Pharmaceutical Technology Is Now PharmTech: A Sharper Name for a Smarter Industry

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

Ask the Expert

Outsourcing Partnerships Fuel Global Biopharma Discovery and Scale-Up

Drug Digest February 2026 

How It Helps Avoid Facility and Equipment Problems

A “Plan, Prevent, Prove” Approach

QC Microbiology Application Specialist, MilliporeSigma

Member of the PDA Week 2026 planning committee

Michelle Dennis at MilliporeSigma explores how biofluorescent particle counting and RFID traceability are transforming real-time environmental monitoring.

Emerging QC Technologies Reshaping Pharmaceutical Manufacturing

Michelle Dennis, QC Microbiology Application Specialist with MilliporeSigma and member of the PDA Week 2026 planning committee, sat down with 

 to discuss two cutting-edge technologies shaping the future of pharmaceutical quality control: biofluorescent particle counting and RFID-enabled traceability.

On the environmental monitoring side, Dennis highlights the transformative potential of biofluorescent particle counting as an alternative to traditional methods, adding, "Biofluorescent particle counting differs from traditional environmental monitoring techniques in that it's real-time. So instead of having to grow up the plate, wait several days, see if anything grows, you're getting real-time data, so you can take action immediately, and potentially save a batch from later failure." Beyond speed, the technology offers added efficiency by capturing both viable and non-viable particulates from passive and active air samples simultaneously, eliminating the need for two separate tests.

Regarding FDA acceptance of biofluorescent particle counters, Dennis notes that conversations with the agency have been encouraging. "It sounds like they've had the chance to interact with the FDA, and it really comes down to your validation plan, but overall, the FDA does seem to be accepting this technology," she says. Wider adoption is expected to follow.

Dennis also speaks to the promise of RFID-enabled traceability in GMP environments, particularly its impact on documentation efficiency. She is especially struck by data presented by speaker Adithya Balasubramanian, which showed that RFID labeling reduced operator documentation time by as much as 60% in some cases. She acknowledges that successful implementation will require thoughtful training around defect classification and proper use of scanning technology, but expressed confidence that teams can adapt with the right preparation.

Videos

PharmTech Weekly Roundup-March 27, 2026

Merck’s multi-billion-dollar acquisition of Terns Pharmaceuticals 

reinforces the industry’s focus on allosteric inhibition as a primary strategy to overcome drug resistance in oncology.The deal centers on TERN-701, an investigational oral drug candidate.

neurologic symptoms via surrogate endpoint, signaling evolving rare disease development standards, demonstrating a growing regulatory flexibility toward using biochemical surrogate endpoints to fast-track treatments for ultra-rare diseases.

In conference news, PDA Week saw discussions on a variety of topics. Malav Parikh, director, Quality Risk Management, Global Quality Compliance and Systems, Takeda moderated a session on 

the adoption of digital simulations for transport validation

 and 2D barcodes with digital footprints to combat increasingly sophisticated global counterfeiting. Ryan Murray of ValSource spoke about the 

use of a holistic contamination control strategy,

 supported by innovative far-UVC technology and robust environmental monitoring, for maintaining a consistent state of compliant control was also featured. Richard Jaenisch and David Jaenisch highlighted how 

 are enabling adaptive, competency-focused workforce training that ensures no learner falls behind during intensive technical workshops; and a 

Human-AI Training Parallelization framework

 provides a transparent method for integrating generative AI into existing workflows while strictly protecting sensitive intellectual property. Check out 

 to watch interviews with some of the PDA Week session speakers.

, manufacturers announced commitments to expanding domestic finished-dose capacity and specialized technologies like high-potency spray drying to mitigate global supply chain risks. 

are building end-to-end manufacturing chains for antibody-drug conjugates while pioneering sustainable, methanol-free fermentation processes at an industrial scale.

New content on PharmTech.com this week included a 

look at advancements in ensuring drug product quality.

 Quality was a key topic this week with the latest episode of 

discussing how preventing high-level recalls requires a proactive quality unit that regularly walks the shop floor to identify systemic vulnerabilities and human errors before they reach the patient. Columnist Cheryl Barton also took a look at 

how Europe is implementing its most significant pharmaceutical legislation

 in two decades, introducing joint clinical assessments to harmonize evaluations and expedite patient access.

USP’s Tony Lakavage provided his thoughts on 

 and gave insight on how the US Pharmacopeia is utilizing its 

to identify geographic concentration risks and advocate for the adoption of advanced manufacturing technologies.

Partha Anbil, a cognitive enterprise transformation leader with IBM’s Healthcare and Life Sciences practice, 

 have become essential for balancing the massive computational power of the public cloud with the private infrastructure required for GxP compliance and IP security.

And Denis Beckford Vera, head of Radiopharmacology, Champion Oncology, explained how 

requires bridging the preclinical-clinical gap by utilizing patient-derived xenograft models to provide more accurate clinical predictions.

Whether through the integration of Pharma 5.0 automation or the onshoring of critical ingredients, the goal remains the same: ensuring a resilient supply of high-quality medicines. Staying informed on these integrated strategies is no longer optional—it is a requirement for modern pharmaceutical leadership.

 to watch this week’s interviews and read the latest news and technical articles.

This week, three core themes have emerged: the digital transformation of quality systems through AI and hybrid cloud architectures; the pursuit of supply chain resilience via onshoring and advanced mapping; and a regulatory push toward real-time data and flexible approval pathways. 

EU Approved J&J's Self-Administered Daratumumab | Created with Canva

The Committee for Medicinal Products for Human Use of the European Medicines Agency to 

 This regulatory update enables the subcutaneous formulation of this CD38-directed antibody to be administered by patients or their caregivers starting from the fifth dose. The adoption of daratumumab represents a major achievement in the application of delivery technologies, specifically the co-formulation of daratumumab with recombinant human hyaluronidase PH20, which utilizes Halozyme’s ENHANZE drug delivery technology. As the first anti-cancer injectable approved for self-administration in Europe, this development highlights a successful transition from clinic-based infusion to a more flexible subcutaneous model that maintains established safety and efficacy.

The technical success of this therapy is rooted in its ability to target CD38, a surface protein prevalent on multiple myeloma cells.

 By binding to this protein, the therapy inhibits tumor growth and induces cell death, a mechanism that has now been applied across ten distinct therapeutic indications, including light chain amyloidosis and various stages of multiple myeloma.

Ester in ‘t Groen, EMEA therapeutic area head Hematology, Johnson & Johnson, noted in a press release,

 “Daratumumab has played a transformative role in the treatment of multiple myeloma and has become a foundational therapy across the disease continuum since its first approval nearly a decade ago. Today we are proud to continue innovating with daratumumab, and this label update marks the first European approval of an anti-cancer injectable for self-administration.”

What Are the Clinical and Systemic Implications?

The shift toward self-administration addresses significant logistical bottlenecks in healthcare systems.

 By decentralizing the administration process, the pharmaceutical industry can help alleviate the pressure on hospital infrastructure while accommodating the evolving needs of the patient population.

This pivot toward patient-centric delivery is supported by clinical data from ten Phase III trials demonstrating significant improvements in survival outcomes for both newly diagnosed and relapsed patients.

 The move to home-based care is a direct response to the practical challenges faced by those undergoing long-term treatment.

Yusri Elsayed, MD, MHSc, PhD, global therapeutic area head of Oncology, Johnson & Johnson, explained in the press release,

 “For more than 20 years, Johnson & Johnson has been dedicated to advancing care for people living with multiple myeloma. Despite advances in treatment, patients continue to face significant challenges, and we remain focused on supporting the community through ongoing research, innovation and collaboration with healthcare professionals. Inspired by early real-world experiences, today’s milestone reflects our dedication to not only push the boundaries of science, but also to help ensure patients have access to treatment options that meet their evolving needs.”

From a development perspective, the partnership between Janssen Biotech and Genmab A/S to commercialize this therapy has resulted in its use by over 748,000 patients globally, underscoring the scale required for foundational oncology treatments.

 The ability to offer administration flexibility is a critical differentiator in a crowded therapeutic market.

Thomas Lund, MD, PhD, head of Hematological Section, Vejle Hospital, said in the press release,

 “For many patients living with multiple myeloma, treatment can involve frequent hospital visits and the challenge of fitting care around everyday life. The possibility for self-administration of daratumumab subcutaneous represents meaningful progress for those who would prefer the opportunity for greater flexibility in how or where they receive their care. For the medical community, it reduces pressure on healthcare systems and provides healthcare professionals with more choice in how they tailor treatment to individual needs and preferences, while maintaining the well-established safety profile and efficacy of daratumumab.”

How Is Targeted Drug Delivery Evolving Beyond Systemic Administration?

The industry’s focus on localized, patient-centric delivery is further exemplified by an investigational intravesical drug-releasing system for bladder cancer.

This system, Erda-iDRS, provides prolonged release of erdafitinib directly into the bladder, reducing systemic exposure. Phase I results showed an 89% complete response rate in cases with FGFR alterations.

