Your browser doesn't support javascript.
Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.
Algorri, Marquerita; Acharya, Ajay; Bernstein, James; Cauchon, Nina S; Chen, Xiao Hong; Huynh-Ba, Kim; Krantz, Carol; Li, Tao; Li, Yiwei; McLamore, Sherita; Roberts, Scott W; Schwinke, David; Shah, Rakhi; Schirmer, Andrea; Strickland, Helen; Tang, Kin; Watson, Timothy.
  • Algorri M; Amgen Inc., Thousand Oaks, CA USA.
  • Acharya A; Merck & Co., Inc., Kenilworth, NJ USA.
  • Bernstein J; Live Oak Pharmaceutical Consulting, Inc., Raleigh, NC USA.
  • Cauchon NS; Amgen Inc., Thousand Oaks, CA USA.
  • Chen XH; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of New Drug Products, Silver Spring, MD USA.
  • Huynh-Ba K; Pharmalytik, LLC, Newark, DE USA.
  • Krantz C; Seagen, Inc., Bothell, WA USA.
  • Li T; Seagen, Inc., Bothell, WA USA.
  • Li Y; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD USA.
  • McLamore S; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of New Drug Products, Silver Spring, MD USA.
  • Roberts SW; Novo Nordisk A/S, Vandtårnsvej 114, DK-2860 Søborg, Denmark.
  • Schwinke D; AbbVie, North Chicago, IL USA.
  • Shah R; U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of Pharmaceutical Manufacturing Assessment, Silver Spring, MD USA.
  • Schirmer A; Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT USA.
  • Strickland H; GlaxoSmithKline US, Research Triangle Park, NC USA.
  • Tang K; Genentech, Inc., South San Francisco, CA USA.
  • Watson T; Pfizer Inc., Groton, CT USA.
AAPS Open ; 8(1): 19, 2022.
Article in English | MEDLINE | ID: covidwho-2196524
ABSTRACT
The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for innovative oncology products Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid (PQAAid). The panel sessions were held on August 27, 2021, for the discussion of RTOR, and January 21, 2022, for the discussion of Project Orbis and the PQAAid. Both panel sessions included representatives from the US Food and Drug Administration (FDA) and subject matter experts from the pharmaceutical and biotechnology industries, with the aim of facilitating knowledge sharing on CMC-specific advantages, challenges, eligibility criteria for participation, and operational modifications instituted through the utilization of these acceleration initiatives. Key topics included managing cross-regional regulatory CMC requirements, adapting to expedited development timelines, coordinating interactions between health authorities and industry, and potential opportunities for future improvement and expansion of these programs. As RTOR, Project Orbis, and PQAAid are relatively new initiatives, the experiences shared by the panel experts are valuable for providing deeper insight into these new regulatory pathways and processes.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Qualitative research / Randomized controlled trials Language: English Journal: AAPS Open Year: 2022 Document Type: Article

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Type of study: Qualitative research / Randomized controlled trials Language: English Journal: AAPS Open Year: 2022 Document Type: Article