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By Bayer HealthCare Pharmaceuticals
Only one in 10,000 active ingredients created by researchers in a lab is turned into a potential drug. But pharmaceutical research is not only expensive and time-consuming, it’s a process where most drugs don’t make it to market or into the hands of patients. How drugs make the long journey from lab to market.
Even if today a handful of vaccines against the coronavirus have been developed and made available to people in many countries around the globe, the threat of COVID-19 remains. There is still no effective treatment for the disease widely available and current vaccines may not be effective against new, emerging viral variants. Researchers worldwide are doing what they can to accelerate the search, but the process is far from easy.
Looking at today’s processes and regulations, it’s still a long road from a promising active ingredient to a medicine on a pharmacy shelf – a road with many twists, turns, and dead ends. That makes drug development very time-consuming and expensive. It can take more than 10 years from an initial idea to market readiness. With every stage of development, the costs increase. Towards the end, it is not uncommon to see investments of $2.2 billion to advance one therapy to market.
Technological and financial risks
There is no guarantee for success. Not every product in development turns out to improve a patient’s quality of life significantly while checking all the boxes regarding safety and efficacy. Even in the last phase of clinical trials, where a new drug is tested in humans, it still has, on average, a 40 percent chance of failing. Drug development carries technological and financial risks, and it requires people working in it to not get discouraged by setbacks.
At Bayer, about 7,400 people worldwide work to discover new active ingredients and develop them into drugs and treatments. In Boston, for example, Bayer has established the East Coast Innovation Center in Cambridge to leverage the proximity of this unique life science community.
Bayer’s goals are to cure patients of diseases and lessen suffering. That is what drives internal specialist and epidemiologist Richard Nkulikiyinka, who has been working at Bayer for almost 13 years. Today, he heads the heart and kidney disease team.
At the beginning of his career in medicine, Nkulikiyinka worked as a resident physician in an emergency room where he witnessed daily how important drugs can be. “I constantly attended to many patients with severe bouts of acute illness. Some had life-threatening heart problems or acute asthma attacks,” he says. “As there are tried and tested drugs that often provide immediate and dramatic relief, it was always a nice feeling to be of help to patients and their families.”
Soon he began asking himself what it would feel like to be the one developing these drugs. So Nkulikiyinka decided to leave his job at the hospital and start a career in research.
The importance of teamwork
Since then, his work has contributed to the health of people around the world. He has never regretted taking this step: “Drug development is a job that comes with many hopes and possibilities. If we’re successful, it’s a step forward for patients and for medicine in general. That’s motivation enough for me to face these challenges anew every day.”
Drug developers all share certain traits: curiosity, an inquiring mind, a need to get to the bottom of unsolved questions and an appreciation for good teamwork. “Our experts from around the world are some of the best in their fields,” Nkulikiyinka says. “Solving problems with them and exchanging ideas is a lot of fun.” This business is based on collaboration, both within the company and with others. Seen from the outside, the competition between different pharmaceutical companies may look fierce. “There is some truth in that, of course, but mainly, it’s good-spirited competition. There’s a strong common interest in advancing drug development together. It’s a highly invigorating combination,” Nkulikiyinka says.
Failing leads to new insights
If the long search for a new drug is successful, the reward for researchers is all the greater. Just recently, Nkulikiyinka and his team witnessed the regulatory approval for a drug they helped develop. “We are very proud that we were able to conclude this process within 10 years,” he says. To get to that point, about 8,000 patients and healthy volunteers participated in 35 trials in 50 countries.
This is not the first drug that Nkulikiyinka has seen through clinical trials and submitted for regulatory approval. That is particularly remarkable because the chances for success in the pharmaceutical industry are usually slim, with only an average of one out of 10 drugs starting clinical trials finally being approved by regulatory authorities and made available for patients. Many of his successful colleagues at Bayer will never bring a drug to market in the course of their career. But they’re still doing a good and important job because every failure offers new insights that help researchers adjust and change course. Being highly motivated never to give up is a critical factor for anyone working in drug development. So is the ability to deal with setbacks.
Over three billion dollars per year for research and development
Bayer invests about $3.3 billion each year in research and development and works with partners who have special expertise in these areas. Their motivation is to find new answers to unanswered questions.
Acting in concert, exploring new avenues, and never giving up in the face of setbacks – these ideas guide drug development at Bayer. Or, as Nkulikiyinka says: “It doesn’t matter how successful you are, there are always people out there whose medical problems are not yet resolved. That’s a reason to keep going.”
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