Translational Scientist, Biomarkers, Experimental Medicine

Daniel S. Johnston, Ph.D.

*** ****** **** ******

Trappe, PA

Cell: 484-***-****

SUMMARY

• Experienced translational scientist with proven research and project management skills

• 10 years of pharmaceutical industry experience

• Directed over $10M in outsourced research projects in area of translational medicine

• Experience as translational medicine representative on clinical development teams

• Broad experience using genomic and proteomic technologies to drive development of patient selection and pharmacodynamic biomarkers to guide clinical strategy

• Knowledge of drug development from target identification to phase III in multiple therapeutic areas

• Areas of expertise: Translational Medicine, Oncology, Stem Cells, Reproductive Medicine, Endocrinology, Molecular Biology, Transcriptional Profiling, Proteomics

EMPLOYMENT HISTORY

Wyeth Research & Pfizer Pharmaceuticals 2000-Present

2006-Present: Translational Medicine

Oncology (2006-present)

• Extensive use of transcriptional and genomic profiling, proteomics and imaging to identify and validate biomarkers for preclinical and clinical assets

• Directed over $4M in external oncology biomarker research projects, 2007-2010

o Lead programs to identify patient selection biomarkers to guide patient selection in the clinic

o Manage multi-drug differentiation studies to assist marketing and positioning strategy

o Lead programs to identify pharmacodynamic biomarkers to monitor compound action and elucidate PK/PD relationship to direct dosing in clinical trials

• Chair, Oncology Early Biomarker Strategy Team

• Evaluate clinical biomarker data

• Review clinical assay validation and analytical validation reports

Women’s Health (2007-2008)

• Managed clinical and preclinical research efforts in Translational Medicine in the area of Reproductive Disorders

o Development of novel animal models for preclinical testing of compounds

o Evaluation of novel imaging methodologies to expedite go/no go decisions in the clinic

o Identification of novel proteomic pharmacodynamic biomarkers from urine to non-invasively monitor disease status in the clinic

• Over $6M in Women’s Health biomarker research projects approved 2007-2009

• Member of Reproductive Disorders Core Learn Team

• Co-Chair, Reproductive Disorders Early Clinical Science Subteam

2000-2006: Women’s Health Research

• Directed a team of researchers to identify, validate and develop small molecule inhibitors for male and/or female contraception

• Project Team Leader for three small molecule drug development projects

• Lead efforts in target identification, creation and evaluation of genetically modified animals, development of high throughput assays, secondary and tertiary screens

PERFORMANCE, AWARDS, FELLOWSHIPS AND ELECTED POSITIONS

• Wyeth Eagles Class of 2009. An invited development program for the top performing mid-level employees in R&D

• Executive Council, American Society of Andrology, 2007-Present

• Above and Beyond Award. Wyeth Research, December, 2007

• Burroughs-Wellcome Fund Award for Outstanding Trainee Research. American Society of Andrology, April, 2000

• NIH National Research Service Award (NRSA), 1998-2000

• The Larry L. Ewing Award. The Johns Hopkins University, 1996

• The Carl Shultz Award. The Johns Hopkins University, 1996

• NIH Predoctoral Trainee, 1992-1996

ADDITIONAL TRAINING/DEVELOPMENT

• Wyeth Eagles Program (2008-2009)

• Wyeth Research Drug Development Training, (2004, 2009)

• Advanced Topics in Drug Development, Wyeth Pharmaceuticals (2008)

• Wyeth Scholars, (2007-2008)

• Future Leaders Workshop, Wyeth Research, (2006-2008)

• Team Leadership Workshop, Wyeth Research (2004)

• Drug Development, Temple University (2001)

ADDITIONAL ACTIVITIES:

• Wyeth Research Collegeville Institutional Animal Care and Use Committee (2003-present)

• Male Contraceptive External Advisory Committee, University of Kansas Med. Center (2006-present)

• Multidisciplinary Expert Review Panel for the Contraception and Reproductive Health Branch of the NICHD (2008)

MENTORING

Postdoctoral Fellow: Michael A. Nolan, Ph.D. (2004-2006)

Summer Interns: Paula Green, Senior, Haverford College (2001)

Tamia Harris, Senior, Haverford College (2002)

Kevin Kopko, Sophomore/Junior, Syracuse University (2003, 2004)

Mark Solarz, Senior, Notre Dame University (2006)

EDUCATION

Ph.D., The Johns Hopkins University, 1996

B.A., Colby College, 1990

POSTDOCTORAL RESEARCH:

School of Molecular Biosciences, Washington State University 1997 – 2000

Purification and surgical transplantation of testicular stem cells

Michael D. Griswold, Ph.D., advisor

DOCTORAL RESEARCH:

The Johns Hopkins University 1990 – 1996

Sperm-Zona Binding in the Mouse: Evidence for multiple glycan binding sites on the mouse zona pellucida

