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Good Day BIO: The role of patient advocacy in R&D
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Good Day BIO Newsletter  •  October 18, 2022
Today’s new episode of the I am BIO Podcast features two patient advocates who have played a role in bringing potential treatments to rare disease patients. We recap Bayer’s event yesterday exploring how biotech can help farmers reduce their footprint AND increase their yields. (729 words, 3 minutes, 38 seconds)
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The Surprising Role of Patient Advocates in Drug Development
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I am BIO Podcast  •  October 18, 2022
Patient Advocates do more than raise money—they are active participants in the drug development process. While the ALS Ice Bucket Challenge garnered global attention, lesser-known patient advocates also flex their expertise to drive new treatments and cures.  In this episode, we talk with two moms, one who is a patient herself, about their work as partners in research and development, helping bring treatments for two rare diseases to the market. 
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Good Day BIO: Why we need to fix PBMs
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Good Day BIO Newsletter  •  October 17, 2022
Happy Monday. We have more details on Biden’s EO on addressing prescription drug prices—and what BIO says about it—as well as the UN’s just-launched One Health action plan. (652 words, 3 minutes, 15 seconds)
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BIO encourages Administration to "bring transparency to the broken rebate system"
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Press Release  •  October 14, 2022
After the White House announced plans to sign an Executive Order directing the Department of Health and Human Services (HHS)  to explore additional actions to lower prescription drug costs, Nick Shipley, Chief Advocacy Officer at the Biotechnology Innovation Organization (BIO), made the following remarks: "The Administration cannot truly address Medicare patients’ out-of-pocket cost concerns unless HHS reforms the shadow rebate market in which PBMs operate. These middlemen have distorted the marketplace as they have consolidated in recent years -- and PBMs have continued to leverage their size and market influence to ensure they can rake in enormous profits at the expense of vulnerable patients and their checkbooks. "Patients cannot benefit from the breakthrough therapies that scientists work hard to create if they cannot afford them. To increase access and reduce patient out-of-pocket costs, BIO has expressed support to HHS and CMMI to bring transparency to the broken rebate system responsible for inflating costs as well as explore innovative payment models that bring financial relief to patients.  "We will continue to advocate for policies that encourage innovation and patient access to the medicines and care they need. Rather than playing politics with America’s seniors and most vulnerable, we look forward to working with this Administration and lawmakers in a pragmatic way to ensure access and affordability of medicines and other health care needs is a priority."
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Good Day BIO: World Food Day, Taiwan Expo USA, and CSBA highlights
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Good Day BIO Newsletter  •  October 14, 2022
Breaking this AM, Biden will sign an EO asking HHS to "explore additional actions it can take to lower prescription drug costs." Ahead of World Food Day, we look at how biotech can ensure no one is left behind when it comes to accessing nutritious food. Plus, we recap a busy week for biotech partnerships, from the Taiwan Expo in Washington, D.C., to several CSBA member events nationwide. (644 words, 3 minutes, 13 seconds).
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Good Day BIO: Omicron-focused vaccines authorized for kids
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Good Day BIO Newsletter  •  October 13, 2022
The FDA authorized Pfizer-BioNTech and Moderna bivalent vaccines targeting the Omicron COVID-19 variant for kids. A biodiversity report shows urgent need for action – and we tell you how biotech can help. (621 words, 3 minutes, 6 seconds)
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U.S. Regulatory Environment
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BIO Professional Development Courses  •  October 12, 2022
Overview of the government agencies/trade organizations that “regulate” drug and medical device promotion: FDA; OIG; PhRMA; AMA; and ACCME. 
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Welcome to Healthcare
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BIO Professional Development Courses  •  October 12, 2022
Learn the basics for working within the regulated industry of healthcare, including government agency oversight, role of diverse stakeholders (e.g., HCPs, payers, patients, caregivers, industry, government), importance of confidentiality (with 10-question quiz). 
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Sunshine Act
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BIO Professional Development Courses  •  October 12, 2022
Overview of Physician Payments "Open Payments Program" (Sunshine Act), which requires manufacturers of drugs, medical devices/ biologicals that participate in U.S. federal health care programs to report certain payments/items of value given to physicians/teaching hospitals.
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Scientific Exchange/Safe Harbor
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BIO Professional Development Courses  •  October 12, 2022
Overview of key elements of scientific exchange based on several FDA guidance documents including responding to unsolicited requests for off-label information about prescription drugs and medical devices and distributing scientific and medical publications on unapproved new uses – recommended practices. Covers range of activities including definition of scientific exchange and safe harbor, general guidelines for compliant content, responding to unsolicited questions for off-label, and distribution of scientific and medical publications on unapproved new uses.
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