Course Content

8:30 AM – 9:00 AM
Introduction & Group Activity 1:

• Why Build a Lab? (motivational discussion with someone who has done it)
  Shane Needham
• R&D and Clinical Needs (opportunities and challenges)
  Mark Hayward, Ganesh Moorthy, Shane Needham
• Types of Customers, Studies, Matrices and Analytes (defining the goals of the business)
  Mark Hayward, Ganesh Moorthy, Shane Needham

9:00 AM – 10:15 AM
Fundamentals:

• Liquid Chromatography - there are 3 ionization states for each ionization site (how to achieve total control of retention and separation (maximizing selectivity and sensitivity / LC peak concentration)
  Mark Hayward, Ganesh Moorthy, Shane Needham
• Fast Liquid Chromatography: How to push the limits on cycle time (maximizing throughput)
  Mark Hayward
• Design of Experiments (DOE) tuning of the MS for maximum sensitivity
  Mark Hayward
• nano-LC/MS/MS or LC/HRMS (further maximization of sensitivity)
  Mark Hayward

10:15 – 10:30 AM - Break

10:30 AM – 12:00 PM
Sample Preparation:

• Common sample preparation methods (Protein Precipitation, LLE, SPE, SLE and Phospholipid Removal)
  Ganesh Moorthy
• Sample Prep - High performance SPE for all sample matrix types (clean samples, enrichment, and automation achieved simultaneously)
  Mark Hayward
• Automation and informatics for high throughput (maximizing results per FTE)
  Mark Hayward

12:00 PM – 1:00 PM - Lunch

1:00 PM – 1:30 PM
Group Activity 2: Instrument and technique selection (picking the right tools for the task)
Ganesh Moorthy

1:30 PM – 2:45 PM
Bioanalytical Validation and Implementation

• Basic Validation in Early Phases (doing just enough)
  Mark Hayward
• Later Phase Validation to address full requirements
  Ganesh Moorthy

2:45 PM – 3:00 PM - Break

3:00 PM– 3:30 PM
How to Build the Lab?

• Choosing Location, Instruments and People (building the toolbox)
  Ganesh Moorthy
• Business Development and Project Management (building the business)
  Ganesh Moorthy
• Managing Quality, Timeline and Budget (managing ongoing operations and growth)
  Ganesh Moorthy

3:30 PM– 4:00 PM
Group Activity 3: Budgeting / building a Mass Spec Lab / getting customers / daily operations (a group discussion with someone who has done it)
Mark Hayward, Ganesh Moorthy, Shane Needham

Instructors:
Mark Hayward, Active Ingredient Technologies
Ganesh Moorthy, The Children's Hospital of Philadelphia

Guest Discussion Leader:
Shane Needham, Alturas Analytics