MacGregor CV 2015
- 1. Current as of November 2015 P a g e | 1 Resume Thomas R. MacGregor, Ph.D. 10 Wixted Avenue Danbury, CT 06810-8126 +1 203 792 3574 (home) +1 203 739 5660 (mobile) trmacgregor@snet.net Wife Linda and Daughter Kiri-Lin SUMMARY A retired scientist with 33 years of pharmaceutical experience in the successful development and worldwide registration of new and reformulated drug products with a proven track record in organizational skills, project planning, publications, and budget management seeks a consulting opportunity. EMPLOYMENT HISTORY Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT: 1979 – 2012 Retired: Last position was Executive Director of Clinical Pharmacokinetics and Pharmacodynamics within the Translational Medicine Department. Award: 1994: First scientist inducted into the President’s Circle for his work in filing 3 New Drug Applications in one year. The Ohio State University, Columbus, Ohio, 1973 - 1979, Research Associate St. Anthony’s Hospital, Columbus, Ohio, 1974 - 1976, Pharmacy Intern EDUCATIONAL HISTORY Ph.D. in Pharmaceutical Sciences from the University of Connecticut in 12/85 Dissertation Title: Measurement of Human Lung Absorption of Metaproterenol Given Via An Aerosol Using a Stable Isotope Approach. Diss Abstr Int B 1986, 47(2), 589, Univ Microfilms Int #DA8607863, University of Connecticut, 183 pp. Advisor: Harold G. Boxenbaum, Ph.D. Academic Honors: Elected to Rho Chi Pharmacy Honor Society M.Sc. in Pharmaceutical Chemistry from The Ohio State University in 8/79 Thesis Title: Pharmacokinetics of Naltrexone in the Dog and Chemical Characterization and Kinetics of Naltrexone Glucuronide Conjugates. Advisor: Richard H. Reuning, Ph.D. B.S.Pharm. in Pharmacy from The Ohio State University in 6/77 B.Sc. in Microbiology from The Ohio State University in 12/72 Academic Honors: Undergraduate Honor Student in Microbiology High School Diploma from Sandusky St. Mary High School, Sandusky, Ohio in 6/69 Award: Rank of Eagle Scout awarded in April, 1965.
- 2. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 2 COMMUNITY ACTIVITES Science Horizons, Inc. Science Horizons, Inc. was an annual Danbury regional science and math fair affiliated with the INTEL International Science and Engineering Fair. Actively participated on various committees within this organization since its inception 28 years ago: • judge (1986-1995) • guest speaker (1989) on the topic of Artificial Intelligence, Robotics, and Computers in Drug Research • Scientific Review Committee and Institutional Review Board (SRC/IRB) member including chairman (1997-2010) • President (2001-2012) o fair operated on a budget of $40,000 per annum using donated funds raised from local corporations o successfully produced one international award winner, multiple state winners, and awarded over $100,000 in college scholarships. Awards: Multiple awards from the CT State Fair for SRC/IRB work and Presidential work and from the INTEL International Science and Engineering Fair for overall winner including a $1,000 honorarium for the fair’s operating budget. Danbury Public Library • treasurer of the Friends of the Danbury Public Library (1995-1997) having fiduciary responsibility of over $350,000 in investments and funding of the Library’s outreach programs as determined by the Board • Since inception in 1991, actively participates in the monthly book discussion group and recently compiled a historical database of readings for the 25-year group St. Mary Parish in Bethel, CT • active volunteer within the community through church and the Knights of Columbus • appointed to the St. Mary Middle School Advisory Board by the Bishop of Bridgeport (2015-2018) Award: In 2011, Linda and Thomas were awarded the St. Augustine Medal of Service for volunteerism by the Diocese of Bridgeport. UConn College of Agriculture, Health and Natural Resources • certified Master Gardener (2013) • certified Advanced Master Gardener (2015) and Mentor • volunteer at the Fairfield County Extension Office as an Advanced Master Gardener
- 3. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 3 PROFESSIONAL ACTIVITIES American Chemical Society (ACS) of Western Connecticut • elected chairman in 1991 and assumed the office in 1993 o received training from the national office on management and budgets, public relations, and leadership motivation. o submitted an annual report of activities, a financial report demonstrating an improved the cash-flow of the section by 10 o headed the nominations committee that presented and elected a full slate of candidates for the first time in three years. o In 1996, the national and local boards asked him to chair the Section again to fill a vacancy due to illness • chairman of National Chemistry Week in 1991 through 1995 for the section. o On November 2, 1991, National Chemistry Week brought 25,000 children and parents to the Danbury Fair Mall for a day of Chemistry. The success of this one day event was the subject of a cover page article in Chemical & Engineering News, November 25, 1991. o Award: In 1992, awarded by ACS the prestigious Phoenix Award in Washington, DC for the Western Connecticut Section's work on this event. o In 1993, National Chemistry Week was celebrated throughout Fairfield County with displays in libraries, history of Chemistry talks at local universities, a satellite transmission on "Teaching High School Chemistry" to teachers in the Fairfield County area, and demonstrations by local chemists at a one-day event at Western Connecticut State University to close National Chemistry Week. o Award: nominated for a Phoenix Award by the National ACS office of Public Outreach (second in three years). o appointed to the National Chemistry Week Task Force for the American Chemical Society to present the viewpoint of the 183 local sections on the appropriation of a $2.3 million Public Outreach budget o Award: In 1995, received second Phoenix Award for “Outstanding Media Coverage” of the 1994 National Chemistry Week. American Association of Pharmaceutical Scientists (AAPS) Active participant within the Clinical Sciences Section of American Association of Pharmaceutical Scientists (AAPS): • together with Dr. Alice Till, crafted the Strategic Plan for the Section that was accepted verbatim by the AAPS Executive Council. • participated on the Graduate Education Committee (3-year term) • appointed to the AAPS Awards Committee • elected chairman the Clinical Sciences Section in 1997 • following a two-year term on the Executive Board, appointed to the Publications Board (1998) to oversee the creation of electronic journals such as AAPS PharmSci and AAPS PharmSci Tech; these highly respected journals are now the flagship journals of this Society.
- 4. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 4 Appointed to the Regulations and Science Policy Committee at the inception of AAPS: • under the direction of former FDA commissioner, Dr. Jerry Goyan, produced key public statements on: o animals in research o guidelines vs. Agency regulations o scientific fraud o clinical testing populations. INSTITUTIONAL ACTIVITIES During a 33 year career at Boehringer Ingelheim Pharmaceuticals, Inc., managed a small group that performed clinical pharmacokinetic trials • wrote the Clinical Pharmacology sections (2.7.1 and 2.7.2) of global new drug applications resulting in the approval of 21 drugs for the US and global markets • made numerous presentations at FDA Advisory Committees • wrote and defended numerous citizen’s petitions on demonstrating drug bioequivalence • appointed to sit on the FDA’s Office of Pharmaceutical Sciences’ Oral Inhalation and Nasal Drug Products (OINDP) Expert Panel as a representative from industry o expertise in the area of bioavailability and bioequivalence of locally administered drug products o participated with Agency Reviewers in developing Industry Guidances for the development of novel and generic inhalation and nasal drug products With the sponsorship of Boehringer Ingelheim: • presented a series of lectures to the University of Connecticut Pharmacy School, the Graduate School, and the School of Medicine • presented Pharmacy and Chemistry career talks at local high schools of Ridgefield, Danbury, and Immaculate • In 2009, team-taught a Spring Semester course on “Drug Development” at MIT lecturing on the topic of developing Inhalation Drugs
- 5. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 5 PUBLICATIONS 1. Riggs MM, Seman LJ, Staab A, MacGregor TR, Gillespie W, Gastonguay MR, Woerle HJ, Macha S. Exposure−response modelling for empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor, in patients with type 2 diabetes. British Journal of Clinical Pharmacology 2014; 78 (6): 1407–1418. 2. Giaquinto C, Anabwani G, Feiterna-Sperling C, Nuttall J, Mompati K, Königs C, Mensa FJ, Sabo JP, Yong C-Y, MacGregor TR, Nguyen T, Quinson A-M. Steady-state pharmacokinetics of nevirapine extended-release tablets in HIV-1-infected children and adolescents: an open- label, multiple-dose, cross-over study. Pediatr Infect Dis J 2014; 33(7): e173-9. 3. MacGregor TR. Brewer’s Choice. Home & Garden News. October-December 2013: 12. 4. Riggs MM, Staab A, Seman L, MacGregor TR, Bergsma TT, Gastonguay MR, Macha S. Population pharmacokinetics of empagliflozin, a sodium glucose cotransporter 2 inhibitor, in patients with type 2 diabetes. J Clin Pharmacol 2013; 53(10): 1028-38. 5. Lehr T, Yuan J, Hall D, Zimdahl-Gelling H, Schaefer HG, Staab A, MacGregor TR, Jayadev S. Integration of ADME genotyping data into a population pharmacokinetic analysis of nevirapine. Pharmacogenetics & Genomics 2011; 21:721–730. 6. Garraffo R, Lavrut T, Ferrando S, Durant J, Rouyrre N, MacGregor TR, Sabo JP, Dellamonica P. Effect of Tipranavir/Ritonavir Combination on the Pharmacokinetics of Tadalafil in Healthy Volunteers. J Clin Pharmacol 2011; 51:1071-1078. 7. MacGregor TR. “Forgiving” a Missed Daily Dose. Letter to the Editor. AIDS Research and Human Retroviruses 2011; 27(4): 345-346. 8. Huang F, Allen L, Huang DB, Moy F, Vinisko R, Nguyen T, Rowland L, MacGregor TR, Castles MA, Robinson P. Evaluation of steady-state pharmacokinetic interactions between ritonavir- boosted BILR 355, a nonnucleoside reverse transcriptase inhibitor, and lamivudine/zidovudine in healthy subjects. Journal of Clinical Pharmacy and Therapeutics 2012; 37(1):81-88. 9. Huang F, Scholl P, Huang DB, MacGregor TR, Taub ME, Vinisko R, Castles MA, Robinson P. Concomitant administration of BILR 355/r with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) increases exposure to FTC and tenofovir: a randomized, open label, prospective study. Basic & Clinical Pharmacology & Toxicology, 2011; 108:163-170. 10. Sabo JP, Cong X, Kraft M-F, Wallace L, Castles MA, Mauss S, MacGregor TR. Lack of a pharmacokinetic interaction between steady state tipranavir/ritonavir and single dose valacyclovir in healthy volunteers. Eur J Clin Pharmacol 2011; 67:277-281. 11. Huang F, Scholl P, Huang DB, MacGregor TR, Vinisko R, Castles MA, Berger F, Robinson P. Co-administration with lopinavir and ritonavir (LPV/r) decreases the exposure to BILR 355, a non-nucleoside reverse transcriptase inhibitor (NNRTI), in healthy volunteers. J Clin Pharmacol 2011; 51:1061-1070. 12. Dumond JB, Vourvahis M, Rezk NL, Patterson KB, Tien H-C, White N, Jennings S, Choi SO, Li J, Wagner MJ, La I, Drulak M, Sabo JP, Castles MA, MacGregor TR, Kashuba ADM. A Phenotype-Genotype Approach to Predicting CYP450 and P-glycoprotein Drug Interactions with the Mixed Inhibitor/Inducer Tipranavir/ritonavir. Clinical Pharmacology & Therapeutics 2010; 87(6):735-742.
