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CDRC: Drug Repurposing Provides Big Impact for Patients

  1. Home. Every Cure. (2023, January 4). Retrieved February 3, 2023, from http://www.everycure.org
  2. Richardson, K. (2022, September 19). ABC7NY staff. Every Cure: New nonprofit aims to identify generic drugs to help cure rare diseases. Retrieved February 3, 2023, from https://abc7ny.com/amp/every-cure-rare-disease-nonprofit-clinton/12240968/
  3. Weintraub, K. (2022, September 18). New uses for old drugs? every cure offers hope for people with rare diseases. USA Today. Retrieved February 3, 2023, from https://www.usatoday.com/story/news/health/2022/09/18/clinton-initiative-every-cure-generic-drugs-rare-diseases/10359380002/

CPTR: Revitalizing the Pipeline:

  1. Talwar, Amish, et al. “Tuberculosis—United States, 2018.” Morbidity and Mortality Weekly Report 68.11 (2019): 257.
  2. “Trends in Tuberculosis, 2019.” Center for Disease Control and Prevention. Accessed 16 December 2020.
    https://www.cdc.gov/tb/publications/factsheets/statistics/tbtrends.htm
  3. Annabel, B., D. Anna, and M. Hannah. “Global tuberculosis report 2019.” Geneva: World Health Organization (2019).
  4. Robinson, Sally, and Robert Giffin, eds. Addressing the threat of drug-resistant tuberculosis: a realistic assessment of the challenge: workshop summary. National Academies Press, 2010. pp. 82-85.
  5. Zumla, Alimuddin I., et al. “New antituberculosis drugs, regimens, and adjunct therapies: needs, advances, and future prospects.” The Lancet infectious diseases 14.4 (2014): 327-340.
  6. “Tuberculosis Therapeutic Area User Guide v2.0.” CDISC. Accessed 16 December 2020.
    https://www.cdisc.org/standards/therapeutic-areas/tuberculosis
  7. European Medicines Agency. qualification-opinion-vitro-hollow-fibre-system-model-tuberculosis-hfs-tb_en.pdf. Published Rev 2015. Accessed 16 December 2020.
    https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/qualificationopinion-vitro-hollow-fibre-system-model-tuberculosis-hfs-tb_en.pdf
  8. Critical Path Institute. “TB ReFLECT – Meta-analysis of Phase III Quinolone Data.” Critical Path Institute. Accessed 16 December 2020.
    https://c-path.org/programs/cptr/cptr-tools/modeling-simulation-tools/tb-reflect-meta-analysis-of-phase-iii-quinolone-data/
  9. Gardner, Iain, and Oliver Hatley. “New Tools Support Developing Better TB Drugs.” Best of the Blog 2017: 39.
  10. Talwar, Amish, et al. “Tuberculosis—United States, 2018.” Morbidity and Mortality Weekly Report 68.11 (2019): 257.
  11. U.S Food and Drug Administration. 204384s000lbl.pdf. Published Rev 2012. Accessed 16 December 2020.
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202811s016lbl.pdf
  12. TB Alliance. Pretomanid_Full-Prescribing-Information.pdf. Published Rev 2019. Accessed 16 December 2020.
    https://www.tballiance.org/sites/default/files/assets/Pretomanid_Full-Prescribing-Information.pdf

 

PRO Consortium: Integrating Voices of Patients, Enabling Future Therapies:

  1. NIDDK. Irritable Bowel Syndrome (IBS) | NIDDK. National Institute of Diabetes and Digestive and Kidney Diseases. Accessed 4 December 2020.
    https://www.niddk.nih.gov/health-information/digestive-diseases/irritable-bowel-syndrome
  2. Canavan, Caroline, Joe West, and Timothy Card. “The epidemiology of irritable bowel syndrome.” Clinical epidemiology 6 (2014): 71.
  3. Camilleri, Michael, et al. “Reviews in Basic and Clinical Gastroenterology and Hepatology.” Gastroenterology 135.6: 1877-1891.
  4. M Ervin, Claire, and Allen W Mangel. “Clinical trials in irritable bowel syndrome: a review.” Reviews on recent clinical trials 8.1 (2013): 9-22.
  5. Fehnel, Sheri E., et al. “Development of the diary for irritable bowel syndrome symptoms to assess treatment benefit in clinical trials: Foundational Qualitative Research.” Value in Health 20.4 (2017): 618-626.
  6. 202811s016lbl.pdf. Published Rev 2020. Accessed December 4, 2020.
    https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202811s016lbl.pdf

 

Polycystic Kidney Disease Outcomes Consortium: Impact on Industry and Patients:

  1. Wouters, O. J., M. McKee, and J. Luyten. “Estimated research and development investment needed to bring a new medicine to market, 2009-2018 [published March 3, 2020].” JAMA.
  2. Harris, Peter C., and Vicente E. Torres. “Polycystic kidney disease.” Annual review of medicine 60 (2009): 321-337.
  3. PKD Foundation. “What is ADPKD?” PKD Foundation. Accessed 18 December 2020. https://pkdcure.org/what-is-adpkd/

 

Critical Path for Alzheimer’s Disease Consortium: Answering Critical Unmet Needs through the Critical Path for Alzheimer’s Disease:

  1. Gauthier, S., Rosa-Neto, P., Morais, J. A. & Webster, C. World Alzheimer Report 2021: Journey through the diagnosis of dementia. https://www.alzint.org/u/World-Alzheimer-Report-2021_29.09.pdf (2021).
  2. 2021 Alzheimer’s disease facts and figures. Alzheimers Dement 17, 327–406 (2021).
  3. Economic Burden of Alzheimer Disease and Managed Care Considerations. AJMC https://www.ajmc.com/view/economic-burden-of-alzheimer-disease-and-managed-care-considerations.
  4. Cummings, J., Lee, G., Zhong, K., Fonseca, J. & Taghva, K. Alzheimer’s disease drug development pipeline: 2021. Alzheimers Dement (N Y) 7, e12179 (2021).
  5. Cummings, J., Feldman, H. H. & Scheltens, P. The “rights” of precision drug development for Alzheimer’s disease. Alzheimer’s Research & Therapy 11, 76 (2019).
  6. Conrado, D. J. et al. Hippocampal Neuroimaging-Informed Clinical Trial Enrichment Tool for Amnestic Mild Cognitive Impairment Using Open Data. Clin Pharmacol Ther 107, 903–914 (2020).
  7. Hill, D. L. G. et al. Coalition Against Major Diseases/European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer’s disease. Alzheimer’s & Dementia 10, 421-429.e3 (2014).
  8. European Medicines Agency (EMA). Qualification opinion of low hippocampal volume (atrophy) by MRI for use in regulatory clinical trials – in pre-dementia stage of Alzheimer’s disease. (2011).

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