Curriculum Vitae

Gerald J. Kolaja, DVM, Ph.D., DACVP

Personal:
Residence:

2500 6th Avenue #107

San Diego, CA 92103
Home phone: 619 795 8858
Cell phone: 805 231 0818
Email: gkolaja@me.com

Undergraduate:

Michigan State University

East Lansing, MI
BS- Biology

Veterinary:

Michigan State University

East Lansing Michigan
D.V.M

Graduate:

University of Maryland
School of Medicine
Baltimore, MD
Ph.D. Pathology

Preceptorship:

US Army, Veterinary Corps

Edgewood Arsenal, MD
ACVP Diplomate

Education:

Society Memberships:
American College of Veterinary Pathologists

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Society of Toxicologic Pathology, Editorial Board, Committee

On Toxicologic Pathology Registry and Chairman of the Annual
Meeting Poster Session 1990-1993
Employment History:
BCN Biosciences
Partner and Head of Toxicology 2013 to present
I joined BCN in 2013 as a partner and head of the toxicology program. My
responsibilities include coordinating toxicology and efficacy studies with contract
labs. Also, I participate in management discussions regarding planning, strategy
and execution of studies. BCN was awarded a collaborative agreement in 2013
to develop a radiation mitigator for the Biomedical Advanced Research and
Development Authority (BARDA).
Compan Thera
Chief Medical Officer - October 2009 - present
I am co-founder and Chief Medical Officer of Compan Thera, a company focused
on the development of targeted therapeutics for the treatment of lymphoma in
companion animals. Responsibilities include planning, monitoring and reporting
safety and efficacy studies in dogs treated for lymphoma. As a co-founder of the
company I am also responsible for the management of the company and
allocating company resources. In concert with the other co-founders, strategic
decisions are made with regard to the progression of our veterinary therapeutic
through development and registration with the FDA.
Balboa BioConsulting
Pathology and Safety Assessment Consultant - September 2008 - present
I established Balboa BioConsulting in 2008 to provide expertise to
pharmaceutical and biotechnology companies in toxicologic pathology and safety
assessment strategies. Histopathology of toxicology studies is provided in
support of pre-clinical development programs. The emphasis of Balboa
BioConsulting is in evaluating safety issues and establishing strategies for
resolution. Coordination of preclinical programs to enable Phase I clinical studies
is also provided.

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Amgen
Distinguished Fellow/Scientific Director/Scientific Executive Director July 2002
November 2007
Responsibilities for this position included representing the Vice President of
Metabolic Disorders and Pathology on development teams as an Early
Development Leader (EDL). The focus of this responsibility was to expedite the
development process, integrate pre-clinical data and provide risk assessment
expertise. Additionally, to assist the development teams in identifying
appropriate animal models to evaluate pre-clinical safety and efficacy. I have
served on Project Strategy Teams as an Early Development Leader (AMG 303,
AMG 386, peg B1, and AMG 753). This role included presentation to the
Research Review Board and Development Review Board on a regular basis to
update on progress of development programs. An additional responsibility
included providing expertise to business development activities in evaluating
external laboratories. These laboratories provided immunohistochemistry
services and developed diagnostic kits for Amgen products. Another
responsibility was the assignment to corporate committees responsible for the redesign of Amgen administrative processes and improvement of work processes.
These committees include Six Sigma and Corporate Leadership. Report writing
for all of Amgen research programs has been the focus of the latest Six Sigma
project. I also participated in the redesign of the early Project Strategy Team
process. The position was also responsible for coordinating pre-clinical
toxicology and pathology data into development programs as required. I also
coordinated and assisted in writing and editing the pharmacology section of the
BLA for palifermin. This resulted in an early submission to the FDA for this
product.
I was also responsible for providing pathology support to several discovery
programs in phenotyping knock out mice, characterizing orphan receptors using
ISH and IHC. Teams were located in both Thousand Oaks as well as the San
Francisco site. I also served on the Corporate Compliance and Quality
Committee to ensure pharmacology studies are in compliance with world-wide
regulations. I have served as a consultant for the restructuring of the
commercialization process at Amgen. I served on the committee to select a
system for electronically capturing data from pharmacology studies.

