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

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

Q: We are updating our training program for this year and wondered if you are aware of any new regulations for data integrity?

A: No new regulations were published in 2025 specific to data integrity. The evolving global regulatory systems do, however, address data integrity within the context of revised or new parts of the legislation.

The European Commission (EC) has published

 the revision of Good Manufacturing Practice (GMP) Guidelines Chapter 4 (Documentation), Annex 11 (Computerised Systems) and New Annex 22 (Artificial Intelligence) for public consultation. All three documents address data integrity, namely:

Chapter 4 clarifies the requirements for the management of electronic records, signatures, and data integrity while ensuring consistency with the concurrent revision of Annex 11.

Annex 11 strengthens controls related to the assurance of data integrity, audit trails, electronic signatures, and system security.

Annex 22 addresses the quality of model training data, and the management and processing of test data for AI models.

FDA published the Center for Drug Evaluation and Research 2026 Quality Management Maturity (QMM) Prototype Assessment Protocol Evaluation Program in February 2026.

 The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice requirements. Data governance is a topic covered by this program.

This clearly shows that it is necessary to search beyond the term “data integrity” to stay abreast of developments in this field. Furthermore, these updates continue to emphasise the need to comply with good practices, such as good documentation practices. This may sound trivial, but it isn’t. The many inspection observations relating to data integrity are often nothing more than a lapse in having documented processes or creating records that are true and are documented in a timely manner.

As mentioned, there are no new regulations on data integrity, per se. Instead, new or updated regulations are necessary to cover advancements in science and technology. Data integrity remains a key concept throughout and importantly, the requirements for data integrity compliance remain unchanged. You may refer to them as ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available).

Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22. European Commission. 

https://health.ec.europa.eu/consultations/stakeholders-consultation-eudralex-volume-4-good-manufacturing-practice-guidelines-chapter-4-annex_en

CDER Quality Management Maturity. FDA.gov. February 11, 2026. 

https://www.fda.gov/drugs/pharmaceutical-quality-resources/cder-quality-management-maturity

Lopez J. Quality Essentials: Inspectional Coverage of QMS and Data Integrity. Presentation at the Compounding Quality Center of Excellence Annual Conference September 11, 2023. 

https://www.fda.gov/media/179075/download

Siegfried Schmitt, PhD, is vice president, Technical at Parexel. 

Articles

No 2025 regulations were issued that exclusively target data integrity, but multiple evolving frameworks reinforce it within broader GMP and quality initiatives. The European Commission opened consultation on revised GMP Chapter 4 and Annex 11, plus a new Annex 22 for artificial intelligence, each strengthening expectations for electronic records, audit trails, signatures, security, and AI training/test data controls. FDA’s 2026 CDER Quality Management Maturity prototype program also elevates data governance. Persistent inspection findings often reflect weak documentation and untimely, non-contemporaneous record creation against ALCOA+ principles.

It is necessary to search beyond the term “data integrity” to stay abreast of developments in this field, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

Evolving Regulatory Systems Stress Importance of Data Integrity

Image Credit: Adobe Stock Images/KatherineWelles.com

Eli Lilly has rolled out a multi-dose KwikPen version of tirzepatide, marketed as Zepbound, for chronic weight management—signaling a packaging update for one of the obesity market’s fastest-expanding treatments.

Described by the company as “the most prescribed weight management medication in 2025,” Zepbound is now offered in a multi-dose pen designed to deliver a full month’s supply per device. The new format is available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg strengths.

The launch follows sustained demand for GLP-1 and dual GIP/GLP-1 receptor agonists used in obesity treatment. This new multi-dose pen is designed to boost convenience for patients and potentially streamline distribution compared with single-dose autoinjectors.¹ 

 also reported that the pen will contain four weekly doses, aligning with the drug’s once-weekly administration schedule.²

"As part of our commitment to supporting people living with obesity in their weight management journey, we are introducing a new option with the Zepbound KwikPen, a device trusted by patients globally and in the United States for other Lilly medicines, commented Ilya Yuffa, executive vice president and president of Lilly USA and Global Customer Capabilities, in the release.

Although Lilly characterizes the move as an access expansion, industry observers will closely monitor whether the new presentation also addresses supply chain pressures that have affected GLP-1–based therapies over the past two years.

How could the multi-dose format affect manufacturing and device supply?

Device components have been a critical bottleneck across the GLP-1 category, particularly for prefilled, single-use autoinjector pens. A multi-dose configuration may reduce the total number of device units required per patient over a given period, potentially easing strain on injector component supply and assembly capacity.

While Lilly has not publicly detailed manufacturing efficiencies tied to the KwikPen format, consolidating four doses into one device could lower packaging material use, decrease device assembly cycles, and improve distribution efficiency.

