New drug research and development without breaking the billions of myths

New drug research and development without breaking the billions of myths

September 07, 2016 Source: Science Network

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First staggered for 8 hours in a dilapidated jeep, then took a slender canoe across the river. When Nathalie StrubWourgaft finally reached a clinical center in the Congo, she was exhausted. But my real work has not yet begun.

In July 2010, the clinical company is about to launch a treatment for sleeping sickness. But the project faces a series of problems. Refrigerators, computers, generators and fuels all need to be shipped by sea. Local health officials also need training to collect data using unfamiliar equipment. Moreover, contingency plans are needed to protect experimental participants from armed conflict.

For Wourgaft, a former executive at a pharmaceutical company, it was a long way off, and she had commissioned clinical trials with old, powerful hospitals. But the current medical consultant for the Neglected Diseases Drug Development Organization (DNDi) believes that the Congo project can be completed. It turned out that she was right.

The data shows that DNDi will be able to approve the sleeping sickness drug non-cytosine next year. It will greatly improve the existing treatments for sleeping sickness: laborious intravenous injections or 65-year-old arsenic-based drugs will be eliminated.

Burning money

The industry generally believes that the development of new drugs is a burning business. In 2014, the Tufts Drug Research and Development Center found that the cost of developing a new drug was about $1.4 billion, the indirect time cost was $1,163 million, and the follow-up research and development cost was $312 million. The total price of developing a new drug is as high as 2.87 billion US dollars. Although some people are skeptical, GlaxoSmithKline CEO Andrew Witty believes that the offer is too high, and the average cost also covers countless failed drugs that fall at various stages of drug discovery, but the high investment in new drug development is an indisputable fact.

DNDi does not seem to be a success story in an expensive and challenging drug development process. In the past 10 years, the organization has only approved treatments for six diseases including sleeping sickness, malaria and Chagas disease. In addition, the organization has 26 drugs in progress, but this cost a total of 290 million US dollars, equivalent to about a quarter of the cost of developing a new drug for large pharmaceutical companies.

What is the secret of DNDi's success? The answer is Product Development Partners (PDPs), which work to reduce costs through close collaboration with universities, governments, and businesses. This mode of cooperation between non-profit organizations has gradually become popular since 2000. Because the drugs developed are mainly prevalent in the poorest people on the planet, they are not valued by the profit-seeking pharmaceutical companies. Regulators have also lowered their requirements as much as possible to save patients earlier.

Currently, policy makers are beginning to consider promoting the model. “For a long time, people think that the development of new drugs is too complicated, and only large pharmaceutical companies can accomplish this task.” Suerie Moon, a global health expert at the THChan Public Health Institute in Harvard, USA, said, “I think we can learn from the DNDi example today. A lot of experience and apply them to other diseases that are more concerned."

Similarly, DNDi is also looking for alternatives to expensive hepatitis C drugs and developing antibodies against drug-resistant infections, which are areas that pharmaceutical companies are not willing to address. Once the outcome, these efforts will challenge traditional assumptions about drug discovery and reduce the price of drugs that are rising. “We can't compare financial figures one by one, but we believe that DNDi can create different models for product development,” said executive director Bernard Pécoul.

Flowing operation

Médecins sans Frontières (MSF) launched DNDi (DNDi was born out of MSF) with its 1999 Nobel Peace Prize. Its members accused the population of poor countries of lacking life-saving drugs and therefore supported the operation of DNDi. Pécoul, who has worked at MSF for more than 20 years, took over the organization established in Geneva, Switzerland in 2003.

But at the beginning of the establishment, pharmaceutical executives expressed doubts about DNDi. Because the development of new drugs is an expensive and long process, and requires a lot of professionals, "DNDi is not optimistic at first," Fran? OisBompart recalls.

So Pécoul and colleagues decided to start with easier and safer projects. In 2001, the World Health Organization (WHO) called for the development of new drugs to alleviate the problem of malaria resistance caused by the single use of artemisinin. Because the areas where malaria broke out are mostly poor and unable to afford excessive drug prices, large drug companies are not active because they are unprofitable.

So Pécoul contacted Sanofi - the company has exactly two antimalarials: one based on artemisinin and the other based on amodiaquine. Pécoul proposes to cooperate with Sanofi to develop a combination drug: DNDi is responsible for the clinical trial costs and related work of the new drug combining the two drugs. In return, Sanofi will not patent the drug and control the drug price in one course of treatment. One dollar, halved for children. "It doesn't sound reasonable. The prices of these two drugs are 2 to 3 times, respectively," Bompart said.

