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2023 PDA Annual Meeting

2023 PDA Annual Meeting

Apr 03 - Apr 05, 2023
New Orleans, LA

Back to the Future: Learning from the Past in a Patient-Centric World

  • Conference
  • The Americas
Program Highlights

Highlights from this year's program: A free night on Tuesday to explore all that New Orleans has to offer, the Member Lounge located in the Exhibit Hall, and 12 Interest Group sessions!

Overview

The PDA Annual Meeting is the premier meeting on pharmaceutical/biopharmaceutical manufacturing science and technology.

The 2023 theme, Back to the Future: Learning from The Past in A Patient-Centric World, will spotlight the critical connection between our patients and the manufacturing process and enabling a patient-focused mindset on the manufacturing floor.

This event provides a forum for sharing knowledge on developing new modalities and the adoption of innovative approaches and processes. You will dive into exciting interactive sessions designed for manufacturing leaders, technical experts/scientists, and early career professionals. No matter what your area of focus, you are sure to come away with tangible and practical solutions to improve your operations.

PROGRAM PLANNING COMMITTEE

  • Amanda McFarland, MS, ValSource, Inc. (Co-Chair)
  • Kenneth Paddock, Baxter Healthcare (Co-Chair)
  • Kakolie G. Banerjee, PhD, MilliporeSigma
  • Jason Kerr, MBS, MBA, Redica Systems
  • Guido Kremer-van der Kamp, Merck Chemicals GmbH
  • Peter J. Makowenskyj, MEng, G-CON Manufacturing, Inc.
  • Kate Malachowski, PhD, Novavax
  • Malav Parikh, ME, Takeda
  • Diane M. Paskiet, MS, West Pharmaceutical Services, Inc.
  • Susan J. Schniepp, Regulatory Compliance Associates Inc.
  • Lauren Specchio, Baxter Healthcare
  • Kristin N. Valente, PhD, Merck & Co., Inc.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Posters
  • SUNDAY, 02 APRIL

    13:00 – 16:00 | Biopharmaceutical Advisory Board (Invitation Only)

    13:00 – 16:00 | Regulatory Affairs and Quality Advisory Board (Invitation Only)

    13:00 – 16:00 | Science Advisory Board (Invitation Only)

    14:00 – 19:00 | Registration Open
    Beat the Monday rush by picking your badge up on Sunday afternoon!

    18:30 – 21:30 | PDA Awards Dinner (Invitation Only)

    MONDAY, 03 APRIL

    07:00 – 18:30 | Registration Open

    08:30 – 09:30 | Portfolio Steering Committee Meeting (Invitation Only)

    09:00 – 11:00 | Chapter Council Meeting (Invitation Only)

    09:45 – 10:45 | Advisory Board Leaders Meeting (Invitation Only)

    11:00 – 12:00 | Interest Group Leadership Meeting (Invitation Only)

    13:00 – 15:00 | P1: EveryLife Foundation for Rare Diseases: The Foundation and Patient Perspective
    Moderator:
    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    The EveryLife Foundation is a nonprofit, nonpartisan organization dedicated to empowering the rare disease (RD) patient community to advocate for impactful, science-driven legislation and policy that advances the equitable development of and access to life saving diagnoses, treatments, and cures.

    In this inspiring opening plenary, EveryLife Foundation’s Executive Director, Julia Jenkins, will share key takeaways from a 2019 study which looks at the economic impact of RD in the U.S. Kelly Baker, a member of the Young Adult Rare Representatives (YARR) group, will also share her perspective as a patient living with a rare disease. She will deliver a history of home parenteral nutrition and how it has changed significantly in an effort to improve both safety and patient quality of life.

    13:00 | Welcome from PDA Leadership and Meeting Co-Chairs
    Susan J. Schniepp, Chair, PDA Board of Directors and Distinguished Fellow, Regulatory Compliance Associates Inc.
    Glenn E. Wright, MA, President and CEO, PDA
    Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
    Kenneth Paddock, Quality Director, Sterility Assurance, Baxter

    13:30 | Impact of Patient Voice in Public Policy 
    Julia Jenkins,
    Executive Director, EveryLife Foundation for Rare Diseases

    14:10 | The Past, Present, and Future of Home Parenteral Nutrition: A Patient's Perspective
    Kelly A. Baker,
    Young Adult Rare Representative, EveryLife Foundation for Rare Diseases

    14:30 | Q&A

    15:00 – 15:30 | Refreshment Break

    15:30 – 17:00 | P2: Digitization of Pharma: Achieving Cybersecurity in Healthcare
    Moderator: Kenneth Paddock, 
    Quality Director, Sterility Assurance, Baxter

    Cybersecurity has become increasingly visible, touching all aspects of our lives. In healthcare it involves the protection of electronic information and assets from unauthorized access, use, and disclosure. This illuminating plenary session addresses the three goals of cybersecurity: protecting the confidentiality, integrity, and availability of information. Participants will hear from subject matter experts regarding ongoing cyber risk issues that healthcare organizations are confronting, from patient security to supplier relationships to external threats affecting data integrity. They will also address security soft spots, consider the bigger picture for patient safety, and provide a cybersecurity strategy for third-party risk management to provide the level of comfort patients deserve regarding their healthcare information.

