We know that vaccine development programs face several challenges that set them apart from other types of healthcare product development programs. For example, when a vaccine is presented to the immune system during vaccination there are many questions that arise. Is the immune response vigorous enough (or too vigorous), is the right type of immunity being stimulated by the vaccine, how long does the immune response last and how rapidly is it recalled on exposure to a pathogen?
Also, we observe that industry trends are to move to purer subunit or vectored vaccines, and these trends bring new issues with them. Purer vaccines tend to be less immunogenic, creating the need to do adjuvant studies to identify vaccine-adjuvant pairs that stimulates an appropriate immune response while ideally raising no safety signals. With vectored vaccines the questions revolve around how the host immunity to the vector affects the vaccine immune response and the ability to use these vectored vaccines again in the future. We have worked with a number of companies to resolve or mitigate these technical challenges.
Vendor management is a critical aspect of a vaccine development program. Vaccine clinical trials can be extremely long (multi-year) and can involve a large numbers of subjects (10,000+) to achieve statistically significant results. Vaccine targets for dangerous pathogens are typically biosafety level 2+ or higher, requiring access to labs that can accommodate the pathogen being studied. Many vaccines are needed in undeveloped regions of the world, necessitating low final sale prices and culturally based methods of distribution.
The immunization procedure must be as simple as possible and the vaccine should be stable at room temperature or higher so it can be shipped to any location worldwide. Finally, after FDA approval, vaccines need to receive vaccine advisory committee recommendations in order to achieve acceptance in the marketplace. Finding appropriately qualified vendors, and managing those relationships and contracts, is an area where the LBG group has significant expertise. We have worked with most of the major vendors of these services, developed management plans, and executed on those plans.
LBG consultants have years of experience working on multiple types of vaccines including the following:
- Infectious Disease Vaccines
- Pandemic Influenza Responses
- Encapsulated Plasmid DNA Vaccines
- Biodefense Vaccines including Ebola, Norovirus VLPs, Hepatitis B, West Nile, Yellow Fever, Anthrax (rPA), Plague, Influenza Vaccines
Navigating the many hurdles above is made easier when you’ve already encountered and have experience overcoming the obstacles. LBG consultants are available for the strategic planning of your vaccine program, product development support (quality, regulatory, clinical and CMC), as well as business development support when your program is ready for partnering. We can provide the technical and strategic expertise necessary to guide your company’s progression to a marketed product.