 For fill-finish operations, fewer individual pens per patient may simplify throughput planning and reduce secondary packaging complexity.

However, multi-dose pens introduce different handling and user considerations, including dose dialing and needle replacement. The commercial and pharmacovigilance implications of broader multi-dose use in obesity populations remain to be seen.

How might this impact distribution and channel strategy?

A one-month, multi-dose pen may impact dispensing across retail and specialty pharmacy channels. Fewer individual units per prescription could reduce pharmacy handling time and potentially improve inventory turnover metrics. On the other hand, higher per-unit value concentration in a single pen may increase financial exposure per damaged or lost unit in transit.

From a logistics standpoint, GLP-1 therapies typically require refrigerated storage. Any reduction in package volume per monthly treatment could improve cold-chain efficiency, particularly as obesity drugs continue to scale into broader patient populations.

The broader context is sustained demand growth. Lilly and other manufacturers have invested heavily in manufacturing expansion to meet rising demand for obesity therapies.

 Whether the multi-dose format materially alleviates device-related bottlenecks will depend on production scale, supplier diversification, and regulatory validation timelines.

What does this signal about GLP-1 market competition?

Lilly’s move comes amid intensifying competition in the obesity market, particularly against semaglutide-based products. According to 

, Zepbound has gained significant market share since launch, reflecting robust demand for tirzepatide in weight management.²

Expanded device formats may serve multiple strategic goals: increasing patient convenience, improving adherence, managing production capacity, and differentiating in a crowded therapeutic class. As additional GLP-1 and dual-incretin therapies advance through development, manufacturers may increasingly rely on formulation and device innovation to compete beyond efficacy data alone.

What are the broader implications for pharma supply chains?

The launch of Zepbound’s multi-dose KwikPen underscores a recurring theme in the obesity therapeutics market: device configuration and manufacturing scalability are increasingly central to commercial success.

As obesity drugs transition from specialty growth products to high-volume chronic therapies, supply chains must adapt to:

Forecast volatility tied to payer coverage and competitive positioning

While Lilly frames the new pen as an access-enhancing measure, its operational impact will be evaluated in real time by manufacturers, wholesalers, pharmacies, and payers navigating one of the fastest-growing categories in pharmaceuticals.

For industry stakeholders, the key question is whether device innovation can keep pace with demand expansion—or whether manufacturing constraints will continue to shape competitive dynamics in 2026 and beyond.

1. Eli Lilly and Company. Zepbound (tirzepatide), the most prescribed weight management medication in 2025, now available in multi-dose KwikPen. 

. Published February 23, 2026. Accessed February 23, 2026. 

https://www.prnewswire.com/news-releases/zepbound-tirzepatide-the-most-prescribed-weight-management-medication-in-2025-now-available-in-multi-dose-kwikpen-302693937.html

2. Constantino AK. Eli Lilly launches Zepbound obesity drug pen with one-month doses. 

https://www.cnbc.com/2026/02/23/eli-lilly-launches-zepbound-obesity-drug-pen-one-month-doses.html

3. Cole C. Lilly invests $3.5B in Pennsylvania injectable medicine facility. 

 Published January 30, 2026. Accessed February 23, 2026. 

https://www.pharmtech.com/view/lilly-invests-35b-in-pennsylvania-injectable-medicine-facility

4. Zubulake Z. Johnson & Johnson announces $1B investment in pennsylvania manufacturing site. 

 Published February 19, 2026. Accessed February 23, 2026. 

https://www.pharmtech.com/view/johnson-johnson-announces-1b-investment-in-pennsylvania-manufacturing-site

Eli Lilly introduced a multi-dose KwikPen presentation of tirzepatide (Zepbound) for chronic weight management, delivering four weekly doses per device across 2.5–15 mg strengths. The shift responds to sustained GLP-1/dual-incretin demand and may mitigate device-component bottlenecks associated with single-use autoinjectors. Potential benefits include reduced unit counts, simplified fill-finish and secondary packaging, and improved cold-chain logistics. Tradeoffs include user-step complexity (dose dialing, needle changes) and greater per-unit value exposure during distribution. Competitive differentiation beyond efficacy is increasingly device-driven.

The multi-dose pen, designed to deliver a full month’s supply, could help alleviate device supply limitations and influence future distribution strategies.

Eli Lilly Introduces Multi-Dose Zepbound KwikPen to Expand Obesity Treatment Options

Andrew Mitchell is associate vice president of Business Development at BioVectra.

