New fraud report: Information theft is Asia’s biggest fear

A major survey of global executives has found that physical theft (41%) is the most common problem for companies in Asia, followed by information theft (31%) and regulatory or compliance breaches (28%).

Globally, the average company loss to fraud has increased by 22%, largely driven by the credit crunch and tough economic climate. Companies lost an average of $8.2 million to fraud in the past three years, compared to last year’s $7.6 million.

More than four out of five companies surveyed (85%) have suffered from corporate fraud in the past three years, up from 80% in last year’s survey. For larger companies the proportion suffering from fraud rose to 90%.

Source: NetworkWorld

So where will you smoke from October 2? lets share

Though in the beginning, the fine would be only Rs 200, the government is trying to amend the act and in future the fine may go up to Rs 1,000.

Even the employer can be fined if somebody is found smoking within the office premises.

Some of the options?

1. Parking area?

2. Basement Parking area?

3. or else..

October 2, smoking would be banned in all public places

From October 2, smoking would be banned in all public places.

Private offices and other establishments can no longer have designated rooms for puffing cigarettes. The ban also includes hotels and restaurants.

According to Health Minister Anbumani Ramadoss, smokers will have to step outside into open space if they wish to smoke.

Though in the beginning, the fine would be only Rs 200, the government is trying to amend the act and in future the fine may go up to Rs 1,000.

Even the employer can be fined if somebody is found smoking within the office premises.

Indian contract manufacturing market to touch $2.46 bn

Indian contract manufacturing market is expected to touch $2.46 billion by 2010 with a CAGR of 41.7 per cent from $869 million in 2007, a report said.

“Indian companies, through their high quality-low cost production models, have bagged some impressive deals in the contract manufacturing space. These deals validate India’s potential to achieve a larger share of the global manufacturing outsourcing market,” consulting firm KPMG said in its latest pharma report.

Winning outsourcing deals signify Indian companies have been able to win the trust and confidence of multinational companies, it said.

Indian companies Nicholas Piramal, Cadila, Shasun, Dishman, Jubilant, Matrix, Strides, Ipca and Divi’s are into contract manufacturing business.

In the future, Indian players would move up the value-chain in the contract business, KPMG said.

At present Indian companies are involved in the manufacture of active pharmaceutical ingredients and intermediates, solid and liquid dosage forms and simple vaccines.

Source: Business Standard

Top 10 mistakes biotechs make (and how to avoid them)

1. Not thinking strategically about IP

Intellectual property and licenses are at the core of everything a biotech company does. But too often, biotechs don’t think strategically about their licenses and patents–both what they own and what they’ll have to license from others. In order to be successful, a company needs to think about the IP relating o its drug candidates on a variety of levels early on. How strong is the patent protection? Will the company have freedom to operate? How will a buyer or partner view the terms and conditions of your licenses? How well will the patents hold up against challenges from generic companies?”Think globally,” encourages Ferruolo. What plans are in place to develop and commercialize the drug in the U.S., Europe, Asia and emerging markets? Companies need to think strategically about IP and spend their money wisely. “The key is to have the right advisors internally or externally who think long term.” So what can you do to avoid an IP nightmare? Instructs Ferruolo, “Ask yourself this: If I were a buyer or partner doing IP due diligence, where would I poke holes and see issues? Identify the and fix them now.”

2. Not understanding the target market

Before investing millions of dollars and many years into a drug, biotechs should think about the commercial viability of the end product. “Don’t treat your R&D process as just a research project,” advises Ferruolo. Not only should your company assess the drug’s activity, management must also determine if there’s a reasonable and timely path to approval. As for its market potential, ask yourself this: Can the drug be differentiated? Will it be reimbursed? Study Medicare and Medicaid and find out how drugs or other products like yours are being reimbursed in the current market. Have realistic expectations, because healthcare costs are on the rise and there’s less tolerance for expensive meds. A super-expensive drug–even an effective one–may not be worth pursuing if there are alternatives on the market.

3. Not raising enough money

Too often, biotechs don’t raise as much money as they could because management wants to avoid dilution. Often, the decision is made to raise just enough money to the next development milestone, with the assumption that the company will then be able to raise a new round at a higher valuation and thinks the company has enough cash to get by. “That is just plain dumb,” Ferruolo says bluntly. Drug development inevitably takes more money and time than anticipated, so biotechs should raise as much money as they can, when they can. “Alex Zaffaroni use to say, “It’s not the size of your slice of the pie; it’s the size of the pie that matters,’” notes Ferruolo. Too often founders and investors fight over the relative size of their slice of the pie. “Even in this environment, people continue to have unrealistic expectations about valuation.” As a result, a lot of money is sitting on the sidelines and not being put to work in the industry.

