A recent publication in Emerging Microbes and Infections (EMI) features Worcester HIV Vaccine (WHV) as one of nine biotech companies actively contributing to the development of an HIV vaccine worldwide. Given that the HIV vaccine field is currently at a somber point – not having made real progress in the past four decades and numerous phase 2 and 3 trials failed to show effectiveness – the role of small biotech companies to advance the HIV vaccine field deserves a closer look.
Highlighting the advantages as well as challenges faced by small biotech companies, Roger Tatoud et al. explore possible support mechanisms necessary to overcome those challenges in order to support small biotech in the advancement of HIV vaccine development. Small biotech companies are in a unique position in which they can remain more agile than large pharmaceutical companies, quickly adapt to scientific advancements with a higher risk tolerance opening up new possibilities for innovation and scientific discovery. However, those opportunities also come with challenges, of which securing funding is the most significant hindering factor for initiating, sustaining, and growing a small biotech company and its product.
Financial barriers are indeed also the biggest impediment for WHV, affecting the pace at which PDPHV progresses through the development program. Despite showing extraordinary data in early-phase trials and the phase 2 vaccine supply already produced and available for clinical research, the advancement of PDPHV’s further efficacy testing has been delayed due to the large costs of conducting a phase 2 trial which requires long-term planning and funding from multiple sources. Because of the success of HIV treatment and current preventative methods other than vaccines, the value in investing in HIV vaccine development seems questionable to investors and other stakeholders for multiple reasons.
The International AIDS Society (IAS) HIV Corporate Partnership Program (CPP) Vaccine Group – established two years ago to bring together industry and non-industry partners to address the complexities of HIV vaccine research and development (R&D) – deliberated over the issues faced by small biotech companies in the HIV vaccine field and now published an outline of multiple suggestions and strategies to overcome those issues. Roger Tatoud et al. propose a multi-faceted approach that includes enhanced communication, fostering innovation, and implementing strategic funding models. The suggested recommendation to successfully support biotech’s continuous involvement in HIV vaccine R&D not only addresses the financial hurdles, but also covers issues within business development and management, intellectual property, clinical research (including regulatory affairs), policy and advocacy, and research coordination and dissemination.
Read the paper here.
