India announce new formula for compensating death during clinical trials

 India has released formula to determine quantum of compensation in cases of SAEs of deaths occurring during clinical trials

The formula is available at (http://www.cdsco.nic.in/formula2013SAE.pdf)

The Guideline is available at (http://www.cdsco.nic.in/compention.pdf)

As per the new rule the compensation is calculated as

Compensation = B * F * R/99.37

Here, B = Base amount (Rounded) which is fixed as INR 800000. This base amount has been fixed with consideration of minimum wages act.

F = Factor depending on the age of the subject as per the Annexure given, which is based on Workmen Compensation Act.

R = Risk factor depending on the seriousness and severity of the disease, presence of co – morbidity and duration of disease of the subject at the time of enrolment in the clinical trial between a scale of 0.5 to 4.0 as under:
0.50 – Terminally ill patient (Expected survival not more than 6 months)
1.0 – Patient with high risk (Expected survival between 6 to 24 months)
2.0 – Patient with moderate risk (Moderate risk if not defined)
3.0 – Patient with mild risk (Mild risk is not defined)
4.0 – Healthy volunteers or subject of no risk

Here, 99.37 is the factor for age 65 in the table of worksmen compensation act. The concept used is that the base amount INR 8,00,000 should refer to the age of 65 years which corresponds to factor 99.37.

Thus, considering an example:
If the age of the subject is 30 years, the factor F as per the factor given in the table comes to 207.98
If the subject is Healthy, R = 4.0
Thus,
Compensation = 8,00,000 * 207.98 * 4.0 / 99.37 = 6,697,554/-

However, in case of patients whose expected mortality is 90% or more within 30 days, a fixed amount of INR. 200000 should be given.

If calculations are done, the compensation amounts range from Rs. 400,000 to a maximum of Rs. 7,360,000 depending on the following factors:
a) Age
b) Risk factor

The CDSCO has still not released any clarity on the calculation of compensation amount in case of clinical trial related injury (Which does not progress to death)

Content from email by: SenseCR

How to improve R&D productivity: the pharmaceutical industry’s grand challenge

 

 

Scott Stern Kellogg School of Management speaks about “New Drug Development: From Laboratory to Blockbuster to Generic,”

Scott Stern, Associate Professor, Kellogg School of Management, speaks on the topic of, “New Drug Development: From Laboratory to Blockbuster to Generic,” at the Judicial Symposium on The Pharmaceutical Industry: Economics, Regulation, and Legal Issues, hosted by the Northwestern Law Judicial Education Program

Health Council of Canada says some prescription drugs approved for use in Canada may be less safe than consumers think, due to poor Pharmacovigilance/Post Market Surveillance rules

Canada’s Food and Drugs Act relies on drug companies to submit adverse reaction reports, which drug users submit if they suspect they are experiencing negative side effects. Drug users also can submit the reports directly to Health Canada, but it still leaves the government to rely on outside parties to report problems.

In 2009, Health Canada received 27,496 adverse reaction reports — a number that has increased steadily over time. Health Canada needs the power to require pharmaceutical companies to conduct more post-market monitoring and to share the results, Abbott said. The council also would like to see the federal government hold the power to impose penalties for companies that do not comply.

Health Canada is already modernizing its regulations to allow for stronger monitoring after the drug goes to market. The government also has established a Drug Safety and Effectiveness Network to study the safety of drugs in the market.

The Canadian pharmaceutical industry welcomes modernized regulation, said Mark Ferdinand, vice-president of police research and analysis for RX&D, the pharmaceutical industry association in Canada.

However, Ferdinand said consumers should recognize that there is already a formal, rigorous post-market reporting system in place.

“No one has any interest in seeing a drug used inappropriately in the real world. A lot of people have invested a lot of time, effort, certainly money … to ensure what they are producing and what they are providing to patients is safe and effective,” he said.

Ferdinand said drug safety often depends on the way medicine is prescribed. He said it has to be “the right medication, for the right person, at the right time.”

Chinese drug discovery market predicted to grow 23% per annum

China’s health and medical industry is advancing rapdily within genomics, combinatorial chemistry and high-throughput screening, China has been recognised as an important location to which drug discovery is being outsourced.

The Chinese drug discovery market reached US$315.0 million in 2009 and is predicted to expand at a compound annual growth rate of 23% from 2009 to 2016.

China has opportunities for scientific expertise and complete infrastructure, which are important for drug discovery activities. Separate from India, China is also viewed as a profitable market, this will assist pharmaceutical companies improve drug finding at a reasonable cost.

