PROFESSIONAL EXPERIENCE:

Pfizer/Pharmacia, Drug Safety Research & Development (DSRD)

Sr. Director, Inflammation & Immunology Therapeutic Area Lead (2007-2018):
Managed nonclinical safety strategies for small molecule and biotherapeutic projects in inflammation and autoimmunity from idea to loss of revenue. Supervised toxicology representatives on drug development teams. Accountable for quality and execution of toxicology deliverables (toxicology plans, study protocols and reports, stage-gate documents, regulatory submissions, due diligence). Provided toxicology expertise to R&D programs via participation on R&D governance bodies.

Development & Regulatory Strategy Lead (2006-07):
Designed toxicology strategies as representative on drug development teams. Prepared safety assessments for regulatory submissions and queries; represented toxicology line at meetings with health authorities. Mentored junior colleagues and reviewed draft regulatory submission documents. Co-chair impurity council.

Safety Assessment Unit Head (2004-06):
Managed 5 MS/PhD scientists preparing nonclinical safety assessments for regulatory submissions. Reviewed and approved toxicology study reports and summary documents. Advised development teams on nonclinical safety and regulatory issues.

Associate Research Fellow, Safety Assessment (1999-2003):
Evaluated and summarized nonclinical safety data for regulatory submissions and queries, and safety assessments of excipients, impurities, etc. Supervised associate scientist in these activities. Represented toxicology line on drug development and in-licensing teams.

US Food & Drug Administration, Division of Pulmonary & Allergy Drug Products

Pharmacologist (1995-99):
Recommended regulatory actions based on evaluation of nonclinical regulatory submissions. Contributor to regulatory guidance documents. Served on Carcinogenicity Assessment Committee. Represented Agency at external meetings. Responsible for workload assignment, secondary review, and hiring as interim team leader.

Hoffmann-LaRoche Inc.

Research Investigator (1991-94):
Supervised cardiovascular drug discovery projects and safety pharmacology studies. Developed small animal models of anaphylaxis, inflammation, and bronchial hyperreactivity to support drug discovery projects in asthma, allergy, and inflammation.

Boston University School of Medicine, Departments of Pharmacology and Medicine

Postdoctoral Fellow to Associate Professor (1979-1991):
Supervised graduate students, fellows, and technicians investigating myocardial ischemia, diastolic heart failure, cardiac hypertrophy, diabetic cardiomyopathy, and cardiovascular safety of hemoglobin-based blood substitutes. Instructed medical, dental, graduate, and undergraduate students in various pharmacology topics.

EDUCATION:

• Temple University, Philadelphia, PA, BA, Biology
• The University of Michigan, Ann Arbor, MI, PhD, Pharmacology
• Boston University, Boston, MA, Postdoctoral Fellowship, Cardiovascular Research

SELECTED ACCOMPLISHMENTS:

• Managed nonclinical safety strategies for inflammation/immunology drugs including: Xiapex, Xeljanz, Abrocitinib, >20 small molecules and biotherapeutics in Phases 1-3 
• Managed preparation of nonclinical safety sections for 27 FIH submissions from 2004 to 2006
• Member of cross-functional team that reduced IND submission time by 18 working days
• Authored nonclinical section of industry-first micro-dose screening IND
• Devised regulatory strategies for: specifications for degradation products in inhaled drugs; genotoxic drug products and degradants; toxicological qualification of extractable impurities in inhaled drug products
• FDA Pharm/Tox reviewer for first inhaled corticosteroid approved for children < 4 years old
• Lead FDA Pharm/Tox team that validated use of ICH impurity guidelines for inhaled drugs
• Author/co-author of 38 peer-reviewed journal articles

• Pfizer Team Award: Tofacitinib Cardiovascular Safety Council (2010)
• Pfizer Portfolio Award: Xiapex European MAA submission (2009)
• Pharmacia Special Recognition Award: Productivity and quality of safety assessments (2002)
• FDA On the Spot Awards: Regulatory approaches to degradants in inhaled drugs (1997), and Development of drugs with positive in vitro genotoxic findings (1998)
• Sigma Xi - Scientific Research Society (1981)
• NIH Predoctoral (1974-1976) and Postdoctoral (1979-1981) fellowships
• Duncan McCarthy Award (for research presentation), University of Michigan (1978)
• Delta Sigma Rho - Tau Kappa Alpha forensic honor society (1974)

