Drug Discovery of Biologics Primer 201 builds upon the foundational knowledge of Drug Discovery of Biologics Primer 101, focusing on systematic insights into therapeutic antibody discovery. This course begins with the significance of antibody screening and structure-based affinity maturation, emphasizing antibody Chemistry, Manufacturing, and Controls (CMC) liabilities. Covering four therapeutic antibody classes, including immune checkpoint inhibitors, this class showcases the factors that influence early drug candidate selection. The data and transition criteria essential for advancing candidate drugs from the discovery phase to preclinical development are also covered. Enroll today to deepen your therapeutic antibody drug discovery knowledge!

Small Molecule Drug Discovery Primer 101 teaches the essential steps to finding and bringing new compounds to market. From identifying potential drug targets to optimizing lead compounds, this class demonstrates how scientists refine small molecule drugs before they undergo preclinical and clinical trials. Discover how proven techniques like computational modeling, in vitro testing, and animal studies are crucial in identifying promising medicinal options. Don't miss this opportunity to become conversant in the fast-paced world of pharmaceutical research!

Drug Discovery of Biologics Primer 101 is a must-have class for those new to medicines derived from living organisms. It delves deep into the five-step drug discovery process, spanning target identification and verification to candidate identification, validation, and optimization. This class reveals the utility of in silico, in vitro, and in vivo disease models in elucidating functional pharmacology activity. Drug Discovery of Biologics Primer 101 ends by demonstrating how the data analysis is used to make crucial candidate drug go or no-go decisions. Seize this opportunity to learn the fundamentals of biologics drug discovery. Reserve your spot now

Diagnostics' Role in Medicine Today introduces the ever-expanding molecular diagnostics industry. This class defines the groundbreaking field of qualitative and quantitative biomarker measurements. These crucial measurements help identify diseases, select treatments, and monitor chosen therapies. Get ready to explore a wide range of foundational diagnostics used in both research and clinical settings, such as immunochemistry, microbiology, and infectious disease diagnostics. The course ends by focusing on companion diagnostics. The showstopper is a culminating case study on HER2 cancer/Herceptin that highlights real-world evidence of how companion diagnostics help patients receive appropriate therapy. Learn foundational concepts applied in the research and clinic settings and become diagnostic proficient, enroll today!

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.