Science Weekly Extra: Paul Davies on the search for ET

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Alok Jha and Robin McKie speak to astrophysicist Paul Davies from Seti – the Search for Extraterrestrial Intelligence

Science Weekly: New ways to find aliens

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Why there’s an eerie silence from outer space; Rick Potts on the origins of humans; and the use of sound in theatre

Drug and device development is all about Regulatory and Data.

Regulatory Affairs projects at Target Health

Target Health is pleased to announce the receipt of two very interesting pre-IND/IND regulatory projects involving new chemical entities (NCEs) in the areas of pain and inflammation. These programs are for novel products which will address unmet medical needs. Target Health now provides regulatory support to over 30 companies and academic institutions both in the US and the rest of the world including: England, France, Germany, Israel, Korea, Switzerland and Turkey.

We are preparing an eCTD NDA which will be submitted Q4 and we expect at least two FDA approvals this year for programs that used Target e*CRF®. A third NDA is also under final review. We also provided full CRO services for each of these programs. We have now been directly involved in 27 global regulatory approvals since 1993; 17 with Target e*CRF® and 4 in 2009.

For more information about Target Health and our software tools for paperless clinical trials, please contact Warren Pearlson (212-681-2100 ext 104) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health at www.targethealth.com

Calcium May Help You Live Longer

Getting a bit more calcium in your diet could help you live longer. Swedish researchers found that men who consumed the most calcium in food were 25% less likely to 1) ___ over the next decade than their peers who took in the least calcium from food. None of the men took calcium supplements. The findings are in line with previous research linking higher calcium intake with lower mortality in both men and 2) ___. While many researchers have looked at calcium and magnesium intake and the risk of chronic 3) ___, less is known about the association between consumption of these nutrients in food and mortality. For the study, Dr. Joanna Kaluza of the Karolinska Institutet in Stockholm and her colleagues looked at more than 23,000 Swedish men who were 45 to 79 years old at the study’s outset and were followed for 4) ___ years. All had reported on their diet at the beginning of the study. During follow-up, about 2,358 died. The top calcium consumers had a 25% lower risk of dying from any cause and a 23% lower risk of dying from 5) ___ disease during follow-up relative to men that had the least amount of calcium in their diet. Calcium intake didn’t significantly influence the risk of dying from cancer. Men in the top third based on their calcium intake were getting nearly 2,000 milligrams a day, on average, compared to about 1,000 milligrams for men in the bottom third. The US Recommended Dietary Allowance (RDA) for 6) ___ intake is 1,000 milligrams for men 19 to 50 years old and 1,200 milligrams for men 50 and over. “Intake of calcium above that recommended daily may 7) ___ all-cause mortality,” Kaluza and her colleagues conclude. Calcium could influence 8) ___ risk in many ways, for example by reducing blood pressure, cholesterol, or blood sugar levels. For the men in the study, the main sources of calcium in the diet were milk and milk products and cereal products. In contrast to calcium, there was no relationship between 9) ___ consumption and overall mortality or deaths from cancer or heart disease. Study participants’ intakes ranged from around 400 milligrams per day to around 525 milligrams; the RDA for magnesium is 420 milligrams for men 31 and older. This analysis may have found no effect for magnesium because all of the men in the study seemed to be getting enough of the mineral in their diet. Further studies are needed in other populations with lower dietary magnesium intakes to address this issue. Future research should also look into calcium and magnesium intake from drinking 10) ___, which can be a significant source of these minerals. SOURCE: American Journal of Epidemiology

ANSWERS: 1) die; 2) women; 3) disease; 4) ten; 5) heart; 6) calcium; 7) reduce; 8) mortality; 9) magnesium; 10) water

