***Curriculum Vitae***

**Grace T. Bartoo, Ph.D., R.A.C.**

Address: 131 Glenn Way #7, San Carlos, CA 94070

Work Phone: (650) 654-4484 x30

Email: \-\--

**Education**

Regulatory Affairs Certification

Ph.D., Bioengineering, University of Washington, Seattle, WA

Dissertation: Quantitative Neuropathological Measures in Alzheimer\'s
Disease

M.S., Electrical Engineering, University of Washington, Seattle, WA

Thesis: Automated Detection of Senile Plaques in Alzheimer\'s Disease
Using Image Analysis

B.S. with Honors, Bioengineering, University of California, Berkeley, CA

**Professional Experience**

**1998 -- present Vice President, Clinical and Regulatory Affairs**

**Instrumentation for Science & Medicine, Inc., San Carlos, CA**

I am a senior partner in this medical device consulting firm. For our
clients, I have provided services in the areas of regulatory strategy,
510(k) and PMA submissions, project management, statistical, data
analysis, quality (verification and validation), study design, and study
monitoring. Internally I am responsible for setting up and implementing
the company's quality system, and also all financial operations.

**1993 - 1998 Clinical Research Consultant**

**Bartoo Biomedical**

Provided over 2,000 hours of service, primarily with a client on a class
III medical device clinical trial. I worked with a team of statisticians
and clinicians to design the studies. I also wrote protocols and study
manuals, designed case report forms, prepared submissions and made
presentations to the Food and Drug Administration. I managed the
preclinical trials which consisted of approximately 40,000 cases from
three trial sites and was completed in approximately six months.

**1995 - 1996 Program Manager, Commercialization**

**1988 - 1992 Technical Founder, Director of Clinical Affairs**

**NeoPath, Inc., Bellevue, WA**

As a founder and the first employee of this venture capital financed
company, I played a key role in this growing company, which has
successfully raised over \$70 million and is publicly traded. The
company developed a cervical smear analyzer, which incorporates
innovative mechanical, optical, electronic and pattern recognition
technologies. As the company grew from the start up stages, I became the
Director of Clinical Affairs, where I was responsible for basic clinical
research and clinical trials.

I left the company to complete my Ph.D. and was rehired after graduation
as Program Manager. I was responsible for the programs/projects required
to commercialize the cervical smear analyzer in the United States,
Australia, and Europe. Assembling teams from multiple departments, my
responsibilities included setting up the infrastructure required for
commercialization such as a customer and technical support system;
introducing the first devices into commercial sites and coordinating
evaluation studies; conducting and presenting analyses of strategic
corporate issues for executive management; setting the corporate goals
for the employee bonus program; and evaluating the company's progress
towards meeting those goals.

> **Research Assistant**
>
> **University of Washington Alzheimer's Disease Research Center,
> Seattle, WA**

During my graduate studies, I developed a semi-automated image analysis
system that quantifies the amount of protein deposits on
immunohistochemical sections of the human brain. Development of this
system included the development of a microcomputer-controlled
three-dimensional stage, generation of the control software, and design
and implementation of image analysis software. I used this system in a
variety of biological experiments, including research in Alzheimer's
disease and mathematical modeling of brain tumor growth. During my
research studies, I was based in the Neuropathology laboratory and also
conducted research on neoplastic diseases, especially gliomas.

> **Intern**
>
> **IBM Palo Alto Scientific Center, Palo Alto, CA**

I designed and implemented a novel software algorithm for semi-automatic
spatial registration of MRI, CT and SPECT brain images on the IBM 5090.
I also conducted a study comparing this algorithm against manual image
registration.

**1982 - 1986 Research Engineer**

**MedaSonics, Inc., Milpitas, CA**

I was the project engineer for the compa­ny\'s first software product, a
database management system based upon the IBM PC. The product included
menu driven graphical user interfaces, custom reports, database query,
and advisory diagnosis capabilities. As part of this project, I worked
closely with multiple departments and accomplished the following:
developed the product concept; managed a team of engineers and
technicians; programmed and validated software; wrote and pro­duced user
manuals; wrote standard operating procedures (SOPs); supported formal
re­lease of the product; conducted training of national sales and
clinical staff; and supported clinical testing of the product.

