Meeting Up in San Antonio NEXT WEEK!

[karen z]

We will miss you Paty!!!
K

[sassy]

I don't know who will be able to put up with my snoring this year Paty!

We will miss you!!!

[Joan M]

I'm attending and will stop by the table. And perhaps see you at breakfast in the hotel!

Joan

[Paula O]

So glad you are coming too, Joan! That's great.


Paula

[Paula O]

Right now I'm slated to attend an optional Genomic Health Pt Advocate meeting that scholorship advocates were invited to Thursday night . I am looking over the itinerary of symposium events and came across this description below for "Her2: Applying the latest developments to clinical practice". I'm considering the possibility of perhaps switching to it although it looks totally geared to physican's reaching a consensus of the best treatment plan for Her2 patient cases in small discussion groups. Seating is limited and registration is ahead of time on-line. Have you guys ever attended one of these small group discussion formats? Are they suitable for non-physican's to just listen in on? While I'd find it interesting, it's not like I'm an oncologist with a lot to contribute to small group discussion.

Any of you guys going to this? The Hot Topic mentoring session will be at the Convention center right before this, finishing up at 7:30 PM and the other meetings beginning at either 7:30 or 8 PM at the Grand Hyatt and Marriot Rivercenter. I know there are shuttle buses running frequently between hotels. Are the hotels pretty close together and reasonable to get to one meeting to another at a different hotel pretty quickly?

http://clinicaloptions.com/Oncology/...bs/Agenda.aspx

Open Satellite Event Thursday 7:30 - 10 PM
Event Overview
Location:
Marriott Rivercenter
Salon E, Third Floor
101 Bowie Street
San Antonio, Texas
Join us in San Antonio for this important educational event.
Interactive Symposium Format
A leading expert will introduce each case to help kick off your small group discussion on the optimal clinical management of patients with HER2-positive breast cancer.
One iPad will be available at each table to use as a group (to view details of the case as well as other tools to augment your discussions).
Your table will be asked to reach a consensus on how to manage the case and then submit your vote via the iPad. You will have the opportunity to discuss your table’s approach to the case with the larger group.
A distinguished panel of breast cancer experts will then briefly discuss the case and the approach they would take.
Agenda
Didactic Presentation 1: HER2 Testing and Current Knowledge on the Biology of HER2-Positive Tumors (15 min)

•Small group and faculty panel case discussions on HER2 testing and interpretation (15 min)

Didactic Presentation 2: State of the Art in Treating Advanced and Metastatic HER2-Positive Breast Cancer (15 min)

•Small group and faculty panel case discussions; selecting therapy for HER2-positive breast cancer (30 min)

Didactic Presentation 3: Research Highlights: New Agents and Therapeutic Strategies for HER2-Positive Breast Cancer (20 min)

•Small group and faculty panel discussions (10 min)

Question and Answer Session (15 min)
Event Date Details
Thursday, December 6, 2012

7:30 PM - 8:00 PM Registration and Dinner
8:00 PM - 10:00 PM Symposium

[karen z]

I would say we go to these events when we can- they are good. I plan on going. Everything is close by so walking from one event to the next (possibly in a hurry) is very doable.
KZ

[Paula O]

I don't have a Smart Phone but am passing this along in case folks are interested but did not receive the info yet. It was emailed to me today.

Receive symposium updates, information in the palm of your hand

Discover your smartphone's hidden potential and stay connected to the San Antonio Breast Cancer Symposium (SABCS) on the go with this free official symposium application, developed by Ascend Integrated Media.

What to expect from the mobile app
Here & Now: The "Here" portion of the feature lets you enter your location and the system presents you with a list of exhibitors within a specific radius. The "Now" aspect of the feature provides a schedule of events taking place at that specific moment in time, so that you are always aware of the event itinerary.

Presentations: Presentation title names, presentation numbers, categories and dates

Exhibitor Listings: Search for companies at SABCS 2012

Wayfinding: Uses the interactive exhibit hall floor plan to help you map your time on the hall floor

Entertainment: San Antonio activities you can enjoy

Stay in touch using SABCS's texting program
Stay informed of important SABCS issues and not-to-be-missed presentations and events by opting in to the new mobile texting program.

These messages sent directly from SABCS organizers keep you abreast of key events, times and locations. You'll receive no more than five messages each day, from Dec. 4 to 8, 2012.

