Understanding the Economics of Microbial Threats Proceedings of a Workshop (2018) / Chapter Skim
Currently Skimming:
7 Accelerating Research and Development of Antimicrobial Medical Products
7 Accelerating Research and Development of Antimicrobial Medical Products
Pages 75-86
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 75... ...
for antimicrobials. The session was moderated by Jami Taylor, board advisor at Stanton Park Advisors and included brief remarks from four panelists: Paul Schaper, executive director of global public policy at Merck & Co., Inc.; Joanna Wolkowski, vice president of portfolio and decision analysis at Pfizer Inc.; Thomas Cueni, director general of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
|
From page 76... ...
Because of the lack of pull incentives, fewer drugs are coming to market, he noted, and several companies have left the antimicrobial development arena despite receiving push incentives such as grants from BARDA. In addition to misaligned incentives, Schaper highlighted regulatory challenges related to product reimbursement that discourage manufactur 1 Several governments and global initiatives have offered push incentives, such as the Bio medical Advanced Research and Development Authority (BARDA)
|
From page 77... ...
Related to this challenge, he said that new payment system models and innovative incentives are needed to ensure that antimicrobial manufacturers are compensated for their investments regardless of actual use. Ensuring Commercial Viability of Antimicrobial Research and Development Joanna Wolkowski, vice president of portfolio and decision analysis at Pfizer Inc., provided an overview of Pfizer's programs addressing multiple aspects of AMR, including antimicrobial stewardship, resistance surveillance, regulation, and manufacturing of products to treat and prevent bacterial infections.
|
From page 78... ...
According to Cueni, "The problem with AMR is that it doesn't have a face." To illustrate, he compared progress made in the area of antimicrobials versus pandemic influenza preparedness from the time they were both identified as top areas for research by the World Health Organization's (WHO's) Priority Medicines for Europe and the World report to now.3 Cueni argued that society has seen galvanization since the 2009 H1N1 pandemic, including the formation of the Pandemic Influenza Preparedness Framework, but he said there has been no equivalent for AMR, seen as a "silent potential killer." Along with other speakers in the workshop, Cueni remarked on the conundrum of investing in standby med 3 WHO's Priority Medicines for Europe and the World was commissioned in 2004 and updated in 2013 (WHO, 2013)
|
From page 79... ...
Market entry rewards would guarantee income for pharmaceutical companies for bringing products onto the market as standby drugs designed for low volume of use; however, Cueni has yet to see any entity provide adequate funding in market entry reward initiatives. Transferable market exclusivity (TME)
|
From page 80... ...
He noted that both large and small pharmaceutical companies are lowering their investments in antimicrobial research, despite the growing global need for new products. He agreed with Wolkowski that the major challenge impeding antimicrobial product development relates to negative forecasted returns on investment.
|
From page 81... ...
To address this overall crisis within public health but also within industry, Kfoury called for greater collaboration on diagnostic innovation among pharmaceutical companies, diagnostic companies, governments, and nongovernmental partners to bring about novel products capable of addressing specific resistant pathogens. DISCUSSION The discussion began with Anas El Turabi, Frank Knox fellow in health policy at Harvard University, who asked the panelists if they have seen any evidence of more drug effectiveness and shorter hospital stays in cases where institutions have shifted to a value-based purchasing paradigm and incentivized the use of more appropriate, albeit expensive, medications.
|
From page 82... ...
He argued that the key challenge is that there is no market for new antimicrobial products, citing clear opportunities for profit from new products for diseases like Alzheimer's; this means that industry is likely to lower their future investments in antimicrobials in the coming years. To clarify, Wolkowski laid out a pharmaceutical company's portfolio perspective in making investment decisions, which can come down to investing in a novel antimicrobial to combat AMR versus pursuing an oncology indication versus a rare disease for which there are
|
From page 83... ...
Kimberly Thompson, president of Kid Risk, Inc., asked panelists to comment on the idea of limited trust and understanding among industry and health systems on the value of medical products, and specifically what happens when the market appears uninterested in paying for the full value of the product. She cited MenAfriVac as a successful public–private partnership that was able to make an investment case for manufacturers by anticipating demand for the group A meningococcal conjugate vaccine and bringing a new product to market.6 She noted that the anticipated demand may not be there for antimicrobials, yet the challenge is to overcome the "valley of death" in getting stakeholders to understand the full value of developing antimicrobials.
|
From page 84... ...
He shared examples of willing collaborators in public–private partnerships, including the Global Antibiotic Research and Development Partnership, a joint initiative of WHO and the Drugs for Neglected Diseases Initiative, and other initiatives borne out of Wellcome Trust, as well as the German R&D Hub and the United Kingdom. According to Cueni, these stakeholders recognize that these partnerships are not sufficient to develop the number of products needed for the future, and thus new pull incentives are necessary in light of this shortfall.
|
From page 85... ...
He mentioned that the AMR Industry Alliance had begun addressing the issue of environmental discharge related to antimicrobial production, particularly in China and India, and stated that industry response will require a One Health approach. He also highlighted the importance of transparency, not only among industry, but also for consumers who have to make decisions about buying food that has been exposed to antimicrobials.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.