Curriculum Vitae

Walid M. Awni, Ph.D., ARF Vice President, Clinical Pharmacology & Pharmacometrics

Research and Development Abbvie

Contact Information

Office D4PD, AP13A One North Waukegan Road, North Chicago, IL 60064

Employment History

Current Positions;

2013-Present: Vice President, Clinical Pharmacology & Pharmacometrics Research and Development, Abbvie

Previous Positions within Abbott/Abbvic:

2005: Promoted to Senior Director, Clinical Pharmacology & Pharmacometrics

200 I: Promoted to Global Director, Clinical Pharmacokinetics

2000: Promoted to Director, Clinical Pharmacokinetics

1997: Promoted to Manager, Clinical Pharmacokinetics & Toxicokinetics

1995: Promoted to Section Manager, Pharmacokinetics & Biopharmaceutics

1993: Promoted to Group Leader, Pharmacokinetics & Biopharmaceutics

1992: Senior Research Scientist, Pharmacokinetics & Biopharmaceutics

Previous Positions before Joining Abbott/Abbvie:

1986 to 1992: Director, Pharmacokinetics & Drug Metabolism The Drug Evaluation Unit Hennepin County Medical Center Minneapolis, Minnesota S54 lS

1984 to 1992 Assistant Professor then Associate Professor Department of Pharmaceutics, College of Pharmacy University of Minnesota Minneapolis, Minnesota 55455

Academic Qualifications Ph.D. in Pharmaceutics (Pharmacokinetics) College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA

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Publications: Full Manuscripts (Published)

I. Polepally AR, Mensing S, Khatri A, Beck D, Liu W, Awni WM, Menon RM, Dutta S. Dose- and Formulation-Dependent Non-Linear Pharmacokinetic Model of Paritaprevir, a Protease Inhibitor for the Treatment ofHepatitis C Virus Infection: Combined Analysis from 12 Phase I Studies. CUn Pharmacokinet 20 l6 Mar 21.

2. Khatri A, Dutta S, Dunbar M, Podsadecki T, Trinh R, Awni W, Menon R. Evaluation of Drug-Drug Interactions Between Direct-Acting Anti-Hepatitis C Virus Combination Regimens and the HIV-1 Antiretroviral Agents Raltegravir, Tenofovir, Emtricitabine, Efavirenz, and Rilpivirine. Antimicrob Agents Chemother 2016 Mar 7.

3. Khatri A, Dutta S, Wang H, Podsadecki T, Trinh R, Awni W, Menon R. Evaluation of Drug-Drug interactions Between Hepatitis C Antiviral Agents Ombitasvir, Paritaprevir/Ritonavir, and Dasabuvir and HI V-1 Protease Inhibitors. Clin Infect Dis 2016 Apr 15;62(8):972-9.

4. Menon RM, Klein CE, Podsadecki TJ, Chiu YL, Dutta S, Awni WM, Pharmacokinetics and tolerability of paritaprevir, a direct-acting antiviral agent for HCV treatment, with and without ritonavir in healthy volunteers .. Br J Clin Pharmacol. 2015 Dec 28. doi: 10.111 J/bcp. 12873.

5. Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase lb/2 Studies. AAPSJ2016 Jan;l8(1):270-80..

6. King JR, Dutta S, Cohen D, Podsadecki TJ, Ding B, Awni WM, Menon RM. Drug-Drug Interactions between Sofosbuvir and Ombitasvir-Paritaprevir-Ritonavir with or without Dasabuvir. Antimicrob Agents Chemother 2015 Nov 23;60(2):855-61.

7. Sadri PS, Dutta S, Wang H, Podsadecki TJ, Polepally AR, Khatri A, Zha J, Chiu YL, Awni WM, Menon RM. Drug Interactions with the Direct-Acting Antiviral Combination of Ombitasvir and Paritaprevir-Ritonavir. Antimicrob Agents Chemother 20 l 5 Oct 12;60(1):105-14.

