Major Big Pharma Moves, Pressures of Capital Markets at Intersection with Autologous Versus Allogeneic

Behind the Headlines Episode 25

Questions about Real-World Evidence and Supply Chain Security

Ask the Expert

Small Molecules, APIs, and Excipients—Trends, Challenges, and Opportunities

Drug Digest September 2025

The 100% tariff on imported drugs will pressure pharma companies to build manufacturing sites in the US or face significant costs.

How 100% Pharmaceutical Tariffs Will Impact Domestic Manufacturing and Supply Chains

Responses to the FDA draft guidance "Considerations for Complying with 21 CFR 211.110"

Stakeholders React to FDA's Push for Quality, Integrity, and Uniformity

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Behind the Headlines Episode 24: Surging Implementation of Sequence Event Reporting in CMC Analytics,

Behind the Headlines is a bi-weekly panel discussion examining the latest trends, readouts, and other factors that drive pharmaceutical news and innovation. Each episode features consultants, venture capitalists, scientists, patient advocates, and journalists discussing the prior weeks’ top news while seeking to highlight the more enduring lessons that hide behind the headlines.

In episode 24, Aaron B. Cowley, PhD, CSO, Recipharm Advanced Bio; Renee A. Hart, president and CBO, LumaCyte; and Vibha Jawa, PhD, FAAPS, CSO, EpiVax, look at the recent round of Mega-Deals, in part driven by Big Pharma patent cliffs, but also a need to cover-every-technology-and-expertise-base for complex manufacturing of advanced therapy medicinal products.

In this current spate of M&A activity, the panel examines AbbVie’s acquisition of Gilgamesh Pharmaceuticals’ investigational therapy, Bretisilocin, for $1.2 billion (1); Enlaza Therapeutics’ collaboration with Vertex Pharmaceuticals for the development of war-lock drug conjugates and T-cell engagers (worth up to $2 billion) (2); and Argo BioPharma’s agreement with Novartis (a combined potential value of up to $5.2 billion), for “long-acting siRNAs which are designed to deeply and durably target disease-causing proteins represent an important paradigm shift in prevention and treatment of cardiovascular diseases” (3).

Because of its more direct impact on pharmaceutical chemistry, manufacturing, and controls and process analytical technology, the panel spent significant time to understanding the reasons the Waters-Becton Dickinson Mega Deal, valued around $17.5 Billion (4). On balance, it was thought the recurring revenue and regulatory knowledge in precision medicine and diagnostics afforded by Becton Dickson was the largest attraction for Waters to move ahead on this deal.

The panel rounds out the discussion asking what are the bright new technologies arriving, and what we’d wish for in our Christmas stockings come December.

AbbVie. AbbVie to Acquire Gilgamesh Pharmaceuticals' Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder, Expanding Psychiatry Pipeline. Press Release. Aug. 25, 2025 

https://news.abbvie.com/2025-08-25-AbbVie-to-Acquire-Gilgamesh-Pharmaceuticals-Bretisilocin,-a-Novel,-Investigational-Therapy-for-Major-Depressive-Disorder,-Expanding-Psychiatry-Pipeline

Enlaza Therapeutics. Enlaza Therapeutics Announces Strategic Collaboration with Vertex Pharmaceuticals to Develop War-Lock Drug Conjugates and T-Cell Engagers for Improved Conditioning and Certain Autoimmune Diseases. Press Release. Sept. 2, 2025, 

https://enlazatx.com/press_release/enlaza-therapeutics-announces-strategic-collaboration-with-vertex-pharmaceuticals-to-develop-war-lock-drug-conjugates-and-t-cell-engagers-for-improved-conditioning-and-certain-autoimmune-diseases/

Argo Biopharma. Argo Biopharma Announces Multi-Asset License and Option Agreements with Novartis for Novel Molecules for Cardiovascular Diseases. Press Release. Sept. 3, 2025 

https://www.argobiopharma.com/news/153.html

Waters. Waters and BD's Biosciences & Diagnostic Solutions Business to Combine, Creating a Life Science and Diagnostics Leader Focused on Regulated, High-Volume Testing. Press Release. July 14, 2025. 

https://ir.waters.com/News--Events/newsroom/news-details/2025/Waters-and-BDs-Biosciences--Diagnostic-Solutions-Business-to-Combine-Creating-a-Life-Science-and-Diagnostics-Leader-Focused-on-Regulated-High-Volume-Testing/default.aspx

Videos

Aaron Cowley, Recipharm Advanced Bio; Renee Hart, LumaCyte; and Vibha Jawa, EpiVax, go behind the headlines to delve deeper into recent market deals driven by Big Pharma patent cliffs and the complex manufacturing of ATMPs. 

