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CDRC Accomplishments

Accomplishments

A significant number of accomplishments were completed in Year 9 across several diseases (infectious, non-communicable), clinical trials (decentralized outpatient, inpatient embedded in clinical practice), and the development of tools to automate the extraction of quality key data variables from electronic health records. Specifically, this includes:

Drug Repurposing FAQ Icon
  • Stood up the Medicines Repurposing International Network (MERIT) in collaboration with NHS. The network consists of fourteen organizations spanning eight countries plus the European Union and the World Health Organization. The network supports collaboration and communication between publicly funded drug repurposing initiatives.
  • Assisted in the development, consensus, finalization, and deployment of a sarcoma clinical case report form for CURE ID with input from multiple stakeholders.
  • Initiated contract with xCures to extract data from sarcoma patient EHRs for PEComa cases.
    Students from Clemson University School of Medicine and Interns from CDRC extracted PEComa cases from the literature to CURE ID.
  • Established and led monthly sarcoma workgroup calls for patients, clinicians and FDA OCE (Oncology Centers of Excellence) to develop a sarcoma pilot within CURE ID.
  • Engaged with stakeholders to determine potential to share data with CURE ID (Broad Institute, National Cancer Institute (NIH), EHE Foundation, and the Insituto Nationale dei Tumori in Milan).
  • Aligned with community of international sarcoma clinicians on development of a global master protocol for ultra rare sarcomas and the launch of such a trial (PUSH).
  • Partnered with Sarcoma Foundation of America who agreed to host a patient centered webinar (Jan 18, 2024) that introduces the initiative with CDRC, clinician and xCures perspectives followed by questions from patients.
  • Engaged Aadi Bio Science to promote CURE ID to their prescriber network to recruit physicians and patients to participate in the sarcoma pilot.\
  • Engage with NCI regarding data sharing for rare sarcomas.
Infectious Diseases FAQ Icon
  • Partnered with HeHealth to review and edit the Mpox CRF on CURE ID and to promote outreach to patients.
  • Created an international STI surveillance group under the auspices of WHO with existing surveillance efforts in the US, Canada, and the UK to partner on a project to identify repurposed drugs for Neisseria gonorrhea with additional countries as observers. This group helped create the CRF for Neisseria gonorrhea.
  • Organized a monthly Long COVID Clinical Think Tank call series consisting of 27 clinical trialists regulators, academicians and foundations across the US, Canada, and Europe to review and discuss challenges in setting up and designing clinical trials for this disease.
  • Created an international implantation mycosis workgroup under the auspices of WHO to partner with treatment clinics in Brazil, Mexico and Madagascar on a project to identify repurposed drugs for four distinct fungal infections with additional countries as observers.
  • Developed and finalized a case report form for Implantation Mycosis, sent to NCATS and is now available on CURE ID.
Rare Diseases FAQ Icon
  • Finalized clinician and patient case report forms for RASopathies and submitted to NCATS for inclusion in CURE ID.
  • Established a patient group to provide stakeholder input.
  • Engage NCI regarding RASopathies and their registry.
Clinical Trials FAQ Icon
  • Long COVID Outpatient Decentralized Pilot Trial
    • Worked with Berry Consultants and clinical trial collaborators to develop and optimize decentralized trial design for the treatment of patients with Long COVID in the outpatient setting.
    • Identified Principal Investigator and co-Investigator to develop and finalized pilot protocol to assess the feasibility of methods and procedures for later use in a larger scale decentralized platform adaptive randomization clinical trial.
    • Obtained Emory IRB approval for randomized pilot trial treating Long COVID. Submitted IND amendment to FDA for pilot protocol.
    • Posted trial on ClinicalTrials.gov: NCT05946551.
    • Developed Part 11 compliant REDCap database for electronic data capture of trial data.
    • Trial enrollment anticipated to start mid-January, 2024.
  • Inpatient Trial
    • Worked with Berry Consultants and clinical trial collaborators to develop and optimize trial design for the treatment of patients with sepsis in the inpatient setting.
