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o Resourceful entrepreneur with 24 years of experience directing strategy
development and operations teams in R&D, Regulatory Affairs,
Manufacturing, Business Development, Marketing, Quality, Finance, Project
Management and Alliance Management.
o Corporate Officer with a demonstrated ability to generate shareholder
value. Helped generate almost $40 billion in revenue through product
development, market expansions, and business deals.
o Exceptional innovator with an unparalleled record of persuading the FDA
to accelerate development, modify requirements, reverse rejections, and
add novel information or language to labels.
o Cutting-edge scientist and businessman that has helped manage the
lifecycle of biologics, small molecules, gene therapies, IVD assays,
autoinjectors, combination products, and personalized medicines,
including:
Enbrel , ADVATE(, Vectibix , AVINZA , ONTAK , NeucardinTM, SureClick ,
MotangaTM, rilotumumab, omecamtiv, the Therascreen( KRAS RGQ PCR kit, and
the Avant Autoinjector System.
o Stellar leader and people manager, with the references to prove it.
PROFESSIONAL EXPERIENCE
Zensun USA, San Diego, CA 2014-Present
VP of Business Development, Quality, Regulatory and Scientific Affairs
(Corporate Officer)
o Leading the company's strategic efforts in developing and commercializing
4 novel therapeutics for the treatment of heart failure and cancer.
o Leading negotiations for business development deals to enable the
marketing of products by partners.
o Directing the generation of Regulatory strategy and filings for clinical
and manufacturing development.
o Establishing the Quality System that covers GMP, GCP, GLP, and Financial
policies and procedures.
AMGEN, Thousand Oaks, CA 2006-2013
Director and Senior Manager, Global Regulatory Affairs and Safety
o Directed regulatory strategy development and filing operations for
Oncology, Inflammation, and Cardiovascular programs.
. Set over 50 precedents at the FDA (more globally), obtaining approval
in each case for something that no company has ever been allowed to do
before.
. Directed over 75 supplemental BLA/NDS filings to obtain approval for
new combination products, inclusion of clinical data into labels,
device modifications, manufacturing changes, testing methods, etc.
. Directed the generation of the filing strategy and Agency interactions
for the first Amgen-developed device: a reusable, electromechanical
autoinjector (also an industry first).
o Accelerated the development of several programs by 3-5 years through
renegotiation of SPA agreements. These resulted in global drug and
device approvals that will generate billions of dollars in revenue as
well as the saving of hundreds of millions of dollars in clinical study
costs.
o Co-led Manufacturing Teams in reducing the cost of goods by increasing
yields and eliminating testing.
o Developed strategies for assay validation, marketing applications and
Agency meetings with IVD partners.
Ligand Pharmaceuticals, San Diego, CA 2003-2006
Senior Manager, Quality Assurance and Regulatory Affairs
o Served as Chief Operating Officer for the Vice President and a department
of 40 people.
. Directed the department's Finance Team. Managed a $9 million budget
for product testing, personnel, and capital expenditures (including
depreciation).
. Built a coordinated, SOX-compliant financial system that saved the
department as much as $700,000 per year by increasing control over
expenses and processes.
. Developed an improved process for capturing Quality Assurance
activities associated with manufacturing, which reallocated almost
$2 Million in expenses per year to cost of goods sold.
. Directed the department's Project Management Team. Coordinated APRs,
audits, etc.
o Directed the sNDA/BLA filings for licensing the manufacturing of AVINZA
and ONTAK at new facilities.
o Co-led preparations for two FDA Advisory Committee Meetings on
accelerated approval of orphan drugs.
o Provided Regulatory/Quality approval of promotional materials, change
control, manufacturing records, etc.
Baxter International, Glendale, CA and Deerfield, IL 2000-2003
Senior Manager, Regulatory Affairs, BioScience Division (2002-2003)
o Led the Regulatory Filing Team and the CMC content generation for global
licensing applications for ADVATE, the world's Number 1 recombinant
treatment for hemophilia.
. The submissions were the first electronic marketing applications filed
in the US, Europe, and Canada.
Manager, Business Planning and Development, BioScience Division (2001-2002)
o Pioneered Baxter BioScience's General Manager Development Program
o Assessed potential partnership, in-licensing, and acquisition candidates,
as well as potential business opportunities presented by foreign
governments.
. Initiated discussions with a venture capital firm that led to a
partnership with a biotech company.
Marketing Consultant and Intern (2000-2001), Renal Division
o Restructured the online marketing campaign for KidneyDirections, a web
site designed to expand the market for a peritoneal dialysis product
line. Increased customer registration by 85% while reducing costs by
90%.
o Directed the corporate-wide implementation of tracking software to
measure web site traffic, to identify paths of customer arrival, and to
determine the effectiveness of media buys for all external web sites.
Vanderbilt-Ingram Cancer Center, Nashville, TN 1997-1999
Research Scientist
o Discovered the function, mechanism, and anti-cancer properties of a novel
gene, demonstrating its potential use as a drug target or gene therapy
for RAS-transformed tumors.
o Discovered the mechanism through which a mutant protein causes leukemia,
revealing several potential drug targets for therapeutic intervention.
Universit de Montr al, Montr al, Qu bec 1991-1996
Research Scientist (1995-1996) and Doctoral Student (1991-1995)
o Built the first Molecular Biology research facility in the Department of
Pharmacology.
o Led 10 successful research projects studying drug targets for depression,
hypertension, and hypotension.
