Digitalization, automation, artificial intelligence (AI), enhanced data analysis, and a growing trend toward more personalized products will be among the hottest pharmaceutical developments in 2019, according to industry experts.

Such modern trends may be common for most industries, but pharma traditionally has been slow to accept change, partly due to cost factors and largely due to regulatory requirements.

But in 2019, the pharmaceutical industry is facing a storm surge of challenges, including mounting pressure to reduce costs and lower prescription drug prices, continuing concerns over counterfeit products entering the supply chain, and a reevaluation of expensive research programs aimed at developing blockbuster drugs while placing increasing emphasis on smaller-scale targeted biologics.

Still unknown going into 2019 will be the full impact of the U.K.’s Brexit breakup on both the[SC1]  country and the rest of the European Union as companies scramble to adjust operations and avoid disruptions in pharmaceutical supplies. So far, indications are that plans to avoid problems are proceeding smoothly, but the real test will begin when the scheduled breakup occurs on March 29.

Another big unknown going into 2019 involves mandated track-and-trace serialization requirements as the EU’s Falsified Medicines Directive (FMD) February 9 deadline approaches and the U.S. government’s Drug Supply Chain Security Act (DSCSA) moves another step closer to full implementation. Word is that a variety of companies still are not ready to meet the serialization directives, especially in Europe.

Pharmaceutical Processing reached out to executives in the U.S. and Europe for their views on the major issues, challenges, and developments they expect to see in 2019. Participants included:

• Paul Cianciolo, Sr VP Business Solutions, TraceLink
• Julien Faury, VP Operations, Adents
• Erik Haeffler, VP Manufacturing Services, Recipharm
• Tom Kottler, CEO, HealthPrize Technologies LLC
• Bob Lenich, Global Life Sciences Director, Emerson
• John McCullough, Continuous Improvement Engineer, Sharp Services
• Evren Ozkaya, Founder and CEO, Supply Chain Wizard
• Anita Paz, Innovation Consultant, Tjoapack
• Daniel Tedham, Managing Director, Wasdell Manufacturing
• Tu Tran, VP Sales & Marketing, Pharma Tech Industries
• Ben Wylie, Senior Product Manager, ChargePoint Technology

The following are edited excerpts of their responses.

Q. What market trends in pharma do you see developing as we head into 2019?

Daniel Tedham: The pharmaceutical industry no longer is focused on mass production and a “one size fits all” approach. The drug pipeline now is more heavily devoted to developing novel treatments for rare diseases and meeting the demand for personalized medicine.

The pipeline for blockbusting treatments affecting high patient populations is not as prominent as it was 10 to 20 years ago, with the focus instead moving towards smaller volume biotech products.                                                               

Therefore, throughout 2019 I would expect to see further breakthroughs for rarer conditions. It also is likely that advances in technology for medicine administration will come hand in hand with this shift as each company continues to try to differentiate itself and patient experience from its competitors and add value.

Bob Lenich: Organizations are constantly growing both the number of new therapies they produce, and their manufacturing capacity. These changes are driving many new trends in the industry: including a push toward finding ways to begin incorporating core competencies of digital transformation.

There are several key strategies behind the drive toward digital transformation. First, many organizations are making the change from batch to continuous production, particularly in the newest therapies. We expect to see this transition continue, with many plants being built or converted to continuous use facilities over the next three to five years.

Pharmaceutical manufacturers have more options than ever before for speeding up technology transfer, which help new treatments come to market more quickly. Modular and scalable solutions for development in labs, clinical production, and commercial production are accelerating the development pipeline. These same manufacturers then add toolsets to automate change management, making it far more efficient to perform technology transfers.

One of the biggest opportunities is the growth of personalized medicine. As new gene therapies and CAR-T cell therapies gain traction, manufacturing must “scale out” to reflect a more people-based process rather than “scaling up” as organizations have done in the past. Going from bench scale to commercial scale with personalized therapies is creating a whole new world of possibilities and challenges.

Paul Cianciolo: Currently, many members of the global pharmaceutical supply chain are focused on preparing their internal systems, implementing new software solutions, and modifying business processes to meet the requirements of the EU FMD, the U.S. DSCSA, as well as other global track-and-trace initiatives.

Tremendous amounts of unit-level product data will be created, and for organizations that have invested appropriately in information technology (IT), the opportunity to transition this data into an information asset will deliver significant enterprise benefits in a variety of ways.

