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Advanced Therapies(USP)

 

 

USP-APEC Center of Excellence for Advanced Therapies

Pilot Virtual Training on“Starting and Raw Materials for Advanced Therapies”

 

March 1, 3, 8, 9 (Americas) / March 2, 4, 9, 10 (Asia)

 

 

Day 1 : March 1st (Americas) / 2nd (Asia) – 3 hours
Time Topic Speaker
20 min Introduction : Welcome and Objective for the Program USP
Session 1: Terminology - Definitions and examples of starting, raw and ancillary materials
1 hr - Introduction to Raw materials & Excipients
- Guidance and standards to support Quality & demonstration of Suitability
- Specific considerations for advanced therapies
Rajesh Patel
(Bristol-Myers Squibb)
- Specific concerns for materials used to manufacture advanced therapies
- Differences between different grades of materials
Nicole Larmore
(Janssen)
Session 2: Advanced Therapies - Raw material expectations from different regulatory bodies
1 hr Expectations on raw materials for Advanced Therapies

 

1) Japan

 

2) Canada

 

3) United States
Masaki Kasai (PMDA)

 

Martin Nemec
(Health Canada)

 

Irina Tiper
(US FDA)
30 min Live Discussion / Q&A Session
Day 2 : March 3rd (Americas) / 4th (Asia) – 3 hours
Session 3: Selection and sourcing of materials
2.5 hr Risk-based approaches to demonstrate suitability of use of materials used and how to ensure the supply and quality

 

1) Supplier’s perspective

 

2) Consultant’s perspective

 

3) Qualification of raw materials

 

4) Contract Manufacturer’s perspective
Claudia Zylberberg
(Akron Biotech)

 

Heath Coats
(Paraxel International)

 

Aaron Mack (Biogen)

 

James Brown
(Aldebron)
30 min Live Discussion / Q&A Session
Day 3 : March 8th (Americas) / 9th (Asia) – 3 hours
15 min Recap of Days 1 & 2 USP
Session 4: Case studies to cover raw/starting materials and finished products
2.5 hr Case Study I: Cell Therapies, with CAR-T additional aspects

 

Case Study II: Gene Therapy product

 

Case Study III: Tissue engineered product
Richard Snyder
(Thermo Fisher Scientific)

 

Michael Havert
(bluebird bio)

 

Nikhil Gheewala
(Cytex Therapeutics)
30 min Live Discussion / Q&A Session
Day 4 : March 9th (Americas) / 10th (Asia) – 3 hours
Session 5: Lifecycle Management of raw materials in advanced therapy products
2 hr Case Study : Common issues during product’s lifecycle when raw materials must be substituted or later in formulation Christopher Bravery
(Advanced Biologicals)
Common Regulatory expectations due to changes and how they are best addressed CMohammad Heidaran
(Parexel)
1 hr Closing session discussion
     - Summarize the learning
     - Identify future training opportunities and discuss next steps