Expanded access to healthcare data will modernize drug-safety assessment and product development.
Aug 1, 2008
By:
Jill Wechsler
|
The Sentinel System aims to generate more adverse event reporting by health professionals, to analyze health information more effectively, and to enhance FDA methods for communicating new safety information to providers and patients.
By taking the patient's well-being into account, manufacturers can improve their productivity.
Aug 1, 2008
By:
Kim Thomas, Darren Hieber
|
Manufacturers of biopharmaceuticals can improve productivity by taking patient wellness into account.
When a new plant relies heavily on single-use technologies, facility design no longer depends on the process. Instead, other considerations, such as workflows, take center stage.
Aug 1, 2008
By:
Andrew Sinclair, Miriam Monge
|
In addition to making technical developments, vendors are also looking at ways to improve supply-chain security. By offering standard, off-the-shelf products, vendors are able to shorten lead times and improve the security of supply.
Economic incentives and regulatory flexibility can spur development of treatments for small patient populations.
Jul 1, 2008
By:
Jill Wechsler
|
The US Food and Drugs Administration is boosting its efforts for orphan drugs development.
In the current market crisis, biotech IPOs and financing are down, but partnering continues, and M&As are as hot as ever.
Jun 1, 2008
By:
G. Steven Burrill
|
Following the market crisis of the first quarter of 2008, biotech IPOs and financing are down, but partnering continues, and mergers and acquisitions (M&As) remain hot.
Proper auditing can ensure the selection of a capable contract manufacturer.
Jun 1, 2008
By:
Josée Ethier, Chantal Déziel
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It is important to understand critical aspects of the CMO's capabilities. Only by auditing certain key areas can the sponsor be assured of the quality of the materials produced.
Biotech companies fear comparative effectiveness analysis will emphasize product costs over value.
Jun 1, 2008
By:
Jill Wechsler
|
The comparative research approach may be preferable to price controls in the guise of government negotiations for the Medicare drug benefit, coverage denials, and limits on access to new technologies.
To understand the overall cost impact of disposable technologies, it is necessary to build a robust model that covers the entire process.
Jun 1, 2008
By:
Andrew Sinclair
|
The current focus on cost-of-goods (COGS) models is underplaying the benefits of disposables technology in biopharmaceutical manufacturing. The best method for accounting for the benefits of reduced and delayed capital expenditures is through the use of NPV analysis.
The biomanufacturing building boom is merging with several industry trends to create a looming overcapacity situation.
May 1, 2008
By:
Jim Miller
|
The current overcapacity situation in the bio/pharmaceutical industry is a reminder that CMOs need to come up with business models and value propositions that are based on more than just selling capacity.
