Award Data

ABSTRACT The identification and removal of process-related protein impurities (PRPI) from biologic products is a critical step in drug development. Despite recent improvements in the purification and processing of biologics, the presence of immunogenic PRPI continue to raise concerns about drug safety and efficacy. We propose an innovative approach for assessing immunogenicity risk of PRPI using o ...

In this Phase IIB SBIR project for Alzheimer’s disease (AD) drug development, Neurodon LLC proposes to conduct preclinical development and IND-enabling activities on our novel, orally available lead and backup compounds that, in our preceding Phase II project, showed neuroprotection and beneficial effects on learning and memory in a transgenic model of AD. Despite the enormity of AD as a nationa ...

PROJECT SUMMARYThe objective of this Phase I study is to develop a 3-month delivery buprenorphine formulation for treating opioid use disorder (OUD). Developing a long-acting injectable buprenorphine formulation is urgently necessary for treating OUD. Currently, only two 1-month buprenorphine injectable formulations, Sublocade® and Brixadi®, are approved by the U.S. Food and Drug Administration ...

PROJECT SUMMARY: Opioid Use Disorder (OUD) in pregnant women, Neonatal Opioid Withdrawal Syndrome (NOWS) and associated hospital costs have dramatically increased in the past decade, with an American child is born suffering from NOWS every 15 minutes. The ongoing opioid epidemic is further worsened by the COVID- 19 pandemic. Despite medication treatment for OUD with buprenorphine or methadone, the ...

PROJECT SUMMARY Thoracic surgery (TS), especially pneumonectomy, lobectomy and segmentectomy, are common and very painful surgeries for lung lesions with high incidence of uncontrolled acute surgical pain, chronic post- thoracotomy pain and excessive opioid use. Those with poorly controlled acute surgical pain are at risk for chronic post-surgical pain (CPSP), long-term opioid use and opioid addic ...

ABSTRACT Neurological disorders affect millions of people each year, many with no cures. Researchers and clinicians are actively seeking a deeper understanding of how the human brain functions to develop new treatments and cures. Optical functional imaging is a tool broadly applied in neuroscience. The advance of genetically encoded functional indicators allows the visualization of neuronal activi ...

PROJECT SUMMARY Advances in clinical imaging technologies have increased the incidental detection rate of cystic pancreatic lesions. However, patients remain at risk due to the lack of a definitive diagnosis that accurately assesses if these cysts are pre-malignant. In the absence of robust diagnostic indicators, clinicians must balance patient safety due to a cystic lesion's rapid and aggressive ...

It is estimated that approximately 5-10% of all diagnosed cancers are caused by Hereditary Cancer Syndromes (HCS) that are associated with germline mutations (inherited genetic mutations passed directly from a parent to a child that create a genetic predisposition to certain types of cancer). Recent epidemiologic models indicate that 1 in 279 people may be carriers of one of the most common HCS, a ...

Summary Climate change is an urgent public health threat, and climate-related health risks disproportionately impact vulnerable populations. Public health agencies have underscored the need to develop scalable and innovative health-equity centered, multi-level interventions that offer tools and resources to 1) raise awareness of the inextricable link between climate change and health and 2) suppor ...

PROJECT ABSTRACT Although rt11 million family/friends are caregivers to rt6 million people with Alzheimer's Disease (AD) and AD- Related Dementias (AD/ADRD), they do not typically receive personalized education, strategies and support to manage their own wellbeing and complex dementia-related symptoms. Lack of personalized care contributes to $321 billion annually in AD/ADRD care costs. In respons ...