digiM Awarded FDA IDIQ Contract to Support Product Guidance Development

digiM Awarded FDA IDIQ Contract to Support Regulatory Assessment of Complex Drug Products and Guideline Development

digiM has received an Indefinite Delivery Indefinite Quantity (IDIQ) Contract from the US FDA for the regulatory assessment and guideline development for complex drug products. The contract (Award No: FDA-75F40124D00022) supports microstructure characterizations and in vitro release simulations for high priority generic drugs. Studies will support agency efforts to ensure the affordability and availability of safe, high-quality medicines. Through analysis of selected reference listed drug (RLD) products and in house formulations, this project intends to advance the foundational understanding of drug product quality attributes and release mechanisms which may be key to consider in the development and regulatory review of generics. 

The contract, titled “3D Microscopy, Artificial Intelligence-based Quantification, and Modeling for Non-Clinical Evaluation and Regulatory Support of Complex Drug Products,” will begin in 2024, with optional expansions up until 2027. The RLD products covered under this contract include polymeric implants, long acting injectables, microspheres, in situ forming depots, inhalers, transdermal and topical products, and oral dosage forms.

Studies will focus on microstructure analysis of RLD products and in house formulations with designed formulation changes to determine impact on product quality and performance. Under the first approved work order, digiM will work with selected academic partners to manufacture in house formulations of the reference listed products. These in house “generics” will be designed to be both equivalent and nonequivalent, allowing for a complete understanding of what impacts structure has on product quality and performance. 

The priority products selected to study include: 

• Ozurdex dexamethasone intravitreal implant
• Perseris risperidone extended-release injectable suspension 
• Mirena levonorgestrel-releasing intrauterine system
• Eligard leuprolide acetate injectable suspension
• Liletta levonorgestrel-releasing intrauterine system
• Bydureon BCise exenatide extended-release injectable suspension 

In addition to these product-specific studies, the IDIQ will be used to assess the utility and regulatory pathway of image-based release testing to complement and reduce in vitro testing of long-acting products. The award will also be used for the creation of an online RLD database platform, which will provide generic developers with an open suite of product specific data as a feedback loop to accelerate internal development. 

The study outcomes will bolster industry knowledge for the microstructure attributes of selected RLDs. Study findings will be assessed in FDA considerations for product specific guidances, including characterization pathways for microstructure CQAs and Q3 bioequivalence comparisons. With this IDIQ, digiM will actively support the FDA’s mission in enabling the launch of more affordable and accessible generic medicines. 

About digiM Solution

digiM is a technology provider that supports drug product development with end-to-end microstructure CRO and software solutions. digiM’s I2S cloud software integrates AI image processing, microstructural analysis, digital formulation, image-based simulation, and data management forthe lifecycle of advanced microscopy data analysis. I2S modules are custom built to address the most critical questions and attributes of pharmaceutical materials. Through integration of microscopy based digital twins and in silico modeling, the digiM platform provides a full spectrum understanding of drug product properties and performance.

digiM works closely with leading innovators and generic developers to navigate development challenges, partnering with over 100 pharmaceutical companies, 200 therapeutic programs, and 1,600 drug intermediates and products. digiM works closely with regulatory bodies, including the FDA, paving an advanced understanding for the role microstructures play in product quality, while also bridging the gap between industry and agencies.