- 6. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 6 13. Goebel FD, MacGregor TR, Sabo JP, Castles M, Johnson PA, Legg D, McCallister S. Pharmacokinetic Characterization of Three Doses of Tipranavir Boosted with Ritonavir on Highly Active Antiretroviral Therapy in Treatment-Experienced HIV-1 Patients. HIV Clinical Trials 2010; 11(1):28-38. 14. Macha S, Yong C, Darrington T, Davis M, MacGregor T, Castles M. In Vitro-In Vivo Correlation for Nevirapine Extended Release Tablets. Biopharm Drug Dispos 2009; 30:542-550. 15. Macha S, Yong C-L, MacGregor TR, Castles M, Quinson A-M, Rouyrre N, Wilding I. Assessment of Nevirapine Bioavailability from Targeted Sites in the Human Gastrointestinal Tract. J Clinical Pharmacol, 2009; 49(12):1417-1425. 16. Cammett AM, MacGregor TR, Wruck JM, Felizarta F, Miailhes P, Mallolas J, Piliero PJ. Pharmacokinetic Assessment of Nevirapine and Metabolites in HIV-1 Patients with Hepatic Fibrosis. Antimicrob. Agents Chemother. 2009; 53(10): 4147-4152. 17. Huang F, Drda K, MacGregor TR, Scherer J, Rowland L, Nguyen T, Ballow C, Castles M, Robinson P. Pharmacokinetic of BILR 355 after multiple oral doses coadministered with low dose ritonavir. Antimicrob Agents Chemother 2009; 53:95-103. 18. Huang F, Koenen-Bergmann M, MacGregor TR, Ring A, Hattox S, Robinson P. Pharmacokinetic and safety evaluation of BILR 355, a second generation non-nucleoside reverse transcriptase inhibitor, in healthy volunteers. Antimicrob Agents Chemother 2008; 52:4300-4307. 19. Walmsley S, Katlama C, Lazzarin A, Arasteh K, Pierone G, Blick G, Johnson M, Jones P, MacGregor T, Leith J. Pharmacokinetics, Safety, and Efficacy of Tipranavir Boosted With Ritonavir Alone or in Combination With Other Boosted Protease Inhibitors as Part of Optimized Combination Antiretroviral Therapy in Highly Treatment-Experienced Patients (BI Study 1182.51) J Acquir Immune Defic Syndr 2008; 47:429–440. 20. Hall DB and MacGregor TR. Case control exploration of relationships between early rash or liver toxicity and plasma concentrations of nevirapine and primary metabolites. HIV Clinical Trials, 2007; 8(6):391-399. 21. Rowland LS, MacGregor TR, Campbell SJ, Jenkins R, Pearsall AB, and Morris JP. Quantitation of five nevirapine oxidative metabolites in human plasma using liquid chromatography - tandem mass spectrometry. J Chromatogr. B, 2007; 856:252-260. 22. Chen L, Sabo JP, Philip E, Mao Y, Norris SH, MacGregor TR, Wruck J, Garfinkel S, Castles M, Brinkman A, Valdez H. Steady State Disposition of the Nonpeptidic Protease Inhibitor Tipranavir When Coadministered with Ritonavir. Antimicrobiol Agents Chemother. 2007; 51(7):2436-2444. 23. Kappelhoff BS, Huitema ADR, van Leth F, Robinson PA, MacGregor TR, Lange JMA, Beijnen JH. Pharmacokinetics of nevirapine: once-daily versus twice-daily dosing in the 2NN study. HIV Clinical Trials 2005, 6(5):254-261. 24. Mukwaya G, MacGregor T, Hoelscher D, Heming T, Legg D, Kavanaugh K, Johnson P, Sabo JP, McCallister S. Interaction of ritonavir-boosted tipranavir with loperamide does not result in loperamide-associated neurologic side effects in healthy volunteers. Antimicrobial Agents Chemotherapy 2005, 49(12):49034910.
- 7. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 7 25. Kappelhoff BS, van Leth F, Robinson PA, MacGregor TR, Baraldi E, Montella F, Uip DE, Thompson MA, Russell DB, Lange JMA, Beijnen JH, Huitema ADR for the 2NN study group. Are adverse events of nevirapine and efavirenz related to plasma concentrations? Antiviral Therapy 2005; 10(4):489–498. 26. Derendorf H, VanderMaelen C, Brickl R, MacGregor T, Eisert W. Dipyridamole bioavailability in subjects with reduced gastric acidity. J Clin Pharmacol, 2005; 45:845-850 27. Kappelhoff BS, van Leth F, MacGregor TR, Lange JMA, Beijnen JH, Huitema ADR for the 2NN study group. Nevirapine and efavirenz pharmacokinetics and covariate analysis in the 2NN study. Antiviral Therapy 2005 10(1):145–155. 28. MacGregor TR, Sabo JP, Norris SH, Johnson P, Galitz L, McCallister S. Pharmacokinetic Characterization of Different Dose Combinations of Coadministered Tipranavir and Ritonavir in Healthy Volunteers. HIV Clin Trials 2004; 5(6): 371-382. 29. Skowron D, Leoung G, Hall DB, Robinson P, Lewis R, Grosso R, Jacobs M, Kerr B, MacGregor T, Stevens M, Fisher A, Ogden R, Yen-Lieberman B. Pharmacokinetic evaluation and short-term activity of stavudine, nevirapine, and nelfinavir therapy in HIV-1-infected adults. J Acquir Immune Defic Syndr 2004; 35 (4):351-358. 30. McCallister S, Valdez H, Curry K, MacGregor T, Borin M, Freimuth W, et al. A 14-day dose- response study of the efficacy, safety, and pharmacokinetics of the nonpeptidic protease inhibitor tipranavir in treatment-naive HIV-1-infected patients. J Acquir Immune Defic Syndr 2004; 35 (4):376-382. 31. Sabo JP, Lamson MJ, Leitz G, Yong CL, MacGregor TR. Pharmacokinetics of nevirapine and lamivudine in patients with HIV-1 infection. AAPS PharmSci 2000; 2 (1):e1. 32. Lamson MJ, Sabo JP, MacGregor TR, Pav JW, Rowland L, Hawi A, et al. Single dose pharmacokinetics and bioavailability of nevirapine in healthy volunteers. Biopharm Drug Dispos 1999; 20:285-291. 33. Riska P, Lamson M, MacGregor T, Sabo J, Hattox S, Pav J, et al. Disposition and biotransformation of the antiretroviral drug nevirapine in humans. Drug Metab Dispos 1999; 27 (8):895-901. 34. Barton RW, Thome D, MacGregor TR, and Possanza GJ. A Proposed Immunogenicity Test for Inhalation Grade Soya Lecithin. Pharmacopeial Forum 1997, 23(6): 5345-5351. 35. Wood CC, MacGregor TR. Atrovent (Ipratropium Bromide) Nasal Spray 0.03% - a new, specific treatment for the runny nose in perennial allergic and nonallergic rhinitis. Allergy Clin Immunol Int 1996, 8 (5/6):187 -188. 36. Wood CC, Fireman P, Grossman J, Wecker M, MacGregor T. Product characteristics and pharmacokinetics of intranasal ipratropium bromide. J Allergy Clin Immunol 1995; 95 (5, Part 2):1111-1116. 37. MacGregor TR, Sardi ED. In vitro protein binding behavior of dipyridamole. J Pharm Sci 1991; 80:119-120. 38. MacGregor T, Matzek K, Keirns J, Vinocur M, Chonko A. Oral Pharmacokinetics of Pirenzepine in Patients with Chronic Renal Insufficiency, Failure, and Maintenance Haemodialysis. Eur J Clin Pharmacol 1990; 38 (4):405-406.
