Category: Blog

In clinical drug development, success hinges on the ability to make the right decisions early and with confidence.

Consider a promising biopharmaceutical therapy that enters trials with high expectations.

Despite strong preclinical data, variability in patient response threatens the study’s viability.

Traditional approaches might rely on broad patient recruitment, hoping for statistical significance.

But this trial takes a different path, leveraging biomarker testing to stratify patients based on genetic, proteomic, and metabolic signatures.

The result?

A targeted study design, enriched patient selection, improved efficacy outcomes, and a smoother regulatory path.

Why Biomarkers Matter in Clinical Development

Biomarkers are not just lab measurements; they are the foundation of precision medicine.

By providing early insights into drug response, safety, and disease progression, biomarker testing enhances the probability of success for novel therapies.

Key roles of biomarkers in drug development:

• Target Identification & Validation – Help identify and confirm biological targets associated with disease pathways, guiding the early stages of drug discovery.
• Patient Stratification – Identifying the right patient population for targeted therapies.
• Pharmacodynamic & Efficacy Monitoring – Real-time insights into a drug’s biological activity and therapeutic impact, supporting dose selection and treatment optimization.
• Safety & Toxicity Assessment – Detecting potential adverse effects early.
• Regulatory Decision making & Companion Diagnostics – Supporting FDA/EMA approval processes with validated biomarker data.

Challenges in Biomarker Development

While biomarker-driven strategies offer immense advantages, their success depends on rigorous validation, assay reproducibility, and regulatory acceptance.

• Variability in Sample Collection & Analysis – Standardization is critical for reliable data.
• Translational Gaps from early to late-stage clinical trials– Ensuring biomarkers remain predictive across different trial phases.
• Regulatory Complexity – Aligning with global guidelines for biomarker qualification and companion diagnostics.

A strategic approach that integrates biomarker selection, analytical validation, and clinical implementation is essential to overcoming these challenges.

Veeda Lifesciences: Advancing Biomarker-Driven Research

At Veeda Lifesciences, we recognize the transformative potential of biomarkers in clinical development.

Our specialized biomarker services support:

• End-to-end biomarker services – Comprehensive support from early discovery to clinical validation, tailored to your therapeutic program’s needs.
• Custom Assay Development and Validation – Expertise in developing fit-for-purpose and regulatory-compliant assays for both soluble and cellular biomarkers.
• Immunogenicity & Mechanism of Action Insights – In-depth analysis of immune responses and pharmacodynamic markers to support biologics, vaccines, cell, and gene therapies.
• Multi-Platform Biomarker Analysis – Leveraging Flow Cytometry, ELISA, MSD, and ELISpot for high-sensitivity and multiplexed biomarker testing.
• Regulatory Driven Clinical Support – Assay development aligned with FDA/EMA guidelines for BLA and NDA submissions for critical clinical decision-making.

With cutting-edge platforms and a team of scientific experts, Veeda Lifesciences enables sponsors to integrate biomarker strategies seamlessly into clinical trials, enhancing drug efficacy, improving patient selection, and accelerating regulatory approvals.

What’s Next? The Future of Biomarkers in Drug Development

As AI-driven biomarker discovery, multi-omics integration, and real-world data analytics continue to evolve, biomarker testing will further refine drug development, reducing late-stage failures and ensuring targeted, cost-effective therapies.

References:

1. Translational Biomarkers in Drug Development. Available at: https://www.altasciences.com/bioanalysis-cro/translational-biomarkers
2. Facing Our Risk. The Role of Biomarker Testing in Cancer Research. Available at: https://www.facingourrisk.org/blog/tag/biomarker-testing
3. The Biomarker Advantage in Clinical Trials. Available at: https://blog.healthverity.com/the-biomarker-advantage
4. Pacific BioLabs. Biomarkers in Drug Development. Available at: https://pacificbiolabs.com/biomarker
5. Pacific BioLabs. Large Molecule Bioanalysis. Available at: https://pacificbiolabs.com/large-molecule-bioanalysis/
6. Biomarkers at FDA. Available at: https://www.fda.gov/science-research/about-science-research-fda/biomarkers-fda

COVID-19 delivered a powerful lesson to the world: without advanced therapies like vaccines, we could have found ourselves in an endless cycle of lockdowns and global health crises.

As the pandemic unfolded, pharmaceutical companies were under immense pressure to innovate and act quickly.

In this high-stakes race, mRNA-based injectable vaccines became a prime example of how ground-breaking technology could respond quickly to global health needs.

This success has sparked a growing demand for complex injectable therapies, not just to save lives, but to enhance patient outcomes and quality of life, further fuelling the rise of injectables in medicine.

Injectable Market Growth Driven by Technological Advancements

As the injectable drug market continues to grow, technological breakthroughs are leading the way.

It’s no longer just about preserving drugs; it’s about delivering them in smarter, more effective ways for a longer time.

New delivery systems are now being designed to improve patient convenience, boost compliance, and elevate treatment success.

Innovations such as nanoparticles, liposomes, and degradable implants are enhancing the bioavailability, stability, and effectiveness of injectables, making them more versatile and applicable for a range of conditions, from acute diseases to chronic illnesses.

These developments are not only improving existing treatments but also paving the way for the next generation of therapies that are more patient-friendly, precise, and effective for all age groups.

Explosive Market Growth for Injectable Drugs

The global Injectable Drugs Market is on an impressive growth trajectory.

It was valued at USD 569.89 billion in 2024 and is expected to reach USD 820.05 billion by 2029, growing at a CAGR of 7.55%.^{* 1}

Several factors are contributing to this rapid growth: the rise of chronic diseases, continuous advancements in drug delivery technologies, and substantial investments in R&D.

Together, these forces are reshaping the future of healthcare, and injectable drug delivery solutions are at the forefront of this revolution.

With an increased focus on precision medicine and treatment optimization, the market is well-positioned for sustained growth in the years to come.

Regional Growth: How Different Markets Are Powering Injectable Delivery Solutions

North America: Leading Innovation and Market Growth

North America, particularly the United States, has long been a leader in the injectable drug delivery space.

However, what sets the region apart today is not just its substantial market share but its ability to pioneer transformative healthcare technologies that shape global trends.

The growth in the injectable drug delivery market is mainly driven by a robust healthcare system, substantial patient base, and high healthcare spending.

The U.S. market itself was US$ 202.88 billion in 2024, growing at a 6.8% CAGR through 2034.

Factors such as the increasing incidence of chronic diseases (e.g., diabetes and cancer), the rising demand for biologics (including insulin and cancer treatments), and an aging population are pushing the market’s expansion.

The U.S. also benefits from an advanced healthcare infrastructure, with over 916,000 hospital beds and 33.7 million admissions annually, facilitating the widespread use of injectable drugs.

