2018 has come to the end, and we are glad to look back to what was achieved and to share GCT year in the Highlights!
We would like to thank our long-term partners for the credibility, trust and loyalty, and we hope for the new accomplishments together in the coming year!
We thank all GCT employees for the great contributions made this year to the advancement of the global healthcare. Wishing you and your family a Happy New Year!
Growing steadily, GCT has extended its presence in Europe, now having full-service clinical operations in the Republic of Moldova. This small country offers a generous variety of clinical trial sites, making it possible to approve between 70 and 90 trials annually. What is more, the average timeline to obtain the regulatory approval is only month and a half.
2018 PROJECTS OVERVIEW
This year we have enhanced our therapeutic portfolio with new clinical trials in Oncology, Ophthalmology, Cardiology, Dermatology, CNS, and across all Phases. With great pleasure we would like to go over some of the major accomplishments of this passing year.
GCT study team is proud to announce a huge milestone achievement – the last study subject has been randomized in multinational Phase III clinical study in patients with a previous preterm delivery – the largest obstetrics/gynecology study conducted so far. GCT was responsible for the enrollment of over 1,000 patients in CEE region including Ukraine, Russia, Hungary, Czech Republic and Bulgaria. Last patient was randomized in April 2018.
In the beginning of the year, GCT has successfully received regulatory approval for Phase II Age-related Macular Degeneration program in the EU. Patient recruitment was completed on time, and all patients have now completed the treatment. With PK samples being analyzed, GCT and Sponsor are working closely towards studies’ completion.
An International Multicenter Phase II study in Patients with Non-Hodgkin lymphoma is currently ongoing in 6 countries, including Ukraine, where it was initiated by GCT. The enrollment was successfully completed in September, and due to the efficient work of the Ukrainian sites, the required number of participants were randomized within a very short period.
GCT received an approval for an international, double-blind, Phase III, cardiac surgery study sponsored by a European biopharmaceutical company. In November, the leading Russian Cardiology Institute has randomized the first patient in the study.
GCT has been awarded the international multicenter Phase I-II study in adult participants with relapsed or refractory Peripheral T Cell Lymphoma (PTCL). The planned study will be conducted across 17 sites by GCT in the U.S., Russia and Ukraine.
A randomized, double-blind, placebo-controlled phase II trial will be conducted at 3 U.S. sites under GCT management. Study design assumes enrollment of approximately 30 patients with mild to moderate Alzheimer’s Disease randomized in 3 treatment groups.
GCT team is conducting qualification of pre-selected professional Alzheimer’s Research Centers and will be ultimately responsible for crucial study activities, including regulatory support, local project management and monitoring.
2018 CONFERENCES & EVENTS
We continue to actively participate in the industry events worldwide and we hope to meet with you even more frequently in 2019. We would like to thank all the event organizers for thebrightest moments and valuable networking opportunities.
Photo: Eugene Selivra, MD, CEO, GCT
GCT was proud to be one of the key Sponsors for this two-day event. EM-Phases 2018 served as a professional platform for all parties involved in improving and advancing clinical trials in Central, Eastern & Southern Europe, Turkey & MENA, Russia & EAEU. Our CEO, Eugene Selivra, MD delivered his presentation “Do you need a local partner to speak the local language?”
Photo: Irina Ryzhkova, Deputy Director Legal Affairs, GCT-Russia at IV ST.Petersburg International Oncology Forum
Over 4000 participants visited the forum organized by the National Research Institution of Oncology. Irina Ryzhkova, Deputy Director Legal Affairs at GCT-Russia, spoke on “Protecting Investigators’ Rights” topic, which triggered heated debates at the round-table discussion.
Photo: Dr. Eugene Selivra, CEO GCT, with Ingela Wiking, the owner and CEO of IRW Consulting
Eugene Selivra enjoyed most pleasant meetings with our old partners and acquired new valuable connections at Life Science Days, the central networking event for Scandinavian Pharmaceutical, Biotech and Medical Device business.
The Clinical Trial Financial Management summit took place in Philadelphia on December 5-6, 2018 to gather together Sponsors, CROs, AMCs and sites to discuss the management of financial aspects of clinical trial agreements.
Nataliya was representing CROs, and shared best practices used at GCT, alongside with the Sponsor and Site representatives
Dr. Jeffrey T. Apter was invited to be the keynote speaker at Alzheimersmeet – 2018 at Hyatt Regency in Dubai, UAE. GCT President gave a speech on the topic “Current Trends in Disease Modifying/ Preventive Therapies for Alzheimer’s Disease” during the ‘World Congress on Alzheimer’s Research and Therapeutic Advances’ held by Aquilus International and Alzheimersmeet committee. He highlighted the latest techniques used to reduce AD symptoms and fight the disease.