Dr. Jane Goodall and Vivodyne Issue Open Letter to Congressional Leaders to Include FDA Modernization Act as a Rider in the Food and Drug Amendments Act of 2022

WASHINGTON, September 08, 2022--(BUSINESS WIRE)--Dr. Jane Goodall, DBE, UN Messenger of Peace and Founder of the Jane Goodall Institute, a conservation organization focused on environmental and humanitarian education, community-centered conservation, and primate care and research; and Vivodyne, an innovative biotechnology platform that cultures lab-grown human tissue and eliminates the need for animal testing, today announced that they have delivered a letter to Congress urging its inclusion of the FDA Modernization Act of 2021 (H.R.2565 / S.2952) as a rider on the Food and Drug Amendments Act of 2022 and FDA Safety and Landmark Advancements Act of 2022.

As the development of therapeutics for human diseases continues to yield increasingly precise and human-specific drug candidates such as monoclonal antibody biologics, immunotherapies, and gene therapies, the inability for animals to mimic and predict the safety and effectiveness of these new drugs in humans continues to become a bottleneck to progress in human health. At the same time, the potential of artificial intelligence to predict and optimize the structures and dosing regimens of better drugs hinges on the availability of massive quantities of high-quality human data, which animals cannot provide.

The FDA Modernization Act would allow the FDA, which works at the forefront of qualifying animal-free, human-predictive New Alternative Methods (NAMs) for predicting drug outcomes, to empower scientists and researchers to use the results of these cutting-edge platforms to accelerate the development of better, safer medicines that are more affordable for patients.

The full text of the letter follows:

September 7, 2022

The Honorable Frank Pallone
Chairman, House Committee on Energy & Commerce
2125 Rayburn House Office Building
Washington, DC 20515

The Honorable Cathy McMorris Rodgers
Ranking Member, House Committee on Energy & Commerce
2125 Rayburn House Office Building
Washington, DC 20515

The Honorable Patty Murray
Chair, Senate Committee on Health, Education, Labor & Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

The Honorable Richard Burr
Ranking Member, Senate Committee on Health, Education, Labor & Pensions
428 Senate Dirksen Office Building
Washington, DC 20510

Dear Representative Pallone, Representative McMorris Rodgers, Senator Murray, and Senator Burr,

As lifelong advocates for the humane treatment of animals, and as scientists working to improve and accelerate the development process of lifesaving drugs, we write to urge you to support the inclusion of the FDA Modernization Act of 2021 (H.R.2565 / S.2952) as a rider on the Food and Drug Amendments Act of 2022 and FDA Safety and Landmark Advancements Act of 2022, which would allow new drugs to be assessed for safety and effectiveness using modern, human-predictive biomedical research tools. We cannot continue to vainly expect caged animals to accurately predict human drug responses.

Currently, over 90% of drugs that enter human clinical trials based on animal experimentation fail the clinical trial process; how many times must we hear that cures to deadly diseases like cancer have been discovered in mice, only for those cures to be ineffective — or worse, have adverse or fatal effects — when they are tested on people?

Cutting edge advancements in human-specific medicines — lifesaving anticancer immunotherapies, biologics like monoclonal antibodies, and the next generation of vaccines — all rely on precision targeting of human-specific proteins and human physiological features for their profound leaps in effectiveness. The uniquely human targets of these drugs are simply not produced by animals, or not produced in an identical fashion, so we cannot rely on animal testing to predict safety and potency in humans. Mandating that such promising drugs are tested on animals where they are guaranteed to fail, will only inhibit their further development. We cannot allow this to happen, nor can we risk bringing them to human clinical trials understudied or compromised by unpredictive animal data.

To continue to advance the future of our biomedical technologies and accelerate the development of cures to human diseases, we cannot continue to rely on cruel and crude dissections of animals, nor on antiquated FFDCA mandates conceived before the advent of modern testing technologies that can predict human drug responses better than experimentation on animals.

We need the FDA to empower researchers to use such modern tools that permit them to study new drugs directly on engineered human tissues, lifelike "organ-on-a-chip" and "organoid" platforms, and Micro-Physiological Systems (MPS) for human-relevant testing that have been demonstrated repeatedly to better mimic and predict real human responses than animals can. Importantly, these modern approaches do not rely on the use of embryonic stem cells or other materials that raise ethical concerns.

More than ever, we need to leverage modern biomedical technology that accelerates, improves, and reduces the cost of safe and effective new medicines for Americans and the world at large.

We thank you and appreciate your support for the FDA Modernization Act by including it in the FDA User Fee package.

Sincerely,

Dr. Jane Goodall

Dr. Dan Huh

Dr. Andrei Georgescu

Jane Goodall Institute

Associate Professor of Bioengineering, School of Applied Sciences, University of Pennsylvania
Chief Science Officer, Vivodyne, Inc.

Chief Executive Officer, Vivodyne, Inc.

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Contacts

Amalia Lytle, Prosek Partners
646-818-9271