Pharmaceutical companies are at a significant crossroads in terms of how they engage with customers, innovate, and adopt digital capabilities. On one hand, there is an increasing demand for personalization of drugs, while on the other hand, global inflation and uncertain market trends are causing challenges for the industry. These factors, in addition to a lower number of clinical trials during the pandemic, caused a downturn in 2023.  

2024 has seen a revival for pharmaceutical companies, driven by increased consumer spending and stabilization of inflation in the US and EU regions. Clinical trials have also resumed as companies strive to develop and launch safer and more effective drugs while containing their R&D and manufacturing costs. We believe personalized drugs and patient care plans, technology adoption by pharmaceutical companies, improved quality and access to drugs, and mergers and acquisitions are the significant trends that will affect the pharmaceutical industry in 2024 and beyond. 

Personalized Drugs and Patient Care Plans 

As the industry evolves, a combination of new therapeutic developments and changing healthcare policies is reshaping its landscape. The future of this industry will not only be focused on developing new drugs but also on providing more holistic and focused patient care. Personalized patient care helps healthcare providers make accurate diagnosis and tailor a suitable treatment plan for patients resulting in more effective recovery and results. This can also reduce healthcare costs by avoiding unnecessary procedures and medications that may not be effective for an individual patient. This trend is expected to continue this year and beyond. Areas such as weight management/obesity, autoimmune diseases, oncology, and diabetes are expected to grow. In addition to treating diabetes, the inclusion of GLP-1 drugs for treating obesity and weight management issues is expected to be a significant growth driver and the demand for such drugs for weight loss has never been higher. Companies have also started to look for personalization opportunities in this domain.  For example, Eli Lilly, which manufactures Tirzepetide – an advanced GLP-1 drug, has started their distribution network along with personalized patient coaching. Innovations such as cell therapy and precision medicines will also play an important role. 

Technology Adoption 

Digital transformation and data can help pharma companies to increase their productivity and operational efficiency. Developing and establishing a secure digital core that includes a modern data foundation, flexible AI architecture, and smart business applications are key to driving growth and innovation. These capabilities allow companies to collect and integrate data across various platforms and locations. The data can then be leveraged to provide key business insights to decision-makers and managers. AI and ML can be of great use to generate intelligent business reports to reflect key business KPI’s and interpret market trends which in turn helps optimize business processes and maintain organizational agility. AI can also be adopted to deliver personalized patient care plans and has the potential to revolutionize disease detection and prevention. By analyzing large data sets, AI algorithms can detect subtle trends, patterns, and risk factors which can potentially contribute to certain diseases and epidemics. As per recent reports, Lilly is collaborating with OpenAI to discover novel medicines for treating drug-resistant bacterial infections. Such innovations will continue to revolutionize the way pharmaceutical companies operate. 

In the coming years, the ability to leverage AI and ML (Machine Learning) technologies will remain a critical differentiating factor which will provide pharmaceutical companies a key lever for gaining strategic advantage in the market. Such technologies can potentially be adopted across the drug development cycle, from the discovery of candidate molecules to streamlining clinical trials, resulting in faster time to market, while helping to reduce development, manufacturing, and logistical costs. Pharmaceutical companies also generate a huge amount of data from various sources. Managing such a huge volume of data efficiently while maintaining various regulatory compliances like IDMP, HIPAA, and GDPR is an ever-increasing challenge. Technology can play a key role in effectively managing this data in a secure and regulated manner while ensuring adequate monitoring and governance. There is also a need to integrate with third-party data providers to validate, enrich, and cleanse the data pharmaceutical companies are accumulating. Companies realize the value of maintaining high-quality data to drive their futuristic digital initiatives. Hence, as companies look to embrace newer technologies, a strong focus will remain on traditional areas such as master data management, data governance, and data quality. Senior industry leaders, such as Vas Narasimhan, CEO of Novartis, continue to emphasize the need for having access to high-quality, trusted data and the importance it has in the success of any digital initiative.  We expect companies to continue to invest in consolidating and streamlining their data assets, and this trend will only get stronger as more companies strive to make their business customer-focused, and data-driven. 

Improved Quality and Access 

Name-brand drugs are often expensive due to high initial investments in R&D and hence over a period of time, customers tend to move to cheaper options. Such migrations increase patient’s access to drugs while increasing pressure on pharma companies to provide high-quality generics at competitive prices. In addition to this, there are several existing and proposed policies focused on drug price reform and control. These factors mean that making high-quality drugs available at reasonable prices is still a challenge. The entry of Chinese pharmaceutical companies in Europe is also contributing to the evolving dynamics and pricing of pharmaceuticals. Per the European Parliament, the EU is 85-90% dependent on the Chinese market for all ingredients and 33% dependent on it for active ingredients. This poses critical challenges in terms of access and quality control, hence forcing policymakers to reevaluate their strategy to counter over-dependence on a single source.   

As per the 2023 report published by the WHO, 2021 saw a new high in global spending on healthcare. This reached US$ 9.8 trillion or 10.3% of global gross domestic product (GDP). Hence, debates around drug affordability, accessibility, and the strategies of payers in managing healthcare costs continue to remain a challenge for all parties concerned. Changes in policies and formulary decisions are also evident. Such adjustments are typically aimed at mitigating costs while avoiding drug overuse/abuse, indicating a greater level of scrutiny for access to critical and high-cost medications. The emphasis on policies to optimize access will continue to compete with efforts to ensure drugs are medically necessary. 