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Immunex
Director of Pathology - November 2000 July 2002
Responsible for managing and providing leadership to the Pathology Department
for Immunex that supported the Discovery and Clinical Development programs.
The pathology program was developed from a single pathologist supporting a
limited number of discovery programs to 5 pathologists and 11 technical staff
supporting the entire discovery and clinical development programs over a period
of 14 months. Responsibilities in Discovery Research included providing
morphologic support for animal model development, phenotyping knock out and
transgenic mouse models, collaborating with individual investigators evaluating
the therapeutic potential of antibodies and proteins, coordinating
immunohistochemistry support for all research and clinical development
programs and participating on discovery staff planning and strategy meetings.
Clinical Development was supported by providing input to toxicology
development programs, providing immunohistochemistry and diagnostic support
to clinical development programs and conducting peer reviews for GLP
toxicology studies. Pathology department staff members monitored animal
studies that had primary pathology endpoints.
Senior Investigator, Clinical Development - January - November 2000
I provided pathology support to clinical development programs by monitoring
toxicology studies, conducting immunohistochemistry on human tumors and
participation on project development teams. I served as the acting Director of the
Bioanalytical Laboratory and provided leadership and management to this group.
I actively participated in clinical development staff meetings related to clinical trial
implementation. I also provided collaborative support to discovery programs and
served on the Pharmacology sub team for the CD40L program. I presented an
overview of the use of CD40L in the treatment of cancer at the 2001 Pharma
meeting.
Pharmacia and Upjohn
Vice President, Toxicology Operations - North America

1996-1999

Responsibilities included providing leadership and management to a staff of over

125 scientists, associates, technicians and secretaries in pre-clinical discovery
support and pharmaceutical development. Review and approval for all regulatory
documents, such as INDs, NDAs, expert reports and toxicology summaries
produced by Pharmacia and Upjohn for the U.S. Research and Development site
was a major component of this position. Another major responsibility was the
oversight of external toxicology studies conducted through contract research
organizations.
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This position required close collaboration with discovery research, clinical

development, drug metabolism research and pharmaceutical sciences. In
addition, this position included serving as a member of the Preclinical
Development staff. This responsibility required being intimately involved and
collaborating with senior management in formulating strategy for worldwide
pharmaceutical development and registration. Close interactions were also
maintained with the Pharmacia and Upjohn discovery and toxicology programs in
Italy, Sweden and Japan. Interactions with regulatory agencies regarding preclinical development issues were an integral responsibility of this position. Close
interactions with CEDR were maintained and included participation on FDA
sponsored collaborations with industry to streamline the IND process.
This position required the frequent briefing of senior research and development
staff on progress of development programs. Also, frequent discussions with the
FDA regarding pre-clinical safety issues were part of the responsibilities of this
position.
Director, Pathology & Toxicology Research

1988-1996

This position was responsible for the management and scientific leadership for 56 scientists in drug discovery support and development. Review of study design,
study reports and regulatory documents were a key part of this position. This
position was responsible for formulating toxicology development plans for
pharmaceutical products under development at the Upjohn Company.
Drug Safety Program Director, European Operations, Crawley, England 19861988
This position was responsible for establishing a toxicology laboratory in the UK
for the Upjohn Company. This involved establishing and monitoring toxicology
programs through contract laboratories in Europe. Interactions with regulatory
agencies in Europe regarding pre-clinical development issues were a
responsibility of this position. In addition, this position was responsible for dayto-day interactions with the Upjohn Company marketing, regulatory, clinical and
pre-clinical programs
Associate Director, Pathology Toxicology Research

1984-1986

This was an entry-level management position responsible for the management of

a group of 3-4 scientists conducting toxicology studies in support of
pharmaceutical development.

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Research Veterinary Pathologist/Toxicologist 1979-1984

This position was responsible for conducting toxicology studies and providing
pathology expertise in the development of pharmaceutical products.
U.S. Army
Aberdeen Proving Ground, MD: 1976-1979 - Major, Chief of Pathology and
Director of the pathology preceptorship training program.
Aberdeen Proving Ground, MD: 1972-1976 - Trainee in Pathology Training
Program in US Army Preceptorship Program.
Ft. Bragg, NC - Post Veterinarian: 1970-1972 - Responsible for Post veterinary
duties and disease surveillance program.
Vietnam - 9th Medical Laboratory: 1969 - Responsible for rabies diagnosis and
acting as the project officer for a tropical canine disease program. Acted as
second in command for the Veterinary program at the 9th Medical Laboratory and
supervised the activities of several enlisted personnel. Awarded Bronze Star
Medal for Service.
Aberdeen, MD - Post Veterinarian: 1968-1968 - Responsible for Post veterinary
program that included animal disease surveillance and food inspection.

