Medical Director and Chairman of the Board

Consultations in general clinical pharmacology, in clinical development of NCE, and in calcium and metabolic bone disease, especially osteoporosis clinical trials. Medical monitoring, regulatory assessments of client’s products for medical devices, OTC agents. Head of medical affairs group providing all trial services for clients ranging from protocol development to clinical operations to data management to final report completed.

Norwich Eaton Pharmaceuticals/Procter & Gamble Pharmaceuticals (10 years)

Medical Director, Clinical Pharmacology and Experimental Therapeutics

Medical Director, Metabolic Bone Disease and Osteoporosis Therapeutics

Director for Clinical Trials and Medical Monitor:

Strategic planning for clinical trial program for new drugs from preclinical development through Phase I through Phase III human testing. Developed and wrote protocols, directed, and monitored pivotal Phase III trials for intermittent, cyclical etidronate treatment regimen for postmenopausal osteoporosis; presentations of data to European Regulatory Authorities for successful registration and marketing launch. Designed and developed clinical trials for prevention and treatment of glucocorticoid-induced osteoporosis with etidronate or with residronate. Prepared and wrote clinical sections for IND for new chemical entities ( risedronate) and for NDA submissions. Final reports of clinical trials and studies: analysis and interpretation of trial results and clinical assessment and meaning of statistical reports for large multicenter Didrocal osteoporosis trials; for studies on treatment of hypercalcemia with etidronate IV; for dose-ranging trials; for pharmacokinetic studies of etidronate in patients with chronic renal diseases, and in elderly women. In addition to directing clinical research for development of agents for treatment of calcium disorders and osteoporosis, served as Medical Monitor for drugs under development in the following therapeutic areas: asthma, bronchitis, cardiotonic, dysrhythmic, non-narcotic analgesic, antiarthritic, endocrine and metabolic oral peptides (calcitonin, insulin) formulations, cholesterol metabolism.

 

The University of Rochester School of Medicine and Dentistry (13 years)

The University of Arkansas for Medical Sciences (8 years)

SUNY Health Sciences Center, Syracuse (4 years)

Teaching: Basic courses in general pharmacology; clinical pharmacology; attending in general internal medical services; attending in clinical pharmacology and rational therapeutics; attending in endocrinology and metabolic diseases (diabetes), subspecialty in mineral disorders and metabolic bone diseases; courses in introduction to medicine and physical diagnosis. Directed and conducted workshops on clinical pharmacology and rational therapy for the aged patients for Veterans Administration Regional Educational Centers. Developed curriculum in Clinical Pharmacology SUNY HSC, Syracuse.

Patient Care: Conducted general medicine clinic at Rochester General Hospital and at VA Medical Center, Little Rock; also conducted specialty clinic and consultative service for metabolic bone diseases at Rochester General Hospital and Strong Memorial Hospital, and at University Hospital, Little Rock; consultative services in clinical pharmacological, therapeutics, and toxicological problems at all hospitals. Service in diabetes clinic and in general endocrine and metabolic disease consultation in VA Hospital and University Hospital, Little Rock.

Research: Regulation of parathyroid gland metabolism in vitro parathyroid glands by organ cultures; effect of chronic renal disease on parathyroid and vitamin D metabolism; influence of aging on pharmacokinetic and metabolism of drugs (theophylline, etidronate disodium in human studies); clinical trials of agents for treatment of osteoporosis, Paget’s disease, hypercalcemia, metastatic bone disease, and hypertension.

 

1996 - Present SUNY Upstate Medical Center, Syracuse, N.Y.

Professor of Medicine (Clinical Pharmacology)

1994 - Present Norwich Clinical Research Associates Ltd

Medical Director, Clinical Pharmacology and Clinical Research

1984 - 1994 Procter & Gamble Pharmaceuticals Inc.

(formerly Norwich Eaton Pharmaceuticals, Norwich, N.Y.

