Susan Haigney

The pharmaceutical industry experienced a complicated 2025, with challenges arising in a variety of areas including supply chain security and market demand. 

 imposed by the Trump administration in the United States, geopolitical unrest, and 

 created a web of complexity that required the right talent, investments in technology, and embracing innovation.

, takes a look back at the past year and gives his opinion on which trends will carry over from 2025 into 2026.

PharmTech: Which trends did you see or experience in 2025 that you believe impacted the pharmaceutical industry the most?

 In 2025, we witnessed a fundamental shift: pharma finally began treating clinical operations as a strategic advantage rather than a necessary evil. AI emerged as a true differentiator in accelerating development timelines by streamlining administrative workflows, enhancing protocol design, improving site selection, and enabling precision patient matching at scale.

At the same time, the convergence of decentralized trial infrastructure and real-world data unlocked entirely new operational models. Sponsors can recruit patients nationwide through telemedicine, capture continuous data via connected devices, and integrate EHR [electronic health records] insights directly into trial databases with unprecedented ease.

In an environment where competitors often pursue similar therapeutic targets, success is no longer defined solely by marginal differences in the science. It hinges on who can execute faster while maintaining rigorous scientific and operational integrity.

What strategies are most effective in attracting and retaining top talent, especially as technological advancements shift frontline and technical roles?

It goes beyond compensation. It starts by creating an environment where people can do meaningful work with a tangible impact. When teams understand how their work contributes to better research or improved patient outcomes, engagement and retention naturally improve. Talented individuals also crave autonomy in the workplace. Small, empowered teams and room to experiment help people feel trusted and motivated.

How does the industry plan to maintain competitive advantage as patent cliffs, rising generic-drug competition, and pricing reforms intensify margin pressures?

Maintaining competitive advantage requires shifting from a model driven primarily by commercial exclusivity to one grounded in operational excellence and innovation throughout the development lifecycle. As patent cliffs and pricing reforms reduce the buffer that once protected returns, companies are increasingly focusing on improving the efficiency and predictability of R&D. This includes adopting technologies that shorten development timelines, redesigning trial processes to reduce operational waste, and making earlier, clearer decisions about which programs deserve continued investment.

Competitive advantage is also retained through obtaining real-world evidence, developing patient-centric delivery models like direct-to-consumer programs and companion apps that present a drug product as part of a holistic experience or treatment for a patient. Companies are also looking upstream by strengthening pipelines through strategic partnerships. The companies that adapt to these pressures will be those that prioritize efficiency, evidence generation, and patient relevance.

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

Looking ahead to next year, AI will continue to move from experimentation to practical integration, particularly in protocol generation and design, patient stratification, and decision support. We’ve already seen transformational improvements across the industry with advanced technologies. I believe there will also be increasing pressure for evidence that reflects real clinical use, especially as payers and regulators become more value focused. This is driving innovation in continuous data collection, long-term follow-up, and integrated evidence strategies that span from early clinical development through post-market evaluation.

, an end-to-end, full-service contract research organization running radically faster, more reliable clinical trials for life science pioneers. Beckwith was previously a venture capital investor and partner to biotech and digital health companies. He took part in the COVID-19 vaccine trial as a volunteer where he saw how trial outcomes could be improved by focusing on patient experience, ultimately leading to the formation of Lindus Health.

Articles

The pharmaceutical industry faced a challenging 2025, marked by supply chain issues, geopolitical tensions, and rapid technological advancements. A significant shift occurred as clinical operations were recognized as strategic assets, with AI playing a crucial role in streamlining processes. Decentralized trials and real-world data integration emerged as new operational models. To maintain competitive advantage amid patent cliffs and pricing pressures, companies focused on operational excellence and innovation. Looking to 2026, AI's integration and evidence-based strategies will drive innovation and drug development.

Meri Beckwith, Co-CEO of Lindus Health, provides a look at how trends that developed in 2025 will impact the pharmaceutical industry in 2026. 

Quick Execution with Operational Integrity

Embryonic stem cells , Cellular therapy , Regeneration , Disease treatment | Image Credit: ©Giovanni Cancemi -stock.adobe.com

On Jan. 5, 2026, the Fujifilm Life Sciences Group announced that FUJIFILM Irvine Scientific has been officially rebranded as 

, as of Jan. 1, 2026 (1). The company has been providing cell culture solutions, such as of cell culture media, feeds, specialty chemicals and reagents, single-use technologies, and human-induced pluripotent stem cell capabilities for the life sciences market for 55 years, and the name change better aligns with the company’s history.

“All of us at FUJIFILM Biosciences take immense pride in being a people-focused company that empowers our colleagues to create an exceptional customer experience,” said Brandon Pence, president and chief operating officer, FUJIFILM Biosciences, in a press release (1). “We utilize our 55-year legacy of deep industry knowledge to collaboratively develop innovative solutions and technologies that are supplied from our global network of manufacturing facilities. With this approach and our ongoing investments, we look ahead to a strong future with our employees, customers, and partners around the world.”

What does the future hold for FUJIFILM Biosciences?

spoke with the editors of PharmTech Group in June 2025

 in advance of BIO 2025 about the future of the company (2).

“I think it's impressive when you look back over the last 15 years of the entrance into life sciences that FUJIFILM has made, and then the investment that has continued, and will continue into the future around how we add value in this space," Pence said in the interview. "Organically building out manufacturing facilities and supply chain routes to our customers across three different critical geographies has been an important part to how we've driven success and how we see the future shaping up.

“One of the areas that I think is impressive about the investment at FUJIFILM is in looking at areas that add value and have a direct impact on the quality of biologics that are being manufactured. Looking at cell culture and the business that was acquired in 2018 and now into the bio CDMO space, when you think about biologics, the cell itself is the therapy, or it's producing the therapy. And so, FUJIFILM has taken an approach of what is driving improvements in, and the quality of, the biologic coming out of the process, and then ultimately ending up with patients.”

FUJIFILM made some significant investments in 2025. In April 2025, FUJIFILM Biotechnologies 

 for more than $3 billion to provide production of Regeneron’s products for a period of 10 years at its large-scale manufacturing facility in North Carolina, which the company planned to expand to accommodate the agreement.

“As the United States is the largest market for biopharmaceuticals, FUJIFILM Corporation has made significant investments in the US of about $4 billion in building world-class biopharmaceutical manufacturing sites, life sciences capabilities, and growing its technical talent,” Toshihisa Iida, director, corporate vice president, general manager of Life Sciences Strategy Headquarters and Bio-CDMO Division, FUJIFILM Corporation, Japan, said in a press release about the deal (3). “Additionally, through our previously announced expansion efforts, we are pleased to share that we’ve already added 500 new positions as part of our overall goal of creating 1400 new jobs in North Carolina by 2031.”

“I think as you look at FUJIFILM going forward, our foundation is in the reagents, materials, and the processes that directly impact performance in bioprocessing,” Pence continued in the interview (2). “And as we look to the future, both organically and inorganically, investments that will continue to be in that space will add value to our customers. And then keeping in mind that we're looking at ways in which we can support them in the regions they're operating in or in the regions where their patients are. And so, you'll see manufacturing facilities across the entire organization in life sciences spanning Europe, the US, Asia Pacific, and beyond that. So, it's an exciting time to be a part of FUJIFILM, and I think that the areas that we're focused upon are truly being recognized by our customers.”

FUJIFILM. FUJIFILM Irvine Scientific Now Officially FUJIFILM Biosciences. Press Release. Jan. 5, 2026. 

https://fujifilmbiosciences.fujifilm.com/us/blog/fujifilm-irvine-scientific-now-officially-fujifilm-biosciences.html

Lavery, P. BIO 2025: Building Relationships Amid a Rebrand. 

https://www.biopharminternational.com/view/bio-2025-building-relationships-amid-a-rebrand

FUJIFILM. FUJIFILM Biotechnologies and Regeneron Sign a 10-Year U.S. Manufacturing Agreement Valued at Over $3 Billion. Press Release. April 22, 2025.

 https://fujifilmbiotechnologies.fujifilm.com/about/news/fujifilm-diosynth-biotechnologies-and-regeneron-sign-10-year-us-manufacturing-agreement/

FUJIFILM Irvine Scientific has rebranded as FUJIFILM Biosciences, reflecting its 55-year legacy in cell culture solutions. The company emphasizes its commitment to innovation and customer experience, leveraging its global manufacturing network. Significant investments include a $3 billion agreement with Regeneron to expand biopharmaceutical production in North Carolina, aiming to create 1,400 jobs by 2031. FUJIFILM's strategic focus on reagents, materials, and bioprocessing performance underscores its dedication to supporting customers across key global regions, enhancing the quality of biologics and expanding its life sciences capabilities.

FUJIFILM Irvine Scientific has changed its name to FUJIFILM Biosciences to better align with the company’s work in cell culture media manufacturing. 

FUJIFILM Irvine Scientific Becomes FUJIFILM Biosciences

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

 promoted its five-cubic-foot double cone tumbler blender for small- to mid-scale powder processing. The Ross Double Cone Tumble Blender Model DCB-5 is designed to work for high-precision processes using high-density materials.

What makes this model provide repeatable homogeneity?

The blender features a large, hinged vessel cover for proper sealing and access for additions and cleaning and a stainless-steel type 305 jacket rated for 50 pounds per square inch gauge to heat or cool batches (1). At full speed, the blender is capable of 24 rpm and is powered by a direct-drive hollow-bore reducer and a 3 horsepower (HP) totally enclosed, fan-cooled brake motor suitable for variable frequency drive (VFD) operation. Effective deagglomeration is achieved via a 2 HP intensifier bar with dual six-inch chopper blades that turn up to 1520 rpm, and the double cone vessel is rated for vacuum up to 29.5 Hg.

A wide, stable base with carbon steel support frame, pad plates for mounting, and integrated guardrails create safe distribution of forces, according to the company. There is 40 inches of clearance, provided by the removable legs, below the discharge point, which is has a six-inch butterfly valve with a tri-camp outlet.

Vacuum blending and drying are provided via an oil-lubricated rotary vane vacuum pump that is mounted inside the support frame and plumbed to the blender by a rotary union (1). A seven-inch color touch screen user interface, internally mounted VFDs for the blender and intensifier bar, and a dedicated motor starter provide controls management.

How important is equipment maintenance and/or replacement in pharma?

Blenders and mixers are extensively used in small-molecule drug manufacturing. Switching out older equipment for new and upgraded models, like the Ross Double Cone Tumble Blender, can be part of a pharmaceutical company's equipment maintenance plan. But how can a company determine if new equipment is necessary? 

Because most pharmaceutical manufacturing occurs under good manufacturing practices (GMPs) aligned with regulatory guidelines, the equipment used in these facilities must be regularly evaluated, maintained, and replaced when necessary (2, 3). A review of equipment and facilities should be part of a company’s quality management system, and a risk-based approach to prevent equipment problems and control contamination can be key to meeting GMP requirements (4).

Routine inspections, equipment calibration, and equipment cleaning should be performed and documented. “Beyond regulatory expectations, proactive maintenance also drives operational efficiency and strengthens credibility with regulators. This enables companies to stay competitive while protecting patient safety,” Pranav Vengsarkar, PhD, director, process R&D and site head at Avantor, said in an interview with 

AI and digital monitoring can assist in the prediction of needed updates and incorrect calibration, Dr. Vengsarkar asserted. “This approach supports GMP compliance and minimizes downtime. It also reflects smart manufacturing—leveraging data to maintain equipment performance, improve efficiency, and scale to new modalities without compromising product quality or patient safety.”

Companies should perform internal audits and risk assessment so ensure their operations are up to current GMP standards, according to Dr. Vengsarkar (4).“Drivers include new technologies, scaling across modalities, or updated compliance requirements,” Dr. Vengsarkar notes. “These upgrades safeguard product quality and patient safety while also improving efficiency, flexibility, and adoption of innovative processes. A periodic review of a GMP facility is a critical process to ensure it remains in a validated state and compliant with current regulations.”

Charles Ross & Son. ROSS DCB-5 Double Cone Tumble Blender Achieves Superior Homogeneity in Heavy-Duty Applications. Press Release. December 2025.

FDA. Current Good Manufacturing Practice (CGMP) Regulations. 

https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturing-practice-cgmp-regulations

https://www.ema.europa.eu/en/human-regulatory-overview/research-development/compliance-research-development/good-manufacturing-practice

Haigney, S. How a “Plan, Prevent, Prove” Approach Helps Avoid Facility and Equipment Problems. 

https://www.pharmtech.com/view/how-a-plan-prevent-prove-approach-helps-avoid-facility-and-equipment-problems

The Charles Ross & Son's DCB-5 Double Cone Tumble Blender is engineered for precision in small to mid-scale powder processing, featuring a robust design for repeatable homogeneity. Key components include a stainless-steel jacket for temperature control, a high-speed intensifier bar for deagglomeration, and a vacuum system for blending and drying. In pharmaceutical manufacturing, maintaining equipment under GMP guidelines is crucial for operational efficiency and regulatory compliance. Proactive maintenance, aided by AI and digital monitoring, ensures equipment performance, minimizes downtime, and supports product quality and patient safety.

ROSS’s DCB-5 Double Cone Tumble Blender can handle high-density materials and provides repeatable homogeneity and powder blending properties, according to the company. 

Double Cone Tumble Blender Provides Homogeneity in Heavy-Duty Applications

Industry Outlook 2026: The Impact of Novel Therapies

 preparation for the new year, the editors speak with experts in the industry to find out which trends happened in the past year that they think impacted the industry the most and will, they believe, continue into the new year. Campbell Bunce, chief scientific officer at Abzena, pointed to two trends in 2025 that stood out: the influx of novel therapies and onshoring of manufacturing facilities to the United States.

Next-generation biologics, such as bispecifics, fusion proteins, and multi-specifics, have multiple functionalities that provide “more bang for your buck in one molecule”. There have also been more approvals of antibody drug conjugates (ADCs) in the past year, according to Bunce, which creates excitement in the industry.

“But one thing that's particularly exciting, I would say, on the sort of drug type front, is antibody-oligo conjugates [AOCs],” Bunce says. “They're particularly driven by companies like Avidity and Dyne, who are really spearheading these next generation by conjugates, where we're using antibodies to target oligonucleotides into cells that will impact certain sort of disease inducing pathways. We're seeing particular excitement around using these types of drugs for muscular dystrophies.”

Bunce points out Novartis’ acquisition of Avidity Biosciences, a biopharmaceutical company located in San Diego that focuses on drugs that enable RNA delivery to muscle, in October 2025 as an example of the excitement surrounding these therapies. Avidity is pioneering AOCs, according to Novartis, for genetic neuromuscular diseases and will provide programs to advance Novartis’ neuroscience strategy (1).

On the onshoring front, Bunce sees a shift toward manufacturing drugs closer to home. “Onshoring manufacturing capabilities in the US has been something that we've seen significant activity around,” Bunce explains. “Abzena built into the US some years ago, kind of deliberately as a deliberate promise to a shareholder base at the time, and we find ourselves really well positioned to sort of capture a lot of the benefits that we're seeing in that sort of migration of manufacturing into the US, particularly around ADCs.”

Novartis. Novartis Agrees to Acquire Avidity Biosciences, an Innovator in RNA Therapeutics, Strengthening its Late-Stage Neuroscience Pipeline. Press Release. Oct. 26, 2025. https://www.novartis.com/news/media-releases/novartis-agrees-acquire-avidity-biosciences-innovator-rna-therapeutics-strengthening-its-late-stage-neuroscience-pipeline

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 Campbell Bunce, I'm the Chief Scientific Officer at Abzena. Abzena is CDMO with significant front end sort of R and D capability that supports discovery, design, the candidate selection for for manufacture. And you know, as a CDMO, we can support that manufacturer through to clinical studies, and we are planning now to build out interface three and commercial capabilities as well. Our focus very much is on biologics and by conjugates. So a lot of what we're seeing these days is, you know, next generation molecules from essentially building on the on the shoulders of the success of antibodies, as well as ADCs, antibody drug conjugates that are going to be extremely successful in cancer. I've been with the business 10 years prior to that, I spent 18 years or so in biotech, and I came to Abzena when we were starting to build out from early R and D capability and into our GMP manufacturing capabilities. And we do that, of course, two territories, one in the UK for the front end R and D services, and two sites in the US and one in Bristol, near Philadelphia, for chemistry and ADC manufacture, and one in San Diego, where we do biologics scale manufacture there as well.

Which trends Did you see or experience in 2025 that you believe impacted the pharmaceutical industry the most? 

I think there are two trends in the pharmaceutical industry that we've noticed have an impact on the industry in general. One is the evolution of drugs. Drug development itself, you know, the types of drugs.

So as I mentioned, you know, we're seeing sort of next generation biologics. So bispecifics, fusion proteins, multi specifics that build into the biologic multi functionalities. So you know, bigger bang for your buck in the one molecule. And so we're seeing evolution of those, as well as the continuing excitement around antibody drug conjugates. So a few more approvals over the last year or so in that area, and we are really well positioned to support that, both from the design all the way through to manufacturing, GMP manufacture of those complex molecules, where we're bringing chemistry and sort of biology together. But one thing that's particularly exciting, I would say, on the sort of drug type front, is antibody oligo conjugates. We're seeing a lot of exciting activity. They're particularly driven by, you know, companies like avidity and dying, who are really spearheading these next generation bioconjugates, where we're using antibodies to target oligonucleotides into cells that will impact certain sort of disease inducing pathways. So we're seeing particular excitement around using these types of drugs for muscular dystrophies. And actually that's led to a guest, Novartis recently in the news, acquiring avidity for $12 billion so that's a significant amount of money, which kind of I think, goes to the sort of exciting nature of utilizing this type of approach for difficult to treat disease indications. So that's one thing. The other is, of course, across the geopolitical side of things, where we are seeing a genuine shift towards where folks are looking to manufacture drugs. Big focus in the US, of course. So on shoring manufacturing capabilities in the US has been something that we've seen significant activity around for us at Abzena, you know, this is, you know, part look, but part by design. You know, we built into the US some years ago, kind of deliberately as a deliberate promise to a shareholder base at the time, and we find ourselves really well positioned to sort of capture a lot of the benefits that we're seeing in that sort of migration of manufacturing into the US, particularly around ADCs. And there's not a lot of folks can actually manufacture ADCs to scale,and we're one of those companies that can do that, right?

Videos

PharmTech spoke with Campbell Bunce, chief scientific officer, Abzena to find out which trends in 2025 impacted the industry the most.

Dividing cancer cells - 3D illustration | Image Credit: ©peterschreiber.media - stock.adobe.com

The field of cancer treatment saw a variety of advancements in 2025, from new dedicated centers to approved treatments to novel therapies. In this overview, 

 takes a look back at significant oncology news in 2025.

What cancer drug development and approvals happened in January?

The focus on lung cancer was particularly sharp, highlighted by the European Commission’s (EC) approval on January 21 of 

Johnson & Johnson’s Lazcluze (lazertinib) combined with Rybrevant (amivantamab)

 (1). This chemotherapy-free regimen was authorized as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC) (1).

Further advancing lung cancer care, the National Institute for Health and Care Excellence in England and Wales issued positive recommendations on January 22 

 (2). Imfinzi (durvalumab) was recommended for adults with untreated extensive-stage small cell lung cancer when added to standard chemotherapy, having shown a sustained overall survival benefit (2). Tagrisso (osimertinib) was recommended as an adjuvant treatment option following complete tumor resection for adults with stage IB to IIIA NSCLC who have the specific EGFR mutations (2).

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) also 

 for approval in January in the European Union (3). These included Datroway (datopotamab deruxtecan) for breast cancer and Tivdak (tisotumab vedotin) for recurrent or metastatic cervical cancer (3).

 announced a collaboration on January 2 to advance IBI3009, a novel delta-like ligand 3-targeted antibody drug conjugate candidate for advanced SCLC (4).

How did access to cancer drugs expand in February?

The clinical-stage radiopharmaceutical company 

 an oversubscribed $112 million Series C financing round in February (5). This funding was to be used to accelerate clinical development of its radionuclide therapy pipeline and expand the company's manufacturing capacity.

AstraZeneca’s Lynparza (olaparib) was accepted

 for use within National Health Services Scotland by the Scottish Medicines Consortium. This acceptance provided a new treatment option for adults with human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer who possess germline BRCA1 or BRCA2 mutations and have previously undergone chemotherapy (6).

What regulatory approvals were granted in the spring?

 for extension of their therapeutic indications (7). Notably, a positive opinion was issued for Opdivo (nivolumab) for a perioperative regimen, including neoadjuvant Opdivo and chemotherapy followed by surgery and adjuvant Opdivo, for resectable NSCLC in patients with PD-L1 expression. CHMP also extended indications for the cancer treatments Bosulif (bosutinib) and Calquence (acalabrutinib). The biosimilar Jubereq (denosumab) received a positive opinion for preventing skeletal-related events in adults with advanced malignancies involving bone.

full approval to Bayer’s Vitrakvi (larotrectinib

), a first-in-class tropomyosin receptor kinase (TRK) inhibitor (8). This approval is specifically for treating solid tumors in both adult and pediatric patients with a neurotrophic TRK gene fusion.

What infrastructure investments occurred in May?

On May 1, 2025, Aviva Capital Partners and Socius announced a 

 to develop a new cancer research and treatment center in Sutton, London, located at the London Cancer Hub (9). The project aims to accelerate cancer research and contribute to the discovery and development of new diagnostic technologies and cancer drugs.

AstraZeneca announced on May 6, 2025, that 

Calquence (acalabrutinib) received approval in the EU

 (10). Acalabrutinib, a second-generation Bruton’s tyrosine kinase (BTK) inhibitor, was approved in combination with bendamustine and rituximab for treating adults with previously untreated mantle cell lymphoma who are ineligible for an autologous stem cell transplant.

CellCentric completed a $120 million Series C funding round

 to advance inobrodib, a potential first-in-class oral p300/CBP inhibitor for multiple myeloma. This agent targets the reduction of transcription factors MYC and IRF4 to address therapy resistance in patients with relapsed or refractory multiple myeloma (11).

2025 Oncology Milestones: A Year of Breakthroughs (Created using NotebookLM)

BioNTech announced plans on June 12, 2025, to acquire CureVac

 in an all-stock transaction valued at approximately $1.25 billion (12). This acquisition aimed to accelerate the development and manufacturing of next-generation messenger RNA (mRNA) immunotherapies for oncology by combining the strengths of the two German biotechnology companies.

 included the following recommendations for market authorization (13):

• Zemcelpro (dorocubicel/unexpanded umbilical cord cells) received conditional marketing authorization for treating adults with hematological malignancies who require allogeneic hematopoietic stem cell transplantation when no other suitable donor cells are available.

• The orphan drug Ogsiveo (nirogacestat) was approved for the treatment of adults with progressing desmoid tumors.

• The biosimilar Vivlipeg (pegfilgrastim) received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy.

Priothera was awarded nearly €1.7 million

 in non-dilutive funding via a French government innovation competition (i-Nov) (14). This funding will support a clinical program evaluating its novel oral S1P receptor modulator, mocravimod, as an addition to commercial CAR-T cell therapies for hematologic malignancies.

 oncology services contest at the BIO 2025 convention in June (15). The contest aims to accelerate the development of recombinant protein-based cancer therapies, offering the winner credit toward Mabion’s end-to-end CDMO services.

Were there advancements in radiopharmaceutical therapies?

 concerning oncology therapeutic radiopharmaceuticals (RPTs) (16, 17). 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development

 was created to help drug sponsors identify an optimized dosage for RPTs used in oncology indications during clinical development.

Radiopharmaceuticals have evolved from treating superficial tumors to treating internal tumors. FDA's 

 an increasing need for drug sponsors to demonstrate a better understanding of pharmacodynamics, potential toxicity liabilities, and the therapeutic window for these new systemically injected therapies, alongside designing clinical trials to gather data on dosimetry (17).

 that it entered into agreements with Hengrui Pharma to develop treatments for several therapeutic areas, including new therapies for GSK’s oncology pipeline (18).The collaboration included 11 programs for which Hengrui Pharma will lead development through the completion of Phase I trials.

What strategies for research and manufacturing happened?

In September, the Phase IIa clinical trial for the small-molecule immunotherapy drug HTL0039732 was launched by 

 (19). This investigational therapy targets the EP4 receptor to address tumor-mediated immunosuppression, aiming to boost responses in resistant solid tumors. Also focused on novel approaches, 

Medicines Discovery Catapult (MDC) and Crown Bioscience

 announced a strategic partnership to create an integrated platform to accelerate the development of radiopharmaceuticals (20).

 for medications to treat breast, bladder, and gastric cancers (21). Studies include arms of trials for trastuzumab deruxtecan (Enhertu), a Phase III trial of datopotamab deruxtecan (Datroway), and final overall survival results for perioperative durvalumab (Imfinzi).

What developments were at the end of the year?

United Kingdom National Nuclear Laboratory and MDC

 co-led a project focused on developing next-generation cancer treatments known as Targeted Alpha Therapies (22).

 (teclistamab-cqyv), used in combination with daratumumab for relapsed or refractory multiple myeloma, was awarded FDA’s Commissioner’s National Priority Voucher (23) one day after Phase III MajesTEC-3 trial data were released showing the Tecvayli combination produced superior outcome. This voucher offers the opportunity to accelerate drug review to just 1-2 months.

Indivumed and the Wilmot Cancer Institute

 at the University of Rochester Medical Center launched a joint venture to accelerate the development of novel cancer therapeutics (24). This collaboration focuses on patient-centric R&D, initially targeting advanced solid cancers.

Johnson & Johnson. European Commission Approves Lazcluze (lazertinib) in Combination with Rybrevant (amivantamab) for the First-Line Treatment of Patients with EGFR-Mutated Advanced Non-Small Cell Lung Cancer. Press Release. Jan. 21, 2025.

AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025

EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025. Press Release. Jan. 31, 2025. 

Innovent Biologics. Innovent Enters into Exclusive Global License Agreement with Roche for Novel DLL3 Antibody Drug Conjugate. Press Release. Jan. 2, 2025. 

AdvanCell. AdvanCell Successfully Completes an Oversubscribed US$112M Series C Financing. Press Release. Feb. 3, 2025. 

AstraZeneca. Lynparza (olaparib) Accepted for Use in Scotland to Treat Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer After Chemotherapy. Press Release. Feb. 10, 2025. 

EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 24–27 March 2025. Press Release. March 28, 2025.

Bayer. US FDA Grants Full Approval of Vitrakvi (larotrectinib) for Adult and Pediatric Patients with NTRK Gene Fusion-Positive Solid Tumors. Press Release. April 10, 2025. https://www.pharmtech.com/view/bayer-announces-fda-s-first-full-approval-of-ntrk-inhibitor

Aviva. Aviva Capital Partners and Socius Submit Plans for £1 Billion Development to Create the World’s Leading Centre for Cancer Research and Treatment. Press Release. May 1, 2025. 

AstraZeneca. Calquence Plus Chemoimmunotherapy Approved in the EU as First and Only BTK Inhibitor for 1st-Line Mantle Cell Lymphoma. Press Release. May 6, 2025. 

CellCentric Secures $120 Million Investment to Advance Inobrodib for Treating Multiple Myeloma.

BioNTech Announces Strategic Transaction to Acquire CureVac in Public Exchange Offer

EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 16–19 June 2025. Press Release. June 20, 2025. 

https://www.pharmtech.com/view/six-biosimilars-part-of-ema-s-authorization-recommendations-in-june

Priothera Secures €1.7 Million i-Nov Funding by Bpifrance for Rare Blood Cancer Clinical Program.

Mabion. Mabion Launches €500,000 Services Contest to Support Next-Gen Oncology Breakthroughs. Press Release. June 17, 2025. 

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development. Draft Guidance for Industry

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-dosage-optimization-during-clinical-development

Haigney, S. The Impact of FDA’s Guidance on Clinical Trials for Radiopharmaceuticals. 

https://www.pharmtech.com/view/the-impact-of-fda-s-guidance-on-clinical-trials-for-radiopharmaceuticals

GSK. GSK and Hengrui Pharma Enter Agreements to Develop Up to 12 Innovative Medicines Across Respiratory, Immunology & Inflammation, and Oncology. Press Release. July 28, 2025. 

Nxera Pharma and Cancer Research UK Announce First Patient Dosed in Phase 2a Trial of Investigational Cancer Immunotherapy HTL0039732

Haigney, S. MDC and Crown Bioscience. Medicines Discovery Catapult and Crown Bioscience Form Strategic Global Alliance for Radiopharmaceutical Innovation. Press Release. Sept. 11, 2025. 

AstraZeneca Furthers Ambition to Redefine Cancer Care with First Data from Four Major Pivotal Trials at ESMO.

UK Nuclear Revolution Powers Next-Generation Precision Cancer Therapies.

FDA Proactively Awards National Priority Voucher Based on Strong Phase 3 Study Results. News release. FDA. December 15, 2025. Accessed December 15, 2025. 

https://www.fda.gov/news-events/press-announcements/fda-proactively-awards-national-priority-voucher-based-strong-phase-3-study-results

Indivumed and University of Rochester Medical Center Expand Collaboration for Patient-Centric Discovery of Novel Therapeutics.

In 2025, significant advancements in oncology included new drug approvals, infrastructure investments, and strategic collaborations. Key developments involved the approval of Johnson & Johnson's Lazcluze and Rybrevant for NSCLC, AstraZeneca's Imfinzi and Tagrisso for lung cancer, and Bayer's Vitrakvi for TRK gene fusion-positive tumors. Infrastructure investments included a £1 billion cancer research center in London. Strategic collaborations, such as BioNTech's acquisition of CureVac, aimed to enhance mRNA immunotherapies. The FDA issued guidance on radiopharmaceuticals, and new initiatives focused on expanding oncology pipelines and innovative cancer therapies.

In this overview, PharmTech takes a look back at significant news in the development and approval of cancer treatment in 2025.

A Year of Advancements in the Treatment of Cancer

Quality Control Check: Scientist Using Digital Tablet Computer and wearing Protective Suit walks through Manufacturing Laboratory. Product Manufacturing: Pharmaceutics, Semiconductors | Image Credit: ©Gorodenkoff -stock.adobe.com

Construction and maintenance of manufacturing buildings and equipment fall under good manufacturing practices (GMPs) regulations (1–5). Pharmaceutical manufacturers can comply with these rules in the form of risk-based maintenance programs. 

