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PUBLICATIONS

Summer 2012
   
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Marketplace & Business

Business Management

Big Pharma in Crisis?

Despite the challenges the industry currently faces, Big Pharma is looking for new ways to render the drug development process more efficient and sustainable, as Chris Swain of Cambridge MedChem Consulting discusses.

 
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UK Survey

Life Science Expectancy

Nick Stephens at RSA explores the results of the UK Life Science Industry Leaders Survey, highlighting disappointment at the Government’s lack of support for the industry and the areas with potential for growth.

 
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Pain Management Therapeutics

In Search of Relief

With an ageing population and promising new treatments in the pipeline, the pain management market is set to continue its growth. Swapna Soni at GBI Research highlights the key trends in this sector.

 
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Clinical Trials

Strategic Outsourcing: Clinical Trial Management

Changing Landscapes

Outsourcing the management of a clinical trial can prove to be a beneficial strategy. Tom Avery at ERT considers the pros and cons of such an approach, with reference to respiratory therapeutics and ePRO.

 
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Regional Trials: Asia

Find your Partner

As Asia continues to grow as a centre for international drug development, it can be useful to consider the benefits of working with a local CRO, as Young Jack Lee at LSK Global PS discusses.
 
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Feasibility Studies

Weighing up the Options

Alexandra Terzakis at SIRO Clinpharm suggests that a feasibility study is essential to the success of a clinical trial, incorporating regulatory considerations, patient recruitment expectation and any anticipated costs.

 
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Early Phase Trials: Oncology

Starting Blocks

As the field of oncology drug development continues to grow, Jane Bentley at Novella Clinical explores the best way to optimise Phase 1 clinical trials, from improving protocol preparation to monitoring data.

 
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Legal & Regulatory

Obesity Drug Development: FDA Guidance

The Heart of the Matter

Regina M Ballinger at Thomson Reuters provides an overview of the obesity drug market, and considers the regulatory guidance in relation to a number of potential new drugs in the pipeline.

 
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Observational Studies: Regulatory Considerations

Seeing Clearly

Providing real-world data for decision making, non-interventional studies (NIS) must still adhere to the relevant regulations. Rohini Chari at United BioSource Corporation explores the key considerations for setting up an NIS.
 
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US Pedigree Laws

Patchwork Approach?

US drug pedigree laws were established in order to combat the rise in counterfeit drugs. Dirk Rodgers of RxTrace.com examines these regulations and suggests that they need to go much further in order to ensure supply chain integrity.
 
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Drug Development & Delivery
Drug Development: Virtual R&D

A New Dimension

Karyn Korieth at CenterWatch investigates the development of new virtual research companies, which seek to overcome declines in productivity by adopting radical new methods for R&D.
 
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Reviews & Previews

Book Review

A Problem Shared

Graham Hughes reviews Portfolio Programme and Project Management in the Pharmaceutical and Biotechnology Industries, edited by Pete Harpum.

 
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Data Management & IT Solutions

Strategic Outsourcing: Data Management

An Evolution of Engagement

Greater involvement in the CRO-sponsor relationship, coupled with a consideration of the technology involved in research, can help both parties to remain competitive, as Graham Bunn at Medidata Solutions Worldwide explains.

 
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Cool Chain, Labs & Logistics
Supply Chain: Outsourcing

Turning Tide

Outsourcing logistics activities need not be as daunting a task as many pharmaceutical companies perceive it to be. Fabio Mioli at DHL Supply Chain discusses the benefits of working with a specialist supply logistics service provider.
 
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In Conclusion

Paying the Price

Graham Hughes considers the industry’s approach to drug pricing.

 
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Medical Writing

Regulatory Submissions

Re-Writing the Rule Book

Outsourcing the process of writing regulatory documents provides reliable expertise, flexibility and cost-efficiency, as James Sawyer at Prism Ideas explores.

 
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News and Press Releases

Takeda Provides Updates on Its Pharmacokinetic-guided Prophylaxis Studies at ISTH 2020, Reinforcing Its Commitment to Advancing Personalized Care for People with Bleeding Disorders

July 12, 2020 - The Data Demonstrating Benefits of Pharmacokinetic-Guided Prophylaxis Therapy in Hemophilia and von Willebrand Disease are Among 13 Presentations from Takeda’s Hematology Portfolio and Pipeline
More info >>

White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
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Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

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