How AI can be used in drug development to shorten development timelines.

Pharma Fundamentals: Utilizing Artificial Intelligence in Drug Development

CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation investigations

Manufacturing Intelligence: How Digital Twins Are Changing Cleanroom Validation

Ask the Expert

This week's headlines saw oncology investment; persistent pressure on supply chain resilience and drug availability; and the importance of operational readiness.

PharmTech Weekly Roundup—June 12, 2026

How evolving regulatory expectations are reshaping pharma development and manufacturing.

Drug Digest April 2026

Navigating FDA Shakeups and Obesity Drug Wars

Behind the Headlines Episode 28

PharmTech Weekly Roundup--June 12, 2026

This week's headlines saw a wave of high-stakes oncology investment as companies race to secure next-generation therapeutic platforms; persistent pressure on supply chain resilience and drug availability; and the growing importance of operational readiness—whether that means data infrastructure for AI, carbon accountability, or access systems for complex modalities like radiopharmaceuticals.

 for $10.6 billion, gaining two late-stage kinase inhibitors targeting ROS1 and ALK alterations in non-small cell lung cancer—both carrying FDA Breakthrough Therapy designations with potential approval decisions later this year.

 have committed a combined $4 billion to protein degrader platforms—J&J acquiring Firefly Bio for its tumor-targeted degrader conjugate technology, and Roche licensing Nurix's BTK degrader bexobrutideg—signaling that targeted protein degradation is becoming a primary pipeline priority in oncology.

European Medicines Agency published its 2025 annual report

, which detailed the agency’s approval of 104 human medicines in 2025, including 38 new active substances and several first-in-class therapies, while also advancing a draft policy that could reduce the clinical data burden for biosimilar development.

US Pharmacopeia’s 2025 annual drug shortages report

 found that while the total number of shortages declined by 23% in 2025, drug discontinuations rose 60% year-over-year—with low-priced generics and sterile injectables at highest risk, pointing to structural fragility in the supply base.

Nicholas Richardson, vice president of clinical development at Precision for Medicine,

 explained how radiopharmaceuticals require an integrated system of isotope production, just-in-time distribution, nuclear medicine licensing, and trained personnel that makes patient access inherently complex—and developers must build site strategy and supply chain infrastructure into development planning from the outset.

 argues that companies must move beyond reactive tariff responses and build documented, quality-led supply chain resilience strategies — including dual sourcing and qualified backup suppliers — that can withstand FDA scrutiny and protect patient access.

 explain how pharmaceutical organizations should evaluate three clinical data architectures — data warehouses, data lakes, and data lakehouses — based on their AI readiness, governance requirements, and technical capacity, with the lakehouse model offering the most comprehensive capabilities for large research-intensive institutions.

David Vázquez, climate principal consultant, Nexius Projects,

 spoke about how pharmaceutical suppliers face growing pressure to calculate and report product-level carbon footprints as major customers like AstraZeneca, the UK NHS, and regulators in France begin mandating emissions data—with experts noting that carbon accounting also surfaces manufacturing inefficiencies that can reduce costs.

Thank you for watching. Be sure to read all the news and feature content on PharmTech.com.

Videos

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

, co-hosts Chris Cole and Richard Jaenisch explore the emerging role of digital twins in cleanroom design and qualification in pharmaceutical manufacturing with guest Jonathon Thompson, global director of the digital center of excellence at CAI.

To view the full fascinating, practical, engaging conversation, click here!

Digital twins of cleanrooms are offering measurable reductions in commissioning time, rework, and pressure excursion investigation, but only when paired with rigorous real-time data verification, explains Thompson. He adds that the technology's core value lies not in replacing IQ/OQ/PQ, but in catching design flaws before construction locks them in.

The traditional cleanroom qualification workflow exposes problems late, Thompson notes, often after equipment is already installed and early-phase processes are running. Digital twins, fed with 3D building information modeling (BIM) models, HVAC specifications, personnel flow data, and physics-based fluid dynamics simulations, allow manufacturers to stress-test facility designs upstream. Thompson points to tangible returns: 10–30% reductions in commissioning time and resource hours, 20–50% reductions in rework, and 30–70% faster root cause identification during pressure excursions.

Regulatory acceptance, Thompson argues, depends on how the twin is used. "If you're using this digital twin as your single source of truth without verifying that data in real time with what's actually happening out in the field," he warns, "they're going to start to question it." Continuous process verification—cross-referencing the model against live environmental monitoring data, particle counts, and pressure differentials—is what earns FDA and EMA confidence in the approach.