Behind the Headlines Episode 24: Surging Implementation of Sequence Event Reporting in CMC Analytics, Billion Dollar Deals Push Further Consolidation or Collapse, and an Analytics Wish List

Businessman hand pressing button Training. sign on virtual screen. business Mentoring Learning Education Browsing concept | Image Credit: © NaMong Productions - stock.adobe.com

Optimizing training for performance in the pharmaceutical industry was a key theme at the PDA Regulatory Conference 2025, with discussions centered on moving beyond basic compliance to leveraging digital tools for more relevant and responsive learning. Industry experts Marc Glogovsky and Richard Jaenisch shared insights on the evolution of training methodologies and the potential of new technologies on Monday, September 8, 2025 in the session “Competency-Based Training and Digital Learning,” moderated by PharmTech editorial adivisory board member and 

 co-host Susan Schniepp, fellow, Regulatory Compliance Associates.

Why is training for performance a necessity in regulated industries?

Training is more than a checkbox; it is a legal requirement, said 

Marc Glogovsky, Business Unit Manager of Microbiology at ValSource, Inc

., who emphasized that every person involved in operations must receive job-specific, ongoing training in Good Manufacturing Practices (GMP), delivered by qualified individuals. Unfortunately, training sometimes devolves into rote exercises lacking relevance. As Glogovsky observed, employees question modules like “lockout tagout” that have little practical connection to their duties. Effective training, he stressed, ensures personnel are “fit for purpose.”

This isn’t just theoretical. In 2024, there were 27 FDA 483s citing training deficiencies among 561 total for drug products, Glogovsky noted, a trend seen year after year. “If you're not giving them the proper tools, the proper training… you’re going to get some type of half-assed response… not in line with what the [GMP] expectations are,” he stated.

What are the common challenges facing traditional training programs?

Both speakers acknowledged major obstacles in traditional training. Glogovsky cited the overwhelming number of regulations across GMP, good clinical practice, good distribution practice, etc., skill gaps caused by evolving roles, rapid tech shifts, and high employee turnover. In-person training often strains resources, leads to disengagement, and can cause “burnout” for instructors and learners alike, he added. As Glogovsky joked, “If you give me training at 10:00 on a Monday, it's going to be a good day; you give that to me at 4:59 on a Friday, good luck.”

Richard Jaenisch, Director of Education and Outreach at Open Biopharma Research and Training Institute

, echoed these points, stressing the “human factor,” noting that people switch organizations, and systems’ needs change swiftly.

How can digital transformation elevate learning management systems?

Digital learning management systems (LMSs)—from 

—are central to modernizing training. Jaenisch explained that these systems, accelerated by the COVID-19 pandemic, simplify audit readiness, allow easy tracking, and enable learning “anywhere, anytime.” Interactive features like quizzes within videos and global accessibility are advancing continuously. Micro-certifications are also becoming standard for validating workforce skills.

What roles do VR and AR play in practical skill development?

Virtual Reality (VR) and Augmented Reality (AR) transform hands-on skills training, said Glogovsky, who found VR “eye opening” for cleanroom work, letting staff see how actions alter airflow in a way impossible to replicate in person. Jaenisch described VR as invaluable for onboarding, reducing risk and costs, and supplying critical feedback on techniques like aseptic manipulation.

AR is a game-changer for “digital work instruction,” they both agreed. With AR, protocols and schematics overlay live equipment, and trainees can practice virtually using digital twins of facilities—essential for complex, unfamiliar tasks and equipment.

Is gamification an effective strategy for enhancing engagement?

Gamification applies game mechanics—points, badges, leaderboards—to increase engagement. Glogovsky noted it can “be quite engaging,” turning even reticent operators competitive. Yet Jaenisch cautioned that gamification doesn’t motivate everyone, joking that “Some people don't need no stinking badges” and explaining that misapplied gamification may favor “addiction over utility,” distracting from true learning. Extrinsic motivators like financial incentives and time off often work better, and gamified elements need purposeful, personalized integration.

How can generative AI revolutionize training content and delivery?

Generative artificial intelligence (AI) is reshaping workforce training, said Jaenisch, who called it one of the “two big fundamental changes” in digital learning. Key AI applications that he noted include:

Content summaries: AI rewrites standard operatice procedures (SOPs) or training content for clarity and accessibility, especially for non-native English speakers.

Quiz generation/assessment: Automated, adaptive quizzes measure understanding instantly.

Personalized learning: AI fine-tunes curricula to individual needs.

24/7 feedback: Intelligent tutoring systems can support learners in real-time, offering tailored guidance.

At Open Biopharma, digital interactive SOPs use AI to analyze quiz answers deeply, giving specific feedback, even for partially correct responses, and tracking progress in detail. Glogovsky also noted AI’s usefulness for generating training visuals and materials.

What are the barriers to adopting new digital training tools?

Despite digital potential, adoption is challenging, according to Jaenisch, who pointed to the high costs of LMS and AI tools—an LMS can run tens of thousands of dollars, while sophisticated generative AI can cost hundreds of thousands to millions, he added. Implementing these systems demands robust data infrastructure, regulatory clarity (often lacking or inconsistent between the US and EU), and organizational readiness for change.

