Christopher Cole

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.”

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*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.

Videos

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

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

Articles

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

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 

Correlates of Immunity—Artificial Intelligence program

, a £118 million (US$158 million) initiative focused on understanding immune responses and vaccine protection against antibiotic-resistant pathogens.


Concerns are rising in the US over the removal of key advisory figures, including 

Paul Offit, from FDA vaccine advisory committee

 under HHS Secretary Robert F. Kennedy Jr.


Finally, the Pistoia Alliance announced an 

 to establish standards and protocols for the safe and responsible adoption of "agentic AI" in the life sciences.

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.

PharmTech Weekly Roundup – Week of September 1, 2025

Silver Spring, MD, USA - June 25, 2022: Closeup of the FDA sign seen at its headquarters campus in Silver Spring, Maryland. FDA is a federal agency of the Department of Health and Human Services | Image Credit: © Tada Images - stock.adobe.com.

Major shifts in federal vaccine policy under Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. are reshaping the advisory landscape that underpins US vaccine approvals and immunization strategy (1). These developments could signal a more unpredictable regulatory environment with direct implications for vaccine development, manufacturing, and commercialization.

Paul Offit, pediatrician and co-inventor of the rotavirus vaccine, was recently removed from the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)—a panel central to evaluating vaccine safety and efficacy data for approval (1). Although Offit had previously agreed to a two-year term extension at the agency’s request, his position was abruptly terminated. HHS stated that approximately a dozen advisory members across eight FDA panels were removed after their service terms expired, but no clarity was provided on renewals.

Offit’s removal follows a series of high-profile exits driven by policy changes:

CDC Director Susan Monarez was dismissed last week after pressure from Kennedy (2).

Three senior CDC officials resigned in protest of Monarez being forced out, warning that systematic dismantling of scientific advisory structures jeopardizes evidence-based policymaking (3).

Vinay Prasad exited his position as head of the FDA

’s Center for Biologics Evaluation and Research amid tumult in biologics oversight, and then 

All 17 members of CDC’s Advisory Committee on Immunization Practices were fired

 in June, eliminating the independent body that sets national vaccination recommendations.

 in March, citing interference and misinformation.

For vaccine developers, these shifts raise several critical issues:

Regulatory Uncertainty: The removal of independent scientific advisors creates ambiguity around how future vaccine candidates will be assessed. Developers may face greater unpredictability in approval timelines, safety evaluations, and market authorization pathways.

Market Dynamics: Offit and others have argued that Kennedy’s approach could restrict vaccine availability and affordability (1). If this leads to reduced public uptake or changes in reimbursement structures, it could directly impact revenue models for manufacturers.

Erosion of Scientific Oversight: The sidelining of established experts could weaken confidence among investors, healthcare professionals, and international stakeholders in the rigor of the US vaccine regulatory system—a reputation that has historically underpinned global trust in pharmaceutical innovation.

Policy Misalignment: Offit’s willingness to critique certain broad immunization strategies (such as universal annual coronavirus vaccination) highlights that expert debate has been suppressed alongside anti-vaccine policymaking (1). Industry stakeholders may face a regulatory body less receptive to evidence-based nuance, which is typically critical for guiding clinical trial design and targeted rollout strategies.

Kennedy is set to appear before the Senate Finance Committee this week, where lawmakers are expected to question his vaccine policy decisions (1). The outcome may provide early signals on whether Congress could intervene or push back against the erosion of traditional scientific advisory mechanisms.

As the regulatory climate continues to shift, bio/pharma companies should prepare for greater political volatility in vaccine policy, with implications for development pipelines, regulatory strategy, and long-term commercial planning.

Offit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp

CDC Director Susan Monarez fired by Trump administration after refusing to resign, citing 'reckless directives'

CDC leaders fight back in wake of attack on agency, public health

Recent changes in federal vaccine policy under HHS Secretary Robert F. Kennedy Jr. are altering the advisory framework for US vaccine approvals and immunization strategies. The removal of key figures like Paul Offit from the FDA’s VRBPAC and other advisory bodies has led to concerns about regulatory uncertainty, market dynamics, and the erosion of scientific oversight. These shifts could impact vaccine development, manufacturing, and commercialization. As Kennedy faces scrutiny from the Senate Finance Committee, the bio/pharma industry must brace for increased political volatility in vaccine policy.

Paul Offit removed from FDA vaccine panel as RFK Jr. reshapes US immunization policy, raising concerns for bio/pharma and regulation.

Pharma Implications of Paul Offit’s Removal from Vaccine Advisory Committee

Cereno's PAH drug got FDA Fast Track. Novo plant cited for contamination. Gilead's HIV PrEP approved in EU. Nelson Labs expanded testing.

PharmTech Weekly Roundup – Week of August 24, 2025

In this first installment of a new PharmTech 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.

