Category Archives: Events

The Heightened Importance of Contract Manufacturing Organizations

by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief

One of the most thought-provoking presentations at the recent PDA / FDA meeting in Washington DC was given by Guy Villax, CEO of Hovione Pharmaceuticals.  Hovione Pharmaceuticals offers a range of contract services including but not limited to, product development, manufacturing of API and drug products, and analytical support.  Guy’s presentation was one of two on the opening day that addressed ‘Current Quality Challenges for Pharmaceutical Executives.’  He began his talk by saying that 60% of small molecule APIs for new NDAs are made by contract manufacturers.  I was surprised by the figure.  This is clearly different than practices of 15-20 years ago and, according to Guy, represent a migration of CMC knowledge to CDMOs.  That alone calls for us to re-evaluate the relationship between CDMO and sponsor firms, particularly for the virtual firms.

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FDA and the 2012 U.S. Presidential Election

FDA Matters has been wondering: when is the right time to start talking about the 2012 U.S. Presidential election and how it might affect FDA’s future? The best answer is: when Congress has finished its FDA policy work for the year. With the enactment of FDA user fee reauthorization legislation and a pending agreement on government funding for the first half of FY 2013 (starts October 1, 2012), it is now time to start talking.  Continue reading

Mid-Year 2012 Report on FDA: Opportunities, Threats and Accomplishments

So much is going on at FDA right now, that it is difficult to pick just one topic for this week’s FDA Matters. Instead, we are going to take a quick tour of some “hot spots” at FDA and how they might affect the agency over the remainder of the year and beyond.

Please read on…there is something for everyone in the topics covered.

The “Lost” FSMA Regulations. At the very end of 2010, Congress passed the Food Safety Modernization Act (FSMA). The law was intended to fundamentally re-set the term under which FDA acts to assure a safe food supply. It focuses on preventing problems, rather than fixing or limiting them afterward. FSMA provides the agency with new authorities and additional resources consistent with FDA’s role of overseeing a global food supply. Continue reading

Tufts Report Reveals Increased Pharma Interest in Adaptive Trials

Improving the efficiency of clinical trials has become one of the most important priorities for pharmaceutical companies around the world. In its annual R&D management report, the Tufts Center for the Study of Drug Development (CSDD) recently estimated the full price of bringing a new drug to market at over $1.3 billion. The report indicated that any areas where R&D costs can be curtailed are extremely interesting to Pharma’s major players. Continue reading

FDA Matters Mailbag: Hatch-Waxman, Biosimilars, User Fees and More

Over the last month, FDA Matters has covered a wide-range of FDA-related topics: the agency, industry, and Congress, as well as medical innovation, user fee reauthorization legislation, food safety and post-market surveillance. The response has been great: FDA Matters has many new readers and I received a number of interesting questions. Continue reading

Adaptive Clinical Trials Can Bring You “Beyond the Shadow of a Drought”

R&D production in the pharmaceutical industry has fallen more than 70% over the last 15 years, according to a recently published report, “Beyond the Shadow of a Drought: The need for a new mindset in pharma R&D,” by a group of analysts at the Oliver Wyman consulting firm.  According to this insightful analysis, the underlying causes have not seemed too alarming because pharmaceutical companies still continue to have net incomes of 20% to 30%, and the industry has sustained a 6% annual growth even during the current global economic turmoil. Continue reading