Colleague,

Good Morning!

PDA descended into Palm Springs Tuesday night on bikes, in trams and on foot to experience desert culture and the nostalgia that gave this iconic destination its star power. Day Three was the capstone of this year’s homecoming event offering more in-depth professional expertise, connections with solution providers, celebrations of innovative poster presentations and a continuation of the spirited Interest Group conversations.

Let Your Light Shine Through

The Final Plenary served as a benediction to PDA’s annual homecoming.  It would seem counterintuitive that an accident of nearly being burned alive would transform an individual into an empowered self-advocacy messenger.  Artist and burn survivor Allison Massari gave an inspiring invitation to the audience to think about their purpose and recognize the impact they can have on others. A mesmerizing storyteller, her 11-year journey from being engulfed by flames to becoming a voice for the power of compassion so captivated the audience that this was one session when no one was on their phones. Her passage from patient to a self-fulfillment coach has messages for everyone. True happiness is self-generated from within, not from an external source. Everything we do makes a difference, and small acts of kindness cannot be underestimated. Gratitude and compassion heal the places that medicine cannot touch.

She appeals to the humanity in everyone encouraging us to be defiant. To believe in ourselves. To face our own pain and be brave. To pause with micro-moments and gifts to ourselves. We all have heard variations of these themes before, but Allison’s openness and vulnerability gave truth to the power of her remarkable experience, and the lessons she shared with a room full of strangers. She says we all have invisible scars, but that does not mean we have to be victims.

Ongoing Education

If you want to be part of an enthusiastic group of experts, attend next year’s Lightning Talks.  Attendees cheer on the presenters who complete their talks at exactly 6 minutes 40 seconds.  On Wednesday the three presenters did a great job with timing and fielded questions that dug deeper into the content. The topics were varied with “Particle Loss in Tubing During Airborne Particle Counting,” (overheard, particles play bumper cars with molecules in tubes); “Lean Approach to Analytical Panels to Support Cleaning Validation” and “The Generated Pre-Trained Transformer Parallels Project: A Practical Method for Generative AI Integration into Workforce Development and Biomanufacturing Research and Manufacturing.” This last one is a mouthful for a project for humans to work in tandem with AI to enhance tribal knowledge (read organizational knowledge banks). Trying to get people comfortable with AI is met in equal parts with wonder, concern, and mistrust. Also overhead, it’s a steep learning curve to extract valuable, credible information from LLM tools, especially when all they want to do is to please you.

Interest Group Highlights

PDA Week is about choice, and there were 16 different Interest group meetings over the past three days. The forums are open, safe spaces to share issues, challenges, success stories and best practices. You can sum up how important they are with this key question: “We come to these conferences, and everyone seems to have the same problem. How do we work together?” The IGs are one important way to collaborate and partner up. Don't forget all of PDA's Interest Groups are now on LinkedIn. Join your groups of interest and get connected.

The IG discussions bridge theory to application with nuts-and-bolts operational details on how to disrupt, innovate, solve problems and support continuous improvement. A few highlights from the sessions include a lively well-attended session on Combination Products with a wide-ranging conversation about large volume to subcutaneous injections, emerging technologies and applications, OBIs, SaMD & AI Regulations, digital health and human factors, and platform technologies. An equally interesting share session for the Drug Compounding IG was an exploration of quality culture and who is responsible for quality in an organization. A cautionary note: A poor-quality culture could be defined as when compounders don’t know who the patients are who are taking their products.  The group also recommended that IGs start pulling warning letter data to help facilitate needed improvements. An added benefit?  Those findings could help drive the topics covered during the IG meeting. 

The IG Annex 1 leaders had a comprehensive discussion on contamination control strategies (CCS) in the context of pharmaceutical manufacturing, emphasizing the importance of clear guidance and risk-based approaches. Participants expressed the need for better understanding and clarification of existing guidelines, highlighting the challenges faced during regulatory inspections. Many participants noted the ambiguity in existing guidance documents, making it difficult for organizations to comply effectively. They emphasized the need for clearer instructions that can be universally understood and applied. There was a strong interest in implementing risk-based approaches as alternatives to traditional methods. Participants shared success stories of using such approaches, especially during regulatory inspections, where different interpretations by inspectors can lead to confusion. The importance of cross-functional collaboration was highlighted, noting that effective contamination control requires input from various stakeholders including quality, engineering, and regulatory teams.

