Beruflich Dokumente
Kultur Dokumente
EDUCATION:
PhD, Biochemistry, University of Nevada, Reno, NV - 1989
Allie M. Lee Honorary Graduate Cancer Research Fellowship
School of Medicine Certificate of Research Achievement
BS, Biochemistry, California Polytechnic State University, San Luis Obispo, CA -
1982
Graduated with Honors, Mu Alpha Theta Honorary Mathematics Club, Alpha Gamma Sig
ma Scholarship Society, Irvine Company Scholarship
TECHNICAL TRAINING:
Good Laboratory Practice/Good Manufacturing Practice (GLP/GMP) Training
State of Nevada Systems-Wide Radiation Safety Training (40 hour course)
American Society of Clinical Pathology (ASCP) Certified Phlebotomist (6-month co
urse)
SKILL SETS:
Areas - Years Experience - Last Used
Drug Metabolism/Pharmacokinetics - 21 years - Currently used
Pharmacology/toxicology (In Vitro and In Vivo) - 26 years - Currently used
Safety Pharmacology - 7 years - Currently used
Free radical biochemistry - 23 years - Currently used
Analytical and bioanalytical methods development - 10 years - Currently used
Regulatory documentation practices - 7 years - Currently used
Bioenergetics and Intermediary Metabolism - 21 years - Currently used
Protein Purification - 14 years - Currently used
Validation (GLP/GMP) - 4 years - 1 year
Quality Control (GLP/GMP) - 2 years - 8 years ago
Techniques/Instrumentation
In Vivo Techniques (efficacy models, PK, toxicology, surgery) - 26 years - Curre
ntly used
Enzymatic Assays (turnover, inhibition, induction, kinetics) - 26 years - Curre
ntly used
UV/Vis Spectrophotometry (static and kinetic) - 26 years -Currently used
Cell Culture - 26 years - Currently used
HPLC (RP; UV/Vis, RI, fluorometric, radiometric, MS detectors) - 15 years - Curr
ently used
TLC - 23 years - Currently used
Immunochemistry (mAb, ELISA) - 5 years - Currently used
Electrophoresis (PAGE, agarose) - 14 years - Currently used
Column Chromatography (GPC, ion exchange, affinity, etc) - 14 years - Currently
used
Electroretinography - 2 years - 1 year ago
Moisture Determination (KF titrations) - 2 years - 8 years ago
Microbiology (cfu, API, etc) - 2 years - 8 years ago
Electrochemistry (CV, polarography, ISE) - 14 years - 8 years ago
ESR/Spin Trapping/Spin Stabilization - 4 years - 10 years ago
ACTIVITIES:
University of Nevada System/Nevada State Department of Education, Instructor for
Science and Technology Day; Presenter for regional science and medicine exposit
ions
Washoe County School District, Consultant to teachers/students; Judge for local
and countywide science fairs Northern Nevada Cancer Council, Volunteer for celeb
rity tennis tournament fundraiser
Juvenile Diabetes Research Foundation of Cleveland Ohio, Volunteer for fundraise
r
ASSOCIATIONS:
Safety Pharmacology Society
American Chemical Society
International Society for Free Radical Research
American Association for Cancer Research
American Association for the Advancement of Science
Alpha Chi Sigma Professional in Chemistry Fraternity
PUBLICATIONS
Book Chapters
Hodnick, W.F., Roettger, W.J., Kung, F.S., Bohmont, C.W., and Pardini, R.S., "In
hibition of Mitochondrial Respiration and Production of Superoxide and Hydrogen
Peroxide by Flavonoids: A Structure Activity Study." In: Plant Flavonoids in B
iology and Medicine: Biochemical, Pharmacological and Structure-Activity Relatio
nships. Prog. Clin. Biol. Res. Vol. 213 (V. Cody, E. Middleton, Jr. and J.B. Ha
rborne, eds.) Alan R. Liss, Inc., New York, pp. 249-252 (1986).
