Area of presentation - ICSE General Contract Services - Serialisation – the vital role of the CDMO
Speaker Name: Erik Haeffler - Vice President, Manufacturing Services
- What are the current global trends driving the pharmaceutical sector you are working in? How does your company respond to those trends?
There is a clear trend towards outsourcing in the pharmaceutical sector – contract manufacturing has become a strategic part of most companies’ supply chains. The financial pressures faced by pharmaceutical companies have been a key driver for this, alongside the need to access specialist expertise and technologies that are not always available in-house. CDMOs are now much more integral and there is increasing use of the phrase ‘full service provider’ as customers increasingly demand a turnkey service. This has very much driven Recipharm’s focus on delivering a full-service offering – it is our job to manage complexity for our customers. Of course, we are witnessing growing consolidation in the outsourcing space and Recipharm follows a merger and acquisition (M&A) strategy in order to continue to expand our global reach and service offering.
2. What are the top challenges faced by the pharmaceutical sector you represent at this moment? How does your company deal with these challenges?
One of the greatest challenges affecting the pharmaceutical sector at present is the introduction of new legislation for the tracking and tracing of drugs throughout the supply chain. At Recipharm, we are taking a proactive approach to preparing for the EU Falsified Medicines Directive (FMD) and last year we established a dedicated taskforce and committed to invest more than €40 million in our serialisation programme. While many CMOs are falling behind in their preparations, serialisation is very much a priority for Recipharm and we will be ready ahead of the February 2019 deadline.
3. What topic are you presenting at the Pharma Insight Briefings and why is this subject so important to the market at this time?
I will be presenting on the vital role of CDMOs in overcoming the challenge of pharmaceutical serialisation. Complying with the new regulations is business-critical as those that don’t meet the February 2019 deadline will no longer be able to supply to key markets.
4. What can attendees to your session expect to gain and which challenges does this content address? Why should they include your presentation in their agenda?
Serialisation is a topic that should be front of mind for all organisations within the pharmaceutical supply chain. My presentation will not only provide some interesting insight into the current levels of preparedness in the industry, it will also consider some of the key challenges presented by serialisation and how they can be overcome. Perhaps most importantly, there will be some useful guidance on what pharmaceutical companies should consider when reviewing and assessing their supply networks. If your contract partners fail to prepare for serialisation, your business risks being responsible for product shortages and disruption to the supply of vital medicines.
5. How do you see your sector of the market evolving in the next 5 years?
One of the main trends I expect to see is a consolidation of the fragmented nature of the sector. Small-scale providers that have very few contracts and slim margins, will struggle to survive in the long term. Many of these CMOs will be acquired by larger players in the sector. CMOs that can provide solutions across the globe including supporting market access restrictions such as those in Russia, Turkey and some other countries, are best positioned for future success.