When bringing a novel oral vaccine biotechnology platform to market, Dr. van Oosterwijk and Dr. Brooke struggled to identify experts with experience with non-traditional licensing, manufacturing, and quality experience. There were many who had experience with go-to-market experience with traditional products, which requires a wide breadth of knowledge to navigate the regulatory process, but few that had to work with regulators to combine existing regulatory pieces to fit novel breakthrough technologies that do not follow a traditional pathway.

With a combined background of over 30 years in regulated environments and professional experience with drug development, trial design, statistics, dose-response, pharmacokinetics, pharmacogenomics, and public health, we drew on our combined experience to take a product from an idea to market. Our journey involved generating a protective IP strategy, product safety profile, manufacturing and facility regulatory requirements, product quality (pure, potent, safe, and effective), engaging regulators, generating product regulatory documentation, and a licensing strategy to bring the first product of the novel platform to market.

Reflecting back on the process and the hurdles we experienced during the process, our vision of helping others struggling with the process led to creating Orange LLC; a consulting group that has as its first priority to support others in their struggle by working with them to find solutions that work with regulators to address requirements needed to bring a product to market and keep it on the market.

We are always open to meeting new people to connect with others in the heath biotechnology space, regulators, and experts. If you are interested in a conversation with creative experts with extensive experience, we hope you will reach out and we can help you on your path to a more predictable and successful experience in the biotechnology space.

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