Although Sanofi did not make much profit from it, but could improve the public image of the company, Pécoul finally succeeded in convincing Sanofi to accept the proposal. By the time this drug was approved in 2007, the cost of drug production was finally controlled to the agreed level. Hundreds of millions of pills were shipped to Africa and distributed, and countless lives were saved, and the project cost only $14 million, which is a slap in the pharmaceutical industry.

Although they have improved existing drugs, some of them still have shortcomings. For example, DNDi's sleeping sickness therapy, NECT, reduced the number of 56 intravenous injections to 14 in standard therapy. This is still a problem for some countries: cleaning needles is difficult and long-term hospitalization is not possible. People need pills.

Drug development starts from time to time and burns money. Tens of thousands of trials are needed in the laboratory to find candidates. Since there is no laboratory, DNDi has done this through cooperation. DNDi screens new drugs from a wide range of compounds, working with biotech or pharmaceutical companies to screen them with their compound libraries.

Because each other's areas of concern are different, DNDi will not move the cakes of these companies, so the company is happy to share this precious information. DNDi then conducts activity testing through high-throughput screening centers such as the Pasteur Institute in Korea and the University of Dundee in the United Kingdom. “All of our practices are the same as for large pharmaceutical companies, except that DNDi is a smaller compound,” said DNDi founder and head of clinical trials, RobDon.

Through this collaboration, DNDi developed a non-cytosine that is expected to fight unicellular parasitic infections in 2007 and entered clinical trials in 2009. DNDi has also found Sanofi, hoping it will help it submit a new drug approval application to the regulatory body, and DNDi is also responsible for completing its clinical trial for sleeping sickness. Sanofi said that human trials may be difficult because sleeping sickness is not common and most patients live in remote, unstable areas.

Although clinical trials in poor areas face shortages of materials, poor transportation, difficulty in recruiting test subjects, and personal safety risks due to war, DNDi is still trying to complete clinical trials in Congo and Central Africa this year.

Breaking billions of myths

The clinical trial of non-cytosine will end this year, costing $45 million, and Wourgaft hopes the data will be approved by management. The drug will help 21 million African-risk people. In the coming months, Wourgaft will also launch another trial for the new oral drug SCYX-7158. The drug is expected to cure sleeping sickness in a few days. DNDi expects to require $50 million from development to approval.

This has broken the "superstition" that pharmaceutical companies need more than a billion dollars to develop new drugs. According to DNDi, on average, the cost of developing a new drug ranges from $110 million to $170 million. As with the Tufts Drug Development Center budget, these prices also include the theoretical cost of failed projects.

Of course, DNDi acknowledges that there are additional subsidies that pharmaceutical companies do not have. Because the organization is virtual, its operating costs are low. Cooperative research organizations charge less than the fees charged to pharmaceutical companies. In addition, DNDi has received a lot of unpaid help, and scientific consultants are willing to enjoy research to save lives only with a low salary. “DNDi can get a lot of free stuff.” Richard Bergstr, Director General of the European Union Pharmaceutical Industry Association? m said, “Our business and some colleges provide them with public services.”

DNDi is now respected in the industry. "Although DNDi comes from MSF, they have not let ideology hinder progress," said GlaxoSmithKline Vice Chairman Jon Pender. They praised Pécoul's communication skills and DNDi's strategy to address the challenges.

Policy makers have also begun to pay attention to DNDi. Last year, WHO hoped that DNDi would consider developing antibiotics to solve the problem of bacterial resistance. DNDi has received a $22 million seed fund from GARD, a global antibiotic research and development organization, to study and treat several new drugs from the perspective of new drugs and new compound drugs. “We are worried about the increasing cost of drugs, and this project is also an attempt by the DNDi model to be applied in Western countries,” said Marja Esveld, Scientific Advisor of the Dutch Ministry of Health.

Finally, when it comes to the difference between the pharmaceutical company and DNDi, Wourgaft is not considering the cost of research and development, but the value of human life. She recalled her experience at the Congo sleeping sickness test site. She sat next to a female patient and talked to the patient's desperate family. Later, she knew that the patient was saved. "When you see this, you know the value of what you are doing."

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