Other Employment:
Consultant Pathologist with University of Maryland in the conduct of pathology
review of the potential carcinogenicity of Aspartame: 1978-1979
Consultant Pathologist, Litton Bionetics, Rockville, MD - National Toxicology
Program: 1978-1979
Veterinary Practice, Birmingham, MI - Small animal practice: 1969-1970
Self-employed, Montague, MI - Veterinarian in a small animal and dairy practice:
1967-1968

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Publications:
1. Kolaja, G.J and Fairchild, D.G. (1973): Leiomyoma in the duodenum of a dog.
Amer. Vet. Med. Assoc. J. 163, 275-276.
2. Kolaja, G.J. and Hinton, D.E. (1976): Histopathologic alterations in shell gland
accompanying DDT-induced thinning of eggshells. Env. Poll. 10, 225-231.
3. Kolaja, G.J. and Hinton, D.E. (1977): In vitro inhibition of microsomal Ca
ATPase from eggshell gland of mallard duck. Bull. Env. Contam. Tox. 1(5), 591594.
4. Kolaja, G.J. (1977): The effects of DDT, DDE and their sulfonated derivatives
of eggshell formation in the mallard duck. Bull. Env. Contam. Tox. 17(6), 697701.
5. Kolaja, G.J. (1977): The effects of DDT on eggshell formation in the mallard
duck. Ph.D. Thesis, University of Maryland.
6. Kolaja, G.J. and Hinton, D.E. (1977): Effects of DDT on eggshell quality and
Ca ATPase. J. Tox. Env. Hlth. 3, 699-704.
7. Kolaja, G.J. and Hinton, D.E. (1978): Ultrastructural alterations in the eggshell
gland after chronic exposure to DDT. Env. Pollut. 17,237-244.
8. Werner, R., Balady, M.A. and Kolaja, G.J. (March 1978): Phycomyocotic
dermatitis in an eastern indigo snake. Vet. Med. Small Ani. Clin., pp. 362-363.
9. Kolaja, G.J. and Lund, J.E. (1981): Monocytic origin of Fischer Rat Leukemia.
Micron, 12, 99-100.
10. Ruwart, M.J., Rush, B.D., Friedle, N.M., Piper, R.C. and Kolaja, G.J. (1981):
Protective effects of 16, 6-dimethyl PGE2 on the liver and kidney.
Prostaglandins, Sup. Vol. 12, 97-102.
.
11. Lincoln, K.L., Kolaja, G.J. and Mathews, J. (1981): A scanning electron
microscopic comparison of normal and postmenopausal osteoporotic trabecular
bone. Micron, 12, 1295-296
12. Bonnema, K.J., Kolaja, G.J., Piper, R.C., Ruwart, M.J., Lancaster, C. and
Nezamis, J.E. (1981): Morphologic evaluation of gastric cytoprotection by 16,16dimethyl PGE2. Micron, 12, 309-310.

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13. Block, E.M., Jones, C.L., Stevens, D.R., Kolaja, G.J. and VonVoigtlander,
P.F. (1981): Comparison of endothelial corneal lesions in Fischer 344 rats after
treatment with an antidepressant drug U-48753E or imipramine. Micron, 12, 307308.
14. Kolaja, G.J. and Fast, P.E. (1981): Lupus-like kidney lesions in MRL mice.
Micron, 12, 305-306.
15. Kolaja, G.J. and Fast, P.E. (1982): Renal lesions in MRL mice. Vet. Path.,
19, 663-668.
16. VonVoigtlander, P.F., Kolaja, G.J. and Block, E.M. (1982): Corneal lesions
induced by antidepressants: A selective effect upon young Fischer 344 rats. J.
Pharm. Exp. Therapeutics, 222, No. 1, 282-286.
17. Wiser, S.K. and Kolaja, G.J. (1982): PAS staining of paraffin embedded
tissue for ultrastructural evaluation. Micron, 13, No. 4, 451-452.
18. Ruwart, M.J., Sammons, D.W., Kolaja, G.J., Rush, B.D., Friedle, N.M. and
Adams, L.D. (1982): Alloxan-induced hyperglycemia in rats is reduced by 16,16dimethyl-PGE2. Research Commun. in Chem. Path. and Pharm., 40, No. 2, 233243.
19. Smith, R.J., Bowman, G.J., Iden, S.S., Kolaja, G.J. and Wiser, S.K. (1983):
Biochemical, metabolic and morphological characteristics of human neutrophil
activation with pepstatin A. Immunology, 49, 367-377.
20. Ochoa, R., Kolaja, G.J. and Klei, T.R. (1983): Hemosiderin deposits in the
equine small intestine. Vet. Path., 20, 641-643.
21. Elliget, K.A. and Kolaja, G.J. (1983): Preparation of primary cultures of rat
hepatocytes suitable for in vitro toxicity testing. J. Tissue Culture Methods, 8, 16.
22. Kolaja, G.J., VanderMeer, D.A., Packwood, W.H. and Satoh, P.S. (1993):
The use of SDS PAGE to detect renal damage in Sprague Dawley rats treated
with gentamicin sulfate. Toxicol. Pathol. 20:603-607.
23. Kolaja, G.J., Packwood, W.H., Bell, R.R., Ratke, C.C. and Stout, C.L.
(1994): Renal Papillary Necrosis and Urinary Protein Alterations Induced in
Fischer- 344 Rats by D-Ormaplatin. Toxicol. Pathol. 22:29-38.