Medical Director, Regulatory and Clinical Affairs

Section Head, Clinical Pharmacology and Experimental Bone Therapeutics

Director of Clinical Pharmacology, Medical Affairs

1976 - 1984 University of Arkansas for Medical Sciences, Little Rock, AR

Professor of Medicine and Pharmacology; and, Chief, Clinical Pharmacology Division, College of Medicine

1970 - 1976 The University of Rochester School of Medicine and Dentistry, Rochester, NY Associate Professor of Pharmacology and of Medicine

1969 - 1970 St. Mary’s Hospital Medical School, London, UK

Visiting Professor in Biochemistry (Drug Metabolism)

Boston University School of Medicine,

M.D., magna cum laude, 1955

State University of New York Health Science Center, Syracuse:

Intern in Medicine, 7/15/55 - 6/30/57

Assistant Resident in Medicine, 7/1/55 - 6/30/57

Resident in Medicine, 7/1/57 - 6/30/57

Research Fellow in Medicine, 7/1/58 - 6/30/59

in Renal and Electrolyte Metabolic Disorders, - L.G. Raisz, M.D., Director

National Institutes of Health, National Heart Institute, Bethesda, MD;

Postdoctoral Research Fellow in Endocrinology, 9/1/61 - 6/30/63,

in Laboratory on Endocrinology and Metabolic Diseases - F.C. Bartter, M.D., Director

University of Rochester Medical Center, Rochester, NY;

Trainee in Clinical Pharmacology, 7/1/63 6/30/65,

in Clinical Pharmacology Unit and Laboratory on Calcium Regulation and Metabolic Bone Diseases, L.G. Raisz, M.D., Head and Director

New York: #079390

Arkansas: #C-5317

Veterans Administration Hospital, Little Rock, AR

Physician and Chief, Clinical Pharmacology Section

University Hospital, UAMS, Little Rock, AR

Attending Physician

Rochester General Hospital, Rochester, NY

Consultant in Medicine;

Attending Physician

Strong Memorial Hospital, Rochester, NY

Senior Associate Physician

American Society for Pharmacology and Experimental Therapeutics

American Society for Clinical Pharmacology and Therapeutics

American College of Clinical Pharmacology

Endocrine Society

American Society for Bone and Mineral Research

Bone and Mineral Metabolism

Regulation of parathyroid hormone synthesis and secretion by humoral and by

pharmacological agents (corticosteroids, vitamin D metabolites, thiazide diuretics).

Clinical pharmacology and therapeutics

Phase I and Phase II Dose Ranging, Pharmacodynamic, and Pharmacokinetic Human Trials.

Endocrine and Metabolic Disease, especially in Osteoporosis clinical trials, treatment of Paget’s disease, hypercalcemia, and metastatic bone diseases.

Geriatric clinical pharmacology

Effect of aging on drug metabolism and on therapeutic responses/drug interactions.

Have presented 51 formal lectures, seminars, and medical staff rounds to health professional groups (other than medical students). A list of titles is available on request. Additional presentations, not listed, were to clinicians, investigators, or research groups on the design and results of pivotal clinical trials with intermittent, cyclical etidronate regimen for treatment of osteoporosis (postmenopausal and corticosteroid-induced); on the management of hypercalcemia; as well as on other topics on pharmaceutical drug development.

I have published 41 papers related to my research work; and18 published for presentation

at research meetings. Bibliography is available on request. In addition I have completed over 20 formal reports on clinical trial results, FDA, IND, NDA, and PLA submissions at Procter &Gamble Pharmaceuticals and for NCRA clients. These are not listed due to confidential proprietary considerations.

1) Raisz, L.G., W.Y.W. Au, and R.L. Scheer. Studies on the renal concentrating mechanism. III. Effect of heavy exercise. J. Clin. Invest. 38:8, 1959.

2) Raisz, L.G., W.Y.W. Au, and R.L. Scheer. Studies on the renal concentrating mechanism. IV. Osmotic diuresis. J. Clin. Invest. 38:1725, 1959.

3) Au, W.Y.W. and L.G. Raisz. Studies on the renal concentrating mechanism. V. Effect of diuretic agents. J. Clin. Invest. 39:1302, 1960.

4) Raisz, L.G., W.Y.W. Au, and J. Tepperman. Effects of changes in parathyroid activity on bone metabolism in vitro. Endocrinology 68:783, 1961.