What does the future hold for biomanufacturing training?

Looking ahead, biomanufacturing training is moving toward a “unified, intelligent learning ecosystem.” Centralized LMS platforms, integrated VR/AR for skills building, carefully applied gamification, and micro-certifications will define future models. Overcoming obstacles hinges on phased pilots, commitment to compliance and talent growth, security by design, and ongoing measurement.

A digital-first mindset—rooted in compliance, ethics, and relentless improvement—will grow a skilled workforce. Glogovsky advocated, “I would like to see training done every day—don’t just slam someone with 75 days of training into one week.” Breaking training into daily sessions supports mentoring, sharing, and transparency. Jaenisch’s group plans daily 20-minute sessions with generative AI, enabling continuous learning and real-time progress tracking for both individuals and teams.

Articles

Optimizing training in the pharmaceutical industry is crucial for compliance and performance, with digital tools enhancing learning experiences. Industry experts emphasize the need for job-specific, ongoing training to meet Good Manufacturing Practices (GMP) standards. Traditional training faces challenges like resource strain and disengagement, while digital learning management systems (LMSs) offer flexibility and audit readiness. Virtual Reality (VR) and Augmented Reality (AR) enhance practical skills training, and generative AI personalizes learning. Despite high costs and regulatory challenges, a digital-first approach promises a unified, intelligent learning ecosystem for biomanufacturing.

Navigating Regulatory Training: Digital Transformation Strategies for a Smarter Pharma Workforce

Feliza Mirasol is the science editor for 

On the cusp of a profound transformation, the bio/pharmaceutical industry is driven by an exponential surge in data generation and the sophisticated capabilities of artificial intelligence. With approximately 400 exabytes of data, equivalent to 18,000 trillion books, produced globally each day—much of it unstructured—the challenge and opportunity for leveraging this information are immense, said 

, co-founder and chief scientific officer, Aizon, at the 

 occurring Sept. 8–10 in Washington, DC.

Data Governance to Ensure Regulatory Compliance, Data Protection, and Future Readiness for Advanced Use Cases

,” Manzano pointed out that this data deluge, combined with the widespread availability of computing power and data storage, is fueling an artificial intelligence (AI) renaissance that promises to redefine drug discovery, development, and manufacturing. AI is proving to be a scientifically validated tool, even playing a crucial role in Nobel Prize-winning research in chemistry and physics in 2024, demonstrating its capacity to solve complex problems and model intricate biological processes (1). Understanding and strategically implementing data-driven AI is no longer optional but an imperative for enhancing safety, quality, and efficiency, ultimately benefiting the patient.

How can bio/pharma operations maximize data value?

At its core, AI is a mathematical tool, Manzano explained in his talk. However, AI’s efficacy hinges entirely on the quality and management of data. Data in the pharmaceutical context extend far beyond traditional numbers and lists, encompassing diverse unstructured images, sounds, and continuous values collected from various systems.

Regulators are keenly aware of this, frequently referencing data and metadata in AI guidelines, emphasizing their critical role in transforming raw information into actionable knowledge. This focus is not without reason, Manzano said, emphasizing that more than 25% of warning letters issued by FDA since 2019 have cited data accuracy issues, a complex problem that continues to challenge the industry. This concern is further underscored by 

® Group highlighting common FDA 483 findings and strategies to prevent regulatory non-compliance, often rooted in data management deficiencies (2). For bio/pharmaceutical companies, ensuring robust data integrity and compliance is paramount, as regulatory actions can significantly impede progress and public trust.

The journey to effective AI implementation is heavily weighted toward data preparation, consuming an estimated 80% of an AI project's time. This rigorous preparation ensures that data are findable, accessible, interoperable, and reusable, known as the FAIR principles, which are essential for quality AI outcomes. As more data is integrated, the potential for knowledge extraction and sophisticated AI models increases, yet this also adds layers of complexity to data and model management, Manzano said in his talk.

What AI-driven innovations are the industry seeing in bio/pharmaceutical manufacturing and development?

The practical applications of AI across the bio/pharmaceutical lifecycle are profound. Consider the management of human plasma, a highly variable raw material for which donations cannot be refused and establishing full product genealogy is exceptionally difficult, Manzano highlighted. AI can be applied here to integrate batch record information with data from other systems, such as programmable logic controllers and online controls, which transforms these diverse data into knowledge that can guarantee expected yields. Through AI, crucial process variables, such as pH in plasma fractionation, can be identified and adjusted to achieve target outcomes. This capability moves beyond trial-and-error, enabling predictive models that recommend optimal process parameters based on raw material characteristics and desired yields (3,4).

