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Ever feel like you can’t see the forest for the trees? In everyday life, it’s easy to get bogged down in details. This can be especially true in a field like drug development where it can take ten years (under the best circumstances) or more to see your work come to fruition. In this guest post, PATH’s Drug Development program asked its staff to reflect on the question, “What comes to mind when you think of drug development?” A few of their responses appear below. This is the third and final post in a three-part series on drug development. You can read part 1 here, and part 2 here. Want to join the conversation? We’d love to hear your thoughts on drug development! Leave your feedback in the comments below or tweet us @GHTCoalition or @OneWorldHealth using #DrugDev101.

In a notable move for global health research efforts, Australia this week announced funding for four groups developing new drugs, vaccines, and diagnostics for malaria and tuberculosis (TB). The funding was provided by the Australian Agency for International Development (AusAID) under the Medical Research Strategy, which outlines how Australia will invest in medical research and development (R&D) to improve health in the Asia Pacific region. The AUD$10 million in funding went to four product development partnerships (PDPs)—Aeras, the Foundation for Innovative New Diagnostics, the Medicines for Malaria Venture, and TB Alliance. This new funding marks the first time that Australia has invested in PDPs, a noteworthy step that illustrates Australia’s changing global health and international development strategy. Australia this week announced funding for four groups developing new drugs, vaccines, and diagnostics for malaria and TB. The funding was provided by AusAID under the Medical Research Strategy. Photo credit: PATH/Evelyn Hockstein According to Nick Chapman, senior analyst at the Australian global health group Policy Cures, the AusAID funding represents the country’s growing recognition that product development is a key element of global health programming. He adds that the investment in four global PDPs marks a changing strategy for how Australia funds health research. “This is the first time Australia is committing to funding best-in-world research—not just domestic academic researchers—and also is a significant boost to its product development funding, as Australian investment has traditionally been very skewed to basic research,” he said, adding, “We hope that an expanded Medical Research Strategy will help form part of a more rational funding landscape for global health R&D in Australia. The key challenge in the short term is ensuring that its future is secure under what is likely to be a new government come September.” This new funding from Australia could also have significant implications for global health R&D funding on a broader scale. Australia emerged from the global recession with a “relatively healthy economy and with a growing aid budget,” Chapman noted. Therefore, the country is “actually very well placed to increase its funding for global health R&D.” Additionally, Australia is one of only a few governments in recent years to fund PDPs for the first time. This is significant, as funding from other governments, such as the United States, for global health and product development programs is increasingly at risk. "AusAID should be congratulated for its commitment to funding best-in-world research, and for playing an important role in increasing Australia's investment in product development,” Chapman said. “We hope that amount of funding available under the Medical Research Strategy continues to increase so that its impact can be fully realized." This week also saw new funding for PDPs from the United Kingdom through its Department for International Development—more welcome news for global health research and innovation. It is critical that other governments follow the example set by Australia and the United Kingdom and increase their support for global health product development—a particularly important message for the US Congress when it returns next month to continue debating the fiscal year 2014 budget. Kim Lufkin is the GHTC’s communications officer.

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week. The United Kingdom’s Department for International Development has announced it is investing £138 million—or approximately $215 million—over the next five years into nine public-private partnerships to support the development of new drugs, vaccines, insecticides, diagnostic tools, and microbicides. In the newest issue of Frontlines, the online magazine from the US Agency for International Development, the agency looks back at some of its most successful projects—several of which involved investments in innovation, research, and development. Belgian scientists have taken early steps toward the development of a new drug to treat sleeping sickness. Ahead of the upcoming United Nations General Assembly next month, Secretary-General Ban Ki-moon has released a report with updates on the Millennium Development Goals and next steps. The Global Post reports on an in-depth research project examining diarrheal disease in the developing world, which could be used to help develop new vaccines and other tools against childhood diarrhea.

Hing Sham, PhD, joined PATH recently as head of research and preclinical development for the Drug Development program. Hing has more than 30 years in the private pharmaceutical industry, where he led major projects for various diseases, including HIV, cancer, diabetes, and Alzheimer’s. In this guest post, Hing answers questions about the risks associated with drug development and the intricacies involved in bringing a drug to market. This is the second post in a three-part series on drug development. Q: Drug discovery and development is a long process. Estimates of the cost to develop a drug up to the point of regulatory approval can range from $150 million to $1.3 billion. Could you summarize drug development in just a few words? A: In a few words, drug development is not for the faint of heart! What I mean by that is drug development is one of the most complicated and high-risk businesses in the world. When you think about what we’re trying to do, which is basically to correct a physiological process so it functions the same way it would in a healthy individual, it’s very complex and riskier even than going to the casino. In drug development, from choosing the right target to successfully completing multiple phases of clinical trials to clearing regulatory hurdles, there are many things that can go wrong. Under the best circumstances, your success rate is around 20 percent. It’s definitely a worthwhile endeavor, but each new hurdle brings with it a new set of anxieties. Hing Sham, PhD, joined PATH recently as head of research and preclinical development for the Drug Development program. Credit: PATH/Elena Pantjushenko. Q: What is the most exciting part of drug discovery? A: For me, the most exciting moment is when the different puzzle pieces come together to form a clear profile of a potentially successful drug candidate. Before this can happen, you have to have already chosen the correct target to treat within the human body and then have chosen the right compound from thousands of possibilities to target that mechanism for the desired effect. In addition, you have to determine that the compound has gone through the right testing to ensure that it’s in the best position to clear clinical trials and other safety hurdles. When all of that begins to align for the first time, it’s very exciting. Q: One concept you’ve emphasized as inherent to successful drug development is the importance of “failing early.” What does it mean to fail early, and why is that a good thing? A: Failing early isn’t a new idea in the drug development industry, but it’s a term that’s gained popularity as philanthropic foundations have encouraged a shift to the left in the product development pipeline. It is important to answer core questions early to avoid spending resources on products that will not be able to move forward and will languish in the “valley of death,” the term for scientific discoveries that don’t fit the criteria for further development. Failing early doesn’t mean that a team is encouraged to fail. Instead, it means that when the data are discouraging, the team should accept that, and move on to more promising prospects. Q: Is it difficult to keep your judgment clear and make these tough calls? A: I think, even if the results indicate you’re heading in the wrong direction, the desire to see your efforts through is part of human nature. As a researcher, it’s tempting to come up with other experiments that could enhance your understanding of a drug, even though they aren’t necessarily critical to the core questions under investigation. Within a project, stakeholders must engage in rigorous debates to determine what the critical questions are for a project’s success. Making these determinations early on provides the best framework for evaluating a drug candidate’s promise at various stages of development. Q: What do you find most fulfilling about your work? A: After 30 years in the private pharmaceutical industry, I have an immense appreciation for what the private sector does in devoting resources to research for lifesaving therapies. Now with PATH, I feel I have the unique opportunity to bridge the best of the private and nonprofit sectors to tackle a tremendous need for efficacious drugs for diseases unique to poor countries. It’s fulfilling to know that our work is bringing the best science to bear on some of the world’s most challenging health issues.