Featured Global Regulators include:
Dolores Hernán
Pérez de la Ossa, PhD
Rapti Madurawe, PhD
David Doleski
Kurt Brorson, PhD
Division Director (Acting),
Office of Process and
Quality Specialist/Human
Medicines Evaluation Division, Facilities, FDA/CDER/OPQ,
Conference Co-Chair
EMA, United Kingdom
Deputy Director (Acting),
Office of Process and
Facilities, FDA/CDER/OPQ
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Conference Code: ISPE2016
Lab Chief (Acting),
Office of Biotechnology
Products, FDA/CDER/OPQ
WEDNESDAY, 20 APRIL 2016
08.00 – 10.00 Session Leaders: Theodora Kourti and Kelly Swinney
Location:
Holiday 4 – 5
Opening Keynote
• Opening Remarks
ohn Bournas, President and CEO, ISPE
J
Theodora Kourti, PhD, Senior Vice President, Global Regulatory Affairs,
ISPE, Conference Co-Chair
• Challenges in Implementation of Continuous Manufacturing
afni Bika, PhD, Vice President, Manufacturing Science and
D
Technology, GMS, Bristol-Myers Squibb
Regulatory Session I
• Regulatory Considerations for Continuous Manufacturing
Dolores Hernán Pérez de la Ossa, PhD, Quality Specialist,
Regulatory/Human Medicines/Scientific Advice and Protocol Assistance,
EMA, United Kingdom
•C
ontrol Strategy Considerations
Rapti Madurawe, PhD, Division Director (Acting), Office of Process and
Facilities, FDA/CDER/OPQ, Conference Co-Chair
•C
GMP Considerations
David Doleski, Deputy Director (Acting), Office of Process and Facilities,
FDA/CDER/OPQ
10.00 – 10.30
Networking Break 10.30 – 12.30 Session Leaders: Rapti Madurawe and Richard Steiner
Location:
Holiday 4 – 5
General Session
• Business Case Drivers and Deployment Strategies in
Continuous Drug Product Manufacturing
Lawrence De Belder, Senior Principal Engineer, Johnson & Johnson, Belgium
• Design for Product Quality Assurance in End-to-End
Pharmaceutical Manufacturing
Richard Braatz, PhD, Edwin R. Gilliland Professor of Chemical
Engineering, Novartis-MIT Center for Continuous Manufacturing
• Online Chromatography Platforms in Drug Substance
Continuous Processing
Gordon (Randy) Lambertus, PhD, Senior Research Scientist, Process
Design and Development, Eli Lilly & Co.
• Drug Product, Portable, Continuous, Miniature, and Modular
Stephen Hammond, Senior Director/Team Leader, Process Analytical
Sciences Group, Pfizer Inc.
12.30 – 13.30
Lunch
13.30 – 14.30 Session Leaders: Stephen Hammond and David Doleski
Location:
Holiday 4 – 5
Breakout Topic Presentations
• Maintenance – PAT Model/Equipment
elly Swinney, PhD, Senior Director, Drug Product Continuous
K
Manufacturing Lead and Process Analytical Technology (API & DP),
Vertex Pharmaceuticals, Inc.
Theodora Kourti, PhD, Senior Vice President, Global Regulatory Affairs,
ISPE, Conference Co-Chair
2
www.ISPE.org/2016-Continuous-Manufacturing
• Quality Considerations for End-to-End Manufacturing
Y
anxi Tan Cain, PhD, Executive Director, Global Quality Assurance,
Merck & Co.
Gretchen Allison, Senior Director, Team Lead Validation, Pfizer Inc.
• Sampling Considerations in Continuous Manufacturing
C
atherine MacConnell, Engineering Specialist, Pharmaceutical
Commercialization Technology, Merck & Co., Inc.
Wyatt Roth, PhD, Senior Research Scientist, Eli Lilly & Co.
14.30 – 16.00 Breakout
Discussion
Sessions
Maintenance
– PAT
Quality Model/Equipment
Considerations
for End-to-End
Manufacturing
Location:
Holiday 1
Location:
Holiday 4 – 5
Moderators:
Kelly Swinney, PhD,
Senior Director, Drug
Product Continuous
Manufacturing
Lead and Process
Analytical Technology
(API & DP), Vertex
Pharmaceuticals, Inc.