    15:30 | Accelerate Your Operational Technology Network Security Journey 
    Pamela Docherty, MChE 
    Life Sciences Industry Manager, Siemens Industry
    Chuck Tommey, MS, PE, Digital Connectivity Executive, Siemens Industry

    15:55 | Securing the Digital Future of Pharmaceuticals: A Cybersecurity Risk Management Approach 
    Vinicius Tarantino,
    Head of Digital Compliance and Protection, GxP-CC

    16:20 | Q&A

    17:00 – 19:00 | Grand Opening Celebration in Exhibit Hall

  • TUESDAY, 04 APRIL

    07:00 – 17:30 | Registration Open

    07:00 – 08:30 | Continental Breakfast

    07:15 – 08:15 | Breakfast Session 1: Metrics, Culture, and Maturity: Is this an Inflection Point?
    Moderator: Denyse D. Baker, PE, RAC, Associate Vice President, External Engagement and Advocacy, Global Quality Compliance, Eli Lilly and Company

    It has been 10 years since the first federal register (FR) notice from FDA requesting industry suggestions for quality metrics. In this session, participants will hear from industry and FDA panelists on what has been learned during this period, experiences with FDA pilot programs, and whether the additional focus on quality management maturity (QMM) could lead to a fundamental change away from a compliance mindset to an excellence framework for manufacturing quality systems.

    07:15 | Panel Discussion
    Sarah Barkow, PhD, Director External Engagement, Bristol Myers Squibb
    Niraj Mehta, PhD, Executive Director, Global Quality Transformation, Merck & Co., Inc
    Steven R. Mendivil, Past Chair of PDA’s Quality Metrics & Quality Culture Task Force
    Alex M. Viehmann, Division Director, OPQ, CDER, U.S. FDA

    07:15 – 08:15 | Breakfast Panel Discussion: Disruptors IG — The Path to Improvement
    Moderator:Hal Baseman, MBA, Chief Operating Officer, ValSource, Inc.

    Our industry could use more “disruptors” – people, discussions, and ideas that challenge the status quo, that ask those important “why and why not” questions. This breakfast session will be devoted to the “Disruptor Interest Group” so to speak. It will be a forum to discuss what attendees feel need to change in our industry and ideas for doing so, regardless of what, or how long, it would take to get there. Discussion points may vary from things such as improvements to aseptic processing, regulatory requirements, and post-approval changes (PAC) to technology and defining the ultimate desired state for sterile product manufacturing. There will be a brief presentation to prime the discussion and then an open forum to hear your views and ideas. PDA SAB leadership will be there to listen, suggest, and help direct those ideas to respective PDA teams, interest groups (IGs), and task forces. If this sounds like a departure or disruption from the norm, then we are well on our way. Interested? Join us!

    07:15 | Panel Discussion
    Hal Baseman, MBA, Chief Operating Officer, ValSource, Inc.
    Gabriele Gori, PDA SAB Vice-Chair
    Maik W. Jornitz, Principal Consultant, BioProcess Resources LLC

    08:30 – 10:00 | P3: Emerging Technologies: What the Future Holds for ATMPs
    Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON Manufacturing, Inc.

    Over the past decade, we have seen the emergence of many new and novel technologies in the biotech industry. But where do we head from here? In this plenary, participants will hear two of our industry thought leaders discuss how their companies are pushing the boundaries of what is possible and accelerating the development of new drugs while paving their own path. They will also provide a glimpse of how their companies will advance ATMPs into the future.

    08:30 | Moving Up the Central Dogma and Moore's Law in Biomanufacturing
    Hari Pujar, PhD, MBA, Operating Partner, Flagship Pioneering

    08:55 | Developing Allogeneic CAR and CAd γδ T-Cell Therapies to Fight Cancer
    Don Healey, PhD,
    Chief Technology Officer, Adicet Bio

    09:20 | Q&A

    10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall

    10:15 – 10:45 | Press Preparation Session (Invitation Only)

    10:45 – 12:15 | Concurrent Sessions

    A1: Shedding Light on Contamination Control
    Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter

    Contamination of sterile medicinal products arise from multiple factors including raw materials, cells used for production, the manufacturing environment, storage, and handling. Guidelines have been developed to address risk of contamination in dosage form manufacture of biologic products. However, advanced therapy medicinal products (ATMPs) have additional complexities, and clearance opportunities may be limited.  This session will examine contamination control and virus risk reduction strategies across the entire manufacturing process based on well-established biomanufacturing in contrast to ATMP bioprocessing. The EU GMP Annex 1, EU GMP for ATMPs and ICH Q5A revision will be discussed and an overview of new ANSI/PDA Standard for Virus Retentive Filtration will be highlighted.