 

Eli Lilly CIO Michael Heim says Lilly will increase use of cloud computing in clinical data management

Eli Lilly’s CIO Michael Heim says that the drug giant’s right to know where in the cloud its data resides, and to know the provider’s disaster recovery plans are chief issues that will drive the use of cloud computing in clinical data within drug discovery and development projects.

An interview with Michael Heim is available at InformationWeek

Clinical approval success highest for smallest firms among the top 50 Pharmaceutial companies

The top 10 pharmaceutical companies out of the world’s top 50 have lower estimated overall clinical approval success rates than do smaller firms in that group, but nonetheless appeared to have some R&D productivity advantages, according to a new study completed by the Tufts Center for the Study of Drug Development.

Despite experiencing lower overall clinical success rates, the top 10 firms terminated a greater proportion of their failures in early stage clinical testing, compared to the other 40 companies in the group, the study found. Failing early lets developers redirect resources into other projects and avoid more costly later stage failures.

While the very largest firms had lower approval success rates, they did make the decision to terminate earlier in the development process, which can help improve productivity of their new product pipelines.

The study was based on 1,734 compounds that entered clinical testing between 1993 and 2004, for the top 50 companies, which had 2006 revenues of more than $1 billion. The timeframe allowed for analysis of the full development cycle. Clinical approval success rate is the share of investigational new compounds entering clinical testing that eventually obtain FDA marketing approval.
The study, reported in the September/October Tufts CSDD Impact Report, released today, also found that:
1.  Small molecules accounted for 85% of the drugs that entered the clinical pipelines of top 50 pharmaceutical firms in the 1993-04 period.
2. Large molecule clinical approval success rates outpaced small molecules by nearly 2:1 for each top-50 pharma size group examined.
3. Across all top company size groups, transitioning compounds from Phase II to Phase III was a substantial hurdle.

the study is available at http://csdd.tufts.edu/

personalized medicine might be making drug development more complicated

According to a new report from the Tufts Center for the Study of Drug Development at Tufts University 12 to 50 percent of the drugs companies are developing, depending on the company, involved a personalized medicine approach.

The Tufts report is based on a survey of 25 companies, large and small, to which 16 companies responded, as well as interviews with representatives of 13 companies.

Relatively few drugs are now accompanied by such so-called companion diagnostic tests. They are most common in oncology. The breast cancer drug Herceptin, for instance, is given only to women whose tumors have an abundance of a protein called Her2.

According to the report Other key therapeutic areas in which personalized medicine is making headway include cardiovascular, central nervous system, and immunologic therapies, whereas personalized medicine development is just getting started for metabolic and respiratory therapies, as well as virology.

 

World Ecconomic Forum India Economic Summit | Collaborative strategy for drug discovery

The Coverage of the World Ecconomic Forum India Economic Summit is available at  http://blog.livemint.com/wefindia/

I was more interested in the Collaborative Strategy for Drug Development read the interview with Suven Lifesciences a prefered partner to Eli Lilly and Co in Drug Discoverya dn Development in India. http://www.livemint.com/2009/11/10204140/India-Economic-Summit–Collab.html

 

India looses USD 1 Billion Investment in Drug R&D to China due to lax Indian patent laws-

Did I really read the news correct or was I just plain drunk on a weekend while reading it. Turns out it is true. Just a week after the Novartis CEO has blasted the Indian IP laws, Novartis has announced plans to invest 1 Billion US Dollar in China for Drug Discovery and Developement. The plan calls for hundreds of new hires and new research facilities in Changshu.

Novartis is  waging a high-stakes court fight over patent protection for the cancer blockbuster Gleevec, No wonder the Novartis CEO Daniel Vasella had enough and announced that the subcontinent’s reputation as a low-cost R&D center is losing its luster.

In his interview he has quoted “There is a significant difference between India and China–in the political system, in the decision making processes, in the complexities of the processes and in the continuity,” Vasella tells the Economic Times. “I think India has potential but things take longer to get done. It may come as a surprise but China has made tremendous progress in IP and is enforcing IP in pharmaceuticals.” And the CEO made it clear that a high court ruling on Gleevec could prove a decisive turning point for India’s R&D industry.

In 2006, Novartis made a commitment to build a $125 million R&D facility in Hyderabad. The next year, after the company lost a patent battle over its blockbuster cancer drug, Gleevec (

I thought China also didnt had a great IP law to speak of. How many times we saw news stories about fake chinesse counterbrands.

