John’s One-Year Anniversary Letter to BIO Membership.
March 4, 2025
Dear Colleagues,
This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we increasingly have the tools, talents, and technologies to address a range of challenges in human health, the environment, and food security – allowing us to alleviate an enormous amount of human suffering.
These stunning advancements, though, are at a crossroads. Not only does the U.S. face intense global competition as the world's center of excellence in biotechnology innovation, but we also face a series of societal and political challenges that threaten key elements of our industry's foundation. In short, we are at an inflection point. We can either continue with a system that unnecessarily slows progress and distorts our choices, or reform it to better benefit patients and those in need.
Eight years ago, President Trump highlighted the shortcomings of our drug approval system in his first address to a joint session of Congress. I recall it vividly, because I was there. As you may know, my daughter Megan has Pompe disease, a rare neuromuscular disorder. During his remarks, the President highlighted Megan’s condition and spoke directly to her in the audience. He added, “the slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need.” He was right then, just as he is right today.
Yet the way that government reforms the FDA – as well as other regulatory bodies that oversee our industry – must strengthen these agencies, not weaken them. We have an opportunity now to accomplish just that, and we must seize it.
"No organization is better positioned or more intensely focused on creating (and restoring) a strong and expedient innovation ecosystem than BIO."
The Best Job You Could Ever Have
As someone who helped develop a drug that saved my children’s lives, I know what it takes to get a life-changing product to patients. I know where the system’s faults lie – and what needs to be done to fix them. We need to focus on reorganizing and restructuring key agencies and programs to make them far more efficient, less costly, and more certain. At last month’s BIO Board meeting, I laid out my vision and priorities to meet this defining moment for our industry. I began, however, with a quote from one of my mentors, the long-time CEO of Genzyme, Henri Termeer:
“This business of ours requires enormous amounts of resilience and persistence. And in those rare days when you do something remarkable for people… when you go from an idea to a molecule to an approved medicine… cherish it. Those days are few. But in those moments, you will realize this is the best job you could ever have.”
We all feel blessed to work in an industry that enables us to make an often profound difference in people’s lives. I started by fighting for my family, and continue today by advocating for the people I meet and whose stories I share. I know countless individuals hoping for a miracle, but find that our system is too slow. But, as Henri said, we are persistent and resilient. We continue to solve tough problems and deliver hope. And no organization is better positioned or more intensely focused on creating (and restoring) a strong and expedient innovation ecosystem than BIO.
"While threats to our fragile bio-ecosystem abound, so too do opportunities for positive and bold change."
Make the 21st Century The Biotech Century
Focus and impact were two key themes that I brought to BIO one year ago. And while there is much work still to do, we have made great progress.
I wanted to do less, but do it better. To build strong relationships in Washington and in the states. To tell the stories of our industry and its impact on our health, our communities, and our environment. And to ensure BIO remains the trusted source for understanding the potential and priorities of biomedical, energy, and agricultural innovation.
While threats to our fragile bio-ecosystem abound, so too do opportunities for positive and bold change. We believe that we can find common cause with the President and all Members of Congress. Public health. Economic growth. National security. No industry is better positioned to support the United States and our long-term prosperity than biotechnology. Constructive, strategic engagement that yields results for our ecosystem – and by extension people and patients – is our goal, and we aim to earn it through relationship-building, competence, integrity, discretion, and trust. Good advocacy is an art.
Over the past year, I’ve visited dozens of communities across the country – from traditional biotech hubs to up-and-coming clusters. I’ve witnessed innovative techniques in labs, growth opportunities in board rooms, and cross-sector conversations about what it takes to bring a product to market. But despite our industry’s opportunities, I’ve also come face-to-face with the challenges burdening innovators across our sector, namely regulations, funding challenges, and more. I also know threats can be external, such as competition from China, which has invested heavily in biotechnologies as it seeks pre-eminence.
