CURRICULUM VITAE

DANIEL BROWNELL BURNHAM

*** ***** ******** ******

Wayne, PA 19087

cell: 610-***-****

Home email : j3vyuw@r.postjobfree.com

Career Summary:

PhD Physiologist with 22 years experience participating in and leading clinical matrix teams responsible for innovative pharmaceutical research in gastrointestinal, psychiatric and neurological diseases. Key areas of expertise: phase II and III development planning, clinical study design evaluating novel therapeutic targets, oversight of investigative sites, design and preparation of clinical reports, regulatory application dossiers, and full-length peer-reviewed research journal articles

Education and Degrees:

June 1974 B.S., Biology; Denison University, Granville, OH

September 1980 Ph.D., Physiology; University of Texas

Graduate School of Biomedical Sciences

Houston, TX

Positions Held:

1986- 2010: Smithkline and French Laboratories, SmithKline Beecham Pharmaceuticals, GlaxoSmithKline Pharmaceuticals King of Prussia, PA (see page 3 for details of accomplishments)

September 2002 – January 2010 Director, Medicines Development Center, Neurosciences

April 1996 - September 2002 Assistant Director, Clinical Research & Development

July 1989 - March 1996 Senior Investigator, Clinical Research and Development

January 1988 - June 1989 Associate Senior Investigator, Clinical Investigation

April 1986 - December 1987 Staff Fellow, Department of Pharmacology

1980 – 1986: University of California Department of Physiology, San Francisco, CA

August 1983 – March 1986 Assistant Research Physiologist/Visiting Lecturer

October 1980 – August 1983 Postdoctoral Fellow

1975 – 1980: University of Texas Medical School Department of Physiology Houston, TX

September 1975 - September 1980 Research Technician and Graduate Assistant

Teaching Experience:

September 2009 – December 2010 Adjunct Instructor

• Delaware County Community College: Human Anatomy and Physiology 150 and 151

October 1982 – August 1986 Visiting Lecturer

• University of California School of Pharmacy: Physiology 120, (Endocrinology and Gastrointestinal Physiology)

Fellowship and Grant Support:

January 1984 - USPHS New Investigator Research Award

March 1986

August 1981 - USPHS Individual Postdoctoral Research

August 1983 Fellowship Award

Certification:

May 2011 Emergency Medical Technician

• Certification # 162565 Delaware County EHS Council, Inc

References:

William Ball, MD, PhD

Alan Lipschitz, MD

Michael Schwartz, MS, MBA

Details of Accomplishments at

Smithkline and French Laboratories, SmithKline Beecham Pharmaceuticals, and GlaxoSmithKline Pharmaceuticals

September 2002 – January 2010: Director, Medicines Development Center, Neurosciences

• Designed phase II studies in novel psychiatric and neurological indications as member of co-development team for an orexin antagonist, 2008-2009

• Managed clinical team responsible for design of Phase IIb program in primary insomnia, 2006-2007

• Co-managed clinical team responsible for successful Phase IIb evaluation of novel medication in primary insomnia, 2005-2007

• North American clinical scientist on project team responsible for phase IIa development of a paroxetine fixed dose combination product for major depressive disorder, 2003-2005

April 1996 - September 2002: Assistant Director, Clinical Research & Development

• Co-managed clinical team responsible for successful Phase IIb evaluation of in-licensed antidepressant in major depressive disorder, 2001-2003

• Co-managed team responsible for design and initiation of 2 successful Phase III studies that were pivotal to the FDA approval of paroxetine CR in the treatment of premenstrual dysphoric disorder, 1999 - 2001

• Co-designed innovative proof of concept study of paroxetine combination product in depression, 2000

• Designed phase II/III clinical development plan in smoking cessation for paroxetine monotherapy and combination product, 1999

• Co-managed team responsible for design and initiation of two successful Phase III studies which were pivotal to the FDA approval of paroxetine in the treatment of generalized anxiety disorder, 1998.

• Clinical scientist responsible for design of 3 successful Phase III studies evaluating paroxetine CR in the treatment of panic disorder, and prepared ISS, ISE and Item 3 summaries for approved NDA, 1996-1998

July 1989 - March 1996 Senior Investigator, Clinical Research and Development

• Managed clinical team responsible for Phase II 'proof of concept' protocol that successfully evaluated an in-licensed bradykinin antagonist in traumatic brain injury, 1995-1997

• Prepared three Phase III study reports and portions of ISS and ISE for approved NDAs for paroxetine in the treatment of OCD and panic disorder, 1994-1995.

