08.45 Chairperson’s Opening Remarks

08.55 KEYNOTE PRESENTATION Case Study: Development Of A Monoclonal Antibody Using QbD: Results From The Industry Consortium

• Overview of the case study describing monoclonal antibody development from molecule design through validation
• Examples of risk assessment strategy and tools used
• Examples of the use of prior platform knowledge and experimental design for mammalian cell culture and protein purification
• The analysis leading toward critical quality attributes (CQAs) and control strategy
• A proposal for design space and lifecycle management of the process and product

Dr Victor A. Vinci
Director, Bioprocess Operations
Eli Lilly and Company

09.40 Using QbD Approaches To Enable Development Of Real-Time-Release For A Continuous Drug Product Process

• Discussion of the QbD risk management approaches used at Pfizer
• Generation of process understanding and design space capable of supporting a QbD filing
• Moving from batch processing to continuous processing for Pharmaceutical drug products
• Implementation of CQV and RTR in pharmaceutical manufacturing at Pfizer

David Sharp
Senior Principal Scientist
Pfizer

10.20 Business Case On The Use Of PAT In An Oral Solid Dosage Pilot Plant

• Outlining a successful PAT implementation in an Oral Solid Dosage Pilot Plant
• Overcoming some of the key challenges in putting a PAT strategy into practice
• Discussion of how PAT has contributed towards cost saving objectives by helping speed up the development process and shorten the production time

Patrick Bossuyt
SIPAT Sales Executive
SIEMENS

11.30 Case Study: Developing A Successful Change Management Approach When Implementing QbD In A Global Company

• How do you approach implementing new concepts like QbD within the wider business
• Overcoming the challenge of change by illustrating the benefits and securing buy in.
• Ensuring the business keeps running with both current and new paradigm’s during implementation
• Preparing for when QbD is part of how we run the business

Michael Schousboe
Senior QbD Manager, Manufacturing Science and Quality
Novo Nordisk

12.10 Case Study: Application Of QbD In Development: Building The Control Strategy For Drug Substance Critical Quality Attributes In The Manufacturing Process Of A Drug Substance

The quality by design approach adopted for the definition of the control strategy for a drug in development is described. Details are given on:

• The risk assessment done to identify the potential quality critical process parameters
• The multivariate and univariate process studies undertaken to assess the potential quality critical process parameters
• The specification controls on the input materials All these elements of control combined together, allowed the definition of a robust control strategy with the potential to remove the “endproduct testing” for some drug substance-CQAs.

Zadeo Cimarosti
Manager, Chemical Development
GlaxoSmithKline Verona, Italy

12.50 Panel Discussion: Integrating QbD Principles Into Your Lifecycle Management Programme

• Discussing the benefits of integrating the two initiatives
• How can this actually be done? What are the first few steps?

14.20 Case Study: Developing A Strong Business Case For QbD Implementation Within A Contract Manufacturing Company

• Outlining the challenges faced by a CMO
• Discussing the benefits of using QbD in customer projects
• Highlighting some of the difficulties faced and how these were overcome

Hans ter Maat
Senior Process Engineer
DSM Biologics

15.00 Case Study: Model-Based QbD Development Integrated In A Product Life Cycle Management Approach

• The presentation will provide a systematic and proactive QbD development approach enabling to meet current ICH Q8, Q9 and Q10 guidelines
• The characteristics of a model-based QbD development methodology and the resulting benefits will be highlighted
• The presentation will cover the integration of QbD into a Product Life Cycle Management approach and its business value

Philippe Cappuyns
Pharmaceutical Technology Director
Janssen Pharmaceutica

16.10 Case Study: Delivering Robust Manufacturing Processes Using A Structured Critical Process Parameter Workflow

• Exemplification of the GSK API critical process parameter workflow
• Workflow essentials: Planning, process understanding, performance, uncertainty, risk and control
• Making it happen, adding value

Martin Owen
Manager
GlaxoSmithKline

16.50 Case Study: Implementing PAT And QbD At The Formulation Stage

• Outline the challenges faced when implementing these tools earlier in the life cycle
• Discussion of key examples used in transdermal drugs
• Risk analysis study using these tools
• Comparison of predictive and observed results

17.30 Chairperson’s Final Remarks And Close Of Conference