3D render of a medical image with virus cells

Attacking Cancer Cells That Develop Resistance

Cancer remains one of the most intimating challenges in modern medicine, affecting millions of lives worldwide. While cancer treatment progress has been significant, resistance to therapies remains a serious challenge. Cancer cells often adapt and develop resistance to treatments that were once effective, leading to treatment failure and disease progression.

This article explores resistant cancer cells and current strategies to overcome them. Understanding resistance mechanisms and using advanced treatments can ensure successful treatment outcomes despite resistance challenges.

Understanding Cancer Cell Resistance

Cancer treatment faces a significant challenge: cancer cells become resistant to therapies that once worked. These resistance mechanisms vary from genetic mutations and epigenetic changes within cancer cells to the influence of the tumor microenvironment.

The consequences of untreated or recurrent cancer due to resistance are dire, often leading to poor outcomes and decreased quality of life for patients. Despite advancements in our understanding of these mechanisms, overcoming resistance remains a daunting task. The situation demands a collective effort to address this issue head-on.

Moreover, the economic burden of ineffective treatments adds another layer of urgency to the search for solutions. To combat this, it’s crucial to understand these mechanisms and find ways to target resistant cancer cells effectively.

Mechanisms of Resistance

  1. Genetic Mutations: Cancer cells can develop genetic mutations over time, making them less responsive to treatment. These mutations affect important cell functions, allowing cancer cells to survive and grow despite treatment.
  2. Epigenetic Changes: Changes in gene activity, called epigenetic alterations, also contribute to resistance. These changes can silence genes that control cancer growth or activate genes that promote it, making treatment less effective.
  3. Tumor Microenvironment: The environment around tumors plays a role too. Factors like low oxygen, inflammation, and nearby cells can protect cancer cells from treatment, making them harder to kill.

Importance of Finding Strategies to Attack Resistant Cancer Cells

  • Preserving Treatment Efficacy: Resistant cancer cells make treatments that used to work ineffective, lowering survival chances. Finding strategies to overcome resistance helps keep treatments working longer, improving patient outcomes.
  • Expanding Treatment Options: Overcoming resistance means more treatment options for patients. Clinicians can tailor treatment regimens to individual patients by targeting resistant cancer cells and optimizing therapeutic outcomes.
  • Enhancing Survival Rates: Effective strategies to attack resistant cancer cells prolong patient survival. By preventing or delaying disease progression, these strategies offer hope for better long-term outcomes.
  • Addressing Heterogeneity: Resistant cells within tumors vary, showing different resistance levels to specific treatments. Targeting resistant cells helps in reducing the likelihood of treatment failure and disease recurrence.

Current Strategies to Overcome Resistance

Researchers are exploring various innovative strategies to combat cancer cells that develop resistance to treatments. By understanding the underlying resistance mechanisms, these approaches aim to eliminate resilient cancer cells more effectively.

Here are some of the most promising methods being used today.

Targeting Cell-Cycle Kinase Inhibitors

Cell-cycle kinase inhibitors offer a promising solution against cancer resistance. These drugs slow or halt tumor growth by targeting cyclin-dependent kinases (CDKs). CDK inhibitors are effective, especially in hormone receptor-positive breast cancer, and reactivate natural tumor suppressors. 

Yet, cancer cells adapt, driving research into next-gen inhibitors targeting additional cell division enzymes. Consequently, early trials show potential for more effective, longer-lasting treatments, pushing researchers to innovate and outpace cancer’s adaptability for better patient outcomes.

Targeted Therapies

Targeted therapies focus on specific molecular targets linked to cancer. These treatments disrupt cancer cell growth and survival. For example, tyrosine kinase inhibitors (TKIs) block signals that make cancer cells grow. Even though resistance can occur through new mutations, targeted therapies like Imatinib for chronic myeloid leukemia (CML) and Trastuzumab for HER2-positive breast cancer have shown great success. They work best when combined with other treatments to help prevent resistance.

Combination Therapies

Combination therapies use multiple treatments to attack cancer cells from different angles, reducing the chance of resistance. This approach can include chemotherapy, targeted therapy, and immunotherapy. For example, combining BRAF and MEK inhibitors effectively treat melanoma by targeting different parts of the same pathway. This makes it harder for cancer cells to survive. Studies show that combination therapies improve response rates and extend progression-free survival, though managing side effects and interactions is important.

Immunotherapy

Immunotherapy uses the body’s immune system to fight cancer, making it a strong tool against resistant tumors. Checkpoint inhibitors like Pembrolizumab and Nivolumab block proteins that stop immune cells from attacking cancer. CAR-T cell therapy modifies a patient’s T-cells to target cancer more effectively and has been successful in certain blood cancers. Immunotherapy’s ability to adapt to cancer cells helps overcome resistance. Research is ongoing to enhance its effectiveness and manage side effects.

Nanotechnology

Nanotechnology uses nanoparticles to deliver drugs directly to cancer cells, increasing drug concentration at the tumor while reducing overall side effects. This approach can bypass resistance mechanisms like drug efflux pumps. Recent advances show that nanomedicine can improve the effectiveness of chemotherapy and targeted therapies.

Gene Editing and CRISPR

Gene editing tools like CRISPR can modify or correct genes responsible for cancer resistance. By targeting specific genes in resistance pathways, CRISPR can restore treatment sensitivity. Though still experimental, this technique shows promise for precision medicine despite ethical and technical challenges.

