Biopharmaceuticals/Biologics

Biologics: Approved Biologics

Biopharmaceuticals/Biologics

Biologics: Categories

Introduction

Biologics, the Start

Biological Products/Regulation

Regulation of Biologics

The Future

Future Applications for Biologics

Marketplace

Some of the Therapeutic Areas Covered by Biologics

Introduction

FDA Approval for Biologics

Introduction

FDA Approval for Biologics

Biopharmaceuticals/Biologics

Differences Between Biologics and Conventional Drugs (Small Molecules)

Biologics: Overview

Biologics: Welcome

Biological Products/Biologics vs. Biosimilars

Definition of Biosimilarity

Introduction

Define a Biologic (Clarification of Terminology, FDA Changes): Drugs

Biologic DMARDs

Biologic DMARDs: Background

Biological Products

Biologics in the Marketplace

Biological Products

Biologics Overview

Summary: Biologics

Summary: Biologics

Introduction

FDA Approval for Biologics
How Does a Drug Get Approved?

Biological Products/Recombinant Proteins

Discovery and Development of Biologics: Recombinant Biologics

Biological Products/Recombinant Proteins

Production of a Biologic

Biopharmaceuticals/Biologics

Biologics: Specific Subclass of Drug

Biological Products/Allergenics

Discovery and Development of Biologics

Biological Products/Vaccines

Discovery and Development of Biologics

Biological Products/Recombinant Proteins

Discovery and Development of Biologics: Mammalian Cell-Based Systems

Introduction

How Does a Drug Get Approved?

Biological Products/Recombinant Proteins

Manufacturing-Scale Production

Introduction

The Critical Path for Medical Product Development
The Immune System Modulators
Interactive...

Clinical Trials of Biologic Agents

Introduction: Clinical Trials of Biologic Agents

Marketplace

Reimbursement for Biologics

Proteins

Manufacturing Biologic Proteins

Introduction

The Market for Biologics Therapy

Biologic DMARDs

Background: Adverse Events

Biologic Medical Products

Overview: Biologic Medical Products

Introduction

FDA Approval for Biologics
How Does a Drug Get Approved?

Biologic Medical Products

Overview: Biologics vs. Small Molecule Drugs

Biologic Medical Products

Biologics in the Marketplace

Biological Products/Biologics vs. Biosimilars

How Similar Is Similar

Biologics: Introduction

Biotechnology

The Future

Development of Generics: Overview
Future Applications for Biologics

Biological Products/Gene Therapy

Discovery and Development of Biologics: Gene Therapy

Biological Products/Cell Therapy

Discovery and Development of Biologics: Cell Therapy

Biological Products/Biologics vs. Biosimilars

What Are Biosimilars?

Biological Products/Biologics vs. Biosimilars

Regulatory Definitions

Biological Products/Biologics vs. Biosimilars

Demonstrating Biosimilarity

Biologic Medical Products

Production of a Recombinant Biologic

Introduction

Define a Biologic (Clarification of Terminology, FDA Changes)

Introduction

Define a Biologic (Clarification of Terminology, FDA Changes)

Introduction

FDA Approval for Biologics

Biologic Targets

IL-12/23 Antibody

Review of Clinical Trials and Meta-analyses of Biologic Agents

Biologic Treatments and Remission in Early RA

Biological Products/Vaccines

Cost of Vaccines

Introduction

FDA Approval for Biologics

Biologics: Introduction

Economic Impact of Biotechnology in the U.S.

Biological Products/Recombinant Proteins

Enhancement and Variation

Biologic Targets

Structural Differences in TNF-Blocking Biologics
Functional Differences in TNF-Blocking Agents

Introduction: Biologics for Psoriasis

Biologics: Administration

Biologic Targets

Biologic Targets

Summary: Psoriasis and Biologics

Biologic Targets

Marketplace

Stroke
Diabetes Mellitus
Growth Defects
Anemia
Neutropenia
Hepatitis
R...

Endpoints

Clinical Versus Biological Endpoints

Biological Products

Manufacturing Process

Introduction: Biologics for Psoriasis

Biologics, What Are They?
Conventional Versus Biologic Therapies
Biologics: Administration

The Future

Development of Generics: Overview

Biological Products/Blood and Blood Products

Discovery and Development of Biologics: Blood and Blood Products

Biologic Medical Products

Overview: Regulatory Definitions and Mechanism of Action

Systems Biology

Modeling Biological Systems

Marketplace

Getting into the Market: The Approval Process

Introduction

The Critical Path for Medical Product Development

Introduction: Biologics for Psoriasis

Biologics, What Are They?

Biological Products

Biologics and Protein Therapeutics

Review of Clinical Trials and Meta-analyses of Biologic Agents

Comparisons of Clinical Trial Results

Introduction: Biologics for Psoriasis

Conventional Versus Biologic Therapies

Biologic Targets

Structural Differences in TNF-Blocking Biologics

Biologics in Current Use - Abatacept

Use, Indication for RA, Dosage and Administration: Abatacept

Proteins

Monoclonal Antibodies

Marketplace

Stroke
Diabetes Mellitus
Growth Defects
Anemia
Neutropenia
Hepatitis
R...

Non-biologic DMARDs

Introduction: DMARDs

Introduction

Define a Biologic (Clarification of Terminology, FDA Changes)
Protein Structure and Function

Biological Basis of Binge Eating Disorder

Biological Basis of Binge Eating Disorder

Biologic Targets

Pathology of Psoriasis
T-Cell Cytokines
Biologic Targets

Summary: Psoriasis and Biologics

Psoriasis
Immunosuppression
Choice of Therapy
Biologic Targets
Combination Thera...