Insights on New Modalities, Digital Integration, and Manufacturing Innovation

, Andrew Mitchell, associate vice president of Business Development at BioVectra, provides a comprehensive overview of the evolving contract development and manufacturing organization (CDMO) landscape. According to Mitchell, the most significant industry trend that emerged in 2025 was the “boom” of new therapeutic modalities, specifically antibody-drug conjugates (ADCs), RNA, and cell and gene therapies. However, the industry also faced geopolitical turmoil that affected vaccine sentiment and funding cuts that forced small biotech companies to consolidate their pipelines. Despite these challenges, the market saw significant M&A activity.

Digital transformation is increasingly central to manufacturing efficiency. While tools like laboratory information management systems, electronic batch records, and project management software are already established, AI is now emerging in manufacturing and data analysis. A major barrier to AI adoption remains the high cost of proprietary licenses, as companies cannot use public, open-data models for sensitive pharmaceutical work.

The rapid pace of digitalization has created a skills gap, necessitating that staff with traditional chemistry or biology degrees upskill in the IT sector . BioVectra addresses this by collaborating with local universities and training-based companies to provide continuous education, while also using pay and benefits to retain talent.

To improve competitiveness, CDMOs are focused on reducing cycle times to lower costs for clients. Technical innovations include engineering 

 expression systems for extracellular secretion in microbial fermentation, which reduces capital and operational expenses while avoiding hazardous chemicals. Additionally, the use of flow reactors in chemistry ensures cleaner reactions and fewer impurities.

Looking ahead to 2026, Mitchell predicts continued growth in precision oncology and RNA therapeutics. He highlights the increasing importance of drug delivery systems, specifically the development of new lipids to improve the stability of lipid nanoparticles. Finally, there is a trend toward companies seeking CDMO partners that provide a pathway from early-stage development to commercial production.

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.

Hi. My name is Andrew Mitchell. I'm the associate vice president of business development. Business development in BioVectra is the client facing section, the commercial section. And our company is based in Atlantic, Canada. We have four different sites which are using different modalities to manufacture drug substance, primarily drug substance, but also some drug products for the pharmaceutical industry.

Which trends did you see or experience in 2025 that you believe impacted the pharmaceutical industry the most? How and why?

So, I think the biggest trend that we continue to see is the emergence of new therapeutic modalities, specifically at this point in time, ADCs, which are which are really having a boom in the industry, radio ligament therapies, RNA and cell and gene therapies, and also the bio multi specific antibodies as well.

We also see, I mean, it's quite obvious, there's been a lot of geographic political turmoil which has affected particularly the sentiment about vaccines. The industry itself. There have been cuts in funding, which has restricted many smaller biotech pipelines, and generally, there has been a move to consolidate pipelines to maybe one or two maximum in the small biotechs in the clinical trials, which has narrowed the opportunities for people like ourselves in the CDMO field. However, on top of that, there has been a very buoyant pharma acquisition market in 2025 again, continued consolidation in the CDMO field, like ourselves, we were acquired by Agilent in late 2024 and have been going through an integration process in 2025, but there's also been vertical integration by CDMOs, and a noticeable activity by private equity in acquiring CDMO assets as well.

What role do artificial intelligence and digital technologies play in accelerating drug discovery and improving manufacturing efficiency, and what are some unresolved barriers to full adoption?

So, I mean, digital technologies have been moving in for quite some time. I mean, we've got LIMS systems. So, you know, laboratory systems that are that are helping to streamline the progress of samples and testing throughout the system. We now have the use of electronic batch records, which are becoming increasingly more popular in the industry, and also project management software, whether that be monday.com or smart sheets or whichever system that is available to different companies.

And there is now a lot of use starting to emerge of artificial intelligence in manufacturing, analysis of quality data and data in general, but one of the big barriers to this is the cost of the license. You clearly can't use a public data open data AI model. You have to have an AI agent which is specific to your company. And that's a very large cost at the beginning. But it does seem that everybody at the moment is looking at AI in different ways, in terms of manufacturing, and I think that's something that's going to be increasing in the future, and hopefully will bring not just efficiencies, but also productivity as well, into the industry.

How can organizations bridge the widening skills gap created by the rapid digitalization of pharmaceutical manufacturing, and what best practices are emerging for workforce development?

In our industry, it's very common that we have staff with degrees in either chemistry, biology, or engineering or combination of those. But as mentioned in previous discussion,

the use of digitalization is requiring people to also upskill in the IT sector as well, and that works hand in hand with their existing experience. So to do that, we've been working with a number of local universities and also training-based companies to provide our business with the workforce that is trained and efficient to enable us to not only keep talent, but also we have to work to train it constantly and update it, but also incentivize them through pay and other benefits to help them to remain with us.

Which recent innovations in product development or process optimization have had the broadest impact on cost, quality, or speed-to-market in manufacturing operations?

Speaking, specifically from a CDMO point of view, we're all about improving the cycle times of the processes that we operate on behalf of our clients and are continually looking at a process of chipping away to make small improvements.

Improvements, and the many small improvements, add up to a large gain in terms of cycle time reduction for the client, which is always good. They get less time than our client means lower cost, and lower cost basically also means for them, you know, better margins on their drug product, better competitiveness as well. One of the major opportunities we have is in the manufacture of biologics through microbial fermentation. In addition to bringing in technologies which improve the flow in line, sterilizers as one example, we've also been looking at engineering the expression systems, specifically 

, so that we can actually perform extra cellular secretion, and this allows us to cut costs in terms of CapEx, OPEX cycle times, and the use of hazardous and not very nice chemicals when doing the repro refolding of proteins. So, we're always looking at this, these types of improvements, I would say, on our chemistry business, and also in our highly potent business, we're looking at the use of flow reactors to ensure that we get cleaner reactions fewer impurities. Are able to handle a much wider range of reactions and basically then adding that and rounding all of those things off with the use of real-time release and analytical technology.

Which trends do you see driving innovation and drug development in 2026? How and why?

We continue to see the growth in the new modalities. I don't think that we will ever believe that small molecules will go away or mammalian products will go away, but we do believe that there is still a lot more to go. In terms of RNA therapeutics, the cell and gene therapies, they seem to be making headway. They have some hiccups along their path, but seem to be moving in the right direction. We see a lot of work being done on precision oncology, and that we're involved very much in the ADC part of that, the payload part, not so many new payloads. Some are still coming through, but a selection of payloads which can be added to new antibodies to for targeting.

One other part that we see is delivery systems, and this is becoming quite important. People realize that perhaps the lipid systems, just the standard lipid nano particle could be improved, and they're doing a lot in that field to try and find new types of lipids which might improve delivery and stability of the drug product to into the body. And finally, we see a slight change in that companies who perhaps are more constrained in their early stage are looking for companies such as ours that have capabilities in both early stage and a pathway to commercial production. And I think these are the trends which are going to be seen and will continue in 2026.

Videos

PharmTech spoke with Andrew Mitchell, associate vice president of Business Development at BioVectra, about which 2025 trends will continue to impact the pharma industry and how CDMOs can offer solutions.

This week, we highlight big news from Roche, BMS, GSK, J&J, and Lilly, as well as well as key insights from industry experts.

PharmTech Weekly Roundup - February 20, 2026

This week, we’re seeing a strategic shift toward advanced modalities like cell therapies and targeted protein degradation, alongside a structural pivot to rare disease assets to stabilize portfolios against those looming patent cliffs everyone’s talking about, as well as global R&D competition.

Ask the Expert series, regular hosts, Susan Schniepp or Nelson Labs and Siefried Schmitt of Parexel

 highlight that while orphan drug pathways offer financial incentives and expedited timelines, manufacturers must adapt to the complexities of small-batch production and the need for more agile, high-level quality systems.

, which met its primary endpoint of showing superior complete remission in primary membranous nephropathy, marking a major expansion of this molecule into autoimmune kidney disease.

BMS announced that FDA had accepted the New Drug Application for iberdomide

, a first-in-class CELMoD agent for relapsed/refractory multiple myeloma. In a new, transformative approach meant to significantly accelerate the regulatory pathway, the NDA for iberdomide is utilizing minimal residual disease negativity as a primary endpoint.

. On Tuesday, The European Commission approved the company’s depemokimab, brand name Exdensur, the first and only ultra-long-acting biologic in the EU to treat respiratory disease which has an only twice-yearly dosing schedule. GSK also announced new effective data for its RSV vaccine, including reduced hospitalizations in adults aged 60 or older and reduced major adverse cardiovascular events in the same population during RSV-related hospitalization.

investing over $1 billion in a new next-generation cell therapy facility outside of Philadelphia 

to localize production, ensure supply chain resilience for oncology and neurology pipelines, and create 500 specialized biomanufacturing jobs.

Eli Lilly announced it had struck a strategic licensing deal with CSL regarding the IL-6 monoclonal antibody clazakizumab

. Under the agreement, CSL gets an upfront payment of $100 million and remains eligible for future clinical, regulatory, and commercial milestones, as well as royalties on global net sales, while Lilly will be responsible for exploring development, global regulatory approval, and distribution of the treatment to patients with end-stage kidney disease.

In part three of a four-part article series on rare diseases

, Nathan Edwards and Michael Bianco, both of Arya Consulting Partners, examine how revenue concentration and accelerating patent cliffs undermine the traditional blockbuster model, whereas orphan drugs offer a structurally different strategy for stabilizing biopharma portfolios through more durable, predictable, and risk-adjusted long-term value creation. Be sure to check out all 4 parts.

 warning issued from FDA Commissioner Marty Makary

, who said in a TV interview that the US is losing ground to China in early-stage drug development, calling for urgent regulatory reforms to streamline IND applications and trial contracting to maintain Western leadership in R&D speed. The comments suggest that development teams will need to balance the leveraging of speed and capacity of China’s developers with US scrutiny on clinical data provenance, trial diversity, and biosecurity.

Supreme Court Blocks Trump Tariffs | Created with Canva

The Supreme Court's 6-3 decision to strike down duties imposed under the International Emergency Economic Powers Act (IEEPA)

 represents a pivotal moment for professionals in pharmaceutical development and manufacturing who manage international supply chains.¹ Chief Justice John Roberts observed that,¹ "The president asserts the extraordinary power to unilaterally impose tariffs of unlimited amount, duration and scope," yet the administration points to no statute in which Congress authorized such expansive power under the 1977 law. While this ruling invalidates broad reciprocal tariffs, such as the 34% levy on goods from China, its direct impact on the pharmaceutical sector requires a nuanced understanding of the different legal authorities that govern trade.²

Why Does the Distinction Between Legal Authorities Matter for Drug Manufacturing?

It is critical for industry leaders to recognize that most high-profile pharmaceutical tariffs discussed in 2025 were intended to be imposed under Section 232 of the Trade Expansion Act, rather than the International Emergency Economic Powers Act, often referred to as IEEPA.² In spring 2025, the Department of Commerce launched a Section 232 investigation into pharmaceutical imports and ingredients to assess potential national-security risks. President Trump subsequently announced plans for a 100% tariff on branded or patented pharmaceutical products specifically linked to that investigation.

Consequently, the Supreme Court's ruling against IEEPA primarily affects mega-tariffs and global reciprocal actions, while pharmaceutical-specific measures grounded in national-security authority remain potentially in force.² For example, Section 232 tariffs on steel and aluminum are separate and remain in place even after this decision. Furthermore, negotiated exceptions and trade agreements with the UK and EU were designed to shape how Section 232 duties on drugs would be applied, distinct from the broader emergency powers recently curtailed. This means that while some broad import taxes are gone, the targeted investigations into the pharmaceutical supply chain have not been directly invalidated.

How Have the Tariffs Been Affecting the Pharma Industry?

On the tariff developments, Kristin Ciriello Pothier, Americas Life Sciences Leader, KPMG, comments, "Today's ruling and subsequent developments are only part of the story for the life sciences industry, leaving key questions around tariff exposure and trade uncertainties. Now is the time to pressure-test sourcing models and accelerate AI-driven forecasting. Resilience and disciplined scenario planning will be essential as trade dynamics continue to shift."

The tariffs have caused the industry pivot toward domestic manufacturing, which has accelerated global trade tensions.³ Major developers have already committed billions to reshoring to mitigate potential duties and ensure supply chain resilience. For example, 

Eli Lilly and Company initiated plans for four new manufacturing sites

, bringing its total US capital commitments to over $50 billion.⁴ More recently, 

Johnson & Johnson announced a $1 billion investment in a Pennsylvania manufacturing site

What Are the Long-Term Operational Implications of Shifting Trade Policies?

This massive reallocation of capital responds to an invest-or-tariff ultimatum, where high taxes could be avoided by beginning US facility construction.³ This is a vital shift, as 90% of biotech firms rely on imported components for at least half of their approved products. High costs have already squeezed profit margins, forcing some companies to delay R&D. While the court decision limits broad emergency taxes, onshoring continues to provide benefits like improved quality control and reduced miscommunication. Manufacturers are now prioritizing trade compliance and supplier diversification to balance domestic capacity with flexibility. The industry continues to advocate for stable policies to protect critical inputs like APIs and excipients. By investing in domestic R&D and localized APIs, firms aim to strengthen medicine supply security for the future.

​Supreme Court strikes down most of Trump’s tariffs in a major blow to the president. NBC News. Published February 20, 2026. Accessed February 20, 2026. 

https://www.nbcnews.com/politics/supreme-court/supreme-court-strikes-trumps-tariffs-major-blow-president-rcna244827

Sagonowsky E. Supreme Court steps in as Trump’s tariffs are thrown out. FiercePharma. Published February 20, 2026. Accessed February 20, 2026. 

https://www.fiercepharma.com/pharma/supreme-court-steps-trumps-tariffs-thrown-out

Cole C. The year of the tariff: pharmaceutical supply chain reimagined in 2025. Pharmaceutical Technology. Published Year. Accessed February 20, 2026. 

https://www.pharmtech.com/view/the-year-of-the-tariff-pharmaceutical-supply-chain-reimagined-in-2025

Cole C. Lilly invests $3.5B in Pennsylvania injectable medicine facility. Pharmaceutical Technology. Published February 13, 2025. Accessed February 20, 2026. 

