Applications invited as Consultant (New Drug) in CENTRAL DRUGS STANDARD CONTROL ORGANIZATION ( CDSCO )

 

CENTRAL DRUGS STANDARD CONTROL ORGANIZATION, Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Post: Consultant (New Drug)

Essential Qualifications:-
i) A recognized medical qualification included in the First or Second Schedule orPart II of the Third Schedule (Other than licentiate qualifications) to the Indian Medical Council Act, 1956. Holders of Educational Qualifications included in thePart II of the Third Schedule should also fulfil the conditions stipulated in sub-section 3 of the Section 13 of the Indian Medical Council Act, 1956;
ii) Postgraduate Degree in Pharmacology of a recognized University or equivalent;
iii) 8 years experience in the planning of clinical trials including drawing up of protocols of the trials and designing of suitable proforma or in the screening of pre-clinical data and examination of clinical information on 'New Drugs'.

Desirable: Experience of administration of the Drugs and Cosmetics Act, 1940 and/or of manufacture and testing of drugs and knowledge of procedures for approval of New Drugs and/or drawing up of standards of drugs.

Duties:-
The duties in brief of the post are as follows:-
(i) Screening of pre-clinical and clinical data on new drugs molecules from the angle of safety and efficacy;
(ii) Examination of clinical trial protocols in India;
(iii) Liaison with agencies like ICMR, Central Drugs Laboratory, CIPL;
(iv) Examination of packaging insert of promotional materials and monitoring of adverse reactions to drugs.

TORs:- The Consultant will be given specified tasks and deliverables by way of TORs in terms of the assignment which will be monitored at appropriate level/s in CDSCO.

LAST DATE: 8th Oct, 2012

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Advt. No.18/2012

The National Institute of Pharmaceutical Education & Research (NIPER) is an Institute of national importance established by an Act of Parliament under the aegis of Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India. The main thrust areas of the institute are Tuberculosis, Malaria, Leishmaniasis and Diabetes. The Institute has excellent facilities for advanced education and research in pharmaceutical sciences and technology and is looking for faculty of high caliber and potential, willing to face the challenge of building this Institute into a center of excellence.

The Institute intends to fill the four (04) posts of Professor (UR: 02, OBC: 01 & SC: 01) in the following disciplines.

Post: Professor- (Biotechnology-01, Pharmacokinetics-01, Advisor - Business Development- 01, Technology Development of APIs and Dosage Formulations- 01)

1. PROFESSOR (BIOTECHNOLOGY):
The incumbent should have worked in one of the frontier areas of biotechnologyspecializing in cell and molecular biology, stem cells, tissue engineering, cell differentiation and growth etc. addressing the issues of regenerative medicine and developmental biology.
ESSENTIAL QUALIFICATION & EXPERIENCE:
Ph.D with first class or equivalent grade at the preceding degree in the appropriate branch with a very good academic record throughout and at least 10 years of teaching/research/industrial experience with published work of high quality well recognized and established reputation of having made conspicuous seminal contribution to knowledge in pharmaceutical and allied areas.

DUTIES:
In addition to teaching courses and supervising students, the incumbent has to provide leadership for implementing newer approaches in the emerging areas of advanced research.

PAY STRUCTURE:
PB-4 (Rs.37,400 - 67,000/-) with starting pay Rs.48,000/- pm plus Academic Grade Pay of Rs.10,500/- and other allowances at par with Central Government Rules.

MAXIMUM AGE LIMIT:
50 years (relaxable for specially qualified candidates).

2. PROFESSOR (PHARMACOKINETICS):
The institute is looking for a dynamic and result oriented person for the post of Professor (Pharmacokinetics). The incumbent must have post-doctoral training or relevant job experience in DMPK, PK PD modeling / simulation that may relate to development of drug therapies, drug targets, or drug delivery systems. Preference will be given to applicants with training and research expertise in areas of bio-pharmaceutics, BA-BE, or pharmacokinetics / clinical pharmacokinetics. Candidates
with experience in drug metabolism and pharmacokinetic modeling or clinical research are especially encouraged to apply.

ESSENTIAL QUALIFICATION & EXPERIENCE:
Ph.D with first class or equivalent grade at the preceding degree in the appropriate branch with a very good academic record throughout and at least 10 years of teaching/research/industrial experience with published work of high quality well recognized and established reputation of having made conspicuous seminal contribution to knowledge in pharmaceutical and allied areas.

DUTIES:
In addition to teaching courses and supervising students in pharmaceutics, clinical research and drug metabolism, the incumbent will be responsible for managing 24-bed bioequivalence unit (National Bioavailability Centre) of the Institute and providing BA BE inputs and services to in-house projects and Indian Pharma Industry. The candidate is also expected to pursue and establish appropriate research collaborations within the Institute, Pharma or Biotech companies and engage in scholarly activity.

PAY STRUCTURE:
PB-4 (Rs.37,400 - 67,000/-) with starting pay Rs.48,000/- pm plus Academic Grade Pay of Rs.10,500/- and other allowances at par with Central Government Rules.

MAXIMUM AGE LIMIT:
50 years (relaxable for specially qualified candidates).

3. PROFESSOR (ADVISOR - BUSINESS DEVELOPMENT)
The institute is looking for a dynamic and result oriented person for the post of Professor (Advisor - Business Development). The incumbent should have the exposure to pharmaceutical industry and shall possess the ability, capability and to cope up with the requirements and expectations of the institute. He is expected to be a person with positive attitude, capable of problem solving, with a proven ability to coordinate with the industry, set interaction with the niche area clients (both within India and abroad), explore contract research opportunities, licensing of generated know-how / services, consultancy arrangements etc. and in general research management / business development activities of the institute

ESSENTIAL QUALIFICATION & EXPERIENCE:
Ph.D with first class or equivalent grade at the preceding degree in the appropriate branch with a very good academic record throughout and at least 10 years of teaching/research/industrial experience with published work of high quality well recognized and established reputation of having made conspicuous seminal contribution to knowledge in pharmaceutical and allied areas.

DUTIES:
The duties of the incumbent would be to promote business development, business in public – private partnership, contract research, industrial liaison, management of IPR portfolio, transfer of know-how, promotion / linkages of activities of the proposed SME Centre at NIPER and other activities as advised by the Board of Governors from time to time.

PAY STRUCTURE:
PB-4 (Rs.37,400 - 67,000/-) with starting pay Rs.48,000/- pm plus Academic Grade Pay of Rs.10,500/- and other allowances at par with Central Government Rules.

MAXIMUM AGE LIMIT:
50 years (relaxable for specially qualified candidates).

4. PROFESSOR (TECHNOLOGY DEVELOPMENT OF APIs& DOSAGE FORMULATIONS):
The incumbent should have experience in scale up, process / product translation or development and validation activities in the areas of drugs and pharmaceuticals either in new dosage formulations or APIs or both. Experience in setting up, operating and managing pilot plants, process control equipments including analytical laboratories would be an added advantage.

ESSENTIAL QUALIFICATION & EXPERIENCE:
Ph.D with first class or equivalent grade at the preceding degree in the appropriate branch with a very good academic record throughout and at least 10 years of teaching/research/industrial experience with published work of high quality well recognized and established reputation of having made conspicuous seminal contribution to knowledge in pharmaceutical and allied areas.

DUTIES:
The selected candidate shall have the responsibility of managing the existingTechnology Development Centre (TDC) for APIs and upcoming dosage formulations plant and provide its clients, full range of services as an industrial developmental support upto bio-batches or clinical batches.

PAY STRUCTURE:
PB-4 (Rs.37,400 - 67,000/-) with starting pay Rs.48,000/- pm plus Academic Grade Pay of Rs.10,500/- and other allowances at par with Central Government Rules.

MAXIMUM AGE LIMIT:
50 years (relaxable for specially qualified candidates).

PB=Pay Band, AGP= Academic Grade Pay
Application should be accompanied with non-refundable fee of Rs.500/- (Rs.250/- in case of SC/ST) in shape of Demand Draft drawn in favour of Director, NIPER payable at Mohali/Chandigarh.
Application duly filled in prescribed form should be sent to Director, National Institute of Pharmaceutical Education & Research, Sector-67, S.A.S. Nagar (Mohali)-160062.

OTHER AMENITIES/ALLOWANCES
The faculty of NIPER shall be entitled to Dearness Allowance, Medical Allowance, House Rent Allowance, Transport Allowance, LTC and other allowances etc. In addition, the faculty of the Institute shall be given the following special allowances to help them in their professional development.

MEMBERSHIP OF PROFESSIONAL SOCIETIES/PROCURMENT OF JOURNALS
The faculty member shall get 50% subsidy on the cost of membership or of the journals up to a maximum of Rs.5,000/- per year.BOOK ALLOWANCE
The faculty member shall get a book allowance upto maximum of Rs. 5,000/- per year. The books shall ultimately form a part of the Institute’s Library accession.

