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Agenda

Agenda

 

Agenda

As of 30 June 2020
 
 
  • Agenda at a glance

    Monday, July 20

    • P1: It’s Time to Get Personal with Patients

      10:00 a.m. – 11:30 a.m.
    • Virtual Exhibit Hall Open

      11:30 a.m. – 12:30 p.m.
    • P2: Biopharmaceutical Manufacturing

      12:30 p.m. – 1:45 p.m.
    • Virtual Exhibit Hall Open

      1:45 p.m. – 2:15 p.m.
    • Concurrent Sessions

      2:15 p.m. – 3:30 p.m.
    • Virtual Poster Hall Open

      3:30 p.m. – 4:00 p.m.

    Tuesday, July 21

    • P3: A Tale of Two Facilities

      10:00 a.m. – 11:15 a.m.
    • Virtual Exhibit Hall Open

      11:15 a.m. – 12:15 p.m.
    • Concurrent Sessions

      12:15 p.m. – 1:30 p.m.
    • Virtual Exhibit Hall Open

      1:30 p.m. – 2:15 p.m.
    • Concurrent Sessions

      2:15 p.m. – 3:30 p.m.
    • Virtual Poster Hall Open

      3:30 p.m. – 4:00 p.m.

    Wednesday, July 22

    • P4: Strategies for Developing Next Generation Medicine

      10:00 a.m. – 11:15 a.m.
    • Virtual Exhibit Hall Open

      11:15 a.m. – 12:15 p.m.
    • Concurrent Sessions

      12:15 p.m. – 1:30 p.m.
    • Virtual Exhibit Hall Open

      1:30 p.m. – 2:15 p.m.
    • P5: Regulatory and Industry Dialog on Continual Improvement, Innovation, and Reducing Drug Shortages through Science and Risk-Based Approaches

      2:15 p.m. – 3:45 p.m.
  • Daily schedule

    Monday, July 20

     

    P1: It’s Time to Get Personal with Patients
    10:00 a.m. – 11:30 a.m.
      Moderator
    • Melissa S. Seymour, MBA,Vice President, Global QC Operations, Biogen

    The pharmaceutical industry is in an unprecedented time of innovation and development; we are witnessing approvals of new modalities of drugs that are changing and saving lives in ways that have never been done before. In this session, we will hear a patient perspective on how innovation in our industry changes lives and how continued research and development is critical in helping more and more patients. We will also hear about new and innovative technologies currently under development. As in industry, our ultimate goal is to better the lives of the patients we serve. This session will provide a connection to our ultimate goal as we begin the conference.

    • 10:00 a.m. – 10:15 a.m. | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs
      Jette Christensen,
      Chair, PDA Board of Directors
      Richard Johnson, President and CEO, PDA
      Aaron R. Goerke, PhD, Director, Head of MSAT, Roche Singapore Technical Operations, F. Hoffman-La Roche
      Melissa S. Seymour, MBA, Vice President, Global QC Operations, Biogen
    • 10:15 a.m. – 10:45 a.m. | Delivering T Cells to Patients: Challenges and Successes
      Elliot Norry, MD,
      Chief Medical Officer, Adaptimmune US
    • 10:45 a.m. – 11:15 a.m. | Journey to Car-T Cell Therapy
      Tom G. Whitehead,
      Co-founder, Emily Whitehead Foundation
    • 11:15 a.m. – 11:30 a.m. | Q&A

    11:30 a.m. – 12:30 p.m. | Virtual Exhibit Hall Open

    P2: Biopharmaceutical Manufacturing
    12:30 p.m. – 1:45 p.m.
      Moderator
    • Peter J. Makowenskyj, MEng, Director of Sales Engineering, G-CON Manufacturing and Leader, PDA Biopharmaceutical Manufacturing Interest Group

    Industry 4.0, and what is now called Pharma 4.0, has become a very prominent factor in shaping our industry. As an IG, we have agreed establish a working committee on Pharma 4.0 and we will have a short call for volunteers interested in joining the committee, to support either a white paper or technical report. Additionally, we are having two leading experts in Pharma 4.0 give talks on how it is currently shaping our industry.  

