MedTech
Article | July 16, 2022
With advances in data analytics and machine learning, the move from descriptive and diagnostic analytics to predictive and prescriptive analytics and controls—allowing us to better forecast and understand what will happen and thus optimize process outcomes—is not only feasible but inevitable, according to Bonnie Shum, principal engineer, pharma technical innovation, technology & manufacturing sciences and technology at Genentech.
“Well-trained artificial intelligence systems can help drive better decision making and how data is analyzed from drug discovery to process development and to manufacturing processes,” she says.
Those advances, though, only really matter when they improve the lives of patients. That’s exactly what Shum expects.
“The convergence of digital transformation and operational/processing changes will be critical for the facilities of the future and meeting the needs of our patients,” she continues. “Digital solutions may one day provide fully automated bioprocessing, eliminating manual intervention and enabling us to anticipate potential process deviations to prevent process failures, leading to real-time release and thus faster access for patients.”
To turn Bioprocessing 4.0 into a production line for precision healthcare, real-time release and quickly manufacturing personalized medicines will be critical. Adding digitization and advanced analytics wherever possible will drive those improvements. In fact, many of these improvements, especially moving from descriptive to predictive bioprocessing, depend on more digitization.
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MedTech
Article | July 13, 2022
Introduction
The medical and life-science industries are experiencing a robust transformation with the increasing prevalence of various types of diseases, including infectious diseases, chronic disorders, and acute conditions around the world. As a result, a significant rise in demand for more effective therapeutic drugs and bionics is being witnessed, leading to a swift increase in the number of clinical trials.
For a successful trial, it is important for biotech companies to ensure the data submitted to regulatory bodies regarding clinical trials is accurate, reliable, and definitive from an ethical point of view. A reliable clinical trial management system plays a vital role in collecting, monitoring, and managing clinical data. The availability of high-quality clinical data also helps clinical research institutions make efficient treatment decisions and provide proper patient care.
Hence, a number of biotech companies and research organizations are focusing on leveraging innovative clinical trial management solutions to handle a large amount of data, particularly in multi-center trials, and generate reliable, high-quality, and statistically sound data from clinical trials. However, selecting the most appropriate and reliable clinical trial management system is vital for the clinical trial's success. Let's see some of the steps that will assist these firms in choosing the right CTMS.
Key Steps for Selecting Right Biotech Clinical Trial Management System
Prioritize Study Needs
Considering and prioritizing study needs is a crucial step in choosing the most reliable clinical trial management system for biotech companies. Prioritizing helps them to identify a solution that improves the study's quality and removes uncertainty for researchers when faced with difficult choices.
Hence, biotech and life-science organizations should choose a clinical trial system that is simple to use, well-organized, and suitably designed to minimize the number of clicks required to complete a task.
Select CTMS with Multiple Integrations
Integrated clinical trial management systems provide the best value for the companies’ funds as they guarantee the smooth functioning of research protocols. In addition, integrations are necessary to fully understand the importance and advantages of clinical trial management software for ensuring smooth transitions between site management and data collection.
Biotech and clinical research should look for CTMS platforms that can integrate with electronic medical record (EMR) platforms and clinical research process content (CRPC) billing grids. This will allow them to use the same billing designations and ensure compliance while minimizing the need for duplicate processes.
Ensure System Compliance and Security
Clinical research organizations need to adhere to a plethora of complex regulations in order to ensure compliance with one of the most challenging environments of principles, which is information security and privacy. Security and system compliance are vital aspects of choosing the right CTMS solutions for biotech firms as they assist in building trust and form a part of the system’s duties.
While selecting CTMS systems, it is essential for companies engaged in clinical research to ensure that these platforms are able to configure both, group and individual permissions, along with having a data backup and recovery plan for hosted systems. This will allow companies to assess the privacy and security implications of research and anticipate complications that may arise in each phase of the project.
Assess the Scalability
Choosing a scalable CTMS that can accommodate various types of fluctuations and expansions enables biotech and clinical firms to quickly adapt to fast-changing trends and demand spikes while reducing maintenance costs and enhancing user agility.
As scalability also means secure and expanded data storage, these businesses should instead use SaaS solutions than manually manage an ever-growing collection of hard drives. The right CTMS ensures accommodating the firm’s availability requirements without incurring the capital costs associated with expanding a physical infrastructure.
The Closing Thought
A well-executed and successful clinical trial involves multiple stages and processes. Several quality controls and stringent adherence to regulations are essential for the steps, along with efficient cross-departmental processes and procedures. Incorporating the right CTMS paves the way for paperless data collection, regulatory filing, and fiscal management tools for biotech researchers and administrative personnel.