CONTRACT RESEARCH & CONSULTANCY
The Institute encourages the faculty members to undertake consultancy work or work on sponsored projects.

GENERAL INFORMATION
1. Mere eligibility will not entitle any candidate for being called for interview. The Institute reserves the right to place reasonable limit on the total number of candidates to be called for interview.
2. The Institute reserves the right to withdraw advertised post(s) at any time without assigning any reason. Institute also reserves the right to fill or not to fill the post(s) and its decision in this regard shall be final.
3. Reservation policy will be followed as per Government of India rules. The candidates are required to attach valid caste certificate as per format prescribed by the Government of India.
4. The process of selection may include presentation / seminar / interview or a combination thereof.
5. Envelope containing the application form must be super scribed with ‘Application for the post of ______________ (discipline applied for)’.
6. Applicant(s) serving in Government / Semi-Government / Public Sector Undertakings/ Autonomous organizations must send their application ‘Through proper channel’.
7. The names, addresses and occupations of the two referees must be given in the application.
8. The age of Superannuation will be as per UGC norms.
9. Candidates shall have to produce original testimonials at the time of interview.
10. CANVASSING IN ANY FORM MAY LEAD TO CANCELLATION OF CANDIDATURE.
11. No interim enquiries/correspondence/communication of any sort will be entertained on the matter.
12. All appointments are contractual in nature for a period of five (05) years or attaining the age of superannuation, whichever is earlier. The contract can be renewed depending upon performance and mutual consent. However, except for the consequences of being on contract, the position filled on contract shall accrue all the benefits of permanency as per rules of NIPER.
13. Incomplete application or without relevant supporting enclosures (self attested copies of degree / certificates / marks sheets / experience certificate, reprint of important publications etc.) will be out-rightly rejected.
14. How to Apply: Application form is available at <below>. The candidates fulfilling the eligibility criteria may submit their application on the prescribed application form along with testimonials and latest passport size photograph along with a fee of Rs.500/- (Rs. 250/- for SC/ST) in the shape of Demand Draft favouring Director, NIPER, payable at Mohali / Chandigarh to Director, NIPER, S.A.S. Nagar – 160 062.
15. The last date for receipt of application form is 08-10-2012.
16. The Institute will not be responsible for non-receipt of application(s) within the stipulated date due to any postal delay / loss of application / document sent in transit.

 

Application Form

Walk-in-Interviews for the post of Assistant Dietician, Physiotherapist, Pharmacist, Perfusionist at AIIMS

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

Ansari Nagar, New Delhi-110 608.

The Institute proposes to hold Walk-in-Interviews for the following posts of engagement on purely contract basis:-

Date of  Interview : 17.08.2012 (Friday)

GENERAL CONDITIONS
1. Upper age limit is 35 years on the date of walk in interview which is relaxable for SC, ST, and OBC candidates and Govt. Servants, as per rules.
2. Eligible and willing candidates may Walk in for interview on dates mentioned above alongwith their bio-data/application in the prescribed format (Annexure-I).
3. The application in the prescribed proforma should be on a good quality A4 size paper.
4. The candidate should report at the Recruitment Cell, 1st Floor, Administrative Block, AIIMS, Ansari Nagar, New Delhi-110608 between 09:30 A.M. to 10:30 A.M. positively on respective date. Candidates reporting after scheduled time will not be allowed to appear in the interview.
5. The candidates should bring along original certificates in support of his/her age, educational/professional qualification, experience etc., one recent passport size colour photograph and a set of photocopies of the relevant documents duly attested by a Gazetted Officer failing which he/she will not be allowed to take the interview.
6. In case of large number of applicants, the Institute may conduct the interviews over 2-3 days or hold a screening test or adopt any other criteria deemed appropriate to shortlist the candidates. The decision of Institute authorities will be final and no correspondence what so ever will be entertained in this connection. To avoid inconvenience, the applicants are advised to send a copy of their application by e-mail on the following e-mail addresses (post indicated against each), atleast one day before the scheduled date of interview, so that necessary arrangements are put in place for smooth conduct of interviews:-
(i) walkinaiimsassistantdietician@gmail.com – for Assistant Dietician
(ii) walkinaiimsphysiotherapist@gmail.com – for Physiotherapist
(iii) walkinaiimspharmacist@gmail.com – for Pharmacist
(iv) walkinaiimsperfusionist@gmail.com – for Perfusionist
7. The above assignments are purely on contract basis, initially for a period of six months.
8. The Incumbent selected shall have no claim what-so-ever for regularization of their services in the AIIMS.
9. Candidates are advised in their own interest to satisfy themselves about their eligibility as per the notified eligibility criteria to avoid disappointment at a later stage. Candidates meeting the eligibility criteria and producing all the prescribed documents will only be interviewed.
10. If any candidate is found canvassing for his/her selection, he/she will be disqualified for being called for interview/being selected.
11. The other terms and conditions are mentioned in Annexure-II.

CLICK HERE FOR ORGINAL NOTIFICATION

Inside the Brain: Unraveling the Mystery of Alzheimer's Disease

The human brain is a remarkable organ. Complex chemical and electrical processes take place within our brains that let us speak, move, see, remember, feel emotions and make decisions. Inside a normal healthy brain, billions of cells called neurons constantly communicate with one another.They receive messages from each other as electrical charges travel down the axon to the end of the neuron. The electrical charges release chemical messengers called neurotransmitters. The transmitters move across microscopic gaps, or synapses, between neurons. They bind to receptor sites on the dendrites of the next neuron.This cellular circuitry enables communication within the brain. Healthy neurotransmission is important for the brain to function well. Alzheimer's disease disrupts this intricate interplay. By compromising the ability of neurons to communicate with one another, the disease over time destroys memory and thinking skills. Scientific research has revealed some of the brain changes that take place in Alzheimer's disease. Abnormal structures called beta amyloid plaques and neurofibrillary tangles are classic biological hallmarks of the disease. Plaques form when specific proteins in the neuron's cell membrane are processed differently. Normally, an enzyme called Alpha-secretase snips amyloid precursor protein, or APP, releasing a fragment. A second enzyme, Gamma-secretase, also snips APP in another place. These released fragments are thought to benefit neurons. In Alzheimer's disease, the first cut is made most often by another enzyme, Beta-secretase. That, combined with the cut made by Gamma-secretase, results in the release of short fragments of APP called Beta-Amyloid. When these fragments clump together, they become toxic and interfere with the function of neurons. As more fragments are added, these oligomers increase in size and become insoluable, eventually forming Beta-Amyloid plaques. Neurofibrillary tangles are made when a protein called tau is modified. In normal brain cells, tau stabilizes structures critical to the cell's internal transport system. Nutrients and other cellular cargo are carried up and down the structures called microtubules to all parts of the neuron. In Alzheimer's disease, abnormal tau separates from the microtubules, causing them to fall apart. Strands of this tau combine to form tangles inside the neuron, disabling the transport system and destroying the cell. Neurons in certain brain regions disconnect from each other and eventually die, causing memory loss. As these processes continue, the brain shrinks and loses function. We now know a great deal about changes that take place in the brain with Alzheimer's disease, but there is still much to learn. What other changes are taking place in the aging brain and its cells and what influence do other diseases, genetics, and lifestyle factors have on the risk of developing Alzheimer's disease as the brain and body age? Scientific research is helping to unravel the mystery of Alzheimer's and related brain disorders As we learn more, researchers move ever closer to discovering ways to treat and ulimately prevent this devestating, fatal disease.

Source: "Alzheimer's Disease Education and Referral Center, a service of the National Institute on Aging."

FDA approves Lucentis to treat diabetic macular edema

The U.S. Food and Drug Administration today approved Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), a sight-threatening eye disease that occurs in people with diabetes.

An injection administered once a month by a health care professional, Lucentis is intended to be used along with good diabetic blood sugar control.

DME is a condition in which fluid leaks into the macula, the center part of the retina where sharp, straight-forward vision occurs. The fluid makes the macula swell, causing vision to blur.

According to the Centers for Disease Control and Prevention, diabetes (type 1 and type 2) affects about 26 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years. In 2010, 3.9 million adults diagnosed with diabetes reported trouble with their vision.

“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema,” said Renata Albrecht, M.D., director of the Division of Transplant and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”

The drug’s safety and effectiveness to treat DME were established in two clinical studies involving 759 patients who were treated and followed for three years. Patients were randomly assigned to receive monthly injections of Lucentis at 0.3 milligrams (mg) or 0.5 mg, or no injections during the first 24 months of the studies. After 24 months, all patients received monthly Lucentis either at 0.3 mg or 0.5 mg.

The studies measured the number of patients who gained vision, as measured on an eye chart. Results showed that between 34 percent and 45 percent of those treated with monthly Lucentis 0.3 mg gained at least three lines of vision compared with 12 percent to 18 percent of those who did not receive an injection. No additional benefit was observed with the higher monthly Lucentis dose of 0.5 mg.

