Life science has always been a cornerstone of human progress. In our modern era, it plays an even more crucial role. As we confront various global challenges, solutions seem daunting. However, life science, with its blend of biology and technology, offers hope.
Traditional methodologies are merging with cutting-edge digital solutions. This amalgamation promises to revolutionize our approach.
In research labs, hospitals, and field studies, digital tools are becoming indispensable. They enhance accuracy, speed up processes, and enable real-time data analysis.
Such digital prowess paves the way for breakthroughs once thought impossible. As we delve into this article, we'll shed light on the current landscape of life science.
We will explore emerging trends, challenges, and the digital solutions addressing them. Through real-world examples, we'll witness the transformative power of technology in life science. We stand on the precipice of a new era. One where life science, empowered by digital solutions, can overcome global hurdles.
Life Science Today
The life sciences sector experienced a whirlwind of changes in 2022. As Europe emerged from the confinements and aftereffects of the Covid pandemic, life science supply chains worldwide encountered significant disruptions. Both the production and distribution spheres were affected, highlighting the sector's vulnerabilities.
Looking ahead, 2023 continues the momentum. With a series of regulatory shifts during this year, the life sciences industry is poised for another transformative year:
- Regulatory Changes in Pharmaceuticals and Medical Devices: The European Commission is hard at work revamping the pharmaceutical legislative framework. The goal? Crafting regulations that are both future-proof and resilient against crises. Alongside, new UK medical device regulations are set to be published, reaffirming the global nature of these changes.
- New Regulations from EMA: The European Medical Agency (EMA) has greenlit a slew of regulations for 2023. These will supplant Annex 11, encompassing facets like IT Systems, Data Integrity, Cloud Services, Agile methodologies, Infrastructure, and AI. Such a comprehensive overhaul is testament to the evolving nature of life sciences in a digital age.
- The Birth of the Unified Patent Court: The Unified Patent Court (UPC) and its unitary patents will be a landmark addition for innovators. Scheduled for an April 1, 2023 launch, this system aims to streamline patent portfolios.
- Empowerment of EU Consumers: Come summer 2023, the EU will unveil a game-changing directive: the Consumer Collective Redress. This mechanism empowers EU citizens to pursue collective redress actions, marking a significant shift in consumer rights.
- The Ascendancy of AI: With the explosion of 'big data', artificial intelligence is propelling life sciences into uncharted territories. New AI legislations are anticipated, reflecting the technology's profound impact on the sector.
- A New Era of Clinical Trials: The EU's Clinical Trials Information System (CTIS) is set for a major overhaul. Starting January 31, 2023, all new clinical trial applications must navigate through CTIS. By January 31, 2025, existing trials are also expected to transition. The aim? Greater transparency, with an increasing volume of clinical trial data accessible to the public.
Despite this flurry of promising initiatives, it's worth noting that many have already faced delays. The timelines, though optimistic, are not set in stone. Yet, for European life sciences IT executives, these changes represent more than regulatory shifts. They see technology investments as pivotal — both to optimize supply chains and to cement resilience in an ever-shifting landscape.
The intersection of technology and life science is more pronounced than ever. As we journey through 2023, these developments promise to redefine the sector in ways we're only beginning to grasp.
Life Science Trends
As we delve deeper into the intricacies of life science in 2023, it's vital to understand the emerging trends shaping the sector's trajectory. These tendencies not only reflect the current aspirations and innovations but also provide a blueprint for the next generation of breakthroughs.
Here are some of the most notable trends we anticipate:
Embracing the Metaverse for an Enhanced Digital Experience
The concept of the metaverse has moved beyond the confines of tech enthusiasts and is now penetrating the realm of life science.
Predictions suggest that by 2028, 60% of life science organizations will be active participants in the metaverse.
The initial focus? Leveraging this immersive digital realm for HealthCare Professional engagement, training, and sales enablement.
Furthermore, the metaverse will play a pivotal role in the evolution of digital therapeutics, providing an innovative platform for treatment and patient engagement.
AI-Powered Pharmacovigilance
The dangers of "black swan events" in the pharmaceutical realm underscore the need for robust pharmacovigilance systems.
By 2025, a whopping 80% of pharmaceutical companies will integrate AI-enabled pharmacovigilance solutions. The hallmark of these systems? The "human in the loop" approach, ensuring that while AI provides unparalleled data analysis, the human touch remains integral.
