By Joseph Marks, Event Director, CPhI North America
Fueled by its nearly 200-year history, the USP is taking a new look at the value and execution of pharmaceutical quality
For nearly 200 years, the U.S. Pharmacopeia (USP) has established standards for the identity, strength, quality, and purity of drugs manufactured, distributed, and consumed around the world. While establishing standards facilitating the creation of quality drugs has always been a central focus, in recent years, USP has had an elevated focus on pharmaceutical quality, including the daunting challenge of understanding the value of that quality.
USP CEO Ronald Piervincenzi, Ph.D., will be one of the keynote speakers at CPhI North America in May 2017, and I had the opportunity to talk with Ron to get a bit of a sneak preview of some of the thoughts, initiatives, and information he will be sharing within his talk.
CPhI: The concept of quality has become an important focus for USP in recent years. Could you share some of USP’s work within this area?
Piervincenzi: Yes, the concept of quality has always been at the forefront of the USP’s mission, but the importance and formalization of this understanding has grown in importance. While our work to advance pharmaceutical product quality is diverse, I would like to talk about four key areas: a global definition of medicine quality, understanding the value of quality, the work of USP’s new Quality Institute, and further refining risk-based approaches to quality. Let’s first talk about what might seem somewhat rudimentary, but it is really not—the definition of quality.
We are currently working with industry, regulators, and our volunteer experts to create an umbrella definition that can be applied no matter where a given stakeholder is within the pharmaceutical supply chain. The narrow view of quality is that a particular medicine is created in the right way and that, ultimately, the drug is what it reports to be. Yet, the definition of quality needs to be much broader than that, starting with research and development and continuing through patient use. After all, beneficial impact on patients is the reason pharmaceutical quality is important.
We will be launching the USP Quality Institute this year, a major new initiative, to help move this conversation forward. The Institute will generate research and evidence to better inform conversations relating to the value of quality — answer questions on the beneficial impacts on patients and society of high quality, as well as on the costs associated with the absence of quality. Finally, the data collection and analysis that will be done by the Quality Institute will help us to refine risk-based approaches to quality. These understandings will ultimately continue to better the standards that the U.S. Pharmacopeia creates while helping to facilitate evidence-based decision making by healthcare policy stakeholders globally.
CPhI: A common definition of quality is an interesting concept, but do you think a common definition is possible, important or helpful?
Piervincenzi: We do believe that having a common definition of quality is useful for raising awareness of and applying importance to the criticality of quality. The concept of quality sounds simple, but when you look even just a little bit beneath the surface, it is not.
Ultimately, pharmaceutical quality is about ensuring that the right active ingredient, of the expected potency and purity gets to the right patient, in the right dose at the right time to drive the expected clinical outcome. There are many facets to this. Every aspect of a medicine’s lifecycle must be designed and executed to support the drug’s intended purpose — from the way in which active ingredients, drug formulations and drug delivery systems are developed to manufacturing processes to supply chain security to packaging, labeling, proper dispensing, and instructions for use.
As you can see, the implementation of quality varies markedly, depending on the point within the pharmaceutical value chain in question, but an encompassing concept of quality is both possible and important.
CPhI: How does the work of the USP specifically support pharmaceutical quality?
Piervincenzi: Early in my tenure as CEO of USP, I was advised that we must always remember our broad responsibility to advocate for quality medicines for all patients. The USP has always taken this mission very seriously, but we continue to advance our capabilities. Launching the Quality Institute is a great case in point.
The Quality Institute’s goal will be to generate and disseminate evidence to quantify the value of quality, based on rigorous research. There is a cost to creating quality drugs and ensuring that only quality medicines are available in a healthcare system, so what is that actually worth? Conversely, what does the lack of quality cost in both negative health outcomes and in actual dollars?
Through the Quality Institute, we're creating a senior level advisory group of public health, regulatory, and industry thought leaders to help guide the Institute’s research agenda. This effort is taking us out of our day-to-day work at USP and helping to contribute to the much broader question of pharmaceutical quality to help advance evidence-based policy decision making by healthcare policy makers.
Of course, USP’s ability to meet the industry’s and regulators’ need for quality standards remains our most important role in advancing quality medicines for the benefit of patients. We have worked very hard on our efficiency and responsiveness so that we can be of needed help to manufacturers around the globe.
CPhI: How does a shared understanding of quality and its value impact the drug supply in global markets?
Piervincenzi: I have very regular dialogs with health authorities, as well as with pharmaceutical CEOs and COOs and one of the pressing issues consistently raised by these executives relates to drug supply within developing markets.
There are numerous reasons USP is working to elevate quality standards in developing markets. First, it is the right thing to do because access to poor quality drugs is really no access at all. Patients quickly know when they are receiving substandard drugs. They then lose faith in their medical system, which is not only a humanitarian issue—it is a global health issue. For instance, infectious flare-ups in one region of the globe can spread or drive antimicrobial resistance, if they are not treated swiftly and effectively.
Many of the international drug manufacturers we work with have global quality systems – not different quality levels for different markets. For them to compete in developing markets, they need established levels of quality that are met by all manufacturers. In other words, they cannot compete with low-quality product suppliers, and have asked the USP to engage in elevating quality standards in these markets.
CPhI: Is there an example of USP helping to advance quality in an area utilizing new technologies and approaches?
Piervincenzi: A great example is around continuous manufacturing. Continuous manufacturing offers so many advantages, but pharmaceutical companies have a great deal of vested infrastructure. Innovator companies are carefully moving toward continuous manufacturing as they begin commercial manufacturing of new drugs. But generics and contract manufacturing companies have a hard time tolerating both the capital investment required and the uncertainties due to regulatory guidances that are, by design, not prescriptive.
We are collaborating right now with industry, academia, and the U.S. FDA on a large research project to create foundational standards to bring additional structure around the move to continuous manufacturing and lowering the associated risks.
Ronald T. Piervincenzi, Ph.D. is the CEO of United States Pharmacopeia. Most recently, as a VP in Development Sciences with Biogen Idec, he led new work around value-based medicine. Prior to that, he was a partner in McKinsey & Company's Global Pharmaceutical and Medical Products Practice. Dr. Piervincenzi earned his M.S. and Ph.D. from Duke University in Biomedical Engineering.
He will be speaking about about USP’s work during his “Partnering for Quality: A New Era” keynote at CPhI North America – May 16-18, 2017 in Philadelphia, PA.