1993: The Year Women Entered Clinical Trials & Why This Matters for Human Health (with jessica federer)
about the episode
What happened in 1993 still affects medicine today.
That was the year women were required to be included in NIH-funded clinical trials, a shift that helped begin correcting decades of male-centered medical research. In this powerful conversation, Sharon Kedar CFA sits down with Jessica Federer, former Chief Digital Officer at Bayer and Managing Director of The Women’s Health Fund, to explore why this moment matters not only for women’s health, but for human health, innovation, and the future of medicine.
They discuss how exclusion from research shaped diagnostics, drug dosing, autoimmune disease, heart health, cancer care, and why one of the world’s largest multi-trillion dollar industries still has enormous opportunity ahead.
This Episode Is For You If:
You want to understand why women’s health impacts everyone
You’re curious how clinical trials shape modern medicine
You care about innovation, investing, longevity, and better healthcare outcomes
What You’ll Learn:
Why women were historically excluded from many clinical trials
How 1993 changed medical research standards
Why better science creates better care for everyone
Key Takeaways:
Clinical research has historically relied heavily on male data, creating downstream gaps in care.
Including women in research improves diagnostics, treatment, safety, and outcomes across medicine.
Women’s health may be one of the greatest innovation opportunities of our time.
Jessica Federer
About jessica federer
Jessica Federer is a trailblazer and market builder. She was the first female chief digital Officer in the global pharmaceutical industry. She now sits on public and private boards, convenes the Health of Women Investor Summit and is the managing director of the Women’s Health Fund. She also serves on the Yale Institutional Review Board and the Yale Blavatnik Fund advisory.
Connect with her on LinkedIn, Instagram, TikTok and Youtube.
Episode Outline
(00:00) Welcome Jessica Federer
(00:50) Why Jessica cares deeply about women’s health
(02:10) Why 1993 was a turning point in clinical trials
(04:33) NIH rules requiring women in funded research
(08:28) Why women spend more years in poorer health
(12:08) Mammograms, heart disease, and missed opportunities
(15:36) Why cancer treatment may look barbaric in hindsight
(18:53) Why top talent is moving into women’s health
(21:13) Autoimmune disease and the need for better systems
(25:29) The next frontier: brain health and hormone science
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Sharon Kedar CFA: Welcome to the podcast.
Jessica Federer: Oh, I'm so excited to finally be on your podcast.
Sharon Kedar CFA: People don't know that much about just the pure magic that you are. Like they know that you do the Nasdaq conference. That you were the Chief Digital Officer at Bayer and that you have this Women's Health Fund, but I don't think people understand the force of nature that you are like in terms of transformation.
Do you have a personal why, as a woman yourself, that you really care about women's health? I feel like we all are bringing a why that a lot of us aren't even talking about. That's probably like the next level is for some of us to actually talk about stuff.
Jessica Federer: Yes. My why is that fundamentally, I think it's unjust that we have an entire multi-trillion dollar industry that is basically half science; it's on half the population. And I completely understand why women were excluded and prevented from being in clinical trials for many years because the thalidomide disaster was so horrific; we didn't know enough about science. Technology wasn't advanced enough. The only thing we could really do to protect women and children was just say, you can't be in the science. But when we changed that in 1993, we haven't put enough emphasis on really closing the gap that happened. And so it's still astounding to me that it was just in 2024 that we saw what pregnancy does to a woman's brain.
It was just in 2025, we saw how an embryo implants. These are fundamental, exciting scientific breakthroughs, and we're just now getting to them. So for me, as someone in the industry who wants to see new innovation come to change people's lives, when you have a space that is this ripe for disruption, it's not waiting on new cell and gene therapy, technologies, manufacturing equipment, anything.
We just have to put women in the lens. That's an incredible opportunity for value creation in the short term.
Sharon Kedar CFA: It's amazing what you've done with it. Let's bring it back to 1993 and why women weren't included in personal trials 'cause I don't think people really understand that. And to frame it up so we can put a marker on 1993, Jurassic Park was like the thing. Whitney Houston's I Will Always Love You dominated the charts, it was the time of the X-Files. So that's a little bit of what happened that year. But can you talk about why women were not included in trials and what that means.