Monoclonal Antibodies

Biologic Therapies

Biologic DMARDs

Introduction to Biologic Disease-Modifying Antirheumatic Drugs (DMARDs)

Background on Biologic Therapies

Biologics in the Treatment of Rheumatoid Arthritis (RA)

Summary: Psoriasis and Biologics

Combination Therapy

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Eculizumab

Biologic Targets

Pathology of Psoriasis

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Ustekinumab

Guidelines for Use of Biologics

Choice of Therapy

Summary: Psoriasis and Biologics

Psoriasis

Summary: Psoriasis and Biologics

Choice of Therapy

Background on Biologic Therapies

Monoclonal Antibodies

Summary: Psoriasis and Biologics

Immunosuppression

Biologic Targets

T-Cell Cytokines

The Future

Development of Generics

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Eculizumab
MAbs/Biologics: Ustekinumab

Introduction

Protein Structure and Function

The Future

Development of Generics

Regulation of Biological Products and Drugs

Drug Regulation, Clinical Studies, CDT, and CMC

The Future

Development of Generics

Marketplace

Anemia

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Introduction: Psoriasis Therapies and Treatments

Introduction: Psoriasis Therapies and Treatments

Marketplace

Getting into the Market: The Approval Process

Review of Clinical Trials and Meta-analyses of Biologic Agents

Efficacy of Biologic Agent Monotherapy in MTX-Naive Patients

TNF-Targeted Biologics in Current Use - Etanercept

Warnings: Etanercept

Marketplace

Neutropenia

Marketplace

Asthma

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Introduction

The Immune System Modulators

Marketplace

Stroke

Marketplace

Diabetes Mellitus

Marketplace

Hepatitis

Marketplace

Rheumatoid Arthritis

Marketplace

Crohn Disease

Marketplace

Breast Cancer

Introduction

Protein Structure and Function

Introduction

Protein Structure and Function

Biologics in Current Use - Abatacept

Warnings: Abatacept

Other Biologics in Current Use - Rituximab

Warnings: Rituximab

Introduction

Protein Structure and Function

Biologics in use for RA

Effector Mechanisms: TNFα

Biologics in use for RA

Effector Mechanisms: Inhibition of TNFα

Other Biologics in Current Use - Tocilizumab

Dosage Modifications: Tocilizumab

Other Biologics in Current Use - Tocilizumab

Warnings: Tocilizumab

SLE Treatments: MAbs/Biologics

Monoclonal Antibodies (MAbs) Biologics: Introduction

Immunosuppression

Immunosuppression

Regulation of Biological Products and Drugs

Biological Product Regulation

Biologic Targets

Functional Differences in TNF-Blocking Agents

Biological and Physicochemical Determinants of PK

Summary: Biological and Physiological Determinants of PK

Other Biologics in Current Use - Anakinra

Warnings: Anakinra

Biological Basis of Binge Eating Disorder

Summary of Biological Basis of Binge Eating Disorder

Other Biologics in Current Use - Tocilizumab

Mechanism of Action: Tocilizumab

Introduction

Protein Structure and Function

Introduction to Therapeutic Immunology

Biologic Therapies

Introduction to Therapeutic Immunology

Categories of Biologic Therapy

Biosimilar Medical Products

Patent Cliff and Biologic Medicines in Development

Aβ Immunotherapy

Biologics

Summary: Biosimilars

Summary: Biologics and Biosimilars

Biologic Medical Products

Enhancement and Variation

Guidelines for Use of Biologics

Choice of Therapy
Choice of Therapy: Treatment Choice and Guidelines

Marketplace

Multiple Sclerosis

Proteins

Types of Cytokines
Protein Modifications
Manufacturing Biologic Proteins
Agonist

Marketplace

Growth Defects

Marketplace

Cutaneous T-Cell Lymphoma

TNF-Targeted Biologics in Current Use - Infliximab

Warnings: Infliximab

Review of Clinical Trials and Meta-analyses of Biologic Agents

Introduction: Review of Clinical Trials

TNF-Targeted Biologics in Current Use - Golimumab

Mechanism of Action: Golimumab

TNF-Targeted Biologics in Current Use - Adalimumab

Mechanism of Action: Adalimumab

TNF-Targeted Biologics in Current Use - Golimumab

Warnings: Golimumab

Other Biologics in Current Use - Anakinra

Mechanism of Action (MOA): Anakinra & IL-1Ra

TNF-Targeted Biologics in Current Use - Etanercept

Mechanism of Action: Etanercept

TNF-Targeted Biologics in Current Use - Adalimumab

Dosage, Administration, and Warnings

TNF-Targeted Biologics in Current Use - Certolizumab Pegol

Warnings: Certolizumab Pegol

Etanercept

Dosage and Administration

TNF-Targeted Biologics in Current Use - Infliximab

Mechanism of Action (MOA): Infliximab

Biologics in Current Use - Abatacept

Mechanism of Action (MOA): Abatacept & CTLA4

TNF-Targeted Biologics in Current Use - Etanercept

Use: Indication for Rheumatoid Arthritis, Dosage and Administration

TNF-Targeted Biologics in Current Use - Infliximab

Use: Indication, Dosage and Administration for RA

TNF-Targeted Biologics in Current Use - Golimumab

Use and Indication for RA: Golimumab

Guidelines for Use of Biologics

Choice of Therapy: Treatment Choice and Guidelines

TNF-Targeted Biologics in Current Use - Adalimumab

Use in RA: Indications, Dosage and Administration

TNF-Targeted Biologics in Current Use - Certolizumab Pegol

Mechanism of Action: Certolizumab Pegol

Other Biologics in Current Use - Rituximab

Recommended Dose for Rheumatoid Arthritis and Concomitant Medications: Rituximab

Other Biologics in Current Use - Tocilizumab

Use, Indication, Dosage and Administration: Tocilizumab

Review of Clinical Trials and Meta-analyses of Biologic Agents

Sequential Use of TNFα inhibitors

Adalimumab

Adalimumab Warnings

Review of Clinical Trials and Meta-analyses of Biologic Agents

Efficacy of Biologic Treatment and MTX Combination Therapy in MTX-Experienced Patients

