July 1, 2020 PAP-Q2-20-CL-001
The COVID-19 pandemic has brought the pharmaceutical industry into the spotlight, because pharmaceutical solutions — both therapeutics and vaccines — are required to address this monumental societal challenge. The pharmaceutical industry is obligated to deliver medicines to patients in need — and the focus of the industry must always be the patient, whether or not a global pandemic is underway.
Our ultimate goal is to make quality life-improving, life-saving, and preventive medicines that are accessible to patients. Even under the strain of the COVID-19 pandemic, we cannot lose sight of the need to deliver medicines efficiently with reduced cycle times in order to increase speed and availability and, where possible, reduce costs.
Disruptions in the pharmaceutical supply chain due to COVID-19 are the biggest, most immediate challenges that the industry faces today. In addition, there are no vaccines or drugs effective against SARS-CoV-2, the virus that causes COVID-19, although the U.S. FDA recently gave emergency approval to Gilead Sciences’ antiviral drug remdesivir. Developing such products takes significant time. Finding ways to improve our ability to bring new drugs to market is absolutely essential, not only for COVID-19 patients, but for the millions of people suffering from countless diseases that lack effective medicines.
One of the problems facing drug manufacturers is the disconnect between the actual time it takes to bring a new drug to market and the perception among the public and government officials of how long that time should be. The normal path to success is tortuous; it typically takes 10–12 years to receive approval for a new vaccine or therapeutic. The public (and many politicians) often do not grasp the need for this time frame and may perceive the slow and rigorous drug development pipeline as evidence that the industry is failing to meet its social responsibilities.
There is also an ongoing misperception on the part of the public and many government stakeholders that the pharmaceutical industry prioritizes profit over its societal responsibilities. This misperception has unfortunately led to measurable, negative consequences.
Faced with significant pricing pressures and the realities of the costs of drug development and commercialization, many drug companies have, over recent decades, sought new efficiencies afforded by moving manufacturing operations to emerging economies, such as China and India, not realizing the extent of the risks that this globalization has introduced into the pharmaceutical supply chain.
Additionally, the lack of new, potent antiviral medicines with the potential to treat COVID-19 patients can be attributed to the societal demand for the cheapest possible medicines. For many years, antibiotics and antivirals that have existed for decades have been commoditized. Bacteria and viruses have developed resistance after long-term exposure to these older drugs. Drug manufacturers, meanwhile, shifted R&D dollars away from anti-infectives, because the market is unwilling to pay for more costly antibiotics and antivirals.
This collision of conditions has created an environment in which the very survival of the pharmaceutical industry is endangered, as combined challenges increase the cost of drug development. A sustainable pharmaceutical sector will be very difficult to realize, given that the industry is already struggling to meet unrealistic cost and pricing expectations, which are unlikely to change.
To be successful going forward, the industry must find a way to change these social perceptions without an impact on its responsibility to develop and deliver medicines. To accomplish this goal, society must be educated about the true cost of drug development and commercialization, while the pharma industry must accept that a focus on achieving efficiencies and cost reduction is imperative. A consensus within and outside the industry must be established that, if cost remains the paramount concern, many diseases will go untreated. Pharma companies, meanwhile, must find ways to reduce their costs.
Regulatory agencies must also participate in developing a new model for drug approvals, while investors must be willing to accept more reasonable returns. The lengthy approval process is the greatest contributor to the high cost of drug development. If the regulatory process could be accelerated, drugs could reach the market more rapidly, and expenses could be significantly reduced. While investors do merit a return on their investments in pharmaceutical companies, current expectations for 15% or greater returns are impractical given the challenges faced by the industry overall.
The pharmaceutical industry cannot solve all of the world’s problems. What it can do, however, is focus on the basics that will lead to optimization of efficiency and productivity. If every organization focused on cutting out waste from their systems, reducing variability, and increasing accuracy, significant gains in efficiency and productivity would result, leading to acceleration of development timelines and reductions in cost across the board.
An important aspect of boosting the efficiency of the overall pharmaceutical industry is a more effective use of underutilized capacity. Large pharmaceutical companies will need to gain a much better understanding of their current operations — what capabilities they have for different dosage forms (e.g., regular or highly potent tablets, capsules, liquids, ointments, sterile injectables), where they are located, and what percentage of that capacity is being used.
Companies also need a greater awareness of their processes so that, if challenged to increase output, they have the knowledge to determine where those processes can be implemented. Identification of critical components and bottlenecks to increasing throughput is also essential to properly prepare for future increases in demand.
In addition, it is important to have “whole-network thinking” and not be limited to specific sites and internal locations. Knowledge of the capabilities and capacities of contract manufacturers that can be leveraged in the case of a crisis, such as the COVID-19 pandemic, is invaluable.
The COVID-19 pandemic has highlighted the crucial role that pharmaceutical innovation plays in addressing societal needs. The industry must build on this understanding and shift the court of public opinion away from the incorrect view that the pharma industry is only out to enrich shareholders. We must effectively communicate the message that the development and manufacture of safe and efficacious drugs is an essential component of healthcare, yet is a time-consuming and expensive process, even under optimal conditions.
At the same time, continuous effort must be applied to increasing efficiency and productivity, shortening development timelines, and reducing overall costs. That includes not only eliminating waste from our development and production processes, but also simplifying and accelerating the drug approval process.
As importantly, while the challenges that can be tackled immediately should be prioritized in the short term, they must be balanced with efforts to address long-term issues, particularly with respect to the capabilities and capacities that will be needed to effectively respond to potential future crises. Changes need to be made to enable the cost-effective production of high-quality medicines that meet regulatory standards using processes with minimal waste within shorter time frames. Establishing a sustainable pharmaceutical supply chain is essential to fulfilling the mandate of the industry — delivering medicines to patients to save and improve human lives.
Tim Tyson is currently Chairman and CEO of TriRx Pharmaceutical Services, LLC and Chairman at Icagen Inc. He also currently serves on the board of Tyme Technologies Inc. Mr. Tyson recently served as Chairman and CEO of Aptuit LLC. He was Chairman and CEO from 2008 to 2012 leading a restructuring, acquisition and successful sale of a major portion of the company prior to stepping out as CEO to serve and guide the company as Chairman up until 2016. His corporate career spans over 35 years in the pharmaceutical industry.