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I agree 100%......very interesting! That’s what I got out of it too.
Good Read:
https://endpts.com/whats-coming-pazdur-marks-and-woodcock-discuss-fda-changes/
What’s coming? Pazdur, Marks and Woodcock discuss FDA changes
by zachary brennan - raps — on November 14, 2018 03:48 PM EST
Updated: 03:49 PM
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PDF
Three of the FDA’s directors — Richard Pazdur, Peter Marks and Janet Woodcock — took the stage Wednesday at Prevision Policy’s Biopharma Congress to discuss all things FDA: from why the agency is viewed more positively now than in the past to what needs to happen in each of their centers.
CDER director Woodcock said that the difference between years past, when FDA was viewed negatively, and now is that there has been a sort of scientific revolution, with biology being harnessed in novel ways and investments at NIH paying off.
Richard Pazdur
Oncology Center of Excellence director Pazdur also noted the tremendous growth in understanding diseases and in the immunology of cancer.
“One part of the piece in oncology is that our staff has embraced these changes,” he said, noting they’re “not just bean counters for survival data” but have gotten involved in the science of oncology. The staff are partners in the process rather than just ticking boxes, he said.
And Marks, director of the Center for Biologics Evaluation and Research, explained how the idea of screening libraries of compounds has gone out the window, while nowadays it’s more about rational drug development – “and gene therapy is the epitome of that.”
On the topic of gene therapy, Marks noted there are now 700 investigational new drug applications before FDA. But compare that with cell therapies, he said, noting a gray market of unproven treatments, which in some cases are nothing better than badly manufactured snake-oil that don’t contain live cells. He also said the use of unapproved stem cell therapies around the country is a surrogate marker for how Right to Try may play out. FDA doesn’t usually learn about what is going on until something really bad happens, Marks added.
On the prospects of what’s to come at FDA, Woodcock noted the real-time review pilot in the Oncology Center of Excellence, which reviews parts of a submission before the entire application is submitted, is “foreshadowing something bigger.” But she also explained how the speed of reviews does not really influence the results, saying: “what has changed is the cost of these drugs, and it’s changed the debate because of value.”
Nowadays and moving into the future, there’s a societal benefit and harm discussion that implicitly invokes “trade-offs in value – that’s the new debate we’re having – too fast and too slow is really not the issue.”
For Marks, the biggest problem moving forward for gene therapies is the quantum leap needed in manufacturing and to applying the techniques beyond just rare diseases. “We need to do the kind of transformation Steve Jobs did for digital,” with manufacturing gene therapies. He also noted FDA is “very lenient” about some of its manufacturing standards for getting gene therapies into Phase 1 trials, but scaling up the manufacturing is what’s difficult.
Moving into the future legislatively, Woodcock said she’s interested in legislation on generic drug labeling. “We have to clean up the armamentarium so it doesn’t get out of date,” she said. She further noted FDA is working with Congress on over-the-counter drug reforms, which is the basis for the Office of New Drug modernization. “If we don’t get the OTC reform, we’ll have to pull back on the OND reforms,” she said.
Image: Janet Woodcock
First published here. regulatory focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email news@raps.org for more information.
OUCH! #120 caps is a 1 month supply. Didn't think you could use Vascepa coupon for 1 month supply. Coupon says only for 3 month supply.
AMEN!! I'm good through end of 2019.
Bought more, myself.....easy money!
Yes, it's a non issue
TTE, I think that varies with each patient. It took 80mg to get me from 145 LDL to 90 LDL. It took 10mg Zetia to get me below 70 LDL per Card recommendation to between 50-60 LDL.
RR
Nuke,
I will say this for comparison. My script was sent from my doctor to Walgreens on November 2nd. When I went to pick up my script of V, the cost was $35.00 for a 1 month supply with my insurance. Then, I handed my coupon from the Amarin website to her and she said I could only use the coupon for a 3 month supply, and asked if I would like a 3 month supply, which of course I said YES. So, she filled my 3 month supply at a cost of $9. No questions asked with regards to using the coupon.
RR
Got it
Wow, that's very impressive! So with the blood test, are they getting a measure of that protein in my blood to check for inflammation? Was that graph provided to you? I would love to know what my baseline was prior to starting V.
Thanks,
RR
Thanks jfm
I appreciate the response. My markers for the blood test are the same as usual. I'll have questions regarding the inflammation when I visit him in April. Hopefully he can explain to me the risk, and see how much he is up to speed on V by then.
Thanks,
Rapid Runner starts Monday
GLTY
smarterer,
When BB says LDL were lowered but inflammation persist....where does the inflammation exist, primarily? Is it the blood vessels, coronary arteries? I brought my cardiologist the primary RI results and two days later I get a call saying my numbers looked good, but if I wanted a script of V he would prescribe. But he wants a blood test in a month.
Is 1 month on V going to show any change? And how do you test for inflammation?
Thanks,
RR
Just received my 1st 90 day supply of Vascepa for $9. Is everyone else taking (2) twice per/day?
Thanks,
RR
I'm actually on the production side. I never had much interest in drilling other than understanding the process. Production is much more mentally challenging, safer, cleaner, and job security.
north,
I'm right in the heart of Cajun country.
RR
raf, no way should you pick up your winnings. Just send me the ticket by certified mail so I can buy more AMRN before it Explodes!
;)
VuBru,
My Cardiologist and my Brother-n-law's offices are right next to each other and their friends. With the information I'm going to bring to him (which he may be already aware of), I don't think he will say know. I just want to see his face when I hand him that article....
Thanks,
RR
ggwpq,
Yes I do....I can't express how grateful I am to all of you guys here. I have enough information to hand to my doctor when I get home on the 30th. I'm really looking forward to getting on Vascepa, and reaping the rewards of my AMRN shares. Exciting tmes for me here!
