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  • 1.  May 29 - Wondering Wednesdays for World Health

    Community Leadership
    Posted 05-29-2024 14:04

    Happy Wednesday everyone! 

    We've had some great engagement the past couple of weeks around the challenges in bringing innovative and complex therapeutics to low and middle income countries. We've been discussing this in the context of cell and gene therapy, but Joleen's recent posts highlighted the progress but also the remaining barriers to global access for mAb therapeutics. While advances in technology and manufacturing may have reduced costs, access still remains a barrier. Here's an interesting article from last year in the lancet that considers the role public health and IP play in enabling access. 

    Expanding access to biotherapeutics in low-income and middle-income countries through public health non-exclusive voluntary intellectual property licensing: considerations, requirements, and opportunities

    As pharmaceutical scientists, how does public health and IP considerations impact how we prioritize technology development or design and develop products? What are your thoughts?



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    Erica Schlesinger
    VP, Technical Development
    Seran Biosciences, LLC
    Bend OR
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 2.  RE: May 29 - Wondering Wednesdays for World Health

    Posted 05-30-2024 12:17

    Thanks for sharing this great article. While addressing IP challenges is a worthy goal, it seems unlikely to be sufficient as a standalone intervention to address this issue. A broader question is that innovation in new product development, including biosimilars development, is driven by market forces that really shape and constrain the downstream availability of medical technologies based on perceived market needs in non-LMIC countries. In principle, there should be room to innovate to develop biologic products that would be financially successful in LMICs, if the right investments were made, but such investments are typically not undertaken...



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    Gerard Honig
    Associate Director, Biomarker Research
    Otsuka Pharmaceuticals
    Glassboro NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 3.  RE: May 29 - Wondering Wednesdays for World Health

    Community Leadership
    Posted 06-21-2024 13:21

    Thank you @Gerard Honig! What would be the right investments and should we be focusing on collaborations and partnerships help with access? Focusing on the needs in non-LMIC countries, how can we effectively have new therapeutics available and accessible?



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    Allison Radwick Ph.D.
    Sr Regulatory & Policy Comms Mgr
    USP
    East Fallowfield PA
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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  • 4.  RE: May 29 - Wondering Wednesdays for World Health

    Posted 06-30-2024 16:13

    Great questions. It is plausible to attract investments in developing therapeutics for diseases affecting LMICs, so long as product(s) might eventually be sold for at least as much as it costs to manufacture it, on net. If there is any profit margin, even if small, it should be possible to develop sustainable businesses to address the need. Probably funding from nonprofits and/or governments would be needed to support product development, as it would be difficult to fundraise from VCs with this type of business model.  

    Cheers,

    Gerard



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    Gerard Honig
    Associate Director, Biomarker Research
    Otsuka Pharmaceuticals
    Glassboro NJ
    [email protected]

    Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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