    • 12:30 p.m. – 1:00 p.m. | Maximize Your Understanding of Operational Realities in Manufacturing with Predictive Insights using Big Data, Artificial Intelligence, and Pharma 4.0
      Toni Manzano, PhD,
      Co-founder and CSO, Bigfinite
    • 1:00 p.m. – 1:30 p.m. | Applying Pharma 4.0 Concepts to Cell and Gene Therapy Manufacturing
      Vasu Rangadass, PhD,
      CEO, L7 Informatics, Inc.
    • 1:30 p.m. – 1:45 p.m. | Q&A

    1:45 p.m. – 2:15 p.m. | Virtual Exhibit Hall Open

    2:15 p.m. 3:30 p.m. | Concurrent Sessions

    DEVELOPING NEW MODALITIES
    A1: Changes in Manufacturing and Quality Processes for Cell and Gene Therapy Products
      Moderator
    • Cori Sandy, Associate Director, Quality Systems, AveXis

    As we enter a new era in advance therapy medicinal product (ATMP) manufacturing, we learn of new challenges facing both the industry and regulators. Rapid product deployment to meet patient needs while adapting facilities and existing processes is a continuous challenge for companies stepping into the cell and gene therapy arena. This can include commonly used open systems which increases the opportunity for adventitious agents to be introduced, affecting sterility. Additionally, maintaining and monitoring the integrity of the cells as they advance through the manufacturing process can present challenges. Regarding the regulatory framework, understanding that there are countries still developing guidance and regulations and ones that have an existing framework have subtle differences between them. This session will focus on complexities associated specifically to manufacturing of cell and gene therapy products.

    • 2:15 p.m. - 2:45 p.m. | An Innovative Approach to a Gene Therapy Facility Start Up
      Greg Gara,
      VP Gene Therapy Manufacturing, Sarepta Therapeutics
      Tony Khoury,
      Senior Vice President, Project Farma
    • 2:45 p.m. - 3:15 p.m. | Advanced Therapies: Implementing Phase Appropriate Regulatory Requirements to Facilitate Successful Development and Release
      Aidan J. Harrington, PhD,
      Principal Consultant, DPS Group
      Michael J. Gorman, MS, PMP, LSSBB,
      Principal Consultant, DPS Group
    • 3:15 p.m. - 3:30 p.m. | Q&A
    ENGINEERING DATA SOLUTIONS
    B1: Leveraging Data to Improve Efficiency and Effectiveness
      Moderator
    • Arne Zilian, PhD, Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

    This session will discuss practical applications of machine learning (ML) in pharmaceutical manufacturing. Presenters will share a case study showing, being in a situation of rapidly growing demand, how to improve outcomes like manufacturing efficiency and effectiveness, planning/execution, time to release, and process yield. Participants will leave with a better understanding of the technical, cultural, and financial challenges to be overcome when introducing ML tools in complex regulatory environments.

    • 2:15 p.m. - 2:45 p.m. | Learning from Introducing AI/ML based solutions at the Manufacturing Sites
      Fausto Artico, PhD,
      AI/ML Product Manager, GSK
    • 2:45 p.m. - 3:15 p.m. | An Advanced Process Control Framing to Application of Analytics and Modeling for Biopharma Manufacturing Processing
      Kaschif Ahmed, PhD,
      Advanced Process Control Engineer, Biogen
    • 3:15 p.m. - 3:30 p.m. | Q&A
    INTEREST GROUP
    IG1: Filtration
      Leader
    • Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing

    In this session, participants will hear updates on various projects and task forces related to filtration, including PDA/BPOG PUPSIT, PDA/ANSI, and the PDA Prefiltration Task Force.

