Development Research

*

Anu Dixit

** *******, ******, ** ***** Phone: 805-***-****, E-mail: abneex@r.postjobfree.com

Summary

Experienced Biotechnology/Pharmaceutical industry Research Scientist with expertise in:

* Assay Design/ Development/ Validation * Molecular and Cell Biology Techniques

* Biomarker Development * Technology Development

* Regulatory Affairs * Publications and Scientific Writing

Key Accomplishments

• Developed and validated cell based bioassays, ELISA’s, proliferation and reporter gene based assays

to measure the potency of therapeutic antibodies at Amgen.

• Authored technical reports on assay development and validation and on the Biacore (Fc functionality)

assay development at Amgen.

• Successfully evaluated the effectiveness of new implantable devices in a gene therapy approach to

treating human growth hormone deficiency and Haemophilia at Baxter International. The study

resulted in a significant advancement of the understanding of implantable device therapies and a

publication in the Journal of Molecular Medicine.

• Utilized molecular and cell biology techniques to detect the occurrence of heart attacks at the

University of Michigan. The research resulted in 3 publications in peer-reviewed journals.

• Master of Science thesis research on the regulation of the transferrin receptor in B lymphocytes

resulted in 2 publications in the Journal of Immunology.

Experience

Amgen, Inc.- Thousand Oaks, CA 2002- 2008

Senior Associate Scientist (2006-2008) Molecular Sciences (Biomarker development)

Played a key role in the department’s efforts to design/ develop assays for measuring biomarkers for oncology

and diabetes. Analyzed statistics and authored technical reports. Presented at inter-departmental meetings.

• Studied Her3 as a biomarker in Oncology. Successfully developed an ELISA and a MSD

assay that measures levels as low as 0.1ng/ml of Her3 in the presence of various biological

matrices.

• Utilized the AdnaTest Select immune-magnetic bead technology to select and enrich as

low as 5 tumor cells in 7.5 ml of peripheral blood. The method achieved the difficult task of

isolating low numbers of tumor cells in blood while keeping these cells intact for further

research. These cells were analyzed using the AdnaTest Detect technology of RT-PCR

followed by microchip analysis on an Agilent bio-analyzer to identify expression of breast

cancer antigens.

• Analyzed peripheral blood samples for the presence of key biomarkers using FACS and

ELISA.

• Maintained and created master and working cell banks of various cell lines.

• Authored detailed analytical methods and assay development reports.

Associate Scientist (2002-2006) Process Development (Assay Development)

Designed, developed and validated bioassays to measure the potency of drug candidates. Authored assay

development and validation reports. Trained QAL associates. Worked cross-functionally with

Pharmaceutics, QAL, Clinical Immunology and Statistics to disseminate information and drive decisions.

Oncology/Neurology/Inflammation/Metabolic Disorders

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• Designed and constructed expression vectors systems using molecular biology techniques.

Transfected mammalian cells. Established and maintained stable cell lines expressing recombinant

proteins. Set up cryo- cell banks of various cell lines.

• Developed, validated and transferred to QAL using GLP guidelines, reporter-gene (Luciferase)

and proliferation (Alamar Blue) based bioassays and receptor- ligand binding (HTRF, ELISA, Alpha

Screen) assays to measure the potency of therapeutic antibodies in clinical trials.

• Authored analytical methods and the assay development reports. Used Statistical software (StatLIA,

Softmax pro, SigmaPlot, JMP), Excel, Word and Powerpoint.

• Successfully adopted the b-DNA platform to develop a bioassay to determine the potency of drug

candidates by measuring the up regulation of key genes during signaling.

Technology Development (BIAcore)

• Established FcRn binding analysis capability using the Biacore 3000 to evaluate the functionality of

the Fc portion of the antibodies and supported FcRn binding studies for 3 drug candidates.

• Developed and authored the Analytical Science equipment guideline and SOP for the Biacore 3000.

• Authored the technical report on the qualification of the Fc functionality assay.

• Wrote the COTS plan and requirement document for the validation of the Biacore 3000 instrument.

Baxter International – Round lake, IL 1992-1997

Research Associate II (1992-1996) Gene Therapy- BioScience Division

Used Baxter’s TheracyteTM device to test the feasibility of using gene therapy for the treatment of human

growth hormone (hGH) and Factor VIII deficiency. Collaborated with bioengineers, histologists and the

animal facilities group to ensure the success of the project. Authored the publication of the research.

• Constructed vectors and established stable cell lines expressing high levels of hGH and Factor VIII.

• Conducted experiments to evaluate the effectiveness of Baxter’s Theracyte™ device in animals. hGH

producing cell lines were loaded into the Theracyte™ device, implanted into mice and monitored

over time. Significant levels of hGH were achieved and persisted for up to 6 months.

• Published research in the Journal of Molecular Medicine.

Regulatory Affairs Associate II (1996-1997) Baxter Corporate Research

Assisted Regulatory Affairs personnel in writing reports and compiling FDA submission packages.

• Prepared detailed reports for regulatory purposes on four separate clinical trials on the use of the

Theracyte™ device in humans. Compiled data, analyzed results and documented conclusions.

• Coordinated cross functionally to prepare and compile the pre-IND package and the device master

file for submission to the FDA.

University of Chicago- Chicago, IL 1992

Senior Research Associate Dept. of Cardiology

• Successfully set up a new molecular and cell biology laboratory at the Dept. of Cardiology.

• Researched and developed enzymatic techniques to detect the occurrence of heart attacks.

• Prepared primary cardiac myoblast cell lines and studied their differentiation into myotubes.

• Employed molecular and cell biology techniques such as PCR, northern and western blots, DNA foot

printing and restriction enzyme digests to research the transcriptional regulation of the troponin C

gene to understand its role during the occurrence of heart attacks.