- 8. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 8 39. Steen SN, Hughes EM, Sharon G, MacGregor TR. Efficacy of oral mexiletine therapy at a 12-h dosage interval. Chest 1990; 97 (2):358-363. 40. Lowenthal DT, Matzek KM, MacGregor TR. Clinical pharmacokinetics of clonidine. Clin Pharmacokinet 1988; 14:287-310. 41. MacGregor TR and Reuning RH. The Mouse Tail-Flick Method for Evaluation of Narcotic Antagonist Sustained Release. Int J Pharmaceutics 1987, 38, 171-177. 42. MacGregor TR. Measurement of Human Lung Absorption of Metaproterenol Given Via An Aerosol Using a Stable Isotope Approach. Diss Abstr Int B 1986, 47(2), 589, Univ Microfilms Int #DA8607863, University of Connecticut, 183 pp. 43. Matzek KM, MacGregor TR, Keirns JJ, Vinocur M. Effect of Food and Antacids on the Oral Absorption of Pirenzepine in Man. Int J Pharm 1986; 28:151-155. 44. Hatch F, McKellop K, Hansen G, MacGregor T. Relative bioavailability of metaproterenol in humans utilizing a single dose, stable isotope approach. J Pharm Sci 1986; 75:886-890. 45. MacGregor TR. Therapeutic Drug Monitoring and Toxicology by Liquid Chromatography; Wong SHY (ed). Reviewed for LC Magazine 1986, 4, 45-50. 46. Matzek KM, MacGregor TR, Keirns JJ, Vinocur M, Hurwitz A. Oral pharmacokinetics of pirenzepine in man following single and multiple doses. Int J Pharm 1986; 28:85-91. 47. Wayjen RGA van, Ende A van den, Tol RGL van, MacGregor TR, Keirns JJ, Matzek KM. Pharmacokinetics of transdermally delivered clonidine. In: Weber MA, Drayer JIM, Kolloch R, editors. Low Dose Oral and Transdermal Therapy of Hypertension. Darmstadt: Steinkopff, 1985: 141-145. 48. MacGregor TR, Matzek KM, Keirns JJ, Wayjen RGA van, Ende A van der, Tol RGL van. Pharmacokinetics of transdermally delivered clonidine. Clin Pharmacol Ther 1985; 38:278-284. 49. MacGregor TR, Relihan GL, Keirns JJ. Pharmacokinetics of oral sustained release clonidine in humans. Arzneimittelforschung 1985; 35:440-446. 50. Farina PR, MacGregor TR, Horhota ST, et al. Relative Bioavailability of Chlorthalidone in Humans After Single Oral Doses. J Pharm Sci 1985 74, 995-998. 51. MacGregor TR, Keirns JJ, Farina PR, Matzek KM, Horhota ST, Esber HJ. Chlorthalidone pharmacodynamics in beagle dogs. J Pharm Sci. 1985;74(8):851-856. 52. MacGregor TR, Farina PR, Hagopian M, Hay N, Esber HJ, Keirns JJ. Analysis of chlorthalidone in biological fluids by high-performance liquid chromatography using a rapid column cleanup procedure. Therapeutic Drug Monitoring 1984;6(1):83-90. 53. MacGregor TR, Nastasi L, Farina PR, Keirns JJ. Isolation and characterization of metaproterenol-3-O-sulfate: a conjugate of metaproterenol in human urine. Drug Metab Dispos. 1983;11(6):568-73. 54. MacGregor TR, Drum MA, Harrigan SE, Wiley JN, Reuning RH. Naltrexone metabolism and sustained release following administration of an insoluble complex to rhesus monkeys and guinea-pigs. J Pharm Pharmacol. 1983 Jan;35(1):38-42. 55. Boxenbaum HG, Jodhka GS, Ferguson AC, Riegelman S, and MacGregor TR. The Influence of Bacterial Gut Hydrolysis on the Fate of Orally Administered Isonicotinuric Acid in Man. J Pharmacokin Biopharm 1974, 2, 211-237.