Beyond manufacturing, AI is also advancing quality control in novel therapies. For instance, the Parenteral Drug Association, in collaboration with the European Medicines Agency, is utilizing AI for quality control in advanced therapy medicinal products, allowing for the prediction of batch success an hour in advance (5). This collaboration provides critical lead time for decision making without replacing human labor or traditional lab testing, enhancing efficiency and patient safety for those awaiting these crucial treatments, Manzano said.

"Everyone in this room, we are working for pharma, but we are [also] working for patients, so we have to [always] have in mind that everything we do is because there is a patient waiting,” he emphasized in his talk.

The industry's embrace of digitalization is progressing, Manzano concluded, pointing to a recent survey indicating an average maturity score of 3.5 out of 5. That is a notable increase from 2.6 in 2019. While challenges such as cybersecurity compliance and budget constraints remain top concerns for the industry, the perceived benefits are clear, Manzano asserts: respondents anticipate significant improvements in process efficiency and quality through digitalization, especially in areas such as production, research, and quality control. AI, when applied with scientific rigor and supported by high-quality, well-managed data, offers a significant opportunity to navigate the inherent complexities and variability of bio/pharmaceutical operations, ensuring that the ultimate focus remains on the patient.

1. Longhi, S.; Ventura, S.; Macedo-Ribeiro, S.; et al. When Artificial Intelligence Meets Protein Research [Version 1; Peer Review: 2 Approved, 1 Approved with Reservations]. 

New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483s

Quality and Regulations 2025 eBook August 2025.
3. IDBS. Enhancing Process Performance with AI in Bioprocessing. Blog Post. May 22, 2025. 

https://www.idbs.com/knowledge-base/enhancing-process-performance-with-ai-in-bioprocessing/


4. Cheng, Y.; Bi,X.; Xu, Y.; et al. Artificial Intelligence Technologies in Bioprocess: Opportunities and Challenges. 


5. Manzano, T. PDA Europe and EMA Unite. 

https://www.pda.org/pda-letter-portal/home/full-article/pda-europe-and-ema-unite

The bio/pharmaceutical industry is undergoing a transformation driven by data generation and AI capabilities. With vast amounts of unstructured data produced daily, AI is becoming essential for drug discovery, development, and manufacturing. Effective AI implementation requires rigorous data preparation, adhering to FAIR principles. AI applications in manufacturing and quality control are enhancing efficiency and patient safety. Despite challenges like cybersecurity and budget constraints, digitalization is advancing, with significant improvements anticipated in process efficiency and quality. The industry's focus remains on benefiting patients through these technological advancements.

Bothe data integrity and quality of data are critical for drug discovery, manufacturing efficiency, regulatory compliance, and patient safety.

PDA 2025: How Data-Driven AI Transforms Quality Control & Development

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Woman using nasal drops | Image Credit: © Alliance - stock.adobe.com

 announced on Sept. 8, 2025 that the first large-scale analysis demonstrating real-world, clinical evidence of treatment outcomes of its epinephrine nasal spray (Neffy) has been accepted for publication as correspondence in the 

 (1). The nasal spray’s performance was observed in routine clinical practice in patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy.

How many patients have been successfully treated?

In a grouping of 545 patients, ARS Pharma said, nearly 9 out of 10 (89.2%) were successfully treated by a healthcare provider with a single dose of the spray (1). That response rate is consistent with meta-analyses that have reported 88.9% of patients successfully treated with one dose of epinephrine intramuscular injection or auto-injector.

The real-world data build upon prior clinical evidence—in particular, a prospective Phase III study in which, among 15 patients, none who were treated with the nasal spray required a second dose to treat the initial anaphylactic reaction (1).

, MD, professor of Medicine and Pediatrics and chief of Clinical and Translational Research in the USF Health Morsani College of Medicine’s Division of Allergy and Immunology at the University of South Florida and a member of ARS Pharma’s scientific advisory board, said that the real-world data reinforce statistics that have previously been published.

“The finding that about 9 out of every 10 patients were successfully treated with a single dose of Neffy in more than 500 patients is essentially identical to the historic response rates observed with epinephrine injection,” Casale said in an ARS Pharma press release (1). “We believe these real-world outcomes data support the clinical interchangeability of Neffy and epinephrine injection, building on the clinical studies conducted for FDA approval that showed Neffy achieved blood levels and pharmacodynamic responses within the range of approved injection products.”

Where has the nasal spray been approved so far?

 ARS Pharma’s epinephrine nasal spray, through fast track designation, for adults and children weighing at least 30 kilograms (66 pounds) in August 2024, making it the first non-injection emergency treatment for type 1 allergic reactions including anaphylaxis (2). That approval was based on cumulative results from four studies measuring epinephrine concentrations in 175 adults following administration of either the nasal spray or an injection, finding that blood concentrations were comparable between the two methods.

