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Toolkit for Advocates

We’ve made it easier for you to access information and share content about biotechnology and how it improves our daily lives, from prescription medications and a resilient food supply to renewable energy and sustainable bioprocessing materials. The information you discover can easily be shared on Twitter, Facebook and LinkedIn.

Infographics
Issue Briefs
Video
Infographics (48)
Biodefense and Vaccines
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Help Ensure Providers Have Access to All Approved Immunizations
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Provider choice means providers decide what immunization is best for their patients.
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Value of Vaccines: A Landmark Achievement
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Vaccination is often cited among the 10 greatest public health achievements of the 20th century. Only access to safe and clean water has had a larger effect on human health by preventing disease and extending lifespans.
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Use of Human Cell Lines in Critical Vaccines and Therapies
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To develop a vaccine that can be produced on a large scale, researchers must grow viruses or bacteria in large quantities and with great consistency.
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Vaccine Development, Licensure & Safety
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The creation of a vaccine involves scientists and medical experts from around the world, and it usually requires 10 to 15 years of research before the vaccine is made available to the general public.
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COVID-19 Vaccine Supply Chain: How We Are Vaccinating the Globe
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To ensure people get safe and effective vaccines as quickly as possible, biotechnology companies have leveraged global partnerships and innovative collaborations to reach patients all around the world.
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Pandemic Influenza
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When compared to other emerging diseases, see why influenza poses an especially dangerous and unique threat to society.
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Infectious Disease Product Incentives
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Certain infectious disease products have limited or no commercial market. No one incentive will address all challenges.
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Biodefense at a Glance
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Learn about how America has become the global leader in civilian biodefense.
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Legislation
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Engaging in the Federal Rulemaking Process; How patient advocacy groups can get involved in the rulemaking process
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Learn how patient advocacy groups can get involved in the federal rulemaking process.
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Food and Drug Administration Expedited Approval Programs
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The goal of expedited approval pathways is to provide safe and effective therapies for serious, unmet medical needs as quickly as possible.
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Effects of Sarbanes-Oxley 404(B) on Biotech Innovation
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Resources for emerging growth biotech companies would be better used for science than compliance with Section 404(b), economists find.
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Hatch-Waxman: Balancing Innovation and Drug Competition
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Learn about the Hatch-Waxman Act and its role in balancing innovation and drug competition.
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PDUFA At-A-Glance
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PDUFA provides greater consistency, certainty and predictability in the FDA's drug review programs.
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The Bayh-Dole Act
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Learn about how the Bayh-Dole Act benefits the U.S. economy, consumers & patients.
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Inflation Reduction Act
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The Orphan Cures Act
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The ORPHAN Cures Act is bipartisan legislation that would maintain existing incentives and boost research into new treatments for the 30 million Americans currently suffering from one of more than 7,000 rare diseases. The bill would achieve this by amending the Inflation Reduction Act’s harmful orphan drug exclusion and incentivizing critical follow-on investment into rare disease drug development.
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IRA Drug Negotiation: At a Glance
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Maximum Fair Price: A manufacturer of a drug selected for negotiation will be required to offer a “maximum fair price” for the selected drug with respect to Medicare beneficiaries.
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IRA - Medicare Part D and ‘Smoothing’ of OOP Costs/MPPP
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Currently, millions of Medicare beneficiaries reach the catastrophic phase in January or February, which exacerbates the financial hardship of the high prices of OOP costs. The Inflation Reduction Act (IRA) will allow Medicare beneficiaries to spread their out-of-pocket cost over the course of the plan year.
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Inflation Reduction Act – Medicare Part D Redesign/ Patient Out-Of-Pocket Cap
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The IRA restructures the Medicare Part D benefit to provide financial protections for beneficiaries and changes the contribution structure for plans, the government, and manufacturers.
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IRA Medicare Inflation Rebates: At A Glance
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The Inflation Reduction Act (IRA) of 2022 requires biopharmaceutical companies to pay rebates to the government if the price for drugs in Medicare Part B or Part D increase faster than the rate of inflation.
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340B
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Patient Benefits from 340B Have Eroded
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Congress created the 340B Drug Discount Program to help uninsured and vulnerable patients gain access to affordable prescription drugs and services. Over the years this program has expanded well past the original intent of Congress and now patients are not seeing the benefits they deserve.
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DSH Hospital Abuse the 340B Drug Pricing Program
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DSH Hospital Abuse the 340B Drug Pricing Program
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How DSH Hospitals Abuse the 340B Drug Pricing Program
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How DSH Hospitals Abuse the 340B Drug Pricing Program
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340B Backgrounder
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In 1992, with the support of the biopharmaceutical industry, Congress created the 340B Drug Pricing Program to help uninsured and vulnerable patients. As part of the law, drug manufacturers provide significant discounts on outpatient medicines and treatments to select eligible health care “covered entities” — often referred to as safety- net providers.
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Cost & Value of Biopharmaceuticals
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The U.S. Bioscience Industry Fosters Innovation and Drives America’s Economy Forward
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The bioscience industry and its supporting ecosystem drive bold innovations to address unmet human needs in the U.S. and around the world, including developing new breakthrough therapies that treat deadly diseases. The collective efforts of the industry and our public and private stakeholders have met the challenges of the COVID pandemic head-on, while lessening the impacts of climate change and nourishing a growing global population.
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Private Sector's Critical Role in Biomedical Innovation
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There is a misguided perception that NIH funding, not private market investment, is largely responsible for the creation and approval of new therapies. A new study by Vital Transformation¹ tests that hypothesis by tracking more than 20,000 patents linked to NIH grant over a 20 year period, identifying those associated with clinical trials and approved medicines, and quantifying the public and private investments made for those investigational and approved medicines.