These solutions promise to enhance patient safety, support value-based pricing, and bolster demand management with real-time visibility.
Sustainability by Design (SbD)
Sustainability is no longer an afterthought; it's a design principle. By 2025, it's anticipated that half of all life science organizations will have embedded intelligent tech platforms to champion sustainability-by-design strategies.
These platforms will meticulously track value chain emissions across diverse domains, from manufacturing sites to individual products. And there's more on the horizon: by the end of 2024, initiatives focused on drug serialization and traceability mandates will yield tangible results.
Life science companies globally can expect up to a 20% reduction in revenue leakage, thanks to enhanced transparency.
In summation, as we navigate the complex tapestry of life science in 2023 and beyond, these trends signify a promising and innovative era. An era where technology and ethical considerations seamlessly intertwine, heralding unparalleled advancements and solutions for the global community.
Challenges & Opportunities in Life Science: Navigating the Evolving Terrain
The life science industry, poised at the brink of significant transformations, is bracing itself for multiple challenges:
- Legal Changes and Future Regulation: 2023 will usher in considerable legal amendments for life sciences products, defining the scaffolding for subsequent regulations.
- Regulatory Compliance and Privacy: This stands as the paramount challenge for European life sciences, with 80% of IT executives stressing its significance.
- Supply Chain Optimization: With an emphasis on meeting current demands and safeguarding against prospective disruptions, supply chain robustness is crucial.
- New Practices and Talent: Integrating novel practices, bolstering training regimes, and ensuring talent retention are pivotal.
- Privacy and Compliance Concerns: Among EU healthcare providers leaning into tech innovation, 78% express apprehensions related to privacy, legal, and regulatory issues.
- Cybersecurity: As technology's role amplifies, safeguarding data and systems becomes indispensable. Cases such as the hacking and subsequent leak suffered by the Hospital Clínic in Barcelona in March 2023 show the importance of cybersecurity. We must not forget that personal health data is being managed, and that this is highly sensitive information, the leaking of which has important consequences for the patient's life.
- Cold Chain Management: Overseeing temperature-sensitive pharmaceuticals within the cold chain is vital for maintaining product integrity, ensuring patient safety, and fulfilling regulatory standards.
- Health Data Collection and Interoperability: Gathering data to enhance physician engagement and patient journeys is paramount. Furthermore, 65% emphasize its importance for regulatory submissions, while 35% highlight its role in value-based pricing.
- Intelligent Health Infrastructure: The future hinges on modern infrastructures combined with trust programs and intelligent automation, ensuring enhanced data security and operational integrity.
- Technical Challenges: Emerging technologies such as the Internet of Things (IoT), enterprise resource management, track and trace solutions, master data management, blockchain, and intelligent automation present their own unique challenges.
- Cloud-based Applications: These have become business-critical for life sciences, with the need to ensure reliability, security, and functionality.
- Virtual Care & Tele-health: telemedicine is another growing trend. Companies such as Teladoc Health in the US are transforming the way people go to the doctor, with 92% of medical consultations successfully resolved virtually.
While challenges are rife, the horizon is also brimming with opportunities that promise a transformative impact:
- Efficiency & Cost-Effectiveness: Tackling challenges head-on can lead to streamlined operations and significant cost reductions.
- Innovation & Scalability: Overcoming barriers offers avenues to be more innovative and allows for scalable growth.
- Customer Satisfaction: By addressing pain points, life science organizations can significantly enhance customer satisfaction.
- Sustainable Growth: Embracing change and driving innovations can pave the way for long-term, sustainable growth.
In conclusion, as 2023 unfolds, the life science sector will undoubtedly encounter myriad challenges. Yet, with a proactive approach, these very challenges can be the catalysts for unprecedented opportunities, shaping the industry's future in unimaginable ways.
A clearer approach: VASS success stories in Life Science
VASS has worked on numerous life sciences projects, achieving remarkable results. Next, we will delve deeper into some success story examples to better understand how innovation can be achieved in this sector.
Donation Portal for Fundación Cofares
The project's goal was to technologically develop the Donation Portal within COFARES' Public Area. As a technological expert, VASS led the creation of a responsive, multi-language portal. This portal included a form that allowed users to attach their donation receipts.