8. Khatri A, Menon RM, Marbury TC, Lawitz EJ, Podsadecki TJ, Mullally VM, Ding B, Awni WM, Bernstein BM, Dutta S. Pharmacokinetics and safety of co-administered paritaprevir plus ritonavir, ombitasvir, and dasabuvir in hepatic impairment. J Hepatol 2015 Oct;63(4):805-12. Epub2015 Jun 10.

9. Badri P, Dutta S, Coakley E, Cohen D, Ding B, Podsadecki T, Bernstein B, Awni W, Menon R. Pharmacokinetics and Dose Recommendations for Cyclosporine and Tacrolimus When Coadministered With ABT-450, Ombitasvir, and Dasabuvir. Am J Transplant. 2015 May; 15(5): I 3 l 3-22.

10. Sharma S, Eckert D, Hyams JS, Mensing S, Thakkar RB, Robinson AM, Rosh JR, Ruemmele FM, Awni WM. Pharmacokinetics and exposure-efficacy relationship of adalimumab in pediatric patients with moderate to severe Crohn's disease: results from a randomized, multicenter, phase-3 study. Jnjlamm Bowel Dis 2015 Apr;2 I ( 4):783-92.

11. Menon RM, Badri PS, Wang T, Polepally AR, Zha J, Khatri A, Wang H, Hu B, Coakley EP, Podsadecki TJ, Awni WM, Dutta S. Drug-drug interaction profile of the all-oral

Curriculum Vitae-Awni 3

anti-hepatitis C virus regimen of paritaprevir/ritonavir, ombitasvir, and dasabuvir. J Hepatol 2015 Jul;63(1 ):20-9. Epub 2015 Jan 31.

12. An G, Liu W, Duan WR, Nothaft W, Awni W, Dutta S. Population pharmacokinetics and exposure-uric acid analyses after single and multiple doses ofABT-639, a calcium channel blocker, in healthy volunteers. AAPSJ 2015 Mar; 17(2):416-26. Epub 2015 Jan 8. Erratum in: AAPS J2015 Mar;17(2):48 l-92. 13.

13. Liu W, Dutta S, Kearns G, Awni W, Neville KA. Pharmacokinetics of hydrocodone/acetaminophen combination product in children ages 6-17 with moderate to moderately severe postoperative pain. J Clin Pharmacol 2015 Feb;55(2):204-1 l. Epub 2014 Sep 26.

14. Kaefer A, Yang J, Noertersheuser P, Mensing S, Humerickhouse R, Awni W, Xiong H. Mechanism-based pharmacokinetic/pharmacodynamic meta-analysis of navitoclax (ABT-263) induced thrombocytopenia. Cancer Che mother Pharmacol 2014 Sep;74(3):593-602. Epub 2014 Jul 23.

15. An G, Liu W, Katz DA, Marek GJ, Awni W, Dutta S. Population phannacokinetics of the 11 P-hydroxysteroid dehydrogenase type 1 inhibitor ABT-384 in healthy volunteers following single and multiple dose regimens. Biopharm Drug Dispos 2014 Oct;35(7):417-29. Epub 2014 Aug 30.

J6. Xiong H, Pradhan RS, Nada A, Krivoshik AP, Holen KD, Rhodes JW, Gordon GB, Humerickhouse R, Awni WM. Studying navitoclax, a targeted anticancer drug, in healthy volunteers--ethical considerations and risk/benefit assessments and management. Anticancer Res 2014 Jul;34(7):3739-46.

17. Chiu YL, Lorusso P, Hosmane B, Ricker JL, Awni W, Carlson DM. Results of a phase I, open-label, randomized, crossover study evaluating the effects of linifanib on QTc intervals in patients with solid tumors. Cancer Chemolher Pharmacol 2014 Jan;73(1):213-7. Epub 2013 Nov 16.

18. An G, Liu W, Katz DA, Marek G, Awni W, Dutta S. Effect of ketoconazole on the pharmacokinetics of the l lB-hydroxysteroid dehydrogenase type 1 inhibitor ABT-384 and its two active metabolites in healthy volunteers: population analysis of data from a drug-drug interaction study. Drug Metab Dispos 20 L3 May;41(5):l035-45. Epub 2013 Feb 19.

