W. Mark Vogel, PhD
Pfizer – Drug Safety Research & Development
610 Main Street, Cambridge, MA 02139
Pfizer (previously Pharmacia), Drug Safety Research & Development (DSRD)
Sr Director, Inflammation & Immunology Therapeutic Area Lead (2007-present): Manage nonclinical safety strategies for small molecule and biotherapeutic projects in inflammation and autoimmunity from idea to loss of exclusivity. Supervise 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). Provide toxicology expertise to R&D programs via participation on R&D governance bodies.
Development and 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, CDER 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, Pharmaceuticals R&D
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.
Temple University, Philadelphia, PA (1970-74) BA, Biology
The University of Michigan, Ann Arbor, MI (1974-79) PhD, Pharmacology
Boston University, Boston, MA (1979-81) Postdoctoral Fellowship, Cardiovascular Research
- Managed nonclinical safety strategies for inflammation/immunology drugs including: EU registration of Xiapex, JAK inhibitor Xeljanz through registration, >12 small molecules and biotherapeutics in Phase 2, and First-in-Human for >10 small molecules and biotherapeutics.
- 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 33 peer-reviewed journal articles and book chapters.
AWARDS AND FELLOWSHIPS:
- 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).
OTHER PROFESSIONAL ACTIVITIES:
- Co-director,graduate course in drug development, Boston University, (Spring 2011)
- 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).
- 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;42(1):229-42.
- Radi Z, Bartholomew P, Elwell M, Vogel WM. Comparative pathophysiology, toxicology, and human cancer risk assessment of pharmaceutical-induced hibernoma. Toxicol Appl Pharmacol. 2013;273(3):456-63.
- Vogel WM. The development of safety thresholds for leachables in orally inhaled and nasal drug products. In: Ball DJ, Norwood DL, Stults CL, Nagao L, editors. Leachables and Extractables Handbook: Safety Evaluation, Qualification, and Best Practices Applied to Inhalation Drug Products. Hoboken: John Wiley & Sons; 2011.
- Smith DA, Morgan P, Vogel WM, Walker D. The use of Cav rather than AUC in safety assessment. Reg Toxicol Pharmacol, 2010;57(1):70-3.
- Ball D, Blanchard J, Jacobson-Kram D, McClellan RO, McGovern T, Norwood DL, Vogel WM, Wolff R, Nagao L. Development of safety qualification thresholds and their use in orally inhaled and nasal drug product evaluation. Toxicol Sci 2007;97(2):226-36.
- Bell RR, Merriman TN, Vogel WM, Phillips JM, Khan KN. Evaluation of the effects of subchronic oral administration of n-butyl maleate in the Sprague-Dawley rat. J Toxicol Environ Health (Part A) 2007;70(12):1038-45.
- 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. Regulatory Toxicol Pharmacol 1997;25:189-93.
- Vogel WM, Bush LR, Cavallo GC, Heathers GP, Hirkaler GM, Kozak MZs, Higgins AJ: Inhibition of long-chain acylcarnitine accumulation during coronary artery occlusion does not alter infarct size in dogs. J Cardiovasc Pharmacol 1994;23:826-32.
- Vogel WM, Cassidy G, Valeri CR: Effects of o-raffinose-polymerized human hemoglobin on coronary tone and cardiac function in isolated hearts. In: Chang TMS, editor. Blood Substitutes and Oxygen Carriers. New York: Marcel Dekker; 1993.
- 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;121:442-9.
- 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. Circ Res 1991;84:387-99.
- 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;66:406-15.
- 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. In: Brewer G, editor. The Red Cell, Seventh Ann Arbor Conference. New York: Liss Inc; 1989, pp 407-422.
- 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;257:H365-74.
- 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. Biomat Art Cells Art Org 1988;16:227-235.
- Vogel WM, Apstein CS: Effects of chronic alloxan-induced diabetes on sensitivity to myocardial ischemia in rabbits. Circ Res 1988;62:975-82.
- Apstein CS, Wexler LF, Vogel WM, Weinberg EO, Ingwall JS: Comparative effects of ischemia and hypoxia on ventricular relaxation in isolated perfused hearts. In: Grossman W, Lorell BH, editors. Diastolic Relaxation of the Heart. Boston: Martinus Nijhoff; 1987, pp 169-184.
- 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;41:89-93.
- Vogel WM, Dennis RC, Cassidy G, Apstein CS, Valeri CR: Coronary constrictor effect of stroma-free hemoglobin solutions. Am J Physiology 1986;251:H413-20.
- Vogel WM, Cerel AW, Apstein CS: Post-ischemic cardiac chamber stiffness and coronary vasomotion: the role of edema and effects of dextran. J Molec Cell Cardiol 1986;18:1207-18.
- Connelly CM, Vogel WM, Wiegner AW, Osmers EL, Bing OHL, Kloner RA, Dunn-Lanchantin DM, Franzblau C, Apstein CS: Effects of reperfusion after coronary artery occlusion on post-infarction scar tissue. Circ Res 1985;57: 562-77.
- Apstein CS, Dennis RC, Briggs LL, Vogel WM, Frazer J, Valeri CR: Effect of erythrocyte storage and oxyhemoglobin affinity changes on cardiac function. Am J Physiol 1985;248:H508-15.
- Vogel WM, Briggs LL, Apstein CS: Separation of inherent myocardial fiber tension and coronary vascular "erectile" contributions to wall stiffness of rabbit hearts damaged by ischemia, hypoxia, calcium paradox and reperfusion. J Molec Cell Cardiol 1985;17:57-70.
- 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;53:378-88.
- Connelly CM, Vogel WM, Hernandez YM, Apstein CS: Movement of the necrotic wavefront after coronary artery occlusion in the rabbit. Am J Physiol 1982;243:H682-90.
- 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;51:465-78.
- Apstein CS, Vogel WM: Coronary arterial vasodilator effect of ibuprofen. J Pharmacol Exp Thera 1982;220:167-71.
- 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 supply-demand imbalance. J Clin Invest 1981;68:91-102.
- Vogel WM, Lucchesi BR: An isolated blood perfused feline heart preparation for evaluating pharmacological interventions during myocardial ischemia. J Pharmacol Methods 1980;4:291-303.
- 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 Thera 1980;212:560-8.
- Vogel WM, Lum D, Lucchesi BR: Methylprednisolone sodium succinate treatment in global ischemia of the cat isolated heart. J Cardiovasc Pharmacol 1979;1:53-68.
- Vogel WM, Lucchesi BR: Methylprednisolone and the size of myocardial infarcts. Chest 1978;73:444-5.
- Nielsen CJ, Sando JJ, Vogel WM, Pratt WB: Glucocorticoid receptor inactivation under cell free conditions. J Biol Chem 1977;252:7568-78.
- Nielsen CJ, Vogel WM, Pratt WB: Inactivation of glucocorticoid receptors in cell-free preparations of rat liver. Cancer Res 1977;37:3420-6.
- Vogel WM, Zannoni VZ, 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;55:588-95.