[ElaineM]

This information might be helpful in our quest to get
T DM1 approved.
CANCER DRUG DEVELOPMENT AND APPROVAL
By, Ginny Mason, RN, BSN
Executive Director, ibcRF
The Food and Drug Administration (FDA) has a huge task as the 'federal watchdog'. Carefully evaluating the safety and efficacy (effectiveness) of medications in a prompt and thorough manner is difficult. The FDA does not evaluate cost. We in the public tend to want new drugs that work and are safe, NOW.....but often serious adverse effects aren't known until the drug is in wider use. Newer is not always better.
The FDA is broken up into various divisions with each division focusing on a specific medical area. To help guide the FDA in their decision making process there are a variety of panels made up of medical professionals in the given field, biostatisticians, industry representatives, consumer representatives and patient representatives. The Oncologic Drug Advisory Committee (ODAC) is the panel devoted to cancer drug review.
In 2007, I was appointed to serve a four year term as the consumer representative on ODAC. The ODAC consumer representative is typically a medical professional who has ties to the oncology community, but is not typically a patient themselves. It's been an interesting and informative experience as I've learned more about the drug development and approval process. Since the group deals with all types of cancers I've had to review my medical textbooks and do some extra reading in preparation for many of the meetings as well as wade through the copious amounts of material supplied by the FDA and sponsor. Far more preparation time goes into the meeting than is involved in the actual in person meetings. FDA committee meetings are open to the public and all comments and voting are public record. Typically the meetings are held in a hotel in the general Rockville, MD area and announced at least a month in advance. I would encourage you to attend if you are able to learn more about the process. Meeting information is at www.fda.gov
A recent issue of The Duke Comprehensive Cancer Center "Notes" carried a good "Ask the Expert" column on ODAC. ODAC panel member Gary Lyman, MD, MPH, FRCP, professor of medicine and director of the Comparative Effectiveness and Outcomes Research at Duke University School of Medicine and the Duke Comprehensive Cancer Center, provides the 'expert' commentary for the column. This piece gives a good overview of ODAC and the drug development and approval process. Dr. Lyman is just one of the excellent practitioners that I've had the opportunity to interact with on ODAC along with a variety of others in the oncology community.
To read the full article go to:
www.cancer.duke.edu/notes and click on the Fall 2010 issue, "Ask the Expert" is on the last page.
http://www.cancer.duke.edu/docs/Canc...01009-Fall.pdf


CANCER DRUG DEVELOPMENT AND APPROVAL

By, Ginny Mason, RN, BSN
Executive Director, ibcRF

The Food and Drug Administration (FDA) has a huge task as the 'federal watchdog'. Carefully evaluating the safety and efficacy (effectiveness) of medications in a prompt and thorough manner is difficult. The FDA does not evaluate cost. We in the public tend to want new drugs that work and are safe, NOW.....but often serious adverse effects aren't known until the drug is in wider use. Newer is not always better.

The FDA is broken up into various divisions with each division focusing on a specific medical area. To help guide the FDA in their decision making process there are a variety of panels made up of medical professionals in the given field, biostatisticians, industry representatives, consumer representatives and patient representatives. The Oncologic Drug Advisory Committee (ODAC) is the panel devoted to cancer drug review.

In 2007, I was appointed to serve a four year term as the consumer representative on ODAC. The ODAC consumer representative is typically a medical professional who has ties to the oncology community, but is not typically a patient themselves. It's been an interesting and informative experience as I've learned more about the drug development and approval process. Since the group deals with all types of cancers I've had to review my medical textbooks and do some extra reading in preparation for many of the meetings as well as wade through the copious amounts of material supplied by the FDA and sponsor. Far more preparation time goes into the meeting than is involved in the actual in person meetings. FDA committee meetings are open to the public and all comments and voting are public record. Typically the meetings are held in a hotel in the general Rockville, MD area and announced at least a month in advance. I would encourage you to attend if you are able to learn more about the process. Meeting information is at www.fda.gov

A recent issue of The Duke Comprehensive Cancer Center "Notes" carried a good "Ask the Expert" column on ODAC. ODAC panel member Gary Lyman, MD, MPH, FRCP, professor of medicine and director of the Comparative Effectiveness and Outcomes Research at Duke University School of Medicine and the Duke Comprehensive Cancer Center, provides the 'expert' commentary for the column. This piece gives a good overview of ODAC and the drug development and approval process. Dr. Lyman is just one of the excellent practitioners that I've had the opportunity to interact with on ODAC along with a variety of others in the oncology community.

