Statement of Work: Dr. Peter Burbelo

1\. [Objectives]{.underline}

The contractor will work with Dr. Michael Iadarola and other members of
the Neurobiology and Pain Therapeutics Section. The contractor will
conduct multidisciplinary molecular, biochemical, pharmacological, and
clinical laboratory research. Dr. Peter Burbelo\'s work will focus on
understanding mechanisms of chronic pain, methods of treating chronic
pain, and mechanisms of other neurological diseases related to injury,
inflammation or infection using state-of-the-art biochemical and
molecular biological methodology. The contractor will work with Dr.
Michael Iadarola and other members of the Neurobiology and Pain
Therapeutics Section. The areas of investigation include examination of
vanilloid agonists such as resiniferatoxin and their effect on
inflammatory process in the periphery and their ability to induce
nervous system plasticity and gene regulation in specific neurons and
neural circuits and more broadly in the brain or other organs if
indicated. These studies will be conducted in cell lines, primary
cultures of nervous system cells as well as *in vivo* studies using
animal models. Dr. Burbelo will also be involved in analysis 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
paraneoplastic syndromes, multiple sclerosis and infectious diseases,
especially viral diseases that affect sensory neurons.

2\. [Approach]{.underline}

The contractor will be involved in implementing state-of-the-art cell
biology and molecular biological methods for analysis of neural circuits
and induced gene expression during states of pharmacological,
physiological or pathophysiological activation and the treatment of such
states. The contractor will be involved in analysis human neurological
disorders and in animal models or in vitro cells that model 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 other ongoing research in the
laboratory related to experimental pain control using both in vitro cell
lines and primary cultures, use of genetically encoded reporter systems
and expertise in construction of targeting vectors for transgenic and
gene deletion studies. These include studies related to vanilloid
agonists such as RTX and other compounds developed by the laboratory.

b\) The contractor must have a working knowledge of and experience in
signal transduction, gene regulation and molecular biology. The
contractor must have a strong background in generating mammalian and
bacterial expression vectors, mutagenesis, high-throughput cloning, cell
biology and immunofluorescene, and experience in protein/DNA sequence
analysis. The contractor must have a working knowledge of and 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 he has developed 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.

g\) The contractor should have excellent oral communication skills and
be able to independently write high-quality manuscripts for publication
in top tier journals.  

**Personnel, evaluation and schedule**

A. [Personnel]{.underline}

d\) The contractor must have a working knowledge of and experience in
signal transduction, gene regulation, molecular biology and disease
diagnostics. The contractor has advanced skills in molecular biological
methods such as generating mammalian and bacterial expression vectors,
mutagenesis, high-throughput cloning, cell biology, RNA extraction, cDNA
synthesis, polymerase chain reaction (PCR), cloning of DNA fragments and
cDNAs and subcloning into plasmids and various forms of differential
hybridization. The contractor shall have experience in microscopy using
immunofluorescene, and experience in protein/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 August 21^st^,
2006 to January 21^st^, 2007. The contractor will be paid a total of
\$60,000 for this 6 month period.

**Justification**

Attached is a request for \$60,000 to provide Per Diem and travel for
the services of Dr. Peter Burbelo. Under this contract, Dr. Burbelo will
provide advanced research services to the Neurobiology and Pain
Therapeutics Section, NIDCR. His contract will run from August 21st,
2006 to January 21st, 2007. The work required is highly specialized,
technical and knowledge and skills based. Dr. Burbelo has all of the
technical skill and knowledge and training 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 microscopic microsurgery, good skills with computer
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 Burbelo has the training, experience and intellectual
acumen to perform the more insight-driven aspects of the research in an
exemplary fashion. Considering all of his skills, Dr. Burbelo 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 11 checks on the following days for the following
amounts:

September 1st for \$5, 454

September 15^th^ for \$5,454

September 29^th^ for \$5,454

October 13th for \$5,454

October 27th for \$5,454

November 10^th^ for \$5,454

November 24th for \$5,454

December 8th for \$5,454

December 22nd for \$5,454

January 5th, 2007 for \$5,454

January 19^th^ for \$5,454

Checks will be issued Dr. Peter D. Burbelo. Payment to Dr. Burbelo as
per diem and travel expenses during his stay at NIDCR. It is estimated
that Dr. Burbelo will arrive at NIDCR on August 21^st^, 2006 and will
depart on January 21^st^, 2007. A total of \$60,000 shall be paid in
12payments. 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