Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Chris Spivey

January lends us a default perspective looking back while also forwards. In doing so, we might better see the big picture and what this offers in terms of setting goals and aligning resources. Warren Buffet is almost as famous for suggesting methods to focus priorities, as he is for having sacks of money lying around. Almost. The best place to start looking is what worked last year.

Humira will be the top selling drug in 2021 with around $20 billion in sales, followed by Keytruda at nearly $17 billion, then Revlimid a little under $13 billion, with the rest of the best all coming in around $8 billion—Eliquis, Eylea, Opdivo, Stelara, Biktarvy, Imbruvica, and Xarelto—all household names, if they were not so challenging to pronounce (1). What stands out is the rising complexity and technical bravery of the research and development that went into making these drugs effective and accepted.

Pharmaceutical sophistication has advanced in lockstep with the startling discoveries of the golden biotech era. While working in-the-trenches, it makes sense to intellectually understand how a therapeutic antibody might block a PD 1 receptor, or why a ubiquitin E3 ligase (a kissing cousin of thalidomide) induces tumor cell apoptosis. What requires end-of-year clarity to comprehend is that we are entering at long last an era when we can, shockingly, use the word cancer and the word cure, in the same sentence. This key obvious trend, becoming an imperative in the financial accounting of industry performance, has been somewhat obscured by the limelight stealing COVID-19 vaccines, pills, and rapid tests.

This takes nothing away from pandemic success stories. It does not diminish the salutary effects of increased and improved communications skills across the board. It will have occurred to some of our more alert readers that vaccine and therapeutics sales during 2021 will have dramatically changed the picture of who came out on top in the sales of drugs this year. But that’s precisely the point—those large numbers for COVID-19 vaccines and treatments hide the importance of ongoing progress toward multiple other cures. Pandemic discussion has taken the oxygen out of the room for everyone else. January is the kind of month that can make your head spin.

Statista, Projected Top 10 Global Pharmaceutical Products by Sales in 2026, 

Chris Spivey is the Editorial Director at 

When referring to this article, please cite it as C. Spivey, “January Makes Your Head Spin,” 

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January is the kind of month that can make your head spin.

January Makes Your Head Spin

We have been living through a period where institutions and rules are being questioned. I am proud to work in an industry where colleagues, rules, and institutions have stood up well through this conversation. Some rules were deliberately broken, some barriers reduced. One concrete example comes from FDA guidance documents on abbreviated new drug applications where bioequivalence studies for generic drugs resupply with expired batches were deemed permissible “as long as sufficient evidence can be provided to demonstrate the acceptability of the test product batch” (1). Supply chain contingencies immediately transformed from an abstract concept to a concrete process for most of us.

Regarding investments in technology, a survey from Zebra Technologies reported that 86% of patients agree that increased technology spending would provide a competitive edge in managing pharmaceutical supply chain stability, security, and traceability (2). That number rises to 92% when answered by industry decision makers. Of these decision makers, 96% then consider supply chain visibility confers on them a competitive advantage. Key areas targeted for future spending for these decision makers are location technology, temperature monitor and sensors, temperature sensitive labels, prescriptive analytics, and machine learning. The findings continue, stating, “compliance remains an issue for the pharmaceutical industry. About one third of industry decision makers surveyed rank compliance among the top five challenges facing their industry today. Among the pharmaceutical industry verticals, manufacturing experiences the most significant lag in compliance.” Institutions and rules held up well during this time of emergency. We have learned what areas of our manufacturing supply chain held up, while also learning which areas we need to strengthen.

While not everything went smoothly over the past two years, we have manufactured great outcomes from alarming adversity. Nearly eight billion doses of COVID-19 vaccines have now been administered (3). We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.

Development of Abbreviated New Drug Applications During the COVID-19 Pandemic—Questions and Answers, Guidance for Industry

Pharmaceutical Supply Chain Vision Study: Technology-led Transparency Drives Resiliency

Bloomberg, “More than 7.84 Billion Shots Given: COVID-19 Tracker,” Vaccine Tracker, Last Updated Nov. 25, 2021.