Antoni Vilaseca Cabo MD, adjunct physician of Urology Service, Hospital Clínic de Barcelona, noted in a press release,

 “In this study, treatment with Erda-iDRS led most patients with FGFR-altered disease to achieve a complete response by the end of the second treatment cycle, and many of those responses were sustained over time. Achieving and maintaining a complete response is particularly meaningful in this setting, where recurrence is common and requires repeated surgical intervention”. This Johnson & Johnson initiative marks a significant shift toward precision-based, biology-driven care.

Johnson & Johnson. Johnson & Johnson’s DARZALEX (daratumumab) becomes the first oncology injectable approved for administration by patients or caregivers. Beerse (Belgium): Johnson & Johnson; 2026 Mar 27. Press release.

Johnson & Johnson. Johnson & Johnson highlights promising first-in-human Erda-iDRS (formerly TAR-210) results in intermediate-risk non–muscle-invasive bladder cancer. Raritan (NJ): Johnson & Johnson; 2026 Mar 13. Press release. 

https://www.jnj.com/media-center/press-releases/johnson-johnson-highlights-promising-first-in-human-erda-idrs-formerly-tar-210-results-in-intermediate-risk-non-muscle-invasive-bladder-cancer

Articles

EMA approved Johnson & Johnson’s daratumumab SC for self-administration, Europe’s first oncology injectable to offer this treatment flexibility.

Implications of EU Approval for J&J's Self-Administered Daratumumab

Tony Lakavage, executive vice president and head of Global External Affairs at the US Pharmacopeia (USP)

 to discuss the major regulatory, economic, and environmental trends disrupting the pharmaceutical industry. As well as what USP is doing to help the sector adapt.

The Pharmaceutical Industry Is Dealing with Many Disruptions. What Are the Biggest Forces Driving That?

Lakavage: There have been several major trends hitting the industry simultaneously. On the pricing side, we've seen the Inflation Reduction Act (IRA) kick in with mandatory price negotiations for high-cost medicines, and that list of selected drugs continues to grow. On top of that, there's the Most Favored Nation (MFN) initiative, through which several large innovator companies have been negotiating medicine prices for federal programs with the administration. Together, these create significant pressure on R&D budgets, investment decisions, and manufacturing. The industry really has never seen this level of pricing disruption all at once.

Are those pricing trends expected to ease, or is this the new normal?

They're built in at this point. IRA will continue expanding, and MFN is set to add new mandatory programs through the Centers for Medicare and Medicaid Innovation. Right now MFN has been voluntary, but that's reportedly changing. So these pressures are going to be with us. The downstream effects will eventually reach the generics industry too, not just innovators, though the timeline there is longer.

At the same time, the administration is pushing companies to manufacture more in the United States. How does that fit with the pricing pressure?

That's exactly the tension. There's a clear imperative from the administration to invest more in US manufacturing and R&D, and we have seen meaningful commitments. This has come mostly from innovators, but some from generics companies as well. The problem is that production is less expensive in most other countries, and the economics for the generics industry don't support the level of investment needed. Generic medicines are often priced below the cost of production. That's a fundamental challenge that needs more attention, because you can't build a resilient domestic supply chain if the economic model for generics is broken.

Supply chain resilience has become a national security conversation. How serious is the vulnerability?

For years, supply chain fragility has been tied to ongoing drug shortages, the system hasn't been able to absorb a wide range of disruptions. But now there's a growing concern that the medicine supply chain could essentially be weaponized through trade. The concentration of key starting materials in China in particular represents a real vulnerability, both for national security and patient care.

We created the USP Resiliency Center specifically to tackle this. A flagship program is the USP Medicine Supply Map, which now charts the full upstream supply chain for every approved U.S. medicine — where the finished dose is made, where the API comes from, and where key starting materials originate. For the first time, we can actually see where the vulnerabilities are for each medicine. That's significant because supply chain resilience was for so long considered too complex to attack, we simply didn't understand it. Now we do. From there, the levers include advanced manufacturing technology, nearshoring to allied countries, and longer-term onshoring. Each plays a role.

In terms of sustainability. Is that mostly about reducing environmental footprint?

It's broader than that. Yes, reducing the environmental footprint of pharma manufacturing is central. However, sustainability is also about efficiency, resource conservation, and cost savings. In quality testing alone, more efficient methods use fewer natural resources and save industry money. What we're seeing with Pharma 5.0 is the integration of digital systems that do real-time quality monitoring while simultaneously reducing unnecessary resource consumption. Within facilities, companies are minimizing waste and transitioning to more environmentally friendly solvents.

What role do USP standards play in that effort?

