2021 PDA/FDA Joint Regulatory Conference

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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

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. 

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

Contact

Program Inquiries
Molly E. O’Neill, CMP
Training Course Inquiries
David Hall
Registration Customer Care

Standard Pricing

Standard Member Price

$1,341

GovernmentMember Only

$392

Health AuthorityMember Only

$392

StudentMember Only

$157

AcademicMember Only

$392

Non-Member

$1,537

See Qualifying Criteria for Member Types.

Day 1

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

Day 2

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

Day 3

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

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