“This approval marks a watershed moment in addressing an unmet medical need for people with type 1 allergies—a treatment alternative that avoids the need to inject epinephrine with a needle, which can be fraught with anxiety and fear for many,” 

, ARS Pharma co-founder, president, and CEO, said at the time (2).

Another advancement for the ARS Pharma product, commercialized outside the United States, Australia, New Zealand, Japan and China by Denmark-based 

 under the name EURneffy, came in July 2025 when the Medicines and Healthcare products Regulatory Agency 

 in 2-mg form for the same classification of patients in the United Kingdom as in the US (3). At that time, launch of the product in the UK was expected in the second half of 2025.

Real-World Evidence Supports Clinical Effectiveness of Neffy (epinephrine nasal spray) in Patients Experiencing Anaphylaxis.

FDA Approves First Nasal Spray for Treatment of Anaphylaxis.

EURneffy Approved as the First Needle-Free Anaphylaxis Treatment of Adults and Children in the UK.

San Diego-based ARS Pharmaceuticals has announced the publication of real-world clinical evidence demonstrating the effectiveness of its epinephrine nasal spray, Neffy, in treating anaphylaxis. In a study involving 545 patients, 89.2% were successfully treated with a single dose, aligning with historical response rates of epinephrine injections. The FDA approved Neffy in 2024 for adults and children over 30 kg, marking it as the first non-injection emergency treatment for type 1 allergic reactions. The nasal spray has also been approved in the UK, Australia, New Zealand, Japan, and China.

The performance of ARS Pharmaceuticals’ Neffy marginally outpaced historical reports of epinephrine injection effectiveness.

Epinephrine Nasal Spray Comparable to Injection in Real-World Data of Patients Experiencing Anaphylaxis

Glenn Wright previews the 34th PDA/FDA Regulatory Conference, spotlighting AI, quality culture, FDA trends, and collaboration shaping industry progress.

Glenn Wright Highlights AI, FDA Insights at 34th Annual PDA Regulatory Conference

PDA President and CEO Glenn Wright highlights the significance of the 34th Annual PDA Joint Regulatory Conference, noting his long-standing connection to the event: “I was actually chair of this conference when it was year number five… I've been involved with PDA for 36 years.” He praises the alliance between industry and regulators, emphasizing that “we really have kind of a nice industry-FDA collaborative conference.”

This year’s agenda captures emerging trends, including artificial intelligence (AI) in manufacturing and compliance. Wright shares his enthusiasm: “I always talk about the tidal wave of AI and data analytics that's gonna be hitting the industry. It really is good for the patient. It really means we have more control of the processes.” Attendees can also expect sessions on quality culture, effective remediation, and the critical roles of CDMOs and CMOs in modern manufacturing.

The conference remains a vital source for regulatory updates. “Some really great updates from FDA, really talking about trends that they're seeing, which is really important for the industry as a whole to understand what's going on out there,” notes Wright. He concludes with optimism, adding “We're just really excited. It's gonna be, I think, a hugely successful conference again for year number 34.”

Check out all our 

*Editor’s Note: This transcript is a direct, unedited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.


Glenn Wright, I'm the president and CEO of PDA.

Well, I'm really excited about this year's conference, our 34th regulatory conference. I can remember, quite some time ago, I was quite new to the industry and I was actually chair of this conference when it was year number five. So that should tell you I've been involved with this conference for quite a long time.

I've been involved with PDA for 36 years. You know, every year this conference surprises me because there's always exciting things that are going on in the industry and it kind of captures that, as well as with the heavy FDA involvement. We really have kind of a nice industry FDA collaborative conference, and this year, the topics are diverse. I mean, we're gonna be talking about AI in manufacturing, which I am really excited about. We're also gonna be talking about AI in auditing. I just got done doing a presentation on that topic. It's really incredible when you think about what AI may do in that whole auditing area in regard to looking at data, looking for anomalies, trying to find challenges that a company may have or an area may have, you know, so that's gonna be kind of exciting to me 'cause we see that AI space just continuing to grow. And then just AI in manufacturing, right, because again, you know, if we're thinking about product quality, once we get AI in manufacturing—and it's really ramping up, right. So I think I always talk about the tidal wave of AI and data analytics that's gonna be hitting the industry. It really is good for the patient. It really means we have more control of the processes. So that's just one small area I'm excited about.

I'm also excited about the talks on quality culture and really how to implement quality culture. I think that's fantastic. And there's a couple talks on remediation. So, you know, once you've had challenges and now you're gonna have to remediate those challenges, how do you go about that? How do you develop your plan? Some exciting things there. Again, it covers so many things, supply chain is on there, supply chain disruption, some discussions around use of contract services, so CDMOs and laboratories, and that's really important for the industry now as we see continued increases in the use of CDMOs and CMOs. They're so important because they have the technology that we need a lot of times, and so as new products get more and more complex, a lot of times those CDMOs and CMOs are just critical for that operation. But how do you manage that and how do you make sure you've got enough control over your contracted operations? So, some discussions on that, which I think are gonna be really exciting. I always like group topics, around the pre-approval inspections and what can you kind of expect in pre-approval inspections and what are the trends? So, we're gonna have some topics on that.