The Donation Portal serves as a comprehensive database that captures all movements throughout the donation process. Internal users from Fundación COFARES can manage all donations, processes, receipts, and signatures resulting from donor interactions with the platform. An essential part of this project was the integration of the portal with the Redsys payment gateway.
Thanks to this project's successful completion, COFARES now has a digital channel to streamline the operations of its foundation.
Actions Undertaken:
- Web development of the Portal.
- Backoffice development.
- Web analytics of all interactive elements on the pages.
- Integration with the payment gateway.
- Dynamic generation of PDF documents with donation receipts once confirmed and subsequent email dispatch of these receipts.
- Definition and execution of functional tests.
- Automation of unit tests.
- Functional and technical documentation of the solution.
- Training for contributing users.
- Post-implementation support.
Technology Used: Liferay Digital Experience Platform.
A Transformative CRM Approach for Intuitive Surgical
Intuitive Surgical is a pioneering firm that designs, manufactures, and markets robotic products. Their core mission is to enhance clinical outcomes via minimally invasive surgery.
Intuitive Surgical faced the daunting task of replacing their legacy CRM environment. Their goal was to have an integrated system that would streamline their Quote-to-Cash future state while ensuring improved clinical results.
The Solution: VASS presented Intuitive Surgical with the SAP CRM 7.0 EHP4 Service. This solution features Service Agreements, Service Contract & Warranty Management, Returns & Repairs Management, Field Service, Product Service Letters, Interaction Center with CTI, and Install Base Management.
Engagement: The collaboration began with a shared vision and the creation of a strategic roadmap. This aimed to define the necessary business requirements and future processes vital to the transformation's success. The roadmap's results encapsulated:
- Categorization and prioritization of business & technical requirements.
- Considerations regarding processes, solutions, data, and finance.
- Solution recommendations.
- Proposed system architecture.
- Detailed month-by-month implementation timeline.
- Further insights and recommendations in areas such as CX research, Process, Reporting, and OCM.
Outcomes: Following the recommendations of the roadmap:
- Intuitive Surgical underwent business process redesign in specific areas in Quote-to-Cash, setting the foundation for subsequent implementations.
- They are now evaluating their master data and have embarked on a journey to discover and utilize an MDM solution for enhanced data management in the future.
Benefits Realized: Intuitive Surgical experienced a myriad of benefits from the integration:
- Automation features were integrated seamlessly. Examples include the automatic creation of Installed Base, Installation Field Service Orders, Warranty, Contracts, Preventative Maintenance, Field Service orders, and proactive escalation from Robotic System Logs.
- The CRM was integrated with their ERP, resulting in streamlined Equipment and Equipment BOMS, financial and costing integrations, Billing, Inventory Management, and a Sales Process for Contracts and Agreements using SAP VC.
With VASS's expert assistance, Intuitive Surgical now possesses a state-of-the-art CRM system that not only meets their clinical aspirations but also positions them for future growth.
Driving Clinical Excellence with Roche
Roche stands at the forefront of the pharmaceutical industry, dedicated to improving healthcare outcomes across the globe.
For a decade, we've proudly served as Roche's preferred partner, playing an integral role in their international global support team, particularly within the Clinical Essays business unit. Our collaboration has spanned across 30 countries, where we've embarked on groundbreaking improvement projects and delivered relentless support to end-users.
Key Improvement Initiatives:
1. Seamless Integrations:
- We've orchestrated a robust integration between SAP ECC and the 4G Clinicals supplier portal.
- A second significant integration linked SAP ECC with DHL Deutschland, ensuring that Roche's supply chain runs efficiently.
2. Intelligence in Clinical Supply Management:
Together, we co-designed an advanced Clinical Supply Management solution with SAP, enhancing Roche's ability to manage their clinical supplies effectively.
3. SAP System Unification:
One of our most ambitious undertakings involved transitioning from 33 distinct SAP ECC systems to a unified S/4 HANA system. This monumental move paved the way for streamlined operations and increased efficiency.
Technologies Deployed: Throughout our engagement, we've employed state-of-the-art technologies including SAP ECC and S/4 HANA, specifically delving into modules such as PP, SD, WM, MM, and QM.
Our enduring partnership with Roche underscores our commitment to technological innovation and excellence in the healthcare sector. Together, we continue to set benchmarks and drive transformation in clinical operations worldwide.
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