• Developing a new drug is important, but it is not a final outcome. The foundation must not view drug development as an end in itself; it is just one step in a long road toward saving lives. For all of paromomycin’s cost and safety advantages, it is conceivable that governments, NGOs, and clinicians will not choose to buy it. (As mentioned earlier, one drawback is the fact that it must be delivered through injections rather than orally.) Like commercial pharmaceutical companies, non-profits must use every tool at their disposal to understand the market for a new treatment, the attitudes and practices of those who need treatment, and the smartest ways of building demand. Without these comprehensive efforts, the expense of drug development—and the opportunity to help save thousands of lives—could be lost.
  
   
• We underestimated the funding that would be necessary to bring this product to market. iOWH has been frugal with its resources and has brought in significant volunteer and in-kind support. But even with careful stewardship, when it comes to neglected diseases, the final stages of drug development are extremely expensive—and not easy to predict with certainty ahead of time. We ask grantees for highly detailed cost projections, but we are learning that we need to allow for uncertainty and flexibility.
   
  
• It is essential for grantees to have a strong, local project manager. When iOWH initiated its clinical trial, the organization tried to navigate complex local issues from a distance; they didn’t have a local project manager with access and credibility on the ground. Fortunately, they were able to rectify this by hiring an outstanding on-site project manager, who worked very effectively with local leaders and scientists. (iOWH is now planning to open two local offices in India, staffed by Indians.) This project taught us that we need to ensure that our grantees have high-caliber local project managers in place at the outset of such efforts—and that we need to be willing to pay for this.
   
  
• The foundation must be willing to step in to mediate disputes (but pick its battles carefully). At one point, the foundation stepped in to ask an international agency to expedite the release of critical data our grantee needed in order to carry out its trial. That agency felt that we were heavy-handed. We do not take that criticism lightly; we recognize that we need to be very careful if we are to avoid being “a bull in a china shop.” But in this case, we feel that it was an appropriate use of our voice. If a similar scenario presented itself in the future, we would step in sooner. 
   
• Without our funding, the Institute for OneWorld Health’s current funding model would need to change. iOWH has proven that a nonprofit pharmaceutical firm can develop new medicines for diseases of poverty. However, we must acknowledge that its ability to meet this goal rests heavily on a single source of financial support. The foundation has committed nearly $180 million to iOWH for a host of different projects, approximately 96 percent of its funding. To ensure that iOWH succeeds over the long term and that other nonprofit organizations join the field, we need to find ways of helping iOWH expand its funding base. 
   
• Visiting local project sites is essential for the foundation’s program officers. If we had not conducted site visits or had not been granted the ability to speak directly with the local iOWH project manager on a regular basis, we would not have had a full understanding of the nature of the delays in the clinical trial, and we might have pulled back our support prematurely.

Next: Next Steps