Medical Writer-Scientist

Christine Thiffault, PhD, PMP

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

Flemington, NJ 08822

Residence: 908-***-****

Cell: 847-***-****

**********@*******.***

http://www.linkedin.com/in/christinethiffault

SUMMARY

Research scientist with comprehensive understanding of disease processes and demonstrated proficiency in applying in vivo and in vitro models to advance drug discovery for neurodegenerative diseases. Expertise in preclinical and clinical development of biologics and small molecules and in the development of cell-based assays to support discovery projects thereby accelerating the drug development processes. Writing experience encompasses IND documentations, pre-clinical technical protocols and reports, safety toxicology reports, scientific journal publications, SOPs, and NIH grants.

SCIENTIFIC EXPERTISE

• CRA/CRC Pharmaceutical Clinical Research Program: GMP, FDA Regulation,

Pharmaceutical Drug Development, 21 CFR, GCP, ICH guidelines, OSHA, HIPPA, SOP /

Protocol / Informed Consent /CRF /IB / IND / ISO and Document Control.

• Writing experience encompasses IND documentations, preclinical technical protocols and reports, safety toxicology protocol and reports, scientific journal publications, SOPs, and NIH grants.

• In vitro and in vivo models of neurodegenerative diseases with a focus on Parkinson’s disease, Alzheimer’s disease and stroke

• Gene therapy approaches for the treatment of Parkinson’s disease

• Growth factor delivery for the treatment of Parkinson’s disease

• Cell-based therapy for stroke

• Mitochondrial dysfunction in aging and degenerative diseases

• Free radical involvement and detoxifying pathways in aging and neurodegenerative diseases

• Investigation of pharmacological targets which prevent or delay neuronal cell death

• Nitric oxide and its role as a mitochondrial toxicant and in stroke

• Toxicological evaluation of experimental compounds in the pre-clinical species (rodents)

• Investigation of the mechanism underlying small molecule-induced toxicity to support discovery and development projects

• Development of predictive cell-based assays to evaluate experimental compounds for toxic liabilities

PROFESSIONAL EXPERIENCE

Johnson & Johnson Family of Companies 2007-2011

Johnson & Johnson is divided into three segments: Consumer, Pharmaceutical and Medical Devices and Diagnostics with more than 250 operating companies located in 60 countries providing broad-based health care products with earnings of $61.6 billion annually.

Senior Scientist 2008-2011

Advanced Technologies and Regenerative Medicine

A Johnson & Johnson Medical Devices and Diagnostics Franchise

Supported cell therapy for the stroke program. Performed preclinical study in rodent model of temporal middle cerebral artery occlusion (tMCAo), process development for manufacturing and assay validation (Clinical PK). Supported cell biodistribution study to support GLP toxicology and non-GLP efficacy studies.

• Provided preclinical reports and authored IND submission enabling reports.

• Developed a unique technique to label cells with radiotracer and tracked labeled cells in a rodent model of tMCAo using SPECT.

• Validated a PCR method and generated SOPs to support clinical PK study by leading the bioanalytical team.

• Improved cell labeling procedure amenable to manufacturing and created technical transfer document. Supported QA audit for potential manufacturing site.

• MRI was used for the first time to correlate pharmacodynamic events including changes in the vasculature and white matter reorganization with behavioral and histological outcomes in rat brain following tMCAo.

• Determined the mechanism whereby cell infusion led to behavioral and histological (synaptogenesis and angiogenesis) improvements in rats following tMCAo. Proteomics and gene expression analysis revealed that cells modulated the immune response.

Senior Scientist 2007-2008

Johnson & Johnson Regenerative Therapeutics, LLC

A Johnson & Johnson Medical Devices and Diagnostics Franchise

Supported growth factor delivery for the Parkinson's disease program. Performed safety and efficacy evaluations of formulation and growth factor for the treatment of Parkinson’s disease using 6-OHDA rat models.

• Performed toxicological studies in rodents and delivered on project timeline by submitting reports.

• Implemented and directed off-site collaborative efforts to support an IND submission.

Abbott Laboratories 2003-2007

Abbott Park, IL, USA

A global, broad-based health care company providing pharmaceutical and health care products with earnings of $20 billion annually.

Scientist

Department of Cellular, Molecular and Exploratory Toxicology

Determined the optimal in vitro or ex vivo strategy to evaluate compounds for toxic liabilities by collaborating with project teams in various therapeutic areas. Designed experiments, prepared protocols and reports to support non-GLP toxicology studies and provided interpretation of clinical pathology data. Presented findings in-house as well as at scientific meetings. Supervised one M.S. research scientist.

