In collaboration with AIIMS and PGI Chandigarh, the institute has created scaffolds on which stem cells can be grown into tissues, which then develop into a full organ. The organ thus developed can be used for transplantation. At present, these scaffolds — made of biodegradable polymers — are being used for animal testing in Paris.

Explaining that this marvel of tissue engineering has an edge over the traditional donor system of organ transplantation, professor Bhuvanesh Gupta from the bioengineering group, textile department, IITD, said: “Since a new organ can be developed on the scaffolds using patient’s own cells, there will be no need of finding a donor. There will be no chances of rejection either like in a normal organ transplant.”

The technology requires making a scaffold which is like a mould using a biodegradable polymer. It is developed by knitting the polymer for an organ like a bladder, which needs expansion. For tubular structures like a blood vessel, it’s braided. Once a scaffold is ready within a week, it is coated with protein so that it becomes bio-receptive allowing cells to grow easily.

“A very small amount of native cells can be taken from the healthy part of a patient’s dysfunctional organ through biopsy. The cells are then seeded on the scaffold to form a tissue patch. Developing a scaffold that favours cells’ growth is crucial,” explained Professor Gupta. The new organ thus formed on the scaffold can be transplanted in the body. “The scaffold degrades in the body within a few months leaving behind a well-functioning organ. It’s like harvesting your own organ,” Gupta added.

Stem cells can also be used in place of native cells. Stem cells can be used to form the tissue of any organ while native cells can only form the organ from which they are extracted.

The scaffolds are the result of a 10-year-long research by Professor Gupta and Professor Alok Ray from IITD’s centre for Biomedical Engineering. The IIT team, which includes four students, has worked with Professor J Hilborn from University of Uppsala in Sweden, Professor Didier Letourneur from Bichat Hospital and Professor Joelle Amedee from University of Bordeaux in France in this research. The Department of Biotechnology, Government of India and also the European Union are funding the project.

“We have developed biodegradable scaffolds based on polylactic acid copolymers in the form of tubular as well as knitted structures for the blood vessel and urinary bladder reconstruction. Seeding the cells on these scaffolds is done by AIIMS and PGI Chandigarh group,” Professor Gupta said. Cells grow beautifully on these scaffolds. If successful, the process can be used for treating ailments of the bone by developing cartilage and for treating burn injuries by developing skin tissues. The scaffolds will be especially useful for cardiac patients as they can avoid by-pass surgery and also be used for developing liver if the original one fails due to Hepatitis. “We have to go a long way to make the scaffold technology useful for humans. But the work is on,” Gupta said.

FDA Drug Approval

The FDA hasn’t yet tallied its year-end drug approvals but will have the number by Friday. As of Dec. 1 the agency reported 25 new drugs approved.  In 2008 it approved 25 new drugs, that number is likely to go up by one when the final tally is taken.
During 2009, the agency added 31 new or updated “black box” warning labels to drugs already on the market. That was down from 56 boxed warnings in the previous year, when the agency issued several broad warnings that resulted in boxed labels for entire groups of drugs.

The 2009 totals suggest a moderate approach to regulation from FDA, despite drug industry concerns that recently-appointed Obama administration officials would result in fewer drug approvals.

President Barack Obama tapped Commissioner Margaret Hamburg and Deputy Commissioner Joshua Sharfstein last year to restore the agency’s credibility, following a string of safety problems involving everything from blood thinners to peppers to peanut butter.

FDA issues warnings to the public when it first begins looking at potential side effects with a drug, even if no direct link has been established.  The agency issued five early communications last year, including reports of liver damage with GlaxoSmithKline PLC’s over-the-counter weight loss pill alli and heart problems with Roche’s asthma drug Xolair. Both issues are still under investigation. In 2008 the agency issued two early communications. Since last spring, FDA regulators moved to shut down makers of phony swine flu remedies, defective nasal sprays and dietary supplements that contain steroids.

FDA also stepped up actions against bogus or dangerous consumer products. 

Drug industry executives have criticized the FDA in recent years for approving fewer new drugs. Drug approvals peaked at 53 in 1996 and have bounced around in the twenties and teens in recent years. Many critics suggest the agency has become too cautious in response to the safety scandal surrounding Vioxx, the Merck painkiller which FDA approved in 1999 but then pulled from the market in 2004 due to heart risks.

FDA officials have countered that new drug submissions have been declining for a decade as companies struggle to come up with new medications. The FDA can’t approve drugs that aren’t submitted.

New drugs cleared in 2009 included Novartis’ kidney cancer drug Afinitor and Bausch and Lomb’s pink eye medicine Besivance.

Currently FDA is operating within its goal of taking 10 months to review regular drug applications and six months for priority applications.

