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There are many different approaches for assessing process parameter criticality, and assessing which process parameters have a significant impact on critical quality attributes (CQAs) is a particular challenge. Including an unimportant process parameter as a critical process parameter (CPP) in a control strategy can be detrimental. The authors present a statistical approach to determine when a statistically significant relationship between a process parameter and a CQA is large enough to make a practically meaningful impact (i.e., practical significance).

Statistical Tools to Aid in the Assessment of Critical Process Parameters

On 2 July 2025, the European Commission (EC) announced a “bold and ambitious” new life science strategy to position the European Union (EU) as the world’s most attractive place for life sciences by 2030 (1). This strategy aims to positively impact public health, create jobs, and provide access to innovative, environmentally friendly technologies, thereby enhancing the EU's strategic resilience. Previously, President Ursula von der Leyen emphasized that the strategy for European life sciences was a priority in the political guidelines for 2024–2029, stating that, “we need to put research and innovation at the heart of our economy” (2). In January 2025, the EC also published the Competitiveness Compass, focusing on how to improve research and innovation (R&I) to boost competitiveness and promote innovation in biotechnology (3).

The EC has identified several strengths, including the presence of biotech clusters and leading academic institutions that operate with freedom and encourage diversity and inclusion. Additionally, the EU ranks second behind the United States (US) in terms of global high-value patents, holding 18% share of patents compared to 39% in the US (1). The life science industry continues to invest heavily in R&I, with 15% of the world’s top firms residing in the EU (1). However, the EC also recognizes that to improve R&I it must overcome numerous barriers, such as turning scientific breakthroughs into real-world applications, improving scalability in the EU, creating a more cohesive R&D ecosystem, utilizing healthcare data and artificial intelligence (AI) more effectively, and streamlining the regulatory process to reduce complexity and duplication (1).

How will this strategy unlock Europe’s life science potential?

To overcome these issues and achieve the life science strategy goals, the EC has outlined three interconnected phases that will impact the entire life science value chain:

optimising the R&I ecosystem to achieve a globally competitive life science sector

ensuring smooth and rapid market access for life science innovations

boosting the uptake and use of life science innovation.

The EC recognizes the need to optimize the R&I ecosystem and develop a globally competitive life science sector. This can be achieved through enhanced cooperation, more efficient resource use, and a comprehensive approach that leverages data and AI, develops adequate skills, and promotes a sustainable industry. The EC will provide new incentives for long-term multi-country clinical trials and rare disease research, strengthen EU bioclusters, and establish a network of European Centres of Excellence in advanced therapy medicinal products (ATMPs) (4). The EC also aims to establish a European Life Sciences R&I Data Assembly to improve cross-regulatory collaboration and enhance the interpretation of data regulations (5).

To ensure life science innovations reach the market smoothly and quickly, the European Medicines Agency (EMA) will need to establish more innovation-friendly regulations, and the EU will need to increase investments from both private and public sectors. A number of legislative changes and regulatory reforms are underway to simplify and modernize the approval processes, such as the Biotech Act and the EU Pharma Package, and these should help make the EU’s regulatory environment more conducive to biotech innovation (5–6). For instance, the Biotech Act, announced in July 2024, seeks to tackle barriers through legislative and policy changes across five key areas: regulation, financing, scale, skills, and data (7).

The creation of new knowledge is an essential basis for a vibrant life sciences ecosystem and for the development of technologies and innovations. The EC will invest more than €10 billion (US$11.9 billion) in various programs, such as Digital Europe, EU4Health, and Horizon Europe, to help build this knowledge base (8–10). Meanwhile, Member States and stakeholders must strengthen their connection with citizens to help reduce misinformation and build trust. They also need to collaborate more closely with end-users to ensure solutions meet their specific needs. Overall, this should help accelerate the adoption and use of life science innovations (1).

What is the future outlook for EU life sciences?

Although the EU is currently in a strong R&I position, the biotechnology sector remains highly competitive. In recent years, China has increased biotech investments following regulatory reforms, improvements in domestic manufacturing, and the implementation of the Healthy China 2030 initiative (11). Additionally, the implementation of US–EU framework on an agreement for reciprocal, fair, and balanced trade has resulted in a 15% tariff on pharmaceutical raw ingredients, APIs, and completed drug products imported into the US. This has raised expenses for branded pharmaceuticals developed by multinational corporations and created market uncertainty. Private investors are concerned that potential investments may slow due to pricing pressures, and biotech companies may hesitate to invest in new projects to expand operations, given the risks associated with tariffs (12–13).

Now more than ever, the EU needs to boost its investment in the life sciences sector and tackle longstanding issues that have hindered the region’s competitiveness and limited European patients' access to the latest treatments. Plans to introduce the Biotech Act in 2025, along with enhanced support for small and medium-sized enterprises and improvements to the regulatory framework, are positive developments. The European Federation of Pharmaceutical Industries and Association (EFPIA) welcomed the news; although, Nathalie Moll, Director General of EFPIA, warned that “for Europe to truly lead, it needs to invest in medicines, attract investment, accelerate turning that investment into new treatments and economic growth, and ensure that patients across the EU have access to them at the same pace as other regions” (14).

EC. A Competitiveness Compass for the EU 

Five Facts to Know: EU Life Sciences Strategy

. https://www.edelmanglobaladvisory.com. 2 July 2025. https://www.edelmanglobaladvisory.com/insights/five-facts-know-eu-life-sciences-strategy

 May 2025. https://www.europarl.europa.eu/RegData/etudes/BRIE/2025/772866/EPRS_BRI(2025)772866_EN.pdf

The New EU “Pharma Package”: Preparing for the Trilogue

. Crowell.com. 30 June 2025. https://www.crowell.com/en/insights/client-alerts/the-new-eu-pharma-package-preparing-for-the-trilogues

European Commission Sets Out New EU Life Sciences Strategy

. 1 Aug. 2025. https://www.osborneclarke.com/insights/european-commission-sets-out-new-eu-life-sciences-strategy

EU4Health Programme 2021-2027–A Vision for a Healthier European Union

. EC.europa.eu. (accessed 30 Sept. 2025). https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en

(accessed 30 Sept. 2025). https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe_en

Healthy China 2030: A Vision for Health Care

. https://www.ispor.org/docs/default-source/publications/newsletter/commentary_health-care_china_2030.pdf

Assessing the Impact of Tariffs on the Pharmaceutical Industry

. https://www.pharmafocuseurope.com/articles/impact-of-tariffs-on-pharmaceutical-industry.

The Impact of Tariffs on the Life Sciences Industry - Healthcare & Life Sciences Blog

31 Mar. 2025. https://healthcarelifesciences.bakermckenzie.com/2025/03/13/the-impact-of-tariffs-on-the-life-sciences-industry/

EU Life Science Strategy: A Springboard for European Life Sciences

. Efpia.eu. 2 July 2025. https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/eu-life-science-strategy-a-springboard-for-european-life-sciences/

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

The European Commission has unveiled a comprehensive life science strategy to establish the EU as a global leader in life sciences by 2030. This initiative aims to enhance public health, create jobs, and foster innovation through environmentally friendly technologies. The strategy focuses on optimizing the research and innovation ecosystem, ensuring rapid market access for innovations, and increasing the adoption of life science advancements. Key measures include regulatory reforms, increased investments, and the establishment of European Centres of Excellence. The strategy also addresses challenges such as scalability, data utilization, and regulatory complexity.

The European Union aims to become the most attractive place for life science by 2030.

PharmTech News

European Union Life Science Strategy

Metabolic dysfunction-associated steatohepatitis (MASH) is a type of non-alcoholic fatty liver disease (NAFLD) affecting more than 250 million people worldwide, and the number of cases in advanced stages is expected to double by 2030. Underlying conditions such as obesity, type 3 diabetes, and metabolic syndrome can increase the risk of MASH. For many years, MASH has been difficult to treat, and several products have failed in clinical development, including Genfit’s peroxisome proliferator-activated receptor (PPAR) agonist elafibranor, Gilead's ASK1 inhibitor selonsertib, Intercept Pharmaceuticals' farnesoid X receptor (FXR) agonist obeticholic acid, and Novartis/Conatus' pan-caspase inhibitor emricasan.

In the past few years, significant progress has been made, and new products have entered the MASH market. In March 2024, the US Food and Drug Administration (FDA) approved Madrigal Pharmaceuticals’ orally active, selective thyroid hormone receptor (THR)-β agonist, Rezdiffra (resmetirom), for adults with MASH with moderate to advanced liver scarring (fibrosis), alongside diet and exercise (1). In June 2025, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended granting conditional marketing authorization for Rezdiffra in MASH (2). On 19 Aug. 2026, the European Commission approved Rezidiffra, and the company is planning its first European launch in Germany in the fourth quarter of 2025 (3, 4).

In August 2025, Novo Nordisk received FDA approval for its injectable weight-loss drug Wegovy (semaglutide) for patients with MASH and moderate to advanced liver fibrosis, without cirrhosis, in combination with a reduced-calorie diet and exercise (5). The conditional clearance was based on Phase III results, where the glucagon-like peptide-1 receptor agonist (GLP-1RA) demonstrated improved liver scarring without worsening the condition and resolved MASH without making scarring worse (6,7). Eli Lilly is also seeking approval for its injectable dual-action gastric inhibitory polypeptide (GIP)/GLP-1RA, Zepbound (tirzepatide), based on its Phase II SYNERGY-MASH trial in patients with and without type 2 diabetes, and with stage 2 or 3 fibrosis (scarring) (8).

What investments are Big Pharma making in MASH?

MASH is seen as the next frontier in metabolic diseases, and numerous clinical trials are underway evaluating hormone analogs, receptor agonists, and enzyme inhibitors 

MASH drug development has attracted significant interest from pharma and private investors. In the GLP-1 space, Boehringer Ingelheim has teamed up with UK-based Zealand Pharma to develop survodutide. This dual glucagon/GLP-1 agonist has demonstrated a placebo-adjusted 64.8% improvement in fatty liver disease (9).

In May 2025, GSK acquired Boston Pharmaceuticals' lead asset efimosfermin for US$1.2 billion plus US$800 million in milestone payments. Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in Phase II clinical development for the treatment of MASH (10). US-based Akero Therapeutics and 89bio are also developing FGF21 analogs, efruxifermin and pegozafermin, respectively (11, 12).

Which European frontrunners are targeting MASH?

Several European biotechs are developing innovative approaches to target the underlying cause of MASH and liver fibrosis. These include:

focuses on developing novel small-molecule therapies targeting fibrosis, lysosomal storage disorders, and oncology. Its lead program, lanifibranor (IVA337), is an orally active pan-PPAR agonist. It demonstrated promising results in a Phase IIb placebo-controlled trial in patients with active MASH, improving the resolution of MASH without worsening fibrosis (13). Lanifibranor is currently being evaluated in NATiV3, a pivotal Phase III clinical trial in patients with MASH and fibrosis stages F2 and F3; the trial is due to complete in September 2026 (14).

 is a clinical-stage biopharmaceutical company specializing in fibrolytic and anti-inflammatory diseases. Its lead compound, Vonafexor, is an orally active, non-steroidal agonist of NR1H4 (FXR, or bile acid receptor). In the Phase II LIVIFY study, Vonafexor significantly reduced liver fibrosis and inflammation markers, decreased liver fat and weight, and improved liver and kidney functions (15). In January 2024, the company raised €39 million (US$45.39 million) in Series C funding to develop Vonafexor further (16).

, is a biotechnology company focused on discovering and developing innovative peptide-based medicines. It has created several candidates targeting the metabolic brain axis, including Survodutide, a glucagon/GLP-1 dual agonist, which is being developed with Boehringer Ingelheim for MASH (Phase II) and obesity (Phase II), and petrelintide, an amylin analogue that it is co-developing with Roche. This compound could represent a new class of treatment for obesity (17).

In the United States, several biotech companies are working on MASH candidates, including MetaVia, which is developing DA-1726, a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist (18).

Additionally, significant progress has been made in developing biomarkers and diagnostics to identify patients at risk of MASH. For example, France-based Genfit has created a non-invasive diagnostic program that includes an 

test to detect NIS4+ and NIS2+. At the same time, Nordic Bioscience has identified biomarkers targeting neo-epitopes of collagen fragments that can be used to risk-stratify patients. (19, 20).

The global MASH market was valued at US$7.9 billion in 2024 and is forecast to grow to US$31.8 billion by 2033, with a compound annual growth rate of 17.7% from 2025 to 2033 (21). After many failed attempts, the industry has finally identified new ways to reduce liver fat buildup. While Madrigal's orally active Rezdiffra was the first to enter the US and European Union markets, it now faces competition from Novo’s injectable Wegovy, and Eli Lilly is not far behind. It will be interesting to see how the MASH landscape evolves and whether new approaches, such as oxyntomodulin analogues and gene silencing agents, can capture a share of this lucrative market in the future.

FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease

Madrigal Receives European Commission Approval for Rezdiffra™ (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis.

Madrigal Pharmaceuticals Reports Second-Quarter 2025 Financial Results and Provides Corporate Updates.

FDA Approves Treatment for Serious Liver Disease Known as ‘MASH’

Sanyal, A. J.; Newsome, P. N.; Kliers, I.; et al.

 Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis

Semaglutide 2.4 mg Demonstrates Superior Improvement in Both Liver Fibrosis and MASH Resolution in the ESSENCE Trial.

Loomba, R.; Hartman, M. L.; Lawitz, E. J.; et al. (2024). T

irzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis

Survodutide US FDA Breakthrough Therapy Phase 3 Trials MASH.

GSK. GSK to Acquire Efimosfermin, a Phase III-Ready Potential Best-in-Class Specialty Medicine to Treat and Prevent Progression of Steatotic Liver Disease (SLD). Press Release. 14 May 2025.

 akerotx.com/clinical-trials (accessed 20 Aug. 2025).

89bio Receives EMA PRIME Status for Pegozafermin in the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Fibrosis and Compensated Cirrhosis.

Francque, S. M.; Bedossa, P.; Ratziu, V.; et al.. 

A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH. 

ClinicalTrials.gov. Study Details | A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) (accessed 21 August 2025).

Ratziu, V.; Harrison, S. A.; Loustaud-Ratti; et al. 

Hepatic and Renal Improvements with FXR Agonist Vonafexor in Individuals with Suspected Fibrotic NASH. 

ENYO Pharma. ENYO Pharma Announces a €39 Million Series C Financing and FDA Clearance to Advance Vonafexor in a Phase 2 Clinical Trial for Patients with Alport syndrome. Press Release. 3 Jan. 2024.

MetaVia Doses First Patient in the 48 mg MAD Cohort of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity to Further Explore Maximum Tolerated Dose.

Nash Or Mash Treatment Market Growth Rate, Industry Insights and Forecast 2025-2033

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

Editor's note: The references in this article have been updated. 

Metabolic dysfunction-associated steatohepatitis (MASH), a subtype of non-alcoholic fatty liver disease, is projected to see a significant increase in advanced cases by 2030. Recent advancements include FDA and EMA approvals of Madrigal Pharmaceuticals' Rezdiffra and Novo Nordisk's Wegovy for MASH treatment. Big Pharma is heavily investing in MASH, with companies like GSK acquiring assets and others developing innovative therapies. European biotechs are also making strides with novel treatments. The MASH market is expected to grow substantially, driven by new therapeutic approaches and diagnostic advancements.

Novo Nordisk’s Wegovy will be competing with Madrigal Pharmaceuticals’ Rezdiffra in the metabolic dysfunction-associated steatohepatitis arena. 

Competition in MASH Is Heating Up as GLP-1s Gate-Crash the Party

*Test what you learn with a 3-question quiz at the end of the article!

What would it be like to reduce the audit trail review (ATR) burden in laboratories and manufacturing spaces all while satisfying inspector expectations? With more than 100 external inspections of Eli Lilly and Company’s commercial manufacturing sites conducted in the two years since the company published a novel and enhanced ATR assessment process, Lilly has established a sustainable and tested approach. This article describes how the company was able to achieve this.

Based on both external evaluation and internal assessment, the need to examine the data integrity (DI) governance program to ensure it remains in alignment with current regulatory expectations was determined. One area identified for further review was ATR. At that time, a need to make the ATRs more consistent was recognized, and the global requirements also needed to be enhanced. Additionally, requirements for data review needed to be more standardized. These enhancements were essential to maintaining trusted data and meeting ALCOA+ (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available) principles.

Desiring to upgrade the approach across all sites, external consultants were hired to help build an enhanced global ATR process. However, the implementation of this global process was not specific enough, and uncovered potential inconsistencies in implementation, confusion from site and global teams, and frustration about the global process being too open-ended. Because the implementation strategy was open to local interpretation, information technology (IT) support teams were responsible for determining how to assess their systems and independently determined the DI gaps that needed an ATR. They also determined the justification for DI gaps that would not have an ATR. These independent assessments of the global ATR process were not sufficient to support an overall implementation, so a more holistic approach was needed. With the advances in technology in the pharmaceutical industry, as well as evolving regulatory expectations, a more specific and global process was warranted.

As a result, a centralized data management team was added to the organization to ensure sustainable DI processes were developed and maintained. This team is an independent, strategic, global quality and compliance-level team that supports all functions across operations, research, and commercial. This team is fully dedicated to DI governance and is a key organizational component that establishes DI policy.