Theodora Kourti, PhD,
Senior Vice President,
Global Regulatory
Affairs, ISPE,
Conference Co-Chair
16.00 – 16.30
Sampling
Considerations
in Continuous
Manufacturing
Moderator:
Yanxi Tan Cain, PhD,
Executive Director,
Global Quality
Assurance,
Merck & Co.
Gretchen Allison,
Senior Director, Team
Lead Validation, Pfizer
Inc.
Location:
Holiday 2
Moderators:
Catherine
MacConnell,
Engineering Specialist,
Pharmaceutical
Commercialization
Technology,
Merck & Co., Inc.
Wyatt Roth, PhD,
Senior Research
Scientist,
Eli Lilly & Co.
Grab-and-Go Break 16.30 – 17.15 Session Leaders: Stephen Hammond and David Doleski
Location:
Holiday 4 – 5
Breakout Team Feedback Presentations
• Team Report on Maintenance – PAT Model/Equipment
•T
eam Report on Quality Considerations for End-to-End
Manufacturing
• Team Report on Sampling in Continuous Manufacturing
17.15 – 17.45 Session Leaders: Yanxi Tan Cain and Dafni Bika
Location:
Holiday 4 – 5
Continuous Manufacturing –
Experiences Since Launch
17.45 – 18.45
Welcome Reception
Kelly Swinney, PhD, Senior Director, Drug Product Continuous
Manufacturing Lead and Process Analytical Technology (API & DP),
Vertex Pharmaceuticals, Inc.
Agendas are subject to change without notice. Every precaution is taken to ensure accuracy, but ISPE cannot
accept responsibility for information distributed or contained in these programs, or for opinions expressed.
Continuing Education Units earned at this conference (1 CEU = 10 hours) will be available through ISPE’s website
(log in using your ISPE member profile) 30 days after this event.
Final presentations will be available to all registered delegates through the Continuous Manufacturing website
by 5 May 2016.
CONNECT • SHARE • FOLLOW #ISPECM
www.ISPE.org/2016-Continuous-Manufacturing
3
THURSDAY, 21 APRIL 2016
08.00 – 09.45 Session Leaders:
Gretchen Allison and Dolores Hernán Pérez de la Ossa
Location:
Holiday 4 – 5
General Session
•A
Fully Automated Commercial Control Strategy Including
RTRT for Drug Product Continuous Manufacturing
Kelly Swinney, PhD, Senior Director, Drug Product Continuous
Manufacturing Lead and Process Analytical Technology (API & DP),
Vertex Pharmaceuticals, Inc.
•P
AT and Control Strategy for a Continuous Manufacturing
System: Using Vertical Low-Retained Mass Mixer
S
tephen Hammond, Senior Director/Team Leader, Process Analytical
Sciences Group, Pfizer Inc.
•S
PC/MSPC in Continuous Manufacturing – The Vision
heodora Kourti, PhD, Senior Vice President, Global Regulatory Affairs,
T
ISPE, Conference Co-Chair
09.45 – 10.15
Networking Break 10.15 – 12.15 Session Leaders: Catherine MacConnell and David Pappa
Location:
Holiday 4 – 5
General Session
• Transforming Biologics Manufacturing through Integrated
Continuous Bioprocessing
Christopher Hwang, PhD, Senior Director, Commercial Cell Culture
Development, Genzyme
Regulatory Session II
• Continuous Manufacturing for Bio Processes –
Regulatory Perspective
Kurt Brorson, PhD, Lab Chief (Acting), FDA/CDER/OPQ/OBP/DBRRII
• BARDA Innovation Initiative: Continuous Manufacturing
of Pharmaceuticals and National Security
Jean Hu-Primmer, Health Scientist and Senior Advisor for Continuous
Manufacturing, BARDA
• Process Validation in Continuous Manufacturing
Kelly Tolton, Senior Director, Technical Operations, Vertex Pharmaceuticals, Inc.
• Panel Discussion
All Morning Speakers with Open Q&A
12.15 – 13.15
Lunch
13.15 – 14.15 Session Leaders: Lawrence De Belder and Richard Steiner
Location:
Holiday 4 – 5
Breakout Topic Presentations
• Process Validation and Cleaning Validation
retchen Allison, Senior Director, Team Lead Validation, Pfizer Inc.
G
Joanne Barrick, RPh, Advisor, Global Validation, Eli Lilly & Co.
