Question 1

What are NAMs (new approach methodologies)?

Accepted Answer

NAMs are non-animal methods, systems, and strategies that can help answer key questions about safety, efficacy, and mechanisms of action. They include advanced in vitro models, ex vivo models that use intact human tissues outside the body, in silico models, and integrated testing strategies.

Question 2

Why are NAMs important in cancer drug discovery and development?

Accepted Answer

In oncology, many candidates that look promising in traditional models do not succeed in human trials. NAMs help address this gap by using human-relevant data, including human cells, tissues, and human-derived data, to evaluate how tumors respond to therapies earlier in the development process.

Question 3

What kinds of NAMs are used in cancer research?

Accepted Answer

Common NAMs in cancer research include advanced in vitro models such as spheroids and organoids, microfluidic and lab-on-a-chip systems, ex vivo tumor models that use intact human tumor tissue, 3D tissue-engineered models including 3D bioprinting, and in silico models including AI and machine learning approaches.

Question 4

What is the role of tissue engineering and ex vivo tumor models as NAMs in oncology?

Accepted Answer

Tissue engineering and ex vivo tumor models bring real human tumor biology into controlled, testable systems. Emerging ex vivo tumor models use intact pieces of patient tumor tissue outside the body, preserving key features such as 3D architecture and aspects of the tumor microenvironment, while tissue engineering creates structured 3D microtissues that recreate relevant elements of human tumors.

Question 5

How do in silico models and AI/ML relate to NAMs in oncology?

Accepted Answer

In silico models and AI or machine learning approaches play a complementary, predictive role by turning experimental and clinical data into simulations that anticipate tumor behavior and treatment response. Within a NAMs framework, these models are especially powerful when anchored in human-relevant data generated by advanced in vitro systems, tissue-engineered microtissues, and ex vivo tumor models.

Question 6

How does CerFlux participate in the NAMs ecosystem?

Accepted Answer

CerFlux focuses on human-relevant cancer models that use patient tumor tissue and tissue-engineered microtissues as the experimental backbone for ex vivo and in silico decision-making. Platforms such as the Bioprinted Ex vivo Slice Tissue (BEST) model are being designed to support drug response prediction tools like PEER and PROPHET by generating structured, quantitative response data from human-relevant systems rather than relying primarily on animal studies.

FAQs about PEER®, BEST, and ChipMux™ for Biopharma

What is PEER® and how does it help pharma and biotech?

What is the BEST human-relevant cancer model?

How does PEER® function as a NAM in the preclinical workflow?

How can ChipMux™ be used as programs move closer to the clinic?