    10:45 | Blind Spot: EU ATMP Regulation and the Annex 1 Revision
    Ryan Murray, MS, Senior Consultant, ValSource, Inc.

    11:05 | Virus Retentive Filtration: 2023 Update
    Kurt Brorson, PhD, Vice President, Technical, Parexel International

    11:25 | ICH Q5A Revision: Quality Control Through Viral Contamination Risk Mitigation for Monoclonal Antibodies Drugs, Gene Therapies and Beyond
    Manjula Aysola, Senior Regulatory Consultant, MilliporeSigma

    11:45 | Q&A

    B1: Evaluation of New Technologies in Quality Control
    Moderator: Lauren Specchio, Sterility Assurance Microbiologist (RA III), Baxter

    The development of a reliable contamination control strategy is essential to the production of sterile products. A facility must assess internal resources that can help the strategy be more robust, develop new tools or implement new technologies that can improve the production process or lower risk, and take part in the creation of new standards that can be applied in a manufacturing environment. In this session industry experts will provide insight on contamination control and development of a clean in place consensus standard.

    10:45 | Evaluation of Contamination Control Strategies in Novo Nordisk
    Peter Bisp, MA, QA Specialist, Novo Nordisk A/S

    11:05 | New Technologies Meeting the Focus on Contamination Control Strategies
    Maik W. Jornitz, Principal Consultant, BioProcess Resources LLC

    11:25 | Clean by Design: Draft ASTM E55 Standard for the Specification, Design, Manufacture, and Test of (Bio-)Pharmaceutical Manufacturing Systems That are Easy to Clean in Place
    Richard K. Hall Hall, Business Development, Rattiinox S.r.l.

    11:45 | Q&A

    C1: Digitizing Data and Effective Management Strategies
    Moderator: Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems

    The biopharmaceutical industry has evolved from scraping bark off of willow trees to hacking mRNA to manufacture proteins, and now it is time for data management to catch up! Industry recognizes the urgent need to become more agile and one way to do that is to link disconnected databases in a centralized and standardized way to enable systematic review of the data. In this session, the presenters will explore how to proactively identify the risks in using publicly available data to ensure continuous quality improvement, using eData to streamline the transfer of Quality information from suppliers to manufacturers, and automating real-time data to ensure a total, risk-based contamination control strategy.

    10:45 | Use of Internal and Open-Source Quality Data Indicators for Continuous Quality Improvement and Risk Mitigation Strategies
    Deanna Anderson, Senior Director, Lachman Consultants
    Carrie Colella, Senior Director, Lachman Consultants

    11:05 | Increasing Agility through Digitalization: A Case Study of E-Data Transfer for Quality and Regulatory Information in Supplier-Customer Relationships
    Marius Stoffels, PhD, Product Manager, Digital Solutions, Merck KGaA

    11:25 | True Digital Transformation of a Risk-Based Contamination Control Program Based on Annex 1
    Sheba S. Zaman, Head of Product Specialists and Training Services, Novatek

    11:45 | Q&A
    D1: Working with The Human Factor
    Moderator: Malav Parikh, ME, Associate Director, Global Quality Compliance and Systems, Takeda

    Human factors affect all areas of our industry; from employees and internal procedures to patients utilizing products in clinical and home settings. This session will start with two case studies involving the application of Systematic Human Error Reduction via Process Analysis (SHERPA). One describes improving existing mature manufacturing procedures and the second outlines the development of novel technology start-up procedures. The next presentation will delve into instruction interpretation and execution considerations around biologic therapies that are being transitioned to patient- or caregiver-administration. Last, participants will learn about an approach that integrates patient-centric considerations at the drug development level and how data can be used to shrink the recruitment time for clinical studies.

    10:45 | Using SHERPA to Identify and Reduce Critical Risks Involving Human Factors
    Mimi Ang, MS, Senior Manager, Operational Excellence, Genentech
    Bradford A. Manion, Senior Manager, Operational Excellence, Genentech 

    11:05 | Patient-Administered Therapies: Where Secondary Packaging Plays a Primary Role
    Mark Foster, General Manager, Oliver Design

    11:25 | Integrating Patient Centricity as Part of a Drug Development Program
    Bikash K. Chatterjee, CEO, Pharmatech Associates