EDUCATION:
PhD, Biochemistry, Universit de Montr al, Montr al, Qu bec
MBA, General Management (Healthcare focus), Vanderbilt University,
Nashville, TN
MA, Microbiology and Immunology, Duke University, Durham, NC
BS, Molecular Biology, University of Wisconsin, Madison, WI
Publications:
1. Irvin, B.J., Wood, L.D., Wang, L., Fenrick, R., Sansam, C.G., Packham,
G., Kinch, M., Yang, E., and Hiebert, S.W. TEL, a putative tumor
suppressor, induces apoptosis and represses transcription of Bcl-XL.
Journal of Biological Chemistry 278(47): 46378-86, 2003.
2. Fenrick, R., Wang, L., Nip, J., Amann, J.M., Rooney, R.J., Walker-
Daniels, J., Crawford, H.C., Hulboy, D.L., Kinch, M.S., Matrisian,
L.M., and Hiebert, S.W. TEL, a Putative Tumor Suppressor, Modulates
Cell Growth and Cell Morphology of Ras-Transformed Cells While
Repressing the Transcription of stromelysin-1. Molecular and Cellular
Biology 20(16): 5828-5839, 2000.
3. Fenrick, R. and Hiebert, S.W. Translocation fusion proteins in
leukemia formation. In: DNA Alterations in Cancer: Genetic and
Epigenetic Changes. Ehrlich, M. (ed.). BioTechniques Books, Eaton
Publishing, Natick, MA. pp. PHONE NUMBER AVAILABLE
4. Fenrick, R., Amann, J.M., Lutterbach, B., Westendorf, J., Downing, J.,
and Hiebert, S.W. Both TEL and AML-1 contribute repression domains
to the t(12;21) fusion protein. Molecular and Cellular Biology
19(10): 6566-74, 1999.
5. Fenrick, R. and Hiebert, S.W. The role of histone deacetylases in
acute leukemia. Journal of Cellular Biochemistry (Supplements)
30/3PHONE NUMBER AVAILABLE
6. Marquis, M., Fenrick, R., Pedro, L., Bouvier, M., and De Lean, A.
Comparative binding study of rat natriuretic peptide receptor-A.
Molecular and Cellular Biochemistry 194(1-2):23-30, 1999.
7. Pedro, L., Fenrick, R., Marquis, M., McNicoll, N., and De Lean, A.
Characterization of the phosphorylation state of natriuretic peptide
receptor-C. Molecular and Cellular Biochemistry 178: 95-101, 1998.
8. Fenrick, R., Bouchard, N., McNicoll, N., and De Lean, A.
Glycosylation of asparagine 24 of the natriuretic peptide receptor-B
is crucial for the formation of the ligand binding domain. Molecular
and Cellular Biochemistry 173: 25-32, 1997.
9. Fenrick, R. Cloning and characterization of the bovine natriuretic
peptide receptor-B. National Library of Canada, 698 pages, 1996.
10. Fenrick, R., McNicoll, N., and De Lean, A. Glycosylation is critical
for natriuretic peptide receptor-B function. Molecular and Cellular
Biochemistry 165: PHONE NUMBER AVAILABLE
11. Fenrick, R., Pou, C., Boulieau, M., and Fargin, A. The human 5-HT1A
receptor differentially modulates adenylyl cyclase and phospholipase
C. General Pharmacology 27(2): PHONE NUMBER AVAILABLE
12. Fenrick, R., Babinski, K., McNicoll, N., Therrien, M., Drouin, J., and
De Lean, A. Cloning and functional expression of the bovine
natriuretic peptide receptor-B. Molecular and Cellular Biochemistry
137: PHONE NUMBER AVAILABLE
13. Malim, M., Hauber, J., Fenrick, R., Bohnlein, S., and Cullen, B.R.
Nuclear export of unspliced HIV-1 mRNAs is regulated by the viral rev
trans-activator. In: Human Retroviruses. Groopman, J.E., Chen,
I.S.Y., Essex, N., and Weiss, R.A. (eds.). Allen R. Liss, Inc., New
York, pp. 97-108, 1990.
14. Malim, M., Bohnlein, S., Fenrick, R., Le, S.-Y., Maizel, J.V., and
Cullen, B.R. Functional comparison of the rev trans-activators
encoded by different primate immunodeficiency virus species.
Proceedings of the National Academy of Sciences 86: 8222-8226, 1989.
15. Fenrick, R., Malim, M., Hauber, J., Le, S.-Y., Maizel, J.V., and
Cullen, B.R. Functional analysis of the tat trans-activator of human
immunodeficiency virus type 2. Journal of Virology 63: 5006-5012,
1989.
16. Malim, M., Fenrick, R., Ballard, D., Hauber, J., Bohnlein, E., and
Cullen, B.R. Functional characterization of a complex protein-DNA-
binding domain located within the HIV-1 LTR leader region. Journal of
Virology 63: 3213-3219, 1989.
17. Malim, M., Hauber, J., Fenrick, R., and Cullen, B.R.
Immunodeficiency virus rev trans-activator modulates the expression of
the viral regulatory genes. Nature 335: PHONE NUMBER AVAILABLE
18. Hauber, J., Malim, M., Fenrick, R., and Cullen, B.R. Regulation of
HIV-1 gene expression: The role of the viral tat gene product. In:
The Control of Human Retroviral Gene Expression. Franza, B.R.,
Cullen, B.R., and Wong-Staal, F. (eds). Cold Spring Harbor Press,
Cold Spring Harbor, N.Y., pp.11-22, 1988.
19. Kenney, S., Kamine, J., Markovitz, D., Fenrick, R., and Pagano, J.S.
An Epstein-Barr virus immediate-early gene product trans-activates
gene expression from the human immunodeficiency virus long terminal
repeat. Proceedings of the National Academy of Sciences 85: 1652-
1656, 1988.
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