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

Chris Spivey

The start of a new year always brings energy and ideas. In January, we smashed the champagne bottle of good fortune on our first podcast series (called “Drug Solutions”), our first video interview series (called “Drug Digest”), and a new e-newsletter for our sister publication, 

 (named “BP Elements”). Turns out much of the energy and fresh ideas in 2022 are coming in the form of outside expert interviews. I don’t know if this exactly qualifies as outsourcing our thinking, but as part of our response to the pandemic, that’s perhaps not a bad way to look at it.

Great lessons over the past two years include better ways to learn from others, and to communicate more fully and with tighter focus. Our new vehicles enable easy engagement to experts and ways to form supporting networks in a durable manner. I was mildly interested in oral recombinant vaccine manufacture until I heard the company founder presenting clinical trial highlights alongside the technical explanations of how this platform can be pointed successfully toward a surpassingly wide range of difficult to control and treat infections. Now I follow the field with genuine zeal.

Having these videos and podcasts out in the real world has already provided quite unexpected feedback and comment. Multiple new contacts have spent time to offer novel topics or have asked us to question why we chose a certain approach to a particular field. This kind of interaction is always to be welcomed, especially if we recall lord Reith (founder of the BCC in 1922) said saeva indignatio was not to be had for the mere asking. It was Reith who famously set the mission of broadcasting as being to inform, educate, and entertain.

As we fill out the schedule of topics, personalities, and priorities for these new formats, the terrain seems alive with possibilities. The process of reshaping inevitably leads to fresh insights, even though we have been planning and preparing over most of last year. Good things take time it seems, but time taken repays efforts at the finish line, at the packaging center, and at the sales meeting. In an industry revved up by the need to move quickly, usable information and thoughtful perspective must be distilled and enlivened—just like champagne!


Volume 46, Number 2
February 2022
Page: 10

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

Articles

The process of reshaping inevitably leads to fresh insights.

Celebrate the New

In pharmaceutical science several divergent paths typically exhibit clear validity. Decisions often boil down to embracing instead of eschewing risk, to accelerate as the only priority, or to trust a partner rather than emphasize self-reliance. Each molecule, each company or research group possessing that molecule, has an assortment of strengths and weakness to guard against or to leverage. Multiple factors weigh in the balance when deciding how best to move forward, and increasingly the route chosen is to outsource research, development, and manufacturing.

The global contract development and manufacturing organization (CDMO) industry, averaging across several market research firm estimates, is currently valued around $100 billion (1). In part, this growth is shaped through direct regulatory influences suggesting, if not demanding, that a drug have multiple sites of manufacture to spread the risk for supply chain planning. Above regulations, companies also seek to reduce the complexity of their operations internally, and to reallocate internal resources most effectively.

According to Hanns-Christian Mahler, CEO and board member of ten23 health—a new CDMO that offers development, manufacturing, and testing services for injectables—there are a variety of reasons as to why demand for outsourced services of technical R&D activities is increasing. “[Reasons] include a potential lack of internal asset(s) for a given technology and/or specific requirement,” he says. “For example, the building and operating costs of a sterile fill/finish facility are significant. If a pharma company would not have sufficient molecules in a portfolio that would benefit from being manufactured in that facility, the costs could be quite prohibitive, and outsourcing is surely much more cost efficient.”

There could also be instances where a pharma or biotech company has an asset but does not necessarily have the required technology or features, Mahler continues. For smaller companies, in particular, he adds, there may not be internal knowledge or industry and scientific expertise available. “Hence, specialized providers, such as ten23 health, may provide significant advantages for [such companies], contributing to faster development timelines whilst minimizing and derisking any R&D obstacles that can be anticipated by the Experts,” Mahler states. “Finally, even in existence of internal assets and internal experts, there may be insufficient capacity in house.”

Focusing somewhat on internal capacities and the fact that the outside economic environment is encouraging. Ramesh Subramanian, chief commercial officer, Aragen, believes it is a buoyant time for R&D outsourcing at the moment. He specifies that this buoyancy can be attributed primarily to three reasons, “increased fund flowing into [the R&D outsourcing] space, a high number of targets in the pipeline, and renewed interest in pharma R&D due to the COVID-19 pandemic.”

