Você está na página 1de 13

WILLIAM F. HODNICK, Ph.D.

34375 Lakeview Drive


Solon, OH 44139
(440) 542-0236 - Home
(440) 554-9006 - Cell
whf10376@westpost.net
SUMMARY:
A Professional Research Scientist and Manager with experience in the areas of in
vitro and in vivo pharmacology, safety pharmacology, toxicology and analytical
method development and validation is looking for a leadership position responsib
le for providing direction, implementation and strategies in support of pharmace
utical discovery and/or development programs. Experience includes polyphenolic
natural products, small molecule and biotherapeutic agents for the treatment of
cancer, infectious diseases, obesity, diabetes, asthma, inflammation/pain and CN
S (cognition, ADHD, Parkinson's and Alzheimer's) indications. Also has experienc
e in quality control, regulatory documentation practices, manufacturing, teachin
g and business development. Excellent written, verbal and people skills, detail
oriented, achiever, team player. Proven problem identification and solving abili
ties. Also, significant experience and expertise in free radical biology and med
icine.
RELEVANT EXPERIENCE:
At both Rib-X and Athersys; contributed to the design and execution of a compoun
d screening strategy to move novel compounds with the most favorable pharmacolog
ical, toxicological and safety profiles into development including assessment of
cardiovascular and CNS (modified Irwin) safety in rodents and dogs (in accordan
ce with ICH S7A and S7B guidelines).
At the last three positions (Ricerca, Athersys and Rib-X) worked with colleagues
and supervised research associates to develop, qualify, and implement assays to
characterize the in vitro ADMET and in vivo DMPK, efficacy, toxicology and safe
ty pharmacology profiles of NCEs.
As a toxicology study director (Ricerca) directed regulatory (e.g., GLP, OECD) c
ompliant IND-enabling in vivo toxicology, pharmacology and formulation studies a
s well as contributed to the expansion of service offerings by the design, imple
mentation and validation (IQ/PQ/OQ) of safety pharmacology and other capabilitie
s such visual electrophysiology - electroretinography (ERG) and phototoxicity.
In addition to conducting IND-enabling toxicology programs; while at Vion, desig
ned and implemented GLP/GMP studies necessary for the preclinical and clinical d
evelopment of small molecule and biological therapeutics according to U.S. FDA a
nd ICH guidelines. Responsible for lot release testing and stability indicating
studies for all small molecule APIs and finished drug products. Prepared and r
evised department related GLP/GMP documentation (e.g., SOPs, STPs/ TMs, study pr
otocols and reports, certificates of analysis, etc.) and assisted with relevant
sections (e.g., CMC) of INDAs and other regulatory submissions. Responsible for
the operations of the companywide IQ/PQ/OQ and metrology operations. A member of
a team that was responsible for the establishment of a reference standards prog
ram.
Interacted with multiple departments to plan and achieve deliverable deadlines a
nd reporting consistency, proven problem identification and solving abilities as
evidenced by the design and operation of a product repackaging machine which co
nverted product rejected because of improper packaging to sellable product. This
machine eliminated the need to shut down one of the production lines further in
creasing plant productivity. In collaboration with company chemists, designed a
nd operated a product reprocessing operation that reclaimed defective product (s
crap) to usable starting material for production, which increased productivity a
nd profitability.
People and performance management experience includes responsibility for perform
ance evaluation, hiring, budgeting, GAAP revenue forecasting and encourage/suppo
rt of the scientific and career growth of individuals within reporting line. Wo
rked with sales and client services staff to bring in new clients and capture co
sts associated with study-related changes. Reviewed and/or prepared the scope o
f work section of proposals and/or provided scientific guidance to new and exist
ing clients.
Author or co-author of 60 scientific publications, research abstracts, and chapt
ers.
9+ years of pharmaceutical industry experience.
EMPLOYMENT HISTORY:
NOVELMED THERAPEUTICS, INC., Cleveland, OH
March 2010-Present
A biopharmaceutical company engaged in the discovery and development therapeutic
proteins and small molecules for multiple disease indications
Director, Preclinical Research
Manage/Oversee and troubleshoot studies/projects outsourced to various CROs and
CMOs; assist in company funding through grant writing (SBIR, private foundations
, military) and in the preparation of technical reports and white papers for par
tnering and licensing purposes; design, develop and scale up chromatographic pro
cesses for the purification of monoclonal antibodies and associated fragments.

