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  • 1.  Participants for Doctoral Research Study on Biosimilars

    Posted 28-Aug-2015 11:44

    I wish to solicit the help of members as volunteer research participants for my dissertation. I am a doctoral candidate at Walden University conducting a research study for my dissertation entitled "Exploring regulatory decision process regarding similar biotherapeutics in the United States".

    The purpose of this study is to explore the experiences of leaders/managers in biotherapeutics firms involved in biologic/biosimilars development regarding regulatory knowledge required in the decision-making process for biosimilar products licensing and uptake.

    I am seeking access to 20-25 participants who are leaders, managers and professionals (regulatory/quality) in companies involved in or connected biosimilar development. Their participation will involve answering 15 questions about biosimilar regulations and decision making within their organizations. The interview will be conducted by phone between September/October 2015.

    The outcome of this study will serve to help stakeholders understand currents Biosimilars/similar biotherapeutics regulation and learning in companies. The result will ultimately help biopharmaceutical organization leaders in formulating regulatory process across their organization to ensure compliance with regulation in today’s high regulatory demands. Also, this study is envisaged to contribute to efficient business practice by helping leaders and manager understand regulatory processes important to similar biotherapeutics firms in navigating the new regulatory landscape resulting from FDA issuance of Biosimilar Guidance.

    The research will be conducted in by accordance with Walden University and HHS guidelines on ethical research. Hence, all participating professionals and organizations will be kept confidential. Interested companies will be credited if they so desire in the final report.

    I am available to answer any question anyone may have to help facilitate access to participants for this research.

     

    Kind regards,

    ------------------------------

    Charles Jagun
    DURHAM NC
    United States
    ------------------------------

    Charles.jagun@waldenu.edu



  • 2.  RE: Participants for Doctoral Research Study on Biosimilars

    Posted 28-Aug-2015 22:37
    Charles,

    You are trying to do a great work.

    Skimming through your post, the following caught my attention.

    "Exploring regulatory decision process regarding similar biotherapeutics in the United States"..."The outcome of this study will serve to help stakeholders understand currents Biosimilars/similar biotherapeutics regulation and learning in companies."

    Accordingly, I offer the following for your consideration.  

    In view of the above, I would recommend you please have a chance to read and fully understand the recent FDA guidances on biosimilars. Then please also have a chance to read the relevant and applicable statutory sections and FDA regulations.  Once you are very familiar with the applicable laws/regulations and FDA guidances on biosimilars, you can then begin to talk to professionals working on biosimilars!

    For your convenience, you may refer to the following:
    I believe you will then be ready, willing and able to report the outcome in a practical, actionable manner!  

    s/ David
    ____________________________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    President and CEO | REGULATORY DOCTOR and GCS
    Phone (Toll-Free): 1-(800) 321-8567


    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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    Original Message


  • 3.  RE: Participants for Doctoral Research Study on Biosimilars

    Posted 30-Aug-2015 20:38

    Hi David,

    Many thanks for your comments and suggestions. You are right on the advise to look at FDA Biosimilar Guidance documents and relevant legislation on biosimlars in the US. Actually, the foundation of this study is rooted in the BPCI Act (section 351(k) of the PHS Act) which establishes an abbreviated licensure pathway for biological products shown to be biosimilar to or interchangeable with approved biologic. In addition, this study also incorporate elements of the seven Biosimilar Guidance released by FDA following in the initial draft released in April 2012. However, the focus of the study hinges on regulatory/management in view of these guidelines.

    Your help will continued to be appreciated. You can send me email via charles.jagun@waldenu.edu or ckjagun@gmail.com for specific information on this study.

    Kind regards,

    Charles


    Original Message