Lu Rahman asks Laura Hinton, Operations Director at Gentronix, to offer some insight into the contract research organisation (CRO) market and how Gentronix is making its presence known in this sector.
Gentronix is a specialist contract research organisation (CRO) based in the UK, focused on delivering predictive toxicology products and services to global chemical sectors. Gentronix offers a portfolio of genotoxicity products and services, supporting clients from their very first genetic toxicology screens right through to helping them manage complex genetic toxicology risk assessments. Services to address skin and ocular toxicity are also a key strength of the company, with the ability to address corrosion, irritation, and sensitisation endpoints within its GLP facility.
“One of our main areas of expertise at Gentronix is genetic toxicology, with the ability to advise on strategies to minimise risk to projects. We can support the entire project lifecycle from screening to regulatory studies, including, for example, reduced plate Ames and Micronucleus Test (MNT) formats providing screening stage prediction of mutation and wider genotoxic stress, through to GLP regulatory battery tests in both in vitro (OECD 471, 487 & 490) and in vivo (OECD 474, 488) test systems,” says Hinton.
“Assays are available to address different mechanisms of genetic toxicology, including Ames to assess mutagenic potential and MNT to assess structural and numerical chromosomal damage. We can support Ames positive results with a transgenic rodent mutation assay following OECD guideline 488, providing a lifeline service to high investment compounds that have in vitro predictions of mutagenic potential.”
As well as this the company can provide mechanistic support to discriminate between genotoxic mechanisms. Hinton says this can be a ‘game changer’ in terms of risk assessment and management.
“We also have expertise within the skin and ocular area, providing a battery of tests to allow full assessment of skin and ocular toxicity according to regulatory guidelines, which includes irritation, corrosion, sensitivity and phototoxicity, all following OECD guidelines and allowing an integrated approach to risk assessment. We have established access to 3D human reconstituted skin and ocular models and ex-vivo tissue to support our testing within our laboratories at Alderley Park in the UK,” she adds.
Hinton explains that there will always be a need for the assessment and management of risks, and with advances in analytical techniques, there is increased focus on impurities and assessing risk of these in addition to the parent molecule and metabolites, particularly within the genetic toxicology field. “Nitrosamine impurities are a hot topic across pharma and CROs worldwide, with publications and conference programs reflecting this,” she adds.
One of the biggest challenges for CROs is to address study designs and increase capacity for testing to meet the high demand in the market. “As well as this, there is a challenge to provide services that enable our clients to de-risk projects at an earlier stage in the project lifecycle to avoid late-stage failures, through the utilisation of higher-throughput screening versions of assays,” she says and adds that a focus on minimal test substance usage is also key, enabling comprehensive screening prior to large-scale synthesis. “Coupling early-stage discovery with GLP offerings at the same CRO allows for a fluid pipeline and informs later study design.
“There are a number of requirements for hazard classification and labelling which need careful design of highest tier studies that answer the appropriate questions but don’t produce misleading (and hard to deal with) outcomes. There is also a strong push to develop non-animal methods wherever possible yet maintaining or improving scientific quality.”
Opportunities for CROs
With all this in mind, some of the biggest opportunities for CROs says Hinton, are the ability to collaborate with sponsors to work on new methodology and ensure regulatory work is performed within deadlines set by regulators. “Service demand has never been higher, and CROs that are able to scale capacities while retaining high-quality delivery and scientific engagement have very strong prospects,” she explains.
Benefits of CROs: expert input
“Working with a specialist CRO enables a drug discovery company to access experts as and when they need them, without maintaining expert resource across all disciplines in-house on their own payroll,” says Hinton. “Experienced Study Directors at CROs will be able to advise on study design, help interpret data and prepare expert reports. This expert input throughout the entire process minimises the chance that studies might have to be repeated, ensuring they meet guideline requirements and regulatory expectations. At Gentronix we offer GLP services overseen by highly experienced Study Directors with experience working as toxicologists in the pharmaceutical sector.”
Hinton adds that many assays require laboratory-based staff who maintain their proficiency in specific techniques that cannot easily be sustained if work was to be done sporadically in-house. “When interpreting results from a study it is vital to have a historical control database to compare study results to, which, again, needs to be correctly maintained. Every project will be different, so being able to access a variety of tests that can be tailored to the specific needs of your project and chemistry is another benefit to working with an expert CRO,” she explains.
The CRO market and effect of the pandemic
“The demand upon CROs is currently exceeding pre-pandemic levels. Apart from a few weeks of adjustment to different working patterns, and our sponsors re-starting their compound shipping processes, there has not been a drop in demand for our services. Consolidation in the marketplace from a small number of large organisations has opened up strong opportunities for agile, specialist CROs with expert capacity to support clients addressing toxicology challenges and regulatory safety assessments,” Hinton explains and says that the biggest ongoing challenge is sourcing equipment, reagents and consumables and the large increase in the cost of some of these items.
“Despite the various challenges presented throughout the past three years – Brexit and a global pandemic – Gentronix has gone from strength to strength and successfully cemented itself as a leading CRO even in the face of adversity,” Hinton reveals.
This has been demonstrated by the recent expansion of its laboratory, enabling it to implement new service lines and increase existing service capacity to meet continuing growth in demand. The implementation of a comprehensive ocular and skin toxicology service has enabled the company to expand collaborations with its existing client base, as well as driving new business growth.
The future for the CRO market
“Consolidation of the CRO sector has been happening for a number of years, and we expect this to continue,” explain Hinton. “With numerous pharma and biopharmaceutical companies outsourcing to CROs it has allowed for the market to grow, capacity to increase and consequently efficiencies have been exploited.
“However, there is still a place for expert CROs who can be agile and responsive, offering a tailored approach and catering for global needs in their areas of speciality. Adopting best practice and delivering consistently week-in-week-out, expert CROs will continue to add value to our customers and their projects.”
Volume 23, Issue 1 – Winter 2021/22
About the author
Laura Hinton, an Operations Director at Gentronix, has 14 years of contract research experience and helps to oversee the growth of the company and development of new services. Here, Laura discusses the advantages of using a CRO instead of building capability in-house.