Regulatory Open Forum

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  • 1.  Cell and Gene Therapy

    This message was posted by a user wishing to remain anonymous
    Posted 26-Oct-2018 13:33
    This message was posted by a user wishing to remain anonymous

    I am looking to partner with fellow RA professionals, to write an article on the Regulations of Cell and Gene Therapy.
    Please drop me a line if you like to contribute.

    Best Regards,

    E-mail: biomedsoln@gmail.com


  • 2.  RE: Cell and Gene Therapy

    Posted 27-Oct-2018 06:47
    Dear Anonymous,

    I would love to coauthor a paper with you on cell and gene therapies. I've assisted in the development of these products for decades.

    Thank you.

    Sincerely yours, Suzanne

    ------------------------------
    Suzanne M. Sensabaugh, MS, MBA
    President and Principal Consultant
    HartmannWillner LLC
    100 M Street SE
    Suite 600
    Washington, DC 20003
    Phone: 202-749-8616

    www.hw-fda.com
    ------------------------------

    Original Message


  • 3.  RE: Cell and Gene Therapy

    Posted 29-Oct-2018 18:36
    ​Hello,

    I'm interested.  What do you have in mind?  Suggest that you use my direct email for an off-line discussion.

    Regards,
    Clark

    clark.eid@stjude.org

    ------------------------------
    Clark Eid, Ph.D., PMP, RAC
    Director Project Management
    Therapeutics Production & Quality
    St. Jude Children's Research Hospital
    Memphis, TN
    USA
    ------------------------------

    Original Message


  • 4.  RE: Cell and Gene Therapy

    Posted 30-Oct-2018 09:41
    I would be interested. What are your thoughts on the paper?

    ------------------------------
    Joscelyn Bowersock MSc
    Quality and Regulatory Manager
    Huntersville NC
    United States
    jbowersock@carolinabiooncology.org
    ------------------------------

    Original Message


  • 5.  RE: Cell and Gene Therapy

    Posted 30-Oct-2018 11:22
    Hello,
    I would like to contribute to the article. Nonclinical, MOA, Potency, CMC
    Thanks,
    Gene

    ------------------------------
    Eugene Helsel
    Principal Consultant, Halloran Consulting Group
    ehelsel@hallorancg.com
    ------------------------------

    Original Message


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