Pierfrancesco Morosini has worked in the pharmaceutical sector for 30 years, half in the discovery division of a big pharmaceutical company, and half in various management roles at API CDMO companies.

His domain expertise is in the chemical and business developments for small molecules as drugs, both for the generic and branded pharmaceutical markets, combined with wide skills in commercial strategy, investments and HR organization.

Strategies for success

Highlights from our discussion with Pierfrancesco Morosini, CEO of ICROM.

Pierfrancesco Morosini: “I would like to assure all our stakeholders that despite the general difficulties with global supply chains, and a new wave of rising inflation, ICROM has made its moves to pursue its manufacturing program with no hassles, while minimizing the economic burden to its clients worldwide.”

Reshaping globalisation

The recent past has regrettably been impacted by a number of adverse events: first the COVID pandemic, and now the conflict in Ukraine and geopolitical instability. ICROM is very conscious of its role and duty in delivering APIs for more than 40 countries around the world and it has been doing – and continues to do – its utmost to maintain a stable and secure supply chain with minimal disruptions to manufacturing and CDMO services, to give strong support under challenging circumstances that resonate worldwide.

The pandemic caused by COVID-19, as well as previous quality and environmental issues in far-east pharmaceutical production, have definitely shown that the overall concept of globalisation must be reshaped. We were already experiencing this trend – both for APIs and finished dose formulations – before 2019, but now the “made in” western countries, particularly in Italy, has risen as an indispensable label for many important stakeholders in the healthcare system. It has become clear that reshoring may be required to ensure the safety of supply chains, guarantees of quality, and sustainability of production technologies. This is true for the most strategic production processes, particularly pharmaceuticals.

Commenting on the more recent issues surrounding the conflict in Ukraine, Pierfrancesco says, “While we strive to manage and mitigate cost pressure wherever possible, we would like to stress the fact that in those few cases in which we are forced to apply a price increase, this has been operated on the smaller fraction of the overall cost increase, as ICROM’s commitment is, as always, to cover most of the cost increase by reducing our own margins.”

Steady growth

Aside from these challenges, according to Pierfrancesco, the pharma CDMO landscape has never been so favourable. Referring specifically to the global market for APIs, which is expected to grow at a CAGR of 9.1% this year, Pierfrancesco says that he expects European, and especially Italian API CDMOs, will outperform this rate.

Certainly, ICROM has shown a steady compound annual growth rate (CAGR) of 14% in recent years. This reflects a plan of aggressive investments aimed at enlarging the company’s capacity, extending its range of available best technologies, and increasing digitalization and automation. The company also applied a defensive strategy, including the creation of a new function for the Supply-Chain Management and Control (SCMC), which led, among other results, to higher stockpiling and the qualification of new additional raw material sources at times when other companies were struggling to manage their supply chains.

One recent expansion of interest is a new plant at the Italian ICROM Site, which is scheduled to be in operation later this year. This independent unit has been designed for the low-scale, high-quality production of APIs for use in clinical trials. It will be ICROM’s most advanced GMP unit, fully dedicated to the company’s biotech clients.

Sustainability

Sustainability in chemical production is the most important sine-qua-non of ICROM’s current 5-year investment plan (2021-2026). As an example, says Pierfrancesco, technologies like co-generation or tri-generation are already under consideration, though the real new paradigm will come from innovations for transforming old and polluting chemistries in new, sustainable and efficient processes. Green chemistry is rising in importance, and will pay a significant part in easier and faster regulatory approval processes.