The 4 Main Key Takeaways from the Smart Quality Summit
Last week, we had the opportunity to get together with other industry peers to dive deeper into the emerging trends shaping the Life Sciences, and, especially, the future of the Quality Landscape. We gathered to experience the Re-Evolution of Quality.?
For those who couldn’t be there and enjoy the talks from the experts live, our Knowledge Manager, àngel Buendía ?? , has summarized the main learnings and takeaways that we’ll definitely hear more about in the upcoming years.?
Also, we’ve made the talks available on demand for those who want to get the full experience of the Smart Quality Summit and don’t miss any detail.?
On October 20th, 2022, hundreds of Life Sciences professionals joined together virtually at the Smart Quality Summit 2022 held by Scilife. While the event is still fresh in the minds of those who attended, I will summarize my key takeaways to inspire a re-evolution of quality (rethink, reconnect, re-imagine, and reinvent).
We are in the middle of Industry 4.0, the Fourth Industrial Revolution. New initiatives are transforming manufacturing into a Smart Factory.?
Technology, digitalization, and automation continue to evolve with new buzzwords: Artificial Intelligence, Advanced Analytics, Blockchain, Machine Learning, IoT, Natural Language Processing, and many more.
And what about Quality? Quality is not escaping from this trend at all.??
Traditional Quality is seen as a cost-heavy burden of doing business. Compliance is no longer a competitive advantage because quality is taken for granted.
So, what can organizations do to go beyond traditional quality borders?
This is what the Smart Quality Summit 2022 was about. The speakers showed us a new way of managing quality.
Now, it is time to transform quality into Smart Quality processes: a key catalyst of value creation.
The Summit covered new topics (not only buzzwords) that are important to today’s Life Science quality leaders – quality directors, quality managers, and quality assurance staff - including the following:
The following are the four key takeaways from the Summit we recommend watching on demand. Keep up to date and not be left out of the game!
1. Smart Quality: A key catalyst of value creation
Traditional Quality is focused on meeting compliance requirements with the minimum cost and risk.?
Filip Heitbrink , CEO of Scilife, and Evgeniya Makarova, partner at McKinsey and Company, showed us there is a new way of looking at quality issues with different eyes.?
Smart Quality is a new framework that applies a proactive quality mindset to build quality into processes and products with the help of novel technologies.
Smart Quality Platform, advanced analytics, automation, and real-time trends become key tools to get insightful data and make the right decisions on time.
New technologies help Life Sciences to excel in speed, productivity, quality, performance, efficiency, and cost. The numbers are clear. You can:
2. New technologies at the service of science
Life science companies are now becoming dependent on large data sources to support drug development literature reviews and regulatory reporting.
The use of structured and unstructured data makes knowledge graphs, natural language processing, artificial intelligence, and machine learning a natural fit for the industry.?
Having the right tools makes searching for information, getting insights extraction, categorization, and organization, a piece of cake.
As computer systems are more integrated and datasets become more extensive, computer science is using Machine Learning and Artificial Intelligence to learn from that data and draw conclusions.?
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This technology can be used to maintain, organize and store clinical trial databases, discover and develop new drugs, make better decisions to avoid nonconformities, reduce costs and increase revenue, for example.
However, maintaining the overall quality and regulatory compliance of IT systems and applications is a challenge, as outlined by the current GAMP 5 2nd Edition.
Although this technology is not easy for newbies to understand, make sure to be in the loop. Experts assure this technology will be a necessity in the near future.
3. The new treatments to come: SaMD and CAR-T therapy
Attendees also had the opportunity to ask questions related to Software as a Medical Device (SaMD) and a new cell therapy called CAR-T in two different “Ask Me Anything” sessions. Both sessions referred to devices and therapy that have medical purposes.
In the first session, Mika Siitonen , Medical Development Manager at Labquality, explained the meaning of Software as a Medical Device (SaMD), which is different from the Software in a Medical Device (SMD) term. The differences between FDA and European regulations were also mentioned.
The fast development of software is key to speeding up the time to market. Automation and Agile systems are mainly the cornerstones of fast development. Having documentation in place is also mandatory: SOPs, software development plan, user requirements, functional requirements, safety requirements, etc.?
Having a quality management system (QMS) in place is also a must. The application of Lean methodologies can be useful in developing your quality processes. The efficiency of a QMS platform depends on how agile and smart you are in developing the platform.
Risk assessment is also a basic system to identify the usability, clinical, security, and cybersecurity risks of using a SaMD to get inputs for a proper design. The goal is to mitigate identified risks to reduce their probability of occurring as low as possible.
In the second session, Lieve De Wolf , External Quality Manager CAR-T & Advanced Therapies, made a short presentation about the different therapies that belong to Advanced Therapy Medicinal Products and their benefits: sCT, sCTCM, TEP, GTMP, and combined ATMPs.
Gene therapy seeks to modify a gene’s expression or alter the biological properties of living cells for therapeutic use. These products have the potential to impact human health. These therapies are being announced in scientific journals and the media with superlative benefits.
Gene therapy medicinal products (GTMPs) are biological medicinal products. The active ingredients contain a recombinant nucleic acid that acts as a carrier of genetic information. They are used to regulate, repair, replace, add to, or delete a genetic sequence.
Lieve explained in detail two types of GTMPs, in vivo and ex vivo, and the manufacturing process for CAR-T cells.
In vivo gene therapy, the therapeutic vector, already prepared with the specified sequence, is infused into the patient’s blood circulation. Depending on the disease, the location of the infusion is important.
The other type is ex vivo gene therapy, like in CAR-T therapy. The target cells are removed from the human body. These cells are manipulated in vitro by adding viral or non-viral vectors. Afterward, these modified cells are reinfused into the same or different patients.
4. The impact of the Metaverse on the Pharma Industry
There is a big buzz about the Metaverse in society. Many misconceptions about this technology lead us to believe that many still do not fully understand it.
Metaverse is an interface or platform, perhaps the next internet, that will combine people’s digital and physical lives to come together to work and collaborate.
It is not only a technology for gaming, augmented reality, and virtual reality. It is not going to replace real life, either. It is the next step of the internet, Web3. We will share a virtual universe together, working, learning, and having fun.
Robin Kerbel and Carolyn Whiting from Six Degrees Medical believe the Metaverse will be a reality by 2030. It will promote virtual interaction, improving learning and education in society.
But how is the Metaverse going to impact Life Sciences?
For example, the Metaverse will improve medical education. It will offer immersive learning paths for physicians to practice in different fields: diagnosis and treatments.
Life Sciences organizations will also use it to upskill the knowledge and competencies of personnel. And clinicians will improve communication with patients in clinical trials.
There are countless applications of Metaverse. Just let your imagination run free.
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