Five minutes at CPhI worldwide with …
Chemistry Todat/Pharma Horizon: How did the acquisition with Akka go?
Andrea Sbandelli: CTP has a 27-year history and employs about 230 people. Even if we have been acquired recently by the multinational group Akka Technologies but as CTP we maintain our independence, since we are basically the healthcare division of the group. In the Middle East, we started our operations in Iran and Saudi Arabia. Both are our reference markets in the region along with Qatar, Jordan and United Arab Emirates. Then we have also operations in North Africa (Algeria and Morocco, mainly). Most of our business takes place in Italy and Europe, thanks also to Akka.
Filippo Bini: Akka is a huge consulting group, but they wanted to increase their commitment to Italy mainly for Life Science sector. Both reasons converged on CTP. We had other possibilities than Akka for the acquisition, but we felt Akka was an excellent match since they wanted to accelerate the internal know-how and their European competitiveness on Life Sciences market, allowing us to play an important role inside of the Group. It is going very well. We are uniforming the operations between various countries -CPhI is the first big event that we do together with Akka, and we have representatives of Akka from France, Switzerland, Germany and other countries joining us. We are finally operating on a fully European scale: in Belgium, where we obtained a contract with Janssen-Cilag (a subsidiary of Johnson&Johnson); we are trying to collaborate with Boehringer-Ingelheim, we are in contact with Sanofi, and so on. It is a much wider landscape than before.
CT/PH: What are your services and approach to the customer?
FB: Validation -equipment and utilities testing- is our main service, both in turnover and experience. We have our own suite of instruments, so we do not only prepare the validation documentation but we directly execute the testing. Not everyone offers this. We also offer support in engineering design: in the last ten years we built an engineering team that makes us completely autonomous in design a pharma plant from scratch. We even produce little “turn-on-key” solutions. Then there is all the area of computer system validation: data integrity, serialization, CFR-21 validation. We do not actually code new software; we tried in the past but it is not our real expertise. We validate the solutions and the infrastructure, and we try to find the right product for the customer. We can support Quality area, QA and QC, with a specific team of more than 30 person and recently we have reinforced our the Regulatory Affairs team with the creation of a specific operative division operating in Regulatory documents and also in Pharmacovigilance aspects.
AS: Our relationship with the customer is not limited to simple documentation: we send technicians on the spot and we become a project partner, with our feet on the ground. We become a part of our customer, so to say. In Saudi Arabia we follow two building sites now, one in a pre-existing pharma site, and another that we planned and built from scratch. We design and plan everything: building, facilities, supplies, competitive tenders and so on. We also offer training on all our four
divisions: validation, engineering, process and quality, IT compliance.
CT/PH: What changes you see in regulations?
FB: One area where is a lot of turmoil is data integrity: to ensure and standardize how the mass of data generated by IT systems is handled. It was regulated before as well, but now it is exacerbated.
CT/PH: What is your take on the status of pharma in the Middle East?
AS: There are local markets that have a definite growth potential, and thus can invest. Potential means that the quality of production and the production niches could reach the same level of other, more developed areas. Saudi Arabia has a huge investment capability and has important companies. Other countries in this area suffer a peculiar situation but managed to structure interesting internal markets. The projects we follow are aimed at this kind of upgrade, to further specialize, extend the reach outside of their country or obtain international certifications for CMO such as GMP. To do this they need a Western-like technical partnership, and that is what we provide at CTP. It is a much, much more dynamical region than in Europe. It is easier to find projects that start from scratch to build a completely new site, while in Europe it is more about revamping and upgrades. There is a lot of volatility: what is plausible at the start of the year might become impossible at the end, and viceversa. It requires a constant follow up.
CT/PH: Did international sanctions pose a challenge in dealing with, say, Iran?
AS: Sanctions on Iran have been lifted, but even before they did not present a real obstacle in dealing with us. Some companies even exploited the limits of some countries to enter this market. Iran has always been an interesting market; now that there is again an opening we felt the competition pouring in. The actual international situation might change again; we have to wait and see. For sure Iran will keep looking at Europe as a reference. Which European countries will accept the challenge is the real question.
CT/PH: And what about Russia?
FB: We worked a lot there, we seeded a lot of collaborations, up to the Ukrainian crisis. After that we observed a period of a period of uncertainty and the projects start were put into standby. The Akka group has operations in Russia so it will help to develop our position there. For me, Russia is the most interesting market at the moment -it is huge, with a per capita expenditure in constant growth.
CT/PH: What is your take on CPhI 2017?
FB: For us it is important. It is all about planned meetings -if you expect the casual walk-in, you do not need to show up. We think the CPhI is doing not enough analysis and comparison with other events. Until a few years ago we registered an increasing presence of North Africa, for example. Now, since in North Africa there is the Maghreb Pharma, which is always close in dates to the CPhI, almost all the North African players go there and cannot come here. It is true CPhI has local events in Russia and Turkey, but I do not think they go particularly well. Russians also do not show up, you do not see too many Russian companies here.
CT/PH: What makes CTP unique and puts you above the competition?
FB: Flexibility – we can adapt to all kinds of customers; availability; and, classically but honestly, a customer-oriented approach.