Member News
Oct 1, 2014 20:26:00 GMT -5
Post by mayumi on Oct 1, 2014 20:26:00 GMT -5
When our son was born with optic nerve damage that robbed him of most of his vision, I vowed to dedicate my life to go into eye research. So in the last 30 years, I have helped develop more than a dozen drugs for various forms of eye diseases. I am sure some of you will recognize them or may have even used them. Unfortunately, my son’s condition is very rare and although some research is ongoing, it is too early to tell whether it will prove successful in clinical trials.
My wonderful husband was losing his vision due to diabetes so there was more impetus for me to try really hard. He was my biggest cheerleader. He was looking forward to be one of the first to get the drug but unfortunately, as some of you know, he passed last year. I actually cried when FDA sent me the letter last Friday because I thought of him and how much I missed him. He was and will forever be the love of my life. And oh, how he loved Adam too! I am sure he is watching from heaven and happy for me and all the wonderful things happening to Adam.
Drug development is tough. Out of thousands of compounds that start in a test tube, only a fraction makes it to the market. The first patient in our almost 1000-patient clinical studies was treated in 2005 and now it is 2014 and we finally have FDA approval although it is already approved in 17 European countries. I am responsible for the technical side of product development, reviewing data and putting them together for submission and managing the approval process with health authorities. If I were to estimate, we probably generated about a million pages of documents for the FDA submission alone. Thank God we do everything electronically now and saved a lot of trees.
With this drug approval, I can now take it a little easier. My company wants me to continue on as a consultant. My son and I will move to California by Christmas and start a new life and hopefully I will be able to spend more time with my other passion - Adam. The timing of the EU tour however is not good because even though I will be a consultant, we are launching our drug the first quarter of 2015 and I will be involved in reviewing and approving promos and ads and training sales reps on the do’s and don’ts of selling drugs. And I don’t want to miss our big product launch either. I am hoping to catch up with everyone on the A3 tour.
You can get more information on our company and drug on our website: www.alimerasciences.com
My bio is in About Us/Management Team. You can also PM me if you need more information/literature on our drug.
Hugs to all.
My wonderful husband was losing his vision due to diabetes so there was more impetus for me to try really hard. He was my biggest cheerleader. He was looking forward to be one of the first to get the drug but unfortunately, as some of you know, he passed last year. I actually cried when FDA sent me the letter last Friday because I thought of him and how much I missed him. He was and will forever be the love of my life. And oh, how he loved Adam too! I am sure he is watching from heaven and happy for me and all the wonderful things happening to Adam.
Drug development is tough. Out of thousands of compounds that start in a test tube, only a fraction makes it to the market. The first patient in our almost 1000-patient clinical studies was treated in 2005 and now it is 2014 and we finally have FDA approval although it is already approved in 17 European countries. I am responsible for the technical side of product development, reviewing data and putting them together for submission and managing the approval process with health authorities. If I were to estimate, we probably generated about a million pages of documents for the FDA submission alone. Thank God we do everything electronically now and saved a lot of trees.
With this drug approval, I can now take it a little easier. My company wants me to continue on as a consultant. My son and I will move to California by Christmas and start a new life and hopefully I will be able to spend more time with my other passion - Adam. The timing of the EU tour however is not good because even though I will be a consultant, we are launching our drug the first quarter of 2015 and I will be involved in reviewing and approving promos and ads and training sales reps on the do’s and don’ts of selling drugs. And I don’t want to miss our big product launch either. I am hoping to catch up with everyone on the A3 tour.
You can get more information on our company and drug on our website: www.alimerasciences.com
My bio is in About Us/Management Team. You can also PM me if you need more information/literature on our drug.
Hugs to all.
Enjoy your new home and "semi" retirement.
