Therapeutic Product Immunogenicity Community

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Dear Jason,

What happen to this proposal? Any news on forming a discussion group on the topic of ISI harmonization? 

Best,

Laura

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all - 

I have received some inquiries around this initiative. I will be sending out a call for availability via email today or tomorrow for a kick off session later this month or early Sept.  

We were waiting to hear back from key regulatory team members prior to scheduling.

Be on the look out!

Please reach out if you have any other questions!

Best, 

Jason

Dear Jason,

What happen to this proposal? Any news on forming a discussion group on the topic of ISI harmonization? 

Best,

Laura

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

------------------------------
Jason Pennucci
Director, Bioanalytical Sciences
Moderna Therapeutics
Cambirdge MA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Hi Jason,

I'm interested in joining the ISI discussions with the AAPS group. 

------------------------------
Ravi Shankar Maurya
General Manager, Regulated Bioanalysis, Large Molecule
Lambda Therapeutic Research Ltd
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.

Original Message:
Sent: 05-22-2025 07:38
From: Jason Pennucci
Subject: ISI Template Harmonization

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

------------------------------
Jason Pennucci
Director, Bioanalytical Sciences
Moderna Therapeutics
Cambirdge MA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
------------------------------

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason

Hi all -

We wanted to reach out and follow up on a discussion during our panel re: NAB results reporting harmonization at NBC this year. There was interest around a working group focused on standardization of the Integrated Summary of Immunogenicity (ISI) with a recommended harmonized template. 

I recognize that there is a separate work stream for Immunogenicity Risk assessments and other areas, this effort could add value and complement the work there as well as from standardization of reporting immunogenicity results. 

Looking forward to  hearing feedback from this community here and/or please feel free to reach out to me or the other panelists from the NAB discussion at NBC, Darshana Jani, Susan Irvin, and Amanda Hays.

Best, 

Jason