- 9. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 9 POSTER AND PODIUM ABSTRACTS 1. Sabo JP, Kashuba ADM, Ballow C, Haschke M, Yong C-L, MacGregor TR, Li Y, Kort J. Cytochrome P450 (CYP) interactions with the HCV protease inhibitor Faldaprevir (BI 201335) in healthy volunteers. 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), San Francisco, September 9-12, 2012, abstract A-1248. 2. MacGregor TR, Rubano V, Castles MA, Dewberry H, Ghafouri M, Wood CC. Efficiency of ipratropium bromide and salbutamol deposition in the lung delivered via a soft-spray inhaler or chlorofluorocarbon metered-dose inhaler. European Respiratory Society, Amsterdam, The Netherlands. Abstract 227. 25 September 2011. 3. Aslanyan S, Ballow Ch, Sabo JP, Habeck J, Roos D, MacGregor TR, Robinson P, Kort J. Safety and pharmacokinetics (PK) of single rising oral doses of a novel HIV integrase inhibitor in healthy volunteers. 51st ICAAC, Chicago, September 20, 2011, abstract A1-1725. 4. Else LJ, Sabo JP, Yong C-L, MacGregor TR, Mensa F, Quinson A, Robinson P, Back DJ. Saliva nevirapine (NVP) concentrations as an alternative biofluid for NVP pharmacokinetics (PK) in HIV-infected children. 51st ICAAC, Chicago, September 19, 2011, abstract A1-1164. 5. Riggs M, Macha S, Seman L, Staab A, MacGregor TR, Worle H-J, Gillespie W, Gastonguay MR. Evaluation of efficacy and tolerability using exposure-response modeling for BI 10773 (Empagliflozin), a sodium glucose cotransporter-2 (SGLT-2) inhibitor, in patients with type 2 diabetes (T2DM). 71st Scientific Session of the American Diabetes Association (ADA), 25 June 2011, San Diego, CA. 1069-P. 6. Huang F, Huang DB, Rubano V, Zhang W, MacGregor TR, Castles MA, Robinson P. Safety and pharmacokinetics of BILR 355, a nonnucleoside reverse transcriptase Inhibitor, following a single ascending oral administration of SDS-containing tablet boosted with a low dose of ritonavir in healthy volunteers. American College of Clinical Pharmacology. Baltimore, MD, Poster 019, September 12, 2010. 7. Huang F, Formella S, Schepers C, Rubano V, MacGregor TR, Breithaupt-Groegler K, Smith J. Pharmacokinetics, pharmacodynamics, safety, and tolerability of BI 11634, a novel direct oral factor Xa inhibitor, in a single ascending dose study. American College of Clinical Pharmacology. Baltimore, MD, Poster 018, September 12, 2010. 8. Huang F, MacGregor TR, Yong C-L, Fu Y, Quinson A-M, Castles MA, Robinson P. Mixed effects pharmacokinetic modeling of BILR 355 and its major metabolite BILR 516. 2009 American Association of Pharmaceutical Scientists Annual Meeting, Los Angeles, November 8-12, 2009. 9. Huang F, Allen L, MacGregor TR, Huang D, Vinisko R, Nguyen T, Castles MA, Robinson P. Pharmacokinetic interaction of BILR 355/r and Combivir® in healthy volunteers. 2009 American Association of Pharmaceutical Scientists Annual Meeting, Los Angeles, November 8-12, 2009. 10. Huang F, MacGregor TR, Fu Y, Yong C-L, Quinson A-M, Castles MA, Robinson P. Population pharmacokinetic analysis of BILR 355 in adult subjects. 2009 American Association of Pharmaceutical Scientists Annual Meeting, Los Angeles, November 8-12, 2009. 11. Huang F, Scholl P, Vinisko R, Huang D, MacGregor T, Robinson P. Pharmacokinetic interaction of BILR 355 and Truvada in healthy volunteers. 48th ICAAC Meeting, Washington DC, October 25-28, 2008 Abstract A-950.
- 10. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 10 12. Huang F, Koenen-Bergmann M, MacGregor TR, Ring A, Robinson P. Effect of different boosting agents on the pharmacokinetics of BILR 355. 2008 American Association of Pharmaceutical Scientists Annual Meeting, Atlanta, November 1620, 2008 Abstract W4132. 13. Huang F, Scholl P, Vinisko R, Huang D, MacGregor T, Castles M, Robinson P. Evaluation of pharmacokinetic interaction of BILR 355 and Kaletra in healthy volunteers. 2008 American Association of Pharmaceutical Scientists Annual Meeting, Atlanta, November 16-20, 2008 Abstract W4131. 14. Davis C, Gilliam B, Amoroso A, Redfield R, Piliero P, and MacGregor T. Lack of Pharmacokinetic (PK) Interaction of Tenofovir (TDF) and Emtricitabine (FTC) on Nevirapine (NVP). 11th European AIDS Conference / EACS. Poster P 4.1/03. October 24-27, 2007, Madrid, Spain p.69. 15. S Huettner, A Ring, JP. Sabo, C Hoesl, C Ballow, P Roszko, TR MacGregor, P Robinson. No Significant ECG Effects are Observed with Therapeutic and Supra-Therapeutic Doses of Tipranavir Coadministered with Ritonavir (TPV/r). 47th ICAAC Meeting, Chicago, September 17-20, 2007 Abstract A-1422. 16. JP Sabo, C-L Yong, TR MacGregor, M Castles, G Mukwaya, V Kohlbrenner, P Robinson, M Kraft. Nonlinear mixed effects modeling of the steady-state pharmacokinetics of tipranavir for adult healthy volunteers and HIV+ patients receiving TPV 500 mg bid coadministered with RTV 100 mg or 200 mg bid. 8th International Workshop on Clinical Pharmacology of HIV Therapy, 16 – 18 April, 2007, Budapest, Hungary. 17. M Vourvahis, J Dumond, K Patterson, N Rezk, H Tien, J Li, S Choi, N White, M Drulak, J Sabo, M Castles, T MacGregor, A Kashuba. Effects of tipranavir/ritonavir (TPV/r) on the activity of cytochrome P450 (CYP) enzymes 1A2, 2C9, and 2D6 in healthy volunteers. 8th International Workshop on Clinical Pharmacology of HIV Therapy, 16 – 18 April, 2007, Budapest, Hungary. 18. J Durant, P Dellamonica,R Garraffo, A Baakili, N Rouyrre, TR MacGregor, JP Sabo. The effect of tipranavir/ritonavir (TPV/r) on the pharmacokinetics of tadalafil in healthy volunteers. 8th International Workshop on Clinical Pharmacology of HIV Therapy, 16 – 18 April, 2007, Budapest, Hungary. 19. M Vourvahis, J Dumond, K Patterson, N Rezk, N White, S Jennings, H Tien, JP Sabo, TR MacGregor, ADM Kashuba. Effects of tipranavir/ritonavir (TPV/r) on the activity of hepatic and intestinal cytochrome P450 3A4/5 and P-glycoprotein (Pgp): Implications for drug interactions. 14th Conference on Retroviruses and Opportunistic Infections, Feb 25 – 28 2007, Los Angeles, CA. 20. JP Sabo, M Elgadi, J Wruck, W Cameron, TR MacGregor, M Kraft, H Valdez, D Mayers. The Pharmacokinetic Interaction Between Atazanavir/Ritonavir (ATZ/r) and Steady-State Tipranavir/Ritonavir (TPV/r) in Healthy Volunteers. 7th International Workshop on Clinical Pharmacology of HIV Therapy, 20 – 22 April, 2006, Lisbon, Portugal. 21. JP Sabo, S Macha, C Oksala, C Edwards, P Jones, TR MacGregor, H Valdez, D Mayers. Stereoselective Pharmacokinetics (PK) of Methadone after Coadministration with Steady-State Tipranavir/Ritonavir 500/200 mg bid (TPV/r) in Healthy Volunteers. 7th International Workshop on Clinical Pharmacology of HIV Therapy, 20 – 22 April, 2006, Lisbon, Portugal.
