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BIO Office Hours: Crafting FDA Meeting Package (Day 2)
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December 7, 2023
Successful interactions with the FDA are critical for regulatory development programs. Similarly, an investigational new drug (IND) submission is one of the key milestones in product development and one that sponsors want to get right the first time. Regulatory experts with PSC Biotech will hold twenty-minute virtual appointments focused on tips for crafting meeting packages, including INTERACT packages and writing an IND submission. What to expect in the overview & 20-minute Zoom session: Tips to increase the likelihood of FDA meeting acceptances Review of draft FDA/INTERACT meeting packages Tips for writing an IND submission
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Using March-In as a Price Control Mechanism Is a “Dangerous Precedent To Set”
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Intellectual Property, Patents, Cost & Value of Biopharmaceuticals  •  Press Release  •  December 7, 2023
The White House just announced plans to use Bayh-Dole “march-in rights” to step in and license patent rights of drugs “developed with federal funding” to other manufacturers when the price of the drug is deemed too high. BIO's Chief Advocacy Officer, Nick Shipley, made the following statement: "Using the Bayh-Dole Act’s march-in process as a mechanism to control prices is a dangerous precedent to set. The move would create yet another element of uncertainty within the biotech industry at a time when policy makers have been increasingly adding obstacles to innovation.  This type of policy would discourage the exact type of private-public sector partnerships that the Bayh-Dole Act was designed to encourage, and it would undermine a valuable piece of the drug discovery process. For smaller biotech companies, which are responsible for the bulk of medical innovation, this undermines the ability to raise capital and maintain a stable investment base from strong private sector funding, which is the vast majority of investment that allows them to usher in new waves of biomedical innovation.  Any policy that encourages the government to seize private company patents is a policy that discourages investing in companies that have accepted government funding, such as SBIR grants or working with universities that have received NIH funding.  "It is also disappointing that the White House chose to include this in its broader statement when there are so many other overdue promising policy recommendations where we could find common ground to work together to bring down health care costs.  The announcement touches on reforms to address the long-overdue problem of PBM and provider consolidation, lack of transparency in those sectors, and other elements of oversight that have been long-discussed but never enacted.  We look forward to seeing the Administration apply the same rigor and scrutiny they so willingly bring to our industry to the PBM and…
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CSBA Letter in Support of ORPHAN Cures Act
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Orphan & Rare Diseases, Patient Advocacy, Council for State Biotechnology Associations (CSBA)  •  Letters, Testimony & Comments  •  December 7, 2023
The Council of State Bioscience Associations wrote House and Senate leaders to urge support of H.R. 5539 and S. 3131, the Optimizing Research Progress Hope and New Cures Act. 
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John F. Crowley
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Bayh-Dole march-in surprise
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Good Day BIO Newsletter  •  December 7, 2023
The White House made a surprise announcement today about using Bayh-Dole march-in rights. A House committee advanced additional PBM reform bills, and a new poll shows that Americans support advancing biotech to address climate change. (526 words, 2 minutes, 37 seconds)
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BIO Office Hours: Crafting FDA Meeting Package (Day 1)
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December 6, 2023
Successful interactions with the FDA are critical for regulatory development programs. Similarly, an investigational new drug (IND) submission is one of the key milestones in product development and one that sponsors want to get right the first time. Regulatory experts with PSC Biotech will hold twenty-minute virtual appointments focused on tips for crafting meeting packages, including INTERACT packages and writing an IND submission. What to expect in the overview & 20-minute Zoom session: Tips to increase the likelihood of FDA meeting acceptances Review of draft FDA/INTERACT meeting packages Tips for writing an IND submission
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Plan your JPM Week with BIO
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Good Day BIO Newsletter  •  December 6, 2023
It’s not too early to start thinking about your 2024 networking and business development opportunities—learn more about BIO’s JPM Events Guide app and an opportunity for early-stage startups to get support. Plus, BIO recently urged the President’s Export Council (PEC) to take action on agricultural exports. (544 words, 2 minutes, 43 seconds)
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Industry Leader and Globally Recognized Patient Advocate John F. Crowley Appointed to Lead BIO as President & CEO
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Press Release  •  December 5, 2023
The Biotechnology Innovation Organization (BIO) is proud to announce that industry leader and military veteran John F. Crowley will be its new President and CEO, effective March 4. He will replace Rachel King, a longtime BIO board member and industry trailblazer who has served as BIO’s CEO on an interim basis for the past year.Crowley is best known for his role as an entrepreneur in the biotechnology industry following the 1998 diagnosis of his two youngest children with Pompe disease, a rare and often fatal neuromuscular disorder. His children’s diagnosis inspired him to co-found a biotech company to develop a treatment that he credits with ultimately saving his children’s lives. The Crowley family journey was depicted in the major motion picture “Extraordinary Measures” starring Harrison Ford, Brendan Fraser, and Keri Russell. In 2005, Crowley went on to help found Amicus Therapeutics, a now 500+ person global biotechnology company, where he served as Chairman and CEO from 2005-2022 and is presently the company’s Executive Chairman. He will remain in that role until he transitions to BIO.Crowley’s decades of biotech experience and deep passion for the field will be pivotal in helping BIO reimagine how the world thinks about drug development. He is a strong supporter of policies that empower innovation, enable entrepreneurship, and put patients first. Crowley also has been a leading voice globally for universal access to medicines, especially for children, people living with rare and other life-threatening diseases, and those with disabilities. As the father of two children living with a rare disease, he brings a unique understanding of the challenges patients, their families, and caregivers face, as well as the transformative opportunities that biotechnology presents to alleviate human suffering. This has been his life’s mission.“In every role I’ve held in my life—biotech founder, U.S. Navy intelligence officer, husband and most importantly, father and…
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BIO names John Crowley as new CEO
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Good Day BIO Newsletter  •  December 5, 2023
BIO names John F. Crowley as the new CEO—Bio.News spoke with him about why biotech innovation is personal and what he hopes to achieve in his new mission. Also, BIO has a message for COP28 delegates: biotech is climate tech. (623 words, 3 minutes, 6 seconds)
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White House, BIO zero in on methane
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Good Day BIO Newsletter  •  December 4, 2023
COP28 continues with a major methane announcement from the White House, just one week ahead of BIO’s panel on methane. Last week, a BIO member company told House New Democrats why IP protections are vital to innovation. (593 words, 2 minutes, 57 seconds)
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