I’d expect the more transformative gains to be earned by the companies that leverage serialization requirements to build digital bridges between themselves and their network of direct and indirect trading partners, and ultimately out to patients who consume their products. The companies that effectively develop these new information sharing programs based on the digitalization wave created by serialization requirements will be the ones to capture the truly revolutionary benefits.

Ben Wylie: The pharmaceutical industry is seeing huge demand in oncological and immune-suppressant therapies, which is fueling the increase in drug manufacturing using high potency active pharmaceutical ingredients (HPAPIs). This has serious implications throughout the supply chain; however, the result is a growing need for manufacturers to look at more innovative containment strategies to meet high potency handling requirements.

Another key trend again has been due to demand increase. This time the need to process sterile potent compounds, such as sterile active pharmaceutical ingredients (APIs) powder and oncology drugs, have presented challenges to aseptic manufacturing. This is because these compounds require all the parameters for aseptic manufacturing, while also containing the process from an operator exposure perspective.

Julien Faury: Modern software companies rarely look past three- to five-year planning cycles due to the rapid change of technology and business requirements.

However, if we look at the current pace of change in automation, robotics, regulatory requirements, consumer demands for both information and transparency from the manufacturers of the products they purchase, and the manufacturer’s desire to both utilize data for marketing purposes as well as continued improvement processes, we begin to see an exponential increase in software’s role in pharma.

Q. What hot new technologies might we see entering the pharma market in 2019?

Bob Lenich: Many organizations are just beginning to embark on the digital transformation journey that will define how their plants operate for the coming decades. New technologies focus strongly on common pharmaceutical manufacturing challenges such as reliability, efficiency, documentation, and reporting.

One of the most exciting technologies that manufacturers are beginning to embrace is the use of simulation of equipment and unit operations using digital twin technology. Organizations now can create digital replicas of their operating environment. Using these digital twins, teams can leverage data from process design to improve operator training, while also helping to deliver operation improvements across the lifecycle of the plant. As use increases, these technologies also will take advantage of capabilities in both augmented and virtual reality.

Emerging technologies are helping forward-thinking organizations embrace the value of the new digital worker. We’re seeing much more adoption of mobile technologies in pharmaceutical manufacturing to allow users to stay connected to their processes and access the information those processes generate from anywhere at any time.

Daniel Tedham: Next year may be slightly too soon to see this come to fruition; however, printable electronics and how these are integrated into pharmaceutical products no doubt is going to come into use in the near future, meaning we likely will see companies explore this more in 2019.

Incorporating electronics into product packaging, as well as in the product itself, will give companies access to real-time information that has not been easily or accurately attainable in the past. Sensors could potentially be able to determine when a product is used, its storage conditions, ensure security by following its location, determine resupply requirements, and identify which market a product is being used in, something that is a really exciting prospect. 

John McCullough: In terms of hot new technology, the world is anxiously awaiting developments in AI, but despite general optimism, I don’t expect AI within even 10 years, let alone 2019. However, as a consequence of the immense R&D being performed in pursuit of AI, we are seeing breakthroughs in quantum computing. This is likely to yield huge benefits in the near future, allowing us to analyze colossal data sets in new, unexpected ways.

I also see opportunities for pharma in leveraging technology that already is in use in other industries. There are huge opportunities in incorporating software/technology that could streamline regulated processes that are, by today’s standards, slow and burdensome.

Julien Faury: Definitely blockchain technology, which already pervasively has impacted business and society.

Additionally, pharmaceutical companies are trying to keep pace with the various changes brought about by digital technology. The Cloud, advanced analytics, AI, and the IoT are among the innovations that are transforming both pharma and the healthcare industry in the same ways they already have transformed the media, retail, and banking industries.

Pharma executives are well aware of the disruptive potential and are experimenting with a wide range of digital initiatives.

Ben Wylie: Disposable technology is increasingly becoming a well-established system that offers a cost-effective and flexible process design for commercial production at biopharmaceutical facilities. Overall, the cost advantages and flexibility make this solution especially attractive as an alternative process capability.

Q. Much attention is being paid today on gathering and analyzing data. How is that being used in pharma and will we see major developments in that direction in 2019?

Tu Tran: Data driven decision making will only get deeper as our systems and tools become increasingly ubiquitous and sophisticated equalizing the playing field regarding access, and enabling all decision makers to finitely quantify events with metrics that ultimately serve to clearly dissect and differentiate alternatives—replacing subjectivity with objectivity and thereby enabling more insightful and rapid decision making. 

