Jep [cv]

CURRICULUM VITAE

James E. Patrick, Ph.D.
Patrick’s Pharmaceutical Consulting, LLC
Date Established: 22 Nov 2004
Consultant, Drug Disposition:
• Drug Disposition Program Design, Management • Study Placement, GLP/Scientific Monitoring • Report Preparation, Regulatory Document Preparation (Pharmacokinetics Written and
Areas of Drug Disposition Expertise:
• Drug Disposition (Absorption, Distribution, Metabolism, Excretion) Program and Study • In Vivo Nonclinical and Clinical ADME studies
Description:

Headed Drug Disposition department for Schering-Plough Research Institute (SPRI) for
over 23 years (1980-2004); preceded by 7 years at Ortho Pharmaceutical (a Johnson &
Johnson company) (1973-1980); At SPRI, responsible for planning, organizing and
directing all preclinical and clinical absorption, distribution, metabolism and excretion
(ADME) studies on developmental drugs (all therapeutic areas, including gene therapy) in
support of research and regulatory requirements for NDA/HRD submissions; also
responsible for metabolite isolation and identification for compounds under development, as
well as for the identification of enzymes (P450s / UGTs) involved in the metabolism of
compounds under development. Participated in presentations to the FDA, FDA advisory
panels, and EMA. At SPRI, contributed to over 16 NDAs/HRDs, including mometasone
furoate, desloratadine, ezetimibe, temozolomide, integrilin, ribavirin and posaconazole.
Over 50 publications and 60 abstracts in the area of drug disposition.
Contact Information:
Patrick’s Pharmaceutical Consulting, LLC
Telephone:

eMail address:

Education:
Worcester Foundation for Experimental Biology Post Doctoral Fellow, Steroid Biochemistry, 1971-1973 Pennsylvania State University, University Park, PA
Professional Organizations:
• International Society for the Study of Xenobiotics • American Society for Pharmacology and Experimental Therapeutics Publications