• Guest lecturer graduate course in drug development, Boston University, (2011, 2013, 2015, 2017)
• Product Quality Research Institute leachable/extractable impurities working group (2000-2006)
• Organizing committee for Parenteral Drug Association (PDA) extractables workshop (2001)
• FDA spokesperson at meetings of: Society of Toxicology (1998), FDA/Industry Public Workshop (1999), Drug Information Association (1999), American College of Toxicology (1999)
• FDA/CDER Committees & Work Groups (1996-1999): Immunotoxicology, Reproductive Toxicity, Narrow Therapeutic Index Drugs, Chemistry Submissions for Inhaled Drugs, Extrapolating First Dose in Humans; facilitator for new reviewers' workshops and Pharm/Tox retreats
• ASPET annual meeting organizing committee (1985), Nominating Committee alternate (1997).
• Boston University Committees (1983-1991): Graduate Education, Curriculum Review, Medical Student Promotions, Fellowships & Awards, Academic Standards
• Hoffmann LaRoche - Institutional Animal Care and Use Committee (1992-1994)
• Reviewer for: NIH Study Section, Short Term Training Grants (1984); Veterans Admin. research grants (1984, 1987); Massachusetts AHA Affiliate Grants and Fellowships (1990-91)

1. Radi ZA, Vogel WM, LaBranche T, Dybowski JA, Peraza MA, Portugal SS, Lettiere DJ.Renal and Hematologic Comparative Effects of Dissociated Agonist of the Glucocorticoid Receptor and Prednisone in Dogs With and Without Food Restriction.Int J Toxicol. 2018 May/Jun;37(3):223-233. doi: 10.1177/1091581818763804. Epub 2018 Mar 19. PubMed PMID: 29554821.
    
2. Collinge M, Ball DJ, Bowman CJ, Nilson AL, Radi ZA, Vogel WM. Immunologic effects of chronic administration of tofacitinib, a Janus kinase inhibitor, in cynomolgus monkeys and rats - Comparison of juvenile and adult responses. Regul Toxicol Pharmacol. 2018 Apr;94:306-322. doi: 10.1016/j.yrtph.2018.02.006. Epub 2018 Feb 15. PubMed PMID: 29454012.

3. Radi ZA, Vogel WM, Bartholomew PM, Koza-Taylor P, Papanikolaou A, Wisialowski T, Nambiar P, Ball DJ. Cellular and functional actions of tofacitinib related to the pathophysiology of hibernoma development. Regul Toxicol Pharmacol. 2017 Dec;91:93-102. doi: 10.1016/j.yrtph.2017.10.020. Epub 2017 Oct 23. PubMed PMID: 29074274.

4. Chapin RE, Ball DJ, Radi ZA, Kumpf SW, Koza-Taylor PH, Potter DM, Vogel WM.Effects of the Janus Kinase Inhibitor, Tofacitinib, on Testicular Leydig Cell Hyperplasia and Adenoma in Rats, and on Prolactin Signaling in Cultured Primary Rat Leydig Cells.Toxicol Sci. 2017 Jan;155(1):148-156. doi: 10.1093/toxsci/kfw197. Epub 2016 Oct 5. PubMed PMID: 27708194.
    
5. Radi ZA, Vogel MW. Gastric parietal cell atrophy and depletion after administration of a sphingosine-1-phosphate 1 inhibitor. Toxicol Pathol. 2014 Jan;42(1):118-23. doi: 10.1177/0192623313506790. Epub 2013 Oct 31. PubMed PMID: 24178572.
    
6. Brenneman KA, Ramaiah SK, Rohde CM, Messing DM, O'Neil SP, Gauthier LM, Stewart ZS, Mantena SR, Shevlin KM, Leonard CG, Sokolowski SA, Lin H, Carraher DC, Jesson MI, Tomlinson L, Zhan Y, Bobrowski WF, Bailey SA, Vogel WM, Morris DL, Whiteley LO, Davis JW 2nd. Mechanistic investigations of test article-induced pancreatic toxicity at the endocrine-exocrine interface in the rat. Toxicol Pathol. 2014 Jan;42(1):229-42. doi: 10.1177/0192623313508851. Epub 2013 Nov 13. PubMed PMID: 24226507.
    
7. Radi Z, Bartholomew P, Elwell M, Vogel WM. Comparative pathophysiology, toxicology, and human cancer risk assessment of pharmaceutical-induced hibernoma. Toxicol Appl Pharmacol. 2013 Dec 15;273(3):456-63. doi: 10.1016/j.taap.2013.10.011. Epub 2013 Oct 18. Review. PubMed PMID: 24141031.
    
8. Smith DA, Morgan P, Vogel WM, Walker DK. The use of C(av) rather than AUC in safety assessment. Regul Toxicol Pharmacol. 2010 Jun;57(1):70-3. doi: 10.1016/j.yrtph.2010.01.001. Epub 2010 Jan 13. PubMed PMID: 20074607.
    