® spoke with David Basile, VP Technical Operations, Americas, Hovione, about how companies can meet these requirements for GMP facilities and equipment and some of the common mistakes made when working toward compliance.

PharmTech: Which department is responsible for evaluating GMP equipment and facilities?

 The primary groups that participate in the evaluation of GMP equipment and facilities are engineering, maintenance, while quality assurance (QA) oversees compliance and approval. The best companies keep a few dedicated roles focused on maintenance planning and equipment reliability to drive best practices and implement the concepts of reliability centered maintenance.

Do regulatory inspectors request proof of maintenance? If yes, how should this be compiled and presented to the agency?

Yes, it's fairly standard for regulators to request proof of maintenance during GMP audits to verify compliance and confirm that we document all our activities related to the manufacturer and release of our products. You didn't do it, if you didn't document it. We compile detailed electronic records, including preventive maintenance schedules and calibration certificates. These should be presented in a clear and organized manner. In our recent inspections, we've seen that inspectors appreciate being able to get these records in a digital format for portability, and in case they'd like to reference them at their convenience.

Another element here is using what we call our computerized maintenance management system, or CMMS. This is a central repository for all of our maintenance-related activities. This is a key system in the efficient execution of any strong, compliant maintenance program. It provides detailed work order history, preventative maintenance instructions, asset specifications, scheduling, data and spare parts inventory, so we can see trends and pick up drift, for example, to clearly demonstrate that our assets remain in a state of high performance and quality operation. We'd really be flying blind without a CMMS. It's a tool that you can't live without in today's world of pharmaceutical maintenance.

What are the most common mistakes that manufacturers make when it comes to maintaining GMP equipment and facilities?

Failing to do a comprehensive criticality assessment and a risk-based approach, [which can result] in over or under maintenance [is one mistake]. Solely relying on time-based preventative maintenance versus proactive maintenance approaches such as precision alignment or lubrication [is another]. Today's teams need to incorporate conditions-based maintenance using technologies such as vibration analysis. They can no longer just fix things that break. They need to diagnose equipment, looking for early signs of failure before they fully develop. Other examples of this are ultrasound or infrared scanning to ensure motors and electrical systems are wired and operating properly.

Another mistake might be failing to consider design for maintainability during upgrades and not during the design phase. Adequate space and access to equipment, standardized tools, having the right pickups on equipment for condition-based maintenance [are important considerations]. I can't tell you how many times I've seen a filter housing or an instrument placed in the interstitial space above a ceiling with no way to safely access it. Failing to consider design for maintainability and not bringing maintenance in during the design phase is one mistake that people often make.

Not carving out a role for a dedicated maintenance planner is also a misstep. At Hovione, we have a dedicated reliability engineer and maintenance planner that help in the evaluation. This is critical to shorten the mean time to repair and ensure that all tools and supplies needed for the job are available and kitted to support fast first-time-right work order execution. These roles are game changers to the operation and take you from walking to sprinting, especially when candidates bring hands on experience. In fact, the best planners are usually seasoned mechanics.

One final failure we see often is not building in enough time for commissioning. The lifespan of equipment can be greatly influenced during the commissioning phase. This is where maintenance reliability starts. Too often, commissioning is rushed through, and equipment and preventive maintenance plans and required spare parts are not thoroughly assessed. In many cases, due to limited time, the CMMS system is not fully populated with key information to perform comprehensive root cause analysis.

FDA. Current Good Manufacturing Practice (CGMP) Regulations. 

WHO. Health Products Policy and Standards. WHO.int. 

https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards/gmp

Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Pharmaceutical manufacturers must adhere to GMP regulations through risk-based maintenance programs. Multiple departments, including engineering, maintenance, and quality assurance, are involved in evaluating GMP equipment and facilities. Regulatory inspectors often request maintenance documentation, which should be well-organized and preferably digital. A computerized maintenance management system (CMMS) is essential for tracking maintenance activities and ensuring high performance. Common mistakes include neglecting criticality assessments, relying solely on time-based maintenance, and failing to consider maintainability during design. Adequate commissioning time is crucial for equipment lifespan and maintenance reliability.

David Basile, VP Technical Operations, Americas, Hovione, highlights some common mistakes made by pharmaceutical companies when maintaining manufacturing facilities and equipment.