To read the full article go to:
www.cancer.duke.edu/notes and click on the Fall 2010 issue, "Ask the Expert" is on the last page.

CANCER DRUG DEVELOPMENT AND APPROVAL

By, Ginny Mason, RN, BSN
Executive Director, ibcRF

The Food and Drug Administration (FDA) has a huge task as the 'federal watchdog'. Carefully evaluating the safety and efficacy (effectiveness) of medications in a prompt and thorough manner is difficult. The FDA does not evaluate cost. We in the public tend to want new drugs that work and are safe, NOW.....but often serious adverse effects aren't known until the drug is in wider use. Newer is not always better.

The FDA is broken up into various divisions with each division focusing on a specific medical area. To help guide the FDA in their decision making process there are a variety of panels made up of medical professionals in the given field, biostatisticians, industry representatives, consumer representatives and patient representatives. The Oncologic Drug Advisory Committee (ODAC) is the panel devoted to cancer drug review.

In 2007, I was appointed to serve a four year term as the consumer representative on ODAC. The ODAC consumer representative is typically a medical professional who has ties to the oncology community, but is not typically a patient themselves. It's been an interesting and informative experience as I've learned more about the drug development and approval process. Since the group deals with all types of cancers I've had to review my medical textbooks and do some extra reading in preparation for many of the meetings as well as wade through the copious amounts of material supplied by the FDA and sponsor. Far more preparation time goes into the meeting than is involved in the actual in person meetings. FDA committee meetings are open to the public and all comments and voting are public record. Typically the meetings are held in a hotel in the general Rockville, MD area and announced at least a month in advance. I would encourage you to attend if you are able to learn more about the process. Meeting information is at www.fda.gov

A recent issue of The Duke Comprehensive Cancer Center "Notes" carried a good "Ask the Expert" column on ODAC. ODAC panel member Gary Lyman, MD, MPH, FRCP, professor of medicine and director of the Comparative Effectiveness and Outcomes Research at Duke University School of Medicine and the Duke Comprehensive Cancer Center, provides the 'expert' commentary for the column. This piece gives a good overview of ODAC and the drug development and approval process. Dr. Lyman is just one of the excellent practitioners that I've had the opportunity to interact with on ODAC along with a variety of others in the oncology community.

To read the full article go to:
www.cancer.duke.edu/notes and click on the Fall 2010 issue, "Ask the Expert" is on the last page.

CANCER DRUG DEVELOPMENT AND APPROVAL

By, Ginny Mason, RN, BSN
Executive Director, ibcRF

The Food and Drug Administration (FDA) has a huge task as the 'federal watchdog'. Carefully evaluating the safety and efficacy (effectiveness) of medications in a prompt and thorough manner is difficult. The FDA does not evaluate cost. We in the public tend to want new drugs that work and are safe, NOW.....but often serious adverse effects aren't known until the drug is in wider use. Newer is not always better.

The FDA is broken up into various divisions with each division focusing on a specific medical area. To help guide the FDA in their decision making process there are a variety of panels made up of medical professionals in the given field, biostatisticians, industry representatives, consumer representatives and patient representatives. The Oncologic Drug Advisory Committee (ODAC) is the panel devoted to cancer drug review.

In 2007, I was appointed to serve a four year term as the consumer representative on ODAC. The ODAC consumer representative is typically a medical professional who has ties to the oncology community, but is not typically a patient themselves. It's been an interesting and informative experience as I've learned more about the drug development and approval process. Since the group deals with all types of cancers I've had to review my medical textbooks and do some extra reading in preparation for many of the meetings as well as wade through the copious amounts of material supplied by the FDA and sponsor. Far more preparation time goes into the meeting than is involved in the actual in person meetings. FDA committee meetings are open to the public and all comments and voting are public record. Typically the meetings are held in a hotel in the general Rockville, MD area and announced at least a month in advance. I would encourage you to attend if you are able to learn more about the process. Meeting information is at www.fda.gov

A recent issue of The Duke Comprehensive Cancer Center "Notes" carried a good "Ask the Expert" column on ODAC. ODAC panel member Gary Lyman, MD, MPH, FRCP, professor of medicine and director of the Comparative Effectiveness and Outcomes Research at Duke University School of Medicine and the Duke Comprehensive Cancer Center, provides the 'expert' commentary for the column. This piece gives a good overview of ODAC and the drug development and approval process. Dr. Lyman is just one of the excellent practitioners that I've had the opportunity to interact with on ODAC along with a variety of others in the oncology community.

To read the full article go to:
www.cancer.duke.edu/notes and click on the Fall 2010 issue, "Ask the Expert" is on the last page.