9. Bell RR, Merriman TN, Vogel WM, Phillips JM, Khan NK. Evaluation of the effects of subchronic oral administration of n-butyl maleate in Sprague-Dawley rats. J Toxicol Environ Health A. 2007 Jun;70(12):1038-45. doi: 10.1080/15287390601172072. PubMed PMID: 17497415.
    
10. Ball D, Blanchard J, Jacobson-Kram D, McClellan RO, McGovern T, Norwood DL, Vogel W, Wolff R, Nagao L. Development of safety qualification thresholds and their use in orally inhaled and nasal drug product evaluation. Toxicol Sci. 2007 Jun;97(2):226-36. doi: 10.1093/toxsci/kfm058. Epub 2007 Mar 16. Review. PubMed PMID: 17369604.
     
11. DeGeorge JJ, Ahn CH, Andrews PA, Brower ME, Choi YS, Chun MY, Du T, Lee-Ham DY, McGuinn WD, Pei L, Sancilio LF, Schmidt W, Sheevers HV, Sun CJ, Tripathi S, Vogel WM, Whitehurst V, Williams S, Taylor AS. Considerations for toxicology studies of respiratory drug products. Regul Toxicol Pharmacol. 1997 Apr;25(2):189-93. doi: 10.1006/rtph.1997.1099. Review. PubMed PMID: 9185894.
     
12. Vogel WM, Bush LR, Cavallo GC, Heathers GP, Hirkaler GM, Kozak MZ, Higgins AJ. Inhibition of long-chain acylcarnitine accumulation during coronary artery occlusion does not alter infarct size in dogs. J Cardiovasc Pharmacol. 1994 May;23(5):826-32. PubMed PMID: 7521468.
     
13. Vogel WM, Cassidy G, Valeri CR. Effects of o-raffinose-polymerized human hemoglobin on coronary tone and cardiac function in isolated hearts. Biomater Artif Cells Immobilization Biotechnol. 1992;20(2-4):673-7. PubMed PMID: 1391494.
     
14. Connelly CM, McLaughlin RJ, Vogel WM, Apstein CS. Reversible and irreversible elongation of ischemic, infarcted, and healed myocardium in response to increases in preload and afterload. Circulation. 1991 Jul;84(1):387-99. PubMed PMID: 2060109.
     
15. Jacobs AK, Faxon DP, Coats WD, Vogel WM, Ryan TJ. Coronary sinus occlusion: effect on ischemic left ventricular dysfunction and reactive hyperemia. Am Heart J. 1991 Feb;121(2 Pt 1):442-9. PubMed PMID: 1990747.
     
16. Cunningham MJ, Apstein CS, Weinberg EO, Vogel WM, Lorell BH. Influence of glucose and insulin on the exaggerated diastolic and systolic dysfunction of hypertrophied rat hearts during hypoxia. Circ Res. 1990 Feb;66(2):406-15. PubMed PMID: 2137038.
     
17. Connelly CM, Leppo JA, Weitzman PW, Vogel WM, Apstein CS. Effect of coronary occlusion and reperfusion on myocardial blood flow during infarct healing. Am J Physiol. 1989 Aug;257(2 Pt 2):H365-74. doi: 10.1152/ajpheart.1989.257.2.H365. PubMed PMID: 2764125.
     
18. Lieberthal W, Vogel WM, Apstein CS, Valeri CR. Studies of the mechanism of the vasoconstrictor activity of stroma-free hemoglobin in the isolated perfused rat kidney and rabbit heart. Prog Clin Biol Res. 1989;319:407-20; discussion 421-2. PubMed PMID: 2622922.
     
19. Vogel WM, Apstein CS. Effects of alloxan-induced diabetes on ischemia-reperfusion injury in rabbit hearts. Circ Res. 1988 May;62(5):975-82. PubMed PMID: 3359580.
     
20. Vogel WM, Lieberthal W, Apstein CS, Levinsky N, Valeri CR. Effects of stroma-free hemoglobin solutions on isolated perfused rabbit hearts and isolated perfused rat kidneys. Biomater Artif Cells Artif Organs. 1988;16(1-3):227-35. PubMed PMID: 3140918.
     
21. Vogel WM, Hsia JC, Briggs LL, Er SS, Cassidy G, Apstein CS, Valeri CR. Reduced coronary vasoconstrictor activity of hemoglobin solutions purified by ATP-agarose affinity chromatography. Life Sci. 1987 Jul 6;41(1):89-93. PubMed PMID: 3600177.
     
22. Vogel WM, Cerel AW, Apstein CS. Post-ischemic cardiac chamber stiffness and coronary vasomotion: the role of edema and effects of dextran. J Mol Cell Cardiol. 1986 Dec;18(12):1207-18. PubMed PMID: 2434657.
     
