Lisa Henderson
|
This month, Applied Clinical Trials and its accompanying supplement, Oncology & Clinical Trials in the 21st Century, has bonus distribution at both ASCO (the American Society of Clinical Oncology) annual meeting, as well as the 2009 BIO
International Convention. Articles in this issue include a look at the benefits of early strategic development planning, and
improving radiological measurement quality in oncology trials, both which could prove beneficial reading for the biotech moving
into the clinical trials stage of development. In addition, this year Applied Clinical Trials is attending and exhibiting at its first BIO conference and will be located in the Clinical Trials Zone at booth 5543.
A lot has changed in the 30 years since the acknowledged forerunner of the biotech industry, Genentech, was founded. (And
not only that Genentech was purchased by Roche last month.)
The overall traditional model of drug development via big pharma has changed. Over the past 20 years, pharma has gradually
shed its clinical research, development, and operations to CROs and other contract providers. This is in response to its continual
effort to grow smart and be as nimble as its smaller biotech brethren. In the continual search for the new compound and increased
pipeline opportunities using the best business model, we are now seeing the initial results of these forays.
For example, as noted in a news article this month, compound licensing trends from a 2007 Tufts CSDD analysis showed in 2005,
44% of New Molecular Entity (NME) approvals came from large pharma, while 56% came from small/mid-tier pharma. However, new
drug approvals from 2000-2006 indicate that the origins of approval were 66% for large pharma, and 28% for small/mid-tier
pharma. Besides in-licensing and M&As for compounds are the "virtual" pharma companies, which will invest in a compound through Phase
II and present it to a big pharma to take through Phase III and marketing phases. Meanwhile, that global Phase III program
is conducted by the pharma's CRO partner.
The bottom line is that the lines between biotech and pharma are blending. The "traditional" biotech—small, smart, and flexible—can
now be as large as the traditional pharma—behemoth, bureaucratic, and profitable, and vise versa. But the expertise needed
to turn compounds into marketable drugs rests in the world of clinical trials. That expertise includes technology, regulatory,
recruitment, and much more.
The world of oncology is also different from other therapeutic areas. Oncology—part academia, biotech, and grassroots consumer
efforts—has developed its own identity in the world of clinical trials. However, advancements that occur within the CRO industry
in regard to clinical trial efficiencies, will benefit future oncology trials as well.
As the lines continue to blend between what is a biotech and what is a pharma, and even what is a CRO, it is useful that the
lines between academia, industry, and government also blend. Information sharing is key to moving the ball forward.
Lisa Henderson
Editor-in-Chief
email: lhenderson@advanstar.com
http://www.appliedclinicaltrialsonline.com/
