al from Canada
01-17-2006, 01:14 AM
Friday the 13th must have been the day for good news....just when I was slighting the FDA, here comes an announcement that they plan to use updated technologies to approve updated targeted drugs. Now that's what I call a truely novel and inspirational idea, Al
Drug Companies May Use New Lab Tools to Speed Product Approvals http://images.bloomberg.com/mix/box_arrow_listenicon.gifListen (javascript:audioPlayer(%22A=41692200&clipName=Drug Companies May Use New Lab Tools to Speed Product Approvals %22))
Jan. 13 (Bloomberg) -- U.S. regulators and the pharmaceutical industry are using new gene-hunting tools and medical imaging machines to cut years off the decades-long process of testing drugs.
Scientists increasingly use gene-sleuthing technology to identify the biology underpinning cancer, schizophrenia and Alzheimer's disease. Doctors rely on medical imaging devices, such as MRI scans, to diagnose disease. The U.S. Food and Drug Administration said yesterday that it plans to harness these advances to evaluate experimental medicines faster.
The FDA's announcement came after a year in which the number of drug approvals dropped to 20, the second-fewest in a decade. Drug companies, including Pfizer Inc., Merck & Co. and Bristol-Myers Squibb Co., are having trouble developing new products. It's in the FDA's interest to help the industry more efficiently produce treatments, especially for poorly treated diseases, said Scott Gottlieb, the regulatory agency's deputy director for medical and scientific affairs in Washington.
``There is a disconnect between the investment we're making in discovering treatments and the result in practical treatments that are reaching patients,'' Gottlieb said in a Jan. 6 interview. ``We think that there are scientific approaches we could be taking that would help us learn more about drugs in a shorter time and for less cost.''
The long and tedious methods used to craft promising molecules into new therapies are largely unchanged from 50 years ago, while the revolution in human-genome research has unleashed a raft of experimental drugs to fight diseases in new ways. These include cancer medicines, such as Novartis AG's Gleevec and Genentech Inc.'s Avastin, designed to turn off molecules that propel tumor growth.
Embracing Genetic Revolution
Some companies already are embracing the genetic revolution. GlaxoSmithKline Plc takes DNA samples from everyone in its new drug studies. The London-based drugmaker is sifting through the genetic data for clues about which patients will respond to experimental treatments and which may develop side effects, said Allen D. Roses, senior vice president for genetics research.
``As you learn more about the individuals' genetic makeup, then the dose can be varied for each patient'' to maximize benefit and reduce the risk, Roses said in a Jan. 11 phone interview.
The FDA said yesterday in Washington it will relax the rules governing early human studies, making it easier for companies to produce small batches of drugs for testing.
More Science, Fewer Drugs
The agency also paved the way for giving microscopic amounts of promising compounds to people even before animal safety studies are complete. This may allow researchers with sophisticated imaging tests to determine early on whether the drugs are getting to the right spot in the body.
Genetic tests are being designed to identify people who metabolize a drug slowly. Such individuals can often be kept on a drug that might otherwise cause nausea simply by lowering the dosage, Glaxo's Roses said.
Drugmaker investments in biomedical research and development have doubled about every five years for more than a decade, while new drug approvals have fallen. The FDA is encouraging companies to exploit new technology used in drug discovery to also speed up the testing end of drug development, Janet Woodcock, the agency's Deputy Commissioner for Operations, said in a Jan. 11 phone interview.
``You would expect with all the new science, we'd become more efficient and more productive,'' Woodcock said. Since companies can't unilaterally introduce new testing techniques, the FDA must work with industry to initiate the new approaches, she said.
X-Rays, PET Scans
The agency said testing for a drug to treat lymphoma, a blood cancer, is a model for improving human studies.
X-rays, which have been used for decades to see whether tumors shrink in response to chemotherapy, often can't distinguish between cancer and surrounding scar tissue that results from cells killed by the drugs, said Kim Frederick, director of the information resource center at the Leukemia and Lymphoma Society. As a result, X-rays can be an imprecise way to measure whether a new drug is working.
The FDA and others are planning an initiative to see whether a more powerful imaging technique, called positron emission tomography, or PET scans, will work better. The scans from General Electric Co.'s GE Healthcare unit, Siemens AG and Royal Philips Electronics NV can detect whether a treatment has killed the cancer cells.
Testing Drug Safety
If research confirms the value of PET scans in measuring a drug's benefit, the imaging tests may replace the older X-rays, the FDA's Gottlieb said. The agency's imprimatur may also lead to insurance coverage to pay for the scans.
The FDA said it's working with companies and the Critical Path Institute in Tucson, Arizona to create lab tests that predict safety of experimental therapies. The tests would detect whether drugs damage cells and are dangerous to certain organs before they are administered to people, said Raymond Woosley, president of the C-Path institute, which doesn't take drugmaker money and provides neutral ground for industry collaboration.
Drugs deemed safe would get tested on more people faster, Woosley said. The approach may save money, replacing tests using electron microscopes that cost as much as $1 million, he said.
The most widely anticipated use of new technologies is the ability of genetic tests to identify patients who will respond to treatment before it begins. The approach is particularly vital for cancer patients, the FDA's Woodcock said.
Individualized Medicine
The approach, known as individualized medicine, ``is a bit of a two-edged sword,'' said Mary Relling, chairwoman of the pharmaceutical sciences department at St. Jude Children's Research Hospital, in a phone interview from Memphis, Tennessee. St. Jude has used genetic profiles of its patients to guide therapy for more than a decade, she said.
``The impact of all this genetic testing is that the market for any one drug is going to continue to get smaller and smaller as we get better and better at figuring out which portion of the population is likely to benefit from a drug,'' Relling said.
That's why St. Jude is beefing up its drug development, she said in a telephone interview.
