PHARMA 4.0™, The sector that can’t be stopped by crises

AUTOMAZIONE INDUSTRIALE DI VALERIA DE DOMENICO ARTIFICIAL INTELLIGENCE, BLOCKCHAIN, 3D PRINTING: IT’S NOT ONLY MARKET COMPETITIVENESS, THE PHARMACEUTICAL INDUSTRY ADAPTS TO ALL EMPOWERING TECHNOLOGIES IN ORDER TO ENSURE CONTINUITY AND EFFICIENCY IN ANY CRITICAL EMERGENCY. With time currently sort of frozen, we endeavour to carry out a furthering of the Italian pharmaceutical industry, an area in which our country boasts multiple worldwide merits and a recent trend of excellence. Italy now more than ever lays claim to its standing, with the health and wellbeing of all at the forefront. On such issues we sought comment from Teresa Minero, Founder and CEO of LifeBee – a Consulting and Digitalization Company in the Life Science sector – and President of ISPE Italy, European Leadership Team, Global Steering Committee SIG Pharma 4.0™- a non-profit association of pharmaceutical and Life Sciences professionals, who we thank for her time. “As was clearly laid out in a statement from Farmindustria in the latest hours (12th March for those who read, ed.) the pharmaceutical sector, and that of the Life Sciences in general, play an important role in society, and most certainly cannot permit disruption in the distribution and production of essential drugs or medical devices, let alone active clinical trials, which would risk invalidating years of work.” Minero tells us. “This affects those with Covid-19 and indeed the many who continue to be ill and unfortunately require treatment that cannot be postponed, one example being cancer patients. The pharmaceutical industry has taken important measures, from the introduction of smart working for office based services, to implementation, for necessary onsite activities, of continuity and emergency plans to guarantee essential services, while protecting the health of operators and employees. LifeBee too (which regularly provides essential consultation and support to customers, such as in Pharmacovigilance and Regulation or Production, in Laboratories or in Quality itself) has been found on the mark. I hope that we will remerge from this intense experience with a greater awareness of the importance of new technologies, to be used intelligently with a view towards sustainability and solidarity.” A SPOTTED EVOLUTION When discussing the topic of Pharma 4.0™ in April 2019, Minero concluded by defining the phenomenon not as a revolution, but as “full evolution”, since most Italian pharmaceutical companies have been moving towards this type of change for years, if only dotted and sparse. From the joint LifeBee & Sparta Systems meeting last February (dealing with Quality Management in Pharma) several more “psychological” obstacles have emerged, even if the new formula of the Government’s Industry 4.0 plan (which expands investment to potentially non-physical technologies if required) could become an additional incentive for Quality Management Systems. Incentives provided in this direction can certainly help to strongly increase (even among “late adopters”) prospects for integration and digitalization of information: let’s not forget that this is one of the strong points in the 4.0 vision. I must remind myself that all too often in Italy the 4.0 Industry has been perceived as exclusively linked to production machinery, precisely because of the limit set down by legislation to only benefit from incentives when investments are linked to material goods. The constraint has now been removed, and this could most certainly help the 4.0 revolution to escape from production lines and progress to departments such as Quality, Logistics, Regulatory and R&D. Moving more specifically to Pharma 4.0™, information sharing can and should be represented in the continuous improvement of processes within the company itself, but also and above all in the increase of regulatory compliance. The topic we delved into in our February 5th workshop in Milan on “Innovation 4.0 for Quality Assurance Management” is certainly well-fitting. It deals with automating the management of operating procedures, the management of so called Change processes, of Non-Compliance, Market Complaints, CAPA (Corrective Actions & Preventive Actions), Quality Audits (whether internal or external) of Training, to name the main players. There are undoubtedly several regulatory incentives in place, and I would like to highlight a regulation (one of many) currently being established in Europe on IDMP (Identification of Medicinal Product) and still little known. It regards the submission of basic data to the authorities regarding a medicinal product. The submission of said data is a process that even in its current form requires a lot of manhours. IDMP rules provide for an extremely high-level international standardization of shareable data in the direct interest of the patient. These involve a review and often a tuning of information flows within the company, allowing for great potential in all directions with the intelligent use of Digitalization. A MANIFESTO FOR 2030 Recent experience indeed (sometimes even just test cases) of activity improvements with digital technologies in key Pharma 4.0 call to attention even the most distracted. Such examples are many, some even unexpected, such as interesting initiatives involving Blockchain technology, seemingly futuristic but with very intriguing prospects. Probably the most important example however, which sums up very well what is currently happening, is the Italian Pharmaceutical 2030 Manifesto. The 2030 Manifesto (in which major companies such as Dompè and Sanofi took part and which was then presented to the Senate in September 2019) nominates Pharma 4.0™ among strategic objectives and digitalization among areas of operation. First impressions upon reading the Manifesto do indeed provide long lasting assurances, but an important offshoot is highlighting the theme of digitalization, spreading a signal that we are convinced will be picked up by many. In short, in order to return to the image of a spotted Italian Pharma 4.0™, we expect that the area begin to clear and take on a uniform coloration. QUALITY & Artificial Intelligence A preferred representative in discussions put forth by LifeBee is certainly Sparta Systems – a company active in the market in offering compliance and quality management solutions, which has introduced the topic of Artificial Intelligence in QMS. Fabrizio Maniglio (the company’s Solution Engineer) tells us more. “Artificial intelligence can be exploited to help discover the meaning of quality management data basing on relevant past information, thus enabling better productivity and intelligent decision-making within an organization. We have structurally incorporated artificial intelligence capabilities to support decision-making processes in our product: two examples can offer an idea of their potential. The first is automatic classification: by applying machine learning and natural language processing algorithms, we are able to automatically classify complaints, deviations, and non-compliance, ensuring that critical aspects are prioritized and handled quickly and appropriately. The system can provide suggestions and classification proposals so that Quality Assurance professionals can quickly evaluate new quality factors, allowing higher productivity and intelligent decision-making. The second is automatic correlation: we can also exploit AI capabilities to garner insight into quality data. The system identifies and correlates events of similar quality to assist in subsequent improvement actions.” These principles are at the foundation of the Digital QMS TrackWise System, which is the Sparta System proposal for Pharma companies. “TrackWise Digital is built on, a PaaS platform (Platform-as-a-Service) which consists of an integrated suite of quality functionality (QMS as properly named), including complaints, supplier quality management (SQM), documentation management and training management (DMS, TMS),” adds Maniglio. “TrackWise Digital was built on the back of over 25 years of quality management experience at Sparta Systems and is a scalable, flexible pre-configurated based on recognised industry standards. It is the first QMS in this industry to have decision-making capabilities enhanced by artificial intelligence. The assured benefits of this type of product are many. One of our clients companies, for example, wished to implement efficient, effective and consistent quality processes across multiple business sites around the world to improve customer response capacity and reduce warranty costs: with TrackWise Digital it has been able to internationally harmonize its quality processes based on industry standards and to take advantage of advanced reporting capabilities to demonstrate regulatory compliance, and improve overall quality processes, so improving the operational efficiency too.”