And of course, as we do every year, some really great updates from FDA, really talking about trends that they're seeing, which is really important for the industry as a whole to understand what's going on out there, what are they seeing, because when we think about FDA, you know, we have to remember that they see everything. They're the ones that can really help industry by letting us know what kind of trends are going on, what are they seeing as they go out and do inspections or what they see during submission reviews.

Another great topic this year is gonna be on post-approval changes, which, you know, for me being in regulatory for many, many years, is really exciting because we always kind of forget how important the post-approval change process is, how we need to navigate that carefully. You know, it can take years when you think globally about making a change and getting it approved by all the different countries. So that whole PAC (post-approval change) process, I'm really excited to see that topic on this year's agenda as well.

You know, I think the biggest takeaways from this year's conference, I think they're probably gonna come from the FDA speakers as they talk about some of the things they're seeing, some of the challenges they're seeing. That's always kind of the case. I think in this conference, we hear really great things from industry, kind of some practical approaches on how to do things, how to implement things, and that's really great, but there's always those great nuggets that come out of the agency in regard to things they're seeing and the expectations they have. And, so I think, those two areas… really excited to see what comes out. 

I never quite know, you kind of got to be there, you got to go through the presentations to understand everything. So, I think, on the back end of this, I'm sure I'll have some, nuggets that we've gained from the conference, but we're just really excited. It's gonna be, I think, a hugely successful conference again for year number 34. Again, FDA is heavily engaged in this conference, as is industry. And we've got folks all the way from heads of manufacturing to heads of quality talking—all kinds of folks from the agency, so I really think it's gonna be a great conference.

Glenn Wright previews the 34th PDA Regulatory Conference, spotlighting AI, quality culture, FDA trends, and collaboration shaping industry progress.

Supply Chain Management and Distribution. Fast Global Shipping Delivery Service. Logistics Business concept. Businessman presses place truck button on a virtual touchscreen | Image Credit: © wladimir1804 - stock.adobe.com

New-Generation Supply Chain: Connecting the Links to Reach Common Goals

,” that surveyed 1000 senior executives across four key sectors in 13 countries to discover the reasons why supply chain resilience is a strategic imperative amid geopolitical conflicts and shifts in trade policies. Next-generation supply chains that are agile, sustainable, and artificial intelligence (AI)-powered were listed as a current top three tech priority for 70% of life sciences organizations polled in the report (1).

Does the report have any significant revelations?

A similar percentage (72%) of organizations said they have made significant progress in transforming their supply chains in the three years leading up to the release of the report (up 18 percentage points from 54% in 2022), and almost as high a percentage as that (68%) said they have set a clear vision and objectives for their supply chain (up 33 points from 35% in 2022) (1).

Another key finding in the report is that AI systems, including agentic AI, are increasingly reshaping company operations. Two-thirds (67%) of the executives surveyed said they believed that agentic AI would increase productivity, with 58% being confident it would transform frameworks for supply chains (1). Already, the report said, nearly 1 in 10 life sciences organizations have implemented multi-agent systems or are using AI agents in some way.

That is a timely statistic; on Sept. 4, 2025, the nonprofit 

 bringing together experts from the pharmaceutical, technology, and biotech industries to help shape certain standards and protocols under which AI agents will be allowed to perform (2).

Where do cybersecurity and sustainability rank as priorities?

While supply chains are named by organizations as a prospective top priority going forward, companies and their executives who were surveyed, overwhelmingly, already include cybersecurity high on their list of concerns. For life sciences, more than three-quarters of respondents cite cybersecurity as a major challenge to their supply chains, the highest percentage of all industries polled (1). More organizations are investing in real-time threat monitoring and supplier diversification.

Meanwhile, the geopolitical climate thus far in 2025 is also something organizations are keeping their eyes on. Many, according to the report, have put tariff mitigation strategies in effect to protect their operations and profit margins in response to the shifting trade policies between the United States and other countries (1).

As organizations adopt various practices, including AI, to become more efficient, sustainability is seen as a key driver. The survey said that 76% of organizations have a comprehensive strategy in place for supply chain sustainability, and a similar percentage agrees that sustainable practices not only reduce costs but also deliver increased value in the long term (1). Nearly as many (71%) feel that the value provided by those sustainability initiatives outweighs the potential costs.

What is necessary to build a future-ready supply chain?

To navigate disruption and build new- or next-generation supply chains, the report suggests that organizations take the following steps:

make resilience a continual strategic priority

adopt active risk management to keep ahead of threats

implement human-centered agentic AI as a means of strengthening governance

build sustainable, competitive supply chains through collaboration

leverage AI to establish robust data foundations while implementing cybersecurity protocols

encourage cross-functional alignment for the purpose of creating solutions alongside suppliers (1).

