OnTarget (February 19, 2007)

I.  WHAT'S NEW?
    Target Health Blog
    Business Development Position Open
II.  QUIZ - (Fill In The Blanks)
    Milk +  Silk = Biosteel
III. HISTORY OF MEDICINE
    Animals in Research
IV. INFECTIOUS DISEASE
    Intranasal Influenza Vaccine Works Very Well
V. EPIDEMIOLOGY
    Maternal Seafood Consumption During Pregnancy and Offspring IQ
VI. PEDIATRICS
    New Gene Identified in Patients With Osteogenesis Imperfecta
VII. REGULATORY AFFAIRS
    Baby Food Warning - Earth's Best
VIII. TARGET HEALTH

I. WHAT'S NEW

Target Health Blog

Target e*CRO, is pleased to announce that our Blog (http://blog.targethealth.com/) is up and running. The Blog is both informative and fun and we look forward to having a lot of interpersonal communication. For more information, please contact  Dr. Jules T. Mitchel.

Business Development Position Open

With the release of Target Document® this week, the release of Target e*CRF® in March, and the release of Target Encoder in April, Target Health is looking for an energetic BD person with EDC experience in the pharmaceutical, CRO and biotech space. Background in computer sciences a plus. Existing network of customers is a must. East coast based is desirable. This is an opportunity for the right person to grow a BD department and be part of an exciting growth company. Please fax resumes to Joyce Hays, CEO (212-681-2105).

II. QUIZ (Fill  In The Blanks)

Milk +  Silk = Biosteel

Goat's milk combined with synthesized 1) ___ proteins, has yielded an incredibly light fabric, called biosteel, that is both biodegradable and strong enough to stop 2) ___. The biodegradable fabric would need to be sealed from the environment if used in critical applications such as body armor or spacecraft, because 3) ___ could get in and digest it. Biosteel is created by transferring the spider gene for the protein, into goat mammary cells and collecting soluble protein from the milk. Genetically engineered goats are now producing the protein. The protein can be turned into a supermaterial, because of its natural role in the silk of a spider's web. As the spider secretes the protein solution, the silk dries and pulls taut, transforming the proteins into a nearly crystalline and completely insoluble cable. Tests on natural silk show that it can be stronger and more elastic than high-tensile steel or the Kevlar® found in body 4) ___. Spider silk is five times stronger, by weight, than 5) ___ and more resilient than any polymer fiber. The technique used to make biosteel mimics the spider's own method of production by using goat 6) ___ cells. It turns out that the way mammals produce milk proteins and spiders make silk proteins are broadly 7) ___. Both are produced in skin-like epithelial cells, then held in a space, or lumen, where shear stresses on the protein are minimized. This process termed "transgenics" is a proven and patented technology. This technology focuses on two segments of the 8) ___ device market: wound closure systems, including vascular wound repair devices, hemostatic dressings, patches and glues, and sutures; and other medical device products, such as ligament prosthetic devices. BioSteel® has the potential to become the next generation performance filament because it is tougher and lighter than the incumbent fiber, Kevlar®.

ANSWERS: 1)  spider; 2) bullets; 3) bacteria; 4) armor; 5) steel; 6) mammary; 7) similar; 8) medical 

 

III. HISTORY OF MEDICINE

Animals in Research

The earliest references to animal testing are found in the writings of the Greeks in the third and fourth centuries BCE, with Aristotle (384-380 BCE) and Erasistratus  (304-258 BCE) among the first to perform experiments on living animals. Galen, a physician in second-century Rome , dissected pigs and goats, and is known as the "father of vivisection." Animals have had a role in numerous well-known experiments. In the 1880s, Louis Pasteur, convincingly demonstrated the germ theory of medicine by giving anthrax to sheep. In the 1890s, Ivan Pavlov, famously used dogs to describe classical conditioning. Insulin was isolated first from dogs in 1922, and revolutionized the treatment of diabetes. On November 3, 1957, a Russian dog named Laika, became the first of many animals to orbit the earth. In the 1970s, leprosy multi-drug antibiotic treatments were developed first in armadillos, then in humans. In 1996, Dolly the sheep, was born, the first mammal to be cloned from an adult cell. Edited by Alex Hays.

