Bill Leinweber, President and CEO of National Disease Research Interchange (NDRI) admits that NDRI’s work is complicated, because medical research is complex. For nearly 40 years, NDRI has accepted the challenge of meeting the increasing demands of the medical research community, who rely on high-quality, healthy, and diseased biospecimens to conduct lifesaving research.
“There is not another organization that does everything we do, “explains Leinweber. “We serve researchers across the full spectrum of the life-sciences and provide everything from brain to miniscule tissues that scientists may need.”
The phone rings daily at NDRI, and trained call center staff work 24 hours per day, 7 day per week, 365 days per year to screen offers for tissues and organs from donors ranging from cadaveric to those being evaluated for transplant.
The requests are quite specific and follow strict protocol.
“We screen all protocol criteria until we have a match. This includes the volume, type of medium, how the biospecimens is preserved (fresh, fixed, or frozen), how it should be shipped, the day the lab will accept it- and the age, sex, and the medication the donor was taking. ” Leinweber describes.
NDRI partners with a nationwide network of over 130-tissue source sites, including organ procurement organizations, tissue banks, eye banks, hospitals, and individual donors. As the liaison between procurement sources and the research community, NDRI is supporting major advances in the treatment and cure of human diseases.
“In the US there are 58 organ procurement organizations and we work with 56 of them,” emphasized Leinweber. “All deaths that occur in an acute healthcare setting in the United States by law have to be referred to an organ procurement organization for screening, so if someone passes away, even if they are not registered as a donor, their death has to be reported.”
Recently, NDRI received an $800,000 National Institute of Health (NIH) grant to support research for Alzheimer’s Disease, Autism, and HIV/AIDS; this in addition to a $6.5 million five-year NIH award given in August 2018 for recovery and distribution of human organs on behalf of the Research resource for Human Tissues and Organs (RRHTO).
A unique element of NDRI’s work supported through this agreement is provision and distribution for neurological research supported by the National Institute of Neurological Disorders and Stroke (NINDS). In the last five years, NDRI has provided 884 neurological biospecimens to 79 researchers, including normal and pathological tissues for diseases including ALS, Alzheimer’s disease, Parkinson’s disease, muscular dystrophy, pure autonomic failure, Lewy body dementia and spinal muscular atrophy. The National Heart, Lung, and Blood Institute also provides funds for tissue collection, storage and distribution in support of research into rare lung disease lymphangioleiomyomatosis (LAM), and other heart, lung, and blood tissue research.
“For a researcher, acquiring human specimens can be costly.” Leinweber reminds me, “The fees that are a charged to a researcher by NDRI are about passing on the cost for the procurement of the tissues. Our support from the NIH allows us to provide this service at a discounted rate to scientists supported by the NIH.”
NDRI employs 45 full-time staff, which includes PhD scientists, a 24/7 call center and executive management. Every order is customized, and some may require additional consultation from NDRI’s expert scientists.
“We provide both normal and diseased tissue. Surprisingly, about 60% of what we provide is normal tissue. There may be breast cancer tissue that is removed and the scientist is also interested in the normal tissue that surrounds the cancer that was excised,” Leinweber says.
NDRI has supported select research projects including one in partnership with the Cystic Fibrosis Foundation and Vertex Pharmaceuticals. “There is no animal model for cystic fibrosis,” says Leinweber. Using its extensive national network, NDRI provided suitable human biospecimens to support the development of several therapeutic compounds by industry partners that are now helping Cystic Fibrosis patients lead more productive lives.
“We continue to work with the Cystic Fibrosis Foundation on the procurement of explanted lungs which were used to support the development of the first and second drugs to treat specific mutations of cystic fibrosis,” adds Leinweber.
Identifying therapeutic targets for neuropathic pain is another research project, which investigates alternatives to using opioid-based treatments for pain. Scientists at pharmaceutical companies and academic institutes reached out to NDRI’s dorsal root ganglia (DRG) program which provides researchers with a human model system to study both pain and non-pain neurons. The result? The investigators can experiment directly on human neurons leading to peer-reviewed published medical articles in Nature Medicine and Neuron.
For the past 25 years, NDRI has been partnering with Japan’s non-profit organization, Human and Animal Bridging Research Organization (HAB) to facilitate research using non-transplantable tissue from post mortem human donors, which have been extracted for research use in the US and Europe. At one time, extraction of human organs for research and implant was forbidden in Japan.
Navigating diverse, global cultural ethics in medical research is challenging. Nevertheless, NDRI remains eager to increase its entry into international markets. Dale Foote, International Trade Specialist for the World Trade Center of Greater Philadelphia (WTCGP), has been assisting NDRI to investigate opportunities in, the UK, Canada, South Korea and Singapore. NDRI has already shipped some biospecimens to China.
When asked what obstacles NDRI may have, Leinweber replies, “Science is constantly changing and it becomes both a challenge and an opportunity. It requires us to be able to adapt. We have learned over time that researchers are doing more with less. There was a time when a researcher may have needed a whole liver to conduct a study, maybe now he or she may just need a little bit. Also, 60 to 70% of tissue we provide is fresh tissue v. frozen.”
Leinweber paints the picture, “The researcher may be from Phoenix, we may end up getting the eyes from Brigham and Women’s Hospital in Boston, and the donor may have come from somewhere in New Hampshire. Then, we have to get the courier involved, and it’s all happening in real time.”
At the end of the day, the entire NDRI team has each had a hand in advancing medical research. From their downtown office in Philadelphia, NDRI is navigating the complex web of delivering the organ and tissues entrusted by donor families. Once the package arrives, there is another team waiting to maximize the use of its precious contents to conduct research in hopes to ultimately extend and save lives.