In-house Educational Training Programs

Clinical Research-Clinical Supplies Interactions

1. Avoiding Disconnects, Miscommunications and Unrealistic Expectations between Clinical Research and Clinical Supply Manufacturing ("Clinical Research is from Mars; Clinical Supplies is From Venus")
The relationship between the producer of clinical materials and the clinical “customer” is often less than ideal.  This presentation covers some of the issues that are common to both groups so that all players have an increased appreciation of responsibilities, constraints, and negotiating tools. 

2. At the Interface of GCP and GMP: How Basic Good Clinical Practice Depends on Good Manufacturing Practices
The ICH E6 Guideline (Good Clinical Practice) has numerous sections where manufacturing, packaging, and labeling of clinical materials are discussed.  Why are typical GMP issues covered in a GCP Guideline?  This presentation explains the answer and illustrates the take-home points with examples of good and not-so-good packaging and labeling approaches. 

3. Essential CTM (Clinical Trial Materials) for Clinicians
There is more to study drug than the date it is expected to magically show up at the clinical site.  This presentation depicts the most important issues that clinicians need to be aware of so that the study drug can meet the needs of the clinical protocol without delay.

4. Historical Perspectives of Adequate and Well Controlled Clinical Studies
This is an overview of the key events (pharmaceutical, medical, clinical and technical) that shape the way we develop drugs in the year 2004.  The diverse nature of the topics covered makes this an excellent introduction to most scientists, clinicians and other pharmaceutical industry professionals who may appreciate the "big picture".

5. Workshop - There Ain't No Such Thing as a Simple Clinical Protocol
Attendees will evaluate manufacturing and clinical design issues, differences and trade-offs for a “simple” phase 1 safety study.  Aspects of development that will be covered include biopharmaceutics, analytical method development, formulation, clinical and medical requirements, scale-up potential of the formulation developed, and how all of this fits together to support initial entry into humans of an investigational new drug.  

6. Improving Patient and Site Compliance by Innovative and Common Sense Packaging, Labeling and Distribution Approaches
Sometimes packaging approaches are focused on a container-closure system that protects the product.  Sometimes label text is selected based solely on regulatory requirements. Sometimes these approaches compromise site compliance or patient compliance.  This presentation uses actual photographs of investigational product packaging and labels to illustrate both excellent, good and poor practices.

7. Maximizing Patient Compliance Using 21st Century Electronic Packaging Components
"Drugs don't work in patients that don't take them" said J. Everett Coop, former Surgeon General of the US.  Clinical response data from patients who fail to comply with the dosing regimen is nonetheless averaged with data from those who do, compromising the proof of the clinical hypothesis.  Using historical compliance data and measurement techniques, this presentation will focus on the advantages of knowing who your non-responders are and if that is related to their compliance with the dosing regimen.  

8. IVR (Interactive Voice Response) Systems
The use of IVR systems and their impact on and inter-relationships with their use in clinical packaging (primary and secondary) and distribution systems will be covered. 

9. Presenting CTM Information at an Investigator's Meeting
What is the critical information that is needed to be heard by clinicians, principal investigators and their clinical coordinators?  This short (12 minute) presentation provides what was important for one study that had a few quirks in it.

10. Randomization Workshop
The interrelated concepts of the randomization code, block sizes, clinical packaging approaches, labeling issues, shipping and distribution and dispensing to patients are explored in an interactive workshop.  The impact of not meeting the enrollment projections at a clinical site(s) on the clinical packaging inventory will also be discussed.   

11. Workshop - Defining the Clinical Supply Project by Asking your Medical or Clinical Customer the Right Questions
Using actual (poorly defined) clinical protocols, this workshop enables participants to see the numerous issues that can be explored when conceptualizing a clinical supply project. This exercise is equally educational for clinical researchers as well as clinical supply chain professionals.