JOSEF S. OZER, Ph.D.

** *********** **., ******** ******, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

I. EXPERIENCE

• Molecular Genetic Toxicologist with over 11 years management and over

seven years pharmaceutical industry experience at Pfizer, Merck, Roche,

and Wyeth

• Over 8 years toxicological biomarker development experience for kidney,

liver, and colon

• Biomarker development for lead-op through POC for developmental

compound projects

• Human, rat, primate, mouse, and dog biomarker development

• Designed preclinical toxicological studies and acted as an exploratory

Compound Manager

• Considerable experience in laboratory oversight, design, management, and

project development

• Mastery of recombinant protein purification from insects, mammalian, and

prokaryotic systems and molecular cloning skills

• Mastery of monoclonal and polyclonal antibody design and development

• Mastery of ELISA and MesoScale platforms for quantifying Biomarkers

• Managed projects utilizing small and large molecule biomarkers using LC/

MS/MS

• Managed biotherapeutic PK utilizing LC/MS/MS and ELISA

• Analytical biomarker validation for regulatory submission and

developmental compound programs

• Lead investigator for 1st VXDS safety biomarker submission to FDA and

EMEA; presented application at EMEA

• POM and efficacy/PD biomarker development for translation to the clinic

• Highly self motivated scientist with a dynamic and positive managerial

style. Strong analytical and troubleshooting skills. Scientific discussions

and interactions lead to straightforward and rapidly testable experimental

approaches. Oral and written communications are excellent and promote

team building and matrix managing.

II. EDUCATION

• Postdoctoral Fellow, Roche Institute of Molecular Biology

• Postdoctoral Fellow, American Cyanamid Company/Wyeth

• Ph.D., Cell Biology, Vanderbilt University School of Medicine

• B.A., Biology, University of California at Santa Cruz

• Visiting Student, Medical School, UCLA

• Visiting Student, Medical School, UCSF

III. CURRENT PHARMACEUTICAL INDUSTRY EXPERIENCE

PFIZER (MAY, 2008 TO PRESENT)

Pharmacokinetics, Dynamics, and Metabolism, PGRD

1

JOSEF S. OZER, Ph.D.

10 Jennycliffe Ln., Clarkson Valley, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

PDM Biomarker Lead, St. Louis (R6, Senior Principal Investigator)

Manage site analytical biomarker validation for regulatory submission. LC/MS/MS

small and large molecule biomarker discovery to support compound development in

inflammation, pain, and pulmonary disease indications. Support Drug Safety &

Research Development (DSRD) biomarker efforts in renal and liver toxicity globally.

• Currently manage three independent scientists in an analytical lab with state

of the art technologies for analytical validation and biomarker discovery

• Oversight of regulatory submissions and internal reporting of methods and

data sets

• St. Louis Biomarker Leadership Team Member, Translational Medicine

• GCP ready methods are outsourced to CROs and laboratory maintains

oversight of project deliverables

• Pain indication biomarker panel created and validated for selectivity and

efficacy biomarkers in serum and urine using LC/MS/MS

• Novel serum pulmonary markers methods developed for mechanism and

surrogate clinical endpoints

• PK/PD biomarker studies integrated for cost savings and improved dosage

modeling data

• PK/safety biomarker integration for lead-op applications

• LC/MS/MS based biotherapeutic PK for antibody based therapeutics

• Validation of DSRD safety biomarkers

• LC/MS/MS metabonomic biomarkers for translational safety applications

• Active PSTC HWG member for upcoming VXDS qualification application

• Invited expert reviews on liver and renal toxicity biomarker qualification

• Six external scientific agreements negotiated with industry and academic

partners to develop novel biomarker platforms for GI injury and efficacy

• Four invited international presentations at external scientific meetings

MERCK RESEARCH LABS (JAN., 2005 TO MAY, 2008)

Molecular & Investigative Toxicology and Systems Toxicology, Safety

Assessment

Research Fellow (Level 5)

Developed urine kidney toxicity biomarkers for preclinical use and translational

applications. Managed extensive exploratory studies for kidney and liver

biomarker development.

• Developed and validated kidney toxicity biomarkers for preclinical use

• Qualified kidney markers (Kim-1, albumin, and TFF3) at the FDA and EMEA

• Adapted kidney toxicity biomarkers for mouse, rat, and primate urines

• Validated 9 rat, 6 mouse, and 12 primate kidney toxicity biomarkers

2

JOSEF S. OZER, Ph.D.

