Features:

In the January/February Issue:

Consolidation in Outsourcing
Our financial analyst sums up 2005's big moves
by Michael Martorelli

“The more things change, the more they remain the same.”  So said the 19th century novelist and journalist Alphonse Kerr. That man would probably be astounded to see how many others have used that simple quote to explain profound occurrences across many aspects of business and of life. The nature of the consolidation that took place across the outsourcing industry in 2005 was different in many respects from that experienced in the preceding 12 months. Yet, while the names of the participants changed, their motives, perspectives, perceptions, and philosophies were very similar to those of the companies who found merger partners in 2004. Any way you measure i ... » Read entire article

Process Documentation
Does it really have to be this difficult?
by Monique Garrett

Most sponsors, CROs and technology vendors in the life sciences industry have a good understanding of the risks associated with inferior process documentation. Minimally, failing an audit means lost time and money, a damaged relationship or reputation with the agency or a customer (or both) and diverted resources as the organization attempts to take corrective action or respond to an audit report. These outcomes are not worth the risk to most organizations. In our industry, you don’t get points for good intentions. If it isn’t documented, it didn’t happen. Therefore, a great deal of time and energy is spent on process documentation. The “burden” of ... » Read entire article

Anti-Counterfeiting Initiatives and RFID Practices
Reward, Risk and Regulation
by Kristin Brooks

The year 2005 was a pivotal one for pharmaceutical companies as far as anti-counterfeiting initiatives and more specifically, radio-frequency identification (RFID). The World Health Organization (WHO) estimates that as much as 10% of the half-trillion-dollar pharmaceutical market is counterfeit and the FBI estimates the impact on U.S. companies is $200–$250 billion a year. The awareness and concern about counterfeit drugs in the pharmaceutical supply chain reached its peak in 2004. According to an FDA report, the number of drug counterfeiting cases had increased dramatically in 2004 (58 cases up from 30 in 2003). The increased attention on drug counterfeiting may have led to the ... » Read entire article

Breaking News:

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Executive Moves: Millennium
Millennium Pharmaceuticals, Inc. has made executive appointments and several key promotions. Christophe Bianchi, M.D. will join the company as executive vice president for commercial operations. He will also be an executive officer of the company and a member of the leadership team. Mark Kost has been named vice president, finance. Grant Bogle has been promoted to senior vice president, sales and marketing and Elizabeth Lewis, Esq. has been promoted to vice president, commercial law. The company has also appointed Anna Protopapas, senior vice president, corporate development, as an executive officer and a member of the leadership team.... » Read More


AAIPharma Expands Phase I Capacity
AAIPharma Inc. has opened a new Phase I clinic in the Research Triangle Park area, NC. Located in Morrisville, NC, the state-of-the-art facility will increase the company's Phase I capacity in the U.S. to 144 beds. The focus of this clinic will continue to be the conduct of bio-equivalence trials in support of customers' ANDA programs. It will also provide the company with the infrastructure to strengthen and expand its clinical pharmacology operation in support of NDA programs.... » Read More


Amgen Expands Operations
Amgen has plans to invest in additional manufacturing and R&D operations in the U.S. and will expand its commercial operations in Europe. In Cork, Ireland, the company will invest more than $1 billion in new process development, bulk manufacturing and fill and finish facilities that will give the company capacity closer to the patients it serves in Europe. The company is also adding a manufacturing plant in Puerto Rico to produce Epogen and Aranesp. In 2005, Amgen received licensure of a Neupogen and Neulasta plant in PR and an Enbrel plant in RI, and announced plans to acquire Abgenix, Inc., a biopharmaceutical company with a large manufacturing plant in Fremont, CA.... » Read More

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