Regulatory Open Forum

Hi,

      Does anyone have any experience with FDA's Project Orbis program recently ? If you do, does the sponsor have to submit separate marketing applications to Swissmedic, Health Canada, Singaporean HSA ? If it's a new marketing application, what kind of data to be submitted to these HA's ?
Any additional info about the process is much appreciated.

Mike

------------------------------
Michael Bui
Vice President, Regulatory Affairs
Arlington MA
United States
------------------------------

Hi Mike, 

I have been reading up a lot on Project Orbis lately have some perspectives to share with the disclaimer that I have not been on projects that have pursued this pathway:
- The known examples of Project Orbis were either pursued with RTOR, were for an additional indication post initial approval or a combination of two drugs in a new indication when both drugs were previously individually approved. It isn't clear whether their individual approval was already established in the countries participating in the concurrent approval under Project Orbis. 
-The use of RTOR implies that the companies would have the opportunity to interact with the different HAs and make sure they were meeting their needs for review documents (this could potentially allow for dialogue of whether a full submission or some abbreviated version would suffice to facilitate review)
- I also came across a review article (link below) where it states in regards to Project Orbis - "For pharmaceutical sponsors, this will save having to prepare a separate submission dossier for each region/country in the future." which leads me to think that if Project Orbis is granted by OCE there would be one submission, different scope of approval, and each country would require their own format for the drug label as indicated in the FAQs on the Project Orbis website.
https://www.synchrogenix.com/project-orbis-and-real-time-oncology-review/

-Aditi

------------------------------
Aditi Khurana
Sr. Manager
Fremont CA
United States
------------------------------

Original Message:
Sent: 16-May-2020 13:33
From: Michael Bui
Subject: Project Orbis

Hi,

      Does anyone have any experience with FDA's Project Orbis program recently ? If you do, does the sponsor have to submit separate marketing applications to Swissmedic, Health Canada, Singaporean HSA ? If it's a new marketing application, what kind of data to be submitted to these HA's ?
Any additional info about the process is much appreciated.

Mike

------------------------------
Michael Bui
Vice President, Regulatory Affairs
Arlington MA
United States
------------------------------

Hi Aditi, 

thanks for the link. Seems like one marketing application (NDA) for all HA's except for country specific labeling. 

mike

------------------------------
Michael Bui
Vice President, Regulatory Affairs
Arlington MA
United States
------------------------------

Original Message:
Sent: 17-May-2020 11:23
From: Aditi Khurana
Subject: Project Orbis

Hi Mike,

I have been reading up a lot on Project Orbis lately have some perspectives to share with the disclaimer that I have not been on projects that have pursued this pathway:
- The known examples of Project Orbis were either pursued with RTOR, were for an additional indication post initial approval or a combination of two drugs in a new indication when both drugs were previously individually approved. It isn't clear whether their individual approval was already established in the countries participating in the concurrent approval under Project Orbis.
-The use of RTOR implies that the companies would have the opportunity to interact with the different HAs and make sure they were meeting their needs for review documents (this could potentially allow for dialogue of whether a full submission or some abbreviated version would suffice to facilitate review)
- I also came across a review article (link below) where it states in regards to Project Orbis - "For pharmaceutical sponsors, this will save having to prepare a separate submission dossier for each region/country in the future." which leads me to think that if Project Orbis is granted by OCE there would be one submission, different scope of approval, and each country would require their own format for the drug label as indicated in the FAQs on the Project Orbis website.
https://www.synchrogenix.com/project-orbis-and-real-time-oncology-review/

-Aditi

------------------------------
Aditi Khurana
Sr. Manager
Fremont CA
United States

Original Message:
Sent: 16-May-2020 13:33
From: Michael Bui
Subject: Project Orbis

Hi,

      Does anyone have any experience with FDA's Project Orbis program recently ? If you do, does the sponsor have to submit separate marketing applications to Swissmedic, Health Canada, Singaporean HSA ? If it's a new marketing application, what kind of data to be submitted to these HA's ?
Any additional info about the process is much appreciated.

Mike

------------------------------
Michael Bui
Vice President, Regulatory Affairs
Arlington MA
United States
------------------------------

Hi Michael.

There have been five Orbis approvals, three were supplements and two were for NCE. You can search for them via FDA Press Release. The first one was in September 2019. The most recent one, last week.

Separate filings have to be made in each country. There are country specific requirements (GMP and AAN in Australia, for instance) that need to be followed. 

There will be a presentation at Convergence on approvals via Project Orbis and the ACSS Consortium (worksharing) which will include case studies from companies that have participated in these Pilots.

Hi Linda -- Thank you for the info and clarification on the separate filings for each country. Can you share info about timing of the Convergence and ACSS Consortium meetings and any other details that I can find on the website.

------------------------------
Michael Bui
Vice President, Regulatory Affairs
Arlington MA
United States
------------------------------

Original Message:
Sent: 18-May-2020 08:40
From: Linda Bowen
Subject: Project Orbis

Hi Michael.

There have been five Orbis approvals, three were supplements and two were for NCE. You can search for them via FDA Press Release. The first one was in September 2019. The most recent one, last week.

