Click * at the end of each synopsis to
access the full article online.
SETTING THE RECORD STRAIGHT
ON INNOVATION AND DRUG
DEVELOPMENT
In this concisely written BiotechNow
opinion piece, the author describes the
impact that the modern biotechnology
industry is now having on drug
development, stating "the entrepreneurs,
researchers, and investors working in this
field have firmly established themselves at
the forefront of medical innovation and
the search for new cures and therapies for
previously untreatable diseases." The
author asks the readers not to let the
questionable ethics of a few CEOs in the
pharmaceutical industry overshadow the
commitment the biotechnology industry
as a whole has to alleviating human
suffering and disease through their
innovative medical research.
* Read more here: http://www.biotech-
now.org/health/2015/10/setting-the-
record-straight-on-innovation-and-drug-
development.
WHERE DO YOU START WHEN
DEVELOPING A NEW MEDICINE?
A public-private research initiative
between GSK, the European
Bioinformatics Institute (EMBL-EBI), and
the Wellcome Trust Sanger Institute will
utilize "big data" and genome sequencing
to improve the success rate for
discovering new medicines. In this article
from Drug Discovery Today, the author
describes the new Centre for Therapeutic
Target Validation (CTTV) initiative and
how it aims, through collaboration, to
address a wide range of human diseases,
which includes sharing its data openly in
the interests of accelerating drug
discovery.
* Read more here:
http://www.drugdiscoverytoday.com/view/
37649/where-do-you-start-when-
developing-a-new-medicine/
THE FDA DRUG APPROVAL
PROCESS SIMPLY EXPLAINED
If you are new to the drug
development process, terminology such as
"Phase 2 clinical trials" or "filing of an IND
application"can be quite confusing. In this
article posted on Nanalyze.com, the
authors define specific phases that a new
drug needs to go through in order to
receive approval to be marketed and sold
to consumers.
* Read more here:
http://www.nanalyze.com/2014/09/the-fda-
drug-approval-process-simply-explained/
HOW DRUGS ARE DEVELOPED
AND APPROVED
Straight from the horse's mouth, so to
speak. In this article, the FDA provides an
overview of the process of drug discovery,
development, and approval, from their
perspective, using a case example. Their
site provides some other articles on the
drug approval process you might find
informative.
* Read more here:
http://www.fda.gov/Drugs/DevelopmentAp
provalProcess/HowDrugsareDevelopedand
Approved/
THE FDA'S DRUG REVIEW
PROCESS: ENSURING DRUGS ARE
SAFE AND EFFECTIVE
Here, the FDA presents a nice little
overview of the stages of drug
development and review. They even
jazzed it up a bit with some graphics.
* Read more here:
http://www.fda.gov/Drugs/ResourcesForYo
u/Consumers/ucm143534.htm
CLSA REPORT: TRACKING FDA
DRUG REVIEW PERFORMANCE
The FDA has an important and difficult
job: Ensuring timely and efficient drug
review processes while maintaining
rigorous scientific and safety standards.
Overall, agency performance has
improved markedly, a reflection of the
work by FDA leadership, industry,
Congress and other stakeholders. Still,
there are wide variations across
therapeutic areas.
* Read more here:
http://califesciences.org/2016FDADrugRep
ort/?utm_content=bufferd4cbe&utm;_medi
um=social&utm;_source=twitter.com&utm;
_campaign=buffer
Hot Topics in Drug Development [April 2016]
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Sorted and summarized for you.
Current Trends and Future Predictions
in Drug Development