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Autumn 2015

   
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introduction
Editor’s Letter

Graham Hughes touches on this edition's topical talking points: diabetes and obesity, and the big data phenomenon.
 
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Business and Finance
A CEO’s Worth

Finding a Figurehead


Chris Molloy
at RSA identifies the qualities of biotech leaders that make them such a prized asset, and so integral to attracting investment from within the industry.


 
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Mergers and Acquisitions

Exit This Way


The elevation of CROs has had a knock-on effect on both ends of the pharma spectrum. With mid-tiers eager to expand their ranks, Benchmark International’s Roger Forshaw outlines advice on how smaller specialist firms can capitalise on their commercial value.
 
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Marketplace & Business
Comparator Drugs

Look Before You Leap

Touching on a grey area of concern to many within the industry, Khaled El-Gendy at Fisher Clinical Services provides a ‘how-to’ guide on seeking out the most appropriate business partner in emerging markets. Never has the phrase ‘it’s all in the planning’ rung truer.


 
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Legal & Regulatory
Regulatory Pathways

Common Cause

Steffen Thirstrup
from NDA urges pharma companies to adopt a revised and more integrated approach to market entry. The onset of the adaptive pathway provides the perfect opportunity to lose old habits, rightfully placing consumers at the forefront of their focus.
 
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Drug Development & Delivery
Q&A: Laboratory Technologies

Digesting Data


Munther Baara at Pfizer discusses the current TransCelerate initiatives he is working on – the Shared Investigator Platform and Investigator Registry – and proposes how data can be sensibly managed and utilised to maximise outputs.

 
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Diabetes Focus
Diabetes Technology

Particle Progress


EPC Industry Advisor Shelley Bowers probes newly tested diagnostic techniques with the potential to treat diabetes on a universal scale. Assessing the practicalities of management, she sees reason to be optimistic about their implementation.

 
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Diabetes and Obesity

Body of Proof


Mohamed El Malt and Vijayanand Rajendran from Europital offer a critical analysis of treatment strategies employed to manage obesity in diabetic patients across both the developing and developed worlds.

 
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Data Management & IT Solutions
Data Mergers

Big Data Meets Big Pharma

Citing a collection of the 'value-added partnerships' that have arisen in recent times, GlobalData's Adam Dion discusses the broad appeal of big data for life sciences companies. With data analytics and cloud computing continuing to develop, collaborative efforts are sure to become common practice.
 
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DATA MANAGEMENT
Data Regulation

Big Business

With fresh regulatory proposals along the Brussels pipeline allaying anxieties surrounding data protection, Beverley Flynn at Stevens & Bolton anticipates the imminent embrace of big data within the industry.
 
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Data Presentation

Lost in Translation


Barry Drees of Trilogy denounces the pomposity impeding scientific communication, arguing instead in favour of visual illustration as a means to transmit results into terms easily understood by all.
 
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Central Labs
Q&A: Central Laboratories

Under the Microscope

Hermann Schulz
of synlab pharma institute (formerly INTERLAB) talks to EPC about the prominence of centralised laboratories and how pharma companies have adjusted to the ever-greater expectations of regulatory authorities.
 
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Risk Management
Anti-Bribery and Corruption

Held to Account

Heightened US and UK anti-bribery legislation means firms can no longer turn a blind eye to third-party activity in remote places. Ben Higgins at Stroz Freidberg explains why the failure to act accountably is not worth the risk.
 
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Risk Management

Clean Room, Clean Contracts

Matthew Hardwick
and Marcella Stokell from Norton Rose Fulbright take a look at the key issues for developers when seeking to obtain secure projects. Dissecting alternate agreements on the table, they contemplate how different settlements help meet company targets and legal guidelines.
 
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Review
Event Review: PCMG Conference

Inside Out

EPC Editor Graham Hughes reports back from the recent PCMG Confernce held in Warsaw, divulging the lessons learnt from presentations given by speakers from within and outside of the industry

 
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In Conclusion
In Conclusion

Well Thought Out

Graham Hughes
applies a cautionary tone to the alleged clinical trial breakthrough for treatment of Alzheimer's disease. He warns that we should not jump the gun while prevention remains the best policy.

 
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News and Press Releases

Breakthrough in the global battle against polio: AJ Vaccines granted WHO prequalification for new polio vaccine

Despite ongoing concerted efforts to eradicate polio, it appears to be on the rise again with more cases registered in 2019 than 2018. Looking ahead, AJ Vaccines’ dose sparing technology provides a significant opportunity to expand supply, with the potential to deliver up to 100 million doses over the five-year period 2020-2024 to help meet the currently unmet global demand for inactivated polio vaccines.
More info >>

White Papers

Cleaning Validation: What do you need to consider to ensure a successful outcome?

RSSL

Cross contamination must be avoided in the Pharmaceutical industry at all costs and successful cleaning validation ensures that patients are not put at risk due to cross contamination. The process can be divided into a number of sections each of which must be fully understood and areas of concern addressed to ensure a successful outcome across the entire process. This spans both the manufacturing and subsequent analytical and microbological support. The data used to confirm a positive/successful cleaning validation is underpinned by the results of validated analytical methods. It is essential that these results are truly representative as patient safety is based upon the absence of equipment residues. So what are those areas of concern, what affects your ability to get a successful outcome and what do you need to consider when carrying out a Cleaning Validation exercise?
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Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

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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