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An Inclusive and Impactful Approach to Transparency
Agriculture & Environment, Food & Farm Innovation  •  Letters, Testimony & Comments  •  May 14, 2020
The U.S. government’s regulatory approach cannot exist in isolation. It should be supported by credible transparency measures. A proactive approach to transparency stands to build trust and foster an inclusive environment to address our most pressing societal, nutritional, and environmental concerns. BIO understands that consumers want more information about what is in their food and whether their food is safe. Our members will be a driver of that endeavor. BIO believes that an effective approach for transparency includes: Defined roles for all participants, including government, public and private developers, civil society, the food value chain, and the public Clear principles and goals for building trust and answering questions A mechanism for independent verification and the use of best management practices in the development and introduction of new products Diversity of perspectives represented in governance systems Resources that enable small and emerging company participation A publicly available repository of information about plant, animal and microbial biotechnologies and breeding methods and  A comprehensive and connected communications approach. For more information, on BIO's inclusive and impactful approach to transparency, click here: 
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shopper

BIO Appoints a Physician-Scientist as New President and CEO
Press Release  •  May 14, 2020
Immunologist Michelle McMurry-Heath is Selected  for Her Global Leadership and Commitment to Innovation and Patients Former FDA Official Will Succeed Industry Leader Jim Greenwood  on June 1 as Leader of World’s Largest Biotechnology Advocacy Association The Biotechnology Innovation Organization (BIO) – the world’s largest science and public advocacy organization, representing 1,000 members — announced today that Michelle McMurry-Heath, MD, PhD, will become the organization’s next President and CEO on June 1, succeeding former Rep. Jim Greenwood, who has led the organization since 2005. McMurry-Heath has served in numerous senior leadership roles at Johnson & Johnson (J&J) since 2014. Most recently, as Vice President of External Innovation and Global Leader for Regulatory Science, she led a team of 900 employees charting the evidence generation and regulatory strategy across J&J’s medical device companies, specializing in using cutting-edge tools and innovative methods to bring new breakthroughs to patients. “We are living and working through a period in human history when scientific leadership and knowledge are crucial for our organization, our nation and the world,” said BIO Chairman Dr. Jeremy Levin, CEO of Ovid Therapeutics. “The biotechnology industry is humanity’s great hope to speed medical breakthroughs to patients in record time to treat and prevent COVID-19 disease. With her exemplary scientific background, proven federal health policy leadership and track record of driving scientific progress to benefit patients, Michelle is the right person at the right time to lead BIO and the biotech sector into a new future. We welcome her to this new role and are excited to support her efforts to help shape the future of biotechnology. And as Michelle takes over, on behalf of the Board of Directors of BIO, I want to thank Jim Greenwood. Jim is a towering figure and has facilitated immense contributions to patients’ lives, innovation, our…
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Dr. Michelle McMurry-Heath

Meet BIO’s new President and CEO, Dr. Michelle McMurry-Heath
Good Day BIO Newsletter  •  May 14, 2020
We’re dedicating today’s issue to our exciting news: immunologist Dr. Michelle McMurry-Heath will take the reins as BIO’s President and CEO on June 1. Get to know her and how her global leadership and commitment to innovation and patients will drive our industry forward at this critical moment in history, in 620 words, 3 minutes.
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Dr. Moncef Slaoui “Excellent Choice” to Lead Operation Warp Speed
Human Health  •  Press Release  •  May 13, 2020
Following the announcement that Dr. Moncef Slaoui will lead the Trump Administration's "Operation Warp Speed" initiative, BIO’s President and CEO, Jim Greenwood, issued the following statement:  “Dr. Moncef Slaoui is an excellent choice to lead the President’s Operation Warp Speed initiative. Over his long career, he has demonstrated a strong commitment to public health, innovation and a public-private partnership that are vital to building the collaborations we need to bring new therapeutics, diagnostics and vaccines to the American people. Dr. Slaoui has always stood for scientific excellence, and the biotechnology industry stands ready to work with him as we begin this new effort in the race to eradicate the pandemic.” ###
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Biotech already cured a virus with the letter “C” – do you know which one?
Good Day BIO Newsletter  •  May 13, 2020
If you’re just waking up, BIO’s Phyllis Arthur joined WJLA, Washington DC’s ABC affiliate, to discuss the industry’s response to COVID-19. Watch the segment here. In other news, we’re recognizing Hepatitis Awareness Month and the biotech industry’s work on another “C”-named disease, as well as a llama (!!) who might help us beat COVID-19, in 650 words, around 3 minutes, 15 seconds.
