It seems that Amarex should know what they are doing regarding the BLA. THis is some information from their CEO (emphasis are mine):
Dr. Kazem Kazempour has been the President and CEO of Amarex Clinical Research since 1998. In addition, he serves an adjunct professor of bio-statistics and epidemiology at George Washington University’s School of Medicine and serves on the university’s Regulatory Affairs Advisory Board. Amarex Clinical Research is a globally active clinical research organization, working with international pharmaceutical, biotechnology, medical device companies, and the National Institutes of Health (NIH).
Dr. Kazempour began his career as a mathematical statistician working at the Genetics Institute in 1975. He has worked in various therapeutic areas in multiple capacities, including as a presenter to the Food and Drug Administration, as an FDA reviewer, and as a sponsor representative in diverse areas including anti-infective, AIDS, cardiovascular diseases, vaccines, and wound healing. He has chaired, established, presented to, and participated in, several Data Safety Monitoring Boards for compounds within his area of expertise, and has authored and refereed publications and technical reports both in and for mathematical statistical journals as well as clinical literature.
His expertise has earned him multiple recognition awards from the FDA for his contributions to the drug approval process, particularly for his work on HIV and AIDS clinical trial designs and analyses. He has designed and presented to the FDA meetings and FDA advisory committees on more than 100 different clinical trials and medical devices ranging from Antiviral, HIV, and septic shock, to diabetics and wound healing.
Question: You have received multiple recognition awards from the U S Food and Drug Administration for your contributions in the drug approval process. What are your most significant accomplishments that led to this recognition?
Answer: All of the recognition awards from the US Food and Drug Administration (FDA) were related to my work and contributions to HIV and AIDS drug development and approval during my FDA tenure as statistical reviewer for the Center for Drug Evaluation and Research (CDER). This division of the FDA is responsible for assuring that HIV drugs are safe and effective for use by people in the U S.
My tenure with the FDA began after several years with various US universities where I taught statistics, and employment with several US pharmaceutical companies. Most importantly, my work commenced at the beginning of the HIV epidemic when drugs for HIV and AIDS were first being developed; i.e., in the late 1980’s. These drugs included AZT, ddI and ddC which were the first drugs developed. In fact, throughout my FDA tenure, I was heavily involved in the review and the assessment of the safety and efficacy for these early and for subsequent HIV/AIDS drugs.
Then, as now, human clinical trial(s) incorporating a primary endpoint to judge the effectiveness of a drug were required for FDA approval. Given that HIV and AIDS were unknown disease entities and the mechanism of the disease in humans was unknown at the time, the only endpoint or “proof” that a drug was effective against the disease was the prolongation of life. It was obvious to many involved in the drug approval process that it required too much time and was too expensive given the urgent need for effective and safe medications to stem the spread and prevent the needless deaths that were occurring at a phenomenal and exponential rate. It was, therefore, imperative that a substitute or “surrogate endpoint,” to be discovered. I was heavily involved in the FDA acceptance of surrogate marker to be used as an alternative to the “endpoint of death” in clinical trials.
This quest involved the evaluation of a myriad of biological lab and clinical results that were being submitted to the FDA via the drug approval process. My position as statistical reviewer for these drugs allowed me access to extensive data. The challenge was to prove statistically that there existed either a biological or clinical objective measurement that correlated (or responded) in the same fashion as the endpoint of death. After many hours and days/nights we managed to establish correlation of CD4 cell with mortality of HIV/AIDS patients as an acceptable regulatory endpoint.
I can't think of a better person to work on the BLA application as has all the relevant experience including being a former FDA reviewer !!!
Now, in a more serious vein, I believe Dr. Nader trip to the East coast was to pay a personal visit to Amarex and find out wat was going on with the BLA. As he said once: he can't sleep until this is done.
Dr. Kazem Kazempour has been the President and CEO of Amarex Clinical Research since 1998. In addition, he serves an adjunct professor of bio-statistics and epidemiology at George Washington University’s School of Medicine and serves on the university’s Regulatory Affairs Advisory Board. Amarex Clinical Research is a globally active clinical research organization, working with international pharmaceutical, biotechnology, medical device companies, and the National Institutes of Health (NIH).
Dr. Kazempour began his career as a mathematical statistician working at the Genetics Institute in 1975. He has worked in various therapeutic areas in multiple capacities, including as a presenter to the Food and Drug Administration, as an FDA reviewer, and as a sponsor representative in diverse areas including anti-infective, AIDS, cardiovascular diseases, vaccines, and wound healing. He has chaired, established, presented to, and participated in, several Data Safety Monitoring Boards for compounds within his area of expertise, and has authored and refereed publications and technical reports both in and for mathematical statistical journals as well as clinical literature.
His expertise has earned him multiple recognition awards from the FDA for his contributions to the drug approval process, particularly for his work on HIV and AIDS clinical trial designs and analyses. He has designed and presented to the FDA meetings and FDA advisory committees on more than 100 different clinical trials and medical devices ranging from Antiviral, HIV, and septic shock, to diabetics and wound healing.
Question: You have received multiple recognition awards from the U S Food and Drug Administration for your contributions in the drug approval process. What are your most significant accomplishments that led to this recognition?
Answer: All of the recognition awards from the US Food and Drug Administration (FDA) were related to my work and contributions to HIV and AIDS drug development and approval during my FDA tenure as statistical reviewer for the Center for Drug Evaluation and Research (CDER). This division of the FDA is responsible for assuring that HIV drugs are safe and effective for use by people in the U S.
My tenure with the FDA began after several years with various US universities where I taught statistics, and employment with several US pharmaceutical companies. Most importantly, my work commenced at the beginning of the HIV epidemic when drugs for HIV and AIDS were first being developed; i.e., in the late 1980’s. These drugs included AZT, ddI and ddC which were the first drugs developed. In fact, throughout my FDA tenure, I was heavily involved in the review and the assessment of the safety and efficacy for these early and for subsequent HIV/AIDS drugs.
Then, as now, human clinical trial(s) incorporating a primary endpoint to judge the effectiveness of a drug were required for FDA approval. Given that HIV and AIDS were unknown disease entities and the mechanism of the disease in humans was unknown at the time, the only endpoint or “proof” that a drug was effective against the disease was the prolongation of life. It was obvious to many involved in the drug approval process that it required too much time and was too expensive given the urgent need for effective and safe medications to stem the spread and prevent the needless deaths that were occurring at a phenomenal and exponential rate. It was, therefore, imperative that a substitute or “surrogate endpoint,” to be discovered. I was heavily involved in the FDA acceptance of surrogate marker to be used as an alternative to the “endpoint of death” in clinical trials.
This quest involved the evaluation of a myriad of biological lab and clinical results that were being submitted to the FDA via the drug approval process. My position as statistical reviewer for these drugs allowed me access to extensive data. The challenge was to prove statistically that there existed either a biological or clinical objective measurement that correlated (or responded) in the same fashion as the endpoint of death. After many hours and days/nights we managed to establish correlation of CD4 cell with mortality of HIV/AIDS patients as an acceptable regulatory endpoint.
I can't think of a better person to work on the BLA application as has all the relevant experience including being a former FDA reviewer !!!
Now, in a more serious vein, I believe Dr. Nader trip to the East coast was to pay a personal visit to Amarex and find out wat was going on with the BLA. As he said once: he can't sleep until this is done.
2