The most common side effects reported in patients treated with Lucentis include bleeding of the conjunctiva, the tissue that lines the inside of the eyelids and covers the white part of the eye; eye pain; floaters; and increased pressure inside the eye (intraocular pressure).

The FDA previously had approved Lucentis to treat wet (neovascular) age-related macular degeneration (AMD), a condition in which abnormal blood vessels grow and leak fluid into the macula. Lucentis also is approved to treat macular edema following retinal vein occlusion, a blockage of the small veins that carry blood away from the retina that can cause fluid to leak into the macula.

Lucentis is marketed by South San Francisco, Calif.-based Genentech.

Source: FDA

Red in the Face

Understanding Rosacea

Some people think of a rosy complexion as a sign of good health. But red patches on the face may point to something more troubling—a long-lasting skin disorder called rosacea.

Rosacea (pronounced ro-ZAY-she-ah) may start as redness on the cheeks, nose, chin or forehead. It might even look like an outbreak of pimples. But over time, the condition can worsen. Inflammation can make affected skin swollen and sensitive. Red, thick, bumpy skin may appear on the face, causing discomfort and distress. Up to half of people with rosacea also develop eye problems. Eyelids may become inflamed, and vision impaired.

Rosacea affects an estimated 14 million Americans. The causes of rosacea are unclear. The condition tends to run in families, so genes likely play a role.

Although anyone can get rosacea, lighter-skinned populations are at greater risk. People who blush frequently may also be more vulnerable. It usually first strikes in middle age, when people are between 30 and 60 years old. Women are 3 to 4 times more likely than men to develop rosacea, especially during menopause. But rosacea symptoms are generally more severe in men.

Rosacea symptoms can come and go, flaring up for weeks or months and then subsiding. Over time, the facial redness can deepen and become more permanent.

People are often embarrassed by rosacea flare-ups. “The physical appearance can be debilitating for people, causing them to lose work or to have low self-esteem,” says Dr. Richard Gallo, a skin expert at the University of California, San Diego. “Many psychological problems are the consequence of having this red, puffy face.”

Things that cause flare-ups are called triggers. Although they vary from person to person, common triggers include hot foods or beverages, spicy foods, alcohol, extreme temperatures, sunlight, stress, exercise and hot baths.

To identify and then avoid triggers, Gallo says, “take a very careful record of the things that you eat and the things you are doing. Then also record when your rosacea is flaring, and see if you can put the two together.”

Because rosacea tends to worsen over time, early detection is critical. There’s no test for rosacea, and several other conditions can have similar symptoms. Your doctor needs expertise and experience to make a diagnosis. A dermatologist—a physician who specializes in skin disorders—can aid with rosacea detection and care.

Although there’s no cure for rosacea, medical treatments and lifestyle changes can reduce symptoms. Antibiotics taken orally or applied to the skin can lessen redness and bumps. For more serious cases, laser surgery can remove visible blood vessels, reduce redness or correct thickened, bumpy skin.

NIH-funded scientists continue to search for new insights into rosacea. Gallo and his colleagues have found that some people with rosacea have high levels of inflammation-causing chemicals in their skin. The researchers are using this knowledge to develop experimental therapies that are now being tested in clinical trials.

If you have troubling facial redness, talk to a dermatologist or other health care provider. Taking steps early on will help to control and reduce the symptoms of rosacea. 

Source: NIH

Dizziness Can Be a Drag

Coping with Balance Disorders

Imagine reaching for something on a grocery shelf and suddenly feeling unsteady. Or looking over your shoulder to back up the car and having things start whirling around you. Most people feel dizzy now and then. But if that feeling persists or interferes with your daily life, it could be a sign of a balance disorder.

A balance disorder makes you feel as if you’re moving, spinning or floating, even though you’re quite still. More than 4 in 10 Americans will experience an episode of dizziness sometime during their lives that’s significant enough to send them to a doctor. 

Dizziness can range from feeling lightheaded to woozy to disoriented. Feeling that you or your surroundings are spinning is called vertigo. Any of these sensations can be extremely distressing.

“Balance is a multisystem function,” explains NIH hearing and balance expert Dr. Daniel Sklare. It begins with a series of signals within the tiny balance organs of the inner ear. These organs work with your brain’s visual system to give you a sense of your body’s position. They also keep objects from blurring when your head moves. Sense receptors in skin, joints and muscles also send balance-related signals to the brain. The brain receives and coordinates information from all these different body systems. Balance disorders can arise when any of these signals malfunction.

Because balance is so complex, it can be hard to figure out the underlying cause of certain problems. Some balance disorders can begin suddenly. They might arise from an ear infection, a head injury or certain medications. Low blood pressure can lead to dizziness when you stand up quickly. Disorders related to vision, muscles, bones or joints can also contribute to balance problems.

“As America gets older, many people with imbalance have a collection of these problems,” says Dr. Gordon Hughes, NIH clinical trials director for hearing and balance. “They might have aging of the ear, aging of vision, cataracts, muscle weakness from losing some muscle mass or arthritis in the hips, plus other problems like diabetes.”

Researchers have identified more than a dozen different balance disorders. The most common is a sudden, often harmless burst of vertigo that might arise with an abrupt change in the position of the head, like when you bend over to tie your shoes. Technically known as benign paroxysmal positional vertigo (BPPV), this condition can result from a head injury or simply from getting older. BPPV sometimes occurs when tiny calcium crystals in the inner ear become displaced. In that case, your doctor can treat BPPV by carefully moving the head and body to reposition these particles. An NIH-supported clinical trial showed that this treatment works well for BPPV.

Another common balance disorder is known as Ménière’s disease. It can develop at any age, but most often strikes adults between 40 and 60 years of age. Symptoms include intense vertigo, hearing loss, nausea, tinnitus (a ringing or buzzing in the ear) and a feeling of fullness in the ear. Ménière’s disease usually affects only one ear.

Some people with Ménière’s disease have single attacks of dizziness separated by long periods of time. Others may experience many attacks closer together over a number of days. Some affected people have vertigo so extreme that they lose their balance and fall. These episodes are called “drop attacks.”

An attack of Ménière’s symptoms, while not life-threatening, can feel completely overwhelming. The symptoms arise because of a change in fluid volume within the inner ear. But its underlying cause remains unknown. Scientists estimate that 6 in 10 people either get better on their own or can control their vertigo with diet, drugs or devices. In severe cases, surgical therapies can end the dizziness but might affect hearing.

NIH-funded researchers at the University of Washington are now exploring a new treatment option to stop a Ménière’s attack. An implant behind the ear is designed to control abnormal electrical activity in the nerve that sends balance information to the brain, bringing the sensation of spinning to a halt. The device is now being tested in clinical trials.

If you think you may have a balance disorder, talk with your health care provider. Your doctor can assess whether your symptoms might be caused by a serious disorder, such as a heart or blood condition. If an inner ear balance disorder is likely, you may be referred to a specialist such as an otolaryngologist, a doctor with expertise in the ear, nose and throat. You might receive a hearing test, a balance test and possibly an imaging study of the brain.

Work with your doctor to figure out how to cope with your dizziness on a daily basis and reduce your risk of injury. For example, wear low-heeled shoes or walking shoes outdoors. You might decide to try using a cane or walker. Safe, secure handrails in stairwells and grip handles in bathrooms can help make your home safer. Driving a car may be especially hazardous, so ask your doctor if it’s safe for you to drive.

A specialized rehabilitation therapist can give you a set of head, body and eye exercises to help reduce dizziness and nausea.

Meanwhile, researchers continue to work to develop new, more effective approaches. In one experimental rehabilitation strategy, now in clinical trials, scientists have created a “virtual reality” grocery store. It allows people with balance disorders to walk safely on a treadmill through computer-generated store aisles. While holding onto a grocery cart, they can look up and down, turn their heads and reach for items on virtual shelves. By doing this, they safely learn how to navigate an environment that can be challenging for someone with a balance problem.

“The key for people looking for treatment is to go to the best team of clinical experts that they can gain access to,” says Dr. Sklare. “It’s very important to get that level of assessment.” 

Source: NIH

Goodness of Tea

AArticle by Mili Sarkar (Nutritionist /Yoga Instructor)

On average, Indian people drink approximately 3-4 cups of tea a day with about 70% of the UK & British population drinking tea on a regular basis. And tea drinking is most common in older people, the 40 plus age range On-going research is discovering that at this level of intake tea may offer significant health benefits. Drinking three or more cups of tea a day is as good for you as drinking plenty of water and may even have extra health benefits, say researchers.

The work in the European Journal of Clinical Nutrition dispels the common belief that tea dehydrates. Tea not only rehydrates as well as water does, but it can also protect against heart disease and some cancers, UK nutritionists found. Experts believe flavonoids are the key ingredient in tea that promotes health.

