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2021 PDA FDA

2021 PDA/FDA Joint Regulatory Conference

The Roaring 20s: Crisis, Collaboration, Commitment to Quality

Sep 27 - Sep 29, 2021
Eastern Standard Time | Online
  • Virtual
  • Conference
  • Online
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Program Highlights

Listen to the Podcast – Find out directly from the 2021 PDA/FDA Joint Regulatory Conference Co-Chairs why, after 30 years, this conference remains the most influential conference in the industry and what critical knowledge you will gain by attending!

We're pleased to announce that three Center Directors and ORA's Associate Commissioner for Regulatory Affairs will be presenting at this year's conference!

Patrizia Cavazzoni, MD
Patrizia Cavazzoni, MD
Director, Center for Drug Evaluation and Research, FDA
Peter W. Marks, MD, PhD
Peter W. Marks, MD, PhD
Director, Center for Biologics Evaluation and Research, FDA
Steven M. Solomon, DVM, MPH
Steven M. Solomon, DVM, MPH
Director, Center for Veterinary Medicine, FDA
Judith McMeekin, PharmD
Judith McMeekin, PharmD
Associate Commissioner for Regulatory Affairs, Office of Regulatory Affairs, FDA

Overview

The Parenteral Drug Association (PDA) and the U.S. Food and Drug Administration (FDA) are once again co-sponsoring the PDA/FDA Joint Regulatory Conference, which is now in its 30th year. This flagship conference provides opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. The Conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. The roles of robust systems, facilities, processes, raw material quality, supplier relationships, industrial modernization, and quality risk management are emphasized. Case studies are presented throughout the conference to provide practical insights into these concepts and illustrate how sustainable compliance establishes the foundation for quality and supply consistency. International collaboration efforts that improve quality and benefit the consumer are also highlighted. 

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Agenda

  • Day 1
  • Day 2
  • Day 3

  • MONDAY, 27 SEPTEMBER

    09:15 – 11:00 | Plenary 1: Opening Plenary        
    Moderator: Francis RW Godwin, MBA, Office Director, CDER, U.S. FDA

    CDER’s Center Director, Dr. Patrizia Cavazzoni, will launch the 30th Anniversary of the PDA/FDA Joint Regulatory Conference by discussing how we are making it through the pandemic, and will share her vision on the latest initiatives that continue to advance quality of drugs now and post-pandemic. Next, AstraZeneca's Dr. Darrin J. Cowley will discuss experiences in the pandemic, and lessons learned about managing partnerships and maintaining commitment to quality even during the most challenging times. The session will underscore how sustainable CGMP compliance is assured through robust quality systems and highly capable manufacturing, and how this framework assures reliable drug quality and availability.

    09:15 | Welcome and Opening Remarks from PDA Leadership and Conference Co-Chairs
    Jette Christensen, Chair, PDA Board of Directors and Scientific Director, Novo Nordisk
    Richard M. Johnson, MSc, President and CEO, PDA  
    Francis RW Godwin, MBA, Co-Chair, PDA/FDA Joint Regulatory Conference and Office Director, CDER, U.S. FDA
    Valerie Whelan, Co-Chair, PDA/FDA Joint Regulatory Conference and Vice President, Quality Operations, Amgen Inc.

    09:35 | Patrizia Cavazzoni, MD, Director, CDER, U.S. FDA

    10:00 | Q&A with Dr. Cavazzoni

    10:15 | Operating during a Global Pandemic Lessons Learned: Development through Production
    Darrin J. Cowley, PhD,     President Head of Developmental Quality, Biologics, AstraZeneca

    10:40 | Q&A with Dr. Cowley

    11:00 – 11:30 | Virtual Exhibit Hall Open and Connect & Network

    11:30 – 13:00 | Plenary 2: Emerging Stronger through Collaboration 
    Moderator: Valerie Whelan, Vice President, Quality Operations, Amgen Inc.

    A wise man said that “Perseverance is not a long race; it is many short races one after the other.”

    Over the last eighteen months, we have won many of these short races together as we have adapted to the changing landscape driven by the pandemic. In this session we will hear from regulatory and industry leaders on those races; the practical challenges we have overcome from the simple to the complex, the transformative level of collaboration we have seen internally and externally, the innovation that we have accelerated and the changes that will enable us to emerge stronger.

    11:30 | Engaging Stronger Together: A Regulatory Perspective
    Ashley B. Boam, MSBE, Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER, U.S. FDA

    11:48 | Covid-19 Industry Perspective: Practical Challenges and Transformations
    Melissa S. Seymour, MBA, Chief Quality Officer, Biogen

    12:09 | Q&A with Speakers and Additional Panelist
    CDR Emily T. Thakur, RPh, Team Leader, CDER, U.S. FDA

    13:00 – 13:30 | Virtual Exhibit Hall and Connect & Network

    13:30 – 15:00 | Concurrent Sessions

    QUALITY ASSURANCE AND QMS

    A1: Managing Investigations in a Global Network
    Moderator: Rick L. Friedman, MS,     Deputy Director, OMQ, CDER, U.S. FDA

    Today's global pharmaceutical supply chain typically includes many contributors to production of a drug. Strong quality system provisions and actions are needed when deviations, OOS results, or failures occur to ensure communications and close collaboration on investigations and resolutions. This session will address the attributes of quality systems that successfully manage cross-organizational investigations, with an emphasis on lessons learned and practical case studies.

