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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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Gene Therapy Primer
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BIO Professional Development Courses  •  August 15, 2024
Gene Therapy Primer presents the scientific principles and regulatory intricacies of manipulating DNA to cure rare diseases. This class uncovers the mechanics of viral vectors and the thought process behind selecting the perfect vector for each unique application. It provides valuable insight into critical factors determining which diseases are suitable for gene therapy intervention and why. Get an in-depth understanding of the FDA approval process and the rigorous standards used to evaluate the safety and effectiveness of gene therapies. Enroll now in Gene Therapy Primer and become well-versed in this medical revolution!
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Medical Device Approval Primer
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BIO Professional Development Courses  •  August 15, 2024
Medical Device Approval Primer takes a close look at the complex world of regulatory approval pathways. With a focus on the FDA and EMA agencies, it identifies the regulatory compliance requirements and different medical device classifications, from Class I to III, that are critical to ensuring patient safety. This primer provides insight into the FDA and EMA organizational structure and approval pathways, such as 510(k), De Novo 510(k), PMN, and PMA. Learn about the importance of Quality System Regulations (QSR) requirements, Good Laboratory Practices (GLP), and Good Clinical Practices (GCP) used worldwide in medical device development. Become fluent in assessing risk and choosing the appropriate medical device approval pathway. grab your seat today!
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Preclinical Development Primer 201
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BIO Professional Development Courses  •  August 15, 2024
Preclinical Development Primer 201 builds upon the established knowledge in Preclinical Development Primer 101, utilizing real-world examples and case studies to delve deep into the specific tests and data required to file a successful Investigational New Drug (IND) application. The class focuses first on efficacy, centered around pharmacology studies, including binding and potency assays, and second on safety, including ADME, HERG, DART, PK/PD, mutagenicity, and carcinogenicity testing. This primer examines each preclinical test's goals and outcomes, evaluating data results to determine therapeutic margin, side effects, and optimal drug concentration. Finally, the class describes the workflow, timeline, and standards for validating and qualifying these tests. Don't miss this opportunity to understand preclinical developments. secure your spot today! 
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Preclinical Development Primer 101
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BIO Professional Development Courses  •  August 15, 2024
Preclinical Development Primer 101 guides you through the essential steps of early-stage drug development and the efficacy and safety standards that must be met prior to beginning clinical trials. This class integrates the key disciplines of pharmacology, pharmacokinetics/ pharmacodynamics, and toxicology to showcase the attributes that make a compelling drug candidate. This primer finishes by revealing the regulatory steps to file an Investigational New Drug (IND) application required to initiate clinical trials. This 101 class equips you with the foundational knowledge needed to understand the basics of preclinical development. Join now and gain a command of the preclinical process!
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