“Data integrity is crucial in pharmaceutical product development”—quotes Morten Olesen.
Data integrity helps establish trust between the industry and regulatory bodies and can reduce the frequency of audits. Keeping this in mind, biotech, and pharmaceutical companies are utilizing data management tools and developing detailed data integrity plans.
Under the leadership of Morten Olesen, the Founding Partner at CIMS, the company is committed to ensuring data integrity. This dedication helps pharmaceutical businesses address the complexities of clinical drug development with confidence. CIMS provides the accurate and reliable data needed by regulatory agencies and the sector to confirm the safety, efficacy, and quality of products.
From Chaos to Clarity
CIMS specializes in clinical data integration within the pharmaceutical industry, providing solutions to help companies manage information during clinical drug development. Morten Olesen states that “decisions based on low-quality data can lead to mismanagement.” The company aims to assist clients in leveraging the increasing volume of data to enhance their revenue.
In clinical trials, ensuring data integrity involves economic considerations as well as time and complexity. A single critical data element can impact costs within a larger dataset. CIMS combines supply chain management with information management and encourages continuous improvement through Kaizen learning, supporting pharmaceutical companies in maintaining quality and compliance standards in clinical development.
Risk-based thinking is integrated by CIMS into its solutions, prioritizing data integrity for clients. By employing supply chain management theories such as information logistics and data intelligence, CIMS aligns stakeholder and information flow, promoting collective review and cross-functional ownership.
Balancing Innovation and Regulation in Pharma
In the pharmaceutical sector, regulatory requirements mandate that data owners maintain accountability for traceability in all aspects. Morten Olesen notes that “information management is a challenging task, requiring insight gained through solid education and long-term experience.” Companies often face difficulties in balancing innovation with regulation. CIMS addresses this challenge through a unique approach based on ISO 9001:2015-inspired risk-based thinking, information supply chain management (ISCM), and the 3*T (Truth-Trust-Traceability) framework, ensuring that data is accurate, validated, and verifiable.
Data Integrity Redefined
CIMS utilizes five standardized tools for data exchange and processing, specifically designed for five regulatory operations:
- Vendor management
- Data processes
- Information management
- Clinical processes
- Audits QA/QC
These tools assist clients in streamlining their processes, leading to significant reductions in trial execution time on key performance indicators. In addition to ensuring data integrity, CIMS provides standalone services such as QMS audits, STAT audits, advanced analytics, change management, post-merger integration, lean process development, and project management. CIMS also supports pharmaceutical organizations in implementing dashboards and improving key performance indicators.
Philosophy Meets Practice
Morten Olesen’s work at CIMS has played a key role in advancing the company’s position in the pharmaceutical sector. CIMS is recognized as a leading auditor in the industry with a strong background in data science, which has allowed for more sophisticated auditing processes.
Morten Olesen emphasizes the company’s philosophy, drawing inspiration from Danish philosopher Søren Kierkegaard: “If one is truly to succeed in leading a person to a specific place, one must first and foremost take care to find him where he is and begin there.” This principle guides CIMS in meeting clients where they are, assessing their strengths and shortcomings, and finding the right solutions for them.
Currently, CIMS is working on developing innovative data auditing tools to improve clients’ compliance strategies. The company has demonstrated adaptability during the COVID-19 pandemic by transitioning to remote work. Moving forward, CIMS aims to enhance clients’ capabilities and expand into medical device production.
Redefining Glucose Monitoring with GLUCARE
The GLUCARE Consortium
The GLUCARE consortium is a pioneering collaboration. It includes Zimmer & Peacock (ZP) from Norway, Safe Implant Technology ApS (SIT) from Denmark, and Aalborg University (AAU) from Denmark. The consortium has been awarded funding by the Eurostars program. The goal is to develop a groundbreaking implantable biosensor for continuous glucose monitoring (CGM). Competing against 506 other consortiums, the GLUCARE project has secured a budget of approximately €1.3 million.
The GLUCARE project aims to seize a significant market opportunity by developing the first long-term (over two years) implantable biosensor for CGM. This innovative device will provide real-time glucose measurements, enhancing diabetes management for patients. The project focuses on advancing technology by creating and validating a functional CGM biosensor prototype with a novel surface coating, GP5. This coating will significantly reduce adverse reactions and improve subcutaneous residency time. By the end of the GLUCARE project, the consortium expects to deliver a fully developed prototype tested in animal models, ready for clinical validation.
Beyond 180 Days
The current CGM biosensors have a limited lifespan of up to 180 days, requiring frequent surgical replacements. This process raises concerns about cost-effectiveness, reliability, and safety. These challenges have a significant impact on the 463 million diabetic patients diagnosed annually, who typically spend around €3000 per year on CGM devices. GLUCARE aims to enhance the quality of life for these patients by offering a cost-effective and dependable CGM solution, which can help reduce the risk of comorbidities.
