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Digitalization In Pharma Research

Introduction

The Pharmaceutical industry is the backbone of the healthcare system. To always level up themselves and stay ahead of the competition, pharmaceutical companies expand their work by adapting new technologies. 

In this era, with of help of incredible and fast-developing advancements in technology and the huge amount of data harnessing, great tools and technologies can easily improve the entire drug discovery and development journey.

Ahead in this article, we will explore the need for digitalization in the pharmaceutical industry R&D and the potential benefits it holds.

Role of Digitalization in Pharmaceutical Companies’ R&D (Research and Development)

The world we are living in is not bounded with any limitations so are pharma companies. Constantly changing demands of consumers and their hustle lives make digitalization a mandatory step in pharmaceutical companies but also serves as a less time-consuming platform to keep an eye on their health. 

Apart from this pharmaceutical companies also need Digitalization in the R&D department for the following:

Accelerating Drug Discovery

If we consider the traditional process of drug discovery it is often expensive and time-consuming. Digitalization can help to revolutionize the process by integrating all the data-related methodologies such as artificial intelligence or AI and machine learning. These new technologies enable researchers to easily access massive data sets and also to identify patterns and make predictions. 

Digital tools can easily analyse a huge number of chemical compounds and hence can easily reduce the time for screening potential drug candidates. This will indeed help in the fast identification of potential targets and will also increase the efficiency of the drug discovery process.

Enhancing Clinical Trials

Clinical trials are a crucial and mandatory part of drug authentication. They are critical for analysing the safety and efficacy of a drug candidate. In clinical trials, digitalization can also help to improve the patient’s recruitment data collection and monitoring throughout the whole clinical trial process.

Furthermore, the digital platforms of pharmaceutical companies can reach a broader end of the population of potential participants. This will also help to ensure a more diverse and representative patient population. 

Moreover, digital tools facilitate remote monitoring of the patients ensuring real-time data collection and analysis. This eventually will not only enhance patients’ participation but also will improve the accuracy and efficiency of data collection for better decision-making.

Improving Data Integration and Collaboration

Pharmaceutical R&D holds huge amounts of data including clinical trials, electronic health records and many others as well. Implementing digitalization and cloud-based solutions can help companies to integrate huge data sets and can overcome the issues like data silos.

Data integration also helps researchers attain an exact view of patients’ histories and treatment verdicts. This eventually helps to make a strong and established decision to decide on a specific treatment and medications for the patients. 

Also, digitalization tools allow clinicians and researchers to work effortlessly across various locations enhancing their expertise, ideas and knowledge.

Optimizing Drug Manufacturing and Supply Chain

Digitalization also plays a crucial role in transforming drug manufacturing and supply chain processing. By using it, companies collect real-time data on health equipment manufacturing and supply chain logistics. This helps to keep a continuous eye on the early detection of issues which helps in reducing downtime and increasing overall productivity.

Also, the introduction of digitalization can create virtual replicas of manufacturing plants or supply chain processes. This creates a better opportunity for creating various scenarios for planning. At the same time, this will be a cost-effective solution for pharma companies. 

Ensuring Regulatory Compliance

The pharmaceutical industry works in a very complex and highly regulated environment. Digitalization can help to automate documentation track changes and provide an authentic and transparent audit trial making regulatory inspections simple and reducing chances of errors.

Moreover, real-time monitoring and access to data can enable pharmaceutical companies to quickly identify all the relevant concerns and actively address them. This helps the patients ensure their safety and also helps the company maintain their reputation. It also helps the company to gain the trust of regulatory bodies and stakeholders.

Enabling Personalized Medicine

Personalized medicine is something that aims at providing treatment to every individual as per the requirements of their bodies, gene makeup, lifestyle and other important factors. By promoting digitalization pharmaceutical companies can keep the data of the patients along with other crucial and confidential information safe. This will enable pharmaceutical companies to reach precision in medicines as per the needs of the patients.

Additionally, the newly introduced concept of AI (Artificial Intelligence) tools can also help in this scenario. These tools can easily analyse the huge amount of data of patients and genetic profiles and can plan a specific treatment as per the requirements. This will enhance targeted therapy development and will also enable healthcare providers to make informed decisions based on the personalized data of the patients.

Benefits of Digitalization in Pharma Companies

The digitalization in the field of pharmaceutical companies’ R&D shows numerous benefits as follows:

  • Easy collection of data in one place
  • Help increase efficacy and manufacturing using digital changes
  • Can get more work done in less time
  • Shows low dependency on manual labour
  • The progress or no progress is easily visible
  • Helps expand business
  • Personalized treatments and therapies to the consumers as per their needs

Conclusion

Digitalization is no longer an option but is the need of the hour for a step ahead in pharmaceutical companies’ R&D departments. By introducing digital tools, technologies and data-driven approaches pharmaceutical companies not only can unlock a treasure of accelerating drug discovery but also improve clinical trials. Also, it will help you optimize manufacturing processes that will ensure regulatory compliance and provide personalized medicines. 

The need for digitalization in the pharmaceutical industry is now a mandatory step to be taken to ensure the immense benefits and facilities these technologies can provide to consumers. The pharmaceutical companies that will embrace this transformative step will indeed gain a reputation in the market and also build a competitive advantage by delivering unpredictable innovations. 

The introduction of digitalization in pharmaceutical companies’ R&D will not only improve the present condition of medical health throughout the country but also will show proven results in improving global healthcare outcomes.

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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.

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Building a Strong Foundation: The Core Elements of Successful Pharma Businesses

Introduction 

In the world of pharmaceuticals, finding success is not just about making a strong firm of effective drugs and treatments. Moreover, it involves building a strong foundation for long-term profitability and making a positive impact on patients’ lives. So let’s dive deeper into acknowledging the core elements of establishing a thriving pharma business and its significance.

What are the necessary core elements of establishing a Pharma Business?

Pharmaceutical companies face various challenges to gain a reputation and name in the market to establish themselves. Let’s know the core elements required for establishing a successful pharmaceutical business including:

Vision and Purpose:

Every successful pharmaceutical company requires a clear vision and purpose that guides its operations. A focused vision helps provide long-term goals and aspirations for the company. It helps business to define its objectives, stay focused and navigate through all challenges. 