If the drug gets FDA approval, chances are really good that the stock is going to go up. So, we’re looking for drugs that will likely get approval, but we’ll still have to confirm that the drug has the chance to make money. If it’s got no competitor, great, but more likely we’ll have to figure out how much market share the drug can take if it’s only slightly better than its competitor; anything else is gravy.

We’ll take a look at the pipeline too, but companies don’t usually provide much information about drugs they have in the pipeline. We definitely want to invest in companies that have potential upcoming dugs, but they’re a long shot and years away at best, so drugs not currently in clinical trials won’t be counted towards potential share price. In short, we’ll count the lack of a pipeline as a strike against the company, but you don’t get any credit for having someone warming in the bullpen.

People-Money Before Brains

Now, you’d think that the most important thing in terms of management was how smart they are. While that’s important, and we’ll certainly take a look at it, I’m more interested in how invested the top management people are in the company. If their shirt is on the line, I figure our interests (share price) will be aligned. After a stock purchase, this is something to keep an eye on. If you see insider selling, it’s a good idea to reevaluate your position. On the other hand, if you see them buying more shares, it’s a sign they have confidence in their potential product; you might want to have a second look and add to your position.

Financials-Burn Rate Is King

Since the companies I’ll be evaluating generally don’t have any profits, the number one criteria for evaluating their financials is their burn rate. If they don’t have enough money to last until they get their first drug to market, they’re going to have to get more financing (by taking on a development partner, selling the rights to the product, or by offering more shares). This usually results in a lower share value because of the loss (or dilution) of the potential profits.

Bringing It All Together-A Formula

So assuming no red flags have popped up in the above sections we can use a simple formula for figuring out stock price:

(Drug market * Expected market share * Chance of getting to market)/ total shares=Expected earnings per share

Expected earnings per share * expected PE = Buy price

If the actual stock price is lower, then it’s a buying opportunity. Does that mean you should buy? Well, maybe, but maybe not. The two I put in bold are basically educated guesses. You have to feel comfortable that your guesses are correct. Also, you need to balance your risk. If a drug has a 5% chance of getting to market, it doesn’t really matter if it’s a current bargain, because it’s still a long shot. The law of averages says you need to invest in a lot of those (about 60) to make sure you’re going to make money.

For an investing public, it is much easier to trade NYSE stocks profitably than NASDAQ stocks, if you are trading from home over internet. This is because the rules in place on the New York stock exchange are much friendlier to the online trader than those on the NASDAQ exchange.

How to identify the stocks, weather it is traded in NASDAQ or NYSE?  If the stock has a one, two, or three letter symbol, it trades either on the NYSE or the American Exchange.  If it has a four or five letter symbol, it is a NASDAQ stock.  There is higher risk in day trading NASDAQ stock from home.

In NASDAQ, the market makers has huge advantage over the internet day traders. Put it simply, if you are a day trader it is better to trade NYSE stocks rather than NASDAQ stocks.

The trick is to get  in early on the stock picks that have the potential to EXPLODE.  Some hot penny stocks pop like a champagne cork on New Year’s Eve… while many other penny stocks gradually build a foundation and make consecutive daily gains that provide very healthy profits. 

Trading penny stocks can bring you healthy profits. Though internet traders have advantages today that have never before had in trading, they are still at thr slight disadvantage compared to the real players in the market place, namely the market makers and the specialists.

There are hundreds of pennystock newsletters out there which advise you on picking the right penny stocks. But none of then will not advise you when to sell your shares.  Most greedy investors will hold the shares hoping for more profit. More damaging is that they will put invest more money when the stock reaches the peak. You should be selling instead of buying then. Invesors are left to make their own decision on selling the stocks.  In selling timing is the most important.

The rule of thump is that, you should trade only when the odds are in your favour.  The only time the odds are truely in your favour is when you trade with the house, by being at the same side of the trade as the wallstreet.

Day trading can be quite lucrative, but only if you know what you are doing.  The key to day trading is to trade only when the odds are in your favour. Profits are awarded to only those who acts very quickly. There is no margin for error. No profits, no paycheck.

Day traders are not investors, they are traders. In fact, day traders may not even know the  names  or lines of business of the companies they are trading. Typical day tradrs are concerned about only the nest five minutes.  Every trade you make has to be precise, well calculated move. The goal: to get in, to make a profit, and to get out, as quicklyand as safely as possible. Day traders serve one and only one function: They are middlemen in the buying and selling of stocks.  They are not worried about detauls of the stock they are trading.

Good day traders can make literally tens of thousands of dollars in a single day.  But any time you can make that kind of money, there is also a chance, however slight,  that you can also lose that kind of money.