Industry Expert Discusses the Value of the PDA/FDA Joint Regulatory Conference 2024
How do you build a great pharmaceutical conference? It is a fusion of art and science, designed for scientists by scientists who are by nature problem solvers and advocates for expanding knowledge and expertise to deliver positive results.
PDA caught up with Janeen Skutnik-Wilkinson, Co-Chair of this year’s PDA/FDA Joint Regulatory Conference, who helps orchestrate the agenda and experience along with her Co-Chair, Milind Ganjawala, a Division Director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research. PDA interviewed Skutnik-Wilkinson and got a behind-the-scenes look at what is in store for this popular, 33-year-old event. Skutnik-Wilkinson’s enthusiasm is infectious, and her industry knowledge is broad and deep. As Co-Chair, she says she is lucky:
"…because part of my day job is regulatory intelligence and external engagement. I have to be on top of what’s happening in the quality and current good manufacturing practice (CGMP) space around the world. I also do course work within our industry with peers and participate in various activities throughout the year with PDA."
Skutnik-Wilkinson is a huge advocate of lifelong learning and the ability to meet with professional peers to collaborate and work together to advance the industry. She believes that this conference meets both of these needs. She adds, “The number-one reason to attend this year’s event is the rich content delivered by experts who will touch on all the hot topics, trends and pain points in the industry.” She also thinks this is a unique opportunity to connect with the large number of FDA regulators who will attend the conference.
Quality Culture
Quality and quality culture is largely about the people who ensure quality standards are met, according to Skutnik-Wilkinson. This conference is dedicated to bringing bright, creative, scientific minds to work together, learn from case studies, and become ambassadors for actionable, practical solutions and best practices in their organizations. The conference is also a chance to pause from the day-to-day pressures in the labs and take a breath with colleagues to think and rethink differently about common challenges. She believes this is especially important for this sector of the pharmaceutical industry, which is under constant pressure to perform. Skutnik-Wilkinson also says the access to U.S. federal regulators on a one-on-one basis at the conference is invaluable. The atmosphere is collegial and supportive, with networking and unexpected encounters that can contribute greatly to problem-solving and innovative approaches to quality.
Skutnik-Wilkinson is also an ardent connector, who takes the lead in bringing people together in a common cause to improve the industry.
Qualified Experience
As Co-Chair, Skutnik-Wilkinson is particularly well qualified with an impressive 29 years of experience. She is currently the Director of Global Quality, Regulatory Intelligence and External Engagement at Moderna and formerly held leadership positions at Biogen and Pfizer. Her expertise in regulatory intelligence, compendial activities and quality and regulatory policy is complemented by her knowledge of documentation, change control, analytical method validation and product launch. This gives Skutnik-Wilkinson the breadth and depth to help shape the content of the conference and the future of the industry, and having been actively involved in PDA since 2000, she knows firsthand what valuable content members need. Skutnik-Wilkinson is a former member of PDA’s Regulatory and Quality Advisory Board, has co-chaired or spoken at several conferences, was a co-author of the first PDA Standard and of PDA Technical Report No. 54-6: Formalized Risk Assessment for Excipients and is the co-chair of the PDA Pharmacopeial Interest Group. She has also participated in several of PDA’s commenting teams for various regulations, guidances and compendial standards.
On Trend
“I work with Milind, and we review everything the planning committee suggests,” she said, “ensuring that it meets the objectives of the industry, PDA and the FDA.” The PDA/FDA Joint Regulatory Conference focuses on the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle.
One of the hot topics that will be covered at the conference is—no surprise—artificial intelligence (AI). Over-hyped, under-hyped or hyped just about right, the value of AI is in the eye of the beholder. Skutnik-Wilkinson says it depends on who you ask, and there will be plenty of perspectives presented at the event. She elaborates:
"I think AI can do a lot of fantastic things and I see a lot of opportunity for our industry. If we use it properly, AI will allow us to do what humans do best, which is use our brains. AI is great in relieving repetitive tasks and allowing people to get back to what they do best: thinking."
About the Expert
Janeen Skutnik-Wilkinson, Moderna, Inc.
