Paul Miller and Michael Dunne are scientists. Dr. Miller is a microbiologist whose training focused on understanding how the genes of bacteria work. He came to work for Pfizer, the world's largest research-based biomedical and pharmaceutical company, in the early 1990s, for the opportunity to apply cutting-edge research techniques in pursuit of new and better antibiotic medicines. He now serves as Research Therapeutic Head for Antibacterials at Pfizer, looking not only for ways to stop bacteria but also to delay or minimize antibiotic resistance.
Dr. Dunne is a medical doctor who decided to focus on research when he got frustrated with the limited range of effective medicines, including those needed to treat patients suffering from infectious diseases. In some cases, drugs were simply not available to help him and other doctors treat those patients effectively. That drive to cure disease and make a real difference in the lives of patients took Michael Dunne into clinical research. Today, he serves as Pfizer’s Vice President and Head of Development for the Infectious Diseases Therapeutic Area.
Both men work at neighboring Pfizer research centers in the Groton-New London, Connecticut, area, and their work goes hand in hand. Dr. Miller’s team includes biologists, chemists and drug metabolism scientists with world-class expertise in what medicines need to do to eliminate harmful bacteria, and in what happens to these same medicines inside the human body. They conduct the groundbreaking research to develop bold, innovative ideas for new antibiotics. Dr. Dunne’s team then takes the most promising ideas and puts them through their paces, working and testing to find ways to turn ingenious breakthroughs into safe and effective medicines.
The new drug development process is an obstacle course. On its way to the market, a new medicine faces roadblocks at every turn. Some do not advance because blood concentrations of the active ingredient never reach effective levels. Others falter because they are metabolized by the body in ways that could produce significant side effects. Manufacturers must perform test after test, often spending a decade or more and hundreds of millions of dollars to eliminate from development initially-promising medicines that cannot meet stringent standards of safety and efficacy.
Developing antibiotics is even more difficult, because bacteria are always changing. As Dr. Miller says, “if somebody has high cholesterol at age 40, a remedy like Lipitor® should work in his body pretty predictably for the rest of his life. But bacteria are not like people – they multiply quickly and accumulate mutations very rapidly.” Because new antibiotics must stay ahead of or at least keep pace with this highly adaptable adversary, bringing a new antibiotic all the way to market becomes an extremely complex and costly endeavor.
Risks are part of business, and manufacturers have learned over time how to predict and manage them. But recently, the risks have become less predictable, as federal regulators have changed the requirements for new drug approvals on specific infections like bronchitis, otitis media, sinusitis or other common illnesses. Every change calls into question when – or even if – manufacturers will see a return on years of work and hundreds of millions of dollars worth of investments. But because of competition from generic drugs, consumers expect to pay relatively little for antibiotics, whether old or new.
As a result, the financial returns on investments in new antibiotics have stagnated, even as those investments have become more risky. “Society’s sending us mixed messages,” says Dr. Dunne. “As scientific leaders, we see a growing medical need and want to meet it, but if society’s giving us a signal that we shouldn’t invest here, we’re going to listen.” A clearer regulatory path is what Dr. Miller and Dr. Dunne argue is needed. “With clear rules of the road and an expectation of competitive reimbursements, you’ll see investments in new antibiotics,” says Dr. Dunne. Dr. Miller echoes that hope, adding “we got into research because we want to make a difference. This should be a solvable problem.”