We are a small team of consultants from both Canada and the United States that together have many decades of experience in the relevant fields needed to accelerate your progress to initial clinical trials around complex vaccines and therapeutics including biologics, cell therapies, and gene therapies, including non-viral mRNA and DNA vaccines and therapeutics. Our team has played key roles in helping successfully transition X proteins, Y cell therapies, and Z gene therapies from preclinical to clinical phase of development.

We know that you have limited time and funding to achieve key investor milestones, including advancing your vaccine or therapy into a first-in-human study. We understand the key regulatory demands around biologics, cell therapeutics and gene therapies, and critical things to achieve or avoid to make it possible to reach your clinical goals on time and within budget.

Our team knows how to accelerate your timeline to first-in-humans 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 in the next pandemic—especially monoclonal antibodies and vaccines—we know how to position your company for success with the US Federal government. Our consultants have many years of experience and have successfully won and managed over $80 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 for management of Federal awards.