Hodnick, W.F., Kalyanaraman, B., Pritsos, C.A., and Pardini, R.S., "The Producti
on of Hydroxyl and Semiquinone Free Radicals During the Autoxidation of Redox Ac
tive Flavonoids." In: Oxygen Radicals in Biology and Medicine. (M.G. Simic, K.
A. Taylor, J.F. Ward and C. von Sonntag, eds.) Plenum, New York, pp. 149-152 (19
89).
Hodnick, W.F. and Pardini, R.S., "Inhibition of Mitochondrial Function by Flavon
oids." In: Flavonoids in Health and Disease. (C. Rice-Evans and L. Packer, eds
.) Marcel Dekker, Inc., New York, pp. 179-197 (1997).
Hodnick, W.F., Ahmad, S., and Pardini, R.S., "Induction of Oxidative Stress by R
edox Active Flavonoids." In: Flavonoids in the Living System. (J. Manthey and
B. Buslig, eds.) Plenum, New York, pp. 131-150 (1998).
Journal Articles
Hodnick, W.F., Kung, F.S., Roettger, W.J., Bohmont, C.W., and Pardini, R.S., "In
hibition of Mitochondrial Respiration and Production of Toxic Oxygen Radicals by
Flavonoids: A Structure-Activity Study." Biochem. Pharmacol. 35:2345-2357 (19
86).
Hodnick, W.F., Bohmont, C.W., Capps, C., and Pardini, R.S., "Inhibition of the M
itochondrial NADH-oxidase (NADH-Coenzyme Q Oxido-reductase) Enzyme System by Fla
vonoids: A Structure-Activity Study." Biochem. Pharmacol. 36:2873-2874 (1987).
Hodnick, W.F., Milosavljevic, E.B., Nelson, J.H., and Pardini, R.S., "Electroche
mistry of Flavonoids: Relationships Between Redox Potentials, Inhibition of Mito
chondrial Respiration and Production of Oxygen Radicals by Flavonoids." Biochem
. Pharmacol. 37:2607-2611 (1988).
Heisler, C.R., Hodnick, W.F., and Ahmad, S., "Evidence for Target Site Insensiti
vity to Cyanide in Spodoptera Eridania Larvae." Comp. Biochem. Physiol. 91C:469
-472 (1988).
Hodnick, W.F., and Sartorelli, A.C., "Reductive Activation of Mitomycin C by NAD
H: Cytochrome b5 Reductase." Cancer Res. 53:4907-4912 (1993).
Hodnick, W.F., Duval, D., and Pardini, R.S., "Inhibition of Mitochondrial Respir
ation and Cyanide Stimulated Generation of Reactive Oxygen Species by Selected F
lavonoids." Biochem. Pharmacol. 47:573-580 (1994).
Hodnick, W.F., and Sartorelli, A.C., "The pH-Dependent Reduction of Adriamycin C
atalysed by NADH: Cytochrome b5 Reductase." Cancer Lett. 84:149-154 (1994).
Sartorelli, A.C., Hodnick, W.F., Belcourt, M.F., Tomasz, M., Haffty, B., Fischer
, J.J., and Rockwell, S., "Mitomycin C: A Prototype Bioreductive Agent." Oncol.
Res. 6:501-508 (1994).
Sartorelli, A.C., Belcourt, M.F., Hodnick, W.F., Keyes, S.R., Pritsos, C.A., and
Rockwell, S., "Preferential Kill of Hypoxic EMT6 Mammary Tumor Cells by the Bio
reductive Alkylating Agent Porfiromycin." Adv. Enz. Reg. 35:117-130 (1995).
Belcourt, M.F., Hodnick, W.F., Rockwell, S., and Sartorelli, A.C., "Differential
Toxicity of Mitomycin C and Porfiromycin to Aerobic and Hypoxic Chinese Hamster
Ovary Cells Overexpressing Human NADPH: Cytochrome C (P-450) Reductase." Proc.
Natl. Acad. Sci. USA 93:456-460 (1996).
