You have been in SAP for 20 years - what have been the main changes in the relationship between tech and the life sciences?
When I look at the steep evolution of the life sciences in the last two decades, one central change is the focus on patients. In the past, manufacturers focused more on research and development for global needs, but today patient centricity is a priority for the industry. We have many initiatives to get so-called ‘real world evidence,’ which captures and shares patient demographics and outcomes from drugs and medical devices to improve the product. There is a sense of urgency to meet the end consumer needs, offer personalization, and advanced therapy medicinal products. That is what our industry is learning from consumer products, which was not on the radar of life science organizations two decades ago. At SAP, we believe it is important to be patient-centric and to look at challenges like outcome-based reimbursement, regulations, and margin pressures to help the industry adapt and create value that supports long-term growth.
As in other industries, risk-resilient supply chains have also become increasingly important following the Covid-19 pandemic, which caused significant demand fluctuation. Twenty years ago, the industry’s supply chain was linear, whereas now it is more circular. There is more collaboration between the value chain entities, whether you look at sub-contracting companies who are developing and/or manufacturing products upstream, or you look downstream with wholesale retailers. We are also experiencing mergers and acquisitions between bigger pharmaceuticals and biotech companies. Targeted treatments with cold chain logistics are gaining more traction, causing the traditional model and channels to be obsolete when it comes to innovations in biologics. The life sciences industry including advancement in medical devices is changing rapidly, so we need to change accordingly.
As you claim, the dynamics of supply chains have changed, and digitization is now a tool to improve its efficiency. In what concrete ways can digitization have this impact on the supply chain?
Covid-19 proved that supply chain networks have to be resilient.
Regulatory agencies around the world protect their citizens by requiring serialization documentation of ingredients to ensure pharmaceutical products follow local regulations. All this additional paperwork increases the burden on the industry, not just when it comes to source transparency, but also for the IT systems that have to be ready to support traceability. Hence, IT departments should be proactive in order to achieve that visibility across the supply chain - and here is where companies like SAP come in. Product quality is very important in our industry, and if we want to deliver optimized quality control and quality assurance processes, we need to ensure a better enabling technology for batch release.
What is the importance of standardized platforms for cell and gene therapies?
Think about a personalized drug. The process starts with a patient's blood sample that was captured in a hospital. Based on the lab reports, the manufacturer gets relevant inputs. They need to manufacture, then deliver that drug in a determined period of time - let us say within three weeks. The challenge appears the moment the doctor identifies a patient and schedules an appointment for drug infusion. Then the manufacturer should be able to quickly communicate their ability to deliver that drug within the three weeks. In such cases, standardized platforms have relevant data – they can reduce that turnaround cycle time, improve the accuracy of the manufacturer’s communications, and collaborate better with the healthcare provider. By providing the most advanced platforms and the best IT tools, this cycle can become more efficient. And if we save even one day, we are in the range of huge saving potential both monetarily and saving people’s lives.
The important feature of cell and gene therapies is that we are not dealing with a generic medication, but with the specific customer’s medication - what we call chain of identity. If you take a batch size of one, the burden of the supply chain is exponentially increased, and so are the costs. That’s why these therapies are still so expensive. Today, there might be some cancer patients that can afford this kind of costly drug, but we need to make it accessible to all - and here, again, the efficiency provided by standardized platforms like SAP’s can attain that accessibility. It is for this reason that we must ensure that the ’supply chain of one’ principle is sustained by the right IT platforms with chain of identity and chain of custody. With a circular economy, a sustainable supply chain can become, to an extent, standardized. Then managing many simultaneous supply chains becomes a possibility.