    11:45 | Q&A

    12:15 – 13:45 | Lunch, Tech Talks, and Poster Presentations in the Exhibit Hall

    13:45 – 15:15 | Interest Groups

    IG1: Facilities and Engineering

    • IG Leaders
      • Shelley M. Preslar, MBA, President and COO, Azzur Training Center Raleigh LLC
      • Joachim W. Regel, Account Manager, Bioprocess Systems, Merck Chemicals GmbH

    IG2: GXP Auditing and Inspections AND Quality Systems

    • GXP Auditing & Inspections IG Leaders
      • Gabriele Gori, PDA SAB Vice-Chair
      • Ghada N. Haddad, PhD, Executive Director, Global cGMP and Compliance Auditing Organization, Merck & Co., Inc.
    • Quality Systems IG Leaders
      • Eva M. Urban, MSc, Director QRM and Internal Audits, CSL Behring
      • Michele Simone, Director, Corporate Quality Compliance, Risk Management, and Continual Improvement, Bracco

    IG3: Lyophilization AND Sterile Processing/Parenteral Drug Manufacturing

    • Lyophilization IG Leader
      • Edward H. Trappler, President, Lyophilization Technology, Inc.
    • IG Volunteer
      • Vanessa Vasadi Figueroa, MA, Executive Director, Microbiology, Quality Executive Partners, Inc.

    IG4: Microbiology/Environmental Monitoring

    • IG Leaders
      • Marc Glogovsky, MS, Senior Consultant - Microbiology, ValSource, Inc.
      • Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK

    IG5: Quality Risk Management AND Technology Transfer

    • Quality Risk Management IG Leaders
      • Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
      • Malav Parikh, ME, Associate Director, Global Quality Compliance and Systems, Takeda
    • Technology Transfer IG Leader
      • Beth J. Haas, MChE, Owner/Consultant, Haas Pharma Consulting

    IG6: Supply Chain Management

    • IG Leader
      • Amelia (Amy) L. Mutere, MS, Senior Director, Quality Compliance, Exelixis

    15:15 – 16:00 | Refreshment Break and Poster Presentations in Exhibit Hall 

    16:00 – 17:30 | Concurrent Sessions

    A2: What’s New? Innovation in Industry
    Moderator: Kristin N. Valente, PhD, Executive Director, Purification of Late-Stage Vaccines & Biologics, Merck & Co., Inc.

    Some of the best innovations involve improving the way ubiquitous activities are performed. This session will discuss key considerations involved in drug product process development, including computational modeling, small-scale model implementation, and phase-appropriate strategies for accelerated process development. Next, participants will be presented with a numerical optimization algorithm that identifies the largest possible design space, thereby improving process robustness and operability. The session will conclude with an update on the 2022 BioPhorum Roadmap, including a case study on technology development for improved buffer preparation techniques.

    16:00 | Key Considerations in Biologic Drug Product Process Development
    Sonia Bedi, PhD, Associate Director, Regeneron

    16:20 | Novel Algorithm to Identify Largest Design Spaces
    Thomas Zahel, PhD, Head of Innovation, Körber Pharma

    16:40 | BioPhorum Industry Vision Roadmap 2.0 and Collaboration Case Study: NIMBL-BioPhorum Buffer Stock Blending System
    Pranav S. Vengsarkar, PhD, Manager - Process Development, Avantor

    17:00 | Q&A

    B2: Using a Scientific-Based Approach to Disrupt the Status Quo
    Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter

    Breaking away from the traditional process by doing something different, focusing on improvement, delivering additional value, and looking at the situation in a different light are key aspects to challenging the status quo. This thought-provoking session will begin with a presentation on a holistic approach to understanding the microbial bioburden risk of the manufacturing process. Next, a case study on lessons learned on designing a rapid microbiological method validation strategy will be presented. The final presentation will shed light on the evaluation of data from three disparate sources collected over an extended period (2008 to 2021) to understand whether there is an industry-wide risk to patients from drug- and device-borne endotoxins.

    16:00 | Understanding and Controlling Pre-Sterilization Bio-Burden in Terminally Sterilized Products
    Paul T. Lopolito, Technical Services Senior Manager, STERIS Corporation

    16:20 | Rapid Micro Methods: How Should we Design and Sustain the Right Validation Strategy? A Case Study Based on a Rapid Sterility Method
    Joanny Salvas, Senior Manager, Pfizer

    16:40 | A Nontrivial Analysis of Patient Safety Risk from Parenteral Drug and Medical Device Borne Endotoxin
    Edward C. Tidswell, PhD, Executive Director AQ, Merck & Co., Inc.

    17:00 | Q&A

    C2: Extracting Insights from Data, Experience, and Knowledge: Using State-of-the-Art Technology to Bring Quality Operations to the Next Level
    Moderator: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH

    Twenty-first-century digitalization allows for capturing large amounts of data. But what do we do with all the available data? We need next-generation digital tools to gain insights and actionable information. In this session, presenters will share insight on methods and approaches to tackle these challenges to better serve companies’ quality and business needs, including API mapping, graph theory, and machine learning, all while preserving data integrity.