Emerging Experimental Treatments

New experimental treatments are being explored to fight resistant cancer cells. These include novel small molecules, antisense oligonucleotides, and adaptive therapy strategies. These innovative approaches are in various stages of research and trials, showing potential for future use in overcoming resistance.

Bottom Line

In our quest against cancer, resistant cancer cells stand as formidable opponents. Yet, with advancing knowledge and technology, we have potent weapons at our disposal. We’ve explored various strategies to combat resistance, from targeted therapies to immunotherapy and cutting-edge techniques like nanotechnology and gene editing.

Similarly, we at Globela, are open for collaboration across disciplines and borders, driven by the goal of defeating cancer. Globela’s Oncology department is committed to offering the highest quality products at affordable prices so that as many people as possible can benefit.

Whether you are a patient, a caregiver, or a healthcare professional, we are here to help you in your journey towards a cancer-free future.

WhatsApp Image 2024-06-17 at 18.40.16

Transforming Metastatic Breast Cancer Treatment: The Critical Role of Independent Research

Metastatic breast cancer (MBC) is a serious and complex form of cancer that continues to challenge researchers and clinicians. While there have been advancements in treating early-stage breast cancer, MBC remains difficult to manage and treat effectively. Independent scientific research is crucial in finding new ways to understand and combat this disease.

This article explores the latest discoveries in MBC research, focusing on how independent studies make a real difference in patient care.

Introduction

Metastatic breast cancer (MBC), or stage IV breast cancer, occurs when cancer spreads from the breast to other parts of the body like bones, liver, lungs, or brain. Unlike early-stage breast cancer, MBC isn’t curable and needs lifelong treatment. However, advancements in research are crucial for improving patient outcomes and quality of life.

Importance of Advancements in MBC Research

  • Improving Survival Rates: New treatments can help patients live longer.
  • Enhancing Quality of Life: Research leads to therapies that manage symptoms and reduce side effects.
  • Personalized Medicine: Discoveries enable tailored treatments based on individual genetics, improving effectiveness and reducing unnecessary treatments.
  • Understanding Metastasis: Insights into how and why cancer spreads can lead to new preventative measures and treatments.

The Current State of Metastatic Breast Cancer

MBC affects many individuals worldwide. In the United States, it is estimated more than 168,000 women will be living with metastatic breast cancer in 2020. Despite advances in detection and treatment, MBC remains a leading cause of cancer-related deaths among women, with a median survival of about three years after diagnosis.

Challenges in Treating MBC Compared to Early-Stage Breast Cancer

  • Complex Treatment: Early-stage breast cancer can often be treated with surgery and localized therapies. MBC requires systemic treatments like targeted therapy and immunotherapy to address cancer cells throughout the body.
  • Treatment Resistance: Metastatic cancer cells can develop resistance to treatments, reducing their effectiveness and necessitating new therapies and combinations.
  • Tumor Diversity: MBC tumors often contain different types of cancer cells, making it difficult to find a one-size-fits-all treatment. Different cells may respond differently to the same therapy.
  • Quality of Life: Managing MBC involves not only controlling cancer spread but also addressing symptoms and side effects, such as pain, fatigue, and emotional distress, which impact the patient’s quality of life.

The Role of Independent Scientific Research

Independent scientific research is conducted by researchers or organizations not directly affiliated with major institutions or government bodies. It is often funded by private foundations, non-profits, or individual donors, allowing for greater flexibility and innovation.

It is important for the following reasons:

  • Innovation and Flexibility: Independent researchers can explore new ideas and approaches that larger institutions might overlook.
  • Filling Knowledge Gaps: They can study areas that are often underfunded, contributing to a more complete understanding of MBC.
  • Collaboration and Cross-Disciplinary Work: Independent groups often work with other researchers, patients, and advocacy groups, fostering a comprehensive approach to finding solutions.
  • Rapid Response to Emerging Data: These researchers can quickly adapt to new findings, ensuring the latest discoveries are promptly investigated and translated into treatments.

Recent Breakthroughs in MBC Research

In the relentless pursuit of combating metastatic breast cancer (MBC), recent years have seen remarkable breakthroughs that are reshaping the landscape of treatment options and patient outcomes. These breakthroughs result from tireless efforts from independent researchers dedicated to unraveling the complexities of MBC.

Here’s a closer look at some of the most significant advancements:

On/Off Switch for MBC

In a recent study, researchers led by Lingyin Li, a Stanford biochemistry professor, found that the protein ENPP1 plays a key role in breast cancer’s resistance to immunotherapy and its spread. ENPP1 is found in both cancerous and healthy cells and is linked to immunotherapy resistance and metastasis in breast cancer patients.

Collaborating with UCSF professors, the team confirmed ENPP1’s predictive value in patient outcomes. Mouse studies showed that blocking ENPP1 reduced tumor growth and metastasis by suppressing the immune response. Dr Li suggested that ENPP1 acts like a “dam,” blocking immune signals and allowing cancer cells to hide.

These findings could help guide treatment decisions and improve therapies for breast cancer and other cancers that evade the immune system.

Two-pronged Immunotherapy for Metastatic Breast Cancer

Researchers at Washington University School of Medicine have found a way to make metastatic breast tumors in bone susceptible to the body’s immune system. By boosting certain immune cells, they cleared breast tumors in mice and prevented them from returning.