In addition to raising as much money as possible, biotechs need to pick their VCs wisely. It’s important to pick an experienced VC with deep pockets to lead, one that will be able to syndicate of similar investors. Those are the investors you want on your board to support subsequent rounds, even if they grind you down some on the initial valuation.

4. Not having a regulatory strategy

Early on, get the latest and greatest in regulatory expertise. Make sure your chosen advisor is well-versed in current FDA requirements and issues so that he or she can recommend the best strategy for clinical development and regulatory approval. According to Ferruolo, it is important for biotechs to identify the best regulatory strategy for getting approval, including understanding alternative clinical designs and exploring other indications or endpoints that may be a more viable path to regulatory approval. “Too often companies pursue a regulatory path without critically assessing other possibilities that may be reasonable given the company’s resources and objectives,” says Ferruolo.

5. Not listening to the FDA

It’s crucial for biotechs to engage the FDA throughout the course of drug development; not having a dialogue with the agency can delay or even kill a drug. Have a pre-IND meeting with the FDA, if possible. Ferruolo notes that the agency has been reluctant to have IND meetings recently, but companies should try to keep an open line of communication anyway.

If your company does manage to score a meeting, take to heart what the agency says. “When the FDA says ‘we think you ought to consider’ something, that should not be viewed as a suggestion, but as a mandate,” he explains. “Companies are foolish if they don’t follow what the FDA has suggested.” A biotech takes on significant and unnecessary risk if it doesn’t follow an FDA suggestion or proactively address the FDA’s concerns.

You listen some of the best FDA related Webinars on ComplianceOnline
6. Designing trials poorly

“I once heard a very experienced biotech pioneer say, ‘there’s no such thing as a failed drug, but there are failed trials,’” recalls Ferruolo. “If you have a drug/biologic that has activity, when it fails, it’s not because of the drug or molecule, it fails because you haven’t designed the trial properly.” Do you have the right endpoints? Are they appropriately defined? Are you pursuing the right indications? Know the answers to those questions before starting expensive clinical trials.

7. Not properly powering trials

Pivotal clinical trials must be properly powered based upon the level of activity shown in earlier trials and preclinical studies. Big Pharma typically powers their trials at no less than 80 percent. If you are an emerging biotech designing pivotal trials for the drug candidate that is going to make or break you, you should aim to power the trials at 90 percent. Admittedly, there may be reasons–above all limited financial resources–that will make that hard to do. But the alternative may be that tombstone press release where you have to disclose that while the data from the trials showed “positive trends,” the results were not statistically significant and the endpoints were not met.

8. Relying heavily on third parties, especially CROs

No third party will put the urgency and care into your development program that you will. When it comes to working with CROs, often your trials will be of a much lower priority than those of bigger company that are repeat clients. There is a strong trend to outsourcing, but frequently the more a small company can do in-house the better, according to Ferruolo. Of course, going it alone is expensive and companies have to find a practical balance between in-house work and outsourcing. “There will be a variation in how much outsourcing is necessary,” he explains. “But do as much as you reasonably can do with people who live, die, sleep and eat thinking about nothing but your program. What they lack in experience may be made up in commitment.”

9. Not being ready for success

At long last, you’ve finished your trials, your drug is approved and you’re ready to go–but you don’t have enough of the drug to initiate sales because a manufacturing and supply sources are not in place. It’s an understandable situation for small biotechs, says Ferruolo. Oftentimes they’re not prepared for large scale manufacturing. However, being unprepared to commercialize wastes valuable time and can substantially reduce the ROI. If it takes a company a year to get up to speed, that is one year of lost sales-and a year of patent protection squandered.

Especially in difficult funding times, biotechs have to marshall and conserve their resources, and often focus all their efforts on clinical trials. Planning and preparation for manufacturing and commercializing are deferred, often with unrealistic expectations for making up the tie or assuming a partner or buyer will resolve the problem. Lack of such planning has been fatal to many deals. And companies who choose to go it alone often admit they made they made it through pure luck. Ferruolo recalls the words of one Agouron exec talking about the experience of launching Viracept. “He said, ‘If we knew how difficult it was we would have never tried to do it on our own,’” recalls Ferruolo. Agouron was eventually bought out by Pfizer.