    • Identified Principal Investigator and co-Investigators.
    • Identified all necessary variables required to be extracted from EHRs for the trial.
    • Developed a modified Delphi process to generate consensus amongst partners regarding treatment options that should be evaluated first.
    • Working with Every Cure advanced AI engine to identify and rank repurposed drugs of interest to take to the clinic.
EHRs Data Extraction FAQ Icon
  • Data transfers received from 7 institutions (>75,000 COVID patients). Projected to exceed 10 institutions and 100K patients for the project.
  • Invited to lead RWD and data standards committee at SCCM. Specifically asked to bring regulatory perspective and build strategic partnership to elevate standard of evidence generated across critical care research. C-Path to co-facilitate stakeholder listening session at SCCM annual meeting in January 2024 to explore unmet needs and interest in drug repurposing and regulatory grade research in critical care.
  • Invited to serve on common data elements steering committee for National Trauma Research Registry. This project is backed by the DoD and specifically interested in receiving regulatory guidance from CDRC to enhance trauma research on repurposed drugs.
  • CDC Grant Sub-award: Pregnant People-Infant Linked Longitudinal Surveillance to sustain, improve, and expand surveillance efforts from entities that have data systems to identify pregnant people-infant linked longitudinal data. The goal is to ensure timely reporting of key exposures and outcomes that impact pregnant people and infants, to improve data quality and share evolving outcome data, to innovate clinical strategies, and to build a strong collaborative network.
Peer-Reviewed Publications FAQ Icon
Non Peer-Reviewed Publications FAQ Icon
Posters FAQ Icon
  • “Making OMOP Happen: An Implementation Science Approach” Authors: Maya Younoszai, Pam Dasher, Danielle Boyce, and Smith Heavner accepted for the October 20th, 2023, OHDSI Symposium in New Jersey.
  • “Repurposing in RASopathies”. Authors: Shira Strongin, and Heather Stone. Presented at the CDRC Annual Meeting in Washington, D.C.
  • “Deploying the Edge Tool Suite to Extract Real-World Data: an Implementation Science Approach”. Authors: Maya Younoszai, Danielle Boyce, and Smith Heavner. Presented at the CDRC Annual Meeting in Washington, D.C.\
  • “CURE Pregnancy Treatment Repository: Prioritizing Systematic Collection of Real-World Data to Identify Effective Treatments in a Special Population”. Authors: Mili Duggal, Reema Charles, Nalini Oliver, and Heather Stone. Presented at the CDRC Annual Meeting in Washington, D.C.
  • “Lowering the OMOP ETL Barrier for Clinical Registries”. Authors: Smith Heavner, Trayson Llano, Zachary Wang, Marco Schito, Heather Stone, Pam Dasher, Tresha Russel, Vishakha Kumar, Ben Saeks, Michael Cooke, Rahul Kashyap, Matt Robinson, and Paul Nagy. Presented at the CDRC Annual Meeting in Washington, D.C. and at 2023 OHDSI Symposium in New Jersey.
  • “Landscape Analysis of Drug Treatments for PEComa” Authors: Jamila Johnson, Dakota Makulec, Reema Charles, Marco Schito, and Smith Heavner presented at the CDRC Annual Meeting in Washington, D.C.
  • “Leveraging the EPIS Framework to Extract Real-World Data from the Electronic Health Record” Authors: Dasher P., Younoszai M., Boyce D., and Heavner S. Abstract accepted for 16th Annual Conference on the Science of Dissemination and Implementation Science. December 10- 13th, 2023 in Arlington, VA.
  • “The Landscape of Infections Caused by Rare Bacterial Pathogens” Authors: Reema Charles, MBBS, MS, Barbara Milani, Daniel Argaw Dagne, Bisma Ali, Heather Stone, MPH, Marco Schito, Raghavendra Tirupathi, MBBS, MD, and Nalini Oliver at IDWeek 2023 in Boston.