    13:30 | Managing Investigations with Supply Chain Partners Using a QRM Mindset
    Emma Ramnarine, MS,     Executive Director, Global Head External Development Collaborations, Genentech/Roche

    13:55 | Effective CAPA Practices as a Competitive Advantage
    Lisa C. Newcombe-Dierl,     Vice President Corporate Quality, Amgen Inc.

    14:20 | Q&A with Speakers and Additional Panelists
    Victor R. Gaines,     Branch Chief, CDER, U.S. FDA

    SUPPLY CHAIN AND MANUFACTURING CHALLENGES

    B1: Supply Chain Collaboration and Product Approvals during a Pandemic
    Moderator: Paul Z. Balcer,     Consumer Safety Officer, CDER, U.S. FDA

    As treatments for COVID-19 infections were deployed during the pandemic, we were faced with challenges in drug supply of life saving medicines. Some countries enacted export bans of certain drugs, and other factors including plant staffing caused strains on the existing supply chains of APIs, raw materials, and finished drug products. Pandemic travel bans limited inspections of drug manufacturing facilities. We will examine the effect of the pandemic on drug supply chain and drug applications. The session will include regulatory experiences with EUAs and how use of tools such as remote assessments provided insight into facilities named in drug applications.

    13:30 | Supply Chain and Inspections during the Public Health Emergency (PHE)
    Mahesh R. Ramanadham, PharmD, MBA,     Associate Director Scientific Operations, OPMA, OPQ, CDER, U.S. FDA

    14:03 | Supply Chain Collaboration during a Pandemic
    Pat C. O'Sullivan, MBA,     Vice President Supply Chain for Sanofi Genzyme, Sanofi

    14:17 | Q&A

    EMERGING TRENDS AND INNOVATION

    C1: Holistic Capacity Planning: Best Practices and Lessons Learned from New Therapeutic Modalities
    Moderator: Ingrid Markovic, PhD,     Senior Science Advisor, Office of the Center Director, CBER, U.S. FDA

    Sudden onset of market and public health demands during in the face of global pandemic could lead to major capacity crunches causing production delays and/or unintended product quality outcomes. Holistic evaluation of process, facility, and operational requirements to identify potential bottlenecks is critical when planning for projected commercial manufacturing expansion (scale-up or scale-out) to ensure timely delivery of transformative therapies to patients with consistent product quality. Rapid advancement of C&GTs products and COVID-19 vaccines necessitated implementation of flexible and sustainable operational and facility designs. These could offer valuable learnings with operational aspects of individualized therapies possibly as challenging as those for the off-the-shelf products.

    What are the best practices how firms incorporate effective end-to-end capacity planning? What are the regulatory expectations for capacity analysis and process expansion validation?

    This session will invite regulatory and industry experts to discuss key considerations for end-to-end capacity planning mitigating supply chain vulnerabilities for cutting edge lifesaving therapies.

    13:30 | Capacity Considerations for Cell & Gene Therapy Products
    Kimberly LW Schultz, PhD,     GTB CMC Reviewer, CBER, U.S. FDA

    13:50 | Capacity Considerations for Individualized Therapies
    Alicia D. Collins,     Senior Director, Cell Therapy Global Product Supply Planning and Management, Bristol Myers Squibb

    14:10 | mRNA Vaccines: A Paradigm Shift for Product Development and Manufacturing Capacity
    Roger Nosal, MA,     Vice President, GCMC, Pfizer

    14:30 | Q&A with Speakers and Additional Panelist
    Lily Y. Koo, PhD,     Biomedical Engineer, CBER, U.S. FDA
    Sau (Larry) L. Lee, PhD, Deputy Director of Science, OPQ, CDER, U.S. FDA

    15:00 – 15:30 | Virtual Exhibit Hall and Connect & Network

    15:30 – 17:00 | Ask the Regulators

    U.S. FDA investigators, reviewers, and compliance officers will answer your questions in this Q&A session that will provide you with insights regarding current topics and initiatives.

    Review-Based Panel Discussion                               
    Moderators: Denise M. DiGiulio, Senior Director, Johnson & Johnson and Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc.

    • Kristen L. Anderson, PhD, Microbiologist, CVM, U.S. FDA
    • Bing Cai, PhD, Division Director, CDER, U.S. FDA
    • Patricia F. Hughes, PhD, Senior Scientific Advisor, CDER, U.S. FDA
    • Derek S. Smith, PhD, Deputy Director, Office of Pharmaceutical Manufacturing Assessment, OPQ, CDER, U.S. FDA

    15:30 – 16:15 | Pre-Recorded Panel Discussion

    16:15 – 17:00 | Live Panel Discussion and Q&A  

    Inspection-Based Panel Discussion
    Moderators: Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA and David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

    • Sandra Boyd, Consumer Safety Officer, ORA, U.S. FDA
    • CDR Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA
    • Rachel C. Harrington, Senior Advisor, ORA, U.S. FDA
    • Laura S. Huffman, MS, Senior Policy Advisor, CVM, U.S. FDA
    • Quallyna N. Porte, MBA, Branch Chief, CDER, U.S. FDA
    • Richmond Yip, Supervisory Consumer Safety Officer, ORA, U.S. FDA

    15:30 – 16:15 |Pre-Recorded Panel Discussion

    16:15 – 17:00 | Live Panel Discussion and Q&A

  • TUESDAY, 28 SEPTEMBER

    08:30 – 09:30 | Special Topic Sessions

    Special Topic 1: Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product during Ultra-Cold Chain Storage and Distribution
    Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.  