23. Vogel WM, Dennis RC, Cassidy G, Apstein CS, Valeri CR. Coronary constrictor effect of stroma-free hemoglobin solutions. Am J Physiol. 1986 Aug;251(2 Pt 2):H413-20. doi: 10.1152/ajpheart.1986.251.2.H413. PubMed PMID: 3740293.
     
24. Connelly CM, Vogel WM, Wiegner AW, Osmers EL, Bing OH, Kloner RA, Dunn-Lanchantin DM, Franzblau C, Apstein CS. Effects of reperfusion after coronary artery occlusion on post-infarction scar tissue. Circ Res. 1985 Oct;57(4):562-77. PubMed PMID: 4042284.
     
25. Apstein CS, Dennis RC, Briggs L, Vogel WM, Frazer J, Valeri CR. Effect of erythrocyte storage and oxyhemoglobin affinity changes on cardiac function. Am J Physiol. 1985 Apr;248(4 Pt 2):H508-15. doi: 10.1152/ajpheart.1985.248.4.H508. PubMed PMID: 3985174.
     
26. Vogel WM, Briggs LL, Apstein CS. Separation of inherent diastolic myocardial fiber tension and coronary vascular erectile contributions to wall stiffness of rabbit hearts damaged by ischemia, hypoxia, calcium paradox and reperfusion. J Mol Cell Cardiol.1985 Jan;17(1):57-70. PubMed PMID: 2580987.
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27. Lerman RH, Apstein CS, Kagan HM, Osmers EL, Chichester CO, Vogel WM, Connelly CM, Steffee WP. Myocardial healing and repair after experimental infarction in the rabbit.Circ Res. 1983 Sep;53(3):378-88. PubMed PMID: 6136345.
     
28. Connelly C, Vogel WM, Hernandez YM, Apstein CS. Movement of necrotic wavefront after coronary artery occlusion in rabbit. Am J Physiol. 1982 Nov;243(5):H682-90. doi: 10.1152/ajpheart.1982.243.5.H682. PubMed PMID: 7137361.
     
29. Vogel WM, Apstein CS, Briggs LL, Gaasch WH, Ahn J. Acute alterations in left ventricular diastolic chamber stiffness. Role of the "erectile" effect of coronary arterial pressure and flow in normal and damaged hearts. Circ Res. 1982 Oct;51(4):465-78. PubMed PMID: 7127681.
     
30. Apstein CS, Vogel WM. Coronary arterial vasodilator effect of ibuprofen. J Pharmacol Exp Ther. 1982 Jan;220(1):167-71. PubMed PMID: 7053413.
     
31. Serizawa T, Vogel WM, Apstein CS, Grossman W. Comparison of acute alterations in left ventricular relaxation and diastolic chamber stiffness induced by hypoxia and ischemia. Role of myocardial oxygen supply-demand imbalance. J Clin Invest. 1981 Jul;68(1):91-102. PubMed PMID: 7251868; PubMed Central PMCID: PMC370776.
     
32. Vogel WM, Lucchesi BR. An isolated, blood-perfused, feline heart preparation for evaluating pharmacological interventions during myocardial ischemia. J Pharmacol Methods. 1980 Dec;4(4):291-303. PubMed PMID: 7206737.
     
33. Vogel WM, Romson JL, Bush LR, Shlafer M, Lucchesi BR. Protective effects of dimethyl-propranolol (UM-272) during global ischemia of isolated feline hearts. J Pharmacol Exp Ther. 1980 Mar;212(3):560-8. PubMed PMID: 7359356.
34. Vogel WM, Lum D, Lucchesi BR. Methylprednisolone sodium succinate treatment in global ischemia of the cat isolated heart. J Cardiovasc Pharmacol. 1979 Jan-Feb;1(1):53-68. PubMed PMID: 94382.
     
35. Vogel WM, Lucchesi BR. Methylprednisolone and the size of myocardial infarcts. Chest.1978 Apr;73(4):444. PubMed PMID: 630958.
     
36. Nielsen CJ, Sando JJ, Vogel WM, Pratt WB. Glucocorticoid receptor inactivation under cell-free conditions. J Biol Chem. 1977 Nov 10;252(21):7568-78. PubMed PMID: 914827.
     
37. Nielsen CJ, Vogel WM, Pratt WB. Inactivation of glucocorticoid receptors in cell-free preparations of rat liver. Cancer Res. 1977 Sep;37(9):3420-6. PubMed PMID: 884685.
     
38. Vogel WM, Zannoni VG, Abrams GD, Lucchesi BR. Inability of methylprednisolone sodium succinate to decrease infarct size or preserve enzyme activity measured 24 hours after coronary occlusion in the dog. Circulation. 1977 Apr;55(4):588-95. PubMed PMID: 837501.