"The localisation policy has helped us obtain more contracts with customers because small or mid-sized companies who relied only on imports are now required to produce in Turkey. Without the technical production and R&D facilities, it is very difficult for such companies to transfer the product to Turkey, and thus they reach not only CMOs, but also CROs who can execute the dossier transfer for them."
Could you start by bringing our audience up to date with the latest development at Era Pharma?
Era Pharma is the only accredited independent R&D laboratory for pharma industry in Turkey. In the latest of our achievements, Era was audited by the Ministry of Health as a pre-requisite for Turkey to enter the PIC/S membership, which was realized in 2018.
How is the status of a GMP accredited R&D centre changing the prospects for Era Pharma?
As the only organisation enjoying this status, of course this plays into our ability to conduct analysis for different companies which we could not carry out before. For our clients who target export markets, and for the foreign pharma companies who enter to Turkey, they require an independent R&D centre, in turn accredited by the Ministry of Health.
Why is Era Pharma still the only independent CRO and other companies don’t emerge with the same model?
Providing high quality service for a long time is a very expensive and laborious task for R&D companies. There are R&D incentives in Turkey but unfortunately very inadequate and mainly in tax benefits area and none of them are in advance. Big branded generic pharma companies in Turkey, like Deva, Bilim, or Abdi İbrahim already have their own R&D, but they still work with us, because we present them a predictable and manageable time & risk share for their R&D projects and more practical ways which requires deep market experience and a high expert level of knowledge. However, our main customers are mid-sized players, who cannot sustain their own R&D. We offer SMEs an opportunity to develop and launch their own, local products in the market, and not import. However, confidentiality is a core aspect, especially since a project can be ongoing for years. Therefore, I would say the model we have in place at Era is ridden with challenges and involves many dimensions, which deters other players from entering this field.
How has the localisation project impacted your business relationships with foreign and local partners?
The localisation policy has helped us obtain more contracts with customers because small or mid-sized companies who relied only on imports are now required to produce in Turkey. Without the technical production and R&D facilities, it is very difficult for such companies to transfer the product to Turkey, and thus they reach not only CMOs, but also CROs who can execute the dossier transfer for them.
Taking into account factors such as macroeconomic instability, but also incentives to boost R&D, could you paint an image of how is demand for R&D outsourcing being felt by Era?
Last year was a tough one, if not the worst, for Turkey pharmaceuticals, and the ripple effects of the shock continue to be felt today, albeit to a lesser extent. Government support was stalled.
When the macroeconomics are in bad shape, outsource services companies are one of the first to feel the tumult. Unfortunately, we are not able to cut costs much, because we need well educated, high quality personnel whose expertise ranks above that of the biggest pharma companies, in order to create a persuasive argument why to bring the more difficult projects to us. On the other hand, clients could cut costs by outsourcing their projects, but outsourcing R&D is still a new idea for Turkey and many are not exploring this option yet.
What are the plans for Era Pharma in the foreseeable future?
One of our core ambitions is to have our own pilot production plant. Without this plant, we are sending our clients to CMOs, when we could ourselves cash in that revenue. Moreover, if we are to aim for FDA approval for registration dossiers, we would need to produce the first batch in house, which is another bottleneck to our business. Secondly, Era is also looking at opportunities in the biotech sector, which is an important segment starting to shape up.