Jessica Federer: Absolutely. So putting into context that science is always an exploration of the unknown. And we have now really good systems in place to protect people. When you go back to the beginning, early days of science, we had some really bad failures. Let's take the Tuskegee Syphilis Study experiment, where scientists observed African American men without giving them treatment to watch a disease progress. While there was a treatment that had come available and they just let these people suffer. So on the backs of these horrible ethical clinical trial research failures, we then had the situation where a lot of women started taking a drug called thalidomide while they were pregnant to help with nausea and morning sickness.
And it caused devastating birth defects. And they're still among us today. And this impacted so many families around the world, and that really caused the industry to step back and say, are we doing the right thing?
Letting women of childbearing age participate in clinical trials? Now, keep in mind, this was decades ago, we didn't have all the modern forms of contraception. We didn't know so much about the human body as we do now. So the safest route to protect a generation of children was just to say women of childbearing age should not be included in clinical trials.
And it was truly done to protect them because that was the limited amount of knowledge we had in science. It really was an experiment. And can you sleep at night knowing you let a woman enroll in a study and something horrible may happen to her child because of that? So the safest bet was just take women out.
So then around the nineties, the movement started coming up of, we're starting to understand more. We have better contraceptive options. We know more about science. We're starting to understand that well, women seem to be experiencing autoimmune disease and cardiovascular disease and Alzheimer's disease differently than men.
They seem to be having twice the rate of side effects to most drugs than their male counterparts. We need to look more into this. And that's when we had the law passed, the National Institutes of Health resolution passed in 1993 that required women and minorities to be included in NIH funded research.
That was it. So if the government is gonna put taxpayer dollars into NIH funded research, it has to include women and minorities. And it was very basic. It didn't say at what levels, it didn't say what representation. It just said they need to be involved. And so it's taken many years. In fact, just last year, December 2025, the FDA put out this incredible draft guidance on how to power studies differently to see the differences in sex.
So this is huge, and it just came out in December. But slowly, since 1993, since the time of Jurassic Park and Groundhog Day and Whitney Houston, we have slowly been integrating women more into science. And this is just a reaction. If we'd started from scratch, we'd say, the humans that grow and birth every life on the planet deserve to be the basis for our studies.
They deserve to have a very different focus because that is where all of our human life comes from. Let's really study that. Now we're really playing catch up and saying, okay, how do we build this in? How do we do another study? How do we look at this differently? How do we get away from using male cells and male mice?
How do we start to change the system? How do we break away from these integrated systemic structures that were first structurally put in place to protect women, but then ended up harming them?
Sharon Kedar CFA: That was such an incredible summary and for those listeners and viewers, you can see why this is the person who, convenes a waiting list only Health of Women conference.
Can we talk about 1993 and the implications for women in terms of lifespan and healthspan? And also, I think sometimes people think there's like this polarity where it's one gender versus another, and my lens is always, I've got a husband, I've got a son, I've got two daughters.
To me this is human health.
Jessica Federer: When it comes to human health, we're always in continual discovery and learning mode, right? So sex is really important as a biological variable. If a cell has a Y chromosome, it's gonna behave differently than a cell without a Y chromosome. But we're also starting to learn how important your microbiome is.
If you have a certain microbiome, you're not gonna respond to certain chemotherapies, but you may suffer and go through it anyway. So we're starting to understand how different people are. And, you know, in the early days of science, we just didn't have the capacity to measure all of these variables.
We weren't aware of all of these variables. So we pretty much accepted that you made a drug, and this is why that risk benefit consideration is so important at the FDA. What's the benefit compared to the risk? And if someone's already terminal and you know, they're already going to pass away from this terrible disease, we accept a higher degree of risk in the studies or side effects.
If somebody's a healthy, active person and they just wanna take a new birth control pill, then we have a really low tolerance for side effects and risks because that risk balance level ratio is off. And this is another really important consideration; I expect that as science continues to advance, we will find more factors that are heavily impacting how we respond to diseases, how we respond to drugs, as we start to understand more about gene expression and personalized medicine.
But this is a pretty fundamental one because we know that 23rd chromosome. We can study it, we know we've, we excluded it, and now we need to add it back in. But that will be one component of enriching our scientific understanding.
