Alan Morgan offers an overview of Europe's rapidly evolving CRO landscape.
Perceptive Informatics (US), the technology subsidiary of PAREXEL International Corporation (US), has announced the release of an enhanced version of its comprehensive clinical trial management system (CTMS) IMPACT technology.
An adaptive clinical trial is defined as a study that includes a sequence of interim analyses to enable sponsors to modify the course of a trial dynamically. The earliest and simplest forms of adaptive trials were those where interim analyses were used to stop trials early, because of overwhelming (and statistically significant) evidence of efficacy.
Over the past four decades, Ireland has developed a thriving pharmaceutical sector, thanks to a government policy designed to promote inward investment. It is now the world's largest net exporter of pharmaceuticals, with 29 plants approved by the US FDA. Initial pharma manufacturing operations in the 1960s focused on primary manufacture, and formulation into finished dosage forms followed later. However, as costs rise and it is becoming ever cheaper to manufacture medicines in places such as India and China, the country is trying hard to move up the value chain, into research and development.
Every component of the European pharmaceutical sector — industry, regulators, clinicians and academics — is going to spend the next few weeks in a desperate attempt to regain its respectability and rebuild confidence. In the latest crisis to hit the sector, the "blame the other guy" approach is likely to feature even more prominently than usual. So expect some starshells bursting over the usually sombre world of European Union consultations.
By involving members of the relevant groups as required, each workshop can extract information to match the interests of all of these stakeholders.
According to popular myth, older elephants instinctively leave their group when they reach a certain age, and direct themselves to a special area known as the elephants' graveyard, where they die, alone and far from the group. There are those who believe that the elephants' graveyard is an accurate analogy for regulatory affairs in the pharma industry, where old, exhausted R&D folk migrate over to Regulatory for their last few years before retirement.
Pfizer's ousted chief executive has left with a controversial financial package totalling up to $200 million. In a filing with the US Securities and Exchange Commission, Pfizer noted that Henry (Hank) McKinnell, who stepped down as chief executive in July 2006, will receive over $180 million consisting of stock totalling more than $20.7 million, $77.9 million in deferred compensation and cash, and an estimated $82.3 million in pension benefits (an annual payment of $6.6 million for the rest of McKinnell's life). Contingent on future stock performance, McKinnell could also receive up to an additional $18.3 million stock award.
The wrangle over the unexpected generic version of Sanofi-Aventis' blood-thinning agent Plavix (clopidogrel) is set to continue, after a US court granted the company, and its US marketing partner Bristol-Myers Squibb (BMS), an injunction blocking Apotex's rival product.