19. Othman AA, Nothaft W, Awni WM, Dutta S. Effects of the TRPVI antagonist ABT-102 on body temperature in healthy volunteers: pharmacokinetic/ phannacodynamic analysis of three phase 1 trials. Br J Cfin Pharmacol 2013 Apr;75(4):1029-40.

20. Dutta S, Awni W: Population pharmacokinetics of ABT-594 in subjecls with diabetic peripheral neuropathic pain. J Clin Phann Ther 2012 Aug;37(4):475-80. Epub 2011 Dec 7.

21. Dutta S, Hosmane BS, Awni W: Population analyses ofefficacy and safety of ABT-594 in subjects with diabetic peripheral neuropathic pain. AAPSJ. 2012 Jun; 14(2): 168- 175. Epub 2012 Feb 11.

22. Othman AA, Lenz RA, Zhang J, Li J, Awni WM, Dutta S. Single- and multiple-dose pharmacokinetics, safety and tolerability of the selective alpha-7 neuronal nicotinic

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receptor agonist, ABT-I 07, in healthy human volunteers. J Clin Pharmacol 2011 ;51(4):512-526.

23. Noertersheuser P, Pradhan R, Klein C, Williams L, Palaparthy R, Garimella T, Lichtenberger 0, Awni W. Exposure-Clinical Response Analysis ofParicalcitol in Patients with Chronic Kidney Disease (Stage 5) on Hemodialysis or Peritoneal Dialysis. J Clin Pharmacol. August 2012; 52 (8), 1162-1173.

24. Ng J, Chiu YL, Awni W, Bernstein B, Causemaker SJ, Klein CE. Pharmacokinetics and Safety of the Lopinavir/Ritonavir Tablet 500/125 mg Twice Daily Coadministered With Efavirenz in Healthy Adult Participants. J Clin Pharmacol August 2012; 52(8),1248-54.

25. Othman AA, Nothaft W, Awni WM, Dutta S. Pharmacokinetics of the TRPVl antagonist ABT-102 in healthy human volunteers: population analysis ofdata from three Phase l trials. J Clin Pharmacol 2012 Jul; 52(7):1028-41

26. Zhu T, Awni W, Hosmane B, Kelly M, Sleep D, Stolzenback J, Wan K, Chira T, Pradhan R. ABT-335, the choline salt of fenofibric acid, does not have a clinically significant pharmacokinetic interaction with rosuvastatin in humans. J Clin Pharmacol 2009; 49: (1):63-71.

27. Klein CE, Chiu YL, Awni W, Zhu T, Heuser RS, Doan T, Breitenbach J, Morris JB, Brun SC, Hanna GJ. The tablet formulation of lopinavir/ritonavir provides similar bioavailability to the soft gelatin capsule formulation with less pharmacokinetic variability and diminished food effect. J Acq Im mun DefSynd 2007;44( 4):401-411.

28. Chiu YL, Klein CE, Woodward WC, King KR, Naylor C, Awni W, Brun S. Lack of effect of gastric acid-reducing agents on the pharmacokinetics of Jopinavir/ritonavir in HIV-infected patients. AIDS Patient Care and STDs 2007;21(4):247-251.

29. Palaparthy R, Pradhan R, Chan J, Rieser M, Chira T, Galitz L, Awni W, Williams LA. Effect of omeprazole on the pharmacokinetics of paricalcitol in healthy subjects. Biopharm Drug Dispos 2007;28(2):65-71.

30. Karyekar CS, Pradhan RS, Freeney T, Ji Q, Edeki T, Chiu W, Awni WM, Locke C, Schwaitz LB, Granneman RG, O'Dea R. A phase I multiple-dose escalation study characterizing pharmacokinetics and safety of ABT-578 in healthy subjects. J Clin Pharmacol 2005;45(8):910-918.

31. Blakesley V, Awni W, Locke C, Ludden T, Granneman R, Braverman L. Are bioequivalence studies of levothyroxine sodium formulations in euthyroid volunteers reliable? Thyroid2004; 14(3):191-200.

