CPSA USA 2019

Clinical and Pharmaceutical Analysts United:
Human Wellbeing is Our Responsibility

Short Course

Short Course 5
Business of Science:
Biomarker CRO Selection, Qualification and Oversight

Monday, October 28, 2019
8:30 am - 4:00 pm
Sheraton Bucks County Hotel
Langhorne, Pennsylvania

Mark Hayward
Mark Hayward

Ganesh Moorthy
Ganesh Moorthy

Shane Needham
Shane Needham

  Now, more than ever, diagnostics and bioanalytical labs are standalone business entities expected to provide high quality, regulatory robust results quickly while managing profitable business operations in the background on a fee for service basis. This short course digs deep into the operational aspects of producing the results with high quality quickly, so this may be achieved in high quantity per FTE to keep the cost per result decidedly competitive. In addition, this course explores managing the building of the business to find ways to prioritize the right needs at the right time at the right cost. Building a successful bioanalytical lab requires proper infrastructure, acquisition of suitable instruments, recruiting and retaining talented scientists and leadership team. There will be significant emphasis on thorough interaction between all involved so all leave the course knowing compellingly more than they did at the start.

Course Content

8:30 AM – 9:00 AM
Introduction:

  • Why Build a Lab?
  • R&D and Clinical Needs
  • Types of Customers, Studies, Matrices and Analytes
  • Opportunities and Challenges

9:00 AM – 10:15 AM
Fundamentals:

  • Liquid Chromatography: There are 3 ionization states for each ionization site (how to achieve control of retention and separation)
  • Fast Liquid Chromatography: How to push the limits on cycle time
  • Design of Experiments (DOE) tuning of the MS for maximum sensitivity nano-LC/MS/MS for maximizing sensitivity

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)
  • Sample Prep - High performance SPE for all sample matrix types (automated)
  • Automation and informatics for high throughput

12:00 PM – 1:00 PM - Lunch

1:00 PM – 1:30 PM
Group Activity 1: Instrument and Technique Selection

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

  • Small Molecules
  • Large Molecules

2:45 PM – 3:00 PM - Break

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

  • Choosing Location, Instruments and People
  • Business Development and Project Management
  • Managing Quality, Timeline and Budget

3:30 PM– 4:00 PM
Group Activity 2: Budgeting and Building a Mass Spec Lab

Group Discussion and Closing Remarks

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

Guest Discussion Leader:
Shane Needham, Alturas Analytics

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