• Published research in Journal of Molecular and Cellular Biology.

University of Michigan- Ann Arbor, MI 1989-1992

Senior Research Associate Dept. of Cardiology

• Studied the transcription regulation of troponin C genes during muscle development.

• Published research in the Journal of Biological Chemistry and in Molecular and Cellular Biology.

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Education

Master of Science (M.S.), Microbiology and Immunology, University of Iowa, Iowa City, IA.

Post Graduate Diploma, Analytical Chemistry, University of Mumbai, Mumbai, India

Bachelor of Science (B.S.), Microbiology and Immunology, University of Mumbai, Mumbai, India.

Recommendations provided on request

Publications

1. Futran, J. Kemp, J.D., Field, E.H., Vora, A.J. and Ashman, R.F. Transferrin receptor synthesis is an

early event in B cell activation. Journal of Immunology, 143: 787-792, 1989.

2. Vora, A.J., Stunz, L.L., Kemp, J.D. and Ashman, R.F. Two mechanisms of anti-Ig induced

transferrin receptor induction in B cells. Journal of Immunology, 145: 2099-3004, 1990.

3. Parmacek, M.S., Bengur, A.R., Vora, A.J. and Leiden, J.M. The structure and regulation of

expression of the murine fast skeletal troponin C gene. Journal of Biological Chemistry, 265: 15970-

15976, 1990.

4. Parmacek, M.S., Vora, A.J., Shen, T., Barr, E., Jung, F and Leiden, J.M. Identification and

characterization of a cardiac-specific transcription regulatory element in the slow/cardiac troponin C

gene. Molecular and Cellular Biology, May 1992.

5. Parmacek, M.S., Hon, S, Jung, F., Dixit, A.V., Shen, T., Leiden, J.M. A novel myogenic regulatory

circuit controls slow/cardiac troponin C gene transcription in skeletal muscle. Molecular and Cellular

Biology, Vol 14, No. 3, 1994.

6. Josephs, S.F., Dixit, A.V., Loudavaris, T., Young, S.K., and Johnson, R.C. In vivo delivery of rHGH

from genetically engineered human fibroblasts implanted within Baxter immuno-isolation devices.

Journal of Molecular Medicine 77(1): 211-4, Jan 1999.

Key Abstracts and Presentations (1989 to present)

1. Vora, A.J., Kemp J.D. and Ashman, R.F. Whole anti-Ig increases transferrin receptor expression on

B-lymphocytes while blocking proliferation. Annual meeting – Federation of American Societies for

Experimental Biology, New Orleans, LA, March 1989.

2. Vora, A.J., Kemp J.D. Field, E.H. and Ashman, R.F. B cell Fc receptor engagement determines the

mechanisms of transferrin receptor induction. Seventh international congress of Immunology, Berlin,

FGR, July 1989.

3. Parmacek, M.S., Vora, A.J., O’Conner, M.F. and Leiden, J.M. Structure and regulation of the murine

fast skeletal troponin C gene. Amer. Heart Assoc. Dallas, Texas, Nov 1990.

4. Parmacek, M.S., Vora, A.J., and Leiden, J.M. Distinct Cis-acting sequences regulate cardiac

troponin C gene expression in heart and skeletal muscle. Amer. Heart Assoc. Dallas, Nov 1990.

5. Parmacek, M.S., Bengur, A.R., Vora, A.J., and Leiden, J.M. Identification of a tissue specific

developmentally regulated enhancer element in the murine cardiac troponin C gene. Clinical Research

38:295 A, 1990.

6. Parmacek, M.S., Vora, A.J., Palaniappan, S. and Leiden, J.M. Distinct transcription enhancers

regulate cardiac troponin C gene expression in heart and skeletal muscle. Clinical Research 39:295 A,

1991.

7. Parmacek M.S., Barr, E., Vora, A.J., Jung, F. and Leiden, J.M. Identification of a cardiac specific

transcription enhancer that regulates the expression of the slow/cardiac troponin C gene in vitro and

in vivo. Circ. Suppl. 84:11-86, 1991.

8. Josephs, S.F., Loudavaris, T., Dixit, A.V., W.W. Zhang and Johnson R.C. Long term in vivo gene

expression using the Baxter TheracyteTM system. Cold Spring Harbour, September 1996.

9. Crouse, J., Dixit A.V., Vardhanyan, L., Mukku, M. Development of a gene expression assay for

AMG 954 (ABX-EGF). Process Development Symposium, San Diego, May 2004.

10. Dixit, A.V., Oliner K. and Venkat, M. Using BIAcore Technology to establish a functional assay for

The Fc Region of Antibodies/ Peptibodies. Process Development Symposium, Seattle, May 2006.

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11. Wang, S., Suggs, S., Kelley, K., Dixit, A.V., Osgood, T., Coxon, A. and Bao, H. Cellular

Microparticles as a Potential Pharmacodynamic Biomarker of Anti-cancer Therapy. Amgen Medical

Sciences Poster Session, Thousand Oaks, October, 2006.

12. Dixit, A.V., Bao, H. Use of Magnetic Bead Technology to detect and enrich low numbers of tumor

cells from peripheral blood. Amgen Medical Sciences Poster Session, Thousand Oaks, May, 2008.

Technical Reports

• Authored the Analytical Science equipment guideline (ASEG- 0017r00) for the Biacore 3000.

• Authored the Technical Report on the qualification of the Fc Functionality assay.

• Wrote the validation plan for the Biacore 3000 instrument.

• Authored the Analytical Methods and Method Development Reports for bioassays that measured the

potencies of 3 drug candidates.

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