Accellient Partners | News and Events

EVENTS

THE IMPACT OF VASCULAR INJURY ON DRUG DEVELOPMENT
SOCIETY OF TOXICOLOGY, 2011, WASHINGTON DC
William D. Kerns, DVM, MS, DACVP
Accellient Partners, Waltham, MA

Over the past 30 years, countless compounds in development have been labeled as causing vascular injury in healthy animals during the routine conduct of safety studies. Although some of these compounds have been approved as products, a majority of the compounds have been shelved while industry and academic scientists attempt to define methods to prove that these hazards are not relevant to humans; in humans, there is a background of vascular pathology in most in western cultures, making this even more challenging. Proving a negative is a daunting task. The intent of this presentation is to review this drug development problem across the industry and to assess its impact from a cost and lost opportunity perspective.

LEADERSHIP ROLES FOR VETERINARY PATHOLOGISTS IN THE BIOTECH INDUSTRY...BEYOND CONSULTING
AMERICAN COLLEGE OF VETERINARY PATHOLOGISTS ANNUAL MEETING
DECEMBER 2011, NASHVILLE, TN
William D. Kerns, DVM, MS, DACVP
Accellient Partners, Waltham, MA

Veterinary Pathologists and other medically qualified practitioners are ideally suited professionals to compete for senior leadership positions in the biopharmaceutical industry, following sufficient hands on experience in the industry and/or additional training in drug development, business and finance. These roles range from entrepreneurial leadership positions in start-up biotech companies and service companies to leadership roles in academic technology transfer to entrepreneurs-in-residence in venture and equity backed financial organizations and others.

KEY PUBLICATIONS

van Troostenburg, A. R., Clark, E. V., Carey, W. D. H., Warrington, S. J., Kerns, W.D., Cohn, I., Silverman, M. H., Bar-Yehuda, S., Fong, K.L. L., Fishman, P. Tolerability, pharmacokinetics, and concentration-dependent hemodynamic effects of oral CF101, an A3 adenosine receptor agonist, in healthy young men. Int J Clin Pharmacol Ther, 42: 534-42, 2004.

Kerns WD, et al. Drug-Induced vascular injury—A quest for biomarkers. Toxicol Appl Pharmacol, 203 (1): 62-87, 2005.

Dietsch GN, DiPalma CR, Eyre RJ, Pham TQ, Poole KM, Pefaur NB, Welch WD, Trueblood E, Kerns WD and Kanaly ST. Characterization of the Inflammatory Response to a Highly Selective PDE4 Inhibitor in the Rat and the Identification of Biomarkers that Correlate with Toxicity. Toxicol Pathol, 34: 39-51, 2006.

Fong KL, et al. Preclinical evaluation of Hematide, a novel erythropoiesis stimulating agent, for the treatment of anemia. Exp Hematol, 34(10), 1303-1311, 2006.

Stemmer, S.M., Benjaminov, O., Medalia, G., Silverman, M.H., Kerns, W.D., Bar-Yehuda, S., Fishman, S., Harpaz, Z., Farbstein, M., Fishman, P. Phase 1/2 Trial of CF102, a Selective A₃ Adenosine Receptor (A₃AR) Agonist, in Patients with Hepatocelluar Carcinoma, Int J Clin Pharmacol, Poster no. 384, 2008.

Silverman M….Kerns WD…Fishman P. Clinical Evidence for Utilization of A3 Adenosine Receptor as a Target to Treat Rheumatoid Arthritis: Data from a Phase II Clinical Trial. J Rheumatol, 35: 1-8, 2008.

Woodburn KW, Fan Q, Schatz PJ, Wilson SD, Fong KL, Norton D. A subchronic murine intravenous pharmacokinetic and toxicity study of Hematide™, a PEGylated peptidic erythropoiesis-stimulating agent. Drug Chem Toxicol, 33(1): 28-37, 2008.

Woodburn KW, Wilson SD, Fong KL, Schatz PJ and Norton D. Chronic pharmacological and safety evaluation of Hematide, a PEGylated peptidic erythropoiesis-stimulating agent, in rodents. Basic Clin Pharmacol Toxicol, 104(2): 155-163, 2009.

I. Avni…. W. Silverman, W. Kerns, ….P. Fishman. Treatment of Dry Eye Syndrome with Orally Administered CF101. Data from a Phase 2 Clinical Trial. Ophthalmology, in-press, 2010.

Woodburn KW, Fan Q, Schatz PJ, Wilson SD, Fong K-L, Wagner VO, Ramadevi Gudi R, Krsmanovic L, Paranjpe M, and Shah SA. Genotoxic assessment and toxicity evaluation of peginesatide in CByB6F1 hybrid mice. Drug Chem Toxicol, 34(3): 240-249, 2011.

Hoffmann M, Kumar G, Schafer P, Cedzik D, Capone L, Fong K-L, Gu Z, Heller D, Feng H, Surapaneni S, Laskin O, and Wu A. Disposition, metabolism and mass balance of [14C]apremilast following oral administration. Xenobiotica, 41(12):1063-75, 2011.

Woodburn KW, Holmes C, Fong K-L, Sloneker S, Strzemienski P, and Solon E. A Tissue Distribution Study of 14C-Peginestatide Following Intravenous Administration in Male Cynomolgus Monkeys using Quantitative Whole Body Autoradiography (QWBA) and Microautoradiography (MARG), Anaemia in CKD 1-5 poster, 2011.