1. Ramanathan R, Reyderman L, Su AD, Alvarez N, Chowdhury SK, Alton KB, Wirth M, Clement R, Statkevich P, Patrick JE. Disposition of desloratadine in healthy volunteers; Xenobiotica. 2007 July; 37(7): 770-787. 2. Ramanathan R, Reyderman L, Kulmatycki K, Su AD, Alvarez N, Chowdhury SK, Alton KB, Wirth M, Clement R, Statkevich P, Patrick JE. Disposition of loratadine in healthy volunteers; Xenobiotica. 2007 July; 37(7): 753-769. 3. Ghosal A, Chowdhury SK, Gupta S, Yuan Y, Iannucci R, Zhang H, Zbaida S, Patrick JE, Alton KB. Identification of human liver cytochrome P450 enzymes involved in the metabolism of SCH 351125, a CCR5 antagonist; Xenobiotica. 2005 May; 35(5): 405-417. 4. Ramanathan R, Alvarez N, Su AD, Chowdhury S, Alton K, Stauber K, Patrick J. Metabolism and excretion of loratadine in male and female mice, rats and monkeys; Xenobiotica. 2005 Feb; 35(2): 155-189. 5. Ghosal A, Yuan Y, Hapangama N, Su AD, Alvarez N, Chowdhury SK, Alton KB, Patrick JE, Zbaida S. Identification of human UDP-glucuronosyltransferase enzyme(s) responsible for the glucuronidation of 3-hydroxydesloratadine; Biopharmaceutics and Drug Disposition. 2004 Sep; 25(6): 243-252. 6. Ghosal A, Hapangama N, Yuan Y, Achanfuo-Yeboah J, Iannucci R, Chowdhury S, Alton K, Patrick JE, Zbaida S. Identification of human UDP-glucuronosyltransferase enzyme(s) responsible for the glucuronidation of posaconazole (Noxafil); Drug Metabolism and Disposition. 2004 Feb; 32(2): 267-271. 7. Ghosal A, Hapangama N, Yuan Y, Achanfuo-Yeboah J, Iannucci R, Chowdhury S, Alton K, Patrick JE, Zbaida S. Identification of human UDP-glucuronosyltransferase enzyme(s) responsible for the glucuronidation of ezetimibe (Zetia); Drug Metabolism and Disposition. 2004 Mar; 32(3): 314-320. 8. Reyderman L, Statkevich, P, Thonoor, CM, Patrick, J, Batra, VK, Wirth, MA. Disposition and pharmacokinetics of temozolomide in the rat; Xenobiotica. 2004 May; 34(5): 487-500. 9. Ghosal A, Hapangama N, Yuan Y, Lu X, Horne D, Patrick JE, Zbaida S. Rapid determination of enzyme activities of recombinant human cytochromes P450, human liver microsomes and hepatocytes; Biopharmaceutics and Drug Disposition. 2003 Dec; 24(9): 375-384. 10. Kosoglou T, Meyer I, Veltri EP, Statkevich P, Yang B, Zhu Y, Mellars L, Maxwell SE, Patrick JE, Cutler DL, Batra VK, Affrime MB. Pharmacodynamic interaction between the new selective cholesterol absorption inhibitor ezetimibe and simvastatin; British Journal of Clinical Pharmacology. 2002 Sep; 54(3): 309-319. 11. Zhong R, Hernandez A, Alton KB, Kishnani NS, Patrick JE. High-performance liquid chromatographic method for the quantification of unbound evernimicin in human plasma ultrafiltrate; Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences. 2002 May 25; 772(1): 191-195. 12. Patrick JE, Kosoglou T, Stauber KL, Alton KB, Maxwell SE, Zhu Y, Statkevich P, Iannucci R, Chowdhury S, Affrime M, Cayen MN. Disposition of the selective cholesterol absorption inhibitor ezetimibe in healthy male subjects; Drug Metabolism and Disposition. 2002 Apr; 30(4): 430-437. 13. Morrissey RE, Horvath C, Snyder EA, Patrick J, MacDonald JS. Rodent nonclinical safety evaluation studies of SCH 58500, an adrenal vector for the p53 gene; Toxicological Sciences. 2002 Feb; 65(2): 266-275. 14. Morrissey RE, Horvath C, Snyder EA, Patrick J, Collins N, Evans E, MacDonald JS. Porcine toxicology studies of SCH 58500, an adrenal vector for the p53 gene; Toxicological Sciences. 2002 Feb; 65(2): 256-265. 15. Tong W, Chowdhury SK, Chen J-C, Zhong R, Alton KB, Patrick JE. Fragmentation of N- oxides (deoxygenation) in atmospheric pressure ionization: investigation of the activation process; Rapid Communications in Mass Spectrometry. 2001; 15(22): 2085-2090. 16. Ezzet F, Wexler D, Statkevich P, Kosoglou T, Patrick J, Lipka L, Mellers L, Veltri E, Batra V. The plasma concentration and LDL-C relationship in patients receiving ezetimibe; The Journal of Clinical Pharmacology. 2001 Sep; 41(9): 943-949. 17. Zbaida S, Brieland J, Krieter P, Loebenburg D, Krishna G, Horne D, Lu X, Yuan Y, Hare R, Cayen MN, Patrick JE. In vitro uptake of SCH 27899 (evernimicin) by rat alveolar macrophages; Antimicrobial Agents and Chemotherapy. 2001 Mar; 45(3): 959-961. 