Ned Sharpless: I want to begin by thanking Dr. Biden for joining us today. Its great to have the first lady visit the NCI.

We all need this morale boost: 2020 has been a pretty rough year. This global tragedy of the public health has been hard on an agency whose mission is devoted to advancing the public health, so we really appreciate your interest and I want to express our heartfelt thanks.

Despite the challenges of the last year, it has been a remarkably productive time for cancer research and a remarkably productive time at the NCI. We are seeing progress against cancer at a faster rate than at any time in human history:

Lots of new great scientific advances that translate into new ways to diagnose, prevent, and treat cancer,

Important advances in cancer screening and prevention, and improvements in how we do clinical trials,

Record numbers of FDA approvals for new drugs and devices for cancer, and, importantly,

A steadily dropping annual cancer mortality.

Cancer mortality in the U.S. has been declining since the early 1990s, but in the last few years the pace of that progress has sharply accelerated, with the largest year-over-year declines in cancer mortality in the history of our statistics occurring in the last two years in a row!

As you know, Feb. 4 is World Cancer Day, which focuses on Intl Progress Against Cancer. NCI is proud to work with many international partners throughout the world to address cancer on a global scale and that work is coordinated by our outstanding Center for Global Health.

In 2021, the National Cancer Institute is partnering with others across the community to commemorate the 50th anniversary of the National Cancer Act, legislation that established some of the programs that form the backbone of todays cancer research enterprise. So, its really a good time to reflect on whats been accomplished and how much work remains.

Its all too clear that despite this progress I mentioned, this has not been good enough. We still have too many Americans dying of cancer, and we have too little progress against certain types of cancer like pancreatic cancer and glioblastoma. And even when we have treatments for these cancers that are able to cure some of these patients, often these treatments are really toxic and leave patients with lifelong survivorship challenges.

And now we have this new problem against that backdrop of the pandemics effect on cancer diagnosis and cancer care. The pandemic has closed hospitals and clinics throughout the country. And because of this, there have been many delays in screenings, diagnosis, and treatments, and we believe these delays incurred may translate into worse outcomes for people with cancer over the next decade.

So, a main challenge right now for the NCI is to get over the disruption caused by the pandemic and to get back on that great pace of progress in cancer research. We will face this challenge and declare together that nothing will stop us, nothing will stop us in our work on behalf of people with cancer.

And I know that Dr. Biden is very much with us in this challenge. The first lady, as everyone knows, has been a longtime advocate for cancer research and for people with cancer. Her interest in the topic began in the 1990s when friends were diagnosed with breast cancer. And I think we are all aware of Beau Bidens battle with glioblastoma, succumbing to that disease in 2015 and the impact this has had on the president and first lady.

In fact, I think it was this private tragedy of the Biden family that led to a really great public act, the Beau Biden Cancer Moonshot, which came about under the leadership of then-Vice President Biden. The NCI staff here today, took that vision and ran with it, bringing together stakeholders across the research community to work towards the goals he set for us.

To date, this has led to the launching of more than 240 exciting new programs and initiatives aimed at the laudable goal of rapidly accelerating cancer progress. It includes things like expanding our ability to treat cancer by awakening the immune system.

The Moonshot has worked on new approaches to fight childhood cancer. And there are Moonshot initiatives aimed at improving cancer care and underserved populations so that all patients can benefit from cancer progress and this is really just scratching the surface. There are many more great programs in the Moonshot. It is our fervent hope and belief at the NCI that this remarkable effort to improve the lives of all people with cancer will live up to Beaus memory. So Dr. Biden, thank you again for coming today and we were so eager to hear your remarks.

Jill Biden: Thank you, Dr. Sharpless, and your remarks are so heartwarming to me. Ned, were so grateful to have an accomplished researcher, academic inventor, physician, and author at the head of our nations premier cancer research institution. So, thank you for your leadership.

And Dr. Collins, thank you for joining us today as well and for your years of service at NIH in three administrations now. On behalf of both the president and me, I also want to thank you and the NIH for helping to create the vaccines and the treatments that are going to save so many lives and help our nation recover. And were just so lucky to have you.

So, its a pleasure to visit the National Cancer Institute virtually today. And Im grateful to be coming to you from the White House today as your first lady. Its the honor of a lifetime, but I know that even more than that, its a responsibility to serve the American people.

