Five+ years ago, when PAXAFE was but a seedling, Pharmaceutical planning, transportation and quality teams viewed the role of a transportation control tower differently than they do today.

Back then:

• Transportation control towers were either built in-house or sourced to each IoT device provider that was being implemented. Specialization and verticalization of control towers was a nice to have, but not a requirement — particularly around cold chain & high-value goods
• Quality teams’ product release process was coveted with a proverbial ‘Hands Off — Don’t Touch!’ sign, where the majority of product release decision-making — even product temperature parameters — were not shared with providers
• Standard Operating Procedures (SOPs) and risk assessments were also not shared externally, given the sensitivity of network information and the lack of provider capabilities that could operationalize that information
• Visibility program success was measured by device deployment and tracking dots on a map, rather than tying data to SOPs and workflows that highlight and unlock real savings
• Visibility services, monitoring and ‘hyper-care’ were accepted as status quo during the pandemic, as there was little price sensitivity towards anything that could impede vaccine distribution and logistics

Much has evolved since 2020.

The industry has come to a realization that the IoT, visibility and risk management solutions of the past decade have done little to move the needle to deliver on the intended & promised outcomes of a sophisticated transportation control tower:

• Product waste and loss ratios rising year over year
• Operational inefficiencies are more prevalent, not less
• The ability to make quick, intelligent decisions and conduct tradeoff analysis remains elusive… analysis is done on static, dated datasets with expensive consultants and data teams

That said, we are seeing encouraging signals from the industry and their evolving expectations from visibility and risk management.

Here are five of the top trends that PAXAFE has identified:

1.) The data-agnostic control tower

Building a control tower in-house costs millions of dollars up front + hundreds of thousands annually in maintenance and lacks the desired functionality of the business.

Alternately, relying on device control towers means that Pharma has multiple platforms to log-in to, and — given that IoT providers’ primary focus is just that… IoT — software and intelligence can come off as an afterthought with the same desired functionality problem.

Today, Pharma is demanding not just data agnostic control towers that can overlay passive, active, carrier milestone, ELD & container data into a singular view to provide a holistic data set and accurate source of truth…but Pharma is demanding control towers that are PHARMA-specific.

Gone are the days that generalized control towers tracking commodities are asked to ingest, process, and operationalize Pharma data into value for the world’s most important products.

Pharma is now demanding control towers bring deep domain and subject matter expertise around GxP, temperature and quality workflows, version management and traceability, product release, exceptions management, complex reporting, multi-device / logger shipments, aggregate insights and prescriptive recommendation.

2.) Automating the product release process

Ok, this is a work in progress. Pharma is extremely cautious in augmenting, let alone partnering on a product release process that does not include the Quality Manager making the ultimate release decision.

That being said, 5 years ago any part of this was entirely off the table.

Today, Pharma is starting to tinker with various models where product release decisions can be made in GxP validated control towers, but retains deep oversight over the actual decision.

For example, today’s workflows involve downloading and uploading various PDFs and CSV files into various platforms / QMS, conducting manual calculations, and doing this logger by logger. Much of this process can be centralized, digitized and automated, whilst still enabling the QA manager to retain ultimate release sign-off manually.

We believe that organizations will continue to shift towards a hybrid model where some of the process is automated, but still requires oversight and manual release until enough trust in the platform, process and GxP validation is secured.

3.) Digitizing the SOP, risk assessment and lane qualification process

Standard Operating Procedures (SOPs) and risk assessments have historically ticked off a compliance checkmark, but failed to add value.

As a result, Pharma has been reluctant to share these holistic documents with service providers.

More recently, we’ve seen this trend reverse now with the understanding that the combination of contextualized data, automated workflows and gen-AI can actually unlock material value in capturing the delta between SOPs (i.e. what is supposed to happen) versus lane performance and risk monitoring (i.e. what is actually happening), and auto-generating both root cause and recommendations hyper-contextualized to the bounds of existing workflows and processes.

4.) The realization that the real value of visibility is in planning

The value derived from a visibility program is in part correlated to where your organization sits on the IoT deployment maturity curve:

Yes, monitoring and intervening at-risk shipments is important. In and of itself, a 10% excursion reduction is not just a loss avoidance — it’s a reduction in the volume of shipments needing to go through disposition, RCA, CAPA and the broader quality process (which yields material time savings).

But big ticket savings (which drive multiples on ROI and investment) come from planning optimization, which as a by-product will result in fewer temperature deviations and excursions on future shipments.

These larger optimization opportunities can be operationalized and implemented if an organization has real-time data and evidence (from its own network) to make these kinds of decisions. A sample of decisions include:

• air to ocean and general route optimization, ensuring only qualified routes are utilized
• understanding where over-packaging or under-packaging exists, and modifying SOPs to either reduce packaging spend of reduce number of temp issues in transportation
• reduce contracted lead time to minimize inventory carrying costs
• understand when vendor SLAs are violated
• drive IoT selection based on device performance
• Optimize pickup times / days of week to maximize transportation performance
• Accelerate lane qualification lead times
• Drive SOPs with dynamic data rather than static data with dated studies

5.) Emphasis on reducing alert noise and minimizing monitoring costs

Let’s face it — device alerts are a terrible proxy for actual shipment risk. The majority of shipments with alerts pose no real risk to product, while — on the flip side — there are shipments with no device alerts yet those same shipments face very real risk to product.

The ability to contextualize holistic risk, prioritize action and silence alerts and shipments that pose no risk enables Pharma customers to drive monitoring service level reductions and expectations around monitoring costs.

For example, utilizing technology and algorithms that contemplate holistic shipment risk enables some companies to reduce their LSPs’ monitoring service tier, driving significant savings and aligned incentives.

About PAXAFE

PAXAFE is a logistics orchestration & decision intelligence platform that helps cold chain manufacturers and Logistics Service Providers (LSPs) reduce monitoring & intervention costs [for IoT-enabled visibility], digitize & automate Lane Validation and Lane Risk Assessments (LRA), and incorporate prescriptive recommendation into the real-time visibility network.