But here is the upside , the chineese dont challenge the patents in Courts. China is behind India in pharmaceutical chemistry, so they are not so keen in spending time to another way to manfacture the drug. But China is way ahead of India in Medicinal Chemistry,  pre-clinical and toxicological study infrstructre. SFDA the Chineese equivalent of FDA, is taking a lot bold steps and investment to ensure fast trial registration, proper Pharmacovigilance reporting etc. net net it is faster to run R&D in China

India is yet to have solid infrastructre or plans for clinical trial monitoring or pharmacovigialance . The WHO fund for a national pharmacovigilance monitoring policy and infrastructre has already elasped in 2008. And we are yet to see any increase in number of adverse events reported in India .

India will make similar progress, he opined, when Indian pharmaceutical companies have more IP they want to protect. Then, the companies will force the government to act and increase IP protection.

Pfizer announced it would close six out of its 20 R&D facilities around the globe as part of its post-Wyeth-acquisition consolidation but the company’s Shanghai R&D operation is not affected – an implicit endorsement of China’s R&D.

Ok we Indians will wait till then , and just pray that the Red Dragon is not going to burn the Indian the pharma industry till that time

Shorter Path to drug Discovery share research on failed compounds between companies the new MIT lead approach-

The moment I learned about this new project started by MIT, I could think of only one thing, I want to be part of it.  The Massachusetts Institute of Technology, have, started a pharmaceutical innovation program  to help drug companies adapt some successful approaches now used in aeronautics, like lean management and information-sharing among rivals.

The M.I.T. initiative, called NEW Drug Development ParadIGmS or NEWDIGs has garnered the support of

• Aetna
• Bayer Healthcare
• Brookings Institution
• Centers for Disease Control and Prevention (CDC)
• Eli Lilly and Company
• U.S. Food and Drug Administration (FDA)
• Johnson & Johnson
• Medco Health Solutions Inc.
• Pfizer Inc.
• Quintiles Transnational Corp.
• Vertex Pharmaceuticals Inc.
• WellPoint Inc.

One short-term goal is to identify, and rectify, the root causes of bottlenecks in the existing system. Longer term, the ambition is to create new prediction models, new ways to share information about the biology of diseases, and a new inclusiveness involving earlier participation of regulators, health insurers, health care providers and patients.

So How do they plan to change the way we conduct drug discovery and developement?

1.  share information about compounds they have tried and shelved, for reasons like toxicity or inefficacy.

Results of clinical trials are availale online for free, whether or not they succeed. But no pharma company talks about projects that fail at an earlier stage. A result is that companiesother  waste many millions going down experimental paths that their competitors have already tried and failed.

A visual Path of the changes suggested in the Enterprise Transformation is shows here , the document can be downloaded from the MIT website

India begins serious efforts to ensure patient safety- Rejoice if you are in US Obama is going to penalize hospitals with high one-month readmission rates for transitioned patients

MUMBAI: A mop left inside a patient’s stomach after a surgery, an expired drug administered to an ailing person or a hospital-acquired

infection-medical errors are a nightmare for both doctors and patients. Such incidents, which are usually swept under the carpet, will now be recorded and reported to an independent body in India. This will be done in an attempt to streamline and improve the Indian healthcare system.

Indian Confederation for Healthcare Accreditation (ICHA), a non-profit organisation consisting of various associations, would spell out clear-cut healthcare standards, train employees of hospitals, nursing homes and clinics in spotting medical errors and adverse reactions as well as encourage them to report the same in order to create a database

ICHA is organizing the first Patient Safety Conference in India on November 27-29 at Delhi. India is still trying to increase the number  Adverse Event Reporting related to cliical trials and post makret surveillance. Indian community doctors and helath expert swamped with treating more ethan  hundered patients every day ( yes I mean more than Hundered, average Indian physician attemps to more than 100 patients in Indian community hospital and governments run medical colleges), has no time to report Adverse Event and Drug Safety concerns on time and effectively. This is despite the formation of a National Drug Safety and Pharmacovigilance Programe supported by severl regional centres.

In United States one in five patients discharged from the hospital experiences an adverse event within three weeks. Two-thirds of those outcomes are drug-related, with many of them potentially avoidable, according to a recent report issued by an expert panel of internists, hospitalists and emergency physicians.

