Advancing Therapeutic Development for Pain and Opioid Use Disorders Through Public-Private Partnerships Proceedings of a Workshop (2018) / Chapter Skim
Currently Skimming:
6 PublicPrivate Partnerships to Advance Pain and Opioid Use Disorders Research and Development
6 PublicPrivate Partnerships to Advance Pain and Opioid Use Disorders Research and Development
Pages 55-68
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 55... ...
. • Given the complexity and broad impact of chronic pain and the opioid epidemic across many fields, multidisciplinary partner ships that foster collaborations outside neuroscience might open new possibilities for therapeutic development (Heidbreder, Kaufmann, Powers)
|
From page 56... ...
. • Creating a clinical trials network for chronic pain would allow coordinated and more efficient testing of novel treatments in more heterogeneous populations, including lower income and minority populations and children, which is essential for developing treat ments that are effective in the real world (Koroshetz, Ostrovsky, Veasley, Volkow)
|
From page 57... ...
Other points endorsed at the stakeholder meetings convened by NIH included the creation of a research trial network, the development of biomarkers to demonstrate target engagement and stratify patients for trials, the development of objective measures of pain sensitivity, reengineering preclinical platforms to have better predictive efficacy, and applying new technologies to improve pain drug discovery, said Volkow. Robert Gereau pointed to the example of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN)
|
From page 58... ...
William Maixner suggested that the primary goal of a pain consortium might be to collect and integrate data from large human cohort studies, develop subpopulations, and do molecular profiling to begin validating targets and developing new chemical entities or repurposing existing compounds. A second goal, he said, would be to develop new bioinformatics tools for target discovery.
|
From page 59... ...
Chris Flores of Johnson & Johnson suggested that this platform also promote standardization and the use of informatics approaches, and consider many themes mentioned throughout the workshop, including the importance of spontaneous versus evoked pain behaviors. He also advocated focusing on validated targets, including cannabinoids, the opioid receptor, and various ion channels.
|
From page 60... ...
An additional goal of the preclinical testing platform could be to explore why the preclinical model was not predictive of the Phase II results and apply the learnings from those studies to improve future preclinical testing programs, said Koroshetz. Accelerating Translation with a Network for Clinical Pain Research One important goal of a PPP would be to develop a clinical network for pain that goes beyond enabling more efficient clinical trials, but also enables discovery research, said Volkow.
|
From page 61... ...
Putting together a clinical research network to conduct biomarker studies, deep phenotyping, and clinical trials will require streamlined operations and platforms that improve quality and efficiency, said Petra Kaufmann, director of Office of Rare Diseases Research at the National Center for Advancing Treatment Sciences. A single Institutional Review Board review, streamlined contracting, and improved data management systems, for example, can shorten the time to launch and complete a clinical study, she said.
|
From page 62... ...
Koroshetz suggested that another strategy might be to challenge existing heavily resourced programs with diverse expertise such as NIH's Clinical and Translational Science Awards (CTSA) to respond to the opioid crisis.
|
From page 63... ...
Children are not little adults, but they are willing and able to participate in clinical trials, said Powers. Moreover, pediatric specialists across disciplines have demonstrated the ability to collaborate and execute clinical trials, for example, through the Cystic Fibrosis Therapeutic Development Network.4 Powers cited an additional advantage of networks beyond the efficiencies mentioned by Kaufman.
|
From page 64... ...
Christian Heidbreder suggested that PPPs might also focus attention on studying the effectiveness of extended-release buprenorphine and/or other treatments in patient subpopulation programs; exploring the pharmacogenetics of addiction; and developing programs to deliver extendedrelease formulations of buprenorphine in emergency department settings as a way of preventing opioid overdose and subsequent relapse to drugseeking and drug-taking behaviors. There has also been interest in developing biomarkers for vulnerability of addiction, which could increase understanding of why some people but not others become addicted, and identify new therapeutic targets that are less likely to trigger addiction, said Volkow, adding that NIDA has been working for many years in this area.
|
From page 65... ...
, wondered if multiple partnerships are needed to address different paths individuals take on the road to addiction, such as physical or psychological pain. Indeed, Volkow noted that only a small minority of patients who are prescribed opioid analgesics for pain management ever develop an opioid use disorder (estimated around 10 percent)
|
From page 66... ...
CMS requires patients to be at the center of studies, with determination of risks and benefits central to coverage decisions for treatments as well as diagnostic and prognostic tests, she said. Because of the complexity of the Medicare population, co-morbidities are a particular challenge in the context of how Medicare views data and evidence, said Ling, noting that arthritis, cancer, and several other conditions associated with high pain levels are common in this population.
|
From page 67... ...
Ostrovsky suggested that new PPPs consider approaching states early to learn about their concerns regarding coverage of novel therapeutics and diagnostics. FINAL REMARKS Koroshetz reflected on the workshop presentations, noting that the stories shared by Veasley and Jessica Hulsey Nickel set the stage for framing discussions around what is important for patients.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.