Q & A with Dr. Manfred Schmolz, founder and CEO/CSO of Experimental and Diagnostic Immunology
This week I had an opportunity to touch base with Dr. Manfred Schmolz, founder and CEO/CSO of Experimental and Diagnostic Immunology (EDI) in Germany. EDI is a contract research and development laboratory that works for pharmaceutical, cosmetics, and chemical companies. Formally trained as a microbiologist, Dr. Schmolz focused his studies on human immunology for over 30 years. In that time, he developed innovative in vitro assays to model the human immune system. As you know, NAVS supports the development of technologies that advance science without harming animals, and we were impressed that the inventive models Dr. Schmolz has developed can do just that.
Modeling the human immune system is a challenge for scientists, because this system is extremely complex. The body has several types of specialized immune cells that need to communicate with other cells in various tissues and organs, in addition to responding to a wide variety of signals. One of the major criticisms of in vitro models of the immune system is that they lack the complexity of the in vivo immune system, and scientists in favor of using animal models believe that the complexity of animals makes them more useful models in these studies. And that is where Dr. Schmolz comes in -- he has recognized the issues that come with in vitro models that are too simplified, and has helped overcome this problem by inventing more elaborate cell culture models that more closely mimic the complexities of the human immune system.
I had an opportunity to speak with Dr. Schmolz about his cell-based models, and here is what he had to say.
Q. Why was your company interested in developing in vitro assays?
A. Mouse and rat immunology formed the basis of immunological research in the past decades. Nevertheless, the availability of immune cells in the peripheral blood makes it so easy to isolate human cells from the immune system for in vitro investigations that there is actually only little reason to use non-human cells. The main reason, however, is that despite the similarities between human and mouse/rat immune cell activities, there are a lot of differences. In many situations these latter prevent a reliable prediction of what drug activities will be found in the human body when animal cells are used in pre-clinical experiments.
Q. Does your assay system have advantages/disadvantages over other currently available models?
A. Reliability in the prediction of drug effects in vivo to my opinion depends mostly on the complexity of the testing environment that can be created in vitro. Thus, our focus from the beginning on (more than 15 years ago) always was on complexity. The co-culture systems we developed around immune cell cultures still can be considered second to none. The basis for each of these is a thoroughly developed human whole-blood culture that is combined with differentiated human tissue cells in the second, communicating compartment.
Q. Can aspects of this assay be transitioned to the development of other in vitro assays?
Absolutely: The adding of complexity should become a major goal also for other types of in vitro systems.
Q. Does use of this type of assay replace/reduce animal testing? If so, can you approximate by how much?
A. We actually didn't develop these systems to replace animal testing, but just because we were convinced that these add the quality of being totally human. They surely do have the potential to reduce animal use (and I would be more than happy about that). However, I am not able to judge the size of this effect.
Q. Is data from your model more likely to predict what happens in humans than data from animal models?
A. To our opinion, this [is] surely the case. Nevertheless, there are other situations, where a whole organism still has the advantage of higher complexity (providing for example the link between the CNS [central nervous system] and the immune system), despite the inter-species differences.* However, this speaks in favor of a careful and thorough stepwise testing in humans, wherever possible, rather than for using animals with all their inter-species differences, causing new imponderability.
*Dr. Osenkowski adds: It should be noted that the higher complexity of animal models does not ensure that they accurately predict human response. Even non-human primates, our closest relatives, have failed to accurately predict drug response in humans. Additionally, the heterogeneity of humans (with respect to our unique genetic profile and environmental exposures) is not well represented in animal models, and one major reason drug candidates can fail during late stages of drug development.
NAVS would like to thank Dr. Schmolz for his contribution to Science Corner and for his hard work developing in vitro technologies. NAVS agrees that more complex, in vitro models have great potential to accurately mimic in vivo human conditions. As these models are based on human cells, they have greater relevance to the human condition than animal models. Complex in vitro models have great potential to accelerate the process of drug development and increase the rate of clinical success. For more information on human-relevant, in vitro models generated by Dr. Schmolz of EDI, please click here.