Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies. A report by the Analysis Group for the Pharmaceutical Research and Manufacturers of America (PhRMA) documents more than 5,000 new medicines in the pipeline globally, many for untreated diseases and life-threatening conditions. The promise is that this more robust pipeline will lead to more new critical therapies for patients. Read more »

A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. PharmTech’s January issue highlights what the pharma industry can expect in the upcoming year.

Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.

We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy. Eli Lilly Chairman, President and CEO John C. Lechleiter recently weighed in on the issue with respect to the pharmaceutical industry in offering his perspective on the importance of including data exclusivity provisions for biologics as found in US law for the Trans-Pacific Partnership (TPP), a regional free trade pact in Asia under negotiation.

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Laboratories that offer stem-cell treatments have come under close scrutiny by FDA. Read more »

Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at adrakulich@advanstar.com. (*Note: We will keep your name and company affiliation anonymous.)

Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.

Sample questions:

• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?

Biopharmaceutical manufacturing has certainly come a long way in terms of innovation, but now it has many more miles to go, literally—on a truck.

On Wednesday, Sept. 26, 2012, I will be attending GE Healthcare Life Sciences’s ReadyToRock Tour 2012 in Piscataway, New Jersey. This 1000-ft² mobile suite features the company’s ReadyToProcess platform, which contains bioreactors, filters, tubing and connectors, chromatography systems, and columns—all preconditioned, ready to plug in, and use. GE’s team of experts will also be on board for live presentations and demonstrations of the equipment.

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Researchers are trying to find better, cheaper ways to produce biodegradable and bio-based polymers.  Although one of the main drivers for this research is to compete with fossil-fuel-based polymers in large-volume, consumer plastics applications, medical applications, such as microcapsules for drug delivery, may also benefit.  While it seems odd, the researchers found that waste oil from cooking fried food can be used as a raw material in the polymer production process.  Read more »

PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal. Bennett states that while the US may be lagging behind in spurring innovation programs, he believes the passage of the Prescription Drug User Fee Act (PDUFA) will improve the situation.

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Athletics and drugs do not share the spotlight often, but when the two combine, it usually turns heads. At the center of this spectrum is the omnipresent controversy of performance-enhancing drugs. An issue that was once conveniently covered up in order to pack ballparks and, thus, maximize profits (e.g., the inflated power numbers in Major League Baseball in the late 1990s and early 2000s) is now the subject of hyper-scrutiny by professional sports leagues, athletic committees, and even the US federal government—courtesy of taxpayer-funded revenue.

In 2012, this issue takes center stage on the international level leading up to the 30th Olympiad in London, which opens today. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the global Biotechnology Industry Organization (BIO), and the World Anti-Doping Agency (WADA) have announced the launch of the 2 FIELDS 1 GOAL: Protecting the Integrity of Science and Sport campaign, a program that aims to achieve the goals of the Joint Declaration on Cooperation in the Fight against Doping in Sport.

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Roche’s recent announcement that it will be closing its venerable Nutlley, NJ R&D site is the latest in a string of mergers and reorganizations that have resulted in the loss of thousands of life-sciences jobs from New Jersey, and an exodus of both R&D and manufacturing from a state known as the home of big Pharma. Read more »