    Studies have shown that ultra-cold temperatures (-70° C and colder) can introduce risk to the container closure integrity (CCI) of a sealed sterile product vial. This session will present and describe a robust approach for mitigating this risk using work done for the BNT162 mRNA vaccine as a case study. The work included the application of QbD principles to generate robust analytical data on the primary packaging system in the development phase, and then using this data for risk-based qualification and control of the vial sealing process. The holistic approach described and discussed in this session is useful for upcoming therapies needing an ultra-cold chain for storage and distribution.

    08:30 | Effects of Ultra-Cold Chain Storage and Distribution on Vial Container Closure Integrity
    Derek I. Duncan, PhD,     Director Product Line, LIGHTHOUSE Instruments

    08:50 | Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product during Ultra-Cold Chain Storage and Distribution
    Michael T. Edey,     Principal Engineer, Pfizer and Abriana Rozentsvayg, MA, Director Packaging Project Engineering, GTS Packaging and Device SVCS, Pfizer

    09:10 | Q&A

    Special Topic 2: Quality Management Maturity (QMM) and Metrics:  What Does the Future Hold?
    Moderator: Clarice H. Hutchens, PhD, MA, DM, Senior Director, Pfizer

    Hear latest update from CDER/OPQ on their QMM and Metrics programs. PDA’s Quality Management Maturity Task Force has built upon prior PDA research to assess the top QMM elements for FDA consideration in their QMM program. PDA’s Quality Culture Assessment Tool standards team will share a sneak peek of the public draft of the standard being released for peer review this fall. This session will begin with a brief update on PDA’s QMM initiatives with their recommendations on which QMM elements are important for FDA to consider in developing an assessment model. FDA OPQ will present a brief status of the QMM Pilot and their future metrics and QMM plans. A prepared interview with FDA and industry panelists will follow with time for audience Q&A at the end.

    08:30 | Summary of PDA’s Recent QMM and Standards Initiatives
    Denyse D. Baker, PE, RAC, Senior Director of Global Regulatory Policy, AstraZeneca

    08:43 | QMM Pilot Status and Future QMM/Metric plans
    Alex M. Viehmann, Operations Research Analyst, CDER, U.S. FDA (INVITED)

    09:00 | Q&A with Speakers and Additional Panelists
    Jeff R. Broadfoot, MBA, Senior Director, Quality, Emergent BioSolutions Inc. 
    Steven R. Mendivil, BS,     Senior Advisor for Quality, Amgen, Inc.

    Special Topic 3: Current Microbiology Topics
    Moderator: Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc.

    In 1993, the FDA published the Guide to Inspections of Microbiological Pharmaceutical Quality Control Laboratories that described the use of “normal flora” (current term, environmental isolates (EI)) in addition to the USP designated Quality Control microorganisms to evaluate growth promotion of microbiological culture media. The original guidance recommendation, over the last few decades, has expanded to the inclusion of EI in a broader range of microbiological methods becoming a standard regulatory inspectional observation. This presentation will discuss use of EIs for compendial methods that have prescribed microorganisms that are representative of the most commonly encountered EIs. The discussion will also focus on when EI use is appropriate for inclusion with method validation and other microbiological applications.


    08:30 | Do Environmental Isolates Have a Role in Method Suitability and Growth Promotion in the Microbiology Laboratory?
    Dennis E. Guilfoyle, MS, PhD, Senior Director, Microbiology Regulatory Compliance, Johnson & Johnson

    08:49 | Q&A with Speakers and Additional Panelists
    Robert M. Barbosa, Drug Specialist and Pre-Approval Manager, ORA, U.S. FDA
    Stephen E. Langille, PhD, Senior Microbiology Consultant, Valsource, Inc.

    09:30 – 09:45 | Break

    09:45 – 11:15 | Plenary 3: Compliance Office Updates
    Moderator: John D. Ayres, MD, Risk Assessment Clinician, Pharma Safety Solutions, LLC

    Featuring Office of Compliance leaders from the U.S. FDA Centers and Office of Regulatory Affairs, this session continues as one of the highlights of the Conference. In a virtual Roundtable format, U.S. FDA’s top leaders in Compliance and Enforcement will describe their programs, initiatives, and recent actions related to inspection and compliance. Current regulatory challenges and FDA’s current enforcement strategy for a wide array of medical products will be addressed.  This is the best possible opportunity for you to understand U.S. FDA’s thinking and expectations for industry compliance. Most importantly, there will be ample time for the audience to ask questions of U.S. FDA’s senior leadership.

    09:45 | CBER Compliance Updates
    Melissa J. Mendoza, JD, Deputy Director, Office of Compliance and Biologics Quality, CBER, U.S. FDA

    10:00 | CDER Compliance Updates
    Donald D. Ashley, JD, Director, Office of Compliance, CDER, U.S. FDA

    10:15 | CVM Compliance Updates
    Cindy L. Burnsteel, DVM, Deputy Director for Drugs and Devices, Office of Surveillance and Compliance, CVM, U.S. FDA

    10:30 | ORA Compliance Updates
    Alonza E. Cruse, Director, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA

    10:45 | Q&A

    11:15 – 11:45 | Virtual Exhibit Hall and Connect & Network

    11:45 – 13:15 | Plenary 4: Current GMP Compliance Trends and Topics
    Moderator: David L. Chesney, MSJ, Principal and General Manager, DL Chesney Consulting, LLC

    New this year as a plenary, this perennial “standing room only” session will include presentations from CDER and CBER CGMP managers that are designed to provide insights beyond the usual “Top 10” 483 observations. Attendees will learn about major CGMP issues and notable warning letters. These presentations will be followed by a discussion with Center and ORA panelists.