• Supportive role at FDA Advisory Committee Hearings that voted in favor of the safety of Nonprescription Cimetidine in the treatment of heartburn, 1993-1994.

• Co-managed design of 2 successful Phase III studies, and managed team in preparation of clinical reports, ISS, ISE, and Item 3 summaries, for approved NDA amendment supporting cimetidine postprandial heartburn prevention indication, 1991-1992.

January 1988 - June 1989 Associate Senior Investigator, Clinical Investigation

• Prepared extensive ISS literature review of cimetidine-drug interactions that was critical to FDA approval of NDA for nonprescription cimetidine in the treatment of heartburn, 1989-1991.

• Prepared protocols and CRFs for three cimetidine-drug interaction studies, monitored clinical sites, and prepared clinical reports, 1988-1993.

Publications

Stock, A.D., Burnham, D.B., Hsu, T.C. Giemsa banding of meiotic chromosomes: description of a procedure for cytological preparations from solid tissues. Cytogenetics 11: 534-539, 1972.

Burnham, D.B., Williams, J.A. Effects of high concentrations of secretagogues on the morphology and secretary activity of the pancreas: a role for microfilaments. Cell Tissue Res. 222: 2010212, 1982.

Burnham, D.B., Williams, J.A. Effects on carbachol, cholecystokinin and insulin on protein phosphorylation in isolated pancreatic acini. J. Biol. Chem. 257: 105**-*****, 1982.

Burnham, D.B. Epithelial cell production and mucosal morphology in colonic obstruction. Cell Tissue Res. 230: 185-196, 1983.

Purello, F., Burnham, D.B., Goldfine, I.D. Insulin regulation of protein phosphorylation in isolated rat live nuclear envelops: potential relationship to mRNA Metabolism. Proc. Natl. Acad. Sci., 80: 1189-1193, 1983.

Purello, F., Burnham, D.B., Goldfine, I.D. Insulin receptor antiserum and plant lectins mimic the direct effects of insulin on nuclear envelope phosphorylation. Science, 221: 462-463, 1983.

Burnham, D.B., Williams, J.A. Activation of protein kinase activity in pancreatic acini by calcium and cyclic AMP. Amer. J. Physiol. 246: G500-F508, 1984.

Burnham, D.B., McChesney, D., Thurston, D., Williams, J.A. Interaction of vasoactive intestinal polypeptide and cholecystokinin on amylase secretion and glucose transport by mouse pancreatic acini. J. Physiol. (London) 349: 475-482, 1984.

Burnham, D.B., Williams, J.A. Stimulus-secretion coupling in pancreatic acinar cells. J. Pediatric Gastroenterology and Nutrition. 3: 1-10, 1984.

Williams, J.A., Burnham, D.B. Calcium and stimulus-secretion coupling in pancreatic acinar cells. In: Calcium in Biological Systems, ed, R.P. Rubin, G. Weiss and J.W. Putney. New York, Plenum, 1985.

Hootman, S.R., Picado-Leonard, T.M., Burnham, D.B. Muscarinic acetylcholine receptor structure in acinar cells of mammalian exocrine glands. J. Biol. Chem. 260: 4186-4194, 1985.

Burnham, D.B., Munowitz, P., Thorn, N., Williams, J.A. Protein kinase activity associated with pancreatic zymogen granules. Biochem. J. 227: 743-751, 1985.

Burnham, D.B. Characterization of CA2+ activated protein phosphatase activity in exocrine pancreas. Biochem. J. 231: 335-341. 1985.

Burnham, D.B., Monowitz, P., Hootman, S.R., Williams, J.A. Regulation of protein phosphorylation in pancreatic acini: distinct effects of CA2+ ionophore A23187 and 12-0-tetradecanoylphorbol 13-acetate. Biochem. J. 235: 125-131, 1985.

Williams, J.A., Burnham, D.B., Hootman, S.R. Cellular regulation of pancreatic secretion. In: Handbook of Physiology; Alimentary Canal; J. Forte, editor; American Physiological Society, Bethesda, MD, 1987.

Burnham, D.B. Evaluation of the role of protein phosphorylation in the regulation of pancreatic enzyme secretion. In: Proceedings of the Gastrointestinal Secretion Symposium; International Union of Physiological Sciences, 1988.

Burnham, D.B., Soling, H-D., William, J.A. Evaluation of mysoin light chain phosphorylation in isolated pancreatic acini. Amer. J. Physiol. 254: G130-134, 1988.

Burnham, D.B., Sung, C.K., William, J.A. Regulation of protein phosphorylation in pancreatic acini by cyclic AMP-medicated secretagogues: Interaction with carbamylcholine. Biochem. Biophys. Acta 969: 33-39, 1988.

Burnham, D.B., Fondacaro, J.D. Secretagogue-induced protein phosphorylation and chloride transport in Caco-2 Cells. Amer. J. Physiol. 256: G808-G816, 1989.

Fondacaro, J.D., Kolpak, D.C., Burnham, D.B., McCafferty, G.P. Cecetomized rat: a model of experimental secretary diarrhea in conscious animals. J. Pharmacol. Meth. 24: 59-71, 1990.

Acton, G., Broom, C., Burnham, D.B., Laroche, J., Wareham, K., Friedman, C. Effects of low dose cimetidine on nocturnal acid secretion in healthy volunteers. Aliment. Pharmacol. Ther. 5: 61-67, 1991.

Burnham, D.B., Miller, D., Karlstadt, R., Friedman, C., Palmer, R. Famotidine increases alcohol plasma concentration in healthy subjects. Aliment. Pharmacol. Ther. 8: 55-61, 1994.

Lydiard, R.B., Steiner, M., Burnham, D.B., Gergel, I.P. Efficacy studies of paroxetine in panic disorder. Psychopharmacol. Bulletin 34: 175-182, 1998.

Weinberg, D., Burnham, D.B., Berlin, J.A. Effect of histamine-2 receptor antagonists on blood alcohol levels: a meta-analysis. J. Gen. Internal Med. 13: 594-599, 1998.

Marmarou, A., Nichols, J., Burgess, J, Newell, D., Troha, J., Burnham, D.B., Pitts, L. Effects of a bradykinin antagonist in severe traumatic brain injury: results of a multicenter, randomized placebo-controlled trial. J Neurotrauma 16: 431-444, 1999.

Pollack, M.H., Zaninelli, R., Goddard A., McCafferty, J.P., Bellew, K.M., Burnham, D.B., Iyengar, M.K. Paroxetine in the treatment of generalized anxiety disorder: Results of a placebo-controlled, flexible-dosage trial. J.Clin. Psychiatry 62: May, 2001.

Hollander, E., Allen, A., Steiner, M., Wheadon, D.E., Oakes, R., Burnham, D.B. Acute and long-term treatment and prevention of relapse of obsessive-compulsive disorder with paroxetine. J. Clin. Psychiatry 64 (9): 1113-1121, 2003.

Burnham, D.B. Fixed-dose combination drugs: considerations for phase II and III clinical development. American Pharmaceutical Outsourcing 6 (5): 46-48, 2005.

Sheehan, D.V., Burnham D.B., Iyengar M.K., Perera P. Paxil CR Panic Disorder Study Group. Efficacy and tolerability of controlled-release paroxetine in the treatment of panic disorder. J. Clin. Psychiatry 66 (1): 34-40, 2005.

Carmody, T.J., Rush A.J., Bernstein I., Warden D., Brannan S., Burnham D., Woo A., Trivedi MH. The Montgomery Asberg and the Hamilton ratings of depression: a comparison of measures. Eur. Neuropsychopharm. 16 (8):601-11, 2006.

Abstracts

Burnham, D.B., Johnson, L.R. Role of gastrin in the proliferative response to intestinal obstruction. The Physiologist 21: 15, 1978.

Burnham, D.B. The proliferative response to intestinal obstruction. Fed. Proc. 39: 767, 1980.

Burnham, D.B., Williams, J.A. High concentrations of secretagogues induce alterations in both pancreatic acinar morphology and zymogen secretion: a role for microfilaments. J. Cell Biol. 91: 403a, 1981.

Burnham, D.B., Williams, J.A. Cholecystokinin, carbachol and insulin induce alterations in phosphorylation of specific proteins in isolated pancreatic acini. Fed. Proc. 41: 1359, 1982.

Burnham, D.B., Williams, J.A. The existence of calcium and cyclic AMP-activated protein kinases in isolated pancreatic acini. Fed. Proc., 42: 456, 1983.