 

IV. INFECTIOUS DISEASE

Intranasal Influenza Vaccine Works Very Well   

Universal vaccination of children 6 to 59 months of age with trivalent inactivated influenza vaccine has recently been recommended by U.S. advisory bodies. As a result, a study published in the New England Journal of Medicine (2007;356:685-696), was performed to evaluate alternative vaccine approaches to childhood vaccinations. For the study, the safety and efficacy of intranasally administered live attenuated influenza vaccine was compared with those of inactivated vaccine in infants and young children. Children 6 to 59 months of age, without a recent episode of wheezing illness or severe asthma, were randomly assigned in a 1:1 ratio to receive either cold-adapted trivalent live attenuated influenza vaccine (a refrigeration-stable formulation of live attenuated intranasally administered influenza vaccine) or trivalent inactivated vaccine in a double-blind manner. Influenza-like illness was monitored with cultures throughout the 2004–2005 influenza season. Safety data were available for 8,352 children, and 7,852 children completed the study according to the protocol. There were 54.9% fewer cases of cultured-confirmed influenza in the group that received live attenuated vaccine than in the group that received inactivated vaccine (153 vs. 338 cases, P<0.001). The superior efficacy of live attenuated vaccine, as compared with inactivated vaccine, was observed for both antigenically well-matched and drifted viruses. Among previously unvaccinated children, wheezing within 42 days after the administration of dose 1 was more common with live attenuated vaccine than with inactivated vaccine, primarily among children 6 to 11 months of age. In this age group, 12 more episodes of wheezing were noted within 42 days after receipt of dose 1 among recipients of live attenuated vaccine (3.8%) than among recipients of inactivated vaccine (2.1%, P=0.076). Rates of hospitalization for any cause during the 180 days after vaccination were higher among the recipients of live attenuated vaccine who were 6 to 11 months of age (6.1%) than among the recipients of inactivated vaccine in this age group (2.6%, P=0.002). According to the authors, among young children, live attenuated vaccine had significantly better efficacy than inactivated vaccine, and that an evaluation of the risks and benefits indicates that live attenuated vaccine should be a highly effective, safe vaccine for children 12 to 59 months of age who do not have a history of asthma or wheezing. (ClinicalTrials.gov number, NCT00128167).

 

V. EPIDEMIOLOGY

Maternal Seafood Consumption During Pregnancy and Offspring IQ   

Seafood is the predominant source of omega-3 fatty acids, which are essential for optimum neural development. However, in the USA , women are advised to limit their seafood intake during pregnancy to 340 g per week. Since this number is not cast in stone, a study published in The Lancet (2007;369:578-585), was performed to assess the possible benefits and hazards to a child's development of different levels of maternal seafood intake during pregnancy. For the study, 11, 875 pregnant women completed a food frequency questionnaire assessing seafood consumption at 32 weeks' gestation. Multivariable logistic regression models including 28 potential confounders assessing social disadvantage, perinatal, and dietary items were used to compare developmental, behavioral, and cognitive outcomes of the children from age 6 months to 8 years in women consuming none, some (1–340 g per week), and >340 g per week. The study used the Avon Longitudinal Study of Parents and Children (ALSPAC) as the data source. Results showed that maternal seafood intake during pregnancy of less than 340 g per week was associated with increased risk of their children being in the lowest quartile for verbal intelligence quotient (IQ) (no seafood consumption, odds ratio [OR] 1•48; some, 1•09; overall trend, p=0•004), compared with mothers who consumed more than 340 g per week. Low maternal seafood intake was also associated with increased risk of suboptimum outcomes for prosocial behavior, fine motor, communication, and social development scores. For each outcome measure, the lower the intake of seafood during pregnancy, the higher the risk of suboptimum developmental outcome. According to the authors, maternal seafood consumption of less than 340 g per week in pregnancy did not protect children from adverse outcomes; rather, beneficial effects on child development was observed with maternal seafood intakes of more than 340 g per week, suggesting that advice to limit seafood consumption could actually be detrimental. The authors added that these results show that risks from the loss of nutrients were greater than the risks of harm from exposure to trace contaminants in 340 g seafood eaten weekly. 