For CDMO and modular facilities, where equipment configurations and product mixes change frequently, the stakes around model maintenance are especially high. Thompson observes that "we've got to change the mindset" to treat the BIM model as a living asset subject to change management, not a static deliverable from the capital project phase. As generative AI and light detection and ranging-based reality capture mature, automated model updating may eventually reduce that burden, making the digital twin a true operational constant rather than a commissioning tool.

CAI's Jon Thompson details how digital twins cut cleanroom commissioning time by up to 30% and accelerate GMP deviation investigations.

Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) syndrome

GSK has secured Orphan Drug Designations from both the FDA and the EMA for momelotinib in the treatment of Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) syndrome, a rare and severe hemato-inflammatory condition for which no approved therapies currently exist.

 The dual designation marks a meaningful step in expanding the therapeutic profile of a drug that is already approved for myelofibrosis across several major markets.

VEXAS syndrome is a clonal myeloid disorder that sits at the intersection of rheumatology and hematology.

 Clinically, it presents with a broad spectrum of inflammatory manifestations, including prolonged fever, relapsing chondritis, vasculitis, and lung involvement, alongside hematologic complications such as macrocytic anemia, thrombocytopenia, and progressive bone marrow failure that can evolve into hematologic malignancy. Caused by a somatic mutation in the UBA1 gene located on the X chromosome, the condition predominantly affects men over 50. Its prognosis is poor: five-year mortality sits between 30 and 40%, yet the disease remains without any approved treatment options. The designations were supported by retrospective case data suggesting that Janus kinase inhibitors may offer therapeutic benefit in VEXAS, along with a case report indicating clinical improvement with momelotinib specifically, including reductions in disease-related inflammation and hematological manifestations.

What Does This Mean for Momelotinib's Development Program?

Momelotinib's mechanism sets it apart from other Janus kinase inhibitors.

 The compound inhibits JAK1 and JAK2, pathways implicated in constitutional symptoms and splenomegaly, while also targeting activin A receptor type I, which reduces circulating hepcidin levels and contributes to anemia benefit. That triple-pathway inhibition is central to why the molecule is attracting attention beyond its current indication.

The drug is already approved in the US for intermediate or high-risk myelofibrosis in adults with anemia and holds approvals in the EU, UK, and Japan for myelofibrosis with disease-related splenomegaly, symptoms, or moderate to severe anemia.

 The VEXAS program represents a deliberate expansion into adjacent hematological territory.

GSK has initiated planning for the ATLAS phase II/III trial, which will evaluate momelotinib's efficacy and safety in VEXAS syndrome and serve as the foundation for planned global regulatory submissions.

 The study design is scheduled to be presented at the 2026 European Hematology Association Congress in June.

Orphan drug status in both the US and EU confers regulatory and commercial incentives, including extended market exclusivity and reduced filing fees, that influence how companies prioritize and resource development programs.

 For a molecule already navigating post-approval lifecycle management in myelofibrosis, these designations reinforce the case for continued manufacturing investment and supply chain planning.

The VEXAS indication also introduces formulation and development considerations.

 As a rare disease with a predominantly older male patient population and complex hematological presentation, any eventual commercial program will require close coordination between clinical, regulatory, and manufacturing teams well ahead of any potential approval. The ATLAS trial design, when presented at the European Hematology Association Congress, will be worth monitoring for signals that could shape those downstream requirements.

How Does This Fit into GSK's Broader Hematology & Oncology Push?

The VEXAS designations arrive as GSK pursues an aggressive expansion across hematology and oncology.

The company recently announced a $10.6 billion agreement to acquire Nuvalent

, a clinical-stage biopharmaceutical company with two late-stage non-small cell lung cancer assets, zidesamtinib and neladalkib, both currently under FDA review with potential 2026 approval decisions. The deal also includes a phase I HER2 inhibitor and a preclinical portfolio built around precision medicine. Together with the momelotinib VEXAS program, the moves signal a deliberate strategy of targeting conditions where existing therapies carry meaningful efficacy or tolerability limitations.

