Funded by NIH for~30 Years
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2 Funded by NIH for~30 Years NIMH NHLBI NHGRI NIAMS ORDR NIH Office of the Director ORIP NCI OD NEI NIDDK NIAID
3 NDRI Rare Disease Biospecimen Program Penn Medicine Center for Orphan Disease Research & Therapy Fall Retreat November 2, 203
4 NDRI MISSION STATEMENT To advance disease research through the procurement, preservation and distribution of human cells, tissues and organs. To provide researchers on the cutting edge of disease research with the biomedical resources that are essential for their work.
5 NDRI Since 980 Served more than 5,000 investigators with over 300,000 biospecimens 2,500 publications
6 Additional Funding Corporate Pharma/biotech industry Provided tissues to > 330 for-profit entities in last 5 years Special Initiatives Cystic Fibrosis Foundation PA State Formula Grant Joslin Diabetes Center
7 Key Metrics ~4,000 Offered Tissues Nationally NDRI 24/7 ~,300 Tissues Banked ~3,000 Tissues Matched & Placed ~3,700 Diseased Tissues 82 Types
8 673 USA Researchers Hawaii Alabama 2 Arkansas 4 California 09 Arizona 3 Colorado 2 Connecticut 0 DC New Jersey 6 Delaware 3 Florida 3 Georgia 0 Indiana 8 Illinois 20 Iowa 3 Kansas 3 Kentucky 4 Louisiana 4 Mass. 77 Maryland 57 Maine Michigan Minnesota 3 Missouri 8 Montana North Carolina 6 Nebraska 4 New Hampshire New Mexico 2 New York 50 Ohio 27 Oklahoma 3 Oregon 4 Pennsylvania 5 Rhode Island 2 South Carolina 4 Tennessee 0 Texas 27 Utah 2 Virginia 0 Vermont Washington 3 Wisconsin 0 Miss. West Virginia
9 00 International Researchers 8 Countries Canada 37 Netherlands Belgium 2 Scotland Finland Ireland Denmark Germany 5 United Kingdom 27 France 3 Switzerland 4 Austria Israel Italy 4 2 India Japan 3 Taiwan Australia 5
10 NDRI Procurement Network Sites 56 Organ Procurement Organizations 37 Eye Banks 23 Tissue Banks 46 Hospital Donor Sites 8 Remote Sites ~200 Recovery Personnel
11 Biospecimen Application Process. Application Tissue needs/donor profile IRB document Project synopsis CV/biosketch 2. Feasibility review internal/external 3. Customized protocol development
12 Scope of Consent NDRI protocol approved by UPenn IRB Research use unrestricted Permission to use: - For profit - Therapeutics or diagnostics - Genome sequencing Potential access to complete health record No compensation to donors
13 Researchers Diversity Dorsal Root Ganglia Cell Biology Respiratory Cancer Blood Cardiovascular Reproductive Renal Rare Disease Neuroscience Musculoskeletal Medical Devices Endocrine Immunology Ocular Digestive
14 Biospecimen Diversity Normal tissues Diseased tissues common and rare HIV+ and HCV+ tissues High quality non-transplantable organs Low-PMI tissues Cancer tumors/normal adjacent tissues Cord blood/placenta/umbilical cord CD34 + stem cells Normal /TD/T2D pancreatic islet cells
15 What are Researchers doing with ) Gene expression, genotyping & cell lines - mrna - DNA - Fibroblasts 2) Functional analysis - Ion channel studies - Drug/ compound screening 3) Drug development Human Tissues?
16 NDRI Rare Disease Program
17 Program Summary 2003 to 203 Tissues Procured 9,604 Rare Diseases Represented 207 Tissues Shipped 4,470 Donors 603 Researchers Served 264
18 NDRI Rare Disease Online Biospecimen Catalogue 4,862 Specimens Representing 77 Diseases Lymphangioleiomyomatosis (LAM) 59 Von Hippel-Lindau Disease 388 Cystic Fibrosis 294 Sarcoidosis 266 Idiopathic Pulmonary Fibrosis 228 Polycystic Kidney Disease 207 Systemic Scleroderma 79 Amyotrophic Lateral Sclerosis (ALS) 65 Polymyalgia Rheumatica Ehlers-Danlos Syndrome 00
19 NDRI Rare Disease Private Donor Program Current Living Registrants 437 Rare Diseases Represented 54 Registrants with Tissues Recovered 289 Tissues Procured 4,698 Rare Diseases Represented 67
20 NDRI Procurement Network Sites 56 Organ Procurement Organizations 37 Eye Banks 23 Tissue Banks 46 Hospital Donor Sites 8 Remote Sites ~200 Recovery Personnel
21 Amyotrophic Lateral Sclerosis Projects Funded by ATSDR/McKing Corp & Boston VA Patients identified and consented by collaborators NDRI Private Donor Program personnel do tissue recoveries nationwide Utilizes hospital, OPO or funeral home facilities Collects brain, spinal cord, csf (bone & skin) Kits provided by NDRI, specimens shipped to collaborators biobanks Recoveries completed < 24 hours post mortem
22 Cystic Fibrosis Project NDRI provided ~200 CF lungs for Cystic Fibrosis Foundation-funded project Explanted lungs recovered from CF patients undergoing transplant Two new drugs developed by Vertex Pharmaceuticals Kalydeco - FDA approved VX809/Kalydeco in Clinical Trials Almost every primary cell used in the Vertex discovery was from an NDRI lung Chris Penland PhD Director of Research, Cystic Fibrosis Foundation
23 LAM Project 7//2008 to 6/30/203 Transplant Candidates Consented by NDRI 76 Tissues Procured 2,036 Number of Donors lung transplants, kidney transplant, 30 pleural effusion drains, 7 hysterectomies, 3 cadaveric donors LAM Researchers Served 3 Tissues Shipped from LAM Repository 826 Number of Donors 92
24 NDRI Rare Disease Biospecimen Alliance Formed in 2007, ~ 30 VHO members NDRI maintains registries of consented donors and approved researchers Recovers and ships tissues following death or surgery Focus is on providing tissues not a static biobank Difficult to reach critical mass of relevant tissues in individual diseases Targeting VHOs in diseases with active research programs supporting researchers with a clear unmet need for human tissues
25 Thank you!
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