Dispatches from PCT

Regulatory costs will rise, fines will increase, expert warns

By Dan Stanton contact

- Last updated on GMT

Related tags: Clinical trial, Contract research organization

Economic landscape is bleak, warns expert at PCT yesterday
Economic landscape is bleak, warns expert at PCT yesterday
Economic uncertainty and a bleak fiscal outlook will lead to over-regulation and increased fines in the clinical trial industry, according to an economic expert at PCT.

“It feel like we are driving at 100km per hour in the fog without being able to find the brakes,”​ was how co-founder of economic publication 8 Monthly Barometer, Thierry Malleret, described the current landscape to delegates at Partnerships in Clinical Trials (PCT) yesterday.

The forces that will shape the business world of tomorrow are playing their part in blurring decision makers in all industries, with evidence of this effect already in place in the pharma world, Malleret told the room.

“The fiscal outlook will make well-being mandatory,”​ he said, with the first mechanism in place to deal with the economic crisis being to regulate more. “The trend of over-regulation is already apparent in many spheres and this will increase.”

He added the pharma world would feel this in the form of increased regulatory and compliance costs, with fines becoming common-place. Just this year, he said, fines in the clinical trial worl stood at $10.6bn in the US alone.

Interdependence affecting India

The Financial Times reported Monday​ 157 previously approved clinical trials in India have been suspended due to discrepancies over numbers of deaths​ in the industry, and this, Malleret said was evidence of the times we are living in.

No longer can a company be dependent of the industry as a whole and malpractice by one firm will have lasting repercussions across the board, he argued, as is the case in India.

Velocity and Transparency

The velocity of the industry was also addressed with the cost of sequencing genomes used as an example of how rapidly things are changing. The first genome to be sequenced cost $3bn, he said, but by 2009 it had dropped to $100,000 with the cost expected to be $1,000 by 2014.

Furthermore, post Edward Snowden, transparency has become a critical issue with implications that will affect future business. “Everything is visibke to everyone,”​ he said, and industry must realise this.

Private Equity warning

In a Q&A session, Malleret was asked whether the recent spate of investment by private equity firms in contract research organisations (CROs – see PRA and RPS’s merger​, Bracket​, or PPD​, as examples) was a sign of the times.

“Many private equity firms don’t give a toss but only do it for financial gain,”​ he said. Such behaviour was characteristic of how speculation is affecting industry, but – he warned – inherent of the collateral damage the current climate is causing.

Related news

Show more

Related products

show more

What to consider when working with CRFs

What to consider when working with CRFs

Formedix | 01-Nov-2021 | Technical / White Paper

For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned with meticulous attention...

Automating clinical trials for success

Automating clinical trials for success

Formedix | 06-Oct-2021 | Technical / White Paper

This article gives gives a brief overview of why automation is absolutely essential for clinical trial success.

What should a clinical metadata repository do?

What should a clinical metadata repository do?

Formedix | 26-Jul-2021 | Technical / White Paper

Choosing a clinical metadata repository (MDR) software can be a tough task as the capabilities and features of your chosen MDR could make or break your...

Adapting supply chains to new ways of working

Adapting supply chains to new ways of working

World Courier | 15-Jul-2021 | Technical / White Paper

COVID-19 has changed the way we operate. We have adapted our supply chain solutions to meet our clients’ requirements while following World Courier standard...

Related suppliers

Follow us

Products

View more

Webinars