•C
ontinuous Manufacturing for Bio Processes
Steven Miller, Director, MedImmune/AstraZeneca Supply Biologics
Christopher Hwang, PhD, Senior Director, Commercial Cell Culture
Development, Genzyme
Andre Walker, Principal, Andre Walker Consulting
4
www.ISPE.org/2016-Continuous-Manufacturing
•C
ontrol Strategy, PAT, and Soft Sensors in Continuous Manufacturing
Jun Huang, PhD, Senior Manager, Advanced Manufacturing Technology, Pfizer Inc.
Christian Airiau, PhD, Process Analytics, Team Manager, GlaxoSmithKline
• CGMP Considerations for Continuous Manufacturing
D
avid Doleski, Deputy Director (Acting), Office of Process and Facilities,
FDA/CDER/OPQ
Theodora Kourti, PhD, Senior Vice President, Global Regulatory Affairs,
ISPE, Conference Co-Chair
Christine Moore, PhD, Global Head and Executive Director, GRACS CMC –
Policy, Merck Research Laboratories
14.15 – 15.45 Breakout Discussion Sessions
Process Validation
and Cleaning
Validation
CGMP
Considerations
for Continuous
Manufacturing
Location:
Holiday 4 – 5
Location:
Holiday 1
Moderator:
Gretchen
Allison, Senior
Director, Team
Lead Validation,
Pfizer Inc.
Joanne Barrick,
RPh, Advisor,
Global Validation,
Eli Lilly & Co.
Control Strategy, PAT,
Continuous
and Soft Sensors
Manufacturing for
in Continuous
Bio Processes
Manufacturing
Location:
Holiday 2
Location:
Holiday 3
Moderator:
David Doleski,
Deputy Director
(Acting), Office
of Process and
Facilities, FDA/
CDER/OPQ
Moderator:
Jun Huang, PhD,
Senior Manager,
Advanced
Manufacturing
Technology,
Pfizer Inc.
Moderator:
Steven Miller,
Director,
MedImmune/
AstraZeneca
Supply Biologics
Theodora Kourti,
PhD, Senior Vice
President, Global
Regulatory Affairs,
ISPE, Conference
Co-Chair
Christian Airiau,
PhD, Process
Analytics,
Team Manager,
GlaxoSmithKline
Christine Moore,
PhD, Global Head
and Executive
Director, GRACS
CMC – Policy,
Merck Research
Laboratories
15.45 – 16.15
Christopher
Hwang, PhD,
Senior Director,
Commercial
Cell Culture
Development,
Genzyme
Andre Walker,
Principal,
Andre Walker
Consulting
Grab-and-Go Break 16.15 – 17.00 Session Leaders: Lawrence De Belder and Richard Steiner
Location:
Holiday 4 – 5
Breakout Team Feedback Presentations
• Team Report on Process Validation and Cleaning Validation
•T
eam Report on CGMP Considerations for Continuous
Manufacturing
•T
eam Report on Control Strategy, PAT, and Soft Sensors
in Continuous Manufacturing
•T
eam Report on Continuous Manufacturing for Bio Processes
17.00 – 17.15 Closing Session
• Conference Outcomes
Location:
Theodora Kourti, PhD, Senior Vice President, Global Regulatory Affairs,
Holiday 4 – 5
ISPE, Conference Co-Chair
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www.ISPE.org/2016-Continuous-Manufacturing
5
Thank you to our Program Committee Members!
Conference Chairs:
Rapti Madurawe, PhD, Division Director (Acting), Office of Process and Facilities,
FDA/CDER/OPQ
Theodora Kourti, PhD, Senior Vice President, Global Regulatory Affairs, ISPE
Committee Members:
Gretchen A. Allison, Senior Director, Team Lead Validation, Pfizer Inc.
Yanxi Tan Cain, PhD, Regional Head Quality Operations, Novartis Pharma AG
Lawrence De Belder, Senior Principal Engineer, Johnson & Johnson
David Doleski, Deputy Director (Acting), Office of Process and Facilities, FDA/CDER/OPQ
Steve Hammond, Senior Director, Process Analytical Support, Pfizer Global Supply
Robert Frederick Meyer, Plant Engineer, Merck
David M. Pappa, Technical Services, Eli Lilly, Inc.
Sonja S. Sekulic, SPECTech Group Lead, Pfizer Inc.
Richard Steiner, Business Development Manager, GEA Pharma Systems
Kelly Swinney, PhD, Associate Director, Vertex Pharmaceuticals, Inc.
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