Biomarker Assay Development - Pre-Conference Short Course

Short Courses*
Monday, January 31
9:00 am-12:00 pm

SC1: Translating Biomarkers from the Lab to the Clinic

The course offers a unique and practical perspective for successfully translating the pre-clinical work done for qualifying, testing and validating biomarkers, into the clinic. Case studies and examples related to biomarkers developed will be presented. Some of the key questions that will be discussed are mentioned below.

Course Instructors:

Calvert Louden, M.D., Senior Director of Pathology, Johnson & Johnson Pharmaceuticals

Thomas Bocan, Ph.D., Senior Director, Head of BioImaging Center, PharmaTherapeutics Research & Development, Pfizer Inc.

William B. Mattes, Ph.D., DABT, Independent Consultant, PharmPoint Consulting

• How do you define a biomarker?
• How do you differentiate qualification versus validation and what has been the historical process for acceptance?
• How do you design and implement studies to identify new biomarkers? What are the scientific, technical, statistical, and philosophical challenges?
• What’s involved in the pre-clinical qualification of biomarkers? What’s a gold standard and what are the positive, negative, and non-toxic controls?
• How do you bridge the gap between pre-clinical and clinical findings? How much data is enough?
• What factors do you consider when designing clinical studies to test and validate biomarkers? How do you tackle the practical challenges, set expectations right and get internal/external consensus for effective decision-making?
• What are the important regulatory considerations and how do you avoid major pitfalls?
• What roles have the consortia played? How have they helped in consensus building and data accumulation?

SC2: Best Practices in Fit-for-Purpose Biomarker Assay Validation

This course will provide an in-depth discussion on the best practices for the development and validation of “fit-for-purpose” biomarker assays for its intended applications. It will cover the basics on the types of biomarkers and methodologies for assaying them and also provide details on criteria to be assessed and options to be evaluated. Key factors guiding decisions in method development and validation will be illustrated with examples and case studies. Some of the key topics that will be discussed are mentioned below.

Course Instructor:

Ameesha Batheja, Ph.D., Senior Scientist, Investigative Toxicology, Johnson & Johnson Pharmaceutical R&D

Wenying Jian, Ph.D., Senior Scientist, BA/DMPK Global Pre-Clinical Development, Johnson & Johnson Pharmaceutical R&D

• Introduction to nomenclature of biomarkers and types and methods for biomarker development & validation
• Acceptance criteria for fit-for-purpose assays
• Criteria for assay development, including choice of reference standards, QC conditions, stability, matrix effect, use of sample controls
• Sample collection, handling and storage
• Pros and cons of using commercial kits
• Statistical considerations

*Separate Registration Required