The Times of India

Telugu News

Saturday, February 5, 2011

UCSD researchers get $5.6M in stem cell grants

Three researchers at UC San Diego were awarded about $5.6 million in grants aimed at funding efforts to remove technological barriers to moving stem-cell research projects into clinical trials.

The California Institute for Regenerative Medicine awarded nearly $33 million in grants Thursday to 19 researchers across the state. CIRM was established in November 2004 as the state's stem cell agency, thanks to voters' passage of Proposition 71.

"These awards are a crucial component of CIRM's commitment to accelerate the development of stem cell-based therapies for people of the world,'' CIRM President Alan Trounson said. "CIRM funds all stages of therapy development, from basic research to translational awards, but any of these could be stalled by technological bottlenecks. In funding these innovative tools and technologies, CIRM is removing those barriers before they can delay cures.''

Among the grant recipients announced today were UC San Diego researchers Lawrence Goldstein, Karl Willert and Shu Chien. Goldstein and Chen each received about $1.8 million, while Goldstein was awarded about $2 million.
 

Some stem cells hold on to their past, researchers say

Stem cells created from mature cells, called induced pluripotent stem cells, retain a distinct 'memory' of their former purpose that might limit their potential for therapeutic use.

Stem cells made from mature cells and rewound to an embryonic-like state retain a distinct "memory" of their past that might limit their potential for therapeutic use, scientists reported Wednesday in the journal Nature.

In a side-by-side comparison of these induced pluripotent stem cells and embryonic stem cells, researchers from the Salk Institute in San Diego found a consistent pattern of reprogramming errors — places where the iPS cells did not revert completely to an embryonic state.

"This study definitively demonstrates that there are differences between the two cell types," said Joseph Wu, a stem cell biologist at the
Stanford University School of Medicine who was not involved in the research.
Knowing exactly what those differences are is a key step in developing ways to use iPS cells to treat diseases, experts said. Most researchers still consider embryonic stem cells to be the gold standard for regenerative medicine because they can grow into any type of cell in the body. But many scientists and policymakers would like to see treatments based on iPS cells because they can be made without destroying embryos. In addition, iPS cells can be custom-made for patients, ensuring a perfect genetic match.

To catalog the differences between the two cell types, the Salk team, led by molecular biologist Joseph Ecker, studied the epigenomes — chemical markers attached to DNA that regulate the way genes dial on and off — of 11 different cell lines.

They looked at 1.2 billion places in each genome where such chemical markers exist. The analysis was unusually rigorous — and therefore unusually revealing, Ecker said. Earlier studies examined representative regions in the genome, rather than the whole thing.

"Up to this point, people were looking through a keyhole," he said. "We're opening up the door."

For the most part, the contents of Ecker's metaphorical rooms looked alike. But when they zoomed in, inconsistencies emerged.
Large regions of the iPS epigenomes hadn't reverted to the embryonic state, but instead held on to the epigenetic memory of their tissue of origin. When the researchers used the iPS cells to create mature cells in the lab, this memory persisted.

The regions were clustered near telomeres and centromeres, structures that help direct how chromosomes divide.

"There is something about these regions that makes it harder to modulate the epigenome," Ecker said.

In some ways the iPS cells were different from one another, suggesting the reprogramming process itself might contribute to aberrations, he added.

That does not mean iPS cells can't be used in medicine, experts said. Improvements in technology could one day erase their epigenetic memory.

In addition, Wu said, scientists might find ways to harness that epigenetic memory to help treat disease. For example, if heart cells generated from iPS cells retain some of their cardiac characteristics, he suggested, they might be useful in therapies to treat
heart disease.

"We need to do more research to see what exactly this means," he said.
 

Stem cells for broken hearts - 2

Early work on bone marrow cells to heal fragile hearts showed only modest effects. But new research looks at different types of stem cells. 'We're trying to tear pages out of nature's playbook,' says a Chicago cardiologist.
 
Hoping for a more direct approach that could generate new tissue, Marbán started studying stem cells that come from the heart instead of from bone marrow.

These so-called cardiac progenitor cells naturally repair heart muscle — but they do so far too slowly "to cope with a catastrophic injury" like a heart attack, Marbán says.

The cells are also rare, accounting for about 1 in every 40,000 working heart cells, he estimates. But in larger concentrations, they might be able to speed up the healing process.

To find out, Marbán is leading a trial involving patients who have suffered heart attacks within the past month. First a cardiologist threads a catheter through a patient's neck and into his heart to collect "little snippets of tissue," Marbán says. Those are then cultured in the lab for about a month, until the initial population of cardiac progenitor cells grows to tens of millions. Finally, they're infused back into the patient's heart through another catheter.

The hope is that the cardiac stem cells will take root and reverse the scar. Results should be out later this year. "Let's just say we're extremely encouraged," Marbán says. "It looks like it's working, and cleanly."

Multipurpose cells

In other labs, researchers are focused on more powerful, pluripotent stem cells that have the potential to grow into any type of tissue in the body. Some labs are using embryonic stem cells, and others are studying induced pluripotent stem cells derived from adult tissues and rewound to an embryonic-like state.

"The only cell type that becomes a heart cell is a pluripotent stem cell," says Dr. Deepak Srivastava, director of the Gladstone Institute of
Cardiovascular Disease at UC San Francisco. If bone marrow stem cells or cardiac progenitor cells do manage to create new heart muscle, he says, "it will be a tiny amount."

But research involving pluripotent stem cells is still preliminary. At the Harvard Stem Cell Institute in Boston, Dr. Kenneth Chien has grown mouse embryonic stem cells into a strip of mature cardiac tissue. But Chien's "heart patch," described in a 2009 edition of the journal Science, was only six to seven cell layers thick — too thin to work as a graft or grow blood vessels. He says he is now developing a three-dimensional cardiac muscle patch "akin to a heart Band-Aid."

Any therapy derived from pluripotent stem cells is a long way from being ready to test in humans. Among other technical hurdles, replacement tissues grown from embryonic stem cells run the risk of rejection, just as with organ transplants. In addition, the same forces that make both types of stem cells so flexible also mean they have the potential to generate tumors. When pluripotent stem cells are used to grow heart cells, researchers have encountered difficulty getting them to beat in sync with surrounding heart tissue.

So some of the most promising work with pluripotent stem cells isn't about making replacement heart tissue but finding other ways to ramp up the heart's own healing abilities. For example, Srivastava's lab has identified three genes that convert connective cells in the heart called fibroblasts directly into cardiomyocytes. Murry calls the research, which was published last year in the journal Cell, a potential "game changer."

Northwestern's Losordo has been studying stem cell treatments for about 14 years. He agrees that the best approach might be to apply what scientists have learned about creating stem cells to turn back the clock within a person's own body. "If you can make a patient's own cell behave as if it's younger, problem solved."
 

Stem cells for broken hearts - 1

Early work on bone marrow cells to heal fragile hearts showed only modest effects. But new research looks at different types of stem cells. 'We're trying to tear pages out of nature's playbook,' says a Chicago cardiologist.
 
It's one of the most vexing problems in medical science: How can you mend a broken heart?

A decade ago, researchers and cardiologists thought they had found an answer in stem cells. These powerful cells lurk throughout the body, repairing and maintaining tissues as needed. In the laboratory, scientists can transform them into heart cells. When implanted in animals, they grow into new heart tissue too.

So it was with high hopes that researchers transfused stem cells into patients suffering from
heart failure — people whose hearts, weakened by heart attacks or other conditions, no longer pumped enough blood through their bodies. But in clinical trials, the effects have been modest. Stem cells appeared to help, but not as much as doctors had hoped — and not in the ways they had expected.

Now those early results are pointing researchers toward other types of stem cells that may be better suited to help repair cardiac muscle. With 5 million Americans currently suffering from heart failure — and their ranks sure to grow as 76 million baby boomers march into old age — cardiologists are counting on breakthroughs in stem cell therapy.

