Name of Lead Author: Dennis Liotta
Organization: Emory University
Country: United States

Submission

Extending the DRIVE Model to Africa by Dennis Liotta
Presented at a TEDx held at the United Nations Office in Geneva on 11th February, 2016 by Dennis Liotta

Zika Virus. Dengue Fever. Chikungunya. These diseases, which are all transmitted by the Aedes mosquito, afflict millions of people around the world. Very recently, the WHO, for only the fourth time in its history, declared the current Zika virus outbreak to be a global health emergency. Although Zika Virus, Dengue Fever and Chikungunya have all been known for decades, no drugs have ever been developed to treat them. Why? Because their markets are too small to gain the attention of pharmaceutical companies.

The cold, hard truth is that it can cost billions of dollars and take over a decade to develop a new drug. So, pharmaceutical companies almost always pursue drugs for diseases likely to result in the largest profits. Unfortunately, this model is ill suited for diseases that primarily afflict the poor of the world – the so called neglected diseases.

The Centers for Disease Control in Atlanta estimates that annually 3 billion people worldwide are at risk of contracting a neglected disease and, of those, more than half a million people each year will die. So, just imagine the worldwide impact if we could develop a viable approach for creating drugs for neglected diseases!In 1990, when this picture of a young man dying of AIDS appeared on the cover of LIFE magazine, the virus was taking the lives of many of our most promising and creative people. At the time AIDS was a neglected disease, since infected patients didn’t live long enough to create a sustainable market. During this period, I was an organic chemistry professor at Emory University and saw an opportunity to use my skills and experience to help get this heartless killer under control. So, I made it my personal goal to create drugs that were so effective that AIDS could be transformed from a death sentence to a manageable chronic disease.

After some time my lab was able to prepare some promising new compounds and file our first US patent application on them on Feb. 1, 1990, which, fortuitously, was seven days ahead of our competition. This proved to be the crucial step in securing our rights to the drugs, lamivudine and emtricitabine, both of which have profoundly transformed how we treat HIV infected patients.

When combination therapies first became available in the mid 1990s, patients were required to take 15 to 20 pills each day, some before they ate and some after they ate. Due to the complexity of the regimens, non-compliant patients were at risk of developing resistance. By 2006, however, patients could take Atripla, which combines three drugs, one of which is emtricitabine, into a single daily dose. This regimen is so effective that patients who take it can now live virtually normal lives for decades. In the United States we estimate that over 90% of all HIV infected persons on therapy take or have taken one of our drugs.

Our success here, which shows that drugs can come from sources other than pharmaceutical companies, also had a downside. It took thirteen years to develop emtricitabine and I’ve often wondered how many lives were lost during that time.

Clearly, we needed a better way to develop drugs, particularly drugs for neglected diseases.

To do this, we must find ways of catalyzing more research in this area. One novel approach to this comes from networking organizations, like WIPO Re:Search, that match innovators with potential partners to create a kind of “speed dating” mechanism for early stage therapeutics development.

Secondly, we need to address the funding gap in the development process, known as “the valley of death”, where promising technologies can wither and die due to a lack of sufficient infrastructure and resources. At present, most of the funding for neglected disease research comes from philanthropy, but, with only philanthropic funding, it’s hard to sustain a development process that might take a decade or more to complete. As one possible solution to this problem, we invested some of our emtricitabine patent royalties into a small, non-profit drug development company called DRIVE, an acronym for Drug Innovation Ventures at Emory. DRIVE is led by a team of highly experienced scientists, many of whom have been successful at developing antiviral drugs. Without shareholders or investors, DRIVE can address the most critical unmet needs rather than those that might produce the highest profits.

DRIVE’s focus is on single stranded RNA viral infections. These infections, most of which only have modest commercial potential, account for approximately 80% of our worldwide viral disease burden. By targeting a mixed portfolio of major market and neglected diseases, DRIVE was able to use revenues obtained from licensing the patent of a large market drug to subsidize research on neglected viral diseases. Thanks to lessons learned, this process took only 15 months, which is notable since the comparable process for emtricitabine took 4 years.

So, how can we expand DRIVE’s proof of concept into a worldwide framework that could more rapidly address neglected viral diseases? How can we, as a global community, assemble the pieces needed to develop drugs for diseases of the poor, like Dengue Fever, Chikungunya and Zika virus?

Over the past 15 years, I have worked extensively in Africa with drug development scientists and entrepreneurs. I have seen first hand the quality of the science and the passion people bring to diseases that affect their own communities. So, selecting Africa as the first target region for our worldwide initiative seemed obvious. In November, 2015 we entered into a formal partnership with ANDI, the African Network for Drug and Diagnostics Innovation, which is a UN-based organization, headquartered in Addis Ababa.

This partnership involves two components, the first of which is the training of African scientists in the business and legal aspects of the biopharmaceutical sector, helped, in part, by our colleagues here in Geneva at the World Intellectual Property Organization. The participants will be selected from the over 40 ANDI Centers of Excellence and will be taught the intricacies of creating pharmaceutical development plans along with the intellectual property management needed to support those plans. The second component of our partnership involves the creation of regional hubs distributed around Africa that are modeled after DRIVE and leverage ANDI’s expertise in promoting African-led health innovations.

Just like with DRIVE, each hub will focus part of their attention on a disease with large market potential and use revenues from those activities to subsidize development of therapies for neglected diseases. Importantly, since this model involves partnerships with government and non-government agencies, we can assure that drugs derived from this initiative will be affordably priced and accessible to all.

Imagine a world where important healthcare solutions emerge from focused networks of scientists and entrepreneurs operating through creative, non-profit structures. Imagine a world where today’s neglected diseases become tomorrow’s treatable conditions, just as we saw with AIDS. Imagine a world where companies that focus on neglected disease can do good and do well at the same time. Even better, imagine a world where neglected diseases are things of the past. Thank you.

Bibliography and References

The Centers for Disease Control and Prevention. June 2011. http://www.cdc.gov/globalhealth/ntd/