The full Capgemini report is available in PDF form 

; a detailed infographic summarizing the key findings can be 

1. Roelofsen, V.; Charpiot, V.; Elasri, I.; et al. 

. Capgemini Research Institute, September 2025.
2. Pistoia Alliance. 

Pistoia Alliance Unveils Agentic AI Initiative and Seeks Industry Funding to Drive Safe Adoption.

The Capgemini Research Institute's report highlights the strategic importance of resilient supply chains amid geopolitical and trade policy shifts. It emphasizes the role of agile, sustainable, and AI-powered supply chains, with 70% of life sciences organizations prioritizing these technologies. Significant progress in supply chain transformation is noted, with 72% of organizations advancing in this area. AI, particularly agentic AI, is seen as a key productivity driver. Cybersecurity remains a major concern, especially in life sciences, while sustainability is recognized for its long-term value. The report outlines steps for building future-ready supply chains.

More than 700 out of 1000 senior executives surveyed believe that next-gen supply chains should be among the top tech priorities for life sciences organizations.

Supply Chain Challenges and Solutions Outlined in Capgemini Report

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS) | Image Credit: © Tada Images - stock.adobe.com

The Parenteral Drug Association (PDA) Regulatory Conference, marking its 34th year, will offer a forum for dialogue between global regulators and industry professionals from the pharmaceutical sector (1). Though FDA is not an official co-sponsor of the 2025 event, more than 30 FDA experts will participate as speakers, moderators, and panelists, underscoring significant agency support. The conference theme, “Achieving Current Good Manufacturing Practice Excellence: Sustainable Compliance Across the Lifecycle,” directly addresses core challenges and objectives for professionals in pharmaceutical manufacturing and development. This sustained engagement from FDA leadership provides crucial opportunities for the industry to deepen its understanding of regulatory expectations and evolving compliance landscapes.

Understanding FDA priorities and compliance trends

A key focus will be the second plenary session on the first day, dedicated to current good manufacturing practice compliance trends and topics (2). This session is particularly relevant for professionals seeking to strengthen their compliance frameworks and advance their quality systems to meet global standards. Speakers will include Francis Godwin, Director, Center for Drug Evaluation and Research (CDER) Office of Manufacturing Quality; Jonathan Swoboda, Consumer Safety Officer, Center for Biologics Evaluation and Research (CBER) Office of Compliance and Biologics Quality; Jeffrey Meng, Associate Director, Emerging Technologies and Advanced Manufacturing, Office of Inspections and Investigations (OII) Medical Products Inspectorate; and Dillard Woody, Branch Chief, Center for Veterinary Medicine (CVM) Office of Surveillance and Compliance. Their presentations will offer detailed insights into the latest compliance trends, which is essential for maintaining regulatory adherence and ensuring patient safety. Following this, FDA officials are scheduled to contribute as speakers and panelists across most breakout sessions, providing further detailed discussions on various topics (2).

Navigating regulatory challenges and enforcement outlook

The third day of the conference will feature “Plenary 4: Regulatory Priorities and Enforcement Outlook,” a session critical for professionals seeking to understand FDA’s focus areas and potential enforcement actions (2). This plenary will feature presentations from Melissa Mendoza, Director, CBER Office of Compliance and Biologics Quality; Jill Furman, Director, CDER Office of Compliance; Cindy Burnsteel, Deputy Director, Drugs and Devices, CVM Office of Surveillance and Compliance; and Ivy Sweeney, Acting Director, Office of Human and Animal Drug Inspectorate, OII. Anticipating these regulatory shifts and enforcement postures is vital for proactive strategic planning and risk management.


Additionally, a preconference roundtable hosted by the PDA’s Capital Area Chapter on Sunday, September 7, focused on FDA Complete Response Letters (CRLs) (2). Thomas Cosgrove, former Acting Director, CDER Office of Compliance, led discussions examining the increasing frequency and significance of CRLs. This session provided a timely overview of the challenges these letters pose and their implications for regulatory strategy and operational readiness in drug development, directly impacting the timelines and resource allocation for new product applications. Registration fees for this roundtable are being directed to the PDA Jette Christensen Early Career Professional Grant, supporting the next generation of leaders in the pharmaceutical sector.

The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda

The 34th Parenteral Drug Association Regulatory Conference will facilitate dialogue between global regulators and pharmaceutical industry professionals. Despite not being an official co-sponsor, the FDA will have over 30 experts participating, highlighting its support. The conference theme focuses on achieving excellence in current good manufacturing practices. Key sessions will address compliance trends, regulatory challenges, and enforcement outlooks, featuring prominent FDA officials. A preconference roundtable will discuss FDA Complete Response Letters, emphasizing their impact on regulatory strategy and drug development timelines, with proceeds supporting early career professionals.

