Statement of Work for Dr. Debora Pallos

1.  [Objectives]{.underline}

> The contractor will work with Dr. Thomas Hart and other members of the
> Human and Craniofacial Genetics Section. The contractor will perform
> recruitment and clinical assessment of individuals from families
> segregating gingival fibromatosis. Dr. Pallos's work will focus on
> identification of families segregating hereditary gingival
> fibromatosis, diagnosing which family members are and which are not
> affected by HGF, obtaining informed consent from individuals to
> participate in studies to identify the underlying genetic basis of HGF
> in their families and understanding the mechanism of this disease. The
> areas of the investigation include ascertainment of affected HGF
> probands and their family members, determination of who does and who
> does not have the disease, obtaining appropriate samples for DNA
> isolation including peripheral blood, buccal swabs or oral rinses, and
> obtaining gingival biopsies and in cases of affected individuals,
> performing gingivectomies to treat the condition. Isolated DNA will be
> used to perform genetic linkage studies and perform mutational
> analysis of candidate genes through DNA sequencing. Functional
> characterization of gingival tissues will be performed on cultured
> gingival fibroblasts and cultured gingival epithelial cell. Functional
> studies will also be performed on genomic RNA isolated from gingival
> biopsies and cultured cell. Immunohistochemical studies will be
> performed on gingival biopsies. These studies are aimed at
> identification of the underlying gene defect in each family and in
> determining how the mutations act to cause gingival overgrowth. Dr.
> Pallos will also ascertain individuals with drug induced gingival
> overgrowth, and perform gingivectomies to treat these individuals.
> Resected tissues will be evaluated for gene expression in the same
> manner as described above.

2.  [Approach]{.underline}

> The contractor will be involved in implementing clinical ascertainment
> of individuals with Hereditary Gingival Fibromatosis and drug induced
> gingival fibromatosis. The contractor will be involved in ascertaining
> family members of individuals with HGF, and diagnosing affected
> status. The Contractor will be involved with tissue procurement and
> treatment of affected individuals in her clinic. The contractor will
> be responsible for preparation of samples and shipment to the Human
> and Craniofacial Genetics laboratory for analysis. The contractor will
> work with personnel from the Human and Craniofacial Genetics section
> in preparation of reports including scientific manuscript describing
> findings of molecular genetic studies.

3.  [Methods]{.underline}

> The services will be performed as follows:

a)  The contractor will participate in ongoing research related to
    identification of the genetic basis of Gingival Fibromatosis and
    characterization of the functional defect that causes the disease.
    Specifically the contractor will ascertain individuals affected by
    Gingival Fibromatosis, including clinical diagnosis, collection of
    specimens and preparation of specimens for DNA extraction, cell
    culture and immunohistochemistry.

b)  The contractor must have expertise in clinical diagnosis of various
    forms of Gingival Fibromatosis and the ability to distinguish the
    condition from sporadic phenocopies of the condition. The contractor
    must have a background in genetics, and have the ability to record
    accurate pedigrees.

c)  The contractor will have expertise to inform the affected
    individuals of the appropriate treatment of their condition
    (gingival overgrowth) and provide gingivectomy treatment if the
    patient elects.

d)  The contractor will have expertise to perform standard biopsies of
    gingival tissues.

e)  The contractor will maintain clear and accurate records relating to
    clinical information as well as tracking samples.

f)  The contractor should have excellent oral communication skills and
    be able to participate in writing scientific reports as well as
    clinical records.