And from coast to coast, we face so many diverse and complicated challenges and yet when I was second lady and in my travels across the country over the last few years, Ive seen again and again, that there is one challenge that unites us all, one thread of pain that runs through every community, North and South, rich and poor, in the best of times, the depths of this pandemicand thats cancer.

The first time I heard the diagnosis for someone I loved, I was in my early 40s and the year it happened, not one, but actually four of my friends found out that they had breast cancer. And cancer took the life of both my parents. My sister had to have an auto-stem cell transplant and then, there was our son, Beau, as you referred to. Cancer touches us all and because of that, your work touches us all.

Youve brought the Cancer Moonshot to where it is today. Youve dedicated years to studying our immune systems and supporting clinical trials. Youve lifted up community-based clinics and treatment research. Youve led breakthroughs and discovered new ways to test.

And though this last year has been so difficult, NCI has risen to meet the challenge, uncovering how this pandemic has affected rates and figuring out how to continue this work, your work, because cancer doesnt stop for COVID. For more than 50 years, this organization, your organization has pioneered this frontier. Thanks to you, countless lives have been saved, countless families are whole, and there is more hope than ever for every person who is touched by this disease.

So, on behalf of the president and me, thank you, on behalf of every family who has faced cancer and a very grateful nation, thank you. We are so proud of everything that youre doing here, and now Im more excited to learn about the work that youre doing, so let me pass it back to Ned.

Sharpless: Thank you. To give you a flavor of some of the great work that goes on at the NCI, we have three of our researchers here to tell you about their areas of cancer investigation.

The first is Dr. Worta McCaskill-Stevens. Worta is a medical oncologist and chief of our Community Oncology and Prevention Trials Research Group. And then well hear from Dr. Stephanie Goff, who is a surgical oncologist at the National Cancer Institute. And then finally, from Dr. Ligia Pinto, whos a scientist at NCIs Frederick National Lab.

I thought wed start by hearing about patient outreach and engagement, and this is getting patients from underserved populations into clinical trials. For example, as you can imagine, a big problem in cancer research is translating these exciting new advances in cancer therapy and cancer prevention into real-world progress for all patients. This means reaching cancer patients in rural communities and underserved populations. And its really critical that we figure out how to do this.

And so, Ive asked Dr. McCaskill-Stevens here to come to tell you about the NCORP Network. Worta, will you take it over?

Worta McCaskill-Stevens: Thank you, Dr. Biden and welcome to the National Cancer Institute. Thank you, Ned.

Clinical trials provide the scientific pathway to treatment. However, clinical trials are much more than science. They are about science helping people. Through clinical trials, our aim is to enable the advances in cancer research and to make sure that theyre applied as broadly as possible. We wont have done our job if the outstanding research that we conduct is only enjoyed by a few.

But it all begins by improving access and diligently seeking ways in which we can increase participation in clinical trials. One way that we do this is to take the trials where the people are, and this brings me to the NCI Community Oncology Research Program, which provides access to clinical trials in communities where adults and children with cancer and those who are at risk of cancer live.

The NCI NCORP program is an academic and community partnership in which clinical trials related to the management of symptoms, prevention, screening, the delivery of care, quality of life and disparities and treatment are conducted.

NCORP has 46 community sites, 14 of these sites are focused in areas throughout the country that have large areas of rural patients and racial and ethnic minorities. Over 4,000 physicians participate in this network at over 1,000 sites that reflect very diverse oncology practices.

Enrollment into NCORP traverses over 43 states and includes Puerto Rico in Guam. Enrollment from the NCORP is almost one half of the enrollment in the NCI National Clinical Trials Network, which enrolls over 20,000 patients per year. Enrollment at the local NCORP sites allows those sites to be up-to-date on research tools and for their staff to contribute to the progress against cancer.

Weve learned a lot from the community sites. This has led us to great insights about the importance, for example, of understanding chronic diseases, diabetes, and hypertension, which is so prevalent in underserved communities. Also, to appreciate interactions of socioeconomic factors of social injustice when enrolling, and to have us consider these factors in our trial designs. Allow me to share with you an example of a recent trial that has been practice-changing.