    11:45 | CDER Update
    Francis RW Godwin, MBA, Office Director, CDER, U.S. FDA

    12:10 | CBER Update
    Maria C.H. Anderson, MS, Branch Chief, Biological Drug and Device Compliance Branch, CBER, U.S. FDA

    12:35 | Q&A with Speakers and Additional Panelists
    Monica L. Casey, RVT, Consumer Safety Officer, CVM, U.S. FDA
    Nicholas F. Lyons, MS, Director of Compliance, Office of Pharmaceutical Quality Operations, ORA, U.S. FDA

    13:15 – 13:30 | Break

    13:30 – 15:00 | Concurrent Sessions

    QUALITY ASSURANCE AND QMS

    A2: Non-Sterile Drug Products: Microbial Risks
    Moderator: Pahala Simamora, PhD,     Division Director, OPQ, CDER, U.S. FDA

    Microbial control of non-sterile drug products is essential as the presence of objectionable microcontamination in non-sterile drug products poses a risk to patient safety and product stability. Recent incidents associated with Burkholderia cepacia complex (BCC) contamination in non-sterile aqueous products emphasizes the importance of a robust design and control program to prevent non-sterile drug product manufacturing risks. An effective risk-based approach will help to understand and mitigate potential microbial hazards in manufacturing and evaluate their potential impact on the finished product quality.

    This session will focus on the quality risk management of microbial risks of non-sterile products by taking into consideration, among other things, the dosage form characteristics, hygienic design and maintenance of process equipment, including the water system, cleaning and sanitization program, and the type of manufacturing process as these may impact the contamination risk level.

    13:30 | The Complex: Science, Policy, and Case Studies of The Burkholderia Cepacia Complex in Aqueous Nonsterile Drugs
    Erika A. Pfeiler, PhD,     Supervisory Microbiologist, CDER, U.S. FDA

    13:53 | Microbiological Contamination Controls for Nonsterile Manufacturing
    Andrew Dick, MS,     Vice President Global Hygiene and Microbiology, KDC/One

    14:30 | Q&A with Speakers and Additional Panelist
    Sandra A. Boyd,     Consumer Safety Officer, ORA, U.S. FDA (INVITED)

    SUPPLY CHAIN AND MANUFACTURING CHALLENGES

    B2: Supplier Oversight
    Moderator: Keduo Qian, PhD,     Chemist, CDER, U.S. FDA

    The globalization of pharmaceutical manufacturing of API and FDF has been accompanied by explosive globalization of the supply chains. The number of entities performing distribution, packaging, transportation, warehousing, contract manufacturing/testing, material supply, and other functions, has added greater complexity to ensuring safety and quality of drug products. This session will focus on managing lifecycle risks introduced by global supply entities, as illustrated by real world case studies. The discussion will also reference multiple relevant ICH guidances.

    13:30 | Greenfield Site Biologic Drug Substance Licensure Preparation
    John M. McShane, MBA, Vice President, Biologics, Lachman Consultant Services, Inc.

    13:48 | Risk Management in Technology Transfer: The Receiving Site Perspective
    Mirko Gabriele, PhD,     Senior Director, Global Sterile Strategy Technology & Innovation, ThermoFisher Scientific

    14:23 | Q&A with Speakers and Additional Panelist
    CDR Tara Gooen Bizjak, MBS,     Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    EMERGING TRENDS AND INNOVATION

    C2: Drug Quality Lifecycle: Current Regulatory Concerns
    Moderator: Patricia F. Hughes, PhD,     Senior Scientific Advisor, CDER, U.S. FDA

    Setting the stage for the approval of a quality product application requires the establishment of CMC standards in an application and the selection of manufacturing facilities capable of producing a quality product throughout the product lifecycle. The SARS-CoV-2 pandemic has highlighted the demands of accelerated and streamlined CMC development timelines associated with supplying a quality product to patients without manufacturing delays and disruptions – and doing this while paralleling rapid clinical development timelines. This session will discuss aspects that can allow for streamlining CMC product development and facilitate the submission of a quality application to the FDA. Critical early decisions for the selection of manufacturing facilities and the use of appropriate manufacturing technologies will be discussed.

    13:30 | Regulatory Approaches to Accelerated Sars-CoV-2 Neutralizing Antibody Development
    Maria T. Gutierrez Lugo, PhD, Supervisory Chemist, CDER, U.S. FDA

    13:54 | Delivering Therapeutic mAbs for COVID-19: What Can Be Done in Just One Year
    Pamela C. De Moor, MS, PhD,     Senior Director, Formulations and Drug Product Development, Vir Biotechnology, Inc

    14:17 | From Benchtop to BLA in Record Time: A Case Study
    Michele Lastro, MS, PhD, Executive Director, Regeneron Pharmaceuticals, Inc.

    14:37 | Q&A with Speakers and Additional Panelist
    Gang Chen, PhD,     Vice President, Regeneron Pharmaceuticals, Inc.


    15:00 – 15:30 | Virtual Exhibit Hall and Connect & Network       

    15:30 – 17:00 | Concurrent Sessions

    QUALITY ASSURANCE AND QMS

    A3: Quality Systems: How to Ensure Resilience and Effectiveness
    Moderator: Denise M. DiGiulio,     Senior Director, Johnson & Johnson

    Quality is a mindset that impacts everyone and every relevant decision we make. A quality mindset starts at the top with strong support from executive leadership and is embedded in all functions and actions. A modern quality system and risk management approaches help manufacturers to meet the requirements of the Agency's current good manufacturing practice (CGMP) regulations for drugs (2l CFR parts 210 and 211) on a continuous basis.