When the employees know about the company’s motto, they become more engaged and motivated towards accomplishing that motto. Moreover, it attracts top talents, investors, and collaborators to be inspired by the company’s mission. 

For instance, Globela Pharma has been thriving in the pharmaceutical business since 2006 as they are rigidly clear in their vision to make highly researched, affordable and accessible healthcare products. Additionally, this strong vision and purpose help the company to establish its own identity setting it apart from the competition and creating a level of trust with stakeholders. 

Innovation and Research:

The ever-changing field of pharmaceutical companies constantly demands innovation and research. Innovation is one of the factors that helps to stay ahead in the pharmaceutical industry. Successful pharma businesses invest in their R&D department to discover better and more. 

Just like Globela Pharma, has been forefront of innovation for nearly seventy years. Also, we at Globela have a passion for innovation aligned with the industry’s gold standards to ensure high-quality products. 

Moreover, by embracing innovation, businesses can bring huge profits for the company elevate patients’ care and generate sustainability. 

Regulatory Compliance:

It is crucial to set strict regulations governing the pharmaceutical industry, complying with national and international standards. For every successful pharma business compliance to maintain a positive reputation is mandatory. 

Regulatory compliance includes rigorous quality control but also involves accurate documentation, transparent reporting, and adherence to legal requirements. Implementing robust compliance helps the business to mitigate risks, avoid legal issues, and build a reputation.

Quality Control and Manufacturing:

Quality control is the foremost check in the pharmaceutical industry. Successful businesses implement rigorous quality management systems throughout the manufacturing process to ensure their products meet the highest standards of safety, efficacy, and purity.

It is very crucial to maintain good manufacturing practices (GMP) and invest in state-of-the-art facilities. These investments ensure that manufacturing processes are standardized, efficient, and reproducible. 

Prioritizing quality helps pharmaceutical companies establish trust and dependability with healthcare professionals. The trust for a pharmaceutical company in the market ensures more sales and profits and also encourages the company to work better to maintain the same.

Moreover, maintaining high-quality manufacturing processes aids in ensuring meeting the requirements of the public, minimizing the risk of product recalls and reputational damage.

Market Access: 

While developing exceptional drugs, it is vital to make them accessible to the patients who require them. Market access to various healthcare departments like hospitals, clinics, distributors, and many others helps ensure a strong relationship between the users and the company. It helps to build a name among the consumers and gain market access.

Furthermore, successful pharma businesses understand regional market dynamics and customize their strategies accordingly. They conduct thorough market research to find exact customer needs and preferences. This information enables them to reach out to consumers and tailor their messaging and promotional activities effectively. 

Understanding the market helps companies to optimize pricing strategies, reimbursement models, and healthcare policies. These strategies ensure that medications are accessible to patients at affordable prices which eventually helps them to maximize market penetration and revenue generation.

Efficient Distribution:

Efficient distribution is the key to success when it comes to market access. All the renowned and successful pharmaceutical businesses maintain a strong partnership with distributors ensuring efficient delivery to healthcare providers, pharmacies, and eventually patients. 

Optimization of the distribution process reduces transportation costs, enhances the supply chain and promotes customer satisfaction. Consequently, companies like Globela Pharma with their efficient distribution are supplying their medicines in 42+ nations and building their business foundation day by day. 

Sales and Marketing Excellence:

In a highly competitive market, it is essential to drive product adoption and revenue growth to gain effective sales and marketing strategies. Successful pharma businesses invest in thorough market research to identify customer needs, behaviours, and preferences. 

This collection of knowledge allows them to develop targeted marketing campaigns which eventually help to resonate with a targeted audience. Acknowledgement of equipping the sales team with in-depth products is a crucial factor in achieving sales success. 

Also, the sales team must have appropriate knowledge of the drugs they are promoting, including their benefits, potential side effects, and competitive advantages. Thus, regular training programs are necessary to keep the sales team informed about medical advances and ensure that they can communicate the value and safety of drugs effectively.

Partnerships and Collaborations:

No pharma business can succeed by sitting inside a room. Collaboration is key to addressing complex healthcare challenges, fostering innovation, and expanding market reach. Successful companies actively participate in reaching academia, research institutions, healthcare providers, and other pharmaceutical companies.

Strategic collaborations enable businesses to combine diverse expertise, share resources, and work towards a common goal. Partnering with research institutions and academia facilitates access to cutting-edge research, enabling faster drug development and innovation. 

Collaborations with healthcare providers ensure the right directional clinical research, allowing companies to gather real-world evidence of their drugs’ efficacy and safety. 

Conclusion

Building a strong foundation for a successful pharma business is not an easy task, but surely can be achieved through regular efforts and a multifaceted approach. In order for pharmaceutical companies to grow and impact, they must have a clear vision, adhere to regulatory standards, focus on quality, have strategic market access, execute well on sales and marketing, and establish fruitful partnerships.

With the above-discussed core elements in place, pharmaceutical companies can shape the future of healthcare in an extremely new direction and improve the lives of millions.

Oncology Drug Manufacturing

From Lab to Patient: Prioritizing Safety and Quality in the Oncology Drug Manufacturing Process

Introduction 

Oncology is a term used for the study of cancer. Cancer is a disease characterized by the uncontrollable growth of abnormal cells that destroy body tissues. As per the latest studies, the number of cancer cases in the year 2022 was 14,61,427. The rising rate of cancer has been a matter of deep concern for a long time. This requires authentic medicines and therapies to cure it.

The field of oncology drug manufacturing plays a pivotal role in the fight against cancer. With the ever-increasing demand for effective and safe treatments, it is imperative to ensure the highest standards of safety and quality throughout the manufacturing process. This blog aims to shed light on the key aspects and measures that pharmaceutical companies and regulatory bodies must undertake to guarantee the safety and efficacy of oncology drugs.

Why is safety required to manufacture oncology drugs?

