FDA no longer needs to require animal tests before human drug trials

Science		remove preview
FDA no longer needs to require animal tests before human drug trials New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change-long sought by animal welfare organizations-could signal a major shift away from animal use after more than 80 years of drug safety regulation. View this on Science >

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------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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

Original Message:
Sent: 1/11/2023 9:04:00 PM
From: Twinkle Christian
Subject: FDA no longer needs to require animal tests before human drug trials

FDA no longer needs to require animal tests before human drug trials

Science		remove preview
FDA no longer needs to require animal tests before human drug trials New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change-long sought by animal welfare organizations-could signal a major shift away from animal use after more than 80 years of drug safety regulation. View this on Science >

.

------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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

It will be interesting to see how this plays out. As a member of the Laboratory Sciences sector in Safety Assessment, I work in close proximity with Toxicology experts, and the work done to support Investigational New Drug (IND) Applications relies primarily on in vivo toxicology safety assessment studies. The idea of no longer requiring animals for safety assessment is a fantastic one, and I do hope to see the day where the science, materials, and technology advance so that we can realistically use a designed tissue, organ, or "humanoid" model that is fully functional and capable of providing the information needed to ensure a drug is first and foremost safe before use in human beings.

That said, I do not believe the science, materials, and technology have yet progressed to the point where animal models can be replaced with non-animal models. I think the initiative is a positive one, and hopefully this legislation spurs more work to be done in the non-animal model sector. The complex interplay of different organs, the uptake of a drug compound by various routes of administration, the breakdown of a drug to metabolic species which may very well be the root cause for toxicology concerns, the distribution of the drugs to organs and tissues and its impact on those organs and tissues - these are just a few key pieces of why animal models are critical for safety assessment, because they are the closest thing we have to model the biology of a human being.

------------------------------
Bo Tokarski
Research Scientist 2
Charles River Laboratories Ashland LLC
Ashland OH
[email protected]

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

Original Message:
Sent: 01-11-2023 21:04
From: Twinkle Christian
Subject: FDA no longer needs to require animal tests before human drug trials

FDA no longer needs to require animal tests before human drug trials

Science		remove preview
FDA no longer needs to require animal tests before human drug trials New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change-long sought by animal welfare organizations-could signal a major shift away from animal use after more than 80 years of drug safety regulation. View this on Science >

.

------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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

Agreed. Proposals to replace have been circulating for decades. In my opinion, the biggest step forward here is to allow the FDA to consider approaches without toxicology experiments, which was impossible previously since legally required. While nothing will change in the short term just because the legal requirement is removed, it does open the door for some additional approaches. As toxicologists are understandably risk-averse since that is their function, I anticipate some lively debates at SoT in the decades to come.

------------------------------
Joleen White Ph.D.
AAPS 2023 Global Health Community Past Chair
Bioanalytical 101 Course Development
Head of Bioassay Development and Operations
Gates Medical Research Institute
Cambridge MA
[email protected]

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

Original Message:
Sent: 01-13-2023 08:27
From: Bo Tokarski
Subject: FDA no longer needs to require animal tests before human drug trials

It will be interesting to see how this plays out. As a member of the Laboratory Sciences sector in Safety Assessment, I work in close proximity with Toxicology experts, and the work done to support Investigational New Drug (IND) Applications relies primarily on in vivo toxicology safety assessment studies. The idea of no longer requiring animals for safety assessment is a fantastic one, and I do hope to see the day where the science, materials, and technology advance so that we can realistically use a designed tissue, organ, or "humanoid" model that is fully functional and capable of providing the information needed to ensure a drug is first and foremost safe before use in human beings.

That said, I do not believe the science, materials, and technology have yet progressed to the point where animal models can be replaced with non-animal models. I think the initiative is a positive one, and hopefully this legislation spurs more work to be done in the non-animal model sector. The complex interplay of different organs, the uptake of a drug compound by various routes of administration, the breakdown of a drug to metabolic species which may very well be the root cause for toxicology concerns, the distribution of the drugs to organs and tissues and its impact on those organs and tissues - these are just a few key pieces of why animal models are critical for safety assessment, because they are the closest thing we have to model the biology of a human being.

------------------------------
Bo Tokarski
Research Scientist 2
Charles River Laboratories Ashland LLC
Ashland OH
[email protected]

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

Original Message:
Sent: 01-11-2023 21:04
From: Twinkle Christian
Subject: FDA no longer needs to require animal tests before human drug trials

FDA no longer needs to require animal tests before human drug trials

Science		remove preview
FDA no longer needs to require animal tests before human drug trials New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change-long sought by animal welfare organizations-could signal a major shift away from animal use after more than 80 years of drug safety regulation. View this on Science >

.