Blocking a molecule called p38 MAPK made the tumor area more vulnerable while combining it with an immune therapy called OX40 agonist supercharged T cells, effectively eliminating metastatic tumors.

This approach shows promise for treating metastatic breast cancer and protecting against bone loss. Clinical trials are ongoing for the therapies involved.

Targeting SMYD2 Protein to Prevent MBC

In a study published in Cell Discovery, researchers led by a biologist at CNRS have uncovered a potential breakthrough in understanding metastatic breast cancer. They found that a protein abundant in aggressive breast cancers, SMYD2, might play a pivotal role in promoting metastasis. This protein appears to activate BCAR3, another protein known for aiding cancer cell adhesion and migration.

Through experiments on mice with early-stage breast cancer, inhibiting SMYD2 prevented metastasis, suggesting a promising avenue for early treatment strategies that could potentially improve patient outcomes.

Translating Research into Patient Care

Recent progress in metastatic breast cancer (MBC) research is bringing hope to patients. Turning research into practical treatments follows a step-by-step process:

  • Lab Testing: New treatments are first tested in labs to make sure they’re safe and effective.
  • Clinical Trials: Promising treatments move to human trials, starting small to check safety and dosage, then expanding to see how well they work.
  • Regulatory Approval: Once proven safe and effective, treatments get approval from organizations like the FDA.
  • Guidelines and Monitoring: Approved treatments become part of official guidelines for doctors. They’re also watched closely to make sure they keep working well and are safe in the long run.

Bottom Line

Independent research is vital for advancing our understanding and treatment of metastatic breast cancer (MBC). Despite challenges, researchers have made significant breakthroughs, improving patient care. To sustain progress, we must support independent research efforts through funding and advocacy.

Looking ahead, personalized medicine offers hope for better outcomes. Let’s continue prioritizing and investing in independent research to provide hope and better solutions for MBC patients.

19476ec9-e0b2-45c5-8e57-2119e55f6f12

Green Chemistry: A Catalyst for Transformation in Pharma Manufacturing

Green chemistry, also known as sustainable chemistry, has emerged as a hope for industries striving to minimize their environmental footprint while maximizing efficiency and innovation. Despite pharmaceutical companies’ significant economic contribution, their manufacturing processes contribute to carbon emissions. Pharmaceutical factories typically use dangerous chemicals and produce a lot of waste, but green chemistry can bring significant changes for a better environment. This article delves into how adopting green chemistry practices is necessary to revolutionize the future of pharmaceutical manufacturing.

Understanding Green Chemistry

Before exploring the implications of green chemistry for the pharmaceutical industry, it’s crucial to understand its basics. At its core, green chemistry aims to create chemical products and processes that reduce the use of hazardous substances.

Its principles include minimizing environmental impact and fostering innovation, efficiency, and safety in various industries. In pharmaceutical manufacturing, where complex chemical synthesis and rigorous quality standards are the norm, understanding green chemistry has become pivotal in a new era of sustainability and responsibility.

Consequently, green chemistry revolves around twelve guiding principles established by chemists Paul Anastas and John Warner. These principles encompass the design, synthesis, and utilization of chemical products. Also, these processes minimize environmental hazards and maximize efficiency. Some fundamental tenets included in green chemistry are waste prevention, using renewable feedstocks, energy efficiency, and designing safer chemicals and processes.

Reducing Environmental Impact

The pharmaceutical industry faces the challenge of minimizing its environmental footprint. Traditional processes use solvents, reagents, and procedures harmful to ecosystems and human health. Whereas, green chemistry provides innovative solutions without compromising product integrity. Some of these innovative solutions are: 

  1. Minimizing Waste Generation: Adopting continuous flow technologies and processes reduces waste volume, enhancing efficiency and mitigating pollution. 
  2. Embracing Renewable Feedstocks: Utilizing renewable biomass-derived feedstocks like plant oils and sugars minimizes reliance on finite fossil resources and lowers greenhouse gas emissions. Moreover, it promotes sustainability in pharmaceutical manufacturing.
  3. Optimizing Energy Efficiency: By reducing heat and electricity consumption, maximizing process integration, and leveraging renewable energy sources, pharmaceutical companies can save money and help the environment. Also, it makes their processes work together better, and using renewable energy sources.

Enhancing Safety and Compliance

What comes next in this is enhancing safety and compliance. Ensuring safety and compliance is paramount in pharmaceutical manufacturing. Green chemistry aligns with regulatory efforts to improve safety standards and promote sustainable practices within the pharmaceutical industry and they are: 

  1. Minimizing Exposure to Hazardous Substances: Green chemistry aims to replace toxic substances with safer alternatives, reducing workplace risks and fostering responsible chemical management.
  2. Meeting Regulatory Requirements: Adopting green chemistry ensures compliance with regulations like REACH and TSCA, demonstrating a commitment to sustainability and responsible stewardship.
  3. Embracing Sustainable Development Goals: Green chemistry aligns with SDGs, integrating environmental, social, and economic considerations to combat climate change and promote equitable healthcare.