Belcourt, M.F., Hodnick, W.F., Rockwell, S., and Sartorelli, A.C., "Overexpressi
on of DT-Diaphorase Alters the Bioactivation of Mitomycin C and Porfiromycin in
Aerobic and Hypoxic Chinese Hamster Ovary Cells." Biochem. Pharmacol. 51:1669-1
678 (1996).
Sokoloski, J.A., Hodnick, W.F., Cinquina, C., Mayne, S.T., Kim, C.S., and Sartor
elli, A.C., "Induction of the Differentiation of HL-60 Promyelocytic Leukemia Ce
lls by Vitamin E Succinate and Other Antioxidants in Combination with Low Levels
of Vitamin D3: Relationship to NF-kB." Leukemia 11:1546-1553 (1997).
Hodnick, W.F., and Sartorelli, A.C., "Measurement of Dicumarol-Sensitive NADPH:
(Menadione-Cytochrome c) Oxidoreductase Activity Results in an Artifactual Assay
of DT-Diaphorase in Cell Sonicates." Analyt. Biochem. 252:165-168 (1997).
Belcourt, M.F., Hodnick, W.F., Rockwell, S., and Sartorelli, A.C., "The Intracel
lular Location of NADH: Cytochrome b5 Reductase Modulates the Cytotoxicity of th
e Mitomycins to Chinese Hamster Ovary Cells." J. Biol. Chem. 273:8875-8881 (199
8).
Belcourt, M.F., Hodnick, W.F., Rockwell, S., and Sartorelli, A.C., "Exploring th
e Mechanistic Aspects of Mitomycin Antibiotic Bioactivation in Chinese Hamster O
vary Cells Overexpressing NADPH: Cytochrome c (P-450) Reductase and DT-Diaphoras
e." Adv. Enz. Reg. 38:111-133 (1998).
Belcourt, M.F., Penketh, P.G., Hodnick, W.F., Johnson, D.A., August, P.R., Sherm
an, D.H., Rockwell, S., and Sartorelli, A.C., "Mitomycin Antibiotic Resistance C
onferred to Mammalian Cells Expressing the Bacterial Mitomycin C Resistance Prot
ein MCRA." Proc. Natl. Acad. Sci. USA 96:10489-10494 (1999).
Baumann, R.P., Hodnick, W.F., Seow, H.A., Belcourt, M.F., Rockwell, S., Sherman,
D.H., and Sartorelli, A.C., "Reversal of Mitomycin C Resistance by Overexpressi
on of Bioreductive Enzymes in Chinese Hamster Ovary Cells." Cancer Res. 61:7770
-7776 (2001).
Penketh, P.G., Hodnick, W.F., Belcourt, M.F., Shyam, K., Sherman, D.H., and Sart
orelli, A.C., "Inhibition of DNA Cross-Linking Modulates by Mitomycin C by Perox
idase-Mediated Oxidation of Mitomycin C Hydroquinone." J. Biol. Chem. 276:34445
-34452 (2001).
Krishna, G., Hodnick, W.F., Lang, W., Lin, X., Karra, S., Mao, J., and Almassian
, B. "Pharmaceutical Development and Manufacturing of a Parenteral Formulation o
f a Novel Antitumor Agent, VNP40101M." AAPS PharmsciTech 2(3): Article 14 (http:
//www.springerlink.com/content/92l0607423104773/fulltext.pdf ) (2001).
Seow, H.A., Belcourt, M.F., Penketh, P.G., Hodnick, W.F., Tomasz, M., Rockwell,
S., and Sartorelli, A.C., "Nuclear Localization of NADPH: Cytochrome c (P450) Re
ductase Enhances the Cytotoxicity of Mitomycin C to Chinese Hamster Ovary Cells.
" Mol. Pharmacol. 67:417-423 (2005).
