This time last year, 46% of bio/pharmaceutical companies responding to PharmTech’s annual outsourcing survey indicated that their external spending was growing at the same rate of total R&D spending, and their view of the year ahead was quite upbeat. At the same time, service providers suggested that they had adjusted to new market realities by refocusing their efforts and funding targets. Read more »

Big Pharma’s sales forecast is not likely to improve anytime soon. Consulting firm Bain and Company predicts that the top 25 drug companies’ annual sales growth will be no more than 1% through 2016. To compensate for reduced revenue, investors are urging manufacturers to cut expenses that do not add value. One such expense, in many investors’ eyes, is research and development (R&D). Read more »

Mention New Jersey to someone on the street, and he or she is likely to think of Springsteen, the Sopranos, or (God forbid) Snooki. But PharmTech readers know that New Jersey is an important state for the drug industry. Many big companies, such as Johnson and Johnson, sanofi-aventis, Novartis, and Pfizer, have headquarters or other offices in the state. And the Garden State’s drugmakers are facing the same difficulties that confront the industry at large. Read more »

Outsourcing can have its benefits, but how often do we bother to measure the actual value of our outsourcing relationships? Or the innovation that it delivers? In Europe, at least, the answer is: not very often.

This week, Warwick Business School (UK) released a study (sponsored by Cognizant) looking at European C-suite attitudes to outsourcing. The study encompassed 250 CIOs and CFOs across Benelux, France, Germany, Switzerland, the Nordics and the UK. Read more »

In recently attending several industry events, I heard a common theme from both pharmaceutical companies and their suppliers. The stakes for successfully managing the outsourced relationship have never been higher. For pharmaceutical companies seeking to optimize their external supply networks as part of their overall development and manufacturing strategies, and for contract service providers seeking to be part of that network, the bar is being raised. So what are the changing expectations and critical success factors in outsourcing? Read more »

A sizeable chunk of Big Pharma’s sales will fall off the dreaded patent cliff before the year is out. Patent expirations will allow competitors to market, and patients to buy, generic versions of branded drugs. A renewed focus on discovering and developing new therapies would seem to be the obvious solution for Big Pharma. Yet at least one observer predicts cuts in research and development (R&D) spending throughout the industry. Read more »

I am here in Charlotte, North Carolina, this week for Informex 2011, the trade show of custom and batch manufacturers, which raises a fundamental question. What is the future for outsourcing of chemically synthesized active pharmaceutical ingredients (APIs) and pharma intermediates? Read more »

When Hospira stopped manufacturing sodium thiopental, which is used in lethal injections, it caused a drug shortage, and states began looking for alternate suppliers. At first, the developments made me wonder whether FDA should oversee nonmedical uses of drugs. Now the shortage has led to a federal lawsuit that raises questions about the way the agency controls imported drugs. Read more »

At a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing. Read more »

The confetti from the New Year’s celebrations has settled, and drugmakers are busy planning their activities for 2011. Some people make New Year’s resolutions in hopes of bettering themselves or adopting good habits. After its recent disappointments, the pharmaceutical industry likely will resolve to improve its research and development (R&D) efforts. Read more »