Investigating the Pharmaceutical Ingredients Industry with Myrna Wilson (DCAT Week 2023)

Myrna Wilson, director, Global Marketing, Strategic Growth and Technical Sales, Pharmaceutical Ingredients, Univar Solutions, spoke with Grant Playter, associate editor, to discuss the state of the pharmaceutical ingredients industry shortly after this year's DCAT Week. Topics of discussion include the state of the biopharma supply chain, movements in the patent industry, and more.

Broadly speaking, can you give me your perspective on the state of the ingredients industry? Would you characterize it as in a state of flux? How can companies look to strategically maneuver in this space?

Myrna Wilson: As the world economy continues to recover and evolve post-pandemic and with geopolitical tensions, the ingredients industry is not immune from the impacts of those financial conditions.

As with most industries, the ingredients industry is constantly in a state of flux as it must continuously respond to global supply chain challenges, and – specifically as it pertains to pharmaceuticals – the need for drug manufacturers to continuously improve the medicinal efficacy of their offerings. Also, the increased focus on environmental, social, and governance factors means the ingredients industry will have to evolve to ensure it is either working on how to manufacture its product offerings with environmental footprint considerations or consider alternatives to its current lines that can address those requirements.

Strategic maneuvering all depends on the long-term strategy of each company. However, there are a few elements that should remain at the forefront of a strategy in this industry. For Univar Solutions’ pharmaceutical ingredients team, it means that as we position ourselves to respond to external dynamics, we always consider quality, security of supply, traceability, and documentation of adherence to quality and regulatory standards. If we keep those in the forefront of our planning, we are sticking to the core of what our customers need from us.

We recently passed the three-year mark of the COVID-19 emergency declaration (March 2020 in the U.S.) but many are still talking about its impact on the supply chain. What is your perspective on these alterations? Do you think the just-in-time model may return in full force at some point, or will efforts like onshoring stick around in the long-term?

Wilson: COVID-19 pushed the industry to respond faster and to become more efficient than ever before. It also highlighted supply chain pinch points and forced the entire pharmaceutical industry, and far beyond, to make swift moves to sustain the pressure. While I don’t think our industry has completely recovered from the many supply chain constraints we were presented with, businesses up and down the chain are making changes to their core infrastructure to better position themselves in the long-term.

Shortages that have gone unresolved over extended periods of time have caused the industry to either create or adapt to new supply sources or alter their existing supply chain paths. These sorts of adjustments are often both costly and time consuming, making it unlikely that entities would work to undo new paths created. Additionally, many may have found secondary benefits with these alternative paths, such as improved sustainability outcomes and supply chain optimization.

Also, there has been a push by government entities around the world to onshore their internal access to secure the health of their citizens, even offering incentives to build infrastructure within their borders. Again, the cost to make these moves is significant. Once those investments are made, it would be difficult and costly on a variety of fronts to undo them.

What are some recent technological innovations in your space? Can you illuminate them for our audience?

Wilson: Univar Solutions prides itself on the fact that we have a global network of pharmaceutical laboratories within our solution centers which serve as pharmaceutical application and formulation laboratories to help support the road to innovation and reformulation for our customers and suppliers. Because Univar Solutions sits at such a key intersection in the supply chain with science and technology, we strive to be a true solutions partner delivering benefits far beyond logistics for our customers and suppliers. Distributing the chemical or ingredient is only the bare minimum.

In terms of innovations based on trends in the pharmaceutical space, there has been a significant shift toward creating more palatable drugs and taste-making active pharmaceutical ingredients (APIs). Due to the influence of Generation Z on the drug market, today there is increased focus on not just the efficacy of a drug, but on its taste and ease of consumption.

As an example, drug manufacturers now can create products specifically engineered to deliver two APIs that are unstable when combined with one another. These duo-capsules are game-changers for drug manufacturers and consumers alike, while also delivering significant benefits in sustainability.

Patents are in a bit of an interesting space at the moment, particularly in the United States. The Inflation Reduction Act was signed into law last year, which introduced new price controls and changed how certain drug exclusivities work. Meanwhile, broad genus clauses recently faced challenges at the Supreme Court level in the Amgen vs. Sanofi case, which could have upended how patents are handled in the biopharma space. Can you talk a bit about how the patent industry is preparing for these significant changes?

Wilson: The pharmaceutical industry is facing a big patent cliff. It’s creating urgency among manufacturers in the generics space in the race to get their Abbreviated New Drug Applications (ANDAs) in place so that they can enter the market with their generic. Simultaneously, large pharmaceutical companies who may have held back research and development projects so as not to cannibalize their current product offering in the market may be releasing the follow-up much faster than planned.

Between patent battles, competing offerings, the likelihood of success through the trial process, and the massive cost to take a drug from clinical trials to commercialization, the pipeline of projects should be constantly refilled. It would also seem prudent for drug manufacturers to weigh the commercial viability of their projects by ensuring that their recipes consider cost and security of supply of any materials built into the formulation in earlier trial phases.

As a distributor, it’s a partnership that we aim to offer our customers. It is critical that sourcing and cost implications be part of the planning as production needs to scale up. If a manufacturer partners early with us, we can source, provide secondary sources, and design efficient supply chains that consider quality and security of supply from small quantities to commercial consumption.

Do you have any bold predictions for where the biopharma industry will be ten years from now?

Wilson: The rate that technological developments accelerate in any space is increasingly exponential, and the life sciences industry is changing and evolving at an amazing pace. A 10-year prediction would be truly hypothetical based on where research and development are currently focused. Personalized medicine developed based on each person’s body could be leaps and bounds from where it is now. The biopharma industry already has a promising pipeline of therapies being evaluated for cancer treatment and rare diseases. Hopefully, the brilliant minds working on the next wave of projects will work to eradicate some of these rare diseases and begin finding cures for even the deadliest of cancers.

Idealistically in 10 years, targeted gene therapy can be used for everything, not just limited to rare diseases or those that scientists know the molecular pathways for. This could result in sought-after cures, with little to no side effects. The intensity around curative therapies for chronic conditions along with advances in early detection technology could reduce the need for medications considered to be lifelong medications.

An increasingly aging population with a longer average lifespan could also provide a new source of challenges for the biopharma industry, as scientists look for a way for to keep the population living with relatively good health and mobility into their 90’s and 100’s. Finally, 10 years from now, with that aging population and the continued push to make health care more affordable for everyone, we could see big movements to somehow make these sizable developments more accessible.

For more of our coverage on DCAT in 2023, viewers can visit this page.