Serialization and drug prices remain the top issues for executives up and down the pharmaceutical pipeline in 2018.
Although the U.S. Food and Drug Administration (FDA) has issued a one-year delay for enforcing the first-phase of Drug Supply Chain Security Act (DSCSA) requirements, companies, especially those that were well behind in their plans to meet the new rules, may still be facing an uphill climb.
The FDA waived the penalty phase, but the regulations still take effect on Nov. 27, and most in the industry concede that a further enforcement delay is likely off the table.
Along with preparing for these regulatory hurdles, serialization remains a hot topic in 2018. Pharmaceutical companies will also be concentrating on ways to bring down drug prices, calls for more rapid approvals of generic drugs and biosimilars; improving data collection, analysis, and connectivity across the supply chain; increasing the use of automation; keeping up with an explosion of new technologies; and, ultimately, the ongoing commitment to deliver better patient outcomes.
Pharmaceutical Processing recently reached out to several industry professionals and asked for their thoughts on the key pharmaceutical trends heading into 2018. Here’s what they had to say:
Where does the serialization effort stand today and what hurdles still need to be addressed in the coming year?
Brian Daleiden, VP, Industry Marketing, TraceLink: The industry has made great strides given all the complexity, scale, and scope of challenges in meeting the initial DSCSA serialization requirements. In 2018, I think that some companies will still be refining their serialization processes, the implementation of their full systems, etc. as well as accelerating their work with supply chain partners to meet the next steps in the 2017–2020 phase, especially around saleable returns, verification, and other operational processes where the exchange of serialization data and related queries about that data are necessary.
The industry will be deeply involved in testing out platforms for verification and methodologies using GS1 standards for data exchange at scale. Additionally, 2018 is the year where industry conversations around the value-added use of serialization and transactional data will be coming more to the forefront as companies now have an infrastructure in place and start to get real world experience in managing serialized product in the supply chain flow.
Carlos Machado, Serialization Director, SEA Vision US: With the deadline for the DSCSA being extended to 2018 due to lack of readiness in the industry, it is clear there is still a long way to go for many companies to ensure compliance. In particular, smaller and mid-sized players with limited resources to devote to the serialization challenge should turn to third-party implementation partners to map out and oversee their serialization programs.
Perhaps the biggest hurdle to address during 2018 is supply chain partner connectivity — as well as equipping packaging lines to enable the printing of barcodes on drug products, there should also be a system in place to facilitate the exchange of data between partners. Only then can we achieve the end-to-end visibility that is needed to secure the supply chain and protect against counterfeit medicines.
Mark Quick, VP, Corporate Development, Recipharm: There has been much discussion regarding the lack of readiness for the European Falsified Medicines Directive (FMD) across the pharmaceutical supply chain generally. Contract manufacturing organizations (CMOs) in particular have been cited as being behind in their preparations for the February 2019 deadline. This is extremely concerning given the number of pharmaceutical companies that rely on their CMOs for continuity of supply of medicines in Europe.
It is Recipharm’s view that CMOs have a responsibility to their customers and should in fact be a solution to the serialization challenge, especially for those smaller companies that will struggle to comply alone due to the cost and time burdens. The exchange of data across the supply chain is one of the biggest challenges of serialization, and this hurdle certainly needs to be addressed by many during 2018.
There has been a great deal of focus on bringing down drug prices. What are manufacturers, distributors, and others in the supply chain doing to build efficiencies and contain internal costs to help meet the challenge?
Luis Oquiñena, General Manager, Idifarma: The manufacturers in the supply chain are working intensely to improve and optimize the processes in each area. The application of methods such as lean manufacturing, widely used in other sectors with higher degrees of competition, is another trend in an industry that has traditionally been very conservative in the adoption of new methodologies. Also, better procurement management, which is ‘forcing’ suppliers to look for higher efficiencies, is helping to meet the challenge.
Dexter Tjoa, Director of Corporate Strategy, Tjoapack: Cost is a big concern for the healthcare industry as a whole and pharmaceutical companies have faced downward price pressures from governments for some time now. These pressures have been enhanced by the new serialization regulations as implementing a solution that’s capable of tackling the regulations of multiple markets requires a substantial upfront investment.
Working out who will pay for serialization requirements is likely to have a huge impact on small and mid-sized businesses. For example many smaller companies simply cannot afford the upfront costs and are having to outsource, or face withdrawing from key markets.
However, despite the cost of serialization, companies should look beyond the initial investment, as the long-term benefits could help to generate cost savings for the whole supply chain. The end-to-end visibility that track and trace can offer could help to improve demand forecasting and in turn reduce inventory levels, which could save the industry billions.
It is also likely that we will see more innovative packaging solutions being introduced as a bi-product of serialization, such as postponement or late-stage customization packaging.
Will drug price pressures likely lead to faster medicine approvals by the FDA and EMA, especially in biosimilars and generic drugs?
Quick: I’m not so sure. There is clearly a strong focus on patient safety and I cannot see the regulators compromising on this. There is scope to improve the way in which they process things, which may lead to improved timeliness.
Oquiñena: Public health systems, and ‘payers’ in general are actively looking for a higher competitiveness in the industry. This competitiveness is increased by making the evaluation and approval of generic drugs faster. The increased competition will continue to generate more mergers and acquisitions, but also create a higher dynamism in the development process for new drugs, in which a higher efficiency and reduction of timelines will also be important targets in order to take advantage of shorter times for regulatory evaluation, authorization, and commercial launch.
Will 2018 bring even more emphasis on better data collection and analysis? Are there any specific strategies in that regard on the horizon?
Daniel Chapple, Executive VP and Chief Commercial Officer, Quanticate: Getting the most out of data continues to be a focus across the pharmaceutical industry and this will no doubt continue into 2018. From a statistical perspective, we believe there will be a focus on the use of estimands in clinical trials, which will essentially allow companies to estimate what a missing data value would be. The ICH E9 regulations focused on statistical approaches is currently in consultation but the aim is to be able to utilize all subjects even when data is missing through the use of estimands. This is an example of maximizing the amount of data points in order to make optimal decisions at the earliest stage.
James O’Brien, Global MES Business Unit Lead, Zenith Technologies: Data collection technology has been around for a long time, but how do you really understand if your data is accurate; and how do you actually make use of it to deliver on the promises of Big Data — this is the challenge companies face today. Technology advancements such as MES & Data Historians may collect data, but companies that don’t focus on the integrity of the data, as well as how to best make use of what is collected, will be left out in the cold.
First, it is about establishing the accuracy of the data collected, what you are using your data for, what your data tells you, and how to use it to deliver process knowledge and business intel. Furthermore, this explosion of new and repurposed data analytical tools give context to the data collected. Once operators understand what is business and operationally critical these tools can be used to drive further performance improvements.
What are some of the other significant trends developing in the pharmaceutical sector as we head into 2018?
Daleiden: A close look at patient outcomes and any ability to leverage the new connectivity and information being generated by track and trace investments will drive future initiatives in the sector. We are witnessing more indications and specificity in medicines and more routes through the supply chain, which increases complexity and makes it harder to know if you’re producing the right product, in the right place, and meeting demand.
True innovation and creativity in the supply chain isn’t really going to take off until serialization becomes part of business as usual and companies can leverage the availability of serialization data. Only then can business and commercial owners start to think about this in their terms.
Will other trends in 2018 involve personalized medicine, wearables, patches, or telemedicine?
Chapple: Real world data collection offers a lot of benefits to both pharmaceutical companies and patients. What works in one patient may not work as well in another and gaining concrete insight is of key importance in offering guidance to prescribing physicians.
Gaining access to this data will be a continued focus in 2018 and the use of wearables provides an easy and non-biased way for patients to collect data 24 hours a day. This will generate huge amount of data so it is likely we will see this become a focus moving forward when it comes to collecting and analyzing the necessary data efficiently.
Tjoa: It is likely we’ll see the use of wearables continue to gain prominence. As this type of technology becomes more widely used, the industry will be able to utilize the huge amounts of health data generated in order to monitor things such as patient adherence and the effect of drugs on the user.
The level of data generated as a result of both serialization and wearables is also driving companies to look for more effective ways to store and manage the huge amounts of data being generated. As such it is likely we will see companies continue to explore the benefits of blockchain use cases to create a more efficient and connected supply chain.
Filed Under: Drug Discovery