Serialisation — looking for value-added opportunities15 May 2018
Recipharm's Staffan Widengren, Director Corporate Projects, discusses why CMOs should be focusing on the value-added opportunities presented by serialisation.
The European Falsified Medicines Directive (EU FMD) is just months from its enforcement date. Yet, the industry still has a long way to go if compliance is to be achieved.
TraceLink’s Global Drug Supply Safety and Traceability Report, which includes results from a survey of over 600 respondents, found that 88% of CMOs are concerned that equipment shortages will affect their ability, or their customers’ ability, to comply with the regulations. The survey also revealed that 94% of CMOs felt ‘somewhat’ or ‘very prepared’ for serialisation, yet less than half (42%) had not begun preparing.
Staffan Widengren, Director Corporate Projects at Recipharm, discusses the results of the survey and why CMOs should be focusing on the value-added opportunities presented by serialisation.
Do you think CMOs are right to be concerned about potential equipment shortages in the lead up to the EU FMD?
It’s a legitimate concern, vendors are dealing with significant order volumes and having to prioritize larger customers — lead times from machine vendors have increased significantly from order to delivery in the last year. For a standard machine the lead time today is likely to be over 8 months — Recipharm was working to a timescale of less than 6 months when it started its serialisation program. For businesses yet to select a vendor, they will have to opt for standard machines without customization.
78% of CMOs were already working on value-added projects — why do you think CMOs in the EU are so focused on added-value at this stage?
As the investments required of companies working towards serialisation are so high for a compliance requirement, CMOs are looking for areas where they could gain and add value both internally and for their customers. Developing means of interpreting and utilizing the big data being generated to make improvements in efficiency is a top priority for many.
Why do you think CMOs felt prepared for serialisation despite not having begun any actual preparations?
There’s little doubt that CMOs are aware of the requirement and have begun planning in some way. However, as the serialisation challenge is completely new, there has been some naivety from many businesses and many have failed to appreciate the preparation time required, the lengthening lead times for machines and software from vendors, the complexity of onboarding customers and the difficulty involved in securing approval from top management concerning capex and costs.
Staffan Widengren will be presenting at FutureLink Munich, 5-7 June 2018, on the ‘Final countdown: focus areas for a CDMO before February 2019'.
BMS and Celgene merge to create premier innovative biopharma company
3 Jan 2019
Significantly expands Phase III assets with six expected near-term product launches, representing greater than $15 billion in revenue potential.Read more
An increased risk of a hard or ‘no deal Brexit?
24 Dec 2018
A ‘no deal’ Brexit will change and burden how all industries that move materials and goods across borders, including the pharmaceutical and medical device sectors, do business.Read more
One month on: medical cannabis is still taboo despite change in law
11 Dec 2018
Restrictive guidelines have led many to buy CBD products online, leading to a boom in production with many products going to market without sufficient quality control.Read more
EU FMD - time is running out!
13 Nov 2018
Companies that have left it too late to implement their own solution will have to rely on support from providers, whose resources are already in high demand as the deadline approaches.Read more
Proprietary nasal delivery formulation of diazepam reaches NDA
7 Nov 2018
The absolute bioavailability of the Valtoco intranasal formulation was 96% of intravenous diazepam in a Phase I cross-over trial.Read more
DSCSA one-month countdown!
30 Oct 2018
With only a month to go, it really is too late to start trying to develop an in-house solution.Read more
Global pharma set for strong year
23 Oct 2018
Eight of the top ten pharma nations reporting improving market conditions.Read more
Generics companies to move away from "little white pills"
14 Oct 2018
Accepting more complexity and risk is key for those generics companies seeking competitive differentiation by diversifying their product portfolios.Read more
CMOs to benefit from double digit approvals for ADCs in the next 3 years
9 Oct 2018
Therapeutic ADC market expected to reach $4 billion by 2023.Read more
Movement on the market reflected at CPhI Worldwide 2018
3 Oct 2018
Companies new to CPhI to showcase an exciting range of products and services ranging from electroceuticals to refrigerant alternatives.Read more
Are you a supplier
Here's what we can do for you
- Generate quality leads for your business
- Stay visible for 365 days of the year
- Receive product inquiries and respond to meeting requests directly
- Improve company online presence through Search Engine Optimisation