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Is flexible planning possible in clinical development?

Experts and professionals from the sector shared experiences and opinions at the second Lessons Learned session

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24.04.2015

The importance of a solid clinical development plan and the possibility of shortening it or making it cheaper –in addition to the various collaboration models to fund clinical trials- and the role of partnering were some of the topics discussed by experts and professionals from the sector, debating and sharing experiences at the Lessons Learned session held on Tuesday at the Barcelona Science Park (PCB).

The second session of Lessons Learned –organized by Biocat and CataloniaBio– was a total success, with more than 50 participants from pharma companies, biotech SMEs, health consultancies and hospitals. Over the 4-hour session, experts –moderated by VCN Biosciences CEO Manel Cascalló– expressed their points of view and explained their experience with the questions your must ask yourself and how to approach the design of this complex development process in order to make yourself attractive to capital investors and benefit society.

Gemma Estrada, director of the Biocat Barcelona Clinical Trials Platform (BCTP), spoke about the new tools and technology that allow researchers to accumulate data from different origins, and to interpret and exploit the information more quickly and efficiently. She also highlighted the importance of resolving –when designing a study- the 3P needs: patients, payers and promoters.

Additionally, Josep Lluís Falco, senior manager at Antares Consulting, explained that strategy comes first; developing a plan is second. It is important to start off with a good strategy and then, above all, to have a feasible clinical design in mind.

Joan Perelló, CEO and founder of Laboratoris Sanifit, discussed the impact designing a clinical plan has on attracting investment and explained the “importance of finding a segment of the population to do a quick proof of concept.”

Participants also had the opportunity to hear from Trifermed CEO Sergi Trilla about the lessons learned through real partnering cases at different stages of development. Trilla highlighted the importance of having clear ideas on several issues: a value-based business model that addresses a market need; understanding market forces and main trends; and finding a good partner to help create and attract value, as well as the advantages of internationalization.

Finally, Raül Insa, CEO of SOM Biotech, pointed out three important aspects to take into account when creating a good clinical development plan: not losing sight of what the client wants and being rigorous in regulatory compliance and creative in design.

Sharing experiences to boost competitiveness

The Lessons Learned sessions are a knowledge and networking forum geared towards professionals from companies in the life sciences arena. They aim to be a place to share experiences and reflections on the different strategic areas of knowledge and skills needed to boost the competitiveness of biotechnology companies.

Four more sessions will be held in 2015 covering various topics: IP and strategy (21 May), Negotiating with investors and licensing (9 July), Taxation and MAB crowdfunding (8 October) and Nutraceutics (12 November).

Lessons Learned abril

All of the speakers at the Lessons Learned session on Clinical Developments.

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