Optimizing Efficiency and Cost-effectiveness

In pharmaceutical manufacturing, efficiency and cost-effectiveness are crucial for companies aiming to stay competitive while meeting quality and affordability demands. It can be achieved by embracing green chemistry principles, as many green technologies offer cost savings and process optimization opportunities. Several of them are: 

  1. Streamlining Manufacturing Processes: Green chemistry advocates for simpler, more streamlined processes in pharmaceutical manufacturing. It aims to optimize reaction conditions and employs innovative techniques such as continuous flow chemistry. These approaches lead to improved productivity and cost-effectiveness.
  2. Continuous Flow Chemistry: Continuous flow chemistry enables precise reaction control, reducing solvent usage and enhancing product quality and purity. It facilitates scale-up and agility in meeting market demands.
  3. Reducing Raw Material Waste: Green chemistry minimizes waste by promoting atom-efficient reactions and renewable feedstocks. Metrics like atom economy and E-factor help assess efficiency, leading to less waste and lower environmental impact.
  4. Enhancing Resource Efficiency: Efficient resource use, including energy and water, is central to green chemistry. Technologies like microwave synthesis reduce energy consumption, while bio-based materials lessen reliance on finite resources, mitigating environmental impact.

Innovating Drug Discovery and Development

Green chemistry is not limited to manufacturing; it’s also used in drug discovery and development processes. Traditionally, drug designs prioritize efficacy and potency without considering how they affect the environment. However, if we include environmental concerns when designing drugs, researchers can develop effective and environmentally friendly drugs. A few of them are: 

  1. Designing Eco-Friendly Molecules: In green drug discovery, designing molecules considers therapeutic effectiveness and environmental impact. It involves renewable feedstocks, safer solvents, and efficient synthetic routes guided by ecological profiles.
  2. Biocatalysis and Enzyme Engineering: Enzymes catalyze reactions with high precision and biodegradability, enhancing sustainability. Tailored enzymes enable efficient synthesis of complex molecules, reducing environmental impact in drug discovery.
  3. Green Synthesis Routes: Novel synthesis routes in green drug discovery minimize ecological impact and maximize efficiency. Continuous flow technologies control reactions, reducing waste and resource use for scalable, streamlined processes.
  4. Collaborative Initiatives and Knowledge Sharing: Green chemistry’s full potential in drug discovery requires collaboration. Partnerships and platforms facilitate idea exchange, accelerating innovation for the widespread adoption of sustainable pharmaceutical practices.

Challenges and Roadblocks

Green chemistry promises transformative economic and environmental benefits, reshaping the industry towards sustainability and environmental stewardship. However, the widespread adoption of green chemistry in pharmaceutical manufacturing is not without challenges.

One major obstacle is the inertia of established practices and infrastructure, making it difficult for companies to transition to greener alternatives. Additionally, there may be technical hurdles and regulatory barriers to overcome, particularly when validating new processes and ensuring product quality and consistency.

These challenges require diverse solutions, including:

  • Basic training in process excellence and renewable energy use,
  • Provide financial incentives or awards for companies embracing greener alternatives,
  • Allocate funding for research and development focused on overcoming technical challenges,
  • Work with regulatory agencies to develop clear guidelines for green chemistry practices.

Conclusion

In a nutshell, green chemistry offers a promising pathway towards transforming pharmaceutical manufacturing into a more sustainable and environmentally responsible industry. 

By prioritizing renewable feedstocks, minimizing waste generation, and enhancing safety and compliance, companies can reduce their environmental footprint and improve efficiency and cost-effectiveness. 

Despite challenges such as entrenched practices and regulatory barriers, collaborative efforts and innovative solutions can pave the way for the widespread adoption of green chemistry principles, ushering in a greener future for pharmaceutical manufacturing.

WhatsApp Image 2024-04-29 at 15.15.53

Understanding APIs, Intermediates, and Finished Dosage Forms: A Guide for Pharma Professionals

Introduction

In the intricate landscape of pharmaceutical development and manufacturing, a fundamental understanding of Active Pharmaceutical Ingredients (APIs), intermediates, and finished dosage forms is paramount for professionals in the field.

Each stage is crucial in ensuring efficacy, safety, and regulatory compliance, from the inception of a drug’s synthesis to its final formulation.

This guide aims to provide pharmaceutical professionals with a comprehensive overview of APIs, intermediates, and finished dosage forms, delving into their intricacies, and regulatory considerations within the pharmaceutical industry.

Active Pharmaceutical Ingredients (APIs)

APIs constitute the central ingredient of any drug formulation, providing pharmacological activity or other direct effects in disease treatment, prevention, or diagnosis. They are manufactured through chemical synthesis, fermentation, recombinant DNA technology, or isolation from natural sources.

Processes of API Manufacture

API Process Development and Production involves several processing stages, such as reaction, crystallisation, separation, purification, filter cake washing, solvent swapping, and solvent exchange.

API Process Development Stage: Following drug discovery and early formulation, scientists determine how to convert the Active Pharmaceutical Ingredient (API) into an appropriate dose form for pilot production. Methods devised during this stage are later scaled up for commercial manufacturing pending successful clinical studies.

Selection of Pharmaceutical Manufacturing Machinery: The choice of machinery for blending, extrusion, drying, milling, and micronization is critical. This selection significantly influences the final drug product’s physical characteristics and quality features.

Powder Processing and Particle Size Distribution (PSD): Powder processing involves milling, which reduces particle size for optimal processability, bioavailability, reactivity, and safety. Achieving the suitable particle size distribution (PSD) ensures drug efficacy and delivery to targeted body sites.

API Manufacturers

API production is a complex process involving chemical synthesis or biochemical methods. According to the FDA, Indian and Chinese companies dominate the API manufacturing sector. Pharmaceutical companies usually adhere to their country’s safety standards when manufacturing the final product.