GSK plc. GSK’s momelotinib granted orphan drug designations in the US and EU for VEXAS syndrome. Press Release. June 11, 2026. 

https://www.gsk.com/en-gb/media/press-releases/gsk-s-momelotinib-granted-orphan-drug-designations-in-the-us-and-eu-for-vexas-syndrome

GSK plc. GSK enters agreement to acquire Nuvalent, Inc. Press Release. June 8, 2026. 

https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-nuvalent-inc/

Articles

GSK obtained FDA and EMA Orphan Drug Designations for momelotinib in VEXAS syndrome, a UBA1 somatic mutation–driven hemato-inflammatory disorder with high mortality and no approved treatments. Evidence includes retrospective experience suggesting JAK inhibition benefit and a momelotinib case report showing improvement in inflammatory and cytopenic features. Momelotinib’s JAK1/2 and ACVR1 inhibition may address symptoms, splenomegaly, and anemia via hepcidin reduction. Planning has begun for the ATLAS phase II/III trial, with design details expected at EHA 2026. Orphan incentives support lifecycle investment and manufacturing planning in rare disease.

GSK's momelotinib receives US and EU orphan drug designations for VEXAS syndrome, a rare myeloid disorder with 30–40% five-year mortality and no approved treatments.

GSK's Momelotinib Pursues Rare VEXAS Syndrome Indication

 connected with Tom Sellig, CEO, Adare Pharma Solutions, to discuss manufacturing investment trends, 3D-printed tablets, FDA dynamics, and the workforce strategies shaping the company's growth.

Tom Sellig on CDMO Innovation and US Manufacturing Growth

PharmTech: What Technologies Are Most Central to Adare's Innovation Strategy?

 Patient-centric dosage forms are core to our model, and 3D printing of tablets is one of the most exciting areas driving our growth. The technology allows us to differentiate product formulations and produce a wide range of dosage forms and release profiles in ways that more conventional manufacturing approaches cannot easily match. We're also paying close attention to the ongoing conversation around solubility and bioavailability enhancement. While it's an important capability to have, we think many companies are still working within the boundaries of existing technologies. We're developing what we believe are novel solutions that could leapfrog some of what's currently available in the market.

How Are Shifts at the FDA Affecting Your Development Timelines?

The FDA is going through significant changes right now, and that's creating a genuinely different dynamic between CDMOs [contract development and manufacturing organizations] and pharma companies. The conversation is increasingly about how to accelerate timelines while still working within the regulatory framework. We're actively supporting products that have received priority review vouchers, and that creates real pressure to move faster. It's a challenge, but it's also an opportunity for us to demonstrate the value of a CDMO that has the technical depth to execute under that kind of pressure.

How Is Adare Approaching Talent Acquisition and Retention?

Talent is a critical priority for us. We have an internal acquisition team, but we're also building something we call the Adare Academy, a structured, skills-based development and training program for all employees. It covers both soft skills and hard skills, including science and technology, with an explicit focus on career development pathways. The goal is not just to attract people, but to retain them. Lower turnover translates directly into continuity for our teams, for our client relationships, and ultimately for service quality.

How Do You View the Wave of Reshoring Commitments from Large Pharma, and What Does It Mean for CDMOs?

The scale of investment being discussed is significant. That said, these are long-horizon projects. Whether all of them come to fruition, and on what timeline, remains to be seen. Our response is to focus on what we can act on today: building out selective capacity and capabilities that position us to support the industry's growth as those investments materialize. We don't need to wait for the full wave, we need to be ready when it arrives.

Adare Pharma Solutions is prioritizing patient-centric dosage forms, with 3D-printed tablets enabling differentiated formulations and tailored release profiles beyond conventional manufacturing. The company is also pursuing next-generation solubility and bioavailability approaches intended to surpass current market options. FDA operational shifts are intensifying sponsor–CDMO collaboration around accelerated development, particularly for programs leveraging priority review vouchers. Growth plans emphasize workforce stability via a structured internal training and career-pathway platform. Reshoring commitments are viewed as meaningful but long-cycle, driving selective near-term capacity buildout.

Tom Sellig, Adare, discusses 3D-printed tablets, US reshoring investment, FDA timeline pressures, and workforce development strategies driving CDMO growth.

Q&A: Tom Sellig on Why Complex Formulations Are Driving CDMO Growth

Jordan Xu is an engineering expert specializing in automated pharmaceutical manufacturing systems. He is currently with DROFEN MACHINERY EQUIPMENT CO., LTD, a leading system supplier of turnkey automated assembly lines for insulin pens and aseptic filling systems for PFS. With extensive experience in resolving fill-finish bottlenecks, DROFEN partners with global CDMOs to deliver GMP-compliant, high-speed production solutions that accelerate time-to-market.

Transitioning to fully automated assembly lines

The global shift toward self-administration of biologics has driven the exponential demand for pen injectors.

