In recent months, many pharma businesses have pivoted to entirely new product lines against a backdrop of unprecedented disruption to the supply chain. Gurdip Singh provide pointers to ensure companies are ready to adapt to change.
The supply chain in regulated industries has undergone a revolution in recent months. Many pharma businesses have pivoted to entirely new product lines, against a backdrop of unprecedented disruption to the supply chain. More than ever, change is the new constant. Gurdip Singh provide pointers to help companies ensure they are ready to adapt to change.
Gurdip Singh
Every major pharmaceutical company is experiencing disruption across supply chains, driven by volatility in the supply of parts and raw materials. The requirements for social distancing and employee safety measures add an additional level of pressure.
Across the globe, countries stopped elective surgery to create capacity for treating COVID-19. Medical device suppliers supporting hospitals with procedures such as hip replacements and even elective cardiac surgery have seen a huge impact on their revenue streams. Some have diversified their product ranges to meet the demand for PPE and ventilators. As countries re-open the doors to elective surgery, there is huge pent up demand for product. The requirement to able to ship different product lines rapidly has forced changes in manufacturing shift patterns and logistics.
In the pharmaceutical sector, many players have pivoted their operations to join in the race to develop a vaccine or repurpose existing drugs to treat COVID-19. The need to repurpose patient information labeling rapidly to meet regulatory requirements is an immediate challenge.
Normal has fundamentally shifted. Leaders in pharmaceuticals who understand and act on this new normal will have ample opportunities for growth. The possibility of future pandemics is very real. From now on, suppliers must be mindful that they may have to diversify from mainstay revenue streams at short notice. The dynamic of the supply chain has changed. Traditional, smooth processes will need to adapt to peaks and troughs.
Diversification is key to responding to changes in buyer behavior and the macro economic environment – and avoiding massive dips in conventional revenue streams. A centralized view of data and insights across the whole manufacturing operation will become a standard component of running a manufacturing organization.
For the survival of many organizations, it is vital to accelerate diversification and boost speed to market. Data analytics, harnessing the power of data that companies already have, can help organizations understand their customers’ fast changing needs at a granular level. Getting information about the product to the right stakeholders so they can use it safely and effectively is key. Patient information need no longer be produced only in the form of a label or a leaflet. Consider what is the most effective means for people to consume that information – an online video may be a useful supplement to traditional paper information.
If patient information data is stored at component level, separated into symbol, text, or phrase, right through to adaptations for different languages, it will enable faster change. That way, when a company has to diversify rapidly, it is easy to reuse existing data to create new labeling using confirmed branding, logos and phrases. A medical device company that produces predominantly orthopedic surgical devices might be able to produce ventilators. Reusing existing data, it can get a new product line labeled and out very rapidly. Anyone selling a drug that can be used to treat COVID-19 can repackage and deliver it within a matter of days.
Social distancing measures have had a huge impact on staffing. Many organizations have been forced to put in place remote working access for office staff – that meets regulatory requirements – at short notice. Manufacturers may lose up to 50% of their on-site personnel.1 To address this, some manufacturers have adjusted shift patterns to reduce the number of staff onsite at any one time. Longer term, increasing process automation is more effective.
Analyst firm McKinsey highlights how the manufacturing sector, where physical distancing can be challenging, is tapping into the Internet of Things (IoT): “In the recent past, there was some skepticism about applying the Internet of Things (IoT) to industry. Now, many industrial companies have embraced IoT to devise safety strategies, improve collaboration with suppliers, manage inventory, optimize procurement, and maintain equipment. This virtual shift will help digitize and scale much-needed expertise across the organization to enable the extended and often virtual workforce to become more focused, effective, and more productive.”2
Significantly accelerated deployment of Industrial IoT, is already contributing more data visualization and insights across operations. Remotely managed virtual solutions can help companies adjust to a very different future by reducing costs, enabling physical distancing, and creating more flexible operations.
An urgent re-evaluation of business resilience is ongoing across all regulatory sectors. As life science companies pivot business models to address fast-changing supply challenges, it is difficult to predict the likely long-term changes to the sector. Some things are clear – businesses will always need to focus on driving efficiency. Additionally, companies need to answer some pressing questions. How ready is the business to work with a reduced supply chain headcount? How are work processes affected by employees working from home or a reduced or variable headcount in future?
Second waves of infection and local lockdowns are already happening. Is your business prepared in case of another lockdown? Can you easily transition processes to offer new essential product lines? Better labeling automation is key to driving agility and accelerating processes that get new product to market – and to patients.
Gurdip Singh is CEO of Kallik.
Notes
FDA Approves Autolus’ Aucatzyl for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
November 12th 2024Approval of Aucatzyl was based on results of the FELIX trial, which demonstrated a 63% overall complete remission rate among efficacy-evaluable patients with relapsed/refractory B-cell acute lymphoblastic leukemia.