    • 2:15 p.m. - 2:35 p.m. | PDA/BPOG PUPSIT Update
      Maik W. Jornitz, MSEng, CEO, G-CON Manufacturing
    • 2:35 p.m. - 2:55 p.m. | A Quality by Design (QbD) Approach to Microbial Retention Validation
      Kathleen S. Souza, MS,
      R&D Manager, Microbiology, MilliporeSigma
    • 2:55 p.m. - 3:15 p.m. | Update on PDA ANSI Standard on BSR/PDA Standard 05-201x, Consensus Method for Rating 0.1 Mycoplasma Reduction Filters
      Martha J. Folmsbee, PhD,
      Principal Scientist, Pall Corporation
    • 3:15 p.m. - 3:30 p.m. | Q&A
    INTEREST GROUP
    IG2: Microbiology
      Leader
    • Marc Glogovsky, Senior Consultant - Microbiology, ValSource, LLC

    Regulators expect facilities to have a robust cleaning and disinfection program in place when manufacturing sterile parenterals. This session will cover: Cleaning and Disinfection Fundamentals – Specifically, an approach to cleaning and disinfection design, cleaning versus disinfection, reviewing chemistries and disinfectant/antimicrobial efficacy points to consider when evaluating chemistries. This would involve microbial organisms, contact times, chemical compatibility and in-use expiration. This session is designed to provide the basics needed to develop your own compliant cleanroom contamination control program.     

    • 2:15 p.m. - 2:45 p.m. | Cleaning and Disinfection Fundamentals
      Chris Richey,
      Regional Manager – Northwest U.S. & Western Canada, Veltek Associates, Inc.
    • 2:45 p.m. - 3:30 p.m. | Q&A

    3:30 p.m. – 4:00 p.m. | Virtual Poster Hall Open

    Tuesday, July 21

    P3: A Tale of Two Facilities
    10:00 a.m. – 11:15 a.m.
      Moderator
    • Ghada N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co., Inc.

    Aging manufacturing facilities have become a major concern as the industry tries to keep pace with the advancements in technology while balancing costs. Modular facilities construction provides on-demand scaling of biopharmaceutical production and laboratory space. Flexible manufacturing models enable facility footprint reduction and increased efficiency. A hybrid manufacturing network of conventional and next-generation plants can best serve patient needs. In this session we explore the challenges of modernizing aging facilities and the next generation biotherapeutic advancements of modular manufacturing.

    • 10:00 a.m. - 10:30 a.m. | Modular Manufacturing
      Michael J. Abernathy, MS, RAC,
      Executive Director, Regulatory Affairs, Amgen Inc.
    • 10:30 a.m. - 11:00 a.m. | Modernizing High-Volume Sterile Manufacturing: A Tale of Two Facilities
      Anthony M. Pavell, MS,
      Plant Manager, Fresenius Kabi
    • 11:00 a.m. - 11:15 a.m. | Q&A

    11:15 a.m. – 12:15 p.m. | Virtual Exhibit Hall Open

    12:15 p.m. – 1:30 p.m. | Concurrent Sessions

    DEVELOPING NEW MODALITIES
    A2: Overcoming Challenges in Supply Chain for New Modalities
      Moderator
    • Shelley M. Preslar, MBA, PMP, Managing Partner, Azzur Group Raleigh

    There is no question that the development of recent drug product modalities has provided impressive additions to the patient treatment portfolio. With these scientific breakthroughs come significant changes to the traditional manufacturing process. Considerable differences can be found in the supply chain when considering the manufacturing of personalized medicine such as advanced therapy medicinal products (ATMPs). The supply chain must be completely mapped and controlled from the collection point through manufacturing and back to the patient to ensure that patient-specific treatments arrive at the correct patient within the limited window of time (commonly hours to days). This session will explore approaches to addressing these new supply chain considerations, while continuing to ensure a safe and effective patient treatment.

    • 12:15 p.m. - 12:45 p.m. | The Ethics of Things: Data and Risk Management in the Final Frontier that is the Drug Supply Chain
      Monique L. Sprueill, MS, CMQ-OE, PMP,
      Senior Manager, Strategy, Insights & Innovation, Johnson & Johnson
    • 12:45 p.m. - 1:15 p.m. | The Impact of Innovation on Building the Facilities of the Future
      Jim Watson, Senior Director, Project Farma
      Brian Stamper,
      Director of Manufacturing, Kite Pharma
    • 1:15 p.m. - 1:30 p.m. | Q&A
    ENGINEERING DATA SOLUTIONS
    B2: Data Integrity Issues from Human Factors to the Management Responsibilities
      Moderator
    • Jason Kerr, MBS, Quality Assurance Specialist, Amgen, Inc.

