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 your progress into clinical trials for complex vaccines and therapeutics including biologics, cell therapies, and gene therapies (including specialities in non-viral mRNA and DNA vaccines and therapeutics). Our team has helped successfully transition dozens of therapeutics from preclinical to clinical phase of development, including management of early-phase clinical trials.

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 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.

For those whose technologies address both standard medical requirements as well have the potential to make a difference as a countermeasure to emerging health threats to the US and Canada—including the next pandemic—we know how to position your company for success with the US government. Our consultants have many years of experience and have successfully won and managed over $150 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 Federal awards with the US and Canadian governments.