Anderson, J.T., Ting, A.E., Boozer, S., Brunden, K.R., Crumrine, C., Danzig, J.,
Dent, T., Faga, L., Harrington, J., Hodnick, W.F., Murphy, S.M., Pawlowski, G.,
Perry, R., Raber, A., Rundlett, S.E., Stricker-Krongrad, A., Wang, J., and Benn
ani, Y.L., "The Identification of Novel and Improved Antimitotic Agents Derived
from Noscapine." J. Med. Chem. 48(23): 7096-7098 (2005).
Bayard R. Huck, Luis Llamus, Michael J. Robarge, Thomas C. Dent, Jianping Song,
William F. Hodnick, Chris Crumrine, Alain Stricker-Krongrad, John Harrington, Ku
rt R. Brunden and Youssef L. Bennani. "The Identification of Pyrimidine-Diazabi
cyclo[3.3.0]octane Derivatives as 5-HT2c Receptor Agonists." Bioorg. & Med. Che
m. Lett. 16(11): 2891-2894 (2006).
Bayard R. Huck, Luis Llamus, Michael J. Robarge, Thomas C. Dent, Jianping Song,
William F. Hodnick, Chris Crumrine, Alain Stricker-Krongrad, John Harrington, Ku
rt R. Brunden and Youssef L. Bennani. "The Design and Synthesis of a Tricyclic
Single-Nitrogen Scaffold that Serves as a 5-HT2c Agonist." Bioorg. & Med. Chem.
Lett. 16(15): 4130-4134 (2006).
Abstracts and Presentations
Hodnick, W.F., Roettger, W.J., Bohmont, C.W., and Pardini, R.S., "Inhibition of
Mitochondrial Respiration and Production of Toxic Oxygen Radicals by Flavonoids:
A Structure Activity Study." Fed. Proc. 43:1942 (1984).
Hodnick, W.F., Kung, F.S., and Pardini, R.S., "Production of Superoxide and Hydr
ogen Peroxide by Redox Active Flavonoids." Gordon Research Conference on Oxygen
Radicals in Biology and Medicine (1985).
Hodnick, W.F., Kung, F.S., and Pardini, R.S., "Production of Superoxide and Hydr
ogen Peroxide by Redox Active Flavonoids." Fed. Proc. 44:1081 (1985).
Hodnick, W.F., Roettger, W.J., Kung, F.S., Bohmont, C.W., and Pardini, R.S., "In
hibition of Mitochondrial Respiration and Production of Superoxide and Hydrogen
Peroxide by Flavonoids: A Structure Activity Study." Proceedings of the Sympos
ium of Plant Flavonoids in Biology and Medicine, Buffalo, N.Y. (1985).
Hodnick, W., "Inhibition of Mitochondrial Respiration and the Production of Toxi
c Oxygen Species by Flavonoids: A Structure-Activity Study." Univ. of Nevada S
chool of Medicine Student Research Convocation (1986).
Hodnick, W.F., Milosavljevic, E.B., Nelson, J.H., and Pardini, R.S., "The Relati
onship Between Redox Potentials, the Inhibition of Mitochondrial Respiration and
the Production of Toxic Oxygen Species by Flavonoids." Fed. Proc. 45:1931 (198
6).
Kalyanaraman, B., Hodnick, W.F., and Pardini, R.S., "The Production of Hydroxyl
Radical by Redox Active Flavonoids." Fed. Proc. 45:1931 (1986).
Hodnick, W.F., Pritsos, C.A., Kalyanaraman, B., and Pardini, R.S., "The Role of
Oxygen in the Cytotoxic Action of Flavonoids." Satellite Meeting of the Society
for Free Radical Research on Oxygen Radicals and Anti-oxidants in Cancer and Ag
ing (1987).
Hodnick, W.F., Kalyanaraman, B., and Pardini, R.S., "The Production of Hydroxyl
and Semiquinone Free Radicals During the Autoxidation of Redox Active Flavonoids
." Fourth International Congress on Oxygen Radicals (1987).
