Evolution of CROs
As new companies and chemistries come to market, contract research organizations (CROs) help suppliers minimize data gaps and analyze preliminary risks to ensure successful product launches.
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By Nicole Wisniewski
Contributor
Companies bringing new products to market must comply with new regulations and requirements. They are looking for reliable data to present to several countries, as well as support for data interpretation, which is what puts contract research organizations (CROs) in higher demand.
“Our workload in the pipeline is increasing. More than ever before, our clients are outsourcing to rationalize and optimize their internal resources,” said Fanny Vanel, Marketing and Communication Manager at Staphyt, a multi-specialist global CRO.
“Regulatory requirements are intensifying. Today, the renewal of an active substance requires more work than in the past because of the increase in requirements. For example, waivers, which can justify the non-implementation of a study, are less and less accepted by certain authorities. Today, the support of a CRO is essential to have access to an evolving pool of expertise and to accelerate the marketing of their products.”
In the past – prior to the 1970s, some experts estimate – research and development projects for agrochemicals were fully managed in-house. CROs were only relied on for overflow, less strategic work and under strict supervision, representatives from Eurofins Agroscience Services explained.
Today, “the role of the CRO is to generate scientific data according to regulatory or research needs and dynamics,” said Leticia Rossi, Sales Consultant at Merieux NutriSciences, which offers CRO solutions from product development to market suitability.
Companies employ CROs for a variety of reasons.
“We generally use CROs for a variety of reasons, but much of the benefit is derived from time savings,” said David Allen, Vice President, Crop Productivity, Stepan Co. “This can either be from a CRO having a skill set or competency that we don’t have that would require too much time or money to build ourselves. They might also have a skill set we already have, but have the required resources or assets to complete the contracted task that we cannot complete due to competing internal priorities.”
Eurofins Agroscience Services, a company with more than 30 years of experience in crop protection, offering technical knowledge and regulatory support to agrochemical manufacturers and the seed industry, stated: “By offering regulatory expertise, dossier preparation, strategic guidance, data generation, liaison with authorities, and global regulatory support, CROs can greatly assist agribusiness companies in successfully registering new products through the complex and detailed regulatory process.”
For the team at Wilbur-Ellis, CROs serve a multitude of purposes.
“We work with CRO’s because it provides the opportunity to get multiple in-depth trials out in different locations across the areas we serve, allowing us to test products under different agronomic conditions,” said Kara Schut, Eastern Technical Services Manager – Research and Product Development. “For Wilbur-Ellis, working with CRO’s is a benefit because it provides quality replicated trial results. This allows us to be on the forefront with new product introductions. By testing products in the pipeline, we’re able to determine the benefits and weaknesses of each, ensuring that we are providing products that support the sustainability of our business and the success of our growers.”
Some counteracting trends are driving the need for CRO services, including a decline in new substances being developed, as well as several older substances leaving the market in some regions of the world, especially the European Union. Also, a continued increase in data requirements per substance and the number of generic development projects are at play.
“While the first two reduce demand, the latter drive demand,” Eurofins Agroscience Services stated. “CROs also play a critical role for newcomers to the agricultural sector who generally have a limited agronomic and regulatory background. They heavily rely on our expertise to de-risk and successfully manage their research and development program with novel biosolutions or disruptive agtech tools.”
The growing skillsets required to complete this work necessitates the need for additional assistance. “With little or no in-house capacity and resources, new players and start-ups call on us,” Vanel said. “Obtaining the regulatory data required for the approval of an active substance or the marketing authorization of a specialty always requires more skills in agronomy, risk assessment, toxicology, ecotoxicology, physio-chemistry, etc.”
CROs are becoming an essential key in a company’s success by providing consulting, strategy, and global support.
“We have moved from a fairly standard customer/supplier relationship to a more integrative approach,” she said. “[Our customers] need more global support – both in terms of services and geographical coverage.”
CROs offer a variety of services and matching the offerings with a company’s needs is a key to success.