Sharon Kedar CFA: When we think about women being included in 1993 in clinical trials, and before that basically the 75 kg male being the standard, I think sometimes it's just so big that it's hard to unpack.
But have you seen any work on, and do you think that there's a correlation even, between the stat that our mutual friend Lucy Pérez put out at your conference, which was at the stock exchange in 2024, about how women spend 25% of our lives in poorer health than men, and it's during our peak years, and we don't fully understand why. Do you think that the clinical trial gap is part of that and do you think that we can catch up?
Jessica Federer: Oh, such a good question, Sharon.
It is. It is really a part of it. Women have side effects at about twice the rate of men for prescription drugs. A large number of the drugs recalled from the market in the last decade have been due to side effects that were seen in women that weren't seen in the clinical trials because they weren't powered to see the differences in sex. And if you think about women having twice rate of side effects, if you think about the fact that they really weren't studied, and we don't understand why women are 80% of autoimmune patients or two thirds of Alzheimer's patients or 50% more likely to die in the year after a heart attack than men, it makes sense that women would have more time in poorer health, and then that would translate into an economic impact because they're unable to fully participate in work. And that's on top of taking care of their families.
Interestingly, women are the majority of physicians and nurses and providers and med students now.
And you would think that would change, but we have to go back to the fundamental science. What are we teaching in medical schools? How are we training physicians? You've had some phenomenal guests in the last years that have really brought this home of what this means for bone health, for heart health, for hormone health.
You've made it really real for people. And at the end of the day, we need to bring this back into the companies that are researching and developing drugs. We need to bring it back into the IRBs, the ethics boards, that are approving these studies. We need to bring it back into the health systems that are reimbursing women's surgeries at lesser rates than the exact same surgery on men.
We need to bring it back into society in a way that makes it accessible and equitable.
Sharon Kedar CFA: I have to say,
I think the way we're gonna make change, just having spent a couple years, spending time with folks like yourself as a personal passion, I think it's gonna be through disease categories.
Part of creating change is that you're actually sharing. Do you know any other woman who co-leads a multi-billion dollar VC in the life sciences who's transparently sharing her hormone replacement protocol? That was a trailblazer baller move to say, this is impacting me.
Jessica Federer: To say, let's make it acceptable to talk about something that impacts all the people we love.
So first, thank you. Thank you.
Sharon Kedar CFA: I have chills because I just think that if I am struggling and I saw five doctors, what do other people go through? And I will relentlessly pursue an answer. I've always just been like, problems are solvable.
You just made it acceptable for the next generation, for this generation and the next generation by breaking the stigma and just doing it. You made me feel comfortable going online and sharing my mammogram results 'cause I have extremely dense tissue and what is fascinating to me and infuriating is that on every single mammogram, you can see if a woman has breast arterial calcification, which is an indicator of other arterial calcifications that could be problematic for heart disease, right?
Jessica Federer: You could see it on every mammogram, but we have never told women that you have breast arterial calcifications. So finally, Dr. Nina Vincoff, when she was at Northwell Health at the time, she did this little study and said let's see if women find value in knowing. It immediately saved a number of lives. So the health system rolled it out, and now in this lovely little text message you get after your mammogram, it tells you, here, do you have BAC?
How much BAC do you have on a ranking of one to four? And then, do you need to go to a cardiologist right away and have follow-up medical attention? And if you step back and you think, what's the leading killer of women? Heart disease.
It's not breast cancer, it's heart disease. But if in the mammogram, you can see someone's heart disease risk, you can see if they're gonna have a heart attack, you can see those arterial calcific, why wouldn't we be telling them?
Sharon Kedar CFA: I think what you're talking about is the opportunity which is, we're in an era where there is low hanging fruit. And it's one where, I think we care about not just lifespan, but this word that people talk about: health span.
And so when we say one in eight women will have breast cancer, but there's a high survival rate. I'm like, okay, but what happens when she's diagnosed? And chemotherapy and radiation? It is very traumatic. What I don't understand is mammography is 1960s technology. So if they're squishing your breast hard, you basically need to say thank you 'cause they need a quality image. And then, for the half of people who have dense breasts, the image, and I don't even know if AI can really address this, but the image that shows breast cancer it's basically a white tennis ball in the snow.