10 Jennycliffe Ln., Clarkson Valley, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

• Developed human kidney toxicity biomarker ELISAs for Phase 2B Trial

• Completed over 25 successful exploratory in vivo studies for biomarkers

• Compound Manager for > 15 exploratory compounds

• Lead Investigator for >25 Merck in vivo exploratory studies

• Study Director for 3 CRO in vivo exploratory studies

• Submitted reports for in vivo exploratory studies

• Coordinated projects with Banyu, Japan and Mirabel, France

• Lead Investigator – kidney primate study in Mirabel

• Lead Investigator – 3-month mouse biomarker range finder for Phase 2B trial

• Merck representative for Liver Critical Path Initiative (PSTC)

• Merck co-rep for Kidney Critical Path Initiative (PSTC)

• Merck alternate for Kidney ILSI Initiative

• Implemented MesoScale technology for toxicological biomarkers

• Assessed Luminex technology for toxicological biomarkers

• Followed GLP practices for Safety Assessment studies

• Completed Merck Management Training

• Completed MRL Drug Discovery Course

• Completed Part 11 Compliance Training

• Managed Biomarker Discovery Group (2 FTE)

• Managed Versatile Workforce Training Candidates (1-3 FTE year round)

• Managed Masters Candidates at Merck

• Managed biomarker project in Mirabel, France

• Co-Managed Wistar rat biomarker evaluation at Merck

• Managed development of 5 dog kidney toxicity biomarker Assays

• Considerable experience with OPX2 software for study design

• Negotiated an ESA with Harvard Medical School for biomarker assays

• Collaborated with Harvard Medical School on a joint biomarker publication

• Liver, Kidney and, Inflammatory committee member for transcription

biomarker development (Taqman, Taqcard, MicroArray)

• Assisted development of transcriptional profiles for renal and liver injury for

lead-op applications

IV. ADDITIONAL PROFESSIONAL EXPERIENCE

BOSTON UNIVERSITY SCHOOL OF MEDICINE (1999-2005)

Department of Pharmacology and Experimental Therapeutics

Assistant Professor

I managed a 1000 square foot laboratory with three scientific staff. Facilities

included tissue culture, molecular genetics, and biochemistry capabilities. Our

research focused on molecular mechanisms governing cancer proliferation and

neuronal degeneration. Engineered reagents to develop neurons and colonic

epithelium for ex vivo cellular expansion and therapeutics. I conceived,

implemented, and managed research projects.

• Colon cancer & disease biomarker development

• Project planning and management

3

JOSEF S. OZER, Ph.D.

10 Jennycliffe Ln., Clarkson Valley, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

• Neuron and colon cell ex vivo expansion tools

• Pharmacogenomic study of early onset of Parkinson’s disease

• Transgenic model of Parkinson’s disease

• Differentiation therapy for cancer

• Characterizing ApoAI Downstream Enhancer for atherosclerosis therapeutics

• Gene regulation mechanisms of action in cancer verses normal cells

• Recombinant mammalian, yeast, and E. coli expression systems

• Genomic data mining for gene discovery

• In vitro transcription assay development, biochemical fractionations

• Howard Temin NCI Scholar

• Salary fully funded by external grant awards

• Graduate and Medical teaching in Pharmacokinetics and Antibiotics

• Material transfer agreement with Human Genome Sciences, Inc.

• Grant submission with NIH and DOD

• IACUC and IRB submissions

• Managed Laboratory budget

• Assisted with managing University budgets

• Member of University Animal Space Committee to maximize space use

THE WISTAR INSTITUTE (1995-1999)

Staff Scientist Instructor

I managed scientific projects for studying the function of novel human

transcription factors

• Expressed Sequence Tag data mining

• Eukaryotic in vitro transcription, biochemical fractionation

• Yeast molecular biology and gene expression

• Biochemical purification of transcription complexes

• Academic liaison with Human Genome Sciences, Inc.

• Trained laboratory staff

• Managed laboratory technicians

• Grant writing and fellowship awards

• Presented at international meeting

• Salary fully funded by my external grant awards

THE ROCHE INSTITUTE OF MOLECULAR BIOLOGY (1993-1995)

Hoffmann-LaRoche, Inc.

