InstructorRoyed Training
TypeOnline Course
Student Enrolled2
Price$225 USD / 12375 INR
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Basics of biopharma by royed training

Introduction

Who should attend

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About Biopharmaceutical Industry

basics of biopharma

The objective of biopharma basics training is to impart fundamental know-how about biopharma market, different classes and regulations. In fact, focus is on learning biopharmaceutical R&D, biopharma market dynamics, manufacturing and regulatory aspects. Moreover, this comprehensive training program provides detailed understanding of both innovator biotech and biosimilar (similar biologic) in a single course. This advanced certification course utilizes interactive online learning tools to provide real life practical exposure. Therefore, participants will have understanding about the biopharmaceutical (biotech and biosimilar) market. Above all, users will be understanding key terminologies which are used in biopharma industry. 

  • Course Code: RYD-021
  • Title of the course: Competency Development Training in Basics of Biopharma
  • Types of the course: Online self pace learning course. User can conveniently access the course at own convenient timing.
  • Duration: 1 Week
  • Course Certification: It will be provided on completion of the course.
  • Eligibility: Graduation / 3rd or final year graduation in any discipline. Even the final year student can join the course.

Objective of the Basics of Biopharma Course: Gain in-depth insights into biopharma market dynamics, different classes, and regulations.

🎓 Key Learning Outcomes

  • Understanding Biopharma Market Fundamentals
  • Exploring Biopharmaceutical R&D Processes
  • Navigating Regulatory Landscape
  • Grasping Manufacturing Principles
  • Identifying Key Terminologies Used in the Biopharma Industry

Who should attend this course?

  • Biopharmaceutical professionals seeking to improve their skills in the regulatory environment.
  • Pharmaceutical professionals who wants comprehensive knowledge about the biopharrmaceutical industry.
  • Those moving into regulatory affairs from other areas within a bio-pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others).
  • Anyone wishing to update their knowledge on USFDA regulatory knowledge for biopharma and biosimilars Regulatory Affairs, Registration and Documentation assistants/officers/managers.

📆 Convenient Self paced Learning:

  • Access the course 24×7 at your own pace
  • Engage with lectures, simulations, self-assessment tests, and a final certification examination
  • Download course study modules for offline reference

About Biopharmaceutical Industry

The biopharmaceutical industry is a branch of the pharmaceutical industry that focuses on developing drugs and therapies using biological processes. Biopharmaceuticals are derived from living organisms such as cells, tissues, or microorganisms and are used to treat various diseases.

The industry has grown significantly in recent years due to the increasing demand for novel and effective treatments for complex diseases such as cancer, autoimmune disorders, and genetic disorders. Biopharmaceuticals have shown promising results in treating these diseases by targeting specific molecular pathways in the body.

The biopharmaceutical industry includes various players such as biotechnology companies, pharmaceutical companies, research organizations, and academic institutions. These organizations work together to discover, develop, and commercialize biopharmaceutical products.

But the development process for biopharmaceuticals is complex and time-consuming, requiring significant investments in research and development, clinical trials, and regulatory approvals. However, the potential benefits of these products make the industry an attractive area for investment and growth.

Overall, the biopharmaceutical industry plays a critical role in advancing medical science and improving patient outcomes by developing innovative therapies that address unmet medical needs.

Key Classes about Biopharmaceuticals

Biopharmaceuticals are a diverse group of products that can be classified into several categories based on their structure, mode of action, and therapeutic application. Here are some common classes of biopharmaceuticals:

Monoclonal Antibodies

Monoclonal antibodies (mAbs): These are proteins that are engineered to target specific antigens on the surface of cells and are used to treat various types of cancer, autoimmune disorders, and infectious diseases.

Recombinant proteins

Recombinant proteins: These are proteins that are produced using recombinant DNA technology and are used to replace or supplement missing or defective proteins in the body. Examples include insulin for diabetes and erythropoietin for anemia.

