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cGMP Primer
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BIO Professional Development Courses  •  August 20, 2024
cGMP Primer introduces the benefits and challenges of current Good Manufacturing Practices. The first section sets the stage with the regulatory bodies that enforce cGMP worldwide and the laws that pertain to it. This class takes a deep dive into the six cGMP pillar requirements, including Quality Management System (QMS), Premises and Equipment, Personnel Training, Materials Management, Documents and Records, and Validation and Qualification. This primer ends with a focus on regulatory audits, the Establishment Inspection Report (EIR), non-compliance, and remediations such as a 483. Two real-world case studies provide the opportunity to showcase your newfound knowledge by identifying the non-compliance and determining the corrective action. Take your spot for this introductory cGMP course!
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Gene Therapy Manufacturing Primer 101
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BIO Professional Development Courses  •  August 20, 2024
Gene Therapy Manufacturing Primer 101 is a foundational class that ventures into the essential AAV production platforms, comparing four different approaches and dissecting the key elements of the AAV cassette. This class illustrates the basic upstream/downstream bioprocessing stages, contrasting suspension and adherent cell lines. Bioreactors, such as hyperstacks and iCellis, are examined for their role in this cutting-edge process. This primer ends by summarizing the role of CMC in AAV development, giving an overview of identity, potency, purity, and sterility testing required by the regulatory authorities. Grab your seat today for this introductory course and become conversant in gene therapy manufacturing!
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Gene Therapy Manufacturing Primer 201
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BIO Professional Development Courses  •  August 20, 2024
Gene Therapy Manufacturing Primer 201 is a deep dive into cGMP manufacturing processes for AAVs. This class explores in detail the science and regulatory controls of AAV gene therapy manufacturing. It begins by elucidating the critical steps in upstream vector cGMP production platforms, including Transient Transformation (TT), Baculovirus Expression (rBV/Sf9), Herpes Simplex Expression (HSV/BHK), and Producer Cell Lines (PCL). It continues by focusing on CMC strategies and precursor materials for each production platform. Purification strategies, AAV vector product characterization, analytical testing for safety and quality, viral vector manufacturing facility design, and regulatory considerations for AAV vectors are considered in detail. Take the next step and learn the highly technical aspects of AAV gene therapy manufacturing. Enroll today!
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Diagnostic Measurements Primer
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BIO Professional Development Courses  •  August 20, 2024
Diagnostic Measurements Primer unravels the importance of direct and indirect measurements and their vital role in obtaining regulatory approval. This class begins with the art of constructing and reading a standard curve to determine unknown analyte concentrations. The agenda extends to testing accuracy, focusing on the ins and outs of specificity, sensitivity, false positives/false negatives, and true positives/true negatives. These concepts are reinforced with a graphics exercise on distributions, exploring the varied factors contributing to data variability and bi-modal distribution. This class ends with two real-world case studies critiquing data from mammography for breast cancer and PSA diagnostics for prostate cancer. Learn what it takes to secure diagnostic approval by learning acceptable measurement thresholds. Register today!
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Implementing a Biosafety Program Primer
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BIO Professional Development Courses  •  August 20, 2024
Implementing a Biosafety Program Primer discusses the principles, practices, and personnel related to biosafety and biosecurity programs. This class explains the identification principles of biologic and select agents, categorizing them into four risk levels. It breaks down the practices involving various techniques, such as targeted diversification, chain shuffling, and formulation, which aim to address CMC liabilities. This primer discusses the roles of personnel involved in biosafety programs, including the institutional biosafety committee, biosafety officer, and biosecurity director. It ends with a detailed look at workplace controls and how to report/ investigate breaches should they occur. Grab your spot today and ensure a robust biosafety and biosecurity program in your organization!
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Drug Development, Review & Lifecycle Management
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Policy

How value-based payment agreements can boost access
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Good Day BIO Newsletter  •  August 19, 2024
Today, we take a deep dive into value-based payment arrangements and FNIH’s new program to define and treat Parkinson’s, plus more news about mpox, the Cancer Moonshot, and the DNC. (709 words, 3 minutes, 32 seconds)
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Interviewing for a Life Science Job
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BIO Professional Development Courses  •  August 16, 2024
Interviewing for a Life Science Job showcases proven strategies to prepare for successful interviews with engaging activities to reinforce learning. This class uncovers the significance of selfanalysis and explores useful tools, including the renowned Myers-Briggs Personality Test. It teaches how to create an impactful digital profile on LinkedIn and to find job opportunities using suggested job boards. Additionally, this course delves deep into interview preparation—from researching the company to mastering the art of nonverbal communication, which plays a pivotal role in creating positive impressions. The course ends with common interview questions and responses to ensure a polished, professional performance. Be ready to crush your interview and register today.
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BIO Statement On Selected Drugs in Medicare under Inflation Reduction Act
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Press Release  •  August 15, 2024
The Biotechnology Innovation Organization (BIO) released the following statement after today’s announcement from the Centers for Medicare & Medicaid Services (CMS) on selected drugs under the Inflation Reduction Act (IRA):“While the Inflation Reduction Act puts a cap on senior’s out-of-pocket costs, it also contained some very damaging parts that will impede the development of newer and better medicines for all. Important aspects of the IRA are also damaging to the critical role of the United States and our allies to remain the centers of excellence in biotechnology worldwide. With today’s announcement, we see the start of unilateral government mandated price controls. This will inevitably lead the U.S. on a path to higher costs for patients and less access to innovative medicines.  “The lack of transparency and a scientific approach to decision-making throughout this process undermines the value that these medicines bring to patients in the U.S and around the globe. We are also just beginning to see the harm to patients caused by the unintended consequences of penalizing medicines made as pills. The IRA also includes a damaging provision that will curtail the development of medicines for multiple rare genetic diseases.“At the same time, Congress and the administration must turn their full attention to health insurers and middlemen who profit by denying Medicare patients and others access to the medicines that their doctors prescribe. This is the source of high costs at the pharmacy and the denial of access to lifesaving treatments and cures. Delay and denial from health insurance companies equals suffering and death. This must be addressed, as well as correcting the most egregious parts of the IRA.”
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Applying for a Life Science Job
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BIO Professional Development Courses  •  August 15, 2024
Applying for a Life Science Job demonstrates the power of a well-crafted resume and cover letter and why both are crucial for landing your dream life science job. This class outlines the step-by-step process of writing a compelling resume and cover letter that stands out from the crowd. It details how to tailor both documents to each opportunity and showcase your unique skills and experiences. The culmination is two exciting, hands-on activities: writing your resume and cover letter! Get ready to excel in your job search. Enroll today and unlock your career potential!
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