A model summer: Preclinical research developments rise with the temperature

By Maggie Lynch contact

- Last updated on GMT

(Image: Getty/Andrey Popov)
(Image: Getty/Andrey Popov)

Related tags: preclinical, preclinical development, Preclinical services, Drug development, Drug discovery

As summer heated up, the pharmaceutical industry saw major developments in preclinical models from new software to 3D-printed tissue, all in the name of drug development.

June

June 2019 saw the French software firm, Dassault Systémes acquire Medidata for $5.8bn​ (€5.24m) in an all-cash transaction to combine modeling and simulation with data science. With the acquisition, Medidata became a wholly-owned subsidiary of Dassault Systems.

Dassault’s EVP, CFO and corporate strategy officer, Pascal Daloz, stated that the acquisition was in an aim to create “the first end-to-end scientific and business platform for the life sciences industry.”

According to Bernard Charles, vice chairman and CEO of Dassault Systémes, the combination of modeling with real-world evidence analytics capabilities created a “profound catalyst to personalized health, patient-centric experiences, and the next standard of medical practices.”

He added that while the ‘perfect model’ for drug development is still years away “data science has to be correlated to modeling and simulation.”

July

Not long after the acquisition of Medidata from Dassault, Lovelace Biomedical was awarded a $20m contract with the National Institute of Health​ to lead disease model research in July.

The preclinical contract research organization (CRO) was awarded the contract under an agreement to lead four institutions in creating and characterizing disease models for unmet medical needs.

The group started immediately with a research program focused on sickle cell disease and began work with research institutions that have demonstrated specific capabilities to understand the genetic underpinnings of diseases.

On July 11, 2019, Repositive relaunched its Cancer Models platform​ with an accessible directory to increase visibility while still maintaining confidentially. The relaunch saw the CRO’s directory of preclinical cancer models publicly available.

The directory holds 5,300 models in one portal. The models were created in partnerships with 18 specialist CROs including Cellesce, Nexus Pharma, Antineo, Xentech, Shenzhen Invivo, and Shanghai LIDE Biotech.

According to the CRO, the relaunch came at a time when drug development was advancing toward an era of precision cancer medicine and researchers needed to source preclinical models with molecular and genomic profiles.

Fiona Nielsen, CEO of Repositive said, “It’s an evolving process and we are keen to speak to researchers from both pharma and CROs to ensure we’re building the product they need to support their preclinical efficacy studies.”

August

On August 1, 2019, Taconic commercialized its rodent model​ preconditioned with diet-induced nonalcoholic steatohepatitis (NASH) for preclinical research.

According to Taconic, the mice were developed after an increased demand for preconditioned models was seen. This demand was related to the time delays seen in drug discovery, as researchers can be required to wait up to 26 days to have models available and ready for the study.

Michael Seiler, vice president of Taconic’s commercial model portfolio, stated researchers had to previously “plan studies months in advance and were left with little flexibility as new compounds were discovered along the way.”

Previous to the commercial launch of its NASH mice, Taconic also released its TruBiome product platform to enable the development of models with customized microbiota profiles.

Around the same time, Prellis Biologics, a San Francisco, CA-based biotechnology company, closed a $10.5m investment round to develop technology to accelerate drug screening through 3D tissue printing.

Prellis’ holographic 3D printing technology can be used to support preclinical research as it delivers biocompatible vascularized tissue blanks to pharmaceutical and academic markets.

Melanie Matheu, CEO of Prellis told us, “Our vascular tissue blanks provide an oxygen and nutrient permeable environment that once seeded with cells supports 3D cell growth.”

Matheu added that cell growth in three dimensions has advantages over conventional two-dimensional cell cultures and serves as a better model for actual human cell behavior.

The company’s technology is currently being used for research in oncology, tissue development, neurobiology, and drug testing in over 30 research labs including University of California San Francisco, Johns Hopkins, University of California Irvine, and Memorial Sloan Kettering.

Later in August, GlaxoSmithKline (GSK) and Tara Biosystems’ demonstrated that Tara’s engineered heart-on-a-chip​ system replicated responses found in adult humans.

Misti Ushio, CEO of Tara Biosystems, stated, “We can now confidently apply our technology to assess emerging compounds in drug discovery and development and predict potential clinical effects.”

Tara has validated its platform by analyzing compounds with known responses. The company’s findings have also demonstrated that the system can predict how human hearts will respond to various drugs, which Ushio said had been a challenge until now.

The heart-on-a-chip system was developed through the use of 3D human cardiac tissues known as Cardiotype tissues. Such tissues are produced by using human-induced pluripotent stem cells (iPSCs), which have matured on Tara’s Biowire II platform.

“The platform enables researchers to gather human-relevant functional data in the lab, providing a surrogate measure for how effectively the human heart pumps blood in the presence of potentially toxic drugs,”​ said Ushio.

Similarly, researchers have recently demonstrated that miniature livers​ can develop steatohepatitis and fibrosis, which can enable personalized hepatic drug discovery and toxicity platforms.

Researchers from Tokyo Medical and Dental University and Cincinnati Children’s Hospital Medical center reported that, in an effort to move beyond early models, they worked to create organoids that were more representative of the mix of pro-fibrotic and inflammatory cell types found in the human liver.

The reported project generated evidence that this type of organoid can serve as a model for the efficacy of drugs.

Related topics: Preclinical Research

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