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The Product Development Process and Regulatory Affairs

This section of the program will detail the product development process 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 discovery, validate and develop products. In diagnostics and therapeutics what is the process for preclinical research, entry into and through phase I, II and II 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.

Key concepts will cover:

  • Overview of Bioscience Industries with focus in Biopharmaceutical Product Development
  • Innovation and Startup Challenges
  • Technology as a foundation for the Product Development Process and Productivity
  • Startup Service Business
  • Therapeutic Target Identification and Validation
  • HTS, Lead Development and Optimization
  • Preclinical Development – ADME/Tox and GLP
  • 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
  • Global Biotech & Pharmaceuticals


The Business of Bioscience

Complimenting the Product Development Process and Regulatory Affairs section, the goal of this section is to provide participants with an introduction to the management issues and challenges pertinent to the bioscience business environment. Participants will be presented with an overview of the various business models that comprise the bioscience industry, and 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.

Key concepts will cover:

  • The Business of Bioscience
  • Concepts of Business
  • Intellectual Property
  • Technology Management
  • Entrepreneurship
  • Finance


Corporate Culture and Career Development Strategies

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.

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Application for Spring 2012

Space is limited. All applicants are encouraged to apply early.



  Director CBT
Chair BME Dept.

   > Clint Rubin, StonyBrook
"To be competitive in industry, biosciences graduates must understand the intricate process of translating basic research into innovative, market driven products. Further, these graduates must be able to navigate the complex pathways of intellectual property management and the regulatory affairs of agencies such as the FDA. There is a critical need for programs that encourage life sciences students to integrate industry-relevant training and experience with their basic science education."



> Program Development     
center for biotechnology develops workforce programs and certificate programs for ny state bioscience industry
> Continued Support    







Core Curriculum

home for fundamentals of bioscience industry certificate contact the center for biotechnology certificate program site map for bioscience industry certificate program