18. Ramanathan R, Su A-D, Alvarez N, Blumenkrantz N, Chowdhury SK, Alton K, Patrick J. Liquid chromatoggraphy/mass spectrometry methods for distinguishing N-oxides from hydroxylated compounds; Analytical Chemistry. 2000 Mar 15; 72(6): 1352-1359. 19. Zbaida S, Du Y, Shannon D, Laudicina D, Thonoor CM, Ng K, Blumenkrantz N, Patrick JE, Cayen MN, Friary R, Seidl V, Chan TM, Pramanik B, Spangler M, McPhail AT. In vitro metabolism of 10-(3-chlorophenyl)-6,8,9,10-tetrahydrobenzo[b][1,8]naphthyridin-5(7H)-one, a topical antipsoriatic agent. Use of precision-cut rat, dog, monkey and human liver slices, and chemical synthesis of metabolites; Biopharmaceutics and Drug Disposition. 1998 Jul; 19(5): 315-332. 20. Alton KB, Kosoglou T, Baker S, Affrime MB, Cayen MN, Patrick JE. Disposition of 14C- eptifibatide after intravenous administration to healthy men; Clinical Therapeutics. 1998 Mar-Apr; 20(2): 307-323. 21. MacDonald JS, Morrissey RE, Patrick JE. Designing non-clinical safety evaluation programmes for gene therapy products: a personal view. In SA Griffiths & CE Lumley (Eds.). Safety evaluation of biotechnologically-derived pharmaceuticals: facilitating a scientific approach; Proceedings of a CMR international workshop held February, 1997. Kluwer Academic Publishers 1998: 115-128. 22. Kosoglou T, Patrick JE, Cohen A, Radwanski E, Christopher D, Affrime MB. Pharmacokinetics of isosorbide-5-mononitrate after oral administration of an extended-release mononitrate formulation versus a standard dinitrate formulation; Clinical Therapeutics. 1995 Mar-Apr; 17(2): 241-251. 23. Kosoglou T, Kazierad DJ, Schentag JJ, Patrick JE, Heimark L, Radwanski E, Christopher D, Flannery BE, Affrime MB. Effect of food on the oral bioavailability of isosorbide-5-mononitrate administered as an extended-release tablet; The Journal of Clinical Pharmacology. 1995 Feb; 35(2): 151-158. 24. Alton KB, Hernandez A, Alvarez N, Patrick JE. High-performance liquid chromatographic assay for N-[2(S)-(mercaptomethyl)-3-(2-methylphenyl)-1-oxopropyl]-L-methione, the active plasma metabolite of a prodrug atriopeptidase inhibitor (SCH 42495), using a thiol selective (Au/Hg) amperometric detector; Journal of Chromatography. 1992 Sep 2; 579(2): 307-317. 25. Wagner JG, Ganes DA, Midha KK, Gonzalez-Younes I, Sackellares JC, Olson LD, Affrime MB, Patrick JE. Stepwise determination of multicompartment disposition and absorption parameters from extravascular concentration-time data. Application to mesoridazine, flurbiprofen, flunarizine, labetalol, and diazepam; Journal of Pharmacokinetics and Biophamaceutics. 1991 Aug; 19(4): 413-455. 26. Tenero DM, Bottorff MB, Given BD, Kramer WG, Affrime MB, Patrick JE, Lalonde RL. Pharmacokinetics and pharmacodynamics of dilevalol; Clinical Pharmacology and Therapeutics. 1989 Dec; 46(6): 648-656. 27. Given BD, Parentesis GP, Christopher JD, Herron J, Patrick JE, Kramer WG, Affrime MB. Antihypertensive effect of dilevalol is directly related to dose and plasma concentrations; The American Journal of Cardiology. 1989 Jun 5; 63(19): 12I-16I. 28. Kramer WG, Perentesis GP, Affrime MB, Patrick JE. Pharmacokinetics of dilevalol in normotensive and hypertensive volunteers; The American Journal of Cardiology. 1989 Jun 5; 63(19): 7I-11I. 29. Kramer WG, Nagabhushan N, Affrime MB, Perentesis GP, Symchowicz S, Patrick JE. Pharmacokinetics and bioavailability of dilevalol in normotensive volunteers; The Journal of Clinical Pharmacology. 1988 Jul: 28(7): 644-648. 30. Alton KB, Petruzzi RF, Patrick JE. High performance liquid chromatographic assay for dilevalol in human plasma and urine using a PRP-1 column and fluorimetric detection; Journal of Chromatography, Biomedical Applications. 1988 Mar 18; 425(2): 363-372. 31. Radwanski E, Nagabhushan N, Affrime MB, Perentesis G, Symchowicz S, Patrick JE. Secretion of dilevalol in breast milk; The Journal of Clinical Pharmacology. 1988 May; 28(5): 448-453. 32. Sybertz EJ, Watkins RW, Ahn HS, Baum T, La Rocca P, Patrick J, Leitz F. Pharmacologic, metabolic, and toxicologic profile of spirapril (SCH 33844), a new angiotensin converting inhibitor; Journal of Cardiovascular Pharmacology. 1987; 10 Suppl 7: S105-S108. 33. Powell ML, Weisberger M, Dowdy Y, Gural R, Symchowicz S, Patrick JE. Comparative steady state bioavailability of conventional and controlled-release formulations of albuterol; Biopharmaceutics and Drug Disposition. 1987 Sep-Oct; 8(5): 461-468. 