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September 2019|December 2019

NIH Pain Consortium Quarterly Meeting Minutes – 9/3/2019

Welcome & NIH HEAL Update
Walter Koroshetz, NINDS

Dr. Linda Porter has officially been named the Director of the Office of Pain Policy and Planning.

The NIH HEAL initiative launched in FY18 with funds for 2018-2019.  The NIH OD set the overall research priorities and invited all ICs to propose plans for HEAL Programs.  RFAs were released and reviewed in approved areas. Proposals were presented and discussed at the Multi-Disciplinary working group (MDWG) meetings.

Decisions on funding of proposed NIH HEAL Initiative projects are being made through the HEAL executive committee, IC councils, and the HEAL MDWG. Final decisions will be made by the HEAL Executive Committee led by Dr. Collins.

The FY19 Tentative spending plan shows an estimated total of $930 million dollars.  The range of research priorities include Implementation Science (28%); Clinical Pain Research (22%); Medicine Development (16%); Pre-Clinical Pain Research (14%); Prevention & Treatment (12%); SBIR/STTR, Program Evaluation, RMS (5%) and Infants & Children (3%).

The Pre-clinical pain research includes discovery and validation studies, devices, PSPP (animal and human cell preclinical screening platform), and SPARC – Stimulating Peripheral Activity to Relieve Conditions (which receives funds from NIH Common Fund).

Clinical research in pain management includes biomarker studies, a common fund-supported study on the transition from acute to chronic pain; An Early Phase Pain Investigation Clinical Network (EPPIC-NET); and comparative effectiveness research: Effectiveness Research Network and Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM).

 

Update on the Natural Products and Pain Workshop/potential trans-NIH working group
Wen Chen & Craig Hopp, NCCIH

The natural products and pain workshop was held on Feb 6th 2019.  Workshop organizers included Wen Chen & Dee Gamliel (NCCIH), Michael Oshinsky (NINDS), Philip Sanderson (NCATS) and Barry O’Keefe (NCI) and Flora Katz (FIC) who joined the post workshop meetings.  The major recommendations were for more repositories for compounds and assays, and more discovery science. 

The workshop is not part of the HEAL program, but there are elements from both that can be leveraged so as not to reproduce efforts.  These include the HEAL objectives to accelerate the discovery and pre-clinical development and advance new non-addictive pain treatments through the clinical research pipeline. 

A natural products and pain platform was developed.  Starting with an electronic knowledgebase to a targeted repository (potentially pulling from the NCI natural products library) to targeted and phenotypic assays to translational research.  At different stages, philanthropic participation, industry and existing or new HEAL initiatives could be incorporated. This isn’t considered a linear process, processes may occur in parallel.  The proposed platform was approved through NCCIH concept clearance in June 2019.  A supplement has been received for data mining as a first step.

HEAL Programs for pain in which natural products are relevant and included are the discovery and validation of novel pain targets; preclinical screening platforms & novel drug development; discovery and validation of biomarkers, biomarker signatures and endpoints for pain indications; and data & asset sharing and the early phase pain investigation clinical network. 

Emerging collaborations at NIH: NCCIH provides support for postdocs to identify active natural product compounds; NCI provides NCATS with Natural Product Library; NCATS screens in analgesic assay and provides NCI information on active fractions.

What is the landscape of natural products? The NCI natural products library is part of the cancer moonshot.  The collections aren’t inherently cancer-related. They have 200,000 collections this year, but it’s unknown how many would have potential analgesic properties. There is an electronic database for natural products called natural products alerts.  The goal would be to pull a library of analgesic targets from the NCI NP library.

 

Pain Consortium Website & Pain Awareness Month Updates
Leah Pogorzala, NINDS

September is Pain Awareness Month.  The NIH Pain Consortium website (painconsortium.nih.gov) currently features various pain programs including the Common Fund’s Acute to Chronic Pain Signatures program, the NIH HEAL Initiative, the IPRCC and more.  The website has sections on about Pain consortium, Meetings & Events; Funding & Research; News; Health Information; and a Resource Library. Pain Awareness Month activities include social media posts on pain, the HEAL initiative, a highlight of headache/migraine pain, particularly a new Pain Trainer App for children that will be released in Sep. 2019, and an interview by pediatric pain researcher Dr. Andrew Hershey.  Highlights from PC institutes include NCCIH who is hosting its 20 year anniversary, and NHLBI who recognizes sickle cell awareness month in September.

Dr. Pogorzala asked the group for feedback on what they find most helpful and would like to see.  Members commented that the meeting minutes were useful for them and the about page which features member contact information for each IC was most valuable to prospective and current pain researchers. Other ideas included finding a way to leverage HEAL information without it being overwhelming; tying in science advances; including HEAL CDEs for pain research; headache CDEs; common fund permanent link; SPARC research link; and a BRAIN component.  For pain awareness month, the idea to combine interviewing a patient and a researcher for the same pain condition was proposed (consider podcasts).  Dr. Volkow proposed we consider a color and symbol for pain. This could potentially be launched as a challenge to the pain community at or before the NIH Pain Consortium Symposium.

 

Common Fund A2CPS Update
Linda Porter, NINDS

The Common Fund Acute to Chronic Pain Transition (A2CPS) program is co-chaired by Nora Volkow and Walter Koroshetz and the lead coordinators are John Satterlee and Linda Porter.  Trish Labosky is the lead coordinator on the Common Fund side.  The program consists of a clinical coordinating center (CCC), a data coordinating center (DIRC), three omics data generating centers (ODGCs) which analyze omics that come in, and finally multisite clinical centers (MCCs) which conduct the clinical studies. 

The goal of the program is to identify a signature based on a group of biomarkers that can predict an acute pain event moving into chronic pain or resilience.

The first round of NOFOs has been released, all have been awarded except for one MCC.
The first multisite clinical center award went to John Burns’ group from Rush University. They will be looking at knee replacement surgery which has high prevalence and a high level of transition to chronic pain.  Specific inclusion and exclusion criteria will need to be determined to deal with issues with prior chronic pain and functional disability.

This project is closely associated with HEAL and will share CDEs and data sharing and patient engagement protocols.

A second MCC was not awarded and an NOFO was re-issued. A webinar for investigators will be held September 19th.  The kick-off meeting for the program will be September 25-26th.

 

Survey Data on Effects of Prescribing Practices
Linda Porter, NINDS

Dr. Porter provided an update on a potential project that would utilize survey data to evaluate the impact of rapid opioid tapering on persons with pain. Dr. Nahin suggested the Medical Expenditure Panel Survey (MEPS), which recruits an estimated 20,000 adults who are followed every year at 6 month intervals. The participants keep medical record diaries and information such as tests, procedures, drugs, and diagnoses are collected from the provider and verified by pharmacists.  This information can be used to assess the impact of opioid tapering on comorbidities such as epilepsy and delirium as well as mortality outcomes such as acute cardiovascular events, suicide and alcohol-related deaths. There are over 20 years of MEPS data, years can be combined to increase sample size.   

One of the challenges mentioned was the survey not being able to capture people who leave the healthcare system after rapid opioid tapering because they are in such dire straits. 

NIDA, OBSSR and ORWH expressed interest in pursuing a statement of work for a contract to pull these data together.

 

IPRCC & PC Symposium 2020 Updates
Cheryse Sankar, NINDS

The Interagency Pain Research Coordinating Committee (IPRCC) is accepting nominations for 2020 members through September 23rd.

The 2020 NIH Pain Consortium Symposium will be held on June 3rd and June 4th, 2020.  The symposium will no longer be held in conjunction with the NIH HEAL Investigator’s meeting.

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