July 21, 2019trends

Pfizer’s Diet

Innovation On Rise, Says Citeline

July 16, 2012

Is the industry’s reliance on me-too drugs on the verge of reversing? Could pharma be on the cusp of a new cycle of innovation? That’s the possibility raised by Ian Lloyd. He has been studying industrial R&D for more than 20 years and currently serves as editorial director of Citeline, part of the Informa empire of trade shows and scientific publications. Citeline recently issued its annual report on clinical R&D. The British firm draws upon a mix of proprietary, unpublished research and public data from government trial registries such as ClinicalTrials.gov. Biologics & Small Molecules Citeline’s research process is intensive. The organization monitors the medical literature and corporate press releases. That’s easy enough. But Citeline also periodically labors to verify that a much-heralded compound in clinical testing is in fact progressing toward regulatory approval or market launch. The vetting process knocks some projects out of the database, ensuring it contains only…more...

$21 Billion JNJ Pact

Pipeline Snapshot: Synthes

April 29, 2011

Earlier this week, JNJ said it will buy the Swiss medical device firm Synthes for $21.3 billion. A debased U.S. dollar isn't worth much these days. Still, 21.3 billion of anything…more...

Amgen’s Expert

Is Project Management ... Strategy?

July 13, 2010

The project manager’s lot in life is not always glamorous and filled with the drama of a James Bond movie. But as with any job in any industry, the project manager’s…more...

Ethics Study

Rewarding for Recruitment

May 10, 2010

In watching respiratory therapists recruit for two studies under way in her departments at both Mount Sinai Hospital and SickKids Hospital in Toronto, neonatologist Sharon Unger thought she saw a trend.…more...

Almac's Web Tracker

Smart Supply Thermometers

March 12, 2010

Not all that long ago, shippers of drug supplies for clinical trials were content to know: Did our drug ship? Then they wanted to learn: Did our supplies get stuck in Ukrainian customs—or at the depot? Now Almac Clinical Services is offering another level of detail, allowing sponsors to hop online to learn How long did DHL…more...

All Sites Benchmark

MCC Goes Sigma

January 26, 2010

The drug development industry has spun its wheels for years, trying to come up with universal metrics to measure speed and efficiency. But metrics that accurately measure quality in a trial? No one has attempted that yet. Until now. The Metrics Champion Consortium (MCC), a non-profit collaborative effort of sponsors, contract research organizations (CROs) and vendors, was…more...

Our How-To

Special Protocol Assessments

January 12, 2010

Wondering what the FDA's special protocol assessments (SPAs) are all about, but too afraid to ask? Last year's Drug Information Association's (DIA) 45th annual meeting was especially helpful, as representatives of Bristol-Myers Squibb, GlaxoSmithKline (GSK) and the FDA's Office of New Drugs within the Center for Drug Evaluation and Research (CDER) presented on the topic. An SPA,…more...

Industry Survey

Frost Report on CROs

September 29, 2009

What's to become of the contract research organization (CRO) industry while the economy attempts to right itself? According to a recent report by Frost & Sullivan, there's good news: the CRO industry will likely keep growing. In the current climate, pharmaceutical and biotechnology companies are unlikely to invest in in-house capabilities to conduct their own clinical trials,…more...

Go East Young Man

ClinPage Master Providers Overview

What the members of the 2009 ClinPage Master Providers list have in common.

Biometrics Specialists

Quanticate In U.S.

Quanticate is raising its U.S. profile and considering acquisitions.

Webinar, New Guidance

EDC Is Dead? Long Live EHRs?

Thoughts on a potentially transformative alternative to EDC, the electronic health record (EHR).

A Quickening Process

Trials Thriving In Brazil

This emerging market just got more competitive with some new, potentially exciting regulatory changes. The first in a series.

Magic Pen

Kayentis: Back to The Future

From France, a hybrid system that uses special paper and a scanner-pen to gather clinical data.

100 Languages Spoken Here

Profile: Global Language Solutions

With ISO certification, a California firm tries to lower regulatory risks inherent in translation by ensuring high quality—and avoiding mistakes.

PharmaNet Outlook Down

S&P On CRO Industry

PharmaNet was downgraded from stable to negative by Standard and Poor’s, thanks to $60 million in lost contracts.

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