Review of Clinical Trials and Meta-analyses of Biologic Agents

Efficacy of Combined Biologic Treatment and DMARD Therapy in DMARD-Experienced Patients

Other Biologics in Current Use - Rituximab

Mechanism of Action (MOA): Rituximab

Other Biologics in Current Use - Anakinra

Use in RA, Indications, Dosage and Administration: Anakinra

Other Biologics in Current Use - Rituximab

Use, Indication for RA, Dosage and Administration: Rituximab

Review of Clinical Trials and Meta-analyses of Biologic Agents

Sequential Use of TNFα inhibitors: Comparing Studies

Adalimumab

Overview: Description
Indication
Dosage and Administration

Review of Clinical Trials and Meta-analyses of Biologic Agents

Efficacy of Biologic Treatment and MTX Combination Therapy in MTX-Naive Patients

Ustekinumab

Indication

Foundational Clinical Trials

Metastatic Melanoma: Biologics

Regulation of Biological Products and Drugs

Biological Product Regulation: Biologics License Application (BLA), New Drug Application (NDA), Comm...

Adalimumab

Overview: Description

Background of Clinical Trials

Clinical Trials of Biologic RA Treatments

Adalimumab

Dosage and Administration

Infliximab

Dosage and Administration

Etanercept

Etanercept Indication

Etanercept

Safety

Ustekinumab

Ustekinumab Safety

Clinical Applications of Monoclonal Antibodies

Biological Actions of mAbs

Overview: DNA Discovery and Structure

Accumulation of Biological Knowledge: Chromosomes and DNA

Regulation of Biosimilars

Allowable Differences Between the Biosimilar and the Reference Biologic

Adalimumab

Indication

Adalimumab

Pivotal Trials

Infliximab

Infliximab Indication

SLE Treatments: MAbs/Biologics

Belimumab: Indication

SLE Treatments: MAbs/Biologics

Belimumab: Clinical Trials

Adalimumab

Adverse Reactions

Infliximab

Infliximab Safety

Psoriasis Therapies

Biologics: TNF-Targeted Agents

Biological and Physicochemical Determinants of PK

Drug Elimination: Metabolism and Excretion

Overview: DNA Discovery and Structure

Accumulation of Biological Knowledge: Trait Inheritance

Endpoints

Endpoints
Primary and Secondary Endpoints
Objective and Subjective Endpoints
Clinical...

Etanercept

Overview: Description of Etanercept
Etanercept Indication
Dosage and Administration

TNF-Targeted Biologics in Current Use - Certolizumab Pegol

Use, Indication for RA, Dosage and Administration: Certolizumab Pegol

Infliximab

Overview: Description of Infliximab
Infliximab Indication
Dosage and Administration

Ustekinumab

Overview: Ustekinumab
Indication
Dosage and Administration

Immunosuppression

Immunosuppression
Tuberculosis (TB)
Tuberculosis Testing and Monitoring

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Trial Design

Drug Discovery

Results of Biological Processes

Psoriatic Arthritis Therapies

Disease-Modifying Anti-Rheumatic Drugs (DMARDs): Biologics

Adalimumab

Pivotal Trials: Psoriasis Trial II
Psoriasis Trial II: Efficacy
Adverse Reactions

SLE Treatments: MAbs/Biologics

Belimumab: Clinical Trial 1(Phase II)

