Science Weekly: The money behind science

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Alok Jha looks at how research is funded, Nasa’s Ares rocket launch and a song about climate change

 Target Health Sponsors Conference on Innovations in Drug Delivery Technologies 

The 2009 Pharmaceutics Conference, Innovations in Drug Delivery Technologies, will bring together researchers and companies involved with drug delivery and pharmaceutical research to share their successes and challenges in new research techniques, therapies and devices. The program includes: 

  • Dr. Gary Cleary, Co-Founder – Corium, International Inc.
  • Dr. Veerappan Subramanian – Founder, President and CEO – Novel Labs, Inc.
  • Dr. John Siekierka, Director of Sokol Institute for Pharmaceutical Life Sciences, Montclair University
  • Dr. Tong Kong – William Ka Lung Cheung – Pharmacokinetics, pharmacogenomics and pharmacodynamics of dietary cancer chemopreventive phytochemicals and Nrf2-mediated signaling of anti-redox/oxidative stress response.
  • Dr. Bozena Michniak-Kohn – Priya Batheja –  Topical and transdermal drug delivery/nanocarriers and novel human skin equivalents for permeability and irritation testing.
  • Dr. Tamara Minko – Dr. Oleh Taratula –  Nanotechnology-based delivery of drugs, siRNA, antisense oligonucleotides, and peptides for treatment and imaging.
  • Dr. Patrick Sinko – Siva Naga Sree Priya – Mechanisms and applications of biopharmaceutics and polymers to drug delivery and targeting in the therapeutic areas of AIDS, chemical counterterrorism, and cancer.
  • Dr. Guofeng You – Dr. Vincent Duan – Elucidation of the molecular and functional characteristics of drug/xenobiotic transporters, their implications in human physiology and diseases, and their applications to drug therapy

Date: Friday, November 20, 2009 (9:30 AM – 4:30 PM)

Location: Life Sciences Building – New Jersey Center for Biomaterials

145 Bevier Road

Piscataway, NJ  08854

For more information about Target Health and our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website at    www.targethealth.com

Men & Women NOT Needed for First Step in Making Babies

Scientists at Stanford University have found a way to take out the first step in making babies –by creating sperm and eggs from 1) ___ stem cells. Researchers used stem cells taken from embryos in the first days of life and hope to soon be able to repeat the process by using pieces of 2) ___. A team led by Renee Reijo Pera at Stanford University in California developed a technique that turned human embryonic stem cells green when they started growing into sperm and 3) ___. After isolating the reproductive cells, the scientists worked out which genes made them grow properly by switching different 4) ___ on and off. Writing in the journal Nature, the scientists describe how that one gene, called DAZL, is involved in the formation of gender cells from the start. Two related genes are switched on later to steer the cells to full 5) ___. The main significance of the work is not to attempt to generate gametes for couples who do not produce them naturally. Rather, the work describes a system in which various aspects of germ 6) ___ development can be studied in vitro. The science paves the way for men and women with fertility issues to have their own 7) ___ children. The breakthrough raises a number of moral ethical questions -including the possibility of children being born through entirely artificial means. The sperm had heads and short tails and are thought to have been mature enough to fertilize an egg. The eggs were at a much earlier stage but were still much more developed than any created so far. The science also raises the possibility of ‘male eggs’ made from men’s skin and ‘8) ___ sperm’ from women’s skin. Some critics argue that it is wrong to tamper with the building blocks of life.

ANSWERS: 1) embryonic; 2) skin; 3) eggs; 4) genes; 5) maturity; 6) cell; 7) biological; 8) female

Julius Wolff MD (1836-1902)

Remodeling of bone occurs in response to physical stresses – or to the lack of them – in that bone is deposited in sites subjected to stress and is reabsorbed from sites where there is little stress. 

Julius Wolff born and educated in Berlin, was a German Surgeon/Anatomist who served as military surgeon during the Franco-Prussian War and some other minor campaigns. Wolff proposed Wolff’s law that mechanical stress was responsible for determining the architecture of bone. Wolff’s law states that bone in a healthy person or animal will adapt to the loads it is placed under. If loading on a particular bone increases, the bone will remodel itself over time to become stronger to resist that sort of loading. The internal architecture of the trabeculae undergoes adaptive changes, followed by secondary changes to the external cortical portion of the bone, perhaps becoming thicker as a result. The converse is true as well: if the loading on a bone decreases, the bone will become weaker due to turnover, it is less metabolically costly to maintain and there is no stimulus for continued remodeling that is required to maintain bone mass. Two examples are:

  1. Tennis players often use one arm more than the other. The racquet-holding arm bones of tennis players become much stronger than those of the other arm. Their bodies have strengthened the bones in their racquet-holding arm since it is routinely placed under higher than normal stresses.
  2. Astronauts who spend a long time in space will often return to Earth with weaker bones, since gravity hasn’t been exerting a load on their bones. Their bodies have reabsorbed much of the mineral that was previously in their bones.

