The first PharmAround conference took place in Hustopeče near Brno on 9 and 10 November 2012.
The introductory afternoon of the conference was devoted to presentation of the
PharmAround project and of other large CEITEC and ECRIN infrastructures supporting development of science and applied research in the Czech Republic.
The European project CEITEC was presented by the executive manager, Markus Dettenhofer,
Ph.D. Vision of the Central European Institute of Technology in Brno is to become the over regional centre of scientific excellence, results of which will be comparable with the leading centres of similar focus and comparable fully with the leading global institutions of this kind, and the research groups will utilize the unique possibilities following from synergies between live and inanimate science.
ECRIN, European Clinical Research Infrastructure Network, is the research infrastructure supporting realization of multinational academic clinical trials. It was presented by
M.D. Christine Kubiak, executive manager of the project. The introductory presentation of the infrastructure was followed by M.D. Demlová, Director of the Institute of Pharmacology and by
M.D. Svobodník of FNUSA-ICRC by presentation of the university and clinical module CZECRIN.
CZECRIN has the ambition to become the member of the pan-European ECRIN network, support of mainly the Czech research teams, academic clinical research an incorporation of local institutions and research terms into international clinical research projects in Europe being the core objective.
The issue of academic clinical trials in the field of children’s oncology was summarized by
M.D. Múdrý from Clinic of Children’s Oncology of The University Hospital Brno and this section was closed by M.D. Němcová from the State Institute for Drug Control (Regulator’s view).
The final workshop of this day was devoted to academic clinical trials. The workshop

discussed practical issues connected with realization of academic clinical trials/studies.
The day was closed by presentation of the posters.
The morning on Saturday was opened by presentation of the issue of early phase studies, i.e. studies of phase I. Lecture of M.D. Obermannová clarified briefly design of phase I studies. The
3+3 model utilized as a standard has been developed for assessment of toxicity of treatment and for finding the maximum tolerated dose, which in the era of the molecularly targeted
treatment does not satisfy fully requirements of the modern therapy. A number of designs have
been developed with the objective to accelerate this phase of the clinical study, unfortunately change in the field of early clinical assessment, the so called first in men studies, is very complex and will become the important task of the research teams. The second part of the lecture was devoted to presentation of the Phase I Unit focused only and exclusively on oncology studies; it was established in February 2012 in Masaryk Memorial Cancer Institute.
The introductory lecture was extended by doc. Votava from the 2 nd Faculty of Medicine of Charles
University by presenting the topic of “Biosimilars“. The first part of the lecture was devoted to requirements of regulatory authorities, to news in EMA instructions for ”Similar Biological Medicinal
Products“; the lecture was closed by proposal of the practical procedures necessary for the fulfilment of the conditions of marketing authorization of biosimilars.
The issue of the “Orphan drugs”, i.e. medicinal products for rare diseases, was presented by
M.D. Kubáčková from the University Hospital Motol, her lecture was also devoted to presentation of the website www.orpha. net enabling quick orientation in the issue of “orphan “ diagnoses. The
objective of the “orphan “ policy is to ensure availability of the complex care for the patients with rare diseases (psychological care, social care, medical care) , to determine a clear legal status
(conditions and advantages) of specialized treatment centres and to ensure access of the patients to
new drugs for rare, not yet incurable diseases in the future.
Results of pre-clinical research were presented by the lecturers from Masaryk University and from

FNUSA-ICRC. M.D. Pešl presented possibilities of utilization of the stem cells in cardiology and the
first research realized by ICRC. Mesenchymal stem cells and possibilities of application in therapy
was the core topic of the lecture of Mgr. Skopalík from the Institute of Pharmacology – ACIU.
Dendritic cells and clinical study of phase II in oncology patients with metastasizing renal carcinoma, running in cooperation with the Faculty of Medicine of Masaryk University, was presented by professor Michálek.
The last lectures of the conference were devoted to medicinal products for modern therapy.
The overview lecture, presented by M.D. Demlová, opened this section. Presentations of M.D. Deml from CEITEC and M.D. Kotrba from Pharmeco were dedicated to the issues of modern therapy control and to price and reimbursement aspects.
The first PharmAround conference brought a number of education lectures mapping the “drug life
cycle”, enabled meetings of academic, pre-clinical and clinical specialists with representatives of the
regulatory authority and also enabled confrontation of different aspects and views by a live interdisciplinary discussion.