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New Medicine Pipeline Tracker Illustrates Unprecedented Effort to Eradicate COVID-19
Business Development, Human Health  •  Press Release  •  May 12, 2020
The Biotechnology Innovation Organization (BIO) today unveiled a first-of-its-kind, interactive tracker of the new treatments and vaccines in the COVID-19 pipeline. This online resource illustrates the unprecedented campaign being undertaken by biopharmaceutical innovators to combat – and ultimately eradicate – the novel coronavirus.  Unlike other tracking tools, BIO’s Industry Analysis Team has identified funding sources from the onset of each project; de-duplicated multiple programs and trials for the same drug; and pinpointed the locations of companies discovering these important innovations. The tracker also organizes and categorizes projects in ways that will help public and private sector funders more strategically and holistically assess and prioritize programs to speed their advancement.  Here are some key takeaways: In the fight against COVID-19, more than 400 unique drug programs were launched in just 16 weeks, including 101 experimental vaccines and 138 programs aimed directly at the SARS-CoV-2 virus;   Private-sector innovators are responsible for more than 90% of vaccines and therapeutics in development to protect individuals and communities from COVID-19;   More than 70% of COVID-19 R&D is being undertaken by small companies; and   More than 50% of this important work originated on American soil.  Among other features, the tracker breaks down the programs by types of approaches, or modalities, being tested to combat COVID-19, and includes information about type of organizations and companies involved in developing the molecules, funding the research, and sponsoring trials. Sourcing of drug names and phase of development comes from BioCentury, Biomedtracker, and international BIO affiliate organizations. As scientists and researchers work around the clock to develop therapeutics and vaccines to fight against COVID-19, this tracker will be updated weekly on Mondays to ensure you have the most recent…
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This new tool can help you track COVID-19 R&D
Good Day BIO Newsletter  •  May 12, 2020
ICYMI: Last night, Centers for Medicare and Medicaid Services (CMS) took an important step forward for America’s seniors and the future of innovative CAR T-cell therapies. Here’s our take. We have an announcement, too: the launch of a cool new COVID-19 R&D tracker. There’s also been a lot of chatter on biofuels and the biobased economy—one of the most important tools available for getting the American economy back to full health. Here are 915 words, about 4 and a half minutes.
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CMS Announcement an Important Step Forward for Patients, Transformative Therapies
Human Health, Cost & Value of Biopharmaceuticals  •  Press Release  •  May 11, 2020
Today, the Centers for Medicare and Medicaid Services announced that it is proposing to create a new Medicare-severity-diagnosis related group (MS-DRG) designed specifically for reimbursing providers administering CAR T-cell therapies to cancer patients. The new proposed regulation, which has been released as part of this year’s inpatient prospective payment system (IPPS) proposed rule, is expected to be finalized this summer.  Following the announcement, BIO’s Executive Vice President for Health Policy, Dan Durham, issued the statement below:  “The Trump administration has taken an important step forward for America’s seniors. Transformative therapies not only save lives, but they also provide enormous benefits to society more broadly by lowering other costly health care spending,” said BIO’s Dan Durham. “Ensuring patients have access to these medical breakthroughs without disruption or delay is paramount, and it begins with CMS’ recognition of the value of innovation and CAR T-cell therapies. We look forward to working with the administration to achieve this goal.”  ###  
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“What worries me the most is that we’re going to miss the next emerging disease”
Good Day BIO Newsletter  •  May 11, 2020
It's Monday...and National Twilight Zone Day. Of course it is. But for today, we're sticking with this theme by taking a look back when several researchers warned us about a future pandemic from a virus-like SARS—16 years ago. Here's a quick 500 words, under 3 minutes.
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Moderna Therapeutics and the search for a COVID-19 vaccine
Good Day BIO Newsletter  •  May 9, 2020
In this special weekend edition of Good Day BIO, we’re introducing Biotechnology: Beyond Imagination, a new series highlighting the technology and scientific advancements of BIO Digital participating companies and BIO member companies. Featuring videos and blog posts that will enhance your understanding of technologies being developed in our industry, this series will demonstrate how cutting-edge advancements hold promise for our future and truly go beyond imagination.
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