Mergers and Acquisitions  

Big Pharma will continue to focus on consolidating its market share and product pipelines through M&A. One such example is Pfizer’s acquisition of Seagen in a deal worth $43 billion. However, due to pushback from the United States Federal Trade Commission (FTC) on M&A, and high debt leverage, such large acquisitions will remain at moderate levels. At the same time, greater activity can be expected in smaller-sized acquisitions. Per a report published by S&P Global, the pharmaceutical industry will see robust growth through 2027.  

To conclude, the pharmaceutical industry will continue to see sturdy growth through 2024 and beyond.  Innovation and technology adoption will play a crucial role in this growth story while personalized health plans and policies to optimize access to high quality drugs will be significant contributing factors. M&A will continue to play a role but at relatively moderate levels; large acquisitions may be few and far between. However, as discussed above, there are some challenges and pitfalls that the industry needs to remain conscious of to ensure sustained growth and development.  

How can Fresh Gravity help?  

At Fresh Gravity, our team of domain experts and technology consultants have extensive experience working with some of the biggest pharmaceutical companies. We strive to enable and empower our customers by providing business-focused solutions on master data management, data quality, and governance. We have experts with hands-on experience working with and building cutting-edge solutions using AI/ML tools and various data platforms. We have also developed several in-house solutions to help our customers in areas such as clinical study protocol digitization, clinical study automation, IDMP compliance, and clinical data repositories. To know more about our offerings, please reach out to us at info@freshgravity.com

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In the highly regulated sectors of pharmaceuticals, biotechnology, and medical devices, adherence to Good Practice (GxP) guidelines is paramount. These guidelines ensure that the products are safe, achieve their intended purpose, and adhere to quality processes throughout their lifecycle. A crucial component of GxP compliance is the implementation and maintenance of validated data systems. These systems not only safeguard the integrity of data but also ensure that every piece of information is retrievable as well as accurately recorded and processed thus, supporting the overarching goal of protecting Patient health. 

Understanding GxP and Its Importance 

GxP encompasses a variety of “good practices,” including Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP), among others. While each set of practices addresses different aspects of product development and manufacturing, they all share a common thread: rigorous data management. GxP guidelines are designed to ensure that data, whether related to product development, manufacturing, or distribution, is handled with the utmost integrity, traceability, and security. 

The Role of Validated Data Systems in GxP Compliance 

A validated data system is meticulously tested and proven to consistently produce accurate, reliable results. Under GxP guidelines, such validation is not a one-time activity but an ongoing process of checks and balances. This ensures that the system remains compliant, even as software updates and technological advancements occur. The key aspects of validated data systems include:

• Data Integrity and Traceability

Every piece of data must be attributable, legible, contemporaneous, original, and accurate (ALCOA). Validated data systems ensure that data is recorded precisely at the time of the activity and is traceable back to its source, ensuring transparency and reliability.

• Data Security

Protecting sensitive data from unauthorized access is a critical component of GxP compliance. Validated systems employ robust security measures, including access controls and encryption, to safeguard data throughout its lifecycle.

• Data Backup and Retrieval

In the event of a system failure or data corruption, it is essential for all data to be recovered and easily retrievable for audit purposes. Validated systems are equipped with efficient backup and recovery procedures to mitigate data loss risks.

• Change Control and Documentation

GxP guidelines emphasize the importance of thorough documentation and controlled procedures for any changes made to the system. This includes software updates, changes in data handling processes, and modifications to security protocols. 

Navigating the Validation Process 

Validating a data system under GxP guidelines involves the following key steps: 

• Planning: Defining the scope and objectives of the validation process, including risk assessments to identify and mitigate potential data integrity issues. 
• Specification: Detailing the functional and operational requirements of the system to meet GxP standards. 

• Testing: Conducting rigorous testing to ensure the system meets all specified requirements. This includes both dynamic testing (testing the system under simulated real-world conditions) and static testing (reviewing the system’s code, design, and documentation). 
• Implementation: Carefully deploying the validated system while ensuring that all GxP requirements continue to be met. 
• Maintenance and Review: Regularly reviewing and maintaining the system to ensure ongoing compliance with GxP standards. 

Fresh Gravity’s Approach towards GxP Validation 

Fresh Gravity approaches GxP (Good Practices) validation with a meticulous and forward-thinking strategy,
understanding its crucial role in the life sciences and pharmaceutical industries where compliance, data integrity, and patient safety are paramount.
Fresh Gravity integrates the latest technological advancements with a deep commitment to maintaining regulatory standards, ensuring that systems and processes not only meet but exceed the stringent requirements set forth by global regulatory bodies. By leveraging a combination of automation, digital innovation, and expert insights, Fresh Gravity streamlines the validation process, making it more efficient and less prone to human error.
This approach facilitates faster time-to-market for essential medical products while establishing a robust foundation for compliance that can adapt to the evolving landscape of GxP requirements. Fresh Gravity’s dedication to incorporating best practices in technology and process management transforms GxP validation from a mandatory regulatory hurdle into a strategic advantage, enhancing quality, reliability, and trust in the products and services. 

The Bottom Line 

In the world of pharmaceuticals, biotech, and medical devices, where the stakes are incredibly high, investing in and maintaining validated data systems isn’t merely a regulatory requirement but a cornerstone of quality and trust. By ensuring compliance with GxP guidelines, companies not only safeguard their reputation and financial well-being but, more importantly, ensure the safety and efficacy of products that impact millions of lives around the world.  

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