"We're trying to tear pages out of nature's playbook," says Dr. Douglas W. Losordo, director of the program in Cardiovascular Regenerative Medicine at
Northwestern Memorial Hospital in Chicago.

Hearts and bones

As the era of regenerative medicine dawned, stem cells seemed a perfect candidate to rebuild damaged hearts.

The stem cells in
bone marrow were particularly tantalizing. Long used to rebuild the immune systems of cancer patients, scientists discovered that they also have the capacity to grow into heart muscle, blood vessels and other tissues — at least under certain laboratory conditions. Bone marrow is easy to extract from patients, and the therapeutic cells derived from it are a perfect genetic match for patients, greatly reducing the risk of tissue rejection.

Researchers and clinicians imagined using stem cells to undo the damage caused by a heart attack. In just a few minutes, a blockage in an artery can cut off oxygen to
the heart, killing as many as a billion cells. The cells, for the most part, don't grow back. Instead, what remains is scar tissue and a weakened circulatory system.

Heart attacks aren't nearly as deadly as they used to be — more than 4 out of 5 heart attack victims are still alive after one year, according to a study last month in the American Journal of Medicine.

But the damage caused by a heart attack can result in heart failure — and patients diagnosed with heart failure have an average life expectancy of less than five years, according to Dr. Chuck Murry, director of the Center for Cardiovascular Biology at the University of Washington in
Seattle.

"It's deadlier than
breast cancer," Murry says.

That helps explain the enthusiasm for clinical trials involving stem cells from bone marrow. From 2002 to 2006 alone, there were at least 18 randomized controlled studies involving nearly 1,000 patients.

"Everyone started putting bone marrow in the heart," says Christine Mummery, a researcher at Leiden University Medical Center in the Netherlands, who has studied how to turn stem cells into heart muscle cells called cardiomyocytes.

But the results, she says, were a mixed bag. The treatment appeared to be safe, but patients had only transient improvement.

"People went from being very sick to a little less sick," Mummery says.

There is a silver lining: Even stem cells that don't grow into new heart cells seem to help patients in other ways. As the bone marrow transplant trials continue, researchers are trying to sort it all out.

"It's a little bit mysterious," says Dr. Eduardo Marbán, director of the Cedars-Sinai Heart Institute in Los Angeles.

Marbán, like many, believes the improvements came about because transplanted cells secreted chemicals that boosted heart function — not because any new heart tissue grew. The "stem cells are working mostly by raising an alarm to resident cardiac stem cells. They seem to work indirectly."

Medical journal bans drug company ads

An Australian medical journal has "stopped all drug advertising forthwith" over concerns it could unduly influence doctors, and has called on similar publications to do the same.

The journal of Emergency Medicine Australasia, which publishes the latest research and unique patient cases in the field of emergency medicine, has announced it will no longer carry advertisements paid for by pharmaceutical companies.

Such advertising could "change the prescribing practices of doctors", said professors George Jelinek and Anthony Brown in a joint statement on Thursday.

"It is time to show leadership and make a stand, and medical journals have a critical role to play in this," they said.

"At Emergency Medicine Australasia we have, therefore, drawn a line in the sand, and have stopped all drug advertising forthwith.

"We invite other journals to show their support and follow suit by declaring their hand and doing the same."

Prof Jelinek is medical director and professorial fellow in the Emergency Practice Innovation Centre at St Vincent's Hospital and the Faculty of Medicine at the University of Melbourne.

Prof Brown is from the Department of Emergency Medicine at Royal Brisbane and Women's Hospital, and the School of Medicine at the University of Queensland.

They said the ban followed discussions with fellow emergency medicine specialists, who had aired concerns such as:

- Advertised drugs were supported by evidence that was neither "of reasonable quality, nor independent".

- There were cases of "dubious and unethical" research practices by the industry, including "ghost authorship" where scientific papers do not disclose all of their authors.

- Academics could also face industry pressure to withhold negative research, and together this could "inflate views of the efficacy" of heavily promoted drugs.

The professors also said drug ads were counter to a medical journal's mission to provide objective data that enabled doctors to make judgments based on the best available evidence.

"Meanwhile doctors - and indeed journal editors - generally deny they are influenced (by the ads), yet clearly they are," they said.

"Drug companies value drug advertising in medical journals because it works ... generating at least US$2 - US$5 in revenues for every dollar spent."

Australian law restricts pharmaceutical companies to advertising their products only in medical journals, and about a dozen specialist and subscription-based magazines and newspapers that target the nation's health professionals.

Peak pharmaceutical body Medicines Australia (MA) said the professors' stated concerns were a "gross misrepresentation" of the industry's interaction with doctors.

"The fact is the industry has a strict code of conduct that requires companies to meet a high ethical standard," said MA chief executive Dr Brendan Shaw.

"Advertising in medical journals must be accurate, balanced and fully supported by government-approved product information.

"It is a legitimate means of keeping doctors abreast of the choice of new medicines that are available to them."

He said there was a global policy requiring drug companies to publish the results of clinical trials whether they had a positive or negative outcome, and all contributing researchers should be named.

Emergency Medicine Australasia is the journal of the Australasian College for Emergency Medicine.

Clinical trials tend to exclude older patients, study finds

Are older adults not properly represented in clinical trials? That's the conclusion of a study published this week in the Journal of General Internal Medicine.

Led by researchers from the Robert Wood Johnson Foundation, the team surveyed 109 clinical trials, finding that 20.2% of them excluded patients above a specified age, and 45.6% of the rest excluded people with conditions that could relate to the elderly (for example, a physical disability or other functional limitation).
 

This is an issue, the authors point out, because as the population ages, medical professionals will need guidance on what to prescribe and how to treat the elderly. But many of these studies seem in one way or another to be avoiding the issue altogether.

"Unfortunately, funding remains inadequate to sufficiently expand geriatrics research," the authors wrote, pointing to a 2004 journal review that found only 5% of studies focused on older adults.

Perhaps age and age-related issues are seen as factors that would confound an experiment's results. But, the study authors point out, those very factors are what need to be tested, because a young person's reaction to a drug may be very different – even dangerously different – from an older person's response.

 

 

Pharma Voice - January 2011


 
On The Cover
Millennials: Problems or Prodigies?
Gen Yers entering the work force will bring disruptive change to the current culture, as well as a high level of success.
  By Robin Robinson

 
Features
The Genome: The Next 10 Years
Despite the promise of advancements in understanding the human genome, significant challenges remain for bringing products to market that take advantage of this evolving discipline.
  By Denise Myshko

Achieving Global Launch Excellence
Defining what comprises a global launch is almost as complex as executing a global launch strategy.
  By Taren Grom, Editor

SFE With a New Business Model
The time is now for the much-talked about move to a consumer-centric sales model.
  By Robin Robinson

Biotech: Raising Capital in a Tight Market
The venture capital environment is in a transition period, slowly recovering from the conditions that have plagued the entire economy.
  By Denise Myshko

Emerging Market: Ola Brazil
Latin America's biggest market accelerates.
  By Kim Ribbink

Engaging the Empowered E-Patient
The growing consumer use and exchange of online health information is changing the balance of power in the patient-physician relationship.
  By Carolyn Gretton

Quick Response Codes (QR) Codes - The Next Frontier for Pharma


Using Social Media to Listen Before You Leap
Contributed By Chris Kelly, M.ED., Director, Health Education and Jeff Greene, Director, Digital Strategy, HealthEd
http://www.pharmavoice.com/archives/issue.esiml?id=148
 

Avastin may be linked to fatal side effects, study says

Avastin may be linked to fatal side effects, study says
 
By Mary Forgione, Tribune Health

Avastin, a popular cancer drug that slows the growth of some types of tumors, may also be linked to an increased risk of death, new research suggests.

