The PDA Biotechnology Advisory Board (BioAB) is supported by and works closely with the PDA Scientific and Regulatory Affairs Department  The BioAB is both strategic and tactical in focus:;  it is a critical source for identifying biotechnology issues of interest to PDA members globally. Once an issue is identified, the BioAB forms a Task Force to study and to prepare written comments or documents, such as Technical Reports. PDA Biotechnology comments are also posted to the PDA Web site for public viewing and are highlighted in the PDA Letter.

The BioAB is intended to be:

PROACTIVE

• Identify scientific/technical/regulatory issues affecting biotech products for which the recognition and reputation of the PDA can provide a forum for discussion
  • Focus on those scientific/technical areas in biotech that are still rapidly evolving (e.g., latest advances/approaches in virus testing, standardization needed for filtration, needed reference standards for gene therapy biological products)
  • Focus on those areas which are different than other pharmaceuticals (e.g., why bulk sterility testing is necessary for biologics and not for drugs)
  • Focus on those areas where regulatory guidance is lagging behind other pharmaceuticals (e.g., FDA guidance on formatting biologic drug substance CMC information in the CTD format)
• Once an issue is identified, and prioritized by the BioAB, develop a means for which the PDA could exercise leadership in bringing together industry and regulatory authorities to discuss and move forward with an action plan to address the issue

SUPPORTIVE

Serve as a resource for SAB and RAQC for review of regulatory documents and technical reports related to biopharmaceuticals

For more information about the PDA Biotech Advisory Board, contact Iris Rice, Manager, S&RA Department at PDA.