“Planning for Reimbursement Success in Clinical Development”

Sven Kili of Sanofi Biosurgery joined us for Stem Cells & Regenerative Medicine Congress USA 2014 to present about ‘ Planning for Reimbursement Success in Clinical Development’.   Download his presentation now to understand more about: Focusing on value in planning and carrying out a clinical development plan Mechanisms to develop a value message Key opinion leader management and reimbursement planning Launch activities–focusing …

Exploratory Development Strategies

At the 2014 Exploratory Clinical  Development World Europe, Andreas Wallnoefer, Senior Vice President, Roche, gave a presentation on “Exploratory Development Strategies.” Download and learn: Strategic Considerations in R&D What not to do What to do Enhancing Probability of Success What matters for R&D productivity Exploratory Development strategies Personalized Healthcare and tailored Summary & Conclusions Download Presentation Found this interesting? Join us …

Clinical development planning needed for an effective product launch

Sven Kili, Senior Director, International Medical Affairs – Biosurgery, Sanofi joined us at the 9th Annual World Stem Cells & Regenerative Medicine Congress to present on ‘Clinical development planning for an effective launch.’ Download this presentation now to find out: Designing a clinical trial programme to support planned commercialisation Launch Strategies and timing Post-marketing activities –including Key Opinion Leader Management …

Download: What can we do to accelerate drug development?

  At last year’s Exploratory Clinical Development World Europe event, Massimo Bai, Global Head Clinical Pharmacology, UCB, gave a presentation entitled “What can we do to accelerate drug development?” Download and learn: Exploring valuable tools How (un)successful is drug development? Attrition rates grown…more late stages failures Better Understanding of Exposure, Occupancy, PD Modulation The challenging process of developing new drugs …

“Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?”

  This article, provided by iCardiac Technologies, is entitled The IQ-CSRC Prospective Clinical Phase 1 Study: “Can Early QT Assessment Using Exposure Response Analysis Replace the Thorough QT Study?” Learn about: Study Design Selected Drugs And Doses Ecg And Pharmacokinetic Methodology Data Analysis And Interpretation Criteria For Qt Assessment Justification Of Sample Size Can The Outcome Of The Study Influence The Current Paradigm For …

Download ebook: Top challenges in developing predictive biomarkers

  At Exploratory Clinical Development World Europe 2013, we gathered several high level attendees and produced video interviews discussing the topic: “What are the challenges in developing predictive bio-markers?” These video interviews have been gathered and presented in the following ebook and contain feedback from: Maria Hernandez Fuentes, Kings College London Fred Pritchard, Celerion James Dow, Daiichi Sankyo Borje Darpo, iCardiac …

Download Presentation: Innovative R&D, why not?

Earlier this year at the BioPharma Asia Convention, Hiro Sugii, VP and Head of CMR division Japan & Korea, Novo Nordisk delivered the presentation ‘A pharma perspective: Assessing challenge and opportunity in expanding clinical development beyond Japan.  Innovative R&D, why not?' The outline of this presentation is as follows: Latest situation of Japanese Regulatory Affairs Understanding the pro-active globalization of …

Increasing struggles in cell therapies manufacturing as production ramps up

Even though there has been an increasing number of cell therapies advancing to late-stage clinical development, several aspects of cell therapy development continue to present considerable challenges for large scale commercialization. It is clear that production of biologics in general carries higher risks than of small molecules pharmaceuticals and this becomes even more evident as production of cell therapies ramps …

Top 5 Presentations from Last year’s World Orphan Drug Congress Europe

As the agenda and speaking faculty takes shape for the 4th Annual World Orphan Drug Congress Europe, we wanted to take a look back at some of the leading presentations, debates and discussions that took place at last year's event. According to a new 2013 Orphan Drug Industry Report from Evaluate, the worldwide orphan drug market is set to reach …

Download: Clinical developments in the therapeutic antibody space – the results to look out for

In talking to many high-level personnel from across the  therapeutic antibody field, one thing becomes blatantly obvious – they want to see some clinical data. The state-of-play across the different sub-fields of the antibodies sector is vastly different – the ability to generate therapeutic monoclonal antibodies is well and truly established, and their effectiveness as disease treatments proven. In the …