Fixing Broken Medical Supply Chains
A National Press Foundation briefing
Though this briefing was geared towards journalists, it featured an intriguing discussion from Meredith Broadbent, senior advisor, Center for Strategic and International Studies (CSIS) and a former chair of the U.S. International Trade Commission.
The COVID-19 pandemic exposed serious vulnerabilities in our global medical and pharma supply chains and experts expect that threats to supply chain resiliency will only increase in the future. This newfound attention on supply chain resiliency has created what Broadbent says is a “dangerous momentum” for a U.S. government policy focused entirely on reshoring supply chains.
Broadbent asserted in her presentation — which complements a recent CSIS report — that “no single country can produce all that it needs to fight COVID-19, let alone cure it.” Instead, policymakers should opt for an approach that builds resiliency through diversification, trust and communication.
CSIS suggests that Congress should authorize the Office of the U.S. Trade Representative to negotiate a reciprocal “trusted partner network.” This series of networks would support international cooperation and help industries respond to new global challenges. According to Broadbent, “experience and economic reality suggest that the path to more resilient and secure medical supply chains is through rational diversification, flexibility, and closer cooperation with trusted partners, not protectionism and government directives to make everything at home.”
Aired March 16, 2021
An archived presentation is available via the National Press Foundation’s YouTube channel.
The report is available for download on CSIS.org
2021 PDA Annual Meeting
Parenteral Drug Association virtual event
The Parenteral Drug Association annual meeting is designed to examine the current biopharma manufacturing environment and explore how companies are adapting through the modernization of facilities, approaches and processes. One of the more colorful sessions this year was a presentation from Jeffrey Baker, deputy director, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA.
Baker opened by applauding the biopharma industry on their progress with COVID-19.
“We are turning the corner because of the work of the biopharma community, doing what needed to be done, when it needed to be done,” said Baker.
And yet, Baker challenged whether, overall, we are seeing the same energy and innovation and willingness to get it done in manufacturing that we’ve seen in discovery and development.
According to Baker, although more than 90 percent of FDA submissions are supplements to Biologics License Applications (BLAs), very few, if any, reflect modernization or deployment of new manufacturing technologies. He says the agency is “not seeing continuous improvement and continuous learning.” Instead BLA supplements mostly consist of adjustments of the buffer, label, concentration or site change.
“So what’s up with this?” Baker asked. Is it the fault of regulators? He argued “no,” pointing out that the FDA has encouraged development of advanced manufacturing technologies for 20 years through strategic plans, working groups, partnerships and programs.
In January 2019, as part of an active listening program, the FDA partnered with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and had discussions with 11 major pharma companies about the adoption of new manufacturing technologies. They asked manufacturers, “With respect to the regulatory landscape what changes would you like to see implemented that would enable your company to deploy innovative technology for manufacturing and continue improvement?”
The key outcome? There is rarely a business case for implementing new manufacturing technologies. According to Baker, this was “interesting in its refreshing bluntness.” Companies reported that pre-launch, new technology poses a risk to timelines. And post-launch, global change management, including maintaining separate process for different markets, is a hurdle.
Ultimately, concluded Baker, it should be about optimizing value and not minimizing costs. “Until we look at manufacturing as a value center not as a cost center — something to be optimized rather than minimalized — we are never going to engage the innovation engine that is driving discovery, driving target validation, driving new public health solutions, in manufacturing.”
Aired March 15-17, 2021
This presentation, as well as additional event content, is available on-demand
Pittcon 2021
Annual Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy virtual event
The annual Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy is a favorite among those looking for the latest innovations and solutions to lab challenges. With the theme “Science: Now more than ever,” Pittcon 2021 was an all-virtual event for first time in its 72-year history.
Pittcon’s keynote talk, known as the Wallace H. Coulter Lecture, was delivered by Joseph Powell, former director of the American Institute of Chemical Engineers and retired chief scientist from Shell.
When it comes to energy sources, “prepare for change, the future will surprise you,” said Powell. With multiple energy sources now available, the focus has shifted to selecting and optimizing the most sustainable options.
“Sustainability is now about addressing climate change and not the lack of access to energy,” said Powell.
During his lecture, Powell discussed the historic and current role of industrial labs and chemical industry innovation in delivering on society’s needs for a sustainable future. Most developments have been driven by the need to deliver cleaner product to the marketplace, using processes that reduce environmental footprint.
Powell pondered: How do we move wind and solar into the energy system, while continuing to use natural gas in a cleaner way? His lecture presented case studies in technology development that will help manage CO2 and carbon during the energy transition over the next 50 years so that we can meet important climate change goals.
Aired March 8–12, 2021
Conference sessions are available on-demand until June 12 at Pittcon.org.
