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Introduction of Hadine Joffe
Hadine Joffe, Harvard Medical School, US
Tuesday, Dec. 12, 2017 · 1:47 p.m. · 07m 49s
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pleasure to be here it seems cruel and unusual that i was able to make it
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from london after travelling from boston raj got stuck in boston so in in london
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so i appreciate the opportunity to speak here just a little bit by way of introduction about my work
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i'm a psychiatrist uh my work and research over the last twenty years has been in understanding how
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a female hormones in the brain translate into there are psychological symptoms predominant
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depression also insomnia and a little bit in menopausal uh ha class
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which are brain from down on the workers and healthy women and also
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in breast cancer patients and i use it as a model
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to understand how a female hormones extent that we can uh
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in human systems understand the basis of these uh conditions
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i'm also here representing at harvard medical school at brigham and women's hospital we have uh
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cross cutting centre for women's health research called the converse enter
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for women's health research and i'm now be executive director
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so my own work has been in depression i'm i'm representing a broader work um
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what i like to think about as an investigator who's worked both within
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race in with the industry studies in clinical trials a mechanistic work
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is a few key concepts and the first concept i'd like to separate
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out there is that we as a society have accepted that age
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is the factor for drug investigation to the extent that
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we need to study drives in children and then the elderly before they are really
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widely used and f. d. a. at least the us approved for that treatment
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and i really applaud all the work that the f. t. a.
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did in the progress of the of the this martial described
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to uh advocate for the inclusion of sex race and age and all these studies
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i think more as a society we haven't really reconciled sex in the same way that
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we can reconcile age as a specific a factor that we need to is
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investigate um it's the reason why data out there but are not always
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stratified it's the reason why i we don't even always asked
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um so in the air of precision that is and um i think we should be putting age
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and sex hand race up there really very prominently um as
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we approach our drug investigation and device investigation as well
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some other key considerations for clinical trials that uh i wanna bring up and some
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of these are gonna be mentioned by the panel going forward as well
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it's certainly inclusion engagement of women we've made tremendous progress
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particularly in late phase trials interface for trials um of women
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where the indication would be pulp for men and women
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and as you heard from marsha or not fifty percent of
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the clinical trial population you lay trials as women
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um and that is really fantastic these are the people that the disease
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of facts and these are the people be taking these row
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i do think that we still have a lot of room for improvement for the
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early phase studies for the studies where we're looking at drug toxicity is
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very early signs of of efficacy um where and the proportion of women involved is
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much lower although it has improved um it's still somewhere around thirty percent
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ah as marshall comment on that a bit later as well so that that is an important area for
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improvement because if we want to know about toxicity is
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an adverse response in a windows finding studies
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we need to study uh the people in whom the drug abuse and that includes a greater proportion of women
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um i also wanted to say that once we in rolling miniseries
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and i've been conducting trials in women of reproductive age both
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with pregnancy potential also late um reproductive age and then paused for a long time
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that there are very it's relatively simple ways
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to include these women and assess
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for some of the concerns we have which of course the predominant concern
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this potential for pregnancy um we we do have standards in ways of
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engaging people ran contraceptive practised says whether in studies of that
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um we can in alderman or studies and we can include those vary widely in very straightforwardly
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um the other factor i wanted to to mention with regard
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to this population is that there are some conditions
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which are much more variable and uh something like depression of course if you assess somebody today versus
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two weeks ago you might potentially get a slightly different respond
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to uh yeah this survey to press and uh
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self purported assessment of depression or even a clinician reader dipper assessment
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and that might vary in some women with her menstrual cycle
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so it is some uh an advantage to know where
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somebody isn't a menstrual cycle on to know whether
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she is has regular menstrual cycle and you know where she is at the time that you
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assessor and that can be done with relatively cheaply in relatively simply as well
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if i could push the bar little bit higher you could say that perhaps there would be an advantage to assessing
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i people at the same cycle phase um for for all their depression
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assessments for instance and that does take more coordination to time there
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um i also wanna comment on analysis you've heard a lot about um the importance of
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keychain and and analysing data by sex um there are some really
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important advances that con out of those kinds of uh work
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both for men and for women learning that certain doses are more effective uh for men than for women
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learning that certain toxicity some more or less common in men and women and just to give
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you know a few examples that you may or may not have heard
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about there's a noose or tone and pace treatment or a depression
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in which made by to kate and which they very
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appropriately responsibly ah analysts the data and saw
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that women had a better affix see at the higher dose and that would guide treatment
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um if you were treating a woman uh in the future there's also
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data that everybody's knows about with all the dumb for toxicity
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um and that our applauding the the company for looking
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at that at that uh sex specific effects
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i also want to applaud a mark for doing similar work with
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super accent which is a new hypnotic aged use for insomnia
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where again they found a slightly higher plot levels um and
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slightly greater toxicity um in women at at the higher
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doses in before to use them at the lower doses so this kind of guidance really doesn't former clinical care
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um the call to action going forward is for all of us to be involved i think this
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is a multi pronged approach there's no way to regulate this into action there's no way to
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in force this within h. and finding another european funding mechanisms
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um we all need to be in probably only to take
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responsibility for looking for for reaching out and making
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sure that our our research subject population distributed along the
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population that we would expect to receive treatment
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i'm too and all these women and study them appropriately according to their menstrual cycle
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and also uh to think about early phase fine moment um when
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so on that i will turn the floor over to um my colleague from brigham and
Conference Program
Welcome Words
Maria Teresa Ferretti, President, Women's Brain Project
Dec. 12, 2017 · 8:48 a.m.