A larger role than most people realize. USP standards are used in roughly 22,000 manufacturing facilities worldwide that supply medicines to the U.S. and to 140 countries globally. When we update our standards to reflect modern, more sustainable technologies, the impact is enormous. USP's membership recently passed a resolution making this a key objective for the next 5 years: integrating modern technologies into our standards to reduce the industry's overall environmental footprint. That includes eliminating animal testing, reducing reliance on toxic chemicals, and finding greener alternatives at every step.

Pharmaceutical manufacturers are confronting unprecedented, concurrent pricing disruption from IRA negotiations and an expanding MFN framework, with downstream implications expected to reach generics over time. This is colliding with policy pressure to reshore production and R&D, despite structurally thin or negative margins in generics that undermine domestic capacity building. Supply-chain fragility is increasingly viewed through a national-security lens given geographic concentration of key starting materials, particularly in China. USP is responding with supply mapping and standards modernization to enable resilience and sustainability.

Tony Lakavage, USP, outlines pharma disruptions, pricing shifts, supply chain risks. As well as greening standards to build a resilient supply chain.

How USP Is Navigating Global Disruptions and Building a Better Future for the Industry

FDA Approves First Agent for Hunter Syndrome | Created with Canva

The FDA has approved Denali's tividenofusp alfa-eknm (Avlayah) to treat neurologic manifestations of Hunter syndrome, a rare X-linked lysosomal storage disorder affecting approximately 500 people in the United States.

 The approval marks the first time a product has cleared regulatory review specifically for the neurologic dimension of the disease, a distinction with meaningful implications for how rare disease programs are designed, evaluated, and brought to market.

Hunter syndrome results from the accumulation of glycosaminoglycans within cellular lysosomes, disrupting physical and mental development by causing progressive abnormalities across the skeleton, heart, respiratory system, brain, and other organs.

 Avlayah is administered as a once-weekly intravenous infusion. The approved indication covers pediatric patients weighing at least 5 kg, when treatment is initiated prior to advanced neurologic impairment, in either a presymptomatic or symptomatic state.

What Does the Approval Pathway Tell Us About Evolving Regulatory Standards?

The agency granted accelerated approval based on a surrogate endpoint rather than direct clinical outcomes data.

 Specifically, reduction of heparan sulfate in cerebrospinal fluid served as the basis for approval, with the review team determining this measure was reasonably likely to predict clinical benefit. Heparan sulfate is among the glycosaminoglycans that accumulate in the disorder and is linked to organ damage occurring in early childhood.

CDER Director Tracy Beth Hoeg, MD, PhD, stated, in a press release,

 "This accelerated approval was based on a surrogate endpoint: reduction of cerebrospinal fluid heparan sulfate, which the review team determined was reasonably likely to predict Avlayah's clinical benefit. Heparan sulfate is one of the glycosaminoglycans that accumulates in the body in this disorder and is linked to the organ damage that occurs in early childhood."

The sponsor submitted results from a phase I/II multi-cohort, single-arm, open-label trial enrolling 47 pediatric patients aged 3 months to 13 years.

 Among the 44 patients with measurements at week 24, the average reduction from baseline in cerebrospinal fluid heparan sulfate was 91%, with individual results ranging from 72% to 98%. At baseline, no patients had levels below the established upper limit of normal; by week 24, 93% of patients with available measurements had fallen below that threshold.

The study design, open-label, single-arm, with a biochemical surrogate as the primary endpoint, reflects the practical constraints of developing therapies for conditions with very small patient populations.

 This is territory familiar to rare disease teams, where conventional randomized controlled trial structures are often ethically or operationally impractical in the presymptomatic population.

FDA Commissioner Marty Makary, MD, MPH, said, in the press release,

"The FDA is capable of doing two things: one, exercising regulatory flexibility; and two, complying with our obligation under the law to approve drugs based on 'substantial evidence' of effectiveness. We will continue to do everything we can to accelerate treatments for rare diseases."

What Comes Next for Post-Market Confirmation?

Accelerated approval carries with it the obligation to confirm clinical benefit through post-market study.

 A randomized clinical trial to evaluate Avlayah's clinical benefit is currently underway and reported to be more than 95% enrolled. The transition from accelerated to full approval will depend on that trial's outcome, making robust process consistency and supply reliability during the post-market period operationally significant.

 "Families with young children with Hunter syndrome will have access to a product that may favorably alter the course of the disease at the crucial time in life when there is the greatest potential for benefit."

From a safety and pharmacovigilance standpoint, the labeling carries a boxed warning for allergic reactions, including anaphylaxis, requiring that therapy be initiated in a healthcare setting with appropriate monitoring.

