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Network Organizations
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Networking Resources, Key Networks and Organizations  •  May 16, 2024
List of organizations engaged in the progress of women and minorities in the workplace.
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Comments of the Biotechnology Innovation Organization (BIO) to The USPTO February 13, 2024 Inventorship Guidance for AI-Assisted Inventions, 89 FR 10043
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Intellectual Property  •  Letters, Testimony & Comments  •  May 15, 2024
On behalf of its member organizations, Biotechnology Innovation Organization (“BIO”) respectfully submits this Comment in response to the United States Patent and Trademark Office’s (the “Patent Office” or “PTO”) February 13, 2024 Request for Comments. See 89 FR 10043 (the “Guidance”). BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO members include startup companies developing their first commercial products to multi-national Fortune 500 pharmaceutical corporations. The use of artificial intelligence and machine learning (together: “AI”) tools is becoming increasingly common, though not ubiquitous, among BIO’s member companies, who deploy this technology to assist in drug discovery, clinical trial design, manufacturing process improvements, and a range of other applications. While BIO’s member companies have not yet developed a uniform view on the Office’s Inventorship Guidance, we would like to offer a few high-level comments that we believe reflect prevalent attitudes among BIO’s membership.
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AI patent guidance creates uncertainty
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Good Day BIO Newsletter  •  May 15, 2024
Today, the House Committee on Oversight and Accountability will mark up the amended BIOSECURE Act—we’ll be watching. Meanwhile, BIO explains why new AI patent guidance creates uncertainty and a North Carolina treasurer’s report calls out 340B abuses in the state. (592 words, 2 minutes, 57 seconds)
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Common Types of Blind Spots and Biases
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Employee Recruitment, Unconscious Bias  •  May 15, 2024
Learn more about five types of blind spots or biases that may exist within your organization.
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Job Profile
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Employee Retention, Talent Review and Succession Planning  •  May 15, 2024
This robust internal job profile includes key elements for succession planning within your organization. 
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Talent Card Template
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Employee Retention, Talent Review and Succession Planning  •  May 15, 2024
This succession planning tool provides a step-by-step process for identifying employees to assume certain key/critical roles in an emergency and/or long-term scenario.
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Talent Review and Succession Planning Process
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Employee Retention, Talent Review and Succession Planning  •  May 15, 2024
A framework to gain perspective on key individuals with high potential within your organization.
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Stepwise Analysis of Female/Male Salary Differences
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Employee Retention, Pay Equality Analysis Methods  •  May 15, 2024
This framework provides a guide to analyzing gender pay differences.
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Conducting Pay Equity Audits
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Employee Retention, Pay Equality Analysis Methods  •  May 15, 2024
Learn more about steps to take for conducting a pay equity audit within your organization.
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Accelerating CMC Readiness for Selected Drug and Biologic Applications
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Webinars  •  May 15, 2024
Through 2027, the FDA is conducting a Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot (CDRP) Program to facilitate CMC development of selected products under investigational new drug applications with potential expedited clinical development timeframes. The pilot is a joint effort by both FDA's Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Selected drug development programs receive extra opportunities to discuss product-specific CMC concerns with the FDA reviewers through CMC-focused Type B meetings to help product development keep pace with their clinical development. In combination with PhRMA and the FDA, BIO hosted a webinar to inform BIO and PhRMA's memberships about the CDRP: What sorts of products are eligible, what is needed to apply, and why an IND sponsor of a promising product with an expedited clinical development timeframe would want to enlist in this pilot. This webinar will provide additional insights into the CDRP application process, and the planned public workshop designed to promote innovation and understanding in product development.
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Good Trouble for Good Medicine

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