  • “Landscape Analysis to Identify Effective Drug Repurposing Candidates for the Treatment of Implantation Mycoses: Comparison of World Health Organization Survey Treatment Data” Authors: Reema Charles, MBBS, MS, Barbara Milani, Daniel Argaw Dagne, Bisma Ali, Heather Stone, MPH, Marco Schito, Raghavendra Tirupathi, MBBS, MD, and Nalini Oliver at IDWeek 2023 in Boston
  • “Case Reports on CURE ID, and The Lesser Known Treponemal Infections: A Review of Non-Syphilitic Cases”Authors: Ashima Gupta, MBBS, Saarthak Malhotra, MBBS, Aasa Deepika Kuditipudi, MBBS, Reema Charles, MBBS, MS, Tahsin Farid, MD MPH, Raghavendra Tirupathi, MBBS, MD, and Barath Prashanth Sivasubramanian, M.B.B.S at IDWeek 2023 in Boston.
  • “From OMOP to CDISC SDTM: Successes, Challenges, and Future Opportunities of Using EHR Data for Drug Repurposing in COVID-19” Authors: Wesley Anderson, Ruth Kurtycz, Tahsin Farid, Shermarke Hassan, Kalynn Kennon, Pam Dasher, Danielle Boyce, Will Roddy, Smith F. Heavner at OHDSI Global Symposium, 2023 New Jersey.
  • “Developing an End-to-End Data and Analytics Pipeline Using AWS Resources and Natural Language Processing to Support the Analysis of Repurposed Drugs” Authors: Wesley Anderson, Roopal Bhatnagar, Smith Heavner, Marco Schito, Shu Chin Ma, Klaus Romero, Jagdeep Podichetty at ACoP 14 in Maryland.
Communications FAQ Icon
  • Rare Disease Day Impact Story: “Drug Repurposing Provides Big Impact for Patients and social media posts on publications https://c-path.org/impact_story/drug-repurposing-provides-big-impact-for-patients/
  • The CDRC co-Chair, Dr. David Fajgenbaum, Keynote address is on C-Path’s YouTube channel and can be accessed here.
  • The CDRC Annual Meeting Q&A interviews are officially posted on C-path’s YouTube channel and can be accessed from the CDRC website.
  • Smith Heavner, PhD, RN’s podcast episode on AACN’s leadership podcast. Leading Research and Impacting Patient Outcomes (blubrry.com).
  • SCCM’s Critical Connections Newsmagazine features Smith Heavner on page 18, “REDISCOVER-ICU”. The article talks about utilizing data to study drug repurposing beyond Covid-19 Critical Connections Summer 2023 by SCCM – Flipsnack.
  • In Honor of #JulySarcomaAwarenessMonth, CDRC wrote an Impact Story titled “By Bringing Patients’ Voices to the Forefront, Sarcoma Advocates Illustrate Community’s Innovative Impact” surrounding two dedicated partners, Denise Reinke and Lisa De Young. By Bringing Patients’ Voices to the Forefront, Sarcoma Advocates Illustrate Community’s Innovative Impact | Critical Path Institute (c-path.org).
  • In this podcast episode, listen to Ms. Heather Stone, FDA’s health science policy analyst in the FDA’s Office of Medical Policy, and Dr. Marco Schito, Executive Director of the Critical Path Institute’s CURE Drug Repurposing Collaboratory (CDRC) discuss CURE ID and the exciting plans to expand the tool beyond infectious diseases. CURE ID can be found online at https://cure.ncats.io or it can be downloaded from the App or Play store as “CURE ID”. Listen to the podcast here: https://lnkd.in/gFrA2VFT
  • Completed a Clinical Scholars Program with 8 CURE ID Clinical Scholars, second round of Clinical Scholars will begin in January 2024.
  • Developed outreach materials, partnerships, and tools to engage patients for sarcoma projects that were IRB approved posted on the Patient Center.
Presentations Delivered at Conferences FAQ Icon
  • Smith Heavner attended and presented “Leveraging the SCCM Discovery VIRUS COVID-19 Registry to Evaluate Drug Repurposing Research Dataset” at SCCM Annual meeting in San Francisco, CA January 20-24, 2023. Also successfully identified 16 additional sites to implement the Edge Tool in EHRs for the project.