Welcome adress
Françoise Grossetête, member of the European Parliament
Dec. 12, 2017 · 8:55 a.m.
Presentation of the day
Sylvia Day, Forum host and WBP ambassador
Dec. 12, 2017 · 9:01 a.m.
Introduction of Elena Becker-Barroso
Elena Becker-Barroso, Editor-in-Chief of The Lancet Neurology
Dec. 12, 2017 · 9:21 a.m.
231 views
Introduction of Gillian Einstein
Gillian Einstein, University of Toronto, Canada
Dec. 12, 2017 · 9:28 a.m.
Introduction of Else Charlotte Sandset
Else Charlotte Sandset, Oslo University Hospital, Norway
Dec. 12, 2017 · 9:39 a.m.
Introduction of Carol Brayne
Carol Brayne, University of Cambridge, UK
Dec. 12, 2017 · 9:44 a.m.
Introduction of Maria Teresa Ferretti
Maria Teresa Ferretti, President, Women's Brain Project
Dec. 12, 2017 · 9:52 a.m.
158 views
Introduction of Liisa Galea
Liisa Galea, University of British Columbia, Canada
Dec. 12, 2017 · 9:56 a.m.
Introduction of Lawrence Rajendran
Lawrence Rajendran
Dec. 12, 2017 · 10:03 a.m.
244 views
Introduction of Thorsten Buch
Thorsten Buch, Director, Institute of Laboratory Animal Science (LTK), University of Zurich, Switzerland
Dec. 12, 2017 · 10:08 a.m.
Introduction of Meryl Comer
Meryl Comer , President & CEO, Geoffrey Beene Foundation Alzheimer's Initiative
Dec. 12, 2017 · 10:59 a.m.
Introduction of Mary Mittelman
Mary Mittelman, New York University School of Medicine, US
Dec. 12, 2017 · 11:05 a.m.
Introduction of Angela Abela
Angela Abela , University of Malta, Malta
Dec. 12, 2017 · 11:13 a.m.
Introduction of Tania Dussey-Cavassini
Tania Dussey-Cavassini, Former Swiss Ambassador for Global Health, Switzerland
Dec. 12, 2017 · 11:20 a.m.
480 views
Introduction of Rajendra Dhamane
Rajendra Dhamane
Dec. 12, 2017 · 11:29 a.m.
Introduction of Sofia Petersson
Dec. 12, 2017 · 1:23 p.m.
Introduction of Raj Long
Raj Long , Bill and Melinda Gates Foundation, Vice-Chair, World Dementia Council
Dec. 12, 2017 · 1:30 p.m.
201 views
Introduction of Antonella Santuccione Chadha
Antonella Santuccione Chadha , Swissmedic, Swiss Regulatory Agency, Switzerland
Dec. 12, 2017 · 1:32 p.m.
371 views
Introduction of Marsha B. Henderson
Marsha B. Henderson, Food and Drugs Administration, Office for Women's Health, US
Dec. 12, 2017 · 1:36 p.m.
Introduction of Maeve Cusack
Maeve Cusack, European Institute for Women's Health
Dec. 12, 2017 · 1:43 p.m.
Introduction of Hadine Joffe
Hadine Joffe, Harvard Medical School, US
Dec. 12, 2017 · 1:47 p.m.
Introduction of Maria Houtchens
Maria Houtchens, Harvard Medical School, US
Dec. 12, 2017 · 1:55 p.m.
Introduction of Valerie Bruemmer
Valerie Bruemmer, Senior Medical Advisor, Eli Lilly
Dec. 12, 2017 · 2:03 p.m.
Introduction of Malou Cristobal
Malou Cristobal, Polytrauma/ TBI / Vestibular Rehabilitation Program, New York Harbour
Dec. 12, 2017 · 2:08 p.m.
Panel Discussion: Sex and gender in clinical trials for brain and mental diseases – Reconsidering the way we test drugs
Dec. 12, 2017 · 2:12 p.m.
113 views
Wrap up of Panel Discussion 3
Raj Long , Bill and Melinda Gates Foundation, Vice-Chair, World Dementia Council
Dec. 12, 2017 · 3:23 p.m.
Presentation of Sofia, Robot
Sofia, Robot
Dec. 12, 2017 · 3:28 p.m.
Introduction of Nicoletta Iacobacci
Nicoletta Iacobacci , Singularity University Geneva
Dec. 12, 2017 · 3:32 p.m.
Introduction of Fabrizio Renzi
Fabrizio Renzi, Innovation and Technologies Director, IBM, Rome
Dec. 12, 2017 · 3:36 p.m.
Introduction of Joanna J. Bryson
Joanna J. Bryson , University of Bath, UK
Dec. 12, 2017 · 3:48 p.m.
Introduction of Myshkin Ingawale
Myshkin Ingawale, Facebook
Dec. 12, 2017 · 3:58 p.m.
Introduction of Kathryn Goetzke
Kathryn Goetzke, President, Chief Mood Officer & Founder, The Mood Factory, and Founder, iFred
Dec. 12, 2017 · 4:07 p.m.
Introduction of Nikolaos Mavridis
Nikolaos Mavridis , Interactive Robots and Media Labs, MIT, US
Dec. 12, 2017 · 4:13 p.m.
Panel discussion: Digital biomarkers and new technologies – New tools to support women's brain health
Dec. 12, 2017 · 4:26 p.m.
Closing remarks
Mara Hank Moret
Dec. 12, 2017 · 5:12 p.m.
605 views
