Ed Price
Each year industry leaders prognosticate about the year ahead and its challenges and opportunities. However, this year may be a bit different.
Isaiah Howard, Thomas Cocciardi
The release of the 2017 ICH GCP E6(R2) guidelines marks a paradigm shift in clinical research. Risk is mentioned no fewer than 30 times in the guidance. ICH GCP E6(R2) section 5.1 requires that the sponsor of a trial, “implements and maintains systems for quality assurance and quality
and control.”
Krista Armstrong
Clinical trials can be dauntingly complex. The high-stakes culmination of years - sometimes decades - of research, they involve rigorous data requirements, close regulatory scrutiny, intricate logistics, and intense cost pressures.
Mark Sawicki, Ph.D.
Applying validation standards to bio/pharmaceutical logistics, the science of transporting bio/analytical, clinical and manufactured product, is an important and essential challenge as global demand for biotechnology continues to rise.
Carrie Lewis
In the pharmaceutical industry, choosing your suppliers/partners is a critical task, much like choosing your spouse/partner. You must find a partner that you work well with, that you “click” with, and that you can work with for many years to come to ensure the relationship flourishes.
PYRAMID Laboratories, Inc. is a CMO focused on parenteral drug products, offering a comprehensive pipeline of services to pharmaceutical and biotech companies.
Guy Webber, BSc (Hons), MSc (Dist)
For every 10,000 molecules entering drug discovery, 9,999 will fail during some stage of the development process and only one will become a successful marketed drug (and even then, it is not certain development costs will be recouped).
Stella Stergiopoulos
Ample anecdotal stories and studies in the literature indicate that
the global investigative site selection process is highly inefficient and
ineffective. A 2012 study conducted by my colleagues at the Tufts Center
for the Study of Drug Development (Tufts CSDD), for example, showed
that site identification through activation timelines are long and highly
variable. That same study indicated that across all therapeutic areas,
clinical trial sponsors must double the planned enrollment period to
recruit the target number of study volunteers. Other studies show that,
even after doubling the planned enrollment period, a high percentage
of sites under-enroll and fail to recruit the requisite number of patients.
Anvit Vasavada, M.S., Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
Testosterone is a male sex hormone produced in the testicles. With the
onset of puberty in males, testosterone secretion is responsible for a
number of physiologic changes including increase in genital size, changes
in hair growth, increase in height, enlargement of the prostate and
seminal vesicles, lowering of the voice and changes in the psyche. Male
hypogonadism is a disorder in which a man has testosterone deficiency,
which results in symptoms such as reduced sex drive and infertility.
Sunny Christian, MS, Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
This column summarizes newly approved drugs and new indications and
patient population for already approved drugs from June to September
2017. This includes New Drug Applications (NDAs), Biologics Licensing
Applications (BLAs) and Biosimilar applications. FDA granted approvals
to 61 applications in these four months.