Diagnostic Development Primer is a comprehensive guide to navigating the complex world of approval pathways. This class begins by examining the vital roles that various United States government agencies play in regulating In Vitro Diagnostics (IVD) and Laboratory-Developed Tests (LDTs). It provides a detailed description of the regulatory requirements for Class I, II, and III diagnostic approval pathways. A review of the internationally recognized Quality System Regulations (QSR) and how they impact the design and manufacturing of diagnostic products closes out section two. This primer wraps up by explaining the reimbursement process for Medicare, Medicaid, hospitals, and private payers, breaking down complex inpatient DRG codes and outpatient CPT codes. Enroll now in the Diagnostic Approval Primer and become well-versed in the approval process of molecular diagnostics. Let's start your journey today!

Clinical Development 401: Phase IV uncovers what happens after a new drug gains approval and enters the marketplace. This class, the 4th and final in the comprehensive Biotech Primer Clinical Development series, exposes the crucial role of regulatory agencies in protecting public health by monitoring all drugs' pharmacovigilance in real-world conditions. The FDA's safety information and adverse events reporting program called MedWatch is highlighted. Don't miss out on this opportunity to be informed on post-approval drug considerations. Complete your understanding of the clinical trial process by signing up for Clinical Development 401: Phase IV today

Clinical Development 301: Phase II/III focuses on the purpose and critical differences between well-controlled Phase II and III studies. This class expertly explains the art of trial design and how each protocol measures efficacy via primary and secondary endpoints. Section two focuses on pharmacovigilance and the pivotal role of independent Data Safety Monitoring Boards who exhaustively review data to make critical recommendations about trial continuation, modification, or termination. Clinical Development 301 reveals the regulatory considerations of special designations that can accelerate the drug candidates' development. The class ends with an explanation of the New Drug Application (NDA) and Biologics License Application (BLA) that must be filed with and approved by the FDA to receive drug marketing approval. Join us to continue building your expertise in Clinical Development!

Clinical Development 201: Phase I provides insights into Phase 0 and Phase I clinical trials, including their purpose and regulatory requirements. This class, the second in the Biotech Primer Clinical Development series, showcases the indispensable role of gathering preliminary pharmacokinetics and pharmacodynamics data to determine the appropriate dosage of experimental treatments. Strategies of Single Ascending Dose (SAD), Multiple Ascending Doses (MAD), and Maximum Tolerated Dose (MTD) protocols are explained in thorough detail. Clinical Development 201 outlines how researchers vigilantly monitor participants, meticulously collect vital safety data, and expertly evaluate the effectiveness of new treatments using well-defined endpoints. Don't miss this opportunity to enhance your clinical trials expertise. Enroll now to secure your seat! 

Biopharma Business Acumen Primer provides a comprehensive understanding of the business considerations needed to develop and bring a life-saving cure to the marketplace. It begins with an exploration of the financing vehicles and sources required to develop a cure. The class then examines the intricacies of intellectual property management, followed by a focus on lifecycle management strategies for medicines so sponsors can wring out the maximum value of each asset. Biopharma Business Acumen ends by breaking down the complex world of U.S. drug pricing. This course provides the knowledge necessary to navigate the challenges and opportunities in the healthcare field. Enroll today and contribute to the vital mission of bringing cures to those in need!

Clinical Development 101: General Principles sets the stage for the entire Biotech Primer clinical development series by covering the essential terms, milestones, and considerations needed to understand the clinical development process. This Primer dives into the core principles of current Good Clinical Practices and how to manage risk for study volunteers. Clinical Development 101 focuses on the most relevant study designs, inclusion/exclusion criteria for selecting participants, and ethical considerations that must be met. The class ends by establishing master data management and reporting standards required for regulatory filings. Register now for Clinical Development 101: General Principles and establish a baseline understanding of clinical trials.

Biosimilars Primer explains the science, manufacturing technology, and regulatory requirements for receiving approval to market biosimilar products. Beginning with an overview of protein structure, function, and production, this class hones in on different types of biologics and how each fights disease. This class highlights how production conditions can alter a biosimilar, causing it to function differently than its reference product. The course ends with a Safety and Regulation section that examines immunogenicity and approaches to demonstrating biosimilar safety and efficacy that have been acceptable to the FDA and EMA. Four real-world case studies illustrate the complexity and versatility of biosimilars in treating various medical conditions. Enroll today! 

Biomanufacturing Primer introduces the ever-evolving world of biomanufacturing. It gives a scientific overview of essential topics such as the intricacies driving cell lines, cell banks, upstream/downstream bioprocessing, and the latest advancements in this dynamic field. The class compares the fascinating differences between bacterial and mammalian cell lines and explains which drug products each can and cannot produce. The concept of cell banks, both master and working cell banks, and their critical manufacturing roles are explained in detail. This primer outlines the art of upstream bioprocessing (optimizing cell growth and scale-up) and downstream bioprocessing (harvesting and purifying protein drug products). The class ends by highlighting incredible advancements such as continuous bioprocessing, single-use technologies, and critical quality attributes. Register today for this informative class and gain a foundational understanding of biomanufacturing!

Cell Therapy Primer offers a comprehensive introduction to cell therapy development, manufacturing, and commercialization. This class delves into the scientific benefits and challenges of autologous and allogeneic cell therapies. Cell Therapy Primer focuses especially on Chimeric Antigen Receptors (CARs), their proven approach to treating blood cancer, and their potential applications in solid tumors and beyond. The course also introduces stem cell therapies and applications in regenerative medicine. Enroll now to gain an understanding of the groundbreaking potential of cell therapy!