Opt in to the texting program
You may opt in to the program by texting "SABCS 12" to 80802. Text "SABCS Stop" to stop receiving texts from SABCS. Standard text message rates apply and are only available through US operators.

Download the free app now
Enter m.sabcs.ascendmedia.com into your mobile browser to then start your download or text "SABCS App" to 80802. (This texting shortcode option is only available through US operators.)

[karen z]

WOW- Now we really are meeting up next week- in one week !!!!
o.k., back to grading.
kz

[StephN]

Thanks, Paula -
Anyone who is registered by today got that email blast about the smart phone app. They have had that the last 2 or 3 years anyway that I knew about. I think Chrisy used it.

My phone is only semi-smart ...

[Paula O]

Debbie, How's your talk, “Advocate Perspective on Trial Design and T-DM1” for NBCC's Project Lead's Advanced Topics coming along? That's really cool that you're doing that--good for you! You go, girl I am looking forward to hearing you and Dr Hurvitz' “Latest Trials and Evidence for T-DM1 in Metastatic Breast Cancer” right before you.

This is going to be such a wonderful learning experience! I like the looks of the Her2 small group discussions that I shared the link to above. I got a postcard in the mail yesterday about it as well as another session too which I guess you guys going to the Symposium probably did too. The info says that space is limited and people are supposed to register ahead so don't forget to sign up on line if you are going to that one. I still haven't decided if I'll be going to that meeting or the Genomic Health Advocate Program.

I'd love to hear about the her2support booth in the exhibit area. What literature do you give out? I bet you've had some interesting conversations with folks stopping by. Do you have business cards for Her2support.org?

IMHO It seems like a great idea for us to set a specific date, place, and time for us ALL to connect, meet each other and we can get a group picture. Let's make it happen--I imagine that if those of us not part of the exhibit booth team just randomly stop by we won't see everybody. Don't you guys rotate taking turns in the booth? What are the exhibit hours--the whole time during meetings or other set times? For those of us who have never gone before, we wont recognize each other in the crowds without an initial contact I don't suppose. Debbie L. and I were in the same break-off discussion group the whole time during Project Lead this summer and neither of us recognized that we were both part of this forum the entire week we were there.

I've mentioned the possibilities that'll work for me--they've got us hopping on a tight schedule pretty much attending most every session plus additional ones (On Wednesday breakfast is at 6:15 and last meeting ends at 10). Debbie mentioned that she is carpooling with others and an evening meet-up after the meetings isn't good for her.

I know you guys at the booth will have lots of time together but I'd like to propose getting everybody attending the symposium together briefly to meet each other sometime during the break on Wednesday 12 - 1;35 (How about 12:30?) The sessions before then are at Exhibit Hall D--shall we meet there?

There is a session on Her2 Positive Breast Cancer from 6 PM to 7:30 In Exhibit Hall D on Tuesday. Maybe we can all sit together and that is the one night I am free after 7:30PM. Would our group want to connect after the meeting? While we chat, if people like the idea I'd be glad to offer to give feet, hands neck, or back rubs to any of you guys who wants one while we all visit. I am not a Massage Therapist but I've been told that I do a good job so if anybody has sore feet from all the walking or has any neck kinks, or could use some pampering, I'll do my best. :0) Rubbing feet in a hotel lobby wouldn't exactly work--we could go to one of our motel rooms (mine is fine or elsewhere) to hang out, or go out for something to eat instead of a chat with massages included, or whatever. If this isn't good with you guys, not a problem. I'm just tossing around some ideas and hoping we can arrange a time or two for us all to meet up. It would seem a shame for us to be travelling from all over the country and not have at least a little time all together. I'd love to get to know you guys. :0)

HER2-Positive Breast Cancer – Exhibit Hall D
Moderator: Eric P. Winer, MD
Dana-Farber Cancer Institute
Boston, MA

Adjuvant therapy of HER2 positive breast cancer – the next installment
Karen Gelmon, MD
BC Cancer Agency
Vancouver, CANADA

Advances in HER2+ breast cancer
Nancy U. Lin, MD
Dana-Farber Cancer Institute
Boston, MA

Neoadjuvant approach in HER2 over-expressing breast
cancer: Therapeutic implications and biomarker discovery
Mothaffar Rimawi, MD
Baylor College of Medicine
Houston, TX