    This session will explain why regulatory actions are taken and how regulators determine regulatory significance. An experienced quality professional will share her knowledge and experience in the remediation of several Consent Decrees and warning letters. The road to remediation has required systemic improvements in quality culture and quality systems. Insights into establishing and sustaining a culture of quality assurance (and thus CGMP compliance) will be explained by senior leadership from both the regulatory and industry perspective.

    15:30 | Carmelo Rosa, PsyD, Division Director, Office of Manufacturing and Product Quality, CDER, U.S. FDA

    15:55 | QMS – Quality Impact
    Michele H. Piepoli,     Senior Quality Consultant, Johnson & Johnson

    16:20 | Q&A with Speakers and Additional Panelist
    Paul Edson, Vice President,     J&J Regulatory Compliance, Johnson & Johnson

    SUPPLY CHAIN AND MANUFACTURING CHALLENGES

    B3: Manufacturing during and after the Pandemic
    Moderator: Mary E. Farbman, PhD,     Executive Director, Global Quality Compliance, Merck & Co., Inc.

    This session will focus on some of the many challenges manufacturers face when bringing critical medicines to market during a pandemic. We will focus on concrete strategies firms used during the past year to address high absenteeism, prevent disease spread in their facilities, handle supply chain disruptions, and determine what work could be managed from remote settings. In addition, the session will focus on how firms assessed their current microbial controls strategies for effectiveness in preventing entry of SARS-CoV2 particles into their production streams. Finally, we will discuss the regulatory expectations for manufacturing during times of high absenteeism and under pandemic conditions.

    15:30 | "This was their finest hour."- Winston Churchill Manufacturing during a Global Pandemic
    Kathy A. Demarest,     Executive Director, Quality, Amgen Inc.

    15:51 | Quality Considerations and Verification of SARS-CoV-2 Safety Margins
    Thomas R. Kreil, PhD,     Vice President, Global Pathogen Safety, Takeda

    16:09 | Manufacturing During and After the Pandemic: A Regulatory Perspective
    CDR Tara Gooen Bizjak, MBS,     Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    16:34 | Q&A

    EMERGING TRENDS AND INNOVATION

    C3: Improving Manufacturing via Modern Technology
    Moderator: Rebecca E. Dombrowski, MS,     Supervisory Investigator, ORA, U.S. FDA

    The pandemic has highlighted challenges throughout the world in ensuring continuity of operations in both the public and private sector. The use of modern technology during these times has reinforced the value of highly capable manufacturing and robust quality management. During this session we will present some of the ways modern technologies can be used to strengthen operational controls, enhance oversight and monitoring, minimize the potential for human error, and contribute to the advancement of public health. Hear from experts in the field on the potential applications of modern manufacturing technologies including isolator design, automation, and other innovative efforts. The session will also address how modern technology can be used to enhance knowledge management to the benefit of both industry and regulatory decision making.

    15:30 | Robotics and Biometrics Initiatives in Drug Product Manufacturing
    James C. Weber,     Advisor IT - Digital Manufacturing, Eli Lilly and Company

    15:50 | Facilitating Deployment of Autonomous Mobile Robotics (AMRs)
    Carl-Helmut Coulon, PhD, Head of Future Manufacturing Concepts, INVITE GmbH and David Wolton, Engineering Technology Lead, Takeda

    16:10 | Considerations for Adopting Modern Technologies
    Nicholas A. Violand,     Investigator/Drug National Expert, ORA, U.S. FDA

    16:30 | Q&A

  • WEDNESDAY, 29 SEPTEMBER

    08:30 – 09:30 | Special Topic Sessions

    Special Topic 4: PDA QbD Book and PDA Vaccine Development Lifecycle Technical Report
    Moderator: Valerie Whelan, Vice President, Quality Operations, Amgen Inc.

    Quality by Design (QbD) is not a new concept in fact, the first thoughts on it date back to the 1950s, but it’s more typically associated with the FDA’s steps to include QbD concepts into cGMPs starting in 2002 and the publication of ICH Q8 in 2006. It places an emphasis on product and process understanding and process control based on sound science and quality risk management. Over the last eighteen months the true value of QbD in facilitating the rapid but effective development and safe deployment of quality vaccines to fight a global pandemic has been realized. This session will highlight specific applications of QbD in vaccine development with reference to the soon to be published PDA Technical Report, but also remind us of the value of investing in this type of approach more broadly within our industry as outlined in the PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, published in March 2021.


    08:30 | Strategies for Vaccines Development and Lifecycle Management: What We Are Advocating For
    Sabrina Restrepo, PhD,     Director, Merck & Co., Inc.

    08:50 | Quality by Design: An Indispensable Approach to Accelerate BioPharmaceutical Product Development
    Cristiana Campa, PhD,     Technical R&D Advisor and Fellow, GlaxoSmithKline

    09:10 | Q&A with Speakers and Additional Panelist
    Amin Khan, PhD, Chief Science Officer, Human Health, GreenLight Biosciences, Inc.