The Transitions of Care Consensus Policy Statement published jointly in August in the Journal of Hospital Medicine and the Journal of General Internal Medicine by the American College of Physicians, the Society of Hospital Medicine, the Society of General Internal Medicine, the American Geriatrics Society, the American College of Emergency Physicians and the Society for Academic Emergency Medicine.

The panel said hospitals and outpatient physicians should be held accountable for properly transitioning patients, coordinating care, involving family in decision-making and communicating key information in a timely fashion. The group also called for national standards and performance metrics.

It proposed that the following elements about patients should always be communicated as quickly as possible:

• Principal diagnosis and problem list.
• Medication list, including over-the-counter items.
• Medical home or transferring physician or institution and contact information.
• Patient’s cognitive status.
• Test results and pending test results.

The recommendations come on the heels of increased scrutiny of how well doctors and hospitals prevent readmissions. President Obama has proposed bundling payments for hospitalization and care delivered within 30 days after discharge, penalizing hospitals with high one-month readmission rates. The administration says the move would save $8.4 billion and give hospitals more financial incentive to reduce the 20% 30-day readmission rate among Medicare patients.

Succeeding at open-source innovation: An interview with Mozilla’s Mitchell Baker and the USD $34 million Indian Government plan for Opensource Drug Development

Benjamin Franklin said “As we enjoy great advantages from the inventions of others we should be glad of an opportunity to serve others by any invention of ours; and this we should do freely and generously.” – Any one listening !

Leaders and veterans in Biotechnology and Health care research industry may not be welcoming open source ideals. But IT industry has set new benchmarks and proved that open source brings in much needed new ideas and innovation. So hear out loud from none other than chairman and former CEO of Mozilla. The article is published for free at the Mckinsey quarterly

Mitchell comments that Mozilla’s real contribution isn’t just the browser but the model of participation.

In 2005 annual report on Association of American Medical Colleges acknowledged that industry, academic and government researchers can and must work together to remove scientific hurdles in drug development.

For hte uninitaited a look at the article published in Nature Magazine in 2006 with help from Pharma major Eli Lilly-Open source R&D and collaborative drug discovery and other related blogs  MnDoci FuturePundit

And don’t think these are just rants of an overenthusiastic researchers, who doesn’t know the dynamics of business, why because Director-General of the Council for Scientific and Industrial Research (CSIR) in, India unveiled a USD $34 million plan for Open Source Drug Discovery. CSIR is one of the world’s largest publicly funded R&D organisations 38 laboratories working on a range of subjects from molecular biology to road research to Himalayan bio-resources. The Council has more than 4,000 scientists working for it at these 38 labs.

The January 18 2008 meeting in NewDelhi in India was organized by Knowledge Commons, Delhi Science Forum, IIT Delhi, Red Hat and Sun on Free and Open Source model of knowledge. The highlight of the event was opensource drug development — make sure you read the Opensource India blog by Venkatesh

CSIR’s chief Sameer K. Brahmachari says, he looks for “taare zameen par” (stars on earth, a reference to one of Bollywood’s latest blockbusters), in large numbers

OSDD has the support of Sun Microsystems Inc. Hewlett-Packard, IIT Delhi, Red Hat and Indian corporate houses like TCG Life Sciences.

Related Topics Video: open source drug discovery for neglected diseases from google tech talks , Articles: The Ecconomist -An open-source shot in the arm

If you still think open source has no place in biotechnology and life science its not likely that you would listen to Alexander Graham Bell

“Great discoveries and improvements invariably involve the cooperation of many minds. I may be given credit for having blazed the trail, but when I look at the subsequent developments I feel the credit is due to others rather than myself.’

Chikken Tikka and Alzheimer’s !!

Does eating a lotf of spicy curry eliminates the chances of geting cancer and diseases like Alzheimer’s thats a yummy proposition, I wish it was that easy, but apparently the Indian curry cuisines has the capacity to prevent the onset or delay the disease, but dont reach out for the qwik e mart yet. The curry doesnt do the job all by itself ,one of the key spices used ‘the Turmeric’ does that work, Ayurvedic medicine practioners has known the value of turmeric for a very long time, the stuff even finds its ways into soaps and cosmetics           

Scientists have for the first time isolated bisdemethoxycurcumin, the active ingredient of curcuminoids, a natural substance found in turmeric root that stimulates the immune system to destroy brain-clogging proteins that cause Alzheimer’s.

Researchers found that bisdemethoxycurcumin boosted immune cells called macrophages to clear amyloid beta. Amyloid beta is a peptide that forms the plaques found in Alzheimer’s disease.

