Spring Break 2014: AAPS Blog Edition

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The AAPS Blog is on spring break this week, recharging our batteries at an undisclosed location.

We will return on April 22, and that week will include posts related to Earth Day, World Laboratory Animal Liberation Week, and the May AAPS Newsmagazine cover story. So please visit us then!

Meanwhile, if you have suggestions for blog topics or if you want to contribute to the blog, please contact us at aapsblog@aaps.org.

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The Expanding Universe of the CRO

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John KamerudJohn Q. Kamerud, Ph.D., is scientific director at Eurofins Pharma Bioanalytical Services, where he serves as scientific and technical advisor for both clients and internal teams for development, validation, and application of assays to comply with scientific goals and regulatory requirements. He has over 20 years of experience in the development, validation, and implementation of immunoassay methods.

The past few years have seen a tremendous amount of restructuring, integration, and “right-sizing” within our industry. According to Forbes, pharma companies have laid off more than 300,000 workers since 2000. A substantial proportion of these were in research and development (R&D) functions. Does that mean that drug development has come to a standstill? Hardly. According to FiercePharma, global R&D spending in the pharma industry increased approximately 228% in the decade 2000–2010. Much of that slack is being taken up by CROs (contract research organizations), which saw a doubling in employment during the same decade, according to the Center for the Study of Drug Development at Tufts University.

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Is Social Media the Modern-Day Way to Gain Access to Experimental Drugs?

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Karen AddisKaren Addis, APR, is senior vice president at Van Eperen & Company, a full-service public relations and marketing communications agency in the Washington, D.C., area, where she specializes in healthcare communications. You can contact her at kaddis@veandco.com.You can also follow her on Twitter or connect with her on LinkedIn.

Until a few weeks ago, few people outside of the small town of Fredericksburg, Va., had heard of Josh Hardy, a 7-year-old who had been suffering from various forms of cancer since he was nine months old.

But all that changed in early March when his mom used social media to draw public attention to her son’s story, which recently had taken a turn for the worse. Josh had been in the hospital recovering from a bone marrow transplant when he developed a serious infection. He most likely was going to die if he did not receive the experimental drug brincidofovir, which had been shown in clinical trials to clear up adenovirus infections in children.

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Synthetic Organ Gardening: We Can Rebuild Him!

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Robert BellRobert G. Bell, Ph.D., is president and owner of Drug and Biotechnology Development LLC, a consultancy to the pharmaceutical industry and academia for biological, drug, and device development.

Although I’m from the George Reeves Superman era, I recall my younger brother (whose age gap between us fades as I age) loving Lee Majors as the Bionic Man. It was the show’s character Oscar Goldman who said “Gentlemen, we can rebuild him. We have the technology. We have the capability to build the world’s first bionic man. Steve Austin will be that that (bionic) man.”

It seems scientists at Harvard Apparatus Regenerative Technology (HART) were inspired and have succeeded in synthesizing human tracheas. The tracheas are made by growing a patient’s own stem cells on a synthetic scaffold. This technology may be adapted to create other organs in the future, such as a replacement esophagus, heart valve, or kidneys. HART creates the scaffolds by spinning nanofibers into a tube that is custom fit for each patient, and then the scaffold is seeding with the patient’s stem cells. Growing the patient’s stem cells on the scaffold provides a good environment for bone marrow stem cells that can then develop into various cell types both in the incubator and after they are implanted into a patient. Since 2008, eight patients in Russia have undergone trachea transplantation using synthetic windpipes, and HART is working with the Food and Drug Administration to initiate clinical trials in the United States.

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BCS Subclassification and IPD Methodologies

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Yasuhiro TsumeYasuhiro Tsume, Ph.D., is a scientist at University of Michigan. He has worked in various research projects such as prodrug strategies, cancer therapeutics, in vivo predictive dissolution (IPD) methodologies, and translational studies.

In a recent article, in vivo predictive dissolution (IPD) methodology and subclassification for the Biopharmaceutics Classification System (BCS) class II and class IV are introduced and discussed. This report proposes a simple extension of BCS class II and class IV to include subclasses of acid (a), base (b), and neutral (c). Those drugs will be called BCS class IIa, IIb, IIc, IVa, IVb, and IVc. BCS class I and class III drugs are highly soluble regardless of pH condition. Therefore, the subclassification of BCS class I and class III is unnecessary. On the other hand, the physical property of class II and class IV drugs has a huge impact on drug dissolution in the aqueous solution. Hence, the selection of dissolution media and pH condition for in vitro dissolution studies of those drugs will be one of key factors to predict in vivo. The pH condition in the gastrointestinal (GI) tract is drastically changed from the stomach (pH 1-3) to the small intestine (pH 4.5-7.4). This pH change would directly affect the solubility of those BCS class II and IV drugs. Therefore, the subclassification of BCS class II and class IV drugs would make it easier to select the key condition of in vitro dissolution studies for in vivo prediction of drug dissolution. Eventually, the right selection of in vitro dissolution methods and conditions would allow biopharmaceutical scientists to predict accurate in vivo dissolution of test compounds and to speed up the design of those formulations.

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