5) Au, W.Y.W. Broad-spectrum antibiotics. Amer. J. Nursing. 64:105, 1964.

6) Raisz, L.G., W.Y.W. Au and P. Stern. Regulation of parathyroid activity in The Parathyroid Glands: Ultrastructure, Secretion and Function. Ed. P.J. Gaillard, R. B. Talmage and Ann M. Budy, University of Chicago Press, 1965, pp. 37-52.

7) Au, W.Y.W. and L.G. Raisz. Effect of vitamin D. and dietary calcium on parathyroid activity. Amer. J. Physiol. 209:637, 1965.

8) Hellman, D.E., W.Y.W. Au and F.C. Bartter. Evidence for a direct effect of parathyroid hormone on urinary acidification. Amer. J. Physiol. 209.643, 1965.

9) Raisz, L.G., J.E. O’Brien and W.Y.W. Au. Parathyroid size and uptake of alpha-aminoisobutyric acid in intact and hypophysectomized rats. Proc. Soc. Exper. Bio. Med. 119:1048, 1965.

10) Ney, R.L., W.Y.W. Au, G. Kelly, I. Radde and F.C. Bartter. Actions of parathyroid hormone in the vitamin D-deficient dog. J. Clin. Invest. 44:2003, 1965.

11) Au, W.Y.W., J.R. Engerman, and L.G. Raisz. Acute effect of metal ions on uptake of alpha-aminoisobutyric acid (AIB) by rat parathyroids in vitro. Proc. Soc. Exper. Biol. Med. 122:285, 1966.

12) Au, W.Y.W. and F.C. Bartter. Effect of vitamin D on in vitro bone calcium metabolism. Endocrinology 78: 1100, 1966.

13) Au, W.Y.W. and L.G. Raisz. Restoration of parathyroid responsiveness in
vitamin D-deficient rats by parenteral calcium or dietary lactose. J. Clin. Invest. 45:1572, 1967.

14) Raisz, L.G., W.Y.W. Au, J. Friedman, and I. Niemann. Thyrocalcitonin and bone resorption. Studies employing a tissue culture bioassay. Amer J. Med. 43:684, 1967.

15) Raisz. L.G., W.Y.W. Au, J. Friedman and I. Niemann. Inhibition of bone resorption in tissue culture by thyrocalcitonin in Calcitonin, Proceedings of the Symposium on Thyrocalcitonin and the C Cells. William Heinemann Medical Books, Ltd., London, 1968, pp. 215-222.

16) Friedman, J., W.Y.W. Au and L.G. Raisz. Responses of fetal rat bone to thyrocalcitonin in tissue culture. Endocrinology 82:149, 1986.

17) Raisz, L.G., J.S. Brand, W.Y.W. Au and I. Niemann. Interactions of parathyroid hormone and thyrocalcitonin on bone resorption in tissue culture in Parathyroid Hormone and Thyrocalcitonin. International Congress Series 159, ed. Talmage and Balanger, Excerpta Medica Foundation, Amsterdam, pp. 370-380, 1969.

18) Raisz, L.G., J.S. Brand, D.C. Klein and W.Y.W. Au. Hormonal regulation of bone resorption in Progress in Endocrinology (ed. C. Gual and F.J.B. Ebling), Excerpta Medica Foundation, Amsterdam, pp. 5, 696-703, 1969.

19) Roth, S.I., W.Y.W. Au, A.S. Kunin, S.M. Krane and L.G.Raisz. Effect of dietary deficiency in vitamin D, calcium and phosphorus on the ultrastructure of rat parathyroid gland. Amer. J. Path. 53:631, 1968.

20) Au, W.Y.W. and L.G. Raisz. Extraction and concentration of serum calcitonin with oxidized cellulose in Calcitonin, Second International Symposium, William Heinemann Medical Books, Ltd., London pp. 110-116, 1970.

21) Au, W.Y.W., and L.G. Raisz. Detection of thyrocalcitonin in rat serum by direct tissue culture bioassay. Endocrinology 86: 1231, 1970.

22) Bleyer, W.A., W.Y.W. Au, W.A. Lange, Sr. and L.G. Raisz. Studies on the detection of adverse drug reactions in the newborn. I. Fetal exposure to maternal medications. J.A.M.A. 213:2046, 1970.