RICERCA BIOSCIENCES, LLC, Concord, OH


December 2005-March 2009
A preclinical drug discovery and development CRO and CMO
Senior Manager of Pharmacology, Discovery Biology
(August 2007-March 2009)
Managed/Supervised in-house drug metabolism, pharmacokinetics, in vitro and in v
ivo disease/efficacy programs/staff (oncology, infectious diseases, inflammation
and diabetes/metabolic diseases) 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; respon
sible for administrative functions including approval of billing and time sheets
, performance evaluation, hiring and GAAP revenue forecasting; encourage/support
scientific and career growth of individuals within reporting line; interact wit
h multiple departments to plan and achieve deliverable deadlines and reporting c
onsistency; work with sales and client services staff to capture costs associate
d with study-related changes.
Senior Scientist/Study Director, Toxicology & Pharmacology
(December 2005-July 2007)
Directed regulatory (e.g., GLP, OECD) compliant in vivo toxicology and pharmacol
ogy studies; study associated responsibilities include the overall technical con
duct of the study and the analysis, interpretation, documentation and reporting
of the results; performed general toxicology, toxicokinetic and pharmacokinetic
studies; contribute to the expansion of service offerings by the design, impleme
ntation and validation (IQ/PQ/OQ) of a visual electrophysiology - electroretinog
raphy (ERG), phototoxicity and safety pharmacology capabilities.
ATHERSYS INC., Cleveland, OH
October 2003-December 2005
A biopharmaceutical company engaged in the discovery and development therapeutic
products in multiple disease areas
Senior Scientist, Pharmacology
Responsible for set-up and management of the in vitro ADMET and in vivo laborato
ry operations; work with colleagues and supervise research associates to develop
, qualify, and implement assays to characterize the in vitro ADMET and in vivo D
MPK, efficacy and safety pharmacology profiles of NCEs; contribute to the design
and execution of a compound screening strategy to move novel compounds with the
most favorable pharmacological, toxicological and safety profiles into developm
ent.

THERACOUR PHARMA, West Haven, CT


2003
A fledgling start-up company engaged in the discovery and development of vehicle
s for drugs with poor aqueous solubility and/or bioavailability
Consultant
Consulted regarding ADMET and Regulatory Affairs (GLP/GMP, IND) issues.

RIB-X PHARMACEUTICALS, INC., New Haven, CT


2002-2003
A small molecule structure-based drug discovery and development company focused
on the treatment of antibiotic-resistant infections
Senior Research Fellow
Provided oversight in the set-up and facilitate the start-up of the ADMET labora
tory operations; work with colleagues and supervise research associates to devel
op, qualify, and implement assays to characterize the ADMET properties of NCEs;
contribute to the design and execution of a compound screening strategy to prior
itize novel compounds with the most favorable pharmacological and toxicological
profiles.

VION PHARMACEUTICALS, INC., New Haven, CT


2000-2002
Development stage pharmaceutical company with products for the treatment of canc
er
Research Scientist II
Devised and directed analytical and bioanalytical methods development and valida
tion for small molecule and biological therapeutics; responsible for the lot rel
ease testing and stability indicating studies for all small molecule APIs and fi
nished drug products; managed and troubleshot analytical and QC issues involving
CMOs and CROs; prepared and revised GLP/GMP documentation and relevant sections
of INDs and other regulatory submissions; supervised IQ/PQ/OQ and metrology ope
rations.
YALE UNIVERSITY SCHOOL OF MEDICINE, New Haven, CT
1989-2000
Associate Research Scientist (Research Faculty) (1993-2000)
Conceived and conducted in house and collaborated laboratory research projects;
planned and prepared grants; directed and supervised graduate and undergraduate
student researchers; organized and participated in colloquia for graduate and me
dical students.
Postdoctoral Associate (1989-1993)
Designed and executed laboratory research; formulated and composed grants.

UNIVERSITY OF NEVADA, Reno, NV 1982-1989


Graduate Research Assistant
Devised and engaged in laboratory research; supervised and lectured in graduate
and undergraduate teaching laboratories and classes on biochemical techniques, b
ioenergetics, toxicology, and metabolism.

CAL-AURUM INDUSTRIES, Westminster, CA 1978


Precious metal plating, super-finishing and secondary refining
Electroplater
Designed and operated a product repackaging machine; operated high-throughput pr
ecious metal plating and super-finishing processes; developed and operated a scr
ap reprocessing operation; formulated and conducted cost analysis and projection
s.

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).

