The Plasma Protein Therapeutics Association (PPTA) plays an important role in helping ensure plasma-derived therapies can reach millions of patients worldwide. As a longtime member of the PPTA and one of the world’s leading plasma-based biotechs, CSL Behring is a key supporter of the PPTA’s efforts.
Karen Etchberger, CSL Behring’s Global Head of Digital Technology and Execution Systems, was recently elected head of the PPTA Global Board of Directors, which she has been a member of since 2013. Vita recently sat down with Karen to get her thoughts on the role PPTA will play in the new decade.
Vita: Congratulations on this new position. You will serve a three-year term at the start of a new decade. What are the major themes you see on the horizon for the PPTA?
Karen Etchberger: Thank you! I’m very excited about the opportunity to help lead this important industry association. I really see three themes setting the tone for the PPTA’s immediate agenda: education, access and helping shape key regulatory discussions. The education component is two-fold. We have to help our stakeholders understand what can drive access challenges surrounding plasma-derived products and we also have to educate them on the industry’s commitment to ensuring reliable access. It’s all about ensuring the patients we serve across the globe have as few hurdles as possible in their path to getting lifesaving plasma-derived therapies. Working with regulators is a huge part of delivering that access. The PPTA will play a major part in developing a path forward to optimize plasma collection and access to plasma-derived therapies in several key markets, including the European Union and China.
Vita: Plasma-derived therapies are often at the center of a story about availability. In your new role, how much of the conversation will be about this, particularly outside of the United States?
KE: As an association, we need to support patients and their ability to access their therapies through a productive dialog with the global policymakers, both in terms of how plasma and the resulting therapies are regulated and reimbursed. There is already an active dialog both among regulators and within the PPTA to better understand what is driving any changes in usage. One of the association’s priorities over the coming year is to invest more time and effort to really get a handle on how plasma protein therapies are being used and whether that use has changed over time.
How has your experience with CSL Behring – in a variety of leadership roles – informed the way you’ll help guide the PPTA?
I have been fortunate to see CSL Behring from many different perspectives and it’s important that I apply those perspectives to my role with the PPTA as well. While there are many important individual topics where the association can bring value, it’s very important that we understand how those topics are interrelated. We want to be laser focused on the priority areas where PPTA can really make a difference for the patients that rely on our important therapies.
As you were starting your new role, the PPTA addressed Coronavirus (COVID-19). What should patients know about the safety of plasma-derived medicines?
Patients should know that existing manufacturing methods provide significant safety margins against viruses like COVID-19. This is a large-sized virus (approximately 120 nm in diameter). Its size and lipid envelope make it highly susceptible to steps with virus inactivation and removal capacity used during the manufacturing processes, such as pasteurization, solvent-detergent (S/D), low pH incubation, pasteurization, dry-heat treatment and virus filtration. More information is available on the PPTA website.
With its campaign “How Is Your Day?” the PPTA profiled plasma donors as well as patients, giving vivid examples about how plasma therapies positively impact health and quality of life for many people. Do you plan on bringing “patient focus” to your new role?
The association needs to have a balanced focus between patients, donors and relevant stakeholders. The “How is Your Day” campaign was initiated because PPTA recognized the need to also focus on the importance of donors without whom our therapies would not be possible; this campaign has been very well received by both donors and patients.