In-house Educational Training Programs

In-house educational programs are customized to your specific needs and requirements.

• customized to topics and scheduling
• held at your location
• cost and time-effective; no travel costs for your staff
• complementary to your internal training program

Strategic Planning for CMC Development

1. Transitioning from Research (Discovery) to Early Drug Development
The identification and selection of lead candidates is often made without an appreciation of developability of a compound, specifically, whether there will be formulation problems. Here, we cover what some of the critical preformulation issues are, and what kind of information they provide.  Conducting these studies, either in the research laboratory of a small start-up virtual company or at a CMC formulation contractor, can identify, minimize or eliminate most formulation problems.

2. Strategies and Tactics for Smart and Efficient CMC Drug Development
Managing sequential CMC activities (API, analytical, formulation, clinical manufacturing and packaging and scale-up) in a dynamic R&D atmosphere.  The use of internal resources and contract organizations will be included.

3. CMC Basics - A Roadmap of Easily Avoidable Problems
There are numerous pitfalls in CMC development both for the un-wary as well as for firms more experienced in development.  We will cover some of the more common tactical blunders a firm can make and provide specific and simple examples how these types of problems can be minimized or eliminated.   

4. Advanced CMC Basics - Integration of CMC, Toxicology and Clinical Activities
This presentation covers the specific API, analytical, preformulation and formulation development activities that are prudent to conduct in early development.  The coordination among these disciplines and their progress is key to other groups, e.g., toxicology studies and clinical manufacturing.  Here's how to avoid placing any of these CMC disciplines on the critical path.
 
5. Defining Formulation, Manufacturing and Clinical Supply Strategies
Formulation development is the process used to design the dosage form and delivery system that will initially meet clinical study requirements and eventually be transformed into a commercial product.  Knowing the specific clinical requirements and then working backwards isn't always an option in a fast-paced organization.  This discussion asks the key questions that will enable you to begin this task earlier and with fewer false starts.