B Michael Silber, PhD
Professor
Bioengineering
School of Pharmacy

Current research interests include discovering, developing and launching innovative breakthrough therapeutic and diagnostic products for diseases with high unmet medical need, including pain, inflammation, cancer, eye, neurodegenerative, and infectious diseases.

He is also President and CEO of Reiley Pharmaceuticals focused on breakthrough products for pain, cancer and infectious disease, President and CEO of MacRegen focused on breakthrough drugs for age-related macular degeneration, Senior Advisor at Clinakos, Novakos, and Neurokos, and Scientific Advisory Board member of NextBio/Illumina and Optivia. He was previously President and CEO of Elmedtech, Senior VP of R & D at Roche, VP of R & D and CSO at ALZA/J & J, Director of R & D at Pfizer, Senior Director of R & D at Cetus, and Director of R & D at Lederle Labs.

Dr. Silber has contributed to the discovery, preclinical and clinical development, registration, or commercial success of 23 FDA approved drugs (12 of which have been block busters) and drug devices and diagnostics in many disease areas. He is the author of more than 215 peer-reviewed publications, book chapters, patents, abstracts, and invited presentations.

He has discovered and developed medicines and breakthrough technologies in pain, neurological and neurodegenerative (e.g., Alzheimer’s, Parkinson’s, ALS, MS, FTD, TBI, CTE, CJD), psychotherapeutic (e.g., depression, schizophrenia, ADHD), cancer, eye disease, obesity, diabetes, infectious, lipid, inflammatory, cardiovascular, skin, and respiratory diseases.

Hobbies include mentoring graduate and health profession students, tennis, skiing, photography, and travel.

• Biaryl amides and hydrazones as therapeutics for prion disease in transgenic mice.
  The Journal of pharmacology and experimental therapeutics 2013 Lu D, Giles K, Li Z, Rao S, Dolghih E, Gever JR, Geva M, Elepano ML, Oehler A, Bryant C, Renslo AR, Jacobson MP, Dearmond SJ, Silber BM, Prusiner SB
• Optimization of Arylamides as Novel, Potent and Brain-penetrant Antiprion Lead Compounds.
  ACS medicinal chemistry letters 2013 Li Z, Rao S, Gever JR, Widjaja K, Prusiner SB, Silber BM
• Discovery and Preliminary SAR of Arylpiperazines as Novel, Brainpenetrant Antiprion Compounds.
  ACS medicinal chemistry letters 2013 Li Z, Gever J, Rao S, Widjaja K, Prusiner SB, Silber BM
• 2-Aminothiazoles with improved pharmacotherapeutic properties for treatment of prion disease.
  ChemMedChem 2013 Li Z, Silber BM, Rao S, Gever JR, Bryant C, Gallardo-Godoy A, Dolghih E, Widjaja K, Elepano M, Jacobson MP, Prusiner SB, Renslo AR
• Pharmacokinetics and metabolism of 2-aminothiazoles with antiprion activity in mice.
  Pharmaceutical research 2013 Silber BM, Rao S, Fife KL, Gallardo-Godoy A, Renslo AR, Dalvie DK, Giles K, Freyman Y, Elepano M, Gever JR, Li Z, Jacobson MP, Huang Y, Benet LZ, Prusiner SB
• Discovery of 6-substituted indole-3-glyoxylamides as lead antiprion agents with enhanced cell line activity, improved microsomal stability and low toxicity.
  European journal of medicinal chemistry 2011 Thompson MJ, Louth JC, Ferrara S, Jackson MP, Sorrell FJ, Cochrane EJ, Gever J, Baxendale S, Silber BM, Roehl HH, Chen B
• 2-Aminothiazoles as therapeutic leads for prion diseases.
  Journal of medicinal chemistry 2011 Gallardo-Godoy A, Gever J, Fife KL, Silber BM, Prusiner SB, Renslo AR
• Driving drug discovery: the fundamental role of academic labs.
  Science translational medicine 2010 Silber BM
• Toward a 21st-century health care system: recommendations for health care reform.
