TraceLink: “As deadlines for the EU Falsified Medicines Directive (FMD) and the Drug Supply Chain Security Act (DSCSA) became imminent in early 2018, we saw a significant surge in demand for our services as companies looked for support in their serialisation programmes,” says Allan Bowyer, Director of Industry Marketing, TraceLink. “By the end of the third quarter, we were serving more than 1000 customers in 43 countries, representing a 46% year-on-year increase.”
“We launched a number of services to support final preparations for the FMD and DSCSA deadlines to ensure that our customers would have the ability to meet regulation deadlines and achieve compliance. To help smaller pharmaceutical companies comply with EU FMD, we released EU FMD Express, a cost-effective offering for companies with simple supply chains. We also released a European Medicines Verification Organisation (EMVO) conformance test kit, a streamlined programme enabling our EU FMD customers to complete conformance testing and receive EMVO approval to submit data to the EU Hub.”
The milestones achieved in 2018, he says, are just a few examples of how the pharmaceutical supply chain is experiencing a digital transformation, opening up further opportunities driven by the new technologies generated by traceability needs and the utilisation of shared data derived from pharmaceutical serialisation requirements.
Zenith Technologies
When asked about the most important innovation of the last year, CEO Joe Haugh immediately cites the use of cloud-based manufacturing execution system (MES) applications to support cell therapy production processes for the treatment of cancer.
He says: “Cell therapy is already moving from a manual lab environment to a more automated, larger-scale production one. The objective is to make the cell therapy process as robust, efficient and error free as possible. Better manufacturing strategies will play a role in commercialising and ultimately improving patient access to personalised medicines. Automating cell therapy processes through an MES is a cost-effective, reliable and efficient method of solution delivery.”
“Using a cloud-based MES, we can add batch contextualisation electronically to provide a more complete picture of the cell therapy process and increase success rates. There is currently a significant cost associated with cell therapy to treat cancers. As we move into 2019, MES and automation will contribute to the reduction of manufacturing costs, which will help to make the therapy more accessible to patients,” he adds.
And, commenting on the most influential trend of 2018, Joe observes that the outsourcing of automation services under managed service contracts has seen significant growth.
“One of the biggest challenges the industry faces is finding sufficient talented engineering resources that are able to innovate and introduce technologies to transform life science manufacturing whilst preparing them for the digital future. Outsourcing can give companies instant access to the right resources to achieve system reliability and continuous improvements whilst making cost savings and meeting compliance requirements.”
Business as usual in 2019
Allan Bowyer, Director of Industry Marketing, TraceLink
TraceLink: “As we say goodbye to 2018, the DSCSA enforcement for manufacturers will go into effect and the industry will focus squarely on meeting the FMD deadline of February 2019.
As companies race to be ready, their last 9 months have been intensely focused on integrating partners, validating solutions and completing onboarding with the European Medicines Verification Organisation (EMVO),” says Allan Bowyer: “Beyond the deadlines, we expect to see businesses working on returning to a business as usual state while they begin to explore the additional value offered by their serialisation investment.”
The impact of serialisation is often company wide and will extend beyond implementation. One of the biggest challenges related to handling serialised products is integrating use cases into existing processes to maintain operational efficiencies.
“To manage this transition, we will see the emergence of new expert roles, new organisational structures and, in some cases, increased outsourcing for serialisation-related activities. Once serialisation has been fully operationalised and businesses have regained the efficiencies lost through implementation, there will be a focus on extracting value from serialised data and supply-chain partner connectivity,” he adds.
Increased visibility and information sharing up and down the supply chain, as well as the launch of patient-centric programmes that enable the ultimate consumers of medicines to interact with real-time product information based on uniquely identifiable products, are just a few of the benefits that leaders throughout the industry believe will come from serialisation.
Business leaders will also come to learn in the coming year that their ability to realise these additional benefits will depend on the solution they chose for their serialisation programme. Visibility across the supply chain can only be facilitated by a network approach, wherein everyone is connected via a shared platform.
“It’s important to remember that while the first major milestone of the DSCSA passed in 2018 with enforcement for manufacturers, the Saleable Returns Verification requirement phased in during November, introducing another challenge for the industry. The regulation dictates that wholesalers will only be able to redistribute saleable returned product after they verify the product identifier encoded on the package or homogenous case returned.
“The Healthcare Distribution Alliance estimates that nearly 59 million saleable returns are processed annually, the product identifiers of which will need to be verified in the distribution channel under DSCSA,” states Allan.
“Much of the burden of this verification will fall on the original manufacturers or repackagers who placed the product on the market and who must by law respond to verification requests from trade partners. For a given manufacturer, this may mean managing tens of thousands to more than a million verification requests annually in the near future. In response, the industry has been developing Verification Router Services (VRS) to help facilitate and automate these verification requests.”
