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What Trump’s immigration ban means for biotech innovation
Good Day BIO Newsletter  •  June 24, 2020
We have a lot of news today. We examine President Trump’s recent immigration proclamation and what it means for biotech innovation, as well as takeaways from yesterday’s Senate HELP Committee hearing on pandemic preparedness. Read to the end for news from inside the beltway, including a preview of today’s Senate Agriculture hearing on legislation that could support biotech solutions for climate change. Here are around 850 words, or 4 minutes.
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Orphan Drugs: BIO Comments on Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations
Orphan & Rare Diseases, Rare Diseases  •  Letters, Testimony & Comments  •  June 23, 2020
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA or Agency) for the opportunity to submit comments on the Draft Guidance for Industry “Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations” (Draft Guidance or Guidance). BIO appreciates FDA’s efforts to provide drug developers with guidance pertaining to what features FDA will consider when making determinations of “sameness” for gene therapies in the context of orphan drug designation, especially as the landscape for gene therapy products continues to evolve. BIO generally finds the Draft Guidance helpful and we believe that the framework is drafted in a way that supports development of innovative gene therapy products. BIO appreciates the three bulleted “cases” provided by FDA in the Draft Guidance and believes the “cases” are sufficiently exhaustive in demonstrating under what circumstances FDA would consider two gene therapy products either the same or different. However, we do request that FDA clarify that gene editing products are out-of-scope for the guidance and will be subject to case-by-case determinations.  The complete comment letter can be found below.
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As Companies Work Around the Clock to Address COVID-19, BIO Outlines Key Policy Priorities to Prevent the Next Pandemic
Press Release  •  June 23, 2020
BIO Board Member Dr. Gerberding to testify this morning The Senate Committee on Health, Education, Labor and Pensions, chaired by Senator Lamar Alexander, will hold an important hearing today to examine lessons learned from the current global health crisis to help make sure we are better prepared for the next pandemic. Public health expert and patient advocate, Dr. Julie Gerberding, will join the discussion, alongside former top policy leaders.  The biopharmaceutical industry is racing to eradicate COVID-19, with nearly 600 programs currently underway to combat the deadly virus, including more than 150 vaccine programs, more than 180 antiviral treatments and more than 250 therapies to treat the various consequences of COVID-19 infection. As these important efforts continue, the Biotechnology Innovation Organization (BIO) has been working closely with its members to identify policy priorities intended to ensure the United States is better prepared for future pandemics. As BIO’s Phyllis Arthur, Vice President for Infectious Diseases and Diagnostics, said in advance of today’s hearing: “Being better prepared for the next pandemic must be a top priority for our nation, and today’s hearing will help create the type of policy environment needed to make that possible. Chairman Alexander and Ranking Member Murray are to be applauded for their leadership, and we look forward to answering Chairman Alexander’s call for input with a comprehensive set of recommendations that will help ensure our nation is better prepared for future infectious disease outbreaks and other biosecurity threats.” As today’s important hearing gets underway, here are three key areas for Congressional leaders to explore: Ensuring a Functioning Market: As the major purchaser for biodefense countermeasures and drugs to address public health emergencies, a well-resourced, stable, and strategically managed Strategic National Stockpile is critical to ensuring continued private investment in the…
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COVID-19 cases are surging—here’s what we know.
Good Day BIO Newsletter  •  June 23, 2020
It’s a packed news day. BIO’s Dr. Michelle McMurry-Heath has an update on the surge in COVID-19 cases across the United States and the outlook for a vaccine, and some Green lawmakers in Germany signal support for gene editing in agriculture. It’s also a busy day in Washington, with a few hearings to watch. Here are around 860 words, just over 4 minutes.
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The biotech innovator trying to treat COVID-19 cytokine storms
Good Day BIO Newsletter  •  June 22, 2020
We start the week with some news to make you feel good: a new episode of the I AM BIO Podcast features a young biotech innovator whose entire family was on the frontlines of the pandemic, and there’s more support for legislation that would advance biofuels R&D. Here are around 650 words, 3 minutes, 15 seconds. Last call! Today, the Duke-Margolis Center for Health Policy will hold a webinar on manufacturing capacity for COVID-19 therapeutics, featuring BIO's own Dr. Michelle McMurry-Heath. Click here to register.
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Letter to Congress to Support Animal Health Infrastructure Amid COVID-19
Agriculture & Environment  •  Letters, Testimony & Comments  •  June 19, 2020
On behalf of the Animal Agriculture Coalition (AAC), representing veterinary medicine, animal science, state agricultural leaders, and various livestock or animal agricultural interests in the U.S., we applaud lawmakers’ ongoing attention to the challenges COVID-19 has inflicted on the nation’s animal agriculture community. As Congress continues deliberations, we urge you to provide $300 million for the 2018 Farm Bill animal disease prevention and management fund to support improved animal health surveillance and laboratory capacity in the current public health emergency and to ensure preparedness for future infectious disease outbreaks through the National Animal Health Laboratory Network (NAHLN), the National Animal Disease Preparedness and Response Program (NADPRP), and the National Animal Vaccine and Veterinary Countermeasures Vaccine Bank.
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World Sickle Cell Day
Good Day BIO Newsletter  •  June 19, 2020
Today, June 19, is Juneteenth, commemorating the end of slavery in the United States. It’s also World Sickle Cell Day, to raise awareness and understanding of a disease that disproportionately affects African Americans in the United States. So, today, we’re dedicating Good Day BIO to the latest news on what biotech is doing to fight sickle cell disease as well as the disease of racial disparities in health care, in around 550 words, just under 3 minutes. Before you log off for the weekend, don’t forget to register for the Duke-Margolis Center for Health Policy’s webinar on Monday about how we can ensure sufficient manufacturing capacity for COVID-19 therapeutics, featuring BIO’s own Dr. Michelle!
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Advancing biofuels and patient access to transformative therapies
Good Day BIO Newsletter  •  June 18, 2020
Today, we have news from Washington on legislation that would support biofuels as well as a proposed rule that would help patients access transformative new therapies. All the details, in around 900 words, 4 and a half minutes. BTW, on June 22, the Duke-Margolis Center for Health Policy will hold a webinar on manufacturing capacity for COVID-19 therapeutics, featuring results from BIO’s recent survey with Boston Consulting Group on current manufacturing needs and capacity. Click here to register.
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BIO’s Dr. McMurry-Heath Calls Congressional Hearing “Important Step” to Addressing Covid-19 Health Disparities
Press Release  •  June 17, 2020
BIO President and CEO Dr. Michelle McMurry-Heath issued the following statement in advance of a congressional subcommittee hearing in the House Committee on Energy and Commerce on racial and ethnic disparities in Covid-19:   “The disproportionate impact of Covid-19 on communities of color is adding another painful dimension to this devastating disease, and it is time to take action. Today’s hearing is an important step in confronting the inequalities we are witnessing in this pandemic and to exploring concrete solutions.    “BIO and our member companies are committed to working with all relevant stakeholders to address the discrepancies in care facing too many minority patients and families. The response from our industry to develop vaccines and treatments to address the pandemic has been unprecedented, and it's important that these therapies and vaccines, once approved, are accessible for everyone regardless of where they may live or the color of their skin.    “I’d like to applaud the committee’s leadership from both sides of the aisle, as well as the other committees that have held similar hearings, for shining a spotlight on this critical issue, and I am hopeful we can advance real solutions that improve health outcomes for all patients.”   Learn more about BIO’s leadership on diversity & inclusion at bio.org/diversity or watch the recent discussion at BIO Digital 2020 with industry leaders on the state of race and equity within the biotechnology industry.   # # #
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Keeping data flowing and soil healthy
Good Day BIO Newsletter  •  June 17, 2020
It’s a busy Wednesday. We have news from our international team on the rise in measures around the world to restrict the flow of data and what we’re doing about it, as well as the winner of the World Food Prize, a pioneer in soil research. We’re also watching several important hearings on Capitol Hill, including the House Energy and Commerce hearing on the disproportionate impact of COVID-19 on communities of color. Here are around 925 words, 4 minutes, 37 seconds.
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