Closer to novel bone drug

The European Calcified Tissue Congress (ECTS) in Prague was the venue of the 2nd OSTEOGROW Progress Meeting from 19-20 May, 2014. OSTEOGROW coordinator, Prof Slobodan Vukičević, hosted the two-day event. Its objective was to implement the preparatory steps of the clinical trial, which is at the core of OSTEOGROW. The FP7-funded research project aims at harnessing novel bone therapy to accelerate and enhance bone repair.

The first day of the meeting saw the follow-up of the present project status, which included the evaluation and discussion of production process and preclinical pharmacologic and toxicological data. Additionally, the preparation of the Phase I application for the regulatory authority in Croatia (HALMED) was discussed.

Detailed report from the scientific advice meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) on May 6th was presented by Ruth Paul. MHRA gave a positive opinion on all questions from the briefing document prepared for the meeting by OSTEOGROW partners.

On the second day, the clinical trial design and implementation as well as recruitment and enrollment criteria for patients were topics for a vivid exchange within the consortium. Moreover, the new member, Prof Vladimir Trkulja of the Zagreb University School of Medicine, was introduced. As a special feature, Katarina Orešković and Radan Spaventi from Triadelta Partners provided consultation for the preclinical and clinical package for regulatory approval.

The fruitful meeting was rounded off by discussions of administrative aspects as well as the exploitation and dissemination of research results. The consortium also decided to hold the next meeting at the beginning of 2015 at the Medical University of Vienna, Austria