    16:00 | Insights from Mapping API Inspection Deficiencies to the Quality Systems
    Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems

    16:20 | Visualizing Document References and Area of Interest using Graph Theory and Machine Learning
    Mike Salem, MA, Associate Director of Data Science - Quality Assurance, Gilead Sciences

    16:40 | From Data Integrity to Quality Intelligence
    Ulrich Köllisch, PhD, Associate Partner, GxP-CC

    17:00 | Q&A

    D2: Not-So-Risky Business: Anticipating, Mitigating, and Managing Supply Chain Risks 
    Moderator: Stephanie N. Lee, MBS, Operations Manager, Amgen Inc.

    In the last few years, the importance and criticality of biopharmaceutical supply chains have been highlighted due to the pandemic and related disruptions. In light of increasing supply chain complexities, companies that take preventative, risk-based actions have trended toward continuity and uninterrupted supply. In this session, the presenters will explore regulatory surveillance as a valuable tool for policy work and external trend identification to drive continuous improvement and proactive compliance; ride the digital transformation wave by delving into a novel risk-scoring system correlating data and yielding risk profiles to alleviate supply chain risks; and apply risk management principles to the procurement of materials essential to enabling patient-centric medicine in the cell and gene therapy space.

    16:00 | The Value of Proactive Regulatory Surveillance
    Sarah Barkow, PhD, Director External Engagement, Bristol Myers Squibb

    16:20 | Correlating Product and Inspection Data to Anticipate Quality Risks in Your Supply Chain
    Bob Buhlmann, Head of Quality Digital Strategy, AstraZeneca

    16:40 | Considering Raw Material Risk in ATMP Manufacturing
    Ryan Murray, MS, Senior Consultant, ValSource, Inc.

    17:00 | Q&A
  • WEDNESDAY, 05 APRIL

    07:00 – 15:30 | Registration Open

    07:00 – 08:30 | Continental Breakfast

    07:00 – 08:15 | Breakfast Session: Developing a Knowledgeable and Skilled Workforce of the Future
    Moderator: Kristin N. Valente, PhD, Executive Director, Purification of Late-Stage Vaccines & Biologics, Merck & Co., Inc.

    Succeeding in the pharmaceutical industry requires continuous upskilling of the workforce to meet the evolving technical processes and regulatory expectations. This session will highlight how three different groups are accelerating upskilling to create a more agile workforce. Participants will first be presented with a case study on how one company enhanced the technical competency of its employees by developing a computer-based training program. The next presentation will review the process of navigating the regulatory complexity of new modalities with a case study on oligonucleotide therapy. The session will conclude with a presentation from the Society for Sterility Assurance Professionals (SfSAP) and their development of open-access learning frameworks for different sterilization modalities.

    07:00 | Capabilities Development for Sterile Manufacturing
    Mauro Giusti, MSc,
    Senior Director, Site External Network, Eli Lilly and Company

    07:20 | Overcoming the Regulatory Challenges of Oligonucleotide Therapy CMC
    Janmeet Anant, PhD, Senior Regulatory Consultant, MilliporeSigma

    07:40 | Knowledge, Skills, and Experiences: Competencies for a Sterility Assurance Professional
    James Vesper, PhD, MPH, Director, Learning Solutions, ValSource, Inc.
    Arthur Dumba, Director and General Manager, Society for Sterility Assurance Professionals 

    08:00 | Q&A
    08:30 – 10:00 | ECP Session: PDA Propels - How to Jumpstart Your Career and Get the Most Out of Your PDA Membership
    Moderators: Kate Malachowski, PhD, Associate Director, MS&T, Novavax and Tita Tavares, Director, Azzur Group

    Ready to jumpstart your career or meet your next new hire? This session will share inspiring stories and advice from early career professionals (ECPs) and students who have participated in the ECP mentoring program and global pharmaceutical student (GPS) program. This session will also highlight the journey of a recent graduate as she traveled the world supporting COVID vaccine tech transfer and production at multiple manufacturing sites. Finally, the session will include an interactive Q&A panel for the audience to interact with the panel of experienced professionals, ECPs, and students.
    08:30 | Experience as an ECP in the PDA Mentoring Program

    Kelly Waldron, PhD, Business Unit Manager (Quality and Manufacturing Science) and Senior Consultant, ValSource, Inc.
    Stephanie N. Lee, MBS, Operations Manager, Amgen Inc.

    08:50 | Experience in the PDA GPS Program
    Tita Tavares, Director, Azzur Group
    Sharif Tusuubira, Doctoral Candidate, University of Kansas Department of Ecology & Evolutionary Biology
    Robin Usselman, Business Development Manager, ACIC Pharmaceutical Machinery

    09:10 | Things I had to Learn at Warp Speed in the Era of Operation Warp Speed
    Nina Rosso, Bioprocess Engineer, Novavax, Inc.

