Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid
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, an...
| Main Authors: | , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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SpringerOpen
2022-12-01
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| Series: | AAPS Open |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41120-022-00066-1 |
| _version_ | 1811188199252295680 |
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| author | Marquerita Algorri Ajay Acharya James Bernstein Nina S. Cauchon Xiao Hong Chen Kim Huynh-Ba Carol Krantz Tao Li Yiwei Li Sherita McLamore Scott W. Roberts David Schwinke Rakhi Shah Andrea Schirmer Helen Strickland Kin Tang Timothy Watson |
| author_facet | Marquerita Algorri Ajay Acharya James Bernstein Nina S. Cauchon Xiao Hong Chen Kim Huynh-Ba Carol Krantz Tao Li Yiwei Li Sherita McLamore Scott W. Roberts David Schwinke Rakhi Shah Andrea Schirmer Helen Strickland Kin Tang Timothy Watson |
| author_sort | Marquerita Algorri |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T14:15:32Z |
| format | Article |
| id | doaj.art-2c2f8a02d513464d9193e9db29da553a |
| institution | Directory Open Access Journal |
| issn | 2364-9534 |
| language | English |
| last_indexed | 2024-04-11T14:15:32Z |
| publishDate | 2022-12-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | AAPS Open |
| spelling | doaj.art-2c2f8a02d513464d9193e9db29da553a2022-12-22T04:19:25ZengSpringerOpenAAPS Open2364-95342022-12-01811910.1186/s41120-022-00066-1Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment AidMarquerita Algorri0Ajay Acharya1James Bernstein2Nina S. Cauchon3Xiao Hong Chen4Kim Huynh-Ba5Carol Krantz6Tao Li7Yiwei Li8Sherita McLamore9Scott W. Roberts10David Schwinke11Rakhi Shah12Andrea Schirmer13Helen Strickland14Kin Tang15Timothy Watson16Amgen Inc.Merck & Co., Inc.Live Oak Pharmaceutical Consulting, Inc.Amgen Inc.U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of New Drug ProductsPharmalytik, LLCSeagen, Inc.Seagen, Inc.U.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of Pharmaceutical Manufacturing AssessmentU.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of New Drug ProductsNovo Nordisk A/SAbbVieU.S. Food and Drug Administration, Office of Pharmaceutical Quality - Office of Pharmaceutical Manufacturing AssessmentBoehringer Ingelheim Pharmaceuticals, Inc.GlaxoSmithKline USGenentech, Inc.Pfizer Inc.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.https://doi.org/10.1186/s41120-022-00066-1RegulatoryFDARegulatory efficiencyAccelerated reviewChemistry, Manufacturing, and ControlsProject Orbis |
| spellingShingle | Marquerita Algorri Ajay Acharya James Bernstein Nina S. Cauchon Xiao Hong Chen Kim Huynh-Ba Carol Krantz Tao Li Yiwei Li Sherita McLamore Scott W. Roberts David Schwinke Rakhi Shah Andrea Schirmer Helen Strickland Kin Tang Timothy Watson Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid AAPS Open Regulatory FDA Regulatory efficiency Accelerated review Chemistry, Manufacturing, and Controls Project Orbis |
| title | Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid |
| title_full | Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid |
| title_fullStr | Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid |
| title_full_unstemmed | Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid |
| title_short | Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid |
| title_sort | meeting report advancing accelerated regulatory review with real time oncology review rtor project orbis and the product quality assessment aid |
| topic | Regulatory FDA Regulatory efficiency Accelerated review Chemistry, Manufacturing, and Controls Project Orbis |
| url | https://doi.org/10.1186/s41120-022-00066-1 |
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