The Heightened Importance of CROs for Agrochemical Companies
Some call it extremely demanding. Others call it risky. It’s the research, development, and registration of new chemistries, and it’s no secret that it’s a challenging process for agricultural product creators.
A CropLife International study pegs the cost at more than $280 million. During this lengthy period, many factors can complicate the process: Customer needs can change, new regulatory requirements can emerge, competitive products can preempt opportunities, to name a few. After all, these chemistries are some of the most regulated in the world, so the process requires thorough and repetitive testing.
“Moving new products to the farmer, especially in the renewable biological realm, requires rigorous product development, including regulatory strategy and field development in parallel with marketing and a robust technology adoption platform,” explains Jerry Duff, founder and president of AgriThority, an independent global science resource based in Kansas City, Missouri.
Now add a pandemic to the mix when travel, in-person meetings, and visiting field research trials are limited. A tough job just got tougher.
For chemical manufacturers who conduct most of their R&D internally, the pandemic meant putting in place COVID-19 safety protocols, dealing with travel restrictions, and finding additional permanent staff members. Where these changes weren’t possible, agrochemical companies turned to Contract Research Organizations (CROs) as strategic partners to assist them with the 100-plus studies and field trials the R&D process required, providing solutions; ensuring quality control; and keeping research, product evaluation and registration moving forward.
In fact, the use of CROs has grown — not only to ensure products in the middle of the cycle weren’t stalled when COVID-19 hit, but also to assist in the complicated R&D process for additional chemistries.
“As regulatory consultants, we have received more requests and have more projects than before,” shares Piyatida Pukclai, Asia-Pacific Business Development and Regulatory Policy Lead with Knoell, a scientific and regulatory team that helps products with global marketability based in Germany. She says business in the company’s crop protection division has been up 5% each year since COVID-19 and predicts this will continue to increase in 2022.
For agrochemical companies, when all the phases of new chemistry R&D and introduction align smoothly, the result could be a home run. And CROs are playing a more important role in making that happen.
COVID-19’s Impact on R&D
Agrochemical companies were certainly worried about having to pause or cancel their projects and studies when COVID-19 shut down the world in early 2020, Pukclai reports. They sought solutions to help keep their important work moving forward and registrations up to date.
Visiting field trials is one of the most important tools for study management in order to get a thorough assessment of trial performance. COVID-19 clearly limited this, explains Kirsten Heitsch with CropTrials GmbH, an independent private company for agricultural field research and development based in Germany.
Luckily, since most of the company’s work happens in the field, with the right safety protocols in place, field investigators could still do their jobs. While putting these additional safety protocols in place increased company costs, it had no negative impact on sales, says CropTrials GmbH Managing Director Paul Reh.
But study directors couldn’t travel to the trials to physically witness the results. So the team used photos and data to communicate their findings. “It can be difficult to evaluate the assessment data without having actually seen the trial,” Heitsch says. “So to get a better impression of the trial, we received many pictures of the trials at different times.”
“This way we could still serve clients with the data they needed for registration packages,” Reh adds.
Ignacio Colonna, LATAM R&D Manager, AgriThority, agrees. When travel restrictions imposed some limitations in trial execution, impacting costs and timelines, CROs had to develop better resources to objectively record the effects of experimental products without the stakeholders having the chance to visit the trials firsthand. “The use of drone and satellite images played a key role in generating information,” he explains.
For international companies, “the pandemic spurred everyone into a virtual communication mode,” Duff says. “We have moved from fewer in-person meetings to a routine use of internet-based video conferences for presentations and discussions with staff, clients, and suppliers all over the world. Fortunately, we had been using video conferences on a more limited basis for many years, so the transition to a more active use was relatively smoother. We drove more miles and we communicated through video conferences more, but, like the people on the farm everywhere, we persevered.”
The role of the CRO continues to evolve, developing from a fee-for-service type company to a solutions-oriented business.
The progression of the CRO to “R&D partner” status has really intensified since COVID-19, explain representatives from Eurofins Agroscience Services (EAS), which provides regulatory support, lab and field studies, as well as C14-synthesis and analytical services to the agroscience industry.