Well, the answer to this includes the prevention of the hazardous effects of manufactured oncology drugs. As these drugs exhibit the following 6 characteristics while manufacturing which makes it more dangerous to use these drugs without proper safety. Those 6 characteristics are as follows:

  • Carcinogenicity – Substances that cause tumour via., inhalation, ingestion or skin contact are known as carcinogens, and cause carcinogenicity.
  • Teratogenicity – Capacity of a drug to cause congenital anomalies due to harmful chemicals. 
  • Reproductive toxicity – It is a type of toxicity that occurs when a chemical shows adverse effects on the reproductive system. 
  • Organ toxicity – It takes place when a chemical shows ill effects on any of the organs of the body.
  • Geno toxicity – An adverse characteristic of a chemical or a substance to cause gene anomalies.

Drugs with the above characteristics can pose a potential threat to healthcare workers who are often exposed to these drugs while handling them in the course of their daily routine.

In 1979, a study was published about the mutagenic activity observed in the urine of patients who had undergone chemotherapy and also in nurses who administered chemotherapy to them. It was an evident study since occupational exposure risk was published.

The main routes for exposure to cytotoxic drugs take place via skin contact, inhalation, ingestion and sharp injuries. These routes make it more prone to exposure and harm to workers and staff working at that place.

Why is quality required to manufacture oncology drugs?

In a pharmaceutical company, quality assurance is the most basic and widely accepted concept. The basic properties of quality medicine include: 

  • The medicine should show the desired results and the purpose it is taken for.
  • To prevent a patient from accidentally consuming an incorrect or contaminated medicine.

Providing quality medicines not only helps users heal their condition sooner and better but also helps the company maximise its production and enhance its reputation. 

What are the steps that can be implemented to promote quality and safety in oncology drug manufacturing?

The following are some of the solutions that can help achieve safe and quality oncology drugs:

Stringent regulatory framework 

To ensure safety and quality in oncology drug manufacturing, a robust regulatory framework is essential. Regulatory authorities, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, meticulously evaluate and approve drugs before they enter the market. They assess the manufacturing processes, clinical trial data, and safety profiles of drugs, ensuring they meet predetermined standards.

Practising proper manufacturing practices 

Adhering to Good Manufacturing Practices (GMP) is crucial in oncology drug manufacturing. GMP guidelines provide a comprehensive framework for pharmaceutical companies to ensure drugs are consistently produced and controlled according to quality standards. These guidelines cover various aspects, including facility design, equipment maintenance, personnel training, documentation, and quality control. Implementing GMP principles prevents contamination, cross-contamination, and other manufacturing-related issues that compromise drug safety and efficacy.

Quality Control and Quality Assurance 

Implementing stringent quality control and quality assurance measures is vital to ensure oncology drugs’ safety and quality. Regular testing and analysis of raw materials, intermediates, and finished products are essential to detect any potential impurities or deviations from predefined standards. Quality control laboratories equipped with state-of-the-art instruments and staffed by qualified personnel play a crucial role in this process. Additionally, quality assurance ensures that all manufacturing processes adhere to established guidelines and regulations, mitigating the risk of errors or substandard practices.

Supplier Qualification and Validation

Oncology drugs require close collaboration with trusted and reliable suppliers. Pharmaceutical companies must establish stringent qualification and validation processes for their suppliers, including thorough audits and assessments. This ensures that raw materials and components used in drug manufacturing meet the required quality standards and are free from contamination or adulteration.

Risk Assessment and Management 

A comprehensive risk assessment and management approach is essential to identify and mitigate potential risks throughout the oncology drug manufacturing process. This involves analyzing and evaluating all stages, from raw material sourcing to final product distribution. Identifying critical control points and implementing risk mitigation strategies prevent errors, contamination, and other hazards that compromise drug safety and quality. Regular audits and inspections, both internal and external, also contribute to maintaining the highest standards.

Continuous monitoring and improvement 

Oncology drug manufacturing safety and quality is an ongoing process that requires continuous monitoring and improvement. Pharmaceutical companies must establish robust systems for tracking adverse events, conducting post-marketing surveillance, and promptly addressing safety concerns. Continuous improvement initiatives, such as implementing updated technologies, optimizing manufacturing processes, and enhancing staff training, enhance drug safety and quality over time.

Conclusion 

Oncology drugs play a crucial role in cancer treatments. However, ensuring the safety and quality of these drugs is of paramount importance to protect patients’ well-being and optimize treatment outcomes. Globela Pharma manufactures oncology drugs under all the necessary conditions to ensure the best quality. 

To achieve this goal, Globela Pharma adheres to regulatory standards, implements robust quality management systems, qualifies and validates suppliers, utilizes advanced analytical techniques, continuously improves processes, and provides comprehensive training and education. By adopting these strategies and best practices the company guarantees the production of safe, effective, and high-quality oncology drugs, ultimately benefiting patients and improving cancer treatment outcomes.

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.

Accreditations

Achieving Trust and Credibility: The Role of Approvals and Accreditations in the Pharma Industry

Introduction 

The Pharma industry is a highly regulated sector responsible for developing and producing drugs that are safe, effective, and of high quality. Although, achieving trust and credibility within this industry is crucial for companies to succeed, and one of the key ways to do this is through obtaining approvals and accreditations. 

Here ahead in this article, we will let you know how these approvals and accreditations are necessary for any pharmaceutical company.

Approvals in Pharmaceutical Industry

Approvals refer to the process by which regulatory agencies, such as the US Food and Drug Administration (FDA), evaluate new drugs and medical devices to determine whether they are safe and effective for their intended use. The approval process involves extensive clinical trials and rigorous testing to ensure that the product meets the highest standard of safety and efficacy. After approval, it is time to launch a medicine on the market and sell it to patients and healthcare providers. 

Moreover, Approvals provide a competitive advantage they give a strong reputation for the quality and safety of the products. Approvals also provide access to effective and affordable healthcare by manufacturing generic drugs. Because of the approval, Globela Pharma reaches over 30 countries, including developing nations like India.

