While some manufacturers have agreed to meet this cap, there was some initial pushback from PhRMA who felt that investment in R&D might be adversely affected. OSP took the opportunity to sit down with Heather Coglaiti, global head of life sciences strategy and marketing at Rockwell Automation, to discuss how technology can drive improved margins for pharma manufacturers, helping to mitigate the potential impacts of the Inflation Reduction Act.
OSP: How could the Inflation Reduction Act negatively affect the industry?
I have read through various sources that the Act could impact the revenue of pharma manufacturers. Reduced revenue typically means less spending for research and development (R&D), thus impacting new drug discovery and development, less novel drugs and a decrease in number of drugs in the pipeline for the future.
OSP: How could it directly affect R&D?
As mentioned, there are various sources that feel that reduced revenue typically means less investment in R&D. However, deploying technologies can help to mitigate any perceived impacts of the Inflation Reduction Act and help reduce costs, speed time to market, and maintain margins.
OSP: What is the most effective way to shorten the time to market for pharma manufacturers?
Digital technology transfer and the implementation of advanced innovation and technologies such as digital twins and AI are highly effective methods for reducing time to market for pharma manufacturers.
To explain, a digital twin is a virtual replica of a physical asset or process. Digital twins can be utilized in drug development and manufacturing to model, monitor and optimize the operation of equipment, systems, and processes.
Using digital twins, producers can lay the groundwork for easier scale-up with digital twin technology. Built using emulation or simulation software, digital twins can dynamically solve challenges digitally early in the equipment or drug development cycle, reducing production costs and time to delivery.
Utilizing AI across the value chain can also improve process efficiency and accelerate time to market. This can strengthen and augment drug discovery, optimize production, and improve supply chain continuity, quality control, and operations.
Reliably digitizing data helps to remove incumbent silos, establishing a continuous product and process information flow with robust change control from discovery, clinical and commercial development through internal or external manufacturing. This shortens scale-up time by eliminating manual tech transfer redundancies and human error, enabling efficient and effective technology transfer and scale-up, unlocking significant timeline, cost, and profitability improvements.
It also facilitates data reuse, the continuous flow of information, and real-time insights across the value chain -- improving efficiencies and eliminating the need for manual technology transfer events.
OSP: Do you think smaller businesses will adopt the relevant technology?
Businesses of all sizes, including smaller companies, are adopting emerging technologies, while improving efficiency and reducing costs.
OSP: What about those who can’t afford / are opposed to investing in tech?
Investment in technology and innovation drives productivity, reduces costs, and positions manufacturers to better respond to and mitigate dynamic market conditions to maintain profitability. Tech enables operational efficiency, improved product quality, waste reduction, scalability, and flexibility. Those who choose not to invest in technology and innovation will struggle to remain profitable and competitive.
OSP: Are there any other ways manufacturers can help themselves?
Implementing innovative solutions and technology to mitigate the impact by improving operational efficiency and productivity, like the below, will help manufacturers stay at the leading edge of pharma development:
- Implementation of Product Lifecycle Management (PLM) systems
- Leveraging AI technologies
- Utilization of Augmented Reality/Virtual Reality
- Implementation of advanced analytics and advanced manufacturing (i.e., process analytical technology, PAT, and continuous processing)
- Implementation of digital, integrated platforms across the product lifecycle - from drug discovery to commercialization
- Adoption of new, modern manufacturing modalities and systems that are scalable, flexible, fully integrated
OSP: What do you think the long-term effect will be on the industry?
I think the long-term effect is a greater implementation of initiatives that improve margins and enable innovation.
In addition, the debate around drug pricing and access to affordable medications is expected to remain a prominent topic in the coming years. Governments, organizations, and pharmaceutical companies continue to seek solutions that balance innovation, sustainability, and patient affordability.