Regulatory Compliance and Safety

The safety and efficacy of drug products hinge on the quality of their active ingredients, ensured through optimised processes.

Poor API process development and production, along with contaminated active ingredients, are linked to adverse health effects, including fatalities. Thus, regulatory procedures for approving active ingredients are being strengthened globally.

This regulation bolsters the pharmaceutical supply chain, enhancing medication quality and safety. APIs undergo independent pre-qualification processes, ensuring adherence to WHO Good Manufacturing Practices (GMP) and streamlining FPP pre-qualification.

API Intermediates

Pharmaceutical intermediates are chemical compounds synthesised and used to produce active pharmaceutical ingredients (APIs). They are formed at various stages in API synthesis and facilitate API synthesis by serving as building blocks or precursor molecules. They undergo chemical modifications to create the desired API.

Role of Intermediates in API Synthesis

Intermediates play a vital role in API synthesis by enabling controlled modifications for desired chemical properties. They represent various stages in the synthesis pathway toward the API, contributing significantly to the efficiency, scalability, and quality of the synthesis process. Well-designed intermediates can simplify complex routes, enhance yield, and reduce costs.

For example, a common intermediate in API synthesis is [benzene], which can be modified to produce a wide range of APIs. This versatility is one of the reasons why intermediates are so important in API synthesis.

Examples of Pharmaceutical Intermediates

  • Key Intermediates: Central to API synthesis, these intermediates undergo multiple transformations to form the desired API structure.
  • Protecting Group Intermediates: Involving temporary modifications of functional groups in the API molecule, protecting groups prevents undesired reactions.
  • Salt Formation Intermediates: APIs are sometimes produced as salts to enhance stability and solubility.
  • Chiral Intermediates: Introduce handedness into APIs, enabling the production of specific forms.

Regulatory Consideration:

Pharmaceutical intermediates are subject to GMP guidelines for quality control, compelling manufacturers to establish appropriate systems and processes. To ensure safety and quality, they must identify and control synthesis-related impurities as regulatory authorities require.

Process validation is necessary to maintain consistent quality in manufacturing, with manufacturers obliged to demonstrate process capability to meet specified standards. Additionally, comprehensive documentation is vital for traceability and regulatory assessment, ensuring integrity and compliance throughout the pharmaceutical intermediate manufacturing process.

Finished Dosage Forms (FDFs) 

A finished dosage form (FDF) represents the consumable, finalised drug product. It encompasses tablets, pills, liquid solutions, and other forms of FDFs. All FDFs contain an API along with other inactive components.

Different types of FDF

There are various types of finished dosage forms, each with unique properties and applications:

  1. Tablets: Tablets are solid dosage forms containing API and excipients. They come in multiple shapes, sizes, and colours, and can be designed for immediate release, extended release, or enteric coating.
  2. Capsules: Capsules are solid dosage forms encapsulating API and excipients in gelatin shells. They come in two main varieties: hard capsules (powder, granules, or pellets) and soft capsules (liquid or semi-solid fill).
  3. Liquids: Liquid dosage includes solutions, suspensions, and syrups. These are commonly used for paediatric and geriatric patients and individuals who have difficulty swallowing solid dosage forms.
  4. Ointments: Ointments are semi-solid dosage forms often used for topical application. They are typically a combination of an API and a base and are used for dermatological, respiratory, and ophthalmic purposes.
  5. Inhalants: Inhalants are intended to be inhaled into the lungs. They can be metered-dose inhalers, dry powder inhalers, or nebulized solutions and are often used for respiratory conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD).

Regulatory Oversight

The FDA mandates manufacturers to demonstrate the efficacy of medications through laboratory settings and clinical trials involving actual patients. Stricter criteria and inspections have been implemented to regulate medications produced outside the home countries of pharmaceutical corporations.

Conclusion

Understanding APIs, intermediates, and finished dosage forms is pivotal for pharmaceutical professionals. The production of APIs encompasses rigorous processes, impacting the efficacy and safety of drug products from development to manufacturing.

Regulatory compliance ensures quality and safety, with intermediates playing a vital role in API synthesis. Diverse finished dosage forms cater to various patient needs. They are regulated to ensure efficacy and safety. Strengthening regulatory oversight is crucial for maintaining medication quality and safety and safeguarding public health globally.

WhatsApp Image 2024-02-29 at 18.43.52

Beyond the Virus- The Connection Between CVD and COVID-19 Complications

Introduction-

The world witnessed a catastrophe in the form of the COVID-19 pandemic. As per statistical data, more than 702 million active Covid positive cases are present worldwide. Moreover, the world lost around 7 million to the deadly virus. The COVID-19 is characterised by severe respiratory distress syndrome caused by novel SARS-CoV-2. 

At the beginning of COVID-19, evidence of the acute symptoms of the pandemic was pretty straightforward. However, several studies are being carried out to analyse the long-term sequelae of COVID-19. Reports of the trials suggest a strong link between COVID-19 and Cardiovascular Diseases.

According to the World Health Organization, Cardiovascular Diseases are the leading cause of mortality worldwide. Heart attack and stroke are significant CVDs that have high mortality prevalence. The data put forward by a report, COVID-19 and Cardiovascular Diseases, published in 2020, stated a high occurrence of CVDs in COVID-19-positive patients, with more than 7% of patients experiencing myocardial injury due to the virus. 

