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Before you begin your Thanksgiving prep, we recap last week's Clinical Trial Diversity Summit, how the "faceless middleman" is raising your healthcare costs, and promising news from USDA. (890 words, 4 minutes, 27 seconds)
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BIO Clinical Trial Diversity Summit seeks to advance equity in clinical research |
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Last week, BIO’s Clinical Trial Diversity Summit, presented in partnership with Howard University and in collaboration with the Diversity Convergence Project, sparked dialogue on how to enhance diversity and inclusion in clinical research.
Why it matters: “We are seeing an ongoing lack of participation by diverse groups in trials,” said Wayne Frederick, M.D., Howard University President Emeritus and Interim CEO of the American Cancer Society and ACS CAN. Increasing diversity in clinical trials is the way to health equity, said former NIH Director Francis Collins, M.D.
The biggest barrier: Although many factors contribute to the lack of diversity in clinical trials, the top issue is a lack of access to these trials, said Dr. Frederick.
One solution: Howard University’s new National Research Center for Health Disparities (NRCHD) is a 200,000-square-foot facility dedicated to advancing research, policy, and talent development to improve health outcomes for underserved populations, said Howard President Ben Vinson III, Ph.D.
Another effort: The Diversity Convergence Project engages 200-300 stakeholders in workshops, virtual meetings, and in-person events to develop a National Action Plan to improve clinical trial diversity, explained Carolyn Shore, Ph.D., of the National Academies of Sciences, Engineering, and Medicine.
The role of community engagement: - “You have to be intentional and active about how you listen to the community’s needs, desires, and wants, and about what participation should look like.” –Michael Crawford, Assistant VP for Strategy and Innovation at Howard.
- “We need to make sure that we’re asking and that we’re asking in the right way.” – FDA’s Cheryl Anne Boyce, Ph.D.
- “The trust factor is important.” – Howard Medical School Dean Andrea Hayes Dixon, M.D.
Read more on Bio.News: |
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I am BIO Podcast: ‘The faceless middleman between you and your doctor’ |
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Insurers and pharmacy benefit managers (PBMs) chasing profits prevent patients from getting the drugs they need, explains the latest episode of the I am BIO Podcast.
What’s happening: PBMs and insurer utilization management practices, like step therapy and prior authorization, deny patients drugs their doctors prescribe.
A patient’s challenge: Deb Constein recalls being pulled off an effective drug for debilitating gastroesophageal reflux disease. She was required to try several cheaper medications—and have a colonoscopy and endoscopy—before her insurer allowed her to get her needed drug.
“It cost the healthcare system thousands of dollars as far as more diagnostics to show that no, there wasn’t healing, and I still did need a higher-tier medication,” Constein says. “They clearly set the patient aside. It’s all about money.”
A doctor’s challenge: Dermatologist Dr. Harrison Nguyen employs two full-time professionals “to essentially fight with insurance to get patients access to medications.”
The role of policy: Arcutis Biotherapeutics CEO Frank Watanabe says these access challenges hurt drug makers’ ability to innovate. The Safe Step Act would regulate step therapy, while legislation in the Senate to disincentivize pharmacy benefit managers from promoting drugs that are more profitable for them.
Listen at www.bio.org/podcast or wherever you get your podcasts.
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APHIS exempts more types of biotech plants from regulation |
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On Nov. 12, the U.S. Department of Agriculture announced that biotech plants made through modifications achievable by conventional breeding are exempt from strict regulation. BIO has long called for the change.
What’s different: Plants modified through biotechnology can fall under 7 CFR part 340, which strictly controls movement and/or planting. USDA’s Animal and Plant Health Inspection Service (APHIS) rule change increases the type of plants exempted from that regulation.
Why it matters: Plants improved by biotech enhance food security and reduce agriculture’s climate impact by making crops more able to survive extreme conditions, reducing the need for external inputs, preventing waste, and providing more sustainable materials and energy.
Biotech improvements to plants often yield the same results as traditional cross-breeding, as the regulation recognizes—but with biotech, improvements occur over a matter of months instead of decades.
“BIO played a key role in urging the agency to consider these exemptions and believes these modifications will enable not only major biotech firms but also smaller businesses and academic institutions to drive cutting-edge agricultural development, benefiting both the U.S. economy and global food security,” BIO explains.
The bottom line: “This promising update supports the latest advancements in science and biotechnology, encouraging innovation across a broader range of agricultural products,” BIO’s statement says.
Read more on Bio.News. |
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What Else to Read This Week
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BIO at COP29: BIO’s Tamra Spielvogel (front row, second left) participated in a COP29 side event, “Scaling Finance for Energy Efficiency, Clean Energy, and Biobased Solutions,” in Baku last week. Her panel explored the emerging stock of biobased and carbon-negative materials, feedstock, and commercial products and the importance of transparent standards. BIO also organized a panel, “Leveraging Biotech Value Chains to Advance Food Security and Sustainability,” and Spielvogel joined another panel, “Circular Bioeconomy Solutions from the Land.”
Access to new FDA-approved Alzheimer's drugs has been limited by Medicare policies, according to experts speaking during an Axios event sponsored by Eli Lilly. “While innovations in cognitive health care have made progress in improving treatments for challenging diseases like Alzheimer's, many people face barriers to accessing care and medicines,” Axios noted. Participants called for policy that allows equity in access to the new Alzheimer's drugs approved by the Food and Drug Administration (FDA).
Vir Biotechnology reports positive results in a hepatitis delta clinical trial. Tobevibart in combination with elebsiran, “the most-advanced and potential first-of-its-kind investigational human monoclonal antibody and siRNA combination,” achieved 100% virologic suppression in phase 2 clinical trials. |
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Beltway Report: What's Ahead in Washington
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Recess. Happy Thanksgiving! |
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