Institute for International Research

There are 2 pre-conference workshops available:

AM Pre-Conference Workshop B1:
Biomarker Validation versus Biological Effects – Is your Drug Really having an Effect?

How can biomarkers help us get to proof of concept? With emerging technologies, developments in biomarkers are having an impact on clinical development strategies. There are more and improved opportunities to augment your development program. This workshop takes attendees through the following issues so you can determine how implementation of biomarkers early in the clinical development program
will benefit your study:

• What does it take to validate a biomarker?
• What do you need to ensure that the appropriate testing was done?
• What is the number of patients/studies needed?
• How to optimize the relationship of biomarkers and clinical outcomes
  • Development or possible use of biomarkers as surrogate markers of endpoints for marketing approval?
• What new biomarkers are bringing innovation to product development?
  • Possible use of genomics/proteomics
• How can biomarkers help to increase safety, reduce costs and research with patients sooner?
• How many biomarkers are too many biomarkers in one study?
• How are biomarkers useful in certain therapeutic areas?
  • Oncology is a good area to examine – what can we learn from oncology that is useful in other areas?
    

Workshop Leader:
J. Margaretha Oortgiesen, Director, Integrated Drug Development
CATO RESEARCH

PM Pre-Conference Workshop B2:
Strategic Planning for Patient Recruitment in Phase I: Healthy Volunteers versus Disease Populations

We have seen big developments in the trends of patient recruitment this past year where more and more companies are recruiting patients in Phase I studies. How is this going? There are many issues and  questions around successfully recruiting healthy volunteers versus patients. This "compare and contrast" workshop addresses challenges and explores solutions to the following:

• How do you find patients for Phase I studies researching in a specific therapeutic area?
• What are the strategies to overcome the difficulty in recruiting patients for Phase I?
• What leads to good enrollment? 
• How do you price patient payment versus volunteer payment to balance between coercion and volunteerism?
• What are the differences in ethical issues with volunteers versus patients?
• How do you recruit for studies overseas versus US based studies?
• Exploring the new trend of creating informed consent videos – how does this differ for a volunteer and a patient?
• What are the main issues associated with the consent process and how do we make it easier for both volunteers and patients?

Workshop Leader:
Nathan Messinger, Executive Vice President of Sales and Marketing
INCLINIX, INC.