Man v. microbes: Can we win the war against antibiotic resistance?
Tuesday, November 18, 2014
11:00 AM - 11:55 AM
Steven Gilman, Chief Scientific Officer and Executive Vice President, Research & Development, Cubist Pharmaceuticals Inc.
William Hanlon, Vice President, Head of Global Regulatory Affairs, Covance
Luciano Marraffini, Assistant Professor and Head, Laboratory of Bacteriology, The Rockefeller University
Jean Patel, Deputy Director, Office of Antimicrobial Resistance, Centers for Disease Control and Prevention
Charlene Reed, CEO, The Foundation to Combat Antimicrobial Resistance
Luke Timmerman, Biotechnology Journalist
Antibiotic resistance has become a major public health crisis, with more than 23,000 deaths annually and $55 billion in economic impact. At Partnering for Cures, biotechnology journalist Luke Timmerman moderated a panel, "Man v. microbes: Can we win the war against antibiotic resistance?", where panelists discussed the possibilities for accelerating antibiotic development, including predictive preclinical models and reducing costs through new models that decrease the need for costly multi-year studies with large populations. Timmerman noted the problems facing antibiotic development, and he asked if there was "something wrong with the model" because "we've seen pharma companies drop out of antibiotic specialization" at the same time investor interest in the area continues.
Representing the industry perspective, Steven Gilman of Cubist Pharmaceuticals explained that companies are facing the perception that antibiotics should always be completely effective and inexpensive, while facing steep odds in development and arguing the value of new therapies. Industry also faces the challenge of leading the field in antibiotic stewardship to ward off resistance and misuse. Gilman noted that, in contrast to other pharmaceutical company models, antibiotics companies "use an orphan approach. We don't want to treat everybody, we want to treat just the niche of those patients that are most benefitted by our product. We treat a small fraction of patients."
Jean Patel from the Centers for Disease Control and Prevention (CDC) discussed the agency's education campaign, which had just kicked off their Get Smart Week 2014 to raise awareness of the threat of antibiotic resistance. She said education campaigns have been effective but have "limited reach." Patel explained the need for new tools to measure antibiotic use, which would lead to better stewardship: "We're getting to a place in antibiotic stewardship where programs have to become more sophisticated."
According to Patel, recent surveys indicate that only 50 percent of hospitals have implemented stewardship programs. "There's been a call from CDC that every hospital should have a stewardship program, but this is going to be a challenge to implement," she said. "To have a robust antibiotic stewardship you need manpower and expertise." Charlene Reed of the Foundation to Combat Antimicrobial Resistance explained that the problem is lack of awareness of antibiotic resistance, especially when many people believe that antibiotics are 100 percent effective. Reed said infections can "affect anybody, anywhere, at any time; you don't just get infections at a hospital."
The panel discussed the need to address other difficulties in antibiotic development, including creating the diagnostics to rapidly identify the correct course of treatment for infections. The regulatory burdens facing antibiotics have begun to be addressed with the Generating Antibiotics Incentives Now Act (GAIN Act) that created new incentives, such as priority review at the FDA and five-year licensing exclusivities. William Hanlon of Covance explained that these incentives are a "good start, and FDA has done a lot over last few years to have more partnerships with sponsors." Hanlon said that harmonization with global standards for development would be a major policy incentive for antibiotic development.
From the scientific research perspective, Luciano Marraffini from Rockefeller University explained how this problem relates to a larger scientific problem of the microbiome and bacteria's effects on health. Focusing on antimicrobials to create new vaccines is one of the most promising areas of medical research today, with decreasing MRSA infections as one positive impact. Marrafini also said that the community needs to focus on implementing the proper limitations on antibiotic use to prolong the effectiveness of new treatments.
The panelists highlighted the need for new ways to combat hospital-acquired infections as a difficult problem for hospitals to address. There is a need to recognize where infections are happening to drive prevention strategies. Patel said that CDC is not overly prescriptive to hospitals in terms of forcing them to adopt a particular strategy of intervention versus prevention steps: "It's not a one-size-fits-all approach." The panel discussed the possibility of using human genome sequencing to identify the source of infections in a hospital.
Wrapping up, the panel identified the need for new pathways to invest in the development of antibiotics, through enhancing government investment through BARDA, buying up supply, controlling access, and allowing the exclusivity period to be applied to a different product that recoups its development cost.