Meanwhile, Canada is becoming an increasingly important market, expected to grow at a CAGR of 8.7% between 2024 and 2034.

The adoption of biologics, coupled with the country’s stringent regulatory framework, has created a favorable environment for injectable drug growth.

Europe: A Mosaic of Regulatory Precision and Market Diversity

The European market benefits from well-established healthcare systems and strong government support for pharmaceutical innovation, positioning the region as a major hub for injectable drug delivery solutions.

European countries are highly diverse in terms of market needs and healthcare priorities.

For instance, while Germany focuses heavily on managing its aging population with more injectable therapies, the United Kingdom is emphasizing new drug delivery technologies for diabetes and cancer treatment.

France, on the other hand, is rapidly expanding its injectable manufacturing capacity, positioning itself as a key player in drug production.

Europe’s aging population is a significant driver of demand for injectable drugs, particularly those related to chronic diseases.

Older patients are more likely to require biologic injections, such as insulin or injectable biologics for autoimmune diseases.

This trend is particularly evident in Germany, where the increasing elderly demographic is boosting the demand for injectables in long-term care settings.

Asia-Pacific: Fast-Growing Market with Expanding Healthcare Needs ^*4

The Asia-Pacific region is set to experience the fastest growth in the injectable drug delivery market, with a projected CAGR of 8.7% from 2024 to 2029.

This growth is driven by a rapidly expanding healthcare infrastructure, rising patient populations, and increasing awareness of injectable therapies.

The region’s focus on improving access to biologic drugs and the rising prevalence of chronic diseases like diabetes, respiratory diseases, and cancer are propelling market growth.

Countries such as China, India, and Japan are seeing significant demand for injectable therapies, and local governments are enacting policies that support domestic pharmaceutical manufacturing and foreign investment.

As healthcare access improves, especially in emerging markets, the demand for injectable drug delivery systems is expected to rise sharply.

3 Key Drivers of Growth in the Injectable Drug Delivery Market

Rise of Biosimilar & Biologics

The rise of biosimilars and biologics is significantly reshaping the injectable drug delivery market, aligning with the healthcare sector’s shift toward more personalized and targeted therapies.

Biosimilars, as cost-effective counterparts to branded biologics, are becoming an integral part of treatment strategies, expanding access to advanced medical care.

Meanwhile, biologics such as monoclonal antibodies, gene therapies, and RNA-based treatments are addressing unmet medical needs with superior efficacy and safety profiles.

Their impact on the injectable drug delivery market is profound, driving advancements in production, administration, and therapeutic efficacy.

For healthcare providers, these innovations mean improved outcomes, patient compliance, and accessibility.

For pharmaceutical companies, they represent a chance to lead in a competitive, high-growth market.

And for patients, they signify better, more affordable care tailored to their needs.

As biologics and biosimilars continue to shape the future of medicine, the injectable drug delivery market is set to thrive, bridging the gap between cutting-edge science and real-world patient care.

Addressing Chronic Diseases

The surge in chronic diseases such as diabetes, cancer, and autoimmune disorders demands precise, fast-acting treatments, and injectable devices excel at delivering medication directly into the bloodstream for immediate therapeutic effects.

For example, diabetes care heavily depends on routine insulin injections, while advanced cancers and autoimmune disorders are effectively managed through biologics administered via injection.

As personalized medicine gains traction, injectable drug delivery systems provide tailored solutions that not only improve patient outcomes but also cater to the growing need for durable, effective, and long-term treatment options.

Injectables also play a vital role in managing infectious diseases like HIV/AIDS and tuberculosis (TB).

TB treatment, for example, combines oral antibiotics with injectable drugs like rifampin and streptomycin, ensuring effective disease control and reducing the risk of drug resistance.

This dependency on injectables drives advancements in formulation technologies and delivery systems, aiming to enhance both efficacy and patient adherence.

Together, the rising burden of chronic and infectious diseases, advancements in technology, and a growing emphasis on personalized care are positioning the injectable drug delivery market as a cornerstone of modern healthcare innovation.

Advancing Drug Formulations for Patient Convenience

Advancements in drug formulation and delivery technologies are significantly fuelling the growth of the injectable drug delivery market.

One game-changer is long-acting injectables (LAIs).

These depot formulations release medication steadily over extended periods, reducing the need for frequent injections.

This not only makes treatment more convenient for patients but also ensures consistent drug levels in the body, leading to fewer fluctuations and better results.

LAIs have become a foundation of innovation, meeting the needs of patients managing chronic conditions and demanding less frequent, yet highly effective, treatment options.

New technologies, such as prefilled syringes, auto-injectors, and microneedle systems, are transforming the way care is delivered.

Ready-to-use (RTU) injectables, such as prefilled syringes, simplify dosing, saving time and reducing errors.

Auto-injectors enable patients to take charge of their treatments at home, thereby boosting confidence and compliance.

Microneedle systems add another layer of comfort with near-painless delivery, making injections less daunting.

These advancements are fueled by rising investments in research and development, as well as a strong focus on quality manufacturing.

Together, they’re driving the injectable market to new heights, delivering treatments that are more accessible, reliable, and tailored to the needs of modern healthcare.

References:

1. https://www.mordorintelligence.com/industry-reports/sterile-injectable-drugs-market/market-size
2. https://www.futuremarketinsights.com/reports/injectable-drug-industry-analysis-in-north-america
3. https://www.futuremarketinsights.com/reports/injectable-drugs-market
4. https://www.mordorintelligence.com/industry-reports/sterile-injectable-drugs-market
5. https://www.globenewswire.com/news-release/2024/11/06/2975894/28124/en/Sterile-Injectable-Drugs-Strategic-Market-Research-Report-2024-Global-Market-to-Reach-1-4-Trillion-by-2030-Biosimilars-Gain-Traction-Opening-New-Opportunities.html

Diabetes Mellitus is not just a health condition; it’s a global crisis affecting millions.

This chronic condition, marked by elevated blood sugar levels, manifests in two primary forms: Type 1 and Type 2 Diabetes.

While they share common symptoms, their underlying causes and management strategies differ.

• Type 1 Diabetes is an autoimmune disorder where the body’s immune system mistakenly attacks and destroys Insulin-producing cells in the pancreas. As a result, the body can no longer produce Insulin, the hormone necessary for regulating blood sugar. People with Type 1 Diabetes require lifelong Insulin therapy to survive, as the body cannot manage blood sugar levels on its own.
• Type 2 Diabetes, on the other hand, is primarily a metabolic disorder. It occurs when the body either becomes resistant to Insulin’s effects or doesn’t produce enough Insulin to maintain normal glucose levels. Type 2 Diabetes is the more prevalent form, accounting for approximately 90% of all diabetes cases. It is closely linked to lifestyle factors such as diet, physical inactivity, and obesity.