  Annals of internal medicine 2009 Arrow K, Auerbach A, Bertko J, Brownlee S, Casalino LP, Cooper J, Crosson FJ, Enthoven A, Falcone E, Feldman RC, Fuchs VR, Garber AM, Gold MR, Goldman D, Hadfield GK, Hall MA, Horwitz RI, Hooven M, …
• Pharmacogenetics, Edited by Werner Kalow, Urs Meyer and Rachel Tyndale
  Pharmacogenomics, Biomarkers and the Promise of Personalized Medicine 2001 Silber, B Michael
• CYP2D6 genotyping as an alternative to phenotyping for determination of metabolic status in a clinical trial setting.
  AAPS pharmSci 2000 McElroy S, Sachse C, Brockmoller J, Richmond J, Lira M, Friedman D, Roots I, Silber BM, Milos PM
• in Biomarkers and Surrogate Endpoints: Clinical Research and Applications, edited by G. Downing
  The Importance of Biomarkers in Drug Discovery and Development-Focus on Alzheimer's Disease 2000 Silber, B.M.
• Proceedings of the First International Pharmacogenomics and Pharmacogenetics Forum, edited by T. Noguchi and Y. Fujita
  Use of Genetic Variation-Response Outcome Relationships in Drug Development and Discovery 1999 Silber, B.M.
• The prediction of human pharmacokinetic parameters from preclinical and in vitro metabolism data.
  The Journal of pharmacology and experimental therapeutics 1997 Obach RS, Baxter JG, Liston TE, Silber BM, Jones BC, MacIntyre F, Rance DJ, Wastall P
• A novel quantitative method for determining the biodistribution of radiolabeled xenobiotics using whole-body cryosectioning and autoradioluminography.
  The Journal of pharmacology and experimental therapeutics 1995 Potchoiba MJ, Tensfeldt TG, Nocerini MR, Silber BM
• Pharmacokinetics of tiqueside (beta-tigogenin cellobioside) in dogs, rats, rabbits, and monkeys.
  Journal of pharmaceutical sciences 1995 Inskeep PB, Connolly AG, Cole MJ, Luther EW, Biehl ML, Marzetta CA, Savoy YE, Silber BM
• Pharmacokinetic principles in the design of immediate-release components in sustained-release formulations with zero-order release characteristics.
  Journal of pharmaceutical sciences 1991 Cheung WK, Silber BM, Yacobi A
• Pharmacokinetics of YTR830H and piperacillin after intravenous coadministration.
  Journal of chemotherapy (Florence, Italy) 1989 Cheung WK, Greene DS, Kuye O, Shin K, Tonelli AP, Houston A, Hibberd M, Faulkner RD, Silber BM
• Pharmacokinetics of YTR830H in healthy human subjects.
  Journal of chemotherapy (Florence, Italy) 1989 Cheung WK, Greene DS, Kuye O, Smith MP, Holder A, Fernandez P, Houston A, Faulkner RD, Silber BM
• Bioequivalency of oral suspension formulations of cefixime.
  Biopharmaceutics & drug disposition 1989 Faulkner RD, Sia LL, Barone JS, Forbes SJ, Silber BM
• Pharmacokinetics of Nilvadipine After Multiple Dosing to Steady-State
  Drug Dev. Indus. Pharm. 1989 Cheung, W.K., Sia, L.L., Hibberd, M., Pearse, S., Woodward, D.L., Desjardins, R.E., Bernstein, J., Yacobi, A., and Silber, B.M.
• Importance of oral dosing rate on the hemodynamic and pharmacokinetic profile on nilvadipine.
  Journal of clinical pharmacology 1988 Cheung WK, Sia LL, Woodward DL, Graveline JF, Desjardins RE, Yacobi A, Silber BM
• Pharmacokinetic evaluation of a sustained-release formulation of trihexyphenidyl in healthy volunteers.
  Journal of pharmaceutical sciences 1988 Cheung WK, Stravinski SS, Engel SI, Sia LL, Yacobi A, Silber BM
• Absolute bioavailability of cefixime in man.
