Ed Price
Quite often viewed as the modern era in chemical manufacturing, continuous manufacturing has been gaining steam over the past few years as a means to manufacture drugs more efficiently, ensure safety and bring products to market faster.
James Man
The pharmaceutical industry has focused considerable effort on increasing organizational agility, particularly in terms of reducing cycle times and getting products to market faster. But too often this has failed to produce meaningful improvements - because agility alone is not the answer.
Tobias Kanacher
Modeling and simulation have been used in the pharmaceutical industry for over twenty years and can be advantageous for drug sponsors seeking to improve their drug development process and decision making.
Diane Farrugia, Dr. Mark Cilia, Prof. Anthony Serracino Inglott
The EU Good Distribution Practice (GDP) guidelines apply to manufacturers, wholesalers and other actors involved in the distribution of medicinal products. The revised GDP guidelines of the European Union were published on 8 March 2013 and became effective six months later, nineteen years after the previous publication of 1 March 1994.
Bikash Chatterjee, Matthew Finch
Among the most remarkable technical advances seen within the healthcare sector over the last decade is the fast growing sector of regenerative medicine. Breakthrough technologies are empowering re- generative medicine through the introduction of new, more accurate, easy-to-use tools and new drug therapies with the potential to be dis- ease modifying, capable of reversing the damage of certain diseases.
Dr. Steve Brabbs
Pharmaceutical companies increasingly outsource their peripheral activities to focus on core activities but there is one area where outsourcing has long been the norm and that is logistics. Especially with international supply chains, the practical and technical complexities of shipments have almost always been managed by third-party logistics providers (3PLs) who coordinate the activities of all the players involved.
The growing complexity of clinical trial protocols and diminishing operational feasibility of many of today’s trial designs is demanding that the industry rethinks the status quo. The introduction of the ICH E6 (R2) guideline last year is a key indicator of the types of changes that need to be implemented in the industry, and most notably it strongly advocates a risk-based approach, rendering the implementation of these principles a matter of GCP compliance.
Rhonda Henry has more than 27 years of clinical research experience, all of which have been with PPD. As vice president of site networks and patient centricity for the global contract research organization, Henry develops PPD’s site network strategies and patient-centric trial models to improve the company’s sites and patients capabilities and expand its service offerings.
Vivek Sharma
The past decade has seen significant advances in new cancer treatments through the development of highly selective small molecules that target a specific abnormality responsible for the disease. Traditional cytotoxic agents were another approach to treat cancer; however, unlike target- specific approaches, they suffered from adverse effects stemming from nonspecific killing of both healthy and cancer cells.
Sunny Christian, MS, Amitkumar Lad, PhD, Anvit Vasavada, M.S., Hemant N. Joshi, Ph.D., MBA
This quarterly review on New Drug Applications (NDAs) contain data for applications approved for the first time during the second quarter of 2018, which includes New Molecular Entities (NMEs) and new biologics.