Cardiometabolic Risk of Second-Generation Antipsychotic Medications During First-Time Use in Children and Adolescents

Cardiometabolic effects of second-generation antipsychotic (SGA) medications are concerning but have not been sufficiently studied in pediatric and adolescent patients naive to antipsychotic medication. As a result, a study published in the Journal of the American Medical Association (2009;302:1765-1773), was performed to evaluate the association of SGA medications with body composition and metabolic parameters in patients without prior antipsychotic medication exposure. The study, named “Nonrandomized Second-Generation Antipsychotic Treatment Indications, Effectiveness and Tolerability in Youth” (SATIETY), was conducted between December 2001 and September 2007 at semi-urban, tertiary care, academic inpatient and outpatient clinics in Queens, New York, with a catchment area of 4.5-million individuals. Of 505 youth aged 4 to 19 years with 1 week or less of antipsychotic medication exposure, 338 were enrolled (66.9%). Of these patients, 272 had at least 1 post-baseline assessment (80.5%), and 205 patients who completed the study (60.7%). Patients had mood spectrum (n = 130; 47.8%), schizophrenia spectrum (n = 82; 30.1%), and disruptive or aggressive behavior spectrum (n = 60; 22.1%) disorders. Fifteen patients who refused participation or were non-adherent served as a comparison group. Drug interventions included treatment with aripiprazole, olanzapine, quetiapine, or risperidone for 12 weeks. The main outcome measures were weight gain and changes in lipid and metabolic parameters. After a median of 10.8 weeks of treatment, weight increased by 8.5 kg (3.9 lbs) with olanzapine (n = 45), by 6.1 kg (2.8 lbs) with quetiapine (n = 36), by 5.3 kg (2.4 lbs) with risperidone (n = 135), and by 4.4 kg (2 lbs) with aripiprazole (n = 41) compared with the minimal weight change of 0.2 kg (0.1 lbs) in the untreated comparison group (n = 15). With olanzapine and quetiapine, respectively, mean levels increased significantly for total cholesterol (15.6 mg/dL and 9.1 mg/dL), triglycerides (24.3 mg/dL and 37.0 mg/dL, non-high-density lipoprotein (HDL) cholesterol (16.8 mg/dL and 9.9 mg/dL, and ratio of triglycerides to HDL cholesterol (0.6 and (1.2). With risperidone, triglycerides increased significantly (mean level, 9.7 mg/dL. Metabolic baseline-to-end-point changes were not significant with aripiprazole or in the untreated comparison group. According to the authors, first-time second-generation antipsychotic medication use was associated with significant weight gain with each medication, and that metabolic changes varied among the 4 antipsychotic medications.

ONCOLOGY

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microRNA May Help Predict Survival and Response to Treatment For Patients With Liver Cancer

