“emerging Trends In Broad And Narrow Claims: Learning From Landmark Patent Cases” – Life sciences is a broad field concerned with improving health and well-being. It includes areas such as drugs, clinical trials, medical equipment, disease identification and treatment, biomedical science, cell biology and biotechnology. The sector includes organizations engaged in research and development, commercialization and technology transfer in these areas.
Recent advances in industrialization and the adoption of digital technologies have revolutionized the life sciences industry and changed the overall treatment paradigm.
“emerging Trends In Broad And Narrow Claims: Learning From Landmark Patent Cases”
The growing use of digital tools and platforms, Artificial Intelligence (AI)/Machine Learning (ML), Augmented Reality (AR)/Virtual Reality (VR), Internet of Things (IoT), Blockchain and Robotic Process Automation (RPA) has been a game changer in 2022. Advanced digital platforms, tools and software have improved the productivity, accuracy and compliance of a range of tasks in the life sciences sector. According to the ArisGlobal Market Research Report 2021, nearly 83% of respondents from the sector believe that their organizations are using automation in their R&D processes, whether it’s automating specific processes through rules-based automation or deploying more advanced technologies. The primary benefits of adopting and implementing automation technology include cost reduction through increased efficiency and better adherence to quality standards. Respondents also expected to gain deeper understanding to facilitate better decision-making, simplify cross-departmental collaboration, and increase adaptability and extensibility.
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Decentralized clinical trials involve a variety of digital technologies that allow research to be conducted without the need for face-to-face interaction between research teams and study participants. Adoption of more decentralized patient-centered trials is increasing because they offer advantages such as significant cost reduction and generation of reliable clinical data through continuous monitoring.
A number of contract research organizations (CROs) have taken the lead in developing decentralized and virtual trials. As the pandemic continues, adoption of decentralized studies is accelerating; manufacturers reported that only 41% of clinical trials in 2021 were conducted using a traditional on-site method, and approximately 60% were hybrid or fully virtual and decentralized. Manufacturers will continue to outsource portions of their trials to CROs in the short term until they build internal capabilities for hybrid and decentralized trials.
Regulators and biopharmaceutical companies are working hand-in-hand with the sector to rapidly revise regulations and facilitate progress. Patients have also become more receptive to virtual/remote healthcare alternatives, further supporting the adoption of these platforms and solutions. This has led to the accelerated growth of several digital platforms: remote patient monitoring (RPM) solutions, including telehealth applications; Internet of Medical Things (IOMT); automatic pill dispensers; wearable devices and sensors; and the use of electronic clinical outcome assessment (eCOA).
Evidence gathered from real-world data (RWD) provides life sciences companies with insight into how their medicines are being used. Unlocking value from RWD is the only way the industry could accelerate clinical trials and support regulatory decisions such as approval of new indications or label expansion for existing drugs. Prominent life science and health care companies (LSHC) use the information to support the development of clinical trial design and observational research to develop therapeutics. Pharmaceutical companies would need to take a pragmatic, collaborative approach with end-to-end (E2E) evidence management strategies by breaking down traditional silos of evidence using platforms and processes to access data and knowledge assets across the organization to support informed decision-making give. creation. However, creating and implementing such strategies will likely require assessing and re-tuning their existing infrastructure, governance, operating models, people and processes.
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RWDs are observational data that are typically collected when an approved medical product is on the market and used by “real” patients in real life, as opposed to clinical trials. The US Food and Drug Administration (FDA) points to potential sources of RWD such as electronic health records (EHRs), insurance claims, disease registries, products, and data obtained from other sources that can provide insight into a patient’s health status. patient.
Biopharmaceutical, pharmaceutical and biologics companies are now focusing on new types of collaboration. Partnerships around clinical trials, research, big data and more allow them to pool resources, leverage additional expertise, and increase results and outcomes.
Companies are adopting various methods to support the growth of their clinical trial development market, accelerate product launches and experiment with new designs. They also use cutting-edge technologies such as artificial intelligence. These digital systems allow medical professionals to use data from previous trials, even those that have failed, to improve their designs.