Separate filings have to be made in each country. There are country specific requirements (GMP and AAN in Australia, for instance) that need to be followed.

There will be a presentation at Convergence on approvals via Project Orbis and the ACSS Consortium (worksharing) which will include case studies from companies that have participated in these Pilots.

------------------------------
Linda Bowen MSc, RAC, FRAPS
Past Chair NJ NY RAPS Chapter

Original Message:
Sent: 17-May-2020 11:23
From: Aditi Khurana
Subject: Project Orbis

Hi Mike,

I have been reading up a lot on Project Orbis lately have some perspectives to share with the disclaimer that I have not been on projects that have pursued this pathway:
- The known examples of Project Orbis were either pursued with RTOR, were for an additional indication post initial approval or a combination of two drugs in a new indication when both drugs were previously individually approved. It isn't clear whether their individual approval was already established in the countries participating in the concurrent approval under Project Orbis.
-The use of RTOR implies that the companies would have the opportunity to interact with the different HAs and make sure they were meeting their needs for review documents (this could potentially allow for dialogue of whether a full submission or some abbreviated version would suffice to facilitate review)
- I also came across a review article (link below) where it states in regards to Project Orbis - "For pharmaceutical sponsors, this will save having to prepare a separate submission dossier for each region/country in the future." which leads me to think that if Project Orbis is granted by OCE there would be one submission, different scope of approval, and each country would require their own format for the drug label as indicated in the FAQs on the Project Orbis website.
https://www.synchrogenix.com/project-orbis-and-real-time-oncology-review/

-Aditi

------------------------------
Aditi Khurana
Sr. Manager
Fremont CA
United States

Original Message:
Sent: 16-May-2020 13:33
From: Michael Bui
Subject: Project Orbis

Hi,

      Does anyone have any experience with FDA's Project Orbis program recently ? If you do, does the sponsor have to submit separate marketing applications to Swissmedic, Health Canada, Singaporean HSA ? If it's a new marketing application, what kind of data to be submitted to these HA's ?
Any additional info about the process is much appreciated.

Mike

------------------------------
Michael Bui
Vice President, Regulatory Affairs
Arlington MA
United States
------------------------------

Original Message------

Hi Linda -- Thank you for the info and clarification on the separate filings for each country. Can you share info about timing of the Convergence and ACSS Consortium meetings and any other details that I can find on the website.

Hi Linda, 

Thanks for clarifying that there would be different submissions. It would be helpful to understand the case studies and I look forward to the presentation. 


------------------------------
Aditi Khurana
Sr. Manager
Fremont CA
United States
------------------------------

Original Message:
Sent: 18-May-2020 08:40
From: Linda Bowen
Subject: Project Orbis

Hi Michael.

There have been five Orbis approvals, three were supplements and two were for NCE. You can search for them via FDA Press Release. The first one was in September 2019. The most recent one, last week.

Separate filings have to be made in each country. There are country specific requirements (GMP and AAN in Australia, for instance) that need to be followed.

There will be a presentation at Convergence on approvals via Project Orbis and the ACSS Consortium (worksharing) which will include case studies from companies that have participated in these Pilots.

------------------------------
Linda Bowen MSc, RAC, FRAPS
Past Chair NJ NY RAPS Chapter

Original Message:
Sent: 17-May-2020 11:23
From: Aditi Khurana
Subject: Project Orbis

Hi Mike,

I have been reading up a lot on Project Orbis lately have some perspectives to share with the disclaimer that I have not been on projects that have pursued this pathway:
- The known examples of Project Orbis were either pursued with RTOR, were for an additional indication post initial approval or a combination of two drugs in a new indication when both drugs were previously individually approved. It isn't clear whether their individual approval was already established in the countries participating in the concurrent approval under Project Orbis.
-The use of RTOR implies that the companies would have the opportunity to interact with the different HAs and make sure they were meeting their needs for review documents (this could potentially allow for dialogue of whether a full submission or some abbreviated version would suffice to facilitate review)
- I also came across a review article (link below) where it states in regards to Project Orbis - "For pharmaceutical sponsors, this will save having to prepare a separate submission dossier for each region/country in the future." which leads me to think that if Project Orbis is granted by OCE there would be one submission, different scope of approval, and each country would require their own format for the drug label as indicated in the FAQs on the Project Orbis website.
https://www.synchrogenix.com/project-orbis-and-real-time-oncology-review/

-Aditi

------------------------------
Aditi Khurana
Sr. Manager
Fremont CA
United States

Original Message:
Sent: 16-May-2020 13:33
From: Michael Bui
Subject: Project Orbis

Hi,

      Does anyone have any experience with FDA's Project Orbis program recently ? If you do, does the sponsor have to submit separate marketing applications to Swissmedic, Health Canada, Singaporean HSA ? If it's a new marketing application, what kind of data to be submitted to these HA's ?
Any additional info about the process is much appreciated.

Mike

------------------------------
Michael Bui
Vice President, Regulatory Affairs
Arlington MA
United States
------------------------------