Successful Drug Development Event

Event overview

It was the first face-to-face interdisciplinary expert talk of this series of annual meetings after two online conferences due to the COVID-19 pandemic, and a 14-year long history of face-to-face meetings before.

This annual workshop brings together experts of all disciplines required to set up interdisciplinary teams for the planning, initiation, conduct, and successful finalisation of clinical development projects.

This year’s event discussion revolved around the devastating war in Ukraine, the challenges and how to best deal with the COVID-19 pandemic, and the evolution of clinical trial methodology and tools, all at least to some extent impacted by the most recent geopolitical and healthcare challenges.

Dr. med. Johanna Schenk, FFPM GFMD, Company Officer and Executive Consultant SanaClis DE GmbH, had the pleasure of welcoming five expert speakers and a highly vibrant audience that contributed tremendously to a lively meeting with plenty of comments and questions in the traditionally extensive discussion part of the meeting.

Impact of the war in Ukraine on clinical trials in Ukraine, Russia and Europe

Alexander Fetkovsky, Chief Executive Officer of SanaClis s.r.o., a mid-size global CRO with a strong operational presence in Central & Eastern Europe, outlined as first speaker the pre-war contributions of Russia and Ukraine to global clinical research productivity, the current implications on clinical trial conduct, and expectations for the future when peace will have returned:

There is a joint moral obligation towards patients who have already been enrolled into studies in both Ukraine and Russia pre-war. The
utmost has to be done so that they can continue on study
treatment.
Major operational challenges caused by hindrances for importation and transportation of study drugs, devices, and other clinical trial
materials, organisational and regulatory uncertainties relating to
patients who fled to EU countries or moved to safer Ukrainian
regions have to be managed well.
Majority of the Ukranian sites resumed their work and appreciate the possibility to work on clinical trials. COVID-19 and the war cause a
lack of regular diagnostics and treatment resulting in an even higher
motivation of Ukrainian patients and sites to participate in clinical
trials than already observed prior to the war.
There is a post-war potential for Ukraine to absorb 20-30 % of clinical trial capacity that is expected to be lost in Russia.

Alexander Fetkovsky

CEO

As CEO, Alexander Fetkovsky has overall responsibility for the planning and execution of strategic company initiatives and business partnering, in addition to global operational and financial oversight for multiple clinical programs and clinical trial supply/warehouse operations. He previously held several C-level positions such as Senior Managing Partner and Member of the Board.

Roman Hrynchuk

COO

Roman Hrynchuk is responsible for all SanaClis operational units including Clinical Operations, Clinical Trial Supply Chain, Pharmacovigilance, Medical Affairs and Sourcing. With over 15 years of experience in the pharmaceutical business, Roman leverages a profound knowledge of clinical research and a passion for operations, to continuously improve the company’s performance, while retaining compliance with regulatory requirements and best practices.

Speaker name

Speaker role

Lorem ipsum dolor sit amet, consetetur sadipscing elitr, sed diam nonumy eirmod tempor invidunt ut labore et dolore magna aliquyam erat, sed diam voluptua. At vero eos et accusam et.

Cell & Gene Therapies

Today’s drug development environment was largely designed around small molecules and biologics such as proteins and monoclonal antibodies…

Learn more

Medical Devices

Medical device developers increasingly rely on CROs to expedite time to market and reduce the risk of device recalls. SanaClis is ideal…

Learn more

Biosimilars & Specialty Generics

The development of biosimilars requires a significant investment and risk, but they are vital for R&D as they have an opportunity to provide…

Learn more

Biotech & Pharma

As the drug development process is becoming more complex, pharmaceutical companies leverage all the opportunities as they strive to reduce

Learn more