Friday, March 27, 2009

A Letter to the FDA for Avastin Approval

Dear Cheryl,

I am sure you are smiling down from heaven as you watch our progress effect all of world so other families will not suffer from this tragedy. We are making great strides in honor of your memory and our daughter's future.

Dear FDA representative,

I am a member of the Grey Ribbon Crusade (C.E.O. and Founder of C.E.V.A.N. Louie Foundation, a privately funded society towards brain cancer in early developmental phases) and just got the notification over the weekend about speaking at the FDA approval for Avastin event that I will be personally attending. I beg for your consideration on behalf of my late wife, Cheryl Fernandez Louie, and our 20 month old daughter to speak on behalf of the efficacy of Avastin. My late wife passed away of GBM IV on November 2, 2008 and was a very influential woman in the state of Hawaii (Head of several organizations, responsible for the West Coast tourism that fed the local microeconomy, runner up for Miss Hawaii and won several pageants, and was well known by many). After my wife had 2 cranial resects and an emergency C section within a 4 day span, we went through the standard protocols of treatment. To our dismay, Temador (the only FDA approved chemo with exception to maybe the Gliadel Wafer) proven entirely ineffective with her tumor mass increased dramatically due to immunity. Our oncology shifted to Cedars Sinai Brain Tumor Center under the guidance of Dr. Phuphanich, Dr. Jeremy Rudnick, and of course under Dr. Keith Black and Dr. John Yu in neurosciences. We consulted with the staff at UCLA (Dr. Linda Liau), Duke (Dr. Henry Friedman), and Cedars Sinai (Dr. Keith Black) regarding experimental regimens and they all pointed us towards Avastin. My wife’s tumor tissue was not cryogenically frozen under a controlled environment at Loma Linda University and was wax paraphin blocked at their pathology department. Henceforth, we were not eligible for clinical trials due to the fact that they required biomarkers to track efficacy since there are several tumor types in existence. Fortunately, our insurance approved Avastin (which is 50/50) and we immediately initiated treatment which proved highly effective. My wife asked me to promise that I dedicate my life to giving her just more days to see her daughter and spend time with me and her family. Avastin gave us that chance and the first MRI demonstrated a 80% reduction in tumor size and 95% in the subsequent MRI. I will be willing to authorize release of these medical records to validate these claims from Cedars Sinai (I know because of HIPPA regulatory requirements). We were asked to be a testimonial from the researchers at Genentech (known as a subsidiary of Roche now) since the efficacy was astronomical. On behalf of our brain cancer community, please give me this opportunity to present this information to the FDA to further accelerate the approval of Avastin since it has been a long anticipated wait within our community. Our board consists of a UCLA professor for non profits, CRO – biotech consultant, oncologist from Cedars Sinai network, financial backing from private donors effected by the disease, and extensive networks of volunteers to further our cause. We are an entity that will not take external charitable donations and are considered a well capitalized private foundation. It would be my personal dream to discuss these matters in memory of my late wife, Cheryl Fernandez.

God Bless and thank you for your considerations,

Evan Louie
Founder and C.E.O.
C.E.V.A.N. Louie Foundation for Brain Cancer

Wednesday, March 25, 2009

Here are the things we have done in honor of your memory...

Dear wife,

I have made this commitment about 16 months ago to change the brain cancer community. You know that when I set my mind to something I DO NOT fail and will utilize every resource possible to accomplish that goal. You know that I always used movies to help parallel a reality.. like Braveheart "uniting the clans after losing his wife" or Seven Pounds (true devotion to change lives after losing his wife). I guess I can draw inspiration from a storyline in a movie. LOL You will truly live eternally via all that we have accomplished and one day this organization will be turned over to our daughter, Cevan, as Chairwoman and C.E.O. (not like Godfather III with illegitimate funding trying to use a false guise and coming from an organized crime syndicate LOL), and she will be proud of her mother and father for their accomplishments for the greater good. Till that day my love, smile down on us from heaven and ask God to give us guidance...

C.E.V.A.N. Louie Foundation will be non-profit society dedicated to the treatment and education of brain cancer to families and friends affected by this disease. C.E.V.A.N.'s acronym stands for Cheryl Evan Ventures & Acquisitions Nationally will be the only privately funded society which will take no external charitable donations. The Board of Directors and Executives will take no salary and every dollar and cent will go directly to the target demographic of its community. The Board of Directors will consists of industry leading doctors, researchers, scientists, and activists within its respective community. All funds will go directly to the acceleration of clinical trials for FDA approval, educational programs on preparation and treatment planning, designing and institute new diagnosis protocols within the major healthcare systems and hospital facilities, assistance with disability and medical insurance benefits programs, financial assistance to families, logistical family planning, housing and transportation for brain cancer patients, and building solidarity and unification within the brain cancer community. "There are those who make waves in this world... and those who will bring a tsunami..Never underestimate sheer devotion and passion to overcome" quote by Evan Louie, Founder & CEO of C.E.V.A.N. Louie Foundation.

2/15/09 Organizational framework near completion. Board of Directors identified.

2/20/09 Outreach with educational programs and developmental planning

3/17/09 Met with Cedars Sinai brain tumor center oncologist at the facility. 2 hour meeting to discuss medical advisory board and have commitment. He will also consult with other staff to bring the remaining neuroscience / neurosurgery department to provide direction.

3/18/09 Al Musella, founder of the Musella Foundation, called for 2 hour discussion on brain cancer developments, plagues of community, resource planning, and emailed additional information on entry point into community. Referred to several sites, scientists, and new targets for funding.

3/18/09 Called by leading scientist team to discuss launching a mutation of a treatment that is going into Phase I clinical trials which has proven to target cancer cells with minimal impact to healthy brain tissue. The treatment delivery mechanism is via catheter and has a highly successful chance of efficacy. Team of research scientists consists of R&D teams responsible for current treatments and regimens available for brain cancer. They are now at various large pharmaceuticals or biotech firms.

3/18/09 - C.E.V.A.N. Louie Foundation will now be public domain and 501(c)3 status to be filed and organizational infrastructure developed within 6 week trajectory.

3/19/09 Conversation with Al Musella to gather Bylaws and extraction from Secretary of State. Tentative meeting established in NY for tour of PA lab facilities and designation of attendees for this meeting.

3/19/09 - Recruited Biotech consultant from Premier Research a CRO (Contractor Research Organization). Proposal to discuss services they can provide in biotech sector and involvement with scientific community. Discussed SEER (Surveillance of Epidemiology and End Results) Database of all different cancers and end results of investigations (Thousands of Terabytes of Data). They provide more exposure for NIH grants and further exploratory publications for scientific community. Further discussed idea of establishing Consortium that will aggregate all the industry leading brain cancer community including but not limited to principle investigators, scientists, industry leading neurosurgeons and neuro oncologists from brain tumor centers, NPO's, biotech, pharmaceuticals, brain cancer leading activists, etc.. to develop steering community within a public domain. This Consortium will be a panel discussion and steering committee addressing the agenda of challenges facing the brain cancer community today. There are consideration to build direct contact to the FDA for funding via the Orphan Drug program for early phase clinical trials. Considerations have been made to contact ICH (International Conference on Harmonization) which is the global consortium of standards of policies and protocols for new pharmaceutical drugs to be approved. Gathering resources to help expedite proposals to FDA, medical research, study design, etc..Identifying location of brain tumor bank for tissue repository accession. The members of this Consortium can excise portions and do genomic based testing and identify triggers. This is a cryogenic controlled environment for biomarker testing.
Action items:
1.) Identify FDA regional contact and acquire information on Orphan Drug program to help accelerate phases of new treatment regimens for brain cancer.
2.) Orchestrate methodology and planning for Consortium and utilize private financial backing to fund event. Budgetary planning measures will be accounted for.

3/19/09 Conversation with medical adviser from Cedars Sinai about referral to brain tumor tissue bank. We will require public accessibility for other researchers and scientists within the community.

3/19/09 Recruiting new divisions / departments for organizational chart development.

3/20/09 Spoke to Biotech advisor regarding CRO services involvement as independent consultant. Escalation to Global Director for initial discussion. Considerations for NIH grant to fund Consortium or privately fund event. Phase I program rollout identified for outreach programs. Develop marketing and outbound call center to target all major healthcare systems and hospital facilities to institute newly brain cancer diagnosis protocols. The delivery mechanism shall be via grassroots efforts or direct implementation via FDA guidelines or methods of standardization. Organized and centralized effort to require that all facilities now use cryogenic environment for brain tumor tissue repository (to qualify for clinical trials as secondary treatment options and track biomarkers) Create awareness that these facilities pose a potential legal liability by not providing newly dx patients with this option or legal consent forms that they are aware of this protocol. Build network of existing insource and outsource laboratory environments regionally for tissue repository storage. Key contacts shall be identified.

