2023 ISPE Europe Annual Conference

Journey of a Medical Device Company to Digital Transformation and Operational Excellence | DiaSorin, the Diagnostic Specialist in the IVD Medical Device market, supports the entrepreneurial spirit through DiaSorin Values: - Operational Excellence: lean journey, brief history, methodology, tools and main results (from the impact assessment to the final verification) - Digital Transformation: enabling digitalisation and integration among machines and systems; harmonisation process of a multi-Site platform.

Fighting the Pandemic with Vaccines, Biomedicines and High-Performance IVDs |

The Paul-Ehrlich-Institut has been able to provide regulatory and experimental research support to help fight the pandemic. Our activity focus included (i) scientific advice on COVID-19 vaccine development and clinical trial authorization, benefit-risk assessment in the CHMP at the European Medicines Agency and governmental batch release testing, (ii) national authorization of neutralizing monoclonal antibodies for the treatment of infected persons at risk of severe COVID-19 disease course, (iii) experimental investigation of SARS-CoV-2 rapid antigen test performance and (iv) pharmacovigilance incldg. reports to the public.

The COVID-19 pandemic has brought to light several lessons learned from vaccine and biomedicine development. One key factor has been the unexpectedly high efficacy of the COVID-19 vaccines, which is generally attributed to effective antigen design. Higher efficacy of COVID-19 vaccines has been linked to higher serum titers of CoV-2 neutralizing antibodies, as for example demonstrated by the 4th Wuhan mRNA vaccination (2nd booster), which increases anti-Omicron antibody titers to the level detected early after the 3rd mRNA vaccination (1st booster).

In response to the pandemic, there has been a push for greater regulatory flexibility to rapidly adapt drug legislation and support the development of vaccines and biomedicines. Neutralizing antibodies were thus made available for treatment of infected persons at risk of severe COVID-19 by national authorization. Comparative experimental evaluations of the sensitivity of marketed SARS-CoV-2 rapid antigen tests have been conducted by the Paul-Ehrlich-Institut to enhance pandemic preparedness. Periodical Safety Reports on COVID-19 vaccine pharmacovigilance were made available to the public and helped to enhance vaccine confidence and rational discussions about vaccine safety. The newly inaugurated Center for Pandemic Vaccines and Therapeutics (ZEPAI) at the Paul-Ehrlich-Institut (PEI), with its vision and mission to provide expertise in pandemic preparedness regarding pandemic vaccines and antivirals, will support pandemic preparedness on the basis of lessons learned from the SARS-CoV-2 pandemic. Research activities at PEI include non-clinical research on model vaccines and vaccine-induced immune responses. The regulatory support provided by PEI to vaccine and biomedicine developers has been instrumental in the successful response to the pandemic.

The mega-trend Bioconvergence represents a new frontier of scientific collaboration due to the significant advancement in digital infrastructure and tools. Scientific discovery to real world implementation remains a lengthy and costly endeavor within healthcare. However, digital technologies enable accelerated scientific understanding in all aspects of therapeutic development. At Merck KGaA, we are bringing together the right technologies, knowledge, and partners across our businesses in Life Science, Healthcare and Electronics to accelerate the speed and impact of scientific discovery. In order to transform traditional drug discovery and development, we are currently building an AI and automation ecosystem for drug discovery as well as implementation of key technologies that increase the clinical phase probability and rate of success.

The digital transformation of the chemical industry is picking up speed. Hardly any company can avoid digitizing its processes, but the extent and speed of digitization projects vary widely. Evonik wants to be a pioneer and has set out on the road to becoming a "Data Driven Company”. The aim is to understand data as a corporate asset and use it as a lever for growth and optimization of its own business. At the end of 2021, the Essen-based Group received an award from the Competence Center Corporate Data Quality (CDQ) for its exemplary data management initiative. Gunnar Weider, Head of IT Strategy, Processes & Architecture explains the development, the status of the initiative and further plans.

EMA's Role in Protecting Public Health in Times of Crisis| The experience of the COVID pandemic showed that a reinforced framework to strengthen structures and mechanisms can ensure better EU level protection, prevention, preparedness and response in crisis situations. Coordination and cooperation between Member States and Third Country Authorities is crucial. EMA’s activities to tackle shortages, scientific review and coordination of clinical trials, as well as alternative tools for the GMP verification of facilities  provided us  with valuable lessons. Europe’s regulatory response to the pandemic is a success story. How can we build on this to prepare and prevent future crises?