A study published Tuesday in the Journal of the American Medical Assn. reviewed randomized controlled clinical trials from 1966 to 2010 with a total of 10,217 patients.

FOR THE RECORD: An earlier version of this post said the FDA withdrew approval of Avastin for breast cancer patients in December. In fact, the FDA moved to begin the process of withdrawing approval. Genentech has requested a hearing appealing this proposed withdrawal, a spokeswoman for the company said in an e-mail.



The rate of death, or "fatal adverse event" in researcher-speak, hit 2.5% for patients who took Avastin, known generically as bevacizumab, and a chemotherapy drug. That compared to 1.5% for those who took chemotherapy drugs alone. The most common causes of death were hemorrhage, neutropenia and gastorintestinal tract perforation. Here's the study abstract.

And by definition, "fatal adverse event" means the death was probably caused by a drug.

Avastin made news in December when the Food and Drug Administration moved to begin the process of withdrawing approval of Avastin as a treatment for breast cancer because the federal agency found no evidence that it extended the lives of women who had the disease. Drug maker Genentech requested a hearing appealing this proposed withdrawal. In that action, the drug was still approved for kidney, brain and lung cancers.

The researchers write in conclusion: "It is important for physicians and patients to recognize the risks as well as the benefits associated with bevacizumab treatment and to monitor closely to identify and treat serious adverse effects."

It's likely we'll be hearing more about this apparent connection in the months and years to come.

 

 

Putting the “Community” in Community Service

Gulf Coast residents have borne – and continue bear – the brunt of Hurricane Katrina. But

make no mistake about it – the Hurricane is a national disaster because it tests our concept as

Americans of our national identity:

One Country. Americans are Americans no matter where we live, without regard for race, creed or color.

Caring. We donate of billions of dollars and billions of hours to charities without any legal obligation.

Individual Initiative. In perhaps no other nation are individuals so empowered to take leadership roles without asking for anyone's permission.

"Can Do" Attitude. We pride ourselves on our ability to tackle and overcome tough challenges.
 
 

In this spirit, pharmaceutical and biotech companies reacted quickly to the Hurricane,

committing over $50 million of money and medical supplies, as well as thousands of hours of

staff time within a few days. Individuals in the clinical research industry have made many,

many personal contributions of time and money. However, few people in clinical research have

yet perceived that Hurricane Katrina is also a huge opportunity to build the clinical research

community

.

Giving a hitch-hiker a ride out of the New Orleans floodwaters creates a qualitatively different

relationship than sitting next to that same person at an industry conference. Hurricane Katrina

gives the clinical research industry the opportunity to move beyond a community of conference

attendees to become an extended "band of brothers." Writing a check to a public relief fund is

admirable, but it is also possible to leverage – at no extra cost – that same contribution into

countless personal relationships that tie the community together.

The clinical research community is like any other business community, so can serve as a

broader example. It includes pharmaceutical (and biotech and medical device) companies,

academic and private clinical research sites, contract research organizations (CROs) and other

suppliers, government funding and regulatory agencies, research subjects, and over 130

industry associations and 110 publications that serve the community directly or indirectly.

Unlike most other industries, however, many participants play dual roles: Most research

investigators are practicing physicians, so they have a dual supplier/customer relationship with

pharmaceutical companies and study participants. Study participants are also patients, so they

also have a dual relationship with both research investigators and pharmaceutical companies.

 

Read Full Article HERE

Published in PharmaVOICE

 

 

Legal Conflict on a Global Scale: Clinical Trial Agreements in the International Context

Most industries globalise to reduce costs: Cost is not, however, the primary driver for the globalisation of clinical research: Low site fees currently are offset by high communication and logistics costs. The primary attraction is generally subject availability. As a side benefit, data quality is better in many developing countries than in developed countries. The multiplicity of legal and regulatory regimes offsets these advantages, and can be serious problems in multinational trials. Clinical trial agreements are a small area of the legal and regulatory impact that will grow in importance as globalisation of the industry continues. In the United States, it takes clinical trial sponsors an average of 35 days to negotiate clinical trial agreements (CTAs) with community-based sites and site management  organisations, and 96 days with academic centers.1 Investigative sites have ranked ÔLegal ReviewÕ and ÔContracts & BudgetsÕ higher than ÔSubject Recruitment Õ as a source of delay for clinical trials.2 New drugs can generate revenue of over USD1 million per day, so the cost of these delays adds up quickly. In addition, most new drugs enjoy patent exclusivity for only a few years at best, so time is of the essence.

In the United States, some of the delays occur when the sponsor is in one state and the site is in another. The difficulties are

magnified when the sponsor or site is outside the United States. It is magnified further when sites are in multiple countries.

It is magnified further when sites and sponsors on multiple trials are in multiple countries. It is magnified still further when

sites and sponsors are in multiple states  and provinces within multiple countries. With the steady globalisation of clinical

research, these difficulties will become ever more burdensome.

 

Read Full Article HERE

Published in Research Global

 

Laws, Regulations and Clinical Trial Agreements

Abstract: As clinical research increasingly becomes a global enterprise, investigators and sponsors must deal with multiple legal jurisdictions, with differing laws, regulations and other rules. A mutual understanding of the legal environment will streamline the clinical trial agreement negotiation process and avoid contracts that are legally unenforceable. A sampling of laws and other rules that impact clinical trial agreements is provided. The objective of this paper is to elicit contributions to a comprehensive and detailed compilation of rules that impact clinical study agreements.

The Legal Environment

As clinical research increasingly becomes a global enterprise, investigators and sponsors must deal with multiple legal jurisdictions, with differing laws, regulations and other rules. (The term "law," as used in this paper, includes both laws and regulations.) These rules establish expectations based on each party's locale. Public and non-profit entities also have various legal constraints. These rules limit the flexibility of investigators (i.e., research sites) when negotiating clinical trial agreements (CTAs). The objective of this paper is to elicit contributions to a comprehensive and detailed compilation of rules that impact clinical study agreements.

Because the rules may be numerous, obscure or subject to change and differing interpretations, it is often difficult even for contract specialists in the affected organizations to understand their application in specific circumstances and to intricate language drafted by sponsors. A mutual understanding of these regional and institutional differences by both sponsors and investigators will streamline the clinical trial agreement negotiation process.

Investigators are subject to rules on multiple

levels:

􀂃 International

􀂃 Multinational

􀂃 National

􀂃 State or Province

􀂃 Ethics Committee

􀂃 Institutional

􀂃 Societal

International.

Various international bodies that define rules for clinical research such as the Nuremberg Code, Declaration of Helinski, and the International Conference on Harmonization ICH E6 Guideline for Good Clinical Practice. However, they do not enforce their rules; they leave that to governments. (There may, someday, be an exception to this generalization: The World Trade Organization theoretically could adjudicate accusations of unfair clinical research trade practices.) In addition, some industry associations publish ethical codes that require member compliance with international rules.

Multinational

. Multinational laws may apply. The European Union (EU) and Mercosur (Uruguay, Paraguay, Argentina and Brazil) have published extensive laws for their member states. Member states may or may not be required to enforce these laws as their own. Adoption of the EU Clinical Trials

Directive by member states is required, and an arduous process of "approximation" is now in progress. Of the Mercosur members, only Uruguay legally enforces Mercosur laws as its own.

National.

Nations in the developed world, and many in the developing world, have laws that govern the conduct of clinical research within their borders, and sometimes outside their borders. These laws are generally variations on a theme, although the variations can be quite significant, and rules that some countries consider important may be absent in other countries. In practice, levels of reporting, auditing and enforcement vary widely, with none at all apparent in some countries.

State and Province.

States and provinces may have their own laws that specifically or incidentally govern clinical research. This generality applies to every state in the United States, but with different specifics. The author is unaware of any county, city or parish laws specific to clinical research, although they may exist, perhaps in countries without states or provinces.

Ethics Committees

. Ethics committees may have rules that do not have legal force but, for practical purposes, are strictly required. Ethics committees may review CTAs as part of their normal review process; anything that potentially impinges on subject welfare (or anything else they consider within their jurisdiction) may receive their attention.
Institutional.
Institutional laws place requirements on specific types of entities such as federal, state, non-profit, or those that receive funding from those sources. Non-negotiable rules of the entity that are not legal requirements are not addressed in this paper. Such rules may originate from the entity's idiosyncratic interpretation of the laws, which have been known to be ambiguous.
 

Societal

. The customs of a society may prohibit contract terms that are otherwise legal. Concepts of personal privacy, for example, may be problematic in societies where the individual is subordinate to the extended family.

A study may be subject to conflicting laws, even if the sponsor and investigator are in the same legal jurisdictions. These conflicts are normally resolved by priority of law, e.g., national laws override state laws, but it may not always be straightforward to untangle (or remember) overlapping conditional requirements, authorizations and prohibitions. For example, if HIPAA requires a disclosure and a state law prohibits it, which prevails? Some laws may apply to one party to an agreement, but not to the other party, e.g., if they are in different jurisdictions or are different types of entities. The parties to the agreement may be unaware of the conflicts of law, unaware of a law at all, or may interpret differently the laws or to whom they apply.

When the sponsor and investigator have knowledge of the entire legal environment, time need not be wasted attempting to negotiate terms that are clearly illegal. Negotiation of the law's interpretation and implementation will provide adequate stimulation for the parties. Of course, there may be circumstances when the conflict between laws, regulations, and legally or self-imposed institutional restrictions make an agreement impossible,

Read Full Article HERE

Published in SRA International 2004 Symposium Proceedings

 

Clinical Trial Injuries

Will Your Client Lose His/Her Medical Practice?

Part Two of a Two-Part Article

By Norman M. Goldfarb

C

linical trial agreements can almost always be negotiated. Most part-time investigators, however, do not have the necessary

legal expertise or time to interpret the agreement and conduct an effective negotiation. Proper legal representation

at present requires an attorney who is expert in this very specialized field. Because sponsor negotiators

often have huge backlogs of contracts in process, and over half of part-time investigators do not negotiate (or even read)

the clinical trial agreement, an investigator who opens a negotiation may never emerge from the queue.

A NEW SYSTEM

A new system to help negotiators is now in the works. Over 200 sites, sponsors, contract research organizations (CROs),

and site management organizations (SMOs) have joined together in MAGI, the Model Agreement Group Initiative. MAGI is

developing a very flexible "multiple-choice" model clinical trial agreement to streamline negotiations in the U.S. and internationally.

MAGI's growing membership includes representatives from over two-thirds of

U.S. News & World Report's Top-

50 Research Medical Schools and Honor Roll hospitals, many of the largest SMOs, the four largest CROs (eight of the top

nine), two of the top four biotechs, and a number of smaller and mid-sized pharmaceutical companies.

One of MAGI's objectives is to educate both parties in the negotiation. Its model clinical trial agreement will therefore

be accompanied by commentary, explaining the implications of the contract text. Attorneys who may not specialize in

these types of contracts will be able to gain valuable insights, and even negotiators without legal expertise will become

much more effective.

MAGI members help draft one of 90 sections of the model agreement

Membership is free and there is no obligation to

use the resulting model agreement. MAGI co-manages a biannual educational conference, offers professional Clinical

Research Contract Professional (CRCP) certification, and publishes a semi-weekly e-newsletter. More information is available

at www.firstclinical.com/magi.

GOOD NEWS FOR CLINICAL INVESTIGATORS

It's best to be prepared for the worst, but the news is not all bad for clinical investigators. To start with, only a small

percentage of the over 2.3 million subjects who take part in studies each year in the U.S. are injured during clinical trials.

Only a small percentage of those injured have a legitimate cause of action against the investigator or sponsor. Most

legitimate causes of action (and many that are not legitimate) are resolved quickly and economically. It's a cost of doing

business for sponsors, and they generally prefer to avoid publicity.

The number of cases that reach trial will probably increase over time, but today, very few do. Of these, defendants

have a good batting average in winning. The best litigation is, of course, litigation that never occurs. Research hospitals

have the expertise and financial resources to protect themselves. In addition to taking part in the MAGI project or something

similar, independent physicians can take several steps to protect themselves from the risk of liability claims by

injured study subjects:

• Do not conduct a trial that is likely to be associated with serious-subject medical problems. In other words, stay away

from acute diseases and fragile populations.

• Ensure that investigators and study coordinators understand and comply with the protocol and Good Clinical Practice.

Understand your medical malpractice insurance — obtain clarification from your carrier if the policy is ambiguous —

and secure adequate coverage. A claim by a sponsor against a small site for financial damages is unlikely, but consider

obtaining an error-and-omissions liability policy to protect against this type of risk. Architects, for example, buy

errors-and-omissions insurance to protect them if a building they design collapses.
 
 
Read Full Article HERE
 
 
 

Clinical Trial Injuries

 

 

Will Your Client Lose His/Her Medical Practice?

Part One of Two-Part Article.

By Norman M. Goldfarb

T

he plaintiff's bar has discovered an opportunity in clinical research. The deep pockets of pharmaceutical companies provide

one attraction, but attorneys are seldom shy about suing anyone who might even remotely be found liable for an

injury. Successful litigation is rare, but the judgments can be expensive. Because of this, many physicians who conduct

clinical research are reviewing their medical malpractice insurance policies. Many others, however, have no concept of the looming

risks and of whether they are protected by their medical malpractice insurance policies when taking part in clinical trials.

WHAT DOES YOUR INSURANCE COVER?

The courts (for example,

Heinrich v. Sweet, 62F. Supp.2d 282, 313 (D.Mass. 1999)) generally regard clinical research

injuries as regular medical injuries, but medical malpractice policies are often ambiguous on the topic of clinical research.

They may refer to coverage for "medical care," which, strictly speaking, clinical research generally is not. People in clinical

trials are not "patients"; they are "subjects," "volunteers" or "participants." Sometimes, unapproved drugs and devices

or clinical research are specifically excluded from coverage. The investigator may be able to purchase a clinical research

rider on the policy, but often not.

Pharmaceutical companies that sponsor clinical trials generally do not call attention to this issue, except by sometimes

requiring medical malpractice insurance in the clinical trial agreement. (Required coverage limits are usually $1 million

per incident and $3 million in aggregate.) Sometimes, they will ask for a certificate of insurance, or the right

to obtain one on request. (Occasionally, they require general property and liability insurance and not medical malpractice

insurance, which probably reflects a contract that has been adapted from a different area of business.) Because many

investigators never read the clinical trial agreement, they will miss these "fine points."

Health insurance companies generally cover the cost of treating subject injuries, but they, too, are becoming more

aware of their exposure to clinical research risks. There is an ongoing debate in the clinical research industry about who

should pay for this treatment. On the one hand, there is evidence that clinical research does not increase, and might even

decrease, direct costs to insurance carriers. In addition, new treatments proven in clinical trials keep people healthier,

reducing insurance carrier costs or at least performing a valuable public service. On the other hand, it is not entirely clear

why insurance companies and their customers should subsidize clinical trials for highly-profitable pharmaceutical companies.

Also, subjects who make health insurance claims may hit their policy limits; their premiums may increase; and,

if they subsequently lose their jobs, new coverage may be expensive and difficult to find.

Unfortunately, injured subjects sometimes want more than free repairs. A few carriers offer special clinical research

malpractice insurance, but it is prohibitively expensive for part-time investigators. One bright spot is that hospitals and

clinics that perform a lot of clinical research usually have professional risk managers and adequate insurance coverage,

subject to the discussion below. (Note, however, that it generally covers only activities on their premises.)

 

WHAT MAY BE MISSING IN THE CONTRACT

Clinical trial agreements generally indemnify clinical investigators for problems with the study drug, but never for the investigator's

negligence. Most indemnification clauses contain loopholes. For example: 1) Injuries caused by study procedures

often are not covered; 2) Injuries prior to randomization — in other words, during the screening process — may not be covered;

3) Even 1% contributory negligence by the investigator may void the indemnification, as may an unrelated deviation

from the protocol on

another
subject; and 4) Prior written authorization may be required to charge the sponsor for treatment.

 

Read Full Article HERE

 

Tuesday, January 25, 2011

Padma Vibhushan for Montek Ahluwalia, Azim Premji

 The government  conferred the Padma Vibhushan on Planning Commission deputy chairman Montek Singh Ahluwalia and Wipro chairman Azim Premji for their contribution to public affairs and trade and industry, respectively. Padma Bhushan is the second highest civilian award.

Other Padma Vibhushan awardees include Former National Security Adviser Brajesh Mishra, technocrat Vijay Kelkar, the late Gandhian economist LC Jain, scientists PK Iyengar & PR Rao, educationist AR Kidwai, culture czarina Kapila Vatsyayan, first woman photo journalist Homai Vyarawalla, litterateurs ONV Kurup & Sitakant Mahapatra and film director A Nageshwara Rao.

The corporate world reaped a rich harvest in the Padma Bhushan category. Featuring in the list of awardees of the country's third highest civilian honour this year are
ITC chairman YC Deveshwar, ICICI MD and CEO Chanda Kochar, Ranbaxy's Analjit Singh, Infosys CEO S (Kris) Gopalakrishnan and Dr Reddy Laboratories' founder-chairman K Anji Reddy. Pioneer of the GVK group, GVK Reddy, NIIT founder Rajendra Singh Pawar and HCL's Ajai Chowdhary.

Aditya Birla Group director Rajashree Birla was conferred the Padma Bhushan. Wife of the late Aditya Birla, she has been looking after ABG's social commitments. Grasim has taken up the education of villagers around Ngada. Indian Rayon has involved itself in medical projects and Tanfac is rehabilitating TB and leprosy patients. Birla has been overseeing each of these social projects.

There was no Bharat Ratna, the country's highest civilian award, for the third year running. The last person to get it was Bhimsen Joshi in 2008. The music maestro passed away on Monday. The Padma awards are conferred by the Government of India to eminent personalities each year on the eve of the Republic Day. The Padma list has 128 names this year - 13 Padma Vibhushans, 31 Padma Bhushans and 84 Padma Shri awards. There are 31 women in the list.

The Padma Bhushans were dominated also by 12 personalities from art and cinema, including ailing Bollywood actor Shashi Kapoor and Waheeda Rahman, music director Khayyam, theatre personality Satyadev Dubey and eminent painters Krishen Khanna and Arpita Singh. No mediaperson figures in the 2010 Padma list.

Among the current crop of stars, actresses Kajol and Tabu and actor Irfan Khan, remembered for his role in Maqbool, walked away with the Padma Shri. Pop singer Usha Uthup also won the Padma Shri in the music category.

Even as talk of master blaster Sachin Tendulkar getting the Bharat Ratna proved to be speculation, the sports category had its own share of Padma honours. Cricketer VVS Laxman was awarded the Padma Bhushan for his successful performance as a batsman, as were wrestler Sushil Kumar, weightlifter N Kunjarani Devi, ace shooter Gagan Narang and discus thrower Krishna Poonia.

In the civil services category, former foreign secretary Shyam Saran, who was part of the nuclear deal negotiations with the US, former cabinet secretary Surendra Singh and MN Buch, known for his work on urban planning, were honoured with the Padma Bhushan.

Among scientists who have made it to the list are Professor M Annamalai, Mahesh Haribhai Mehta, CNR Raghavendran, Suman Sahai and EA Siddiq. All of them were honoured with the Padma Shri. In medicine, the late K Raghavan Thirumulpad was conferred the Padma Bhushan for his contribution to ayurveda and the late Keki Byramjee Grant for his work in cardiology.

Among the educationists, Krishna Kumar and former Delhi University vice-chancellor Upendra Baxi were honoured with the Padma Shri.

Unemployment level dips in South Asia: ILO

South Asian countries, led by India registered a rapid economic growth in 2010 and their unemployment rates dipped marginally from the previous year, says the latest annual Global Employment Trends (GET) report of the International Labour Organisation (ILO).

Globally, however, it was a bad year for jobs for the third successive year.

The annual employment trends survey points to a highly differentiated recovery in labour markets, with persistently high levels of unemployment in developed countries and employment growth coupled with continuing high levels of vulnerable employment and working poverty in developing regions.

These trends set a stark contrast, with the recovery seen in several key macroeconomic indicators: Global GDP, private consumption, investment, and global trade and equity markets all recovered in 2010, surpassing pre-crisis levels, ILO said in its statement on the report.

The report has called for expansion of wage employment and social safety nets and cited India's National Rural Employment Guarantee Scheme as a model for reducing the region's large work deficits, besides asking for less dependence on exports and reorientation of growth toward domestic consumption.

Increasing social protection is crucial for enhancing economic security and encouraging consumption, it said in its policy recommendations.

"Economic growth in the region as a whole declined from 9.1 per cent in 2007 to 5.9 per cent in 2008 and to 5.5 per cent in 2009. It is estimated that the region's economy grew by 8.9 per cent in 2010, led by India, which registered rapid growth of 9.7 per cent in 2010. The Maldives Nepal and Pakistan are lagging,'' it said.

The region's unemployment rate has been fairly stable in recent years, including the economic crisis, ranging from 4.3 per cent to 4.5 per cent between 2007 and 2010.

Globally, unemployment remained at record high for the third straight year since the start of the crisis, ILO said, waring that weak recovery in jobs was likely to continue in 2011, especially in developed economies.

Jobs are back! IT, auto, others to hire thousands

Jobs are back with a bang in India, proving it to be the most optimistic nation in terms of hiring plans.

The 'cautious optimism' that pervaded throughout the last year has evaporated and companies are now looking to hire aggressively.

The IT sector, whose growth had dived to single digits in 2008, has entered another growth phase, with multinational corporations looking to India to expand their footprints, Kris Gopalakrishnan, managing director and CEO, Infosys Technologies, said on Saturday.

With the IT sector back on its feet, companies have started hiring and expanding again. The top five companies are estimated to hire 160,000 to 180,000 new employees in the next one year, Gopalakrishnan said.

This phenomenon offers tier-two and tier-three Indian cities opportunities to expand, he said.

"There are two options for any city - grow or die. If a city does not grow, over time people and businesses start moving out, and ultimately the city dies," he said.
 
 

TCS to hire 37,000 engineers

The country's largest information technology services provider, Tata Consultancy Services has said it will hire 37,000 engineers from campuses for 2011-12, 13,000 more than this financial year.

For 2010-11, TCS had made 24,000 campus offers.

The company has already crossed its hiring target of 50,000 employees for 2010-11 and will be adding 12,000-15,000 employees in the fourth quarter of this financial year.

"For the next financial year, we have decided to hire 37,000 from campuses. Of this, we have already given offers to 23,696 students. These trainees will join TCS towards the end of the first quarter of 2011-12," said Ajoy Mukherjee, vice-president, head, global human resources, TCS. The company visited 171 educational institutions.

If the company manages to add 15,000 people by the end of this quarter, it will have a headcount of more than 200,000. At the end of the third quarter, TCS had a headcount of 186,914.

