FDA Drug Development Workshop Real Time Tweets
Below are Simmaron Research's real time tweets from the FDA Drug Development Workshop on April 25th and April 26th last week. They are notes from most of the workshop sessions. While tweets usually have the most recent on top we have swapped this so the tweets here are in chronological order so you can follow the conversation from the beginning. If you are interested in more updates from Simmaron's Twitter page you can follow us here @RedefiningMECFS.
Right now, Drs. Peterson and Klimas discuss redefining #MECFS before historic @us_fda workshop starts today.— Simmaron Research (@RedefiningMECFS) April 25, 2013
#MECFS patients address immune measurements and immune modulating treatments at historic @us_fda workshop. Very articulate advocates. — Simmaron Research (@RedefiningMECFS) April 25, 2013
Dr. Peterson implores @us_fda to subset patients for assessing treatments, using NK cell function, VO2max, spect and MRI brain scans.— Simmaron Research (@RedefiningMECFS) April 25, 2013
Dr. Peterson describes 25 years of literature ID'ing NK cell function as worldwide marker for #MECFS at historic @us_fda drug workshop. — Simmaron Research (@RedefiningMECFS) April 25, 2013
At #MECFS Drug Workshop @us_fda said it looked for surrogate endpoints in early days of #AIDS to measure efficacy. Secondary infections. — Simmaron Research (@RedefiningMECFS) April 26, 2013
At @us_fda Drug Workshop, Dr. Munos from InnoThink Center focuses on high quality data and open access to innovate in #MECFS treatments.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr. Munos: evidence of a badly broken system where young investigators can't get grants until age 42. #MECFS needs more investigators. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr. Munos: Drs are greatest source of innovation in serious illnesses with no treatments. Couldn't be truer in #MECFS.— Simmaron Research (@RedefiningMECFS) April 26, 2013
@us_fda workshop, CFIDS Assn identifies two phenotypes of #MECFS: immune and autonomic. — Simmaron Research (@RedefiningMECFS) April 26, 2013
@us_fda says Accelerated Approval key is intermediary endpoints that predict clinical trial endpoints.— Simmaron Research (@RedefiningMECFS) April 26, 2013
@us_fda #MECFS workshop: drug development 10-15 years, drug repurposing hope is 5 yrs. Far too long for patients. Work together plz. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Munos: Critical network of physicians essential to innovation plus scientific expertise. #MECFS has passion, maybe networks not close enough— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Montoya: much missing from presentations today. Lots of herpesviruses in patients, HSV. Therapies help these viruses and patients. — Simmaron Research (@RedefiningMECFS) April 26, 2013
@us_fda DrMontoya: measuring cognitive function is where benefit from treating viruses appears first in #MECFS. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Klimas asks panelists about endpoints for #MECFS clinical trials. We want to hear her own opinion!— Simmaron Research (@RedefiningMECFS) April 26, 2013
DrMontoya: measuring cognitive function is where benefit from treating viruses appears first in #MECFS. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr. Montoya:need much more viral and antibody testing of #MECFS patients.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Klimas notes there are immunological treatments that are used effectively by very experienced #MECFS clinicians! — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Bateman tops her list of what types of treatments #MECFS needs most:immune modulators.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Montoya: we use anti-virals to try to prevent the immune cascade that affects #MECFS patients. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Klimas:Natural Killer Cell function tests measure immune system in #MECFS and those are clinical trials we need most.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Montoya at #FDA #MECFS: what we did for #AIDS was multicenter studies and much federal funding. Need #bailout for our patients. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Rowe of Johns Hopkins thinks outcome measures for #MECFS are available now for clinical trials.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Rowe: could design a trial for #MECFS responders, then randomly withdraw treatment to prove efficacy. Hard for patients, but solid, quick — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Snell: #MECFS patients are exercise intolerant. Exercise testing assesses functioning and is objective measurement.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Snell discusses VO2max as outcome measure of treadmill testing for #MECFS at #FDA workshop. Been used for years, correlates w improvement — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Unger #CDC at #FDA workshop speaks of heterogeneity in #MECFS definition. Studying best sites to address subgrouping. Very important!— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Unger: studying 7 clinical sites, including Peterson's, to collect volumes of data of #MECFS patients. Discussing interim analysis now. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Unger #CDC finds heterogeneity in #MECFS patient population overall. Within the 7 sites, there is significant heterogeneity too.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Unger #CDC says additional measures of cognitive function in #MECFS will be analyzed in subset of patients in 7 site study. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Unger #CDC finds mental health and role emotional preserved in #MECFS based on prelim 7-site study. Very important finding.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Rowe identifies the clinical trial gap in #MECFS and #NIH for this illness. — Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Klimas: we have #MECFS clinical trial investigators, who have the patient population and many years of assessing function.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Klimas:best part of meeting is #FDA's invitation to bring trials to them for collaboration and approval. "I will take them up on that" — Simmaron Research (@RedefiningMECFS) April 26, 2013
#FDA rep says #MECFS needs NIH funding for multisite clinical trials using experienced clinicians. Been done in other illnesses.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Klimas: need a small group mtg with #FDA for next steps with very experienced clinicians. — Simmaron Research (@RedefiningMECFS) April 26, 2013
#FDA needs to produce guidance for industry on #MECFS endpoints:FDA's Michele. Plz involve expert clinicians.— Simmaron Research (@RedefiningMECFS) April 26, 2013
Dr Klimas: we have biomarkers now that predict functioning for #MECFS patients. #FDA needs to accept them. — Simmaron Research (@RedefiningMECFS) April 26, 2013
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