    Special Topic 5: AI Research Force (AIRForce) Group: Focus on Artificial Intelligence and Machine Learning
    Moderator: Rebecca E. Dombrowski, MS, Supervisory Investigator, ORA, U.S. FDA

    The exploration of the potential of Artificial Intelligence and machine learning technologies in the pharmaceutical space has gained great interest in recent years. From predictive maintenance to drug development and repurposing and virtual learning platforms, the applications seem boundless. But the question still remains: How can such technology be validated and controlled? In this session, FDA's Division of Bioinformatics and Biostatistics at the NCTR will present a model developed and implemented through their AI Research Force (AIRForce) team. Join us for a behind the scenes look at the design and implementation efforts in developing, qualifying, and piloting an AI system including the challenges faced and lessons learned.


    08:30 | Artificial Intelligence for Regulatory Science Research
    Weida Tong, PhD,     Director, Division of Bioinformatics and Biostatistics, National Center for Toxicological Research, U.S. FDA

    08:55 | Q&A

    Special Topic 6: Risk Management of Non-Ingredient Suppliers
    Moderator: Mai X. Huynh, MS, Supervisory Chemist, CVM, U.S. FDA

    The pandemic has no doubt created lots of shortage in our supply chain, including materials used in the manufacturing process of various drugs and vaccines. Due to the complicated supply chain management, manufacturers come to face with back orders of supplies, such as glass vials, stoppers, sterile filters, single use systems, etc. Distress grows as manufacturers learned that their supply is on back order which forced them to look for alternatives in manufacturing capability and flexibility in regulatory communication with the FDA.

    At this session, you will hear from the FDA the regulatory framework for managing such situation. An example how risk-based approaches and practical quality risk management tools can play a role in the overall control strategy and change management system within the pharmaceutical quality system will also be presented.

    08:30 | Risk Management of Non-Ingredient Suppliers: Current Regulatory Concerns
    Patricia F. Hughes, PhD, Senior Scientific Advisor, CDER, U.S. FDA

    08:45 | The Use of QRM to Ensure Process and Product Control During Non-Ingredient Material Shortage
    Tiffany A. Baker, MBA,     Consultant, ValSource Inc.

    09:05 | Q&A with Speaker and Additional Panelist
    Renée S. Blosser, MS, Microbiologist, CVM, U.S. FDA

    09:30 – 09:45 | Break

    09:45 – 11:15 | Plenary 5: Center Updates                                                                           
    Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    The global regulatory landscape is evolving, and innovative approaches to product life cycle and quality paradigms are met by new real-life challenges and complexities every day – patient-individualized medicines, supply challenges for legacy products, transition to new technologies, highly globalized supply chains. How will U.S. FDA continue to optimize its mission to safeguard the quality, safety, and effectiveness of medicines for patients even with these manufacturing and supply challenges? After introductory presentations, your questions on these and other issues will be posed to FDA executive management from various FDA Centers! In a virtual round table format, the conversation will focus on these issues that are often cross-cutting across different centers and relevant to the entire pharmaceutical space. 

    09:45 | CBER Updates
    Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA

    10:00 | CDER Updates
    Douglas R. Throckmorton, MD, Deputy Director of Regulatory Programs, CDER, U.S. FDA

    10:15 | CVM Updates
    Steven M. Solomon, DVM, MPH, Director, CVM, U.S. FDA

    10:30 | ORA Updates
    Judy McMeekin, PharmD, Associate Commissioner for Regulatory Affairs, ORA, U.S. FDA

    10:45 | Q&A with Speakers and Additional Panelist
    Matthew A. Lucia, DVM, Director, Office of New Animal Drug Evaluation, CVM, U.S. FDA

    11:15 – 11:45 | Virtual Exhibit Hall and Connect & Network

    11:45 – 13:15 | Concurrent Sessions

    QUALITY ASSURANCE AND QMS

    A4: Process Validation Lifecycle: 10 Years in Review
    Moderator: CDR Tara Gooen Bizjak, MBS, Director, Manufacturing Quality Guidance and Policy Staff, CDER, U.S. FDA

    W. Edwards Deming's 14 Points for Total Quality Management includes the following point: Improve constantly and forever every process for planning, production and service. A foundation of modern quality systems for all industries, this point speaks to the framework of the U.S. FDA's pharmaceutical process validation approach. 2021 marks the 10th anniversary of the U.S. FDA publishing the paradigm shifting Guidance for Industry: Process Validation: General Principles and Practices." This session will explore the lifecycle approach to process validation, including discussion of knowledge and data from development lots and commercial scale studies, along with continued process verification (CPV).

    Representatives from FDA and regulated industry will present case studies and examples to illustrate how commercial manufacturers can ensure that the process remains in a state of control over the lifecycle of the product, which includes identifying opportunities and implementing changes to achieve continual improvement. Attend to listen to a discussion of where process validation is and can be - or should be - 10 years from now.