    In the biopharmaceutical industry there are millions of ways that data can be generated and logged, but human factors and inadequate data governance can leave our industry with data integrity issues. In this session, we will dig deeper into fundamental issues that causes data integrity from the human factors and explore data governance to enable leaders to design a system that prevents data integrity issues in the first place.

    • 12:15 p.m. - 12:45 p.m. | Overcoming Human Factors That Are Causing Data Integrity Issues
      Jose E. Soto, PhD, Quality Director, GlaxoSmithKline
    • 12:45 p.m. - 1:15 p.m. | Adventures in Data Integrity: Building Your Governance Program
      Kevin D. Wojtas, Head, 
      Quality Regulatory Compliance, Takeda Pharmaceuticals
    • 1:15 p.m. - 1:30 p.m. | Q&A
    INTEREST GROUP
    IG3: Quality Risk Management
      Leader
    • Amanda McFarland, MS, Senior Consultant, ValSource, LLC

    Health authorities continue to evaluate the industry's use of quality risk management (QRM) principles in lifecycle management of aseptic processes and are looking for the industry's applications of risk management to mature, as is evidenced in draft revision for EMA Annex 1. Aseptic processing has unique risk management challenges including level of severity, difficulty in detection, rare failure occurrence, lack of correlation, and quantifiable data. To address these critical areas, a guidance specific to the development and application of QRM approaches in aseptic processing is needed.

    PDA has formed a task force, made up of aseptic processing and quality risk management experts from industry and health authorities, to develop a practical standard to guide industry and regulators seeking to implement or evaluate QRM approaches in decisions related to the aseptic process design, qualification, operation, monitoring, and investigation activities. Members of the task force will present an overview of effort to date, including challenges of aseptic processing risk management, regulatory expectations, content of the standard, and use this opportunity to solicit input on a topic that will continue to affect industry at a significant level.

    • 12:15 p.m. - 1:00 p.m. | Standard Practice for Quality Risk Management of Aseptic Processes
      Hal Baseman,
      ValSource, LLC 
      Noël M. Long,
      Senior Sterility Assurance Adviser, GE Healthcare 
    • 1:00 p.m. - 1:30 p.m. | Q&A
    INTEREST GROUP
    IG4: Vaccines
      Leaders
    • Jane Halpern and A. Sabrina Restrepo, PhD, Director, Global Vaccines Technical Operations, Merck & Co., Inc.

    The Vaccine Interest Group will include a working session to further develop the planned Technical Report (Vaccine Control Strategies) and inform participants of other activities planned for 2020. In addition, there will be a presentation on developing vaccine technologies that are intended to lower the cost of vaccine manufacturing and increase vaccine accessibility in low and middle-income countries.

    • 12:15 p.m. - 12:45 p.m. |Regulator Representative Invited
    • 12:45 p.m. - 1:30 p.m. | Q&A

    1:30 p.m. – 2:15 p.m. | Virtual Exhibit Hall Open

    2:15 p.m. – 3:30 p.m. | Concurrent Sessions

    DEVELOPING NEW MODALITIES
    A3: Aging Infrastructure Made New Again
      Moderator
    • Ghada N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co. Inc.

    Aging infrastructure brings risk. Aging and poorly maintained infrastructure exposes companies to a number of risks. Deteriorating infrastructure can increase the risk of facilities, processes and systems to meet the demands of the company’s operational goals. The “c” in GMP stands for “current”. This means that companies should be using technologies and systems that are up to date in order to comply with the regulations and that systems and equipment should be adequate enough to prevent contamination, and to eliminate potential mix-ups for example. An older facility does not always mean an aging facility if companies have in place controls to ensure that the facility and processes continue to operate properly. In this session, learn how you can conduct a quality risk assessment exercise to understand the design, procedural, and qualification controls in place to ensure there are no potential risks to product quality and ultimately, to patient safety and if it’s time to rebuild or install new technology/new equipment to protect products, meet current regulations, and to keep up with today’s demands.