 For pharmaceutical manufacturers and CDMOs, scaling up production to meet this demand requires robust automated assembly lines. While individual machines may boast high theoretical throughput, the overall equipment effectiveness (OEE) often suffers due to micro-stoppages, component variations, and integration complexities between pre-assembly and final assembly stages.

Addressing these bottlenecks requires a holistic systems-engineering approach, focusing on the seamless integration of pre-filled syringe (PFS) handling, dosing mechanism assembly, and rigorous quality control at high speeds.

Challenge 1: Component Variability and High-Speed Feeding

One of the primary causes of micro-stoppages in high-speed assembly lines, operating at 100-160 parts per million (PPM), is the dimensional variability of molded plastic components.

 Even minor deviations within acceptable tolerances can lead to jamming in vibratory bowl feeders or misalignment during robotic pick-and-place operations.

 To mitigate this, advanced assembly lines must employ adaptive feeding systems. Utilizing vision-guided robotics for component orientation rather than relying solely on mechanical sorting significantly reduces jam rates. Furthermore, implementing continuous-motion assembly architectures, in which components are assembled on a moving turret rather than intermittent indexing systems, provides smoother handling of fragile parts and accommodates slight dimensional variations without halting production.

Challenge 2: Precision Alignment in Final Assembly

The final assembly of a pen injector, in which the drug cartridge or pre-filled syringe is integrated with the dosing mechanism, is the most critical phase. The alignment must be perfect to ensure the dose accuracy and the mechanical integrity of the device. Misalignment not only damages the glass cartridge, leading to costly product loss, but also poses severe safety risks to the end-user.

 Achieving precision at 160 PPM requires moving beyond standard pneumatic actuators. Servo-driven pressing stations equipped with force-displacement monitoring provide the necessary control.

 By continuously monitoring the force profile during the pressing operation, the system can detect anomalies, such as a slightly oversized cartridge or a misaligned thread, in milliseconds. If the force profile deviates from the validated parameters, the system can abort the operation before glass breakage occurs, rejecting the specific unit without stopping the entire line.

Challenge 3: Seamless Integration of Pre-Assembly and Final Assembly

Many manufacturers procure pre-assembly equipment and final assembly equipment from different vendors. This fragmented approach often leads to integration bottlenecks in which the transfer of sub-assemblies between machines creates buffer accumulation issues and increases the risk of contamination or damage.

 A turnkey approach, in which a single system supplier provides both the pre-assembly and final assembly lines, eliminates these integration hurdles. This allows for a unified control architecture (e.g., a single PLC/HMI platform) and seamless physical transfer systems. By designing the line as a cohesive unit, manufacturers can implement intelligent buffering systems that dynamically adjust the speed of upstream processes based on downstream demand, maintaining a continuous flow and maximizing overall equipment effectiveness.

Challenge 4: Ensuring Compliance and Accelerating Validation

In the highly regulated pharmaceutical industry, high-speed production is meaningless without stringent quality assurance and comprehensive validation (installation qualification/operational qualification/performance qualification).

Implementing 100% in-line inspection at 160 PPM generates massive amounts of data, which can overwhelm standard control systems.

 Modern assembly lines must integrate edge computing to process vision inspection data locally, ensuring real-time pass/fail decisions without latency.

Furthermore, adopting a quality by design approach during the engineering phase ensures that critical process parameters are continuously monitored and controlled.

 Partnering with equipment suppliers who offer comprehensive validation documentation and regulatory support significantly accelerates the factory acceptance testing/site acceptance testing processes and overall time-to-market.

Scaling up pen injector production to meet global demand requires overcoming significant engineering bottlenecks in component handling, precision assembly, and system integration. By adopting advanced servo-control, vision-guided feeding, and a unified turnkey approach to pre-assembly and final assembly, manufacturers can achieve stable, high-speed production. Partnering with an experienced system supplier who understands both the mechanical intricacies and the stringent regulatory requirements is essential for ensuring product quality and accelerating time-to-market in this competitive landscape.

, a turnkey system supplier of automated assembly lines for injection pens and pre-filled syringes for global pharmaceutical manufacturers and CDMOs."

1. Anselmo, A. C., & Mitragotri, S. (2014). An overview of clinical and commercial impact of drug delivery systems. 

https://doi.org/10.1016/j.jconrel.2014.03.053

2. Perrone, M. G., & Maiocchi, M. (2022). 

Applying lean methodologies to improve the OEE of a manufacturing line: a case study in a pharmaceutical company

https://www.politesi.polimi.it/handle/10589/204180

3. Srai, value, S. C., Badman, C., … & Florence, A. J. (2015). Future supply chains enabled by continuous processing—opportunities and challenges. 

Efficient force-displacement monitoring and process control for medical device assembly

5.International Society for Pharmaceutical Engineering (ISPE). (2008). 

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems

6. Sharma, D., et al. (2023). A comprehensive study on Industry 4.0 in the pharmaceutical sector. 

https://doi.org/10.1007/s10668-023-03225-8

7. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2009). 

ICH Harmonised Tripartite Guideline: Pharmaceutical Development Q8(R2)

https://database.ich.org/sites/default/files/Q8_R2_Guideline.pdf

Surging global adoption of self-administered biologics is forcing rapid scale-up of pen-injector manufacturing, where realized throughput is constrained by OEE losses from micro-stoppages, part variability, and handoffs between pre- and final-assembly modules. Key failure modes include molded-component dimensional drift that disrupts high-speed feeding, tight alignment tolerances during PFS/cartridge integration, and vendor-fragmented line architectures that create buffering and contamination risks. Mitigations center on vision-guided adaptive feeding, continuous-motion platforms, servo pressing with force–displacement analytics, turnkey integrated controls, and edge-computing-enabled inline inspection aligned with QbD and GxP validation.

GLP-1 / insulin demand is straining CDMO fill-finish capacity. This piece examines bottlenecks in automated pen injector assembly and strategies to optimize operations.

Overcoming Fill-Finish Capacity Bottlenecks in Automated Pen Injector Assembly Lines

European Union Healthcare: A close-up of white and red capsules symbolizing healthcare against a backdrop of the European Union flag, signifying health and well-being in a European context. | Image Credit: ©pattozher -stock.adobe.com

The European Medicines Agency (EMA) announced the publication of its 2025 Annual Report on June 11, 2026,

 revealing a strong year of regulatory output across both human and veterinary medicines—along with significant advances in biosimilar policy, medicines availability, and the integration of artificial intelligence into agency operations. EMA recommended 104 human medicines for marketing authorization in 2025, of which 38 contained a new active substance that had never previously been authorized in the European Union.

Among the notable human medicine authorizations highlighted in the report were first-in-class and first-in-indication approvals including Rezdiffra, the first authorized treatment for metabolic dysfunction-associated steatohepatitis in the EU; Brinsupri, the first treatment for non-cystic fibrosis bronchiectasis; Teizeild, a first-in-class therapy to delay onset of stage 3 type 1 diabetes; and Waskyra, the first medicine for Wiskott-Aldrich syndrome. Several of these were advanced therapies or gene therapy products, reflecting a continuing shift in the EU's approval mix toward complex biologics and cell and gene therapies.

Three medicines—Brinsupri, Vimkunya, and Yeytuo—received recommendations following accelerated assessment, a pathway reserved for medicines addressing unmet medical needs that compresses the maximum review timeline from 210 to 150 days. In addition, 8 drugs received conditional marketing authorization, enabling early patient access before all data are received.

What Were Some of the Developments in Biosimilars, Critical Medicines, and AI?

In April 2025, EMA published a draft reflection paper proposing a tailored clinical approach for biosimilar development.

 The paper suggested that demonstrated structural and functional comparability, combined with pharmacokinetic data, may be sufficient to establish biosimilarity —potentially reducing the requirement for extensive clinical efficacy studies. The agency noted in the report that this shift has already generated an increased volume of biosimilar scientific advice requests, suggesting sponsors are actively exploring the new pathway.

The report also covers the official launch of the EU Medicines Agencies Network Strategy to 2028, continued maintenance of the Union List of Critical Medicines, and the full operationalization of the European Shortages Monitoring Platform (ESMP) in 2025—all of which have direct implications for manufacturers' supply chain planning and regulatory compliance strategies. The ESMP creates new visibility requirements around stock positions for critical medicines, and manufacturers supplying the EU market should ensure their shortage reporting processes are aligned with the platform's requirements.

The report also highlights how digitalization and artificial intelligence (AI) have reshaped the agency’s operations in 2025, moving from exploratory phases into practical application. The agency is expected to increase its use of AI-assisted review tools in the coming years, with potential implications for how manufacturers should structure and submit dossiers.