Zubulake Z. Johnson & Johnson Announces $1B Investment in Pennsylvania Manufacturing Site. Pharmaceutical Technology. Published February 19, 2026. Accessed February 20, 2026. 

The Supreme Court’s 6–3 ruling curtails use of IEEPA to impose sweeping, open-ended tariffs, eliminating broad reciprocal levies such as the 34% duty on China. However, pharma exposure depends on the governing authority: proposed drug and ingredient tariffs were largely tied to Section 232 national-security powers, including a Commerce investigation into pharmaceutical imports and a floated 100% tariff on branded products. Meanwhile, tariff uncertainty has accelerated onshoring, reshaping capital allocation, compliance priorities, and supply-chain risk management amid heavy reliance on imported inputs.

SCOTUS struck down IEEPA tariffs. Pharma duties under Section 232 persist as they fall outside the ruling's scope.

Supreme Court Rejection of Trump Tariffs Has Nuanced Implications for Pharma Importers

FDA Commissioner Says US is Falling Behind China | Created with Canva

The United States risks ceding leadership in early-stage drug development to China because of avoidable regulatory and operational delays in initiating clinical trials, according to recent comments by FDA Commissioner Marty Makary.¹ In a televised interview, Makary identified hospital contracting, institutional review board (IRB) processes, and Investigational New Drug (IND) application review timelines as key bottlenecks that may be slowing first-in-human and early-phase studies in the US.

How Do US and China Early Development Pipelines Compare?

Currently, China is ahead of the US in clinical trials,

 accounting for around one-third of emerging, global drug approvals.¹ Makary is citing structural constraints that could influence sponsors to conduct phase I and early phase II trials in China over the US. Early development geography can shape subsequent regulatory strategy, patient access, and the global evidence base.

In the interview, Makary called for reforms to streamline trial initiation.¹ He cited three specific areas of concern: protracted hospital contracting negotiations, duplicative or slow-moving ethical review processes, and the time required for IND submission and clearance.

Under current US law, sponsors must submit an IND application to the FDA before initiating clinical trials in humans.² The agency has 30 days to review the application and may impose a clinical hold if safety or protocol concerns arise. While the statutory timeline is fixed, pre-IND preparation, sponsor–FDA interactions, and post-submission queries can extend development timelines. Additionally, multicenter trials often require negotiation of site-specific clinical trial agreements and budget terms, as well as IRB approval, processes that may vary widely across institutions.

China, by contrast, has implemented regulatory reforms in recent years aimed at accelerating drug development.³ In 2017, China’s National Medical Products Administration joined the International Council for Harmonization, committing to align technical requirements with global standards. Subsequent reforms have included implied approval mechanisms for INDs if no objection is raised within a specified period and prioritization pathways for innovative therapies.

Although direct, head-to-head comparisons of median IND review times between the US and China are limited in the peer-reviewed literature, several analyses have documented a substantial increase in China-originated first-in-human trials and oncology innovation programs over the past decade.⁴

These comparisons along with Makary’s comments suggest that future reforms for US drug development will induce additional pressure on producers to shorten tech‑transfer timelines as well as implement more modular or single-use capacity.⁵ US partners will be expected to match the increased speed of China developers while still maintaining the high standards of compliance and quality, as standards are unlikely to be adjusted.

What Do Makary’s Comments Imply About the Future of Clinical Development?

FDA has previously emphasized its commitment to expediting innovative therapies through mechanisms such as Fast Track, Breakthrough Therapy, Accelerated Approval, and 

.² However, these programs primarily affect later-stage development and review. Makary’s comments focus on the pre–proof-of-concept period, where operational inefficiencies rather than formal regulatory timelines may predominate.¹

Adjustments will need to be made to portfolio and trial-location strategy in order for assets to reach first‑in‑human and proof‑of‑concept in competition with China.¹ US and EU developers are under pressure to innovate news ways to streamline early‑phase IND processes and adopt more adaptive or decentralized trial designs to match China’s speed of output.

The US continues to lead globally in total biopharmaceutical R&D spending and in the number of new molecular entities approved annually.⁶ Additionally, the FDA’s 30-day IND review window is relatively short compared with some international counterparts.²

The more salient issue may be system-level fragmentation rather than statutory review times.⁴ A 2020 analysis of global clinical trial trends demonstrated significant expansion of early-phase oncology trials in China, accompanied by regulatory reforms and domestic investment. Still, the quality, reproducibility, and global generalizability of early-phase data require careful evaluation regardless of geography.

What Are the Next Steps for US and EU Manufacturers?

