What is the State of the Industry for Alternative Models

Charles River's Alternative Methods Advance Project launched six months ago. How are things going?

This April, Charles River (CRL) launched the Alternative Methods Advancement Project (AMAP), which solidified a plan that was already in motion: researching and promoting alternatives to animal testing. Over the last four years, the company spent $200 million on alternatives research, and part of the AMAP plan dedicated another $300 million over the next five years.

It has only been six months since the official launch. So, how is it going? We spoke with Julie Frearson, SVP and Chief Scientific Officer, to find out.

Eureka: To start us off, can you give us a brief explanation for what AMAP is and its original purpose?

Frearson: AMAP is CRL's initiative dedicated to pursuing scientific and technological innovation to enhance and accelerate the development of alternatives to the use of animals in evaluation of therapeutic products. AMAP will help us align our activities in partnerships, product and services improvements, and advocacy, ensuring we have a cohesive strategy towards reduction of animal use across our portfolio.

We also established the new Responsible Animal Use (RAU) office, which is comprised of a cross- functional CRL team including experts in animal welfare, science, technology, operations, and advocacy, plus key members of the CRL Board of Directors.

Eureka: Was the impetus for AMAP internal, external, or both? What made us decide to make these changes?

Frearson: The impetus comes from both strategic drivers to ensure CRL is progressing its science towards better translation to human efficacy and safety, as well as a continuous drive to highlight the responsibility that CRL, the industry, legislators and society as a whole has to use animals responsibly and respectfully with long term reduction in mind.

Eureka: Since the program was launched, what strides have we made in animal model reduction?

Frearson: CRL has been active in alternatives for several years already, and the AMAP initiative has enabled the consolidation of existing efforts and provided the impetus for new projects. Presently there are more than 10 programs in flight covering alternatives for reduction, such as complex in vitro models in genetic toxicology and lung safety assessment; technology innovations such as virtual control groups and potential entire platform replacements including next generation sequencing for biologics product testing.

Eureka: There are other R's besides reduction, so what about refinement?

Frearson: Switching to low stress handling of mice and rats is underway at all CRL sites. As of today, 40% of sites have fully switched to LSH with their animals. We have a resource page on our internal website for sites to use for training and for new ideas for implementation. The Q4 3Rs Colloquium Webinar coming up will discuss microsampling in large animals - a nice refinement to traditional blood collection techniques - which uses less restraint and has less impact on the animal.

Eureka: What about replacement?

Frearson: Replacement may be possible for specific toxicology questions such as genetic toxicology and reproductive toxicology. We have partnerships to address both in vivo platforms with possible in vitro assays.

Eureka: Finally, how are regulatory bodies responding to these initiatives?

Frearson: Regulatory bodies are engaging in multiple ways to support and encourage these initiatives including partnering with external scientific groups such as ICHand ICCVAM, and hosting town hall meetings to discuss validation and qualification of new methods. The agencies are also publicly engaging at conferences and workshops discussing how complex in vitromodels might be useful in addressing unmet needs for efficacy and safety assessment as part of IND enabling packages. Recently, a CRL team met with the Deputy Commissioner of the FDA to discuss the future role of alternatives in risk assessment - a great example of the agency's interest in this topic.

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