“In fact, as a direct consequence of this better funding environment, we are seeing increasing number of biotechs pursuing their research programs with renewed vigour,” Subramanian adds. “In the past, those companies that were quite conservative in advancing their discovery programs are now focusing on advancing their assets quickly through the development continuum to reach the proof-of-concept milestone. With this shift, we see more biotechs approaching us for more end-to-end integrated solution offerings, from discovery through to Phase IIb—where their assets get them better valuations. Venture capitalists are also open to a longer-term view on development and willing to take risks for such potential upsides from valuation of successful programs. For Big Pharma, outsourcing of all but core activity is the de rigour approach to achieve fastest development timelines.”

Sy Pretorius, MD, president, Clinical Development, and chief medical officer at Parexel, points to the need to focus on and build a lasting relationship when partnering. “To meet complex industry challenges, successful outsourcing partnerships are essential,” he asserts. “This is necessitated by increasing pressures to reduce the cost of drug development and to bring therapies to market sooner. Rather than purely transactional in nature, these partnerships should be truly collaborative. Strong relationships can foster innovation beyond contractual obligations and typically leads to higher levels of staff engagement and better quality. The reason for continued demand for outsourced services can be attributed to a variety of factors including a burgeoning drug pipeline, record levels of funding, lack of in-house resources or expertise, and increased operational complexities.”

“Outsourcing happens in many different shades,” notes Mahler. “Outsourcing can include full technical programs including drug substance and drug product, it can include only specific studies. It could be only for early-stages of a program or the opposite, just for the commercialization stage. In the end, the outsourcing model needs to fit to the needs of the pharma and biotech company, their own expertise and knowledge base and their preference on either working with the most qualified outsourcing partners for specific studies, versus the preference on working with just one partner.”

Subramanian reflects that the focus of Big Pharma has now shifted to ensure they can retain their core activities in-house. “[Big Pharma’s] definition of core has become a lot smaller as they look to CDMOs to be their R&D engines. We are seeing these emerging trends in R&D outsourcing,” he says. “Pharma/biotechs are looking for more integrated discovery service offerings to leverage on the efficiencies and synergies of chemistry and biology offerings from one service provider/co-location of these capabilities. In the outsourcing of development services, pharma/biotech companies still prefer to have the final drug substance being manufactured closer to their locations in the United States/European Union. Given the greater demand for access to capacities, a large number of these biotechs leverage the capacities/expertise available in Asia to execute the initial steps and the final steps in US/EU.”

The range of relationships is large, encompassing full-service outsourcing (FSO) to functional provider (FSP) type arrangements, Pretorius states. “Likewise, these [relationships] range from tactical/per study outsourcing to more strategic programmatic outsourcing,” he notes. “Landing on the right outsourcing model requires an assessment of each individual organization’s needs. Functional service provision continues to be a core outsourcing model allowing the vendor to provide embedded teams that support sponsors for specific services and work directly with their client’s systems and infrastructure. In other instances, a hybrid, more limited scope might work best”.

Pretorius observes that the pandemic forced industry to reexamine how research studies are designed and conducted, while also demanding record-breaking speed of innovation. “As a result, digital medicine was embraced in ways never seen previously. Decentralized clinical trials (DCTs) became embedded in the overall clinical development ecosystem and part of the new norm in how we operate,” he emphasizes. “At Parexel, DCTs are now being woven into 80% of Phase II/III trials and 100% of real-world evidence new trial proposals include DCT elements.”

However, Pretorius cautions this movement is not without obstacle. “A challenge is the lack of industry-wide data standards and how best to manage more and more data from disparate and diverse sources across multiple platforms while ensuring quality,” he says.

Mahler adds that downstream manufacturing and the supply chain were affected by the pandemic. “The significant demand in vaccine manufacture also led to significant demand in primary packaging and disposables,” he stresses. “This has an impact on the globally available outsourcing capacity for any kind of (sterile) product development and manufacturing, which certainly has become smaller given the capacity need for vaccine manufacturing, and the shortage in supplies of raw materials poses some specific challenges and risks for supply chain planning and inventory.”