Tea’s contribution to overall daily fluid intake as well as the presence of powerful antioxidants called flavonoids, tea, when taken with milk, may also contribute to our daily intake of certain nutrients. Taken on its own tea has no calories but when milk is added to it, can provide a number of vitamins & minerals. Tea provides 70% of our daily Fluid intake. Fluoride is needed to support bone mineralisation and protect teeth against dental caries. For further information about fluid and antioxidants, please refer to the fact sheets, ‘Tea and Hydration’ and ‘Tea and Antioxidant Properties’. Drinking tea is actually better than drinking water. Water is essentially replacing fluid. Tea replaces fluids and contains antioxidants so it's got two things going for it. Claire Williamson of the British Nutrition Foundation said: "Studies in the laboratory have shown potential health benefits.

The evidence in humans is not as strong and more studies need to be done. But there are definite potential health benefits from the polyphenols in terms of reducing the risk of diseases such as heart disease and cancer. In terms of fluid intake, we recommend 1.5-2 litres per day and that can include tea. Tea is not dehydrating. It is a healthy drink.

Studies on caffeine have found very high doses dehydrate and everyone assumes that caffeine-containing beverages dehydrate. But even if you had a really, really strong cup of tea or coffee, which is quite hard to make, you would still have a net gain of fluid. Also, a cup of tea contains fluoride, which is good for the teeth .There was no evidence that tea consumption was harmful to health. However, research suggests that tea can impair the body's ability to absorb iron from food, meaning people at risk of anaemia should avoid drinking tea around mealtimes. After reviewing numerous studies on the benefits of drinking tea, they've concluded that tea is a superior drink.

References:

National Drinks Survey, April 2001, Rao GS (1984) Dietary intake and bioavailability of fluoride.

Ann Rev Nutr 4; 115-136 , Holland, B., Welch, A.A., Unwin, I.D., Buss, D.H., Paul, A.A. and Southgate,

D.A.T. (1991) McCance and Widdowson's The Composition of Foods, 5th

edition, Royal Society of Chemistry, Cambridge.

DoH (1991) Dietary Reference Values for Food Energy and Nutrients for the United Kingdom; Report of the panel on Dietary Reference Values of the Committee on Medical Aspects of Food Policy.

Employee Health: The ‘Yoga’ way

Posted by Mili Sarkar (Nutritionist /Yoga Instructor)

At first I want to say something about our lifestyle. Increasing stress of work pressure has crippled the lifestyle of many. Wellness has thus become an integral part of existence. Feeling stress doubt is a common phenomenon in today’s life. The hectic routine of juggling between home & work can leave you drained out. If this is your routine, you need to take a closer look at some thing very basic, your food platter. So, healthy eating & yoga/exercise is a key to healthy living/fitness. A balanced meal/yoga/relaxation & not only keeps you fit going throughout the day, but also helps to keep illness.  So take care that your body gets all the important nutrients that will keep you hail & hearty. And your meal should be eaten to keep you energetic with the need for inner wellbeing growing at an enormous Pease. We needs to solve certain issues to help you in leading truly healthy lifestyle.

I come to the point that to be happy and healthy with increased job satisfaction-Don’t engage yoga/knowledge of balanced diet in business! However, an enlightened employer looking for a corporate solution for de-stressing events, people and teams-make contact with yoga/knowledge of right diet and create a Great staff benefit and improve productivity!

Please note that yoga in business will not insist on sort of philosophy or spirituality. Yoga in business will focus exclusively on body, breath and mind. Yoga gives your staff the opportunity to experience of mind in the work place. By taking a little time out from the day to day stresses and pressures of the job, employees will be re-energized and be able to tackle their jobs with fresh clarity and vitality. Yoga /diet in your workplace can increase the effectiveness of meetings and presentations, improve morale and staff relations, improving energy levels of staff will tend to improve their work life balance that too easily shifts in favor of work, but with deleterious effects on the health, performance at work and family life.

Stretching the body and working with the breath engages the body’s parasympathetic nervous system-allowing the body to normalize, gradually improving health & posture-defeating fatigue, increasing alertness and leading to improved productivity, feeling of well-being and less time off work due to sickness.

Balanced diet/yoga gives the staff stress free life style for an example-

• Stress Management Employees are stressed by any number of reasons like being promoted beyond their capability, not having factors is the first step to health, gaining perspective and doing something to correct the problems, everybody should have ways to manage their stress. Many  people use sport, caffeine, tobacco or alcohol to unwind themselves after being affected by stress. Wouldn’t it be better if we could manage the stress at source?(You can still enjoy your sport!)You can then work efficiently and avoid throwing the stress onto your body. You can help your employees to be more resilient stress.
• Improve Employee Productivity Your employees are likely to be stressed by the demands of the modern workplace, but you can help them to be more resilient. In return  your employees will naturally work more productively. If you feel better you tend to have more energy for the job. If you are aware of a deadline without becoming paralyzed with dread you can work more efficiently and accurately, If your employees are more often at work rather then absent through a stress-related problem-what does that do for performance? There is no need to let employees find their own way to cope-as an employer you can help. In fact it is almost a no-brainer. Just think- spend a little on STREES MANAGEMENT and gain a lot in productivity, creativity and accuracy.
• Improve Employee Health Having aches and pains is not a normal human condition. Sitting at a desk, focusing on a screen and receiving stressful stimuli all tend to work against a healthy body. Bodies are made to move to be balanced and to have varied activities. Lack of awareness of the body means we only listen when the body shouts with muscle problem, joint problem or serious stress related diseases. We all have a right to good health and you can help your employees to learn how to stay healthy whilst working.
• Sick Absence Minimize And the result of neglecting the body over periods of time disease. The employee has sick leave. Simple aches and tensions when continued over a long period can cause all sorts of problems. Stress related diseases are the most common form of sick absence in India and probably in most developed nations. You can help your employees to avoid this. You can do something about stress reated disease. As an employer, how can you not do something?
• Improve Decision Making Wouldn’t it wonderful if all decisions were made quickly & without worry? When employees can think clearly about the issue and do the right thing? You can help your employees to do this, and the managers & executives too.
• Improve Morale Give your employees the tools to cope and excel and you will reward by improved morale, team working, productivity & creativity. Yoga/Good Diet in business makes good business sense.

GECP-2012 GBioFin Entrepreneurship Certification Programme

Opening for the post of Pharmacist at Central Government Health Scheme, India

 

Company Profile: The “Central Government Health Scheme” (CGHS) provides comprehensive health care facilities for the Central Govt. employees and pensioners and their dependents residing in CGHS covered cities. Started in New Delhi in 1954, Central Govt. Health Scheme is now in operation in Allahabad ,Ahmedabad ,Bangalore , Bhubaneswar ,Bhopal ,Chandigarh , Chennai ,Delhi , Dehradun ,Guwahati , Hyderabad , Jaipur , Jabalpur , Kanpur , Kolkata , Lucknow , Meerut , Mumbai , Nagpur , Patna , Pune , Ranchi , Shillong , Trivandrum and Jammu.

Post: 6

 Eligibility: D.Pharm/B.Pharm
Last Date: 21/8/12

WALK-IN-INTERVIEW FOR CONTRACT MEDICS & PARAMEDICS at ONGC

OIL AND NATURAL GAS CORPORATION LTD
ANKLESHWAR ASSET, ANKLESHWAR

JOIN US BE A PART OF ONGC – A MAHARATNA COMPANY OF INDIA
WALK-IN-INTERVIEW FOR CONTRACT MEDICS & PARAMEDICS

Sl. No.	Name of Post & Duty Pattern	No. of Posts	Qualification	Emoluments
01	Doctor 14 days ON/OFF for Field/ General Duty	03(*)	Candidate should possess MBBS Degree from a recognized University with one year Internship completed and Permanent Registration Certificate from Indian Medical Council.	Rs.35,000/- per month  consolidated.  Annual increase of Rs.1000 per month after successful completion of one year of tenure.
02	Pharmacist (Allopathy) (General Duty)	01(*)	Matric with Science holding recognized Diploma/  Certificate course of two or more years duration from  Pharmacy  Council with 60% marks.  Registration in Pharmacy Council.  Should possess training in First Aid & CPR.	Rs.11,500/- per month  consolidated.  Annual increase of Rs.300 per month after successful completion of one year of tenure.
03	Nurse (General Duty)	01(*)	Matric with Science holding recognized Diploma / Certificate course of two or more years duration from Nursing Council.  Registration Certificate of Nursing Council	Rs.11,500/- per month  consolidated.  Annual increase of Rs.300 per month after successful completion of one year of tenure
04	Dresser Cum Hospital Attendant (General Duty)	03(*)	Matriculate with valid Certificate course in First Aid from St. John’s Ambulance or Red Cross Society	Rs. 7,500/- per month  consolidated.  Annual increase of Rs.150 per month after successful completion of one year of tenure.