- 11. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 11 22. JP Sabo, PJ Piliero, A Lawton, TR MacGregor, J Leith. A comparison of steady-state trough plasma ritonavir concentrations for HIV+ patients receiving an optimized background regimen and ritonavir-boosted tipranavir (TPV/r), lopinavir (LPV/r), saquinavir (SQV/r) or amprenavir (APV/r). 7th International Workshop on Clinical Pharmacology of HIV Therapy, 20 – 22 April, 2006, Lisbon, Portugal. 23. Huang F, Koenen-Bergmann, M., MacGregor, T., Robinson, P., Ring, A., Hattox,S., Mayers, D. Pharmacokinetics of BILR355 after single ascending doses alone and in combination with 100 mg ritonavir (RTV) in healthy volunteers. 7th International workshop on Clinical Pharmacology of HIV therapy. April 20-22, 2006. Lisbon, Portugal. 24. Huang F, Drda, K., Scherer, J., MacGregor, T., Robinson, P., Rowland, L., Nguyen, T., Ballow, C., Mayers, D. Pharmacokinetics of BILR355 after multiple ascending doses co-administered with ritonavir (RTV) in healthy volunteers. 7th International workshop on Clinical Pharmacology of HIV therapy. April 20-22, 2006. Lisbon, Portugal. 25. Cooper C, van Heeswijk R, Bilodeau M, Kovacs B, Sabo J, MacGregor T, Wruck J, Elgadi M, Neubacher D, McCallister S. The pharmacokinetics of single-dose and steady-state tipranavir/ritonavir 500 mg/200 mg in subjects with mild or moderate hepatic impairment. The 3rd IAS Conference on HIV Pathogenesis and Treatment (IAS 2005), Rio de Janeiro, Brazil, July 24-27, 2005. Poster TuPe3, 1B07. 26. Yong CL, Sabo JP, Oksala CG, MacGregor TR, Kohlbrenner V, McCallister S, Leith J, Mayers D. Population pharmacokinetic (PK) assessment of systemic steady-state tipranavir (TPV) concentrations for adults administered tipranavir/ritonavir 500/200 mg bid. 12th Conf on Retroviruses and Opportunistic Infections, Boston, 22 - 25 Feb 2005. 27. Cooper C, van Heeswijk R, Bilodeau M, Kovacs B, Sabo J, MacGregor T, Wruck J, Elgadi M, Neubacher D, McCallister S. The pharmacokinetics of single-dose and steady-state tipranavir/ritonavir 500 mg/200 mg in subjects with mild or moderate hepatic impairment. 6th International Workshop on Clinical Pharmacology of HIV Therapy. Quebec City, Quebec, Canada, April 28-30, 2005. Poster 3.11. 28. Sabo J, Huettner S, MacGregor TR, Wruck J. Evaluation of the bioavailability of tipranavir/ritonavir 500 mg/200 mg oral solution (OS): Comparison to TPV capsules and the influence of food intake in healthy volunteers. 6th International Workshop on Clinical Pharmacology of HIV Therapy. Quebec City, Quebec, Canada, April 28-30, 2005. Poster 3.8. 29. Valdez H, Sabo J, Wruck J, MacGregor T, Garfinkel S, Chen L, Philip E, Mao Y, McCallister S, Norris S. Tipranavir (TPV) excretion mass balance and metabolite profile when co- administered with ritonavir (RTV). 44th Intersci Conf on Antimicrobial Agents and Chemotherapy (ICAAC), Washington, 30 Oct - 2 Nov 2004. 30. van Heeswijk R, Sabo J, MacGregor T, Elgadi M, Harris F, McCallister S, Mayers D. The effect of Tipranavir/ritonavir 500/200 mg bid (TPV/r) on the Pharmacokinetics (PK) of Clarithromycin (CLR) in Healthy Volunteers. ASM 44th ICAAC, Washington, DC. October 30-November 2, 2004, #3326 31. van Heeswijk R, Sabo J, MacGregor T, Elgadi M, Harris F, Mayers D, McCallister S. The pharmacokinetic (PK) interaction between single-dose rifabutin (RFB) and steady-state tipranavir/ritonavit 500/200 mg (TPV/r) in Healthy Volunteers. ASM 44th ICAAC, Washington, DC. October 30-November 2, 2004, #3366
