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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

Nova Biomedical Launches BioProfile® FAST CDV for High Throughput, Fully Automated Cell Density and Cell Viability Analysis

January 3, 2022 – Waltham, MA – Nova Biomedical is pleased to announce the launch of BioProfile FAST CDV™, a high-throughput, fully automated viable cell density and viability analyzer capable of producing results in under 70 seconds with just 100uL of sample volume. In addition, it performs all sample dilutions internally, enabling cell culture samples up to 140e6 c/mL to be analyzed without any external sample dilution. Cell culture samples can be analyzed via the external 36-position load-and-go tray or via an innovative 96-well plate option.
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White Papers

Digital Transformation of the Cold Chain

Sensitech EMEA

The Life Sciences cold chain is a seamless and interconnected global network of people, equipment, data and processes that helps to ensure the safety and integrity of our medicines and vaccines. Cold chain logistics spending totaled $13 billion in 2017, an investment designed to protect some $283 billion in Life Sciences cold chain products, growing at 19% annually.1 Sensitech Inc., a part of UTC Climate, Controls & Security, a unit of United Technology Corp., has played an essential part in the Life Sciences cold chain since 1990, providing a comprehensive set of solutions for manufacturers of biologics, prescription pharmaceuticals, clinical trial materials, and over-the-counter drugs. These solutions help to ensure product quality, patient safety, and regulatory compliance while helping to prevent theft and optimizing cold chain performance.
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