Date of Interview :  16.08.2012                                                                  Time: 0930 Hrs.
Venue: ONGC Dispensary, ONGC Township, Ankleshwar
Reservation : As per GOI Instructions                       
Age : No Bar for Sl.No. 1 & for others, not more than 35 years as on 16.08.2012

*   No. of Posts likely to vary
Note : 
1. Engagement is purely temporary on contract basis for a period upto 30.06.2014.
2. Selection process include written test followed by Interview for posts at Sl.No. 2, 3 & 4.
3. Selected Candidates shall be required to sign a Contract Agreement as per the terms and
conditions of ONGC.
4. Selected candidate will not have any right whatsoever to claim for regular appointment in
ONGC by virtue of working as a Contract Medic/paramedic.
5. No TA/DA will be paid for attending the interview.
6. Only Indian Nationals are eligible to attend the Interview. 
7. Candidates should bring Original Certificates along with one set of photocopies of these
Certificates duly attested by Gazetted Officer and one recent passport size photograph.
8. Candidates claiming reservation in category of SC/ST/OBC should submit prescribed
certificate issued by the competent authority applicable for Central Government Services.

Beyoncé - World Humanitarian Day 2012 Campaign Message

1 Day, 1 World, 1 Message
Help the world take notice and register at http://www.whd-iwashere.org

Published by WorldHumanitarianDay

Diabetes Self-Care at Home (Lifestyle Changes and Glucose Monitoring)

Author: Mily Sarkar

Assistance Nutrition Manager, in Via Media Health, in Britannia/gsk Project,

<milysarkar@gmail.com>

If a person has diabetes, healthful lifestyle choices in diet, exercise, and other health habits will help to improve glycemic (blood sugar) control and prevent or minimize complications of diabetes. Education regarding causes & prevention while maintaining target blood glucose levels is of utmost importance.

Diabetes Diet: A healthy diet is key to controlling blood sugar levels and preventing diabetes complications.

· If the patient is obese and has had difficulty losing weight on their own, talk to a health care professional. He or she can recommend a dietician or a weight modification program to help the patient reach a goal.

· Eat a consistent, well-balanced diet that is high in fibber, low in saturated fat, and low in concentrated sweets.

· A consistent diet that includes roughly the same number of calories at about the same times of day helps the health care professional prescribe the correct dose of medication or insulin.

· A healthy diet also helps to keep blood sugar at a relatively even level and avoids excessively low or high blood sugar levels, which can be dangerous and even life-threatening.

Exercise: Regular exercise, in any form, can help reduce the risk of developing diabetes. Activity can also reduce the risk of developing complications of diabetes such as heart disease, stroke, kidney failure, blindness, and leg ulcers. But under guidance in health care professional

· As little as 20 minutes of walking three times a week has a proven beneficial effect. Any exercise is beneficial; no matter how easy or how long, some exercise is better than no exercise.

· If the patient has complications of diabetes (such as eye, kidney, or nerve problems), they may be limited both in type of exercise, and amount of exercise they can safely do without worsening their condition. Consult with your health care professional before starting any exercise program.

Alcohol use: Moderate or eliminate consumption of alcohol. Try to have no more than seven alcoholic drinks in a week, and never more than one or two drinks in an evening. One drink is considered 1.5 ounces of liquor, 6 ounces of wine, or 12 ounces of beer. Excessive alcohol use is a known risk factor for type 2 diabetes. Alcohol consumption can cause low or high blood sugar levels, nerve pain (neuritis), and an increase in triglycerides.

Smoking: If the patient has diabetes, and smokes cigarettes or use any other form of tobacco, they are raising the risks for all of the complications of diabetes. Smoking damages blood vessels and contributes to heart disease, stroke, and poor circulation in the limbs. If a person needs help to quit tobacco use, talk to a health care professional.

Self-monitored blood glucose: Check blood sugar levels frequently, at least before meals and at bedtime, then record the results in a logbook or daily reviewing diary.

· This log should also include insulin or oral medication doses and times, when and what the patient ate, when and for how long they exercised, and any significant events of the day such as high or low blood sugar levels and how they treated the problem.

· Better equipment now available makes testing blood sugar levels less painful and less complicated than ever. A daily blood sugar diary is invaluable to the health care professional in evaluating how the patient is responding to medications, diet, and exercise in the treatment of diabetes.

. Reinforced education for the person with diabetes & caregiver, particularly concerning the effect of diet, medication & exercise on blood glucose levels & possible development of hypoglycaemia is essential to preventing hypoglycaemia. Knowledge of the possible causes, signs of diabetes & appropriate treatment all form the basis of management of diabetes. Self management of blood glucose by the person when possible or by a families or medical caregiver, should be encouraged in order to detect asymptomatic episodes of diabetes & better adapt treatment.

References:

· American diabetes association, the genetics of diabetes.

· ICMR guidance for management of type 2 diabetes.

Article Courtesy:  Mily Sarkar

Brain hubs boil when hoarders face pitching their own stuff

Impaired decision-making traced to "salience network" — NIH-funded study

In patients with hoarding disorder, parts of a decision-making brain circuit under-activated when dealing with others’ possessions, but over-activated when deciding whether to keep or discard their own things, a National Institute of Mental Health (NIMH)-funded study has found. NIMH is part of the National Institutes of Health.

Brain scans revealed the abnormal activation in areas of the anterior cingulate cortex and insula known to process error monitoring, weighing the value of things, assessing risks, unpleasant feelings, and emotional decisions.

NIMH grantee David Tolin, Ph.D., of Hartford Hospital, Hartford, Conn., and colleagues, report on their functional magnetic resonance imaging (fMRI) study in the August 2012 issue of the journal Archives of General Psychiatry.

Hoarding disorder, a proposed category in psychiatry’s new diagnostic manual, DSM-5, is characterized by avoidance of decision-making about possessions.

The new findings pinpoint brain circuit activity suspected of underlying the lack of self-insight, indecisiveness, sense that the wrong decision is being made, inflated estimates of the desirability of objects, and exaggerated perception of risk that are often experienced with the disorder.

In the study, brain activity of 43 hoarding disorder patients was compared to that of 31 obsessive compulsive disorder (OCD) patients and 33 healthy controls while they had to decide whether to keep or discard their own or others' junk mail and newspapers. Notably, such ownership did not appear to differentially affect brain activity in the OCD patients. Hoarding disorder patients, as expected, decided to keep many more items than the other groups.

"The results of this study reflect an accelerating trend toward finding disturbed regulation of brain systems responsible for various dimensions of behavior that may cut across mental disorders as traditionally defined," said Bruce Cuthbert, Ph.D., director of NIMH's Division of Adult Translational Research.

Anterior cingulate cortex (center) over-activated when hoarding disorder patients had to decide whether to keep or discard their own possessions; it under-activated during decision-making about others’ possessions. The left and right insula (upper left and right) similarly differentially activated in hoarding disorder patients during this task. Picture shows fMRI data superimposed on structural MRI scan. Source: David Tolin, Ph.D., Hartford Hospital.

In this case, the implicated brain areas are hubs of a salience network that weighs the emotional significance of things and regulates emotional responses and states. Hoarding patients' severity of symptoms, self-ratings of indecisiveness, and feeling of things being "not just right" were correlated with the degree of aberrant activity in these hubs. The results add to evidence of impaired decision-making in hoarding disorder and may help to disentangle its brain workings from those of OCD and depression.

The mission of the NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit http://www.nimh.nih.gov.

Source: NIH

FDA approves Marqibo to treat rare type of leukemia

Orphan drug approved under agency’s accelerated approval program

The U.S. Food and Drug Administration today approved Marqibo (vincristine sulfate liposome injection) to treat adults with a rare type of leukemia called Philadelphia chromosome negative (Ph-) acute lymphoblastic leukemia (ALL).

ALL is a rapidly progressing form of blood and bone marrow cancer that is more commonly diagnosed in children than adults. According to the National Cancer Institute, an estimated 6,050 men and women will be diagnosed with ALL and 1,440 will die from the disease this year.

Marqibo is approved for patients whose leukemia has returned (relapsed) two or more times, or whose leukemia has progressed following two or more regimens of anti-leukemia therapy. Marqibo contains vincristine, a commonly used anti-cancer drug, encased within a liposome, a drug delivery vehicle composed of material similar to that of cell membranes. It is an injection administered once a week by a health care professional.

“Marqibo’s approval demonstrates the FDA’s commitment to the development and approval of drugs that address serious, unmet medical needs,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Marqibo provides an additional option for Philadelphia chromosome negative acute lymphoblastic leukemia patients whose disease is unresponsive to available therapies.”

Marqibo is approved under the FDA’s accelerated approval program, which allows the agency to approve a drug to treat a serious disease based on clinical data showing that the drug has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. This program provides earlier patient access to promising new drugs while the company conducts additional clinical studies to confirm the drug’s clinical benefit and safe use. Marqibo also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition.