Makary’s statements should be interpreted as policy signaling rather than evidence of imminent regulatory change, as they were presented with no new trial data or FDA guidance.¹ Comparative metrics on median trial startup times, IND clearance intervals, and contract negotiation durations would be necessary to quantify the scope of the issue.

Future reforms could include expanded use of centralized IRBs, harmonized contract templates across federally funded institutions, and enhanced pre-IND consultation programs.³ Policymakers may also look to international models for implied approval or parallel review mechanisms. Any regulatory adjustments that reduce early-phase startup timelines could influence site selection strategies, patient recruitment, and competitive positioning in global drug development.

Along with likely future reforms to accelerate early‑stage approvals, US authorities be more vigilant with the sharing of data and re-investment in regional development.⁵ The sharing of sensitive biological and clinical data with Chinese developers and other countries of concern are likely to be more restrictive. Development teams will have to balance the leveraging of speed and capacity of China’s developers with US scrutiny on clinical data provenance, trial diversity, and biosecurity.

CNBC. FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals. February 18, 2026. 

https://www.cnbc.com/amp/2026/02/18/fda-chief-warns-us-is-losing-ground-to-china-in-early-drug-trials.html

US Food and Drug Administration. Investigational New Drug (IND) Application. Updated 2023. 

https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application

National Medical Products Administration. China joins ICH and advances regulatory reform. Published 2017. 

Hwang TJ, Carpenter D, Lauffenburger JC, Wang B, Franklin JM, Kesselheim AS. Failure of investigational drugs in late-stage clinical development and publication of trial results. JAMA Intern Med. 2016;176(12):1826-1833. 

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2565715

PharmCube. US Regulatory Tightening: Impact or Benefit on China's Pharma Industry?. LinkedIn. 2025, Sep 15. Accessed February 20, 2026.

https://www.linkedin.com/pulse/us-regulatory-tightening-impact-benefit-chinas-pharma-industry-pmvac/

IQVIA Institute for Human Data Science. Global Trends in R&D 2023. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/global-trends-in-r-and-d-2023

FDA Commissioner Marty Makary warned that avoidable US startup frictions—hospital contracting, IRB workflows, and IND-related back-and-forth—are eroding competitiveness in first-in-human and early phase II development, potentially shifting sponsors toward China. China’s post-2017 reforms, including ICH alignment and implied IND approvals, have coincided with growth in China-originated early oncology trials and a rising share of global approvals. The core vulnerability is operational fragmentation more than statutory FDA timelines. Policy signals point toward centralized IRBs, harmonized contracting, expanded pre-IND engagement, and tighter scrutiny of cross-border data.

FDA commissioner warns US trial startup delays may cede early drug development to China, urging IND and IRB process reforms amid global competitions.

Reasons to Pay Attention to Makary's Comments Around Losing Drug Development Ground to China

J&J Pennsylvania Site | Image Courtesy of Johnson & Johnson

 recently announced a $1 billion investment in a next-generation cell therapy site in Montgomery County, Pennsylvania, just outside of Philadelphia.¹ This development underscores a broader strategic move to localize the production of advanced medicines to ensure supply chain resilience within the US. The facility is designed to support a growing pipeline of transformational treatments for neurological, immune-mediated, and oncological diseases. The integration of scientific excellence with state-of-the-art manufacturing is intended to bridge the gap between discovery and delivery. Joaquin Duato, chairman and CEO, Johnson & Johnson, noted the significance of this trajectory, in a press release,¹ “For 140 years, Johnson & Johnson has been a leading innovator in American healthcare, and we are honored to continue advancing that legacy in Pennsylvania.” He elaborated that,¹ “By uniting scientific excellence with state-of-the-art manufacturing and strategic investment, and by working collaboratively with our communities, we are delivering for patients and creating significant opportunities for workers and families.”

This initiative is a component of a larger $55 billion investment strategy focused on manufacturing, research and development, and technology across the United States through early 2029.¹ These investments indicate a long-term commitment to cutting-edge manufacturing processes that require a workforce specifically trained in advanced technologies. When fully operational, the site is expected to support over 500 skilled biomanufacturing positions, reinforcing the need for specialized expertise in the production of next-generation therapies.

Why Are Regional Ecosystems Critical for Large-Scale Pharmaceutical Manufacturing?

The selection of Lower Gwynedd, PA for this expansion highlights the importance of established life sciences hubs that offer a combination of skilled labor, research institutions, and manufacturing history.¹ Governor of Pennsylvania, Josh Shapiro emphasized the state's competitive stance in this sector, remarking in a press release,¹ “Pennsylvania is a powerhouse for innovation and manufacturing in the life sciences.” He explained the state's recent progress, saying,¹ “Just a few years ago we weren’t even on the field - but today we’re competing and winning. We’ve done it by creating the first economic development plan for Pennsylvania in 2 decades, and following through on it by cutting red tape, making strategic investments in key industries like the life sciences, and strengthening our workforce. That’s why companies like Johnson & Johnson are choosing to double down on their investments here in our Commonwealth - because they know we’ve got the strategy, the workforce, and the speed they need to succeed.”