32. Roza A, Tomlanovich S, Merion R, Pollak R, Wright F, Rajagopalan P, Pruett T, Scandling J, Ryan J, Awni W, Schweitzer S, Greco R, Lam W, Nabulsi A, Hoffman R. Conversation of stable renal allograft recipients to a bioequivalent cyclosporine fonnulation. Transplantation 2002;74(7): 1013-1017.

33. Dube LM, Swanson LJ, Awni WM. Zileuton, a leukotriene synthesis inhibitor in the management ofchronic asthma-clinical pharmacokinetics and safety. CL;n Rev Allerg Immu 1999; 17:213-221.

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34. Wong SL, Drajesk J, Chang MS, Witt G, Awni WM. Dose-propo11ional pharmacokinetics of a new 5-lipoxygenase inhibitor, ABT-761, in healthy volunteers. Biopharm Drug Dfapos 1998; 19: 159-162.

35. Wong SL, Cavanaugh JH, Qian J, Hansen R, Awni WM. Lack of CYP IA2 interaction effect of ABT-761 on the phannacokinetics oftheophylline. Am J Ther 1998;5:303-306.

36. Wong SL, Drajesk J, Chang MS, Lanni C, Witt G, Hansen H, Awni WM. Pharmacokinetics and pharmacodynamics ofsingle and multiple oral doses ofa novel 5­lipoxygenase inhibitor (ABT-761) in healthy volunteers. Clin Pharmacol Ther I 998;63:324-33 1.

37. Wong SL, O'Dea R, Dube L, Awni WM. Effects of ABT-761, a novel 5-lipoxygenase inh ibitor, on the pharmacokinetics of a single dose of ethinyl estradiol and levonorgestrel in healthy female volunteers. J Clin Pharmacol 1998;38:642-648.

38. Wong SL, Kearns GL, Kemp JP, Drajesk J, Chang M, Locke CS, Dube LM, Awni WM. Pharmacokinetics ofa novel 5-lipoxygenase inhibitor (ABT-761) in pediatric patients with asthma. Eur J Clin Pharmacol 1998;54:7 l 5-7 I 9.

39. Awni WM, Cavanaugh JH, Leese P, Kasier JF, Cao G, Locke CS, Dube LM. The pharmacokinetic and pharmacodynamic interaction between zileuton and terfenadine. Eur J Clin Pharmacol 1997;52:49-54.

40. Awni WM, Locke CS, Dube LM, Cavanaugh JH. Evaluation of the diurnal variation in the pharmacokinetics of zileuton in healthy volunteers. J Cl in Pharmacol 1997;37:388­394.

41. Awni WM, Wong W, Chu S-Y, Patterson K, Hansen R, Machinist JM, Drajesk J, Keane WF, Halstenson CE. Pharmacokinetics ofzileuton and its metabolites in subjects with renal impairment. J Clin Pharmacol l 997;37:395-404.

42. Sramek JJ, Mack RJ, Awni WM, Hourani J, Jhee SS, Barto S, Cutler NR. Two rapid dose titrations of sertindole in patients with schizophrenia. J Clin Psychopharmacol 1997; 17:419-422.

43. Wong SL, Cavanaugh JH, Shi H, Awni WM, Granneman GR. Effect of divalproex sodium on amitriptyline and nortl'iptyline pharmacokinetics. Clin Pharmacol Ther I 996;60:48-53.

44. Awni WM, Granneman GR, Locke C, Brandwein SR, Dube LM. Population pharmacokinetics of zileuton, a selective 5-lipoxygenase inhibitor, in patients with rheumatoid arthritis. Eur J Clin Pharmacol 1995;48: 155-160.

45. St. Peter JV, Braeckman RA, Granneman GR, Locke CS, Cavanaugh JH, Awni WM. The effect ofzileuton on antipyrine and indocyanine green disposition. Clin Pharmacol Ther l 995;57:299-308.

46. Fischer AR, McFadden CA, Frantz R, Awni WM, Cohn J, Drazen JM, Israel E. Effect of chronic 5-lipoxygenase inhibition on airway hyperresponsiveness in asthmatic subjects. Am J Resp Crit Care Med 1995; 152:1203-1207.