Amyloid plaques are found outside the neurons. Two major pathways are involved in breakdown of APP (amyloid precursor protein) which makes the protein called B-amyloid protein. responsible for plaques .One pathway is normal and causes no problem. The second results in the changes seen in Alzheimer’s and in some of the other dementias.

Collaborative Drug Discovery

Collaborative Drug Discovery Releases Next Generation Database for Both Private Collaborations and Public Open Access

Collaborative Drug Discovery enables scientists to archive, mine, and collaborate to more effectively develop new drug candidates for commercial and humanitarian markets.

 The technology enables novel community-based research efforts that become more and more useful as additional participants contribute data. Publicly available data sets currently in the system include the FDA orphan and approved drugs and small molecule drug discovery data dating back over half a century. These data sets pertain to a diverse group of neglected diseases, including malaria, tuberculosis, African Sleeping Sickness, Chagas Disease and Leishmania.

Tougher times for Drug Resistant Bacteria

The Secret of how to prevent bacteria from developing drug resistance has been revealed in a new study.Drugs called bisphosphonates, widely prescribed for bone loss has been found to help in preventing an enzyme that helps in conjugation of bacteria, by help of which it derives drug resistance.

Many highly-drug resistant bacteria rely on an enzyme, called DNA relaxase, to obtain and pass on their resistance genes. Relaxase  plays a crucial role in conjugation as it is the gate keeper that starts and stops the movement of DNA between bacteria durig conjugation.

researchers at the University of North Carolina at Chapel Hill, have stopped the microbes’ ability to spread, among other advantageous mutations, resistance to antibiotics, by disabling the enzyme using molecules known as  bisphosphonates

The study by Matthew Redinbo and his associates is published in this week’s Proceedings of the National Academy of Sciences USA

The antibiotic-resistant Escherichia coli bacteria that were trying to pass their genes along, actually died when their DNA relaxase was shielded thus preveinting the spread of drug resistant bacteria andpossibility of more mutations.

The news is will bring fresh hopes at a stage when drug–resistant strain of the bacteria Staphylococcus aureus infects over 1 million US hospital patients every year.

From science to business

It takes upto to 15 years and multimillion  dollar investments  to patent and market one successful drug for pharmaceutical and biotech industry. Trying to make the sure that the scientists receive the best R&D support possible companies have looked at outsourcing and insourcing and everything else.

And the new boy in the buzz world is “crowdsourcing” claiming businesses a way to tap into a larger, global community of scientists and R&D exeutives.

Crowdsourcing is a business model in which a company or institution takes a job traditionally performed by a designated agent (usually an employee) and outsources it to an undefined, generally large group of people in the form of an open call over the Internet. The work is compensated with little or no pay in most cases. However, in a few examples the labor is well-compensated .

Did that made sense it sounds like open source in biotech fields. but hold on your horses, it not that straight forward, remember Nature has published an article about open source in drug discover industry some time back, there is big list of things that makes it a difficult project.

But there is one company that has pulled it off successfully set up by drug giant Eli Lilly in 2001, for its projects Innocentive is one such crowdsourcer, So far, chemicals and life sciences have been the main users of crowdsourcers, offering rewards of up to $1m if they are successful. There are other places , such as Nine Sigma and Yet2.com and Scienteur, offer similar models.

Another firm Procter & Gamble P&G also works with Nine Sigma , YourEncore andYet2.com and Innocentive

Boeing , Dow Chemical , Eli Lilly and Procter & Gamble , Solvay are number of companies that have benefited fro this model ,

IT industry has grown to this level because people were willing to share data and collaborate , ofcourse there is much difference between IT and biological industry . But will scientists from life science industry would do it- So far the answer is No- may in future they might be more open to such needs

Read Related studies Further at
The Value of Openness in Scientific Problem Solving

Can open-source R&D reinvigorate drug research a nature Review

Previous Blogs

Open source in Biotechnology

Online data Sharing for scientists – Will they accept it

This day in genetics history

I thought of adding anadditional catagory to my blogs called “This day in genetics history”  so today May14 is an important day because in

May 14 1796 1st smallpox inoculation administered, by Edward Jenner  marking his first experimental vaccination against the disease

its not so much of junk DNA- University of Oxford Scientists discoveres Cancer cure with it

 Junk DNA is not junk after all

Recently, scientists at the University of Oxford have discovered that ‘junk’ genetic material can switch off cancer tumours, preventing them from growing.