**Teaching Experience**

University of Washington, Seattle, WA

1994 - 1995 Supervisor \-- Independent Study (BIOENG 499)

1988 Teaching Assistant \-- Functional Human Neuroanatomy (CONJOINT 511)

1987 Teaching Assistant \-- Image Processing Workshop (UW Extension)

Honors and Awards

Finalist, IEEE Engineering in Medicine and Biology Society International
Student Paper Competition.

W. M. Keck Foundation Predoctoral Fellowship

ITBM- and IEEE-Sponsored National Bioengineering Student Paper
Competition. Selected as a semi-finalist to present paper at Paris
conference.

Society of Women in Engineering Award

United Technologies Scholarship

> University of California Alumni Scholarship

**Grants**

**Image Analysis of Immunocytochemical Markers in Alzheimer's Disease**

> Principal Investigator: David Nochlin, M.D., University of Washington
>
> Capacity: Co-Investigator
>
> Role: Wrote significant portions of grant proposal (Materials and
> Methods, and Preliminary Results), coordinated image analysis, wrote
> image analysis programs, conducted data analysis.
>
> Agency: National Institute of Aging
>
> Grant Period: April 1994 - April 1995
>
> **Alzheimer's Disease Research Center, Core D, Neuropathology**
>
> Principal Investigator: Shuzo Mark Sumi, M.D., University of
> Washington
>
> Capacity: Consultant
>
> Role: Wrote portions of grant proposal, plan image analysis
> experiments, consult on data analyses, author publications.
>
> Agency: National Institute of Aging
>
> Grant Period: May 1995- May 1999

**Professional and Community Service Activities**

2004 Theme Chair, Industrial Applications and Chair, Industrial
Activities, IEEE Engineering in Medicine and Biology Conference, San
Francisco, CA , Sept. 2004

2003 Theme Chair, Industrial Applications, IEEE Engineering in Medicine
and Biology Conference, Cancun, Mexico, Sept. 2003

2002 -- present Columnist, Regulatory Affairs, Engineering in Medicine
and Biology Magazine.

2000 -- present Region 6 Representative, IEEE Engineering in Medicine
and Biology Society -- Administrative Committee (AdCom) Voting Member

2000 -- 2002 Chair, Professional Activities Committee, IEEE Engineering
and Medicine and Biology Society

2000-2001 Vice Chair, IEEE Santa Clara Valley Engineering in Medicine
and Biology Society

1999 - 2000 Chair, IEEE Santa Clara Valley Engineering in Medicine and
Biology Society

1996 - 1998 Governor (School Board), Fishergate Primary School, York,
England

1995 - 1996 Consultant, Alzheimer's Disease Research Center, University
of Washington, Seattle, Washington

1994 Referee, *IEEE Transactions in Biomedical Engineering*.

1991 - 1995 Image Analysis Consultant, UW Child Development Mental
Retardation Center, Neuroscience Imaging Core.

Coordinator and Chair of Student Professional Awareness Conference
(S-PAC) held during IEEE Engineering in Medicine and Biology Society
(EMBS) 11th Annual International Conference. Over 60 people attended the
S-PAC conference, which included guest speakers from academia and
industry.

Co-coordinator of student volunteer group that supplied the audio visual
services for the IEEE/EMBS 11th Annual International Conference.

Officer of IEEE UW Student Chapter. Activities included participating in
scholarship recipient selection and student social activities
coordination.

Student representative on UW Bioengineering Curriculum Committee.

Treasurer of IEEE Silicon Valley Chapter of EMBS. Activities included
coordinating monthly meetings with guest speakers and yearly one day
symposiums, as well as financial responsibilities.

Publications

6\. Bartoo GT. Risk management. IEEE Eng Med Biol Mag. 2003
Jul-Aug;22(4):166-70, 172.

5\. Bartoo GT. Design controls. IEEE Eng Med Biol Mag. 2003
Mar-Apr;22(2):112-4.