Postdoctoral Fellow

I was the first author of the first paper to clone a transcription factor using

genomic data mining (3rd published EST cloning paper). Assisted in starting a

laboratory in transcriptional regulation.

• Cloned Human General Transcription Factor IIA, small subunit

• Mutagenesis of Transcription Factor IIA for structure/function analysis

• Eukaryotic in vitro transcription

4

JOSEF S. OZER, Ph.D.

10 Jennycliffe Ln., Clarkson Valley, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

• Biochemical isolation of recombinant transcription factors

• Analysis of TFIIA crystal structure

• Presented at invited seminars

LEDERLE LABORATORIES (1992-1993)

American Cyanamid Company (Wyeth)

Cardiovascular Molecular Biology Department

Postdoctoral Fellow

I isolated a novel transcriptional enhancer element that was being assessed as a

target for an atherosclerotic disease therapeutic intervantion.

• Defined the apoAI downstream enhancer element.

• Managed manuscript for peer-review publication.

• Assisted Cardiovascular Molecular Biology Department start-up.

• Report writing.

• Academic liaison with Children’s Hospital, Harvard University.

VANDERBILT UNIVERSITY, Nashville, TN (1987-1992)

Ph.D. candidate

I isolated two mammalian transcription factors using expression cloning

technology. Supervised and trained student staff.

• Developed expression cloning technology at Vanderbilt

• Evolutionary genomic analysis

• CpG dinucleotide genomic analysis

• Managed DNA sequencing laboratory

• Prepared manuscripts for publication

V. PUBLICATIONS

17) …J. Ozer… (2009) J Chromatogr B Analyt Technol Biomed Life Sci. 877:

2052-2060.

16) J. Ozer et al., (2008). Toxicology, 245: 194-205, Co-1st author

15) ...J. Ozer (2006). Stem Cells Dev.15: 175-190. Corresponding author

14) …J. Ozer (2003). Gene, 323: 31-42. Corresponding author

13) J. Ozer et al. (2000). J. Biol. Chem. 275: 122-128. 1st author

12) J. Ozer et al.(1999). Mol. Cell. Biol. 19: 7610-7620. Co-1st author

11) J. Ozer et al. (1998). J. Biol. Chem. 273: 142**-*****. 1st author

10) J. Ozer et al., (1998). Mol. Cell. Biol. 18: 2559-2570. 1st author

9) …J. Ozer…(1997). Virology 239: 340-351.

8) …J. Ozer…(1997). Mol. Cell. Biol. 17: 6624-6632.

7) J. Ozer et al., (1996). J. Biol. Chem. 271: 111**-*****. 1st author

6) …J. Ozer…(1995). J. Clin. Invest. 96: 528-538.

5

JOSEF S. OZER, Ph.D.

10 Jennycliffe Ln., Clarkson Valley, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

5) J. Ozer et al., (1994). Genes & Dev. 8: 2324-2335. Co-1st author

4) …J. Ozer… (1994). Blood 83: 2153-2162.

3) J. Ozer, et al., (1993). Gene 133: 187-195. 1st author

2) J. Ozer, et al., (1993). Gene 124: 223-230. 1st author

1) J. Ozer, et al., (1990). J. Biol. Chem. 265: 221**-*****. 1st author

VI. INVITED PRESENTATIONS

Ozer et al., (2008) 13th ISACP_10th ESVCP_8th AECCP_7th APP Congress (global clinical

chemistry congress), two meeting presentations

Ozer et al., Regulatory Qualification of Aminotransferases

and Biomarkers of Liver Injury, 4th Annual Biomarkers Congress, 26-27 February

2009, The Midland Hotel, Manchester, UK

Ozer et al., Assay Platform Development to Characterize Biomarkers of Therapeutic

Efficacy, ETP Symposium, May 2009, Vancouver, Canada

Ozer et al., Prodromal Biomarkers for Lead Optimization of Renal Injury, AACC

Annual Meeting, Hyatt Regency Hotel, Chicago, July, 2009

VII. SUBMITTED PAPERS

1) Josef S. Ozer, William J. Reagan, Shelli Schomaker, Joe Palandra, Mike Baratta, and,Shashi

Ramaiah, Translational Biomarkers of Acute Drug Induced Liver Injury: The Current State, Gaps

and Future Opportunities, Submitted to Biomarkers, Bonventure and Vaida eds., invited review

2) Josef S. Ozer*, Raj Chetty, Gerry Kenna, Joe Palandra, Anne Lanevschi, Bernard E.