Paula

[phil]

Too bad NBCC leadership did NOTHING to help get T DM-1 approved any quicker. sad that they then talk about trial adesign , jumping on the bandwagon after EMILIA finally got nat'l attention. Why did they not step in when This FDA rejected tdm-1 on 2010. ? because NBCC top leadership is a biased fan of This FDA . They have no understanding of the reality of Stage IV Survival issues. They are more interested in competing w/ other top bc advocacy groups for headlines . Komen and ACS have no understanding either , but at least they dont blindly follow whatever This FDA says about " speeding up " cancer drug approvals " . heres hoping we get a natl bc advocacy organization to ' get it ' in 2013 !

[Paula O]

Here's a raised glass of the carrot baby kale juice I am drinking tonite: (It tastes better than it sounds toasting real change, lots of progress, and significant headway in 2013.

Phil, I left you a question a while back in a thread and apologize if perhaps you already answered me and I just missed it. Here it is again: At the very end of the video you guys made, there was a list of proactive things people can do to work toward expediting approval of T DM-1. It scrolled through very quickly and I wondered if possibly you also have it in a format that is easy for you to copy and paste and share with us. Thanks for what you guys are doing. Your voices are being heard and you are making a difference.

Paula

[phil]

I will try to get that for you . basically , we need natl media attention. Starts w/ local media stories. direct them to our website, http://stageivsurvivor.webs.com . Thanks, Paula , for your understanding and encouragement.
I get real testy about T DM-1. To see NBCC speaking up about future trial design when it isnt EVEN APPROVED FOR STAGE IV NOW, ticks me off. Honestly, I consider This FDAs' bungling of it one of the greatest tragedies in the history of the War On Cancer so far, costs many lives every month that appr. is denied . And NBCC's blind FDA support only helps This Slow FDA slow down even more. . So, I called , sent e-mails to "The Big Three " bc advocacy groups over a yr ago. Only Komen responded then , and talked a lot , did nothing. They did give lukewarm , written support to the Avastin super-responders . I called . e-mailed NBCC several times - no answer. After all, I'm a nobody , not Bill Clinton ! I was at the FDA Avastin hearing when Christine Drucker from NBCC shocked the Avastin Survivors by testifying against them. ran into a NBCC Boston area rep last month, polite talk , but , of course , no acknowledgement of a pro - FDA bias . Talk of ' stopping overuse of bone marrow transplants ", back 10 + yrs ago . What does that have to do w helping stage iv get T DM-1 now ? NBCC did great work w/ original herc in 96, but the operative word is " DID " . Right now their top leadership is way off base w This FDA , no understanding of stage iv needs , and rights. I'm on my second attempt to get in touch w/ ACS New England, met a senior official at a bc walk in Oct. so far no response .
Ok , I'm done , on this thread , because I love it when stageiv fighters get together , support each other , you are my " Wounded Warriors ". Have a great Symposium , if u get to wear our shirts we will be honored . God Bless and Heal.

[Paula O]

Phil, I am new at all this and you know a whole lot more than I do. Would you possibly be able to sum up key facts about TDM-1's delay and help me formulate and articulate some intellegent, well thought-through questions about the current status/availability of: TDM-1/ any other key Her2 related issues BY SUNDAY? I fly out early Monday morning. Perhaps your input would also be helpful to the other ladies who will also be attending. Here is a discussion about this to add to if you like (I appreciate and have printed off the questions that are already posted there): http://her2support.org/vbulletin/showthread.php?t=56299

If it works out, (and I get brave enough) I would like to present some questions in a factual, respectful, totally non-accusatory way if there is opportunity in a related Q & A session and/or perhaps privately with individuals --perhaps I can do a small part in stimulating thinking and action. I'm thinking right now of that quote I posted awhile back "Speak the truth even if your voice shakes". I'm brand new to breast cancer patient advocacy but want to do my part to fight this disease.

There are many Her2 fighters who could be helped with TDM-1 and it's wrong that it is not available to them yet. I understand why you are frustrated and upset, Phil. I appreciate you and your wife working so hard to help others.

