A Renewed Fight Against The Diseases Of The Poor

Corey Casper, MD, Chief Medical Officer, IDRI

The Infectious Disease Research Institute (IDRI) is poised to embark on a bold new step to serve its mission of applying innovative science to develop products to eliminate infectious diseases of global importance. For the past 25 years, IDRI has developed promising new candidates for diagnostics, drugs, and vaccines and then worked with biotech companies and other partners to develop them further into products. Now the organization plans to take its early-stage candidates and deploy them in larger, later-stage human clinical trials in a wider range of settings, with the express purpose of having an expanded portfolio of vaccines, adjuvants, and therapeutics to fight the diseases of the poor. IDRI will accomplish this by expanding on the strength of its current research base, rather than focusing on changing its practice. Its research base focuses on a few key areas:

• developing solutions to make preventative and therapeutic vaccines more effective through adjuvants and novel formulations
• creating diagnostic tests that are feasible for use in low-resource settings
• enhancing the host immune response to prevent acquiring new infections.

Increasing The Number Of Clinical Trial Partners
Rather than develop a clinical trial infrastructure within IDRI, the organization is expanding its list of clinical trial partners, both domestically and internationally, for help in conducting safe, efficient, and large-scale trials.  IDRI currently works with academic and industry collaborators to evaluate the safety and efficacy of its products worldwide. Domestic academic collaborators include the University of Washington, Duke University, University of California-San Francisco, University of Maryland and Vanderbilt University to test new vaccine constructs. International academic institutions in South Africa, Brazil, India, Korea, and Tanzania are also used to test vaccines abroad.

In the coming years, new CROs, academic partners, and government clinical trial networks will be evaluated as partners. (Many of these are already Preferred Development Partners to the Bill and Melinda Gates Foundation.) Potential partners will be evaluated on areas such as their safety track records, value (cost per study participant), efficiency (time from opening to closing a clinical trial), and experience in a given scientific field.

IDRI plans to leverage existing partners such as Sanofi Pasteur, the Bill & Melinda Gates Foundation, and the Wellcome Trust, and then scale up from there. For example, IDRI, Sanofi, and the Gates Foundation have already formed the Global Health Vaccine Center of Innovation. The planned Gates Medical Research Institute offers a unique partnership opportunity that will help move candidate solutions down the product development pipeline, as well.

A shared goal of all partners is to more rapidly and efficiently develop vaccines to meet pressing global health needs. One of the most exciting examples involves advancing a therapeutic vaccine for tuberculosis; a vaccine that protects against infection with the bacteria that causes leprosy with the potential to eradicate the disease worldwide; and new vaccines to prevent infection with Zika, hemorrhagic fever viruses, and diarrheal diseases. Hopefully, this sort of unprecedented collaboration will be the wave of the future, where many world-class players come together as a team to realize goals that might be unique and specific to each partner but can be achieved more rapidly and effectively by working together.

The Benefits Of This New Approach
One example of the benefits of this multisectored approach would be the development of a nimble, flexible vaccine for epidemic respiratory viruses. There are many audiences that would benefit: the US military, public health agencies, and pharma, which would realize a good market share. IDRI will offer its technologies and knowledge to help tackle this and bring vaccine candidates to trial. The aspects that are unique to IDRI involve basic R&D, but also manufacturing, early-phase safety preclinical testing, and technology transfer.

This new approach is complicated, from both a logistics as well as a funding perspective. One funding mechanism could involve Big Pharma retaining rights to promising vaccine or therapeutic constructs in developed world markets while organizations like IDRI work through the translational aspects for use in developing markets. These include cheaper ways of making vaccines at large scale, understanding how a given therapy might have differential safety or efficacy in low-resource populations, or understanding how factors not common in the developed world might impact the profile of a given product (e.g., infection with Malaria, lack of reliable cold chain).

This is a working assumption, not yet a proven model, but tuberculosis may be the best example to date. There is an interest in having a TB vaccine for use in Asia where there are high-resource environments; this would help leverage production of vaccine for use in areas where TB is endemic but resources are limited.

This new strategy will require a new kind of infrastructure for IDRI. For nearly 25 years the organization has operated based on an academic model. To succeed with this new complicated multidimensional strategy involving global partners, IDRI has assembled a more experienced global management team (my arrival and Chief Strategy Officer Dan Stichcomb) and added key areas of expertise to its board of directors, all supported by processes and tools (e.g. ERP and CRM solutions) for making timely and accurate decisions. Some new additions to the board include Richard Lautch, a former financial exec with Starbucks, who brings a good deal of financial/investment/business development knowledge; and Norman Baylor, a 20-year veteran of the FDA, who brings regulatory and product development expertise.

Overlaying all of this is the need for cyber security and data integrity. IDRI is accustomed to working with valuable IP related to our vaccine adjuvants and formulations, but now as it moves toward large-scale trials, it will be engaged in handling sensitive medical data as well.  Furthermore, in receiving funding (through contracts and grants) from the US government, IDRI must maintain a very high level of data integrity and be compliant with the Federal Information Security Management Act (FISMA).

IDRI is in a unique niche. The organization understands basic research, discovery, and intellectual freedom, but it also appreciates the needs of for-profit companies. Now it just needs a clinical trial infrastructure to deliver on its mission and a coalition of the willing and able to join in the quest.