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

Chris Spivey

We are social animals and have survived many thousands of generations through the hallmarks of civilization: delayed gratification and cooperative structures. Priority access to medicines on a national basis, paradoxically, increases risk for all. I write against the backdrop of an outbreak of H5N1 with a 56% mortality rate (1). It’s understandable to seek to minimize risk to one’s own citizens. Collaterally cultivating longer outbreaks in other countries (through absence of access to vaccines), however, allows microbes freedom and resources to evolve into stronger threats for everyone. According to Jane True, VP, mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead at Pfizer, vaccine nationalism “closes down options and reduces global conversation in general” and goes on to ask “can we just agree we’ll have better odds working across borders next time vs. mostly within? The effectiveness of a future global response increases when resources are more efficiently deployed.”

Ascertaining pandemic planning priorities, I intend to question several leaders on how they weigh surveillance versus manufacturing agility and capacity, against infection control or understanding the mechanism of transmission, and so forth. I will report back in a longer format article. Johnson & Johnson’s Blue Knight cooperation with the Biomedical Advanced Research and Development Authority (BARDA) prioritizes investment in novel pandemic countermeasure startup companies, while Abbott’s Pandemic Defense Coalition strengthens surveillance efforts by identifying novel environmental viruses, as the main order of business.

For his part Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, says, “The Center for Biologics Evaluation and Research at FDA looks forward to collaborating with academic and industrial partners to link together the manufacturing and development technologies that will facilitate the rapid deployment of mRNA vaccines whenever needed to address existing and emerging infectious threats” (2).

We now have a recent store of knowledge and experience to better prepare ourselves for what comes next. Vaccine nationalism should not play an instrumental part going forward.

1. WHO. Human Interaction with Avian Influenza A(H5) Viruses. Avian Influenza Weekly Update Number 895. WHO Western Pacific Region. May 12, 2023.

2. Marks, P. Comments in Email Correspondence with 

When referring to this article, please cite it as C. Spivey. Vaccine Nationalism Escalating Risk. 

Articles

Vaccine nationalism strengthens viruses and poses deadly risks for all involved.

Vaccine Nationalism Escalating Risk

Chris Spivey, editorial director, speaks with Sean Hart, CEO and SCO of LumaCyte, on the topic of rapid accurate mRNA potency assay possibilities. 

Videos

Sean Hart, CEO and SCO of LumaCyte, discusses rapid accurate mRNA potency assay possibilities.

Discussing Rapid Accurate mRNA Potency Assay Possibilities with Sean Hart

Chris Spivey, editorial director, speaks with Jane True, vice-president of mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer. In this interview, True shares her perspective on how mRNA will shift commercial models in the pharmaceutical industry, including changes to the "just-in-time" supply chain, pandemic preparedness, and more.

Jane True, vice-president of mRNA Commercial Strategy & Innovation and Global Pandemic Security Lead, Pfizer, shares her perspective on how mRNA will shift commercial models in the pharmaceutical industry.

How mRNA will Shift Pharma Commercial Models with Jane True, Pfizer

The bio/pharma industry is building on the small successes of continuous manufacturing (CM) for the advanced manufacture of bio/pharmaceuticals. With FDA throwing its support behind CM as part of a bigger initiative to progress advanced technologies for biopharma manufacturing, it remains to be seen whether CM technologies will see an uptick in adoption within the industry. In this episode of 

 editors Chris Spivey and Feliza Mirasol discuss with industry experts the advantages and savings that CM may offer as well as the very real obstacles that might make a fully continuous process not feasible, especially in biologics manufacturing.

, owner of Pharmaceutical Engineering Solutions, is a consultant to the pharmaceutical industry working at the interface of technology, R&D, manufacturing, and corporate strategy. He spent nearly 40 years in big pharma, working for Merck, Bristol Myers Squibb (BMS), and Janssen, a Johnson & Johnson company. At Merck and BMS he worked in R&D, rising to vice-president of Process Development at BMS. During those 28 years he was lucky to work on numerous important compounds that went to market, including Primaxin, Mevacor, Proscar, Crixivan , Reyetaz, Entecavir, Muraglitazar, Sprycel, Onglyza (through FDA’s Quality by Design pilot program), Apixiban, Dapagliflozin, and Brivanib.At Janssen, he spent more than 10 years working on manufacturing technology, focusing on integrating data analytics, sensors and models to realize real-time quality awareness and real-time release when possible, along with continuous manufacturing and other manufacturing modalities, covering small molecules, monoclonal antibodies, vaccines, and cell and gene therapy.

 is faculty of the Department of Chemical and Biochemical Engineering, Rutgers University, NJ, and director of pharmaceutical systems engineering. He is the recipient of the prestigious European Federation of Chemical Engineering (EFCE) Excellence Award. His research focus is continuous manufacturing of drug substance and product. He is principal investigator (PI)/co-PI of several projects funded by FDA, National Science Foundation, and companies. He has published more than 75 papers, edited one pharmaceutical systems engineering book published by Elsevier, written more than 12 book chapters, and presented at more than 130 conferences. He is actively serving as a journal editorial board member, and conference session chair.

This episode of Drug Digest is sponsored by:

Drug Digest is a tech talk video series with the 

 editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

In this episode of Drug Digest, Pharmaceutical Technology editors discuss the advantages and savings that continuous manufacturing may offer as well as the very real obstacles that might make a fully continuous process not feasible, especially in biologics manufacturing.

Drug Digest: Advancements in the Implementation of Continuous Manufacturing

Chris Spivey, editorial director, speaks with Vibha Jawa, executive director at Bristol Myers Squibb, on foreign epitopes recognition in what should be fully human antibody therapies. Can HLA genotyping show which binding targets will be most effective per individual patient, or per T cell response predictor in terms of a reverse translation in the clinic? A tangent from our 

focused on High Titer Vector Producing Cells.

