Combating disruption to critical drug supplies

Pharmaceutical Commerce recently interviewed Michael Rabinowitz, CEO of CoEnterprise, a supply chain visibility and collaboration platform provider, about the push for improved supply chain operations brought on by the Covid-19 pandemic. Opinions vary, but in one fairly recent survey, 92% of pharma industry experts predict continued drug shortages post-pandemic, due to various factors, as uncertainty remains.

Rabinowitz works with many of the top pharma companies to tackle supply chain issues. As company founder and CEO, he focuses on enabling enterprises to analyze, interpret and act on their supply chain data with cloud-based technologies.

Michael Rabinowitz

Have Covid-driven drug shortages seemed to stabilize in recent months? Do you see more favorable trends in this area as the pandemic abates a bit, or will certain pharma supply chains face continued uncertainty?

Yes, drug shortages have stabilized despite the increase in demand. The errors in the initial stages of the vaccine distribution shed light on the crucial need for agility and visibility into pharma supply chains.

Although shortages are stabilizing, the global supply chain continues to face constant disruption. Unpredictable incidents within the global trade market—such as the recent Suez Canal fiasco‚ have caused delays and congestion that will likely last into 2022. This continued uncertainty is forcing pharmaceutical companies to reevaluate the data analytics and supply chain management processes and technologies they rely on.

Supply chain leaders are urgently looking for ways to increase visibility and communicate with trading partners faster to find and address issues before they waterfall. 

In your observations, what have been some of the key challenges in maintaining the supply chain for specialized medicines, advanced therapies and the like?

The vaccine, as with many other emerging drugs, brings new requirements. These medicines are costlier, condition-sensitive and have an enormous range in types and therapies. The new way of developing and transporting medicine has inadvertently increased supply chain complexity which has given rise to additional challenges.

The rise of the direct-to-consumer model is a prime example of a new challenge. This model presents hurdles for manufacturers and contributes to an already erratic supply chain. This is where the criticality of supplier collaboration comes in. A platform that allows manufacturers to work together with their partners to track and audit purchase orders and shipments is necessary for successful drug shipments, and ensuring people get the medicine they need, on time.

Pharma’s deep-rooted history in traditional corporate America causes additional difficulty. Every organization is shifting and transforming how they operate (think digital transformation). Pharma needs to be at the front of this transformation.

Many believe distribution operations set in effect during the age of “blockbuster drugs” are no longer viable. Why do you think that’s the case, and what is the risk pharma companies take when relying on legacy processes?

Previous processes that may have worked in the age of the blockbuster are no longer viable due to the drastic shift in economies and consumption. Consumer behavior is drastically different today than it was years ago. Consumers want in-depth information and a variety of options; legacy processes and one-size-fits-all blockbuster drugs inhibit that.

Like the consumer, drug manufacturers also want visibility, especially across the distribution process. But many organizations are stuck with rigid legacy systems that inhibit their ability to see the supply chain in action. This affects their ability to compete, and more importantly, increases the risk of a detrimental disruption in the pharma supply chain that affects patients.

What are the regulatory and financial ramifications around non-compliance for pharma brands as allocation guidelines and policies tighten? Are there new compliance approaches companies need to adopt?

The costliest regulatory and financial ramifications around non-compliance are delays in the drug approval process. These interruptions cost pharma companies reputational damage and downside risk to their share prices.

As a result, pharma companies are leveraging technology to avoid these ramifications as regulatory mandates become more stringent. Data analytics is the foundation for improving product and process quality. It gives pharmaceutical manufacturers the ability to look at trends and find proactive ways to improve their pharmacology. Without this type of technology, companies risk major compliance mishaps similar to the recent plant error around manufacturing of the Johnson & Johnson vaccine.

Together, integrated supply chain management software, processes and people can mitigate compliance risk in the pharma industry, when implemented properly. From a regulatory and compliance standpoint, data analytics is key to predicting trends, improving processes, avoiding oversights and improving innovation.

Previously, the FDA would approve applications in-person, but like everything else in our world, this process has become digital, making it more difficult to manage risk. But these challenges can be overcome with technology.

For example, the use of digitalization can help create counterfeit-proof medications with serial numbers that are trackable across the supply chain, ensuring quality while meeting upcoming serialization requirements. Pharmaceutical companies can also use digitalization to meet the expected increased demands from markets across the globe. Digitalization can help them meet regulations, find manufacturing efficiencies to address cost pressures and use cloud-based information sharing to quickly connect with suppliers and distributors. In addition, automation, smart sensors, social media and health apps can help measure drug compliance and predict demand across regions to support real-time manufacturing.

What are some practical ways pharma manufacturers are turning to data analytics for increased visibility into their supply chain operations?

The pharmaceutical industry is investing heavily in data analytics. Drug manufacturers manage the distribution of drug products from production through to their final delivery destination, whether that be to the consumer, wholesale distributor or pharmacies. This creates thousands of touch points and an overwhelming web of data, making analytics synonymous with success. In fact, IDC projects that organizations that leverage the right digital tools will result in a 15% productivity boost by the end of 2021.

Data analytics equips manufacturers to break down barriers across complex supply chains and consolidate information that’s scattered throughout multiple systems. Making data accessible for all users in all departments creates a multidimensional single source of the truth and provides real-time data into when exactly that shipment will arrive. These insights can drive strategic decision making throughout the entire life cycle from order process, to transport, and beyond.

Real-time collaborating and communication also drives efficiency and cost-savings. It gives manufacturers the ability to fine-tune their processes, solve for discrepancies and reach all tiers and levels in their supply chain networks.

Artificial Intelligence and machine learning are able to run “what-if” scenarios to help pharma companies prepare for black swan events. If you’ve already modeled it, you can prepare in advance for whatever happens.