What specific challenges in pre-clinical oral drug development does this $22M investment aim to address, and how do the expansions in Cincinnati and Bend improve Thermo Fisher's capabilities to overcome these challenges?

• Oral Solid Dose (OSD) drug formulations make up 84 percent of all medications on the market due to storage stability and ease of administration. As the sector continues to grow steadily, pharmaceutical and biotech companies are looking to move away from trial-and-error approaches to find effective formulations, which were historically inefficient, costly processes that often resulted in delays in delivering vital medications to patients. Innovation and cutting-edge capabilities that can accelerate the path from discovery to delivery while maintaining quality and efficacy remain a high priority. 

• By investing in development and manufacturing capabilities in Bend and Cincinnati, we are offering state-of-the art equipment and technologies to support early development of OSD formulations, providing greater flexibility to biotech customers to help them get drugs to patients swiftly and safely. Our investments across these two sites address some of the customer needs we most often hear, providing benefits such as: 

• Speed and flexibility in formulation and process development activities – including integrated Active Pharmaceutical Ingredient (API), solid state analysis, bioavailability and solubility enhancement solutions, to accelerate time-to-market

• Risk mitigation with minimal API- and material-sparing experimental design

• Data-informed decision making, with computational modeling and predictive tools to solve drug development problems and to avoid trial-and-error cycles

• Rapid project initiation, where development work can begin on non-GMP equipment using development grade API, with no cleaning method required

• Simplified supply chain to help customers avoid costly delays

• Optimized manufacturing and scale-up to accelerate milestones

Can you provide more insight into the advanced technologies and next-generation tools being implemented at the expanded sites? How do these innovations accelerate drug development timelines?

• The Bend site expansion doubles the footprint of Thermo Fisher’s center of excellence for early development and advanced drug delivery, including solubility and bioavailability enhancement solutions – which remains one of the largest challenges for pharma and biotech customers in early development phases. The team leverages predictive modeling, machine learning (ML) and Artificial Intelligence (AI) tools that enable faster data-driven decision-making and have a direct impact on time-to-market for their drug candidates. One of those tools was developed and launched in Bend: Quadrant 2™, our predictive platform used to evaluate technologies and excipients to enhance solubility and bioavailability with high accuracy. Others include solutions for stability and packaging modeling, physiologically based pharmacokinetic (PBPK) modeling, and discrete element modeling (DEM). 

• In Cincinnati, the expansion includes a new, pilot-scale high-shear granulation and fluid bed processing suite, as well as the launch of two new major offerings: ASAP® Stability and Compaction Simulation (Styl’One®). Not only will these solutions increase the speed and flexibility in formulation and process development activities, but it will also allow Thermo Fisher to use data-informed decision-making to help their partners solve drug development problems and avoid the trial-and-error cycle.  

How does the expansion of the Bend site’s center of excellence for early development and advanced drug delivery contribute to improving solubility and bioavailability enhancement solutions?

• Solubility and bioavailability enhancement is an area in which Bend’s center of excellence specializes, in addition to digital modeling and early clinical trial material development and manufacturing. As previously mentioned, the team in Bend introduced the Quadrant 2™ solution, which has already analyzed more than 400 small molecules to ensure success in the later stages of the development process. Additionally, this expansion in Bend enables Thermo Fisher to use the site as a hub for the company’s Engineered Solutions, a group of scientific experts who focus on accelerating and mitigating risk in the drug development process through AI/ML solutions.  

• Overall, this expanded capability and utilization of digital modeling will help reduce and avoid the trial-and-error cycle for solubility enhancement technology selection, allowing Thermo Fisher to support pharmaceutical and biotech customers with more seamless and flexible services for challenges that often arise during early development phases. 

Could you elaborate on the flexible R&D space in Cincinnati? How will this addition specifically support early development projects for small molecule OSD formulations?

• The expansion in Cincinnati introduced a new, 3,200-square-foot space that is specifically dedicated to research and development (R&D) non-Good Manufacturing (GMP) to support early development of OSD formulations, providing greater flexibility to our biotech and pharma customers. The investment includes state-of-the-art technology and equipment that provide numerous benefits for the development of small molecule OSD formulations. 

• Specifically, the new granulation suite bridges the site’s existing small- and large-scale assets to serve GMP, development and early-phase clinical through small-scale commercial for orphan/rare disease and small volume products. It also adds several new capabilities at this scale. Further early development capabilities made possible by the facility include lab/bench-scale processing capabilities for OSD formulation and process development activities, as well as Drug Enforcement Administration (DEA)-approved space and equipment that is solvent compatible and potent compound (Cat 3A) capable. 

Thermo Fisher has supported over 125 new drug approvals (NDAs) in the last decade. How do these expansions align with your long-term strategy for supporting more clients and achieving faster time-to-market for therapies?

• The 125 new drug approvals that Thermo Fisher has supported over the last decade are only the beginning of the impact we plan to make, together with our partners. The site expansions in Bend and Cincinnati are a demonstration of how we are prioritizing the ongoing development of crucial therapies, specifically in the OSD sector, by leveraging innovative approaches and enhanced capacity to help our customers around the world move their products from discovery to delivery quickly, safely and effectively. 

• Further, this investment is part of Thermo Fisher’s early development initiative to accelerate pre-clinical oral drug product development, with the goal of reducing timelines to GMP production of clinical trial materials. It builds on the company's continued investment in small molecule OSD solutions, including development and manufacturing services in Bourgoin, France; Manatí, Puerto Rico, US; Toronto, Canada; Whitby, Canada; and continuous manufacturing in Greenville, NC, US. 

With expansions also happening in other global locations like France, Puerto Rico, and Canada, how does Thermo Fisher plan to integrate these global sites to create a more unified and efficient drug development ecosystem?

• As the Thermo Fisher network continues to expand across various countries and regions, a top priority remains to provide the necessary support to pharma and biopharma partners around the world as they navigate a drug development process that often crosses borders and, ultimately, aims to deliver medicines to patients globally. Together, Thermo Fisher’s global OSD sites allow us to work with local stakeholders and customers to create strategies that enhance workflow capabilities not just at one specific location, but through innovation at a global scale. We can take the insights we learn at one site and apply it to other sites to help bring critical medications to the patients who need them most in a safe, timely and effective manner. 

• In addition, our teams implement unified programs that span our global network, maintaining the benefits of local access while ensuring the strong backing of global expertise and resources. To give just one example, our quality harmonization efforts drive uniformity across our quality control processes, to maintain standard operating procedures and systems with the same high standards at every phase of the drug development process and every site in our network.