- 12. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 12 32. Kappelhoff BS, Huitema ADR, van Leth FCM, MacGregor TR, Beijnen JH, Lange JMA for the 2NN study group. Nevirapine (NVP) and efavirenz (EFV) pharmacokinetics (PK) and covariate analysis in the 2NN study. ASM 44th ICAAC, Washington, DC. October 31, 2004, H-861. 33. van Heeswijk R; Sabo JP; Cooper C; Cameron W; MacGregor TR; Elgadi M; Harris F; McCallister S; Mayers. The pharmacokinetic interactions between tipranavir/ritonavir 500 mg/200 mg bid (TPV/r) and atorvastatin, antacid and CYP3A4 in healthy volunteers. 5th Int Workshop on Clinical Pharmacology in HIV Therapy, Rome, 1 - 3 Apr 2004. 34. van Heeswijk R; Sabo JP; MacGregor TR; Elgadi M; Harris F; Mayers D; McCallister S. The effect of tipranavir/ritonavir 500 mg/200 mg bid (TPV/r) on the pharmacokinetics of fluconazole in healthy volunteers. 5th Int Workshop on Clinical Pharmacology in HIV Therapy, Rome, 1 - 3 Apr 2004. 35. Roszko PJ; Curry K; Brazina B; Cohen A; Turkie EL; Sabo JP; MacGregor TR; McCallister S. Standard doses of efavirenz (EFV), zidovudine (ZDV), tenofovir (TDF), and didanosine (ddI) may be given with tipranavir/ritonavir (TPV/r). 2nd IAS (International AIDS Society) Conf on HIV Pathogenesis and Treatment, Paris, 13 - 16 Jul 2003 Antiviral Ther 8 (Suppl 1), S428 (2003) 36. Mayers DL, Kohlbrenner VM, Dohnanyi C, Sabo JP, MacGregor TR, Verbiest W, et al. The inhibitory quotient (IQ) of tipranavir/ritonavir (TPV/r) in triple class experienced HIV+ patients; results from BI 1182.52. 2nd IAS (International AIDS Society) Conf on HIV Pathogenesis and Treatment, Paris, 13 - 16 Jul 2003 Antiviral Ther 2003; 8 (Suppl 1):S187. 37. McCallister S; Kohlbrenner V; Squires K; Lazzarin A; Kumar P; DeJesus E; Nadler J; Gallant J; Walmsley S; Yeni P; Leith J; Dohnanyi C; Hall D; Sabo JP; MacGregor TR; Verbiest W; McKenna P; Mayers D. Characterization of the impact of genotype, phenotype, and inhibitory quotient on antiviral activity of tipranavir in highly treatment-experienced patients. 12th Int HIV Drug Resistance Workshop: Basic Principles and Clinical Implications, Cabo del Sol, 10 - 14 Jun 2003 Antiviral Ther 2003; 8 (3):S15. 38. Yeni P, MacGregor T, Gathe J, Arasteh K, Jayaweera D, Jemsek J, et al. Correlation of viral load reduction and plasma levels in multiple protease inhibitor (PI)-experienced patients taking tipranavir/ritonavir (TPV/r) in a phase IIB trial: BI 1182.52. 10th Conf on Retroviruses and Opportunistic Infections, Boston, 10 - 14 Feb 2003. 39. McCallister S, Kohlbrenner V, Squires K, Lazzarin A, Kumar P, DeJesus E, et al. Characterization of the impact of genotype, phenotype, and inhibitory quotient (IQ) on antiviral activity of tipranavir (TPV) in highly treatment-experienced (HTE) patients. 12th Int HIV Drug Resistance Workshop, Cabo San Lucas, 10 - 14 Jun 2003. 40. Yeni P, MacGregor T, Gathe J, Arasteh K, Jayaweera D, Jemsek J, et al. Correlation of viral load reduction and plasma levels in multiple protease inhibitor experienced patients taking tipranavir/ritonavir in a phase IIB trial: BI 1182.52. 10th Conf on Retroviruses and Opportunistic Infections, Boston, 10 - 14 Feb 2003; (CD). 41. Goebel FD; Sabo JP; MacGregor TR; Mayers DL; McCallister S. Pharmacokinetic drug interaction screen of three doses of tipranavir/ritonavir (TPV/r) in HIV-infected patients on stable highly active antiretroviral therapy (HAART). HIV DART Conf, Naples, 15 - 19 Dec 2002.
