Fundamentals of the Bioscience Industry

Core Curriculum

The focus of the Fundamentals of the Bioscience Industry Program Curriculum is the Commercialization Process within the Life Sciences industry. This includes examining the components of the product development process and the business of bioscience as well as touching upon strategies for understanding corporate culture.

Key concepts include:

• Overview of Bioscience Industries with focus in Biopharmaceutical Product Development
• Intellectual Property
• Technology as a foundation for the Product Development Process and Productivity
• Therapeutic Target Identification and Validation
• Preclinical Development
• Regulatory Drug Submissions, IND
• Medical Devices and INDs (InVitro Diagnostics)
• Clinical Drug Development and GCP
• Commercialization Strategies/ Marketing and Sales
• Manufacturing Compliance, NDA and BLA
• Technology Management
• Business Analysis and Management
• Entrepreneurship
• Innovation and Startup Challenges
• Finance
• Corporate Culture and Career Development Strategies

The product development process is examined from a technical, scientific and strategic perspective. Understanding the regulatory process by which a bioscience product is developed and brought to market is critical to understanding what drives bioscience industry development and individual corporate strategy. Participants will be introduced to the FDA and regulatory issues related to the development of drugs, medical devices and biologics. Categories of bioscience businesses will be introduced. What new technologies have emerged and how have these translated from basic science research into commercially viable technologies? How are these technologies developed for research, diagnostic, or therapeutic products or services? Which scientific fields are being applied to discover, validate and develop products? In diagnostics and therapeutics what is the process for preclinical research, entry into and through phase I, II and III of clinical trials? What strategies can be applied in critical path management in preclinical and clinical development? Future trends of this expanding, evolving industry will also be explored.

Participants will also be introduced to the management issues and challenges pertinent to the bioscience business environment. Various business models that comprise the bioscience industry will be covered as well as how different structures influence strategy and the decision making process. Participants will gain an understanding of what drives the corporate decision making process, how to contribute most effectively to the goals of the bioscience organization, and how to best utilize this understanding to advance their own career goals. Class presentations will be augmented with case-studies in order to enhance participant’s applied learning skills.

During the course of the program, participants will also be provided with an understanding of corporate culture and an appreciation for the non-technical skills necessary to advance career goals. Understanding corporate objectives and how they relate to the individual employee, interacting effectively with colleagues, customers, and senior management, and understanding how to advance your ideas within a team environment are just a few of the topics that will be covered. Participants will also receive advice on how to “sell” themselves to potential employers and how to distinguish themselves from other candidates whether pursuing a new career opportunity or promotion. This instruction will challenge the life scientist to “think outside the box” and learn how to navigate the complexities of corporate culture.