Souberbielle, and Shashi Ramaiah, Regulatory qualification of alanine aminotransferase will

increase its utility as a reference standard biomarker of drug induced liver injury, Submitted to

Regulatory Toxicology and Pharmacology. *correspondence.

3) Josef S. Ozer*, Beyond regulatory qualification: new chemical entity lead optimization and

translational pharmacodynamics using renal biomarkers, Submitted to Drug Discovery Today,

*correspondence, invited review.

4) Josef S. Ozer*and Aaron Teitelbaum, Novel prodromal biomarkers that are symptomatic of

injury require histopathologic or clinical chemistry anchors to characterize activity. Submitted to

Journal of Pharmacological and Toxicological Methods, *correspondence, invited review.

5) … Josef S. Ozer…, Polycomblike PHF2: A GABA Regulated Initiator Factor for the GABA-A

Receptor Subunit Gene, Submitted to

Journal of Biological Chemistry

6) Yan Yu, Hong Jin, Daniel Holder, Josef S. Ozer, et al., Biomarkers of Kidney Tubule Injury:

Urinary Trefoil Factor 3 and Albumin, Submitted to Nature Biotechnology.

7) Josef S. Ozer, Frank Dieterle, Sean Troth, Elias Perentes, et al., VXDS Gaps Analysis: Urinary

Biomarkers That Monitor Reversible Tubular Injury and Serum Cystatin C Is a Novel Renal

Functional Biomarker in Rat, Submitted to Nature Biotechnology, Co-first*: Josef S. Ozer, Frank

Dieterle

6

JOSEF S. OZER, Ph.D.

10 Jennycliffe Ln., Clarkson Valley, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

8) Vishal S. Vaidya*, Josef S. Ozer*, Frank, Dieterle*, Fitz B. Collings, et al., Kidney Injury

Molecule-1 Outperforms Traditional Biomarkers of Kidney Injury in Multisite Preclinical

Biomarker Qualification Studies, Submitted to Nature Biotechnology, Co-corresponding* Vishal

S. Vaidya*, Josef S. Ozer*, Frank, Dieterle*

VIII. PAPERS IN PREPARATION

1) Rajkumar Chetty*, Anne Lanevschi, Ina Schuppe Koistinen, Josef S. Ozer, Duncan McHale,

John Pears, Jacky Vonderscher, Frank Sistare, Frank Dieterle, A guidance to preclinical and

clinical safety biomarker qualification incorporating Bradford Hill’s principles of causality

association, Journal TBD, *correspondence.

2) Josef S. Ozer*, Raj Chetty, Gerry Kenna, Nandan Koppiker, Pandher, Karamjeet, Dingzhou,

Li, Joe Palandra, Anne Lanevschi, Bernard E. Souberbielle, and Shashi Ramaiah, Gaps in the

current translational biomarker strategy for drug induced liver injury, Biomarkers in Medicine,

*correspondence

3) Josef S. Ozer*, Joe Palandra, et al., Scope of serum biomarkers for therapeutic efficacy of

inflammatory disorders of the gastrointestinal system, Biomarkers in Medicine,

*correspondence

4) Joe Palandra, Connie Wagner, Etran Zhang, Steve Wene, Ryan Morrison, Dean Messing,

Timothy LaBranch, Shashi Ramaiah, Leo Kirkovsky, Josef S. Ozer*, Novel prodromal

biomarkers that are predictive of histopathologic injury with Cyclosporin treatment, Kidney

International, *correspondence

5) Etran Zhang, Gary Anderson, Steve Wene, Phil Morrison, Paul Brown, Leo Kirkovsky, Greg

Weber, Josef S. Ozer*, A novel LC/MS/MS approach to determine the pharmacokinetics of

intact Stichodactyla toxin in vivo, Journal TBD, *correspondence

6) All active and contributing (Josef S. Ozer) PSTC NWG members (C-Path members, FDA and

EMEA PSTC representatives, and PSTC NWG industry), The nephrotoxicity work group of

the Predictive Safety Consortium – Establishing best practices for biomarker qualification,

Will be submitted to Nature Biotechnology

7) Prof. Bonventre, (Josef S. Ozer), contributors to the manuscript from PSTC NWG and

translational group, ClinXus, Melanie Blank, Points to Consider for Translation of Kidney

Safety Biomarkers to Human, Will be submitted to Nature Biotechnology

8) Authors from FDA BQRT, EMEA PGWG, Marisa Papaluca-Amati, all active and contributing

(5th author of 65: Josef S. Ozer) PSTC NWG members and Kevin Carl / David Laurie, The

VXDS and FDA/EMEA Decisions: Conclusions and Implications of First VXDS Submission,

Will be submitted to Nature Biotechnology

FELLOWSHIPS & AWARDS

7

JOSEF S. OZER, Ph.D.

