Now in its 6th year, the Christine Pierre Clinical Trials Lifetime Achievement Award, in association with mdgroup, celebrates the ground-breaking work and contributions of individuals across the field of clinical trials who are making a positive difference. The shortlist for the 2020 prize has been announced and we are taking a closer look at each of the nominees - see all the profiles here. Here we focus on Dr Blanka Seklecka, Early Clinical Trials Unit Manager at the University Clinical Centre in Gdansk, Poland. Cast your vote here to have your say on this years winner.
Why she was nominated
"Dr Blanka Seklecka is the originator, founder and manager of the first multidisciplinary Early Clinical Trials Unit (ECTU) in Poland. She has created an internal quality system for conducting clinical trials and ECTU goes from strength to strength - after just one year of operation, ECTU has opened 23 clinical trials. Caring for the safety and effectiveness of patient treatment, the Centre cooperates with a computed tomography, magnetic resonance and positron emission tomography laboratory, a pathology laboratory with automated equipment for immunohistochemistry, a genetic laboratory with next generation sequencing and a local laboratory, where urgent tests are performed.
Thanks to Blanka, the ECTU team has knowledge of all phases of clinical trials, the guidelines of international and national governing around clinical trials, and of drug pharmacokinetics and pharmacodynamics. She has trained the team to give them the ability to identify factors affecting safety, related to the active substance, specific pharmaceutical form, administration and characteristics of the population for which the test product is intended.”
In her own words...
“Over 9 years of research management and leadership in therapeutics development projects has given Blanka Seklecka, PhD, MBA, a deep understanding of how to translate human physiology and pathophysiology to pre-clinical models, perform clinical studies and successfully transition programs to Phase 1 and Phase 2 human clinical trials. In addition, she has an excellent understanding of all phases of pharmaceutical research and development, from methods and concepts of pharmacology, molecular and cell biology, protein chemistry, assay development, formulation and small-scale manufacturing. She provides leadership and mentorship and critical process evaluation from initial phases of pre-clinical development including new model development, IND filing for several programs, breakthrough designation, fast track and NDA submission, and subsequent process development from early research to Phase I-III clinical trials. Key among her duties is the recognition that risk directly impacts the likelihood of success and that this risk must be both formally and informally measured throughout the lifetime of a project. After the first year of operation, the ECTU managed by Blanka has opened 23 clinical trials and she has ambitious plans to offer the highest quality in the world.
Blanka graduated from the Technical University of Lodz with a Masters Degree in Biotechnology with a specialization in biochemistry and molecular biology. Blanka stared her PhD in Health Science in 2012 at both Witold Chodzko Institute of Rural Health in Lublin, Poland and Lund University, Sweden in the therapeutic area of nephrology. After obtaining her PhD, Blanka began Postgraduate education in the field of Organizing and Management of Clinical Trials and additionally in 2020, obtained the title of Master of Business Administration. She is a certified Project Manager (Prince2).
Blanka has been working in a number of areas of interest since 2011, firstly at the Animal House - Research and Services Center at the Medical University of Gdansk, dealing with preclinical research and development in the field of cardiovascular disorders and diabetes, then SGPlus, Malmo Sweden fulfilling the role of Preclinical/Clinical Project Manager.
For four years she has been responsible for organization and supervision of 19 bioequivalence studies phase I performed in CE and Canada for the biggest polish pharmaceutical company Polpharma (including literature review, budgeting, sites feasibility, discussions with KOLs and Regulatory Agencies, vendors selection, protocol design to the CSR review and approval, and providing answers to Agencies/clients’ queries).
Blanka’s greatest achievement however is being the head of the Early Clinical Trials Unit at the University Clinical Centre in Gdansk.
Blanka is responsible for the organization and opening of the first interdisciplinary academic clinical research centre in Poland dedicated to the most difficult phase of clinical trials of new drugs, which significantly raises the country's reputation on the world stage.
She has the overall responsibility for the successful initiation, planning, design, execution, monitoring, controlling and closure of more than 20 clinical trials projects. Since June 2020 she is a Coordinator of the Clinical Trials Unit Working Group of the Association for Good Clinical Practice in Poland and clinical development expert in the Medical Research Agency under the Ministry of Health.”
How the voting works
Voting is now open until 9 October 2020, 12pm GMT. We will impartially encourage our online community to vote; each finalist is also encouraged to reach out to their colleagues and contacts. Anyone in the online clinical trials community can vote, but only once each. Both voting and the opinion of the expert panel will be taken into account when choosing the winner. The prize will be presented at the Clinical Trials Europe virtual event on 4 November.