Burnham, D.B., Williams, J.A. CA2+ -activated protein phosphatase activity in pancreatic acinar cytosol. Fed. Proc. 43: 770, 1984.

Burnham, D.B., Munowitz, P., Hootman, S.R., Williams, J.A. Protein kinase activity associated with pancreatic zymogen granules. Fed. Proc. 44: 1229, 1985.

Burnham, D.B., Munowitz, P., Hootman, S.R., Williams, J.A. Distinct effects of A23187 and 12-0-tetradecanolyphorbol 13-acetate on protein phosphorylation in pancreatic acini. J. Cell Biol. 101: 250a, 1985.

Burnham, D.B., Rush, J.A., Fondacaro, J.D. Alterations in protein phosphorylation associated with stimulation of chloride secretion in the human colon carcinoma cell line Caco-2. Gastroent. 92: 1334, 1987.

Fondacaro, J.D., Kolpak, D.C., McCafferty, G.P., Burnham, D.B., Evaluation of antidiarrheal agents using conscious cecectomized rats. F.A.S.E.B. J. 2: A616, 1988.

Fondacaro, J.D., Kolpak, D.C., Burnham, D.B., McCafferty, G. Cecetomized rate: a model of experimental diarrhea in conscious animals. Gastroent. 96: A132, 1988.

Webb, D.D., Major, P., Gombar, C., Burnham, D.B., Friedman. Cimetidine-theophylline interaction: no effect of single cimetidine dose. Gastroent. 94: A538, 1989.

Burnham, D.B., Gombar, C., Hyneck, M., Webb, D., Chretien, S., Wyle, F., Friedman, C.J. Effects of low cimetidine doses on steady-state warfarin pharmacokinetics and prothrombin time. J. Clin. Pharmacol. 29: 862, 1989.

Acton, G., Broom, C., Burnham, D.B., Friedman, C., Laroche, J., Wareham, K. Effect of low-dose cimetidine on nocturnal acid secretion. Clinical Pharmacol. and Therapeutics. 47: 203, 1990.

Burnham, D.B., Friedman, C.J., Asbel-Sethi, N. The prevalence of endoscopic lesions in the upper gastrointestinal tract of frequent antacid users. Gastroent. 104: A49, 1993.

Burnham, D.B., Friedman, C.J., Asbel-Sethi, N. Helicobacter pylori, endoscopic lesions, and demographic and medical characteristics of frequent antacid users. Gastroent. 104: A49, 1993.

Burnham, D.B., Miller, D., Karlstadt, R., Friedman, C., Palmer, R. Effect of famotidine on alcohol absorption. A re-evaluation. Amer. J. Gastroent. 88: 1503, 1993.

Burnham, D.B., Miller, D., Karlstadt, R., Friedman, C., Palmer, R.. Effect of omeprazole on alcohol absorption. A re-evaluation. Amer. J. Gastroent. 88: 1503, 1993.

Steiner, M.X., Oakes, R. Gergel., I.P., Burnham, D.B., Wheadon, D.E. A fixed-dose study of paroxetine and placebo in the treatment of panic disorder. Amer. J. Psychiatry. 1995.

Burnham, D.B., Steiner, M.X., Gergel., I.P., Oakes, Bailer, D.C., R. Wheadon, D.E. Paroxetine long-term safety and efficacy in panic disorder and prevention of relapse: a double-blind study. American College of Neuropsychopharmacology Meetings, September 1995.

Flisak, J., Grotzinger, K., Burnham, D., Bellew, K., McCafferty, J. Paroxetine improves quality of life and functional disability in patients with GAD. American Psychiatric Association Meetings, May 2001.

Seminars and Presentations

"Studies implicating alterations in protein phosphorylation in the regulation of pancreatic protein secretion". Institute of Endocrinology, University of Catania, Catania, Italy; October, 1984.

"Role of protein dephosphorylation in the regulation of pancreatic protein secretion". Department of Biochemistry, University of Dundee, Dundee, Scotland, November, 1984; Department of Membrane Biophysics, Max Planck Institute for Biophysical Chemistry, Gottingen, FRG, December, 1984.

"Intracellular messenger-regulated protein phosphorylation and its role in exocrine pancreatic secretion". Department of Pathology, Thomas Jefferson University, Philadelphia, PA; November, 1986.

“Phase II/III clinical development of fixed-dose combination drugs” Fixed Dose Combination Drugs conference (organized by Center for Business Intelligence), Philadelphia, PA, April 2004.

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