The PDA Regulatory Conference convenes more than 30 FDA experts to discuss cGMP excellence, compliance trends, and regulatory outlook, offering crucial insights for pharma manufacturing professionals.

PDA Regulatory Conference Features More than 30 FDA Experts

Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). | Image Credit: © Tada Images - stock.adobe.com

Two months after saying it would embrace “radical transparency” by 

 (CRLs) issued in response to drug approval applications, FDA said on Sept. 4, 2025 that it was furthering that policy by releasing future CRLs “promptly” after being issued to sponsors (1,2). The agency immediately released 89 previously unpublished CRLs, issued from 2024 to the present, dealing with pending or withdrawn applications (2).

“This is a milestone day for the agency,” FDA Commissioner Marty Makary, MD, MPH, said in an agency press release (2). “By embracing radical transparency—one of the guiding principles of this administration—we’re giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust.”

One newly published CRL that attracted immediate attention was addressed to 

, for an 3,4-Methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of post-traumatic stress disorder (PTSD). The nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) commended FDA for its transparency, but dissented with the decision expressed in 

“Let’s be clear: the CRL reveals a devastating truth—FDA moved the goalposts,” 

, PhD, MAPS founder and president, said in a statement (3). “Thirteen million Americans live with PTSD today. Every year of delay means more will die by suicide and more remain trapped in cycles of trauma and despair. They deserve better ... Lykos will continue negotiations with FDA.”

Following FDA’s initial disclosure of transparency regarding CRLs, 

, for an experimental treatment (deramiocel) for cardiomyopathy associated with Duchenne muscular dystrophy, and 

, for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma (4).

“I wonder if part of the problem is that many biotechs do not have sufficient experience in-house, and rely on contract organizations,” 

, said at the time, speaking from his perspective as a consultant for various industry companies (4). “However, the contract staff may not be sufficiently familiar with the details of the project they are working on. Thus, things fall between the cracks, so to speak.”

What does this mean for drug discovery, development, and manufacturing?

This policy shift ostensibly gives developers, including those in discovery, preclinical, and clinical domains, much earlier access to FDA feedback on safety and effectiveness issues detailed in CRLs (2). Access to these real-time communications enables sponsors to detect recurring deficiencies and better align their study design and regulatory strategies with the agency’s expectations.

Also, CRLs often cite detailed chemistry, manufacturing, and controls (CMC) deficiencies. With immediate public access to these letters—albeit redacted for trade secrets and proprietary information—developers gain indirect insight into the most common CMC pitfalls flagged by FDA. This heightened awareness may allow for more proactive quality assurance and process control planning.

On the other hand, although FDA has committed to “prompt” publication and redaction of confidential information such as trade secrets and personal identifiers, precise timing as it relates to CRL issuance remains unspecified (2). Additionally, the policy currently covers human drug and biologic applications; direction on other application types has not been clarified.

FDA’s searchable database of CRLs can be accessed 

FDA Embraces Radical Transparency by Publishing Complete Response Letters. Press Release.

FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89.

MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-Assisted Therapy.

 Press Release. Sept. 4, 2025.
4. Cole, C. 

CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success.

The FDA has committed to publishing complete response letters (CRLs) promptly after issuance, enhancing transparency and providing insights into drug approval processes. This move aims to accelerate therapy development, offer context to investors, and restore public trust. The release of 89 previously unpublished CRLs has sparked varied responses from companies, with some expressing concerns over shifting regulatory expectations. The policy allows developers to access FDA feedback earlier, potentially improving study design and regulatory alignment. However, the timing of CRL publication and coverage of application types remain unspecified.

The agency says it will now publish complete response letters promptly, offering developers early insight into regulatory deficiencies to improve development planning.

FDA Initiates Real-Time CRL Publication: What It Means for Drug Developers

In this new PharmTech video feature, we highlight the week’s industry news in an easy-to-consume, fun format

PharmTech Weekly News Roundup - Week of September 1, 2025

In this new PharmTech video feature, we’ll highlight the week’s industry news in an easy-to-consume, fun format. New roundups will drop every Friday, so be sure to come back each week. And be sure to check the links below for more in-depth coverage of each story.

Cytokinetics' Aficamten, a cardiac myosin inhibitor, 

significantly outperformed metoprolol in a Phase III trial

 (MAPLE-HCM) for obstructive hypertrophic cardiomyopathy, demonstrating superior efficacy in improving exercise capacity, symptoms, and left ventricular outflow tract gradients.


The European Medicines Agency and the World Health Organization are 

celebrating a decade of successful collaboration

 aimed at enhancing global regulatory capacity and public health.


The University of Oxford and the Ellison Institute of Technology launched the 

Aficamten beat metoprolol for oHCM, EMA/WHO hit 10 yrs, Oxford and EIT collaborated on AI vaccine, Offit's FDA exit stirred policy, and Pistoia set agentic AI rule.

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