summary

o Resourceful entrepreneur with ** 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. 137-148, 2000.

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)

30/31:194-202, 1999.

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: 103-109, 1996.

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): 263-268, 1996.

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: 173-182, 1994.

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: 181-183, 1988.

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.

Contact this candidate