Target Health has been in business since 1993 and runs a very tight ship. We never 1) sold or purchased toxic assets, 2) invested money with Bernie Madoff, 3) had to borrow money to pay bills, and 4) had to lay off a worker due to lack of work. We always felt that the best investment we could ever make would be in our company. Our senior team has lived through many economic ups and downs, the 1987 Stock Market Crash, M&As,. layoffs etc; so we took those lessons learned and applied them to our business model. While our vision is futuristic, our feet are always on the ground.

We also run a truly Green Company: We have replaced paper-based files with electronic files, electronic signatures have replaced overnight mail, we use mugs instead of paper cups for coffee and tea, all offices have windows for natural light and all employees use public transportation to get to work. We have installed a special water filter system and gotten rid of all bottled water.

We are not publicly traded, so we don’t have shareholders pressuring us for higher and higher profit margins. We are able to provide fair prices to our clients, also because we are highly organized and with efficient processes. Last year we did the EDC for 2 of the 25 annual FDA drug approvals. This year a PMA has already been approved and we anticipate an NDA approval shortly. We were also directly involved with an NDA submission this year and we are preparing a full eCTD for a December submission and another one for May 2010. Watch our toolkit grow………….more to come.

For more information about Target Health and any of 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

High intakes of red or processed meat has been implicated as a cause of increased risk of mortality. As a result a study published in the Archives of Internal Medicine (2009;169:562-571) was performed to determine the relations of red, white, and processed meat intakes to risk for total and cause-specific mortality. The study population included the National Institutes of Health-AARP Diet and Health Study cohort of half a million people aged 50 to 71 years at baseline. Meat intake was estimated from a food frequency questionnaire administered at baseline. The covariates included in the statistical model were age, education, marital status, family history of cancer (yes/no) (cancer mortality only), race, body mass index, 31-level smoking history, physical activity, energy intake, alcohol intake, vitamin supplement use, fruit consumption, vegetable consumption, and menopausal hormone therapy among women. Main outcome measures included total mortality and deaths due to cancer, cardiovascular disease, injuries and sudden deaths, and all other causes. Results showed that there were 47,976 male deaths and 23,276 female deaths during 10 years of follow-up. Men and women in the highest vs. lowest quintile of red and processed meat intakes had elevated risks for overall mortality. Regarding cause-specific mortality, men and women had elevated risks for cancer mortality for red and processed meat intakes. Furthermore, cardiovascular disease risk was elevated for men and women in the highest quintile of red and processed meat intakes. When comparing the highest with the lowest quintile of white meat intake, there was an inverse association for total mortality and cancer mortality, as well as all other deaths for both men and women. According to the authors, red and processed meat intakes were associated with modest increases in total mortality, cancer mortality, and cardiovascular disease mortality.

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.

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President Barack Obama announced the appointments of Dr. Margaret Hamburg as Commissioner of the FDA, and Dr. Joshua Sharfstein as the Principal Deputy Commissioner, as well as the creation of a new Food Safety Working Group. This Food Safety Working Group will be chaired by the Secretaries of Health and Human Services and the Department of Agriculture and it will coordinate with other agencies and senior officials to advise the President on improving coordination throughout the government, examining and upgrading food safety laws, and enforcing laws that will keep the American people safe. In addition, the President also announced two other measures to protect the American people. The Department of Agriculture will close a loophole to prevent diseased cows from entering the food supply. And, the government will invest in the FDA to substantially increase the number of food inspectors and modernize food safety labs.

Dr. Hamburg is a nationally and internationally recognized leader in public health and medicine, and an authority on global health, public health systems, infectious disease, bioterrorism and emergency preparedness. She served as the Nuclear Threat Initiative’s founding Vice President for the Biological Program. Before joining NTI, she was the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Prior to this, she served for six years as the Commissioner of Health for the City of New York and as the Assistant Director of the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Dr. Joshua M. Sharfstein is Commissioner of Health for the City of Baltimore. He also serves as chair of the board of four affiliated nonprofit agencies. He has been recognized as a national leader for his efforts to protect children from pieces of jewelry marketed to children, over-the-counter medication, and ensuring Americans with disabilities have access to prescription drugs. He is a member of the Board on Population Health and Public Health Practice of the Institute of Medicine.

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

Researchers in Canada are reporting that proteins found in a common garden pea show promise as a natural food additive or new dietary supplement for fighting high blood pressure and chronic kidney disease (CKD). Those potentially life-threatening conditions affect millions of people worldwide. The study, which was presented March 22 at the American Chemical Society’s 237th National Meeting, is the first reporting that a natural food product can relieve symptoms of CKD. Peas long have been recognized as nutritional superstars, with healthful amounts of protein, dietary fiber, and 1) ___ wrapped in a low-fat, cholesterol-free package. The new research focuses on the yellow garden pea, a mainstay pea variety enjoyed as a veggie side-dish and used as an ingredient in dozens of recipes around the world. In people with high blood pressure, this particular protein could potentially delay or prevent the onset of kidney damage. For people who already have kidney disease, this 2) ___ may help them maintain normal blood pressure levels so they can live longer. High blood pressure, or 3) ___, is a major risk factor for CKD, a condition that has been affecting an increasing number of people in the US and other countries. Estimates suggest that 13% of American adults, about 26 million people, have chronic kidney disease, up from 10%, or about 20 million people, in the 1990s. CKD is difficult to treat, and may progress to end-stage kidney disease that requires kidney dialysis or a kidney transplant. That situation is fostering a search for new ways of treating CKD and preserving 4) ___ function. Working with University of Manitoba colleague Harold Aukema, Ph.D., Rotimi Aluko PhD, purified a mixture of small proteins, called pea protein hydrolysate, from the yellow garden pea. They fed small daily doses of the protein mixture to laboratory rats with polycystic kidney disease, a severe form of kidney disease used as a model for research on CKD. At the end of 8 weeks, the protein-fed rats with kidney disease showed a 20% drop in blood pressure when compared to diseased rats on a normal diet. This is significant because a majority of CKD patients actually die from 5) ___ complications that arise from the high blood pressure associated with kidney malfunction. In both rats and humans with polycystic kidney disease, the condition causes urine output to be severely reduced and the kidneys are unable to properly remove dangerous 6) ___. The study showed that their pea extract caused a 30% boost in 7) ___ production in the diseased rats, bringing their urine to within normal levels. There were no obvious adverse side effects from the pea protein, which is a huge improvement. Based on those promising results, the researchers plan to test the protein extract in humans with mild hypertension within the next year. Scientists do not know exactly how the pea extract works. However, it appears to boost production of cyclooxygenase-1 (COX-1), a protein that boosts kidney function. They point out that eating yellow peas in their natural state won’t produce the same potential health benefits as the purified protein extract. The potentially beneficial proteins exist in an inactive state in natural peas, and must be activated by treatment with special 8) ___. The pea extract does have a very welcome social advantage over fresh peas; it won’t give you gas, because the purified proteins don’t contain the complex plant-sugars found in fresh beans that are known to trigger flatulence. If studies continue to show promise, it is estimated that the extract could hit the consumer market within the next two to three years. The extract could be made into a soluble powder that can be added to foods and beverages or it could be developed into a pill, the scientists say.

ANSWERS
1) vitamins; 2) protein; 3) hypertension; 4) kidney; 5) cardiovascular; 6) toxins; 7) urine; 8) enzymes