MACH32 Inc. is a health technology company that designs and manufactures medical products. MACH32 is currently developing IMSAFE, a drug-delivery system for the treatment of hemorrhage; IMSAFE, delivers a drug called tranexamic acid (TXA) which helps control bleeding caused by traumatic injury including postpartum hemorrhage.

MACH32 is compiling scientific literature and data supportive of IMSAFE in an investigators brochure (IB) document. MACH32 would like to collaborate with students to develop an IB for IMSAFE. The IB will be used to support a new drug regulatory submission with the FDA and Health Canada.

This will involve several different steps for the students, including:

• Reviewing MACH32s IMSAFE regulatory strategy for Canada and the United States.
• Analyzing clinical and non-clinical data.
• Summarizing published scientific literature relating to the safety and efficacy of TXA.
• Organizing literature and data summaries within an investigators brochure skeleton.

By the end of the project, students should demonstrate:

• Understanding of TXA and the IMSAFE product.
• Understanding of MACH32's IMSAFE regulatory strategy in Canada and the United States.
• Understanding of the available published scientific data which is supportive of IMSAFE

Bonus steps would include:

• Contributing additional data sources or information to MACH32s literature catalogue

Final deliverables should include

• An IMSAFE IB final report on the dataset, the problem solved, methodologies and approaches, outcomes and results, and recommended next steps.

Students will connect directly with us for mentorship throughout the project. We will be able to provide answers to questions such as:

• Our current products and their applications
• The current scientific literature and data and guidance in navigating it
• IMSAFE regulatory strategy and long term regulatory goals
• Input on choices, problems or anything else the students might encounter.