Industry News

Lab Study Makes Strides in Mending Hearts

MONDAY, Oct. 12 -- U.S. researchers have achieved a first step toward growing a living "heart patch" to repair damage from heart disease.

Using mouse embryonic stem cells, Duke University bioengineers performed a series of lab experiments that mimicked the way embryonic stem cells develop into heart muscle.

The researchers used a special mold they created to make a 3-D "patch" made of heart muscle cells called cardiomyocytes. The mold had features that enabled the researchers to control the direction and orientation of the growing cells.

The newly created tissue displayed two critical features of heart muscle cells -- the ability to contract and to conduct electrical impulses, the study authors explained in a Duke University news release.

The results were scheduled to be presented at the Biomedical Engineering Society's annual scientific sessions, held Oct. 7 to 10 in Pittsburgh.

"While we were able to grow heart muscle cells that were able to contract with strength and carry electric impulses quickly, there are many other factors that need to be considered," Nenad Bursac, an assistant professor at Duke's Pratt School of Engineering, said in the news release.

The rate of heart muscle cell development is just one area that requires further research.

"Human cardiomyocytes tend to grow a lot slower than those of mice," Bursac said. "Since it takes nine months for the human heart to complete development, we need to find a way to get the cells to grow faster while maintaining the same essential properties of native cells."

More information

The U.S. Centers for Disease Control and Prevention has more about heart disease.

Source: Drugs.com

Health 2.0 on the Rise 35% of U.S. Adults Use Social Media for Medical Information

·NEW YORK, October 7, 2009– About 35% of the U.S. adult population uses social media for health and medical purposes in 2009, according to pharmaceutical and healthcare market research company Manhattan Research’s Cybercitizen Health™ v9.0. These 80 million Health 2.0 Consumers create or consumer content on health blogs, message boards, chat rooms, health social networks and health communities, and patient testimonials.

·Though the Health 2.0 market grew substantially in the past year, it still represents just one of many online resources consumers use to get health information. Furthermore, survey results suggest that not all user-generated content is influential. In 2009, a minority of consumers report they are influenced by Health 2.0 media. But Health 2.0 Consumers are an important group to watch, especially for brand teams focused on the therapeutic segments that rely on user-generated content more than others, such as patients suffering from mental health conditions, fibromyalgia, and ADD/ADHD.

·“While there’s no doubt that social media is a critical area for pharmaceutical marketers, it’s still just one piece of the overall consumer media mix,” said Monique Levy, Senior Director of Research at Manhattan Research, “Our consumer research shows that user-generated content is an important influential resource for certain therapeutic segments, suggesting social media is more of a priority for some brands than others.”

Source: Drugs.com

Biotech insiders mingle at NC conference

NC lines up biotech industry conference, highlighting field the growth promise

RALEIGH, N.C. (AP) -- A meeting this week in North Carolina brings together a big chunk of the industry that mass-produces biological drugs, vaccines and industrial enzymes used in detergents, beer and biofuels.

The BioProcess International Conference starts Monday in Raleigh. It promises industry insiders everything from high-level strategy to nuts and bolts technical case studies.

North Carolina has one of the country's largest biotech industries with more than 400 companies, and the work force is one of the fastest-growing among states. The companies operating in the state include names like GlaxoSmithKline, Novozymes, Pfizer Animal Health, Talecris and Wyeth.

Source: Drugs.com

BIO Highlights Serious Flaws In Recommendations Of Draft Report On Gene Patents And Patient Access To Genetic Tests

The Biotechnology Industry Organization (BIO) provided comments yesterday to the Secretary's Advisory Committee on Genetics, Health and Society regarding its draft report on Gene Patenting and Licensing and Their Impact on Patient Access to Genetic Tests. The report makes several recommendations that would restrict the ability to obtain or undermine the enforceability of patents and exclusive licenses with respect to genetic tests.

"While BIO and our member companies strongly support the mission of the Committee and its goal of improving patient access to genetic tests, we must strongly disagree with its recommendations," stated BIO President and CEO Jim Greenwood. "If implemented, these recommendations would do far more harm than good to patients, particularly the patients of tomorrow who will rely on biotech innovation to bring the promise of personalized medicine to reality."

In its comments, BIO took issue with many of the draft report's recommendations, which were not supported by the Committee's own findings and case studies. Those findings and case studies show how patenting and exclusive licensing practices can be necessary to foster the development of valuable genetics tests for patients, particularly those with rare disorders, and that they have other positive impacts - such as incentives to promote physician and patient education, broader insurance coverage, and improved compliance. Those real benefits were largely ignored by the Committee in proposing its over-reaching and restrictive recommendations.

"The patent, licensing, and tech transfer system in this country is, by any objective measure, working quite well overall. The evidence shows that decisions about what patents to seek and how best to license them are decisions that are best made by the researchers and their commercial partners, who have the greatest incentives to achieve widespread patient access to their discoveries," concluded Greenwood. "Enacting these recommendations would risk thousands of jobs across the country by stifling university-industry partnerships and undermine the country's global leadership in biotech innovation."

Source
Biotechnology Industry Organization

Is Inhaled Insulin Delivery Still A Possibility? Why Has It Been A Commercial Failure?