I'd like to do what I can but I am not at all comfortable "attacking" NBCC leadership or anybody else there. I am willing to speak up and ask questions/make comments in a polite, factual, respectful way. Right now I feel ignorant about the subject so am trying to think through who to talk to that would make a difference and what to say. I'd appreciate anything you can do to educate me on the issues if you can point me in the right direction and have time to write out questions you'd like answers to.



Here are some docs I see listed as coming in one meeting;
Dennis Slamon (Wanna give that guy a great big "thank you" for his part in Herceptin!
Michael Press
Kimberly Blackwell
Howard Burris

There is a Gennentec meeting and other Her2 sessions with other Drs/researchers like
Eric P. Winer, MD
Dana-Farber Cancer Institute

Karen Gelmon, MD
BC Cancer Agency
Vancouver, CANADA

Dana-Farber Cancer Institute
Boston, MA

Mothaffar Rimawi, MD

and others if you take a look at the on-line program.
Anybody know these people personally? Anybody in particular stand out as being good to direct questions to?

Any hints/ tips from your experience? What would you want to say to the Gennentec reps if you were coming, Phil?

Paula

P.S. People who are going to the symposium reading this: any feedback on the questions in my post yesterday morning?

[phil]

Alright Paula , here we go !! " Phils " First rule : W / all these BIG organizations , " its not personal, its impersonal ", helps me kee p my sanity . For ex., This FDA Oncology Drug Review Division ( whew ! ) is not against Lorraine personally getting life-saving tx . Second Rule : We are non-partisan, we are not anti govt, not anti -Big Business , nor anti - Big Research, nor anti - Big Advocacy. Any large organization can lose touch w/ those its designed to serve, merely , by getting too big. and how could they all really understand Stage IV issues , when they havent personally experienced it ? And when , until the past 10 -15 yrs , so few Stage IV pts lived long enough to SPEAK UP , even now too many die too fast, too young . But more and more are living longer, and speaking up . I admire the perseverance of the founders of NBCC , and Metavivor, who dealt w/ many founding mbrs dying . But they did not give up. ( Metavivor does seem to have some affibity for BC Action top leadership. I havent even mentioned BC Action top leaders writing to This FDA in April , 2010, asking them to NOT APPROVE T DM-1 ! ) .
I try not to attack people personally, but I tell it like it is . I had aretired Congressman tell me early on, " They don't talk like that down in DC " . he wanted me to be more " politically correct ', I agonized over that a while, but really feel called to speak truth . I know people don't like to admit mistakes, but we all make them. Peope's lives are at stake . I am more sad than angry w/ the top FDA folks.
hey. breaks over , back to work. Appreciate your willing ness to step out for Stage IV. i will post talking pts later today. God Bless .

[phil]

re above : We are not anti -govt., etc. We are Pro- Stage IV Survivor .
If I were at the Symposium , I would seek out media , and give them the following :
Reasons To Investigate This FDA's ( Mis ) Handling of T DM-1 ;
1. This FDA Rejected Accelerated Approval in 2010 for a drug that had a" 38 % COMPLETE or Significant Response " for 6 months or longer. Isn't this one of the strongest statistical responses ever seen for one of the deadliest cancers ?
2. Doesn't T DM-1 have some of the fewest side efects EVCER in achemo?
3. In 2010 This FDA stated that it rejected T DM-1 partly because " patients had not exhausted all options" . Lorraine and THOUSANDS of others had ! They never interviwewed a single patient !
4. This FDA then mandated that genetech complete a 2-3 year trial comparing T DM-1 to an inferior drug , Tykerb. Tykerb was given acc. approval in 2007-note the date - previous Admin. We want consistent policy involving Stage IV Lives from Admin. to Admin. !
5. After rejecting accelerated approval , This FDA twice rejected Genentechs' request for expanded access data to count towards appr. Why so rigid ?
6. This FDA already knew the breakthrough , revolutionary nature of this " Smart Bomb " drug , yet has made NO attempt to consider early review of EMILIA data the past TWO and a Half Years ! Again, why so slow ? They had the original data from 2012, preliminary EMILIA data since May, , now the Final Data since August !!
7. The Assoc. Press reported at ASCO in June that this " Dream Drug " " just missed the RIGID criteria for immediate approval " . This FDA couldn't bend arule for the best breast cancer drug in 15 years ? One where SIXTY-FIVE PERCENT of the EMILIA Pts getting T DM-1 have lived TWO YEARS SO FAR , and counting ??They coudn'yt think justa little " outside the box " in 2010 , or now ? Even appr. in June would have saved hundreds of lives .
8. Why does This FDA sneak out Press releases on Fridays ? They had a sham hearing in June 2011, revoking Avastin, but the Commissioner waited until the Friday before Thanksgiving to release her final decision . 5 months ! On Friday, June 8th of this year they sent out a Press Release at 8:30 PM EST ?? , giving only conditional appr . to Pertuzumab , denying it to Stage IV Survivors to this day ! Are they ashamed of their actions ? They sure act like it , and should be ! Investigate This FDA !