“As with the broader serialisation laws, different solutions can be employed to meet the requirements. Proprietary and custom solutions will put the entire industry at risk of missing the deadline and jeopardising the safety of patients if they are not interoperable and are not based on open standards. When looking for solutions to meet saleable returns, manufacturers and wholesalers should consider solutions that facilitate real-time information exchange and can support their requirements for additional needs through a digital information sharing platform,” he summarises.
ChargePoint
Ben Wylie, Senior Product Manager, ChargePoint
According to Ben Wylie, Senior Product Manager at ChargePoint: “Drug production using highly potent active pharmaceutical ingredients (HPAPIs) and sterile manufacturing shows no sign of slowing down. As a result, manufacturers across the pharma and biopharma industries must respond to containment challenges if they are to benefit from this growth.”
“Better ways to achieve operator safety and prevent product cross-contamination have been widely discussed and, as we move into 2019, more innovative containment strategies are set to disrupt the market. Smart wireless monitoring technology was introduced in 2018 to give manufacturers increased confidence in their containment solutions.”
“This type of technology enables users to receive crucial equipment usage data quickly and remotely if needed, providing operators with visual feedback and giving confidence in the health status of the equipment. This information allows maintenance teams to take preventive action, resulting in less downtime and improved efficiency during high potency manufacturing,” he adds, concluding: “Such innovative technologies will continue to transform traditional containment solutions in 2019 and the predicted rise of disposable technology will also change the way manufacturers operate.”
Particle Sciences
Barbara Morgan, General Manager, Particle Sciences
Barbara Morgan, General Manager, predicts the rise of non-traditional dosage forms. “A number of factors in the market are reshaping our approach to dosage forms and we are seeing a definite rise in innovative delivery methods such as nasal sprays. Up to 40% of marketed drugs and as many as 90% of those in development are poorly water-soluble APIs, making this an increasingly common issue in pharmaceutical development.”
When these drugs are introduced using traditional oral solid dosage forms, they fail to dissolve, have severely limited bioavailability and therefore have limited therapeutic effect. Now, there are multiple techniques available to increase the solubility of drugs and improve their delivery, particularly the use of amorphous solid dispersions and nanoparticle formulations.
“Alongside this, we are also witnessing an increase in 505(b)2 approvals — an FDA regulatory pathway that involves taking existing APIs into a different route of administration,” she comments, adding: “These approvals grew 50% last year and this regulatory path has become increasingly popular during the last decade, usually involving innovative dosage forms or drug delivery methods that are considered to be complex. With the rising cost of taking new chemical entities (NCEs) to market, we would expect this regulatory pathway to continue to grow.”
“Plus, with further pricing pressure on generic drugs, we would expect a continued interest in complex generics from companies. These complex generics have lengthier and more expensive development programmes and often involve clinical trials, but they allow a market space that is valued and more exclusive,” says Barbara.
“The era of huge-volume blockbuster drugs is fading,” she continues: “And, with this reduction, comes a move away from plant being set up to manufacture drugs that can fill and sustain an entire facility. With drug pipelines requiring more modular and diverse capabilities, CDMOs have been approaching facility expansions with an eye towards flexibility. There is now is a trend towards smaller batches and personalised medicine, requiring drug developers and manufacturers to be nimbler and more flexible to meet these growing needs.”
Wasdell Manufacturing
Daniel Tedham, Managing Director, Wasdell Manufacturing
On a similar theme, Daniel Tedham, Managing Director, notes that mass production and the “one-size-fits-all” approach is no longer the focus for the pharmaceutical industry. Instead, he says, the drug pipeline has moved towards novel treatments for rare diseases and meeting the demand for personalised medicine.
“Smaller volume biotech products are therefore likely to be prevalent throughout 2019 and we can expect to see further breakthroughs for rare and hard to treat conditions. Accompanying this, I would envisage advancements in technology for medicine administration, as companies try to add value and differentiate their products from competitors by improving the patient experience,” he says.
New technologies are also likely to drive change in the year to come. “We should anticipate greater exploration regarding how to integrate printable electronics with pharmaceutical products during the next 12 months. Incorporating electronics into product packaging — and the product itself — could be revolutionary for the industry as companies begin to access real-time information that would have previously been difficult to accurately obtain.”
“There is potential to include sensors in products, which would deliver information regarding how a product is used, its storage conditions, ensure security, determine resupply requirements and identify which market a product is being supplied to. This leads us to the use of data in general across the pharmaceutical sector. As an industry, we need to begin making more decisions that are data-driven and not solely from a market or patient perspective, but also to improve internal operations and quality control at manufacturing sites. This will allow the industry to continuously review and advance its processes, cut costs and future-proof operations,” he concludes.
Final word
The trend that will have the biggest impact on the life science industry in 2019 is, according to Zenith’s Joe Haugh, the convergence of IT and automated shop floor services, which is being driven by the Industrial Internet of Things (IIoT) and Industry 4.0.
“The use of data is going to become increasingly important during the coming years. The industry currently collects data from a wide range of sources and there are a number of projects seeking to connect all of these sources so that companies can ultimately get the best out of the data they collect to make tangible business improvements.”