William W. Wright, Ph.D., advisor

Joel H. Shaper, Ph.D. co-advisor

UNDERGRADUATE RESEARCH:

The Jackson Laboratory Summer Student Program 1989, 1990

Purification and in vitro maturation of murine oocytes

PEER-REVIEWED PUBLICATIONS

1. Coughlin, C.M., Johnston, D.S., Alvarez, J.D., Berkenblit, A., Germa, G., Spittle, C., Strahs, A., Bacus. S., Hill, J., Burczynski, M.E., Binlich, F. and Zacharchuk C. Approaches and limitations of phosphatidylinositol-3-kinase pathway activation status as a predictive biomarker in the clinical development of signaling inhibitors. In Legal Review.

2. Johnston, D.S., Su, Y.A and Alesci, S.A. Mitochondrial Gene Profiling: Translational Perspectives. Pharmacogenomics. 2009 10(10):1645-55.

3. Johnston, D.S., Robinson, J.A., Alesci, S. Translational Medicine Approach to Osteoporosis Drug Discovery Biomarkers; thinking beyond BMD. American Drug Discovery 3(4): 54-59

4. Johnston D.S, Wright, W.W., DiCandeloro, P., Wilson, E., Kopf, G.S. and Jelinsky, S.A. Stage-Specific Gene Expression is a Fundamental Characteristic of Rat Spermatogenic Cells and Sertoli Cells. Proc Natl Acad Sci U S A. 2008 105(24): 8315-20

5. Johnston D.S, Jelinsky, S.A., DiCandeloro, P., Wilson, E., Kopf, G.S. and Wright, W.W. Identification of Testis-Specific male contraceptive targets: insights from transcriptional profiling of the cycle of the rat seminiferous epithelium and purified testicular cells. In Testicular Chromosome Structure and Gene Expression, edited by E. Mitchell Eddy and Michael D. Griswold. Ann N Y Acad Sci. 1120:36-46.

6. Dong, L., Ge, R., Jelinsky, S.A., Finger, J.L., Johnston, D.S., Kopf, G.S, Sottas, C.M and Hardy, M.P. Gene Expression during Development of Fetal and Adult Leydig Cells. (2007) In Testicular Chromosome Structure and Gene Expression, edited by E. Mitchell Eddy and Michael D. Griswold. Ann N Y Acad Sci. 1120:16-35.

7. Chengalvala, M., Johnston, D. S., Stevis, P., Chennathakuzhi, V. and Kopf, G.S. (2007) Gene expression profiling and its practice in drug development. Current Genomics 8(4): 262-270

8. Turner, T.T., Johnston, D.S, Jelinsky, S.A., Tomsig, J.L. and Finger, J.N. (2007) Segment boundaries of the adult rat epididymis limit interstitial signaling by potential paracrine factors and segments lose differential gene expression after efferent duct ligation. Asian J Androl. 9(4): 565-73.

9. Johnston, D.S., Turner, T.T., Finger, J.N., Owtscharuk, T.L, Kopf, G.S. and Jelinsky, S.A. (2007) Identification of epididymis-specific transcripts in the mouse and rat by transcriptional profiling. Asian J Androl. 9(4): 522-7.

10. Roberts, K.P., Johnston, D.S., Nolan, M.A., Wooters, J.L., Waxmonsky, N.C., Piehl, L.B., Ensrud-Bowlin, K.M and Hamilton, D.H. (2007) Structure and function of epididymal protein Crisp-1. Asian J Androl. 9(4): 508-14.

11. Turner, T.T., Johnston, D.S., Finger, J.N., and Jelinsky, S.A. (2007) Differential Gene Expression among the Proximal Segments of the Rat Epididymis Is Lost after Efferent Duct Ligation. Biol Reprod. 77(1): 165-71

12. Jelinsky, S.A., Turner, T.T., Bang, H.J., Finger, J.N., Solarz, M.K., Wilson, E., Brown, E.L., Kopf, G.S. and Johnston, D.S. (2007) The Rat Epididymal Transcriptome: Comparison of segmental gene expression in the rat and mouse epididymides. Biol Reprod 76: 561-570.

13. Nolan, M.A., Wu, L., Bang, H.J., Jelinsky, S.A., Roberts, K.P., Turner, T.T., Kopf, G. S. and Johnston, D. S. (2006) Identification of rat cysteine rich secretory protein-4 (Crisp4) as the ortholog to human Crisp1 and mouse Crisp4. Biol Reprod. 74: 984-991

14. Turner, T.T., Johnston, D.S and Jelinsky, S.A. Epididymal genomics and the search for a male contraceptive. (2006) Mol Cell Endocrinol 250(1-2): 178-83

15. Roberts K.P., Ensrud K.M., Wooters, J., Nolan, M.A., Johnston D.S. and Hamilton, D.W. (2006) Epididymal secreted protein Crisp-1 and sperm function. Mol Cell Endocrinol 16; 250(1-2): 122-7.

