Where are CMOs headed? A Q&A with DSM Pharmaceutical Products CEO Alexander Wessels by Angie Drakulich
DSM Pharmaceutical Products received an award for best CMO in the summer of 2013 from the second annual BioPharma Asia Industry
Awards in Singapore. Pharmaceutical Technology Europe discussed industry trends in pharmaceutical outsourcing with DSM Pharmaceutical Products CEO Alexander Wessels.
DSM Pharmaceutical Products CEO Alexander Wessels
In your experience, what capabilities are CMOs now expected to have that they didn't have 5 or 10 years ago?
Wessels: DSM's stake in the pharma outsourcing market is based on a global portfolio of resources to continuously serve changing customer
needs and bring real value as the pharma industry shifts business models. This requires a breadth and depth of expertise in
the various areas of pharmaceutical technology that can be applied to customer challenges for increasingly efficient processes.
We are embedding such innovations across our mammalian, microbial, chemical and finished dosage platforms. In the area of
process analytical technology (PAT), for example, DSM has demonstrated the efficiencies and safety of microreactor technology
for the commercialscale production of APIs as an example of process intensification to achieve more efficient commercial production,
better manage manufacturing volumes and drive down total costs. In this way, we can challenge current process technologies
with innovations in process intensification for next-generation manufacturing solutions.
What is your view on industry consolidation and where do you think this will lead the CMO sector?
Wessels: Some sectors of the CMO market experience more pressure than others; biopharma growth is still high while consolidation in
the API sector, particularly in the Western countries, is something that we see happening as lower growth rates for innovative
drugs balance out with generics. Increased competition in this space is intense in both an East versus West perspective, as
well as where CMOs can bring cost-effective, sustainable and reliable solutions to the table in any market region. I think
that it is important to note that consolidation is being forced not only from a sustainable capacity perspective, but also
for reasons of quality and safety.
Our global supply chains are expanding and the safety of ingredients and finished drugs has become critical as outsourcing
resources, new and old, are tested. The increase in warning letters being issued clearly indicates a growing concern from
a regulatory perspective. At DSM, we are extremely sensitive to this accountability in manufacturing.
PTE: What trends and topics do you expect to see on the pharmaceutical CMO industry's radar in the year ahead?
Wessels: It has become critically clear that quality and reliability are fundamental to CMO performance and will come to bear in
balancing out providers across the global regions in terms of consolidation and alliances. DSM has a worldwide organisation
of experts in regulatory affairs. These specialists follow changes in local regulations and maintain a close relationship
with the relevant local authorities, ensuring that our products always comply with the regulations of the region. This global
organisation enables us to support and advise our customers on a broad range of regulatory questions; ultimately assuring
quality and reliability.
Additionally, the sustainability of CMOs themselves is a key issue. At DSM, we are not limiting ourselves to the traditional
CMO profile, but becoming a broad pharma partner with an eye on the future of the pharma market from both a supply-chain perspective
and the need for sustainable manufacturing models to support it. We are taking a hybrid approach by strengthening our core,
and diverse, CMO activities in biotech and traditional API and unique finished dosage production, and balancing our portfolio
with activities in biosimilars and generics, involving partners globally, to help them manage their product lifecycles.
Indeed, we are crossing into shared markets in generics where we can achieve new synergies with pharma in meeting demand and
driving growth. This applies as well to biosimilars/biobetters, where we can offer collaboration and asset management and
optimisation via our proprietary manufacturing technologies.