American Medicine and Russian Politics

It was the fall of 1996, and Boris N. Yeltsin was running for re-election as Russia’s first president in the post-Soviet era when he had a heart attack. He was experiencing chest pain from angina and needed a coronary bypass operation. But his Russian doctors said he could not survive such surgery. For independent advice, Mr. Yeltsin reached out to Dr. Michael E. DeBakey, the pioneering Houston heart surgeon. Dr. DeBakey agreed to go to Moscow, and after examining Mr. Yeltsin, he determined that the Russian leader could indeed survive a bypass operation. This was not widely noted when Mr. Yeltsin died in April 2007 at the age of 76, that the consultation very likely saved his presidency, if not his life, and in doing so, it changed the course of history. Among other things, if Mr. Yeltsin had not been re-elected, he would never have had the opportunity to reach deep into the Russian bureaucracy to select Vladimir V. Putin, then an obscure functionary, as his successor. Dr. DeBakey, now 98, had often visited the Soviet Union during the cold war to lecture on, and occasionally perform, the operations and procedures that he had developed. But in those days, Kremlin officials would hardly have asked for a consultation with an American surgeon, no matter how eminent. “Calling in Dr. DeBakey was very important, a signal that he was in very serious condition, and consulting with a world leader in surgery this way was almost unthinkable in the Soviet period,” said Marshall I. Goldman, a Russian expert and senior scholar at Harvard. “It was a measure of Dr. DeBakey’s stature in Russia.” Thomas R. Pickering, who was the United States ambassador to Russia at the time, said it was not clear who would have been elected if Mr. Yeltsin had dropped out of the race. Dr. DeBakey said his confidence in Mr. Yeltsin’s ability to undergo bypass surgery was based on an examination far more thorough than the ones the Russian doctors had conducted. Dr. DeBakey told Mr. Yeltsin that he had confidence in the Russian heart surgeon who would eventually perform the quintuple bypass. Dr. Renat S. Akchurin, had briefly trained under Dr. DeBakey in Houston and specialized in microsurgery, wearing jeweler-type loupes and using an operating microscope to magnify the surgical field when repairing human nerves injured in accidents. Mr. Yeltsin insisted on having the operation at Dr. Akchurin’s hospital, even though it did not have all the emergency equipment Dr. DeBakey thought might be needed. So Dr. DeBakey also promised Mr. Yeltsin that he would watch the bypass operation and bring a team that included his surgical partner, Dr. George P. Noon, along with the equipment in case it was needed. Mr. Yeltsin’s medical team followed Dr. DeBakey’s advice to correct the thyroid and other problems to prepare him for the bypass operation. A key monitor of heart function is the ejection fraction, a test that measures the proportion of blood ejected from the main chamber of the heart in each beat. After the medical tuneup, Mr. Yeltsin’s ejection fraction rose significantly, to 40 from the high 20s. After the operation, the fraction improved to 50, good but still a bit less than normal. Two weeks after his return to work, Mr. Yeltsin was treated for pneumonia. A few years ago, after Mr. Yeltsin developed symptoms of further heart trouble, doctors at the Berlin Heart Center in Germany performed an angioplasty. Dr. Roland Hetzer, who led the German team, called Dr. DeBakey the next day to report that the five grafts that Dr. Akchurin had sewn in Mr. Yeltsin’s heart had remained open and functioning well. But the German team had to clear blockages and place stents in two other areas of Mr. Yeltsin’s coronary arteries. Considering the amount of heart damage Mr. Yeltsin had suffered before the bypass, Dr. DeBakey estimated in 1996 that the surgery would allow Mr. Yeltsin to live comfortably for 10 to 15 years. The Kremlin’s choice of Dr. DeBakey was based on contacts he made among Russian officials over the half-century since he befriended a small group of Soviet doctors who sat by themselves at a surgical meeting in Mexico in the 1950s. Dr. DeBakey took them to lunch and invited them to watch him operate in Houston on their way home. Later, his guests invited Dr. DeBakey to speak at a surgical meeting in Moscow and then translated his text into Russian. It was the first of more than 20 trips that Dr. DeBakey said he made to the Soviet Union. On one trip, in 1973, Dr. DeBakey performed a quintuple bypass on Mstislav V. Keldysh, a nuclear scientist and president of the Soviet Academy of Science. A year later, the nation’s Academy of Medical Sciences elected Dr. DeBakey a foreign member. In a foreword to the Russian edition of Dr. DeBakey’s book “The New Living Heart” (Adams, 1997), Mr. Yeltsin described Dr. DeBakey as “a magician of the heart” and “a man with a gift for performing miracles.” Source: The New York Times, by Lawrence K. Altman MD.