Therefore, the identification of risk factors and prevention of cardiovascular diseases in patients with a COVID-19 history is a challenge for the medical fraternity. Risk factors associated with cardiovascular diseases are well known, such as lifestyle and genetics. However, the role of these two factors in precipitating CVDs in patients affected by SARS-CoV-2 is still unknown.

COVID-19 and CVDs

One of the long-term consequences of the pandemic manifested in the form of an increased global cardiovascular burden. Recent statistical data presents a rise in mortality and morbidity related to Cardiovascular diseases owing to the direct and indirect effects of COVID-19.

Moreover, research has found an interlink between genetic factors and poor lifestyle with cardiovascular disorders in COVID-19 patients. 

The genetic association is determined using the Polygenic Risk Score. High values show a high risk of developing coronary artery disease, atrial fibrillation and venous thromboembolism in people with SARS-CoV-2 infection. Similarly, poor living habits such as smoking habit, increased alcohol consumption, and sedentary living put individuals at a higher risk for developing cardiac complications. 

Although the exact pathophysiology behind the risk of CVD in COVID-19 patients is not yet understood, researchers have attempted to explain a couple of mechanisms. Some of them are:

Direct cardiotoxicity- The SARS-CoV-2 virus directly infects the cardiac cells leading to myocarditis. 

Post-disease hyper-inflammation- Post-COVID-19 cases have shown uncontrolled release of cytokines leading to plaque formation and vascular inflammation. It ultimately precipitates Myocardial Infarction, cardiomyopathy and Heart Failure.

Systemic manifestations- COVID-19 also causes systemic complications such as Disseminated Intravascular Coagulation(DIC), sepsis etc which result in cardiovascular diseases.

Genetics and Lifestyle- Potent Risk Factors for CVD

Genetics and lifestyle influence the occurrence of cardiovascular diseases. A family history of CVD raises the chances of acquiring the disease. The proportion of risk will also be influenced by the age of the affected relative. CVDs such as congenital diseases, high cholesterol levels, and high blood pressure can be inherited. Alteration even in the single gene code can lead to heritable cardiac disorders.

Similarly, lifestyle also influences the prevalence of CVD in an individual. Poor diet, high alcohol consumption, a history of smoking, and less physical activity are culprits of cardiac diseases.

But, how do these two potential risk factors augment the chances of CVDs in people who have a history of COVID-19?

What does Research Show?

A study was conducted between March 2020 and September 2021 on 25,335 COVID-19-positive patients to evaluate the role of genes and lifestyle. The study aimed to correlate the link between PRS(Polygenic Risk Score), lifestyle factors and cardiovascular disorders in selected patients within 90 days after diagnosis of COVID-19. 

A polygenic Risk Score is an accumulation of genetic risk factors for a particular trait. It is an authentic tool to predict precision medicine and cardiovascular disease occurrence rates. In the study, the PRS was determined for cardiac diseases such as venous thromboembolism, coronary artery disease, atrial fibrillation and ischemic strokes. Moreover, the prospective cohort research also used a lifestyle index comprising 9 variables to determine its role in the precipitation of cardiovascular diseases.

The study used the Cox proportional hazard model to calculate the hazard ratio and confidence interval for studying the link between genes and CVD. In contrast, the multivariable Cox regression model was applied to determine the lifestyle factors.

The result of the study confirmed a linear association between gene mutations and a higher incidence of cardiovascular disorders post-COVID-19 infection. The participants with the top 20 per cent Polygenic Risk Score have a high risk of developing atrial fibrillation(3-fold increase), coronary artery disease(3.5-fold increase) and venous thromboembolism (2-fold rise). However, no apparent association is observed between ischemic strokes and genetic factors. Another interesting finding is the positive existence of risk factors even in fully vaccinated individuals.

A positive correlation exists between a healthy lifestyle and a lower incidence of CVDs in COVID-19 patients. It is also noteworthy that COVID-positive cases with unhealthy lifestyles, when switched to healthy living diminished their risk of developing CVDs. Cardiac complications such as CAD and AF also demonstrate an additive rise in patients with high scores of PRS and an unhealthy lifestyle.

The Conclusion

Although the fatal wave of the pandemic is over. The world lost more than a million lives. But, the threat persists. The long-term consequences of COVID-19 in patients with a positive history are still a medical mystery. Several research groups and pharmaceutical companies like Globela Pharma are trying to do evidence-based studies to deal with chronic complications.

blog image 2 (1)

Collaboration-A need of hour to Speed up Access to New Vaccines

Introduction:

The fatal wave of COVID-19 made everyone aware of the importance of vaccines to prevent and control tremendously dangerous and infectious diseases. The whole world during the COVID-19 pandemic needed an efficient vaccine to kill the virus and save them from a lethal contagious disease. Scientists and researchers globally were focused on creating an efficient and reliable vaccine to protect the world from such a dangerous virus. 

During the pandemic crisis, this situation not only demonstrated the importance of vaccines and medicines in our lives but also proved how important it is to have a well-organized and synchronised process for vaccine manufacturing.  To combat all the challenges that the world faced during the time of pandemic a new tool of “regulatory collaboration” came to light. 

In this article, we will learn the importance of global regulatory collaboration and how this global regulatory collaboration helps in achieving a single goal i.e., speed up the access to vaccines.

What does Global Regulatory Collaboration mean?

