Edward S. Price
Concerned with rising R&D costs, many U.S. bio/pharma companies are considering Asian countries, such as India and China, for the development of their Active Pharmaceutical Ingredients (APIs) and pharma products, in the hope of getting a good deal, thanks to low-cost production facilities and cheap labor.
Robert Guzman
Any human enterprise is subject to challenge from its conceptual stage; from financial hurdles to technology and expertise, they all contribute to the success or failure of our goals. The typical business cycle dictates that we need to define our operating model based on the service or product to be provided, and the market we want to target.
Nigel Walker
The presence of particulate matter in pharmaceutical products con-tinues to be one of the top reasons for recall. This year, 11 of the 54 safety alerts issued by the FDA were for the presence of particulates in drug and therapeutic biological products.
Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) approved from July-August 2016. FDA approved 21 NDAs in these two months.
Luke van Hengel
Contracting in any vendor relationship can raise its ugly head when the
parties least need or expect it. It is a given in any outsourcing that a
contract of some sort needs to be put in place; however, there should
be more emphasis on the effort needed to ensure contracting does not
become an obstacle. The typical focus of any vendor relationship is on
delivery, as this ultimately serves the greater goal of this industry – to
bring new treatments to those in need.
MaryAnne Rizk, PhD
Demands today and into the next decade for more and better therapies is placing unprecedented pressure on the global pharmaceutical industry, and it is estimated that by 2020, up to three quarters of clinical trials are likely to be performed by CROs.1 Innovative discovery methodology has increased the number of smaller, emerging biopharma organizations who are keen to develop their products to sell, co-license or take to regulatory approval.
Istvan Udvaros
As the biopharmaceutical industry is facing a longer, more complex,
and more expensive drug development process, all stakeholders must
demonstrate flexibility and the ability to innovate and find solutions
to overcome challenges. Patient recruitment for clinical trials that are
well managed studies, with a high level of consideration towards the
subjects, a close follow up, and robust quality of data collection is one of
the many challenges within the industry.
There has always been a variety of challenges affecting the parenteral manufacturing industry and its participants.
Yulia Nedelcheva
The process of globalization expands the focus of outsourcing to all sectors
of the economy. The main motive for the implementation of outsourcing
strategy is to reduce production costs and to create competitive
advantages both to the companies and to the national economy.
JoAnn P. Pfeiffer
Contracts provided to study sites by industry sponsors contain legal
language that is often confusing and not well understood by the study
site representatives. This article reviews risk areas and contract language
that sites should be familiar with when reviewing and negotiating a
clinical trial agreement. To adequately protect the site, those who review
the contract should clearly understand what they are agreeing to before
approving a contract.
Nicole Stansbury
International Council for Harmonisation Integrated Addendum to ICH E6
R1 - otherwise known as ICH E6 R21
- suggests centralized monitoring
be incorporated as an important monitoring methodology in clinical
trials. Different companies are taking different approaches to deploy
centralized monitoring and these differences will require more detailed
discussions when outsourcing clinical trial services.
Jennifer Peters
What’s been proven to reduce data variance, increase patient compliance and decrease site monitoring costs in clinical trials? For certain, it’s not the continued use of paper records. Digitization of clinical trial processes is the driving force behind real ROI and its demonstrated results are increasing the adoption rate among sites and sponsors.