    09:35 | Q&A

    08:30 – 10:00 | Interest Groups

    IG7: Annex 1 Implementation

    • IG Leaders
      • Marcia C. Baroni, MBA, VP Enterprise GxP Compliance & Systems, Emergent BioSolutions
      • Gabriele Gori, PDA SAB Vice-Chair
      • Stephen E. Langille, PhD, Microbiology Consultant, ValSource, Inc.

    IG8: Cell and Gene Therapy/ATMP AND Quality Risk Management

    • Cell and Gene Therapy/ATMP IG Leader
      • Darius Pillsbury, Senior Consultant, ValSource, Inc.
    • Quality Risk Management IG Leaders
      • Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
      • Malav Parikh, ME, Associate Director, Global Quality Compliance and Systems, Takeda

    IG9: Data Integrity

    • IG Leaders
      • Kir F. Henrici, CEO, The Henrici Group
      • Ulrich Köllisch, Associate Partner, GxP-CC

    IG10: Filtration

    • IG Leaders
      • Maik W. Jornitz, MSEng, Principal Consultant, BioProcess Resources LLC
      • William Peterson, Associate Director of Engineering, Merck & Co., Inc.

    IG11: Process Validation

    • IG Leaders
      • Robert Dream, Managing Director, HDR Company LLC
      • Mauro Giusti, MSc, Senior Director, Site External Network, Eli Lilly and Company

    IG12: Vaccines

    • IG Leader
      • Jane L. Halpern, Executive Director, IAVI

    10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall

    10:45 – 12:15 | Concurrent Sessions

    A3: Accelerating ATMPs into the Future
    Moderator: Peter J.  Makowenskyj, MEng, Director of Design Consulting, G-CON Manufacturing, Inc.

    Novel and advanced therapies are paving the way for treating illnesses in ways that were unimaginable in the past. A large number of these modalities are new and there are still many unanswered questions regarding how to optimize manufacturing. This session will bring together subject matter experts to discuss how the industry can accelerate, optimize, and advance ATMPs into the future.

    10:45 | Accelerating Early Phase Development through Hybrid Manufacturing
    David J. Frank, II, PMP, VP Client Development, Azzur Group

    11:05 | Optimization of Aseptic Manufacturing Risk Mitigation Strategies for ATMPs
    Jeff Odum, CPIP, Practice Lead, ATMPs & Biologics, Genesis AEC
    Jason Rossi, Director, Global Engineering, Cell & Gene Therapy, Catalent

    11:25 | Advances in Gene Editing and the Influence on Novel Therapy Facility Design
    Emily Heffernan, PE, US Director New Process Technology, DPS Group

    11:45 | Q&A

    B3: Educate Like the Future Depends on It: Technology, Strategy, and Implementation
    Moderator: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    In this exciting presentation, the speakers will reflect on the criticality of educating our workforce. Dr. Smith and Mr. Scheler will focus on Johnson & Johnson's experience in using Meta-EA (Meta Error Analysis) to proactively create risk profiles for planned cell and gene therapy manufacturing processes. Ms. Ritchey will provide evidence that training should not be considered an activity of the department, but rather a strategy for building workforce competency. Mr. Ayers will demonstrate that it is imperative that personnel on the manufacturing floor understand the manufacturing processes, but also the ‘why’ behind the requirements for producing sterile medicinal products. Each speaker will offer perspectives on technology, strategy and implementation and the factors needed to shape the future of our industry workforce.

    10:45 | Human Factor Control Strategy for Cell and Gene Therapy Manufacturing: Introducing a Frame-By-Frame Risk Profiling and Mitigation Approach
    Sebastian Scheler, MSc, Managing Director and Chief Methodologist, Innerspace GmbH
    Ron Smith, PhD, Global Head, Janssen Microbiology Quality and Sterility Assurance, Johnson & Johnson

    11:05 | Designing a Training Strategy to Drive Human Error Reduction
    Londa Ritchey, MS, MBA, Quality Director, PharmaLex

    11:25 | Implementation of a New Educational Platform
    Frederic B. Ayers, Advisor - Sterility Assurance, Global Parenteral Products Network, Eli Lilly and Company

    11:45 | Q&A

    C3: Analyze This! An Integrated Approach for Optimization and Risk Assessment
    Moderator: Lauren Specchio, Sterility Assurance Microbiologist (RA III), Baxter

    In the simplest terms, a risk is defined as the effect of uncertainty on objectives. Understanding risk and how we can mitigate and incorporate data-driven decisions is key to an assessment. In this session, the first presentation will discuss analytical lifecycle management and the considerations associated with potential method revision based on method performance monitoring. The next presenter will share the process of gathering risks and data-driven evidence that integrates process mapping and analysis and history aggregation for lifecycle management. The goal of this process is to achieve a multidimensional, knowledge-based approach resulting in a comprehensive picture of the industry. The session will conclude with a presentation on understanding bias and subjectivity, its impact on risk (particularly hazard identification), and a method to reduce bias and promote creative thinking.