The Packaging Innovations IG discussed considerations for RTU packaging, sustainability, reliability, cost and efficiency. Up for debate was whether deep vacuum is an interesting path to explore as a path of sterility. The Quality Systems IG spent time exploring the need for a systemic approach to change control. Although the group had different approaches, they agreed that the key to any change is whether it adds risk or mitigates it. There is always an underlying passive-aggressive acceptance of risk in a push-and-pull syndrome.  One defining characteristic of the work of all the IGs: The devil is in the details.

People's Choice

Everyone at PDA has a voice and the votes were in and tallied for the best-in-class poster presentations. And the people’s choice winners are:

• First Place, “High-Speed Radiographic Analysis of Subcutaneous Injection Depots: Dispersion, Morphology, and Diffusion in Autoinjector Delivery.” Rozhin Derakhshandeh of Purdue University explains, “I introduced synchrotron radiography and designed an image-processing platform capable of visualizing and analyzing drug depot formation in real-time during injection, as well as its post-injection diffusion. This experimental approach helps us understand how delivery parameters affect depot dispersion and absorption, ultimately influencing drug efficacy. Since there’s limited experimental work in this area, I believe it’s valuable to share my findings with the community, gather feedback, and connect with others working on similar challenges.”
• Second Place went to Abi Natesh, Quality Assurance Associate at Lyophilization Technology Inc. and his presentation, “Process Validation for Lyophilized Drug Products: Comparing a Program for Continued Process Verification in Different Lyophilized Products.” He says, “This poster is inspired by LTI’s previous process validation research and builds on the core ideas presented there. This method enhances process consistency, allows for proactive adjustments, and simplifies continued process verification (CPV) without the need for product-specific statistical models.”
• Third Place was awarded to Alyssa Burke, Senior Validation Engineer at BW Design Group, “Incorporating AI into the Process Validation Lifecycle: A Two-Way Street.”She says, “Conversations around Pharma 4.0 and AI have exploded in the last few years, largely due to accessible large-language models (LLMs) such as ChatGPT. This immediately got me thinking about how I could leverage AI within process validation. Continued process verification is often the “forgotten” stage of process validation and is executed at the bare minimum, rather than leveraging data generated to improve quality/control and optimize processes. This seems like an ideal area to implement AI as it has low-to-moderate quality risk and the potential for a high ROI.By showcasing how AI can integrate smoothly into validation lifecycle processes, I hope to provide clarity, promote understanding, and ultimately inspire a more confident adoption of AI technologies.” She adds, “Poster presentations are vital because they offer a concise, visual overview of ideas while encouraging direct engagement and discussion. Each viewer has the ability to vary their time commitment and level of engagement based on the relevance of the topic to their interests. This allows for more meaningful conversations and connections.”

Remember, all of the PDA Week 2025 posters are available on the attendee onsite page and via the Mobile App.

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Same Time, Next Year

We look forward to seeing you at PDA Week next year in Denver, 22-27 March 2026. Our annual homecoming gathering is a profoundly important way to stay connected and relevant in a constantly disruptive marketplace.

Our collective knowledge helps to power the industry and shape our shared future. Having a meaningful forum to learn, share, stretch, and have fun is what helps our members anticipate the future, not catch up to it. 

We have work to do and challenges ahead of us.  As we return to our routines, Allison’s words of wisdom may help everyone stay the course.  She said, “Anyone who eases pain is a healer.”

It’s good to remember that’s what we do and are committed to professionally and personally.

Today and tomorrow substantive training and workshops continue.

For those heading home, thank you for coming home with us this week!

Susan J. Schniepp and Kate Malachowski, PhD

PDA Week 2025 Co-Chairs

Thank You to Our Sponsors!

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