The pandemic has accelerated collaboration with academia, biotech companies and data providers in the LSHC sector. Stakeholders, including regulators, expect this to become the new standard. Along with vaccination, cancer treatment is expected to continue as a major growth catalyst for the life sciences industry. Oncology accounts for 6 of the 10 biggest new sellers and 4 of the 10 best selling products. According to Evaluate statistics, sales of COVID-19 vaccines will reach $10-15 billion in 2021, with the Pfizer/BioNTech vaccine forecast to be the top seller. Evaluate expects Moderna’s COVID-19 vaccine to be the market leader by 2026.
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Boehringer Ingelheim is the first pharmaceutical company in the world to work with Google on quantum computers. It offers the potential to significantly accelerate and optimize the discovery of new drugs.
Life sciences companies are currently focusing on modern medical supply chain management tactics to strengthen their systems, processes and information management. This is the first step to strengthen value stream delivery and cost performance and includes the implementation of new planning and aggregation practices, new inventory management and better translation of demand into capacity and workload.
The second step involves finding available manufacturing conditions and raw material suppliers to establish cost-effective sourcing and procurement approaches.
The third step involves implementing best practices that are simple, effective, and easy to implement. This will help streamline operations, increase productivity and reduce costs for pharmaceutical and life sciences companies.
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Four recent trends in supply chain management include predictive analytics, increased collaboration between providers and suppliers, electronic payments, and cloud computing. The growing acceptance of digitization, artificial intelligence and mechanization has strengthened efficiency in supply chain management and improved the overall resilience and efficiency of the process.
There is also a significant focus on supporting customer-centric engagement and creating more personalized products and service offerings. Life sciences companies want to “go beyond the pill” and make a bigger difference to patient health and well-being. This means trying to understand the engagement points during and even before treatment. As the industry increasingly prioritizes patient satisfaction, new prospects are emerging to add value across the entire product lifecycle, such as physician engagement, research and development, and regulatory operations.
Personalization is also a priority for manufacturers of medical devices. Doctors now use surgical instruments and training aids tailored to patient use cases. For example, health monitoring equipment and home diagnostic devices contain more connected services, education and dashboards designed to improve individual experiences.
The growth of the life sciences sector is driven by new research and innovation, breakthrough drug development, significant funding to accelerate the introduction of drugs, growing government programs and advances in medicine. Life sciences companies are not only increasing investment in drug discovery and R&D, but are also revolutionizing clinical data management, business intelligence and analytics capabilities by incorporating digital transformation, AI, ML, RPA and telehealth consulting.
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Most biopharmaceutical, healthcare and life sciences companies intend to move from conventional technology-centric methods to scalable digital/cloud solutions. They scale enterprise IT infrastructure and cloud applications across the pharmaceutical value chain, therapeutic classes and geographies.
We believe that life sciences leaders should consider the following recommendations if they want to take advantage of emerging digital trends while exploring modern technologies and advanced IT/health technology applications:
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Shweta Gupta has over 12 years of experience in healthcare, life sciences research as a CI and strategic consultant for pharmaceutical companies. He currently works in the private equity and consulting practice at Acuity Knowledge Partners, supporting corporate and healthcare consulting clients in delivering scientific, clinical and commercial insights. He has experience in competitive intelligence, therapeutics evaluation, mergers and acquisitions, market sizing and forecasting, clinical trial analysis and scientific conference coverage. He has experience and knowledge of proprietary databases including Evaluate Pharma, Thomson Cortellis, Adisinsight, Pharmaprojects, Datamonitor and Merger Market.
Prior to Acuity Knowledge Partners, she worked as a research manager at a blue-chip pharmaceutical company. In addition, she also collaborated with Smart Analyst and WNS Global Services and participated in the planning, implementation and closing of client deliverables. In addition, her main role also involved working with the team and developing the business. Each new year brings a spectrum of progress from game-changing breakthroughs to incremental advances in a wide range of fields.
In a noisy media environment fueled by hype and speculation, it can be hard to know where real value is being created. The infographic above that draws from CB