Safe Implant Technology, the owner of the GP5 patent, is actively seeking investors. They aim to support ongoing business development and explore GP5’s potential applications in other relevant MedTech areas involving implantable medical devices.
Integration of Diverse Expertise in the GLUCARE Project
The GLUCARE project involves the integration of various physical and chemical parameters, requiring collaboration among specialized experts from different fields.
In the medical domain, surgical experts address procedural and anatomical challenges. Veterinary specialists provide animal model studies for the preclinical to clinical transition, while medical chemists ensure the stability of bioactive compounds. Immunologists study the immune response for biocompatibility and immunomodulatory therapies.
In engineering, microsensor engineers design precise sensors, and circuit designers create electronic components. Meanwhile, software programmers develop data processing algorithms, IT specialists ensure the integration of hardware and software with cybersecurity, project managers coordinate teams, and data scientists analyze large datasets for insights and treatment optimization.
In clinical operations, data managers uphold data integrity and confidentiality, clinical drug development specialists ensure therapeutic safety and efficacy, quality assurance professionals maintain regulatory compliance, clinical trial leaders manage trials and patient recruitment, and regulatory experts navigate legal standards.
“Robust data management and integrity protocols are essential for the success of GLUCARE, relying on collaboration and seamless data integration at every stage.”
Vision and Challenges in Personalized Medication Development
Limitations in New Compound Discovery
The pharmaceutical industry faces significant challenges as traditional drug discovery pipelines are drying out. The rate of discovering new compounds is decreasing, necessitating a shift towards innovative solutions to maintain progress in medical treatments.
Antibody-Driven Personalized Medication
Antibodies are emerging as the next frontier in pharmaceutical development. Their specificity and efficacy make them ideal for personalized medicine, tailoring treatments to individual patient needs. This shift will lead to more targeted therapies, reducing side effects and improving patient outcomes.
Combination Treatments and Real-Time Monitoring
Personalized medication will also drive the administration of combination treatments. Optimizing these treatments requires real-time monitoring of multiple patient parameters, such as blood pressure, glucose levels, and other vital signs. Real-time data allows for dynamic adjustments to treatment regimens, ensuring optimal therapeutic efficacy.
Technological Integration for Personalized Medication
Connected Monitoring and Administration Devices
For personalized medication to be effective, monitoring devices must be integrated with medication administration devices. This connectivity ensures that real-time data from the patient informs the administration of medication, allowing for precise adjustments based on the patient’s current condition.
Data and Algorithm-Driven Optimization
The foundation of these integrated devices is data and algorithms. Data collected from monitoring devices will continuously inform and refine the algorithms that control medication administration. Advanced AI-driven algorithms will play a critical role in iteratively optimizing treatment based on real-time data, enhancing treatment efficacy and reducing adverse drug reactions (ADRs).
Addressing Adverse Drug Reactions (ADRs)
Personalized medication, supported by real-time data and AI-driven algorithms, has the potential to significantly reduce ADRs. By continuously monitoring individual patient reactions, the system can avoid over- or under-dosing, providing the exact amount of medication needed at any given time.
Ensuring Data Integrity
A crucial aspect of this vision is maintaining data integrity. Continuous and accurate measurement of patient parameters is essential for the system’s effectiveness. Ensuring the reliability and security of this data is paramount to the success of personalized medication.
Practical Example: Diabetes Management
An illustrative example of this vision in practice is the management of diabetes. Real-time monitoring of glucose levels can provide immediate feedback for insulin administration. An integrated system could activate an insulin pump to maintain glucose levels within the accepted range, preventing hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar).
Challenges in Implementing Personalized Medication
Development of Monitoring Devices
Creating reliable, accurate, and non-invasive monitoring devices is a primary challenge. These devices must be capable of continuously measuring a range of physiological parameters with high precision.
Integration of Administration Devices
Integrating monitoring devices with medication administration systems requires sophisticated engineering to ensure seamless communication and coordination between the two.
Algorithm Development
Developing AI-driven algorithms that can interpret complex data sets and make real-time decisions is essential. These algorithms must be robust, adaptable, and continuously improved based on new data.
Implantable Monitoring Devices
One of the most significant challenges is the development of implantable monitoring devices. The human immune system tends to encapsulate foreign objects, which can reduce the sensitivity and accuracy of these devices over time. This issue typically arises within 10 days post-implantation, necessitating innovative solutions to maintain long-term functionality.
Collaborative Efforts and Future Directions
To address these challenges, collaborations between technology and healthcare companies are essential. For instance, CIMS Consult and CIMS eSystems’ engagement with Safe Implant Technology aims to establish a foundation for the described vision. These partnerships will drive the development and integration of advanced monitoring and administration systems, ultimately making personalized medication a reality.
By overcoming these challenges, the future of pharmaceutical development can shift towards more precise, effective, and personalized treatments, significantly improving patient care and outcomes.