Thanks much!
RR
north,
Seems I'm a prime candidate. I appreciate all of you guys help. I was a dummy about CV health prior to my CVE, this has been a very interesting board over the past 10 months or so to read. So many things hit home for me here. I appreciate all of you!!
Thanks,
RR
Chris,
I appreciate much, I just printed it out. I'll turn 56 on Nov. 7th, been working in the Gulf of Mexico for an oil company for a little over 33 years now. I'm hoping Vascepa gives me a big birthday present and I can get out of the GULF for good once and for all!
Thanks for the reply,
RR
ggwpq,
That article hit home pretty good. I'm from South Louisiana where we eat and don't worry much about the effects it has on our arteries. With my HDL's always being around 30, for me I never ever considered my Trig level being an issue,i'm always concerned about my LDL's. Before my CVE, I used to do a screening every year with my job. My LDL's were always red flagged, but I didn't know a damn thing about LDL's and the danger is posed to me, until that fateful night my lower jaw started hurting. I woke the next morning and took and aspirin and went out and cut the lawn, weed eating and all...jaw pain would come and go. I was leaving the next morning to go to work at sea, wife told me I should go to emergency room to get checked, which I did at 5:00pm that afternoon. They drew blood and said my heart enzymes were very high. They admitted me immediately. I was very lucky....I'll be on Vascepa within the next 3 weeks one way or another.
Thanks for the reply,
RR
VuBru....thanks, I definitely will bring it up post 11/10.
north,
That has been my biggest concern, that Cardio Doc would tell me I didn't fit the criteria for Vascepa. After lurking here for the past 10 months, seems there are other benefits to taking Vascepa, and I'm anxious to find out. I took a photo copy of the links, and will check that post.
Thanks much,
RR
jfmcrr,
That's what I'm excited about, what all will pure EPA/V do for me in my situation. I'd really like to be able to get off of the aspirin if possible. My next blood work is in April 2019, i'll contact my cardiologist after Nov. 10th and see if he will prescribe me Vascepa, and see if my overall health and blood results show improvement in April.
Thanks,
RR
mikenab, that was a very good read for me. I can't see my Cardiologist rejecting my use of Vascepa. I'm not too familiar with what effects the Trigs have on my overall CV health, I've always been more concerned with my LDL's which were at the 145 level prior to my CVE. And my lab work read-out from my doctor shows my Trig level being at 167 is good. I've never asked him at what Trig level is acceptable.
Appreciate your response, gives me an even better understanding of my situation....this board has been very educational for me over the months, albeit hard for me to grasp all the numbers thrown around....my background is oilfield.
RR
Thanks Smarterer, that's really what I wanted to hear. Appreciate your reply!
RR
I'm wondering what I could expect my doctor to tell me. Thinking about contacting him before I see him in April.
I have a question for the board.
I had a CVE back in 2013. My Cardiologist started me on low dosage Atorvastatin and continued raising my dosage all the way up to 80mg, but my LDLs would not o below 91. So he also prescribed me 10mg Ezetimibe to get my LDL's down below 70, which it did. I'm also taking an 81mg Bayer aspirin. Here are my latest lab results in September 2018:
LDL's = 61
Trigs = 167
HDL's = 31
My question is, do you think I am a good candidate for Vascepa treatment? My next appointment is in April 2019 and I'm planning to talk to my Cardiologist about putting me on Vascepa.
My other question is, would Vascepa replace the Ezetimibe or would I be taking Vascepa to lower my Trigs only?
Yes, I am an AMRN shareholder since December 2017 and haven't sold a share. And I'm a bit excited about what Vascepa could do for me.
Thanks,
RR
The whole market is taking a haircut, has nothing to do with the company. What I see is huge volume, cheap shares being scooped up. Akoustis can bounce back quickly, no red flags. I'd like to pick up another 20K on the cheap before end of year. All tech stocks are down....
Beginning next month we will begin to see a new era for Akoustis, orders, sales, production ramping up in 4th quarter. What I’m waiting to see here is the product acceptance, manufacturing capabilities keeping up with demand (which is extremely important to big customers), and really what is the underlying reason Akoustis chose to start this venture through a reverse merger. The most interesting thing to me here, which btw is very compelling, is that Akoustis management has very stron ties to some of its competition. So I have to think at some point down the road Akoustis will be a buyout candidate. That said, I think we see $10 before end of year and if production proves it can keep up with demand, $20 is very possible within a year. All this IMO.....i’m Long Akoustis, I don’t see much downside here, but the upside could be substantial. And I must say, Akoustis has done everything they said they would do, and met or exceeded its target dates from the beginning. That’s very important to me to be able to trust management to follow through.
GLTY
Should start getting really interesting in May....
gltu
porcha, if I had to guess, it has everything to do with "options". the "Sizzle Index" for MARA was over 1.0 yesterday. Today it is over 2.0......I think many are starting to cover now.
JMO
Looks like SoftBank Group out of Japan just bought Fortress Investment Group for 3.3 Bil
Yes I did...and after the back filling on Friday, I see us slowly moving back up.
Just a little back filling going on.....
Jalase, I am not a seller by any means. I am holding for a much higher level. I am a holder and buyer. I think 3D nanocolor will be worth at least $10 on its own, JMO! I'm very patient, don't need the $$$ now, and my cost basis is very low!
GLTY
I agree, the "BIG FISH" are jumping all over MARA right now for a "BIG" reason IMO! Excellent observation, Jalase
Possibly, but MARA has been in an uptrend for the past 2 weeks now. Blue skies above $2.07. We'll see today.