Accreditations in Pharmaceutical Industry

Accreditations are certifications that demonstrate compliance with specific standards and guidelines. These standards relate to quality management, environmental sustainability, or other aspects of the company’s operations. Furthermore, Accreditation bodies, such as the International Organization for Standardization (ISO), evaluate companies against these standards and issue certifications to those that meet the criteria.

Additionally, Accreditations provide a framework for benchmarking performance against industry standards and best practices. It helps companies to identify improvements and stays ahead of the competition.Globela Pharma has fulfilled all the majorly accreditations. It is an established ISO, FDCA – India and WHO cGMP accredited company with multiple therapeutic areas. 

Roles of approvals and accreditations in achieving trust and credibility in the Pharma industry

By obtaining approvals and accreditations, pharmaceutical companies can demonstrate their commitment to producing safe and effective drugs that meet industry standards. All this helps to build trust and credibility with patients, healthcare providers, and regulatory agencies to establish credibility.

1. Ensuring Safety and Efficacy

The primary goal of approvals is to ensure that drugs are safe and effective for their intended use. It includes rigorous and repeated testing and assessments to identify potential risks or side effects.

Testings that help to check the efficiency and safety of drugs are:

2. Preclinical testing: In this testing phase, the drug is tested in laboratory settings and on animal models to evaluate its safety and efficacy. This phase includes pharmacological and toxicological tests.

3. Clinical trials: In this phase, the drug is tested on human volunteers in a controlled and monitored environment. Clinical trials are conducted in different phases to evaluate the drug’s safety, efficacy, and side effects. In this process, Pharma companies can demonstrate their commitment to patient safety and earn the faith of healthcare providers and patients at their best which gives them approval and accreditation. 

4. Demonstrating Compliance with Regulations

The Pharma industry is highly regulated, with strict guidelines and requirements for everything from clinical trials to manufacturing processes. By obtaining approvals and accreditations, companies can demonstrate compliance with these regulations and show that they are committed to ethical and responsible business practices. It helps stakeholders to build trust and credibility.

Globela Pharma has implemented a quality management system compliant with ISO, an internationally recognized standard for quality management. This certification demonstrates the Pharmaceutical company’s dedication to producing high-quality products and following ethical and responsible business practices.

5. Improving Quality and Efficiency

Implementing quality management systems and continuous improvement processes helps identify areas of improvement to increase efficiency. Moreover, it can also deteriorate costs and increase productivity, leading to improved profitability and competitiveness in the market. With improved quality and efficiency, companies reduce the risk of product recalls and other quality-related issues. 

6. Enhancing Transparency and Accountability

The Pharma industry has faced criticism in the past for a lack of transparency and accountability. Approvals and accreditations demonstrate a commitment to transparency and susceptibility, which helps to build trust with collaborators. It can also help the company to improve its reputation. Such as Globela Pharma’s commitment to continuous improvement, transparency, and accountability are the reasons that make it an authentic and reliable firm. 

7. Building Reputation and Brand Value

Ultimately, Approvals and Accreditations help to build a company’s reputation and brand value. Companies known for producing safe, effective, and high-quality products are more likely to be authorized by patients and healthcare providers, leading to increased sales and market share. This can help to build the company’s brand value.

Additionally, this not only helps the company to build its name in the world of pharma companies. But, ensures its users a safe and reliable brand to trust for their health.

Conclusion 

Approvals and accreditations are necessary for a pharma company to ensure fair and satisfactory quality medicines and healthcare products. Also, it provides the sections of improvement that keep a company ahead of others. Globela Pharma is also one of the recognised companies with access to effective and affordable healthcare by manufacturing generic drugs with accreditations and approvals.

Overall, approvals and accreditations play a critical role in the success of a pharmaceutical company. They provide assurance, build trust, and can provide a competitive advantage in a highly regulated and competitive industry. 

Innovations in CRAMS How Indian Pharma Companies are Revolutionizing the Industry

Innovations in CRAMS: How Indian Pharma Companies are Revolutionizing the Industry

An era of COVID has indeed changed the whole scenario in the pharmaceutical industry. With the wide range of disruptions and challenges fought due to the coronavirus, various technologies like AI (Artificial Intelligence), quantum computing etc., have got acceptance by different pharmaceutical companies to help conduct R&D efforts, create personalized products and much more. 

In this, the Contract Research and Manufacturing Services or CRAMS, a rapidly growing industry has revolutionized the pharmaceutical industry. They provide cost-effective solutions to pharmaceutical companies, allowing them to focus on their core competencies. 

In all this, innovation is a must and is at the heart of the CRAMS industry. India is one of the leading players in the CRAMS industry, with its pharma companies at the forefront of innovation. Moreover, the global CRO (Contract Research Organisation) as per market value has mainly, reached $39 billion in 2018 and around $44 billion in 2021. 

In this article, we will explain the innovations in CRAMS and how Indian pharma companies are revolutionizing the industry.

What is CRAMS?

CRAMS stands for Contract Research and Manufacturing Services. It involves outsourcing drug development, manufacturing, and research services to third-party providers. It is a procedure where the product’s parent doesn’t produce the item themselves but gets it done by other organizations known as Contract Research Organisations (CRO). 

While understanding CRAMS, there are some important aspects including:

  • Cost-effective solutions
  • Quality assurance
  • Regulatory compliance
  • Intellectual property
  • Process improvement.

Cost-Effective Solutions:

One of the primary advantages of CRAMS is the cost-effective solutions it offers. By outsourcing drug development, manufacturing, and research services, pharmaceutical companies can focus on their core competencies and reduce costs. The involvement of CRAMS in research and manufacturing services offers cost-effective solutions to pharmaceutical companies, allowing them to develop and manufacture drugs and make them available at a lower cost.

Quality Assurance:

Quality assurance is critical in the CRAMS industry, and Indian pharma companies like Globela Pharma ensure that they meet regulatory requirements and maintain high-quality standards. Without proper quality assurance, the drugs manufactured by drug manufacturing companies may cause harm to the patient. 

The various pharma companies rely upon the contract service provider to accelerate research and manufacturing services. Indian pharma companies are investing in quality assurance processes, including quality control and quality assurance systems, to ensure that drugs meet regulatory requirements and are safe for patients.