47. Awni WM, Halstenson CE, Nayak RK, Opsahl JA, Desiraju RK, Minn FL, Matzke GR. Pharmacokinetics of bepridil and two of its metabol ites in patients with end-stage renal disease. J Clin Pharmacol 1995;35:379-383.

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48. St. Peter N, Awni WM, Granneman GR, Karol MD. The effects of lansoprazole on the disposition of antipyrine and indocyanine green in normal human subjects. Am J Ther I 995;2:561-568.

49. Wong SL, Awni WM, Cavanaugh JH, El-Shourbagy T, Locke C, Dube LM. The pharmacokinetics ofsingle oral doses ofzileuton 200 to 800 mg, its enantiomers, and its metabolites, in normal healthy volunteers. Clin Pharmacokin I995;2(Suppl. 2):9-21.

50. Awni WM, Braeckman RA, Granneman GR, Witt G, Dube LM. Pharmacokinetics and pharmacodynamics of zileuton after oral administration of single and multiple dose regimens ofzileuton 600 mg in healthy volunteers. Clin Pharmacokin 1995;29(Suppl. 2):22-33.

5 I . Braeckman RA, Granneman GR, Locke CS, Machinist JM, Cavanaugh JH, A wni WM. The pharmacokinetics of zileuton in healthy young and elderly vo lunteers. Cfin Pharmacokin 1995;29(Suppl. 2):42-48.

52. Awni WM, Cavanaugh JH, Braeckman RA, Chu S-YM, Patterson KJ, Machinist JM, Granneman GR. The effect of mild or moderate hepatic impairment (cirrhosis) on the pharmacokinetics of zileuton. Clin Pharmacokin l 995;29(Suppl. 2):49-61.

53. Awni WM, Cavanaugh JH, Witt G, Granneman GR, Dube LM. The effect offood on the pharmacokinetics ofzileuton. Clin Phannacokin l 995;29(Suppl. 2):62-66.

54. Awni WM, Hussein Z, Granneman GR, Patterson KJ, Dube LM, Cavanaugh JH. Pharmacodynamic and stereoselective pharmacokinetic interactions between zileuton and warfarin in humans. Clin Pharmacokin 1995;29(Suppl. 2):67-76.

55. Granneman GR, Braeckman RA, Locke CS, Cavanaugh JH, Dube LM, Awni WM. Effect ofzileuton on theophylline pharmacokinetics. Clin Pharmacokin l 995;29(Suppl. 2):77-83.

56. Awni WM, Hussein Z, Cavanaugh JH, Granneman GR, Dube LM. Assessment of the pharmacokinetic interaction between zileuton and digoxin in humans. Clin Pharmacokin l 995;29(Suppl. 2):92-97.

57. Awni WM, Braeckman RA, Locke CS, Dube LM, Granneman GR. The influence of multiple oral doses ofzileuton on the steady state pharmacokinetics of sulfasalazine and its metabolites, sulfapyridine and N-acetylsulfapyridine. Clin Pharmacokin 1995;29(Suppl. 2):98-104.

58. Awni WM, Cavanaugh JH, Tzeng T-B, Witt G, Granneman GR, Dube LM. Pharmacokinetic interactions between zileuton and prednisone. Clin Pharmacokin 1995;29(Suppl. 2): I05-111.

59. Awni WM, Braeckman RA, Cavanaugh JH, Locke CS, Linnen PJ, Granneman GR, Dube LM. The pharmacokinetic and pharmacodynamic interactions between the 5­lipoxygenase inh ibitor zileuton and the cyclo-oxygenase inhibitor naproxen in human volunteers. Clin Pharmacokin 1995 ;29(Suppl. 2): 112-124.

60. Hirata-Dulas CAI, Awni WM, Matzke GR, Halstenson CE, Guay DRP. Evaluation of two intravenous single bolus methods for measuring effective renal plasma flow. Am J Kidney Dis 1994;23:374-381.