A global regulatory collaboration simply means the collaboration or working together by regulatory bodies from various countries. It works in different ways to discuss, develop, manage and achieve the same goal. 

The Global Regulatory Collaboration came out as an emerging tool to have more access to vaccines and medications. Also, it helps to manage its proper manufacturing as well as distribution across the globe. 

What is the importance of Global Regulatory Collaboration?

The traditional regulatory process for the validation and approval of vaccines involves a series of rigorous trials and preclinical examinations along with an assessment of manufacturing processes. 

Global regulatory collaboration also plays a vital role in ensuring the rapid development, approval and distribution of vaccines worldwide. 

The era of COVID-19 demanded the healthcare system’s urgency of efficient and useful vaccines along with acceleratory regulatory pathways without compromising on scientific rigour. 

Thus, the Global Regulatory collaboration helps in acknowledging the need for expeditious decision-making along with ensuring excellent standards and quality in vaccine development and efficient distribution. 

How does the Global Regulatory Collaboration aim to speed access to new vaccines?

There are various benefits of Global Regulatory Collaboration as it aims to speed the access to new vaccines.

Global Regulatory collaborations work while promoting the sharing of information, harmonizing standards and promoting mutual recognition of regulatory decisions it enables the availability of access to safe and efficient vaccines. 

So let’s understand it’s working as follows:

Enhancing Information Sharing and Cooperation:

A very crucial aspect of global regulatory collaboration is the exchange of information and cooperation among regulatory authorities. Collaboration enables regulatory agencies to share their data from every event. 

It starts from clinical trials to post-marketing surveillance along with no confidentiality, but total transparency. By enabling access to the expertise and resources of various collaborated regulatory bodies the companies can minimize the approval timelines and other efforts too. 

It also can help companies to facilitate the global availability of safe and quality vaccines throughout the globe. 

Harmonization of Standards:

Various countries have various wide range of rules. Yes, different countries have different and unique regulatory requirements and approval processes which eventually make the consumers suffer for their needs.

Additionally, these processes are time-consuming and require various recognitions. Thus, it takes very long for these vaccines to reach across borders. 

In this, Global regulatory collaboration attempts to harmonize standards and requirements among different agencies to hasten the approval process. 

By ensuring proper synchronisation and utilising recognition companies can prevent the duplication of efforts. Also, it aids the regulatory bodies to speed up access to vaccines without compromising their safety and efficacy.

Mutual Recognition of Regulatory Decisions:

Mutual recognition agreements (MRAs) are the key tools that play a major role in global regulatory collaboration. It allows regulatory bodies to accept the decision and verdict established by another authentic regulatory body. 

This process not only saves time by avoiding fake evaluations but also helps in enhancing trust and confidence in the safety and functioning of approved vaccines.

MRAs’ functioning is so effective and incredible that they make countries rely on the expertise of authentic regulatory agencies and also enable quick authorisation of vaccines within their jurisdictions.

International Consortia and Collaborative Platforms:

International consortia and collaborative platforms have established themselves as the leaders of global regulatory collaboration. Huge and reputed agencies like the World Health Organization (WHO), The International Coalition of Medicines Regulatory Authorities, and the Coalition for Epidemic Preparedness Innovations have also played a major part in cherishing cooperation among regulatory bodies. 

These platforms focus on sharing scientific information, harmonization standards and other relevant information required to help maintain a coordinated global development and distribution of vaccines throughout the globe. The international consortia and collaborative platforms also help by optimising resources and coordinating efforts to make vaccines. 

Impact on Access and Equity:

Global regulatory collaboration has profound implications for access and equity in vaccine distribution. Accelerating the regulatory process ensures the access of vaccines to developing countries as well, as that to the advanced ones. 

For instance, WHO’s very well-known COVAX and other Emergency Use Listing (EUL) had an equal distribution of the vaccines by regulatory collaborating bodies. They also encouraged the sharing of the doses with other countries in need. 

By developing and distributing vaccines across the world the regulatory collaboration not only bridged the gap in accessing vaccines to individuals but also saved thousands of lives reducing health disparities.

Conclusion:

In a nutshell, global regulatory collaborations have proved themselves to be a pillar in saving lives by speeding up access to vaccines during times of crisis. The COVID-19 pandemic has reinforced the need for a synchronised and coordinated regulatory body to ensure the timely availability of safe and effective vaccines. 

As the world continues to battle with an ongoing pandemic and prepares itself for future global health crises, it is now a mandatory part to promote and accept global regulatory collaboration as a smart strategy to accelerate access to life-saving vaccines.

This same goes for the medicines as well. Collaboration is also a need in the manufacturing of medicine as well. In this, Globela Pharma with collaboration services provides rigid cooperation while maintaining the transparency in manufacturing of medicines.

Empowering Access

Empowering Access: The Crucial Role of Pharmaceutical Companies in Affordable Healthcare

Introduction:

Over the last 20 years, Indian pharmaceutical companies have played a crucial role in improving health care in India and around the world. Even during the COVID-19 period, the companies were standing in front to mobilise their resources to fulfil the supply chain despite the lockdown and restrictions in the country. Indian pharmaceutical companies generate 60% of global vaccine production. They contribute to around 40-70% of DPT (Diptheria, Pertussis and Tetanus) and BCG (Bacillus Calmette – Guerin) vaccines produced by WHO (World Health Organisation).