``We have to be honest with the public that the consequence of pursuing individualized medicine is that we're making it less attractive for private entities to develop new drugs,'' she said.
Drug Companies May Use New Lab Tools to Speed Product Approvals http://images.bloomberg.com/mix/box_arrow_listenicon.gifListen (javascript:audioPlayer(%22A=41692200&clipName=Drug Companies May Use New Lab Tools to Speed Product Approvals %22))
Jan. 13 (Bloomberg) -- U.S. regulators and the pharmaceutical industry are using new gene-hunting tools and medical imaging machines to cut years off the decades-long process of testing drugs.
Scientists increasingly use gene-sleuthing technology to identify the biology underpinning cancer, schizophrenia and Alzheimer's disease. Doctors rely on medical imaging devices, such as MRI scans, to diagnose disease. The U.S. Food and Drug Administration said yesterday that it plans to harness these advances to evaluate experimental medicines faster.
The FDA's announcement came after a year in which the number of drug approvals dropped to 20, the second-fewest in a decade. Drug companies, including Pfizer Inc., Merck & Co. and Bristol-Myers Squibb Co., are having trouble developing new products. It's in the FDA's interest to help the industry more efficiently produce treatments, especially for poorly treated diseases, said Scott Gottlieb, the regulatory agency's deputy director for medical and scientific affairs in Washington.
``There is a disconnect between the investment we're making in discovering treatments and the result in practical treatments that are reaching patients,'' Gottlieb said in a Jan. 6 interview. ``We think that there are scientific approaches we could be taking that would help us learn more about drugs in a shorter time and for less cost.''
The long and tedious methods used to craft promising molecules into new therapies are largely unchanged from 50 years ago, while the revolution in human-genome research has unleashed a raft of experimental drugs to fight diseases in new ways. These include cancer medicines, such as Novartis AG's Gleevec and Genentech Inc.'s Avastin, designed to turn off molecules that propel tumor growth.
Embracing Genetic Revolution
Some companies already are embracing the genetic revolution. GlaxoSmithKline Plc takes DNA samples from everyone in its new drug studies. The London-based drugmaker is sifting through the genetic data for clues about which patients will respond to experimental treatments and which may develop side effects, said Allen D. Roses, senior vice president for genetics research.
``As you learn more about the individuals' genetic makeup, then the dose can be varied for each patient'' to maximize benefit and reduce the risk, Roses said in a Jan. 11 phone interview.
The FDA said yesterday in Washington it will relax the rules governing early human studies, making it easier for companies to produce small batches of drugs for testing.
More Science, Fewer Drugs
The agency also paved the way for giving microscopic amounts of promising compounds to people even before animal safety studies are complete. This may allow researchers with sophisticated imaging tests to determine early on whether the drugs are getting to the right spot in the body.
Genetic tests are being designed to identify people who metabolize a drug slowly. Such individuals can often be kept on a drug that might otherwise cause nausea simply by lowering the dosage, Glaxo's Roses said.
Drugmaker investments in biomedical research and development have doubled about every five years for more than a decade, while new drug approvals have fallen. The FDA is encouraging companies to exploit new technology used in drug discovery to also speed up the testing end of drug development, Janet Woodcock, the agency's Deputy Commissioner for Operations, said in a Jan. 11 phone interview.
``You would expect with all the new science, we'd become more efficient and more productive,'' Woodcock said. Since companies can't unilaterally introduce new testing techniques, the FDA must work with industry to initiate the new approaches, she said.
X-Rays, PET Scans
The agency said testing for a drug to treat lymphoma, a blood cancer, is a model for improving human studies.
X-rays, which have been used for decades to see whether tumors shrink in response to chemotherapy, often can't distinguish between cancer and surrounding scar tissue that results from cells killed by the drugs, said Kim Frederick, director of the information resource center at the Leukemia and Lymphoma Society. As a result, X-rays can be an imprecise way to measure whether a new drug is working.
The FDA and others are planning an initiative to see whether a more powerful imaging technique, called positron emission tomography, or PET scans, will work better. The scans from General Electric Co.'s GE Healthcare unit, Siemens AG and Royal Philips Electronics NV can detect whether a treatment has killed the cancer cells.
Testing Drug Safety
If research confirms the value of PET scans in measuring a drug's benefit, the imaging tests may replace the older X-rays, the FDA's Gottlieb said. The agency's imprimatur may also lead to insurance coverage to pay for the scans.
The FDA said it's working with companies and the Critical Path Institute in Tucson, Arizona to create lab tests that predict safety of experimental therapies. The tests would detect whether drugs damage cells and are dangerous to certain organs before they are administered to people, said Raymond Woosley, president of the C-Path institute, which doesn't take drugmaker money and provides neutral ground for industry collaboration.
Drugs deemed safe would get tested on more people faster, Woosley said. The approach may save money, replacing tests using electron microscopes that cost as much as $1 million, he said.
The most widely anticipated use of new technologies is the ability of genetic tests to identify patients who will respond to treatment before it begins. The approach is particularly vital for cancer patients, the FDA's Woodcock said.
Individualized Medicine
The approach, known as individualized medicine, ``is a bit of a two-edged sword,'' said Mary Relling, chairwoman of the pharmaceutical sciences department at St. Jude Children's Research Hospital, in a phone interview from Memphis, Tennessee. St. Jude has used genetic profiles of its patients to guide therapy for more than a decade, she said.
``The impact of all this genetic testing is that the market for any one drug is going to continue to get smaller and smaller as we get better and better at figuring out which portion of the population is likely to benefit from a drug,'' Relling said.
That's why St. Jude is beefing up its drug development, she said in a telephone interview.
``We have to be honest with the public that the consequence of pursuing individualized medicine is that we're making it less attractive for private entities to develop new drugs,'' she said.