10 Jennycliffe Ln., Clarkson Valley, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

MRL Scientific Merit Award I 2008

MRL Scientific Merit Award II 2008

NARSAD Award 2003-2005

American Cancer Society IRG Award 2001-2002

NIH (NCI)- Howard Temin K01 Award 1998-2006

Leukemia Society of America Special Fellow 1998

NIH - NRSA Postdoctoral Fellowship 1997-1998

VFW Cancer Fellowship 1996-1997

VIII. TECHNICAL EXPERTISE

Toxicology

OPX2 software: Designed and managed over 25 preclinical studies to generate reagents

for biomarker development. Experienced with rhesus, rat, mouse, and dog study design

and execution. Acted as Compound Manager Duties for over 15 exploratory

compounds. Acted as Study Director role for CRO studies. Animal and tissue

handling: Assisted with animal necropsies, tissue isolation and handling, label and

sample management for studies with complex collaborations across MRL. Coordinated

with SA Pathology to develop a kidney and liver lexicon in conjunction with CPATH

(below).

Critical PATH (PSTC)

Excel, Spotfire, Resolver software: Lead Merck investigator for the FDA and EMEA

submission of kidney toxicology biomarkers for qualification. This was the first

application for biomarker qualification to the regulatory agencies. I presented the

application to the EMEA, London in a live conference with the FDA. Co-coordinating

the evaluation of a Liver enzyme 4-plex Biomarker set across over 12 Merck

exploratory studies. Acted to assemble complex liver data management for presentation

and publication submission in collaboration with GSK and Pfizer. Submitted kidney

biomarker data sets for CPATH. Presented individual animal kidney biomarker data to

CPATH (Spotfire).

Recombinant Protein Purification

Expertise in mammalian protein purification using a variety of recombinant expression

systems: insect, insect (MIMIC), yeast, E. coli, stable mammalian cells and tags: 6(His),

GST, CA-5 or native untagged protein. Extensive experience with native and denatured

purification strategies for Biomarker ELISA standards. Extensive experience with PCR-

based cloning to generate expression constructs. Collaborated with MRL Structural

Biology as the beta-test for Biomarker production in PICALO and insect culture.

Antibody Development for Biomarkers

Managed CRO and Merck monoclonal and polyclonal antibody development for over 20

analytes in mouse, rabbit, and guinea pig. Affinity purification and functional analysis

in ELISA and Western assays.

Cell Biology

Culture and maintenance of mammalian cell lines, rat primary embryo fibroblasts, rat

primary cortical cells, and human NT2 cell lines (stem and neuronal cultures). Culture

and maintenance of yeast strains for recombinant protein development. Designed and

8

JOSEF S. OZER, Ph.D.

10 Jennycliffe Ln., Clarkson Valley, MO, 63005

636-***-**** (h), 276-***-**** (c) abnj57@r.postjobfree.com

developed eukaryotic cell culture facilities (BUSM). Transfection and gene expression

analysis in culture (luciferase). CHIP gene expression analysis in vivo.

Molecular Biology

Gene discovery in silico, EST cloning, conventional sub-cloning, PCR sub-cloning,

genomic cloning, expression cloning with ds DNA, expression cloning with antibodies,

in vitro transcription (protein production), in vitro transcription (pol II) with purified

components (regulation), native electromobility shift assays-DNA and protein, SDS-

PAGE, protein extract production from mammalian and human tissues.

LC/MS/MS

Currently manage three scientists in an analytical lab with state of the art technologies

for validation and biomarker discovery. Oversight of regulatory biomarker submissions

and internal reporting of methods and data sets. GLP ready methods are outsourced to

Pfizer Groton or CROs and laboratory maintains oversight of project deliverables.

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