    11:45 | Process Validation Lifecycle: Benefits and Learnings from Implementation
    Conor C. Collins, PhD, MBA, MSc,     Head of Validation/PLM for Pharma Supply Technical, GlaxoSmithKline

    12:10 | Process Validation Lifecycle: 10 Years in Review
    Milind Ganjawala, MS, MBA,     Division Director, CDER, U.S. FDA

    12:35 | Q&A with Speakers and Additional Panelist
    Jeffrey D. Meng, MSE, Director, Investigations Branch, OPQO, ORA, U.S. FDA

    SUPPLY CHAIN AND MANUFACTURING CHALLENGES

    B4: ICH’s Initiatives to Advance Global Harmonization, Innovation, and Continual Improvement Throughout Lifecycle
    Moderator: Clarice H. Hutchens, PhD, MA, DM, Senior Director, Pfizer

    A brief overview of ICH initiatives with a deeper dive into ICH Q12 Implementation and ICH Q9 revisions. Learn how ICH Q12 implementation can support LCM and continuous improvement, leveraging PQS to support changes post approval. Recent case studies will be presented. ICH Q9 (QRM) revisions may include additional clarity on the concept of formality in QRM to ensure that the extent of scientific and methodological rigor applied is commensurate with the level of risk, enabling better, more informed, and timely decisions in QRM. Evaluation of supply chain risk along with risks to quality is being considered. The guideline will also discuss controlling subjectivity by addressing bias, using appropriate QRM tools and relevant data. An overview of other ICH initiatives will include Q13 Continuous Manufacturing, ICH Q3E Extractables/Leachables, ICH Q2(R)/Q14, ICH M4Q revisions and a newly approved ICH topic, Structured Product Quality Submissions.

    11:45 | Quality Risk Management: An Update on the Ongoing Revision of ICH Q9
    Kevin J. O'Donnell, PhD, Market Compliance Manager, Health Products Regulatory Authority

    12:10 | Implementation of ICH Q12
    Frank Montgomery, PhD, Global Head, Regulatory CMC, AstraZeneca

    12:35 | Q&A with Speakers and Additional Panelist
    Mahesh R. Ramanadham, PharmD, MBA, Associate Director Scientific Operations, OPMA, OPQ, CDER, U.S. FDA

    EMERGING TRENDS AND INNOVATION

    C4: Moving Quality to the Next Level: "What Would it Take?"
    Moderator: Mike G. Labruto, MS, Executive Director, GlaxoSmithKline

    This session will explore innovative ways to continuously improve quality for the future. We will learn the benefits of tools/techniques that go beyond traditional key performance indicator (KPI) monitoring to exploring ways that provide predictive/leading metrics to better understand an organization’s risk profile. This session will provide insights and case studies from industry speakers on the opportunities and challenges with implementing digitalization within their firms.

    A review of how innovation/digitalization is transforming the traditional ways of working in pharmaceutical manufacturing and testing will be explained. How are companies incorporating such innovation into their quality management system (QMS), and achieving increased productivity and simplified compliance? How do companies embed innovative objectives into their Quality Improvement Plans and quality objectives to effectively be able to respond to problems as they occur or even prior to via predictive measures?

    11:45 | Quality in Automation
    Jeff J. Bedford,     Director, R&D Quality Futures, GlaxoSmithKline

    12:10 | ML-Based Quality
    Ravi Yalamanchili, MS, MBA, Executive Director Global Quality, Merck & Co., Inc.

    12:35 | Q&A

    13:15 – 13:45 | Virtual Exhibit Hall and Connect & Network

    13:45 – 15:15 | Concurrent Sessions

    QUALITY ASSURANCE AND QMS

    A5: Aging Facilities vs. Modern Facilities
    Moderator: Patricia F. Hughes, PhD, Senior Scientific Advisor, CDER, U.S. FDA

    In 2019 FDA issued a report on the continuing state of drug shortages and identified three main root causes which included a lack of incentives to produce less profitable drugs, lack of rewards for mature quality systems that focus on continuous improvement and early detection of supply issues and logistical and regulatory challenges that prevent a quick recovery from supply disruptions. In the 2020 Report to Congress, FDA noted that the supply chain was impacted by the pandemic because of a loss of manufacturing capacity and increased demands of many drug products. Often aging facilities lack a mature QMS and adequate physical structures, and manufacturing capacity becomes constrained. However, modernization of aging facilities can pose significant business and regulatory challenges. This session will explore some of the remedies that can be implemented to modernize and improve facilities and avoid drug supply disruptions. Regulatory approaches to facilitate the approval of process improvements and equipment changes post-approval will be discussed. These efforts may be facilitated through the implementation of ICH Q12.

    13:45 | Case Study: Aging Facilities
    Susan J. Schniepp,     Distinguished Fellow, Regulatory Compliance Associates Inc.

    14:05 | Impact of Aging Facilities on the Issue of Drug Shortage
    Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing Inc

    14:30 | Q&A with Speakers and Additional Panelist
    Rick L. Friedman, MS, Deputy Director, OMQ, CDER, U.S. FDA

    SUPPLY CHAIN & MANUFACTURING CHALLENGES

    B5: Sterile Drug Hot Topics
    Moderator: Douglas A. Campbell, Senior Consultant, InterPro QRA

    The risks related to the manufacture of sterile drug products remained an obstacle as health and safety considerations, travel restrictions, and additional challenges were introduced by the COVID pandemic.  Despite the COVID-related challenges, there was continual discussion surrounding the evolving regulatory expectations for mitigating the risks associated with sterile drug manufacturing operations and the efforts to better understand the best practices for ATMP operations. These are just two examples of the topics involved in this ongoing discussion.

    This session will provide insights, related enforcement actions, and case studies from CDER and CBER speakers, along with an update and discussion of the status of Annex 1.  In addition, this session will highlight discussions related to Containment Control Strategy (CCS) and include an update on the development of the upcoming PDA Technical Report for CCS.

