Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the...

Area of Science:

• Pharmaceutical Regulatory Science
• Oncology Drug Development
• Chemistry, Manufacturing, and Controls (CMC)

Background:

• Innovative oncology products require efficient regulatory review pathways.
• The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community convened panel discussions on novel regulatory initiatives.
• These initiatives aim to accelerate the development and approval of oncology drugs.

Purpose of the Study:

• To share knowledge on the advantages and challenges of novel regulatory review pathways for oncology products.
• To discuss eligibility criteria and operational modifications for initiatives like Real-Time Oncology Review (RTOR), Project Orbis, and Product Quality Assessment Aid (PQAAid).
• To explore insights from US Food and Drug Administration (FDA) representatives and industry experts on these new programs.

Main Methods:

• Two virtual panel discussions were hosted by the AAPS CMC Community.
• Session 1 (August 27, 2021) focused on Real-Time Oncology Review (RTOR).
• Session 2 (January 21, 2022) focused on Project Orbis and Product Quality Assessment Aid (PQAAid), featuring FDA and industry experts.

Main Results:

• Key topics included managing cross-regional CMC requirements and adapting to expedited development timelines.
• Discussions highlighted the coordination of health authority and industry interactions.
• Expert experiences provided valuable insights into the practical application of these new regulatory pathways.

Conclusions:

• Real-Time Oncology Review (RTOR), Project Orbis, and PQAAid are emerging initiatives offering potential benefits for oncology product development.
• Continued dialogue and adaptation are crucial for optimizing these programs.
• Sharing expert experiences is vital for navigating the complexities of expedited regulatory processes.