“By offering solutions rather than ad-hoc services, closer collaboration enables projects to be completed efficiently, resulting in both time and cost advantages,” they say. “Robust IT solutions and increased digital contact enabled effective management of studies and online extranet updates, as well as regular personal communication to keep everyone informed of study progress. This included live video chats, WhatsApp texts and emails, which are already important in communication but became even more essential tools during the pandemic.”
And like many companies are learning as they change their business strategies during the pandemic, some of the solutions will stick post-pandemic. For instance, drone and satellite images helped AgriThority develop analytical approaches the company believes will “benefit product evaluation, providing a more objective, spatial and time-detailed assessment of their effects on crops,” Colonna points out.
Overcoming Staffing Shortages
Just like every business today, staffing challenges are present for agrochemical companies, as well as CROs.
The need and demand for local field trial management has increased due to the travel restrictions of company employees. Some who historically supervised their own trials now rely on outside resources for this service.
“Like many other areas, the shortage of labor has added pressure on some of the CROs,” explains Gloverson Moro, Chief Technology Officer of AgriThority. “If they lack qualified personnel, this results in challenges they have to overcome to sustain the quality of work.
They have continued their research services despite added pressures from both the companies and the less abundant qualified labor force.”
One AgriThority senior field research scientist, Krishan Jindal, has conducted more than 81 field trials across 17 U.S. states on 13 crops so far this year. “He reports only four of his contract researchers experienced a shortage of technical manpower that impacted their trial management,” Moro says. While these labor challenges tend occur annually, this year the impact seemed more visible.
Experts at Knoell say they also had to expand their team to accommodate the numerous requests from agribusiness companies but finding people hasn’t been an issue. Since people can work from home, the job flexibility makes the work attractive, Pukclai says.
Regulatory Relationships and Navigation Strategies
The regulatory component of new chemistry R&D is probably the most challenging and unpredictable. A pandemic certainly didn’t simplify this segment of product registration.
Today, “it is almost impossible to have a face-to-face meeting with a regulatory authority,” Pukclai explains, “and virtual meetings seem difficult.” Although most countries were in lock-down, “most regulatory bodies still expected timely submission of dossiers,” Pukclai adds.
On occasion, data review and decision making by some government agencies has been notably slower, adds representatives from EAS. While several agrochemical businesses were handling their regulatory consulting, liaising with local authorities, and registration support internally, the pandemic has increased their need to outsource these tasks.
“Our clients want to know what’s happening with regulatory requirements regarding their products and if there will be any impact on their registration evaluation or approval of field trials or not; how to deal with the import of samples for studies when the shipment is more difficult than before; will the registration approval be delayed — there’s definitely a lot of interest in that,” Pukclai explains.
Using an international network, Knoell increased regulatory agency communication to get updates on current situations in various countries to keep registrations moving. “We check with the regulatory agencies regularly, and if we sense some delay may occur, we inform the agribusiness companies at an early stage as soon as we can,” Pukclai explains. “In some cases, where it is unpredictable, we provide the evidence to the agribusiness companies to prove that it is unforeseen, and we give some suggestions for such a case, too.”
Even though regulatory agencies face the same kind of limitations as any company, Pukclai says they continue to try and work with companies during these unprecedented times. “We can see that they try to increase the engagement with the industry and regulatory consultants by offering new communication channels or by temporarily relaxing some of their administrative rules due to pandemic circumstances,” she says.
CROs were able to help companies navigate this tricky area because they already have a solid base of regulatory knowledge and expertise, as well as relationships with regulatory bodies.
“We expect the needs for regulatory support to continue,” Pukclai adds.
Knowledge gaps and missing resources, particularly when traditional channels are limited as a result of the pandemic — and even after as new communication tools are embraced — will continue to increase the need for CROs.
“The agroscience industry is dynamic,” representatives from EAS say. “As it is constantly reshaping through consolidation, acquisitions, and development in new sectors such as biopesticides, biostimulants, etc.; this often creates temporary instability.”
As a result, EAS representatives say, “the partnership between clients and CROs has really developed, growing even stronger during the COVID-19 pandemic.”
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