    • 2:15 p.m. - 2:45 p.m. | The Use of Robots in Aseptic Filling in Compounding Pharmacies, Are They Showing Industry the Pathway into the 21st Century?
      Chris J. Smalley, PhD,
      Compounding Pharmacist Advisor, ValSource LLC
    • 2:45 p.m. - 3:15 p.m. | Demonstrating Innovated Facility Modifications of Existing Facilities
      William J. Deckert,
      Global Consultant, CAI
    • 3:15 p.m. - 3:30 p.m. | Q&A
    GMP FOUNDATIONS ENABLING INNOVATION
    B3: Back to the Future: Innovative Quality System Design to Support Rapidly Evolving Technology
      Moderator
    • Shelley M. Preslar, MBA, PMP, Managing Partner, Azzur Group Raleigh

    The pharmaceutical industry in 2020 looks drastically different to that of decades past. The excitement and promise of novel therapeutic modalities, artificial intelligence, machine learning, and Pharma 4.0 have captured industry’s attention. It is easy, in this world, to downplay or even neglect our roots – proven GMP foundations upon which these trending topics must rest. The future of industry will require the creative application of quality principles to our most essential processes, those common to all pharmaceutical processes in the world – basic GMPs. This session will share novel approaches to improve effectiveness and efficiency of GMPs to remind us of the power of these core principles.

    • 2:15 p.m. - 2:45 p.m. | Measuring the Unmeasurable: A Tool for Creating Effective, Measurable Training Content 
      Katherine M. Hebert, MS,
      Senior QA & Ops Training Specialist, Regeneron Pharmaceuticals 
      Ashley E. Giambrone, PhD,
      Associate Manager, Continuous Improvement - Statistics, Regeneron Pharmaceuticals
    • 2:45 p.m. - 3:15 p.m. | Breakthrough Ideas in Quality, Design Thinking Approach
      Huiling Loo, MSc, BSc, 
      Head of Compliance, Roche Singapore Technical Operations
    • 3:15 p.m. - 3:30 p.m. | Q&A
    PDA SOUTHEAST CHAPTER
    Strategic Planning Meeting
      Leaders
    • Renee T. Morley, MBA, Past President, PDA Southeast Chapter and Crystal Booth, MM, President, PDA Southeast Chapter

    We are living in unprecedented times.  Everyone is adapting and changing strategies to keep essential businesses functioning and to keep employees safe. The PDA Southeast Chapter (PDASE) is proud to shift our previously scheduled interactive workshop session to this virtual session.  

    This session will feature an update on the PDA COVID-19 Task Force and strategies to remain healthy. In addition, we will hear from a local North Carolina’s business strategy to switch gears from manufacturing delicious beer to the much coveted, but rarely found, hand sanitizer. 

    • 2:15 p.m. – 2:45 p.m. | PDA Covid-19 Task Force Update
      Jim N. Polarine, MA,
      Senior Technical Service Manager, STERIS Corporation
    • 2:45 p.m. – 3:15 p.m. | From Distillery to Hand Sanitizer
      Jonathan Blitz,
      Founder, Barrister & Brewer LLC
    • 3:15 p.m. – 3:30 p.m. | Q&A and IG Initiatives

    3:30 p.m. – 4:00 p.m. | Virtual Poster Hall Open

    Wednesday, July 22

    P4: Strategies for Developing Next Generation Medicine
    10:00 a.m. – 11:15 a.m.
      Moderator
    • Morten Munk, Director, Global Alliance Management, FUJIFILM Diosynth

    Small molecule was the only player on the pharmaceutical field, until protein-based therapeutics revolutionized the health care space in the 1980s. Since then, these two therapeutic areas have developed tremendously and offer pivotal treatment options for patients all over the world.

    During the last few years, an impressive number of new types of therapeutic products and technologies have emerged and offer new treatments for diseases. This includes personal treatment with genes and whole cells, combinations of small molecules and proteins, treatment with living microbial cells, and many other modalities.