Regulatory Compliance:

Regulatory compliance is another salient feature of the CRAMS industry. Indian pharma companies like Globela Pharma are ensuring that they comply with all regulatory requirements to be fulfilled. They are investing in regulatory compliance processes to ensure that drugs meet all regulatory requirements and are safe for patients. 

This process is necessary for the safety of individuals consuming drugs and other medicated products. Any inferior or ignorant quality procedure at any stage can compromise the health of the patients. Hence, it is vital to regulate proper regulatory compliance to keep the health of individuals uncompromised.

Intellectual Property:

Intellectual property is an asset that pertains to original and novel creations from the human brain or intellect. It may include copyrights, patents and regulatory licences. The Indian pharma companies are ensuring that they protect their intellectual property. Indian pharma companies are investing in intellectual property processes, including patent protection and trademark registration, to protect their innovations and ensure they are not infringed upon.

Process Improvement:

Improvement is something that any working era always has a space for. So is in the CRAMS industry as well. The Indian pharma companies are continuously improving their processes to increase availability, efficiency and reduce costs. 

They are investing in process improvement processes, including lean manufacturing, availability, and affordability of manufacturing services at a very minimal and justified amount.

Innovations in the field of CRAMs

One of the innovations in the CRAMS industry is the use of technology to improve drug development and manufacturing processes. Indian pharma companies are leveraging technology to develop new drugs, improve manufacturing processes, and ensure regulatory compliance. These all require constant efforts and various authentic technologies and collaboration with other companies to maintain quality assurance and the best results.

Technologies aiding in revolutionizing the industry:

One of the innovations in the CRAMS industry is the use of technology to improve drug development and manufacturing processes.

A few innovations that promote revolutionary change and progress in the industry are:

  • AI or Artificial Intelligence – AI is helping industries accelerate the discovery and manufacturing process of drugs. 
  • Huge data and analytics – The cost of production of medicines become the biggest hurdle in launching a new medicine. However, by using data and analytics, Indian Pharmaceutical companies can reduce the exploration cycles and make the new drug or vaccines available sooner for use. 
  • Bioprinting – One of the biggest challenges that are faced by Pharmaceutical companies is clinical trials. Bioprinting technology enables the exact imitation of human organs using the 3D technique. Pharmaceutical companies check the efficacy and effects of a drug on live subjects to observe all the vital changes. Hopefully, bioprinting now can save time as well as effort and also has reduced the dependency on live subjects to initiate clinical trials. 

Role of Collaboration to Uplift the Indian Pharma Companies

Another innovation in the CRAMS industry is collaboration. Indian pharma companies are collaborating with other companies and research organizations to promote drug development, cost-effective solutions, improve manufacturing processes, and share knowledge and expertise. 

This collaboration allows companies to pool resources and knowledge, leading to faster drug development and improved manufacturing processes. Moreover, the companies like globelapharma are working on great R&D efforts, quality manufacturing, and a sturdy distribution system with collaboration. 

Conclusion:

The Indian pharma companies are revolutionizing the CRAMS industry and paving the way for the development of new and innovative drugs. Through new technologies, collaboration, etc., pharmaceutical companies are getting the support they need to achieve growth, find flaws, initiate new conversions, and ultimately provide better health care. 

Moreover, India has already presented itself to be a cost-efficient and quality manufacturer for many Pharma companies. Therefore, with technological advancements and innovations continuing to progress, the pharmaceutical industry is expected to grow and evolve quickly. Thus, its demand will increase in the future throughout the world.

Solving healthcare challenges in underserved regions across the world

Solving healthcare challenges in underserved regions across the world

Introduction:

Healthcare is a primary necessity for every human being, whether you are living in a developed country, a developing country, or any underserved region. Globally, there are numerous healthcare challenges and in underserved regions, healthcare has always been in worse condition than in other parts of the world. 

Countries like Africa, the Middle East, South and South East Asia and Latin America with Africa being one of the most affected, witness more challenges to ensure proper health due to numerous reasons. These regions often lack the vital resources, infrastructure, and healthcare professionals to provide adequate medical care to their populations. 

However, healthcare innovation, research, and development can help address these challenges and improve healthcare outcomes in underserved regions. In this article, we will explore concerning innovative solutions that can help solve healthcare challenges in these underserved regions.

What are the challenges faced by underserved regions to reach out to healthcare? 

Countries like Africa, the Middle East, and South and South East Asia witness more challenges in the healthcare system.

The key disputes that come to underserved regions to achieve good health include are:

  • Low access to healthcare services
  • Shortage of good quality medicines at affordable prices
  • Lack of awareness
  • Unavailability of knowledge 
  • Limited access to various facilities

Solutions to improve healthcare challenges in underserved regions across the world

There are a lot of changes needed for a strong healthcare system. While, it can be achieved through investments in healthcare infrastructure, training of healthcare professionals, provision of medical equipment and supplies and many more. 

Some of the major solutions to strengthen the healthcare system in underserved regions are: 

  • Availability of Telemedicine
  • Educating people about health and its importance 
  • Making healthcare professionals and medicine easily accessible
  • Providing quality medicines
  • Boost medical research
  • Promote more pharmaceutical manufacturing

Availability of Telemedicine– It can enable people in underserved areas to have consultations with specialists even at a long distance. It can be particularly effective in rural areas where only a few healthcare facilities and specialist healthcare professionals are available. 

Educating individuals – Increasing education about healthcare can help improve access to healthcare. This empowers them to take control of their health and seek medical care when needed. Also, educating individuals about the importance of personal hygiene, sanitation, hand washing, and seeking medical help at the right time helps them to avoid any worse conditions. 

Making healthcare easily accessible – Accessibility is the key to a better healthcare system. In underserved regions building primary healthcare centres with high-quality pharmaceutical medicines, medical equipment, and facilities is critical to building a sound healthcare system. 

Providing quality medicines- When it comes to build-up a strong healthcare system the vital factors are availability, quality and affordability of medicines. In terms of quality of medicines, Globela Pharma is providing good value medicines through their continuous efforts and innovations. As part of the solution to the healthcare crisis in underserved regions, it is necessary to innovate affordable pharmaceutical solutions without compromising on quality. It is essential to reach out to every corner of the globe so that everyone has access to quality medicine regardless of their financial capacity. 

