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Introduction of Marsha B. Henderson
Marsha B. Henderson, Food and Drugs Administration, Office for Women's Health, US
Tuesday, Dec. 12, 2017 · 1:36 p.m. · 07m 05s
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very interesting because they make you reflect on your cell and as a the
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director of women's health it dragged ministrations something that's always an act down
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is that i was take care givers well for a mother in law had multiple strokes
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and a stepmother who had a dementia otherwise known as all timers
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and so this area of a discussion became very personal to me
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but uh as i was invited to this event by uh george
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remember getting of course uh having known his incredible wife trish
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i couldn't help but except the invitation at that was extended to me that an incredible
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meryl calmer but uh uh uh and so i'm very pleased to be here
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my office at the us food and drug administration was established in nineteen ninety four
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our office has no regulatory authority but we said in the office of the commissioner
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essay voice for women as a voice for sex as a biologic variable
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our mission to protect in advance the health
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of women through policy science and education
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we monitor and track the participation of women in us clinical trials
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we support regulatory research regarding product it safety and effectiveness
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and we conduct professional training and consumer
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education with international education campaigns
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now consistent with ammunition i've been asked to do two things in all of five minutes
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which is to give an overview of the us food
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and drug administration's policy regarding women in clinical trials
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and to describe our new initiative called averse women in clinical trials
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as you know f. t. a.'s regulations and guidelines other back on about work so
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so i'm gonna give you a little history level lesson to let you know where we are today
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in nineteen seventy seven many of your way of the f. t. a. issued guidelines
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recommending the exclusion of women of childbearing potential in phase one
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uh and and really phase two clinical trials
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it was an over reaction to some dangerous products for when like the little mired in the yes
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in nineteen eighty five f. t. a. issued
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its first requirement to ally specific subgroups
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including p. d. actually in geriatric patients as well as those with renal failure
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to evaluate evidence in support of dosing modifications
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however it it needed some importance subgroups including sex and race
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in nineteen eighty seven we issued guidance clearly stating that both sexes of animals
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should be included in preclinical drug safety studies for products that were
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targeted for use at both sexes yes definitely and i each
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in nineteen ninety three
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we withdrew the restriction regarding
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limiting women of childbearing potential in clinical trials it
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was a guidance that became an actual
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regulation what we call the demographic one in nineteen ninety eight
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in nineteen eighty eight we said that saved ineffectiveness data which
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could be presented by gender age and racial subgroups
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and dosing modifications were to be identified in the applications
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it also included winning of childbearing potential in
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both phase one and relief these trials
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in two thousand we issued what we call the clinical regulations
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and this permits f. t. e. to place a clinical when i in the studies
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the treatment of serious or life threatening disease applications if women or
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men are excluded from the trial due to the reproductive potential
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our most recent guidance has focused one the medical device industry
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and when we published it in twenty fourteen it outlined
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f. t. a.'s expectations regarding sex specific patient moment
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data analysis and reporting of study information but device applications
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and i'm pleased to tell me that over these many years we haven't made a tremendous difference
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it is a myth that when are not included in clinical trials
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and it is a myth that we don't analysts by sex
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over the past ten years women's participation has remained close to and
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sometimes more than fifty percent in like phase drug trials
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and for biological trials button on sex specific products
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for example we did an analysis in twenty thirteen and we've been tracking over
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the years but in twenty thirteen we published a report that says
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that board analysis by sex one hundred percent of the drugs and biologics
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where am i spy sex and eighty eight percent
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of our medical devices what analysts plastics however
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in some product areas we want to see what diversity
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so we developed a new initiative called diverse when in clinical trials
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it takes a three pronged approach the first we
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are hosting scientific workshops and weapon hours
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four f. t. a. reviewers focused one sex as a biologically right
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two we provide external researchers huh
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we can do to get that we do in collaboration with
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the n. i. h.'s office of research on women's health
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and the re we do does we're speaking directly to win and for the first time
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we are asking women to except the invitation to
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participate in clinical trials and i'm message
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is make a difference for yourself and for women like you
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working in partnership with many national organisations we've reached
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millions of women with this next which
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i hope that in this five minutes that had that i didn't treat you
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to ask a lot of questions and so i have now to see
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.
245 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
