Ukraine invasion challenges biopharmaceutical research and operations

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Biotech companies and manufacturers of medical products have condemned the invasion of Ukraine, while seeking to maintain the supply of essential medicines.

Amid continued bombardment, death and destruction resulting from Russia’s invasion of Ukraine, biotech companies and medical product manufacturers have condemned Vladimir Putin’s aggressive tactics, while seeking to maintain the supply of essential medicines for beleaguered populations. As the invasion of Ukraine has intensified since late February 2022, prompting over 2 million citizens to seek safety outside its borders, international energy providers, global manufacturers, major retailers and major financial institutions have halted trade and interactions with Russia. But most international pharmaceutical companies have remained in Russia, citing humanitarian reasons to continue providing patient populations with needed therapies and health products, including those dependent on life-saving new treatments.

Biotech industry leaders, however, have called for a halt to investment in Russian companies and support for research and marketing there. In a letter dated February 27, 2022, the company’s CEOs acknowledged likely delays in clinical trials in Ukraine and Russia and difficulties in producing needed vaccines and drugs in those countries. Venture capitalists joined manufacturers in anticipating supply chain disruptions, but stressed the importance of condemning Russia’s deliberate ‘criminal act’ to disrupt the global economy and ruin the lives of so many. of people.

Decisions to maintain manufacturing and marketing operations in Russia by industry leaders such as Johnson & Johnson, AstraZeneca, Pfizer, Novartis and Abbott have drawn attention, however. Many American and European companies have multiple facilities in Russia and sponsor hundreds of clinical studies in the region. Some CEOs say they will not increase their investments in Russia but will continue to produce drugs to meet public health needs.

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

Brake research

A major concern is how the invasion threatens to limit or halt clinical trials of drugs and biologics in Ukraine and Russia, often halting research programs that provide critically ill patients with access to advanced therapies. Pharmaceutical companies and clinical trial sites based in Ukraine all but collapsed as the Russian invasion destroyed hospitals and research facilities. And biopharmaceutical companies are suspending enrollment in many clinical trials in Russia as the outlook continues to deteriorate.

Analyzes from Clinical Trials Arena and others document that a significant number of research programs were underway in these countries, many of which were part of global research programs. For example, San Francisco-based Tricida pharma recently acknowledged that the horrific situation in Ukraine prompted it to delay expectations for clinical trial results for its chronic kidney disease drug candidate veverimer. However, many clinical trials in the region involve approved drugs seeking broader markets for therapies already available in the United States.

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

In addition, analysts anticipate supply disruptions and price hikes for certain raw materials and supplies imported from Russia. Rising oil and natural gas prices could increase the cost of some plastics used in syringes and medical vials. And the higher cost of transportation could limit access to some materials in the long run, further intensifying efforts to boost U.S. production of medical supplies and products.

About the Author

Jill Wechsler is the managing editor in Washington for BioPharm International.

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