Greetings Blackbriar business partner,

These very challenging times have led many of our regulatory clients to reach out to us at BRS seeking assurances of our preparedness related to the timely completion of their regulatory filings (PMTA’s and/or TPMF’s). Rest assured, we fully appreciate the trust you have placed in us and do not take our commitments to you lightly. We are taking all reasonable steps to proactively address the recognized and controllable risks in order to absolutely minimize the likelihood of a disruption to your application. As this situation is constantly changing, our team reviews these steps daily, and modifies and improves our plan as appropriate. As we recognize that these high-level statements of assurance are being made by most of your business partners, we felt that if might be helpful to provide information on some of the specific steps BRS is taking to minimize the chances of a disruption to the timely completion of your application. We have strategically focused on risks to our people, risks with CRO’s, and risk to supply of materials, as follows:

Labor:

  • All salaried employees that aren’t required in the laboratory or manufacturing facility to directly support analytical testing, production, or shipping/receiving are working from home to minimize contact for them and the team.
  • Our procedures and IT systems that support working remotely were tested well in advance of our work-from-home directive and have proven themselves to be robust and effective in keeping our team productive
  • We have balanced the shift staffing of our analytical lab in order to ensure that we have reduced exposure on any particular shift
  • Day and evening shifts are staggered by 30-60 minutes, meaning they don’t interact with each other coming/going from the building
  • We have implemented hourly full cleaning/sanitizing of all common areas such as breakrooms and restrooms
  • Our analytical lab, cleanroom, and warehouse/distribution center personnel do not interact directly and take separate breaks
  • Hand washing is required anytime an employee prepares to enter a work area (lab, cleanroom, distribution center)
  • All analytical lab employees are wearing face masks while working
  • Any employee who reports symptoms that could be related to corona are required to call-in (not come-in), and must have a doctor’s note prior to returning
  • In order to help ensure we don’t have employees working despite being sick, BRS is offering a sick-pay benefit to hourly employees
  • Note that we have had several employees at our facility with cold/flu/allergies, but no corona cases

CRO’s:

  • We have requested and received contingency plans from each of our contract research partners. Our team is working directly with them on any concerns or questions we identified with those plans to help improve them specifically related to work being done for BRS clients.
  • The biggest potential concern BRS has identified in connection with CRO work is for clinical study partners to have their capacity mandatorily directed toward addressing the corona virus issue based on some potential governmental directive. This concern is presumptive and is not based on specific feedback we have received from the companies we are using for clinical study work. The communication issued by the FDA today on steps clinical study groups can take to increase the likelihood of conducting such studies safely provides some assurance that this topic is one of mutual concern.
  • It is important to note that we have not identified any likely CRO related delays to existing regulatory client contracts as of this writing; however, proposed timelines for new client contracts are being impacted. Specifically, we are working diligently to identify and communicate in advance which sections of applications we predict can be completed by any particular FDA deadline, and what sections will need to be submitted as supplemental information following the submission of the primary application.

Procurement of Raw Materials:

  • Several weeks ago, we started the process of stocking up on supplies that we could predict may become scarce (lab standards and supplies, cleaning materials, bleach, face masks, gloves, alcohol, etc.)
  • We have increased safety stocks of materials used in the production of application test materials and samples
  • Our distribution center remains fully staffed and capable of receiving regulatory application samples sent to us by our clients for use in studies
  • We reach out frequently to key suppliers and shipping companies to validate their fulfillment situation and have had only one concern related to a European supplier, which was mitigated by working through their N. American sister company
  • It has been emphasized with all key suppliers of how critical it is that we get notice as far in advance as possible of any disruption potential

Please be assured that we are proactively communicating with the FDA to reinforce the areas of application completion that are under particular increased time stress as a result of the corona situation and emphasizing the importance of communication from them on specific steps they may take related to regulatory deadlines, although no helpful comments have been received as of this writing. If we identify any reasonably likely disruption to your application, we will reach out to you “sooner than later” so that you have the best visibility we can provide. Additionally, our management team remains prepared to discuss concerns with each customer related to their specific application(s) at your convenience.

Russ Rogers

CEO