    These new treatments and products are typically based on a more profound understanding of the diseases they aim to cure, and required deployment of new technologies, including a wide variety of digitalization technologies, to discover, develop, and produce those new products.

    This session will focus on some of some of these new pharmaceutical regimes and the challenges of making these products available to patients.

    • 10:00 a.m. - 10:30 a.m. | Decoding Innovation in Biopharma Manufacturing
      Patrick G. Buckner,
      Global Head of Industry Solutions - Life Sciences, Amazon Web Services (AWS)
    • 10:30 a.m. - 11:00 a.m. | The New Economics and Efficiencies of Developing and Approving Gene and Cell Therapeutics
      Jeff Galvin,
      CEO, American Gene Technologies International
    • 11:00 a.m. - 11:15 a.m. | Q&A with Additional Panelist
      Diluks De Silva,
      Site Quality Head, Novartis

    11:15 a.m. – 12:15 p.m. | Virtual Exhibit Hall Open

    12:15 p.m. – 1:30 p.m. | Concurrent Sessions

    MODERNIZING PRODUCTS AND MANUFACTURING
    A4: Modernizing Legacy Products
      Moderator
    • Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.

    The diversity of molecules in the pharmaceutical pipeline, and those that are approved for today’s therapies, are changing the regulatory landscape and are a catalyst for manufacturing modernization. Legacy manufacturing systems can be defined by age and/or the suitability of the total system with the molecule and its environment. The quality of pharmaceuticals can be compromised by using antiquated manufacturing equipment, components, and processes. The adaptation of legacy systems to innovative and novel pharmaceutical products may not be possible, regardless of the age. It is foreseeable that patient access to lifesaving medicines will depend upon modernization of manufacturing systems to advance pharmaceutical products for the 21st century. In this session, participants will learn about the risks associated with legacy manufacturing and emerging manufacturing technologies.

    • 12:15 p.m. - 12:45 p.m. | The Impact of Yesterday’s Packaging Components on Manufacturing and Product Quality of Today’s Drug Products and Tomorrow’s Novel Applications
      Diego A. Zurbriggen,
      Technical Account Manager, West Pharmaceutical Services
    • 12:45 p.m. - 1:15 p.m. | Post-Approval CMC Changes and Impact to Global Vaccine Supply: Our Shared Goal of Quality Vaccine Availability for All Patients
      Kimberly Duffy,
      Executive Director, Global Regulatory Affairs Vaccines CMC, Merck and Co., Inc.
    • 1:15 p.m. - 1:30 p.m. | Q&A
    TARGETING REAL-TIME AND PARAMETRIC RELEASE
    B4: Innovative Approaches to Enable Real-Time Release
      Moderator
    • Kristin N. Valente, PhD, Director, Global Vaccine Technical Operations Laboratories, Merck & Co., Inc.

    ICH Q8 and EU GMP Annex 17 define real-time release testing (RTRT) as relying on process data (both measured material attributes and process controls) to ensure product quality. RTRT methodologies have become increasingly common with small molecules, and some initial successes have been demonstrated with therapeutic protein cell culture and chromatography; however, parenteral drugs continue to face challenges with traditionally lengthy release tests such as sterility and adventitious agent testing. Successful implementation of RTRT techniques requires both advanced analytical tools for attribute detection and state of the art mechanistic and empirical models for predicting process performance. This session will explore the blend of novel analytics with process models to enable real-time release. Innovations ranging from disruptive technologies to implemented manufacturing controls will be discussed.

    • 12:15 p.m. - 12:45 p.m. | Rapid Microbiological Release
      Michael J. Miller, PhD,
      President, Microbiology Consultants, LLC
    • 12:45 p.m. - 1:15 p.m. | Assessment of CQA Impact and Potential Opportunities for Real-time Release Testing
      Marisa K. Joubert, PhD,
      Senior Principal Scientist, Process Development, Amgen, Inc.
    • 1:15 p.m. - 1:30 p.m. | Q&A
    INTEREST GROUP
    IG6: Technology Transfer
      Leader
    • Beth Haas, Principal Consultant/Senior Project Manager, Commissioning Agents, Inc | CAI Consulting

    The Technology Transfer IG is actively updating TR-65 to incorporate details on the technology transfer process and a tool for mapping out requirements. This session will provide an overview of the updated TR and provide an interactive session with a case study in the new of the technology transfer tool. Hot topics will also be discussed in this session.