When contemplating the pandemic, Subramanian specifies that, on a global scale there has been an obvious impact on resources, with CDMOs required to prioritize COVID-19 targets and vaccines—an aspect that will continue onto the future as new variants of the virus continue to develop. “Geo-diversity has also been on the rise, and if innovators are too reliant on China, Europe, or India, they will look to rebalancing their spread. However, the net result is that India has been the biggest beneficiary—as there was more reliance on China previously,” he says.

“The other interesting impact of COVID-19 has been the development further down the chain from the messenger RNA (mRNA) vaccines,” Subramanian continues. “So, there is much greater interest now in areas like oligonucleotide discovery and development, and even peptides—areas that Aragen is investing in due to increasing demand. In terms of mRNA vaccines, we are also seeing innovators look for smaller aspects of its production from lipids to linkers—basically they look for anything that can increase speed and deliver customer value.”

Looking beyond the pandemic, Subramanian expects that industry will see a continuation in oncology as a leading therapeutic area of interest, although he adds that there has also been a rapid uptick in demand for central nervous system (CNS) targets. “Almost all Big Pharma is involved in oncology, so on the development side, we see a similar make up in CDMOs and of course in technologies like HP,” he says. “CNS is interesting, as there have been several high-profile failures. So, innovators are looking for partners to advance several candidates simultaneously to increase their chances of success.”

For Mahler, other potential trends that will likely impact outsourcing of R&D services are the diverse therapeutic modalities and APIs being investigated. “For example, in the category of therapeutic proteins, we see increasingly complex formats,” he says. “We also see a huge variety of indications and administration routes, including the challenging intravitreal and subcutaneously administered products.”

Additionally, the trend for self-administration is broadening out to areas such as oncology, where devices are typically required (i.e., an increasing trend towards drug/device combination products), Mahler notes. “Of course, these [trends] bring specific challenges related to the product design, manufacture, and testing,” he adds.

Pretorius returns focus to DCTs. “Given the rapid speed of adoption and the evolving vendor and regulatory landscape, [contract research organizations] CROs are particularly well-placed to deploy DCT strategies because of the breadth of experience obtained across multiple sponsors,” he empathizes. “Some CROs have been active in the space for more than a decade enabling them to leverage significant learnings and expertise.”

Looking toward another burgeoning area, cell and gene therapy, Pretorius lauds the availability of new technologies, which are allowing industry to see the potential of such innovative therapies. “For patients, [cell and gene therapy] provides promising options with potentially less toxicity,” he says. “We are seeing significant interest and investment in this area beyond treatment for oncology.”

As parting thoughts, Mahler expresses his belief that “outsourcing and the development and commercialization of medicines in general should be more a ‘system thinking’ approach. Companies or outsourcing services may be getting so specific about one given part of the product, that the interconnectivity and dependency of all the components of a drug product are being forgotten: a sterile product can only be reliably and reproducibly manufactured if the formulation, primary packaging, and processing parameters are wisely chosen in its entity.”

Furthermore, Mahler stresses the importance of focusing on ‘people’—patients and employees—as well as the planet. “We, at ten23 health, hence embed considerations of fairness and sustainability in all we do. There is only one Planet,” he adds.

Pretorius also points to the larger operating system, observing that outsourcing can also prove beneficial in the area of regulatory operations through aiding with submissions, product registration, tracking agency interactions, and so on. “This [service] requires working in tandem with partner internal regulatory teams and carefully defining roles and responsibilities to assure alignment,” he says. “At Parexel, our regulatory outsourcing teams consist of former regulators from FDA, European Medicines Agency, National Medical Products Administration, among others with specialized knowledge and first-hand experiences of regulatory expectations.”

While there is much to weigh and evaluate, the uptick in outsourcing appears well founded on benefits and advantages. This has led to what might be termed a ‘run’ on available scheduled slots within CMOs and CDMOs. Currently, not only must one place a large cash down payment but also the requesting company must now face wait times of around 12 months to get their place in the que. However, in this case good things take time, and time taken pays dividends at the (pun intended) finish line.