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Biotech Basics
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Advanced/Innovative Manufacturing 101
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Learn more about Advanced/Innovative Manufacturing and its importance to biotech development.
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Advanced/Innovative Manufacturing 101
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Our members are pioneering research into new breakthroughs, but an R&D amortization provision from the '17 Tax Cuts & Jobs Act that just went into effect will negatively impact this work.
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Leveraging V3 for Digitally Derived Endpoints Framework - V3 as Applied to DHTTs Used in Various Drug Development Scenarios
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Leveraging V3 for Digitally Derived Endpoints Framework - V3 as Applied to DHTTs Used in Various Drug Development Scenarios
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What Are Clinical Trials Like Today?
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Learn about clinical trials and get answers to your questions.
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Patient Experience Data Throughout Medical Product Development and Review
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Patient Experience Data is the systematic collection of meaningful data related to the experiences, perspectives, needs, and priorities of patients. Below you will find a graphic that outlines types of patient experience data, how that data might be used in different phases of drug development and review.
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The Partnership of Publicly Research & Private Innovation
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Private entities take foundational knowledge from public research and invent practical applications that result in real-life treatments and cures for patients.
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Patents Drive Innovation of Both New and Improved Products
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In the debate over drug costs, there is a lot of discussion about so-called “evergreening.” The truth is that the U.S. PTO applies the same legal standards to pharmaceutical patents as they do to other technologies.
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Plant and Animal Gene Editing
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Plant and animal breeding are continually improving as people learn more about biology. Gene editing is really just the newest tool in a very long history of biological advancement.
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Human Genome Editing
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Genome editing is based on a naturally occurring system that directs a molecular scissor, called a nuclease, to a target region of DNA.
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Disease Area
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The Next Wave Of Transformative Therapies
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Over the last five years, there has been a dramatic increase in the global development of transformative gene therapies. Given this increase and the global development, there is a clear need for harmonization across global regulatory authorities to ensure that these therapies can be delivered to the patients that need them as quickly as possible. Such harmonization efforts may include regulatory terminology and definitions, and nonclinical, quality, and clinical considerations.
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Treating Genetic Diseases With Gene Therapy
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Gene therapies are being developed to treat multiple diseases, including hemophilia, inherited retinal diseases, and Huntington’s disease.
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Treating Diseases With Cell Therapy
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Gene therapies are being developed to treat multiple diseases, including hemophilia, inherited retinal diseases, and Huntington’s disease.
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Transforming HIV/AIDS into a Chronic Condition
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Advancements by the biopharmaceutical sector have radically altered the trajectory of HIV/AIDS.
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Cancer Medicines
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Biotechnology is helping to transform a terrifying diagnosis into a healthier and longer life for patients.
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Stemming the Coming Alzheimer's Tsunami
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As Baby Boomers age, the rate of Alzheimer's disease will reach epidemic proportions.
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Agriculture & Environment
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Growing Climate Solutions Act
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BIO supports the Growing Climate Solutions Act (GCSA) (S. 1251/H.R. 2820), which will foster sustainability and economic resiliency in agriculture and preserve America’s rich environmental diversity.
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Global Leadership
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BIO recommends several foreign policy actions that will restore our standing as a global leader on biotechnology, enhance economic growth and job creation, and lay the groundwork for leveraging science and American innovation to solve society’s biggest and most pressing challenges.
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Sustainable Sourcing: Decarbonizing Transportation
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Transportation emits more greenhouse gases than any other sector. Thanks to biotechnology, however, we can decarbonize all modes of transportation—air, land and sea—using sustainable sources like plants and waste.
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Rare Diseases
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Priority Review Voucher Programs
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Priority review vouchers provide a powerful incentive to stimulate drug development for underserved diseases or conditions.
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Opioids
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Insurance, Regulation and the Fight Against Opioid Addiction
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Insurance coverage, reimbursement and regulatory challenges are preventing access to innovative treatments for pain and addiction.
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Insurance, Regulation and the Fight Against Opioid Addiction
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Insurance coverage, reimbursement and regulatory challenges are preventing access to innovative treatments for pain and addiction.
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Biomedical Innovation Can Help Solve the Opioid Crisis
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Our industry is working hard to transform the standard of care for pain and addiction through novel and safer next-generation therapies.
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Biomedical Innovation Can Help Solve the Opioid Crisis
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Our industry is working hard to transform the standard of care for pain and addiction through novel and safer next-generation therapies.
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Issue Briefs (1)
340B
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DSH Hospital Abuse the 340B Drug Pricing Program
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Many hospitals in the 340B Program are exploiting lax eligibility criteria and program guardrails to profit from the substantial 340B discounts that were intended to ensure low-income access to discounted prescription drugs and services. 
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Video (3)
Cost & Value of Biopharmaceuticals
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This whiteboard video helps break down the experience of a senior in the Medicare Part D program.
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Aug 5, 2019
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Why are seniors paying so much out of pocket for their medicines?
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Aug 5, 2019
This whiteboard video helps break down the experience of a senior in the Medicare Part D program.
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Why are patients facing higher costs when they go to the pharmacy?
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Jul 26, 2019
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Why are patients facing higher costs when they go to the pharmacy?
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Jul 26, 2019
In this video, you will learn how changes to the way insurance is designed has left some vulnerable patients paying more out of pocket for the medicines they need.
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Opioids
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The Power of Innovation in Addressing the Opioid Epidemic
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Sep 1, 2018
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The Power of Innovation in Addressing the Opioid Epidemic
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Sep 1, 2018
The Power of Innovation in Addressing the Opioid Epidemic
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