 The adverse event profile identified in the trial includes upper respiratory tract infection, ear infection, fever, anemia, cough, vomiting, diarrhea, rash, COVID-19, runny nose, nasal congestion, fall, headache, skin abrasion, and hives. Two safety signals warrant ongoing monitoring protocols: anemia, with hemoglobin assessments required at baseline, three months post-initiation, and periodically thereafter; and membranous nephropathy, with kidney function and urine protein monitoring indicated throughout treatment.

The program received breakthrough, fast track, priority review, and orphan drug designations.

The approval reinforces that the surrogate-to-clinical-endpoint pathway, when properly constructed and transparently communicated, continues to be a viable route to market for conditions which waiting for long-term outcomes data is not a defensible option.

How Does the FDA's Priority Voucher Program Intersect with Rare Disease Development?

The Avlayah approval arrives at a moment of broader regulatory recalibration.

 The FDA's Commissioner's National Priority Voucher pilot program, introduced an ultra-fast review pathway for drugs and biological products of strategic national importance, including Aylayah. Since its launch, the agency has awarded vouchers for 18 products and granted four approvals, including two oncology drugs reviewed in 44 and 55 days after filing. A public hearing on program implementation is scheduled for June 12, with written comments accepted through June 27.

US Food and Drug Administration. FDA approves drug to treat neurologic manifestations of Hunter syndrome. Silver Spring (MD): US Food and Drug Administration; 2026 Mar 25 [cited 2026 Mar 26]. Available from: 

https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-neurologic-manifestations-hunter-syndrome

​ US Food and Drug Administration. FDA schedules public meeting on the Commissioner’s National Priority Voucher Pilot Program. Silver Spring (MD): US Food and Drug Administration; 2026 Mar 20 [cited 2026 Mar 26]. Available from: 

https://www.fda.gov/news-events/press-announcements/fda-schedules-public-meeting-commissioners-national-priority-voucher-pilot-program

The FDA approved Denali’s tividenofusp alfa-eknm (Avlayah) for neurologic manifestations of Hunter syndrome, the first clearance targeting CNS disease in this X-linked lysosomal storage disorder. Indication includes pediatric patients ≥5 kg treated before advanced neurologic impairment, including presymptomatic use. Accelerated approval relied on CSF heparan sulfate reduction as a surrogate endpoint, supported by a phase I/II single-arm study showing marked biomarker declines by week 24. Confirmation of clinical benefit now hinges on an ongoing randomized trial, alongside mandated safety monitoring.

FDA approves first therapy for Hunter syndrome's neurologic symptoms via surrogate endpoint, signaling evolving rare disease development standards.

Denali's Avlayah Approved as First Agent for Hunter Syndrome Neurologic Symptoms

Senior Director
Education, Outreach, and Digital Experience
Open Biopharma Research and Training Institute

Director 
Technology
Prompting Integration Consulting, LLC (PICLLC)

Richard Jaenisch explains how digitally interactive SOPs and Human-AI Training Parallelization help build, measure, and continuously improve AI-era workforce skills.

Digitally Interactive Training for the AI Era

 session exploring how to integrate generative AI into biomanufacturing without sidelining human expertise. Richard Jaenisch, senior director of Education, Outreach, and Digital Experience at Open Biopharma Research and Training Institute, and David Jaenisch, director of Technology at Prompting Integration Consulting, LLC (PICLLC), discuss the Human-AI Training Parallelization: Learning (HATPL) system and its real-world impact on workforce development.

They describe how digitally interactive SOPs (DISOPs) support HATPL, turning procedures into adaptive, competency-focused training modules and assessments. At Open Biopharma, DISOPs are made available to all training courses and also deployed internally to track competency assessment pass rates over time. Because the system asks one question at a time and adjusts difficulty based on each learner’s answers and validation content, instructors gain a kind of “Rosetta Stone” view of how skills develop across sections and sessions.

In their pilot on AI literacy, staff already showed strong baseline competence after several years of human–AI training, but regular DISOP-based assessments plus small, project-centered trainings revealed measurable growth and clearer risk mitigation. The parallel use of DISOPs and hands-on projects creates a traceable record of individual capabilities, helping leaders align people to the right initiatives and identify where targeted upskilling is needed.

The interview also highlights how near-real-time insight prevents learners from falling behind in intensive workshops. If a participant’s competency scores start to lag, instructors can immediately adjust curriculum and support so that no one is “done” on day one of a two-week program. Ultimately, Richard Jaenisch argues that structured, adaptive tools like DISOPs are essential for making generative AI a force-multiplier for people and processes, rather than a replacement for human expertise.