  Journal of clinical pharmacology 1988 Faulkner RD, Fernandez P, Lawrence G, Sia LL, Falkowski AJ, Weiss AI, Yacobi A, Silber BM
• Pharmacokinetics of cefixime in the young and elderly.
  The Journal of antimicrobial chemotherapy 1988 Faulkner RD, Bohaychuk W, Lanc RA, Haynes JD, Desjardins RE, Yacobi A, Silber BM
• In vitro protein binding interaction studies involving cefixime.
  Biopharmaceutics & drug disposition 1988 Bialer M, Wu WH, Faulkner RD, Silber BM, Yacobi A
• Relationship between the pharmacokinetic and pharmacodynamic profile of nilvadipine in the dog.
  Drug metabolism and disposition: the biological fate of chemicals 1988 Wu WH, Henderson BM, Lanc R, Garnes D, Yacobi A, Silber BM
• Bioequivalency of Solid Oral Dosage Forms of Cefixime
  Int. J. Pharmaceut. 1988 Faulkner, R.D., Sia, L.L., Look, Z.M., Barone, J.S., Forbes, St. J., Weiss, A.I., and Silber, B.M.
• Changes in tissue concentrations of 14C-doxorubicin caused by mitoxantrone, mithramycin A and vinblastine in the rat.
  Research communications in chemical pathology and pharmacology 1988 Cheung WK, Aiache M, Yacobi A, Silber BM
• Drug Absorption from Sustained Release Formulations, Edited by A. Yacobi and E. Halperin-Walega
  Utilizing Pharmacokinetic Principles in the Design of Controlled or Sustained Release Formulations 1988 Silber, B.M., Cheung, W.K., and Yacobi, A.
• Pharmacokinetics of nilvadipine after single oral doses in healthy volunteers.
  International journal of clinical pharmacology research 1988 Cheung WK, Woodward DL, Shin K, Hibberd M, Pearse S, Desjardins RE, Yacobi A, Silber BM
• The pharmacokinetics of cefixime in the fasted and fed state.
  European journal of clinical pharmacology 1988 Faulkner RD, Bohaychuk W, Haynes JD, Desjardins RE, Yacobi A, Silber BM
• Determination of cefixime in biological samples by reversed-phase high-performance liquid chromatography.
  Journal of chromatography 1987 Falkowski AJ, Look ZM, Noguchi H, Silber BM
• Liquid-chromatographic determination of five orally active cephalosporins--cefixime, cefaclor, cefadroxil, cephalexin, and cephradine--in human serum.
  Clinical chemistry 1987 McAteer JA, Hiltke MF, Silber BM, Faulkner RD
• Pharmacokinetic profile of cefixime in man.
  The Pediatric infectious disease journal 1987 Faulkner RD, Yacobi A, Barone JS, Kaplan SA, Silber BM
• Pharmacokinetics of cefixime after once-a-day and twice-a-day dosing to steady state.
  Journal of clinical pharmacology 1987 Faulkner RD, Bohaychuk W, Desjardins RE, Look ZM, Haynes JD, Weiss AI, Silber BM
• Pharmacokinetics of cefixime after oral and intravenous doses in dogs: bioavailability assessment for a drug showing nonlinear serum protein binding.
  Research communications in chemical pathology and pharmacology 1987 Bialer M, Wu WH, Look ZM, Silber BM, Yacobi A
• Dose-dependent pharmacokinetics of a new oral cephalosporin, cefixime, in the dog.
  Pharmaceutical research 1987 Bialer M, Batra VK, Morrison JA, Silber BM, Look ZM, Yacobi A
• Decapeptyl: Release from Microcapsules and Testosterone Suppression in the Dog, The Pharmacology and Toxicology of Proteins, pp. 337-349
  Decapeptyl: Release from Microcapsules and Testosterone Suppression in the Dog, The Pharmacology and Toxicology of Proteins, pp. 337-349. 1987 Tonelli, A.P., Nicolau, G., Lawter, J.R., Silber, B.M., Lanc, R.A., Lanzilotti, A.R., Dente, A.R., McWilliams, W.E., and Yacobi, A.
