Teresa Minero, Founder and CEO,

LifeBee

"Many opportunities enabled by new technologies are there to be harvested. A big challenge for management is often to decide what to prioritize and how to create the best sequence of projects, based on financial and staff resources and also its own digital maturity."

Can you provide an overview of LifeBee’s service offering? Together with our customers, we effectively redesign information flows, procedures and digital solutions, but also materials/personnel flows and organization, extensively combining operational excellence, proactive compliance and digital transformation approaches. The focus is on GxP regulated areas such as manufacturing, quality assurance, laboratories, logistics, serialization, regulatory affairs and pharmacovigilance of biopharma, medical devices and nutraceuticals companies. In consulting, LifeBee operates by means of process review interventions with the goal of process optimization, digital innovation, GxP compliance and data integrity and pharma 4.0 strategic plans. In digitalization, LifeBee provides projects feasibility studies, vendor selection, project management and the realization and support of digital solutions for both R&D and operations. LifeBee was recently appointed “Top Laboratory Automation Solution Providers in Europe 2021”. Could you explain through a specific case study how LifeBee can support life science companies on their path towards digitalization? We were delighted to receive this recognition as it represented the acknowledgement of the many successful projects delivered to Life Science Labs. One recent 10-week case study we are proud to share is the Conceptual Design for a pharma multinational company - aimed to optimize the whole Lab including processes, personnel and material flows for a new facility dedicated to a pharma Quality Control Lab (2000 square meters, 40 resources, 220 instruments). A key aspect is the focus on personnel and the instruments capacity to define the best lab layout, personnel organization, instrument pool and investment budget. A dedicated implementation plan has been prepared to be submitted to the Regulatory Agency for approval, considering the discontinuation of the old Lab while maintaining the entire business continuity - no analysis delays or related batch releases will be accepted. The pandemic has greatly accelerated the digital transformation of the pharmaceutical industry. Can you highlight some emerging trends you are observing in Italy in terms of IOT, robotics and big data? The Covid-19 tsunami has further showcased how digitalization plays a central role in making remote work possible in total compliance also within Life Sciences, as long as you have adequate digitalized infrastructure and application portfolio, all designed to really enable effective operability and robust compliance, with strong integration and with procedures and trained personnel in place. In short: a true digital transformation. 4.0 in Pharma is an objective "leap" also in Italy. We increasingly see successful projects using IOT (Industrial Internet Of Things), regulated cloud applications, on-demand and big data analytics and collaborative robotics: technological innovation in continuous improvement in a well-structured and ingenious way. This results in a long-lasting perspective regarding innovation and is part of the progression in the last few years in Italy's role as a leading medicine producer in the EU and as a major exporter. How has the demand for your services evolved in recent years? In the last five years we have constantly grown by 20% on average, much higher than the market. I would interpret this as the result of our unique selling point: we are not only a digital company, nor validation or compliance firm, nor exclusively Lean consultants. We are three in one and this is the key differentiation that our customers choose. In addition, there is evermore the need to guide our customers in their journey towards digital transformation. Many opportunities enabled by new technologies are there to be harvested. A big challenge for management is often to decide what to prioritize and how to create the best sequence of projects, based on financial and staff resources and also its own digital maturity. The design of sustainable and robust 4.0 and digital roadmaps is becoming one of our bestsellers as consulting services. What are LifeBee’s priorities for the next 2-3 years and do you have a final message for our international audience? Our priority is to increasingly extend LifeBee services at an international level, starting from a customer base of 70 companies that on average already export 85% of their production. Following the needs of our customers we deliver 15-20% of our services outside Italy. I have been recently nominated as one of the “Top 25 Healthcare Tech CEOs” in Europe. This stands as a remarkable recognition for our team’s work and surely looks promising for our future plans.

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