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PUBLICATIONS

Autumn 2013

   
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Keynote
Editor’s Letter

Graham Hughes picks up on the theme of risk that runs through many articles in this edition, from informing patients about drug safety, to protecting business operations.
 
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Marketplace & Business
Academic Research Organisations

Lighting the Way

Academic bodies are making a big comeback, challenging contract research organisations in the global trials marketplace. Cyrus Park at Julius Clinical charts their history and addresses some misperceptions over their role.
 
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Business Performance

Battle Ready

Emerging markets are a critical battleground for pharma companies seeking to rejuvenate their R&D business. But is it better to partner with global or local contract research organisations? Igor Stefanov at Synergy Research Group investigates.

 
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Anti-Counterfeiting

False Move

In the ongoing war against fake drugs, legal moves worldwide tend to focus on digital traceability. Mark Davison at Blue Sphere Health emphasises that manufacturers should also consider physical security and processes as part of an integrated strategy.
 
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Legal & Regulatory
Regulatory Affairs

Legal Studies


Regulatory affairs professionals have a critical role in speeding up approvals, reducing risk and improving the efficiency of multiple processes along the product lifecycle. Preeya Beczek at Pharm-Olam International looks at the skills they need.


 
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Drug Safety

Worth the Risk?

The industry hasn’t got the best record when it comes to giving patients sufficient risk information about the safety of medicines. Lisa Bolitho and Mark NelsonTyrrell at ICON Clinical Research explain how regulatory developments aim for a more proactive approach.
 
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Falsified Medicines

Keeping it Real

This summer sees tougher rules on active substances imported into Europe come into force as part of the Falsified Medicines Directive. Michael Finn and Paul Clifford at Matheson look at the implications for those in the supply chain and how they can comply.
 
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India Focus

In Conclusion

Trying Times

There is divided opinion over India as a suitable destination for clinical trials: advocates point to new and improved regulations, but many remain disillusioned, says Graham Hughes.

 
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Science & Innovation
Dosage Forms

Putting the Fizz into Formulation

From ease of swallowing through to simplifed treatment regimens, effervescent tablets and granules provide numerous patient benefi ts. Not suprisingly, a large market exists for their innovative manufacture and development, as Detlev Haack and Martin Köberle at Hermes Pharma explain.
 
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Oncology R&D

Shared Vision

Using imaging-based surrogate endpoints as biomarkers can speed up trials, underline safety and efficacy, and support clinical data for decision-making and regulatory submission, says Oliver Bohnsack at Perceptive Informatics
 
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Therapeutic Innovation

Personalised Medicine

Next Generation

Circulating tumour cell diagnostic tests have only recently become mainstream but now look set to push a new era of targeted therapeutics in oncology – with China positioning itself to take commercial advantage. Ken Pennline at LabCorp Clinical Trials reports.

 
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Risk Management

Risk Management

Healthcare Ecosystem

Expanded boundaries, new technology and end-to-end solutions offer tremendous benefits, but also bring growing complexity and risk that life sciences companies must manage.Heather Fraser at IBM discusses the issues.

 
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Research and Development
Pharma Marketing

Picture This

Pharmaceutical and healthcare brands are tapping into the growing consumer trend which interconnects health and happiness by using imagery to communicate with customers and inspire trust. Michaela Schwing at Getty Images reports.

 
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Interview
Q&A: Patient Engagement

Personal Development

Warning that the current healthcare model is unsustainable, Judith Teall at Exco InTouch examines the industry’s evolution towards personal technologies for patient recruitment and engagement in clinical research.
 
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Interview: Aurélien Dupuy

Industry Forecast

GlobalData’s Director for Oncology, Haematology and Gender Health outlines his career path and argues that the industry – and particularly small pharma – is reaching a critical point.
 
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News and Press Releases

Annual General Meeting of Gerresheimer AG approves dividend increase to EUR 1.20 per share

Duesseldorf, June 24, 2020—Payment of a dividend of EUR 1.20 per share was approved at the virtual Annual General Meeting of Gerresheimer AG.
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White Papers

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
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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.
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