To meet this moment and drive our innovation ecosystem forward, BIO is advocating big bold ideas that support our entire industry:
Reimagine the clinical trial paradigm and FDA review and approval processes
Enable capital formation for emerging biotech innovators, which are engines of growth from agriculture and energy to medicines
Protect and advance intellectual property rights, a cornerstone of our industry
Ensure a resilient and robust manufacturing supply chain in the U.S. and among allies
Looking ahead, even as we make progress in these areas, we must ask ourselves how to overcome persistent barriers to access and ensure that our products and medicines reach the people and communities that need them. For instance, nearly a decade ago, Congress passed the 21st Century Cures Act. Now, we need a series of initiatives focused on 21st Century access, such as reforming the PBM middlemen who soak up profits at the expense of patients, fixing the harmful effects of the Inflation Reduction Act, and addressing obstructive utilization management tactics. Health insurance companies are out of control. And delay and denial equal suffering and death. We have to tackle this obstacle to improved health head on.
We’ll remain strategic, even as we respond appropriately to the issues of the day. And to ensure we stay grounded in the needs of our entire industry and membership, we’ll continue to get out of Washington and into the states and abroad. We’re ramping up our ‘BIO on the American Road’ series after a great visit last month to Colorado. I'll be visiting more cities and industry clusters, as well as leading two international delegations this year, with the first taking place this month to Japan.
"What if we can ensure that everyone has access to newer and better medicines and food security?"
The World Can't Wait
Despite recent challenges for our industry, we remain on the cusp of a golden age of medicine and agriculture. We just need to figure out how to get out of our own way. Imagine if we can achieve even half of the agenda that I just described? What if we measurably reduce the time, cost, and uncertainty of drug development? What if we can ensure that everyone has access to newer and better medicines and food security? What if we truly can Make America – and the World – Healthy Again? What if we can rebuild people’s faith and understanding in the possibilities and promise of our science?
These are truly challenges and opportunities. And they are why I was honored to assume this role one year ago and work with the incredibly talented team at BIO. They, like you, know why we do what we do. It’s because, as Christopher Reeve once said, biotechnology really is just a great big word that means hope. And because when it all works, I believe Henri was right. Working in this industry is the best job you can have.
But the hard days serve as motivation of their own. Last August, I traveled to California to attend a “Celebration of Life” for a 13-year-old young woman named Charlotte Gray. Charlotte died of CLN6 Batten disease, a devastating and fatal neurological disorder. Think of Alzheimer’s, but in a child. Born healthy, by two years of age, she showed symptoms. Over the years, Charlotte lost her ability to walk, speak, see, eat, and think. She was beautiful in every way. And her parents, Kristen and Gordon, moved heaven and earth to save her. They partnered with a researcher, and within two years of diagnosis were able to deliver a gene therapy to her and her younger sister, Gwendolyn. Other children received this therapy as well. For Charlotte and others though, it was likely too little and too late, and she could not be saved.
I know this story well because Amicus Therapeutics, the biotech company that I helped to found and ran for nearly 20 years, acquired this program in 2018. We knew that the effort would face great hurdles in development and the challenges of the gene therapy market, but we believed in the importance of what we were doing, and that a shot in the dark was a shot worth taking. So, we persisted, even as the odds grew longer.
Today, at BIO and across our industry, we persist for those we save and for those like Charlotte who we try to save, but ultimately cannot. We fight for policies that help you grow your business, meet potential partners, and bring your novel ideas to market because every life is worth saving and every shot worth taking. We engage with policymakers because all families and communities deserve solutions to live healthily and sustainably. And above all, we shout from the mountaintops about the promise and potential of biotechnology because patients and people everywhere can’t wait.
I believe strongly in this industry because I’ve seen firsthand what it can achieve and the progress we can make together. After one year at BIO, my faith is greater than ever, even if the climb remains long. There is no turning back at these crossroads, because the reward for patients, communities, and our society is too important to too many. Thank you for your support of BIO and for joining me in this noble cause.
