At the World Agri-Tech summit held in London earlier this month, Kevin Helash, the newly appointed CEO of Belgian ag biologicals firm Biotalys, shed light on the significant challenges facing the agricultural biotechnology sector, particularly regarding the lengthy regulatory processes that can hinder innovation. Helash, who took the reins of Biotalys last October, emphasized the disconnect between the lengthy regulatory timelines—often stretching over eight years—and the expectations of investors who typically operate within a five-year window.
“If you’re trying to fund an eight-year regulatory process with investors who have a window of five years, there’s a disconnect there,” Helash remarked, highlighting a critical issue that many smaller companies face. This disconnect could lead to a future where the biofungicides and bioinsecticides markets are dominated by large corporations, as smaller firms may struggle to navigate the costly and time-consuming regulatory landscape. Alternatively, innovation may shift to countries with more favorable regulatory environments, such as Brazil, where companies can move more swiftly to bring products to market.
Helash noted that the regulatory process has slowed dramatically in both Europe and the United States. While the European regulatory environment has historically been slow, the United States had previously been quicker in its approvals until the COVID-19 pandemic exacerbated delays. Helash explained that Biotalys has been waiting for over three years for the Environmental Protection Agency (EPA) to approve its first biofungicide product, EVOCA. “The expectation was that we’d get EPA registration in 2022, and here we are in 2024 still waiting patiently,” he said. This delay is particularly concerning given that the rate at which existing products are becoming ineffective or are being withdrawn from the market is outpacing the industry’s ability to introduce new solutions.
To address these challenges, Helash has been focused on streamlining operations and reducing costs. He has restructured Biotalys to operate more efficiently, cutting about 25% of operating costs to extend the company’s runway while awaiting regulatory approvals. “For me, it’s all about focus,” he stated, emphasizing the need to concentrate on fungicides while maintaining a collaborative agreement with Syngenta for insecticide development.
Biotalys’ innovative approach to crop protection centers on the use of highly-stable proteins derived from camelids, which are expressed in genetically engineered microbes. This unique technology allows Biotalys to create multiple modes of action for the same pathogen, enhancing the effectiveness of their products. Helash expressed enthusiasm about the potential of their second biofungicide product, Biofun-6, which is currently undergoing field trials and targets several high-value crops. He believes that the ability to combine different modes of action could lead to the development of thousands of unique products.
However, Helash also acknowledged the need for biocontrol products to match the performance of traditional synthetic chemicals. “From a farmer’s perspective, there’s zero room for poor performance when you’re talking about a fungicide or an insecticide,” he stated, underscoring the high stakes involved in crop protection. Despite the challenges of replacing synthetic products entirely, he sees a future where multiple modes of action can coexist in the marketplace, providing farmers with effective tools to combat resistant pathogens.
As Biotalys navigates the complex regulatory landscape, the company remains poised to capitalize on its innovative technology and significant market opportunities. Helash’s leadership and strategic focus on efficiency and product development could position Biotalys as a key player in the evolving landscape of agricultural biotechnology, especially as the demand for sustainable and effective crop protection solutions continues to grow.