About The Course
In this course, you will learn about the complete process of drug discovery, development, pharmacoeconomics, biosimilars, regulatory affairs, managed markets, portfolio management and strategic marketing of a new pharmaceutical drug.
Students will also learn that shifting the current drug discovery paradigm from ‘finding new-entity drugs’ to ‘combining existing agents’ may be helpful for overcoming the current financial challenges that exist in the pharmaceutical/biotech market.
The following course objectives will be:
1. Understand the pharmaceutical and biotechnology market a changing landscape
2. Understand the major aspects of the drug discovery process, starting
with target selection, to compound screening to designing lead candidates.
3. Recognize current modern drug discovery based on the lock-and-key theory, which attempts to use one single compound to hit one target to combat the related disease.
4. Increase understanding of the various drug discovery tools and methods that are used for finding, identifying and designing a new drug.
5. Define and understand the regulatory responsibilities for drug discovery, including but not limited to, an Investigational New Drug Application (IND), New Drug Application (NDA), and product labeling.
6. Incorporate study design methods for consideration in the design of clinical protocols to access safety, tolerability, and efficacy in multiple therapeutic areas.
7. Identify the critical components for development of a commercialization strategy and a marketing plan to launch a new drug.
Frequently Asked Questions
- What resources will I need for this class?
For this course, all you need is an Internet connection, and the time to read, write, and discuss, with your peers.
- What is the coolest thing I'll learn if I take this class?
This course aims to help everyone think about what it takes to develop a new drug. In the context of stringent regulatory and marketing regulations and an increasingly competitive landscape, greater emphasis is need to be placed on when and how each phase of a pharmaceutical products lifecycle is managed in order to maximize return on investment.
You will learn how to develop a Life Cycle Strategic Plan (LCSP) and look at all the key decision gates in drug discovery, development and commercialization including go/no-go decisions for development of a pharmaceutical product.
Asking the right questions at the right time is the key to strategic drug development planning.
The LCSP presentation will include the different sections ranging from draft product label, marketing research, pre-clinical, clinical development, manufacturing, regulatory and legal strategy, intellectual property strategy, marketing, SWOT analyses, pricing, reimbursement, finance and commercialization and sales strategies including potential partnering strategy.