Rising Rates of Type 2 Diabetes

In 2021, an alarming 537 million adults globally were living with diabetes—a figure expected to rise to 783 million by 2045.

The severity of Type 2 Diabetes cannot be overstated, as it is a leading cause of severe complications such as heart disease, stroke, kidney failure, and nerve damage.

Furthermore, 541 million adults are at increased risk of developing Type 2 Diabetes, highlighting the urgent need for effective management and innovative treatment strategies.

Current Market Trends Driving Medication and Treatments for Diabetes Management

The Expanding Market for Diabetes Medications

The market for Type 1 & Type 2 has seen substantial growth, fuelled by the increasing prevalence of the disease and the continuous introduction of novel therapeutic options.

As of 2023, global sales are expected to reach a staggering $67.7 billion, with the United States alone accounting for $38.8 billion.

The growth is driven by several factors, including therapeutic innovation and the introduction of advanced diabetes therapeutics.

The need for better glycemic control, combined with the demand for minimally invasive treatment options, has propelled this market forward.

Insulin: A Pivotal Medication for Diabetes Treatment

Diabetes Management primarily revolves around controlling blood sugar levels through lifestyle changes, regular monitoring, and medication.

For many, Insulin therapy is crucial.

Insulin, a hormone that facilitates the absorption of glucose into cells, remains a cornerstone in diabetes management.

Various forms of Insulin, including rapid-acting, short-acting, intermediate-acting, and long-acting Insulin, are tailored to meet individual needs.

Innovations such as Insulin pens, pumps, and hybrid closed-loop systems have made Insulin therapy more accessible and effective

The global Insulin market is poised for significant growth, with its size expected to increase from USD 23.1 billion in 2022 to approximately USD 83.04 billion by 2032, driven by a compound annual growth rate (CAGR) of 13.70% during the forecast period.

This growth is largely fuelled by continuous advancements in Insulin delivery methods, such as Insulin pumps, smart pens, and patch pumps, which have enhanced patient convenience and adherence to treatment regimens.

These innovations not only improve the patient experience but also create opportunities for market expansion and diversification, making Insulin therapy more accessible and effective for a broader population.

Additionally, the introduction of Insulin analogues has revolutionized diabetes management by more closely mimicking normal human physiology.

These analogues, particularly basal Insulin analogs like Insulin detemir and Insulin glargine, offer numerous benefits, including less variability, longer duration of action, and reduced risk of hypoglycemia, especially at night.

Despite their higher cost, the utilization of long-acting Insulin analogues has been on the rise, particularly in the US & Europe, due to their superior pharmacokinetic profiles and overall efficacy in managing diabetes.

GLP-1 Receptor Agonists: A Game Changer in Diabetes Management

The GLP-1 receptor agonist market is experiencing rapid growth, driven primarily by the increasing prevalence of diabetes and obesity worldwide.

These medications work by stimulating the release of Insulin in response to food intake, thereby improving glycemic control.

These drugs have become a preferred choice for managing these conditions due to their high efficacy, especially in controlling blood sugar levels and promoting weight loss, with a lower risk of hypoglycemia compared to other diabetes medications.

The market is projected to rise significantly, with a compound annual growth rate (CAGR) of 11.7%, reaching an estimated value of US$ 72,127.79 million by 2034.

This growth is also supported by extensive clinical research, which has consistently demonstrated the safety and effectiveness of GLP-1 receptor agonists in achieving positive outcomes in glycemic control, cardiovascular risk reduction, and weight management.

Regulatory bodies are increasingly recognizing the value of real-world evidence (RWE) in complementing traditional clinical trial data, further propelling the growth of the GLP-1 receptor agonist market.

RWE, obtained from observational studies, electronic health records, and patient registries, plays a vital role in post-marketing surveillance.

It provides a more comprehensive understanding of the long-term safety, efficacy, and usage patterns of these drugs in real-world clinical settings.

This shift towards RWE-driven insights is helping regulatory agencies make more informed decisions, reinforcing the importance of GLP-1 receptor agonists in managing diabetes and obesity in a broader, real-world context.

Currently, there are seven GLP-1 receptor agonists available, including Semaglutide, Liraglutide, Exenatide, Lixisenatide, Dulaglutide, and Oral Semaglutide.

The Role of Oral Anti-Diabetic Drugs

Oral anti-diabetic drugs remain the most widely used treatment, particularly in cases where lifestyle modifications alone are insufficient.

These drugs are often the first line of defense, offering a convenient and non-invasive option for patients.

The FDA’s encouragement of new therapeutic options further underscores the importance of these drugs in diabetes management.

As a result, the market is projected to grow from an estimated USD 46.82 billion in 2024 to USD 57.44 billion by 2029, at a compound annual growth rate (CAGR) of 4.17%.

The increasing demand for oral anti-diabetic drugs, combined with the introduction of newer-generation medications, is driving this growth globally.

The Asia-Pacific region, in particular, is expected to register strong market growth, with a CAGR of more than 4% during the forecast period.

Countries like China and Japan are recognized as key markets due to the rapid increase in diabetes cases.

In 2021, the International Diabetes Federation reported that 90 million adults in the South-East Asia Region and 206 million adults in the Western Pacific Region were living with diabetes, with these numbers expected to rise significantly by 2030.

New-generation oral drugs, such as DPP-4 inhibitors and SGLT-2 inhibitors, are gaining traction in these regions, as they have shown the ability to reduce cardiovascular risks in diabetic patients, further driving demand.

Leading pharmaceutical companies are experiencing intensified competition from regional manufacturers, which is contributing to a dynamic and evolving market landscape in Asia.

The expanding diabetic population and the growing availability of generics are expected to sustain the growth of the oral anti-diabetic drug market in the coming years.

Technological Advancements in Diabetes Treatment

Technological innovation in diabetes devices, such as Insulin pumps and pens, is also contributing to market growth.

These advancements offer patients more precise control over their blood sugar levels, reducing the risk of complications.

The integration of digital technology with diabetes management tools is creating new opportunities for patient engagement and personalized treatment plans.

Distribution Channels: The Growing Influence of E-Commerce

Hospital pharmacies have traditionally dominated the distribution of diabetes medications, thanks to their role in providing primary care and their access to trained medical staff.

However, the rise of online pharmacies is reshaping the landscape.

The convenience of online shopping, coupled with attractive discounts, has made e-commerce a promising segment for diabetes drug distribution.

This shift is further accelerated by the COVID-19 pandemic, which has increased patient awareness and acceptance of online pharmacies.

Veeda Group: Trusted Partner for Developing Insulin and GLP-1 Agonists

As the landscape of diabetes management rapidly evolves, new medications and treatment options are offering hope to millions of people around the world.