• Initiated Phase II clinical trials and received the President’s Award for supporting IND filing by providing high quality mechanistic toxicological data and reports on an experimental compound for the treatment of schizophrenia.

• Implemented and validated novel predictive assays for experimental compounds and provided support for proceeding to the development phase.

• Increased the throughput by 10 fold and improved the performance of an existing assay to ensure the timely delivery of data.

• Met project milestones by providing data and reports on Abbott’s experimental compounds and drug development candidates.

Biomedica Inc. 2002-2003

San Diego, CA, USA

A biotechnology company specializing in the development of novel gene-based therapeutics for the treatment of Parkinson’s disease.

Scientist

Performed safety and efficacy evaluations of lentiviral-based gene transfer therapy for the treatment of Parkinson’s disease using MPTP mouse and 6-OHDA rat models. Supervised one B.S. research scientist.

• Designed neurotoxicological studies in rodents under an aggressive timeline and implemented and directed off-site collaborative efforts to provide data to support an IND submission.

• Facilitated data analysis by generating a protocol for the automation and the capture of high quality images using MetaMorph software.

• Supported, with limited resources, pre-clinical development by writing and implementing SOPs, analyzing data and preparing reports for an IND submission.

Geron Corporation 2002

Menlo Park, CA, USA

Geron is a biopharmaceutical company and a world leader in the development of human embryonic stem cell-based therapeutics.

Scientist

Department of Assay Development and Screening

Supported the assay development group through innovation and implementation of cell-based assays

• Developed novel assays for markers to better characterize human embryonic stem cells and neuronal progenitors, and validated these assays for use in product release.

EDUCATION

PhD (Pharmacology) 1997

McGill University

Montreal, Quebec, Canada

B. Sc. Agriculture (Chemistry Major with distinction) 1986

Macdonald Campus of McGill University

Ste-Anne-de-Bellevue, Quebec, Canada

GRADUATE AND POST DOCTORAL TRAINING

Post Doctoral Research Fellow 1999-2002

Center for the Study of Neurodegenerative Diseases

Department of Neurology

University of Virginia

Charlottesville, VA, USA

Supervisor: James P. Bennett Jr., M.D., Ph.D.

Demonstrated the biological relevance of cyclical depolarization of mitochondrial membrane potential and how this phenomenon is altered in Alzheimer’s disease (cybrids cell model). Reported findings to the scientific communities and participated in fund raising. Nominated as an outstanding researcher by the Vice President of Research and Public Service at University of Virginia and received funding from the Commonwealth of Virginia.

Post-doctoral Research Fellow 1997-1999

The Parkinson's Institute

Sunnyvale, CA, USA

Supervisors: Donato A. DiMonte, M.D. and J. William Langston, M.D.

Investigated the role of environmental exposure to toxicants in Parkinson’s disease. Designed a biochemical test for the early detection of Parkinson’s disease in order to provide a therapeutic window of opportunity for the administration of neuroprotective agents.

Graduate Student 1991-1997

Douglas Hospital Research Centre

McGill University

Montreal, Quebec, Canada

Supervisor: Remi Quirion, Ph.D. and Judes Poirier, Ph.D.

Investigated the pharmacological implication of oxidative stress in the brain of Parkinson’s disease patients and in a mouse model (mice administered MPTP) and whether changes in the activity of antioxidant enzymes could be attributed to mitochondrial dysfunction. Received a studentship and two awards for the best oral presentation. Supervised one research assistant.

PROFESSIONAL DEVELOPMENT

2008 The Neurostereology Workshop. Marine Biological Laboratory, Woods Hole, MA

2008 Quality System Regulation (QSR) course for the Medical Device Industry, Norwood, MA

2007 Project Management Professional Certification, Gurnee, IL

2007 Preclinical Safety Workshop: Biotechnology-derived Proteins, Charles Rivers Preclinical Facility, Shrewsbury, MA

2007 Inhibitory RNAs in Neuroscience, Society For Neuroscience, San Diego, CA

2006 Introductory Statistics in JMP, a Statistical Software. Abbott Laboratories, Abbott Park, IL

2005 Data Manipulation in JMP, a Statistical Software. Abbott Laboratories, Abbott Park, IL

2004 Short Course in Pharmacokinetics. Abbott Laboratories, Abbott Park, IL

2004 Genetic Toxicology Principles, Practices and Emerging Challenges. American College of Toxicology, Palm Springs, CA

FELLOWSHIPS AND AWARDS

2010 Recipient of the Silver Encore Award. Team Leader Innovation and Enthusiasm. Cultural Tenet Team dedicated to fostering a culture of enthusiasm and innovation. Focusing on rewards and recognition. Advanced Technology & Regenerative Medicine, LLC, Somerville, NJ