Hepatocellular carcinoma, or HCC, is a common type of liver cancer. Surgery is currently the most effective therapy for this disease, but only about 10-20% of patients are eligible for this option, and even among eligible patients the relapse rate is high. Post-operative (adjuvant) treatment with interferon often follows surgery in an attempt to prevent relapse in some patients, but this approach often fails as well. How HCC develops is unclear. What is known is that it occurs more often in men than in women, and men tend to develop a more aggressive form of the disease. Differences in tumor biology and/or in the tumor microenvironment — the noncancerous tissue surrounding a tumor — may play a role. According to an article published in the New England Journal of Medicine (2009; 361:1437-1447), a small RNA molecule, known as a microRNA, may help physicians identify liver cancer patients who, in spite of their poor prognosis, could respond well to treatment with a biological agent called interferon. Interferon is an experimental therapeutic agent that has been used for many years to treat cancer patients, but with modest benefit. According to the authors, the findings are exciting because an existing drug has been identified that may have great potential for patients with a particular genomic profile and being able to treat patients with an existing drug based on a tumor’s genomic profile should improve its efficacy and reduce the cost of treatment. Since changes in microRNA levels have been noted in various human cancers, variation in the expression of microRNAs involved in HCC were investigated. microRNA molecules play an important role in controlling gene activity by regulating a process known as translation. In translation, another type of RNA molecule, called a messenger RNA (mRNA), copies the genetic code stored within a gene and carries it to cellular structures called ribosomes and, once there, serves as a template to build the cell’s proteins. There are many different types of microRNA, and a single microRNA species can affect the expression of many different proteins. The study measured levels of microRNAs associated with both cancerous and normal tissue in men and women and analyzed microRNA expression profiles from 241 surgery patients. By first comparing the microRNA profiles of normal liver tissue, and then comparing microRNAs in men and women, the study identified several microRNAs that were expressed more abundantly in normal female liver tissue. One of these, miR-26, was highly abundant and showed the greatest difference between the genders, so it was chosen for further analysis. Overall, whether they were male or female, patients who had low levels of miR-26 did not live as long as patients who had higher expression levels of this microRNA. There was about a four-year difference in survival between the patient groups. The researchers validated their findings in three independent groups of HCC patients, and again, those with lower tumor miR-26 levels had poorer survival. In a separate analysis, the team investigated whether miR-26 status influenced sensitivity to interferon therapy. Levels examined the levels of miR-26 in tumor samples collected from 135 patients who participated in a trial that evaluated interferon therapy in addition to other standard therapies following surgery. Among the 72 patients who had received interferon therapy as part of their cancer treatment, the researchers found that those with low tumor levels of miR-26 (indicative of a poor prognosis) benefited from receiving adjuvant interferon therapy. These patients survived at least 7.7 years longer than patients with low tumor levels of mi-R-26 that did not receive interferon therapy. In contrast, patients whose tumors had normal levels of miR-26 did not benefit from interferon. The researchers also validated their findings in a separate group of 79 patients. The results indicate that miR-26 status in tumors may be useful information both to determine prognosis for patients with HCC and to inform the selection of patients who might benefit from treatment with interferon to prevent disease relapse. All patients included in the study underwent surgery between 1999 and 2003 at the Liver Cancer Institute of Fudan University and at the University of Hong Kong Medical Center Centre. Most of the patients were hepatitis B virus-positive Chinese HCC patients. The study noted that more work will be needed to evaluate the association of miR-26 status with outcomes in non-Asian HCC patients. They will also need to examine HCC patients who have other underlying liver diseases, such as those infected with hepatitis C virus and/or have cirrhosis related to alcohol abuse. The research team is planning a prospective trial to further investigate the benefit of interferon therapy in HCC patients who have tumors with low levels of miR-26.

Marriage Protects Men from Clinically Meaningful Elevations in C-Reactive Protein

Minor elevations in CRP (>3 mg/L) are a nonspecific marker of systemic inflammation and predict the future onset of cardiovascular disease. As a result, a study published in Psychosomatic Medicine (2009;71:828-835), was performed to examine the association between marital status and C-reactive protein (CRP) levels after accounting for a range of relevant of demographic, subjective, and objective health indicators and psychological variables. For the study, data were used from the National Social Life, Health, and Aging Project (NSHAP), a population-based study of community-dwelling older adults in the US. Home-based interviews were conducted with the entire NSHAP sample, a subset of whom provided whole blood samples for the CRP analyses. The final sample consisted of 1,715 participants (n = 838 men) with an average age of 69.51 years. Results showed that across the entire NSHAP sample, married men demonstrated the lowest levels of CRP. After adjusting for the competing predictors, marriage remained a unique protective factor against elevated CRP for men (odds ratio = 0.56, 95% Confidence Interval = 0.39-0.79). The absolute risk reduction (for being classified in the high-risk CRP group) associated with being a married man was roughly equivalent to that observed for adults who were normotensive, nonsmokers, and those with a normal body mass index. According to the authors, remaining married in late adulthood affords men unique and robust protection against elevated levels of CRP.

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.

FDA and WebMD Expand Consumer Health Information Partnership

The FDA and WebMD Health Corp. have announced an expansion of their partnership to provide increased access to FDA’s consumer health information. This second phase of the partnership includes expanded content and multimedia tools at www.webmd.com/fda. WebMD is personalizing FDA health information for consumers with five new online FDA sections that will initially focus on allergies and asthma, children’s health, diabetes, heart health and vitamins and supplements. Launched in December 2008, this joint effort has already proven effective in reaching consumers with important safety information. The FDA’s information is also located within WebMD’s homepage, www.webmd.com, WebMD Health News, WebMD Health Search, RSS feeds, and targeted WebMD Newsletters and Special Reports. Since the launch, over 150,000 consumers have accessed the FDA destination on WebMD for health and wellness information on issues ranging from egg safety to contact lens safety to medicine safety. The FDA’s consumer information is also available through WebMD the Magazine, distributed ten times a year and reaching an additional 11 million consumers with each issue. In May, the FDA’s joint partnership center on WebMD’s site increased the reach of the agency’s warning to stop using an over-the-counter weight loss product after reports of serious health problems associated with the product. A special WebMD email alert with the warning reached almost 3 million consumers interested in weight, fitness and health issues-providing the right audience with the right information at the right time. 

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