And mammography is essential. I think that hat is back here. Oh yeah. This is one of my favorite episodes. Mammography is essential. Quality matters. But what I don't understand is if we're missing it for half of women with dense breasts and like mammography's first line, then there's ultrasound, MRI as an option.
Can't we do better? Sharing the mammography is one thing, but weren't you just unsatisfied with the diagnostic?
Jessica Federer: Every year. I'm grateful we have anything available. Let's start with that. Because we have to. We are saving lives. Everybody, go get your mammogram. Do not skip it. It's important.
But can we get to the next gen of mammography already? It is time to upgrade. We are trying to hug that machine and, wiggle it. It is just not efficient. And the other example is ovarian cancer. What is the gold standard for diagnosing ovarian cancer?
Taking out an ovary. The gold standard to diagnose the disease is to remove the organ. So of course, women delay having the surgery to take out the ovary and the fallopian tube, because that's a pretty serious procedure and they wanna rule out everything else first. So by the time ovarian cancer is actually diagnosed, it's quite advanced.
We have some incredible innovations coming to market soon, hopefully, that investors are supporting, that will enable a blood diagnostic, which will make it really simple for people to find out if they've got ovarian cancer and will save so many lives. But these are very frustrating experiences, which lead to what you started with, Sharon, that 25% more time in poor health because of these experiences that we all go through.
Sharon Kedar CFA: If we had women included earlier in clinical trials, I imagine we might be in a different place with the drugs because how can we study drugs if [women are] not in the trials?
Jessica Federer: I think cancer is an area where we are gonna look back 20 years from now. I hope it's 20. It might be longer. Years from now, we're gonna look back at cancer treatments of our lifetime and think they were just so barbaric and inhumane, because we are getting to a world in which we're gonna see a whole other form of cancer treatments that enable the body to fight it itself or non-invasive, that don't have nearly the same dramatic chopping and burning and radiating that we experienced.
And that's why we need to keep advancing science forward because the stuff we have today isn't nearly what it could be. But that's what we have. And I think through every stage of medicine and healthcare, that's the frustration. We know it can be better, but we also know one new medicine takes about 10 years and a billion dollars. And you invest in so many brilliant companies that are accelerating research, trying to improve care and firsthand, how long and how tedious and how expensive it is. But we have to keep innovating if we're ever gonna get away from these frustrating, outdated approaches to get to modernized medicine.
And that goalpost will continue moving and it should continue moving until we get to something that is as humane and respectful and science driven as it possibly can be.
Sharon Kedar CFA: I love that, Jess, and I think it takes a lot of courage and bold action. One of the companies in our portfolio is taking on autoimmune and cell and gene therapy, and this idea that you can reprogram your immune system for an autoimmune disease. They had pretty amazing results.
These ideas, like these big, bold ideas, it's gonna take a lot of courage and it's gonna take the A team. And I think one of the things you're bringing to this and how we can catch up from 1993 is the understanding that ideas need to be investible and that it's the same bar
for human health, whether it's related to women or otherwise. Can you talk a little bit about why that bar got moved, or how there was like a little bit of a misunderstanding? Can you just talk about a little bit about the huge positive shifts we're seeing towards people understanding that yeah, you gotta underwrite this to a real business.
Jessica Federer: You know better than anybody out there. You're seeing these companies pitching to you every day and you're investing in them. It is an evolutionary change. We didn't have women in research. They didn't really have a voice in the research because their data wasn't in it.
But then it wasn't just about the women. Part of this is just science. You and I love the scientific exploration. We love the discovery. We love the new coming into commonplace and the education around it. And how do you take this fascinating new treatment and scale it so everybody has access to it in countries around the world. These are big business challenges.
These are hard things. They are exciting. Yeah.
Sharon Kedar CFA: Like cell and gene therapy. It's super expensive. It's hard to manufacture. Yeah. But do you think that we're at a point where there's enough people willing to do the hard?
Jessica Federer: Yes. And I think we have enough people who are attracted by the hard, right? If it's easy, anyone can do it. So we all go for what's really hard. And anything in CNS, anything in the brain, it's still really hard.
We're literally building the field. We are building the market. This is where I always love going to speak to students at Yale or at Wharton or anywhere I can find students, I talk to them because, if you ask a student, what's the first time we saw what pregnancy did to a woman's brain? They're guessing the first date that we had MRI machines. They're not guessing 2024. So they wanna go in and solve it.