    13:45 | Holistic Contamination Control Strategy (CCS) for Sterile Drugs including Cell and Gene Therapy Products
    Biswarup Dasgupta,     Director, QA Gene Therapy, Sarepta Therapeutics

    14:10 | Hot Topics and Regulatory Expectations in Aseptic Processing
    Brooke K. Higgins, MS,     Senior Policy Advisor, CDER, U.S. FDA

    14:26 | Sterile Drug Hot Topics
    Simone E. Pitts, MS,     National Expert, Pharmaceutical, ORA, U.S. FDA (INVITED)

    14:56 | Q&A with Speakers and Additional Panelist
    Glenn E. Wright, MA, Vice President, Scientific and Regulatory Affairs, PDA

    EMERGING TRENDS & INNOVATION

    C5: All That Data…Now What?
    Moderator: Sharyl D. Hartsock, Senior Director Quality, Global Quality Systems, Eli Lilly and Company

    Could a pirate shortage be the cause of global warming? And does eating cheese increase your risk of strangulation? Sound strange? It’s real data! In the pharmaceutical industry, it’s often said that we make two products. The physical medication that is taken by the patient and the data to support it. It’s imperative that our patients trust that data.

    “All That Data . . . Now What?” will emphasize the fundamental principles of data management and highlight data integrity as a key attribute of operational excellence. Most companies have programs to monitor and look for data integrity lapses. But how do we move from this reactive model to one where data integrity is inherently integrated into our Quality Management System, driving process efficiency and facilitating data-driven decision making through implementation of process-appropriate controls? This session will focus on key concepts of the forthcoming PDA Technical Report on data integrity in quality management systems, and PDA TR84, Integrating Data Integrity Requirements into Manufacturing & Packaging Operations. Industry presenters will demonstrate how implementation of these concepts drives improvements in operational understanding and control. The presentations will be followed by an active panel discussion with both industry and agency representation.

    13:45 | Forthcoming PDA Technical Report on Utilizing the Quality Management System to assure Data Integrity
    Travis A. Frick, MSc, Senior Director, Manufacturing Operations, Istari Oncology
    Kir F. Henrici, CEO, The Henrici Group

    14:04 | PDA TR84, Integrating Data Integrity Requirements into Manufacturing and Packaging Operations
    Bethany B. Rexing, MS, M&Q Data Management Director, Eli Lilly and Company

    14:29 | Q&A with Speakers and Additional Panelist
    Atul J. Agrawal, MS, Supervisory Consumer Safety Officer, ORA, U.S. FDA

    15:15 – 15:45 | Break

    15:45 – 17:30 | Plenary 6: Thanks Science
    Moderator: Mary E. Farbman, PhD, Executive Director, Global Quality Compliance, Merck & Co., Inc.

    We live in a time at which scientific discoveries – and technologies based on them – come at an unprecedented pace . . . and yet also at time when the public may be increasingly slow to trust scientists. How can we improve the way we – scientists, engineers, quality professionals -- communicate with the public about our work? This session will feature CBER Center Director Dr. Peter Marks and Baylor College of Medicine’s Dr. Peter Hotez, who will discuss with us their work in helping the public at large appreciate science and its contribution to public health. At the same time, we’ll take a moment to celebrate some of science’s successes and to appreciate not just how science impacts the world, but how world events impact science, spurring us to ever new innovations and discoveries. 

    15:45 | Peter J. Hotez, MD, PhD, Dean National School of Tropical Medicine, Baylor College of Medicine

    16:10 | Bringing Bespoke Therapeutics into Being
    Peter W. Marks, MD, PhD, Director, CBER, U.S. FDA

    16:35 | Q&A

    17:15 | Closing Remarks

Highlighted Speakers

CAPT Tara Gooen Bizjak
CAPT Tara Gooen Bizjak
U.S. FDA
Alonza E. Cruse
Alonza E. Cruse
U.S. FDA
Francis RW Godwin
Francis RW Godwin
U.S. FDA
Peter J. Hotez
Peter J. Hotez
Baylor College of Medicine
Peter W. Marks
Peter W. Marks
U.S. FDA
Judith McMeekin
Judith McMeekin
U.S. FDA
Melissa J. Mendoza
Melissa J. Mendoza
U.S. FDA
Melissa S. Seymour
Melissa S. Seymour
Biogen
View All

Learning Objectives

At the completion of this conference, participants will gain skills to:

  • Conduct successful investigations of Out-of-Specification (OOS)/Out-of-Trend (OOT) findings
  • Effectively implement data integrity remediation
  • Establish robust processes and maintain state of controls
  • Improve product availability and avoid shortages
  • Manage post-approval changes and change management processes
  • Successfully implement quality management techniques and robust manufacturing
  • Update facilities to support dependable quality and supply

Who Should Attend

Departments
  • Corporate Offices, Research and Development
  • Regulatory Affairs
  • Manufacturing
  • Quality Assurance/Control
  • Marketing
  • Sales
Job Function
  • Quality Assurance
  • Manufacturing
  • Compliance/Inspection Management
  • Supply Chain
  • Auditing
  • Executive Management
Academia
  • Pharmaceutical sciences
  • Regulatory science
Global Regulatory Authorities

Registration Fees

Register Now
Early Registration
Registration Type Price by 31 July 2021
Member $958
Non-member $1098
Govern./Health Authority/Academic Member $280
Govern./Health Authority/Academic Non-member $320
Student Member $112
Student Non-member $124
Early Career Professional
Member		 $479
Regular Registration
Registration Type Regular Registration
 Price after 31 August 2021
Member $1,341 $1,724
Non-member $1,537 $1,976
Govern./Health Authority/Academic Member $392 $504
Govern./Health Authority/Academic Non-member $448 $576
Student Member $157 $202
Student Non-member $174 $223
Early Career Professional
Member		 $671 $862

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