Non-biologic DMARDs: Methotrexate

Pivotal Clinical Studies

Infliximab

Safety: Boxed Warning

Etanercept

Safety: Boxed Warning

Immunosuppression

Tuberculosis (TB)
Tuberculosis Testing and Monitoring

Infliximab

Pivotal Trials: Efficacy of Maintenance
Infliximab Safety

Etanercept

Overview: Description of Etanercept

Etanercept

Pivotal Trials: Efficacy

Ustekinumab

Pivotal Trials: Trial Design

Adalimumab

Pivotal Trials: Psoriasis Trial I

Adalimumab

Psoriasis Trial II: Efficacy

Infliximab

Psoriasis Trial II: Study Design

Etanercept

Psoriasis Trial I: Study Design

Etanercept

Psoriasis Trial II: Study Design

Ustekinumab

Pivotal Trials: Efficacy

Rituximab: Clinical Studies

Rituximab: Clinical Studies

Infliximab

Overview: Description of Infliximab

Ustekinumab

Pivotal Trials: Endpoints

Monoclonal Antibodies in Action

Neutralization of Circulating Factor

Adalimumab

Psoriasis Trial I: Endpoints

Adalimumab

Psoriasis Trial I: Efficacy

Infliximab

Psoriasis Trial III: Study Design

Ustekinumab

Overview: Ustekinumab

Ustekinumab

Pivotal Trials: Overview

Ustekinumab

Efficacy: Effect of Patient Weight

Adalimumab: Clinical Studies

Adalimumab: Clinical Studies

Anakinra: Clinical Studies

Anakinra: Clinical Studies

Abatacept: Clinical Studies

Abatacept: Clinical Studies

Tocilizumab: Clinical Studies

Tocilizumab: Clinical Studies

Monoclonal Antibodies in Action

Effector Mechanisms - Overview

Infliximab

Pivotal Trials: Overview

Infliximab

Pivotal Trials: Endpoints

Infliximab

Pivotal Trials: Efficacy of Maintenance

Etanercept

Pivotal Trials: Overview

Ustekinumab

Dosage and Administration

Monoclonal Antibodies

Monoclonal Antibody Structure

Immunosuppression

Tuberculosis Testing and Monitoring

Infliximab

Psoriasis Trial I: Study Design

Infliximab

Pivotal Trials: Efficacy of Induction

Etanercept

Psoriasis Trials I and II: Endpoints

Background of Clinical Trials

Initial studies with Monoclonal Antibodies

Immunosuppression

Tuberculosis (TB)

Adalimumab

Pivotal Trials: Psoriasis Trial II

Monoclonal Antibodies

Monoclonal Antibody Production

Adalimumab

Pivotal Trials
Pivotal Trials: Psoriasis Trial I
Psoriasis Trial I: Endpoints
Psorias...

Infliximab

Pivotal Trials: Overview
Psoriasis Trial I: Study Design
Psoriasis Trial II: Study Design

Etanercept

Pivotal Trials: Overview
Psoriasis Trial I: Study Design
Psoriasis Trial II: Study Design

Ustekinumab

Pivotal Trials: Overview
Pivotal Trials: Trial Design
Pivotal Trials: Endpoints
Pivot...

Monoclonal Antibodies in Action

Complement Dependent Cytotoxicity (CDC)

Monoclonal Antibodies in Action

Conjugate Delivery: Toxin/Radionuclide

Infliximab: Clinical Studies

Infliximab: Clinical Studies

Monoclonal Antibodies in Action

Receptor Binding: Cross-linking

Monoclonal Antibodies in Action

Receptor Binding: Blockade/activation

Ustekinumab

Efficacy: Trial I through Week 52

Current Treatment

Metastatic Melanoma: Combination and Biologic Therapies

Etanercept: Clinical Studies

Etanercept: Clinical Studies

Golimumab: Clinical Studies

Golimumab: Clinical Studies

Certolizumab Pegol: Clinical Studies

Certolizumab Pegol: Clinical Studies

Monoclonal Antibodies

Monoclonal Antibody Production
Monoclonal Antibody Production: Knowledge Check

Monoclonal Antibodies in Action

Effector Mechanisms - Overview
Neutralization of Circulating Factor
Antibody-Dependent Cel...

Adalimumab

Pivotal Trials: Psoriasis Trial I
Psoriasis Trial I: Endpoints
Psoriasis Trial I: Efficacy

Ustekinumab

Pivotal Trials: Efficacy
Efficacy: Effect of Patient Weight
Efficacy: Trial I through Week...

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Rituximab

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Abatacept

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Infliximab

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Trial Design
Belimumab Clinical Trials 2 and 3: Study Endpo...

SLE Treatments: MAbs/Biologics

Belimumab: Clinical Trials
Belimumab: Clinical Trial 1(Phase II)
Belimumab Clinical Trials...

SLE Treatments: MAbs/Biologics

Belimumab
Belimumab: Indication
Belimumab: Mechanism of Action
Belimumab: Dosage and ...

Monoclonal Antibodies in Action

Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)

Monoclonal Antibodies in Action

Conjugate Delivery: Antibody-Directed Enzyme Prodrug Therapy (ADEPT)

Summary

Medical Products, Medical Device Regulation, Biological & Drug Product Regulation and Combination Pr...

Psoriatic Arthritis Therapies

Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Disease-Modifying Anti-Rheumatic Drugs (DMARDs)...

Psoriasis Therapies

Systemic Therapies: Off-Label Agents
Off-Label Agents: Clinical Efficacy and Safety
Biolog...

Protein Composition

Biologics: Large Proteins

DNA Discovery

Biological Discovery Process

Summary: DNA Discovery and Structure

Biological Discovery

SLE Treatments: MAbs/Biologics

Belimumab

Biological and Physicochemical Determinants of PK

Mechanisms of Drug Absorption

Biological and Physicochemical Determinants of PK

Drug Distribution

Biological and Physicochemical Determinants of PK

Excretion

Non-biologic DMARDs

Sulfasalazine

Biological Products

Modified Therapeutic Proteins

Introduction to Therapeutic Immunology

Edward Jenner: Vaccination
Vaccination Successes
Therapeutic Immunology: Immunodiagnostics...