RIB-X PHARMACEUTICALS, INC.: In support of a structure-based drug design paradig


m, helped establish the ADMET laboratory operations. Facilitated the hiring of d
epartment personnel and responsible for the acquisition of capital equipment (e.
g., LC/MS/MS). Worked with colleagues and supervised research associates to deve
lop, qualify, and implement assays to characterize the pharmacological and toxic
ological (ADMET) properties of NCEs. Assays for in vitro ADMET studies included
Caco-2, PAMPA, cytochrome P-450 isoenzyme inhibition and induction, metabolic (m
icrosomal) stability, protein binding, cytotoxicity and others to help ascertain
structure-activity relationships in a number of species for pharmacophore refin
ement. Contributed to the design and execution of a compound screening strategy
to prioritize novel compounds with the most favorable pharmaceutical profile and
greatest likelihood of success at the early IND stage of development. Institute
d goals for the in vitro and in vivo laboratories and assured that these initiat
ives were aligned and integrated with other department and company-wide objectiv
es. Member of company safety and laboratory animal care and use committees (IACU
C).
VION PHARMACEUTICALS, INC.: As a member of different drug product project teams,
designed and implemented GLP/GMP studies necessary for the preclinical and clin
ical development of small molecule and biological therapeutics according to U.S.
FDA and ICH guidelines. Responsible for lot release testing and stability indic
ating studies for all small molecule APIs and finished drug products. Conceived
and directed the development and validation of analytical and bioanalytical meth
ods. Provided analytical support to discovery projects and pharmaceutics for the
formulation of both parenteral and solid dosage forms. Coordinated analytical a
nd QC issues involving CMOs and CROs. Conducted preclinical and clinical ADME/AD
MET and PK studies. Prepared and revised department related GLP/GMP documentatio
n (e.g., SOPs, STPs, study protocols and reports, certificates of analysis, etc.
) and relevant sections (e.g., CMC) of INDs and other regulatory submissions. Su
pervised the IQ/PQ/OQ and metrology operations. A member of a team that was resp
onsible for the establishment of a reference standards program.
YALE UNIVERSITY: Member of a team determining the part that several Phase I drug
metabolizing enzymes play in the reductive bioactivation of mitomycin antibioti
cs and other quinoid antineoplastic agents in both euoxic and radiobiologically-
resistant hypoxic tumor cells. This problem has been approached using classical
biochemical techniques (protein purification, enzyme kinetics, etc.), monoclonal
antibodies (for use as specific enzyme inhibitors, in immunoassays, and western
blotting), and more recently, by gene transfection and antisense strategies to
evaluate the role of these enzymes in the sensitivity/resistance to redox active
drugs in intact cells. Several enzymes have been investigated as possible biore
ductive catalysts. Significant experience in preparative purification of both so
luble and membrane bound proteins, utilizing almost all chromatographic methods,
and in the development of improved isolation protocols. Such studies not only p
rovide information concerning the mechanism of antineoplastic activity but may a
lso provide insight into the toxic side effects of such agents. Information from
these kinds of studies also set the stage for both diagnostic (e.g., sensitivit
y screening, potential for adverse reactions) and gene therapy (e.g., increasing
tumor sensitivity to chemotherapy, myeloprotection) applications.
UNIVERSITY OF NEVADA and CHEMEX PHARMACEUTICALS: In a contractual agreement betw
een the university and Chemex, conducted laboratory research in support of a use
patent and an Investigative New Drug (IND) application in accordance with Food
and Drug Administration (FDA) regulations, including Good Laboratory Practice (G
LP) and industrial record-keeping procedures. Studies involved small animal surg
ery (rodent, rabbit, and canine); tissue culture (primary and established) and t
he use of several animal tumor models including Sarcoma 180, L1210, P-388, B-16
melanoma, Colon 38; xenografts of both human and veterinary tumors in athymic nu
de mice; and spontaneous or naturally occurring tumors in dogs and range cattle.
Member of the university Biomedical Human Subjects Committee and Institutional R
eview Board (IRB) which was responsible for providing for the protection of huma
n subjects in biomedical research and the development and monitoring of universi
ty policy and procedures involving the use of human subjects in research as set
forth in the Code of Federal Regulations (45 CFR 46 and 21 CFR 56).
Doctoral research entailed investigating the roles of free radicals and perturba
tion of cellular bioenergetic processes in the cytotoxic (in vitro), antineoplas
tic (in vivo), and toxicological activities of flavonoids and related compounds.
Obtained specialized training in radiation and chemical safety, waste management
, laboratory animal care, and industrial microbiology and bioprocess principles.
CAL-AURUM INDUSTRIES: Designed and operated a product repackaging machine which
converted product rejected because of improper packaging to sellable product. Th
is machine eliminated the need to shut down one of the production lines further
increasing plant productivity. Operated high-throughput precious metal plating a
nd superfinishing processes for customers having products with commercial, elect
ronic, biomedical, and military applications and quality control specifications.
In collaboration with company chemists, designed and operated a product reproce
ssing operation that reclaimed defective product (scrap) to usable starting mate
rial for production, which increased productivity and profitability by reducing
production losses and waste. Designed and conducted cost analysis and projection
s for an improved metal plating process.