Vaccines

These are biopharmaceuticals that stimulate the body’s immune system to produce an immune response against specific infectious agents. In fact, vaccines can prevent infectious diseases such as measles, mumps, rubella, and human papillomavirus (HPV).

Gene therapies

These are products that aim to treat or cure genetic diseases by introducing a functional gene into the patient’s cells. Hence, gene therapies have shown promising results in treating rare genetic disorders such as spinal muscular atrophy and inherited retinal diseases.

Cell therapies

These are products that use living cells as a therapeutic agent to treat various diseases. Examples include CAR-T cell therapy for cancer and stem cell therapy for spinal cord injuries.

Biosimilars

These are biopharmaceuticals that are similar to an already approved biologic drug but are manufactured by a different company. Biosimilars can provide cost savings and increase access to treatment options for patients.

Overall, these different classes of biopharmaceuticals offer a wide range of therapeutic options for patients with various diseases, and ongoing research and development in this field of biopharmaceuticals. In fact it is leading to new and innovative treatments.

You must know:

Section 1Basic Fundamental of Biologics Market
Lecture 1Introduction : Biopharmaceuticals
Lecture 2Classification of Biopharmaceutical 
Lecture 3Key features of Biologic | Differences in Chemical Drug Vs. Biologic Drugs
Lecture 4Principle of Naming of Biologic | Understanding on MAB naming system 
Lecture 5Introduction to Biologics and Biosimilar | Key differences | Concept of Reference Product
Section 2Biologics classes - detailed understanding
Lecture 6Recombinant Proteins
Lecture 7Monoclonal Antibodies Vs. Polyclonal Antibodies
Lecture 8Monoclonal Antibodies - detailed understanding
Lecture 9Synthetic Immunomodulators
Lecture 10Production of Monoclonal Antibodies
Lecture 11Cytokines
Lecture 12Interferon
Lecture 13Erythropoiesis-stimulating agent
Lecture 14ATMPs | Types and Classification | Regulatory Mechanism 
Lecture 15mAB - At a glance
Lecture 16ATMPs - At a glance
Lecture 17CAR-T Therapy | Different Types of CAR-T Therapy | Mechanism of action | Challenges | Brainstorming on Concept of Personalized Medicine | Understanding on marketed formulation
Lecture 18Live Biotherapeutic Products | LBPs | Class | Mechanism | Indication Positioning | Regulatory Requirements for LBPs 
Section 3Biologics - Regulatory Affairs
Lecture 19R&D Process & Introduction to drug discovery
Lecture 20Investigational New Drug Application (INDA)
Lecture 21New Drug Application (NDA) 
Lecture 22Biological Licensing Application (BLA)  | 351(a) application | Form 356h | Differentiation with NDA | Timeline | Handling FDA queries
Lecture 23Abbreviated Biosimilar Application - 351(k): Advance Strategic Planning Process : Originator Vs. Biosimilar Development and Regulatory Approval Process | Reference Biologic | Purple Book | Data Requirements
Lecture 24351(a) Vs. 351(k)
Lecture 25Purple Book: Significance | Searching | Assignments
Lecture 26Vaccine development and approval Process
Lecture 27Patent & Exclusivity - Strategic Understanding
Section 4Biologics manufacturing
Lecture 28Biosimilar Development Process
Lecture 29Strategic Consideration for Biosimilar Development 
Lecture 30Bio-Manufacturing Process Information
Section 5Biologic Market Access
Lecture 31Biologic Market Access | Objectives | Various Key Terminologies | Steps of Market Access | Understanding on Pricing and Reimbursement
Lecture 32Market Access Strategic Planning
Lecture 33Value Dossier Preparation : What it is | Significance | Components | What to include
Lecture 34Practical Training on Value Dossier Preparation | Sample Value Dossier with each section with data | Key points to consider while preparing value dossier 
Lecture 35Clinical Data in Value Dossier | Understanding in different types of clinical study with rationale | Case based example on clinical study section writing