 

VI. PEDIATRICS

New Gene Identified in Patients With Osteogenesis Imperfecta

Osteogenesis imperfecta (OI) is a rare disorder that occurs in 1 out of 15,000 to 20,000 births. Patients with OI have weaken bones, frequent fractures and OI is sometimes fatal. The affected gene contains the information for a protein designated P3H1 (prolyl 3-hydroxylase 1), also known as leprecan. P3H1 is part of a complex of proteins that is crucial for refining collagen to its final form. Collagen is an important building block for bone. When the gene does not function, little or no P3H1 is produced, resulting in defective collagen, and a form of OI. About 85% of all OI cases are caused by mutations in the genes that contain the information needed to make collagen. Some cases of OI, however, could not be explained by mutations in the collagen gene. A new study, published online in Nature Genetics (February 2007) has found a second genetic defect that accounts for previously unexplained forms of OI. Although there is no treatment for the disorder, the finding does allow OI experts to test families who have lost a child to OI for the presence of the defective gene. Couples with a child affected by this form of OI could be apprised of their risk for conceiving another child with OI. Similarly, siblings of children affected by the defective gene can also be counseled about their likelihood of carrying the gene.. The authors had earlier predicted that these unexplained OI cases might be caused by absence of proteins that interact with, and chemically modify, type I collagen. In a previous study (New England Journal of Medicine; December 28, 2006), a defect was discovered in the gene that codes for cartilage-associated protein (CRTAP), one of the proteins that work with P3H1 during collagen synthesis. Patients who have a loss of function of either CRTAP or P3H1 will develop severe OI. Of the two genes, mutations in P3H1 are not always fatal, as is the case when individuals do not have a functioning gene for CRTAP. 

 

VII. REGULATORY AFFAIRS

TARGET HEALTH excels in Regulatory Affairs and works closely with many of its clients performing all FDA submissions. TARGET HEALTH receives daily updates of new developments at FDA. Each week, highlights of what is going on at FDA are shared to assure that new information is expeditiously made available.

Baby Food Warning - Earth's Best

Botulism, a potentially fatal form of food poisoning, usually causes illness within 18-36 hours of exposure. Initial indication of illness in infants is decreased frequency or absence of stools. Other signs and symptoms noted are poor feeding, weak suck, lethargy, listlessness, weak cry, decreased body tone, and diminished overall movement. Difficulty with swallowing may be evident as secretions drooling from the mouth. This may be followed by decreased respiratory effort which may lead to respiratory arrest from airway occlusion from unswallowed secretions. The FDA is warning consumers not to use certain jars of Earth’s Best Organic 2 Apple Peach Barley Wholesome Breakfast baby food because of the risk of contamination with Clostridium botulinum, a bacterium which can cause botulism, a life-threatening illness or death. Consumers are warned not to use the product even if it does not look or smell spoiled. The affected product was sold in single individual jars and in variety packs (which contains 4 jars of the apple peach barley in the pack along with other varieties). The food is part of the firm’s “2nd Vegetables, Fruits and Blends” line intended for babies 6 months and older. The food was distributed through retail stores and sold through the Earth’s Best website. If consumers have any of the specified jars in their home, they should not use it and destroy it immediately. No illnesses have been reported to FDA or the manufacturer to date in connection with this problem.  The affected baby food is as follows: 

 For more information about our expertise in Regulatory Affairs, please contact Dr. Jules T. Mitchel or Dr. Glen Park.

 

VIII. TARGET HEALTH

TARGET HEALTH INC. (www.targethealth.com) is a full service e*CRO with full-time staff dedicated to all aspects of drug and device development. Areas of expertise include Regulatory Affairs, comprising, but not limited to, IND, IDE, NDA, PMA and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, Web Trials, utilizing Target e*CRF®, our proprietary Internet-based Clinical Trial System, and Medical Writing. TARGET HEALTH's Pharmaceutical Advisory Dream Team (PADT) assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.

TARGET HEALTH INC.
261 Madison Avenue
24th Floor
New York , NY 10016
Phone: (212) 681-2100; Fax (212) 681-2105

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Dr. Jules T. Mitchel, President
Ms Joyce Hays, CEO