Re: BIO Comments on Office of Management and Budget (OMB) Statistical Policy Directive No. 8 North American Industry Classification System (NAICS)-Request for Comments on Possible Revisions for 2027 (USBC–2024–0032)Dear Ms. Orvis,The Biotechnology…
Under the 340B program, participating manufacturers must offer 340B pricing on their covered outpatient drugs by covered entities, as a condition of having those drugs federally payable under Medicare Part B and Medicaid. Critically, Congress…
Dear Colleagues,
This month marks my one-year anniversary as BIO's CEO. Like most of us in biotech, this post has been a labor of love. At no time in my 25-year career in this industry have I ever witnessed such awe-inspiring science. Today, we increasingly have the tools, talents, and technologies to address a range of challenges in human health, the environment, and food security – allowing us to alleviate an enormous amount of human suffering.
These stunning advancements, though, are at a crossroads. Not only does the U.S. face intense global competition as the world's center of excellence in biotechnology innovation, but we also face a series of societal and political challenges that threaten key elements of our industry's foundation. In short, we are at an inflection point. We can either continue with a system that unnecessarily slows progress and distorts our choices, or reform it to better benefit patients and those in need.
Eight years ago, President Trump highlighted the shortcomings of our drug approval system in his first address to a joint session of Congress. I recall it vividly, because I was there. As you may know, my daughter Megan has Pompe disease, a rare neuromuscular disorder. During his remarks, the President highlighted Megan’s condition and spoke directly to her in the audience. He added, “the slow and burdensome approval process at the Food and Drug Administration keeps too many advances, like the one that saved Megan’s life, from reaching those in need.” He was right then, just as he is right today.
Yet the way that government reforms the FDA – as well as other regulatory bodies that oversee our industry – must strengthen these agencies, not weaken them. We have an opportunity now to accomplish just that, and we must seize it.
"No organization is better positioned or more intensely focused on creating (and restoring) a strong and expedient innovation ecosystem than BIO."
The Best Job You Could Ever Have
As someone who helped develop a drug that saved my children’s lives, I know what it takes to get a life-changing product to patients. I know where the system’s faults lie – and what needs to be done to fix them. We need to focus on reorganizing and restructuring key agencies and programs to make them far more efficient, less costly, and more certain. At last month’s BIO Board meeting, I laid out my vision and priorities to meet this defining moment for our industry. I began, however, with a quote from one of my mentors, the long-time CEO of Genzyme, Henri Termeer:
“This business of ours requires enormous amounts of resilience and persistence. And in those rare days when you do something remarkable for people… when you go from an idea to a molecule to an approved medicine… cherish it. Those days are few. But in those moments, you will realize this is the best job you could ever have.”
We all feel blessed to work in an industry that enables us to make an often profound difference in people’s lives. I started by fighting for my family, and continue today by advocating for the people I meet and whose stories I share. I know countless individuals hoping for a miracle, but find that our system is too slow. But, as Henri said, we are persistent and resilient. We continue to solve tough problems and deliver hope. And no organization is better positioned or more intensely focused on creating (and restoring) a strong and expedient innovation ecosystem than BIO.
"While threats to our fragile bio-ecosystem abound, so too do opportunities for positive and bold change."
Make the 21st Century The Biotech Century
Focus and impact were two key themes that I brought to BIO one year ago. And while there is much work still to do, we have made great progress.
I wanted to do less, but do it better. To build strong relationships in Washington and in the states. To tell the stories of our industry and its impact on our health, our communities, and our environment. And to ensure BIO remains the trusted source for understanding the potential and priorities of biomedical, energy, and agricultural innovation.
While threats to our fragile bio-ecosystem abound, so too do opportunities for positive and bold change. We believe that we can find common cause with the President and all Members of Congress. Public health. Economic growth. National security. No industry is better positioned to support the United States and our long-term prosperity than biotechnology. Constructive, strategic engagement that yields results for our ecosystem – and by extension people and patients – is our goal, and we aim to earn it through relationship-building, competence, integrity, discretion, and trust. Good advocacy is an art.
Over the past year, I’ve visited dozens of communities across the country – from traditional biotech hubs to up-and-coming clusters. I’ve witnessed innovative techniques in labs, growth opportunities in board rooms, and cross-sector conversations about what it takes to bring a product to market. But despite our industry’s opportunities, I’ve also come face-to-face with the challenges burdening innovators across our sector, namely regulations, funding challenges, and more. I also know threats can be external, such as competition from China, which has invested heavily in biotechnologies as it seeks pre-eminence.
To meet this moment and drive our innovation ecosystem forward, BIO is advocating big bold ideas that support our entire industry:
Reimagine the clinical trial paradigm and FDA review and approval processes
Enable capital formation for emerging biotech innovators, which are engines of growth from agriculture and energy to medicines
Protect and advance intellectual property rights, a cornerstone of our industry
Ensure a resilient and robust manufacturing supply chain in the U.S. and among allies
Looking ahead, even as we make progress in these areas, we must ask ourselves how to overcome persistent barriers to access and ensure that our products and medicines reach the people and communities that need them. For instance, nearly a decade ago, Congress passed the 21st Century Cures Act. Now, we need a series of initiatives focused on 21st Century access, such as reforming the PBM middlemen who soak up profits at the expense of patients, fixing the harmful effects of the Inflation Reduction Act, and addressing obstructive utilization management tactics. Health insurance companies are out of control. And delay and denial equal suffering and death. We have to tackle this obstacle to improved health head on.
We’ll remain strategic, even as we respond appropriately to the issues of the day. And to ensure we stay grounded in the needs of our entire industry and membership, we’ll continue to get out of Washington and into the states and abroad. We’re ramping up our ‘BIO on the American Road’ series after a great visit last month to Colorado. I'll be visiting more cities and industry clusters, as well as leading two international delegations this year, with the first taking place this month to Japan.
"What if we can ensure that everyone has access to newer and better medicines and food security?"
The World Can't Wait
Despite recent challenges for our industry, we remain on the cusp of a golden age of medicine and agriculture. We just need to figure out how to get out of our own way. Imagine if we can achieve even half of the agenda that I just described? What if we measurably reduce the time, cost, and uncertainty of drug development? What if we can ensure that everyone has access to newer and better medicines and food security? What if we truly can Make America – and the World – Healthy Again? What if we can rebuild people’s faith and understanding in the possibilities and promise of our science?
These are truly challenges and opportunities. And they are why I was honored to assume this role one year ago and work with the incredibly talented team at BIO. They, like you, know why we do what we do. It’s because, as Christopher Reeve once said, biotechnology really is just a great big word that means hope. And because when it all works, I believe Henri was right. Working in this industry is the best job you can have.
But the hard days serve as motivation of their own. Last August, I traveled to California to attend a “Celebration of Life” for a 13-year-old young woman named Charlotte Gray. Charlotte died of CLN6 Batten disease, a devastating and fatal neurological disorder. Think of Alzheimer’s, but in a child. Born healthy, by two years of age, she showed symptoms. Over the years, Charlotte lost her ability to walk, speak, see, eat, and think. She was beautiful in every way. And her parents, Kristen and Gordon, moved heaven and earth to save her. They partnered with a researcher, and within two years of diagnosis were able to deliver a gene therapy to her and her younger sister, Gwendolyn. Other children received this therapy as well. For Charlotte and others though, it was likely too little and too late, and she could not be saved.
I know this story well because Amicus Therapeutics, the biotech company that I helped to found and ran for nearly 20 years, acquired this program in 2018. We knew that the effort would face great hurdles in development and the challenges of the gene therapy market, but we believed in the importance of what we were doing, and that a shot in the dark was a shot worth taking. So, we persisted, even as the odds grew longer.
Today, at BIO and across our industry, we persist for those we save and for those like Charlotte who we try to save, but ultimately cannot. We fight for policies that help you grow your business, meet potential partners, and bring your novel ideas to market because every life is worth saving and every shot worth taking. We engage with policymakers because all families and communities deserve solutions to live healthily and sustainably. And above all, we shout from the mountaintops about the promise and potential of biotechnology because patients and people everywhere can’t wait.
I believe strongly in this industry because I’ve seen firsthand what it can achieve and the progress we can make together. After one year at BIO, my faith is greater than ever, even if the climb remains long. There is no turning back at these crossroads, because the reward for patients, communities, and our society is too important to too many. Thank you for your support of BIO and for joining me in this noble cause.
As ever,
John F. Crowley
President & CEO