3/20/09 – Phase II to be rolled out - communicate with all leading foundations to pull resources and expedite funding for clinical trials of brain cancer. Consideration to join Blue Ribbon Network when fully operational. Identify standardized informational package to distribute to newly dx patients. Consider protocol to inform new Dx patients to read educational pamphlets and attend monthly UNBIASED webinars / seminars on interpretation of their medical insurance plans, disability insurance and other financial resources available, available clinical trial treatments, noteworthy brain tumor facilities, expectations of primary caregivers, family planning for brain cancer (Living trust & estate planning, advanced healthcare directive / POA, etc..) housing and transportation resources available for brain cancer families, etc… First conference should be a steering committee and / or panel discussion of the brain cancer community consisting of the NPO’s and feedback from the brain cancer families worldwide.

3/21/09 – Discussion about East Coast based NPO that collects, stores, and freezes umbilical cord and stem cells for both research and to be used by donor if needed. Developing lab facility for genetic analysis of brain tumor samples and repository contains 1000 tumor samples. Consideration for centralized lab that collects and stores brain tumor samples, analyzes them, and develops vaccine. Accession to public domain for scientific research, funding, and transportation mechanism TBD. Still waiting on West Coast based brain tumor tissue repository information and availability.
3/22/09 – Working on aggregating findings of existing database of brain cancer regimens for analysis. Bridging biotech advisor and centralized database for analysis. Web site development, content, and organizational chart development underway. 501c3 filing will be addressed after completion of By-Laws and Article of Incorporation.
3/22 C.E.V.A.N. Louie Foundation will be attending the event for Avastin approval by the FDA in Spring Valley MD. Will be sending out request Monday 3/23 to speak at this event on behalf of brain cancer community but deadline was 3/20. We have a compelling story since Cheryl was on the Avastin CPT-11 regimen and 80% and 95% reduction in tumor size in subsequent MRI’s with documentation that can be authorized for release (HIPPA regulatory guidelines) for public domain. Will provide strong credibility on overall impact of our community.

3/23/09 Joined Grey Ribbon Crusade network. A network of Non Profit Organizations pulling together for funding projects correlated to brain cancer. Current pipeline of projects estimated at approximately $600k total. Fundraisers and charitable donations depressed due to economic conditions for these NPO’s. DC Vax project is interesting since moving to Grade II patients and pediatrics.

3/24/09 - Our organization is now involved in the PSA's (Public Service Announcements) for the brain cancer community. The brain cancer awareness month is in May and C.E.V.A.N. Louie foundation will be an integral part in pushing this forward to gain media exposure as a sponsor. PSA's will be provide awareness and fundraising for the Grey Ribbon Crusade who C.E.V.A.N. Louie foundation now belongs to. Proposed idea to contact 1995 World Rugby Champion, Ruben Kruger, who is currently fighting brain cancer to be a iconic speaker (like a Lance Armstrong) of our community. Logistical planning and framework in planning phases for video, DVD, and development of PSA storyboarding in place. Print ad to be developed but may require editing resources. FDA declined a slot as a speaker since I missed their 3/16/09 deadline but still will be present to support our community.I guess the government doesn't have much flexibility on their deadlines. LOL
3/24 All resources allocated for Public Service Announcement with green light. C.E.V.A.N. Louie Foundation will be shown as sponsor on the message when aired. Brain cancer community, we are making strives to get our message out there!!!

The reality of our fight against brain cancer...

