Regulatory Open Forum

Original Message------

Hi all, 

I am writing an assignment on selection of species for Preclinical/nonclinical developmement of a biologic I wished to have an expert opinion on the following topic.
If a company is deciding which animals can be used to test a new antibody for an oncology indication and this indication is not one that affects rodents how you would suggest the team go about this discussion on species selection and how they would present it to the FDA. Also, what is important in the selection of the animal species and how this case can be made to the FDA.  Furthermore would it be important to still consider rodents and whether they provide some level of information.

I would be like to humbly request you to share any information or suggestion regarding this topic from your vast knowledge and experience which would help me gain a better perspective on this topic if possible. Thank you for your kind help.

Sincerely,
Pratik Pednekar
Student,
Northeastern University,
MS in Regulatory Affairs for Drugs, Biologics and Medical Devices
prtkpednekar@outlook.com 
C: +1 (857) 919-9958

Pratik,
The FDA review team is filled with MDs and PhDs like yourself. They will be looking for the same type of evidence that you used to make the choice of species. The choice of species should be based on the applicability of the animal model to a human response. If the species is not established, or only recently established (information can travel slow within the government because they are no longer in academia and have limited options for conferences), for this application then strong scientific justifications will be necessary. I would strongly suggest reaching out to FDA prior to initiating studies for their opinion.

Mike 

------------------------------
Michael Nilo
Network Regulatory Partners
Nilo Medical Consulting Group
Portland OR
United States
------------------------------

Original Message:
Sent: 25-Jan-2017 07:21
From: Pratik Pednekar
Subject: Selection of species for preclinical/nonclinical development

Hi all, 

I am writing an assignment on selection of species for Preclinical/nonclinical developmement of a biologic I wished to have an expert opinion on the following topic.
If a company is deciding which animals can be used to test a new antibody for an oncology indication and this indication is not one that affects rodents how you would suggest the team go about this discussion on species selection and how they would present it to the FDA. Also, what is important in the selection of the animal species and how this case can be made to the FDA.  Furthermore would it be important to still consider rodents and whether they provide some level of information.

I would be like to humbly request you to share any information or suggestion regarding this topic from your vast knowledge and experience which would help me gain a better perspective on this topic if possible. Thank you for your kind help.

Sincerely,
Pratik Pednekar
Student,
Northeastern University,
MS in Regulatory Affairs for Drugs, Biologics and Medical Devices
prtkpednekar@outlook.com 
C: +1 (857) 919-9958

Thank you Kathleen and Michael for your kind inputs. Yes I will definately keep this in mind. Appreciate your help. Thanks once again.

------------------------------
Pratik Pednekar
Student at Northeastern University
MS in Regulatory Affairs
Boston MA
United States
prtkpednekar@outlook.com
C: +1 (857) 919-9958
------------------------------

Original Message:
Sent: 25-Jan-2017 07:21
From: Pratik Pednekar
Subject: Selection of species for preclinical/nonclinical development

Hi all, 

I am writing an assignment on selection of species for Preclinical/nonclinical developmement of a biologic I wished to have an expert opinion on the following topic.
If a company is deciding which animals can be used to test a new antibody for an oncology indication and this indication is not one that affects rodents how you would suggest the team go about this discussion on species selection and how they would present it to the FDA. Also, what is important in the selection of the animal species and how this case can be made to the FDA.  Furthermore would it be important to still consider rodents and whether they provide some level of information.

I would be like to humbly request you to share any information or suggestion regarding this topic from your vast knowledge and experience which would help me gain a better perspective on this topic if possible. Thank you for your kind help.

Sincerely,
Pratik Pednekar
Student,
Northeastern University,
MS in Regulatory Affairs for Drugs, Biologics and Medical Devices
prtkpednekar@outlook.com 
C: +1 (857) 919-9958

Dear Pratik,
To further add to what Kathleen and Michael have mentioned, if there is no appropriate species (as identified by the appropriate in vitro assays which is generally the case with biotherapeutic agents) Agencies will accept in vitro data alone.  I want to re-iterate what Michael mentioned  that you need to have a discussion with the Agency before conducting (or not) any toxicology study(ies) if there are questions regarding species .

However, until you can discuss with them and for completeness of my response I refer you to the most appropriate Guidances for this topic: ICH-M3, ICH-S6 (with supporting Addendum), ICH-S9 (with supporting Q&A). 

