Commercialization of Biotechnology Products

课程简介

/ Indicative Syllabus Process of developing a drug: from bench to a product including Product Life Cycle Management and tools (14 hours) • In vitro activity • In vivo activity • Pharmacokinetics (ADME) and toxicity • Pre-clinical trial • Clinical trial phase I, II and III • Cost estimation of each stage Innovation (4hrs) -- 1 of 3 -- Importance of patents in biotechnology (4 hours) • Different kinds of patents: Utility, Design, Plant, or Provisional Patent. • Writing Descriptions, Claims, or Abstracts for a patent application • Brief introduction to different regulatory bodies around the world. Business plan (4 hours) • Purpose of a business plan. • Different components of a business plan • Writing your own business to raise funding for a start-up biotech company

目标

To understand the process of development and commercialization of biotechnology products. To understand the patent process and the process of regulatory approval .

先修要求

ABCT2101 Biochemistry or ABCT2102 Molecular Biology or ABCT2103 Cell Biology Co-requisite Nil Exclusion Nil

Teaching Pattern

Methodology Lecture, Tutorial, Mini-Project: preparation and presentation of a business plan.