|
|
|
James Roe bringing his asthma story to BIO 2026. Plus Women's Health Month. (1,030 words, 3 minutes, 58 seconds)
|
|
|
|
James Roe's asthma journey leads him to BIO 2026 |
|
|
INDY NXT Driver James Roe, who will discuss his journey as an asthma patient at the BIO International Convention, says he appreciates the biotech industry’s tireless quest for solutions.
“Driven By Purpose” is the theme of the 2026 BIO International Convention, referring to the biotech industry’s focus on achieving better outcomes for patients, public health and the world. Roe tells Bio.News of being driven to overcome his health challenges and use his platform to advocate for patients.
Roe spent weeks in the hospital as a child. “There was always the fear of a sudden asthma attack. And the chances of an attack go up with increased exertion, so as I began my racing career in Ireland, it was something we had to keep an eye on,” he says.
Admiring biotech’s drive: Like racing teams, biotech researchers are never satisfied, Roe says. “Years of work are spent on certain products and research, all with the purpose of being better and more efficient and addressing scenarios and problem-solving.”
Roe a good fit as a BIO 2026 speaker: “James’s story embodies what it means to be ‘Driven by Purpose,’” according to BIO President & CEO John F. Crowley. “His resilience and commitment to overcoming personal health challenges reflect the same determination we see every day across the biotech community.”
Read more on Bio.News.
Register for the BIO International Convention. |
|
|
|
Women’s Health Month: The female perspective on lupus and Parkinson’s |
|
|
Women’s Health Month in May is not just about health issues specific to women, it’s also a reminder that diseases impacting both sexes may affect women differently, and disproportionately.
For example: May is also Lupus Awareness Month, highlighting a condition whose patients are mostly women. And women’s experience with Parkinson’s disease can be different from men’s.
Lupus: This debilitating chronic autoimmune disease can cause the immune system to attack healthy tissue. Roughly 80% of Americans diagnosed with autoimmune disease are women, and in the case of lupus, 90% of patients are women, most often diagnosed during childbearing years.
Lupus “disproportionately affects women from certain racial and ethnic backgrounds, including Black/African American, Hispanic/Latino, Asian American, and Pacific Islander communities,” the Lupus Foundation of America (LFA) tells Bio.News. Researchers aren’t sure why, but the cause may be “differences in our genes and hormones.” Read more on Bio.News.
Women with Parkinson’s face delayed diagnosis, reduced access to specialists, and less informal caregiving support. Women may have different symptoms and may also respond differently to dopaminergic therapies.
“The same disease can translate into a different therapeutic journey for women, with different side effects and care needs,” Ragasudha Botta of Critical Path for Parkinson’s (CPP) tells Bio.News. “Many women are also caregivers themselves to spouses, children, grandchildren, or aging parents and their own symptoms may be minimized.” Read more on Bio.News.
BIO’s Women’s Health Task Forceseeks “to ensure a robust pipeline of biopharmaceutical innovations for women’s health,” according to Michele Oshman, BIO’s Chief Patient Advocate and Task Force executive sponsor. “As part of this mission, we are committed to elevating women’s health.” Read more on Bio.News. |
|
|
|
|
BIO released the following statement upon last week's resignation of Marty Makary, MD as Food and Drug Administration (FDA) Commissioner: “Dr. Makary inherited an FDA in crisis after the DOGE changes, which included the firing of thousands of employees. These staffing and morale challenges were compounded by constant leadership changes over the past year and questions around shifting FDA standards for drug approvals. What we need now is strong, stable and science-driven leadership at the FDA. We are losing the biotech race with China. FDA must be strengthened immediately to ensure that patients continue to benefit from medical miracles and that the United States leads the world in biomedical innovation, which is crucial for the public health, economic growth and our national security.” Makary’s departure preceded other leadership changes at FDA, with Michael Davis becoming the new acting director at FDA’s Center for Drug Evaluation and Research (CDER), Karim Mikhail named the new director at the Center for Biologics Evaluation and Research (CBER), and Lowell Zeta becoming acting FDA chief of staff. Read more here.
Vaccine leaders discuss policy on Capitol Hill. Leaders from BIO member companies in BIO’s Vaccine Policy Steering Committee (VPSC) met with key House and Senate offices on Capitol Hill last week to discuss federal vaccine policy and Congress’ role in supporting vaccine innovation, access, and oversight. The group underlined the importance of an effective patient-centered vaccine liability system, regulatory consistency, and predictable oversight to foster vaccine preparedness, innovation, and investment. Committee members discussed implementation and access concerns, highlighting the need for policies supporting delivery and public access to vaccines. Participants consistently stressed the importance of continued Congressional oversight in identifying challenges, maintaining policy continuity, and advancing measures to support vaccine access for patients and communities nationwide.
BIO patient advocacy Coffee Chat looks at state-level legislation. Collaboration across states and between patient advocates and other stakeholders in the biotech industry is essential for navigating state legislatures and their impact on patient access to needed therapies, panelists told the BIO April Coffee Chat. “We’re finding that the most disruptive pieces of legislation are much more likely to advance in state legislatures first, before eventually gaining traction at the federal government level,” Karin Hoelzer, Senior Director of Patient Advocacy at BIO, told the panel. Read more on Bio.News.
BIO comments on FDA Plausible Mechanism Framework. Advances in individualized therapies targeting specific genetic conditions offer the promise of new treatments for rare diseases, but it can be extremely difficult to generate nonclinical data and near impossible to test these treatments in a standard clinical trial. The Food and Drug Administration (FDA) has proposed guidance for using a “Plausible Mechanism Framework” as an alternative means for proving safety and efficacy of individualized and disease-targeted therapies when a large randomized controlled trial is not feasible. BIO praises FDA’s proposed guidance in written comments, while also urging improvements to make it more practical and effective. Read more on Bio.News.
Bayh-Dole Coalition honors innovators, promotes legislation to protect IP. Recent medical breakthroughs enabling better diagnostics for prostate cancer and Alzheimer’s, and improving real-time imaging of tumors during surgery, are among those highlighted by the Bayh-Dole Coalition in its fourth annual Faces of American Innovation report. Along with celebrating the innovators, the report calls attention to the need for legislation that strengthens IP protections. BIO is a Bayh-Dole Coalition member. Read more on Bio.News. |
|
|
|
BIO President & CEO John F. Crowley makes keynote remarks at the American Society of Gene & Cell Therapy’s inaugural Momentum Gala on May 12. Crowley spoke about the importance of accelerating innovation and access to cutting-edge therapies and the important work of organizations like ASGCT, innovators, patients, and many more to achieving those critical goals. Read more here. |
|
|
|
|
The Senate could vote this week on the $72 billion reconciliation bill to fund Immigration and Customs Enforcement (ICE) and Border Patrol through 2029. The process is expected to feature a drawn-out vote-a-rama, during which Senators have the opportunity to propose amendments. |
|
|
|
|
|