SLE Treatments: MAbs/Biologics

Belimumab: Mechanism of Action

SLE Treatments: MAbs/Biologics

Belimumab: Dosage and Administration

SLE Treatments: MAbs/Biologics

Rituximab: Mode of Action

SLE Treatments: MAbs/Biologics

Rituximab: Efficacy

SLE Treatments: MAbs/Biologics

Rituximab: Side Effects

SLE Treatments: MAbs/Biologics

Abatacept: Efficacy

SLE Treatments: MAbs/Biologics

Abatacept: Side Effects

SLE Treatments: MAbs/Biologics

Infliximab: Mode of Action

SLE Treatments: MAbs/Biologics

Infliximab: Efficacy and Safety

Biological and Physiological Determinants of PK

Basic Pharmacokinetic (PK) Principles

Biological and Physicochemical Determinants of PK

Drug Absorption and an Array of Drug Modality Options

Biological and Physicochemical Determinants of PK

Factors that Affect Drug Distribution

Biological and Physicochemical Determinants of PK

Barriers to Drug Distribution: At the Tissue Site

Histological/Biological Changes

Proteinaceous Deposits

Non-biologic DMARDs

Antimalarials (hydroxychloroquine)

Non-biologic DMARDs: Methotrexate

Methotrexate: Efficacy

Non-biologic DMARDs: Methotrexate

Methotrexate: Use Contraindications

Non-biologic DMARDs: Methotrexate

Methotrexate Dosage: Oral

Non-biologic DMARDs: Leflunomide

Introduction: Leflunomide

Biologic Medical Products

Production of Monoclonal Antibodies

Biological Products

Modified Therapeutic Proteins Improve Function

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Abatacept
Abatacept: Efficacy
Abatacept: Side Effects

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Infliximab
Infliximab: Mode of Action
Infliximab: Efficacy and Safety

SLE Treatments: MAbs/Biologics

MAbs/Biologics: Rituximab
Rituximab: Mode of Action
Rituximab: Efficacy
Rituximab: Si...

Clinical Applications of Monoclonal Antibodies

Receptor Cross-Linking
Inducing Complement-Mediated Cytotoxicity
Inducing Antibody-Depende...

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Trial Design

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Efficacy

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Efficacy

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Warnings and Precautions

Biological and Physiological Determinants of PK

Development of Successful Therapeutic Drugs and The Biology of the Animal and Physicochemical Proper...

Biological and Physicochemical Determinants of PK

Drug Properties and Biology Determine Route of Drug Administration

Histological/Biological Changes

Brain Areas and Characteristic Features

Regulation of Biological Products and Drugs

Drug Regulation: European Registration International Conference on Harmonization (ICH)

Non-biologic DMARDs: Methotrexate

Introduction: Methotrexate (MTX)

Non-biologic DMARDs: Methotrexate

Pivotal Clinical Studies: Methotrexate

Non-biologic DMARDs: Methotrexate

Clinical Studies: Multidrug Combinations

Non-biologic DMARDs: Methotrexate

MTX in Combination: Two Year Randomized, Double-Blind, Placebo-Controlled Trial

Non-biologic DMARDs: Methotrexate

Methotrexate Use: RA Indication

Non-biologic DMARDs: Methotrexate

Methotrexate Dosage: Safety and Side Effects

Non-biologic DMARDs: Methotrexate

Safety Issues and Side Effects

Non-biologic DMARDs: Leflunomide

Use: Indications, Contraindications, Safety Issues and Side Effects

Glucocorticoids

Mechanism of Action (MOA): Glucocorticoids

Clinical Applications of Monoclonal Antibodies

Clinical Applications of Monoclonal Antibodies: Learning Objectives
Detection, Diagnosis, and M...

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Study Endpoints

NSAIDs

Mechanism of Action (MOA): NSAIDs and COX Enzymes

Nonbiologic DMARDs: Leflunomide

Mechanism of Action (MOA): Leflunomide

SLE Treatments: MAbs/Biologics

Belimumab Clinical Trials 2 and 3: Efficacy
Belimumab Clinical Trials 2 and 3: Warnings and Pre...

Nonbiologic DMARDs: Methotrexate

Mechanism of Action (MOA): Dihydrofolate Reductase (DHFR)

Drug Discovery

Drug Discovery
Target vs. Platform-driven Discovery
Target Validation
Targeting Strat...

Protein Composition

Biologics: Large Proteins
Structurally Important Side Chains
Categorize These Amino Acids

Proteins

Antagonist

Proteins

Toxin

Regulation of Biosimilars

Reference Product

Biosimilars

Biosimilars Overview

Learning Objectives

Learning Objectives

Learning Objectives

Learning Objectives

Proteins

Agonist
Neutralization of a Circulating Factor
Antagonist
Toxin

Early Stages for Developing a Formulation

Molecular Characterization

Proteins

Protein Modifications: Pegylation

Medical Products

Regulatory Definitions: Combination Product

Country-Specific Definitions and Regulatory Guidelines

Health Canada

Biology of Eating Behaviors

Biology of Eating Behaviors

BED Pathophysiology

BED Pathophysiology

Biomarkers

Definition of a Biomarker

Biosimilarity

What is Biosimilarity?

Biosimilarity

What is Biosimilarity?

Country-Specific Definitions and Regulatory Guidelines

India Ministry of Science and Technology (MST)

Proteins

Types of Cytokines

Proteins

Neutralization of a Circulating Factor

Monoclonal Antibodies

Neutralization of a Circulating Factor

Summary: RA Treatment Guidelines

Summary: RA Treatment Guidelines

Biosimilars

Biosimilars in the Marketplace

Country-Specific Definitions and Regulatory Guidelines

Japanese Ministry of Health, Labour and Welfare (MHLW)

Proteins

Protein Modifications

Proteins

Agonist

Proteins

Types of Cytokines

Proteins

Protein Modifications

Monoclonal Antibodies

Neutralization of a Circulating Factor

Monoclonal Antibodies

Conjugated Monoclonal Antibodies

Regulation of Biosimilars

Quality and Ingredient Requirements

Combination Product Regulation

Combination Products: Approval as Drug or Device

Overview: Cells (The Basics)

The Cell

The Effect of Food on Pharmacokinetics and Pharmacodynamics in the Treatment of GERD