And so now we have an inkling of the opportunity and I truly believe that the most high impact, the most meaningful scientific advancements during our lifetime, will be in women's health because it's just such low hanging fruit.
And because all these young, brilliant doctors and scientists and analysts and engineers are coming out saying, wait, what? Where are we? This is so fixable. And when you've got these brilliant talent going into this space for something that is truly so fixable, it will get funded, it will get to market, it will change the gold standard.
And this is why you and I like new things that are changing and growing and challenging the norms and changing the status quos. Because once we change the status quo here, once we educate, once we have the scientific knowledge, we're not going back. These are moves that are sustainable.
We are changing the industry forever. We are changing healthcare for the world forever. And that's why we can't leave out half the population.
Sharon Kedar CFA: I just had this huge insight talking to you. I think that because of social media, because of AI being used as your additional doctor. If you're like a teenage girl or college age girl, they're checking what the doctor's saying. And I think that it's also providing sort of an education. It might not be a perfect education, where there's this new generation that's not gonna stand for it. And I think it's gonna be a huge catalyst. And then I think if we marry that up with the implication of AI on human disease overall, I think those forces will collide in our lifetimes.
I'm just gonna throw out and ask you, there's one area that impacts the 25% of women living their lives in poorer health during their peak years that I think is ripe for change. Here's the stats for everyone who has a woman in their lives or a daughter. 80% of autoimmune diseases are in women. We don't understand why. There's over 100 of them and they often coexist, but the rub for the current system, 'cause some of this you can like hack the system or you can go to a Midi health. One Medical has a menopause offering now. You can be like, no, I really, think I need estrogen. But with autoimmune, if it's lupus, it's a certain doctor. If it's Hashimoto's, it's another doctor. If it's MS, it's another doctor. So you're literally trying to make an appointment with a GI, a neurologist, a dermatologist, a rheumatologist... There's so many different doctors when you're trying to figure this out. When it comes to autoimmune, like I just feel like someone's gotta develop an autoimmune AI app because it's not like there's that cross-functional team of the GI, the rheumatologist, neurologist. It's gonna take years if someone has autoimmune. That and HRT the misinformation, and heart. I bet you that's a huge chunk of the 25% issue.
Jessica Federer: Couldn't agree more. I couldn't agree more. Just going to the science of it. So for our listeners, the X chromosome has, let's say over a thousand genes for the immune response and the Y chromosome has in the hundreds. And so women, of course, because they have two of the X's, they have a lot more genes for immune response.
And the reason is, if you're being rational, a woman has to grow a foreign body. Your immune system is supposed to reject foreign bodies. A woman grows a foreign body for nine months with different cells and her body, her immune system needs to be complex enough to grow foreign bodies and not reject them.
And so we do see a lot of immune conditions manifest after birth. And interestingly in women with complex autoimmune diseases during pregnancy, they often have their symptoms subside because the immune system is busy with protecting, you know, and, and growing a new life. And so we are just beginning to start to understand the impact of the genes on the X chromosome. There's an incredible lab, sex-based differences in the immune system lab at La Jolla, and they only do this. And they put out what I think is probably the best publication on the topic last year.
Really amazing publication. Everybody should read it, regardless of your interest in women's health or not. But it looked at how cells respond differently in different organ systems, depending on whether they had a y chromosome or not. And the results were incredible. And nobody's done that before.
How do cells respond differently in different organ systems based on the X or the Y? And the fact that just came out last year is pretty sobering. But you are completely right. Autoimmune diseases are so complex; it factors into the brain, into all of your organ systems, into your quality of life and such a profound way. And most of the time we just expect people to suffer.
Sharon Kedar CFA: If they even get the diagnosis. I dream a world where we can help them get the diagnosis faster.
Jessica Federer: And then have a cell and gene therapy or a treatment that is available to support them.
I saw Jennifer Doudna speak recently in New York City, and every time you hear her speak about the science that is not treating disease, but curing disease. And you just, this is magic. We are curing disease. This is why we all go into science.
This is what drives humanity to look for advancements and progress and advanced knowledge, and share knowledge. It's inevitable. We will get there. You and I will make sure that we continue to focus on it. But I think for future generations, the pull is just too great to do something this good for humanity and for the world.