The commercial failure of Exubera® (Pfizer, New York, NY), the first inhaled insulin product to come to market, led other companies such as Eli Lilly-Alkermes to halt studies of similar drug delivery in development intended to compete for a share of the lucrative diabetes market. Does this signal defeat for efforts to deliver insulin via the lungs? The science and circumstances behind the Lilly-Alkermes decision to discontinue trials of the AIR® inhaled insulin product are explored in a special supplement to Diabetes Technology & Therapeutics, a peer-reviewed journal published by Mary Ann Liebert, Inc. The supplement is available free online athttp:// www.liebertpub.com/dia

The supplement presents the data on AIR inhaled insulin that has been made available by Eli Lilly (Indianapolis, IN) and Alkermes (Cambridge, MA), co-developers of the drug. Eight articles describe various protocols in which the effectiveness and safety of AIR were compared to traditional insulin injections in patients with type 1 or type 2 diabetes. These studies represent noninferiority trials, in which AIR was evaluated for its potential to be at least as safe and effective as subcutaneous (SC) insulin across a range of parameters.

Satish K. Garg, MD, Professor of Medicine and Pediatrics at the University of Colorado Denver, and Editor-in-Chief of Diabetes Technology & Therapeutics, and colleagues report the results of a 2-year Phase 3 trial conducted in 385 patients, in an article entitled, "Two-Year Efficacy and Safety of AIR Inhaled Insulin in Patients with Type 1 Diabetes: An Open-Label Randomized Controlled Trial." The study found AIR to be inferior to SC insulin (in a noninferiority clinical trial design) in its ability to maintain optimal blood glucose levels over time, based on measurements of glycosylated hemoglobin (HbA1c).

Similarly, Angel L. Comulada, MD, FACE, Instituto de Endocrinología, Diabetes & Metabolismo, Toa Baja, Puerto Rico, and coworkers demonstrated inferiority of AIR in their study of 500 patients with type 1 diabetes over 6 months. They report their findings in the article "Efficacy and Safety of AIR Inhaled Insulin Compared to Insulin Lispro in Patients with Type 1 Diabetes Mellitus in a 6-Month, Randomized, Noninferiority Trial."

"The question now remains whether this route of delivering insulin has been exhausted or if it still remains to be explored," write Satish Garg, MD and William Kelly, BS from the University of Colorado Denver in the Editorial "Insulin Delivery via Lungs - Is It Still Possible?" MannKind Corporation recently filed a New Drug Application with the FDA for Technosphere® Insulin. It offers faster onset of action with lower postprandial blood glucose excursions especially in the first two hours and is weight neutral, according to the Editorial.

Source:
Julia Chapman
Mary Ann Liebert, Inc./Genetic Engineering News

Biotech Innovation Could Extend Dosing Intervals, Simplify Production

Many biopharmaceuticals comprise small proteins that are quickly eliminated from the body. Scientists at the Technische Universitaet Muenchen (TUM) combine such small proteins with a kind of molecular balloon that swells and thus prolongs the half-life of the proteins in the body. The TUM spin-off XL-Protein GmbH has now started to further develop this new technology with blockbuster potential.

People who suffer from hepatitis B are often treated with the tissue hormone interferon. However, there is a problem: Interferon is a very small protein, which is filtered from the blood via the kidneys after only a short time. For the patient this means a high-dose injection every other day to keep the effect of the substance from wearing off prematurely.

However, interferon stays in the body much longer when chemically coupled with a synthetic PEG (polyethylene glycol) molecule. PEG is a random coil long-chain polymer string that swells by adsorbing water. That way the PEG molecule becomes large enough that it does not fit through the fine pores of the kidneys - the attached interferon remains in the circulatory system longer, and the patient will need an injection only every one to two weeks.

Using genetic engineering, TU Muenchen scientist Prof. Arne Skerra and his coworkers from the Chair of Biological Chemistry at the Center for Life and Food Sciences Weihenstephan have now developed an amino acid string that tangles up similarly to PEG and also swells in the presence of water. However, unlike many PEG compounds, there is no danger of this biological polymer accumulating in the body. In fact - over an extended period of time - it is discharged or biologically broken down. That happens because this amino acid string (polypeptide) consists of three of the 20 naturally occurring amino acids: proline, alanine and serine, or in short, PAS.

The protein substance interferon, which itself consists of amino acids, can thus be easily generated in "PASylated" form. In first trials with animals, TUM scientists established that PASyated interferon has a half-life in the blood that is prolonged by a factor of 60, which should allow a significant extension of dosing intervals during medicinal therapy.

A further advantage is the simplified biotechnological production: The DNA segments carrying the information for the PAS amino acid sequence and for the interferon can simply be attached to each other and then, for instance, used for transforming bacteria. The bacteria then produce the PASylated interferon in one piece, thus making much fewer production steps necessary in comparison with the chemical coupling of PEG. According to Skerra, "this will lead to a significant drop in production cost."

In principle all small proteins currently used as medication or in development in pharmaceutical companies - for example, growth factors or functional antibody fragments - can be PASylated. Thus there could be a huge market for the new technology. Consequently, Prof. Skerra and his team initiated the founding of a new biotech company, XL-Protein GmbH, which started its operations last spring. "Our technology has the potential to give birth to a whole new generation of blockbuster medications," the TUM biochemist is convinced. Several of the new drugs are already at an advanced stage of preclinical development.

Source:
Patrick Regan
Technische Universitaet Muenchen

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