Colleague,

Good Morning!

Day Two of PDA Week 2025 opened with a look forward during our second Plenary with an investigation of a critical global issue: sustainability. We are at a hinge point in the global pharma marketplace with sustainability in the crosshairs. The two presenters examined complex issues and answers from different vantage points that seamlessly wove together in a lucid use case for sustainability.

Jane Zhang, Co-Founder & Co-CEO of ETCH Sourcing and a self-described supply chain nerd addressed behavioral change in her talk on “Driving Behavioral Change: Unlocking Sustainability Through Procurement and Supply Chain Innovation.” Phil Duncanson, PhD, Senior Director, Global Quality Control at AstraZeneca presented “From Labs to Leadership: A Vision for Carbon-Neutral Pharma Operations.” Old habits die hard; how do you change a mindset? It takes vision, tenacity and empathy. It starts at the top and needs to permeate the organization.

Both Jane and Phil spoke to themes that reinforced and revalidated each other. To start any transformational change, it’s key to ask the right questions to identify the core issues and gaps. Jane described building a sustainability bridge in stages that became a metaphor for the Plenary: The wobbly bridge. That is to say, the bridge to sustainability is not always stable and steady. Jane emphasized that organizational behavior therapy can be useful in helping companies change attitudes and actions. She says intention is motivated by attitudes, subjective norms (confirmation bias), and perceived control. The higher the intention, the more you will do something. Good intentions are often coupled with irrational behavior. She has helped develop a rational playbook to pave the way to sustainability. She adds that the supply chain is being disrupted, opening an opportunity to look at suppliers in new ways that can include quality as a foundational principle in sustainability.

Phil is both a personal and professional advocate for sustainability and presented a comprehensive profile on how to make sustainability a cornerstone in the pharma manufacturing industry, including a voice for wildlife with a shoutout to the venerable horseshoe crab. He suggested ways labs can become green by reviewing, reexamining and challenging how things have always been done – and becoming certified as green labs. Going digital, decreasing waste, and resource reduction are starting points. His question that got the attention of the audience was “How many times have you walked into a lab and everything, I mean everything is on and there are no people around.” He was referring to lights, computers, and equipment in an empty lab. He also addressed the issue of ultra-low temperature freezers and their excessive power usage. Both Phil and Jane agree that talk about sustainability is popular, but for true change to happen, metrics, measurements, data and benchmarks are necessary to reinforce and sustain sustainability.

Key takeaways:

You don’t build a fence when your house is on fire. Leverage your purchasing power to sustain change.

Deep Dives into Innovation and Disruptive Solutions

Tuesday had so many options in the sessions and Interest Group meetings to explore niche expertise in the context of disruption. There is no shortage of innovative strategies and solutions in the pharma industry when it comes to transformation.

Here are a few selects from the 9+ education sessions on Tuesday. Sebastian Scheler, MSc, Managing Director of Innerspace was focused on ensuring consistency in manufacturing through the lens of how tech can help measure risk to make better decisions. He made an interesting case for an analytical approach to evaluate risk in pharma manufacturing with a novel tech solution.

He described an innovative process to establish a knowledge database of potential manufacturing hazards based on the intersection of human actions and objects (needles, pumps, etc.). Using a frame-by-frame matrix enhanced by computer vision, the results are practical warning signals to predict hazards and prevent them all in the pursuit advancing continuous improvement.

The assessment also includes risk mitigation for robots, although evidence reveals that robots are a lot less hazardous than humans. Digital transformation is at pharma’s doorstep; it will take commitment to walk through the portal.

Judith Koliwer, PhD Senior Industry Advisor & Principal Consultant for Advanced Therapies at Körber Pharma Software discussed optimized digital data management. She said to begin, you need to know what you are measuring and what the meaning and importance of the data are. Getting systems to transfer data among themselves is good but you need to account for the different ways data are contextualized and adjust the outputs and other parameters accordingly. AI model improvements are making the management of cell therapies easier and more reliable and avoiding delays and mistakes in donor selection and sample management.