2010 Recipient of the Silver Encore Award. Team Leader impact in the CNTO 0007 biodistribution study to support IND submission. Advanced Technology & Regenerative Medicine, LLC, Somerville, NJ

2009 Recipient of the Silver Encore Award. Key impact in the CNTO 0007 biodistribution study to support IND submission. Advanced Technology & Regenerative Medicine, LLC, Somerville NJ

2009 Recipient of the Gold Encore Award. Organization of 2009 ATRM Research Day. Advanced Technology & Regenerative Medicine, LLC, Somerville, NJ

2007 Recipient of the President’s Award granted by the Vice President of Global Pharmaceutical Research and Development at Abbott Laboratories, Abbott Park, IL

2001 Nominated as an Outstanding Researcher by the vice president of Research and Public Service at the University of Virginia, Charlottesville, VA

1998 Fellowship Recipient of "Fonds de la Recherche en Sante du Quebec” (FRSQ), Quebec, Canada

1997 Fellowship Recipient of "Fonds de la Recherche en Sante du Quebec” (FRSQ), Quebec, Canada

1992 Studentship Recipient of "Fonds pour la Formation de Chercheurs et l'Aide a la Recherche" (FCAR), Quebec, Canada

1992 Recipient of the Best Oral Presentation, Graduate Student Research Day, Dept. Psychiatry, McGill University, Montreal, Quebec, Canada

1991 Recipient of the Best Oral Presentation, Graduate Student Research Day, Dept. Psychiatry, McGill University, Montreal, Quebec, Canada

RESEARCH GRANTS RECEIVED

2000 Commonwealth of Virginia. Alzheimer’s and Related Diseases Research Award Fund, Richmond, VA, USA

INVITED SPEAKER AND INTERVIEWS

2006 Phospholipidosis. CBI 6th Forum on Predictive ADME/Tox, Washington DC, USA

2006 Microscopic techniques to evaluate phospholipidosis in vitro: Application to drug discovery. Microscopy and Microanalysis’ 64th annual meeting, Chicago, IL, USA

2005 Cell-based predictive toxicological assays to support discovery projects. IBC’s 6th international conference on evaluating preclinical drug safety, Boston, MA, USA

2001 An assist in the fight against Alzheimer’s disease. Explorations: Postdoctoral highlights from the University of Virginia. Interview conducted by the Office of the Vice President of Research and Public Service, Charlottesville, VA, USA

1993 Parkinson's Disease, Cardinal Carter High School, Aurora, Ontario, Canada

PUBLICATIONS

1) Ali S. Arbab, Christine Thiffault, Bradford Navia, Stephen J. Victor, Klaudyne Hong, Li Zhang, Quan Jiang, Nadimpalli Ravi S Varma, ASM Iskander, Michael Chopp. 2011. Tracking of human umbilical tissue-derived cells (hUTC) in a rat model of cerebral ischemia following intravenous administration using SPECT Imaging. J. Nucl. Med. Submitted.

2) Quan Jiang, Christine Thiffault, Guang Liang Ding, Li Zhang, Lian Li, Ali S. Arbab, Mei Lu, Brad Navia, Stephen J. Victor, Klaudyne Hong, Siamak Pourabdollah Nejad D., Qingjiang Li, Shiyang Wang, Yi Li, and Michael Chopp. 2011. MRI Detects Brain Reorganization after Human Umbilical Tissue Derived Cells (hUTC) Treatment of Stroke in Rat. Stroke. Sumitted

3) Zhao C., Sun M., Bennani Y.L., Gopalakrishnan S.M., Witte D.G., Miller T.R., Krueger K.M., Browman K.E., Thiffault C., Wetter J., Marsh K.C., Hancock A.A., Esbenshade T.A., Cowart M.D. 2008. The alkaloid conessine and analogues as potent histamine H3 receptor antagonists. J. Med. Chem. 51: 5423-5430.

4) Altenbach R.J., Liu H., Banfor P.N., Browman K.E., Fox G.B., Fryer R.M., Komater V.A., Krueger K.M., Marsh K., Miller T.R., Pan J.B., Pan L., Sun M., Thiffault C., Wetter J., Zhao C., Zhou D., Esbenshade T.A., Hancock A.A., Cowart M.D. 2007 Synthesis, potency, and in vivo profiles of quinoline containing histamine H3 receptor inverse agonists. J. Med. Chem. 50: 5439-5448.