From insulin therapies and GLP-1 receptor agonists to cutting-edge oral anti-diabetic drugs, the growing range of available treatments is leading to more personalized and effective solutions for patients.

At Veeda Group, we are proud to play a key role in this progress.

As an integrated CRO supporting end-to-end drug development, we leverage our extensive expertise to support the development and delivery of life-changing diabetes treatments.

Notably, Veeda Group has conducted 12 Insulin studies—including Insulin Wosulin, Glargine, and Aspart—as well as GLP-1 studies focusing on Liraglutide and Semaglutide.

We are fully committed to driving innovation and improving outcomes for patients globally as we continue to advance the field of diabetes management.

Sources:

• https://www.precedenceresearch.com/diabetes-drug-market
• https://www.msdmanuals.com/en-in/home/hormonal-and-metabolic-disorders/diabetes-mellitus-dm-and-disorders-of-blood-sugar-metabolism/medication-treatment-of-diabetes-mellitus#Insulin-Replacement-Therapy_v25185070
• https://www.mordorintelligence.com/industry-reports/oral-anti-diabetic-drug-market
• https://www.futuremarketinsights.com/reports/glp-1-receptor-agonist-market#:~:text=GLP%2D1%20Receptor%20Agonist%20Market%20Outlook%20for%202024%20to%202034,during%20the%20market%20forecast%20period.
• https://www.grandviewresearch.com/industry-analysis/glp-1-receptor-agonist-market
• https://worlddiabetesday.org/about/facts-figures/#:~:text=537%20million%20adults%20(1%20in,majority%20have%20type%202%20diabetes
• https://www.precedenceresearch.com/Insulin-market#:~:text=Insulin%20Market%20Size%2C%20Share%2C%20and%20Trends%202024%20to%202034&text=The%20global%20Insulin%20market%20size,period%20from%202023%20to%202032

Bioanalytical labs play a crucial role in drug development, providing essential data to answer fundamental questions like “Does it work?” and “Is it safe?”

The speed at which scientists can make informed decisions directly impacts the pace of bringing new drugs to market.

To meet this challenge, labs are turning to digital solutions that streamline operations and improve data quality.

Unlocking the Power of Data

One of the key assets in modern bioanalytical labs is data.

Smart data management can save time, reduce waste, and provide reliable answers quickly.

However, in many labs, data is scattered across various systems, including paper notebooks and spreadsheets.

This fragmented approach makes it challenging to leverage data efficiently, leading to missed opportunities and inefficiencies.

With the rise of connected instruments and advanced analytical instruments like ELNs and LIMS, labs can now integrate their data into a central backbone.

This integration allows for streamlined operations, reduced human errors, and improved data accessibility.

By centralizing data, labs can create user-friendly reports and workflows, enabling scientists to make faster, more informed decisions.

Power of ELN, LIMS, and LES for Bioanalysis

The digital transformation of bioanalytical labs is greatly facilitated by the use of Laboratory Information Management Systems (LIMS), Electronic Lab Notebooks (ELN), and Laboratory Execution Systems (LES).

These systems play crucial roles in streamlining operations, improving data quality, and enhancing decision-making processes.

LIMS (Laboratory Information Management Systems):

LIMS are central to the implementation of a digital strategy in bioanalytical labs.

They provide a structured framework for managing sample information throughout its lifecycle.

By tracking sample details from login to disposition, LIMS ensures that data is captured accurately and consistently.

This centralized approach to data management improves data integrity and accessibility, enabling scientists to make informed decisions more efficiently.

LIMS play a key role in integrating data from various sources, such as instruments, assays, and experiments.

By providing a unified platform for data storage and management, LIMS enables labs to streamline operations and reduce manual errors.

This integration also facilitates compliance with regulatory requirements, as data can be easily audited and traced back to its source.

Overall, LIMS contribute significantly to the efficiency and effectiveness of bioanalytical labs, enabling them to leverage data more effectively and make informed decisions.

ELN (Electronic Lab Notebooks):

ELNs are another essential tool in the digital transformation of bioanalytical labs.

They provide a digital platform for recording and managing experimental data, replacing traditional paper lab notebooks.

ELNs offer several advantages over paper notebooks, including the ability to standardize workflows, automate data entry, and facilitate collaboration among scientists.

One of the key benefits of ELNs is their ability to standardize experimental workflows.

By providing templates for recording experimental details, ELNs ensure that data is captured consistently and accurately.

This standardization not only improves data quality but also makes it easier to search and analyze data.

ELNs also facilitate collaboration among scientists by providing a central platform for sharing and accessing experimental data.

This collaborative approach to data management enables scientists to work more efficiently and effectively, leading to faster decision-making and better outcomes.

LES (Laboratory Execution Systems):

LES are specialized systems designed to automate and enforce procedural steps in the laboratory.

In the context of bioanalytical labs, LES play a crucial role in ensuring that experiments are conducted consistently and according to standard operating procedures (SOPs).

One of the key advantages of LES is its ability to enforce procedural execution during testing.

By encapsulating SOPs into software, LES ensures that each step of the testing process is recorded and completed before moving on to the next step.

This not only improves data quality but also reduces the risk of errors and deviations from protocol.

LES also facilitates real-time monitoring of experiments, allowing scientists to make informed decisions based on up-to-date data.

This real-time feedback loop enables labs to respond quickly to changing conditions and optimize experimental workflows for better results

Refining Bioanalytical Labs: Unifying Digital Solutions for Efficiency, Quality, and Innovation

1. Deliver a Platform-Based yet Personalized Laboratory Experience

While personalization of laboratory technologies can be beneficial in the short term, it often leads to information silos and challenges in information exchange.

A platform-based approach, on the other hand, allows labs to leverage integrated modules aligned with standard enterprise-wide R&D terminologies and capabilities.

This approach, facilitated by tools like LIMS and ELNs, enables better-quality study data generation and enhances collaboration among researchers.

By adopting harmonized approaches across sites, labs can achieve enhanced visibility, real-time tracking of experiment statuses, and improved cross-experimental insights.

2. Leverage Digital Lab Tools to Unlock Operational Efficiency & Cost Savings

Digital lab technologies such as LIMS, ELNs, and quality management systems offer significant operational efficiencies and cost-saving opportunities.

By retiring legacy systems, eliminating redundant data entry, and building audit trails, labs can streamline workflows, ensure data accuracy, and enhance compliance with regulatory requirements.

Additionally, these technologies reduce the time employees spend on manual tasks and enable real-time tracking of project workloads, resulting in substantial time savings per employee.

3. Drive Enhanced Data Reproducibility & Data Analysis to Create Commercial Value

Data reproducibility is a critical challenge in bioanalytical labs, leading to wasted time, decreased resources, and lower scientific output.

Digital platforms that enhance data quality and increase statistical power can address this challenge.

By standardizing higher-quality data, labs can increase reproducibility and improve experimental performance.

Furthermore, leveraging data analytics tools can help labs extract additional value from their data, accelerating the discovery of new indications and molecules.

Veeda’s Integration of LIMS, ELN, and LES Solutions

Veeda’s Bioanalysis solution integrates Laboratory Information Management System (LIMS), Electronic Laboratory Notebook (ELN), and Laboratory Execution System (LES) functionalities to optimize our bioanalytical lab operations.

This integrated approach for bioanalytical studies provides advanced data management, analysis, and automation tools in a single, cohesive system.

LIMS centralizes sample tracking and data management, ensuring traceability and compliance with regulatory standards.

Meanwhile, ELN digitizes experimental data, improving collaboration and reducing manual errors.

The LES further enhances our workflows by automating processes and enforcing SOPs, ensuring consistency and quality in our operations.

This integration enhances our bioanalytical procedures into efficient, reliable testing methods, where we leverage connected instruments and intelligent data management capabilities to consistently improve our deliverable outcomes.

Reference articles:

• https://www.technologynetworks.com/informatics/articles/eln-lims-cds-les-whats-the-difference-313834
• https://www.labware.com/blog/streamlining-bioanalytical-testing-with-a-unified-lims-and-eln-solution

Overview

Pharmacodynamic (PD) biomarkers indicate how a drug affects its target, like a receptor triggering a signalling cascade.

They reflect the drug’s impact on the body’s biological or physiological functions.

Unlike pharmacokinetics, which focuses on how the body processes a drug, pharmacodynamics explores its effects and mechanisms.

These markers are vital in clinical trials, helping assess a drug’s efficacy, safety, and optimal dosage, and in individualizing treatments.

They’re crucial in drug development, aiding researchers and healthcare professionals in understanding a drug’s interactions and suitability for its intended use.

Developing New Chemical Entities (NCEs) involves discovering, designing, and synthesizing novel compounds for therapy.

Bioanalysis, quantitatively measuring drugs and their metabolites in biological samples, is key in NCE development.

Challenges & Considerations

 

Strategies for PD Biomarker Quantitation

Quantifying Pharmacodynamic (PD) biomarkers in bioanalysis involves careful planning and execution to ensure accurate and reliable measurement of the biological responses to a drug.

Here are the strategies concerning requirements and rationale for PD biomarker quantitation in bioanalysis.

 

Veeda’s Capabilities & Approach for Novel Drug Development Program

Bioanalysis is a vital part of drug development, focusing on accurately measuring drugs and their by-products in biological samples.

A successful bioanalysis strategy involves method development, validation, and application in clinical studies.

• At Veeda, method development involves extensive research, considering various factors like drug properties, dose, linearity range, extraction protocols, chromatography, and equipment. Method validation includes experiments ensuring compliance with regulations, such as selectivity, accuracy, precision, sensitivity, matrix effects, and stability studies. In clinical sample analysis, it’s crucial for determining drug levels in biological samples. Incurred sample reanalysis validates reported sample analyte concentrations, ensuring reliability.
• Employing emerging technologies like LC-MS/MS machines, ICP-OES, LIMS, and BSL-2 labs enhances our capabilities. Quality management systems (QMS) establish protocols ensuring consistent quality standards, customer satisfaction, and regulatory compliance.
• Data analysis and statistical approaches at Veeda derive meaningful insights from experimental results, ensuring their reliability and validity.
• Regulatory compliance involves adherence to industry-specific laws, guidelines, and standards.
• Cross-validation with clinical endpoints ensures alignment between laboratory analyses and clinical outcomes, establishing correlations between measured biomarkers/drug concentrations and therapeutic effects/safety outcomes.

 

Our Expertise in PD Biomarker Method Development & Validation

 

Conclusion

Bioanalysis is pivotal in identifying, measuring, and characterizing Pharmacodynamic (PD) markers, which indicate a drug’s biological effects in an organism.

Its role involves:

• Identification: Using techniques like mass spectrometry, immunoassays, and chromatography to screen and identify potential PD markers
• Quantification: Developing precise methods to measure PD markers accurately
• PK/PD Modelling: Integrating bioanalytical data into models for predictive insights on drug concentration and PD marker levels
• Dose-Response Assessment: Analyzing concentration-response relationships to establish dose-response curves
• Early Phase Development: Using bioanalytical data to guide decisions about dosing, further development, and safety concerns
• Safety Assessment: Identifying and measuring biomarkers that signal potential safety issues during drug development

Reference:

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2. Kandoussi H, Zeng J, Shah K, Paterson P, Santockyte R, Kadiyala P, Shen H, Shipkova P, Langish R, Burrrell R, Easter J. UHPLC–MS/MS bioanalysis of human plasma coproporphyrins as potential biomarkers for organic anion-transporting polypeptide-mediated drug interactions. Bioanalysis. 2018 May;10(9):633-44
3. Shin S, Fung SM, Mohan S, Fung HL. Simultaneous bioanalysis of l-arginine, l-citrulline, and dimethylarginines by LC–MS/MS. Journal of Chromatography B. 2011 Mar 1;879(7-8):467-74
4. Yin F, Ling Y, Martin J, Narayanaswamy R, McIntosh L, Li F, Liu G. Quantitation of uridine and L-dihydroorotic acid in human plasma by LC–MS/MS using a surrogate matrix approach. Journal of Pharmaceutical and Biomedical Analysis. 2021 Jan 5;192:113669
5. US Food and Drug Administration; U.S. Department of Health and HumanServices; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Veterinary Medicine (CVM). Bioanalytical Method Validation: Guidance for Industry; U.S. Department of Health and Human Services, Food and Drug Administration: Silver Spring, MD, 2018

Introduction

Chronic Obstructive Pulmonary Disease (COPD) and Asthma are significant respiratory conditions that affect millions worldwide.

In 2019, COPD accounted for 3.3 million deaths and 74.4 million disability-adjusted life years (DALYs), with a global prevalence of 212.3 million cases.

Meanwhile, the prevalence of Asthma has been rising due to increased life expectancy and changing demographics.

Additionally, the overlap of Asthma and COPD cases has become more frequent, presenting unique challenges in diagnosis and treatment.

Current Treatment Landscape

1. Bronchodilators: The use of both short-acting inhaled bronchodilators (albuterol and ipratropium) as rescue therapy and long-acting bronchodilators (LABAs and LAMAs) has become common. Several new bronchodilators are in development, showing promise for future therapies.
2. Muscarinic Antagonist–β2-Agonists (MABAs): MABAs are under clinical trials, though challenges exist in balancing their LABA and LAMA activity.
3. New Corticosteroids: Fluticasone furoate, a once-daily inhaled corticosteroid (ICS) in combination with vilanterol, offers a new option. However, safety concerns related to corticosteroids remain.
4. Phosphodiesterase Inhibitors: Roflumilast is currently marketed as an anti-inflammatory treatment in COPD, but its narrow therapeutic window limits its use.
5. Kinase Inhibitors: Some kinase inhibitors have shown promise in COPD and Asthma models, but challenges in specificity and side effects require further research.
6. Mediator Antagonists: CRTh2 antagonists, cytokine inhibitors, and protease inhibitors have been widely used in Asthma treatment, but their efficacy varies.
7. Antioxidants: While antioxidants like N-acetylcysteine and sulforaphane have been explored, their efficacy remains limited.

Challenges and Suggested Approaches

Researchers face challenges in developing novel drugs for Asthma and COPD, including limited investment by pharmaceutical companies, a lack of funding for basic research, and a scarcity of helpful biomarkers.

To overcome these hurdles, identifying new therapeutic targets and biomarkers is crucial for better patient selection and long-term therapy monitoring.

New approaches in COPD and Asthma treatment include:

• Reversing Corticosteroid Resistance: Finding solutions to the challenge of corticosteroid resistance in patients.
• Resolving Inflammation and Aberrant Repair: Addressing inflammation and tissue repair dysregulation.
• Decelerating Aging: Focusing on strategies to mitigate the impact of aging on disease progression.

Biomarker-Driven Trial Designs

Biomarker-driven trial designs are transforming the landscape of COPD and Asthma treatments, offering a more precise and personalized approach to patient care.

These innovative trial designs focus on specific biomarkers that play a crucial role in understanding the underlying mechanisms of these respiratory conditions and predicting treatment responses.

In COPD, eosinophilic inflammation is a key biomarker that helps identify patients who are more likely to respond favorably to inhaled corticosteroids (ICS) and certain biologic therapies targeting type 2 inflammation.

Conversely, in non-type 2 inflammation, neutrophilia becomes a significant biomarker, guiding clinicians to explore alternative treatment strategies due to a reduced response to ICS.

For Asthma, fractional exhaled nitric oxide (FeNO) levels serve as a valuable biomarker for type 2 inflammation.

Elevated FeNO levels are associated with a higher likelihood of responding well to inhaled corticosteroids (ICS) and specific biologic agents, such as anti-IgE and anti-IL-4R treatments.

Additionally, IgE levels can indicate atopy and predict better responses to ICS and anti-IgE treatments.

Periostin emerges as a promising biomarker in both COPD and Asthma.

It is associated with type 2 inflammation and airway remodeling, making it a potential indicator of treatment response to anti-IL-13 therapies in Asthmatic individuals with high periostin levels.

Summary of Clinical Trial Findings

Biomarkers are essential tools in guiding treatment decisions and assessing therapy response for Asthma and COPD.

These biomarkers help in patient stratification, identifying subgroups likely to respond to specific therapies, and reducing the risk of adverse effects.

Contract Research Organizations (CROs) play a crucial role in advancing biomarker-driven research.

They possess specialized expertise in biomarker discovery, validation, and analysis, accelerating the translation of research findings into clinical applications.

Conclusion

In conclusion, COPD and Asthma present significant global health challenges, affecting millions of people and causing substantial morbidity and mortality.

The current treatment landscape has seen advancements, but unmet needs persist.

Biomarkers offer promising opportunities for personalized treatments, while contract research organizations (CROs) play a crucial role in advancing research and development efforts.

To address the challenges, increased investment in respiratory medicine research is essential.

By fostering collaboration and innovation among stakeholders, we can strive toward better management and improved outcomes for patients living with COPD and Asthma, ultimately enhancing their quality of life.

References:

• https://www.bmj.com/content/378/bmj-2021-069679
• https://erj.ersjournals.com/content/58/5/2004656

Disease Overview

Global Scenario

In developed nations, the prevalence of Chronic Myeloid Leukaemia (CML) is primarily concentrated among the elderly population, typically aged 60 and above.

In contrast, in developing nations, the diagnosis of the disease occurs approximately ten years earlier, impacting individuals in their 50s.

It is the most common type of blood cancer.

Indian Scenario

Chronic Myeloid Leukaemia (CML) is a clonal myeloproliferative disorder of a pluripotent stem cell.

CML is the commonest adult leukaemia in India, and the annual incidence ranges from 0.8– 2.2/100,000 population in males and 0.6– 1.6/100,000 population in females in India.

Out of the 250 CML Trials in active stage, 123 CML Trials worldwide are Phase II trials.

38 CML Trials are exclusively industry-funded or are in collaboration with academia and small biopharmaceutical companies.

Why is there a Need to conduct CML Trials?

CML is the world’s first cancer with specific genotype knowledge, which led to a rationally therapeutic schedule.

Imatinib, a tyrosine kinase inhibitor (TKI), was approved by the FDA to treat CML in 2001.

The discovery of the TKI-based treatment changed the CML disease status from a lethal disease to a chronic disease, especially for patients in the chronic phase.

There has been an apparent improvement in the survival of CML patients in high-income countries like the United States, France, and Japan.

The disease burden of CML distinctly varies in different countries due to diverse opportunities for early-stage screening, novel drugs, and medical resources.

Prevailing Trends in CML Clinical Trials

Targeted Therapies

The development of targeted therapies, such as tyrosine kinase inhibitors (TKIs), has been a significant trend in CML clinical trials.

TKIs, such as Imatinib, Dasatinib, and Nilotinib, have revolutionized the treatment of CML by specifically targeting the abnormal BCR-ABL protein responsible for the disease.

Treatment-Free Remission (TFR)

TFR is a growing area of interest in CML clinical trials.

It focuses on the possibility of discontinuing TKI treatment in patients who achieve deep molecular responses, aiming to maintain disease control without the need for ongoing therapy.

Combination Therapies

Investigating the effectiveness of combining different TKIs or combining TKIs with other agents is an ongoing trend in CML clinical trials.

Combinations may enhance treatment response, overcome drug resistance, and improve long-term outcomes for patients.

History of Targeted Therapy for CML Trials

Key Challenges and Considerations: Operational & Clinical

The challenges in CML clinical trials are based on the four phases as mentioned below:

• Chronic Phase
• Accelerated Phase
• Accelerated Phase with Patients with NO prior treatment
• Accelerated Phase with Patients with prior treatment

CML clinical trials across different phases present obstacles for CROs in their operational and clinical activities.

These challenges include communication and coordination with sponsors, complex protocols, site monitoring difficulties, patient population identification, geriatric research, study cost management, staff training, and utilization of technology-enabled platforms.