    10:45 | Analytical Lifecycle Management and the Criticality of Method Suitability
    Paul Mason, PhD, Senior Director, Lachman Consultants
    Luis Collazo Malave, Senior Director, Lachman Consultants

    11:05 | From Risk to Evidence on a Path Towards Knowledge: A Structured Approach
    Rui Almeida, Head MS&T, Valgenesis | 4 Tune Engineering

    11:25 | Creativity, Subjectivity, and Bias in Quality Risk Management
    Andrew O’Connor, Founding Director, ERA Sciences

    11:45 | Q&A
    D3: Supply Chain Challenges: Ultimately, It’s about the Patient 
    Moderator: Malav Parikh, ME, Associate Director, Global Quality Compliance and Systems, Takeda

    Supply chain issues present a global challenge in our industry. They impact all pharma organizations, but ultimately affect the patient. In this session, we will hear how to balance supply chain integrity/outsourcing, sustainability, and quality as an organization. We will also discuss persistent issues, including the lack of global harmonization and approval timelines and touch upon themes of risk-based approaches and digitization. To close out the session, we will take an in-depth look at PDA Technical Report No. 68: Risk-Based Approach for Prevention and Management of Drug Shortages (TR68).

    10:45 | Supply Chain Integrity, Sustainability, and Quality: How the Intersection Helps Patients
    James M. Fries, CEO, Rx-360

    11:05 | How to Accelerate the Supply of Medicines to All Populations Worldwide: A Regulatory Perspective
    Mic McGoldrick, Technical Advocacy and Policy – CMC, Merck & Co., Inc.

    11:25 | Supply Chain Shortages: True Root Causes and Practical Examples
    Stephan K. Rönninger, PhD,
    Quality External Affairs, Amgen Inc.
    Emabelle Ramnarine, PhD, Pharmaceutical and Healthcare Executive

    11:45 | Q&A

    12:15 – 13:45 | Lunch and Poster Presentations in Exhibit Hall

    13:45 – 15:15 | P4: Meeting Patients' Needs by Making Safe and Effective Medicines Available
    Moderators: Guido Kremer-van der Kamp, Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH and Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    Chronic illnesses and disease outbreaks, both endemic and pandemic, have influenced therapeutic advancements to meet the needs of patients. As innovative approaches to treatments are progressing, new challenges emerge to the efficient development and manufacturing of quality medicines to deliver to patients. A major concern is the “last mile” in providing patients with critical medicines, especially vaccines requiring cold storage. This session will feature CEPI’s efforts to solve this issue with innovative approaches to reducing the need for ultra-cold storage. Advancing treatments will also require a resilient supply chain to ensure the accessibility of safe and effective medicines. The United States Pharmacopeia will provide insight into the identification of supply chain vulnerabilities to avoid disruptions and enable the timely delivery of medicines to patients.

    13:45 | Speed, Access and Quality in Vaccine Development and Manufacturing
    June Kim, PhD,
    CMC LeadCEPI

    14:10 | Drivers of Resilience in the US Pharmaceutical Supply Chain 
    Vimala Raghavendran, MBA,
    Senior Director, Informatics Product Development, United States Pharmacopeia

    14:35 | Q&A

    15:10 | Closing Remarks from Meeting Co-Chairs
    Amanda McFarland, MS,
    Senior Consultant, ValSource, Inc.
    Kenneth Paddock,
    Quality Director, Sterility Assurance, Baxter
  • The following posters will be presented during each break in the Exhibit Hall

    A Roadmap for a Successful Contamination Control Strategy Disinfectant Field Trial
    James N. Polarine, Jr., MA, Senior Technical Service Manager, STERIS Corporation

    A TaqMan-based PCR Multiplex Mycoplasma Detection Assay for Rapid Lot-Release Testing in Cell Therapeutics
    Despina Lymperopoulou, PhD,
    Senior Manager, Pharma Analytics, Thermo Fisher Scientific

    An Evaluation of Plunger Performance for Autoinjectors and Low-Temperature Uses
    Jason Mattia, 
    Components Senior Director, Product Management, West Pharmaceutical Services

    Best Possible Annex 1 Compliance of Single-Use for ATMPs
    Juergen M. Metzger, Product Specialist, Sartorius Stedim North America

    Building a Greater Understanding of Contamination Control through Failure Mode and Effects Analysis: Perspective on Wet Media Milling

