Roger Nosal Receives 2024 ISPE Distinguished Achievement Award

An ISPE member since 2007, Roger Nosal has dedicated his career to bringing global regulators and pharmaceutical industry professionals together to bring lifesaving medicines to patients worldwide. So, it was especially fitting that he was honored with the distinguished achievement award— the highest honor bestowed by ISPE on a member. The award, named for one of the Society’s founders and most esteemed presidents, recognizes an ISPE member who has made significant, long-term contributions to the Society.

Background and Experience

A Principal Consultant with Roger Nosal PharmaCMC Regulatory Consultants, Nosal also serves as Head of Regulatory Strategy for NGT BioPharma Consultants, a consortium of experienced experts and leaders in the development of pharmaceutical products. Before that, he was Vice President and Head of Global Chemistry, Manufacturing and Controls (CMC) at Pfizer, where he was accountable for all global regulatory CMC strategies and applications for innovative products and medical devices. He is the co-author of 24 patents and has publicly presented and published on a wide variety of regulatory and pharmaceutical policy initiatives and topics.

Nosal graduated with degrees in geology and studio art, and he worked briefly for a mining company in Montana before beginning his career in the pharmaceutical industry. “Over a 40-year span, I went from process chemistry to medicinal chemistry. In 1994 at G. D. Searle and then Monsanto, after it was acquired, I was asked to take on a role in regulatory because I had drafted CMC sections for a couple of investigational new drug applications. I learned about regulatory requirements/expectations while I assembled the CMC sections for different products that we were moving through the development pipeline.”

“At the time, CMC was emerging as a distinct regulatory discipline in the industry. I basically grew up with it and learned it,” he said. “I also had a chance to formulate it in the companies that I worked for. At Pfizer, I learned a tremendous amount over the course of several years, not only about the development approach that companies take, but also how to apply that and use that information in the right way for engaging with regulatory authorities and conveying information to them, not just for small molecules, but for just about every molecular entity.

“When I first got into regulatory, the industry had somewhat of an adversarial relationship with regulatory authorities. At least from the vantage point that I had. At the time, I did not know a lot of people who worked at regulatory authorities, but as I got to know them, I realized that what they did was not very different from what the regulatory colleagues at my company did. They were just looking at things from a different perspective than we were. I took it upon myself to work with other colleagues in the industry who were establishing collaborative approaches with regulatory authorities because it was the most effective way to improve regulatory applications and interactions,” Nosal said.

Over the course of his career, Nosal led the CMC team that received global regulatory approvals for Celebrex, a medicine used to manage the pain of osteoarthritis and rheumatoid arthritis. He collaborated with colleagues at Wyeth and Merck to implement Quality By Design (QbD) through US Food and Drug Administration (FDA) pilot program applications, ultimately leading to improved process understanding and post-approval regulatory flexibility.

In 2013, he was awarded the Pharmaceutical Discovery, Development and Manufacturing Forum Award from the American Institute of Chemical Engineers (AIChE) for outstanding contributions to advancing QbD in the pharmaceutical community. From 2018 to 2021, he co-led PhRMA engagement with the US FDA and meetings with the International Pharmaceutical Regulators Programme to address concerns regarding appropriate control for nitrosamines in pharmaceutical products. He also worked on many innovative pharmaceutical technology projects including regulatory approval and the introduction of portable continuous modular manufacturing. He also provided crucial leadership in the global development, distribution, and commercialization of the chemistry, manufacturing, and controls (CMC) for Pfizer’s COVID-19 mRNA vaccine.

As a consultant, Nosal provides regulatory strategy and support for companies that have drug candidates in development. “I really enjoy the fact that there’s not always a right regulatory answer, but there are answers that are very close to minimizing the risks that a lot of companies encounter in their development. Understanding how to minimize and address those risks, and work with regulatory authorities to ensure they are assessed and understood, is probably the best part of this job. Science benefits by building on itself and I think we’re seeing academia, industry, and governments come together to find alternative ways to put together medicines that will not only address the symptoms of disease or deal with diseases, but, in some cases, potentially eliminate them. I think that’s really remarkable. It seems there’s an opportunity for us as an industry to collaborate more effectively with regulators in a way that allows for one regulatory authority to serve as the lead in evaluating an application in a way that other regulatory authorities would be able to approve the same application based on the original approval. During the COVID-19 pandemic, we would not have been able to get vaccines out to all the countries that we did if the regulatory authorities had not collaborated and mutually relied on the approvals that had been granted,” he said.

A Volunteer and Leader

Nosal has been a leader and member of ISPE policy initiatives and Communities of Practice, was the co-founder and past chair of the Regulatory Steering Committee, and served as chair of the Pharmaceutical Engineering® Committee and Product Quality Lifecycle Implementation (PQLI®) Task Teams. In her nomination of him, ISPE Regulatory Steering Committee Chair Sarah Pope Miksinski, PhD, Executive Director, CMC Regulatory Affairs, Gilead Sciences, Inc. wrote, “Roger has demonstrated sustained and impactful presence at the interface of regulators and industry. He frequently contributes and leads efforts related to highly complicated issues, and he has been and remains a recognized thought leader across ISPE membership and within the field.

“In 2023 Roger led [and continues to lead] a highly critical and visible ISPE program geared toward global harmonization. He has repeatedly served as a moderator of global regulatory town hall events at ISPE annual meetings. Roger is frequently sought out as a mentor to both industry and regulatory colleagues alike, which strongly supports his capability in the collaboration zone between industry and regulators. In situations that require a leader with the ability to create a safe space for global regulators and industry colleagues to discuss contentious topics, his name is often at the top of the list,” Miksinski said.

“I find it a privilege to be a member of ISPE. I try to put in as much effort as I can because I enjoy the work that I get to do with other ISPE members. I’ve met outstanding people who collaborate with others to deliver very solid approaches that can be used and adopted throughout the industry,” Nosal said.

ISPE International Honor Awards recognize and celebrate dedicated professionals who volunteer countless hours to support ISPE in its mission. For more information, visit ISPE International Honor Awards.