*Below is the chart that shows the impact of the above-mentioned challenges with respect to CML Phases for a CRO:

*3/4 of the graph is blue: classified as a major impact, 1/4 of the graph is blue: classified as minor impact, 1/2 of the graph is blue: classified as neutral

Veeda Oncology

In conclusion, CML clinical trials have witnessed significant progress, aided by the expertise of Indian CROs.

With our proficiency in managing protocol complexities, addressing the unique requirements of the geriatric population, and optimizing costs, Veeda stands ready to accelerate your upcoming CML trial.

We remain dedicated to offering exceptional support to sponsors engaged in CML research. By leveraging our extensive knowledge, sponsors can expect a seamless trial experience, adherence to regulatory requirements, and the generation of robust data.

Contact us today to know more about Veeda’s CML trial services.

References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6142563/
2. https://www.cancer.net/cancer-types/leukemia-chronic-myeloid-cml/types-treatment
3. https://ehoonline.biomedcentral.com/articles/10.1186/s40164-020-00185-z

Bioassays are involved in each stage of drug discovery, starting from Target Identification until discovering the Lead compound.

Bioassays provide valuable information that displays the therapeutic potency of a drug under investigation.

The data generated during bioassay also plays a vital role in drug development and quality control of finished biological products.

Properly designed bioassays help assess the biological effect, activity, signal transduction process, and receptor binding ability of drug products or biologics on biological targets (proteins) when compared to a reference or standard for a suitable biological system.

The pharmaceutical and biotech companies involved in drug discovery and development are continuously challenged with developing biologically relevant assays for the analysis of multiple potential mechanisms.

The process involves the use of quality critical reagents, use of specific cell lines, and purified test drug and reference drug products, which at times may become a constraint.

Most of these activities require sufficient time, which may become a limiting factor for biopharma manufacturers.

It is worth outsourcing activities to reputed CRO service providers to save time in developmental efforts and also to have an unbiased opinion on the functional activities of the drug product.

Veeda Group has qualified and experienced scientists to design, develop, execute, and validate bioassays for companies, providing premier bioassay services (in vitro and in vivo) that generate meaningful data to support pharmaceutical and biotech companies in their drug discovery and development journeys.

Veeda Group’s Experience in Development and Execution of Bioassays includes:

• Plaque Reduction Neutralization Test (PRNT assay)
• In Vitro Skin Sensitization Human Cell Line Activation test (h-CLAT assay)
• Nab Assay
• Assay Development (Pharmacodynamics, Pharmacokinetics, Immunogenicity, and Biomarker Assessment)
• In Vivo Bioassays for drug molecules like Luteinizing Hormone, Epoetin, HCG, Recombinant FSH, β-HCG, and Insulin.
• ADCC assay for biosimilars and other different assays like Ex Vivo assay, Cell-based assay, Receptor Binding Assay, Cytokine Release Assay, and ADA assay.

Veeda Group provides Integrated Discovery, Development & Regulatory Services with its multiple technology platforms:

• Exploratory toxicology studies
• Regulatory toxicology studies
• In vitro Bioassays
• Ex vivo Bioassays

The group also has the experience to handle a diverse range of Biotherapeutics like Therapeutic Monoclonal Antibodies, Insulin & Insulin Analogues, Cytokines, Low Molecular Weight Heparins, Biosimilars, Hormones & Biomarkers.

Veeda group has demonstrated capabilities to develop recombinant proteins such as non-glycosylated proteins and glycoproteins derived from either bacterial or mammalian host expression systems.

Bioassays in Preclinical Drug Development

Biological assays or bioassays are essential tools in preclinical drug development.

Preclinical bioassays can be in vivo, ex vivo, and in vitro.

In vivo, bioassays provide a more realistic and predictive measure of the functional effects of tests with reference drug products or standard material of defined potency, along with the application of statistical tools, study-specific lab techniques, and adherence to a well-designed study protocol.

These assays capture the complexity of target engagement, metabolism, and pharmacokinetics of novel drugs better than in vitro bioassays.

The most commonly used experimental mammals in in vivo efficacy assays are mice and rats.

Occasionally, other species may be used depending on the sensitivity & suitability of the assays.

Development and Validation of Bioassays

Bioassays are used as a screening method to identify the signals that indicate desired biological activity from a set of compounds.

In general, two different types of signals can be generated by a bioassay: a linear dose-response and a sigmoidal (S-shaped) dose-response.

Since one solution does not fit all bioassays, it is good to evaluate and analyze the data to develop a precise approach to carry out each bioassay.

The life cycle stages of a bioassay are divided into:

• Stage 1: Method design, development, and optimization
• Stage 2: Procedure performance qualification
• Stage 3: Procedure performance verification (fit for purpose)

Developing a bioassay that meets regulatory requirements and gets a drug product registered is a very complex process.

Developing a bioassay includes many strategies and tactical designs like selecting the correct in vivo platform, proper method or plate design, data analysis, system/ sample sustainability strategy, method implementation, method performance, and monitoring.

There are several steps to be followed for the development and validation of bioassays, such as dose-response and curve-fitting selection, development of reference, calculation of potency, bioassay characterization, design of bioassay calculator, standardization and automation of bioassay, and finally, evaluation.

Both method development and validation of bioassays include three fundamental areas:

1. Pre-study (Identification and Design Phase) validation
2. In-study (Development and Production Phase) validation
3. Cross-validation or method-transfer validation

During method development, assay conditions and procedures are selected to minimize the impact of potential sources of invalidity.

Coming to the statistical validation for an in vivo assay, it involves four major components:

1. Adequate study design and data analysis method
2. Proper randomization of animals
3. Appropriate statistical power and sample size
4. Adequate reproducibility across assay runs.

Parallel group design, randomized block design, repeated measures design, and crossover design are the basic types of experimental designs used in in vivo assay.

The following are the key factors that should be kept in mind while designing an in vivo assay:

• All meaningful biological effects (pharmacologically) should be statistically significant.
• If biologically relevant assays are not present, then a range of plausible effects can be considered.
• The key endpoints should be well-defined before the beginning of the assay.
• Animals should be allocated randomly in an appropriate manner to the treatment groups.
• The dose levels should be selected appropriately. Dose and curve-fitting selection is among the most critical aspects of bioassay development. The dose is determined depending on the type of model used to fit the signal to the data. For Sigmoidal designs, a four- or five-parameter logistics (4PL or 5PL) model fits the data, whereas for linear designs, a parallel line analysis (PLA) model fits the data.

For a 4PL model, nine doses are recommended:

1. Three doses in the lower asymptote
2. Three doses in the upper asymptote
3. Three doses in the linear range

In contrast, for a PLA model, a minimum of four doses is recommended. A minimum of three consecutive doses is required to plot the dose curve.