Mukherjee also said the company was reviving its promotion policy for senior management. "Last quarter, we had announced that for junior employees, promotions will happen on a quarterly basis. And we can see the impact of this decision, as the attrition rate in this segment has come down. Staring from this January, we will start the senior promotions twice a year," said Mukherjee.

He also said the company was working on salary rise details and would announce it in April. "It is difficult to share the average hike that we will announce. We are still working on the details. But they will kick in from April onwards." Last year, TCS had given an average salary hike of 10 per cent.

 

Cognizant to hire 25,000 people in 2011

Nasdaq-listed information technology company Cognizant Technology Solutions plans to recruit another 25,000 people in 2011.

CTS, which follows the calendar year as the accounting period, recruited 25,000 people in 2010 too, as it expanded its verticals and focused on new geographies.

"While it is tough to make exact estimates at present, we are looking at recruiting numbers comparable to, if not more than last year's," said R Chandrasekaran, president and managing director of CTS.

He was speaking to reporters after inaugurating the company's second campus in Kolkata. After completion, the facility will be able to house 16,000 IT professionals.

At present, CTS has 8,000 employees in Kolkata. The new campus is one of the company's two major campuses. The other one is in Chennai and it can house 15,000 people. CTS has about 100,000 employees across the country.

The Chennai-headquartered company, which spent $180 million on infrastructure development, both in terms of campus development and leasing space for footprint expansion, is also looking at new regions to expand its reach. It also wants to reduce reliance on the North American market, due to growing protectionism and increasing levels of saturation.

 

FCI to hire 9,000 in next 3 years

The Food Corporation of India, the government's nodal agency for procurement and distribution of foodgrains, today said it will hire 9,000 professionals in the next three years.

"We will fill-up approximately 9,000 posts in various categories in next three years," FCI Chairman and Managing Director Siraj Hussain said during the launch of the revamped website of the organisation.

While the scale of foodgrains dealt by FCI has increased substantially over last three decades, its manpower has been drastically reduced in the wake of staff retirement to almost half, he said.

Currently, there are over 33,000 staff working with FCI across the country. About 20,000 employees will be retired in next two years, he added.

 

Airlines to add 5,000 professionals

Airlines in India are likely to hire 5,000 professionals across various operations this year, including cabin crew, ground staff and pilots, following the evident boom in the aviation sector.

"Airlines had pulled out at least 20% capacity from the market during the downturn. That capacity was restored last year and we see airlines adding another 20% capacity this year and would be hiring 4,500-5,000 people this year," said Kapil Kaul, CEO of aviation consultancy firm Centre for Asia Pacific Aviation, South Asia, said while speaking to a business daily.

In one of its largest hiring programmes since the Indian Airlines-Air India merger, the airline is increasing cabin crew by 700 to tide over the current shortage. New hires will be a mix of trainees and experienced staff.

"The need to hire emerged after we saw a shortage of crew. We will also need a lot of people for our expansion plans, with Delhi airport becoming our hub," said an Air India official, who did not wish to be identified. Air India has 3,200 cabin crew and a negligible attrition rate.

At the same time, Air India Express, the low-cost wing of the airline, is planning to induct four more aircraft and will require 74 new cabin crew members. This addition will help increase the number of flights from 168 to over 200.

Experts say that Air India and low-cost airlines IndiGo and SpiceJet will add more than 1,000 this year.

 

Car makers to employ over 3,000

Passenger vehicle sales likely to rise to 5 million units by 2015 and over 9 million units by 2020, from the current figure of 1.95 million due to the strong domestic demand and export of small cars.

Carmakers in Indian now are eyeing more research and development personnel from India and overseas as they plan to ramp up their capacities to grab a bigger share of India's rapidly growing car market.

General Motors India, Maruti Suzuki India, Hyundai and Mahindra and Mahindra will also new talent from the United States and Europe.

Maruti is likely to hire 1,500 people from India by March. M&M, the country's largest utility vehicle maker, too plans to recruit fresh talent.

 

Accor to create 3000 jobs in India next year

Global hospitality firm Accor has said that it will hire 3,000 people by next year in India to fill vacancies being created at its upcoming hotels in the country.

Accor currently operates eight hotels under brands, Novotel, Ibis and Mercure, and two convention centres that employ about 2,000 people.

"By the end of 2011, we will employ total 5,000 people at Accor operated properties across India," Accor Hotels India, regional director of human resources ashwin A Shirali told media.

About 30 per cent of the job opportunities being created will be for entry level jobs, he said. The company will operate ten new properties that are likely to come up in 2011.

In August this year, Accor had said that it plans to open 90 hotels by 2015, out of which contracts for 60 hotels have already been signed. Around 21 hotels are likely to be operational by the end of 2012.

At present Accor, in partnership with InterGlobe Enterprises, runs hotels under the Ibis brand and has partnership with other companies for Novotel and Mercure brand.

 

Nokia Siemens Networks to hire 800 more

Nokia Siemens Networks, a provider of mobile infrastructure and managed services, will establish a new facility at Navalur in Chennai in addition to the existing facility at Taramani as part of its global network solutions centre.

The new facility, spread across 90,000 square feet, is nearly three times in size from its existing facility.

"We will be scaling up to 1,800 employees in Chennai by 2011, from current 1,000," said Armando Almeida, head of global services at NSN. NSN has a another 1,500 based in Noida.

The Chennai centre provides remote delivery support services including network implementation and managed services. It is one of the three operating GNSCs globally. The other two are at Noida, India and Lisbon in Portugal. Two new centres at Moscow and Sao Paulo are being set up to be in the same time zones as potential markets and also to address language requirements.

"The growth in business is partly in anticipation of 3G services in India and partly due to operators preferring us for network management," said Almeida.

 

Coca-Cola to hire 600

The India arm of global beverage maker Coca-Cola plans to hire around 600 workforce this year, which accounts for around nine per cent of the existing employees, a top company executive has said.

"We are looking at recruiting around 600 employees in our India operations this calendar year," Hindustan Coca Cola Beverages vice president (HR) P V Ramana Murthy said.

The recruitment would be made across all levels, including management trainees, he said.

The company's current head-count stands at 6,500, which will be increased to around 7,100 this year, Mr. Murthy said.

Hindustan Coca Cola has plans to gradually reduce the hiring of lateral talent in its bid to groom trainees into mid management cadre, he said.

"We are planning to slowly, in about five years, reduce hiring of experienced people and increase the recruitment of management trainees. These trainees will be groomed to take over these mid to high level posts in future," Mr. Murthy said.

He said for retaining these groomed executives, the company is planning to incentivise them or offer them compensation, which will be more in the form of emotional and cultural aspect.

"We will concentrate on creating a work environment, which will be more comfortable and have facilities to suit these young executives. If the need arises we will also look into offering them customised incentives," Murthy added.

Hindustan Coca-Cola Beverages is wholly-owned subsidiary of Atlanta-based Coca-Cola, responsible for manufacturing, sale and distribution of beverages across the country.

 

Bright prospects for working moms

With accelerating economy and brightening of employment prospects, 56 per cent of Indian companies are looking to recruit working mothers in 2011.

In fact, research from workplace solutions provider, Regus points out that Indian firms are far more likely to hire returning mothers compared to their global counterparts.

The Regus survey, in which over 10,000 business respondents from across the globe were interviewed during August and September 2010, found that globally 36% of companies expect to hire working mothers in 2011.

This reflects a downward trend in sentiment towards hiring working mums, the same research last found that globally 44% of companies had expressed a desire to hire returning mothers.

India, where 43% of companies plan to add staff overall, counters this trend with fully 56% of firms declaring they plan to hire more working mothers. This figure is down, however, on 64% a year ago.

The survey forms the basis of a Regus report entitled 'Mother's Day? A study of trends in hiring working mothers across the globe', which reveals residual concerns amongst a minority of employers, who still fear that working mothers may show less commitment and flexibility than other employees (37%), leave shortly after training to have another child (33%) or have out-dated skills (24%).