GENETICS

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Hereditary Condition Causing Limb Weakness Traced To Rare Disorder Gene

The peripheral nervous system consists of nerves that reside or extend outside of the brain and spinal cord. Inherited peripheral neuropathies are a diverse group of disorders that cause loss of muscle tissue in the hands, feet, and lower legs of affected patients, usually starting in adulthood. Various genetic causes have been identified for Charcot-Marie-Tooth disease (CMT). the broad category of inherited peripheral neuropathy that affects approximately 125,000 people in the United States. According to a study published in the American Journal of Human Genetics (2010;86:343-352), a gene that causes a fatal childhood brain disorder can also cause adults to develop peripheral neuropathy. The study is the first to show that different mutations in the same gene cause the two seemingly unrelated disorders. In the current study, it was determined that persons with a CMT-like neuropathy have a mutation in the same gene that causes Menkes disease, a severe brain disorder that begins in infancy and is fatal if not treated. This gene, called ATP7A, codes for a protein needed to move the trace metal copper between different compartments within the body’s cells, or out of cells altogether. The mutated gene’s role in distal motor neuropathy was discovered by studying the DNA of two large, unrelated families with multiple affected members. Changes in the DNA of the family members who had the disorder did not appear in the DNA of those who did not have the disorder. The mutations causing distal motor neuropathy appeared to have much lesser effects than did the mutations found in the infants with Menkes disease. Menkes disease arises from other mutations in the same gene, which make the resulting protein unable to fulfill its usual function-transporting copper. As a result, children with Menkes disease have abnormal levels of copper: low levels in the blood, the brain and liver, as well as excess amounts in the kidneys and intestines. However, people with distal motor neuropathy do not have abnormal copper levels. The mutations that cause distal motor neuropathy do not eliminate the protein’s function completely-the protein maintains about 70% of its normal ability to move copper. Still, the study found subtle abnormalities in how the protein itself moves within a cell. The abnormalities apparently affect people’s motor neurons, the nerve cells in the spine that control muscles.

Barrier in Mosquito Midgut Protects Invading Pathogens – Discovery May Inform New Strategies for Blocking Malaria Transmission

According to an article published online in Science (11 March 2010), scientists studying the Anopheles gambiae mosquito, the main vector of malaria, have found that when the mosquito takes a blood meal, that act triggers two enzymes to form a network of crisscrossing proteins around the ingested blood. The formation of this protein barrier is part of the normal digestive process that allows so-called “healthy” or commensal gut bacteria to grow without activating mosquito immune responses. But there is a downside: The barrier also prevents the mosquito’s immune defense system from clearing any disease-causing agents that may have slipped into the blood meal, such as the Plasmodium malaria parasite, which in turn can be passed on to humans. Disrupting the protein barrier, however, can trigger mosquito immune defenses to intervene and protect the insect from infection. The enzymes involved in the protein barrier are called immunomodulatory peroxidase (IMPer) and dual oxidase (Duox). The researchers believe it might be possible to prevent the formation of the protein barrier by immunizing people with IMPer or the proteins that crisscross. This vaccine would generate antibodies that, after a mosquito feeds on a human, could disrupt the barrier, reduce parasite survival in the mosquito and prevent malaria transmission. The role of IMPer-Duox in forming a protective barrier was unexpected – and previously unrecognized. When silenced, or turned off, the gene for either IMPer or Duox, the mosquito’s midgut immune system took over and greatly reduced Plasmodium infection, indicating that IMPer and Duox are both required for parasite survival. The IMPer-Duox system also is found in the mucous membrane of some human tissues, such as the colon. The authors are investigating whether a protective protein barrier similar to that seen in mosquitoes also forms in vertebrates, including humans. If so, the barrier could be part of the process that normally prevents the colon from activating immune responses against commensal bacteria, as this would be harmful and lead to chronic inflammation. The existence of such a barrier in humans could have broad implications for the prevention and treatment of diseases such as chronic inflammatory bowel disease.