5) Schurdak M.E., Abel S.J., Vernetti, L.A. and Thiffault C. 2007. Adaptation of an in vitro phospholipidosis assay to an automated image analysis system. Tox. Mech. Meth. 17: 77-86.

6) Sun M., Zhao C., Gfesser G.A., Thiffault C., Miller T.R., Marsh K., Wetter J., Curtis M., Faghih R., Esbenshade T.A., Hancock A.A. and Cowart M. 2005. Synthesis and SAR of 5-amino- and 5-(aminomethyl)benzofuran histamine H3 receptor antagonists with improved potency. J. Med. Chem. 48: 6482-6490.

7) Thiffault C. and Bennett J.P. Jr. 2005. Cyclical mitochondrial membrane potential fluctuations linked to electron transport, F0F1 ATP-synthase and mitochondrial Na+/Ca+2 exchange are reduced in Alzheimer’s disease cybrids. Mitochondrion. 5: 109-119.

8) Kindler D.D., Thiffault C., Trimmer P.A., Dennis J., Jenkins R.W., Solenski N.J., Alietta M. and Bennett J.P. Jr. 2003. Neurotoxic nitric oxide rapidly depolarizes, permeabilizes and paralyzes mitochondria before activating cell death pathways. Mol.Cell Neurosci. 23: 559-573.

9) Thiffault C., Langston J.W. and Di Monte D.A. 2003. Cerebrospinal fluid 3,4-dihydroxyphenylacetic acid levels after tolcapone administration as an indicator of nigrostriatal degeneration. Exp. Neurol. 183:173-9.

10) Manning-Bog A., Thiruchelvam M., McCormack A., Thiffault C., Langston J.W., Cory-Slechta D.A. and Di Monte D.A. 2002. The herbicide paraquat causes nigrostriatal degeneration and upregulation of alpha-synuclein in a mouse model of Parkinson’s disease. Neurobiol. Dis. 10: 119-127.

11) Thiffault C., Langston J.W. and Di Monte D.A. 2001. Acute exposure to organochlorine pesticides does not affect striatal dopamine in mice. Neurotox. Res. 3: 537-543.

12) Thiffault C., Langston J.W. and Di Monte D.A. 2000. Increased striatal dopamine turnover following acute administration of rotenone to mice. Brain Res. 885: 283-288.

13) Thiffault C., Quirion R. and Poirier J. 1998. Effect of the MAO-B inhibitor, MDL72974, on superoxide dismutase activity and lipid peroxidation levels in mouse brain. Synapse 8:208-211.

14) Thiffault C., Quirion R. and Poirier J. 1997. The effect of L-deprenyl, D-deprenyl and MDL72974 on mitochondrial respiration: A possible mechanism leading to an adaptive increase in superoxide dismutase activity. Mol. Brain Res. 49:127-136.

15) Thiffault C., Theroux-Lamarre L., Quirion R. and Poirier J. 1997. L-Deprenyl and MDL72974 do not improve the recovery of dopaminergic cells following systemic administration of MPTP in mouse. Brain Res. Mol. Brain Res. 44:238-244.

16) Thiffault C., Aumont N., Quirion R. and Poirier J. 1995. The effect of MPTP and L-deprenyl on antioxidant enzymes and lipid peroxidation levels in mouse brain. J. Neurochem. 5:2725-2733.

17) Poirier J., Dea D., Baccichet A. and Thiffault C. 1994. Superoxide dismutase expression in Parkinson's disease. Ann. N.Y. Acad. Sci. 738:116-120.

18) Poirier J. and Thiffault C. 1993. Are free radicals involved in the pathogenesis of idiopathic Parkinson's disease? Eur. Neurol. 33 (Suppl. 1):38-43.

19) Aboul-Enein H.Y. and Thiffault C. 1993. High performance liquid chromatographic applications to thyroidology. LabMedica Interna. 10:9-11.

20) Aboul-Enein H.Y. and Thiffault C. 1991. Rapid liquid chromatographic analysis of flurazepam in pharmaceutical preparation. Toxicol. Environ. Chem. 34:73-76.

21) Aboul-Enein H.Y. and Thiffault C. 1991. Current screening techniques for Down Syndrome. LabMedica Interna. 8:29-31.

22) Aboul-Enein H.Y. and Thiffault C. 1991. Determination of ramipril and its precursors by reverse phase high performance liquid chromatography. Anal. Let. 24:2217-2224.

23) Aboul-Enein H.Y. and Thiffault C. 1991. Identification of some primidone urinary metabolites in dyslexic patient by thin layer chromatography. Anal. Let. 24:209-216.