This was a message to the brain cancer community who shares common experiences. Many of us can sympathize with each other because at some point we all may have lost a loved one or may be struggling in the constant battle against brain cancer. We know that it may be difficult for others to truly understand how brain cancer is unique within our community since it effects not only someone’s physiological status.. but also degradation of their psychological and social well being. I remember that before knowing anything about cancer I would hear coverage of stories on the news and I would feel sympathetic for that family but never would truly empathize with their disposition until my wife was diagnosed with GBM IV 4 months after we were married at 7 ½ months pregnant. All of us may or may be experiencing or have experienced this in some fashion or form… But imagine what its like to plan out a future with your spouse and have your world turned upside down after your married.. sacrificing your career and home to live in hospital 24/7 for months and months.. to know that your daughter will never know her mother and build that bond.. to know what its like to hold your wife down with one hand while she is having a grand mal seizure while feeding your famished screaming infant daughter after ongoing and prolonged sleep deprivation and break in tears feeling helpless.. to see your wife break out in tears because she is coming to realization that she will never know her daughter.. to hear doctors inform your loved one that there is nothing they can do and your wife tell you that don’t worry, my husband will make me better and acknowledging that there is nothing left to do but watch her die.. to slowly watch your wife lose her memory and not know who you are or who her daughter is.. to invest several hours a day slowly orally feeding with each meal.. to watch them go into a catatonic state and wonder if she can hear you.. to witness them go through dual forms of depression (postpartum & bleak prognosis) at the same time and refuse to eat and go to treatments.. to have to physically carry them everywhere and provide custodial care.. to fight insurance, hospitals, doctors, nurses, disability, etc.. to get treatment or mistakes made that caused her to suffer.. to sit in a dark room and watch them every minute for days and months on end. To wonder and feel guilt that if you did something different she would have survived longer. To be informed by the nurses that she will pass any minute and slowly watch her take her last breaths and her pulse stops…. These are just some of my personal experiences and not the stories I hear everyday from the brain cancer families within the community. If you transform this anguish and pain to sheer devotion, it becomes a driving centrifugal force that will make the lives better for those who are affected. We are a rare breed in the cancer community but one that will always know that our strength will help us endure. No matter all the hardships I would do it over and over again to be by your side.

Wednesday, March 4, 2009

Posting from Kyle Ling.. Best man in our wedding

It took me awhile to write this, because every time I want to write about Cheryl - it was like a flush of memories that hit me like a wave. There was one day that I keep thinking about and recall very visually that I still remember like if it was yesterday.

It was one of the sadest day I have ever experience, and that was to attend Cheryl's funeral. When Mike and I came down to San Diego, we wanted to make sure Evan was alright and we wanted to support him. I knew that Evan went through an ordeal and I was upset with myself of not being able to visit him due to my circumstance. When we first met up with Evan, things were joyous between us since we have not seen each other for a long time. Mike and I agreed to help out with the props and portraits to be placed at the wake and funeral service. Once we arrived at the place, we grabbed the portraits, I held the portrait of Cheryl in front of me. I never went thru so much emotions in my heart and my head went for a spin. I went through a rush of all the good memories that I recall of Cherly and Evan back at the Belmont house. After placing the portraits inside the wake, we all rushed out as quickly as we can. I knew Evan was taking it hard and it took every ounce of energy for me to hold back as well. When we were outside, I actually recall the good times that we had when we were together.

One of those times was when I first met Cheryl. She was one of the nicest person I've ever met. I've met her at Evan's house at Belmont for the first time and already she wanted to make sure I leave with some food. Almost every time I come for a visit, Cheryl wanted me to bring food home. She knows that I lived alone and that I would usually eat out. She always wanted to make sure that I have some home cooked meal. She even taught me on how to cook some dishes that I always wanted to learn how to make. I still follow her recipe for certain dishes til this day. From the first day, when I met Cheryl, I knew she was a good person at heart.

There were other times, I was impress with Cheryl on what she knew and what she did. I witness Cheryl save some friends of being embarrassed of what they did. Not only did she help save them from losing face, but she also educate them on what they did wrong. Just from typing this, I realize that Cheryl would have been the greatest mom.

I also recall about some of the conversations we had before. We were talking about different perspectives and how things evolved from family to politics. She was intelligent and very educated. She tries to help out when she can. She even try to set me up with one of her friends. :) It was funny, because she really tried and it didn't work out for me.

Everyone that met Cheryl was impressed by her right away. I remember one of my friend mentioned that Evan was the luckiest guy to have her. There was another friend (female) met Cheryl for the first time and all she talked about was how hot she was. She talked about Cherly so much that I just had to ask if she was planning to switch sides and remind her that she has a boyfriend. lol Cheryl was just quiet and had a smirk. I could tell she just wanted to say "okay, enough now".

All that memories went thru from just holding that portrait. The last time I saw her happy was at their wedding. That was what I was holding and there was a quote I remember: A picture is worth a thousand my case - that picture reminded me of how Cheryl was. She was that kind-hearted, smart person and a good friend. We all miss her.