This is the TAILORx trial. This is the trial that assigned individualized options for treatment. This was the first and the largest of NCIs precision cancer trials. It enrolled over 2,000 woman, 16% of which were minors and most of these women came from rural areas and community settings. This trial showed us that only about 20% of the women with early-stage breast cancer benefited from chemotherapy after surgery. These data affect and apply to 50% of breast cancer in the United States.

This trial, due to its size, the duration, and the fact that it had hypothesis testing, the fact that women may receive less therapy, could only have been conducted within the NCI. We now know using a molecular test that we can identify those women who only need endocrine therapy to reduce their risks of recurrence. These women now dont have to have chemotherapy side effects such as nausea, fatigue, risk of infection, or hair loss. These women can be cured and go back to their families and to their work.

So, that woman in rural America doesnt have to drive many miles to have the chemotherapy. Access to this and other very important clinical trials, we think, is a very important step in the direction of health in cancer therapy. Thank you.

Biden: Thanks. Can you tell me, how do people find out about your trials? Is it through their oncologists and how do you get the word to all the oncologists across this nation?

McCaskill-Stevens: Well, this is actually a network and one of the unique things about the NCORP is that they really connect with their communities. When they come in they bring the specific demographics and understand their patients. They have connections within the community so that the referral patterns come to them.

The NCI also does a great job of providing information to the public about clinical trials. Information comes from our societal meetings, and because its an academic-community partnership, much information is shared at those meetings and those direct contacts with those individuals, those organizations.

Biden: Well, Ive seen a lot of the need for the information to get out to the rural communities as Ive traveled around this country. And really one of the major places that I actually saw a need forlike youre saying, the chemotherapy clinicwas the Navajo nation and how they had no chemotherapy center. And they were traveling two hours to go get chemotherapy and then to travel home.

So, I think we just have to do a better job disseminating information out to communities about whats available to help people, because I think people are desperate for information on people who have cancer. Thank you for all that youre doing. I really appreciate it.

Sharpless: The dissemination of information about clinical trials is a real challenge because its often hard to match patients to the right trial and its something weve really worked on very hard. And having the ability to enroll patients at 1,100 sites nationally has, I think, made that somewhat easier, but theres still challenges that exist. Thanks, Worta.

Next, Id like to have you hear about some really exciting NCI intramural science on how to treat cancer. This involves this topic of cellular immunotherapy, which sounds like science fiction, but the idea is you use a patients own T cells to sweep them up, in a way, and give them back to the patients, reinfuse them to treat their cancer and this technology really was pioneered at the National Cancer Institute. And so Id like to invite Dr. Stephanie Goff to tell you about her exciting work in this area, Stephanie?

Stephanie Goff: Thank you, Dr. Sharpless, and thank you, Dr. Biden. As the daughter of a teacher, its a real honor for me to be able to present my work to you, and a virtual welcome to building 10. Dr. Collins refers to the NIH as the National Institutes of Hope and every place like that needs a house and so this is the house of hope here in Bethesda, where were able to take care of the patients that enroll in all of the clinical trials, across the institutes and centers.

We practice the medicine of tomorrow here and we take that responsibility very seriously. There are approximately 1,600 different clinical trials happening at the clinical center right now. And even in this challenging pandemic year that we just finished, 45 new clinical trials were started by investigators in the NCI and we were able to see over 1,500 new patients from all 50 states and territories.

And the work that we do here is the work that we refer to as first-in-human. So, its really after those long hours and nights in the lab, its when those moments that a theory becomes a reality when youre able to see it work for the first time in a patient and those moments are magical.

I was fortunate enough to train here and now have been able to come back and work side-by-side with my mentor, Dr. Steven Rosenberg, who has been pursuing this concept of immunotherapy quite literally my entire life. And what hes been pursuing is, can we get the immune cells of our body to learn how to see cancer? And because of the pandemic, so many people now understand a little bit about how T cells see things, particularly viruses.

We have a lot of amateur immunologists blooming these days, but can we get T cells to see a patients cancer? And if they can do that, can they make it go away? His career has been one built on bench-to-bedside. That cycle of learning that we all do. When we take something from the lab, we try it in patients once its safe. And then we see if we can get it to work. We learn from the successes, we learn from the failures, and then we go back and we try again.