24) Alli I., Dilollo A., Kermasha S., Thiffault C. and Dumais F. 1990. Diastatic activity of forage additive products containing malt flour. J. Assoc. Off. Anal. Chem. 73:213-215.

25) Alli I., Thiffault C., and Baker B.E. 1985. A device for monitoring silage effluent produced in laboratory silos. J. Dairy Sci. 68:3355-3359.

CONFERENCE PRESENTATIONS

1) Thiffault C., Quirion R. and Poirier J. 1994. Antioxidant enzymes in an animal model of Parkinson's disease. Oral presentation for the 24th annual meeting for the Society of Neuroscience. Miami Beach, FL, USA

2) Thiffault C. and Alli I. 1987. L'activite diastasique de la farine de malt. Proposition de communication du 55e congres de l'ACFAS. Ottawa, Ontario, Canada

3) Thiffault C. and Alli I. 1986. La mesure de l'effluent produit par l'ensilage. Proposition de communication du 54e congres de l'ACFAS. Montreal, Quebec, Canada

ABSTRACTS

1) Thiffault C., Gagne G.D., Schurdak M.E., Blomme E.A.G., and Fagerland J.A. 2006. Microscopic techniques to evaluate phospholipidosis in vitro: Applications in drug discovery. Chicalgo, IL, USA. Microsc. Microanal. 12 (Suppl 2).

2) Thiffault C. 2004. Statins reduce mitochondrial membrane potential in C2C12 cells: A potential mechanism for the statin-induced myopathy. Abstract P21. 25th annual meeting of the American College of Toxicology. Palm Springs, CA, USA.

3) Thiffault C. and Bennett J.P. 2001. Quantitative analysis and frequency power spectrum of cyclical depolarization of the mitochondrial membrane potential: Abnormalities in Alzheimer’s disease. Society for Neuroscience 31st annual meeting. San Diego, CA, USA. Abstract 651.3.

4) Thiffault C. and Bennett J.P. 2000. Mitochondria exhibit a cyclical depolarization: Implications in Alzheimer’s disease. Society for Neuroscience 30th annual meeting. New Orleans, LA, USA.

5) Thiffault C., Langston J.W. and Di Monte D.A. 1999. CSF DOPAC levels as an indicator of striatum dopamine metabolism after tolcapone administration in monkeys. Society for Neuroscience 29th annual meeting. Miami Beach, FL, USA.

6) Thiffault C., Langston J.W. and Di Monte D.A. 1998. Evaluation of pesticides as nigrostriatal dopaminergic neurotoxicants in the mouse. Society for Neuroscience 28th annual meeting. Los Angeles, CA, USA.

7) Thiffault C., Langston J.W. and Di Monte D.A. 1997. Effects of pesticides on the nigrostriatal system in mice. Parkinson Study Group, 11th annual meeting. San Diego, CA, USA. Mov. Dis. 12: 842.

8) Thiffault C., Aumont N., Quirion R. and Poirier J. 1993. Antioxidant enzymes in an animal model of Parkinson's disease. Society for Neuroscience, 23rd annual meeting. Washington, DC, USA.

9) Baccichet A., Thiffault C., Aumont N., Dea D. and Poirier J. 1992. Superoxide dismutase expression in the nigrostriatal pathway of patients with Parkinson's disease. Society for Neuroscience, 22nd annual meeting. Anaheim, CA, USA.

10) Thiffault C., Quirion R., Aumont N. and Poirier J. 1992. The effect of L-deprenyl and MPTP on superoxide dismutase activity in the striatum of C57BL/6 mice. Society for Neuroscience, 22nd annual meeting. Anaheim, CA, USA.

11) Aboul-Enein H.Y. and Thiffault C. 1991. Identification of some primidone urinary metabolites in dyslexic patients by thin layer chromatography. Pharmacy World Congress' 91. Washington, DC, USA.

TECHNICAL SKILLS

Analytical Techniques: HPLC, LC-MS, column chromatography

High Throughput Screening: Cell-based assay, high content analysis (HCA), FACS, guava, FLIPR, plate reader

Protein Biochemistry: ELISA, affinity chromatography, Western blot, electrophoresis, enzymatic assays, RIA, ion channel, affinity purification, subcellular fractionation, receptor binding

Molecular Biology: PCR, RNA and DNA isolations, Northern blot

Chemistry: Protein or cellular radiotracer labeling

Microscopy: HCA, fluorescence, automated microscopy

Software: Word, PowerPoint, Excel, Sigma, Photoshop, Statistical Software (JMP, Systat and GraphPad Prism), Metamorph, Image J, MetaCore, PubMed

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