    • 12:15 p.m. - 1:00 p.m. | Technology Transfer Update
      Derek R. Gallo, BS,
      Director, Technology Transfer, Thermo Fisher Scientific
      Beth J. Haas, MChE,
      Principal Consultant, CAI
    • 1:00 p.m. - 1:30 p.m. | Q&A
    METRICS AND MATURE QUALITY SYSTEMS
      Moderator
    • Carolyn F. Cohran, Phd, Policy Lead, CDER, U.S. FDA

    The Center for Drug Evaluation and Research (CDER) is exploring quality system maturity as an alternative approach to addressing drug shortages and compliance risk. Recently, Dr. Janet Woodcock, CDER Director, has written in support of FDA’s Drug Shortage Task Force’s recommendation of a voluntary rating system of a sites “quality management maturity” that firms could share with potential purchasers to allow quality of supply to be a factor in the purchase of pharmaceuticals. Dr. Woodcock supports introducing transparency of sites ability to sell “quality” to purchasers and patients to enable firms to compete for quality and reliability of the drug supply and not just the lowest cost. Drug shortages has tremendous costs for both the health care industry but also for patients. This rating system would allow purchasers to pay for a more reliable and stable drug supply. PDA, PhRMA, St. Gallen, and other organization have been working on maturity models that help identify mature quality systems and strong quality culture organizations that could be used by industry and FDA’s New Inspection Protocol Project (NIPP). This session will provide an overview of various efforts working on maturity models and FDA’s current plans to adopt and utilize them.

    • 12:15 p.m. - 12:45 p.m. | A Holistic Perspective on Mature Quality Systems
      Ashley B. Boam, MSBE,
      Director, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality (OPQ), CDER, U.S. FDA
    • 12:45 p.m. - 1:15 p.m. | Linking Quality Maturity Models with Quality Culture
      Steven R. Mendivil, BS,
      Senior Advisor, Amgen, Inc.
    • 1:15 p.m. - 1:30 p.m. | Q&A

    1:30 p.m. – 2:15 p.m. | Virtual Exhibit Hall Open

    P5: Regulatory and Industry Dialogue on Continual Improvement, Innovation, and Reducing Drug Shortages through Science and Risk-Based Approaches
    2:15 p.m. – 3:45 p.m.
      Moderator
    • Melissa S. Seymour, MBA, Vice President, Global QC Operations, Biogen

    Recently, the much-anticipated ICH Q12 guideline was finalized, providing a harmonized approach regarding technical and regulatory considerations for lifecycle management. It is the hope of both regulators and industry that this guideline will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the biopharmaceutical sector. Additionally, application of science and risk-based approaches will strengthen quality assurance and improving supply of medicinal product, preventing drug shortage. In this session we will explore implementation from both a regulatory and industry perspective, closing with an expert panel Q&A.

    • 2:15 p.m. - 2:45 p.m.| FDA Perspective on ICH Q12
      Ashley B. Boam, MSBE,
      Director, Office of Policy for Pharmaceutical Quality, Office of Pharmaceutical Quality (OPQ), CDER, U.S. FDA
    • 2:45 p.m. - 3:15 p.m. | Facilitating Continual Improvement, Innovation, and Reducing Drug Shortages through Enhanced Science and Risk-Based Post Approval Change Management
      Emma Ramnarine,
      Senior Director, Global Head External Development Collaborations, Genentech/Roche
    • 3:15 p.m. - 3:30 p.m. | Q&A with Additional Panelist
      Barry Cherney, Executive Director, Product Quality, Amgen
    • 3:30 p.m. - 3:45 p.m. | Closing Remarks & Adjournment from 2021 PDA Annual Meeting Program Planning Committee Co-Chairs