He started that work in patients with metastatic melanoma, a very rare disease, but a very deadly one. And he learned that by stimulating all the T cells in the body with a drug called interleukin-2, which was one of the first immunotherapies to be approved, that he could make peoples tumors go away.

And it wasnt just away for a little while, it was away forever. There was a small portion of patients, maybe 4-5%, but they would live the rest of their lives cancer-free, normal lives, no more chemotherapy, no more additional drugs.

And so, as our tools got better, as Dr. Collins and the work that he did on the human genome became possible, we became able to see tumors much more clearly in a way that we couldnt do before, because the problem is that our immune systems are actually designed to ignore our bodies. We dont want them attacking all the tissues that we have, not to attack our breast or our thigh or our pancreas.

But when that tissue starts to go bad, when it becomes a cancer, what is it that makes it switch? How can we get the immune system to engage? And it turns out when you look down at the very, very fundamental level, at the DNA, when that change is enough to make that cell no longer look like the person that it lives in, thats when the immune system can kick in.

So, if we can find those cells, what can we learn from them? And how can we give them back to patients? Because if we can harness that, then we can just set the body on top of itself. The Achilles heel of that cancer is that it has changed and made itself visible.

I was teaching a course in basic immunology and cancer immunology to a group of breast cancer advocates, when a woman who was suffering from widespread metastatic cancer caught me and said that she wanted to join us as a patient volunteer.

And we did some stuff first to make sure that we werent going to be wasting her time, because time is such a valuable and precious commodity. And once it became clear that she was eligible, I took her to the operating room, I took a small tumor off her chest wall, and we were able to study that tumor in a number of ways.

We were able to look at the DNA changes in her tumor and we were able to test the T cells that lived there. And it turns out that takes us some time and her cancer was worsening, she was having to increase her pain medication, the lymph nodes in her armpit had started to press on her nerves, such that she couldnt use her arm.

And we finally had the cells ready. She came to us in Bethesda, she was here with us for about three weeks and she was convinced the treatment was working even while she was here. Now, Im a little bit more suspect than that and I wanted to watch and wait and see, but it turns out she was right.

Five years later, shes disease-free. She has taken up ocean kayaking. So shes using that arm with no problems and she hasnt had to have another single treatment for her cancer since then. She teases me though that I wont say that shes cured. Ill continue to say though, that she has no evidence of disease.

I could tell you a handful of stories like that, but the reality is there are far more families, as you well know, that dont have happy endings. And I, and so many of us carry those stories with us during the late nights and weekends in the lab and on the ward, because the NCI gives us the space and time to create tomorrows medicine and thats really what were all here for. So, thank you for paying attention to the work thats going on at the NCI. And on behalf of all my colleagues here in Bethesda, welcome.

Biden: Having lived through cancer with so many members of my family and Beau, its just amazing what youre doing and the hope that youre giving to families. Because I know with Beaus cancer, I mean, we tried everything and its just, like youre saying, youre trying all different things and youre giving families hope, and you have no idea how much that means. Thanks.

Sharpless: Thank you, Stephanie. That was terrific. I thought next Id like you to hear, Dr. Biden, a little bit about our work were doing related to SARS-CoV-2, to the coronavirus pandemic. It may not be obvious why the National Cancer Institute would work on coronavirus, but about 30% of cancers worldwide are caused by viruses. And so, theres been a long interest in virology at the NCI.

HIV, the virus that causes AIDS was co-discovered at the National Cancer Institute as was the first effective therapeutic for HIV. And then, John Schiller and Doug Lowy, who are still quite active NCI researchers invented the vaccine against Human Papillomavirus, which shows the significant expertise of the NCI in vaccinology.

Importantly, relevant to SARS-CoV-2, we have this really great serology lab, which studies antibody levels in the blood, run by Dr. Pinto at Frederick National Lab, which had been working on HPV serology with the WHO. Frederick International Lab is the largest federal biomedical research facility, run by the NCI.

And so, when the pandemic began, it was relatively straightforward for the NCI to pivot that serology lab on HPV to SARS-CoV-2 and this is how I think we played a crucial role in the fight against COVID. So, let me get Ligia to tell you about what her team has been doing as part of the coronavirus research effort.