Skutnik-Wilkinson is the Director of Regulatory Surveillance in Global Quality at Moderna. Skutnik-Wilkinson former positions include Director, Global Regulatory CMC Regulatory Intelligence at Biogen, Association Director, Quality Intelligence at Biogen, Vice President at NSF DBA and Director/Team Leader of Quality & Regulatory Policy at Pfizer. In these roles, Skutnik-Wilkinson was responsible for working with trade associations and developing company positions on quality and CMC issues, monitoring global regulations/guidelines/standards. Skutnik-Wilkinson has over 28 years of experience in compendial activities, quality and regulatory policy, and has held a variety of positions with responsibilities in documentation, change control, analytical method validation and product launch. Skutnik-Wilkinson earned a Bachelor of Science from the University of Connecticut in 1994, and she served on PDA's RAQAB and is the co-chair of PDA's Pharmacopeial IG. Skutnik-Wilkinson is a member of the ICH IWG for ICH Q3D Elemental Impurities and was on the EWG for Q3D, and she was the Chair of PhRMA’s Compendial Liaison Team (2000-2012).
She adds, “If you’re using AI appropriately with the appropriate information, you can use generative AI to produce a standard operating procedure.”
The need for guardrails for AI will be a key conversation point at the conference, Skutnik-Wilkinson says; AI tech needs to be implemented carefully and with foresight about its potential ramifications. She believes it takes management with a strong knowledge base of the technology to use it safely. She predicts that, at some point, the industry will come together in consensus with standards and operating ethics to help AI achieve its best potential without going off the rails, so to speak.
The PDA/FDA conference is designed to tackle issues like AI directly and transparently. Skutnik-Wilkinson observes that every organization shares challenges on how to improve, sharing similar barriers to change, transformation and innovation. She asks:
“Do you struggle internally with engaging the whole organization in quality? Do you see too much Big Q (owned by the quality unit and not owned by everyone, and quality as the enforcer, not a strategic partner) and not enough little q (quality mentality belongs to everyone in the organization)? The conversation will provide practical advice on how to ensure everyone understands that quality is not the responsibility of the quality unit alone, that we all have an obligation to our patients to be responsible for quality.”
Collaboration and Partnerships
The unique partnership between PDA and the FDA benefits all attendees, who come from all over the world. Since companies across the globe supply the U.S. market, having direct insight from the FDA will be helpful to participants. Regulators from other regions will also be featured as speakers and panelists.
For anyone still deciding about attending, Skutnik-Wilkinson has provided previews of several key conversations that should tip the scale. She says, “Throughout the agenda, we have a series of insightful sessions that are focused on how companies can improve their quality culture within their organizations,” such as:
- Proactive vs reactive quality. Our industry often responds to 483s with the bare minimum; we implement those commitments, forget about them, and leave all the learnings behind. We do not always think holistically and proactively about what we have learned and how to improve. We will discuss how to identify quality issues before they become failures and how to increase your focus on preventive actions rather than corrective actions.
- De-risk quality control. Case studies will be presented in the use of quality risk management and how companies use out-of-specification and out-of-trend test results to improve the overall lab system, bridging theory to practice.
- Quality-enabling behaviors. Every company wants to have a good quality culture but figuring out how to put one in place and how to sustain it is not always easy. This session will help companies identify techniques to embed quality culture throughout the organization.
- Independence of the quality unit. The quality unit is often the last to know. Does the business sometimes “hand” decisions to quality? If you experience this, this session will provide examples of how you can successfully address this in your company.
- Quality maturity. The maturity level of quality in a company can have a major impact on the business, but it is not always clear to leaders in the organization. This session will feature case studies that will provide guidance into how quality maturity can be a strategic asset and competitive advantage.
- Selection of contract manufacturing organizations. Macro issues that will be discussed are the implications and challenges for particulates in advanced therapy medicinal products, how AI can be used to improve CGMP compliance, current efforts of industry and regulators in the area of platform technology, and exploring the use of digital tools and the impact on data integrity.
Ultimate Connector
Skutnik-Wilkinson is a champion of industry improvement, personally and within an organization. The good news is that every attendee, from first timers to veterans, will have the chance to meet her. She is a well-known “force of nature” for helping everyone get involved, get connected and be immersed in the conference ecosystem, which is designed to build a community of common causes to become better informed, more networked and inspired to lead the industry forward. Make sure you connect with Skutnik-Wilkinson to meet, greet and work with fellow colleagues at the conference. Register today!