Has pharma finally left its innovation and productivity
problems behind? Already this year, some truly breakthrough drugs have been approved,
including Genzyme’s Myozyme for Pompe disease, Pfizer’s Chantix for smoking cessation, Teva’s Azilect for Parkinson’s disease, and
three vaccines from Merck — Gardisil for HPV/cervical cancer prevention, RotaTeq against rotavirus gastroenteritis,
and Zostavax to prevent shingles in older people.
Meanwhile the number of compounds in trials is
surging. The 10 top-selling drug companies in the United States are now doing 50 percent more clinical
trials compared to 2002, according to Tufts Center for the Study of Drug Development. But is this push into
the clinic a sign of new confidence, or just desperation? The answer to that question depends on how this bolus
of new candidates fares.
Oncology is one of the prime fronts in
this battle. No indication needs better new drugs, and a variety of them. At the recent
American Society of Clinical Oncology (ASCO) meeting, the call was for more preclinical
studies of drug activity and more biomarkers. Some companies are answering the call,
but many still don’t see the value of personalized medicine. The risk that a big market will be shrunk down to
a subset of “responders” is still the main deterrent. But it’s also true that finding biomarkers good enough for a
test is extremely difficult. Research clinicians are picking up the ball, doing their own science to uncover
markers that will better guide targeted therapies. Will they end up leading the charge?
Overall, companies seem to be taking a much more
science-driven approach to solving the productivity problem. In our May/June show issue (see “Proof of
Concept” at www.PharmaDD.com), we described this
exciting new trend, which aims to reduce attrition by putting a lot more information gathering upfront.
In this issue, Pharma DD is digging even deeper, uncovering
the specific tools and techniques that are providing that clearer understanding, as in this
month’s “Safety Biomarkers” report. We’ll also continue to track major trends such as the introduction of new molecular
diagnostics and clinical trial registries. In Money Matters, Steven Dickman examines an exciting new financing
trend, while our Hot Targets feature looks at the emerging HDAC inhibitor
market. Nat Goodman’s article “Drugmakers: Optimized for Failure?” provides a
provocative new perspective on old problems. Nat invites
readers to respond to his article, and we hope many of you will send us your own ideas that could help improve
the drug discovery and development process.
A Quick Guide
This July/August issue marks the first official issue of
Pharma DD, which is currently publishing on a bimonthly schedule. Our inaugural May/June show issue
is posted on the Web site (www.PharmaDD.com).
We have several sister publications you can subscribe
to and visit to stay ahead of this rapidly changing field:
■ PharmaWeek (www.PharmaWeek.com) is a weekly
newsletter that delivers the world’s top pharma/biotech headlines as well as exclusive market analysis on topics
such as biogenerics, CCR2 inhibitors,multi-kinase inhibitors, breakthrough HCV therapeutics, and more.
■ Bio•IT World (www.Bio-ITWorld.com) magazine focuses
on the data-driven aspects of pharmaceutical and biotechnology discovery, development, and clinical trials.
■ eCliniqua, Drug Discovery
News, and Systems Biology are just a few of the seven content-specific e-newsletters
also published by Bio•IT World. For schedules and subscription information, see
www.Bio-ITWorld.com.
One of our huge advantages is having access to the
network of experts that help make Cambridge Healthtech Institute (CHI)’s conferences so successful.
These meetings cover everything from QTPCR to clinical trials, and they bring together top researchers and
strategists from pharma, biotech, governmental, and academic organizations. We invite you to see the lineup
of upcoming CHI meetings at www.healthtech.com.
Finally, we truly want to hear from you. Our clients have
given us excellent feedback over the years as CHI worked to establish itself as a premier conference producer. Our
new push into publishing includes new as well as established titles, and we will continue to use your feedback to
make certain these publications keep up with your needs.
An Invitation to Subscribe
Free subscriptions are available to qualified life science
professionals. For more information, go online to www.pharmaDD.com/subscribe or call toll free
at (888) 999-6288.
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