4\. Bartoo GT, Nochlin DN, Chang D, Kim Y, Sumi SM, Martin GM. The Mean
Aβ Load in the Hippocampus Correlates to Severity of Dementia in
Alzheimer's Disease. Journal Neuropathology and Experimental Neurology.
vol. 56, pp. 531 - 540, 1997.

3\. Tracqui P, Cruywagen, GC, Woodward DE, Bartoo, GT, Murray JD,
Alvord, EC. A Mathematical Model of Glioma Growth: The Effect of
Chemotherapy on Spatio-Temporal Growth. Cell Proliferation. vol. 28, pp.
17 - 31, 1995

2\. Bartoo GT, Lee JSJ, Bartels PH, Kiviat NB, and Nelson AC. Automated
Prescreening of Conventionally Prepared Cervical Smears: A Feasibility
Study. Laboratory Investigation vol. 66(1) pp. 116 - 122, 1992.

1\. Bartoo GT, Kim Y, Haralick RM, Nochlin D, Sumi SM. Mathematical
Morphology Techniques for Image Processing Applications in Biomedical
Imaging. SPIE vol. 914 pp. 466 - 475, 1988.

Invited Lectures

**Topic: Image Analysis in Alzheimer\'s Disease**

19\. University of Washington Weekly Medical Imaging Seminar, Seattle,
WA, 1995

18\. Axon Instruments, Foster City, CA, 1995

17\. University of Washington Electrical Engineering Weekly Seminar on
Imaging, Seattle, WA, 1994.

16. Alzheimer\'s Disease and Related Disorders of Aging CME Course,
    Seattle, WA, 1993.

15\. University of Washington Center for Bioengineering Faculty/Student
Retreat, Seattle, WA, 1993.

14\. Friends of Alzheimer's Disease Research, Seattle, WA, 1989.

13\. University of Washington Electrical Engineering Weekly Seminar on
Imaging, Seattle, WA 1989.

12\. University of Washington Primate Center, Seattle, WA 1988.

11\. Merck and Co., Philadelphia, PA 1988.

10\. University of Washington Pathology Presents Seminar, Seattle, WA
1988.

9\. Alzheimer\'s Disease Research Center Seminar, Seattle, WA 1988.

**Topic: Automation of Cervical Smear Screening**

8\. University of Washington Electrical Engineering Weekly Seminar on
Imaging, Seattle, WA, 1991.

7\. Mountain States Association of Cytotechnology, Albuquerque, NM,
1990.

6\. Pacific Northwest Cytotechnologists Association, Seattle, WA, 1989

5\. New York State Department of Health, Albany, NY, 1989

**Topic: Other**

4\. "Journeys -- Grad School and Beyond,"

University of Washington Weekly Seminar on Bioengineering, Seattle, WA
2000.

3\. "Biological Applications of Microscopic Imaging,"

Pacific Northwest Electron Microscopy Society Regional Conference,
Seattle, WA 1994.

2\. "Anatomy of a Start Up,"

University of Washington Bioengineering Student Association, Seattle,
WA, 1991.

1\. "Applications of Mathematical Morphology Techniques in Image
Processing,"

IBM Palo Alto Scientific Center, Palo Alto, CA 1988.

Abstracts (Platform or Poster Presentations)

19..Katsnelson Y, Lapshin V, Claude J, and Bartoo GT. Transcranial
.Electrotherapy Stimulation Device for the Temporary Reduction of Pain.
25^th^ Annual International Conference Engineering in Medicine
Conference, Cancun, Mexico (submitted).

18\. \"Quantitative Imaging for Clinicopathological Correlates in
Alzheimer\'s Disease.\" Bartoo GT and Kim Y.. 17th Annual International
Conference Engineering in Medicine and Biology Conference, Montreal,
Quebec, Canada. Sept. 19-23, 1994, speaker.

17\. \"Image Analysis Measurements of A-Beta and Tau Load in
Alzheimer\'s Disease and Elderly Controls.\" Bartoo GT, Nochlin D, Sumi
SM. XII International Congress of Neuropathology, Toronto, Ontario,
Canada. Sept. 18-24, 1994, poster.