U.S. Senator Dave McCormick reinforced this perspective, noting in a press release,¹ “Pennsylvania leads in life sciences and advanced manufacturing because we consistently deliver what companies like Johnson & Johnson need to succeed: a skilled workforce, premier research institutions, and proven manufacturing strength.” He added that,¹ “This $1 billion-plus investment in a new Lower Gwynedd facility is a testament to that leadership and will produce life-changing treatments for patients, along with new and good jobs for our Commonwealth.” The presence of ten existing facilities in the state, covering over 2 million square feet, provides a robust foundation for this new cell therapy site to thrive. This strategic expansion ensures that the vast majority of advanced medicines will be manufactured in the US to directly serve the domestic market.

What Factors Drive the Concentration of Large-Scale Manufacturing to Pennsylvania?

The expansion of major facilities, including a 

$3.5 billion Eli Lilly site in the Lehigh Valley

, illustrates why Pennsylvania is a primary choice for large-scale pharmaceutical operations.² Strategic proximity to leading research universities ensures a consistent pipeline of specialized talent, which is vital for maintaining technical manufacturing standards. Additionally, the region provides established infrastructure, reliable utility access, and efficient transportation networks necessary for complex supply chains. State initiatives to simplify regulatory processes further enhance the local business environment. These hubs facilitate the adoption of advanced data analytics, ensuring operational reliability for critical therapies.

Johnson & Johnson. Johnson & Johnson expands U.S. footprint with more than $1 billion investment in next generation cell therapy manufacturing facility in Pennsylvania. News release. New Brunswick, NJ: Johnson & Johnson; February 18, 2026. Accessed February 19, 2026. 

https://www.jnj.com/media-center/press-releases/johnson-johnson-expands-u-s-footprint-with-more-than-1-billion-investment-in-next-generation-cell-therapy-manufacturing-facility-in-pennsylvania

Eli Lilly and Company. Lilly selects Pennsylvania as home for its newest injectable medicine manufacturing site. News release. Indianapolis, IN: Eli Lilly and Company; 2023. Accessed February 19, 2026. 

https://investor.lilly.com/news-releases/news-release-details/lilly-selects-pennsylvania-home-its-newest-injectable-medicine

Johnson & Johnson is investing more than $1 billion to build a next-generation cell therapy manufacturing facility in Lower Gwynedd, Pennsylvania, strengthening US-based production capacity for advanced medicines. The site is positioned to support a growing pipeline spanning oncology, immune-mediated, and neurologic diseases, and is part of a broader $55 billion US investment plan through early 2029. Once fully operational, it is expected to create more than 500 skilled biomanufacturing roles. The choice of Pennsylvania reflects the value of mature life sciences ecosystems, infrastructure, and workforce readiness.

A $1 Billion Pennsylvania cell therapy site investment bolsters domestic manufacturing, creating 500 skilled biomanufacturing jobs.

Johnson & Johnson Announces $1B Investment in Pennsylvania Manufacturing Site

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. and a member of Pharmaceutical Technology's Editorial Advisory Board.

Ask the Expert: Working with Regulators to Develop Orphan Drugs

 video series. This series is an extension of the 

 Group’s long-running print column in which industry experts answer common quality and regulatory questions from the industry. This video series expands on topic areas to include development and manufacturing concerns to help those working in the industry better understand bio/pharmaceutical requirements. Have a question you would like answered? Send it to 

, and it may appear in a future episode or print column.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, a Nelson Labs Company, and Siegfried Schmitt, Vice President, Parexel, answer the question:

“We are a medium sized company and are looking to develop a new drug and are thinking of applying for orphan drug status. Do you have any suggestions for working regulators?”

For medium-sized pharmaceutical companies considering developing a drug for orphan drug designation, the transition from traditional development to rare disease therapy requires a shift in regulatory, clinical, and operational planning. An orphan drug is defined by the size of the population it treats; in the United States, this generally refers to conditions affecting 200,000 or fewer people,

In this episode of Ask the Expert, Susan J. Schniepp, Nelson Labs, and Siegfried Schmitt, Parexel, discuss the benefits of orphan drug development and how a mid-sized company can work with regulators through the pathway to approval. 

Featured Content

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

Behind the Headlines Episode 28

Ask the Expert

Drug Digest February 2026

A “Plan, Prevent, Prove” Approach