We will solve the technical, the operation, the cost issues. We will solve it. We will find these cures.
Sharon Kedar CFA: Jess, my last question for you is if you had one on your wishlist. I have many, but one that I'm adding today is an AI for autoimmune.
What do you add to the list?
Jessica Federer: I think it'd be something around the brain. We know so little about the brain and now starting to understand how hormones affect the brain so profoundly during menopause, during pregnancy, during every stage of life. And knowing that, we see such a big disparity by sex in Alzheimer's disease, in all mental health conditions.
Sharon Kedar CFA: But Jess, when you say brain, you're really talking about so many different diseases, right?
Like you're talking about Alzheimer's, you're talking about probably MS. You're talking about... You know? I think that the answer is gonna be just that some A team players getting together and having the courage to think differently.
Having the courage to say, I don't know. But whether it's like how we transform early detection of breast cancer, like I am unsatisfied. I really am.
Jessica Federer: We will have better options. If I take the postpartum example, we didn't even know how many women had postpartum. Because until there's a treatment, women really aren't getting diagnosed.
Having served on the board of Sage Therapeutics, where we launched the drug for postpartum depression. Your hormone levels in your brain go to a hundred times what they usually are when they're pregnant and then they drop.
And so with this new treatment, most women feel better in a day or so. And to see that turnaround and then to see the parents come to the board meetings and tell you, you saved her life. You saved mom and baby. And now women can call their doctors, they can feel better and, most of them can feel better quickly.
That is a lifesaving change. And it is my hope that we will see more innovations like this.
Sharon Kedar CFA: I have so many ideas after talking to you. My brain is just going.
Jessica Federer: We're gonna keep making the world better one day at a time. One experiment, one study at a time. Thank you, Sharon.
Additional Resources
Bayer: https://www.bayer.com/en/
National Institutes of Health (NIH): https://www.nih.gov/
U.S. Food and Drug Administration: https://www.fda.gov/
Jennifer Doudna: https://vcresearch.berkeley.edu/faculty/jennifer-doudna
About Your Host
Sharon Kedar, CFA, is Co-Founder of Northpond Ventures. Northpond is a multi-billion-dollar science-driven venture capital firm with a portfolio of 60+ companies, along with key academic partnerships at Harvard’s Wyss Institute, MIT’s School of Engineering, and Stanford School of Medicine. Prior to Northpond, Sharon spent 15 years at Sands Capital, where she became their first Chief Financial Officer. Assets under management grew from $1.5 billion to $50 billion over her tenure, achieving more than 30x growth. Sharon is the co-author of two personal finance books for women. Sharon has an MBA from Harvard Business School, a B.A. in Economics from Rice University, and is a CFA charterholder. She lives in the Washington, DC area with her husband, Greg, and their three kids.
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FAQs
What Changed in 1993 for Women’s Health?
In 1993, the NIH Revitalization Act required women and minorities to be included in NIH-funded clinical research. It marked a major step toward more representative science and better evidence for treatment decisions.
Why Does Inclusion in Clinical Trials Matter?
Clinical trials influence how drugs are dosed, how risks are measured, and how treatments are approved. More representative trials can lead to safer, more effective medicine for broader populations.
Why Is Women’s Health a Major Investment Opportunity?
Jessica Federer explains that women’s health is not a niche category. It touches fertility, menopause, autoimmune disease, cardiovascular health, cancer, mental health, diagnostics, and longevity, making it one of the most significant growth areas in healthcare innovation.
Why were women excluded from clinical trials?
Historically, safety concerns, especially after the thalidomide tragedy, led many researchers to exclude women of childbearing age from trials.
How does this affect medicine today?
It can impact everything from side effect profiles to diagnostic delays and treatment effectiveness.
Is women’s health only relevant to women?
No. Better science for women improves families, workplaces, economies, and healthcare systems overall.
Who is Jessica Federer?
Jessica Federer is a healthcare executive, investor, former Bayer Chief Digital Officer, and Managing Director of The Women’s Health Fund.
Who is Sharon Kedar CFA?
Sharon Kedar CFA is an investor, operator, and host of Innovate & Elevate, where she explores the ideas shaping human health and innovation.