ICH-M3 (R2):  General toxicology study recommendations
ICH-S6 (R1) + Addendum: Biotherapeutic focused
ICH-S9 +Q&A:  Oncology product focused

Good luck. 

------------------------------
Suzanne Thornton-Jones
Director
AbbVie
North Chicago IL
United States
------------------------------

Original Message:
Sent: 28-Jan-2017 06:22
From: Pratik Pednekar
Subject: Selection of species for preclinical/nonclinical development

Thank you Kathleen and Michael for your kind inputs. Yes I will definately keep this in mind. Appreciate your help. Thanks once again.

------------------------------
Pratik Pednekar
Student at Northeastern University
MS in Regulatory Affairs
Boston MA
United States
prtkpednekar@outlook.com
C: +1 (857) 919-9958
------------------------------

Original Message:
Sent: 25-Jan-2017 07:21
From: Pratik Pednekar
Subject: Selection of species for preclinical/nonclinical development

Hi all, 

I am writing an assignment on selection of species for Preclinical/nonclinical developmement of a biologic I wished to have an expert opinion on the following topic.
If a company is deciding which animals can be used to test a new antibody for an oncology indication and this indication is not one that affects rodents how you would suggest the team go about this discussion on species selection and how they would present it to the FDA. Also, what is important in the selection of the animal species and how this case can be made to the FDA.  Furthermore would it be important to still consider rodents and whether they provide some level of information.

I would be like to humbly request you to share any information or suggestion regarding this topic from your vast knowledge and experience which would help me gain a better perspective on this topic if possible. Thank you for your kind help.

Sincerely,
Pratik Pednekar
Student,
Northeastern University,
MS in Regulatory Affairs for Drugs, Biologics and Medical Devices
prtkpednekar@outlook.com 
C: +1 (857) 919-9958

This message was posted by a user wishing to remain anonymous

Hi,
I suggest you check out ICH S6 and the associated Q&A.  They specifically address how to identify a relevant species, and how to proceed in the absence of a relevant species.
Good luck!
Original Message:
Sent: 25-Jan-2017 07:21
From: Pratik Pednekar
Subject: Selection of species for preclinical/nonclinical development

Hi all, 

I am writing an assignment on selection of species for Preclinical/nonclinical developmement of a biologic I wished to have an expert opinion on the following topic.
If a company is deciding which animals can be used to test a new antibody for an oncology indication and this indication is not one that affects rodents how you would suggest the team go about this discussion on species selection and how they would present it to the FDA. Also, what is important in the selection of the animal species and how this case can be made to the FDA.  Furthermore would it be important to still consider rodents and whether they provide some level of information.

I would be like to humbly request you to share any information or suggestion regarding this topic from your vast knowledge and experience which would help me gain a better perspective on this topic if possible. Thank you for your kind help.

Sincerely,
Pratik Pednekar
Student,
Northeastern University,
MS in Regulatory Affairs for Drugs, Biologics and Medical Devices
prtkpednekar@outlook.com 
C: +1 (857) 919-9958

This message was posted by a user wishing to remain anonymous

Great discussion and feedback! I see that ICH S6 is for pharmaceuticals. What about medical devices? Is there a similar guidance document for medical devices regarding animal models?
Original Message:
Sent: 28-Jan-2017 23:56
From: Anonymous Member
Subject: Selection of species for preclinical/nonclinical development

This message was posted by a user wishing to remain anonymous

Hi,
I suggest you check out ICH S6 and the associated Q&A.  They specifically address how to identify a relevant species, and how to proceed in the absence of a relevant species.
Good luck!
Original Message:
Sent: 25-Jan-2017 07:21
From: Pratik Pednekar
Subject: Selection of species for preclinical/nonclinical development

Hi all, 

I am writing an assignment on selection of species for Preclinical/nonclinical developmement of a biologic I wished to have an expert opinion on the following topic.
If a company is deciding which animals can be used to test a new antibody for an oncology indication and this indication is not one that affects rodents how you would suggest the team go about this discussion on species selection and how they would present it to the FDA. Also, what is important in the selection of the animal species and how this case can be made to the FDA.  Furthermore would it be important to still consider rodents and whether they provide some level of information.

I would be like to humbly request you to share any information or suggestion regarding this topic from your vast knowledge and experience which would help me gain a better perspective on this topic if possible. Thank you for your kind help.

Sincerely,
Pratik Pednekar
Student,
Northeastern University,
MS in Regulatory Affairs for Drugs, Biologics and Medical Devices
prtkpednekar@outlook.com 
C: +1 (857) 919-9958