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MedTech
Article | July 12, 2022
Natural remedies have been employed in medicine since antiquity. However, a large number of them fail to go past the clinical trial stages. In vivo instability, poor solubility and bioavailability, a lack of target-specific delivery, poor absorption, and side effects of the medication are only a few of the problems caused by the use of large-sized materials in drug administration.
Therefore, adopting novel drug delivery systems with targeted medications may be a solution to address these pressing problems. Nanotechnology has received tremendous attention in recent years and has been demonstrated to help blur the boundaries between the biological and physical sciences. With great success, it plays a vital part in enhanced medication formulations, targeted venues, and controlled drug release and delivery.
Limitations of Traditional Delivery Trigger the Adoption of Nanoparticles
The field of nanotechnology and the creation of drug formulations based on nanoparticles is one that is expanding and showcasing great potential. It has been thoroughly researched in an effort to develop new methods of diagnosis and treatment and to overcome the limitations of several diseases' current therapies. As a result, nanoparticles are being used to improve the therapeutic effectiveness and boost patient adherence to treatment by increasing medication bioavailability, drug accumulation at a particular spot, and reducing drug adverse effects.
The nanoparticles could be transformed into intelligent systems housing therapeutic and imaging agents by manipulating their surface properties, size, correct drug load, and release with targeted drug delivery.
Nanostructures facilitate the release of combination medications at the prescribed dose since they remain in the blood circulation system for a long time. Therefore, they result in fewer plasma fluctuations with decreased side effects. Due to their nanoscale, these structures can easily enter the tissue system, promote the absorption of drugs by cells, make medication administration more effective, and ensure that the medicine acts at the targeted location.
The Way Ahead
Nanomedicine and nano-delivery systems are a comparatively new but fast-evolving science in which nanoscale materials are used as diagnostic tools to deliver drug molecules at precisely targeted sites in a controlled manner. It is finding applications for the treatment of diseases such as cardiovascular, neurodegenerative, cancer, ocular, AIDS, and diabetes, among others. With more research and technological advancement, these drug delivery solutions will open up huge opportunities for companies that work with them.
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MedTech
Article | July 16, 2022
Introduction
Recent developments in the bioengineering of monoclonal antibodies (mAbs) have revolutionized the treatment of numerous rheumatic and immunological disorders.
Currently, several immunological disorders are successfully being targeted and treated using innovative medical techniques such as immunotherapy. Leading companies are increasingly investing in research activities to expand the usage and application of immunology for the treatment of various infectious diseases, including multiple sclerosis, inflammatory bowel disorders, lupus, and psoriasis, leading companies are increasingly investing in research activities.
Today, the efforts of researchers in immunology, with a long history of study and research, have borne fruit, as bioengineered mAbs are now being employed in clinical practices.
Accelerating Investments: Paving the Way for Immunology
The increasing prevalence of infectious diseases, cancer, and immune-mediated inflammatory disorders (IMIDs) is raising the need for more precise classification and an in-depth understanding of the pathology underlying these ailments.
Numerous leaders in the biotechnology domain are thus focusing on undertaking numerous strategies, such as new facility launches and collaborations, to address the need by finding deeper inroads into immunology and its use in disease treatments.
For instance, in 2022, the University of Texas MD Anderson Cancer Center announced the launch of a visionary research and innovation hub, the James P. Allison Institute, to find new roads in immunotherapy, develop new treatments, and foster groundbreaking science.
These developments will result in better diagnosis through the use of selective biomarkers, and early detection of fatal diseases and their treatment, which will prevent complications from happening. Also, the identification of high-risk populations through a deeper understanding of genetic and environmental factors can assist in the prevention of disease through immunotherapy.
The Way Forward
Immunology has led to the development of biotechnology, making it possible to develop novel drugs and vaccines, as well as diagnostic tests, that can be used to prevent, diagnose, and treat a wide range of autoimmune, infectious, and cancerous diseases.
With the rapid advancement in technology and the integration of artificial intelligence, immunology is finding its way into an array of domains and industries, encompassing several research areas including medicine, pharmaceuticals, agriculture, and space.
Today, not only researchers but also leading biotech and pharmaceutical companies have recognized that conventional therapies with pharmaceutical and chemical products are being replaced by products derived from immunology. This is because they work well for health problems, are environmentally friendly, and are also emerging as a wealth-generating business in the medical field.
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