This trend is apparent in all fields from sports to pharma. Despite their obvious differences, both gather and analyze data to validate quality [to confirm that current SOPs work], identify gaps [to understand what/where variances exist], and illuminate insights [to set forth a path for continuous improvement]—which also then can be measured to quantify progress. Ultimately, progress manifests itself in higher quality, reduced waste, faster delivery, and lower cost.

Bob Lenich: Data is no longer just a byproduct; it is the new currency. Organizations must be able to collect data and put it in context for use in production decision support, real-time product release, and better handling of variability. This need for data capture and contextualization means manufacturers are seeing exceptional benefit in the availability of automated documentation and reporting.

Anita Paz: Over the last couple of years, we’ve seen a growing industry interest into how gathering and analyzing data could help make improvements to supply chain operations.

By generating very big databases, recent developments such as serialization have created a huge opportunity for the pharmaceutical supply chain. In order to digest the gathered data and generate insights, smarter forms of analysis are required—this is where machine learning already plays an important part.

However, while big data is made available for the track-and-trace of the medicine, data pools associated with internal operations, manufacturing lines, and quality controls remain limited in size. As pressure to reduce costs, maintain standards, and improve efficiencies continues to increase in 2019, it is small data-driven machine learning that will become more important.

Q. The serialization move is well underway in both the U.S. and Europe. Would you say it’s on schedule, or is a large portion of the pharma industry struggling to meet the requirements?

Julien Faury: In talking to colleagues, we are finding that even with the radical enforcement set to be in place in the EU in 2019, companies are struggling to keep up. Regulatory requirements constantly are evolving per country, while in the U.S. most companies are either already compliant or will be ready by the deadline. 

It seems that we (in the U.S.) are running a marathon but, in the EU, they are running a sprint while still working toward developing more innovation solutions, without much guidance.

Evren Ozkaya: The struggle is real both in the U.S. and EU; 100 percent readiness seems not possible for the EU. While the situation is much better in the U.S. due to the one-year enforcement delay, smaller companies still are struggling to fill their compliance gaps.

“Project mode” is not going to be over at least for another year or two for both regions due to longer than expected project closures, process refinements, postponed go-live targets (with the help of buffer stock).

Finally, the serialization system and process support teams and organizations need to be built in most of the companies, which is required to sustain the compliance continuously. 

Erik Haeffler: The deadline for serialization compliance (in the EU) is fast approaching. Three months is a very short period of time given the scale of the changes that are required to implement a suitable solution. Ideally, contract manufacturing organizations (CMOs) will now have finished testing and validating solutions in order to maintain a continuous supply.

However, for some this is not the case and those that have not completed preparations need to move very quickly to avoid a halt in production while they finalize implementation.

Companies that have been slow in their preparations will need to abandon the idea of customization and stick to standardized solutions.

Q: Are there any other trends that you see developing over the next year?

John McCullough: The pharma industry has been extremely risk-averse. The focus usually has been minimizing risk instead of maximizing performance and patient experience. I think we are starting to see some organizations making efforts to shift the paradigm. Out of the organizations that successfully navigate that culture change, I’m excited to see how they perform within the industry and expect them to do well.

Tom Kottler: We know that increased adherence improves patient outcomes and decreases overall healthcare costs. Now, according to an investor’s note from Credit Suisse analysts focusing on seven large-cap companies, we also know that adherence improvements can increase pharma’s earnings per share (EPS).

According to the analysis, at-scale adherence programs are estimated to positively impact EPS for every single year from 2020 to 2026, with the highest degree of growth occurring with Lilly at 29.5 percent in 2026. Because adherence remains pharma’s greatest source of revenue loss and potential, we believe 2019 will be the year pharma finally addresses adherence at scale and with executive support. 

Paul Cianciolo: Ultimately, I envision a new ecosystem of supply chain partners who, in conjunction with the patients they serve, have a new opportunity beginning in 2019 to participate in a global, digital supply network that enables participants to opt in to share information in a variety of ways, based on incredible new business and value-exchange models. This information exchange will be the fundamental driver of increased product safety, empowered patients, and a more effective and efficient global medicine supply chain.
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This story also can be found in the November/December 2018 issue of  Pharmaceutical Processing.

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