Boosting medical research- Medical research is essential to addressing healthcare challenges in underserved regions. It will help identify the most persistent healthcare challenges and develop solutions. One example of successful medical research is the development of vaccines and immunizations. Vaccines are critical in preventing the spread of infectious diseases such as HIV/AIDS, Malaria, Tuberculosis, Cholera, and Neglected tropical diseases. In addition, vaccines can help prevent seasonal infections and allergies.

Pharmaceutical manufacturing – It can help address healthcare challenges by ensuring that essential medicines are available to these people at a very affordable price. Where there is no comprise on the quality of the medicine, despite their financial status it will help in strengthening the healthcare system. Although, this can be achieved through partnerships between pharmaceutical companies and governments in underserved regions.

What innovative steps can be taken to resolve some common issues in underserved areas?

In underserved regions, some diseases are more prevalent than others like malnourishment, diabetes, infectious disease, etc. In order to combat these diseases definite innovative measures are necessary. Such as: 

  • Non-communicable diseases: A group of diseases like diabetes, cardiovascular disease and cancer are becoming increasingly prevalent in underserved regions. A multifaceted approach is needed to address these diseases, which includes healthcare innovation, strengthening of the healthcare system, and educational efforts in the healthcare field. 

For instance, promoting innovation in forming mobile health applications will help individuals monitor their health. This type of innovation will help address the problem as early as possible. Additionally, healthcare education is also critical in managing these diseases. It can include education on healthy lifestyles, such as healthy eating and exercise. 

In addition, making people aware of the importance of regular medical checkups will help reduce the complications associated with these diseases.

  • Neglected Tropical Diseases: A group of diseases that affect more than one billion people globally, relatively more in underserved regions. These diseases include dengue, chikungunya, Guinea-worm disease, leprosy, lymphatic filariasis, onchocerciasis, sleeping sickness, etc. The aim of solving the healthcare challenges in the underserved region requires scaling up through improving public health. 

For that, it is vital to establish a public health centre with adequate medical professionals, good quality pharmaceuticals, and medical equipment. Moreover, in managing NTDs, it is essential to regulate water sanitation and hygiene properly. 

  • Malnutrition and Poverty: Malnutrition and poverty are significant healthcare challenges in underserved regions. A wide approach can be addressed to improve the status of malnutrition and poverty in these underserved areas. 

Poverty reduction is also critical in addressing malnutrition and poverty. This can be achieved through investments in education, job creation, and social safety nets. 

In addition, increasing healthcare awareness and education can help individuals take control of their health and seek medical care when needed.

Conclusion:

In a nutshell, we all know that in various parts of the globe, people are not fortunate enough to access all the health facilities and take advantage of them. Hence, the healthcare challenges in underserved regions are complex and multifaceted. However, healthcare innovation, research, and development can help address these challenges and improve healthcare outcomes in these regions. 

By working together and leveraging technology, we can help ensure that everyone has access to the medical care they need to live healthy and productive lives. There is a very well-known saying that “HEALTH IS WEALTH”. By drawing a good amount of attention towards the healthcare sector we can not only save a good amount of wealth but can also provide a great amount of happiness in their life, to cherish it happily with family, friends and loved ones.

Cancer blog-min

The Importance of Early Detection and Prevention of Cancer

Introduction

Health is indeed the greatest wealth one can have.  Being vigilant towards the health of yourself and your loved ones is a top priority. This involves routine health check-ups and regular monitoring required as per physician’s advice relevant to an individual’s medical history. Any disturbance found in the body’s normal rhythm can hence be caught at an early stage and appropriate measures can be taken for its treatment and/or management. Amongst other ailments, cancer diagnosis can be most terrifying. Since there is no definite cure for Cancer, early stage diagnosis can greatly help in better treatment outcome and improved Quality of life.

Role of early diagnosis & screening-

The two main components of early detection of cancer are, i) early diagnosis and ii) screening. Early diagnosis focuses on detecting symptomatic patients as early as possible, while screening refers to the use of tests performed to detect cancer early on healthy individuals who have not yet shown symptoms of disease and are asymptomatic. The aim of screening is to reduce ailments and mortality caused by cancer. It is an effective method which is widely accepted and beneficial to people who are at risk with regards to cancer. This is crucial as it is one of the first actions taken to prevent disease. Furthermore, patients whose cancer is detected at an early stage possess a higher chance of cured disease, complete recovery, increased quality of life and longevity. Efforts to improve the selection of candidates for cancer screening, in order to understand the biological basis of carcinogenesis, and the development of new technologies for cancer screening will allow for improvements in the field over time.

Goals of early detection- 

The goal of cancer screening and early detection is to cure cancer by detecting the malignancy, or its precursor lesion, at an early stage prior to the onset of symptoms, when treatment of cancer is most effective. Indeed, overall cancer mortality has decreased by 25% from 1990 to 2015 for the United States U.S.), with even greater declines in the mortality rates for colorectal cancer (47% among men and 44% among women) and breast cancer (39% among women). A portion of this decrease can be attributed to the introduction of high-quality cancer screening for colorectal and breast cancer. The most successful cancer screening programs lead to the identification of precursor lesions (e.g., cervical intraepithelial neoplasia (CIN) with cervical cancer screening and colonic polyps with colorectal cancer screening) where the treatment of the precursor lesion leads to a decrease in the incidence of invasive and lethally spreading cancer over a period of time.

Application of various Imaging techniques-

Imaging tests used in diagnosing cancer may include Computed tomography (CT) scan, Magnetic resonance imaging (MRI) scan, Breast MRI, X-rays and other radiographic tests, Mammography, Nuclear medicine scans (bone scans, PET scans, Thyroid scans, MUGA scans, gallium scans), Ultrasound. Imaging tests are only part of cancer diagnosis and treatment. A complete cancer work-up includes assessment of medical history by a certified health care professional, a thorough physical exam, blood work and other lab tests.

