Regulatory Open Forum

 View Only
  • 1.  Preparing your first BLA

    Posted 12-Mar-2019 10:23

    As a company, we are undertaking efforts to prepare a BLA submission for a cellular therapy product.  I was wondering if anyone could share some lessons learned when preparing a BLA, especially when it's the first one for the organization.  Do you have any good resources to use in the process?  Do you have any planning tools like a submission tracker etc. that you would be willing to share?  I am also looking for a contract regulatory project manager to lead the effort.  If interested please contact me by 03/15 for a copy of the RFP.  

    Thank you,

    Stephen Westover
    Pittsburgh, PA

  • 2.  RE: Preparing your first BLA

    Posted 13-Mar-2019 08:10
    ​Congratulations - that is an exciting milestone!  Hopefully you have some internal regulatory expertise, but I absolutely support bringing in some external help - this is a huge effort.  I would recommend the Biologics Consulting Group (they have some great people on staff) or Cato Research (a CRO with a long history helping less experienced sponsors file interesting niche products).  Both would be able to help with the type of activities you list here. 

    Best of luck on this adventure!



    Cato Research:

    Catherine Anderson PhD, RAC
    Associate Director - Regulatory CMC
    Hillsborough NC
    United States

  • 3.  RE: Preparing your first BLA

    Posted 18-Mar-2019 14:47
    Edited by Pratik Pednekar 18-Mar-2019 14:47

    Hi Stephen, 

    I am currently working on authoring the CMC sections of a new BLA which my company is planning to file later this year. Some of the submission planning tools which have proved to be very productive in tracking this beast of a submission are as follows:

    1) Veeva: I have worked on a couple of QMS systems before but this is the most robust QMS I have used. Very user-friendly and super convenient in searching documents, checking-out, and checking-in docs, sending docs for reviewing or authoring and sending reminders to the reviewers about their due date. 
    2) Smartsheet: This is something new which was introduced in our company and this is 1000 times better than any other project management software I have ever used. You can generate reports and update tasks in a very lucid and simple manner. Since I was involved in the project management of this submission for a while, I can definitely vouch for this software to make your life a lot easier. 
    3) PleaseReview: This has made the review of documents very convenient as it helps to keep accountability and clear visibility for all the review comments. Combining PleaseReview as a function in Veeva has made the review process much more transparent and clear. 

    Hope this was helpful. 


    Pratik Pednekar,
    MS in Regulatory Affairs, RAC-US
    Boston, MA,
    United States