| Industry In Figures |
Deloitte IMS
Regional Focus: Central Europe (German speaking region)
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| Drug discovery |
Dr Oliver Steinbach, Head of department technology management, Altana Pharma
The "silent" movement from functional genomics to therapeutics: the latest progress in combining RNAi and disease biology.
RNAI has so far been strong in the cancer field (in vivo and invitro models) but Dr Steinbach investigates a shift towards the disease area (inflammatory, central nervous system). He looks at the latest progress in the application of rNAI to improve efficiency and productivity at target validation stage.
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| Manufacturing |
Roddy Martin, GM and VP Life Sciences, AMR Research
- Harmonising business processes across manufacturing facilities to ensure Gmp compliance
- Lean thinking in a manufacturing environment
- Industry perspectives: 21st century initiatives
Rolf Staal, Process Robustness Network, Former Head of Industrial Excellence at AVENTIS PHARMA
Operational Excellence: Rolf Staal explains the various aspects (from product to process: PAT, Six Sigma DFSS, SPC, Process Robustness, technology) that lead to operational excellence, how they fit together and how they compliment each other.
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| Raw materials |
Competition in the world APIs market
Dr. Alberto Mangia, President of CPA (Chemical Pharmaceutical Generic Association) undertakes a detailed analysis on the increasing and fierce competition on a worldwide scale among major countries producing active pharmaceutical ingredients (APIs), with a particular emphasis on generic APIs.
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| Drug Delivery |
In light of the 50 anniversary of the commercialisation of inhalers, John Pritchard, 3M Global Inhalation Drug Delivery Laboratory Manager will cover the chronology of the development of the pMDI over the past 50 years, using this as the basis for looking at trends, future challenges and opportunities for this method of drug delivery.
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| < Back to Editor's Choice |
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| Global Perspective |
Cover story: No blockbusters: pharma in crisis
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Drug Development |
Hans Hoogkamer, Director of Life Cycle and Portfolio Alignment, Business and Science Affairs
Miriam Halperin-Wernli, VP, Head of Business and Science Affairs
ACTELION Pharmaceuticals
Product lifecycle & portfolio management: integration support corporate strategies
Given today’s challenges, what is ideal role of Product Lifecycle Management (PLM) in pharma? Hans Hoogkamer looks at how to create value using PLM & portfolio management as well as reducing time to market & maximising profitability by integrating PLM & portfolio management.
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| Process Engineering |
Rick Friedman, Team Leader, Guidance and Policy, Office of Compliance, CDER, FDA
The guidelines for aseptic processing
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| Supply Chain |
Enrico Camerinelli, Head of the Supply-chain Council in Europe and Chief Research Officer
Forecasting: event-based. Assumption-based forecasting
Improving forecasting technologies
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| Contract services |
William K. Sietsema, PhD, Vice President, Clinical & Regulatory Strategic Planning, Kendle
Co-Authors: Alfred von Krempelhuber, PhD, Manager, Clinical Development, and Jens Vollmar, MD, Medical Director, Bavarian Nordic
Conducting a Global Program with a Vaccine
Global development programs for vaccines present special challenges for drug developers. This article describes a global team collaboration between the sponsoring company, a global clinical research organisation, and other providers for a series of clinical trials which together make up the development program of a smallpox vaccine. The challenges of writing globally-relevant protocols and of study execution in multiple countries will be discussed. Solutions and other best practices for conducting these clinical trials will be presented.
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