The drug’s effectiveness was evaluated in a single clinical trial in adult patients whose leukemia had relapsed at least two times despite standard treatments, and who had at least one previous treatment response lasting at least 90 days. The study objective was to determine the response rate to Marqibo, as either a complete remission (CR) or a complete remission with incomplete blood count recovery (CRi). Of 65 patients enrolled, 10 patients, or 15.4 percent, responded with either a CR or CRi. In the 10 patients achieving CR or CRi, the median duration of documented remission was 28 days. The median time to the first event of relapse, death, or next therapy was 56 days.

The safety of Marqibo was evaluated in two single-arm trials of 83 patients who received the clinical treatment regimen. Serious adverse events such as low white blood cell counts with fever, low blood pressure, respiratory distress and cardiac arrest occurred in 76 percent of the patients studied. The most common side effects observed during clinical studies include constipation, nausea, low blood cell counts, fever, nerve damage, fatigue, diarrhea, decreased appetite, and insomnia.

Prescribing information for Marqibo will carry a Boxed Warning alerting patients and health care professionals that the drug must be administered only through a vein (intravenously) because it is deadly if administered in other ways, such as into the spinal fluid. The Boxed Warning also states that Marqibo has different dosage recommendations than vincristine sulfate injection alone. To avoid overdose, it is important for health care professionals to verify the drug name and the dose before administration. Special requirements for preparation of the drug are detailed in the label.

Marqibo is marketed by Talon Therapeutics Inc., based in South San Francisco, Calif.

Source: FDA

BRAIN'S STEM CELLS "EAVESDROP" TO FIND OUT WHEN TO ACT

Studies in mice reveal how mood-altering drugs may affect brain stem cells

A single parvalbumin-expressing interneuron (red) surrounded by many adult neural stem cells (green) in the brain’s hippocampus.

Credit: Gerry Sun

Working with mice, Johns Hopkins researchers say they have figured out how stem cells found in a part of the brain responsible for learning, memory and mood regulation decide to remain dormant or create new brain cells. Apparently, the stem cells “listen in” on the chemical communication among nearby neurons to get an idea about what is stressing the system and when they need to act.
The researchers say understanding this process of chemical signaling may shed light on how the brain reacts to its environment and how current antidepressants work, because in animals these drugs have been shown to increase the number of brain cells. The findings are reported July 29 in the advance online publication of Nature.

“What we learned is that brain stem cells don’t communicate in the official way that neurons do, through synapses or by directly signaling each other,” says Hongjun Song, Ph.D., professor of neurology and director of Johns Hopkins Medicine’sInstitute for Cell Engineering’s Stem Cell Program. “Synapses, like cell phones, allow nerve cells to talk with each other. Stem cells don’t have synapses, but our experiments show they indirectly hear the neurons talking to each other; it’s like listening to someone near you talking on a phone.”

The “indirect talk” that the stem cells detect is comprised of chemical messaging fueled by the output of neurotransmitters that leak from neuronal synapses, the structures at the ends of brain cells that facilitate communication. These neurotransmitters, released from one neuron and detected by a another one, trigger receiving neurons to change their electrical charges, which either causes the neuron to fire off an electrical pulse propagating communication or to settle down, squelching further messages.

To find out which neurotransmitter brain stem cells can detect, the researchers took mouse brain tissue, attached electrodes to the stem cells and measured any change in electrical charge after the addition of certain neurotransmitters. When they treated the stem cells with the neurotransmitter GABA – a known signal-inhibiting product the stem cells’ electrical charges changed, suggesting that the stem cells can detect GABA messages.

To find out what message GABA imparts to brain stem cells, the scientists used a genetic trick to remove the gene for the GABA receptor — the protein on the surface of the cell that detects GABA — only from the brain stem cells. Microscopic observation of brain stem cells lacking the GABA receptor over five days showed these cells replicated themselves, or produced glial cells — support cells for the neurons in the brain. Brain stem cells with their GABA receptors intact appeared to stay the same, not making more cells.

Next, the team treated normal mice with valium, often used as an anti-anxiety drug and known to act like GABA by activating GABA receptors when it comes in contact with them. The scientists checked the mice on the second and seventh day of valium use and counted the number of brain stem cells in untreated mice and mice treated with the GABA activator. They found the treated mice had many more dormant stem cells than the untreated mice.

“Traditionally GABA tells neurons to shut down and not continue to propagate a message to other neurons,” says Song. “In this case the neurotransmitter also shuts off the stem cells and keeps them dormant.”

The brain stem cell population in mice (and other mammals, including humans) is surrounded by as many as 10 different kinds of intermingled neurons, says Song, and any number of these may be keeping stem cells dormant. To find out which neurons control the stem cells, the researchers inserted special light-activating proteins into the neurons that trigger the cells to send an electrical pulse, as well as to release neurotransmitter, when light shines on them. By shining light to activate a specific type of neuron and monitoring the stem cells with an electrode, Song’s team showed that one of the three types of neurons tested transmitted a signal to the stem cells causing a change in electrical charge in the stem cells. The neurons messaging the stem cells are parvalbumin-expressing interneurons.

Finally, to see if this stem cell control mechanism aligns with what an animal may be experiencing, the scientists created stress for normal mice by socially isolating them, and did the same in mice lacking GABA receptors in their brain stem cells. After a week, socially isolated normal mice had an increase in the number of stem cells and glial cells. But the socially isolated mice without GABA receptors did not show increases.

“GABA communication clearly conveys information about what brain cells experience of the outside world, and, in this case, keeps the brain stem cells in reserve, so if we don’t need them, we don’t use them up,” says Song. 

Other authors on the paper include Juan Song, Chun Zhong, Michael Bonaguidi, Gerald Sun, Derek Hsu, Kimberly Christian and Guo-li Ming of Johns Hopkins University, Yan Gu and Shaoyu Ge of State University of New York at Stony Brook, Konstantinos Meletis of the Karolinska Institutet, Z. Josh Huang and Grigori Enikolopov of the Cold Spring Harbor Laboratory, Karl Deisseroth of Stanford University and Bernhard Luscher of Pennsylvania State University.

This work was supported by grants from the National Institute of Neurological Disorders and Stroke (NS047344, NS048271), the National Institute of Child Health and Human Development (HD069184), National Institute of Mental Health (MH089111), the National Institute on Aging (AG040209), the National Alliance for Research on Schizophrenia and Depression, the Adelson Medical Research Foundation, the New York State Stem Cell Science,  the Ellison Medical Foundation, the Life Sciences Research Foundation and the Maryland Stem Cell Research Fund.

Source: JOHNS HOPKINS MEDICINE

Opening in Parexel as Senior Quality Specialist

Title: Senior Quality Specialist
Department: Quality and Compliance
Location: India - Andhra Pradesh - Hyderabad
Employment Type: Full Time
Job Type: Regular

Company Profile:
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

Description:
Senior Quality Specialist
Essential Function
Serve as a quality consultant to designated operational group(s). Activities include: identification of process improvement opportunities, process authoring and review, support for process re-engineering, providing GxP and process expertise to designated operational group(s), support for identification, management and prevention of project quality issues, providing audit and inspection support, and assist with the collection and reporting of project quality metrics as assigned.
Key Accountabilities
- Perform or assist the performing of quality assessments (e.g. quality gates, gap assessment, study file review), feeding back results to the operational teams, line manager and Head of the eClinical QM as appropriate.
- Assist the training groups to determine local training requirements (e.g. in quality processes, SOPs, software, etc.), and where needed support training delivery to ensure operational staff have appropriate training per the functional curricula to support their role.
- Working with the Process Optimization and Management (POM) group, ensure timely review and maintenance of Controlled Documents (e.g. SOPs and Work Instructions) in accordance with the defined timelines (e.g. every two years).
- Support the Validation Services Group (VSG) to ensure that all systems used by operational staff are validated in accordance with the Systems Life Cycle (SLC) and Computerized Validation Committee (CVC) Worldwide Standard Operating Procedures
- Provides support and advice to operational groups on the application of, and adherence to processes and the use of systems.
- Support eClinical QM and operations staff at audits, client assessments or regulatory inspections, as needed.
- Works closely with operations management and with line manager to ensure continuous process improvement.
- Keep abreast of systems and associated standards used within the technical areas that the individual supports.
- Develop project plans for assigned projects in line with Operations and eClinical QM strategies.
- Maintain a positive, results orientated work environment, building partnerships and modeling teamwork, communicating to the team in an open, balanced and objective manner
- Monitors and reports on audit responses, providing metrics as appropriate. Supports staff in use of automated quality systems. Confirms closeout of assessment findings, remediation of RRC audit and regulatory inspection findings in accordance with stated response times.
- Reviews the results of operational QC processes. Initiates escalation of significant quality events to the Head of eClinical QM and the responsible line manager.
- Regularly verifies the use and effectiveness of QC processes and quality gates and if relevant compile representative metrics.
- Using process mapping and analysis techniques identify areas for efficiency gains and process improvements within operations and quality groups, with subsequent development and implementation of action plans.
- Represents the relevant functional group(s), or supports the Head of eClinical QM in representing the functional group(s), in cross-functional forums and initiatives.
- Working with the Validation Services Group (VSG) assesses technology that may include the evaluation of appropriate systems/software to increase quality and productivity.
- Works closely with the Head of eClinical QM and Management within the relevant functional group(s) to ensure continuous process improvement
Skills
- Basic understanding of Computer System Validation and Systems Life Cycle.
- IT literate, Experience with Microsoft based applications and general knowledge of PC functions.
- Culturally aware and ability to think and work globally.
- Ability to travel as needed for the position and to support other offices.
- The ability to work as a team member or independently, with minimal supervision is necessary.
- The ability to gain trust and confidence with a variety of clients within PAREXEL.
- Excellent interpersonal, verbal and written communication skills
- Client focused approach to work
- A flexible attitude with respect to work assignments and new learning
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Ability to effectively mentor less experienced members of staff.