Mortality Among Contraceptive Pill Users 

According to an article published in the British Medical Journal (2010;340:927), a study was performed to see if the mortality risk among women who have used oral contraceptives differs from that of never users. The investigation was a prospective cohort study started in 1968 with mortality data supplied by 1,400 participating general practitioners, the National Health Service central registries, or both. For the study, 46,112 women were observed for up to 39 years, resulting in 378,006 woman years of observation among never users of oral contraception and 819,175 among ever users. The main outcome measures were directly standardized adjusted relative risks between never and ever users for all cause and cause specific mortality. During the course of the study, 1,747 deaths occurred in never users of oral contraception and 2,864 in ever users. Compared with never users, ever users of oral contraception had a significantly lower rate of death from any cause (adjusted relative risk 0.88). They also had significantly lower rates of death from all cancers; large bowel/rectum, uterine body, and ovarian cancer; main gynecological cancers combined; all circulatory disease; ischemic heart disease; and all other diseases. They had higher rates of violent deaths. No association between overall mortality and duration of oral contraceptive use was observed, although some disease specific relations were apparent. An increased relative risk of death from any cause between ever users and never users was observed in women aged under 45 years who had stopped using oral contraceptives 5-9 years previously but not in those with more distant use. The estimated absolute reduction in all cause mortality among ever users of oral contraception was 52 per 100,000 woman years. According to the authors, oral contraception was not associated with an increased long term risk of death in this large UK cohort; indeed, there was a net benefit. The balance of risks and benefits, however, may vary globally, depending on patterns of oral contraception usage and background risk of disease.

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 Task Force Seeks Public Comments on Increasing Transparency with Regulated Industry

The FDA regulates products responsible for about 25% of the gross national product of the US and the industries responsible for these products. Products regulated by the agency – biologics and blood products, human drugs, foods, medical devices, radiation-emitting devices, and veterinary medicines – are integral to public health and to the U.S. economy. The FDA formed an internal Transparency Task Force in response to the Obama Administration’s commitment to achieve “an unprecedented level of openness in Government.” The Task Force is developing recommendations for making information about FDA activities and decisions more useful, understandable, and readily available, while appropriately protecting confidential information. The Task Force held public meetings in June 2009 and November 2009. Based upon input received thus far, the Transparency Initiative has been divided into three phases. The first phase, creating a Web-based resource called “FDA Basics” to provide information on commonly misunderstood aspects of the agency, has been completed. The second phase, improving FDA’s disclosure of information to the public, is underway and the agency intends to issue draft proposals for public comment soon. The request for comment for the third phase follows a series of listening sessions with members of regulated industry in January 2010. Transcripts and summaries of those listening sessions are available. For this final phase, the FDA is particularly interested in comments from all interested parties on how the agency can make improvements in the following areas:

  1. Training and education for regulated industry about the FDA regulatory process in general and/or about specific new requirements
  2. The guidance development process
  3. Maintaining open channels of communication with industry routinely and during crises
  4. Providing useful and timely answers to industry questions about specific regulatory issues

 

Electronic comments may be submitted to http://www.regulations.gov3

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

 

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Target Health (www.targethealth.com) is a full service eCRO 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 (eCTD), IDE, NDA (eCTD), BLA (eCTD), PMA (eCopy) and 510(k) submissions, execution of Clinical Trials, Project Management, Biostatistics and Data Management, EDC utilizing Target e*CRF®, and Medical Writing. Target Health has developed a full suite of eClinical Trial software including 1) Target e*CRF® (EDC plus randomization and batch edit checks), 2) Target e*CTMS™, 3) Target Document®, 4) Target Encoder®, 5) Target Newsletter®, 6) Target e*CTR™ (electronic medical record for clinical trials). Target Health ‘s Pharmaceutical Advisory Dream Team assists companies in strategic planning from Discovery to Market Launch. Let us help you on your next project.