In India employers were particularly concerned about working mums' skills being out-of-date (45%) and about them taking time off to have another child (51%).

On the positive side, a majority of businesses now value returning mothers, with 72% declaring they believe companies that ignore part-time returning mothers are missing out on a significant and valuable part of the employment pool.

In addition, fully 56% regard working mums as offering skills that are difficult to find in the current market; and 57% declare that they value returning mothers because they offer experience and skills without demanding top salaries.

In India, the percentage of those who valued working mothers because of this was higher than the global average (64%), perhaps indicating that there is still a lot of work to be done to reach salary equality between working mothers and their colleagues.

 

 

Oprah Sister: Patricia, Oprah's Secret Half Sister, Revealed

Oprah's huge family secret was revealed on Monday: she has a half-sister named Patricia.

Vernita Lee, Oprah's mother, gave Patricia up for adoption in 1963, but kept her a secret from her daughter. Oprah was nine years old and living with her father when her mother had the baby. She said she never even knew Vernita was pregnant.

Oprah and Patricia were publicly reunited on Monday's show. Oprah showed video of her and her partner, Steadman Graham, driving to Milwaukee to meet Patricia for the first time on Thanksgiving Day last year.

Patricia said she started thinking that Oprah might be her sister when she saw an interview with Vernita Lee on television. The information Lee gave coincided with what she knew about her birth family.

She tried to track down her birth mother, but was told by the adoption that the mother did not want to get in touch with her. But Patricia did manage to track down Oprah's niece, and DNA tests confirmed that they were related. This led to Oprah confronting her mother, who confirmed that Patricia was indeed her half sister. Vernita Lee also appeared on Monday's show.

The 83rd Annual Oscar Nominations

Below is the list of the 83nd Annual Oscar Nominations

Best Picture
"Black Swan"
"The Fighter"
"Inception"
"The Kids Are All Right "
"The King's Speech"
"127 Hours"
"The Social Network"
"Toy Story 3″
"True Grit"
"Winter's Bone"

Best Direction
Darren Aronofsky for "Black Swan"
Joel Coen and Ethan Coen for "True Grit"
David Fincher for "The Social Network"
Tom Hooper for "The King's Speech"
David O. Russell for "The Fighter"

Actor in a Leading Role
Javier Bardem in "Biutiful"
Jeff Bridges in "True Grit"
Jesse Eisenberg in "The Social Network"
James Franco in "127 Hours"
Colin Firth in "The King's Speech"

Actress in a Leading Role
Annette Bening in "The Kids Are All Right"
Nicole Kidman in "Rabbit Hole"
Jennifer Lawrence in "Winter's Bone"
Natalie Portman in "Black Swan"
Michelle Williams in "Blue Valentine"

Actor in a Supporting Role
Christian Bale in "The Fighter"
John Hawkes in "Winter's Bone"
Jeremy Renner in "The Town"
Mark Ruffalo in "The Kids Are All Right"
Geoffrey Rush in "The King's Speech"

Actress in a Supporting Role
Amy Adams in "The Fighter"
Helena Bonham Carter in "The King's Speech"
Melissa Leo in "The Fighter"
Hailee Steinfeld in "True Grit"
Jacki Weaver in "Animal Kingdom"

Adapted Screenplay
Danny Boyle and Simon Beaufoy for "127 Hours"
Aaron Sorkin for "The Social Network"
Michael Arndt, story by John Lasseter, Andrew Stanton and Lee Unkrich for "Toy Story 3″
Joel Coen and Ethan Coen for "True Grit"
Debra Granik & Anne Rosellini for "Winter's Bone"

Original Screenplay
Mike Leigh for "Another Year"
Screenplay by Scott Silver and Paul Tamasy and Eric Johnson. Story by Keith Dorrington and Paul Tamasy and Eric Johnson for "The Fighter"
Christopher Nolan for "Inception"
Lisa Cholodenko and Stuart Blumberg for "The Kids Are All Right"
David Seidler for "The King's Speech"

Animated Feature
"How to Train Your Dragon"
"The Illusionist"
"Toy Story 3″

Art Direction
"Alice in Wonderland": Robert Stromberg (Production Design), Karen O'Hara (Set Decoration)
"Harry Potter and the Deathly Hallows Part 1″: Stuart Craig (Production Design), Stephenie McMillan (Set Decoration)
"Inception": Guy Hendrix Dyas (Production Design), Larry Dias and Doug Mowat (Set Decoration)
"The King's Speech": Eve Stewart (Production Design), Judy Farr (Set Decoration)
"True Grit": Jess Gonchor (Production Design), Nancy Haigh (Set Decoration)

Cinematography
"Black Swan": Matthew Libatique
"Inception": Wally Pfister
"The King's Speech": Danny Cohen
"The Social Network": Jeff Cronenweth
"True Grit": Roger Deakins

Costume Design
"Alice in Wonderland": Colleen Atwood
"I Am Love": Antonella Cannarozzi
"The King's Speech": Jenny Beavan
"The Tempest": Sandy Powell
"True Grit": Mary Zophres

Documentary (Feature)
"Exit through the Gift Shop"
"Gasland"
"Inside Job"
"Restrepo"
"Waste Land"

Documentary (Short Subject)
"Killing in the Name"
"Poster Girl"
"Strangers No More"
"Sun Come Up"
"The Warriors of Qiugang"

Film Editing
"Black Swan": Andrew Weisblum
"The Fighter": Pamela Martin
"The King's Speech": Tariq Anwar
"127 Hours": Jon Harris
"The Social Network": Angus Wall and Kirk Baxter

Foreign Language Film
"Biutiful": Mexico
"Dogtooth": Greece
"In a Better World": Denmark
"Incendies": Canada
"Outside the Law (Hors-la-loi)": Algeria

Makeup
"Barney's Version": Adrien Morot
"The Way Back": Edouard F. Henriques, Gregory Funk and Yolanda Toussieng
"The Wolfman": Rick Baker and Dave Elsey

Music (Original Score)
"How to Train Your Dragon": John Powell
"Inception": Hans Zimmer
"The King's Speech": Alexandre Desplat
"127 Hours": A.R. Rahman
"The Social Network": Trent Reznor and Atticus Ross

Music (Original Song)
"Coming Home" from "Country Strong" Music and Lyric by Tom Douglas, Troy Verges and Hillary Lindsey
"I See the Light" from "Tangled" Music by Alan Menken Lyric by Glenn Slater
"If I Rise" from "127 Hours" Music by A.R. Rahman Lyric by Dido and Rollo Armstrong
"We Belong Together" from "Toy Story 3″ Music and Lyric by Randy Newman

Short Film (Animated)
"Day & Night": Teddy Newton
"The Gruffalo": Jakob Schuh and Max Lang
"Let's Pollute": Geefwee Boedoe
"The Lost Thing": Shaun Tan and Andrew Ruhemann
"Madagascar, carnet de voyage (Madagascar, a Journey Diary)": Bastien Dubois

Short Film (Live Action)
"The Confession": Tanel Toom
"The Crush": Michael Creagh
"God of Love": Luke Matheny
"Na Wewe": Ivan Goldschmidt
"Wish 143″: Ian Barnes and Samantha Waite

Sound Editing
"Inception": Richard King
"Toy Story 3″: Tom Myers and Michael Silvers
"Tron: Legacy": Gwendolyn Yates Whittle and Addison Teague
"True Grit": Skip Lievsay and Craig Berkey
"Unstoppable": Mark P. Stoeckinger