23) Slotkin, T.A., V. DiStefano and W.Y.W. Au. Blood levels and urinary excretion of harmine and its metabolites in man and rats. J. Pharmacol. and Exper. Therapeutics 173:26, 1970.

24) Au, W.Y.W., A.P. Poland, P.H. Stern and L.G. Raisz. Hormone synthesis and secretion by rat parathyroid glands in tissue culture. J. Clin. Invest. 49:1639, 1970.

25) Raisz, L.G., W.Y.W. Au and H.A. Simmons. Calcitonin in human serum (Detection by tissue culture bioassay in medullary carcinoma of the thyroid and other disorders). Arch. Intern. Med. 129:8899, 1972.

26) Raisz, L.G. J. Wener, C.L. Trummel, J.D. Feinblatt and W.Y.W. Au. Induction, inhibition and escape as phenomena of bone resorption, in Calcium, Parathyroid Hormone and the Calcitonins (ed. R.V. Talmage and P.L. Munson). Excerpta medica Foundation, Amsterdam, pp. 446-453, 1972.

27) Licata, A.A., W.Y.W. Au and L.G. Raisz. Secretion of glucosamine containing macromolecules by rat parathyroid glands in culture. Biochim. Biophys. Acta 261:143, 1972.

28) Au, W.Y.W., L.G. Dring, D.G. Grahams-Smith and R.T. Williams. The metabolism of 14C-methyldopa in normal and hypertensive human subjects. Biochem J. 139;1, 1972.

29) Au, W.Y.W., L.G. Dring, D.G. Grahams-Smith, R.T. Williams. The metabolism of 14C-methyldopa in normal and hypertensive human subjects. Biochem J. 129:1, 1972.

30) Weintraub, M., W.Y.W. Au and L. Lasagna. Patient compliance as a determinant of serum digoxin concentration. J.A.M.A. 224-481, 1973.

31) DeWys, W.D., R. Stoll, W.Y.W. Au and M. Salisnjak. Effects of streptozotocin on an islet cell carcinoma with hypercalcemia. Amer. J. Med. 55:671, 1973.

32) Au, W.Y.W. Calcitonin treatment of hypercalcemia due to parathyroid carcinoma. Arch. Internal Med. 135:1594, Dec. 1975.

33) Shih, A.P.L., K. Robinson and W.Y.W. Au. Determination of therapeutic serum concentrations of oral and parenteral meperidone by gas liquid chromatography. European J. Clin. Pharm. 9:451, 1976.

34) Au, W.Y.W. Cortisol stimulation of parathyroid hormone secretion by rat parathyroid glands in organ culture. Science 193-1015, 1976.

35) Su, S.C. and W.Y.W. Au. An improved microanalytical procedure for the quantitation of procainamide and N-acetyl procainamide in serum by high-performance liquid chromatography. Journal Liquid Chromatography 1:783-784, 1978.

36) Licata, A.A., W.Y.W. Au, J. Vera, and F.C. Bartter. Effects of Prostaglandin El on the metabolism in rat parathyroid gland in vitro. Biochim. Biophys. Acta. 582:59, 1979.

37) Rifkin, B.R., B.L. Baker, M.J. Somerman, S.E. Pointon, and W.Y.W. Au. Osteoid removal by mononuclear cells in vitro. Cell and Tissue Research 210:494, 1980.

38) Dutt, A.K., N.D. DeSoyza, W.Y.W. Au, J.L. Hargis and R.L. Tuck. The effect of aminophylline on cardiac rhythm in advanced chronic obstructive pulmonary disease: correlation with serum theophylline levels. Eur. J. Respir. Dis. 64:264, 1983.

39) Schmid, S.E., W.Y.W. Au, D.E. Hill, F.F. Kadlubar and W.Slikker, Jr. Cytochrome P-450-dependent oxidation of the 17a-ethynyl group of synthetic steroids: D-homoannulation or enzyme inactivation. Drug Metabolism and Disposition 11:531, 1983.

40) Au, William Y.W. Effect of vitamin D metabolites on rat parathyroid gland secretion in organ culture. Calcified Tissue International 36:384, 1984.