Biopsy & its types-

Biopsy is another method that aids in detection of Cancer. It is a medical test commonly performed by a surgeon, interventional radiologist, or an interventional cardiologist. The process involves extraction of sample cells or tissues for examination to determine the presence or extent of a disease. The most common types of biopsy includes: (1) Incisional biopsy, in which only a sample, part of affected tissue is removed; (2) Excisional biopsy, in which an entire lump or suspicious area is removed; and (3) Needle biopsy, in which a sample of tissue or fluid is removed through a needle aspiration. Depending on the type of needle used, the procedure is called a core biopsy when performed with a wide needle, and fine-needle aspiration biopsy when a thin needle is used.

Genetic & DNA testing-

Genetic testing is another effective method in Screening for Cancers. It helps in discovering certain mutations (changes) in genetic make-up of an individual, which are more prone to getting certain cancers. The most commonly mutated gene in people with cancer is p53 or TP53. More than 50% of cancers involve a missing or damaged p53 gene. Most p53 gene mutations are acquired. Germ line p53 mutations are rare, but patients who carry them are at a higher risk of developing many different types of cancer.

Routine examinations required to check for warning signs that may lead to Cancer-

There are few warning signs and symptoms that should not be neglected for better health. They are as follows:

-A sore that does not heal, delayed or slow healing

-Unusual bleeding or discharge.

-Thickening or lump in breast or elsewhere.

-Indigestion or difficulty in swallowing.

-Obvious change in wart or mole.

-Nagging cough or hoarseness.

 -A change in bowel habits, including diarrhoea, constipation or consistency of your stool.

-Persistent abdominal discomfort such as cramps, gas or pain.

-Rectal bleeding or blood in your stool.

-Unexplained weight loss.

-Weakness or fatigue, which does not get better after adequate rest.

Importance of early diagnosis and its comparison with late stage diagnosis; along with their respective prognosis-

Lack of early screening leads to late stage diagnosis. In most cases, patients who are diagnosed with cancer at earlier stages show improved survival, clinical outcomes and better quality of life. However, screening for earlier cancer detection remains limited. As of year 2021, broad-based cancer screenings for asymptomatic patients are recommended in the US for just 5 cancer types (breast, cervical, colorectal, lung for a high-risk subset of the population, and prostate).Statistically, 71% of all cancer mortality is from cancers that lack broad-based screenings for asymptomatic patients. Thus, earlier cancer diagnosis results in improved survival. Patients diagnosed with earlier stages of cancer (stage I-II) generally have a higher likelihood of recovery than those diagnosed at a later stage (stage III-IV). For non-small cell lung cancer (NSCLC), stomach, and pancreatic cancers, between 36% and 53% of patients are diagnosed with stage IV cancer, where the cancer has spread to other parts of the body, decreasing survival chances. The 5-year survival rate for non-small-cell lung cancer (NSCLC), stomach, and pancreatic cancers, doubles in all cases when detected at earlier stages. These differences in survival rates emphasize the opportunity to make progress in beating cancer by decreasing late-stage diagnoses with improved and expanded screenings.

Suffering patients progress through more extensive treatment demanded by later stage diagnosis. Quality of life goes down including through physical, emotional, and social functioning. Late-stage diagnosis often requires more intensive and more invasive interventions that result in sometimes difficult and lasting side effects. For example, patients with late-stage NSCLC diagnosis often suffer from dyspnoea, or laboured breathing, after their treatment is complete. Similarly, stomach cancer patients recovering from a partial or full gastrectomy followed by other treatments such as chemotherapy, radiation, and immunotherapy in late stages may suffer from chronic fatigue, difficulty eating, and challenges performing everyday activities.

Conclusion-

A plan for early diagnosis is a key component in controlling and preventing cancer. Main goal is to cure cancer patients, prolong their life considerably while ensuring a good quality of life. Treatment plans need to be integrated with a palliative care programme, so that patients with advanced cancers, who can no longer benefit from treatment, will get adequate relief from their physical, psychosocial and spiritual suffering. Additionally, programmes should include an awareness-raising component, to encourage and educate patients, family and community members about the cancer risk factors and the need for taking preventive measures to avoid contracting cancer.

R&D blog-min

Role of Research and Development in Modern Pharmaceutical Industry

Introduction

In a life cycle of a drug from its discovery till launch, a series of crucial steps are involved in order to comply with regulatory requirements as per respective local regulatory authority. These steps from discovering a new drug to its launch in the market contributes to research and development in the pharmaceutical industry. The process is time consuming and may take several years for completion.

Steps involved in research and development in the modern pharmaceutical industry are as follows, i) early drug discovery, ii) preclinical studies, iii)clinical development, iv) review and approval by applicable regulatory bodies, v) post marketing surveillance.

Identifying a potential target-

Early drug discovery involves target identification and validation, hit discovery, assay development and screening, high throughput screening, hit to lead and lead optimization. Target identification begins with identifying the function of potential therapeutic agents and its role in the disease. It can be approached by direct biochemical methods, genetic interactions or computational interface. However, a combined approach may be required to fully characterize on-target and off-target interactions in order to understand molecular action mechanisms. Main motive of hit discovery is to identify molecules with potential interactions with drug targets.

Assay development-

Different types of assays can be used for assay development and compound screening, ranging from biochemical to cell-based assays. The choice of the assay depends on the biology of the drug target protein, scale of the compound screen, the equipment infrastructure, etc. Factors required for assay development are; i) Pharmacological importance of the assay– ability to identify compounds with the desired mechanism of action, ii) Reproducibility– is readily reproducible across assay plates, screen days and the length of the drug discovery programme, iii) Quality– pharmacology of the standard compounds falls within predefined limits, iv) Effects of compounds in the assay– should not be sensitive to the concentrations of solvents used in the assay.

Screening methods-

High throughput screening, (HTS) involves screening of the entire compound library against the drug target. Knowledge-based screening is a method of selecting from the chemical library smaller subsets of molecules with potential activity at the target protein. Fragment screening is making very small molecular weight compound libraries which are screened at high concentrations. Physiological screening is a tissue-based approach with the response more in direction with the desired in vivo effect.