Vibha Jawa, executive director at Bristol Myers Squibb, discusses foreign epitopes recognition from what should be fully human antibody therapies.

Exploring Foreign Epitopes Recogniton in Personalized Medicines with Vibha Jawa

, Bob Girton, Partner, Edgewater Capital, spoke to 

about how pharma manufacturers should approach building Environmental, Social, and Governance (ESG) within their business operations rather than having it run as a parallel program. Girton will be moderating a panel discussion "

Best Practices in Implementing a Successful ESG Framework

Can you give an overview of the current status and activities of ESG practices in the pharma industry?

: Pharmaceutical companies have long been active in ESG practices. As with the broader efforts around corporate responsibility, those efforts have accelerated in recent years, especially at large multinationals. Most large pharma organizations have set and communicated clear, specific targets, often targeting their greenhouse gas emissions through zero carbon emissions as well as reductions in both input and waste streams. New regulation in both the EU and the US will bring this individualized patchwork closer to a unified effort by setting more consistent requirements and alignment around transparency and reporting. 

Further, these requirements have in recent years been filtering down into small and medium organizations either directly, in order to meet the expectations of their respective stakeholders, or indirectly through the scope two and scope three requirements of the multinational enterprise (MNE). Notably, the direct impact represents the broadest population of companies, and often, these organisations are the most resource constrained and inexperienced in addressing these requirements. That said, to be competitive in the marketplace, this is no longer optional.

In addition to environmental and climate concerns, pharmaceutical companies are working to address social concerns, which focus on equitable access to healthcare. One way this is being put into action is the distribution and pricing of pharmaceuticals and increased diversity and transparency within clinical trials.

What are some common pitfalls? How should pharma manufacturers incorporate those needs?

: There's a lack of clarity on what we really mean by ESG, so breaking down the phrase into a series of actions would be one. Then with the large multinationals, another challenge is that they are applying expectations right down into their vendor network—which might be undeliverable in the way they envisage it, especially without the larger company’s support, guidance, and engagement. So, the main risk is that it can often become little more than a check box exercise. What you don’t want is ESG operating as an island separate unto itself, something that is not embedded in the business.

And this is where we get to the crux of the matter—how and why do you create the business case for ESG? You need to create something or an initiative that is also impactful on the business. To give you a specific example, a company of ours is using green chemistry. They are not undertaking this because its "green" but because the chemistry is better. It's a better solution. And so the business case is embedded inside of what you're actually innovating to the core.

My advice to manufacturers is to stop and review: ask if we go down a climate focused or carbon credit or a diversity, equity and inclusion (DEI) program at our firm, why are we doing it? How is this going to impact how we operate, what decisions we make, what priorities we set, how will it actually make the organization better? And not just going through the motions because a large multinational customer required it; that said, MNEs are requiring it.

The organizations Edgewater works with are typically 20 people to 300. This means for ESG, as in many aspects of our businesses, we are resource constrained, so whatever we identify as ESG initiatives, must also be impactful to the organization.

Does venture capital or private equity money going into CDMOs look for this infrastructure to be in place before investing?

Yes they do, and they want to know that at least the framework of ESG is starting. That's a positive for us. Our investors expect that of us, and I think it speaks of the maturity and awareness of the leadership. In the same way we’d also be looking at tracking their safety statistics. Ideally, we want them to be laying out the plan for the next five years and how they will actually put those checklists, into action.

As an example, at Edgewater we have a shared DEI program that sits across our organizations. Each business has selected a DEI advocate that sits on the council and shares ideas and accountability across our business. As there is no one size fits all, we have established a list of actions and best practices. Beyond helping identify what’s possible, it also helps to establish a shared language. From this "menu”, our DEI council has selected a small number of “must dos”. These are the critical few and serve as a point of anchor or foundation. Beyond the “must dos” the organization may select a series of “may dos”. Taken together, the “must dos” and “may dos” must be linked into what we’re building at each of our organizations. It has to be in our strategy plan, our budget, key performance indicators, and management by objectives for the year, along with clear actions we will take to achieve them.

What also helps with deciding when and what to implement is knowing your customers, knowing your market, being out there, asking the questions, and continuing to revisit the untested. And you may choose not to implement right away, but you're aware that at some point, when I need it, I'll know when to make a trigger point or when to make the decision. And it's going to be around the needs of your customers, as buying some of pilot pieces of equipment for say, continuous manufacturing / flowchemistry—they are not that expensive. Getting the capability and then starting to play with it or maybe partnering with an academic lab. There are a lot of ways to sort of test and feel without actually going the next step. So, I think it's more just a case of being aware of what's going on in your market, rather than saying, I'm just going to ignore it and not implement in methods that are more ESG compliant. The cost of access is so inexpensive now that it's more of a time resource and efficacy than it is dollar concern.

 What will ESG in pharma look like in five years?

: In one line—it will be so much a part of the whole system that we won’t be hosting panel discussions on how it’s supposed to be built and implemented. I strongly believe that if companies adopt measure to be more environmentally and socially responsible, in a way that also impacts its business and operations in a positive manner, others will follow. It will not only be the right thing to do but will also make a lot of sense. Climate change is real and needs immediate attention. Pharma industry, being a major carbon producer, has a huge responsibility to take swift actions that are effective and sustainable in the long run and ESG compliance is the step in the right direction. Additionally, your employees, especially younger generations, expect our organizations to be diverse, equitable, and inclusive. We know that diverse and inclusive teams are much more effective.”

Bob Girton, partner at Edgewater, discusses best practices for how pharma manufactures should incorporate sustainability into their operations.