Be on the lookout for Part 3 of this interview and check out Part 1: 

Human-AI Training Parallelization: Empowering Life Sciences Without Replacing Expertise

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.




My name is Richard Jaenisch. I am the senior director of Education, Outreach, and Digital Experience at Open BioPharma Research and Training Institute in Carlsbad, California.

I am David Jaenisch. I am the director of technology at Prompting Integration and

How we deploy DISOPs at OpenBiopharma is two different ways. One way is we provide it to any training course that happens at OpenBiopharma. So anyone hosting their own course, developing a training with us, co-developing a training, whatever they're doing, we will have it on-site at OpenBiopharma, and we will give them the opportunity to take that curriculum, upload it into DISOPs, and run that competency assessment.

So that data doesn't really give us a lot of the ongoing data which we like to see, unless those individuals continue on with that trend or do multiple trainings with us and we can see the growth over time. We deployed this tool in October of last year. So you would imagine that we haven't had a lot of consistent, specific trainings from multiple groups during that time period to be able to read on that.

However, we also deploy it internally. And so internally, what we found is... we really look at the competency assessment pass rates, and we say, "Okay, how are people doing with these things?" And we have noted that over time we do see a lot more progress on them, and I think that that's twofold. One is you're getting used to the structure because the system is more familiar.

But because the system really only asks one question at a time, and because it is adaptive difficulty, changing the flow according to what you are doing, and how you are answering and how your answer matches with things in the validation material and the validation questions, then, you know, the pass rates really kind of can change from section to section. And so we have a kind of Rosetta Stone, if you will, that allows us to see and assess how those competency assessments trend over time.

And generally speaking, we have found that a lot of our folks are learning a lot more because the first tool we deployed this with was our AI literacy campaigns because it made the most sense, and because I had a lot of the material right and ready to go, and that's how we did our pilot with it, and it worked out very well. We found that not only did most of our staff already have, probably because we've been deploying human AI training parallelization for three years now, but, we found that they already had a good level of competency ahead of time.

But the benefit of deploying DISOPs with regular intervals and also interjecting occasional small, very practical trainings, that are really based around their projects, really meant that the combination of these two, having that hands-on project and having this be the certification that kind of is that traceable record that allows us to understand it, really sees that parallel track so that we can understand their growth, have risk mitigation because we understand where their skills are and where their competencies are. It's very helpful for us in terms of not only figuring out who aligns with what projects, but also who may be needing more certain skills.

There are certain skills that maybe there's a deficiency, maybe we're in the middle of a workshop, and we're deploying this, and we find that there's an individual who's kind of starting to lag behind. But the benefit is then we can then change our curriculum to make sure that they don't fall behind. Because being able to have them know that early means that we don't have to worry about that. In a two-week workshop, if you fall behind on the first day, you're done, man. That's going to be really difficult. So when we deploy it in that situation, we see that very quickly that the individuals benefit because we don't see them lag in that competency assessment in the future days ahead.

Ryan Murray, ValSource, breaks down far UVC technology, holistic contamination control strategies, and environmental monitoring in pharma manufacturing.

Contamination Control Strategies in Pharmaceutical Manufacturing Explained

Ryan Murray, senior consultant, ValSource, discussed key themes from the presentation he moderated at PDA Week 2026 in Denver, which is taking place from March 22-27. The presentation, titled Innovative Contamination Control: Far-UVC Technology and Risk-Based Approaches, featured topics including far UVC technology, holistic contamination control strategies, and the critical role of environmental monitoring.

Murray addressed audience questions about far UVC technology, which is increasingly being adopted in pharmaceutical manufacturing and healthcare settings for continuous decontamination. A common concern with any form of continuous radiation exposure is material degradation, but Murray offered reassurance on that front. He explained, "With continuous decontamination at 222 nanometers, there is some degradation concerns, but those concerns happen far beyond the life cycle of any fixed piece of equipment or product contact surface or anything else that would be a legitimate concern for a pharmaceutical manufacturing operation."

Murray highlighted the contributions to the presentation by Takeda, whose contamination control approach aligned closely with Parenteral Drug Association's 

, a framework built around a holistic strategy. Takeda examined every potential contamination source across their process, from material and people movement to cleaning procedures and environmental monitoring. Murray emphasized that this comprehensive approach is essential, "you can't really attack just some of them. It's a holistic approach."

When it comes to prioritization, Murray recommends identifying the most likely contamination sources with the highest probability of being realized, then working systematically through each category. Underpinning all of this is a robust environmental monitoring program, tracking microbial trends in critical and adjacent areas to evaluate whether existing controls are working. Regular data review and effectiveness checks ensure operations remain both in control and in compliance.