Efficacy and Bioavailability

Country-Specific Definitions and Regulatory Guidelines

European Medicines Agency (EMA) Detailed Requirements

Proteins

The Cytokines

Monoclonal Antibodies

Production of Monoclonal Antibodies in Mammalian Cell Lines

Monoclonal Antibodies

Modifying the Monoclonal Antibody

Monoclonal Antibodies

Neutralization of a Circulating Factor

Monoclonal Antibodies

Receptor Blockade/Activation

Monoclonal Antibodies

Complement Dependent Cytotoxicity

Biosimilar Drug Products

Introduction and Definition: Biosimilars

Monoclonal Antibodies

Receptor Cross-Linking

Monoclonal Antibodies

Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC)

Biosimilars

Biosimilar Overview and Definition

Etiology

Pathogenesis of Schizophrenia

Country-Specific Definitions and Regulatory Guidelines

Food and Drug Administration (FDA) Detailed Requirements

Treatment Goals and Guidelines

American Psychiatric Association (APA) Practice Guidelines

Immunogenicity

Immunogenicity: Introduction

Pharmacokinetics: Absorption

Factors that Affect Absorption: Drug Properties

Therapies: Approved and Off-Label

Therapies: Off-Label

Monoclonal Antibodies

Production of Monoclonal Antibodies by Hybridomas

Monoclonal Antibodies

Modifying the Monoclonal Antibody: Mouse

Monoclonal Antibodies

Antibody Structure and Function

What are the Determinants of PK? ADME

ADME Issues in Drug Development

Psoriatic Arthritis Therapies

Psoriatic Arthritis Therapies: Overview
Treatment Recommendations

Pharmacokinetics: Absorption

Factors that Affect Absorption
Factors that Affect Absorption: Drug Properties
Factors tha...

Regulation of Biosimilars

Manufacturing Requirements

Chemical Process

Methionine Oxidation: Consequences

How Do Proteins Degrade Physically and Chemically?

Chemical Instability: Hydrolysis, Oxidation, Racemization, Deamidation, Disulfide Exchange, Beta-Eli...

What is Biotechnology?

A Breakthrough in Treating Diabetes

Psoriatic Arthritis Therapies

Treatment Recommendations

Biology of Eating Behaviors

Hormonal Control of Energy Homeostasis: Orexigenic and Anorexigenic

Early Stages for Developing a Formulation

Molecular Characterization
Development Timeline
Pre-formulation Studies
Manufacturabi...

Monoclonal Antibodies

Naming Monoclonal Antibodies

Combination Product Regulation

Combination Product Regulation

Introduction

Introduction: Rheumatoid Arthritis Treatment

Government Regulation and Approval Pathways

European Medicines Agency (EMA)

Mechanisms of Molecular Pathogenesis: Summary

Mechanisms of Molecular Pathogenesis: Summary

The Inflammatory Response

The Complement System: Inactive Proenzyme

What is Biotechnology?

Biopharmaceuticals: Therapeutic Areas

What is Biotechnology?

Biopharmaceuticals: Sales

Psoriatic Arthritis Therapies

Psoriatic Arthritis Therapies: Overview

Current Treatment

Metastatic Melanoma: Biochemotherapy (BCT)

Foundational Clinical Trials

Metastatic Melanoma

Foundational Clinical Trials

Metastatic Melanoma: IL-2

Anatomy and Pathophysiology

Risk Factors: Pathogens HPV

Current Treatment

Chemotherapy (CTx): Advantages and Recommendations

Biosimilars

Regulatory Milestones and General Requirements for the Production of Biosimilars

Biopharmaceuticals

Patents and Generics

Biosimilars

Challenges in U.S. Marketplace

Regulation of Biosimilars

Evidence Generation: Non-Clinical

Biosimilarity

What is Biosimilarity?, Demonstrating Biosimilarity

Pharmacokinetics: Absorption

ADME
What is Drug Absorption?
Factors that Affect Absorption
Factors that Affect Abso...

Treatment Guidelines

Management of Subtypes of Psoriasis Adults with Palmoplantar Psoriasis

Biosimilar Drug Products

Demonstrating Biosimilarity: Challenges

Country-Specific Definitions and Regulatory Guidelines

European Medicines Agency (EMA)

Protein Structure

Quaternary Structure

How Do We Study Protein Structure and Protein Stability?

X-Ray Crystallography

Heart Failure: Causes

Left Ventricular Remodeling

Pharmaceutical Therapies for Managing Hyperglycemia

Secretagogues

Disease Mechanism

Axonal Transport Mechanisms

Introduction to Therapeutic Immunology

Immunotherapy

Introduction to Therapeutic Immunology

Limitations of Traditional Immunosuppressive Drugs

Soluble Receptors and Other Cytokine Inhibitors

Overview of Cytokine Therapy: Types of Cytokines

Introduction: IL-1β and IL-1Ra

Introduction to IL-1

Summary: Cell Membranes

Cell Membranes: Summary

Systemic Therapy

Systemic Therapy: Purpose

Psoriasis Therapies

Psoriasis Therapies

Investigational Treatment Strategies

Investigational Clinical Trials: Vaccines and New Targeted Therapies

Diagnosis of Stomach Cancer

Biomarkers Used in Gastric Cancer

Details of Selected Neurotransmitters

Histamine

Regulation of Biosimilars

Evidence Generation: Comparative Data

Regulation of Biosimilars

Summary: Stepwise Approach to Establish Biosimilarity

Country-Specific Definitions and Regulatory Guidelines

Summary of Country-Specific Definitions and Regulatory Guidelines

What are the Determinants of PK? ADME

Interactive Exercise: Drug Absorption and Elimination
Elimination: Metabolism & Excretion
...

