BioBriefing is a comprehensive, virtual two-half-day course providing you with an overview of the development of biopharmaceuticals. The course will start with foundational basics and give a detailed overview of the entire process from discovery to commercialization. As an attendee, you will learn a bit of the science behind biotech products, the clinical research process, regulatory filings, and scale-up for manufacturing. Different types of products such as biologic drugs, biosimilars, personalized medicine, stem cell, and regenerative medicine will be outlined.
Agenda:
Day 1
- How Biology is the Basics of Biotechnology
- Biotechnology Defined
- Cell Types Used in Biotechnology
- Cell Structure and Function
- Cell Signaling Network
- How DNA and Proteins are Biotech's Workhorse
- DNA Structure and Function
- DNA Codes for Proteins
- Protein Structure and Function
- Post-Translational Modifications
- Industry Applications
- Kinase Inhibitor
- Proteomics
- How Disease Occurs in your Body
- Genetic Disease
- Mutation Types and Causes
- Genetic Variation in Humans
- Genetic Basics of Disease
- Infectious Disease
- Pathogens
- Bacterial Infectious Disease
- Viral Infectious Disease
- Genetic Disease
- How Your Body Fights Disease
- The Immune System
- B-Cells and Antibodies
- Epitopes
- T-Cells
Day 2
- How Biologics Fight Disease
- Drug Categories
- Characteristics of Small Molecule Drugs
- Purpose and Mechanisms of Actions of Large Molecule Drugs (Biologics)
- Therapeutic Antibodies
- Monoclonal Antibodies
- Bispecific Antibodies
- Checkpoint Inhibitors
- Gene Therapy
- Gene Editing
- CRISPR
- Cell Therapy
- CAR-T
- Therapeutic Antibodies
- How Biologics Are Made
- Biomanufacturing Process Overview
- Cell Banks
- Upstream Processing
- Downstream Processing
- Formulation
- Analytical Testing Final Product
- How Biologics are Developed
- Traditional Drug Development Pathway
- Gene and Cell Therapy Development Pathway
- Drug Development Metrics
- Changes of Success, Timelines, Costs
- The FDA
- Purpose of Preclinical Development
- Purpose of Phase I, II, III, IV
- IND, NDA, BLA
Who Should Attend?
This course will benefit anyone who is new to the biotech/biopharma industries, needs to know the process at a high level or those who need a refresher. There is no level of prerequisite knowledge or understanding necessary to attend. Additionally, this course will be of value to those who support any step within the development process, including outside vendors.
*This registration is non-transferable and only allows one access per individual, including on-demand access after the conclusion of the course.