By using RNA to switch off a gene involved in controlling cell division, Oxford University scientists may have found a role for RNA in developing new cancer therapies. RNA is the mirror image of DNA, and is used to pass on instructions to the cell to build the proteins that run every body function.

The Human Genome Project found that human DNA carries approximately 34,000 genes that produce proteins. The remaining majority of the genome constituted what was considered to be junk DNA as it had no obvious function. However, this is set to change.

‘‘There has been a quiet revolution taking place in biology in past few years,’’ said Dr Alexandre Akoulitchev, a Senior Research Fellow at Oxford. ‘‘Scientists have begun to see ‘junk’ DNA as having an important function. The variety of RNA types produced from this so called ‘junk’ is staggering and the functional implications are huge.”

Akoulitchev studied the RNA that regulates a gene called DHFR. This gene produces an enzyme that controls the production of molecules called tetrahydrofolate and thymine that cells need to divide rapidly.

“Switching off the DHFR gene could help prevent ordinary cells from developing into cancerous tumour cells, by slowing down their replication. In fact, one of the first anti-cancer drugs, Methotrexate, acts by binding and inhibiting the enzyme produced by this gene. Targeting the gene itself would cut the enzyme out of the picture altogether. Understanding how we can use RNA to switch off or inhibit DHFR and other genes may have important therapeutic implications for developing new anti-cancer treatments.”

This research was funded by The Wellcome Trust and the Medical Research Council.

Original paper: Repression of the human dihydrofolate reductase gene by a non-coding interfering transcript was published in Nature on 22^nd January 2006.

Genetically Guided Treatment For Cancer

Two critical characteristics of breast cancer that are important to treatment can be identified by measuring gene expression in the tumor, a research team led by scientists at The University of Texas M. D. Anderson Cancer Center reports in Lancet Oncology online.

Researchers developed and validated a new genomic microarray test that identifies whether a tumor’s growth is fueled by the female hormone estrogen and the role of a growth factor receptor known as HER-2 that makes a tumor vulnerable to a specific drug.

“This is one important step towards personalized diagnosis and treatment planning based on an integrated genomic test of an individual tumor,” said senior author W. Fraser Symmans, M.D., associate professor in the M. D. Anderson Department of Pathology.

The Lancet Oncology paper results are the latest in an effort by the research team to develop a single test to quickly and efficiently determine the characteristics and vulnerabilities of a patient’s breast cancer and ultimately to guide treatment.

About 70 percent of breast cancers are estrogen-receptor positive and another 15 to 25 percent are human epidermal growth factor receptor-2 (HER-2) positive. Each receptor status requires different types of treatment.

“This moves us closer to developing an integrated single genomic test that could estimate the risk of cancer relapse after surgery, determine the ER and HER2 receptor status, and also gauge the sensitivity of the tumor to hormone therapy and chemotherapy,” says Lajos Pusztai, M.D., Ph.D., associate professor in the M. D. Anderson Department of Breast Medical Oncology, and team leader with Symmans.

Last fall, the group published a study showing that a genomic microarray test can also predict a patient’s response to chemotherapy. They also presented a paper in December showing that another genomic index predicts how an ER-positive patient will respond to hormonal therapy.

The study was funded by the National Cancer Institute, the Breast Cancer Research Foundation and the Goodwin Foundation.

Co-authors with Symmans and Pusztai are: first author Yun Gong, M.D., and Nour Sneige, M.D., of the M. D. Anderson Department of Pathology; Kai Yan, Keith Anderson, and Kenneth Hess, of the M. D. Anderson Department of Biostatistics; Feng Lin, M.D., Vicente Valero, M.D., Daniel Booser, M.D., Jaime Mejia, M.D., and Gabriel Hortobagyi, M.D., of the M. D. Anderson Department of Breast Medical Oncology; Christos Sotiriou, M.D., Ph.D., Institut Jules Bordet, Brussels, Belgium; Fabrice Andre, M.D., of Institut Gustave Roussy, Villejuif, France; Frankie Holmes, M.D., John Pippen Jr., M.D., and Svetislava Vukelja, M.D., of U.S. Oncology-Texas Oncology; Henry Gomez, M.D., of the Instituto Nacional de Enfermedades Neoplasicas, Lima, Peru; and Luis Barajas, M.D., Departmento de Ginecologia Oncologica, Instituto Mexicano del Seguro Social, Guadalajara, Mexico.

Contact: Scott Merville
University of Texas M. D. Anderson Cancer Center