Ukraine Invasion Challenges Biopharma Research and Operations

From supply-chain and clinical-trial disruptions in Ukraine and Russia, to decisions to halt investment or maintain operations, global implications for industry and pharmaceutical production are immense.

Amid continued bombing, death, and destruction from the Russian invasion of Ukraine, biotech companies and medical product manufacturers have condemned the aggressive tactics of Vladimir Putin, while also looking to maintain supplies of essential medicines to the beleaguered populations. As the invasion of Ukraine has escalated since late February, prompting more than two million citizens to seek safety outside its borders, international energy suppliers, global manufacturers, leading retailers, and major financial institutions halted trade and interactions with Russia. But most international pharma companies have remained in Russia, claiming humanitarian reasons for continuing to supply patient populations with needed therapies and health products, including those dependent on vital new treatments.

Biotech industry leaders, however, have been vocal in calling for a halt to investment in Russian companies and support for research and marketing in that country. In a letter dated Feb. 27, company CEOs acknowledged likely delays in clinical trials in both Ukraine and Russia and difficulties in producing vaccines and drugs needed in those countries. Venture capitalists joined with manufacturers in anticipating supply chain disruptions, but emphasized the importance of condemning Russia’s deliberate “criminal act” for disrupting the global economy and ruining the lives of so many.1

Decisions to maintain Russian manufacturing and marketing operations by industry leaders such as Johnson & Johnson, AstraZeneca, Pfizer, Novartis, and Abbott, however, have drawn fire. Many US and European firms have multiple facilities in Russia and sponsor hundreds of clinical studies in the region. Some CEOs say they will not expand investment in Russia, but will continue to produce medicines to meet public health needs.

In an interesting move, a former FDA official and rare disease advocate Tim Cote petitioned the agency to freeze all regulatory requests and actions from firms in Russia or controlled by Russian parties. The aim is to prevent Russian biopharmaceutical companies from building a presence in the US market, one way to emphasize the economic consequences of their nation’s actions.

Curbing research

A major concern is how the invasion threatens to limit or halt clinical trials for drugs and biologics in both Ukraine and Russia, often cutting off research programs that enable patients with critical conditions to access advanced therapies. Ukraine-based drug companies and clinical trial sites have all but collapsed, as the Russian invasion has destroyed hospitals and research facilities. Andbiopharma companies are halting enrollment in many clinical trials in Russia, as the outlook continues to deteriorate.

Analyses by Clinical Trials Arena and others document a sizeable number of research programs had been underway in those nations, many part of global research programs.2 San Francisco-based pharma company Tricida, for example, recently acknowledged that the horrifying situation in Ukraine prompted it to delay expectations for clinical trial results for its chronic kidney disease drug candidate veverimer.3 Many clinical trials in the region, though, involve approved drugs seeking broader markets for therapies already available in the US.

Russia’s actions are slated to have a visible impact on pharmaceutical and vaccine production in India, where vaccine makers have extensive contracts to produce Russia’s Sputnik V COVID-19 vaccine for global distribution. India’s Dr. Reddy’s Laboratories, Serum Institute of India, and Hetero are leading distributors for the Sputnik vaccine, according to press reports. But Sputnik production has been slow and far below earlier expectations, even before the Ukraine crisis, as the Russian product gained only limited market acceptance. The situation is unlikely to change, as efforts by Russia to gain approval from the World health Organization (WHO) for its Sputnik vaccine appear to be on hold.

In addition, analysts anticipate supply disruptions and price increases for certain raw materials and supplies imported from Russia. Rising prices in oil and natural gas could boost the cost of certain plastics used in syringes and medical bottles. And the higher cost of transportation may curb access to certain materials over the long term, further heightening efforts to boost US production of medical supplies and products.

References

1. https://medium.com/@BusinessLeadersForUkraine/call-for-business-leaders-to-economically-disengage-from-russian-industry-5e0352f89f5a

2. https://www.clinicaltrialsarena.com/analysis/ukraine-industry-sponsored-clinical-trial-development-at-risk/

3. https://ir.tricida.com/node/9221/pdf