Riekert Bruinink, Rafik H. Bishara, Ph.D.
It has been more than one year ago that the new EU GDP Guidelines came into enforced implementation. It is an improvement and a step forward over the previous 1994 Guidance as the new one better reflects the various changes in the distribution industry which occurred during the last 20 years.
Xin Bu, John A. Castoro
Analytical method robustness has gained significant attention in the pharmaceutical industry in recent years for many reasons, including regulatory environment change, globalization, and outsourcing trends.
Peter H. Calcott PhD
Successfully navigating the setting up and use of contract manufacturing organizations (CMOs) is a daunting task, or actually, tasks. Over the years
I have set up and managed these relationships successfully and now as a consultant I am often brought in when problems arise. What I find is
often the planning is weak and the execution even weaker. My father used to warn me that with any endeavor “I cannot guarantee success if you plan well but I can guarantee failure if you plan weakly”. And so it is for using a CMO.
Bikash Chatterjee, Jorge Basso
Ensuring supply chain integrity today in the global market requires integrating risk management for a physical and a virtual supply chain. An approach that ensures supplier quality and performance and supply chain integrity is very important. The issuance of HR3204 Drug Quality and Security Act (DQSA) has set the timeline and metrics for demonstrating supply chain integrity for the next decade. To set
the scene, today there are more than 70 countries that have either implemented or plan to implement some form of serialization as a key component of efforts against drug diversion or adulteration.
Dennis Jenke, Ph.D.
An accelerating trend in biotechnology is the use of plastic components in systems used to produce an active pharmaceutical ingredient (API) or a finished drug product (FDP).
Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
This column summarizes New Drug Applications (NDAs) for the third quarter 2014 (July through September 2014). In this quarter, FDA approved 38 NDAs.
Lina Wang, Eduardo F. Motti, M.D.
In the last decade, industry has changed operations of clinical research from a vertical and fixed reporting model, with a large number of in-house professionals dedicated to clinical studies, to a matrix model
involving both internal and external resources, and then gradually moved the bulk of the work to Contract Research Organizations (CROs). To discuss why and how this happened is the main purpose of this article, and how it impacted the work done in the countries where the trials are conducted.
Kevan Reeve
Excellent relationships are the key to success in life—wouldn’t you gree? So why, when I reflect on contract manufacturing organizations (CMOs) working with pharmaceutical companies, do I see a major gap in capability and focus in this all important area? I don’t actually have a definitive answer to that question, but I do have some thoughts on how CMOs and pharmaceutical companies can get great value from their relationships.
Paul F. Skultety, PhD
Arguably, the biggest obstacle to achieving Active Pharmaceutical Ingredient (API) success in formulation development is API solubility. Solubility — the ability of a solute to dissolve in a solvent
in a homogeneous manner — is essential to realizing the desired concentration of a drug in systemic circulation for an anticipated
pharmaceutical response. Yet more than 40 percent of all New Chemical Entities (NCEs) have less than ideal solubility. Fortunately, today’s formulators have a range of excellent and steadily improving echniques
available to provide acceptable solubility. The key to optimizing API success is having access to the right expertise and equipment.
Nigel Walker
According to Nice Insight’s 2015 Pharmaceutical
and Biotechnology outsourcing survey, over half of the companies that outsource only to contract resource organizations (CROs) expect they will achieve reductions in project lengths and costs by
using CROs that employ cloud-based systems.
Nearly 50% of respondents also believe that the use of web-based life science labs will improve cost and time efficiencies. Mobile technology is also seen as enabling communications and study monitoring. In
addition, 96% of survey respondents indicated
an interest in working with a CRO that implements new technologies that improve efficiency, quality, safety, and traceability.