A1.b Statement of Work.docx

Statement of Work

Procurement Request #:0HJAAQBE-2023-72633 Period of Performance: On or before March 15

Title: INCORPORATING GUAMANIAN ALS/PDC AUTOPSY COLLECTION

SECTION 1 – BACKGROUND

Guamanian ALS (Lytico-Bodig), also referred to as ALS/PDC (Amyotrophic Lateral Sclerosis / Parkinsonism-Dementia Complex) is the prototype disorder for examining the intersection of environment and genetics in motor neuron disease, and the factors influencing the overlapping syndromes of parkinsonism, dementia, and ALS.

This collection includes fixed and frozen postmortem brain and spinal cord specimens and the corresponding detailed clinical and pathological records from 400-500 autopsies of ALS-PD-dementia (Lytico-Bodig), standard ALS, and non-neurological Control Decedents that were obtained by the NIH Center on Guam over many decades. The vast majority of the autopsies were completed with post-mortem intervals less than 4 hours.

There are also biofluids samples (serum and CSF), including longitudinal biofluids, collected during life from a selection of the same subjects who underwent autopsies.

This one-of-a-kind collection has been curated at Binghamton University by Dr. Garruto, who is retiring, and wants to ensure that the tissues and associated data are responsibly curated and made broadly available to researchers.

SUBSECTION A – DEFINITIONS

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SECTION 2 – PURPOSE

There are numerous ALS researchers already working with our ALS Postmortem Resources who are eager to use these samples for studies. By harmonizing and integrating these samples and data into our ongoing efforts, we will vastly improve broad and responsible access to these samples, including plans for genomic and transcriptomic analyses – which will be linked back to the clinical and pathological data and made broadly available for researchers.

Excitingly, this collection also includes a significant number of non-neurological control autopsies. Properly matched control autopsy tissues are the single greatest unmet need for ALS researchers, as reflected in our recent survey of ALS Researchers around the world (presented by Dr. Ostrow at the Annual CDC ALS Registry Meeting earlier this year).

SECTION 3 – SCOPE OF WORK

We have worked together with Dr. Garruto to determine the logistics required to move and incorporate these resources into our ALS Postmortem Core.

The materials that need to move include:

· Frozen postmortem specimens currently stored in two chest-style -80C freezers (20cu ft and 17 cu ft). There are approximately 475 boxes of frozen brain and spinal cord tissues, in 3”x5”x5” square freezer boxes. The freezers and freezer racks will stay at Binghamton University, thus replacements need to be purchased.

· A large cabinet filled with formalin fixed tissues.

· Frozen biofluid specimens (serum and CSF), currently stored separately from the tissues.

· Multiple boxes of unstained FFPE slides cut from a selection of fixed and embedded postmortem tissue samples.

· File cabinets (6-7) and several additional boxes containing the associated paper records. These files include clinical records, research data, pathology (e.g. autopsy reports), and information on research projects and publications using the collection.

While these records are extensive, they are not digitized, nor have data elements been extracted from the prose reports and files.

Thus, the main tasks involved in incorporating these resources will be distilling our standardized and harmonized de-identified clinical and pathological data elements and tissue/biofluid/slide inventories from the paper records and inspection and logging of all samples themselves.

SECTION 4 – TASKS TO BE PERFORMED

1. Move Guam Collection from Binghamton University to Temple University. Timing Goal: Late Feb-March.

Origin Location:

Binghamton University Science 3 Building 4400 Vestal Parkway East Vestal, NY 13850 POC: Dr. Ralph M. Garruto rgarruto@binghamton.edu Office: 607- 777- 6562 Mobile: 240-267-0289

Delivery to:

Temple University Medical Education Research Building (MERB) 3500 North Broad St., Suite 711 Philadelphia PA 19140 POC: Lyle W. Ostrow, M.D., Ph.D.

Associate Professor of Neurology Lewis Katz School of Medicine at Temple University Email: Lyle.Ostrow@tuhs.temple.edu Office: 215-707-3040

Mobile: 716-308-5038

May 2020

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

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SECTION 6 – PERIOD OF PERFORMANCE

On or before March 15.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

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SECTION 8 – REFERENCE MATERIALS

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