Regulatory Open Forum

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  • 1.  Key Regulatory Challenges for Start-ups

    Posted 28-Nov-2018 19:35

    Participated in a great panel discussion on the key challenges for biomedical startups at last month's joint OCRA (Orange County Regulatory Affairs Discussion Group)/SBDC (Small Business Development Center at UCI Applied Innovation Workshop. 

    The slide deck containing more detailed supporting points for my panel remarks on the regulatory, clinical, and quality challenges can be accessed at the link below.

    Best,
    Michael

    Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for Start-Ups
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    Ensuring FDA Regulatory Success for Biomedical Companies -- Key Lessons for Start-Ups
    Supporting Materials for Michael Swit's Panel remarks at the Workshop Co-sponsored by the Orange County Regulatory Affairs (OCRA) Discussion Group and the Sma...
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    ______________________________________________
    Michael A. Swit, Esq.
    Law Offices of Michael A. Swit
    San Diego, CA
    e: mswit@fdacounsel.com
    m: 760-815-4762
    www.fdacounsel.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my law firm or any of our clients. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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  • 2.  RE: Key Regulatory Challenges for Start-ups

    Posted 29-Nov-2018 07:45
    Thanks Michael for sharing!

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    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
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    Original Message


  • 3.  RE: Key Regulatory Challenges for Start-ups

    This message was posted by a user wishing to remain anonymous
    Posted 29-Nov-2018 08:47
    This message was posted by a user wishing to remain anonymous


    Totally confusing, especially if this presentation was intended for a small start-up companies : Majority of points may not apply for the small start-ups! Some of the points are very general and may apply for the entire industry.

    For example: "What is the minimum we need to do to get approval?" vs. "What is necessary for us to provide in order to get a first cycle review approval". [if your CEO thinks first option is OK, time to update your CV]"

    For a small start-up with limited funds and are pursuing drug development for a huge unmet medical need targeting a rare Orphan drug indication, the first option is indeed strategically appropriate!! Therefore, a key point is to hire skilled people, with real practical experience (not theoretical) who have in the past enabled regulatory/clinical/preclinical development transitions from a preclinical stage to a registration stage for drugs/biologics, preferably in several therapeutic areas, should be the first step and not advocate that one size fits all philosophy, as this presentation seems to imply.
    Original Message


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