16. \"A Mathematical Model of the Effect of Chemotherapy on Glioma
    Growth.\" Bartoo, GT, Alvord EC, Woodward DE, Tracqui P, Cruywagen
    GC, Murray JD. XII International Congress of Neuropathology,
    Toronto, Ontario, Canada. Sept. 18-24, 1994, poster.

15\. \"A Mathematical Model of the Effect of Surgical Resection on
Gliomas.\" Alvord EC, Bartoo GT, Woodward DE, Tracqui P, Cruywagen GC,
Murray JD. XII International Congress of Neuropathology, Toronto,
Ontario, Canada. Sept. 18-24, 1994, poster.

14\. \"Resection of Gliomas and Life Expectancy.\" Cook J, Woodward DE,
Tracqui P, Cruywagen GC, Murray JD, Bartoo GT, Alvord EC. XII
International Congress of Neuropathology, Toronto, Ontario, Canada.
Sept. 18-24, 1994, poster.

13. \"The Correlation of Tau and Aβ in Alzheimer\'s Disease.\" Bartoo
    GT. Pacific Northwest Alzheimer\'s Disease Research Symposium. June
    1993, speaker.

12\. \"The Prevalence Distribution of Isolated SIL Cells on Conventional
Cervical Smears.\" Bartoo GT, Hughes JP, Mauney M, Kiviat NB, Brancheau
D, and Tucker JT. 39th Annual Meeting of the American Society of
Cytology, Los Angeles, CA, Sept. 1991, poster.

11\. \"Automated Microimaging Systems for Pathology Laboratories.\"
Nelson AC, Bartoo GT, Lee JSJ. Association for Advancement of Medical
Instrumentation 25th Annual Meeting & Exposition, Anaheim, CA May 5-9,
1990, speaker.

10\. \"Mathematical Morphology Techniques for Image Processing
Applications in Biomedical Imaging.\" Bartoo GT, Kim Y, Haralick RM,
Nochlin D, Sumi SM. SPIE Medical Imaging II: Image Formation, Detection,
Processing and Interpretation, Newport Beach, Feb. 2-9, 1988, speaker.

9\. \"Multi-Modality Image Registration Using Centroid Mapping.\" Bartoo
GT, and Hanson WA. IEEE Engineering in Medicine and Biology Society 11th
Annual International Conference, Seattle, WA, Nov. 4-7, 1989, speaker.

8 \"Morphological Image Analysis for Studying Alzheimer\'s Disease.\"
IBartoo GT. EEE Engineering in Medicine and Biology Society 10th Annual
International Conference, New Orleans, LA, Nov. 4-7, 1988, speaker.

7\. \"Automated Quantitation of Senile Plaques and Neurofibrillary
Tangles in Alzheimer\'s Disease by Image Analysis.\" Bartoo GT, Nochlin
D, Kim Y, Sumi SM. 64th Annual Meeting of the American Association of
Neuropathologist, Inc., Charleston, SC, June 9-12, 1988, poster.

6\. \"Automatic Identification of Senile Plaques in Alzheimer\'s
Disease.\" Bartoo GT. ITBM Annual Conference, Paris, France, April 1987,
speaker.

5\. \"Applications of Image Analysis in Neuropathology.\" Bartoo GT.
Biomedical Advances Through the Use of Modern Imaging Methods Symposium,
Seattle, WA, Sept. 24 - 25, 1987, poster.

4\. \"Development of Computer Systems for the Vascular Laboratory.\"
Bartoo GT. 2nd International Vascular Symposium, London, England, Sept.
8 - 12, 1986, speaker.

3\. \"The Personal Computer: A Diagnostic and Research Tool for the
Vascular Laboratory.\" Bartoo GT. 2nd International Vascular Symposium,
London, England, Sept. 8 - 12, 1986, poster.

2\. \"The Personal Computer: A Valuable Diagnostic and Research Tool.\"
Bartoo GT. 31st Annual Convention of the American Institute of
Ultrasound in Medicine, Las Vegas, NV, Sept. 16-19, 1986, poster.

1\. \"Why Do We Need a Computer in Our Laboratory?\" Tong G and Cox D .
29th Annual Convention of the American Institute of Ultrasound in
Medicine, Atlanta, GA, Sept., 1984, poster.