8:30 – 10:15 AM

Moderators: Margaret Szymczak, J&J and Lawrence Yu, FDA

Introduction – Lawrence Yu, FDA

Speakers:

KEYNOTE ADDRESS:  Progress and Challenges in Pharmaceutical Quality – Janet Woodcock, FDA

• Challenges to Building Quality End to End – Michael Thien, Merck
•  New Technologies for Enabling Continuous Manufacturing – Bernhardt Trout, Massachusetts Institute of Technology

10:30 AM – 12:15 PM

Moderators: Vinod Shah, PQRI and Mehul Mehta, FDA

Speakers:

• BCS Guidance and Biowaivers, BCS Monographs – Vinod Shah, PQRI
• InVivo Predictive Dissolution Testing – Scientific Progress in OrBiTo and Enhanced Industrial Application – Bertil Abrahamsson, AstraZeneca
• Generic Drug Industry’s Perspectives on BCS-based Biowaivers – Yu Chung Tsang, Apotex Inc.
• Implementation of BCS Guidance, Analysis of BCS Submissions to FDA and Guidance Update – Mehul Mehta, FDA

Q&A Panel – Above Speakers

1:15 – 5:00 PM

Moderators: Moheb Nasr, GlaxoSmithKline and Robert Iser, FDA/CDER

Speakers:

• Introduction to Product Lifecycle Management – Robert Iser, FDA/CDER
• Innovator Industry Perspectives on Lifecycle Management – Mark Rosolowsky, Bristol-Myers Squibb
• ICH Q12: Opportunities for the Generic Drug Industry – Keith Webber, Perrigo
• Lifecycle Management: Future Vision / ICH Q12 – Moheb Nasr, GlaxoSmithKline
• ICH Q12 / Change Management – Liam Feely, AbbVie
• ICH Q12 / Knowledge Management – Ingrid Markovic, FDA/CBER
• ICH Q12 / Regulatory Opportunities – Mahesh Ramanadham, FDA/CDER

Panel – Above Speakers and Ashley Boam, FDA/CDER

8:30 – 10:15 AM

Moderators: Rik Lostritto, FDA and Gregory Amidon, University of Michigan

Speakers:

• The Future of In Vivo Predictive Dissolution Methods – Gregory Amidon, University of Michigan
• Summary of the Development of the Draft Guidance on Dissolution Testing and Specifications for BCS I and III Immediate Release Products – Rik Lostritto, FDA
• FDA Research in Dissolution – Lucinda Buhse, FDA

10:30 AM – 12:15 PM

Moderators: Paul Seo, FDA and Jim Polli, University of Maryland

Speakers:

• Designing Quality into ER Products: Technology Selection – Alfred Berchielli, Pfizer
• Using Pharmacoscintgraphy to Elucidate In Vivo Performance of Extended Release Formulations – David Sperry, Eli Lilly & Company
• Mitigating Patient Risks Using Dissolution Testing in Manufacturing ER Products – Yihong Qiu, AbbVie
  

1:15 – 3:00 PM

Moderators: Tara Gooen Bizjak, FDA and Louis Yu, Perrigo

Speakers:

• Quality Metrics: An OPQ Perspective – Tara Gooen Bizjak, FDA
• Quality Metrics: An OTC Perspective – Paul Weninger, Perrigo
• Quality Metrics Initiative –The Journey So Far – Máiréad Goetz, Novartis
• Quality Metrics: Complements, Context and Implementation – Russell Wesdyk, FDA

Panel – Above Speakers and Barbara Allen, Eli Lilly and Company

3:15 – 5:00 PM

Moderators: Sau Larry Lee, FDA and Steven Hoag, University of Maryland

Speakers:

• Botanical Drug Development and Quality Standards – Sau Larry Lee, FDA
• Aspects of the Discovery and Development of Plant-Derived Drugs – Douglas Kinghorn, The Ohio State University
• Challenges in Botanical Supplements Product Development and Quality Testing – Vikas Moolchandani, Amway Inc.