[schoonder]

Phil,
If FDA's excuse in rigid implementation of rules that applied to evaluation of t-dm1, a targeted cancer therapy, regulations, which later agreed by head of agency, were obsolete and ineffective for new, cutting edge therapeutics, then what is use of having this governmental FDA oversight (sub)committee, what are their responsibilities in expediently addressing and correcting shortcomings to assure that stage iv her2+ mBC patients didn't receive a death sentence as a result of this ruling?

[StephN]

Paula -
Responding to your idea:
" I'd like to propose getting everybody attending the symposium together briefly to meet each other sometime during the break on Wednesday 12 - 1;35 (How about 12:30?) The sessions before then are at Exhibit Hall D--shall we meet there?"

The exhibit times are from 11 am to 5 pm. Some of us have to be at our table during that whole time, so WE do not get the break you spoke of. However, our place in the exhibit hall will not be hard to find - T-8, and we are an end booth sticking out into the center area.

There are round tables nearby and we can eat our lunch there and take turns being behind our booth. When you check in and get your conference materials, you will get an orange book of the presentation details and a map of the exhibit hall will be in the back of that.

There is still the Tuesday night after the HER2 talks, at 7:30. We will need to find some place for a bite to eat.

Hope this helps.

[Paula O]

Thanks for the info, Phil. Yesterday was the first email within our group looking for cancer survivors for the media to interview after certain sessions. They recruited and got volunteers for someone on Tamoxifen, with diagnosis of Triple negative, and Her2 NEGATIVE. I wonder if they'll be looking for someone who is Her2 positive who wants to talk about TDM-1 and it's delayed availability . I guess that would be me if that opportunity arises after I ask God to help me be brave and bold to speak up and get over feeling chicken-hearted and nervous with a media person or doctor who knows way more than I do . I'm concerned that I don't know enough to represent the cause well enough and am happy to hear the key points and get help with coming up with good questions. Truthfully I feel ill-equipped and inadequate to get before the media and start questioning these doctors either. I can picture it, cameras rolling...my response after they ask me something I don't know or defend their position: "Excuse me please, while I look through my notes from Phil to find the answer to that question." Ha, ha On a serious note though, I'll bring your website address along http://stageivsurvivor.webs.com --even handing somebody that would be a good thing because "You da man, Phil and Lorraine is the gal" in doing a top notch job representing this important cause. It can be rather intimidating to rock boats and question experts but I know one can get over it, just do their best, and speak the truth as you say. What did you do to arrange the interviews you've done, Phil? Are the media mingling among the people afterwards or is this by invitation only ahead of time more typical? I'll bring along all the questions people have shared they'd like answered, and if the opportunities arise to get answers from some of these presnters, I'll try to do that.


I attempted to get Her2/TDM-1 as my "Hot Topic" to be responsible writing up an article in layman's terms which is part of the requirement in getting the scholarship. I volunteered ahead of time for it, asked if I could switch with somebody assigned to it but that didn't work out. That's OK. I'll be learning alot though covering the Mini-Symposium 2: Breast Density: Mechanisms and Clinical Implications.

My favorite nursing job I ever had was as a clinical research nurse working at the U of Az, long, long ago, conducting clinical trials in various phases of study , mostly investigational antihypertensive and cardiac drugs. One time I was asked to present one of our abstracts at an International Symposium in Geneva, Switzerland (a fine place to be invited to I must say--there for a week with enough time to do a bit of touring with the Dr --one of my bosses--and nurse I travelled with which was fun, fun, FUN!). However, I witnessed doctors raking each other's research over the coals, interrogating each other during that conference and others I attended during the Q & A times Honestly, some of those docs seemed downright hostile towards each other after the presenting was done.(Thankfully they were merciful on me after my presentation--Whew, was I ever glad to have the standing up in front of all those doctors from all over the world experience behind me!!!!) I understand the need to back up research and make sure it's good quality stuff and not messing with statistics though and understand the importance of people looking over each other's research and peer review can be a good thing. Is there a lot of grilling of the presenter like that at this conference--is that what these Q & As are like in this conference too ? Have you found any doctors and scientists that have really gotten behind the cause of stopping this crazy delay in getting TDM-1 out there for the patients who need it? What exactly is the concern that is causing the delay by the FDA?

