Dear colleague,

Yesterday was a great opening day and the high energy among our 900+ attendees (a new record of attendance!) created an ideal environment for knowledge transfer, a bridge between theory and practice, and engaging networking. Many sessions were standing room only, a testament to the value of learning from presenters across the FDA and industry sectors.

The exhibit area was full of enthusiasm with meetups and dynamic conversations about innovation and breakthrough solutions. PDA’s PDA Week 2025 T-shirt quickly became the day’s hot collector’s item to have in hand. Supplies will be restocked today at PDA Table 410. Get there early to get yours!

We play as hard as we work, and the reception was buzzing with speakers and attendees forging new connections. The reception’s highlight was honoring Janet Woodcock for the impressive work she has done as the FDA’s Principal Deputy. She has been a good friend to PDA, and we value her insights and support. We hope many of you were able to express your thanks to her for her commitment and leadership all these many years.

On Deck Today

A sneak preview of today’s program includes 31 speakers and eight more in-depth breakout sessions with high-level conversations about rising to the occasion and meeting the future of the pharma industry.

Later this afternoon, make time to take in one or more Interest Group meetings. Each offers common interest professionals an opportunity to learn, discuss and explore a variety of discussion topics. Please explore your options via the agenda in your Mobile App or on the PDA/FDA Conference webpage.

Also, make time to visit the companies and organizations in the vibrant exhibit area. Today is your last chance as they will be moving out at the close of the day.

But First a Reflection

Chevron in conversation. Before we get to Monday’s highlights, here’s something crucial for you: an update report on the reversal of the Chevron case which was presented on behalf of the PDA Capital Area Chapter in Washington DC on September 8.

Thomas Cosgrove, JD, Partner at the law offices of Covington & Burling LLP and former Acting Director of U.S. FDA Center for Drug Evaluation and Research’s Office of Compliance, offered his perspective on the recent Supreme Court ruling. “This is going to be a really interesting and critical next few years as the courts start to re-interpret some of the fundamentals that we have grown to rely on in the food and drug industry in terms of how the industry is regulated and, more broadly, all of the regulatory agencies out there.”

Thomas pointed out that the best way to push forward as an industry after the reversal of Chevron would be to “break things down into fundamentals” by figuring out what the rules are, how to anticipate what the rules might be, how they change and how to make sure that the products that companies are making are safe for patients and also compliant with regulatory expectations.

Thomas explained that starting from fundamentals is important because the courts are no longer deferring to the regulatory agencies on what the law is — judges will now be deciding what the law is, which can potentially create an era of uncertainty when trying to figure out what it means for a drug to be safe, effective and CGMP compliant.

Though Thomas ultimately believes that the courts will make the right decision regarding future rulings, he also believes that for the industry to be better prepared for the future, it needs to ask the right questions of how certain laws will change and in what direction.

Explore more information on the topic on the PDA/FDA Conference Onsite Attendee Webpage>

Monday Recap

From a top-down perspective, there were two recurring themes threaded through the day’s presentations: collaboration and urgency. Many speakers emphasized the need for better communications and coordination to align the industry worldwide.  Pharma works in a networked ecosystem of private and public sectors, and the need for consistency is loud and clear. Whether it’s data-based networks or basic one-on-one sharing, the lines of communication need to stay open and transparent.  

In terms of yesterday’s takeaways, we’re going to focus on the targeted updates from the four FDA Center Offices that were telegraphic in identifying the key issues facing the FDA and the industry at large. The CBER, CDER, CVM and ORA updates review how the FDA is optimizing strategies and actions to safeguard the quality, safety, and effectiveness of medicines for patients factoring in current manufacturing and supply challenges.

Echoing Patrizia Cavazzoni, MD, Director, Center for Drug Evaluation and Research, U.S. FDA who provided a comprehensive regulatory perspective on quality, integrity, and FDA modernization,  Michael Rogers, MS, Associate Commissioner for Regulatory Affairs, ORA, U.S. FDA, with just eight months into his new position, emphasized the need for modernization. ORA is being reorganized and changing its name and responsibilities. The new Office of Inspections and Investigations reflects this move to a more modern model. Rogers stressed that we need relevant training for frontline inspectors to stem the attrition rate.  The narrative for the office will evolve and change, giving it new life and purpose.

Peter W. Marks, MD, PhD, Director, Center for Biologics Evaluation and Research, U.S. FDA agrees that time is an issue in bringing genetic therapies to market converging global regulatory standards. He cited the importance of using our collective learnings from the pandemic as a beacon to accelerate therapies to anticipate future health crises. Whether it be Crispr or applying platform technologies, the industry is facing a transitional time. He added that there is also a sense of urgency because the venture funding model for these new therapies is not necessarily a long-term assurance. He also mentioned that a systemic problem in the US is that we are the most vaccine hesitant nation in the world. A case in point, “We may lose our status as the country that eliminated the measles.”

Douglas R. Throckmorton, MD, Deputy Director of Regulatory Programs, CDER, U.S. FDA commented on the magnitude of drug inventory issues, noting the small percentage of pharmaceuticals that are manufactured in the US and the need to ensure that imported drugs are high-quality and safe.

He cited the many pressures:

• Increased demand including IV narcotics, IV fluids, ADHD drugs, weight loss drugs, tripledemic-related medications
  
• Competition on manufacturing lines and in facilities due to limited capacity
  
• Loss of overall market capacity with-recent bankruptcies and plant closures
  
• Industry-wide short supply of manufacturing components
  
• Inspectional challenges
  

He says we need to connect the dots; natural disaster such as the tornado impact at the Pfizer North Carolina facility and the hurricane season can take out a manufacturing facility with little to no backup.

Drug shortages are a persistent problem with a total of 111 in short supply.  Time, again, is a factor in terms of how long it takes to bring pharmaceuticals to market. He adds we need to stabilize our global supply chains before we implement international standards to prevent harmful drugs from entering into the US.

Another key area for compliance and quality is the pet and livestock drug sector. Matthew A. Lucia, DVM, Director, Office of New Animal Drug Evaluation, CVM, U.S. FDA brought up the parallels between animal and human health.

CVM protects and promotes the health of humans and animals by ensuring the safety of the American food supply, the safety of animal food, and the safety, effectiveness and quality of animal drugs. About 70% of all US households have pets. And in terms of livestock, it has a direct impact on human health. The One Health agenda protects people and animals in a shared environment.

He suggested that two decades of animal genomic alterations is not trivial.  CVM has published proposed labeling regulations for animal drugs. As Lucia says, “Animal health and human heath are global issues.”

Get Ready for Today

No doubt today will be just as impactful and filled with insights and practical applications. Have any learnings to share?  Please respond to this email and we will be happy to share your thoughts on our on-site webpage or in tomorrow’s daily email.

And please don’t forget any questions you have for the Lunch with the Regulators on Wednesday must be submitted by 17:30 Today using the meeting app.

The PDA staff is also actively seeking out short interviews about your conference learnings (less than a minute) in the venue hallways. Look out for them and join the conversation.

Don’t forget to visit the online attendee webpage for featured content, videos and photos from the conference, a special video welcome from me, and so much more.

Explore now>

Sincerely,

Janeen Skutnik-Wilkinson, Co-Chair, PDA/FDA Joint Regulatory Conference and Director, Global Quality, Regulatory Intelligence & External Engagement, Moderna, Inc.