Duval, D., Hodnick, W.F., and Pardini, R.S., "Inhibition of Mitochondrial Respir
ation, Auto-oxidation and Cyanide Mediated Oxygen Consumption by Selected Flavon
oids." FASEB J. 2:A773 (1988).
Hodnick, W.F., and Sartorelli, A.C., "Reductive Activation of Mitomycin C by NAD
H-Cytochrome b5 Reductase." Proc. Am. Assoc. Cancer Res. 32:397 (1991).
Hodnick, W.F., and Sartorelli, A.C., "Reductive Activation of Mitomycin C by NAD
H-Cytochrome b5 Reductase." Yale Comprehensive Cancer Center Research Conferenc
e (1991).
Hodnick, W.F., and Sartorelli, A.C., "NADH: Cytochrome b5 Reductase Catalyzed Re
duction of Adriamycin." Proc. Am. Assoc. Cancer Res. 33:508 (1992).
Hodnick, W.F., and Sartorelli, A.C., "NADH: Cytochrome b5 Reductase Catalyzed Re
duction of Adriamycin." Yale Comprehensive Cancer Center Research Conference (1
992).
Hodnick, W.F., and Sartorelli, A.C., "Generation of Reactive Oxygen Species by t
he Iron Chelate of 1-Formylisoquinoline Thiosemicarbazone (IQ-1)." Proc. Am. As
soc. Cancer Res. 34:59 (1993).
Penketh, P.G., Hodnick, W.F., Shyam, K., and Sartorelli, A.C., "Consumption of O
xygen and Generation of Radical Species During the Activation of 1, 2-Bis-(sulfo
nyl)hydrazines." Proc. Am. Assoc. Cancer Res. 34:272 (1993).
Sartorelli, A.C., Hodnick, W.F., Belcourt, M.F., Tomasz, M., Haffty, B., Fischer
, J.J., and Rockwell, S., "The Mitomycin Antibiotics: Prototype Bioreductive Alk
ylating Agents." International Conference on Bioreductive Drug Activation. Lak
e Tahoe, CA Aug. 16-19, 1994.
Sartorelli, A.C., Belcourt, M.F., Hodnick, W.F., Keyes, S.R., Pritsos, C.A., and
Rockwell, S., "Preferential Kill of Hypoxic EMT6 Mammary Tumor Cells by the Bio
reductive Alkylating Agent Porfiromycin." 35th Symposium on Regulation of Enzym
e Activity and Synthesis in Normal and Neoplastic Tissue. Indianapolis, IN Oct
. 3-4, 1994.
Hodnick, W.F., Belcourt, M.F., Kemple, B., Rockwell, S., Sartorelli, A.C., "Pote
ntiation of Mitomycin C and Porfiromycin Toxicity to Chinese Hamster Ovary (CHO)
Cells by Overexpression of DT-Diaphorase (DTD) cDNA." Proc. Am. Assoc. Cancer
Res. 36:602 (1995).
Belcourt, M.F., Hodnick, W.F., Kemple, B., Rockwell, S., Sartorelli, A.C., "Indu
ction of Differential Toxicity to Mitomycin Antibiotics by Overexpression of NAD
PH: Cytochrome c (P-450) Reductase in Chinese Hamster Ovary (CHO) Cells." Proc.
Am. Assoc. Cancer Res. 36:602 (1995).
Sokoloski, J.A., Hodnick, W.F., Mayne, S.T., Kim, C.S., Sartorelli, A.C., "Induc
tion of the Differentiation of HL-60 Leukemia Cells by Vitamin E and Other Antio
xidants in Combination with Vitamin D3." Proc. Am. Assoc. Cancer Res. 36:348 (1
995).
Hodnick, W.F., Ahmad, S., and Pardini, R.S., "Induction of Oxidative Stress by R
edox Active Flavonoids." Am. Chem. Soc. Book of Abstracts Vol. 212, Div. of Ag.
and Food Chem. Abstract # 0112, (1996).
