Our Technology sourcing and Product Development Process
Research & Development Process
The research and development process for our products and technologies can be divided into several discrete steps or phases, which generally include discovery, validation and development, and end with regulatory approval and commercial launch.
The process for developing seed traits is relatively similar for both GM and non-GM traits. However, the two differ significantly in later phases of development. For example, obtaining regulatory approval for GM seeds is a far more comprehensive and lengthy process than for non-GM seeds. Although our breeding programs and agro-industrial biotechnology solutions may have shorter or simpler phases than those described below, we have used the industry consensus for seed-trait development phases to characterize our technology portfolio, which is generally divided into the six phases.
The first phase in the technology development process is discovery, or the identification of candidate genes or genetic systems, metabolites, or microorganisms, potentially capable of enhancing specified plant characteristics, or enabling an agro-industrial biotech solution. For the most part, we rely on collaborators such as leading academic institutions or private research groups to perform this early-stage discovery work, as we then advance it through our technological platforms and processes. We use the technology infrastructure of our subsidiaries, INDEAR and Inmet, and our scientific teams and know-how to accelerate this process with our third party collaborators, often through the use of government grants, which lowers the risk of our technology development activities. In our experience, the discovery phase typically lasts 18 months, although it may range from as few as six months for microbial solutions to as many as 36 months for plant GM traits.
Proof of Concept
Upon successful validation of the technologies in model systems (in vitro or in vivo), promising technologies graduate from discovery and are advanced to a phase referred to as “proof of concept.” In this phase, the technologies are integrated into, or tested in, target organisms to verify their efficacies using greenhouse trials, field trials, or both. In the case of solutions that require microbial fermentation, these technologies are validated at laboratory scale of between one to five liters of batch production.The goal of the proof of concept phase is to validate a technology within the targeted organism before moving forward with technology escalation activities or extensive field validation, which minimizes risk of investment in technologies that may not prove viable. The proof of concept phase is typically conducted by us as part of our research collaboration with relevant groups and represents the last phase of our technology sourcing collaborations. In our experience, the proof of concept phase typically lasts 36 months, although it may range from as few as six months for a microbial solution to as many as four years for plant GM traits.
In the early development phase, field tests commenced in the proof of concept phase are expanded to evaluate various permutations of a technology in multiple geographies and growing cycles, as well as other characteristics in order to optimize the performance in the targeted organisms. For seed traits, this involves initiating our proprietary technology into desired genetic backgrounds. For solutions involving microbial fermentation, this involves initiating technology escalation activities.The goal of the early development phase is to identify the best mode of use of a technology to define its performance concept. For seed traits, candidate event selection is undertaken in this phase.
Advanced Development and Deregulation
In the advanced development and regulation phase, extensive field tests are used to demonstrate the effectiveness of the technology for its intended purpose. In the case of GM traits, the process of obtaining regulatory approvals from government authorities is also initiated during this phase, and tests are performed to evaluate the potential environmental impact of modified plants. For solutions involving microbial fermentation, industrial-scale runs are conducted. The advanced development and deregulation phase typically lasts about 24 months, with some projects requiring substantial regulatory data taking as many as 3 years. For our molecular farming projects, where grain production will occur within Argentina, we may follow a simplified regulatory approach due to a special set of requirements, which takes less time than traditional GM regulatory approvals.
The pre-launch phase involves finalizing the regulatory approval process and preparing for the launch and commercialization of the technology. The range of activities in this phase includes seed increases, pre-commercial production, and product and solution testing with selected customers. Usually, a more detailed marketing strategy and preparation of marketing materials occur during this phase. The pre-launch phase may last up to 24 months.
The development and integration of technologies into products that can be commercialized is a lengthy and complex process. The length of the process may vary depending on both the complexity of the technology or the type of crop involved. The length of the process of developing technologies affects the uncertainty of product development. For example, during the research and development process, a technology may fail to address the performance criteria required to advance to later development stages or changes in the competitive landscape may occur that could affect the development of a certain technology while alternative technologies may advance.
As indicated, the estimated timeframes of phase duration are based on our experience and estimates. The phases may overlap during the product development cycle and the total development time for a particular product may be longer or shorter than the duration presented above depending on a range of factors, including the type of crop and trait involved, and the amount of resources available, or devoted to its development.