I am just past the two-year mark as BIO’s President & CEO, which arrives as we find ourselves at a defining moment for the future of biotechnology. For fifty years, our industry has delivered one of the great innovation stories in human history. From the earliest recombinant DNA breakthroughs to the sequencing of the human genome, from transforming the fates of patients with sickle cell and cystic fibrosis to astonishing advances in immunotherapy, gene editing, obesity treatments, neuroscience and AI-driven discovery, biotechnology has redefined what is possible in medicine and human health.
But as we embark upon the next 50 years, a stark question confronts us: America invented modern biotechnology, but will we author its next chapter or watch it be written somewhere else?
This question is no longer theoretical. China is now investing at unprecedented speed and scale, with a coordinated national strategy to dominate biotechnology and biomanufacturing. At the same time, here in America, our system for research and development of newer and better medicines has grown overly complex and costly. And it takes too much time. Adding to these man-made challenges are a growing slate of proposed policies – at the federal and state levels – that threaten to weaken the very innovation ecosystem that made America the birthplace of biotech.
There are most-favored nation (MFN) proposals that would import socialist price controls and gut investment in biotech start-ups. There are Prescription Drug Affordability Boards (PDABs) that impose arbitrary price controls at the state level. There are efforts to undermine vaccine confidence, restrict mRNA and advanced technologies, and weaken intellectual property protections. Add to these the continued funding challenges facing many emerging biotech companies, and it becomes clear that the world is not waiting for us. We must evolve quickly, or we lose. And the American people cannot lose. Nor can the rest of the world that depends so heavily upon, and contributes so very much to, the miracles of U.S.-led biotechnologies.
The opportunity ahead is indeed extraordinary – if we choose to seize it. The next 50 years of biotechnology can deliver unprecedented advancements in medicine. In this Century of Human Biology, we hold the power to fundamentally change the course of human health, prosperity and security. But this future depends on the choices we make right now.
"As we embark upon the next 50 years, a stark question confronts us: America invented modern biotechnology, but will we author its next chapter or watch it be written somewhere else?"
ADVANCE INNOVATION, INCREASE ACCESS
The inherent strength of America’s biotechnology ecosystem remains unmatched. Well more than half of all new medicines still originate in small and mid-sized biotechs – companies fueled by scientific courage, investor confidence, entrepreneurial spirit and regulatory predictability. But none of these necessities can be taken for granted.
This is why one of BIO’s top priorities is pushing for bold reform of the FDA and our clinical trial system. The past year has seen dramatic change at the FDA. Some of this change was needed and welcome. Other changes have brought confusion and doubt. Bold ideas and encouraging statements need to be matched with broad stakeholder understanding and adoption, as well as clear and consistent implementation to ensure regulatory predictability and consistency.
Science is advancing faster than policy. It is imperative that FDA keep pace if we want to maintain America’s lead in the biotechnology revolution. As such, BIO is advocating for regulatory reforms that reduce the cost and complexity of early drug development, strengthen the efficiency and predictability of FDA regulatory review, support new models for FDA external engagement and transparency, and account for advances in technology, including AI.
To strengthen our work, we recently created BIO Regulatory Information Data Gathering & Engagement (BRIDGE), our new real-time mechanism for capturing members’ regulatory challenges in order to help identify systemic patterns and engage FDA leadership in problem solving. Please click here to share or report a regulatory issue that you have experienced at any and all levels of FDA engagement.
A second priority is strengthening our critical small and mid-sized biotechs that drive innovation forward. The ability to raise money can make or break a great idea, which is why BIO is offering private company members two new partnerships to assist capital formation. One is called Investor Connect Plus, a partnership with LaunchBio that facilitates targeted one-to-one meetings between biotechs and institutional and strategic investors. The other is with Tracxn, which will offer private members complimentary access to a database of 250K+ active global investors. The goal is to ensure emerging companies have the capital needed to grow and advance the next generation of medicines.
Perhaps the greatest threat facing our industry is the push to codify MFN policies into law by importing socialist price controls and advancing CMMI’s GUARD and GLOBE proposals. BIO is actively advocating against these proposals, which would impose international reference pricing schemes that undermine America’s leadership as the world’s most innovative market, disincentivize investment in high-risk R&D, shrink pipelines – particularly in early-stage technologies – and damage the free-market conditions that make the U.S. the global engine of biomedical innovation. Perhaps counter-intuitively, the most harmful effects would be felt by our small and mid-sized companies, many of which have few or no commercial products.
There is a far better way to lower costs, expand access and ensure a vibrant biotech ecosystem: fix what’s broken in the healthcare system.
Today, up to 50 cents of every dollar spent on medicines goes to middlemen, particularly PBMs – entities that add complexity, distort prices, and impose barriers between patients and the treatments they need. February’s PBM reforms scratched the surface, but we must go much further to eliminate practices that raise costs while restricting access. Our Simplify the System campaign, which can be viewed here, helps explain how.
BIO PRIORITIES FOR 2026 AND BEYOND
At BIO’s March Board Meeting, we outlined four overarching priorities for this year that capture and go beyond the issues described above.
ACCESS — Advance proposals to ensure real access and affordability to medicines. That includes advocating in opposition to MFN, tariffs on medicines, and state-originated barriers to access. Instead, we are advocating for a 21st Century Access and Affordability initiative that holds insurance companies and PBMs accountable and reduces or eliminates patients’ out-of-pocket costs and dramatically reforms insidious insurance company practices like step edits and prior authorizations, whose only purposes are to unfairly delay and deny patients access to their medicines.
INNOVATION — Protect and strengthen America’s biomedical leadership by continuing to advance policies that aid innovation and company growth. That includes addressing FDA challenges and advancing clinical trials modernization, as well as securing PDUFA VIII and protecting and strengthening the entire biomedical research establishment – from our great universities to the NIH, to our small and mid-sized biotechs, to our largest biopharma companies.
STORYTELLING — We have a great story to tell. So, let’s tell it. Let’s humanize who we are, what we do, and why we do it. And let’s build a positive narrative about biotechnology that demonstrates the lifesaving work that our industry does for patients every day. It will be led by our upcoming campaign called ‘The Fight of Our Lives,’ which will showcase the stories of patients whose fates were changed by biotechnology. Storytelling is most effective when told to the right audiences, which is why we will focus on building key relationships with industry stakeholders and audiences.
INSTITUTIONAL STRENGTH — A stronger BIO is able to deepen member value, expand investor tools, and operate more effectively. We will ensure strong board governance and engagement, a world-class BIO team, and our financial strength. Since I began as CEO, we have stood up ten “Centers of Excellence” at BIO, each led by a BIO executive who reports directly to me. These are the teams that ensure our great relevance with sharp focus and deep impact.
The bottom line behind these priorities and our organization is very straightforward: help you grow, raise capital, and advance your science for the benefit of patients everywhere. We believe that the world, and everyone living in it, benefits best when America leads the world in biotechnology.
THE NEXT 50 YEARS
As we look toward the next half-century of biotechnology, one truth is clear: this is our generation’s moment. Our industry started 50 years ago when a young venture capitalist walked into the office of a young university scientist, and they together dreamed of utilizing a new technology to form a company – and an entire industry. Their dreaming led to a revolution in medicine and human health. No one will ever say that they dreamed too small. Let’s dream big again.
I remain deeply optimistic (I ran biotech companies for nearly 25 years; I have to be an optimist!). A patient’s path to hope and to healing isn’t always straight, and sometimes we will have failed that patient. But let us always choose whenever we can to be the first to succeed rather than the last to fail. Let us take those big risks like we have in the last half century. The impact will be immense.
Thank you for what you do, and for being part of this important journey in this remarkable industry. Let us persist together.
Who Will Write Biotechnology's Next Chapter?
Dear Colleagues,
I am just past the two-year mark as BIO’s President & CEO, which arrives as we find ourselves at a defining moment for the future of biotechnology. For fifty years, our industry has delivered one of the great innovation stories in human history. From the earliest recombinant DNA breakthroughs to the sequencing of the human genome, from transforming the fates of patients with sickle cell and cystic fibrosis to astonishing advances in immunotherapy, gene editing, obesity treatments, neuroscience and AI-driven discovery, biotechnology has redefined what is possible in medicine and human health.
But as we embark upon the next 50 years, a stark question confronts us: America invented modern biotechnology, but will we author its next chapter or watch it be written somewhere else?
This question is no longer theoretical. China is now investing at unprecedented speed and scale, with a coordinated national strategy to dominate biotechnology and biomanufacturing. At the same time, here in America, our system for research and development of newer and better medicines has grown overly complex and costly. And it takes too much time. Adding to these man-made challenges are a growing slate of proposed policies – at the federal and state levels – that threaten to weaken the very innovation ecosystem that made America the birthplace of biotech.
There are most-favored nation (MFN) proposals that would import socialist price controls and gut investment in biotech start-ups. There are Prescription Drug Affordability Boards (PDABs) that impose arbitrary price controls at the state level. There are efforts to undermine vaccine confidence, restrict mRNA and advanced technologies, and weaken intellectual property protections. Add to these the continued funding challenges facing many emerging biotech companies, and it becomes clear that the world is not waiting for us. We must evolve quickly, or we lose. And the American people cannot lose. Nor can the rest of the world that depends so heavily upon, and contributes so very much to, the miracles of U.S.-led biotechnologies.
The opportunity ahead is indeed extraordinary – if we choose to seize it. The next 50 years of biotechnology can deliver unprecedented advancements in medicine. In this Century of Human Biology, we hold the power to fundamentally change the course of human health, prosperity and security. But this future depends on the choices we make right now.
"As we embark upon the next 50 years, a stark question confronts us: America invented modern biotechnology, but will we author its next chapter or watch it be written somewhere else?"
ADVANCE INNOVATION, INCREASE ACCESS
The inherent strength of America’s biotechnology ecosystem remains unmatched. Well more than half of all new medicines still originate in small and mid-sized biotechs – companies fueled by scientific courage, investor confidence, entrepreneurial spirit and regulatory predictability. But none of these necessities can be taken for granted.
This is why one of BIO’s top priorities is pushing for bold reform of the FDA and our clinical trial system. The past year has seen dramatic change at the FDA. Some of this change was needed and welcome. Other changes have brought confusion and doubt. Bold ideas and encouraging statements need to be matched with broad stakeholder understanding and adoption, as well as clear and consistent implementation to ensure regulatory predictability and consistency.
Science is advancing faster than policy. It is imperative that FDA keep pace if we want to maintain America’s lead in the biotechnology revolution. As such, BIO is advocating for regulatory reforms that reduce the cost and complexity of early drug development, strengthen the efficiency and predictability of FDA regulatory review, support new models for FDA external engagement and transparency, and account for advances in technology, including AI.
To strengthen our work, we recently created BIO Regulatory Information Data Gathering & Engagement (BRIDGE), our new real-time mechanism for capturing members’ regulatory challenges in order to help identify systemic patterns and engage FDA leadership in problem solving. Please click here to share or report a regulatory issue that you have experienced at any and all levels of FDA engagement.
A second priority is strengthening our critical small and mid-sized biotechs that drive innovation forward. The ability to raise money can make or break a great idea, which is why BIO is offering private company members two new partnerships to assist capital formation. One is called Investor Connect Plus, a partnership with LaunchBio that facilitates targeted one-to-one meetings between biotechs and institutional and strategic investors. The other is with Tracxn, which will offer private members complimentary access to a database of 250K+ active global investors. The goal is to ensure emerging companies have the capital needed to grow and advance the next generation of medicines.
Perhaps the greatest threat facing our industry is the push to codify MFN policies into law by importing socialist price controls and advancing CMMI’s GUARD and GLOBE proposals. BIO is actively advocating against these proposals, which would impose international reference pricing schemes that undermine America’s leadership as the world’s most innovative market, disincentivize investment in high-risk R&D, shrink pipelines – particularly in early-stage technologies – and damage the free-market conditions that make the U.S. the global engine of biomedical innovation. Perhaps counter-intuitively, the most harmful effects would be felt by our small and mid-sized companies, many of which have few or no commercial products.
There is a far better way to lower costs, expand access and ensure a vibrant biotech ecosystem: fix what’s broken in the healthcare system.
Today, up to 50 cents of every dollar spent on medicines goes to middlemen, particularly PBMs – entities that add complexity, distort prices, and impose barriers between patients and the treatments they need. February’s PBM reforms scratched the surface, but we must go much further to eliminate practices that raise costs while restricting access. Our Simplify the System campaign, which can be viewed here, helps explain how.
BIO PRIORITIES FOR 2026 AND BEYOND
At BIO’s March Board Meeting, we outlined four overarching priorities for this year that capture and go beyond the issues described above.
The bottom line behind these priorities and our organization is very straightforward: help you grow, raise capital, and advance your science for the benefit of patients everywhere. We believe that the world, and everyone living in it, benefits best when America leads the world in biotechnology.
THE NEXT 50 YEARS
As we look toward the next half-century of biotechnology, one truth is clear: this is our generation’s moment. Our industry started 50 years ago when a young venture capitalist walked into the office of a young university scientist, and they together dreamed of utilizing a new technology to form a company – and an entire industry. Their dreaming led to a revolution in medicine and human health. No one will ever say that they dreamed too small. Let’s dream big again.
I remain deeply optimistic (I ran biotech companies for nearly 25 years; I have to be an optimist!). A patient’s path to hope and to healing isn’t always straight, and sometimes we will have failed that patient. But let us always choose whenever we can to be the first to succeed rather than the last to fail. Let us take those big risks like we have in the last half century. The impact will be immense.
Thank you for what you do, and for being part of this important journey in this remarkable industry. Let us persist together.
As ever,
John F. Crowley
President & CEO