Ligia Pinto: Thank you, Dr. Sharpless, Dr. Biden. Id like to share with you some of the key highlights of the exciting work on COVID-19 serology that we have been doing at the Frederick National Laboratory and the NCI. Frederick National Lab is a Federally Funded Research and Development Center with the infrastructure and the expertise to rapidly respond to public health crisis, such as the COVID-19 pandemic.

First, Id like to tell you a little bit about myself. Im originally from Portugal and I came to the NCI to do my PhD in immunology almost 30 years ago. My initial plan was to return to Portugal, but I decided to stay because of the incredible research opportunities at the NCI and in the United States in general. Our group works on serology. Let me tell you why we think its important and why this work is being done by cancer researchers.

Serology is the measurement of antibodies in blood predicting response to infection or vaccination. For COVID-19, serology tests are a critical public health tool for identifying individuals who were previously infected with SARS-CoV-2 or were vaccinated, and therefore maybe protected against the new infection. In order to inform public health decisions, antibody tests need to be reliable and highly accurate.

My laboratory at the Frederick National Lab has leveraged our expertise in studying immune responses to Human Papillomavirus infection and cervical cancer vaccines to develop serology tests and standards that are relevant to understanding SARS-CoV-2 infection and immune responses to the virus.

Because of this expertise at the beginning of the pandemic in April, when many serology tests were being developed, the FDA asked us to assist in evaluation of commercially available antibody tests for SARS-CoV-2, leading to evaluating more than 100 of these tests for the FDA. We have been able to do this thanks to a fantastic trans-governmental collaboration.

It has included several government agencies and academic medical centers. The FDA has used our performance evaluation data along with the other information to address some of these tests and reject others. Other critical tools for serology testing are standards. It enables comparison of antibody responses between different vaccines and other antibody studies.

In the spirit of the World Cancer Day, we had already developed standard reagents for our work on HPV and cervical cancer vaccines in cooperation with the National Institutes for Biological Standards and Control and the World Health Organization. And now, we have developed a serology standard for SARS-CoV-2. We are making it available to anyone in the scientific community.

Lastly, we have rapidly implemented a new initiative called Serological Sciences Network, SeroNet. This is one of the largest coordinated efforts across 25 of the nations top biomedical research institutions, where we have organized work collaboratively to study immune responses to SARS-CoV-2.

We believe that this collaborative network is an outstanding resource for tackling the emerging challenges associated with new viral variance, and understanding their potential impact on antibody testing and vaccine efficacy.

Two lessons that we have learned in all these efforts are that collaboration and sharing are key to making rapid advances. Thank you so much, Dr. Biden.

Biden: Thank you.

Sharpless: Well, so thats a sort of brief couple of snapshots of whats going on at the National Cancer Institute. Theres so much more work in both our intramural funded program and our extramural funded portfolio that wed love to tell you about, and we hope we get a chance to have you back sometime to talk more, but we really, really, really appreciate your doing this. It means so much to the National Cancer Institute to have you come and visit, and its so exciting for everyone at the NCI and we very much appreciate it.

Biden: Oh gosh. Thank you, Ned. And thank you to everyone who shared their stories today and what youve been doing. Its just incredible and I have to agree that you are the Institute of Hope, because so many people in this country are patients of cancer or have someone they love thats dealing with cancer, and Joe and I have worked in this space for a long time. I have personally worked with families and caregivers.

One thing I think that we found in the Obama-Biden administration was the benefit of collaboration and how much that meant, whether it was through all the agencies of the government just working together.

And so, I hope that you know of our commitmentof Joes commitment and my commitmentto carry on that work and to really be a partner with you and everybody at NIH, NCI, because weve got to work to fight cancer as we know it. I mean, we have to, because its not a red issue, a blue issue. Its a human issue, it affects all Americans.

So, I want to thank you just really, for all that youre doing. And as you said, Im a teacher and Im a professor of English and writing. So, I want to end with a little poetry today, something beautiful, because, obviously, what youre doing is so beautiful.

So, the poet, Gwendolyn Brooks, another life lost to cancer, wrote:

We are each others harvest:

We are each others business:

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Jill Biden signals White House resolve on cancer research: This is the fight of our lives - The Cancer Letter