Whitepapers

IBV Executive Brief: The new biopharmaceutical blueprint

Reene — Wed, 02 Jan 2008 11:03:21 -0500

Bringing a pharmaceutical product to market takes more than good science. It takes an agile business to respond to the changing market dynamics. This paper explores how service-oriented architecture

IBV study: In the interest of the patient

Reene — Wed, 02 Jan 2008 11:00:33 -0500

While the pharmaceutical industry is seeking to replace the blockbuster model of drug development, healthcare is struggling with rapidly rising costs. This paper explores how by collaborating and

The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities

Thu, 13 Dec 2007 11:28:41 -0500

A major white paper, “The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities,” was published by RegentAtlantic Capital, LLC, a Chatham, New Jersey-based

The hottest jobs in science, and how to land them

Reene — Tue, 27 Nov 2007 08:48:44 -0500

This essential guide provides a comprehensive and systematic overview of careers in the life science industry, with all their ups and downs. The author has conducted interviews with hundreds of key

Survival of the Fittest: Business Process Outsourcing: The Key to Keeping up with the Industry and Regulatory Evolution

zach — Thu, 08 Nov 2007 09:57:20 -0500

According to Darwin’s "Survival of the Fittest" principle, you can’t guarantee success just by becoming bigger or smarter. In Darwin’s theory, the ability to adapt to changing conditions is the

Transforming the Drug Development Process: Finding the critical path to greater efficiency

zach — Thu, 18 Oct 2007 16:49:04 -0400

The industry is under pressure to stem drug attrition rates and alter business strategies to account for fewer blockbuster drugs making it to market. But how do you commercialize drugs more quickly

Roadmap to Reimbursement: A How-to-Guide on Securing Reimbursement

zach — Thu, 20 Sep 2007 15:08:07 -0400

This report, by Fortune 100 reimbursement executive William Ashton, highlights ways companies can avoid common pitfalls and begin to build a complete, effective reimbursement strategy to maximize

10 Tips to Consider when Planning for Accountability, Reconciliation and Destruction of Clinical Trial Material

Reene — Thu, 16 Aug 2007 18:20:34 -0400

All experimental compounds tested in humans during clinical development are under stringent control to ensure that these drugs are administered only to eligible patients participating in approved

Better Feasability For Global Clinical Trials

zach — Tue, 07 Aug 2007 18:02:36 -0400

Today’s clinical trial landscape is littered with trials that fail to meet their planned timelines and patient accrual. For any large Phase III program, a global footprint will be necessary in

Clinical Research in Taiwan, South Korea, and Malaysia

zach — Tue, 07 Aug 2007 17:59:11 -0400

Taiwan, South Korea and Malaysia are fertile ground for clinical research to support global drug development. All three countries offer large patient populations and qualified pools of medical

Evolving Roles for Submission Managers

Wed, 01 Aug 2007 12:54:59 -0400

The field of submission or dossier management has changed significantly in recent years. New electronic submission requirements, new technologies and varied agency implementation schedules for eCTD

Pharmaceutical Product Commercialization

maureen — Mon, 23 Jul 2007 09:46:31 -0400

Increasing R&D costs, generic competition and fragile pipelines make the successful launch of new drugs critically important for pharmaceutical and biotechnology companies. Optimal resource Read more...

The Difference with Biologics: The Scientific, Legal and Regulatory Challenges of Any Follow-On Biologics Scheme

maureen — Mon, 23 Jul 2007 09:19:45 -0400

The paper details the legal and regulatory implications of the many important differences between biologics and traditional “small molecule” drugs. Read more...

The Myth of the Anticommons

maureen — Mon, 23 Jul 2007 09:15:40 -0400

The theory claiming that the over-patenting of biotechnology research hinders the research and development of new treatments is not supported by empirical evidence, concludes a white paper released Read more...