Experience:
Education
- Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Language Skills
- Fluent in written and oral English
Experience
- Substantial clinical trials experience, with adequate experience in the technical services area (e.g. project configuration) or quality management area.

CLICK HERE TO APPLY

Career as Drug Safety Specialist in PAREXEL International

Title: Drug Safety Specialist
Department: Pharmacovigilance
Location: India - Andhra Pradesh - Hyderabad
Employment Type: Full Time
Job Type: Regular

Company Profile:
PAREXEL International is a growing, fast-paced, global Clinical Research Organization (CRO) that has helped bring to market 49 of the top 50 selling pharmaceuticals. In fact, we have worked with all 10 of the world's top 10 pharmaceutical companies.
Given our breadth of expertise and the trust placed in us by major pharmaceutical companies worldwide, PAREXEL can provide you with a number of career options in Clinical Research that can rarely be found within just one company. In fact, over 25% of the positions opened at PAREXEL are filled by current employees working to advance their skills and careers.

Description:
JOB DESCRIPTION
Job Title Drug Safety Specialist
Department Worldwide Medical Services
SBU Clinical Research Services (CRS)
Location Hyderabad
Essential Function
The Drug Safety Specialist will provide technical and process-related expertise to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
Relationships
Reports To Regional Head of PV Operations/Team Manager PV Operations
Directly Supervises None
Provides Work Direction to Drug Safety Assistants, Drug Safety Associates
Works Closely with All Medical and PV staff, Project Management and members of the Clinical Operations Group
External Relationships Clients, Healthcare Professionals, Consumers, Consumer Representatives, Regulatory Authorities, Central Ethics Committees
Key Accountabilities
¿ Develop project specific safety reporting procedures and workflows and provide guidance to the team on the procedures
¿ Develop project specific safety database customization and data entry guidelines
¿ Triage of incoming reports for completeness, legibility and validity
¿ Initial data entry of case reports into safety database / tracking system
¿ Assessment of case reports for seriousness, causality and expectedness
¿ Requesting follow-up i.e. written, telephone
¿ Adverse event (AE) and drug coding
¿ Writing case narratives
¿ Case reconciliation ¿ coordinating activities with Data Management personnel
¿ Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc safety reports etc
¿ Quality control of case reports, line listings and tabulations
¿ Maintaining local drug safety reporting requirements
¿ Regulatory authority reporting (electronic and hard copy)
¿ Literature reviews
¿ Ad hoc requests / queries
¿ Provide drug safety and project specific training
¿ Quality Assurance activities such as preparing for audits, development of templates, checklists and guidelines
¿ Create and maintain project specific working files, case report files and project central files
¿ Inform Medical Project Managers and Regional Head of PV Operations of potential change-in-scope of projects.
¿ Work with Medical Directors/Safety Physicians, as needed, with medical monitoring activities such as:
o drafting, writing and editing of protocols and CRFs
o collection and review of endpoint packages
o review and follow-up laboratory alerts
o review and follow-up patient eligibility for inclusion / exclusion in clinical trials
o review and follow-up protocol violations
o preparing relevant procedures covering the above medical monitoring activities
o review study specific Model ICFs according ICH/GCP criteria
¿ Act as the Medical Monitoring Representative in project teams, as appropriate
¿ Participate in client meetings / investigator meetings/ project specific training sessions
¿ Delegate work as appropriate to Drug Safety Associates and Drug Safety Assistants
Skills
¿ Sound knowledge of drug safety and the drug development process
¿ Knowledge of and ability to interpret and apply global safety regulations.
¿ Experience in data analysis and evaluation of safety data
¿ Demonstrated competence in processing, evaluating and reporting safety information in compliance with the regulations
¿ Good presentation skills
¿ Excellent interpersonal skills
¿ Excellent verbal / written communication skills
¿ Good time management skills
¿ Team player
¿ Client focused approach to work
¿ Experience with computer applications including database management and pharmacovigilance related computing systems
Education (one of:)
¿ Degree in Pharmacy, Nursing, Life Science, or other health-related field , or equivalent qualification
¿ Associates/diploma degree in any of the above with appropriate work experience
Language Skills
¿ Fluent English

Experience:
¿ Drug safety knowledge and two years of experience experience in Safety Database
¿ Experience in working in drug development and/or healthcare environment

Click HERE to APPLY

Govt. Jobs For Technical Assistant, Lab Attendant & Research Fellow In National Institute of Plant Genome Research – New Delhi

National Institute of Plant Genome Research

Applications are invited from suitable candidates for filling up the purely temporary positions of Senior Research Fellow, Junior Research Fellow, Technical Assistants and Lab Attendant in DBT sub-project-1 entitled “Chickpea genome sequence analysis and its alignment to genetic map” of ‘Next Generation Challenge programme on Chickpea Genomics’ under the supervision of Dr. Mukesh Jain, Scientist, NIPGR.

Senior Research Fellow (one post): Emoluments as per DST/DBT norms & as sanctioned in the project.

Qualification: Candidates having M.Sc. degree or equivalent in Bioinformatics with two years of post M.Sc. research experience are eligible to apply. The Computer skills (Linux/Perl/Java) are essential in particular data analysis. The candidate having experience in next generation sequencing data analysis will be given preference. Candidate should have First class/division throughout academic career.

Junior Research Fellow (one post): Emoluments as per DST/DBT norms & as sanctioned in the project.

Qualification: Candidates having M.Sc. degree in Life Sciences, Molecular Biology, Bioinformatics or related field are eligible to apply. Candidate having experience in the area of functional genomics, including transcriptomics, microarray data analysis, generation and analysis of transgenics etc, will be given preference. The candidate should have First class/division throughout academic career.

Technical Assistant (two posts): 8000/- fixed consolidated emolument.

Qualification:Candidates having M.Sc. degree or equivalent in any discipline of life sciences / B.Sc. with at least two years of experience in computer applications are eligible to apply. The candidates having research experience in advanced molecular biology techniques and/or bioinformatics will be given preference.

Lab Attendant (one post): 6000/- fixed consolidated emolument.

Qualification: Matriculate with experience of working in research laboratories.

The positions are purely temporary and are co-terminus with the project. The initial appointment will be for one year, which can be extended/curtailed on the basis of assessment of the candidate’s performance and discretion of the Competent Authority. NIPGR reserves the right to select the candidate against the above posts depending upon the qualification and experience of the candidate. Reservation of post shall be as per Govt. of India norms.

How To Apply : Eligible candidates may apply by sending their complete application in the given format. The attested copies of the certificates and proof of research experience are to be attached with the hard copy of application. The applications should reach at the address given below within 20 days from the date of advertisement. The envelope must be superscribed by “Application for the Post of JRF/SRF/TA/LA in DBT NGCP Sub- Project-1″.

Venue : Dr. Jitender Giri
Staff Scientist – II
National Institute of Plant Genome Research (NIPGR)
Aruna Asaf Ali Marg, P.O. Box NO. 10531,
New Delhi - 110067
Email: jitender@nipgr.res.in
Phone: 011-26735227

More Info: CLICK HERE

TAU Research Links Childhood Obesity to Cancer Risk

 

New study reveals 50% higher risk of urothelial and colorectal cancers in adulthood

Parents are increasingly conscious of the dangers of childhood obesity. There is a growing recognition of health problems associated with extra pounds, including the risk of diabetes, heart disease, and joint and muscle pain.

New research from Tel Aviv University has revealed another significant reason for children to maintain a healthy weight. Dr. Ari Shamiss and Dr. Adi Leiba of TAU's Sackler Faculty of Medicine and the Sheba Medical Center and his fellow researchers found that obesity in adolescence, defined as a Body Mass Index (BMI) in the 85th percentile and above, has a direct link to the incidence of urothelial (bladder and urinary tract) and colorectal cancers in adulthood. According to the American Heart Association, one in three children and teenagers are now considered overweight or obese.