The year also marked EMA's 30th anniversary and the 25th anniversary of the EU Orphan Regulation, which has played a central role in facilitating the development and authorization of medicines for rare diseases. Sixteen of the recommended human medicines in 2025 were for rare disease indications.

“Currently, we are operating in a period of rapid transformation, defined by new ways of working and major legislative changes,” Rui Santos Ivo, chair of the EMA Management Board, stated in the forward of the report.

 “These developments underscore how essential it is for EMA and the network to remain forward looking, agile, efficient, and firmly committed to safeguarding the EU’s high standards for human and animal health while serving all European citizens. They also highlight the need for ever-closer coordination and solidarity across the European medicines regulatory network as we respond to shared pressures on resources, expertise and capacity.”

The full 2025 Annual Report, including detailed statistics and committee highlights, is available on the EMA’s website.

EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines. Press release. EMA. June 11, 2026. Accessed June 11, 2026. 

https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines

Annual Report 2025. The European Medicines Agency’s contribution to science, medicines and health in 2025. EMA 2026. Accessed June 11, 2026. 

https://www.ema.europa.eu/en/documents/annual-report/2025-annual-report-european-medicines-agency_en.pdf

Reflection paper on a tailored clinical approach in biosimilar development. EMA. March 27, 2026. Accessed June 11, 2026. 

https://www.ema.europa.eu/en/reflection-paper-tailored-clinical-approach-biosimilar-development

EMA’s 2025 annual report details 104 positive opinions for human medicines, including 38 new active substances, underscoring continued momentum in first-in-class and advanced therapy approvals. Notable recommendations included first EU treatments for MASH, non-CF bronchiectasis, stage 3 type 1 diabetes delay, and Wiskott-Aldrich syndrome. Accelerated assessment supported 3 products, while 8 received conditional marketing authorization. Policy and operational priorities emphasized a streamlined biosimilar evidence paradigm, strengthened critical-medicines shortage surveillance via ESMP, and expanded AI-enabled regulatory workflows.

The EMA’s annual report shows the agency approved 104 human drugs in 2025 that included first-in-class and first-in-indication therapies. 

EMA Approved 104 Human Medicines in 2025 

President and CEO, Klote Medical Research Advisors

Molly Klote, President and CEO, Klote Medical Research Advisors

 spoke with Dr. Molly Klote, president and CEO, Klote Medical Research Advisors, and moderator of the conference's regulatory track panel, about what the industry must do to navigate a rapidly changing supply chain landscape.

Molly Klote on Reshoring, Tariffs, and the Future of Pharma Supply Chains

PharmTech: What Is Driving the Current Push To Rethink Pharmaceutical Supply Chains?

 The pressure extends well beyond tariffs, though tariffs are clearly part of it. Companies are also responding to geopolitical instability, supplier concentration risks, inspection vulnerabilities, shortage exposure, and deep uncertainty around future policy direction. What I'm hearing from people here at the meeting is that the unpredictability may be as disruptive as the cost itself. Companies need to make long-range manufacturing, sourcing, and regulatory decisions, and they're doing so without knowing which countries will reliably serve as sources or what trade conditions will look like 12 to 24 months from now. That volatility is the core challenge.

For years, the default approach was to source from wherever costs were lowest. That model is no longer sustainable on its own. Companies are now asking how they can build in resilience through dual sourcing, qualified backup suppliers, or greater transparency into their tier-two and tier-three suppliers without restructuring their cost base so dramatically that it compromises affordability or patient access.

Is the Industry Actually Moving Manufacturing Back to the United States?

Not wholesale, and I think it's important to be clear about that. Some selective onshoring is happening, and it makes sense in certain contexts. But the more realistic trend is regionalization combined with supply chain redundancy, building in alternatives rather than relocating everything domestically. Not everything can or should be reshored here. The real work is determining which parts of the supply chain are critical enough to justify higher cost or redundancy and then making those changes in a way that doesn't undermine the affordability and availability of medicines for patients. That balance is difficult, and it requires careful, strategic thinking rather than a reactive response to political pressure.

What Will FDA Be Looking for From Companies as They Adapt Their Supply Chain Strategies?

The FDA is not looking for slogans about resilience. Companies need to be prepared to demonstrate through evidence how they are making resilience a reality. That means having current supply chain maps, formal risk assessments, credible alternate-source strategies, realistic regulatory pathways for supplier or site changes, and governance mechanisms that define when and how the organization responds as risks escalate.