[Personnel, evaluation and schedule]{.underline}

> [A. Personnel]{.underline}
>
> The contractor must have a working knowledge of general dentistry and
> expertise in Periodontology. The contractor must have a working
> knowledge of genetics including modes of transmission of Mendelian
> diseases. The contractor must have expertise in the various forms of
> Hereditary Gingival Fibromatosis and the etiologies of drug induced
> periodontitis. The contractor will be skilled in samples preparation
> for DNA isolation and for transport of tissue samples for cell
> culture, cytogenetics and immunohistochemistry. 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 by discussing a weekly progress report with the
> section chief. If the contractor is considered to be substandard in
> the judgment of the section chief, the contractor will initially
> receive notice of the problem from the section chief and will be
> required to take corrective measures and to demonstrate improved
> performance.
>
> [C. Schedule]{.underline}
>
> The contractor will perform duties related to the study for a minimum
> of 15 hours a week. The contractor will have flexibility to determine
> the days the work is performed, as this will be dictated in large
> measure by subject availability and study subjects availability.
> Failure to schedule and perform the necessary duties shall be
> considered default of the contract.
>
> [D. Reporting Requirements]{.underline}
>
> The contractor shall provide professional services for the Human and
> Craniofacial Genetics Section, NIDCR during the period of September
> 25, 2006 to September 24, 2007. Reports will include data collected
> from families with hereditary gingival fibromatosis, diagnosing which
> family members are and which are not affected by HGF, informed
> consents from individuals to participate in studies to identify the
> underlying genetic basis of HGF in their families and understanding
> the mechanism of this disease. Also includes ascertainment of affected
> HGF probands and their family members, determination of who does and
> who does not have the disease, obtaining appropriate samples for DNA
> isolation including peripheral blood, buccal swabs or oral rinses, and
> obtaining gingival biopsies and in cases of affected individuals,
> performing gingivectomies to treat the condition. Data from isolated
> DNA will be used to perform genetic linkage studies and perform
> mutational analysis of candidate genes through DNA sequencing.
> Functional characterization of gingival tissues will be performed on
> cultured gingival fibroblasts and cultured gingival epithelial cell.
> Data from the functional studies performed on genomic RNA isolated
> from gingival biopsies and cultured cell and Immunohistochemical
> studies performed on gingival biopsies. The studies and information
> gathered assist us in our research aimed at identification of the
> underlying gene defect in each family and in determining how the
> mutations act to cause gingival overgrowth. Dr. Pallos will also
> ascertain individuals with drug induced gingival overgrowth, and
> perform gingivectomies to treat these individuals. Resected tissues
> will be evaluated for gene expression in the same manner as described
> above.
>
> The contractor will be paid a total of \$23,999.82 for this 12 month
> period.
>
> **Justification**
>
> Attached is a request for \$24,000 to provide per Diem and travel for
> the services of Dr. Debora Pallos. Under this contract, Dr. Pallos
> will provide clinical research services to the Human and Craniofacial
> Genetics Section, NIDCR. Her contract will run from September 25, 2006
> to September 28, 2007. The work requires specialized clinical skills
> and basic research skills for sample preparation. Dr. Pallos is a
> dentist with specialized training in the field of Periodontology. She
> is also trained as a geneticist, and has a PhD in human genetics. Dr.
> Pallos is also an authority in the area of gingival overgrowth, and
> has scientific manuscripts related to this topic. The procedures
> described need technical skill and expertise in the area of gingival
> pathology and surgical treatment. She is also proficient with the
> methods related to establishing the needed database and recording the
> appropriate information.
>
> Additionally, Dr. Pallos has the expertise and self motivation to
> successfully perform the project. She is familiar with all goals of
> the proposal, and understands when to support different aspects of the
> project to ensure successful completion. Her specific expertise in the
> area of gingival fibromatosis research makes her an ideal candidate
> for this work.
>
> **[Task Description:]{.underline}**
>
> Firm will issue 26 checks on the following payment days for the
> following amounts:
>
> 9/25/2006 -- 10/6/2006 - \$923.07
>
> 10/9/2006 -- 10/20/2006 - \$923.07
>
> 10/23/2006 -- 11/3/2006 - \$923.07
>
> 11/6/2006 -- 11/17/2006 - \$923.07
>
> 11/20/2006 -- 12/1/2006 - \$923.07
>
> 12/4/2006 -- 12/15/2006 - \$923.07
>
> 12/18/2006 -- 12/29/2006 - \$923.07
>
> 1/1/2007 -- 1/12/2007 - \$923.07
>
> 1/15/2007 -- 2/2/2007 - \$923.07
>
> 2/5/2007 -- 2/16/2007 - \$923.07
>
> 2/19/2007 -- 3/2/2007 - \$923.07
>
> 3/5/2007 -- 3/16/2007 - \$923.07
>
> 3/19/2007 -- 3/30/2007 - \$923.07
>
> 4/2/2007 -- 4/13/2007 - \$923.07
>
> 4/16/2007 -- 4/27/2007 - \$923.07
>
> 4/30/2007 -- 5/11/2007 - \$923.07
>
> 5/14/2007 -- 5/25/2007 - \$923.07
>
> 5/28/2007 -- 6/8/2007 - \$923.07
>
> 6/11/2007 -- 6/22/2007 - \$923.07
>
> 6/25/2007 -- 7/6/2007 - \$923.07
>
> 7/9/2007 -- 7/20/2007 - \$923.07
>
> 7/23/2007 -- 8/3/2007 - \$923.07
>
> 8/6/2007 -- 8/17/2007 - \$923.07
>
> 8/20/2007 -- 8/31/2007 - \$923.07
>
> 9/3/2007 -- 9/14/2007 - \$923.07
>
> 9/17/2007 -- 9/28/2007 - \$923.07
>
> Checks will be issued to Dr. Deborah Pallos. Payment to Dr. Pallos for
> her services for the Human and Craniofacial Section, (HCGS)/ NIDCR. It
> is estimated that Dr. Pallos will begin submitting reports and provide
> collected data to HCGS/NIDCR on 9/25/2006. A total of \$23,999.82
> shall be paid in 26 payments. The checks should be sent via express
> mail to the NIDCR, to the attention of Renata Baginski at the
> following address.
>
> Mailing Address:
>
> Renata Baginski, Administrative Officer
>
> Building 30, Room 508B
>
> National Institutes of Health
>
> 30 Convent Drive, MSC 4324
>
> Bethesda, MD 20892-4324