Children above the 84th percentile in BMI have a 1.42% greater chance, representing a 50% higher risk, of developing urothelial or colorectal cancers in adulthood compared to those beneath it, explains Dr. Shamiss, whose research has been published in the journalsCancer Epidemiology, Biomarkers and Prevention and Obesity.

Understanding the connection

To examine the relationship between obesity and cancers, the researchers conducted a longitudinal study of a cohort of 1.1 million males in the Israeli Defense Forces. Their health information was gathered by the army, with a follow-up period of 18 years. When they controlled for factors such as year of birth and education, the researchers discovered a clear link between childhood BMI and those who were diagnosed with urothelial or colorectal cancers later in life.

While the researchers have so far uncovered risk in two different types of cancer, Dr. Shamiss believes that further research will reveal connections between childhood obesity and a wide range of other cancers, including pancreatic cancer, which he is currently researching.

These findings show a distinct need for more research in this field, he notes. "We need to examine the questions of whether obesity is a direct risk factor for cancer or a confounding factor for a genetic variation, for example," he explains, pointing out that basic research could help researchers to understand the connection between obesity and cancer on a deeper level.

The role of weight loss

One of the crucial questions, says Dr. Shamiss, is whether or not a successful weight loss attempt can reduce a child's risk of developing urothelial or colorectal cancer in adulthood. Their current sample looks at children who were obese and those who were of normal weight, but does not reveal whether weight loss makes a significant difference.

New research should focus on researching the pathogenetic link between obesity and cancer, and whether losing weight in adulthood could lower the risk, Dr. Shamiss says. Although healthcare professionals are already stressing the importance of preventing childhood obesity, this finding certainly adds to the urgency.

Source: AFTAU

Vacancy for post of Assistant Research Scientist/ Research Scientist - DMPK in Advinus Therapeutics - TATA Enterprise

Assistant Research Scientist/ Research Scientist - DMPK - Invivo (Code: ATPL/DMPK2/BLR)

Job Description
:

• Theoretical knowledge of  Pharmacokinetics (PK), experience in leading a group in conducting in-life PK studies, and excellent surgical skills
• Responsibilities include conduct of PK studies in rodents and non-rodents, and development in situ models to determine absorption/ dispositional characteristics of new compounds.
• Coordinate activities of the in-life PK group and perform pharmacokinetic analysis
• Excellent written and oral communication and team-working skills.

Qualifications
:
M.Sc. in Pharmacology or related field
3-5 years of experience in the Pharma R&D sector

Other Info
:
Code: ATPL/DMPK2/BLR

CLICK HERE TO APPLY

Senior Research Fellow Jobs In Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) – Trivandrum

SREE CHITRA TIRUNAL INSTITUTE FOR MEDICAL SCIENCES & TECHNOLOGY

BIOMEDICAL TECHNOLOGY WING, POOJAPURA, TRIVANDRUM – 12

For a CSIR project ‘Development of Hemostatic Scaffold using Biodegradable Polymer and Bio-mimetic Extra Cellular Matrix (ECM) Components for Healing of Chronic Dermal Wounds’ P-8020.

SENIOR RESEARCH FELLOW (SRF) – One Vacancy

No. of vacancies : One

Qualification & Experience: M.Sc (1st Class) in Chemistry (Organic/Polymer/ Applied) OR 1st class B.Tech (Polymer Science/ Technology) with 2 years research experience and knowledge in computer operations.

Emoluments : `18,000/- + 20 % HRA (Consolidated) pm

Maximum age : 35 years. as on 31-7-2012

Mode of selection : Walk-in-interview

Duration : Upto 31-3-2013 or till completion of project, whichever is earlier.

Date & Time of interview : 17-8-2012 at 10:30 AM

Time of reporting : 09:00 AM

Venue : Biomedical Technology Wing, Satelmond Palace, Poojapura, Trivandrum –12 Phone : 2340801

How To Apply : Those who fulfill the above requirements may report for a written test/ interview as per the above schedule along with bio-data and original certificates to prove age, qualification, experience etc. at Biomedical Technology Wing, Poojapura, Thiruvananthapuram – 695 012 of this Institute (Phone No:2340801). No TA/DA will be paid for attending the interview. Candidates reporting after 9.15 AM will NOT be considered for selection. Candidates already in service have to produce a No Objection Certificate from the present employer at the time of interview.

click HERE for original notification

U. S. Food and Drug Administration approved ziv-aflibercept injection for mCRC

Ziv-Aflibercept

On August 3, 2012, the U. S. Food and Drug Administration approved ziv-aflibercept injection (Zaltrap, Sanofi U.S., Inc.) for use in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin‑containing regimen.  Ziv-aflibercept (previously known as aflibercept) is a recombinant fusion protein consisting of vascular endothelial growth factor (VEGF)-binding portions from the extracellular domains of human VEGF receptors 1 and 2 that are fused to the Fc portion of the human IgG1 immunoglobulin.
This approval is based on the results of a randomized, double-blind, placebo-controlled, global, multicenter trial enrolling patients with mCRC that progressed during or within 6 months of receiving oxaliplatin-based combination chemotherapy, with or without prior bevacizumab.

The Phase 3 trial accrued 1226 patients who were randomly allocated (1:1) to receive FOLFIRI (irinotecan 180mg/m² IV infusion over 90 minutes, leucovorin 400 mg/m² IV infusion over 2 hours, followed by 5-FU 400 mg/m² IV bolus, followed by 5-FU 2400 mg/m² continuous IV infusion over 46-hours) with either ziv-aflibercept (N=612) or placebo (N=614).  Ziv-aflibercept was administered at a dose of 4 mg/kg IV infusion over 1 hour prior to FOLFIRI.  The treatment cycles on both arms were repeated every 2 weeks.  Patients were treated until disease progression or unacceptable toxicity.  The primary efficacy endpoint was overall survival (OS).  Treatment assignment was stratified by the ECOG performance status and prior exposure to bevacizumab.

Median age of randomized patients was 61 years, 59% were men, and 98% had an ECOG performance status of 0 or 1.  All patients had received prior oxaliplatin treatment.  A statistically significant improvement in OS was observed in patients receiving FOLFIRI plus ziv-aflibercept compared to those receiving FOLFIRI plus placebo [HR 0.82 (95% CI: 0.71, 0.94), p=0.0032, stratified log-rank test].   The median OS was 13.5 and 12.06 months for patients on the ziv-aflibercept and placebo arms, respectively.  Median progression-free survival in the ziv-aflibercept arm was 6.9 compared to 4.7 months in the placebo arm [HR 0.76 (95% CI: 0.66, 0.87), p=0.00007].  

The most common adverse reactions, (all grades), occurring in ≥ 20%  of patients in the ziv-aflibercept plus FOLFIRI arm (with > 2% difference between arms) were leukopenia, diarrhea, neutropenia, proteinuria, increased AST and ALT, stomatitis, fatigue, thrombocytopenia, hypertension, decreased weight, decreased appetite, epistaxis, abdominal pain, dysphonia, increased serum creatinine, and headache.  The most common grade 3-4 adverse reactions (≥ 5%) reported at a higher incidence in the ziv-aflibercept plus FOLFIRI arm (> 2% difference between arms) were neutropenia, diarrhea, hypertension, leukopenia, stomatitis, fatigue, proteinuria, and asthenia.  

Severe and sometimes fatal hemorrhages, including gastrointestinal hemorrhages, have been reported in patients receiving ziv-aflibercept.  Grade 3-4 hemorrhagic events occurred in 2.9% of patients receiving FOLFIRI plus ziv-aflibercept compared with 1.7% of those receiving FOLFIRI plus placebo.  In addition to hemorrhage, the ziv-aflibercept label contains a Boxed Warning for the serious adverse reactions gastrointestinal perforation and compromised wound healing. 

Arterial thromboembolic events were observed in 1.7% and 2.6% of patients in the placebo and ziv-aflibercept containing arms, respectively.  Venous thromboembolic events were also observed more frequently with ziv-aflibercept:  9% patients in the ziv-aflibercept-containing arm compared to 7% in the placebo-containing arm.  Fistula formation and reversible posterior leukoencephalopathy syndrome have also been reported in patients who received ziv-aflibercept.

The recommended ziv-aflibercept dose and schedule is 4 mg/kg administered as a 60-minute IV infusion every 2 weeks in combination with the FOLFIRI regimen.

Full prescribing information, including Boxed Warning, clinical trial information, safety, dosing, and use in specific populations are available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125418s000lbl.pdf

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System by completing a form online at http://www.fda.gov/medwatch/report.htm, by faxing (1-800-FDA-0178) or mailing the postage-paid address form provided online, or by telephone (1-800-FDA-1088).

Source: FDA