Current Trends and Strategic Options in the Pharma CDMO Market


Supplement: Bio/Pharma Outsourcing Innovation 2022
February 2022
Pages: s30–s34

When referring to this article, please cite it as C. Spivey, “Balancing Internal Focus Against External Capabilities,” 

Demand for outsourced services of technical R&D activities is increasing.

Balancing Internal Focus Against External Capabilities

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

In this episode, Chris Spivey, Editorial Director, and Meg Rivers, Senior Editor, interview industry experts to discuss 2022 trends along with a few trends that emerged in 2021, specifically:

The demand for US-based suppliers in 2022

Ensuring resources in the supply chain, including collaborations with competitors

Sustainability in APIs; API and drug product interface; API and excipient trends

Yvonne Duckworth, Automation Engineer, CRB

Cary Martin, VP of Marketing, August Bioservices

Gabe Longoria, Chief Commercial Officer, Astrea Bioseparations

Merrilee Whitney, Head of Biocontinuum Platform, MilliporeSigma (the Life Science business of Merck KGaA, Darmstadt, Germany)

Helen Anderson, Commercial Lead, USA, Aspen

San Kiang, CTO, Porton Pharmatech/J-Star Research

Anil Kane, Global Head of Technical Scientific Affairs, Pharma Services, Thermo Fisher Scientific

Matthias Bucerius, Head of Actives and Formulation, MilliporeSigma (the Life Science business of Merck KGaA, Darmstadt, Germany)

Jeff Woodhead, Senior Scientist, Simulations Plus

Gregory Lane, PhD, Senior Research Investigator, Bristol Myers Squibb

Podcasts

In this episode of the Drug Solutions podcast, Chris Spivey, editorial director, and Meg Rivers, senior editor, interview experts on up-and-coming 2022 trends in the bio/pharma industry.

Drug Solutions Podcast: 2022 Bio/pharma Trends: US-Based Suppliers, Digitization, and Sustainability

The pandemic cast new light on the importance and vulnerabilities of the distributed nature of the pharmaceutical industry’s specialized supply and shipping infrastructure. Pharmaceutical scale permits, like those for semiconductor or surgical hospital consortiums, lower barriers to entry for otherwise fantastically complicated or fit-for-one-purpose-only technologies to gain traction. Scale also enables designs dedicated to eking out the last precious microns of performance or purity, which can determine the usefulness or failure of an approach. But specialization at this scale also proliferates nesting doll dependency. Each successive layered network of interlocking manufacture depends on an exact product or design specification to feed it. Shortfalls in one seemingly survivable area cascade like crashing waves onto the following layer, and so on throughout the system. Subcontractors focused narrowly to a single design task are reliant on yet more specialized subcontractors. By intention, all are equally synchronized in configuration, tolerance, and material conformation. Seeking alternatives is not simple, easy, or at times even possible. It was a growing source of pride to become so finely tuned that pharmaceutical manufacturing migrated to a just-in-time (JIT) mode to maximize these benefits, but this also exacerbated interdependencies.

Multiple industry contacts recently emphasized better outcomes these past two years from having increased frequency and depth of dialogue. At the 2021 AAPS, PharmSci 360 event in Philadelphia, Gabe Longoria, chief commercial officer at Astrea Bioseparations, encapsulated this well, saying, “I think supply chain challenges have forced a lot of organizations to actually align their overall focus on what they are trying to achieve. And because of these challenges, we’ve had to identify better ways of doing things, such as intelligent standardization protocols. And these same challenges have required finding better ways to provide resources not just to our customers but B2B as well. I think it’s important to recognize and note down those challenges, a lot of which we’ll continue to see in the next 9–12 months, and even after we come out of COVID, we’ll need to continue to look to better align resources toward goals. We’ve been forced to help one another, and we’ve been talking with our competitors to make sure we can do the right thing for our customers. Which has been intensely interesting. The end point is asking, what does the customer experience look like? And all organizations are looking to achieve success in this regard.” Direct and frequent conversation became the norm rather than a luxurious exception, driven by dire need more than anything else.

