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Modules I & II – The Product Development
Process and Regulatory Affairs
Current Course Directors
Tom Ippolito, Vice President, Regulatory Affairs/Quality Assurance
Srinivas Pentyala, Ph.D., Associate Professor, Departments of Anesthesiology, Physiology & Biophysics, Urology and Director of Translational Research, Department of Anesthesiology
Cliff Mintz , Ph.D., CEO, BioInsights
Modules 1 & 2 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. These modules will introduce participants 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? These modules will explore future trends of this expanding, evolving industry.
Learning objectives will include:
- The 3 basic bioscience businesses: products and services, medical devices, therapeutics
- Emerging technologies and their promise for the future
- Technology discovery and validation
- The product development process
- Product development strategies
- The regulatory process for drugs, medical devices and biologics
- How the regulatory process impacts R&D, manufacturing & marketing
- How the regulatory process impacts the individual employee
- Financial considerations
- Ethical considerations
- Case studies will provide participants with an opportunity to explore and present various business development opportunities in a team format
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
Method of Evaluation:
- Group Project Presentations (2) and Written Report (1)
All students must successfully complete the requirements of Module 1 and 2 in order to move on to Module 3.
Module III – The Business of Bioscience
Current Course Directors
Jeff Yablon, Principal, Yablon Management Consulting, Founder, Pharmascan Clinical Trials, LLC.
Lorrence Green, Ph.D., Founder and President, Westbury Diagnostics, Inc.
Walter E. Mardis, Partner, SWG Counsulting
Charles
Ryan, JD, Ph.D., Executive Director, Chief Patent Counsel,
Forest Laboratories.
The goal of this module 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. The course is designed in a case-study format to enhance applied learning skills.
Learning objectives will include:
- Organizational structure and strategy for industries
- Entrepreneurship
- Elements of an effective business plan
- Financial models, private vs. public markets, strategic partnerships
- Intellectual property concepts, the role of the scientist
- Technology valuation and management
Key concepts will cover:
- The Business of Bioscience
- Concepts of Business
- Intellectual Property
- Technology Management
- Entrepreneurship
- Finance
Method of Evaluation:
- Group Project Presentation (1) and Written Report (1)
Module IV - Corporate Culture and Career Development
Strategies
Current Course Directors
Patrick
T. Connor, Ph.D., Associate Director, Scientific and Laboratory
Services Dept. (SLS), Pall Corp.
Saied
Tousi, Ph.D., Sr. V.P., Director, SLS, Pall Corp.
Marianna
Savoca, Director, Stony Brook University Career Center
This module will provide participants with an understanding of the 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 is a highly interactive, hands-on course that will challenge the life scientist to “think outside the box” and learn how to navigate the complexities of corporate culture.
Learning Objectives include:
- Organizational cultural differences (Academia vs. Biotech vs. Big Pharma)
- How to relate corporate goals and objectives to your job
- Developing written/oral communication skills
- Managing the expectations of bosses, colleagues, and customers
- Increasing your value to your employer
- Career development strategies
Key Concepts will cover:
- Basic Effectiveness
- Applying Business Skills
- Corporate Hierarchy
- Technical Skills
- Human/Soft Skills
- Career Development Process
- Personality & Career
- Luncheon Etiquette
- Resume Pointers & Peer Resume Review
- Interview Preparation
Method of Evaluation:
- Group Work and In-class presentations
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