A credible resilience strategy must also be quality-led, not simply procurement-driven. For the FDA, the central question will be whether a company understands its vulnerabilities and has a controlled, documented, and regulatorily realistic plan to protect patients if a supplier, site, country, or logistics route becomes unavailable.

What Regulatory Shifts Should Professionals Expect?

Three things stand out. First, there will be more data-driven FDA oversight of supply chains. The agency wants to see what companies are doing more than what they intend to do. Second, companies should anticipate more risk-based and globally consistent inspection oversight for anything that is globally outsourced. Third, there will be stronger expectations around formal quality risk management. Quality must be built in from the start. The FDA's focus is patient safety, and if your systems are not oriented around that, that is where you will run into serious problems.

What Is Your Overall Message to Companies Navigating This Environment?

Act now and act with specificity. The uncertainty in the current environment is not going away, and the companies that will be best positioned, both commercially and regulatorily, are the ones that treat supply chain resilience as a quality and patient safety imperative, not an external compliance requirement. FDA will reward the companies that can demonstrate they understand their risks and have taken documented, defensible steps to address them.

Escalating tariffs intersect with geopolitical instability, supplier concentration, inspection vulnerabilities, and drug-shortage exposure to force a rethink of pharma supply chains. Unpredictable policy trajectories are as disruptive as direct cost impacts, complicating 12–24 month manufacturing and sourcing commitments. Rather than broad US reshoring, the dominant response is regionalization plus redundancy, emphasizing dual sourcing and deeper tier-2/3 visibility while preserving affordability and access. FDA expectations are shifting toward evidence-based demonstrations of resilience, quality-led governance, formal risk management, and regulatorily executable pathways for supplier and site changes.

Molly Klote, Klote Medical Research Advisors, discusses how pharma must move beyond tariff-driven reactions to build evidence-based, quality-led supply chain resilience that satisfies FDA scrutiny and protects patient access.

Q&A: Molly Klote on Dual Sourcing, Regionalization, and the New Pharma Normal

GSK Acquires Nuvalent to acquire their highly selective inhibitors targeting ROS1 and ALK gene alterations

GSK has entered into an agreement to acquire Nuvalent, a Boston-based clinical-stage biopharmaceutical company, for $10.6 billion, marking one of the more significant oncology deals of 2026.

 The transaction centers on two late-stage kinase inhibitors, zidesamtinib and neladalkib, both are currently under FDA review with potential approval decisions later in 2026. The deal reflects a broader trend in pharmaceutical dealmaking: acquiring programs with clinically validated targets that address measurable gaps in efficacy or tolerability relative to existing standard-of-care therapies.

What Makes These Compounds Distinct from Existing Therapies?

Zidesamtinib and neladalkib are highly selective inhibitors targeting ROS1 and ALK gene alterations, respectively, in non-small cell lung cancer.

 Both have received FDA Breakthrough Therapy and Orphan Drug designations. Their clinical profiles are built around high target selectivity, durable response rates, improved tolerability compared to earlier-generation inhibitors, enhanced blood-brain barrier penetration, and broader mutation coverage.

Non-small cell lung cancer with ROS1 or ALK alterations primarily affects non-smoking adults between 40 and 50 years old.

 Current therapies in this space are associated with resistance mutations and side effects including metabolic and neurologic events that limit long-term use. The new compounds aim to extend effective treatment duration while reducing the adverse event burden.

Data for both assets were presented at major oncology conferences in 2025 and 2026, lending the programs a degree of clinical credibility ahead of their anticipated regulatory decisions.

 Target action dates are set for September 18 for zidesamtinib and November 27 for neladalkib.

How Will This Reshape GSK's Development and Commercial Infrastructure?

From a pipeline architecture standpoint, GSK is positioning this acquisition as a platform play in lung cancer rather than a single-asset transaction. The deal also includes NVL-330, a HER2 inhibitor in phase I trials for HER2-altered non-small cell lung cancer.

 GSK intends to build on this foundation using its own B7-H3 antibody-drug conjugate, currently in phase III development, creating a multi-asset lung cancer franchise.

Both lead assets are small molecules developed using structure-based drug design, a modality that generally offers more established manufacturing pathways than biologics or cell-based therapies.

 Should the FDA approvals come through in 2026 as anticipated, rapid commercial-scale production planning will need to be underway well in advance.

Under the agreement terms, GSK will offer $124 per share in cash, a 40% premium to Nuvalent's last closing price.

The transaction is funded through a combination of new and existing debt facilities and cash and is expected to close in the third quarter of 2026, pending regulatory clearance and shareholder tender conditions.