Margarida Ventura, Quality Risk Management Senior Consultant at ValGenesis discussed how leveraging robust data pools and resources to enhance process knowledge, risk assessment and management allows for greater control and reliability of the process. How many data points do you need to adequately assess risk? It depends on the process, but you need to rely on the experts conducting the risk assessment and not solely on an automated decision process. PUPSIT (Pre-Use/Post-Sterilization Integrity Testing) was in the spotlight in findings in the PDA Annex 1 Survey where 25% have implemented PUPSIT for all processes, about 35% for most, and 40% have not or will not implement it (PDA's Annex 1 Survey Report is now available for purchase/download). Similarly, the Kilmer Community PUPSIT Survey also reported 60% have implemented PUPSIT and 40% shared they perform pre-use integrity tests before filter sterilization. 

At Lightning Speed

Yvonne Groß, Senior Scientist at Sartorius Stedim Biotech gave a Lightning Talk (6 minutes, 40 seconds) on a risk-based approach for PUPSIT simulation. And speaking of Lightning Talks, they are a great exercise in focus and keeping the audience engaged on diverse topics. The talks get to the point quickly. It’s a great way to communicate efficiently and effectively.

There were 8 IG meetings on Tuesday, and we’ll recap their conversations tomorrow.

Heard in the Hallways

There was a lot of buzz about the poster presentations and who to vote for as the top posters of PDA Week. Winners will be announced at lunch on Wednesday along with the winners of the Passport prizes. There was also a lot of conversation about which of the evening activities to experience and enjoy the stunning weather and environment of Palm Springs. The exhibitors were enthusiastic about attendees’ interest in their solutions. Tariffs and changes at the FDA were a concern. And above all, attendees were animated and excited to see each other, meet each other and explore possible opportunities.

Preview of Day Three

We look forward to a busy Day Three. Of great importance to our industry, PDA CEO Glenn Wright is holding a briefing at 07:00 Wednesday morning in Primrose A, “Unpacking FDA CRLs: Manufacturing Hurdles and Industry Response.” He will discuss the current challenge facing the industry related to manufacturing and facility-related Complete Response Letters (CRLs). CRLs are issued at the end of the FDA review cycle for regulatory submission indicating that the submission (BLA/NDA) cannot be approved in its current form. Over the past several years the number of manufacturing and facility-related CRLs has greatly increased, creating unprecedented challenges for the industry. Glenn will provide an update on the current issues and discuss the work being done by PDA on this topic area as well as work being done on behalf of PDA to better understand these CRLs and any predictors that the industry should be aware of.

Wednesday culminates with our final Plenary. We’ll end where we always begin with the patient. Sometimes it’s tempting to get distracted by the dazzle of great innovations, disruptions and life-changing solutions.

It’s important to remember that we do all this meaningful work in service to our final arbiter, the patient. It’s a good way to end the conference component of our week of robust conversation and exploration.

What we do matters, and we appreciate your active participation in PDA as we collaboratively guide our industry forward in disruptive times.

Download PDA Week Pics and More

Visit the attendee On-Site webpage to access PDA Industry and Honor Awards Ceremony and PDA Week photos, view the PDA Week 2025 posters, review PDA Technical Publications related to plenaries and sessions, and so much more.

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You can also access the page from the PDA Week 2025 Mobile App by selecting the Activities and Updates tile.

Stop by the PDA ProShop, PDA Member Lounge and PDA Booth

Make sure to get your PDA Week 2025 T-Shirt at the PDA Booth, stop at the PDA ProShop to load up on PDA Technical Publications, including the Annex 1 Survey Report, and for PDA members, get your limited-edition PDA Microbiology Conference 2025 T-shirt in the PDA Member Lounge.

Look out for our Wednesday recap email on Thursday morning as you prepare to attend PDA's Training and Research Institute workshops or training course.

Sincerely,

Susan J. Schniepp, PDA Week 2025 Co-Chair

Distinguished Fellow, Regulatory Compliance Associates Inc.

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