapy with a small molecule ablative compound
US 9808524B2 · Issued Nov 7, 2017: Combination of local and systemic immunomodulative therapies for melanoma and liver cancer
US 9422260B2 · Issued Aug 23, 2016: Process for the Synthesis of 4,5,6,7-Tetrachloro-3',6'-Dihydroxy-2',4',5',7'-Tetraiodo-3H-Spiro[Isobenzofuran-1,9'-Xanthen]-3-One(Rose Bengal) and Related Xanthenes
US 9273022 · Issued Mar 1, 2016: Process for the synthesis of 4,5,6,7-tetrachloro-3',6'-dihydroxy-2', 4', 5'7'-tetraiodo-3H-spiro[isobenzofuran-1,9'-xanthen]-3-one (Rose Bengal) and related xanthenes
US US9107887 B2 · Issued Aug 18, 2015: Combination of local and systemic immunomodulative therapies for enhanced treatment of cancer
US 8,530,675 · Issued Sep 10, 2013: Process for the synthesis of 4,5,6,7-tetrachloro-3',6'-dihydroxy-2
US 6,825,354 · Issued Nov 30, 2004: Alkynyl containing hydroxamic acid compounds as matrix metalloproteinase and tace inhibitors
US 6,340,691 · Issued Jan 22, 2002: Alkynyl containing hydroxamic acid compounds as matrix metalloproteinase and tace inhibitors
US 6,939,870: Heterocyclic amines such as 3-[2-(4-(1H-indol-3-yl)-3,6-dihydro-1(2H)-pyridinyl)ethyl]-6-7-dimethoxy-4(3H)-quinazolinone, used as antidepressants or anxiolytic agents for prophylaxis of psychological disorders
US 7,101,886: Phenylalkyl And Pyridylalkyl Piperazine Derivatives
US 7,148,235: Substituted-3-indolyl-4-piperidino-alkyl heterocycles for the treatment of depression
US 7,332,506: Substituted-3-indolyl-4-piperidino-alkyl heterocycles for the treatment of depression
Other Publications
Annals of Surgical Oncology · Oct 28, 2014
Xenobiotica · Jul 1, 2014
- Synthesis and SAR of tolylamine 5-HT6 antagonists.Synthesis and SAR of tolylamine 5-HT6 antagonists.
Bioorganic Medicinal Chemistry Letters · May 1, 2009
- 8-Substituted 3,4-dihydroquinolinones as a novel scaffold for atypical antipsychotic activity.8-Substituted 3,4-dihydroquinolinones as a novel scaffold for atypical antipsychotic activity.
Bioorganic Medicinal Chemistry Letters · Oct 15, 2005
Journal of Medicinal Chemistry · Dec 2, 2004
Journal of Medicinal Chemistry · Jun 5, 2003
Journal of Medicinal Chemistry · Jun 5, 2003