Monoclonal Antibodies

Modifying the Monoclonal Antibody
Neutralization of a Circulating Factor
Receptor Blockade...

Modeling Metabolism

The Centrality of Metabolism and Types of Data

Summary: Psoriasis Treatments

Psoriatic Arthritis Therapies

Introduction

Search for Biomarkers in Alzheimer's Disease

How Do Proteins Degrade Physically and Chemically?

Physical Instability: Denaturation, Adsorption, Aggregation, Precipitation
Chemical Instability...

Pharmaceutical Therapies for Managing Hyperglycemia

Secretagogues

Pharmaceutical Therapies for Managing Hyperglycemia

Secretagogues

Medical Products

Regulatory Definitions

Therapies: Approved and Off-Label

Therapies: Approved
Therapies: Off-Label

Choice of Therapy

Psoriasis Severity Affects Treatment Choice

Treatment Guidelines

Management of Subtypes of Psoriasis Candidates for UV-Based, Oral PUVA or Systemic Therapy
Mana...

PK Parameters

Determinants of Pharmacokinetics (PK) and Drug Exposure and Pharmacokinetics

Conclusions

Melanoma: Conclusions

Therapeutic Approach

Therapeutic Approach: ACR Guidelines

Biosimilar Drug Products

Biosimilars in the Marketplace and Drug Development in the U.S.

Biosimilars

Benefits, Risks, Marketing, and Claims

Government Regulation and Approval Pathways

U.S. Food and Drug Administration: Regulatory Oversight

Protein Structure

Protein Structure vs. Function: Primary Structure

Heart Failure: Causes

Left Ventricular Remodeling

Treatment Guidelines

Management of Subtypes of Psoriasis Erythrodermic Psoriasis

Psoriatic Arthritis Therapies

Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

Male Reproductive Physiology

Testosterone as a Prohormone

Surrogate Markers as Clinical Endpoints

Biomarkers as Surrogate Markers

Introduction

Introduction

Summary: Binge Eating Disorder (BED) Disease State

Summary: Binge Eating Disorder (BED) Disease State

BED Pathophysiology

Dopamine Dysregulation and the Yale Food Addiction Scale

BED Pathophysiology

Dopamine Dysregulation: Genetic Factors

Biosimilars

Benefits, Risks, and Patent Life

Biosimilars

Example of a Biosimilar Not Approved by the EMA

Country-Specific Definitions and Regulatory Guidelines

Introduction to Country-Specific Definitions and Regulatory Guidelines

Biopharmaceuticals

Biopharmaceuticals
Patents and Generics
Biopharmaceuticals: Specificity of Action
Mak...

PK in Action

Bioequivalence and Comparability

Regulation of Biosimilars

Substitution and Interchangeability

Regulation of Biosimilars

Evidence Generation: Clinical

Basaglar Insulin Glargine

Immunogenicity: Background

Monoclonal Antibodies

Production of Monoclonal Antibodies by Hybridomas
Production of Monoclonal Antibodies in Mammal...

Introduction

Core PKDM Disciplines Supporting Drug Development

Details of Selected Neurotransmitters

Serotonin (5-hydroxytryptamine, 5-HT)

Overview of Skin Structure and Function

Overview of Skin Structure and Function

Government Regulation and Approval Pathways

U.S. Food and Drug Administration

Biology of Eating Behaviors

Neuronal Control of Energy Homeostasis

Biosimilars

Biosimilars Under Review

Soluble Receptors and Other Cytokine Inhibitors

Soluble Receptors and Other Cytokine Inhibitors
Overview of Cytokine Therapy: Types of Cytokine...

What is Biotechnology?

The History of Biotechnology
What is Biotechnology?
A Global Industry
The Evolution o...

Protein Structure

Protein Structure vs. Function: Primary Structure
Secondary Structure
Tertiary Structure

Immunogenicity

Immunogenicity: Introduction
Factors Influencing Immunogenicity
Factors Influencing Immuno...

Heart Failure: Causes

Index Event
Nature of Index Event
Compensatory Mechanisms
Left Ventricular Remodeling

Pharmaceutical Therapies for Managing Hyperglycemia

Incretins

Pharmaceutical Therapies for Managing Hyperglycemia

Pancreatic Hormones
Secretagogues
Pharmaceutical Therapies for Managing Hyperglycemia

Cellular Organelles

Cellular Organelles

Summary: Cell Structure and Mobility

Cell Structure and Mobility: Summary

Goals of Therapy

Goals of SLE Therapy

The Inflammatory Response

The Complement System: The Complement
The Complement System: The Compete Cascade
The Compl...

Choice of Therapy

Benefit/Risk
Psoriasis Severity Affects Treatment Choice

Overview of Incretins

Other GLP-1 Effects on Beta Cell Function and Mass

Biosimilar Drug Products

Biosimilars in the Marketplace

Biosimilarity

Comparative Pharmacokinetics

Biology of Eating Behaviors

Hunger and Energy Homeostasis

BED Pathophysiology

Impulsivity and Emotional Dysregulation

BED Pathophysiology

Mu-Opioid Signaling Dysfunction

Adaptive T Cell Immunity

CD4+ T Helper Cells and Tumor Immunity

Overview of Breast Cancer

Symptomatology and Diagnosis of Metastatic Breast Cancer

Adaptive T Cell Immunity

CD4+ T Helper Cells and Tumor Immunity

Element-1 Trial

Element-2 Trial

Summary

Summary: Methotrexate (MTX)

Pharmaceutical Therapies for Managing Hyperglycemia

Incretins

Introduction

Pharmacokinetics & Pharmacodynamics Guide Drug Candidate Design and Selection and Advance the Core G...

