BorderBio is an integrated consulting group supporting organizations across Canada and internationally as they navigate the scientific, regulatory, and operational challenges of transitioning new drugs and vaccines into clinical trials. We are a team of consultants from both Canada and the United States that collectively bring decades of experience in the relevant fields needed to accelerate progress into clinical trials for new chemical entities (NCEs) and complex therapeutics including biologics, cell therapies, and gene therapies (including specialities in non-viral mRNA and DNA vaccines and therapeutics). 

We help bring clarity, structure, and strategic guidance to complex research programs.

Our work spans early-stage development into initial clinical trials. We focus on practical, evidence-based solutions that strengthen transition from preclinical to clinical studies, clinical trial planning and execution, and regulatory alignment of preclinical and clinical efforts, to enable development teams to efficiently translate innovative drugs and vaccines in demanding environments. 

Our Approach

BorderBio combines scientific expertise, regulatory insight, and practical operational experience to support research teams working in complex or resource-limited environments. 

We know that you have limited time and money to achieve key investor milestones, including advancing your vaccine or therapy into a first-in-human study. We understand the key regulatory requirements for NCEs, biologics, cell therapeutics and gene therapies, and understand the critical keys to success in reaching your clinical goals on time and within budget. Our team knows how to accelerate your timeline to first-in-human studies while reducing the burn rate of development by leveraging a Health Canada pathway. Successful Canadian Phase 1 studies can be used to support IND filings in the U.S.

While biologics and complex therapeutics remain our primary domain, BorderBio contributes to nonbiologic development efforts when they represent high impact public health opportunities, such as emerging therapies in cancer research and for high risk infectious diseases such as Ebola. 

For those whose technologies address both standard medical requirements as well as have the potential to make a difference as a countermeasure to emerging health threats to the US and Canada—including current outbreaks such as Bundibugyo or the next pandemic—we know how to position your company for success with Federal and international funding partners. Our consultants have many years of experience and have successfully won and managed over $300 million in biodefense and public health response funding from multiple agencies including BARDA, CDMRP, DARPA, DTRA, and the NIH. We can help guide small companies to this funding and to prepare them to successfully manage awards including those with the Canadian and US governments.