Our news stories from this week collectively discuss significant developments in the pharmaceutical industry, highlighting both advancements in drug therapies and critical manufacturing challenges. We detail Cereno Scientific's 

PAH treatment receiving FDA fast-track status

 due to promising trial results, indicating accelerated development for a much-needed therapy. We also report that Gilead Sciences' 

HIV PrEP injectable gained European Commission approval

, offering a novel, less frequent dosing option for HIV prevention. In contrast to these positive strides, we revealed this week that an FDA inspection uncovered 

serious contamination and safety issues at a Novo Nordisk plant

, raising concerns about quality control in drug manufacturing. Finally, we highlighted 

Nelson Labs' expansion of its German and US facilities

, signifying a growing demand for enhanced laboratory and sterility assurance services within the pharmaceutical sector.

Digital Transformation in Pharma Manufacturing: Industry Perspectives Survey

The bio/pharmaceutical manufacturing and development industry is at a critical turning point (1-8). As new modalities move toward commercialization, traditional manufacturing approaches are under intense pressure (5,7-12). At the same time, such technologies as automation, advanced analytics, digital twins, and artificial intelligence are rapidly evolving and promising to transform how medicines are developed, produced, and delivered.

Yet adoption has been uneven. While some organizations are piloting cutting-edge digital tools across their operations, others are still navigating legacy systems, limited resources, or regulatory uncertainty (2-6,10,11,13-18). And even for those further along in the journey, questions remain about integration, workforce readiness, cost, and ultimately, the measurable impact on efficiency, quality, and speed to market (1,2,7,9-12,19-23).

That’s why we’re focusing this survey on digital transformation and technology adoption. We want to understand where the industry truly stands today, what barriers professionals are facing, and what opportunities are most within reach. Your perspective—whether from development, manufacturing, quality, engineering, or regulatory—will help build a clearer picture of the challenges and successes shaping digital change.

By sharing your experiences, you’ll help highlight what’s working, where support is needed, and how the industry can collectively move forward. The insights gathered will inform a broader discussion within the community and provide valuable benchmarks for organizations navigating their own transformation.

Your voice is essential to capturing this moment in the industry’s evolution. We appreciate your time and perspective, and we look forward to sharing the results with you and your peers.

The Importance for CDMOs of Partnering With a Sponsor’s Mindset

How Rare Diseases Shape Drug Manufacturing and Development Innovation (Part 1

MHRA Approves Sanofi’s Teplizumab to Delay Onset of Stage III T1D

Biopharma Development Hurdles: Lessons from Vedanta’s Live Bacteria Cocktail Failure

Sustainability Becomes Essential: Green Manufacturing and Supply Chain Resilience in Bio/Pharma

FDA Approves Precigen’s Immunotherapy to Treat Recurrent Respiratory Papillomatosis

Onshoring’s Unexpected Benefits: Quality, Efficiency, and Supply Chain Resilience

EMA Grants Orphan Designation to Rilzabrutinib for IgG4-Related Disease

ElevateBio BaseCamp Achieves First Multi-Modality ICMC Certification in Commercial CGT Manufacturing

ProBio Launches End-to-End AAV Production at NJ Manufacturing Site

Strand’s Programmable mRNA Pipeline Advances on $153 Million in New Funding

After mRNA Rollback, BARDA Pulls Plug on Vaxart Oral COVID Vaccine Trial

Merck and Daiichi Sankyo’s I-DXd Earns FDA Breakthrough Therapy Status in Small Cell Lung

FDA Grants Breakthrough Therapy Designation to Bispecific ADC for EGFR-Mutant Lung Cancer

FDA Releases Guidance on Oncology Therapeutic Radiopharmaceuticals

Telstar to Showcase Integrated GMP Services at Farmaforum

The Impact of Reclassifying 7-OH Products

Kratom and the Impact of 7-OH Reclassification

FDA Commissioner Applauds Florida Restriction on 7-OH Opioids

Lilly Statement: MFN Pricing Targeted for September 1, Pushback on Pharma Tariffs

Intellectual Property as a Core Strategy in Drug Formulation and Development

Iterum's UTI Drug Launches as First Commercial Oral Penem Antibiotic in US

Bio/Pharma's Tariff Response: Key Insights from Industry Survey Results

The bio/pharmaceutical manufacturing and development industry is undergoing a significant transformation as new modalities approach commercialization, challenging traditional manufacturing methods. Emerging technologies like automation, advanced analytics, digital twins, and AI are poised to revolutionize drug development, production, and delivery. However, adoption varies across organizations, with some embracing digital tools while others face challenges with legacy systems and regulatory uncertainties. A survey aims to capture industry perspectives on digital transformation, identifying barriers and opportunities to inform broader discussions and provide benchmarks for organizations navigating this evolution.

At a critical turning point in the adoption of digital tools across the bio/pharma industry, we want to hear from industry professionals on where things actually stand.