  • CDRC Annual Meeting. April 18th – 20th, 2023 in Washington, D.C. Presentations from the Annual Meeting can be found on the CDRC Website along with speaker bios, and a detailed agenda. CDRC |
  • Marco Schito presented “US and UK government responses to the challenges” at the CeBIL symposium Sustainable health innovation, grand challenges & the law June 14th- 15th, COPENHAGEN
  • Heather Stone spoke on “CURE ID: The Potential to Identify Treatments for Rare Disease Through Drug Repurposing” at the Rare & Orphan Disease Conference. September 11, 2023 Washington, D.C.
  • Marco Schito presented virtually on “Repurposing and better use of clinical data”. Organized by the Spanish regulatory agency AEMPS on the 27th of September in Madrid, Spain regarding the funding challenges in drug repurposing as part of the MERIT regulatory working group.
  • Heather Stone participated as a panelist in panel “The Potential Impact on Drug Repurposing” at the NORD Rare Disease & Orphan Products Breakthrough Summit, Washington, DC. October 15-17, 2023.
  • Smith Heavner, presented on “Collecting and Leveraging Real- World Data” at the. The Health Research Alliance (HRA) Members Meeting, in Chicago, IL. October 16-17, 2023..
  • Keyla Tumas presented “Real-world data for repurposed drugs to treat implantation mycoses” at the Symposium: Neglected Implantation Mycoses: getting out from under the skin. 21st INFOCUS annual meeting for The Latin American Forum of Fungal Infections in Clinical Practice. Nov 16, Iguazu Falls, Brazil.
Conferences Attended FAQ Icon
  • RASNet (RASopathies Network) conference July 21-23, 2023, Denver, CO. Aligned with patient advocates, met rare disease clinicians, researchers, patients, and industry members.
  • Sarcoma Alliance for Research through Collaboration (SARC) Semi-annual meeting. June 2nd, 2023, Chicago, IL Leading into the annual meeting of the American Society of Clinical Oncology (ASCO).
  • ASCO June 2- 6, 2023, Chicago, IL- a unique and unparalleled opportunity to connect with one of the largest, most diverse audiences in global cancer care.
  • Drug Information Association (DIA) 2023 Global Annual Meeting June 25-29, 2023, Boston, MA. The DIA 2023 Global Annual Meeting invited industry, regulatory government, academics, and patients to network, problem-solve, and discuss global and local challenges facing the life sciences community.
  • Critical Care Datathon August 5th and 6th, New York. The Society of Critical Care Medicine’s (SCCM) Datathon is a collaborative event connecting clinicians with data scientists to develop pragmatic data-driven models applicable to the care of critically ill patients using de-identified critical care electronic health record datasets.
  • Dysautonomia International (DI) Conference July 14th and 15th in Washington, D.C. Connect with clinicians, patients, and care partners in the Long COVID community about CDRC and CURE ID work aimed at collecting data on use of drug repurposing in managing symptoms.
  • Data-Driven Drug Repurposing Workshop: Unlocking disease biology and advancing systematic approaches, October 2-4, Redwood City, CA. Hosted by the Chan Zuckerberg Initiative, this workshop brought key actors who are advancing data-driven approaches for drug repurposing.\
  • IDWeek October 11 -15, 2023 in Boston, MA. ID Week is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP).
  • ASTMH on October 18 – 22, 2023. American Society of Tropical Medicine and Hygiene (ASTMH) Annual Meeting was attended in Chicago, IL.
  • CTOS, The Connective Tissue Oncology Society Annual Meeting, from November 1st – 4th in Dublin, Ireland. Met with patient advocates, met oncology clinicians, researchers, patients, and industry members.
  • the BIONJ Patient Advocacy Summit on November 16th in Lawrenceville, NJ. This one-day summit was to educate, engage, and empower the patient advocacy community.

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