• The selection of control groups and time points to collect samples should be optimal.
• The design strategies should minimize variability and maximize information.

To understand the design, developments, and statistical validation of in vivo bioassay in more detail, reach out to us at https://veedalifesciences.com/.

One can also read the guidelines mentioned by NIH by visiting the link:

https://www.ncbi.nlm.nih.gov/books/NBK92013/pdf/Bookshelf_NBK92013.pdf

References

1. A. Little, “Essentials in Bioassay Development,” BioPharm International 32 (11) 2019
2. Padmalayam, Ph.D., Assay development in drug discovery
3. Zwierzyna M, Overington JP (2017) Classification and analysis of a large collection of in vivo bioassay descriptions. PLoS Comput Biol13(7): e1005641. https://doi.org/10.1371/journal.pcbi.1005641
4. White JR, Abodeely M, Ahmed S, Debauve G, Johnson E, Meyer DM, Mozier NM, Naumer M, Pepe A, Qahwash I, Rocnik E, Smith JG, Stokes ES, Talbot JJ, Wong PY. Best practices in bioassay development to support registration of biopharmaceuticals. Biotechniques. 2019 Sep;67(3):126-137. doi: 10.2144/btn-2019-0031. Epub 2019 Aug 5. PMID: 31379198.
5. F Chana and Hursh D. Bioassays through the Product lifecycle: Perspectives of CDER and CBER reviews.
6. Haas J, Manro J, Shannon H, et al. In Vivo Assay Guidelines. 2012 May 1 [Updated 2012 Oct 1]. In: Markossian S, Grossman A, Brimacombe K, et al., editors. Assay Guidance Manual [Internet]. Bethesda (MD): Eli Lilly & Company and the National Center for Advancing Translational Sciences; 2004-. Bookshelf URL: https://www.ncbi.nlm.nih.gov/books/

Lab Informatics: Revolutionising Pharma R&D

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Cancer is a deadly disease leading to the death of many individuals across the globe.

Biotech and Pharmaceutical researchers are carrying out extensive studies to develop drugs to treat cancer.

However, the current medications used in cancer treatment have many loopholes.

They are toxic, lack specificity, and have short half-lives.

The difficulty in administering complex oncology molecules, along with the above hurdles, has led to side effects, non-compliance, and patient inconvenience with many current treatments for cancer.

Liposomes are nano-sized drug delivery systems that have been shown to be quite effective in improving the selectivity of cancer chemotherapeutic agents.

However, clinical trial experts face many challenges when designing a Bioequivalence (BE) study for generic oncology drugs.

It includes selecting the study population, selecting the individual dose for patients, selecting the required study design (cross-over vs. steady-state design), and processing samples at investigator sites due to sampling uncertainty, high patient dropout rates, and stringent regulatory guidelines.

A bioequivalence study is generally conducted in healthy volunteers if the drug has shown a safety profile in a healthy population and is not a narrow therapeutic index drug.

However, the same is not ethically and medically acceptable in most anticancer drugs because of cytotoxicity in a healthy population.

Moreover, the regulatory requirements also vary from region to region.

How to Design a Study for a Generic Oncology Product on Liposome Injection Involving Cancer Patients?

Study Overview

Veeda Clinical Research completed an open-label, randomized, two-treatment, two-period, two-sequence, single-dose, multicentric, fasting, cross-over bioequivalence study of Doxorubicin Hydrochloride Liposome Injection 2 mg/mL in ovarian cancer patients for an Indian based Sponsor Company towards submission to the USFDA.

The study was completed within the stipulated timeframe with meticulous project management.

In both periods, the subjects received a 50 mg/m² single dose (intravenous infusion) of Doxorubicin Hydrochloride Liposome Injection 2 mg/mL (either the test or reference product), according to the randomization schedule created before the trial, on the first day of the chemotherapy cycle.

The washout period was at least 28 days between each consecutive dosing period.

Each cycle began with the collection of serial blood samples; a total of 25 blood samples were collected, with the last blood sample collected at 360.00 hours in each period.

Blood samples starting from 72.00 hours to 360.00 hours were collected on an ambulatory basis in each period to determine free and liposomal encapsulated doxorubicin plasma concentrations for PK analysis.

Subjects Inclusion and Exclusion Criteria

The study involved female patients between the ages of 18 and 65 who had ovarian cancer (confirmed through cytological and histopathological tests) and who were already receiving or scheduled to start therapy with the reference listed drug (RLD) or the reference standard product.

The four major inclusion criteria in this study were:

• Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Subject with Left Ventricular Ejection Fraction ≥ 50%
• Subjects with a life expectancy of at least three months are determined by checking liver, kidney, and bone marrow function.
• Subjects who had recovered from minor (at least one week) and major (at least four weeks) surgery.

Women who were pregnant, lactating, or planning for a family were excluded from the study.

A total of 18 parameters were judged under exclusion criteria.

Some of the major exclusion criteria were:

• Impaired cardiac function with the occurrence of unstable angina/arrhythmia/ myocardial infarction/ Qtc prolongation/ coronary artery bypass graft surgery/ heart failure/ symptomatic peripheral vascular disease within the last six months.
• Known history of brain metastasis.
• Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 according to NCI criteria.
• Positive test results for hepatitis and HIV.

Reporting and Handling of Adverse Events

The investigators reported six serious adverse events (SAEs) during the entire study.

Fever with diarrhea was reported in two subjects.

Another two subjects were observed with Nausea, Vomiting, and weakness.

Fever due to hospitalization and Non-neutropenic fever with acute gastroenteritis were also found in one subject each.

At the time of writing this article, all SAEs have been resolved after constant follow-ups with the patient.

During the study, hypersensitivity reactions due to Doxorubicin Hydrochloride Liposome Injection were avoided by administering Prophylactic Antiemetic and Dexamethasone Injection 8mg.

Conclusion

The study was successful, as the test product showed bioequivalence with the reference product.

The pharmacokinetic parameters like Cmax, AUC_0-t, and AUC_0-∞ were within the range of 80.00 to 125.00%.

Veeda Clinical Research provided end-to-end services in identifying and selecting the clinical trial sites, preparing and submitting regulatory documents like protocol, ICF, CRF, and Clinical Study Report to the drug regulatory authority on behalf of the sponsor company.

Trained and experienced nurses and investigators regularly monitored the oncology patients who participated in the study.

The study was completed successfully with fewer patient dropouts, abiding by the principles of Good Clinical Practice.

Finally, the product was approved by the USFDA.

Experienced personnel, including the Principal and Clinical investigators team at different sites, the project management team, CRAs, phlebotomists, nurses, the medical writing team, and the bioanalytical team of Veeda Clinical Research, are responsible for successfully completing this clinical trial.