Our 'In Profile' feature examines some of the biggest players in the industry and their journey into pharma. Here, we sit down with Ettore Cucchetti, CEO of ACG Inspection at ACG, who discusses the success of a major company milestone, and the challenges and opportunities serialisation presents.
In Profile
How did you get into the pharma industry?
I first entered the pharma industry in 2015 when I started with ACG. I was head hunted whilst working for a technology company in Switzerland, so it meant a transfer to Mumbai in India.
I have always focused on technology, mainly around quality and regulation, so moving into inspections in the pharma industry was a natural and appropriate progression. Whilst traceability as a topic within the industry goes back to the 1980/90s, and we have also seen the evolution of tracing from analogue to digital, pharma is certainly behind other industries when it comes to using tech. Being at the forefront of new technologies and innovations is what really attracted me to working in this industry and to this role at ACG.
Could you discuss your role at ACG?
Inspections was the youngest of the business units within the group when I started. My objective was initially to reorganise the management structure and to develop a comprehensive growth strategy for the unit.
Currently my role as CEO is to focus on introducing new technologies, sourcing new talent, and opening and acquiring new facilities. It’s already been busy - just recently we opened ACG’s Swiss ‘Centre of Excellence’ supporting the company’s continued global expansion. The office will be the headquarters for logistics, development, data, service support, factory acceptance test (FAT) and project management for ACG Inspections in Europe. So far it has been a journey of growth, and we’re excited about what lies ahead.
This year ACG completed its 1,000th track and trace line installation, what does this milestone mean for the company?
It’s a very important milestone, but one that comes with a lot of responsibility. We are relied upon by over 1,000 pharmaceutical businesses to keep track and trace lines functioning globally with trillions of data managed by us for the better future.
ACG has a large global presence, are there any differing serialisation challenges that you’ve come across?
There are many challenges when it comes to serialisation, including the varying regulations from country to country. Challenges can also arise when it comes to relaying and implementing these regulations to individual customers. Each customer has their own business model, supply chain structures and contract manufacturing organisation (CMO), so there are various nuances and idiosyncratic features to consider. It means customisation is key when it comes to working with any customer – every customer is unique, even if one company is operating across a number of territories.
The data flow is huge. Success boils down to proximity and communication and how a company like ours responds and manage the master data.
How big a threat is counterfeiting to the pharmaceutical supply chain?
The threat cannot be underestimated. The statistics around fake and available over-counter products are frightening - whether it’s contamination, incorrect formulations or issues in the manufacturing process.
ACG's Ettore Cucchetti
Ettore Cucchetti, CEO ACG Inspection
A secure pharmaceutical supply chain is key when it comes to protecting customers and fighting counterfeiting. It gives the benefit of recourse of the products and can pinpoint exactly where the product has come from.
Has contract manufacturing and outsourcing contributed to serialisation challenges and counterfeits?
Absolutely. Whether large international pharmaceutical brands or more locally-based ones, they will all use contract manufacturers – bringing everything into the mainstream data flow is a huge task.
The financial investment to support track and trace is considerable. This is an ongoing and continuous journey. Regulations are and will always keep changing, and hopefully improving, as criminals and counterfeiters become more sophisticated. We have a long, long road ahead to safeguard human life and ensure a better future.
What should manufacturers be focusing on next?
Now the regulation has passed, the time has come to focus on data, and this will be the next major step. Predictive consumer behaviour and industry 4.0 are only around the corner.
The whole process is very challenging and hence very rewarding. We discover new ideas and challenges on a daily basis. Only now are we being given the opportunity to address efficiencies in the supply chain. Many companies struggle to grapple with the huge investment required when it comes to serialisation, but I firmly believe we need to look at the bigger picture and the benefits this will bring when it comes to data management.
Conversely, what are some of the industry’s problems and challenges?
Communicating to the customer why they need to implement these technologies given the huge financial outlay and continued investment. This is the first step towards digitisation and being receptive to what it can offer will bring many benefits to the industry.
Following 2019’s milestone, what’s next for ACG?
We are working on our new ‘centre of excellence’ in Switzerland. This has been a very thoroughly thought-through journey. There was a lot of consideration about where to create and build the centre to best serve the next generation. We chose Switzerland because of the type of competency we were looking for and the ease of doing business there.