To create a more robust ATR process, the original process’ authors were interviewed to understand theprocess state, and site and global teams that had started to use the first version were also consulted. It was determined that global data management needed to provide more specific ATR tools to the local manufacturing teams so they could continue to focus on producing high-quality products. The available regulations and industry guidance were then studied that govern ATR (

). Lastly, a deep dive into the existing established DI requirements was performed, and it was determined that they were strong and well-developed. The conclusion of the research was that the company needed an ATR assessment process that was comprehensive and robust, but also easy to follow, keeping in mind the end users’ experience with ATR.

Cross-referencing the company’s DI requirements with the industry regulations and guidance, a specific set of logical controls were documented as expected controls for identified DI vulnerabilities. If systems could not be configured with the expected logical control, minimum ATR activities are expected to be performed and were consequently outlined for each DI vulnerability. Therefore, the result of following this process would mean that DI requirements are either met through a logical control or ATR is performed to mitigate the vulnerability, ensuring no compliance gaps.

The workflow for developing an ATR assessment process is represented in 

The following process was designed for areas to use when evaluating their ATR responsibilities. A lead assessor from the quality, business, or IT group would be appointed and organize the appropriate team of subject matter experts (SMEs) to assess the system. Assessment teams would then:

evaluate potential DI risks based on the established minimum DI requirements

determine if there are the specified logical controls in place that mitigate each risk

document the ATR expectations when those controls do not exist.

This three-part assessment process was expanded upon in a global standard operating procedure (SOP), and an assessment template was created to make it easy for teams to pick up and utilize. When ATR is required, teams follow the process in 

 shows two hypothetical examples of how the process can work with this ATR process flow if the requirement is “end users must not have the ability to modify or delete output data.” These examples are provided for illustrative purposes only, as each company will have its own systems and controls and should not rely on these specific examples.

The assessment process would look like this:

Notice the template phrasing above is “Do users have the ability…?” It is not “Will they…?” Phrases like “Will they…?” or “Can they…?” imply a procedural control is acceptable, and a procedural control is not an acceptable control strategy in the industry. Although a determination of “No Audit Trail Review required” is made in the second hypothetical example, keep in mind there may be additional data reviews for batch release based on other requirements or different regulations. However, if there are logical controls in place that have been validated, the data integrity risk drops significantly.

Novel, enhanced, sustainable approach for ATR

The newly structured ATR SOP has been well-received, and teams were eager to use the assessment template. There is an added benefit in that the SOP has transformed employees’ understanding that if a system can be designed and validated to meet the expected controls in the assessment, a review is not needed, and the time and expense of performing non-value-added data reviews is drastically cut. An in-depth training program was also established and rolled out to every manufacturing site and global support team. The training program introduced the novel and enhanced process and instructed teams on how to effectively assess systems for their ATR needs. This process has directly translated into other improvement initiatives and is another tool to complement the DI by design approach when implementing new systems. This means that systems are designed to meet the expected control instead of the required long-term reviews that would otherwise be required. And when an ATR is required, there is a globally consistent approach that can stand up to external audits.

In conclusion, a more sustainable ATR assessment process was developed and implemented that reduced the ATR burden, enhanced DI compliance, and aligned with current good manufacturing practice expectations. The process involved a three-part evaluation of potential DI risks, logical controls, and ATR expectations based on a set of internal DI requirements and industry standards. The process also led to improved system designs that meet the expected controls and more specifically define when an ATR is needed. The procedure has been completely integrated into the manufacturing space and has been able to withstand external scrutiny.

Diana Russo has more than 20 years of experience in the pharmaceutical industry. She has built her career in the areas of computer system validation, IT quality, and computer systems quality assurance. And while her current role focuses on data integrity, DI has been an important driving force throughout her entire career. She is an audit trail review subject matter expert, a leader in process improvement, and happily challenges the status quo.

Eli Lilly and Company has developed a sustainable and enhanced audit trail review (ATR) process to reduce the burden on laboratories and manufacturing spaces while meeting regulatory expectations. The process involves a centralized data management team and a three-part evaluation of data integrity (DI) risks, logical controls, and ATR expectations. This approach aligns with ALCOA+ principles and current good manufacturing practices. The new ATR standard operating procedure (SOP) has been well-received, leading to improved system designs and a globally consistent approach that withstands external audits.

Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.

A Novel, Enhanced, and Sustainable Approach to Audit Trail Review

Video interview at DCAT with Frank Romanski, PhD, from Lonza CHI

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