- 13. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 13 42. VanderMaelen CP, MacGregor TR, Street JO, Mueller TH. Dipyridamole absorption from a composite capsule versus immediate-release tablets coadministered with aspirin in subjects with reduced stomach acidity. 54th Ann Mtg of the American Academy of Neurology, Denver, 13 - 20 Apr 2002 Neurology 2002; 58 (7) (Suppl 3):A312-A313. 43. Sabo JP, MacGregor TR, Lamson MJ, Baldwin J, Borin M. Pharmacokinetics of tipranavir and nevirapine: a pharmacokinetic interaction study in healthy volunteers. HIV Dart 2000, 'Frontiers in Drug Development for Antiretroviral Therapies', San Juan, 17 - 21 Dec 2000. 44. Lamson M, Maldonado S, Hutman H, MacGregor T, McDonough M, Robinson P, et al. The effects of underlying renal or hepatic dysfunction on the pharmacokinetics of nevirapine (Viramune). 13th Int AIDS Conf, Durban, 9 - 14 Jul 2000. 45. Sabo JP, MacGregor TR, Lamson MJ, Baldwin J, Borin M. Pharmacokinetics of tipranavir and nevirapine: a pharmacokinetic interaction study in healthy volunteers. HIV DART 2000: Frontiers in Drug Development for Antiretroviral Therapies, Isla Verde, 17 - 21 Dec 2000 Antiviral Res 2001; 51 (1):75-76. 46. Lamson M, MacGregor T, Riska P, Erickson D, Maxfield P, Rowland L, et al. Nevirapine induces both CYP3A4 and CYP2B6 metabolic pathways. 100th Ann Mtg of the American Society for Clinical Pharmacology and Therapeutics, San Antonio, 18 - 20 Mar 1999 Clin Pharmacol Ther 1999; 65 (2):137. 47. Tennant W, MacGregor T, Adelglass J, Dockhorn R, Korpalski D, Wecker M. Pharmacokinetic assessment following administration of atrovent nasal spray 0.06 % (ANS) in a pediatric population with naturally acquired common colds. Am J Respir Crit Care Med 1997; 155 (4):A713. 48. MacGregor TR. The use of surrogate markers in pulmonary drug development. 1996. Annual Meeting of the American Association of Pharmaceutical Scientists, Seattle, Washington, USA; October 27-31, 1996. Pharmaceutical Research 13(9):S539. 49. Rajendran N, Johnson WD, Ball DJ, MacGregor TR, Pack FD, Stoll RE, Aranyi C. Nose-only inhalation exposure to ipratropium bromide lactose inhalation blend in Sprague-Dawley rats. 1995. VII International Congress of Toxicology. The International Toxicologist 1995; 7(1):98-P- 12. 50. Lamson MJ, Cort S, Sabo JP, MacGregor TR, Keirns JJ. Effects of gender on the single and multiple dose pharmacokinetics of nevirapine 200 mg/day. 10th Ann Mtg of the American Association of Pharmaceutical Scientists, Miami Beach, 5 - 9 Nov 1995 Pharm Res 1995; 12 (9) (Suppl):101. 51. Lamson MJ, Cort S, Sabo JP, MacGregor TR, Keirns JJ. Effects of food or antacid on the bioavailability of nevirapine 200 mg in 24 healthy volunteers. 10th Ann Mtg of the American Association of Pharmaceutical Scientists, Miami Beach, 5 - 9 Nov 1995 Pharm Res 1995; 12 (9) (Suppl):101. 52. MacGregor TR, Lamson MJ, Cort S, Pav JW, Saag MS, Elvin AT, et al. Steady state pharmacokinetics of nevirapine, didanosine, zalcitabine, and zidovudine combination therapy in HIV-1 positive patients. 10th Ann Mtg of the American Association of Pharmaceutical Scientists, Miami Beach, 5 - 9 Nov 1995 Pharm Res 1995; 12 (9) (Suppl):101.
- 14. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 14 53. MacGregor TR, Shragis ED, Wecker MT, Fireman P. Absorption characteristics of Atrovent Nasal Spray 0.06 % (84 mcg/nostril qid) in volunteers infected with HRV 39. 10th Ann Mtg of the American Association of Pharmaceutical Scientists, Miami Beach, 5 - 9 Nov 1995 Pharm Res 1995; 12 (9) (Suppl):101. 54. Lamson MJ, Cort S, Sabo JP, MacGregor TR, Keirns JJ. Effects of food or antacid on the bioavailability of nevirapine 200 mg in 24 healthy volunteers. Pharm Res 1995; 12 (9) (Suppl):S101. 55. Grossman J, MacGregor T, Wood C, Shragis E, Roszko P. Evaluation of the systemic absorption and excretion of intra-nasal ipratropium bromide following chronic administration in perennial rhinitis patients. 48th Ann Mtg of the American Academy of Allergy and Immunology, Orlando, 6 - 11 Mar 1992 J Allergy Clin Immunol 1992; 89 (1, Part 2):183. 56. MacGregor TR, Wood CC, Shragis ED, Roszko PJ. Evaluation of the systemic absorption and excretion of intra-nasal ipratropium bromide in healthy volunteers. 48th Ann Mtg of the American Academy of Allergy and Immunology, Orlando, 6 11 Mar 1992 J Allergy Clin Immunol 1992; 89 (1, Part 2):182. 57. Roy T and MacGregor T. Bootstrap Confidence Intervals for Bioequivalence Ratios. Pharm Res 1991, 8, S-63. 58. MacGregor TR, Weidler DJ, Matzek KM, Pages LJ, Sardi ED. Influence of midweek rotation on the pharmacokinetics of transdermal clonidine. Pharm Res 1989; 6 (9) (Suppl):S34. 59. MacGregor TR, Weidler DJ, Matzek KM, Pages LJ, Sardi ED. Influence of midweek rotation on the pharmacokinetics of transdermal clonidine. 18th Ann Mtg of the American College of Clinical Pharmacology, Baltimore, 11 - 14 Oct 1989 J Clin Pharmacol 1989; 29:844. 60. Matzek K, MacGregor T, Keirns J, Vinocur M. Oral pharmacokinetics of pirenzepine in man. Pharmacologist 1985; 27 (3):270. 61. MacGregor TR and Reuning RH. Pharmacokinetics of naltrexone and naltrexone glucuronide conjugates in the dog. APhA 27th APS National Meeting, Kansas City, MO, November 11-15, 1979. Abstracts 9(2): 87, abstract 39. 62. MacGregor TR, Staubus AE, Morrison BE, Reuning R. Plasma Kinetics of Naltrexone and Its Glucuronide in the Dog. The Pharmacologist 1977, 19 (2), 173.
- 15. Thomas R. MacGregor, Ph.D. Current as of November 2015 P a g e | 15 SUBMITTED MANUSCRIPTS 1. MacGregor TR, Rubano V, Castles MA, Dewberry H, Ghafouri M, Wood CC. Efficiency of ipratropium bromide and salbutamol deposition in the lung delivered via a soft-spray inhaler or chlorofluorocarbon metered-dose inhaler. Clinical & Translational Science. 2. Ehrlich J, Beck B, Thiedmann R, Marzen K, MacGregor T. Bioequivalence and adhesion evaluation of transdermal clonidine following a change in excipient supplier. International Journal of Clinical Pharmacology and Therapeutics.