Webinar#3: Clinical trials in Ukraine – current status and new growth opportunities
For many years, Ukraine has been a major hub for medical research, biotechs and start-ups. Yet, because of the war, hundreds of clinical trials have been impacted, leaving the future of imperative medical research and vital therapies in jeopardy.
To overcome the threats that the clinical research sector faces in Ukraine, supply chain partners need to mobilise and coordinate their efforts to support, innovate and deliver new solutions that can carry the industry through and beyond this global crisis
Webinar moderator: Samuel Gal Alterovich, Director of Strategic Services and Alliances, Oximio
- The Ukrainian clinical trial market: current situation and challenges for the industry – Olga Vizgalova, Managing Director, Oximio
- Activities undertaken by the MoH to support Ukrainian clinical trials market – Lyudmila Yarko, Head of the expert group of medicines quality and availability of the Pharmaceutical Directorate, MoH
- Oximio business continuity plan: Overcoming operations disruptions – Olga Vizgalova, Managering Director, Oximio
- Regulation updates: Expanded Access Programme regulations in Ukraine – Ievgenii Volynets, Head of Commercial Legal, Oximio
- Expanded Access Programme: New opportunities to support local patients – Oksana Pidmogylna, Business Development Expert, Oximio
- New Oximio solutions: Enabling sites and investigators to focus on their patients – Dmytro Zavada, Key Account Manager, Oximio
Q: Do you experience issues with transport, shipments due to issues with roads, flights not available, etc
A: At the moment, there are no issues with transport, for example, we have our own courier company, and we cover more than 80% of the regions of Ukraine, including Kharkiv, Mykolaiv. And, of course, we hope to get to Kherson soon 🙂
As confirmation of the absence of problems with transport, Oximio delivered more than 7000 shipments to the clinical sites without a single temperature deviation. Regarding the fact that we do not have air traffic, we have everything perfectly arranged for delivery only by cars, and the Ministry of Health and the Ministry of Defense support us as much as possible in delivery.
As already mentioned, the Ministry of Health is preparing letters to customs for the priority of crossing borders, at the same time, the Ministry of Defense will issue our drivers permission to move at night during the curfew.
Q: Maybe difficult to answer, but what in your perspective which depot has less risk Kyiv or Brody
A: Of course, it is hard to assess the less secure region now in Ukraine, unfortunately, missile strikes are delivered chaotically and it is difficult to understand the logic. Taking into account that neither ” Krushynka ” nor “Brody” borders the Russian Federation, it can be assumed that these two regions are equally safe at the moment.
Q: What will happen when the site will be closed after clinical trials ends? What action should be taken for conductiong Expanded Access Program?
The new expanded access legislation in Ukraine, order 1525, entitled “Expanded Access for unregistered medicines”, uses “expanded access” as an umbrella term for few IMP supply options (and not only supply after the trial is over):
- Post trial access: The site closes as the clinical trial ends. The sponsor should submit an application for an Expanded Access program. The application process is detailed in order 1525. The submission will include the details of the tending physician (who does not have to be the PI of the closed trial).
- Access outside of an ongoing trial: an IMP can be provided as part of Expanded Access in Ukraine when a clinical trial is ongoing in Ukraine or in the EU, the US, Australia, Canada, Japan, Great Britain, Israel or the Swiss Confederation. The trial must be phase II or higher.
If these conditions are met, an expanded access program can be opened. Patients can join if:
- They have a life-threatening, long-lasting or severely disabling illness or medical condition;
- They do not have access to alternatives and/or cannot be included in any clinical trial, and, as per a physician’s decision, the use of an unregistered medicinal product is the best choice for them.
Q: Do you have action plan for the blackout?
A: At the moment, power outages caused by Russian attacks are the main risk of disrupting clinical trials. As part of the Oximio BCP (Business Continuity Plan), we have taken the actions to reduce it:
- There is a high-power diesel generator that provides electricity to all rooms, refrigerators, and freezers in the Oximio depots
- We carry out constant testing and maintenance of the generator according to standard procedures. The last test was performed on 6 October 2022, with no issues reported
- Sufficient fuel is available for uninterrupted operation of the generator and full operation of the warehouse
- Ongoing fuel supply is provided via contracts with the largest gas stations and purchase of fuel cards