Drug Development and Pharmaceutical R&D Business Framework

Name: Drug Development and Pharmaceutical R&D Business Framework
Rating: 4.1 (115 reviews)

Introduction to Business Operations in Drug Development & Clinical Research Process

Created byProject Upskill

Last updated 6/2021

English

What you'll learn

Know what are core activities carried out in each phase of the project and their importance
Understand the roles and responsibilities of different business functions in the drug development process
Understand core strategic and project management aspects of business operations in the development of a drug in medium and large biopharmaceutical companies
Understand the terminology used in the drug development project lifecycle
Understand the business platforms and tools used to drive and support drug development projects

Course content

6 sections • 30 lectures • 1h 4m total length

Introduction4:05
This is the very first lecture in this series, where we'll go through introductions and an overview of the course focus areas.
Drug Development in a Nutshell2:42
In this lecture, you will have an overview of the drug discovery and development process.
Knowledge Check on Drug Discovery
Drug Discovery3:09
In this lecture, you'll be given the highlights of the discovery or research phase.
The R&D Pipeline & Portfolio Management: An Introduction3:50
In this lecture, you will understand the concepts of the R&D pipeline and how Portfolio Management helps driving the pipeline.
Investigations in the drug development phase

Pre-Clinical (Phase 0)2:42
In this lecture, you'll be given the highlights of the Pre-Clinical Phase as well as an understanding of the importance of animal research at this stage.
What are Clinical Trials?2:26
In order to understand Clinical Trial Phases I, II and III, you will need to first understand what clinical trials are.
Phase I1:55
In this lecture, you'll be given the highlights of the Phase I.
Phase II1:13
In this lecture, you'll be given the highlights of the Phase II.
Phase III1:21
In this lecture, you'll be given the highlights of the Phase III.
Registration & Launch1:34
In this lecture, you'll be given the highlights of the Registration & Launch Phase.
Phase IV (Post-Launch)0:51
In this lecture, you'll be given the highlights of the Phase IV.
Knowledge check on drug development phases

The R&D Organisation1:44
The organisational structure of R&D varies from company to company. This is the introductory lesson to this section, where we'll set the scene for the people and resource perspective. This lecture identifies the primary functions who collaborate with one another, as a team, to bring a drug to the market.
The CMC Function1:43
In this lecture, you'll explore a CMC function, its roles and and responsibilities in drug development projects.
The Clinical Function1:30
In this lecture, you'll explore a Clinical function, its roles and and responsibilities in drug development projects.
The Non-Clinical Safety Function0:33
In this lecture, you'll explore a Non-Clinical Safety function, its roles and and responsibilities in drug development projects.
The Regulatory Affairs Function1:09
In this lecture, you'll explore a Regulatory function, its roles and and responsibilities in drug development projects.
Project Management Functions1:59
In this lecture, you'll explore Project Management functions, their roles and and responsibilities in drug development project and in the pharmaceutical company
Knowledge check on the R&D Organisation

The Project Team2:17
In this lecture, you'll get an understanding of the generic development team composition.
Project Management Framework3:36
In this lecture, you'll be presented Project Management concepts applied to drug development projects and you'll be able to identify project types.
Global Drug Development Plan & The Target Product Profile (TPP)1:38
In this lecture, you'll be identify key content of the Global Drug Development Plan & understand the importance of Target Product Profile (TPP)
Project Milestones: Overview of milestone types and Phase Milestones2:08
In this lecture, you'll be get an overview of the different project milestones and be introduced to phase milestones.
Project Deliverables1:45
In this lecture, you'll be get an overview of the major project deliverables by function along the project lifetime
Project Decision Points and Project Governance4:33
In this lecture, you'll be introduced to governance, decision making and its relationship to project decision milestones.
Knowledge check on Project Management Framework and Governance

IT Landscape and Information Flow4:19
In this lecture, you'll be get an overview the It systems used in the R&D area and especially, project management system supporting the drug development process and projects in the company.
Project Reporting2:26
In this lecture, you'll be introduced to reporting for key project data and project progress tracking.
Function Reporting1:47
In this lecture, you'll be introduced to reporting for Functions (Departments)
Portfolio Reporting, Performance Indicators and Benchmarking2:12
In this lecture, you'll be introduced to reporting for decision makers, portfolio managers and senior management an get an overview of Key Performance Indicators and Benchmarking.

Requirements

Primarily you have an open mind and the will to learn
It is an advantage if you have you have a background in life science or business.
It is an advantage if you have a strong business acumen and are able to understand business processes and project management concepts as well as workflows or processes
Last but not least, some technical understanding of business technology applications or software used to support business operations are an asset for this course

Description

Are you considering a career in the biopharmaceutical industry? Are you a new employee or non-technical person working in Pharmaceutical R&D?

About This Course

This course will provide you with an overview of the whole Drug Development process, from drug discovery to regulatory submission, with insights into team structure, project management framework, governance & reporting.
In essence, the course will provide you with the assets to be familiarised and make you more comfortable working for or with a biopharma company.

Why You Should Join

To improve the understanding of the essential steps in drug development process with focus on the development stages
Understand the business and operational aspects of managing drug development projects
Understand the responsibilities of R&D functions' and project teams along the drug development process

Learning Objectives

By the end of this course, you will:

Get a solid foundation in the drug development process and who are major actors in a biopharma company
Identify the essential steps in the drug development process
Identify the key functions involved in the drug development process
Recognise the key decision points, phases, workpackages and deliverables in a drug development project

Key Take Aways

Drug Development phases from discovery, through clinical development to submission
Clinical Development : general principles of clinical trials and phase specificities
The Global Drug Development Plan and the Target Product Profile (TPP) and their importance
Roles and responsibilities of R&D Functions (Chemistry, Manufacturing, and Controls, Project Management, Regulatory Affairs, Clinical, Non-Clinical Development)
Project Management framework for modern pharmaceutical development: Project phases, milestones, governance

Target Audience

Professionals new to drug development and clinical research
Scientific and non-scientific employee eager to better understand business and operational aspects of driving drug development projects
Anybody interested in learning more about the drug development process

Who this course is for:

Anybody new to the pharmaceutical sector especially R&D and who would like to work in this sector
People who need a fundamental knowledge on drug development for their job (e.g. IT company which are providers for pharma firms)
Graduate and Undergraduate students, (in biotechnology, life sciences, pharmacy and related pharmaceutical domains), whose institutions do not offer courses like this one
This course is NOT for seasoned professionals in pharmaceutical development

Drug Development and Pharmaceutical R&D Business Framework

What you'll learn

Explore related topics

Course content

Introduction to Drug Discovery & Development4 lectures • 14min

Development Phases (Highlights)7 lectures • 12min

The R&D organisation6 lectures • 9min

Project Management Framework and Governance6 lectures • 16min

Information Systems, Numericals and Reporting4 lectures • 11min

Conclusion3 lectures • 3min

Requirements

Description

Who this course is for: