Moving From Discovery Into Development - How To Make It Happen

This course provides the tools for moving a potential new drug, biologic, device, or process concept into the stringently regulated development environment. The information in this course covers what individuals need to know to place a therapeutic product or process into compliance with constantly changing Food and Drug Administration (FDA) requirements and position it for full scale development.

Principals and senior management of newly formed or about-to-be-formed companies with intellectual properties targeted for development should attend. Researchers who know the laboratory but not the regulated development environment will also find this course helpful, and support staff, such as IT professionals and administrative personnel who must be able to develop systems and manage data compliantly will learn the best ways to do so.

Learning Objectives

Upon completion of this course you will understand:

 The difference between research leading to discovery and research during development
 How to manage the transition from pure discovery to compliant development
 How to assess where you are right now and plan the company’s direction
 Which of the Code of Federal Regulations apply to your product, and how to read and understand what these regulations mean and what you must do
 How industry standards develop and the role of guidance documents
 What the regulators expect and how they inspect
 How to build a team to make the transition happen
 The essential roles the company must fulfill
 How to manage the budget and secure funding
 How to assess and manage your resources, including contractors and consultants
 The importance of quality and how to ensure compliance
 What standard operating procedures (SOPs) are and why you must have them
 How to determine which SOPs you need
 What documentation must be in place to show the product history from proof of concept to product in early development
 How documentation overall is proof of your product’s integrity
 The requirement for training and training records
 The need for change management
 Why you need to perform self assessments as you move forward

Course Description

This course provides a true introduction to the FDA-regulated world of therapeutic products. Participants are encouraged to bring their questions and concerns to the class. A case study provides participants the opportunity to “think it through” and determine a plan for implementation.

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COURSE AGENDA

DAY ONE

Welcome and Introduction to the Course

First Steps after Discovery

 What constitutes discovery and proof of concept
 The difference between discovery and development
 Developing a company/project strategy and understanding how to execute
 How to assess your existing resources
 Determining the goal for the company: IPO, partnering, buyout
 Which branch of the FDA will drive development for your product or process
 How FDA regulations work in tandem with the regulations of other countries

The Regulated World of Therapeutic Products

 How the regulations work, from federal register proposed rule to final rule
 How industry standards develop
 The role of FDA-issued guidance documents
 The regulatory function
 The FDA inspection and review process
 Resources for staying current

Managing the Transition to Development

 Determining what has to happen and positioning the business
 Attaining funding and managing the budget
 Performing gap analysis of existing resources
 Building the team
 Using consultants and contractors
 Setting timeframes

The Quality Component

 Why quality is critical
 The role of standard operating procedures (SOPs) and other “how to” documents and why you must have them
 Determining which procedures must be in place for your product
 SOPs every new company should implement
 Keeping procedures current

Case Study for Overnight Review

DAY TWO

Maintaining Good Early Documentation

 The documentation maze – what’s required and why
- Source data and laboratory notebooks
- Development protocols, amendments, and reports
- Correspondence and study files
- Contracts; requests for proposals and information; proposals
- Audit and evaluation records
- Training records

Training and Change Control

 Why training is mandatory and how to comply
 Job descriptions and goals
 Managing change while maintaining focus
 Conducting self-audits and measuring growth

Case Study Workshop

 Group work: scenario assessment and project plan

Final Q & A and discussion