Panel – Above Speakers and Haibin Qu, Zhejiang University

5:00 – 6:30 PM

Moderator:  Giuseppe Randazzo, FDA

Speakers: 

• How to Interact and Communicate with FDA on Quality Issues
  • Tanya Clayton, FDA
  • Robert Gaines, FDA
    

10:30 AM – 12:15 PM

Moderators: Ganapathy Mohan, Merck and Margaret Caulk, FDA

Speakers:

• Breakthrough Therapy – CMC Challenges – Ganapathy Mohan, Merck
• Breakthrough Therapy Designation – An Industry Case Study – John Groskoph, Pfizer Inc.
• Review Considerations for Break-Through-Designated Products – Olen Stephens, FDA

1:15 – 5:00 PM

Moderators: Mary Oates, Pfizer and Brian Hasselbalch, FDA

Speakers:

• BMS experience with QbD/PAT based PAI by the EMA and FDA – Ambarish Singh, BMS
• An Industry View of Surveillance Inspections – Mary Oates, Pfizer
• Assessing Application Approvability and cGMP Compliance in a Single Inspection – Todd Halpern, Pfizer
• Risk Based Pre-Approval Inspections – Christine Moore, FDA
• Risk Based Surveillance Inspections, Russell Wesdyk, FDA

8:30 – 10:15 AM

Moderators: G.K. Raju, Light Pharma and Ramesh Sood, FDA

Speakers:

• Introduction
• Leveraging the Depth of Industry Knowledge with the Breadth of Regulator Knowledge – Roger Nosal, Pfizer
• The Journey From Good to Great: Transforming the Pharmaceutical Regulatory System – Martin VanTrieste, Amgen

Panel – Above Speakers and Jeffrey Baker, FDA and Tara Gooen Bizjak, FDA

10:30 AM – 12:15 PM

Moderators: Dave Doleski, FDA and Martin VanTrieste, Amgen

Speakers:

•  A Practical and Scientific Approach to Quality Risk Management is Integral to an Effective Quality System – Fionnuala Walsh, Eli Lilly
• Enforcement Perspective:  How QRM and a PQS Can Help Maintain a State of Compliance – Tom Cosgrove, FDA
• Applying Risk Management Principles to Drive Quality Management System Effectiveness – Carlos Monteagudo, Amgen

1:15 – 5:00 PM

Moderators: Ashley Boam, FDA and Tony Tong, Teva

Speakers:

• Introduction
• Evolution of the CMC Review for NDAs – Sarah Pope Miksinski, FDA
• Evolution of the CMC Review for ANDAs – Susan Rosencrance, FDA
• Evolution of Quality Assessments – Recent Trends in FDA Queries – Mike Saleh, Pfizer
• Integrated Quality Assessment – ANDA Perspectives – Siva Vaithiyalingam, Teva
• Challenges Integrating Regulatory Filings and Pre-Approval Inspection with the Expectations of Current Regulatory Guidance – Tony Mire-Sluis, Amgen

10:30 AM – 12:15 PM

Moderators: Katherine Tyner, FDA and Henry Havel, Nanomedicines Alliance

Speakers:

• Introduction – Henry Havel, Nanomedicines Alliance
• Quality Considerations and Regulatory Perspectives for Drug Products Containing Nanomaterials – Katherine Tyner, FDA
• Nanoparticle Size Analysis: A Survey and Review -Marc Wolfgang, Cerulean Pharma
• Industrial Perspective on Nanomedicine Characterization Strategies – Donald Parsons, BIND Therapeutics, Inc.

Panel Discussion- Above Speakers

1:15 – 5:00 PM

Moderators: Anna Schwendeman, University of Michigan and Emanuela Lacana, FDA

Speakers:

• Implementing the Biologics Price Competition and Innovation Act of 2009 and Quality Considerations for the Development of Biosimilar Products – Marjorie Shapiro, FDA
• Physicochemical Characterization of Remicade and its Biosimilar Remsima – Anna Schwendeman, University of Michigan
• Analytical Similarity: Lessons from the First US Biosimilar – Corinna Sonderegger, Sandoz
• Challenges with Establishing a Control Strategy for Biosimilars – Barbara Rellahan, Amgen
• The Making of Advanced Biosimilars: Enabling Advanced Biosimilars through Technical Development and Manufacturing – Orlando Jaquez, Biogen
  

8:30 – 10:15 AM

Moderators:

Arzu Selen, FDA and Rob Ju, AbbVie

Speakers:

• Introduction – Arzu Selen, FDA
• The Role of Tribology in Oral Processing -Stefan Baier, PepsiCo
• In-Vitro Taste Sensors: Methods, Uses and Opportunities – Julie Lorenz, Zoetis

 Panel – Above Speakers and Hari Sachs, FDA; Debbie Avant, FDA; Gil Burckart, FDA; and Karen Thompson, Merck

10:30 AM – 12:15 PM

Moderators:

Geoffrey Wu, FDA and Siva Vaithiyalingam, Teva

Speakers:

• Introduction
• USP Uniformity of Dosage Units– Jon Clark, USP
• Recommendations for the Assessment of Blend and Content Uniformity:  Modern Approaches to Sampling and Testing – James Drennen, Duquesne University
• Statistical Considerations for Establishing Acceptance Criteria for Content Uniformity and Stratified Sampling – Alex Viehmann, FDA
  

1:15 – 5:00 PM

Moderators:

Grace McNally, FDA and Ilgaz Akseli, Boehringer Ingelheim

Speakers:

• Implementing Fundamental Pharmaceutical Science and Materials/Engineer Expertise in Scale-Up – Ecevit Bilgili, New Jersey Institute of Technology
• Using Material Science Methodology and Modeling Predictive Tools to Enable Scale-up – Alberto Cuitino, Rutgers University
• Integrated Product and Process Understanding and Control that Enables Flexible and Efficient Tech Transfer to Different Sites – San Kiang, Consultant, BMS
• Risk Assessment and Troubleshooting Using Fundamental Science and Predictive Tools – Stephen Conway, Merck
• Mitigating Product Risk in Manufacturing or During Formulation Development and Identify Opportunities to Maximize Efficiency -Ilgaz Akseli, Boehringer Ingelheim
• Regulatory Perspective: Advantages of Science Based Pharmaceutical Development in Regulatory Review – Sharmista Chatterjee, FDA
  

10:30 AM – 12:15 PM

Moderators: Paula Katz, FDA and Joseph Famulare, Genentech

Speakers:

• Lifecycle Data Integrity: Consequences and Actions to Proactively Promote Good Documentation Practices – Paula Katz, FDA
• Building Business Processes that Optimize Accurate and Reliable Data – Monica Cahilly, Green Mountain Quality Assurance
• Benefits of Combining Quality Risk Management (Q9) with Pharmaceutical Quality System – Joseph Famulare, Genentech

1:15 – 5:00 PM

Moderators:

Thomas O’Connor, FDA and Diane Zezza, Novartis

Speakers:

• Scientific Considerations for the Assessment of Continuous Manufacturing Processes – Thomas O’Connor, FDA
• Achieving Quality Beyond Compliance Through Continuous Manufacturing – Yanxi Tan Cain, Novartis
• cGMP and Regulatory Considerations for Continuous Manufacturing Processes – Patric Klotzbuecher, FDA
• Quality and Regulatory Considerations for Continuous API: A Case Study – Douglas Mans, GlaxoSmithKline
• Quality and Regulatory Considerations for Continuous Drug Product: A Case Study – Hayden Thomas, Vertex

Panel Discussion – Above Speakers and Rapti Madurawe, FDA

8:30 AM – 12:15 PM

Moderators: Barbara Allen, Eli Lilly & Company and Larisa Wu, FDA

Speakers:

• Pharmaceutical Product Quality, Quality by Design, cGMP, and Quality Metrics – Lawrence Yu, FDA
• Using Control Charts to Evaluate Process Variability – Daniel Peng, FDA
• Quality as Foundation for OPEX – Thomas Friedli, University of St. Gallen
• The Journey From Good to Great: Process Monitoring Leads to Improving Product Quality– Martin VanTrieste, Amgen
• Process Capability and Relationship to Supply Chain – Bryan Winship, Mylan
• Process Capability and Relationship to Quality Management – Barbara Allen, Eli Lilly and Company

1:15 – 5:00 PM

Moderators: Scott Furness, FDA and Bruce Johnson, Perrigo Company plc

Speakers:

• How to Identify Critical Quality Attributes and Critical Process Parameters
  • Jennifer Maguire, FDA
  • Daniel Peng, FDA
• Generic Pharma Perspective on the Identification of Critical Quality Attributes and Critical Process Parameters – Bruce Johnson, Perrigo
• A Structured Statistical Approach to Aid the Assessment of Process Parameter Criticality– Ke Wang, Pfizer
• Identification of CPPs based on CQAs and Mechanistic Process & Product Understanding: A Case Study – Ajit Narang, Bristol-Myers Squibb, Co.

• Emerging Regulatory Initiatives
• Regulatory Submission, Assessment and Inspection
• Product and Process Development
• Manufacturing, Risk Management and Quality Assurance