Ukraine CRO Appeals to Life Science Sector for Support
In an open letter published on Mar. 5, Tomalchov urged fellow drumakers to put pressure on NATO to create a no-fly zone over the country and to sever all ties with Russia, while continuing to donate money and key drug supplies to Ukraine. “The whole drug discovery, biotech and scientific communities “should speak with one voice now.”
Tomalchov’s appeal was flanked by another open letter signed by 400 companies in the life science field, asking them to encourage their peers to disengage from Russia. Among the most prominent signees were executives of Ovid Therapeutics, Nkarta Therapeutics, Global Blood Therapeutics and RA Capital Management.
In his communique, Tomalchov pointed up the importance of Ukrainian companies for the biopharmaceutical supply chain. Enamine, he said, helps supply more than 70% of the world’s stock of chemical building blocks and reagents. Together with compatriot firms Life Chemicals and Otava Chemicals, it is also a major contributor to the world’s supply of chemical screening compounds, providing more than 50% of the molecules used.
The Russian invasion already has impacted pharmaceutical business inside Ukraine as well as internationally, the executive said. In particular it has interrupted clinical trials. Denmark-based Ascendis Pharma, for example, has warned that the conflict could hinder the readout for Phase 3 study of an adult growth hormone deficiency treatment.
Similarly, another biopharma player Tricidia, has delayed a readout for a late-stage chronic kidney disease treatment prospect from the third to the fourth quarter, as 15% of the trial's patients are based in Ukraine.
The Enamine chief also provided some insight into how its operations in Kyiv have been impaired by the fighting. As a precaution, he said, all of the company’s digital data has been “fully transferred” to digital safe servers physically located outside the country, and internal operations are no longer tied to local servers.
In contrast, the CRO’s “entire collection“ of screening compounds and major building blocks are in Kyiv and cannot be supplied to customers at present, though its EU stock in Riga, Lativa, and its US stock in the state of New Jersey are unaffected.
Tomalchov said the Ukrainian government has taken important steps to facilitate logistics inside and outside the country. Without disclosing details, he added that Enamine hopes to at least partially resume the delivery process in the near term, as well as gradually replenish both the EU and the US stocks with substances from Ukraine.
As regards drug synthesis, the company plans to relocate some of its chemists to Riga to continue at least part of its synthesis work for customers there. Its long-term partner, the Latvian Institute of Organic Chemistry (LIOS), will provide lab space for up to 20 chemists.
The work from Latvia will not be as effective and productive as in Kyiv, Tomalchov cautioned, as the EU stock is relatively small and the transfer of reagents and building blocks from Ukraine will be limited. Another issue is that the number of chemists who can transfer to Riga is limited, as many have been mobilized for the resistance effort and men aged 18-60 are prohibited from leaving the country.
To facilitate drug synthesis outside Ukraine, Enamine is also seeking to buy or rent additional sites in Europe or Asia or alternatively enter partnerships with other CROs to leverage their facilities. The CEO said the company will soon disclose additional steps to stabilize its operations.
Author: Dede Williams, Freelance Journalist