The Top 5: June 2016

5th July 2016 (Last Updated July 18th, 2018 11:49)

CTA highlights the best articles from the month of June 2016

The Top 5: June 2016

There were numerous articles in June 2016 that covered a wide range of topical issues. Here are five of the best stories you might have missed... (click the headline to finish reading the story)

 

The Brexit Fallout: What does the future hold for the UK Pharma and Medical Device Industries?

On June 24, 2016, much of the UK woke to the news that its nation had voted to leave the European Union.

The EU referendum result, although not unanimous, was telling as 52 percent of the British electorate voted in favour of a Brexit (or British Exit).

When Prime Minister David Cameron swiftly announced his resignation on the steps of 10 Downing Street, he made clear the onus would be on his successor to negotiate terms of the UK's exit.

Furthermore, once Article 50 of the Lisbon Treaty is invoked, the UK will have two years to wrap up its affairs, drawing to a close its 43-year relationship with the EU.

But as the dust begins to settle, researchers around the country are starting to fret over what the result could mean for UK clinical research. Indeed, the ramifications may not be felt for years to come.

R&D opportunities and challenges in Brazil

Brazil is a large country with over 200 million inhabitants, making it the largest population in Latin America. Divided into five regions, the country is the sixth largest pharmaceutical market in the world where regulatory compliance to clinical trials is upheld by an experienced and qualified workforce.

At first glance, these figures could be attractive for pharmaceutical and biotechnology companies. However, regulatory frameworks in Brazil are restrictive.

 

The Ebola Outbreak: The Challenge of Establishing a Clinical Trial during an Epidemic

The scale of the 2014-2016 West African Ebola outbreak was unprecedented, and led to a global response. As part of this response, clinical trials of the most promising candidate Ebola prophylactic vaccines were fast-tracked for testing in both affected and non-affected countries. Through the EBOVAC1 consortium of global health and research institutions, a collaboration between the London School of Hygiene & Tropical Medicine, the College of Medicine and Allied Health Sciences (Sierra Leone), and Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) was established to coordinate the EBOVAC-Salone clinical trial of a prime-boost Ebola vaccine regimen developed by Janssen. Operating in a compressed timeframe, and with the epidemic still claiming lives across Sierra Leone, the team met significant challenges particularly in the fields of regulation, operationalizing the trial, and community mobilisation.

Would a Brexit place the UK in a regulatory quandary?

Across the British Isles, public discourse in recent months has centred on the United Kingdom's place within the European Union. The two political campaigns at the heart of the debate - Vote Leave and Vote Remain - have engaged in a bitter war of words as each camp argue their case for and against the UK's membership in the EU.

Within the industry, general consensus leans toward the UK staying in the EU, with two of pharma's biggest players, AstraZeneca and GlaxoSmithKline, recently signing a letter declaring their preference to remain. On this, experts have argued that if the UK left the EU, the cost to start-up and conduct trials would sky rocket, thereby damaging the UK's clinical trials market.

Meanwhile, the much maligned EU Clinical Trials Directive (CTD), established in 2001 (adopted in 2004), has been used by those in the leave campaign as a prime example of why UK clinical research would fare better outside the confines of the EU.

Navigating Both Sides of the Consulting-Client Equation

I recently set up a consulting business after spending the vast majority of my 28-year career on the "client side" of the equation. This is my second stint in consulting - the first being a six-month bridge while I transitioned out of one start-up and into another. That was straightforward; only two clients and well-defined start and stop dates. The encore is a very different story and it got me thinking about the various aspects of the consultant-client relationship. For instance, why is a company's experience with one consultant so productive and so poor with another? And why does a consultant perform so spectacularly with one company and can't get anything done at another? We frequently attribute these scenarios to greatly over-simplified clichés without fully understanding the true reasons behind successful and failed consulting relationships. My thoughts below may or may not be applicable to your specific situation but I've provided some insights that might help both sides of the equation.