Force Majeure

Background

 

The development and commercialization of genetically modified crops are complex processes that require a combination of cutting-edge scientific research, robust field testing, and comprehensive regulatory approvals. Helix, a company within the Agroceres Group, working together with Embrapa, the Brazilian National Agricultural Research organization, embarked on a groundbreaking initiative to develop a transgenic maize highly effective against the fall armyworm (Spodoptera frugiperda, or FAW) the most destructive corn pest in Brazil. Hjelle Consulting Group (HCG) played a pivotal role in streamlining Helix’s path to regulatory success by providing scientific insight, regulatory expertise, and a turn-key solution to accelerate the approval process for corn in key global markets. 

 

The Significance of FAW Resistant Maize 

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FAW-protected corn represents a significant technological breakthrough in Brazilian agriculture. Developed through a 100% national public-private partnership between Embrapa and Helix, the event EH913 was unanimously approved by CTNBio (National Technical Commission on Biosafety) in June 2022. The innovation behind the FAW-resistant maize stems from the introduction of a gene from Bacillus thuringiensis (Bt), a bacterium known for its natural insecticidal properties. This modification provides maize with superior resistance to the fall armyworm, a pest notorious for causing devastating crop losses and for becoming resistant to current biotech Bt traits. 

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The efficacy of FAW-resistant maize was rigorously tested through laboratory and field trials conducted in key agricultural regions of Brazil. Results demonstrated that the maize performed extremely well compared to the commercial technologies available. Notably, trials in heavily infested areas such as Rondonópolis, Mato Grosso, confirmed that the EH913 maize showed no significant damage to leaves or ears, even when heavily invested by FAW that were already resistant to other Bt-expressing maize hybrids---making the Helix and Embrapa technology a needed game-changer in pest-resistant crop technology.  The maize event has high toxicity to FAW, including against resistant populations and the Helix and Embrapa product places the “home-grown” technology as an important advance for Brazilian farmers. 

 

The Impact on Brazilian Agriculture 

 

Brazil is now one of the world’s largest maize producers, and effective FAW control is arguably a national emergency and vital to sustaining high crop yields and stability. The FAW has historically inflicted billions of dollars in damage. By leveraging Brazil’s unique biodiversity, and Embrapa’s discovery they were able to develop a FAW-resistant maize hybrids specifically tailored to tropical agriculture. 

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Urbano Ribeiral Júnior, Finance Director of Agroceres, emphasized the uniqueness of approach. “Our approach leveraged Embrapa’s unique understanding of Brazilian biodiversity and soil microorganisms to address our specific agricultural challenges.” This strategic focus on tropical agriculture positions Helix as a leader in sustainable and effective pest management solutions. ​

 

HCG’s Role  

 

HCG began collaborating with Helix in 2018, providing comprehensive support in research and development, GLP and SOP training, field trials, seed testing, managing the Regulatory Science studies, and proactive Regulatory Affairs submissions. HCG’s expertise was critical; HCG’s team in Brazil was outstanding working together with Helix colleagues, CROs and other members of our global HCG “Regulatory on Demand” network to ensure that the Regulatory Science program met both local and international standards for establishing the food, feed and environmental safety of the EH913 event maize. Regulatory approvals have been obtained in the US and Canada and progress continues elsewhere.   

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It helped that HCG’s senior leaders were involved in the testing and approvals of some of the most successful Agricultural Biotechnology products globally - and in Brazil. HCG’s approach to regulatory strategy involved: 

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• Helping design and conduct extensive field trials in diverse environmental conditions to validate the agronomic and phenotypic characteristics of the EH913 maize including product efficacy and lack of adverse environmental effects. 

• Providing and implementing an overall plan for other scientific studies to establish that EH913 grain and forage are safe for consumption, meeting international biosafety and regulatory standards. 

• Strategically assembling and carefully submitting regulatory dossiers to agencies such as the USDA, EPA, and CFIA. 

• Helping with pipeline testing, prioritization and Helix capacity expansion. 

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As a leader in Brazilian maize seed, Helix was quite familiar with trait licensing, seed quality testing, and the overall Brazilian market needs and dynamics - but needed a comprehensive “Regulatory on Demand” collaboration to accelerate the entire process.

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HCG’s expertise enabled Helix to “jump-start” an integrated research and development pipeline, allowing the company to both source additional talent and train their in-house staff, systems and strategy to develop proprietary biotech traits without the need for significant head count expansion in Brazil or internationally. Additionally, HCG helped Helix’s develop quality, regulatory science and pipeline testing capabilities and capacity. And the collaboration with Embrapa scientists helped them better understand the broader international testing considerations needed for Brazilian agricultural advances. In return HCG had the opportunity to work with incredible collaborators at Embrapa and Helix focused on the immense challenges facing Brazilian agriculture. 

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Conclusion 

Helix’s success with FAW-resistant maize is a testament to the power of strategic pipeline collaboration, cutting-edge science, and regulatory excellence. HCG’s role in expediting product pipeline development and regulatory submissions and approvals, through strategic partnering and global project management has been instrumental in bringing EH913 a step closer to solving key market needs. In addition, HCG set Helix up for future success by helping to expand their research and development and regulatory capacity. For biotech and agricultural companies aiming to navigate the complexities of product development and global commercialization, HCG stands as the trusted partner of choice, offering “Regulatory on Demand” solutions that transform innovations into market successes.