Belcourt, M.F., Hodnick, W.F., Rockwell, S., and Sartorelli, A.C., "Overexpressi
on of Mitochondrial or Cytosol Localized NADH: Cytochrome b5 Reductase (FpD) Pro
duces Different Sensitivities to the Mitomycins in Chinese Hamster Ovary (CHO) C
ells." Proc. Am. Assoc. Cancer Res. 38:1 (1997).
Hodnick, W.F., and Sartorelli, A.C., "Role of NADH: Cytochrome b5 Reductase (FpD
) and Cytochrome b5 (b5) in the Reduction of Mitomycin Congeners." Proc. Am. As
soc. Cancer Res. 38:596 (1997).
Belcourt, M.F., Hodnick, W.F., Rockwell, S., and Sartorelli, A.C., Nuclear Local
ization of NADPH: Cytochrome c (P-450) Reductase Enhances Mitomycin Antibiotic C
ytotoxicity to Chinese Hamster Ovary Cells." Proc. Am. Assoc. Cancer Res. 39:59
9 (1998).
Hodnick, W.F., and Sartorelli, A.C., "Reductive Activation of Mitomycin C (MC) a
nd Doxorubicin (Dox) by Nitric Oxide Synthase (NOS)." Proc. Am. Assoc. Cancer R
es. 39:524 (1998).
Hodnick, W.F., and Sartorelli, A.C., "Oxidative Deactivation of Mitomycin C (MC)
Semiquinone Anion Radicals by Mitochondria." Proc. Am. Assoc. Cancer Res. 39:2
20-221 (1998).
Hodnick, W.F., and Sartorelli, A.C., "Reductive activation of mitomycin analogs
by human NADPH:cytochrome P-450 oxidoreductase (FpT)." Proc. Am. Assoc. Cancer
Res. 40:392 (1999).
Hodnick, W.F., Penketh, P.G., Suresh Kumar, G., Tomasz, M., and Sartorelli, A.C.
, "Differential Cross-Linking of DNA by Mitomycin Analogs." Proc. Am. Assoc. Ca
ncer Res. 41 (2000).
Belcourt, M.F., Penketh, P.G., Hodnick, W.F., Pike, J., King, I., Lin, S.L., Sar
torelli, A.C., and Bermudes, D."Expression of the Mitomycin C Activating Enzyme
DT-Diaphorase in Tumor-Targeted Salmonella." Proc. Am. Assoc. Cancer Res. 41 (2
000).
Baumann, R.P., Hodnick, W.F., Seow, H.A., Belcourt, M.F., Rockwell, S., Sherman,
D.H., and Sartorelli, A.C., "Studies on the Mechanism of Resistance to Mitomyci
n C in Chinese Hamster Ovary Cells." Proc. Am. Assoc. Cancer Res. 42 (2001).
Penketh, P.G., Hodnick, W.F., Belcourt, M.F., Shyam, K., Sherman, D.H., and Sart
orelli, A.C., "Peroxidase Mediated Oxidation of Mitomycin C Hydroquinone." Proc.
Am. Assoc. Cancer Res. 42 (2001).
R. Christian Crumrine, W. F. Hodnick, G. Pawlowski, S. Murphy and A. Stricker-Kr
ongrad. "Evaluation of Drug-Induced Cardiac QT prolongation in Dogs: Use of In
tracardiac Electrophysiological Monitoring." Abstract, Proceedings of the Socie
ty of Safety Pharmacology Annual Meeting, San Diego CA (2006).
Hodnick, W.F. "In Vitro Diabetes Models." Presenter and Panelist for Webinar 2
: Nonclinical Models for Diabetic Indications. Speid & Associates Diabetes Web
inar Series (2008).
Hodnick, W.F. Panelist for Webinar 3: Toxicological Evaluation of Diabetes and
Metabolic Therapeutics. Speid & Associates Diabetes Webinar Series (2008).