Volume 45, Number 12
December 2021
Page: 10

When referring to this article, please cite it as C. Spivey, “Breaking the Rules,” 

We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.

Breaking the Rules

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part four, 

serialization from a regulatory perspective

Watch part 1: serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective 

Watch part 3: serialization from a software perspective

With the aggregation considerations for the US Drug Supply Chain Security Act (DSCSA) on the horizon and uncertainties about authentication of medicines in a post-Brexit Europe, questions about compliance—and the security of the drug supply—are at the forefront.

In this discussion, global supply chain experts examine implications of the DSCSA (specifically serialization and aggregation) and topical considerations around the European Union’s (EU) Falsified Medicines Directive (FMD). 

As the aggregation considerations for the DSCSA approaches, what do companies across the bio/pharmaceutical supply chain need to tackle now, and what can they expect going forward? 

Within Europe, compliance with the delegated EU FMD regulation has been required since 2019. However, implementation of the delegated regulation has not been smooth sailing. In what position has Brexit left stakeholders with regards to medicines authentication? Has it been/might it be necessary to further update manufacturing and packaging lines to accommodate variances in regulations?

Experts from across the global supply chain will provide insight and answers to these questions.

 is the vice president of community engagement at GS1 US. GS1 is a not-for-profit organization that develops and maintains global standards for business communication. Angela is responsible for driving broader adoption of GS1 Standards to help industries achieve their goals for improved traceability, information transparency, and data quality.

 leads the GS1 Healthcare Global Public Policy Work Team, which has the mission to interact with decision-makers globally and to provide strategic leadership on the use of GS1 standards in the healthcare sector.

Watch other videos in this keynote series

Equipment Trends in Advanced Solid-Dosage Drug Manufacturing

Advances in Molecule Characterization and Biomanufacturing for Emerging Therapies

Global supply chain experts examine implications of the DSCSA as well as topical considerations around the EU's FMD in this serialization video series ft. manufacturing, packaging, software, and regulatory experts.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Regulatory | Part 4

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part three of four, 

serialization from a software and data management perspective

Watch part 4: serialization from a regulatory perspective 

 is the CEO of advanco, provider for Level 3 and Level 4 Item Level Serialization. Alf has more than 25 years of enterprise software industry experience. He has strong operational experience, specializing in high-growth businesses in Europe and the United States.

 is the president and CEO of Covectra, a leader in track and trace solutions. Steve has more than 30 years of experience in international business development and program management.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Software and Data Management | Part 3

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part two of four, 

serialization from a packaging perspective

Watch part 4: serialization from a regulatory perspective

 is a technical services manager at Sharp, a provider of pharmaceutical contract packaging services. In her role, Lauren is responsible for supporting the development, documentation, implementation, and enhancement of Sharp’s serialization services platform.

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD – Packaging | Part 2

Serialization on a Global Scale: Deep Dive into the US DSCSA and EU FMD was part of a keynote series at INTERPHEX 2021. This is part one of four, 

serialization from a manufacturing perspective

Watch part 2: serialization from a packaging perspective

 is a senior manager (packaging engineering) and serialization program lead with Thermo Fisher Scientific’s Pharma Services, a contract development and manufacturing organization. David has 25 years of experience in the pharma industry, including manufacturing, validation, packaging, engineering, and serialization.

 is an engineering project manager for Catalent Biologics, a contract development and manufacturing organization. Rebecca has more than 13 years of experience in the pharmaceutical industry and project management. Rebecca is responsible for managing the design, implementation, and qualification of large capital projects within the biologics business.

 is the director of corporate projects at Recipharm, a contract development and manufacturing organization. Staffan has between June 2015 and April 2019 acted as program manager for the Recipharm global serialization project and part of a global steering committee that is working closely with Recipharm’s clients to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialization.