Somewhere in America today, a patient is waiting for a treatment that does not yet exist. A family is waiting for a miracle. And thanks to extraordinary advances in biotechnology, a breakthrough may be within reach.
The recent BIO Convention in San Diego brought together patient advocates, biotech company leaders, academics, deal makers and a wide range of stakeholders from across the healthcare ecosystem. One central truth came from this convening: We are living through one of the most consequential and promising periods in the history of medicine.
Take cancer care as just one example. Half a century ago, only half of people diagnosed with cancer survived more than five years. Today, that number has reached 70% – which means that many more people diagnosed with cancer can plan a future.
Yet, this explosion of medical innovation, once unimaginable in biotech, is now confronted with another reality: science is moving faster than the system designed to deliver these benefits to patients can manage. Policymakers, industry, regulators, payers, providers and patient advocates all have a role to play in reducing the frictions that patients experience in trying to get access to medicines.
Today, patients can wait years for promising therapies to move through the clinical development process. Regulatory approval pathways have not always kept pace with scientific complexity. Even after FDA approval, patients can face delayed coverage decisions, restrictive utilization management, fragmented benefit design, and other barriers that slow access to appropriate treatment.
This should be the central healthcare challenge of the next decade: how do we close the gap between discovery and impact?
The answer begins with policy.
First, we should modernize clinical trial complexities so that patients can participate more easily in these trials and therapies can be evaluated more efficiently. Recent FDA and HHS actions to accelerate early-stage trials and explore real-time clinical trial data are welcome steps. Now that momentum should kick start a broader effort to reduce unnecessary burden while preserving the scientific rigor patients depend on.
Second, we need a healthcare system that rewards innovation by ensuring patients can access new therapies once they are available. Scientific progress has little value if patients cannot benefit from it. That means coverage and reimbursement systems should be timely, predictable and grounded in clinical value.
It means patients should not face unnecessary delays after a medicine has been approved as safe and effective by the FDA. And it means aligning incentives across the healthcare system so that breakthroughs are not only discovered but actually reach the people who need them.
Third, policymakers should preserve the conditions that make long-term biotech investment possible in the US. Breakthrough therapies often involve decades of research, billions of dollars in investment and significant risk. Policies that undermine the US investment engine today will directly reduce the number of treatments available to patients tomorrow.
These goals are not in conflict with affordability. Patients need both access and innovation. They need a system that lowers barriers to care while continuing to foster the next generation of breakthroughs.
Too often, the healthcare debate separates these conversations and focuses only on drug prices. Innovation is discussed through the lens of investment, IP, and regulation. Patients are discussed through the lens of cost and access. In reality, they are inseparable.
Every policy decision should be evaluated through a simple question – will this help patients benefit from scientific progress more quickly and more effectively?
That is the challenge before us.
The next generation of medical breakthroughs is already taking shape. The biotech industry is now pioneering the integration of AI and data science into every facet of drug discovery and patient care. This new technological frontier will accelerate our ability to solve the most complex, urgent health challenges in the world. Whether those breakthroughs reach patients will depend not only on what science makes possible, but on the choices policymakers make today to support both access and the great American biopharmaceutical innovation engine.
For the past 50 years, American biotechnology has transformed medicine. The challenge for the next 50 is ensuring that innovation reaches patients faster, more equitably and with greater impact – so that people can spend more time with their loved ones, achieve greater independence, live longer lives and gain new hope where none existed before.
Fritz Bittenbender is Senior Vice President of Public Affairs & Access for Genentech, as well as the current Board Chair of BIO. Genentech is the founder of the biotechnology industry and is celebrating its 50th anniversary this year.