• Pharmacokinetic Approach to the Rational Design of Controlled or Sustained Release Formulations
  J. Control. Rel. 1987 Cheung, W.K., Yacobi, A. and Silber, B.M.
• Sustained and Controlled Release Drug Delivery Systems, 2nd Edition, edited by J.R. Robinson and V.H. Lee
  Pharmacokinetic-Pharmacodynamic Basis of Controlled Drug Delivery 1987 Silber, B.M., Bialer, M., and Yacobi, A.
• The relationship between drug input and mean residence time in the body.
  Biopharmaceutics & drug disposition 1986 Bialer M, Look ZM, Silber BM, Yacobi A
• Nonlinear formation of propranolol metabolites in dogs after portacaval transpositions.
  Journal of pharmacokinetics and biopharmaceutics 1984 Lo MW, Pond SM, Effeney DJ, Silber BM, Riegelman S, Tozer TN
• Pharmacokinetics: A Modern View, edited by L.Z. Benet and G. Levy
  The Use of the Portacaval Transposition Technique to Study Gastrointestinal and Hepatic Metabolism of Propranolol in the Dog 1984 Lo, M.W., Effeney, D.J., Pond, S.M., and Silber, B.M.
• Pharmacokinetics: A Modern View, edited by L.Z. Benet and G. Levy
  Stereoselective Disposition and Glucuronidation of Propranolol in Man 1984 Silber, B.M. and Holford, N.H.G.
• Chemical aspects of propranolol metabolism. Synthesis and identification of 3-(4-hydroxy-1-naphthoxy)propane-1,2-diol as a metabolite of propranolol in the dog, in man and in the rat liver 9000g supernatant fraction.
  Research communications in chemical pathology and pharmacology 1983 Gupte SM, Bartels MJ, Kerr BM, Laganiere S, Silber BM, Nelson WL
• Dose-dependent elimination of propranolol and its major metabolites in humans.
  Journal of pharmaceutical sciences 1983 Silber BM, Holford NH, Riegelman S
• Stereoselective disposition and glucuronidation of propranolol in humans.
  Journal of pharmaceutical sciences 1982 Silber B, Holford NH, Riegelman S
• A technique to study hepatic and intestinal drug metabolism separately in the dog.
  The Journal of pharmacology and experimental therapeutics 1982 Effeney DJ, Pond SM, Lo MW, Silber BM, Riegelman S
• Lack of gastrointestinal metabolism of propranolol in dogs after portacaval transposition.
  The Journal of pharmacology and experimental therapeutics 1982 Lo MW, Effeney DJ, Pond SM, Silber BM, Riegelman S
• An automated HPLC method for the assay of propranolol and its basic metabolites in plasma and urine.
  Journal of chromatographic science 1982 Lo MW, Silber B, Riegelman S
• In vivo effects of the cytochrome P-450 suicide substrate 2-isopropyl-4-pentenamide (allylisopropylacetamide) on the disposition and metabolic pattern of propranolol.
  The Journal of pharmacology and experimental therapeutics 1981 Silber B, Mico BA, Ortiz de Montellano PR, Dols DM, Riegelman S
• Stereospecific assay for (-)- and (+)-propranolol in human and dog plasma.
  The Journal of pharmacology and experimental therapeutics 1980 Silber B, Riegelman S
• The influence of heparin administration on the plasma protein binding and disposition of propranolol.
  Research communications in chemical pathology and pharmacology 1980 Silber B, Lo M, Riegelman S
• Drug Level Monitoring, edited by W. Sadee and G.C.M. Beelen
  Acetazolamide; Hydrochlorthiazide; Tetrahydrocannabinol 1980 Silber, B.M.
• [Hepatic and renal toxicity of enflurane (author's transl)].
  Anesthesie, analgesie, reanimation 1980 Bernad PG, Silber B, Mathieu A
• Spironolactone-associated digoxin radioimmunoassay interference.
  Clinical chemistry 1979 Silber B, Sheiner LB, Powers JL, Winter ME, Sadée W