Lead optimization-

Drug-like molecules must go through different phases to identify the hit lead molecule and optimization with a potency of 100nM – 5mM at the drug target. The refinement process involves generating dose-response curves in primary assay for each hit. Followed by examining the surviving hits in a secondary assay. Generation of rudimentary structure-activity relationship, SAR data and identifying the essential elements in the structure linked with the activity. Lastly, in vitro assays providing significant data with regards to absorption, distribution, metabolism and excretion (ADME) properties as well as physicochemical and pharmacokinetic (PK) measurements. Overall, the aim is to achieve a lead compound optimized with desirable effects on the target that can provide therapeutic benefits within an acceptable safety window. Average time required for this step is 2-6 months.

A glance at preclinical trials-

Preclinical studies or non clinical studies, carries out testing on animals to accurately model the desired biological effect of a drug in order to predict treatment outcomes in patients determining its efficacy, and to identify all toxicities associated with the drug to predict adverse effects for safety assessment. There are two types of preclinical studies, i) in vitro, ii) in vivo, iii) ex vivo assay and iv) in silico. In compliance with good laboratory practices, GLP, in vitro studies are carried out outside of living organisms in a test tube, glass or petri dish. On the other hand, in vivo studies are those which involve living organisms, including animal studies and human clinical trials. Ex vivo assay refers to a medical procedure in which an organ, cell or tissue are taken from the living body for treatment testing such as skin biopsies or isolated samples from tumor biopsy. In silico studies refers to using computer simulations to predict the reaction of a compound with specific proteins or pathogens. 

Goal of preclinical studies involve determination of pharmacokinetics, proof of concept, formulation, optimization & bioavailability, establishing safe dose, therapeutic dose, lethal dose and maximum tolerated dose. The compound from drug discovery is modified through preclinical studies and becomes Investigational New Drug, IND. IND application is filed for review and approval as per guidelines and standards of local and national regulatory authority. On an average the time required for this phase is approximately ranging from 1-6 years.

A complete overview of Clinical trials-

Clinical development of drug discovery begins after approval of IND for further testing. Clinical trials are conducted for testing of the new drug classified into several phases.

Phase 0 and Phase I-  Phase 0 is known as human micro dosing studies, which involves 10-15 individuals who are administered with small amounts of sub therapeutic dose mainly to determine pharmacokinetics, oral bioavailability and half-life of the drug. Phase 0 trials are often skipped to direct Phase I trials unless some of the data is inconsistent from previously conducted preclinical studies. Phase I studies are conducted amongst healthy volunteers to test the safety, tolerability, pharmacokinetics & pharmacodynamics, side effects & adverse effects, optimum dose, half-life and formulation method for the drug. In circumstances when testing for diseases like cancer or HIV, the treatment for which is likely to make healthy individuals ill, clinical patients are selected as an exception. Phase I trials are not randomized and hence are vulnerable to selection bias. This phase involves 20-100 individuals. Phase I trials can be further divided into, i) Single ascending dose, Phase I (a) in which a small number of participants are entered sequentially at a particular dose while monitoring them for a period of time to confirm safety. If no adverse effects are noted, then dose is escalated for newer groups. It is continued until pre-calculated pharmacokinetic safety levels are achieved or intolerable side effects are noted, it is the point where drug reaches at maximum tolerated dose, MTD; ii) Multiple ascending dose, Phase I (b) in which group of participants receives multiple low doses of the drug, which is subsequently escalated for further group of participants up to a predetermined level. It helps in determining pharmacokinetics and pharmacodynamics of multiple doses of the drug along with its safety and tolerability.

Phase II- Phase II trials are performed on larger groups (50–300) and are designed to assess biological activity and effect of the drug. Trial design of Phase II trials are either as case series, which demonstrates safety and efficacy in a selected group of participants, or as randomized controlled trials ,RCT, where some participants receive the drug/device and others receive placebo/standard treatment. Phase II studies are divided into Phase II (a) and Phase II (b). Phase II (a) studies are pilot studies designed to demonstrate clinical efficacy or biological activity of the drug. Phase II (b) studies determine the optimal dose at which the drug shows biological activity with minimal side-effects. It is also known as maximum effective dose, MaxED.

Phase III- Phase III trials are conducted in a large patient population of 300-3000 individuals determining the efficacy of the new drug in comparison to existing standard treatment. They are time consuming and expensive with complicated trial designs such as Randomized controlled multicentre trials with single, double or triple blinded factors in order to avoid bias and clean results. Phase III (a) studies are trial designed and executed to obtain statistically significant data for new drug approval by regulatory authority. Phase III trials that continue while awaiting regulatory approval in order to provide life-saving drugs to patients until the drugs are available in the market are categorized as Phase III (b) studies. Label expansion studies by the sponsor also fall under this category.

Phase IV- If the new drug successfully passes through Phase I, II, and III, with desirable outcomes, the manufacturing, preclinical and clinical data is then submitted as a new drug application, NDA, for review and marketing approval by national applicable regulatory authority. Post approval the new drug is marketed and Phase IV trials begin, which is post marketing surveillance of the new drug and lasts for up to 5 years. The entire process from developing a drug from preclinical research till marketing can take approximately 12-18 years. A Phase IV trial is a drug monitoring trial to assure long-term safety and effectiveness of the drug, vaccine, device or diagnostic test. These trials involve the safety surveillance, i.e, pharmacovigilance and ongoing technical support of a drug after it receives regulatory approval to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive reasons, such as finding a new market for the drug, or other reasons, for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials. The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials. Harmful effects discovered by Phase IV trials may result in a drug being withdrawn from the market or restricted to certain uses; examples include cerivastatin (brand names Baycol and Lipobay), troglitazone (Rezulin) and rofecoxib (Vioxx).

Conclusion

Thus Research & Development is essential when it comes to the pharmaceutical industry, since R&D services not only generate income for the companies involved in the research but it often saves lives. Reliable Pharmaceutical R&D services allow for companies to have technical and manufacturing procedures, quality control measures and production scope aspects as per required standards.