OK, onto the next topic---everybody getting together. Thanks, Stephanie for responding.

Let's plan on this:


---It looks like the easiest time for everybody to meet and connect is right after the 6PM to 7:30 PM Her2 meeting on Tuesday in Exhibit Hall D. Let's remember to get a group photo then. I know Debbie mentioned she is carpooling with others and an evening meetup is difficult but hopefully it'll work out for a short visit anyway since it's right after a meeting. Then, let's everybody who wants to go out to eat together.

Tuesday night looks much better than trying to work something out during exhibit hours. Let's skip my proposal of trying to get everybody together Wednesday too. I'll see how things go for me that day--maybe I'll say hi to whoever is manning the booth during lunch time then. I'm sure we'll all drop by the booth sometime during the week and see whoever is manning it then and perhaps it'll work out to sit together during some of the meetings.

(Please note Stephanie's correction below of directions to Her2 booth--am copying from email so Joan, Debbie, Amy, and I all have it--it's also on the exhibit map of course)

"Our table top booth - T8 - is on the far right side of the plan and is not on the end (like it was last year!).

We were close to those round table over in the middle last year, so none of those close by this time.

Further to the right, and off this map, is the Great Hall where the main presentations will take place. So we are close to that.

Hope this helps give you a mental image of where we should meet."

Paula

P.S. What kind of freebie food is typically availalble during poster sessions, etc? Do you usually see any raw fruit and veggie trays by chance?

[phil]

Schoonder, are you referring to Congress' HELP Committee ? which " oversees " This FDA ? We met w/ them in 2011, Sen. Harkins' aides saw Lorraine, listened , but made only a half -hearted attempt to talk w/ FDA . Each pol. party covers up for their own. But we will be back. They wont be at San Antonio anyway.
This FDA was mad at Big Pharma for not finishing trials they had promised to finish after getting acc. appr in the early 2000's. and felt some drugs ( avstin ) had too much risk . They could have kept avastin appr for metastatic tnbc, but they dont listen to pts in-put , so they revoked it completely. This FDA, w/ a rookie Prez., cracked down , revoking Avastin . Gen, fought back and appealed , along w/ the Avastin super -responders. FDA was pissed, completely affected thier scientific judgement, and they blocked t dm-1. Plus Dr. Pazdur wants longer testing to prove overall survival stats, overriding time to progression, which was gold standard before new FDA commish gave Dr. Pazdur free reign over trial approvals.
Paula , I have some public speaking exp. but always nervous. We think of what we've been thru, all those who never got a chance , and go for it. Politely ask ? at forums , who knows maybe a media person will hear you. Do it for our friends Jay, Jennifer, Tracys mom , who never got the chance to try it. Maybe T DM-1 Miracles will be there as " Living Proof " to add thier input , like Lorraine has . Many T DM-1 ers honestly dont know how lucky they are to have gotten it. and counter This FDAs saying Lorraine is an " outlier ', unusual. Shes unusual only because they rejected appr.
Docs wont say much, but they all thought it should have been appr. in 2010. If they speak against This FDA or Pharma, they get blacklisted from future trials. maybe a famous doc, like Dr. Susan Love, who isnt doing trials ?, might speak. Dont count on it.
We focus on This FDA for reform , others involved later. To Genentech, and Pharma in general, we have already said, " If you think your drug is good enough to be considered for Acc. Approval, its good enough to give out as compassionate use. " Theres not enough comp use , and the mechanism is way too unwieldy.
So go , mingle , tell anyone interested to talk w/ Lorraine. say to anyone, , why wasnt it appr in 2010 ? shouldnt there be an expose' , investigation to prevent such a slowdown from happening again ? get their e-mails and send them to us. We are always ready to talk ! God Bless , have a great time !!