10. Not knowing when to partner

When it comes to partnering, “a lot of bad decisions have been made.” In the 1990s, biotechs partnered early and went public based on the validation provided by the partnering they did. Biotech companies then came to the view that companies were squandering their potential value by partnering too early. The preferred strategy for biotech became holding on to their programs and developing products themselves. “The problem with this is it almost always takes longer to develop a drug than you think. To advance a drug to its first pivotal trial, a private biotech company may have already raised over $100 million and will need access to the public market to raise more funding. What happens when the public markets are closed and the funds cannot be raised?” Waiting until late in the game to partner means your company is shouldering more of the risk.

Source: FierceBiotech

FIFA unveils 2010 World Cup mascot

FIFA unveiled Zakumi, the official mascot of the 2010 football World Cup, in Johannesburg at a television gala broadcast nationwide.

The ZA in Zakumi stands for South Africa  while kumi means ten in assorted African languages. The mascot has been exclusively designed in the host country which will stage the continent’s first ever World Cup.

Source: Rediff

HP to sack 24,600 employees in 3 years

HP (Hewlett Packard) plans to sack 24,600 people over the next three years from its global workforce as part of its restructuring process. Around 50 per cent of the said numbers reduction will happen in the US, reports said.

“Workforce reduction plans will vary by country, based on local legal requirements and consultation with works councils and employee representatives, as appropriate.

Approximately 7.5 per cent of the combined company’s workforce, or about 24,600 employees, will be affected over the course of the program, with nearly half of the reductions occurring in the United States,” the company said.

Source: CIOL

US bans import of 30 generic drugs of Ranbaxy

The Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India.

The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import Alert, under which U.S. officials may detain at the U.S. border, any active pharmaceutical ingredients (API) (the primary therapeutic component of a finished drug product) and both sterile and non-sterile finished drug products manufactured at these Ranbaxy facilities and offered for import into the United States.

The problems at these two Ranbaxy plants relate to deficiencies in the company’s drug manufacturing process. These actions are proactive measures that the FDA is taking in order to assure that all drugs that reach the American public are manufactured according to cGMP requirements. While this action does not involve removing products from the market, FDA has no evidence to date that Ranbaxy has shipped defective products. We will continue to monitor the situation.

Today’s announcement does not impact products from Ranbaxy’s otherplants which are not affected by today’s actions. FDA has inspected those facilities and, to date, they have met U.S. cGMP requirements for drug manufacturing.

The FDA recommends that consumers continue taking their medications manufactured by Ranbaxyand not disrupt their drug therapy, which could jeopardize their health. Patients who are concerned about their medications should discuss their concerns with their health care professional.

Earlier today, the FDA informed Ranbaxy that until it resolves the deficiencies at each of these two facilities and the plants come into compliance with U.S. cGMP requirements, FDA’s drug compliance office will recommend denial of approval of any New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) that list the Paonta Sahib or Dewas plants respectively as the manufacturer of APIs or finished drug products

Ranbaxy is one of the largest foreign suppliers of generic drugs to the United States. The company makes a number of drug products.

The FDA Import Alert covers more than 30 different generic drug products (Drug List) produced in multiple dosage forms and dosage amounts ( i.e., 25 mg, 50 mg, and 100 mg) at these two locations.FDA has evaluated whether these actions would create any potential drug shortages in the United States, and has determined that other suppliers can meet market demand, with one exception. Because Ranbaxy is the sole supplier to the U.S. of one drug product, Ganciclovir oral capsules (an antiviral drug), to avoid creating a shortage of the drug, FDA generally will not detain shipments of this product, and plans to arrange for additional oversight and controls until the company resolves these manufacturing issues.

“With this action we are sending a clear signal that drug products intended for use by American consumers must meet our standards of safety and quality,” said Janet Woodcock, M.D., director, FDA’s Center for Drug Evaluation and Research (CDER). “The FDA has notified other agencies and health care professionals to make them aware of today’s actions so that they can take appropriate action and advise patients as needed.” The Warning Letters issued today document the results of FDA investigations at these two sites.

One Warning Letter addressed problems at Ranbaxy’s Dewas facility found during an inspection conducted by FDA in early 2008. During that inspection, FDA investigators documented significant cGMP deviations in the manufacture of sterile and non-sterile finished products and violations with respect to the manufacture and control of APIs. Specific areas of concern included the following aspects of the firm’s quality control program:

• The facility’s beta-lactam containment program (measures taken to control cross-contamination), which appeared inadequate to prevent the potential for cross-contamination of pharmaceuticals;
• Inadequate batch production and control records;
• Inadequate failure investigations; (A failure investigation is done to address any manufacturing control or product rejection to determine the root cause and prevent recurrence); and,
• Inadequate aseptic (sterile) processing operations.