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24. Bell, R.R., Bombardt, P.A., DuCharme, D.W., Kolaja, G.J., Packwood, W.H.,
Bothwell, B.E. and Satoh, P.S. (1994): A Non-Radioactive Iothalamate and pAminohippuric Acid High-Performance Liquid Chromatographic Method for
Simultaneously Measuring Glomerular Filtration Rate and Renal Blood Flow in
the Rat. (1994) 8, 224-229.
25. Packwood, W.H., Satoh, P.S., Bell, R.R., Kolaja, G.J., and VanderMeer, D.A.
Improved Sodium Dodecyl Sulfate-Polyacrylamide Gel Electrophoresis of Urinary
Proteins for Assessing Renal Function: Method Development and Preliminary
Assessment. (1994) Toxicology Methods 4, 92-101.
26. Olson, H., Betton G., Robinson D., Thomas K., Monro A., Kolaja G., Lilly P.,
Sanders, J., Sipes G., Bracken W., Dorato M., Van Deum K., Smith P., Berger.,
and Heller A. (2000) Concordance of the Toxicity of Pharmaceuticals in Humans
and Animals. Regulatory Toxicology and Pharmacology 32, 56-67.
Abstracts:
Packwood, W.H., Satoh, P.S. Frailey, D., VanderMeer, D.A., and Kolaja, G.J.
(1992): Evaluation of drug-induced nephrotoxicity by SDS PAGE. Society of
Toxicologic Pathologists: Eleventh International Symposium.
Packwood, W.H., Satoh, P.S., Frailey, D., VanderMeer, D.A., Kolaja, G.J. (1992):
Evaluation by SDS-PAGE of drug-induced nephrotoxicity. Thirteenth Annual
Biology/Biochemistry Associates Symposium. (96).
Frailey, D.M., VanderMeer, D.A., Satoh, P.S., Kolaja, G.J., Packwood, W.H.
(1992): SDS-Polyacrylamide electrophoresis of urinary proteins for assessing
renal damage by various compounds: Method development and preliminary
assessment. Upjohn Technicians Symposium.
Kolaja, G.J., Packwood, W.H., Bell, R.R., Ratke, C.C., Stout, C.L.,
VanderMeer, D.A., Frailey, D.M. and Satoh, P.S. (1993): The evaluation of
urinary proteins as a means of assessing renal toxicity. Society of Toxicology,
Midwest Discussion Group.
Boysen, B., Harris, R., Black H., Kircher C., Kolaja, G., Pletcher, J., Riley G.,
Street, S., King, D. The registry of toxicologic pathology for animals.
Kolaja, G., Packwood, W., Bell, R. (1993): The evaluation of urinary proteins by
SDS Page in the assessment of renal toxicity. American College of Veterinary
Pathologists: Forty-fourth Annual Meeting.

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Books:
Kolaja, G.J. and Hinton, D.E. (1979): DDT-induced reduction in eggshell
thickness, weight and calcium is accompanied by inhibition of calcium ATPase.
In: Animals as Monitors of Environmental Pollutants. National Academy of
Sciences, Washington, DC.
Hinton, D., Lipsky, M., Klaunig, J. and Kolaja, G.J. (1982): Hepatic morphology of
the Lesser Bushbaby (Galago): A light and electron microscopic study. In:
Lesser Galago as an Animal Model: Selected Topics Haines, D.E. (Vol. Ed.).
Volume 12, In: Primates in Medicine, Goldsmith, E.I. and Moor-Jankowski, J.
(Series Ed.), S. Krager, BASEL.
Kolaja, G.J., Kirton, K.T. (1994): Toxicology Studies with Prostaglandin E1.
Excerpta Medica, The Role of Alprostadil in the Diagnosis and Treatment of
Erectile Dysfunction. ed. Irwin Golostein and Tom Flue MD.

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