Sound Mixing
"Inception": Lora Hirschberg, Gary A. Rizzo and Ed Novick
"The King's Speech": Paul Hamblin, Martin Jensen and John Midgley
"Salt": Jeffrey J. Haboush, Greg P. Russell, Scott Millan and William Sarokin
"The Social Network": Ren Klyce, David Parker, Michael Semanick and Mark Weingarten
"True Grit": Skip Lievsay, Craig Berkey, Greg Orloff and Peter F. Kurland

Visual Effects
"Alice in Wonderland": Ken Ralston, David Schaub, Carey Villegas and Sean Phillips
"Harry Potter and the Deathly Hallows Part 1″: Tim Burke, John Richardson, Christian Manz and Nicolas Aithadi
"Hereafter": Michael Owens, Bryan Grill, Stephan Trojanski and Joe Farrell
"Inception": Paul Franklin, Chris Corbould, Andrew Lockley and Peter Bebb
"Iron Man 2″: Janek Sirrs, Ben Snow, Ged Wright and Daniel Sudick

Top 50 Search Engines


  1. Google - Google UK - Google Image Search
    Google is a search engine that makes heavy use of link popularity as a primary way to rank web sites. Users across the web have in essence voted for good sites by linking to them.
  2. Ask Jeeves - Jeeves For Kids - Ask Jeeves UK
    Innovative online search service that processes plain-language queries with surprising accuracy.
  3. Lycos - Lycos UK
    Lycos has been around since the early days of the net and is still one of the most popular search engines. The service employs human editors for some of its listings, complemented by crawler-based results. The name Lycos comes from the Latin for "wolf spider."
  4.  Alta Vista - Alta Vista UK -
    An awesome site from Digital, it maintains a HUGE index with powerful and FAST search functions. Coverage is excellent so it is good for broad searching and for offbeat subjects but you can be overwhelmed by too many hits.
  5. LookSmart - Looksmart UK
    LookSmart is the closest rival Yahoo has, in terms of being a human-compiled directory of the web. The high quality of the directory is thanks to a team of nearly 200 full-time professional editors.
  6. Yahoo! - Yahoo UK
    Yahoo is the web's most popular search service and has a well-deserved reputation for helping people find information easily. The secret to Yahoo's success is human beings. It is the largest human-compiled guide to the web, employing 80 or more editors in an effort to categorize the web. Yahoo has at least 1 million sites listed.
  7. MSN (Microsoft)
    Microsoft's MSN service features both directory listings and search engine results. Powered by Inktomi, this is now one of the most powerful search engines.
  8. BBC - Search The Web
    The BBC's "family friendly" search engine, based on Google search technology. Results are clear, uncluttered, relevant, and commercial free. "Our results are the ones that best match your search words - not the ones advertisers want you to see." Excellent!
  9. GigaBlast
    Gigablast is a new search-engine that looks set to challenge Google. It's been set up by a New Mexican Software Engineer, and already producing great search results.
  10. GO Network
    Go is the reincarnation of Infoseek, a newly designed site claiming to have enhanced capabilities, with a 50% larger search index and search results pages that are 30% faster. It offers portal features such as personalization and free e-mail.
  11. HotBot
    This search engine has a great many loyal fans. It very often comes up with the goods where other engines fail.
  12. Open Directory
    NetScape's Open Directory Project aims to build the most comprehensive human-reviewed directory of the web, by relying on a vast army of volunteer editors.
  13. Teoma Search
    Teoma, which means "expert" in Gaelic, determines the authority or quality of a site's content, by using Subject-Specific Popularity. Subject-Specific Popularity ranks a site based on the number of same-subject pages that reference it, not just general popularity.
  14. FAST Search
    One of the new generation of search services, armed with next-generation technology. FAST aims to be bigger, speedier and more accurate than the existing major search engines.
  15. Multi Search
    Multi Search is a powerful tool which will search all the top search engines with one click.
  16. Webcrawler
    One of the first and biggest search engines, and it still produces highly relevant results.
  17. REX
    This is a VERY nice site - a little sense of humour, very professionally done.
  18. HandiLinks
    This is a great directory. HandiLinks listings are all organized into a hierarchical index and it's fast and easy-to-use. It has extensive categorization, and uses a frame design that aids rather than getting in the way of searches.
  19. Snap.com
    Snap.com is a human-compiled directory of web sites, supplemented by search results. It aims to challenge Yahoo as the champion of categorizing the web.
  20. Scour.Net
    A useful multimedia search engine. Use it to find audio, video, images and animation Scour.Net takes you directly to the multimedia you are searching for, quickly and easily.
  21. AAA Matilda
    The most popular search engine outside of North America. Matilda is a very individual search engine from Australia, and growing rapidly in popularity.
  22. UK Plus
    UK Plus features reviews of UK-relevant sites, prepared by a team of journalists. Reviews are grouped into various channels, covering everything from Arts and Business to Travel and Work. They are also searchable.
  23. Direct Hit
    This Popularity Engine tracks the sites that people actually select from the search results list. By analyzing the activity of millions of previous Internet searchers, Direct Hit determines the most popular and relevant sites for your search request.
  24. Dogpile
    Sends a search to a customizable list of search engines, directories and specialty search sites.
  25. Britannica Internet Guide
    This site strives to list only the highest quality sites on the Net. It's now integrated into the Britannicca.com website, so you get a high-quality search engine and encyclopaedia at the same time.
  26. Go2Net
    This is a metacrawler, in other words it searches several other search engines in order to obtain its results. Rapidly gaining in popularity as a web portal.
  27. Alba36.com
    A human reviewed searchable directory to over 2700 specialty and regional search engines, vortals, portals, topical guides, specialized directories and the best web sites.
  28. WhosBest.com
    A search engine that gives ratings for each site.
  29. ANZWERS
    ANZWERS (Australian and New Zealand Web Enquiry and Research System) offers visitors the ability to quickly conduct region and domain specific searches.
  30. Mamma
    Sends search requests to seven major search engines.
  31. NewsTrawler
    Allows you to send a query to one or more news sites from one location. Hundreds of sites are listed, by country and by category.
  32. EuroSeek
    EuroSeek is distinguished from other such engines by a multi-lingual interface.
  33. Your WebScout
    A popular index of the Net's best Web sites, discussion groups and archives.
  34. Northern Light
    A professional researchers' favourite, because it organises material so well by topic. Based in Canada.
  35. SelectSurf
    An excellent website directory, that doesn't overwhelm with too many sites.
  36. BrightGate MetaSearch
    Searches over 20 search engines using a parallel metasearch.
  37. NewsBot
    HotBot's news-only search service.
  38. UKMax
    UKMax allows users to search only pages within the .uk domain or perform a worldwide search. It also offers some directory listings, regional news content, weather reports, and portal features such as portfolio tracking.
  39. SearchUK
    Lists UK-related domains.
  40. Global Online Directory (GOD)
    UK based search engine.
  41. GoTo
    GoTo is the only major search engine which sells listings. Companies can pay money to be placed higher in the search results, which GoTo feels improves relevancy.
  42. Internet Sleuth
    Allows you to search the standard search engine choices or a huge number of specialty sites, all from the same place.
  43. Search Spaniel
    This dog sniffs out several of major search engines at the same time, or you can choose to do the same with an extensive list of specialty search services, such as for entertainment or employment information.
  44. SavvySearch
    Metacrawler type engine.
  45. BOTBOT.com
    BOTBOT parallel search engine and Web Directory - Get multiple results using advanced parallel search technology. Search the Web, News, MP3, Images, Audio, Video and more. Comes up with some good results.
  46. UK Index
    Lists sites based in the UK or that are UK-relevant.
  47. Metafind
    Similar to Dogpile, except that searches only go to search engines.
  48. HuskySearch
    The author of MetaCrawler continues research into information retrieval with this University of Washington-based metacrawler.
  49. Mirago
    UK directory and search engine.
  50. HealthLinks
    Massive directory listing over 4,600 health related websites in 150 categories.