How Does the GSK-Nuvalent Deal Fit into the Broader Oncology Dealmaking Landscape?

The GSK-Nuvalent acquisition is one of several major oncology transactions announced in recent weeks, reflecting sustained industry confidence in targeted therapies with clinically validated mechanisms.

Johnson & Johnson separately agreed to acquire Firefly Bio for $1 billion

, targeting its degrader antibody conjugate platform designed to reach KRAS-driven tumors.

Roche, meanwhile, entered a licensing and collaboration agreement with Nurix Therapeutics valued at up to $3 billion

 to co-develop a BTK degrader for blood cancers.

 These deals suggest that large pharmaceutical companies are prioritizing platform acquisitions and multi-program collaborations over single-asset transactions as the dominant model for pipeline expansion.

GSK. GSK enters agreement to acquire Nuvalent, Inc. Press Release. June 9, 2026. 

https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-nuvalent-inc

Johnson & Johnson. Johnson & Johnson to acquire Firefly Bio, Inc. to expand oncology pipeline with novel degrader antibody conjugate platform. Press Release. June 8, 2026. 

https://www.jnj.com/media-center/press-releases/johnson-johnson-to-acquire-firefly-bio-inc-to-expand-oncology-pipeline-with-novel-degrader-antibody-conjugate-platform

Roche. Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology. Press Release. June 8, 2026. 

https://www.roche.com/media/releases/med-cor-2026-06-08

GSK will acquire Nuvalent for $10.6B to secure late-stage, highly selective ROS1 and ALK inhibitors in NSCLC, with FDA action dates anticipated in September (zidesamtinib) and November 2026 (neladalkib). Both programs emphasize durability, CNS penetration, tolerability, and mutation coverage versus earlier-generation TKIs in younger, often never-smoking populations. The transaction also adds an early HER2 program (NVL-330) and supports a broader lung cancer franchise strategy alongside GSK’s phase III B7-H3 ADC. Deal financing is debt-plus-cash, at a 40% premium.

GSK boosts oncology pipeline with Nuvalent acquisition, advancing FDA-designated ROS1/ALK inhibitors for NSCLC and expanding kinase inhibitor drug development in lung cancer.

GSK Acquires Nuvalent for $10.6 Billion in Lung Cancer Push

Nicholas Richardson is vice president of clinical development at Precision for Medicine.

The development of and access to radiopharmaceuticals depends on a well-defined strategy. 

 spoke with Nicholas Richardson, vice president of clinical development at Precision for Medicine, to find out more about how these products are used to treat cancer and what developers should know about bringing these treatments to patients.

What is unique about the use of radiopharmaceuticals to treat cancer?

 For radiopharmaceuticals, we're talking about products that have the precision of targeted therapy with the cytotoxicity of radiation that is able to be delivered systemically. And what this does is allows for an effect at the site of disease, given all these novel components coming together in one therapeutic product.

And so, when we think about radiopharmaceutical programs, the other thing that is unique about them is they often pair diagnostic and therapeutic aspects to their product. And what that does is it supports diagnostic imaging for the patient, real-time biodistribution assessment, and personalized dose optimization based on dosimetry, which again, is very unique to radiopharmaceuticals. And then lastly, we think about radiopharmaceuticals in that they really do need a specific operational and infrastructural dependence.

Because they are linked to nuclear medicine infrastructure, they have imaging capabilities that are needed to be able to conduct trials for radiopharmaceuticals. And then you also need that radiation safety expertise.

And so, these are really the reasons that set radiopharmaceuticals apart when you think about them and the development of these products compared to other drug products for patients with cancer.

What are some of the specific challenges associated with patient access to radiopharmaceuticals?

Radiopharmaceuticals merge the precision of targeted agents with systemically delivered radiation cytotoxicity, often integrating diagnostic and therapeutic functions. This theranostic paradigm enables imaging-based biodistribution assessment and individualized dosimetry-driven dosing. Patient access is constrained by decay-limited, just-in-time supply chains, nuclear medicine infrastructure requirements, dual regulatory oversight (drug plus radiation), and shortages of trained personnel. Development programs should incorporate access planning early through center-of-excellence site selection, scalable isotope production and distribution, and patient-centric scheduling that balances inpatient needs with outpatient opportunities and half-life–driven monitoring.

Nicholas Richardson, vice president of clinical development at Precision for Medicine, explains why radiopharmaceuticals are unique for patients with cancer and what makes them challenging to develop for those patients. 