Introduction to Pharmacology, Pharmacodynamics and Pharmacokinetics

PK/PD Relationship and Drug Therapies

Basaglar Insulin Glargine

Immunogenicity

PK/PD of Basaglar

Pharmaceutical Therapies for Managing Hyperglycemia

Incretins

PK in Action

PK Prediction

Details of Selected Neurotransmitters

Histamine
Glutamate and Gamma Aminobutyric Acid (GABA)
Peptide Neurotransmitters: Opioid P...

Biology of Eating Behaviors

Hormonal Control of Energy Homeostasis: Leptin

Biology of Eating Behaviors

The Reward Circuit and Appetite Regulation

Regulation of Biosimilars

Pharmacovigilance and Risk Management

Special Populations

NLA: Children and Adolescents

Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

Toxicology Studies for Small and Large Molecules

Glucocorticoids

Production of Lipocortin: Anti-Inflammatory Effects

Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

Toxicology Studies for Small and Large Molecules
Traditional Drugs

Diagnosis

Diagnosis

Specifications and Sign-off (What are the Different Tox Strategies for Small and Large Molecules?)

Toxicology Studies for Small and Large Molecules

Chemical Process

Chemical Stability
Methionine Oxidation
Methionine Oxidation: Consequences
Methionine...

How Do We Study Protein Structure and Protein Stability?

High Performance Liquid Chromatography: Size Exclusion Chromatography (SEC)
High Performance Li...

Pathogenesis of Primary Osteoporosis

Postmenopausal Osteoporosis: Progression and Hormonal Changes

Non-modifiable Risk Factors

Ethnicity

Details of Selected Neurotransmitters

Acetylcholine (ACh)
Acetylcholinesterase (AChE)
Dopamine (DA) and Dopamine Signaling
...

Traditional Immunosuppressive Therapies

Corticosteroids

Glucocorticoids

Glucocorticoids: Steroid Hormones
Production of Lipocortin
Production of Lipocortin: Anti-...

Purpose of the Study

Pharmacokinetics and Pharmacodynamics

Diabetes Annotations

Humalog 200 units/ml KwikPen SmPC

Diabetes Annotations

Abasaglar insulin glargine

Hemostasis

Coagulation: Contact Activation Pathway

Introduction

Characteristics of an Ideal Biomarker

Country-Specific Definitions and Regulatory Guidelines

South Korea Ministry of Food and Drug Safety (MFDS)

Country-Specific Definitions and Regulatory Guidelines

World Health Organization (WHO)

Diagnosis

The HIV Test
Diagnosis
Enzyme Linked Immunosorbent Assays (ELISA), or Enzyme Immunoassays ...

Advancing Technologies

Biomarkers Overview

Traditional Immunosuppressive Therapies

Corticosteroids: Immediate Effect (Anti-Inflammatory)
Corticosteroids: Gene Expression
Cor...

Soluble Receptors and Other Cytokine Inhibitors

Cytokine Neutralizers

Soluble Receptors and Other Cytokine Inhibitors

Abatacept

Pharmacokinetics: Absorption

Factors that Affect Absorption: Route of Administration

Autoimmune Disease Processes

Consequences of Autoimmune Diseases: The Natural History of Autoimmune Disorders

Soluble Receptors and Other Cytokine Inhibitors

Abatacept
Mechanism of Action of Abatacept (Orencia)
Abatacept: A Soluble Fusion Protein

Clinical Applications of Monoclonal Antibodies

A Closer Look At mABS Used as Therapies

Myelination

Neurotrophins

Typical Components of a Protein Formulation

Typical Components of a Protein Formulation

Soluble Receptors and Other Cytokine Inhibitors

Cytokine Neutralizers
Cytokine Inhibitors: Three Major Strategies
Agents That Block Cytoki...

Myelination

Astrocytes
Oligodendrocytes
Myelin in the Peripheral Nervous System
Neurotrophins

NCCN Guidelines

Risk Category and Current Treatment Strategies

Soluble Receptors and Other Cytokine Inhibitors

Soluble Receptor Therapies
Mechanism of Action of Enbrel (etanercept): Tumor Necrosis Factor In...

Current Therapies

Goals of Disease Modifying Therapy (DMT)
Symptomatic Therapies - Symptom Reduction
Hormona...

Cytogenetic Subgroups in MDS

Cytogenetic Subgroups in MDS

Traditional Immunosuppressive Therapies

Traditional Immunosuppressive Therapies
Traditional Immunosuppressive Agents
Corticosteroi...

Current Therapies

Disease Modifying Therapy (DMT): Approved Treatments for Multiple Sclerosis

Advancing Technologies

Biomarkers: Disease Process-Specific Biomarkers
Biomarkers: Inflammation Biomarkers
Biomar...

NCCN Guidelines

Risk Category and Current Treatment Strategies
Components of NCCN Guidelines
Therapeutic A...

Current Therapies

Overview: Current Therapies for MS
Treatment of Acute Relapses: Severe Relapses: Therapeutic P...

Autoimmune Disease Processes

The Etiology of Autoimmune Disease
The Etiology of Autoimmune Disease: Genetic Factors (Risk)

Autoimmune Disease Processes

Consequences of Autoimmune Diseases: Progression and Destruction in Autoimmune Disorders (Mechanisms...