41) Au, William Y.W., A.K. Dutt, and N. DeSoyza. Theophylline kinetics in elderly chronic obstructive airway disease patients. Clinical Pharmacology and Therapeutics 37:472, 1985.

Abstracts

1) Raisz, L.G., W.Y.W. Au and R.L. Scheer. The relationship between net water reabsorption and osmolal clearance as a measure of renal concentrating activity. Clin. Res. 6:284, 1958.

2) Au, W.Y.W. and L.G.Raisz. The impairment of renal-concentrating ability during mercurial diuresis. Clin. Res. 7:280, 1959.

3) Raisz, L.G., W.Y.W. Au, and J. Tepperman. Effect of parathyroid on bone metabolism in vitro. First International Congress of Endocrinology, Copenhagen. pp. 487-788, 1960.

4) Au, W.Y. W. and L.G. Raisz. Parathyroid activity in vitamin D-deficient rats. Clin. Res. 12:261, 1964.

5) Hellman, D.E., W.Y.W. Au and F.C. Bartter. Renal action of parathyroid hormone: evidence for a direct effect on urinary acidification. The Endocrine Society, Program 45th meeting, June 13-15, 1963, p. 11.

6) Au, W.Y.W., J.R. Engerman and L.G. Raisz. Effect of dietary lactose on parathyroid hormone activity in vitamin D-deficient rats. Clin. Res. 14:277, 1966.

7) Au, W.Y.W., I. Niemann and L.G. Raisz. Detection of thyrocalcitonin in the serum of hypercalcemic rats. Fed Proc. 26:368, 1967

8) Au, W.Y.W., and L.G. Raisz. Parathyroid hormone (PTH) secretion in organ culture. Pharmacologist 10:264, 1968.

9) Au, W.Y.W. and L.G. Raisz. Extraction and concentration of serum calcitonin with oxidized cellulose. Calcitonin ‘69, London, July 1969.

10) Au, W.Y.W. , Effect of cortisol, b-estradiol, and testosterone on parathyroid hormone secretion by rat parathyroid glands in vitro. Fed. Proc. 34:336, 1975.

11) Au, W.Y.W. and A. Bukowski. Inhibition of PTH secretion by vitamin D metabolites in organ cultures of rat parathyroids. Fed. Proc. 35:301, 1976.

12) Licata, A.A., W.Y.W. Au, J. Vera and F.C. Bartter. Effects of PGE on rat parathyroid glands (PTG) in vitro. The Pharmacologist 18:233, 1976.

13) Murphy, J.A., W.Y.W. Au, and J.H. Hudson. Biphasic effect of 1,25-dihydroxycholecalciferol on parathyroid hormone secretion from vitamin D-deficient rat parathyroids. Federation Proceedings 38:759, 1979.

14) Au, W.Y.W. and Murphy, J.B. Impaired calcium regulation of hormone secretion in organ cultures of uremic parathyroid glands. Federation Proceedings 3:850, 1979.

15) Hargis, J., A. Dutt, W.Y.W. Au, N. DeSoyza, and L. Drake. Effect of aminophylline on the incidence of cardiac arrhythmia in chronic obstructive pulmonary disease. Clinical Research 27:398A, 1979.

16) Dutt, A., Au, W.Y.W., DeSoyza, N., Hargis, J., Drake, L. Correlation of cardiac arrhythmia during intravenous aminophylline to drug levels and ventilatory function in chronic obstructive pulmonary disease. American Review of Respiratory Disease (Suppl.), 199:109, 1979.

17) Schmid, Stephen E., Au, W.Y.W., Hill, Donald E., and Slikker, W. Jr. Inactivation of cytochrome P-450 following oxidation of the 17a-ethynyl group of synthetic steroids. Pharmacologists 22:228, 1980.

18) Friedman, NM, L.M. Kohse, S.J. Anderson, and W.Y.W. Au, Effects of three dosage regimens of oral phosphate on parathyroid hormone secretion in postmenopausal women with osteoporosis. International Symposium on Osteoporosis, Aalborg, Derunark, Sept. 21-Oct. 1, 1987.