From a logistics and innovation perspective, the pandemic can be considered a smaller scale version of World War II. Development and deployment of radar is a parallel for vaccines in that metaphor. In each case they had been around for many decades, both had to be suddenly optimized and brought to scale in an abbreviated timeline. Each required highly skilled operators working in intensively coordinated interlocking systems. But both were only a key part of the overall response, not the sole basis for defense. Historians and analysts will grasp onto vaccine production when writing accounts of what happened during the pandemic response—just as they did with radar for the Second World War. But that falls short of telling the full story. Calls currently abound for a global commitment to a fully coordinated response next time around. Hence, the need to dig into the details, so that lessons learned are not so easily lost. The obvious is also worth pointing out.Pandemic pressures have transformed pharmaceutical manufacturing in a similar way that Amazon next day delivery became an inviolate rule for the shipping industry, dragging everyone in shipping to deliver at the same accelerated pace. However, vulnerabilities and downsides of JIT manufacturing and specialization were widely recognized well before the pandemic. FDA and the National Institute for Standard and Technology (NIST) came together to draw up plans to implement advanced manufacturing for medical supplies. Other groups became involved. A new manufacturing institute, BioMADE, supported by both industry and the defense department, began to organize.

Kevin Nepveux, vice president, Pfizer Global Supply, recalled, “Development and launch of the Pfizer-BioNTech COVID-19 vaccine was unlike anything I have experienced in my career in Pharma Manufacturing—and without a doubt the highlight. Multiple mRNA vaccine constructs were manufactured and tested in the clinic in parallel versus the normal sequential approach, and the selected strain was immediately scaled, both up and out, to begin manufacturing launch supplies before the pivotal efficacy study even started. In manufacturing alone, Pfizer/BioNTech committed over $1B in CapEx and OpEx before the first sign of efficacy.”

Pfizer went all in, coming out the other side having a changed perspective, as Kevin observes. “Learnings from the vaccine will be enduring, including streamlined internal governance, bringing on multiple supply chains simultaneously compared to normal post-approval expansion, and simplified regulatory engagement.”

FDA’s commitment to conversation and cooperation

Which brings us nicely to FDA, which might otherwise unfairly drop to a footnote to the vaccine success. FDA created a dialogue framework for COVID-19 vaccines to be developed at warp speed. Communication was excellent. In November 2021, FDA updated its resiliency roadmap, pointing out that since April 1, 2021, FDA conducted more than 600 domestic and more than 200 foreign remote regulatory assessments, which included review of records submitted upon request under section 704(a)(4) authority, as well as review of documents and other information voluntarily submitted upon request … more than 100 human and animal food firms participated in voluntary remote regulatory assessments (1).

While these assessments cannot be used to meet FDA Food Safety and Modernization Act (FSMA) mandated surveillance inspections, the assessments provided critical oversight to FDA during the pandemic. Dr. Elizabeth Miller, assistant commissioner for the Office of Regulatory Affairs (ORA) Office of Medical Products and Tobacco Operations, commented, “Throughout the course of this pandemic ORA has had to adjust and change how we work.We have been more agile than ever before.Our regulatory agility is an important cornerstone to delivering the oversight and consumer protection the public deserves from ORA and FDA.”FDA continued with mission critical inspections when they paused routine surveillance. They also developed a new process to assess facilities submitting Emergency Use Authorizations. These investigational activities allow the agency to directly observe operations at manufacturers of COVID-19 therapeutics and assess whether the firm has proper controls in place to ensure the safety, purity, and potency of the COVID-19 product.

It was FDA’s open and frequent communications that helped keep everything rolling forward as smoothly as possible. FDA made strong efforts at transparency in their Resiliency Roadmap, and have energetic plans to continue this as they inaugurate an Inspection Affairs Council to update inspection procedures. This new body within FDA will be headed up by Dr. Judy McMeekin, associate commissioner for regulatory affairs. It is a transformative solution born in part by the elevated contacts and cooperation during the pandemic.

Other lines of defense also needed bolstering, and these are the success stories hidden by the glare of vaccine successes. Hovione CEO Guy Villax said at the 2021 CPhI Worldwide conference in Milan, “In the early days of the pandemic, there were hiccups and delays, but that we didn’t see huge problems points to the resilience of the industry … the industry stepped up to the challenge. Gilead’s remdesivir has a critical excipient which only Hovione manufactures, we massively scaled up to produce a years’ production in only a month. CDMOs [contract development and manufacturing organizations] were doing heavy lifting to support the needs brought on suddenly by COVID-19.”