------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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

Let us have more discussion on this topic in our community. Although certain animal testing may be reduced or even eliminated, I cannot envision how can they be fully avoided in all cases. For example, if there are similar drugs that have already been tested in animals, we may not need to repeat all the drug safety (toxicology) tests. Similarly, if certain enzymes or antibodies are already present in humans and know that they are safe, we may not to conduct their safety evaluation in animals before conducting their clinical trials as new therapies. However, I cannot see how a completely new drug candidate can be administered without any prior experience from live animal studies.

------------------------------
Abu Serajuddin Ph.D., FAAPS
Professor, Industrial Pharmacy
St. John's University
Jamaica NY
[email protected]

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

Original Message:
Sent: 01-14-2023 09:08
From: Joleen White
Subject: FDA no longer needs to require animal tests before human drug trials

Agreed. Proposals to replace have been circulating for decades. In my opinion, the biggest step forward here is to allow the FDA to consider approaches without toxicology experiments, which was impossible previously since legally required. While nothing will change in the short term just because the legal requirement is removed, it does open the door for some additional approaches. As toxicologists are understandably risk-averse since that is their function, I anticipate some lively debates at SoT in the decades to come.

------------------------------
Joleen White Ph.D.
AAPS 2023 Global Health Community Past Chair
Bioanalytical 101 Course Development
Head of Bioassay Development and Operations
Gates Medical Research Institute
Cambridge MA
[email protected]

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

Original Message:
Sent: 01-13-2023 08:27
From: Bo Tokarski
Subject: FDA no longer needs to require animal tests before human drug trials

It will be interesting to see how this plays out. As a member of the Laboratory Sciences sector in Safety Assessment, I work in close proximity with Toxicology experts, and the work done to support Investigational New Drug (IND) Applications relies primarily on in vivo toxicology safety assessment studies. The idea of no longer requiring animals for safety assessment is a fantastic one, and I do hope to see the day where the science, materials, and technology advance so that we can realistically use a designed tissue, organ, or "humanoid" model that is fully functional and capable of providing the information needed to ensure a drug is first and foremost safe before use in human beings.

That said, I do not believe the science, materials, and technology have yet progressed to the point where animal models can be replaced with non-animal models. I think the initiative is a positive one, and hopefully this legislation spurs more work to be done in the non-animal model sector. The complex interplay of different organs, the uptake of a drug compound by various routes of administration, the breakdown of a drug to metabolic species which may very well be the root cause for toxicology concerns, the distribution of the drugs to organs and tissues and its impact on those organs and tissues - these are just a few key pieces of why animal models are critical for safety assessment, because they are the closest thing we have to model the biology of a human being.

------------------------------
Bo Tokarski
Research Scientist 2
Charles River Laboratories Ashland LLC
Ashland OH
[email protected]

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

Original Message:
Sent: 01-11-2023 21:04
From: Twinkle Christian
Subject: FDA no longer needs to require animal tests before human drug trials

FDA no longer needs to require animal tests before human drug trials

Science		remove preview
FDA no longer needs to require animal tests before human drug trials New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change-long sought by animal welfare organizations-could signal a major shift away from animal use after more than 80 years of drug safety regulation. View this on Science >

.

------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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

Hi Abu,
Yeah, I will set this as  discussion topic at our community monthly meeting. Please let me know if you would like to join the discussion and I will add you to the meeting invite.

------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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

Original Message:
Sent: 01-16-2023 15:23
From: Abu Serajuddin
Subject: FDA no longer needs to require animal tests before human drug trials

Let us have more discussion on this topic in our community. Although certain animal testing may be reduced or even eliminated, I cannot envision how can they be fully avoided in all cases. For example, if there are similar drugs that have already been tested in animals, we may not need to repeat all the drug safety (toxicology) tests. Similarly, if certain enzymes or antibodies are already present in humans and know that they are safe, we may not to conduct their safety evaluation in animals before conducting their clinical trials as new therapies. However, I cannot see how a completely new drug candidate can be administered without any prior experience from live animal studies.

------------------------------
Abu Serajuddin Ph.D., FAAPS
Professor, Industrial Pharmacy
St. John's University
Jamaica NY
[email protected]

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

Original Message:
Sent: 01-14-2023 09:08
From: Joleen White
Subject: FDA no longer needs to require animal tests before human drug trials

Agreed. Proposals to replace have been circulating for decades. In my opinion, the biggest step forward here is to allow the FDA to consider approaches without toxicology experiments, which was impossible previously since legally required. While nothing will change in the short term just because the legal requirement is removed, it does open the door for some additional approaches. As toxicologists are understandably risk-averse since that is their function, I anticipate some lively debates at SoT in the decades to come.

------------------------------
Joleen White Ph.D.
AAPS 2023 Global Health Community Past Chair
Bioanalytical 101 Course Development
Head of Bioassay Development and Operations
Gates Medical Research Institute
Cambridge MA
[email protected]

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

Original Message:
Sent: 01-13-2023 08:27
From: Bo Tokarski
Subject: FDA no longer needs to require animal tests before human drug trials

It will be interesting to see how this plays out. As a member of the Laboratory Sciences sector in Safety Assessment, I work in close proximity with Toxicology experts, and the work done to support Investigational New Drug (IND) Applications relies primarily on in vivo toxicology safety assessment studies. The idea of no longer requiring animals for safety assessment is a fantastic one, and I do hope to see the day where the science, materials, and technology advance so that we can realistically use a designed tissue, organ, or "humanoid" model that is fully functional and capable of providing the information needed to ensure a drug is first and foremost safe before use in human beings.

That said, I do not believe the science, materials, and technology have yet progressed to the point where animal models can be replaced with non-animal models. I think the initiative is a positive one, and hopefully this legislation spurs more work to be done in the non-animal model sector. The complex interplay of different organs, the uptake of a drug compound by various routes of administration, the breakdown of a drug to metabolic species which may very well be the root cause for toxicology concerns, the distribution of the drugs to organs and tissues and its impact on those organs and tissues - these are just a few key pieces of why animal models are critical for safety assessment, because they are the closest thing we have to model the biology of a human being.

------------------------------
Bo Tokarski
Research Scientist 2
Charles River Laboratories Ashland LLC
Ashland OH
[email protected]

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

Original Message:
Sent: 01-11-2023 21:04
From: Twinkle Christian
Subject: FDA no longer needs to require animal tests before human drug trials

FDA no longer needs to require animal tests before human drug trials

Science		remove preview
FDA no longer needs to require animal tests before human drug trials New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change-long sought by animal welfare organizations-could signal a major shift away from animal use after more than 80 years of drug safety regulation. View this on Science >

.

------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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

Original Message:
Sent: 1/13/2023 8:28:00 AM
From: Bo Tokarski
Subject: RE: FDA no longer needs to require animal tests before human drug trials

It will be interesting to see how this plays out. As a member of the Laboratory Sciences sector in Safety Assessment, I work in close proximity with Toxicology experts, and the work done to support Investigational New Drug (IND) Applications relies primarily on in vivo toxicology safety assessment studies. The idea of no longer requiring animals for safety assessment is a fantastic one, and I do hope to see the day where the science, materials, and technology advance so that we can realistically use a designed tissue, organ, or "humanoid" model that is fully functional and capable of providing the information needed to ensure a drug is first and foremost safe before use in human beings.

That said, I do not believe the science, materials, and technology have yet progressed to the point where animal models can be replaced with non-animal models. I think the initiative is a positive one, and hopefully this legislation spurs more work to be done in the non-animal model sector. The complex interplay of different organs, the uptake of a drug compound by various routes of administration, the breakdown of a drug to metabolic species which may very well be the root cause for toxicology concerns, the distribution of the drugs to organs and tissues and its impact on those organs and tissues - these are just a few key pieces of why animal models are critical for safety assessment, because they are the closest thing we have to model the biology of a human being.

------------------------------
Bo Tokarski
Research Scientist 2
Charles River Laboratories Ashland LLC
Ashland OH
[email protected]

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

Original Message:
Sent: 01-11-2023 21:04
From: Twinkle Christian
Subject: FDA no longer needs to require animal tests before human drug trials

FDA no longer needs to require animal tests before human drug trials

Science		remove preview
FDA no longer needs to require animal tests before human drug trials New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change-long sought by animal welfare organizations-could signal a major shift away from animal use after more than 80 years of drug safety regulation. View this on Science >

.

------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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

Looking forward to seeing how it plays out. There are 2 nice publications which  specifically looks at liver. I recommend them.

Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry

Baudy, Andreas R., et al. "Liver microphysiological systems development guidelines for safety risk assessment in the pharmaceutical industry." Lab on a Chip 20.2 (2020): 215-225.

https://pubs.rsc.org/en/content/articlelanding/2020/LC/C9LC00768G

 

Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology
Ewart, Lorna, et al. "Performance assessment and economic analysis of a human Liver-Chip for predictive toxicology." Communications Medicine 2.1 (2022): 154.
https://www.nature.com/articles/s43856-022-00209-1

------------------------------
Tsung Tan
Drug Delivery and Infusion Department Manager
Primetech Corporation
Tokyo
[email protected]

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

Original Message:
Sent: 01-11-2023 21:04
From: Twinkle Christian
Subject: FDA no longer needs to require animal tests before human drug trials

FDA no longer needs to require animal tests before human drug trials

Science		remove preview
FDA no longer needs to require animal tests before human drug trials New medicines need not be tested in animals to receive U.S. Food and Drug Administration (FDA) approval, according to legislation signed by President Joe Biden in late December 2022. The change-long sought by animal welfare organizations-could signal a major shift away from animal use after more than 80 years of drug safety regulation. View this on Science >

.

------------------------------
Twinkle Christian
Sr. Scientist
Amgen Inc
Newbury Park CA
[email protected]

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