16. Turner, T.T, Bang, H.J., Attipoe S.A., Johnston, D.S. and Tomsig, J. (2006) Sonic hedgehog pathway inhibition alters epididymal function as assessed by the development of sperm motility. J. Androl. 27(2): 225-32.

17. Johnston, D.S., Wooters, J., Qiu, Y., Kopf, G.S. and Roberts, K.P. Analysis of the human sperm proteome. (2006) In Testicular Cell Dynamics and Endocrine Signaling, edited by Matthew P. Hardy and Michael D. Griswold. Ann N Y Acad Sci. 2005 Dec; 1061:190-202.

18. Johnston, D.S., Jelinsky, S.A., Bang, H.J., DiCandeloro, P., Wilson, E., Kopf, G.S. and Turner T.T. (2005) The Murine Epididymal Transcriptome: Transcriptional profiling of segmental gene expression in the epididymis. Biol Reprod: 73:404-413

19. Johnston DS and Kopf GS. (2005) Pre-clinical research in the pharmaceutical industry. J Androl. 26(1): 13-14.

20. McLean D.J., Friel P.J., Johnston D.S., Griswold M.D. (2003) Characterization of Spermatogonial Stem Cell Maturation and Differentiation in Neonatal Mice. Biol Reprod. 69(6): 2085-91.

21. Anway, M.D., Johnston D.S., Crawford, D. and Griswold, M.D. (2001) Identification of a novel retrovirus expressed in rat Sertoli cells and granulosa cells. Biol. Reprod. 65, 1289-1296.

22. Johnston, D.S., Russell, L.D., Friel, P.J. and Griswold, M.D. (2001) Murine germ cells do not require androgen receptor to complete normal spermatogenesis following spermatogonial stem cell transplantation. Endocrinology 142(6): 2405-2408.

23. McLean, D.J., Johnston, D.S., Russell, L.D. and Griswold, M.D (2001) Germ cell transplantation and testicular function. Trends in Endocrinology and Metabolism 12, 16-21.

24. Boettger-Tong, H.L., Johnston, D.S., Russell, L.D., Griswold, M.D. and Bishop, C.E. (2000) Stem cell transplantation demonstrates that jsd (juvenile spermatogonial depletion) mutant seminiferous tubules are capable of supporting spermatogenesis. Biol. Reprod. 63, 1185-1191.

25. Johnston, D.S., Russell, L.D. and Griswold, M.D. (2000) Advances in spermatogonial stem cell transplantation. Reviews of Reproduction, 5, 183-188.

26. Lok, S., Johnston, D.S., Conklin, D, Lofton-Day, C., Adams, R.L., Jelmberg, A.C., Whitmore, T., Schrader, S., Griswold, M.D. and Jaspers, S.R. (2000) Identification of INSL6, a new member of the insulin superfamily that is expressed in the testis of rat and human. Biol. Reprod. 62, 1593-1599.

27. Johnston, D.S., Wright, W.W, Shaper, J.H., Hokke, C.H, Van den Eijnden, D.H. and Joziasse, D.H. (1998). Murine sperm-zona binding, a fucosyl residue is required for a high affinity sperm-binding ligand. A second site binds a nonfucolylated, -galactosyl-capped oligosaccharide. J. Biol. Chem. 273, 1888-1895.

28. Johnston, D.S., Shaper, J.H., Shaper, N.L., Joziasse, D.H. and Wright, W.W. (1995). The gene encoding murine 1,3-galactosyltransferase is expressed in female germ cells but not in male germ cells. Dev. Biol. 171, 224-232.

29. Schroeder, A.C., Johnston, D. and Eppig, J.J. (1991). Reversal of postmortem degeneration of mouse oocytes during meiotic maturation in vitro. J. Exper. Zool. 258, 240-245.

BOOK CHAPTERS

• Johnston, D.S., Bai, Y., Kopf, G.S. (2003) Utilization of the human genome databases in strategies for contraceptive development. In: The Third International Conference on the Epididymis pp256-270. Ed Hinton B.T. and Turner T.T. The Van Doren Company, Charlottesville

PATENTS

• Coughlin, C.M., Berkenblit, A., Binlich, F., Feingold, J., Germa, C., Johnston, D,. Strahs, A., Zacharchuck, C. A cutpoint in PTEN protein expression that accurately identifies tumors and is predictive of drug response to a pan ErbB inhibitor. U.S. Provisional Patent Application (January, 2010).

• Coughlin, C.M., Berkenblit, A., Binlich, F., Feingold, J., Germa, C., Johnston, D., Strahs, A., Zacharchuk, C. Phosphatidylinositol-3-kinase pathway biomarkers: PI3K Pathway activation as a predictive biomarker for clinical response to pathway inhibitor used as a cancer treatment in breast cancer. U.S. Provisional Patent Application No.61/285,821 (11 December 2009).