Susan Darling, senior director of capillary electrophoresis and biopharma product management and marketing at SCIEX, echoes the sentiment but also emphasizes the knock-on effects of increased calls for speed (see page 32 in this issue of BioPharm International). Darling comments, “Companies are looking to get development times down to 1000 days; they want to develop everything at pandemic speed, even when they have diverse portfolios that include highly complex next-generation products such as multispecifics, gene and cell therapies, and RNA-based treatments, all of which require new and different analytical capabilities.” So the trend line is becoming obvious. More complex molecules at faster speeds for development equals an opportunity for analytical tool makers to sell into a growing unmet need. Manufacturers must adapt quickly to new types of technologies more quickly because their competitors are already doing so. This will also have a knock on effect for products for purification and separations in both upstream and downstream processes, such as novel chromatography materials or quicker acting buffers and solvents, and so on. It is a defining moment for future planning requirements. “The industry is really driving to be creative, not just in terms of analytical solutions, but in how they manage data and pull it together to knock the inefficiencies out of every step,” Darling concludes. “Our customers are challenging us to develop new analytical techniques that provide more information more quickly, and when we bring them new solutions, they are adopting them at a much faster rate than could ever be imagined even a decade ago,” Darling says.

Corning Incorporated also stepped up to the challenge during the pandemic, in part supported by the Department of Defense (DOD), in coordination with Department of Health and Human Services (HHS), who awarded a $15 million Firm Fixed Price contract to Corning Incorporated to expand domestic production of pipette tips for robotic liquid handling instruments (2). But more well known was the Biomedical Advanced Research and Development Authority agreement to give $204 million to expand manufacturing capacity for glass vials to store potential vaccines for COVID-19 (3). Valor Glass vials, first introduced in 2017 and made from aluminosilicate glass, were of great strategic significance. “Velocity Vials” are now being introduced. And what more could a marketing department tell us about the business importance of “Amazoning”, than to use velocity in the product name. Velocity Vials are borosilicate externally coated with Corning’s proprietary technology, to eliminate bottlenecks and speed the delivery of life-saving treatments. These vials have demonstrated a 20–50% improvement in efficiency, up to a 96% reduction in glass particulates, and a 3x reduction in the likelihood of damage that leads to cracks and breaks, according to the marketing materials (4).

Other than the headline vaccines, much of great importance went on or evolved behind the scenes to manufacture excellence out of adversity in the fight against COVID-19. Landmark efforts in communications and cooperation kept the conveyer belts moving. Agilent’s digital solutions group “ramped up to meet the needs of customers by offering cloud-based software for remote instrument access and asset utilization monitoring (to) pulls together advanced IoT sensor technology and data analytics to enable lab-wide visibility,” according to Shane Elliott, vice president, Global Laboratory Solutions Marketing, Agilent.This effort was broad based across multiple vendor platforms, again in a concerted effort to increase and improve manufacturing communications. It was a near universal practice over the past two years. Production line pace is set to accelerate rather than slow down. Pharma production has been industrious in the good old-fashioned sense of the word. Ingenuity and hard work manufactured positive results out of adverse conditions. When serious global policies begin to become clear for the next pandemic planning groups, industrious effort, ingenuity, and improved communications will be the seed crystals for successful outcomes.

 Resiliency Roadmap for FDA Inspectional Oversight (November 2021)

, FDA.gov.
2. DoD, “DOD Awards $15 Million Firm Fixed Price Contract to Corning Incorporated to Increase Domestic Production Capacity of Robotic Pipette Tips,”

, Dec. 23, 2020.
3. BioPharm International Editors, “Corning Expands Glass Vial Capacity,” 

, June 17, 2020.
4. Corning, Velocity Vials, Corning.com, accessed Dec. 14, 2021.


Vol. 46, No. 1
January 2022
Pages: 15–18

When referring to this article, please cite it as C. Spivey, “Industrious Pharmaceuticals,” 

Warp speed is amazoning pharma practices and protocols.

Industrious Pharmaceuticals

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,” 

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.