Affordable healthcare is a fundamental right that everyone should have access to. In a country like India, with a population of over 1.3 billion, ensuring affordable healthcare for all is a monumental challenge. However, Indian pharmaceutical companies have played a significant role in making healthcare more accessible and affordable for millions of people. This blog explores the crucial role of Indian pharmaceutical companies in providing affordable healthcare solutions.

What do these pharmaceutical companies do?

Pharmaceutical companies provide affordable healthcare as an essential aspect of individuals’ and communities’ well-being. These companies play a crucial role in researching, developing, manufacturing, and distributing life-saving medications and treatments. Their contributions are vital to making healthcare accessible and affordable for people across the globe. By investing in research and development, collaborating with healthcare providers, and advocating for policy changes, pharmaceutical companies can significantly impact healthcare affordability. 

Moreover, the Indian pharmaceutical industry has established itself as a global leader in generic drug production. Their expertise and adherence to international quality standards earn them the trust and confidence of healthcare professionals and regulatory bodies worldwide. This leads to increased collaborations and partnerships with multinational pharmaceutical companies. Moreover, this facilitates the transfer of technology and knowledge ultimately accelerating the availability of affordable healthcare solutions globally.

How can Indian pharmaceutical companies help provide affordable healthcare?

Pharmaceutical companies contribute to affordable healthcare in various ways. Explore the potential benefits and challenges associated with their role:

  • Generic Medicines: 

Indian pharmaceutical companies have been at the forefront of producing high-quality generic medicines at affordable prices. Generic medicines are bioequivalent to their branded counterparts but available at a fraction of the cost. Indian companies’ production and distribution of generic medicines have significantly reduced patients’ financial burden, especially in developing countries like India.

  • Research and Development:

Indian pharmaceutical companies like Globela Pharma invest heavily in research and development (R&D) to develop innovative and cost-effective healthcare solutions. By focusing on R&D, these companies have developed generic versions of expensive drugs, enabling patients to access life-saving treatments at affordable prices. Additionally, Indian pharmaceutical companies have made significant contributions to the development of vaccines and medicines for diseases such as HIV/AIDS, malaria, and tuberculosis, further enhancing affordable healthcare options.

  • Manufacturing Capabilities:

India is known for its robust pharmaceutical manufacturing capabilities. The country has a vast network of pharmaceutical manufacturing units that produce a wide range of medicines, including essential drugs. The economies of scale achieved by Indian pharmaceutical companies have led to lower production costs, making medicines more affordable for patients. This manufacturing process has also allowed India to become a major exporter of pharmaceutical products to other countries, further expanding access to affordable healthcare globally.

  • Government Initiatives and Partnerships:

Indian pharmaceutical companies have collaborated with the government and non-governmental organizations to implement various initiatives aimed at providing affordable healthcare. For instance, public-private partnerships have been instrumental in setting up healthcare facilities in rural areas, ensuring access to medicines, and promoting preventive healthcare measures. These collaborations have not only made healthcare more affordable but also improved the overall healthcare infrastructure in the country.

  • Global Health Aid and Philanthropy Initiatives:

Indian pharmaceutical companies have an admirable track record of aiding global health crises through humanitarian initiatives and philanthropic activities. During emergencies such as humanitarian crises, natural disasters and disease outbreaks. Companies have stepped forward by providing essential medicines, vaccines and medical supplies at a subsidized or no-cost basis. Their commitment to social responsibility extends beyond borders contributing to global efforts aimed at improving healthcare access for the most vulnerable populations.

  • Patent Challenges:

Indian pharmaceutical companies have challenged patents on expensive drugs, allowing affordable generic versions. By challenging patents, these companies have played a crucial role in breaking monopolies and promoting competition, resulting in lower drug prices. This has had a significant impact on making healthcare more affordable, not only in India but also in other countries.

Although, Indian pharmaceutical companies have not been easy. Before 1970, most of the pharmaceutical industry was owned by foreign owners. However, thanks to the Indian Patents Act in 1970 and the Drug Policy in 1978. It allowed the next generation of scientists and entrepreneurs to take advantage of the opportunities provided by these resources to build a tremendous pharmaceutical industry.

  • Health Awareness and Education:

Indian pharmaceutical companies have also been involved in creating awareness and educating the public about various health issues. Through campaigns and initiatives, these companies have helped spread awareness about diseases, preventative measures, and the importance of early diagnosis and treatment. By promoting health education, Indian pharmaceutical companies reduce healthcare costs by preventing diseases and promoting overall well-being.

Conclusion:

Indian pharmaceutical companies have emerged as key players in making healthcare more cost-effective and accessible. Their contributions in the form of generic medicines, research and development, manufacturing capabilities, government partnerships, patent challenges, and health awareness initiatives have significantly impacted affordable healthcare in India and beyond. 

Globela Pharma helps attain affordable healthcare by making significant strides in ensuring access to quality medications for all individuals. Through our commitment to innovation collaboration and affordability, Globela is changing the landscape of healthcare by putting patient well-being at the forefront.

At Globela, we are bridging the gap between healthcare and individuals ensuring that quality medicines are accessible to all. By working together with stakeholders investing in research and development and engaging in corporate social responsibility initiatives Globela is reshaping the pharmaceutical industry and transforming lives for the better.

However, there is still work to be done to ensure universal access to affordable healthcare. Continued efforts and collaborations between the government, pharmaceutical companies, and other stakeholders are essential to address the existing challenges. This will make affordable healthcare a reality for all.