Bioanalytical 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 Jason,

I would like to contribute to this as well.

Cheers,

Marit

--------------------

Dr Marit Lichtfuss

Associate Director, Regulated Bioanalysis

Research and Clinical Bioanalytics

30 Flemington Road, Parkville, 3010 VIC, Australia

[email protected]

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 Jason,
I have some thoughts on this and would like to hear other perspectives on this as well. 

Best,

Michael Swanson

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