|
|
- Features:
- In this month's issue:
- Vaccine Production
How will Contract Service Providers help?
by Gil Y. Roth
Almost
every day, we hear another story about the spread of avian flu and the
possibility that it will lead to a pandemic rivaling the disaster of
1918. Responding to this growing fear, the president recently announced
a $7.1 billion plan that would include purchase of 20 million doses of
vaccine to protect against the current strain of avian flu. The plan
also included incentives to develop new production methods, and
protection against liability claims so that vaccine makers would add
U.S.-based facilities. “If a pandemic strikes, our country must have a
surge capacity in place that will allow us to bring a new vaccine
online quickly and manufacture enough to immunize every
Ameri ... » Read entire article
- Outsourcing Discovery Chemistry
Contract research firms respond to client needs
by Steven Heffner
Outsourcing
drug discovery work was a new and uncertain concept three years ago
when Kalorama Information published its first report on the topic. Now,
it’s not only common practice, it’s a necessity for many in the
industry. Certainly, outsourcing of development work like clinical
trials management has been going on for years; contract manufacturing,
too, has proved vital to the industry; and now outsourcing early stage
discovery work is also becoming the norm. Access to innovative
technology, flexibility in approach, the conservation of capital, and
the potential time- and cost savings of contract work are generally all
major drivers of discovery outsourcing as they a ... » Read entire article
- Clinical Industry Developments
Have Wyeth & Pfizer changed the market?
by Scott Lundstrom
A
shake-up is occurring in the clinical outsourcing market.
Pharmaceutical and biotechnology companies are reexamining the ways
that they work with contract research organizations (CROs) and other
outsourcing providers as they seek to increase efficiencies in the
coming years. In a recent study, Industry Developments & Models:
Clinical Outsourc-ing Sponsors Forcing Market Change, Life Science
Insights examined the varying models espoused by two market leaders,
Wyeth and Pfizer, both of which have embarked on major efforts to
analyze their clinical operations and decide which processes should be
outsourced to best-of-breed providers, and which should be performed
in-house. We also hig ... » Read entire article
- Breaking News:
- Plus, don't miss out on the latest news in the Contract Pharma Industry at www.contractpharma.com/news.php
-
Tufts Report Predicts Drug Development Growth
The years of declining R&D productivity will be a thing of the past
according to The Tufts Center for the Study of Drug Development Outlook
2006 report on drug and biotech development trends. "Key to improving
R&D productivity is the willingness of drug developers to use new
discovery tools, such as pharmacogenomics, to accelerate the pace of
translating basic research into viable drug candidates, and the
aggressive management of clinical trials, through advanced data
analysis and outsourcing, to lower cost sites around the world," said
Tufts CSDD Director Kenneth I. Kaitin. "Turning this around will
require the industry, working with regulators, to embrace strategies
and technologies that will enhance development of more complex drugs of
high therapeutic value while improving assessments of product safety
and effectiveness. It's a tall order, but it can be done," Mr. Kaitin
continued.... » Read More
Covalent Signs $2.3 Million Contract for Cardiovascular Drug Trial
Covalent Group, Inc. has signed a $2.3 million contract with a
biotechnology company for the conduct of a multinational Phase II trial
of a new anti-thrombotic agent. This trial will assess the efficacy and
safety of the study drug in an at-risk patient population. Work on the
study is expected to begin immediately. Covalent will provide multiple
services including consulting on trial design and protocol development,
project and study site management, field operations, data management,
biostatistical support, and medical writing. Revenues will be
recognized on a proportional performance basis over the life of the
contract as services are performed.... » Read More
FDA Grants Plavix Priority Review
Sanofi-Aventis and Bristol-Myers Squibb's sNDA for Plavix for treatment
of patients with acute ST-segment elevation myocardial infarction
(STEMI) has been accepted for review by the FDA. STEMI is a heart
attack in which an artery is generally blocked completely for
sufficient time to cause heart muscle damage. This blockage is caused
by clot formation in the arteries, which is also known as
atherothrombosis.... » Read More
Executive Moves: Charles River Laboratories
Charles River Laboratories International, Inc. has named John C. Ho,
M.D. senior vice president, corporate strategy. He will report to
chairman, president and chief executive officer, James C. Foster. Dr.
Ho will lead the company's worldwide strategic plan through
implementing and expediting the plans key initiatives. He has more than
16 years' experience serving pharmaceutical, biotech, medical device
and provider organizations in a variety of capacities including
corporate and M&A strategy formulation, product commercialization,
investment decision making, process reengineering and organizational
redesign. Most recently, he served as a partner in the Health and Life
Sciences Practice at Accenture. He was also a leader in the Discovery
Research and Clinical Operations Practices. Prior to joining Accenture,
Dr. Ho spent five years as a partner in the Life Science Industry Group
of Pittiglio Rabin Todd & McGrath.... » Read More
Lonza Acquires Bioproducts Division of UCB
Lonza has acquired the Bioproducts manufacturing division of UCB for
$145.6 million. UCB-Bioproducts is a chemical peptide manufacturer.
This division, with approximately 300 employees, is located in
Braine-l'Alleud just outside of Brussels, Belgium. The acquisition
provides Lonza with another global site to serve its customer base, in
addition to its sites in Switzerland, the U.S. and Czech Republic.... » Read More
|