34. Alton KB, Petruzzi RF, Patrick JE. High-performance liquid chromatographic assay for azatadine in human urine; Journal of Chromatography. 1987 Jan 9; 385: 249-259. 35. Powell ML, Chung M, Weisberger M, Gural R, Radwanski E, Symchowicz S, Patrick JE. Multiple-dose albuterol kinetics; The Journal of Clinical Pharmacology. 1986 Nov-Dec; 26(8): 643-646. 36. Chung M, Leitz FH, Maier G, Patrick JE, Gural RP, Symchowicz S. Rising multiple-dose pharmacokinetics of labetalol in hypertensive patients; The Journal of Clinical Pharmacology. 1986 Apr; 26(4): 248-252. 37. Alton KB, Desrivieres D, Patrick JE. High-performance liquid chromatographic assay for hydrochlorothiazide in human urine; Journal of Chromatography, Biomedical Applications. 1986 Jan 10; 374(1): 103-110. 38. Powell ML, Weisberger M, Gural R, Chung M, Patrick JE, Radwanski E, Symchowicz S. Comparative bioavailability and pharmacokinetics of three formulations of albuterol; Journal of Pharmaceutical Sciences. 1985 Feb; 74(2): 217-219. 39. Alton KB, Leitz F, Bariletto S, Jaworsky L, Desrivieres D, Patrick J. High-performance liquid chromatographic assay for labetalol in human plasma using a PRP-1 column and fluorometric detection; Journal of Chromatography, Biomedical Applications. 1984; 311: 319-328. 40. Tischio J, Hetyei N, Patrick J. Bromperiodol radioimmunoassay: human plasma levels; Journal of Pharmaceutical Sciences. 1984 Apr; 73(4): 546-548. 41. Alton KB, Hetyei N, Shaw C, Patrick JE. Biotransformation of norgestimate in woman; 42. Weisberger M, Patrick JE, Powell ML. Quantitative analysis of albuterol in human plasma by combined gas chromatography chemical ionization mass spectrometry; Biomedical Mass Spectrometry.1983 Oct; 10(10): 556-558. 43. Wong FA, Bateman CP, Shaw CJ, Patrick JE. Biotransformation of bromperidol in rat, dog and man; Drug Metabolism and Disposition. 1983 Jul-Aug; 11(4): 301-307. 44. Tischio JP, Patrick JE, Weintraub HS, Chasin M, Goldstein G. Short in-vitro half-life of thymopoietin32-36 pentapeptide in human plasma; International Journal of Peptide and Protein Research. 1979; 14(5): 479-484. 45. Patrick JE, Weintraub HS, McGuire JL. Disposition of ORF 9326, a novel contragestational steroid, in animals; Steroids. 1978 Sep; 32(2): 147-156. 46. Alton KB, Patrick JE, McGuire JL. A high performance liquid chromatographic assay for the anthelmintic agent, mebendazole in human plasma; Journal of Pharmaceutical Sciences. 1979 Jul; 68(7): 880-882. 47. Alton KB, Patrick JE. A high-performance liquid chromatographic assay for the anti- protozoal agent, tinidazole, in human plasma; Journal of Pharmaceutical Sciences. 1979 May; 68(5): 599-601. 48. Weintaub HS, Abrams LS, Patrick JE, McGuire JL. Disposition of norgestimate in the presence and absence of ethinyl estradiol after oral administration to man; Journal of Pharmaceutical Sciences. 1978 Oct; 67(10): 1406-1408. 49. Abrams LS, Weintraub HS, Patrick JE, McGuire JL. Comparative bioavailability of a lipophilic steroid; Journal of Pharmaceutical Sciences. 1978 Sep; 67(9): 1287-1290. 50. Alton KB, Patrick JE. High-performance liquid chromatographic assay for suprofen, a potent new analgesic in plasma; Journal of Pharmaceutical Sciences. 1978 Jul; 67(7): 985-987. 51. Alton KB, Patrick JE, Shaw C, McGuire JL. Comparative biotransformation of triflubazam (ORF 8063) in rats, dogs and monkeys; Drug Metabolism and Disposition. 1975 Nov-Dec; 3(6): 445-452. 52. Alton KB, Grimes RM, Shaw C, Patrick JE, McGuire JL. Biotransformation of a 1,5- benzodiazepine, triflubazam (ORF 8063), by man; Drug Metabolism and Disposition. 1975 Sept-Oct; 3(5): 352-360. 53. Femino AM, Longcope C, Patrick JE, Williams KIH. Catechol estrogen methylene ethers; Steroids. 1974 Jun; 23(6): 869-878. 54. Baldwin JE, Patrick JE. The stereochemistry of [2,3] - sigmatropic reactions: the Wittig rearrangement; Journal of the American Chemical Society. 1971 93: 3556-3558. 55. Baldwin JE, DeBernardis J, Patrick JE. Anion rearrangements: duality of mechanism in the decomposition of allylic ether anions and synthetic applications; Tetrahedron Letters. 1970 5: 353-356. 56. Baldwin JE, Patrick JE. The reaction of azides with dichlorocarbene: a new route to isocyanide dichlorides; Chemical Communications. 1968 958.

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