Greg Cathcart, CEO, Excellis Health Solutions
One of the key focus areas of the event is to discuss how, now that compliance deadlines have passed in Europe and the US, digitalised supply chains can realise the business and operational value inherent in serialised data.
Dr Kevin Robinson (KSR) spoke to a number of TraceLink’s partners and asked what initiatives they and their customers are exploring and ... what they think the future holds for serialisation.
KSR: Are you now involved in exploring business or value-based initiatives based on serialisation? What are they and, if not yet, what do the next 1–3 years look like?
Cathcart: Excellis has a three-phase approach to support our customers in the extended pharma supply chain space. We consult and build a strategy, implement compliant solutions and then provide support using our service bureau team to maintain the solutions for our customers on a global basis.
We work with manufacturers, wholesalers and hospitals/dispensers; and, in each segment, we’re working on a number of value initiatives covering issues such as product security and improving patient outcomes. One area that’s of particular interest is using serialised data to better inform cost-driven analyses to support outcome-based pricing in the US; payors/hospitals want to know which treatments offer better patient outcomes and are more cost-effective in the longer-term.
To deliver this insight, manufacturers are starting to collaborate with clinics and hospitals to track outcomes … and serialised data is the communication channel that will help them find and analyse this information. Ultimately, we want to bring all members of the healthcare ecosystem together and encourage dialogue so that everyone can develop smarter approaches to the industry’s challenges; serialisation technology is the springboard to future opportunity.
Avraham: We are exploring a number of initiatives; however, the one that is generating the most interest, and that we believe has the most potential, is supply chain solutions. We are currently working with one company to investigate how serialised data can be used to improve supply and demand logistics and warehousing.
Zeeshan: We are working on a few things and exploring the opportunities that serialised data presents. I believe it’s important that everyone looks at data and asks new questions about what we can do with it. Our focus is helping brand owners to access and use data to optimise supply chains.
Shlomi Avraham, CEO and Owner, ProTechTiv
At CosmoTrace, we’re looking at supply chain optimisation and using data to ensure that supply chains are more comprehensively understood — and that data can help to inform inventory planning and supply and demand. We’re also looking at how digital recalls could improve the drug recall process.
KSR: Is your organisation exploring or delivering other digitalisation programmes? What are they and why?
Cathcart: We have multiple ongoing programmes with clients. One pharmacy group in the US is looking at scanning products when they are inbound, stored, dispensed or discarded, and selling this sales data back to manufacturers. This kind of data is invaluable to manufacturers who want to create end-to-end supply chain visibility and use the insights to inform supply chain planning and reduce inventory whenever possible.
Zeeshan: Digitisation is vital. Serialisation generates huge amounts of data and we need the tools to better analyse and interpret it. The challenge is finding ways to use big data effectively and to ensure businesses throughout the supply chain collaborate on the creation and delivery of these tools.
Apps are key. A mobile tracking solution that allows supply chain leaders to gain full visibility of all their products is a must. At CosmoTrace, we’re looking at different “buckets” of information and how each can be used to create value for everyone … from patient to manufacturer.
KSR: What do you believe the future holds for serialisation?
Dossou Sognon: Tracking and tracing goods, especially sensitive ones, is definitely the future for all industries. Serialisation will soon be required in most markets across the world with the support of local regulations. A worldwide approach and network platforms that enable digital information sharing and collaboration — such as the one TraceLink’s Life Sciences Cloud displays — is the future of serialisation and the core of other opportunities resulting from the data that will emerge from these regulations.
Zeeshan Ahmed, Founder and CEO, CosmoTrace
Avraham: The next stage in the evolution of serialisation will focus purely on digitalising an end-to-end supply chain. Businesses will be tracking products in pharmacies and hospitals all the way to the end user (doctors and patients), who will be able to engage with the product tracking information more and scan the products themselves to be better informed about the history of the medicines they are taking. As well as preventing the distribution of fake drugs into the market, patient engagement will be one of the most important aspects of a serialised supply chain.
KSR: Do you think that future changes to existing regulations (such as the FMD and DSCSA) are likely? What would these changes look like and how should companies factor this into their planning?
Dossou Sognon: Changes to regulations are inevitable. The only remaining question is when? As this is highly unpredictable, the best approach is to design organisational structures, processes and production tools to be as flexible as possible. Agility is the key quality to easily accommodate and factor in these coming changes.
Cathcart: The world will be serialised in the next 10 years. That train has left the station! Every country will mandate for track and trace in one way or another. The FDA and EMA will also continue to tweak laws as we learn more about serialisation processes … but all change will be for the better with the aim of delivering a more secure supply chain.
Take the 2023 DSCSA deadline as an example. The initial guidance from FDA was very open, but it will begin to offer more definition regarding what is required, allowing suppliers to comply with tighter tolerances as we get closer to the date.
Francis Dossou Sognon, Cofounder, Acumen Network
Avraham: There is no doubt that the legislation will change. The initial requirements were about serialising an individual (saleable) unit but, eventually, aggregation will become a legal requirement for all regulations, including the FMD. It offers huge logistical benefits and a number of pharma businesses and wholesalers already require it because of the business benefits; a number of businesses in Israel are already demanding it. Russian compliance is also a very big challenge in Israel; a number of level 1–3 suppliers are struggling with the requirements and, as it stands, it seems that not many companies will be ready for the January 2020 deadline.
Zeeshan: Serialisation will be a mandatory requirement everywhere in the world, sooner or later, and I feel that that should be the case; for me, it’s less of a compliance matter and more about patient safety. Aggregation is key. Although it’s included in the DSCSA, it isn’t part of the FMD … but I predict it will be.
However, whether a regulation requires it or not is almost irrelevant, as the top three wholesalers in the US are demanding aggregation as it enhances efficiency. Companies should start planning for aggregation as soon as possible, whether it’s mandated or not, as wholesalers will start rejecting non-aggregated product at some point.
There are also new regulations on the horizon, such as those in Russia. For companies that need to comply, the lesson from FMD and DSCSA is to get moving early — organisations waiting until the last minute caused a lot of problems as the demand for compliant solutions quickly outpaced the capacity of vendors to supply them.
It’s also important to allow a few months for validation and to ensure compliance before the deadline. Post-implementation, it’s vital that businesses think about ongoing IT and engineering support as it is needed to maintain the continuity of their serialisation processes.
