obstacles, global development, biosimilars

Regulatory provisions as facilitation and obstacles to global development of biosimilars

At the Biosimilar Drug Development World Europe event 2014, Andrea Laslop, AGES PharmMed gave a presentation on “Regulatory provisions as facilitation and obstacles to global development of biosimilars” Download and learn: Biosimilar regulation in EU Biosimilar regulation/approvals in other regions Joint approaches – the biosimilar “cluster“ Summary Download Presentation Found this interesting? Join us at next year’s Biosimilar Drug Development …

observational research, payer, development, value, outcomes research, evidence europe

How can observational research be used to improve value development?

  At Evidence EU 2014, Clément François, Global Outcomes Research, Lundbeck gave a presentation on “Meeting payers’ needs: How can observational research be used to improve value development?” This presentation discusses the use of observational data through the different phases of development, as well as the different data sources for different objectives-from small dataset to large automated health care database. …

Download: The Evolving Landscape of Real World Evidence Development

  Marcus D Wilson, Pharm.D. gave an in depth presentation at last year’s Evidence USA event in Boston on “The Evolving Landscape of Real World Evidence Development: Understanding Value.”  In his presentation, he drives home the point that of all the relationships in healthcare, this one is the most important. Key topics discussed in the presentation include: Key Challenges in …

The Stem Cells Regenerative Medicine Congress is where experts like Russell Marians of LABS Inc meet to network, learn from each other, and discuss the latest stem cells strategies and technology.

LABS Inc on ensuring successful scale-up manufacturing

We were glad to have Russell Marians, Senior Scientist and Manager of Molecular and Cellular Biology at LABS Inc., present at the Stem Cells & Regenerative Medicine Congress in 2013. You can now download his presentation slides and video from the event, where he addresses how a winning assay development strategy is critical to ensure successful scale-up manufacturing. Download the presentation …

Stem Cells USA is where experts like Argos Therapeutic's Fred Miesowicz gather to network, learn from each other, and discuss the latest stem cell strategies and technology.

Fred Miesowicz of Argos Therapeutics on Automated Manufacturing and Commercial Planning

Fred Miesowicz, Chief Operating Officer of Argos Therapeutics, presented at the Stem Cells & Regenerative Medicine Congress in 2013. You can now download his presentation slides from the event, where he addresses how to benefit from automated manufacturing and commercial planning from very early stages of development. You can also view the recording of his presentation alongside these slides, so …

BioPharma Mexico is where experts like AstraZeneca's Ajam Gautam meet to network, learn from each other, and discuss the latest biopharma strategies and technology.

AstraZeneca’s Ajay Gautam on Innovative R&D for Emerging Markets

We were glad to have Ajay Gautam, Executive Director and Head of Emerging Markets R&D at AstraZeneca, present at last year’s BioPharma Mexico. You can now download his slides from the event, where he addressed innovative R&D models for emerging markets under the main heading “How to grow the Mexican pharma industry”. View the presentation here Dr. Gautam has a …

The Current Phase I Landscape

  Can we more efficiently translate our growing biological understanding of cancer into relevant novel treatments?  That is what Dr Bruno Osterwalder, Senior VP, Senior Strategic Advisor Oncology, Merck Serono, Darmstadt, Germany discussed during his presentation at the Exploratory Clinical Development World Europe event held last year. In his presentation, “The Current Phase I Landscape,” Dr Osterwalder covers: Attrition in Phase III Continues …

Download: Top challenges in assessing the safety for a new compound

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 assessing the safety for a new compound?” 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 …

Inforgraphic: Innovation in Pharma 2013

Last week saw Deloitte publish it’s fourth annual report looking at the return on investment pharmaceutical companies are seeing in their research and development projects. The report, co-produced with Thomson Reuters, looks at the current state of development pipelines in 12 top life science companies, and calculates a projected financial return for their products in the late stages of the …

Innovation in Pharma 2013: Top tips for the future

Last week saw Deloitte publish it’s fourth annual report looking at the return on investment pharmaceutical companies are seeing in their research and development projects. The report, co-produced with Thomson Reuters, looks at the current state of development pipelines in 12 top life science companies, and calculates a projected financial return for their products in the late stages of the …