Detailed Summary of Experience
RICERCA BIOSCIENCES, LLC.: Senior Manager, Discovery Biology - Managed/Supervis
ed in-house drug metabolism, pharmacokinetics, in vitro and in vivo disease/effi
cacy programs/staff and coordinate subcontracted services; review proposals and/
or provide scientific guidance to new and existing clients; review protocols and
study reports prepared by Project Leaders/Study Directors. Encourage/support sc
ientific and career growth of individuals within reporting line. Interact with m
ultiple departments to plan and achieve deliverable deadlines and reporting cons
istency. Provide direction for biological programs to assist Medicinal Chemistry
and other departments with client drug discovery campaigns (SAR, lead optimizat
ion, candidate selection and formulation). Assign resources as well as develop a
nd implement goals for the in vitro and in vivo laboratories to meet departmenta
l and company-wide objectives. Responsible for administrative functions includin
g approval of billing and time sheets, performance evaluation, hiring, GAAP reve
nue forecasting and work with sales and client services staff to capture costs a
ssociated with study-related changes. In vitro assays include cytochrome P-450 i
soenzyme inhibition and induction, metabolic (microsomal, S9, hepatocyte, plasma
and artificial gastric and intestinal fluids) stability, protein binding, kinet
ic solubility, enzyme assays, ELISA assay development and qualification, cytotox
icity, cytokine release, adipocyte differentiation and glucose uptake. In vivo s
tudies comprise pharmacokinetic assessments in rodents, dogs and non-human prima
tes, antitumor activity in human xenografts in SCID and nude mice, models of Typ
e 1 and 2 diabetes in rodents and non-human primates, anti-inflammatory activity
(e.g., cytokine secretion) in rodents and rodent models of ischemia-reperfusion
injury.
Senior Scientist/ Study Director, Toxicology and Pharmacology - Directed regulat
ory (e.g., GLP, OECD, EPA) compliant in vivo toxicology and pharmacology studies
. Study associated responsibilities included the overall technical conduct of t
he study and the analysis, interpretation, documentation and reporting of the re
sults. Performed general toxicology, toxicokinetic and pharmacokinetic studies r
equired for drug, agrochemical and specialty chemical development and registrati
on programs. Conducted IND-enabling toxicology programs, which included dose ran
ge finding (DRF)/ maximum tolerated dose (MTD), 28-day toxicity studies and othe
r specialized studies (e.g., dermal and ocular) in rodent and non-rodent species
. Contributed to the expansion of service offerings by designing, implementing a
nd validating (IQ/PQ/OQ) of a visual electrophysiology - electroretinography (ER
G), phototoxicity and safety pharmacology capabilities.
ATHERSYS, INC.: Responsible for the set-up and management of the in vitro ADMET
and in vivo laboratory operations. This entails recruitment of personnel and the
purchase of capital equipment. Develop, qualify, and implement assays and anim
al models necessary to characterize the in vitro ADMET and in vivo DMPK, efficac
y and safety pharmacology profiles of NCEs in collaboration with colleagues. Tra
in and supervise research associates in the performance of bench work and animal
studies. Analyze data; write assay, study and project summary reports, IACUC an
imal protocols, SOPs and scientific publications. Present findings to the approp
riate project teams and executive management. Manage assigned resources as well
as develop and implement goals for the in vitro and in vivo laboratories to meet
departmental and company-wide objectives. Contribute to the design and executio
n of a compound screening strategy to move novel compounds with the most favorab
le pharmacological and toxicological profiles into development. Provide oversigh
t of outsourced studies. In house in vitro assays include PAMPA, cytochrome P-45
0 isoenzyme inhibition and induction, metabolic (microsomal) stability, protein
binding, and solubility (both kinetic and equilibrium). In vivo studies comprise
pharmacokinetic assessments in rodents, dogs and non-human primates, antitumor
activity in human xenografts in athymic nude mice, appetite suppression in rats
and dogs (acute and chronic), control of asthma in the Brown Norway rat model, a
ssessment of cardiovascular and CNS (modified Irwin) safety in rodents and dogs
(in accordance with ICH S7A and S7B guidelines) and rodent models of cognition (
PAR, social and object recognition).