• Michael Nolan, Daniel Johnston, Leeying Wu, and Scott Jelinsky. Rat and Mouse Members of the CRISP Family of Genes. U.S. Provisional Application No. 60/677,670, filed May 4, 2005

INVITED PRESENTATIONS

1. Identification and Validation of Oncology Biomarkers. Eastern Ontario Cancer Regional Innovation Forum, Ottawa, Ontario. Scheduled March, 2010.

2. Patient Selection Biomarkers in Oncology. Cambridge Healthtech Institute, Molecular Medicine Tri-Conference, San Francisco, CA. February, 2010.

3. Preclinical Biomarker Discovery in Oncology. Keynote Lecture, 3rd Annual Rediscovering Biomarkers Conference. San Diego, CA. July, 2009.

4. The Use of Cell Line Panels to Identify Patient Selection Biomarkers in Oncology. Caliper LifeSciences Users Meeting. Hopkinton, MA. June, 2009.

5. The Use of Phamacogenomics in Translational Research. Second International Meeting on Pharmacogenetics of Osteoarticular Disorders, Florence, Italy. April, 2008.

6. Proteomics and Genomics of the Epididymis. Gordon Research Conference on Fertilization and Activation of Development. Holderness School, Plymouth, NH. July, 2007.

7. Analysis of the Rat Testicular Transcriptome. North American Testis Workshop. Tampa, FL. April, 2007.

8. Identification of non-Endocrine Targets for Male Contraception Using Transcriptional Profiling and Proteomics. National Institutes of Health, Center for Population Research, Bethesda, MD. March, 2007.

9. Comparison of the Mouse and Rat Epididymal Transcriptomes. Epididymis IV: The fourth international conference on the epididymis. Chatel-Guyon, France. December, 2006.

10. Biological Research in the Pharmaceutical Industry. Randolph-Macon College. Ashland, VA. September, 2006.

11. Identification and Development of Novel Targets for Male Contraception. The 31st Annual Meeting of the American Society of Andrology. Chicago, IL. April, 2006.

12. Identification of non-Endocrine Targets for Male Contraception Using Transcriptional Profiling and Proteomics. Population Council, Rockefeller University, New York, NY. April, 2006.

13. Development of an Expression Profiling Database of Male Reproductive Tissues in the Rat. Toxicology, Wyeth Chazy. Chazy, NY. December, 2005.

14. Identification of Novel Contraceptive Targets using Transcriptional Profiling, Proteomics and Bioinformatics. University of Washington, Seattle, WA. October, 2005.

15. Pre-Exploratory Project Phase. Wyeth Team Leader Training. Collegeville, PA. September, 2005.

16. Identification and Characterization of Novel Contraceptive Targets using Transcriptional Profiling and Proteomics. Wyeth Discovery Retreat. Princeton, NJ. May 2005

17. Identification of Novel Contraceptive Targets using Transcriptional Profiling, Proteomics and Bioinformatics. United States Environmental Protection Agency. Research Triangle Park, NC. April, 2005.

18. Analysis of the Human Sperm Proteome. XVIIIth North American Testis Workshop. Seattle, WA. March 2005.

19. Identification of non-Endocrine Targets for Male Contraception using Genomic, Proteomic, and Cell-Based Technologies. University of Minnesota. Minneapolis, MN. October, 2004.

20. Identification of Molecular Markers for Diagnosing Male Infertility. Andrology Laboratory Workshop, 28th Annual Meeting of the American Society of Andrology. Phoenix, AZ. April, 2003.

21. Contraceptive Development Strategies Using the Human Genome Database. Epididymis III: The third international conference on the epididymis. Charlottesville, VA. June, 2002 .

22. Murine Germ Cells do not Require Functional Androgen Receptors to Complete Spermatogenesis Following Spermatogonial Stem Cell Transplantation. The 25th Annual Meeting of the American Society of Andrology. Boston, MA. April, 2000.

23. Mouse Sperm-Zona Binding as a Model for Carbohydrate-Dependent Adhesion. Human Frontiers Science Program. Vrije University, Amsterdam, The Netherlands. June, 1996.

EXTERNAL PEER REVIEW FUNCTIONS

Ad Hoc reviewer for:

Archives of Andrology: Journal of Reproductive Systems

Biology of Reproduction

Developmental Dynamics

Gene

Human Reproduction

Journal of Andrology

Journal of Cellular Physiology

Journal of Toxicological Sciences

Molecular and Cellular Biology

Molecular Human Reproduction

Proteomics

Reproduction

System Biology in Reproductive Medicine

The Journal of Biological Chemistry

Trends in Pharmacological Sciences

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