The second Warning Letter addressed the Paonta Sahib facility following an inspection at its Batamandi unit, also in early 2008.This inspection documented various cGMP deficiencies, including the following:

• The lack of assurance responsible individuals were present to determine the firm was taking necessary steps under cGMP;
• Inaccurate written records of the cleaning and use of major equipment;
• Incomplete batch production and control records; and,
• Inadequate procedures for the review and approval of production and control records for drug products.

Following the two inspections, FDA provided Ranbaxy with a separate list of inspectional findings for each of the facilities. In mid-April and May, Ranbaxy responded in writing to these findings in lengthy submissions to FDA. The agency then evaluated its findings, Ranbaxy’s responses, and the firm’s overall inspectional history, an evaluation that required substantial time due to the complex scientific and technical nature of both the identified deficiencies, particularly at the Dewas site, and the firm’s responses. Ultimately, FDA concluded that the firm’s responses were not adequate and that the Warning Letters were the appropriate regulatory response.

“Today’s actions are clearly warranted by the serious violations established by FDA’s investigations at these two sites,” said Deborah M. Autor, director, CDER’s Office of Compliance, FDA. “Until the company addresses these deficiencies, APIs and finished drug products from these plants will remain on the Import Alert, and we will not approve any Abbreviated New Drug Applications or New Drug Applications that list either of the two facilities as the manufacturer of APIs or finished drug products.”

This represents the second time in less than three years FDA has issued a Warning Letter to Ranbaxy. In 2006, FDA cited Ranbaxy for violations of U.S. cGMP at its Paonta Sahib facility.

The FDA will continue to work with Ranbaxy’s Dewas and Paonta Sahib plants to resolve these issues.
Consumers and health-care professionals can report adverse events to FDA’s MedWatch program at 1-800-FDA-1088; by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or online, at the following Internet address: www.fda.gov/medwatch/report.htm

Source: FDA News

2,500 Lehman India employees’ fate uncertain

The fate of 2,500-odd employees working for investment banking giant Lehman Brothers in India remains uncertain following its parent company’s decision to file for bankruptcy protection in the United States.

Lehman said in a statement that its New York office intends to file for bankruptcy protection as it owes over $600 billion to lenders.

However, it highlighted that no other Lehman Brothers’ US subsidiaries or affiliates, including its broker-dealer and investment management subsidiaries, are included in the filing.

The filing for Chapter 11 bankruptcy protection, which allows a company to restructure while creditor claims are held at bay, was made in the US Bankruptcy Court in the Southern District of New York by the investment bank’s holding company, Lehman Brothers Holdings Inc.

Source: Rediff

New EC GMP regulations for radiopharma

Revised good manufacturing practice (GMP) requirements for the production of radiopharmaceuticals have been published by the European Commission (EC).

The updates to the annex are intended to make it compliant with GMP Part II, which laid out additional requirements for actives substances used as starting materials.

In addition the EC has sought to bring the regulations up-to-date with advances in the manufacture of radiopharmaceuticals.

An initial draft was published for public consultation in December 2006. This process has now been completed and

Dead Line:

Companies have until March 1 2009 to become compliant with the new requirements.

The regulations are broken down into subcategories including quality assurance, personnel, production and documentation. These are intended to provide the necessary regulation to prevent cross-contamination, the spread of radioactive material and ensure the quality of the product.

Quality assurance is particularly important in the manufacture of radiopharmaceuticals as the half-lives of some mean they need to be administered shortly after production. Consequently there is not enough time to test the product.

To maintain high standards the regulations insist on rigorous record keeping and for the principles of qualification and validation to be applied, details of which can be found here.

AIM:

Underlying all the regulations is the need for accurate, up-to-date documentation of procedures.

What manufacturers must establish:

1. Manufacturers must establish specifications for raw materials, labelling and packaging materials, critical intermediates and the finished radiopharmaceutical.

2. Specifications must also be put in place for any piece of equipment that could critically impact on the quality of the finished product.

3. The cleaning, sanitisation, sterilisation or maintenance of equipment should be documented to show the product name, batch number, date and time of the activity and signature for the persons involved in these activities.

4. Documents must be kept for a minimum of three years, unless a different timeframe is specified by national laws.

Retention to ensure accountability extends to keeping sufficient samples of each batch of bulk formulated product for at least six months after expiry of the finished medicinal product.

Samples of starting materials, excluding solvents gases or water used in the manufacturing process must be kept for at least two years after the release of the product. This period can be shortened if the material has a period of stability of less than two years.

Annex 3, the complete document covering GMP requirements for the manufacture of radiopharmaceuticals, can be found here.

Source: Outsourcing Pharma