My name is Ryan Murray. I am a senior consultant with ValSource. I consult in the areas of contamination control, aseptic processing, particularly around the processing elements in that. So, I focus largely on technology transfer and commercialization strategies, so PPQ, process performance qualification, and all areas in and around that. I've worked in the pharmaceutical industry for a little over 15 years now. Basically, what's described in the Far UV space for continuous decontamination is 222 nanometers is what's, defined and what's been adopted in some pharmaceutical manufacturing spaces, but as well in healthcare system. So there was a question from the audience that brought that up specifically about material concerns. So continuous exposure to any type of radiation, whether that be gamma radiation or UV light, causes some potential for material degradation. And so, basically what he presented was that with continuous decontamination at 222 nanometers, there is some degradation concerns, but those concerns happen far beyond the life cycle of any fixed piece of equipment or, product contact surface or anything else that would be a legitimate concern for a pharmaceutical manufacturing operation. So there's really no concern with degradation in materials because of this technology. What Takeda presented was their approach that pretty much closely followed the guidance that's in, Technical Report 90 from PDA, which is the holistic approach to contamination control strategy. So what they did was identify all the different areas for a given process that could have an impact on the contamination control strategy, whether that be material, people movement, just movements throughout the facility, their environmental monitoring program, their cleaning aspects. And from that perspective, they took each of those categories, broke it down even further to look at what are the different factors that need to be considered to identify potential risk for contamination in each of those segments. And from there, you can't really attack just some of them. It's a holistic approach. So, as far as prioritization I think you go about it by identifying which are the most likely sources of things with the highest, likelihood of that hazard being realized, and approach it that way. And then at the end, you've covered all your bases from each of those different areas we discussed. So, with any contamination control strategy, one of the biggest aspects of ensuring that you're maintaining control of your environment, is, is how you're detecting it. So what are you measuring to ensure that you're in a state of control? And so much like with Takeda, one of the easiest ways to do that is through a robust environmental monitoring program. So based on the areas, that you identified hazards to be, the most critical areas for monitoring looking at that particular area as well as adjacent areas for microbial trends. That may be showing you where your particular control that you have in place for a specific risk that you identified is either working or not working. So from there, that kind of review cycle of looking at trending, reevaluating your data, and then going back to the effectiveness check, aspect of that particular control to see if it's remaining in control and if you're staying within a compliant state.

Cheryl Barton is director of PharmaVision, 

On 11 December 2025, the European Parliament and the Council of the European Union (EU) reached a political agreement on reforming the EU’s pharmaceutical legislation.

 This is the most significant overhaul of the regulatory framework in more than 2 decades and will help Europe modernize the development and authorization of medicines across the EU.

What Is the New Pharmaceutical Legislation?

The new pharmaceutical legislation replaces the existing legislation for human medicines (Regulation [EC] No 726/2004 and Directive 2001/83/EC), including those for children and rare diseases (Regulation [EC] No 1901/2006; Regulation [EC] No 141/2000).

 In addition, the new legislation introduces a series of targeted amendments to the advanced therapy medicinal products (ATMP) regulation (Regulation [EC] No 1394/2007), the clinical trials regulation (Regulation [EU] No 536/2014), and the European Medicines Agency’s (EMA’s) extended mandate regulation (Regulation [EU] 2022/123).

The new pharmaceutical legislation is designed to, as follows:

•address major public health challenges, including antimicrobial resistance

•adapt the EU regulatory framework to support digitalization and foster innovation

EMA will provide regular updates throughout 2026 on the changes introduced. The new legislation will focus on several areas to support innovation and reduce procedural complexities and administrative burdens, particularly in paediatric and rare disease medicines. It will review medicine shortages and the environmental sustainability of medicines and amend the structure of the EMA scientific committees to improve efficiency and the evaluation of medicines.

The new pharmaceutical legislation will enter into force in 2026, with the following 2 years serving as a transition period to allow EU Member States to align their national laws with the new rules. The European Commission (EC), EMA, and EU Member States will provide implementation guidance to stakeholders in 2026 (

Figure 1. Implementation timeline for new pharmaceutical legislation. (Figure courtesy of the author)

On 12 January 2025, the EU Health Technology Assessment (HTA) regulation came into effect for oncology and ATMPs, with all new medicinal products to be incorporated from 2030 onward.9 The regulation ensures a scientifically based, evidence-driven, multidisciplinary approach to evaluating the relative effectiveness and additional benefit of health technologies compared with existing alternatives. The main objectives are to:

•harmonize clinical assessment methodologies across the EU

•reduce duplication of national assessments

•expedite patient access to innovative therapies

•support sustainable health care systems by providing robust evidence for decision-making.

This marks a major shift in the assessment of health technologies, with clinical evaluations now conducted at the EU level through the joint clinical assessment, which will run in parallel with the EMA process. The EU HTA regulation aims to expedite patient access, reduce duplication of effort across Member States, and harmonize the methodologies used for clinical evaluation.

In October 2025, Regulation (EU) 2025/2086 came into force, significantly affecting the healthcare sector in the EU. It further streamlines the HTA process for medical and in vitro diagnostic devices and is expected to enhance the efficiency and consistency of HTAs. It will benefit patients and health care providers by providing clearer, more reliable information on the effectiveness and safety of new health technologies. 

How Is the UK Aligning Marketing Authorization and HTA Recommendations?

As of April 2026, the pharmaceutical industry will be able to use the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence to obtain UK marketing authorization and HTA recommendations in parallel.

 The joint scientific advice service will provide companies with greater clarity on evidence requirements and more predictable timelines, thereby avoiding unnecessary delays. It should help reduce the time to patient access by 3 to 6 months.

The aligned pathway will be optional for companies with eligible drugs. If preferred, companies can request a later submission date and use the traditional sequential approach. This flexibility may be appealing where global development programmes or regulatory timelines do not align with the earlier submission requirements.

What Are the Implications for European Pharma?

The EU and the UK continue to update legislation to ensure competitiveness and expedite patient access to innovative medicines. The new legislation and alignment of regulatory pathways should help harmonize regulation, reduce complexity and administrative burden, enhance operational efficiency, and drive the delivery of a sustainable health care system.

Reform of the EU pharmaceutical legislation. European Medicines Agency; 2025. Accessed 19 March 2026. ema.europa.eu

Regulation (EC) No 726/2004. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu

Directive 2001/83/EC. European Medicines Agency; 2025. Accessed 19 March 2026.ema.europa.eu

Regulation (EC) No 1901/2006. European Medicines Agency; 2019. Accessed 19 March 2026.ema.europa.eu

Regulation (EC) No 141/2000. European Medicines Agency; 2025. Accessed 19 March 2026.ema.europa.eu

Regulation (EC) No 1394/2007. European Medicines Agency; 2019. Accessed 19 March 2026.ema.europa.eu

Regulation (EU) No 536/2014. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu

Regulation (EU) 2022/123. European Medicines Agency; 2022. Accessed 19 March 2026.ema.europa.eu

Regulation (EU) 2021/2282. European Medicines Agency; 2021. Accessed19 March 2026.ema.europa.eu

Johns A, Andrade A, Johal S, Ryan J. EU joint clinical assessment: a framework for optimising use with cost-effectiveness decision-making. 

Chirico G. How are countries implementing the EU HTA regulation? An updated overview. Remap Consulting; 2025. Accessed 19 March 2026 https://remapconsulting.com/hta/how-are-countries-implementing-the-eu-hta-regulation-an-updated-overview/12.

Regulation (EU) 2025/2086. European Medicines Agency; 2025. Accessed19 March 2026.ema.europa.eu

Medicines: get integrated scientific advice from the MHRA and NICE. MHRA. GOV.UK; 2026. Accessed 19 March 2026.https://www.gov.uk/guidance/medicines-get-scientific-advice-from-mhra

Grubert N. Simultaneous UK marketing authorisation and HTA recommendation. LinkedIn. November 20, 2025. AccessedMarch 19, 2026. https://www.linkedin.com/posts/neil-grubert_uk-mhra-nice-activity-7382473273948807168-XNB_/.

Cheryl Barton, PhD, is founder and director of PharmaVision, Pharmavision.co.uk.

When referring to this article, please cite it as Barton C. The impact of new pharmaceutical and HTA legislation in Europe. 

Europe is implementing sweeping reforms to medicine regulation and health technology assessment, with major implications for oncology, ATMPs, paediatric and orphan products. A new EU pharmaceutical legislative package will replace core human medicines rules, amend ATMP and clinical trials frameworks, and update EMA committee structures, while also addressing antimicrobial resistance, shortages, sustainability, and digitalization. In parallel, EU-level joint clinical assessment for HTA is now live for oncology and ATMPs and will expand to all new medicines by 2030. The UK is introducing optional parallel MHRA–NICE advice to compress access timelines.

New legislation will improve patient access to innovative medicines in Europe and the United Kingdom.

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