Statement of Work: Dr. Sandra Groot

1\. [Objectives]{.underline}

This is a short-term contract (\~3 months) aimed at accelerating the
pace of our clinical research efforts and to obtain clinical expertise
to the project. The contractor will work with Dr. Michael Iadarola and
other members of the Neurobiology and Pain Therapeutics Section. The
contractor will conduct molecular biological, biochemical and clinical
laboratory research. Dr. Groot\'s work will focus on understanding
mechanisms of chronic pain, and mechanisms of other neurological and
autoimmune diseases related to nerve injury, inflammation or infection
using state-of-the-art biochemical and molecular biological methodology.
The areas of investigation include analyses of human clinical samples
obtained from patients with various neurological disorders. These
studies are aimed primarily at patients with chronic pain disorders but
will include a variety of other conditions in which an autoimmune
process has been hypothesized or demonstrated such as Sjogren\'s
Syndrome, Type 1 Diabetes, Multiple Sclerosis, paraneoplastic syndromes,
and infectious diseases, especially viral diseases that affect sensory
neurons. Dr. Groot\'s clinical training as a Physician will provide
needed expertise in human disease processes and interpretation of
clinical and diagnostic data which is important at this juncture. The
contractor can also be involved in training of a more long term IRTA or
pre-IRTA replacement.

2\. [Approach]{.underline}

The contractor will be involved in implementing state-of-the-art cell
biology and molecular biological methods for analysis of
pathophysiological auto-antibodies n human serum. The contractor will be
involved in analysis human neurological disorders and in animal models
or in vitro cell models of such disorders, especially those related to
pain and nerve injury.

3\. [Methods]{.underline}

The services that will be performed are as follows:

a\) The contractor will participate in ongoing research in the
laboratory related to the use of genetically encoded reporter systems
and expertise in construction of specific types of expression vectors
for for generation of antigenic targets.

b\) The contractor must have a working knowledge of and experience in
gene regulation and molecular biology. The contractor must have a strong
background in generating mammalian and bacterial expression vectors,
mutagenesis, high-throughput cloning and cell biology and experience in
DNA sequence analysis related to database searching and cloning. The
contractor will have experience in disease diagnostics. Priority will be
given to candidates with expertise in generating humoral response
profiles to panels of recombinant eukaryotic antigens.

c\) The contractor will implement a new assay developed in the
laboratory for detection of serum antibodies based on liquid-phase
antigen antibody interaction, use of Renilla Luciferase-based fusion
proteins as antigens and expression of antigens in mammalian cell
systems. This assay will be adapted to our BioMek robotic pipeting
platform and readings will be made via a luminometer. The contractor
will make measurements of serum antibodies in various patient cohorts
using this assay. The contractor is expected to be capable of
independently conducting all phases of the assay, assessment of the
resulting data and modification and refinements of the methodology as
needed.

d\) The contractor will maintain detailed records of experimental
procedures and results. High quality laboratory notebooks are
maintained, which will be consulted to extract results and raw data for
processing into graphs for research reports and published manuscripts.
The contractor is expected to perform all necessary data storage in
digital format as well. Records will be retained and reviewed by the
Section Chief.

e\) Data will be analyzed using appropriate statistical approaches to
demonstrate significant differences resulting from experimental
manipulations.

f\) The contractor must have a working knowledge of bioinformatics and
skilled in the use of database search programs related to DNA and
protein sequence analysis and manipulation. The person must be able to
use the information to design DNA cassettes for expression of fusion
proteins.

**Personnel, evaluation and schedule**

A. [Personnel]{.underline}

d\) The contractor must have a working knowledge of and experience in
gene regulation, molecular biology and disease diagnostics. The
contractor has advanced skills in molecular biological methods such as
generating mammalian expression vectors, high-throughput cloning, cell
biology, polymerase chain reaction (PCR), cloning of DNA fragments and
cDNAs and subcloning into plasmids. The contractor shall have experience
in microscopy using immunofluorescene and experience in DNA sequence
analysis and bioinformatics. Personnel provided under the contract will
comply with the rules and policies of the NIDCR and its staff.

B. [Evaluation]{.underline}

The contractor is expected to work in an independent self-motivated
fashion. The contractor is expected to work closely with the Section
Chief and other members of the laboratory and will be evaluated at least
once a week, if not daily by the Section Chief. If the contractor is
considered to be substandard in the judgment of the supervisor, the
contractor will initially receive notice of the problem from the
supervisor and will be required to take corrective measures and to
demonstrate improved performance.

C. [Schedule]{.underline}

The contractor will perform studies for a minimum of 40 hours per week,
Monday through Friday (except any Federal holidays). Failure to arrive
on time or to follow the time schedules or instructions as indicated
shall be considered default of the contract.

D. [Reporting Requirements]{.underline}

The contractor shall provide professional services for Neurobiology and
Pain Therapeutics Section, NIDCR during the period of June 1, to August
10, 2007. The contractor will be paid a total of \$20,500 for this 3
month period.

**Justification**

Attached is a request for \$20,500.00 to provide Per Diem and travel for
the services of Dr. Sandra Groot. Under this contract, Dr. Groot will
provide advanced research services to the Neurobiology and Pain
Therapeutics Section, NIDCR. Her contract will run from June 1, to
August 10, 2007. The work required is highly specialized, technical,
knowledge-based and skills-based. Dr. Groot has all of the technical
skill, scientific knowledge and biomedical research training and
motivation to execute the procedures required in this position in a
high-quality, conscientious fashion. The procedures require a great deal
of personal attention to detail, cleanliness, and knowledge of sterile
tissue culture technique, good skills with microscopy, good skills with
computer molecular biological databases, statistical analyses, and
practical experience with robotic liquid handling devices, luminometers
and various UV and fluorescent plate readers. Without someone filling
this position, the productivity of our laboratory will be less than
optimal. Furthermore, Dr. Groot has the clinical training, experience
and intellectual acumen to perform the more insight-driven aspects of
the research in an exemplary fashion. Considering all of her skills, Dr.
Groot is the ideal candidate for this position.

Mailing address:

Dr. Michael J. Iadarola

Building 49, Room 1A04

National Institutes of Health

49 Convent Drive MSC 4410

Bethesda, MD 20892-4410

Task Description

Firm will issue 6 checks on the following days for the following
amounts:

June 1^st^ for \$3,416

June 15^th^ for \$3,417

June 29^th^ for \$3,417

July 13^th^ for \$3,417

July 27^th^ for \$3,417

August 10^th^ for \$3,416

Checks will be issued to Dr. Sandra Groot. Payment to Dr. Groot as per
diem and travel expenses during her stay at NIDCR. It is estimated that
Dr. Groot will arrive at NIDCR on June 1, to August 10, 2007. A total of
\$20,500.00 shall be paid in 6 payments. The check should be sent via
express mail to the NIDCR, to the attention of Dr. Michael Iadarola at
the following address.

Dr. Michael Iadarola

Building 49, Room 1A04

49 Convent Drive, MSC 4410

NIH

Bethesda MD 20892-4410