“The decision on which CRO’s we work with is based on the history of the work they do and the quality data that we receive,” Schut said. “We are always looking for CRO’s to work with as we continue to expand our business. We find CRO’s through recommendations of others and by attending an annual conference for CRO’s, allowing us to meet with them and explore opportunities with organizations and individuals across our geography.”
CROS GROWING INVOLVEMENT IN BIOLOGICALS
Biological products typically have a different risk profile compared to synthetic crop protection products.
Traditional chemicals are tested using classic chromatographic methods, which are very well established and known. But biological products require different techniques and greater attention placed on testing method development.
For optimal assistance in the management of these new projects, it is crucial to consider the specifics and their modes of action. “Field trials, for example, require a more technical approach, advanced agronomic knowledge, integrated pest management practices, consideration of the crop history of the plot and the pedoclimate environment, etc. to exploit the full potential of these products,” Vanel said.
Rossi agreed, pointing out that some products like plant extracts and others from natural origins “are characterized by the presence of markers, which are chemical substances with known presence on them, usually in low amounts. Others, like fungi, bacteria and viruses, can be characterized by microbiological and molecular biology techniques.”
The biopesticides market continues growing every year, making it pertinent that CROs are ready to offer reliable and high-quality analysis packages in line with the regulatory requirements of different countries for their clients, Rossi said.
CROS are important for biological products because they can “recommend paths to be followed for a smooth process along with consultancy agencies and provide accurate reports, especially regarding requirements that may arrive to the clients after a few years,” Rossi explained. “An experienced CRO can advance this need and have the report ready before the sample expires.”
There are also differences in the regulatory requirements for the analysis of traditional chemicals versus biopesticides. “For biopesticides, it is necessary to perform pathogenicity studies on animals,” in addition to other studies, Rossi said. “To comply with this, CROs need to offer a larger laboratory infrastructure and specialized team, as well as be adapted to work with microorganisms.”
And as the ever-changing regulatory landscape continues to put pressure on agrichemical suppliers of all product types, the need for CROs is increasing, Rossi said, “the CRO is part of an important chain involving the governments, the scientific community and other actors looking to make the life of our planet sustainable, while the population increase and climate change challenge the availability of natural resources.”
“We expect the CRO landscape to continue to change,” Eurofins Agroscience Services representatives agree. “No matter what, the CRO will continue to be a key element of innovation in agriculture.”
CRO TRENDS
Just as the use of CROs have evolved, so have the CROs themselves.
- Increasing regulatory hurdles in Europe have driven up the complexity of the studies required for registration and have led to a reduction of substances that are being developed and subsequently brought to market.
- Many CROs have adjusted and have expanded their expertise, geography, and service portfolios to satisfy client needs.
- Sustainability is also a growing concern. CROs have aligned with sustainability when they started offering alternative methodologies to animal testing for toxicological packages, as well as environmental impact studies for non-target organisms, Rossi said.
- Initiatives like the European Union’s Green Deal are also influencing the sustainability efforts of many players in the agroscience industry.
- “Europe remains the region with the most challenges in terms of time to market and size of data packages to generate – both for chemical and biological products,” Vanel said. “Companies have to face a mature and highly competitive market, but also respond to a political will to reduce the use of chemical pesticides by 50% by 2030 per the Green Deal, as well as to the regulation of biopesticides that is still too much based on the chemical model.”
- Brazilian and Mexican authorities have also been quite demanding and thorough on dossier evaluations.
- According to the Organization for Economic Cooperation and Development’s “Regulatory Governance in the Pesticide Sector in Mexico” report, which identified the gaps, barriers, implementation flaws and inefficiencies that affect the regulatory framework of pesticides in Mexico, the country addresses issues of pesticide regulatory framework “in an ad-hoc way instead of designing a regulatory system that effectively and efficiently covers the whole life cycle of pesticides.”
- This is what might be making pesticide registration in Mexico more challenging since there is little coordination among regulators on registration, such as streamlining the responsibility for granting registration or establishing a cross-agency mechanism for communication and the management of submissions.
- And with Brazil, there is currently a strong growth of biological products. “However, regulations are not moving as fast as innovation,” Vanel said. “There are still products like biostimulant products that do not have a clear regulatory positioning in a commonly accepted dataset.” •