#95 – A to Z on R&D: Challenges and Solutions for Sustained Antimicrobial Drug Development

In this episode, Drs. Helen Boucher (@hboucher3), Ramy Elshaboury, and Mike Dudley (@MikeMNDudley) join host, Megan Klatt (@MeganKlatt3), to discuss barriers to antimicrobial drug development, potential incentives and legislation to promote market growth, and what we can do to ensure the antimicrobial pipeline doesn’t run dry.
 
References
  1. An analysis of antibacterial drug development trends in the United States, 1980-2019: Dheman N, et al. Clin Infect Dis. 2021 Dec 6;73(11):e4444-e4450. doi:10.1093/cid/ciaa859. PMID: 32584952.
  2. Antibacterial R&D at a crossroads: we’ve pushed as hard as we can…now we need to start pulling!: Rex JH, Outterson K. Clin Infect Dis. 2021 Dec 6;73(11):e4451-4453. doi:10.1093/cid/ciaa852. PMID: 32584949.
  3. No Patient Left Behind (website): https://www.nopatientleftbehind.org/ (many useful explainers of how the investment, innovation cycle, and drug pricing work)
  4. ISPOR special task force report on defining elements of value in health care – a health economics approach: Lakdawalla DN, et al. Value Health. 2018 2018 Feb;21(2):131-139. doi: 10.1016/j.jval.2017.12.007. PMID: 29477390.
  5. Generalized cost-effectiveness analysis to assess treatment value in hepatitis C: Chou JW, et al. Am J Manag Care. 2023 Dec;29(12):696-703. doi: 10.37765/ajmc.2023.89468. PMID: 38170486.

Ramy Elshaboury, PharmD, BCPS-AQ ID

Dr. Elshaboury is the director of clinical pharmacy services and PGY2 Infectious Diseases pharmacy residency program director at Massachusetts General Hospital. He is a former chair of the Society of Infectious Diseases Pharmacists (SIDP) Policy & Government Affairs Committee and co-author of the SIDP Position on Incentives to Support Antimicrobial Drug Development.

Michael Dudley, PharmD

Dr. Dudley is the current president, CEO, and co-founder of QPEX Biopharma and has over 30 years of experience in anti-infective R&D and commercialization, including serving on expert regulatory and scientific advisory committees. He is also a member of the SIDP Policy & Government Affairs Committee and co-author of the SIDP Position on Incentives to Support Antimicrobial Drug Development.

Helen Boucher, MD

Dr. Boucher is the Dean and Professor of Medicine at Tufts University School of Medicine and Chief Academic Officer of the Tufts Medicine Health System. She is the chair of the National Institutes of Health Antibacterial Resistance Leadership Group Innovations Working Group and in 2015 was appointed a voting member of the Presidential Advisory Council on Combating Antibiotic Resistant Bacteria.

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