Sharon Burgess
Christa McAuliffe was a hometown hero to me. An American teacher from Concord, New Hampshire, she was supposed to be the first teacher in space. Selected from more than 11,000 applicants, she was to conduct experiments and teach two lessons from aboard the Space Shuttle Challenger. All those hopes were erased just 73 seconds after takeoff on January 28th, 1986.
Richard Dennett, PhD, Romain Le Deun, MSc
Quality by Design can impart strong added value to the overall control strategy of your process and product. While this can take a certain degree of up-front time and cost input, the quality dividends in terms of robustly delivering a process and product that more consistently meets quality expectations and release criteria can easily make up for this
primary investment. Quality by Design doesn’t just stop here, however—additional advantages include validation options, facilitation of change control and post-license variations, and above all, the creation of a positive regulatory confidence with regard to chemistry, manufacturing, and control (CMC).
Harshada Sant, MS, Hemant N. Joshi, Ph.D., MBA
Receiving an approval for a New Drug Application (NDA) is something special for every pharmaceutical company. NDAs can be obtained for new molecules or for existing drug molecules with a new formulation
or for a new indication. In this column, we will be summarizing NDAs for a particular quarter. In this particular column, we have put together a review of NDAs receiving approval from January 2014 to March 2014.
Max S. Lazar
What is going on here? Why are so many problems being encountered by so many Active Pharmaceutical Ingredient (API) manufacturers, especially from India and China? Has the entire industry decided to ignore the rules of the game? Well, here is one man’s opinion on what is going on in the industry and what may be contributing to these problems.
Steve Leonard
There has been a real growth in partnerships between pharmaceutical companies and contract
manufacturers in recent years. Big pharma companies want to focus on their core in-house expertise: discovering and developing new drugs, and marketing them to physicians and patients. Outsourcing arrangements allow big pharma companies to balance capacity and fixed costs and to work with trusted partners to add specific niche activities and specialized capabilities they cannot or choosenot to do in-house.
Naomi Musaji, PharmD, Bindu Narang, MPharm, Vishaka Parulekar, MBBS, DPM
This article reviews Medical Information (MI) with regard to the current landscape, what it entails, how it has grown in complexity, and how it lends well to an offshore outsourcing model. Key learnings and recommendations are provided for best practices that should be considered when employing this model. Finally, 2 case study examples demonstrate how
establishing an integrated working relationship between a pharmaceutical company and a functional service provider (FSP) can result in the successful management and processing of MI.
Kevin Olson
Companies have diff erent reasons for the outsourcing of manufacturing activities but they tend to coalesce around two major drivers of need: (1) outsourcing as the default means by which all of a company’s products are manufactured and (2) outsourcing as a means to augment a company’s existing in-house manufacturing capacity. As one might expect, the path that any particular company chooses is highly related to that company’s size. Large pharmaceutical and biotech companies tend to have a degree of internal manufacturing capacity and therefore use contract resources to supplement their own.Smaller companies—often with shorter corporate histories—rarely choose to go the route
of the large-scale capital expenditures necessary to build these facilities. As a consequence, when they maintain ownership of a product into commercialization, external manufacturing resources are nearly always necessary.
Trials for cancer and orphan diseases are a very important trend in our industry. Most of the new drugs for these indications are posing challenges for the pharma industry on several fronts. First, the protocols are more complex, requiring more treatment
steps. Second, the patient screening criteria is becoming more difficult to satisfy, forcing higher recruitment costs and causing CROs to search
in more remote locations.
Alun C. Tanner, PhD, Bora Sever, MD
Over the last decade, there have been significant changes in the legislation governing the development of pharmaceutical and biologic products—many of these aimed at improving patient safety. A number
of these changes have focused on developing, more quickly, a better understanding of the benefits versus the risks of prescribing a medicine to individual patients, post-approval. This has elevated the importance of an effective pharmacovigilance system as a factor in considering whether or not to grant regulatory approval of both new chemical entities and new indications for existing drugs.