    Johnna Miller, MS, Investigator, GSK
    Alicia Potuck, PhD, Principal Investigator, GSK

    Challenges of Validating a New, Difficult-to-Inspect Product on an AVI Machine with a Novice End-User
    Estefany Bentley, MSc,
    Process Engineer, Körber Pharma

    Cold Storage of Parenteral Drugs: Is It Here to Stay? - Parenteral Packaging Elastomers for Innovative DNA & RNA-based Therapies
    Katie R. Falcone, MSE, 
    Scientific Support Manager, Datwyler Pharma Packaging

    Correlation Between Bulging in Cartridge Seals and Good CCI
    Eugene T. Polini, MBA, 
    Technical Key Account Manager, Datwyler Pharma Packaging

    Determining Optimal Protocols for Residue Management on Cleanroom Surfaces Using Fluorescent Optical Analysis
    David Paul Nobile, Technical Services Group Manager, Contec, Inc.

    Disinfecting Bacterial Spores
    Dan A. Klein, MA, Senior Technical Service Manager, STERIS Corporation

    Evaluation of Acinetobacter Baumannii Biofilm Tolerance to Disinfectants by Electronic Microscopy Applied to Contamination Control Strategy in a Pharmaceutical Industry Facility
    Luciana V. Costa, PhD, 
    Health Public Technologist, Oswaldo Cruz Foundation, Bio-Manguinhos/Fiocruz

    Innovations in Artificial Intelligence Drive Inventory Management for the Production of Single Use Products and Assurance of Supply
    Pranav Vengsarkar, PhD, Manager-Development, Avantor

    Lean Lab-Testing Quality Attributes of Water for Pharmaceutical Production
    Hayden Skalski, Lead Global Product Specialist, Veolia Water and Technologies 

    Microbial Control – Developing a Proactive Strategy to Reduce Risk
    Cindy L. Duhigg, ASQ CQA, CSSBB,
    Global Validation Steward, Alcon

    Minimize Subjectivity on Risk Management Exercises and Decision-Making
    Theo Zacharatos,
    Consultant, ValSource, Inc.

    Post-Pandemic Paradigm Shift: How Will Our World Change?
    Lisa Winstead, MBA, MSc, CQA, Senior Director, Site Quality Head, Resilience Biotechnologies

    Risk Mitigation and Process Debottlenecking in Continuous Biomanufacturing with in-time Delivery/Release and E-data Integration to Enable Continuous Biomanufacturing
    Pranav Vengsarkar, PhD, Manager-Development, Avantor

    Sustainable Supply Chain Practices to Ensure Supply Chain Resilience
    Kevin Williams, MS, 
    Senior Scientist, bioMerieux

    Surveillance: Strategies to Gather Impactful Intel in a World of Abundant Information
    Johnna Miller, MBA, 
    Director of Quality, Amgen Inc.

    Visualization of Environmental Data to Identify and Mitigate Adverse EM Trends
    Amanda Curtis, 
    Microbiology Consultant, VaSource, Inc.
    James Wamsley, Consultant, ValSource, Inc.

Networking Opportunities

MONDAY, 03 APRIL

  • 15:00 – 15:30 | Refreshment Break
  • 17:00 – 19:00 | Grand Opening Celebration in Exhibit Hall

TUESDAY, 04 APRIL

  • 10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall
  • 12:15 – 13:45 | Lunch and Tech Talks in Exhibit Hall
  • 15:15 – 16:00 | Refreshment Break and Poster Presentations in Exhibit Hall
  • Open Evening | Tours now available!

WEDNESDAY, 05 APRIL

  • 10:00 – 10:45 | Refreshment Break and Poster Presentations in Exhibit Hall
  • 12:15 – 13:45 | Lunch and Poster Presentations in Exhibit Hall

Highlighted Speakers

Frederic B. Ayers
Frederic B. Ayers
ValSource, Inc.
Kurt Brorson
Kurt Brorson
Parexel International
James M. Fries
James M. Fries
Rx-360
Julia  Jenkins
Julia Jenkins
EveryLife Foundation for Rare Diseases
Maik W. Jornitz
Maik W. Jornitz
BioProcess Resources LLC
Amanda McFarland
Amanda McFarland
ValSource, Inc.
Kenneth Paddock
Kenneth Paddock
Baxter Healthcare
Hari Pujar
Hari Pujar
Flagship Pioneering
Emma Ramnarine
Emma Ramnarine
Boehringer-Ingelheim
Ed C. Tidswell
Ed C. Tidswell
Merck & Co., Inc.
Sheba S. Zaman
Sheba S. Zaman
Novatek

Additional Information

  • Who Should Attend

    Pharmaceutical/Biopharmaceutical Company Industry

    Facilities and Engineering | Manufacturing | Quality Risk Management | Regulatory Affairs

    Job Functions

    Consultant | Director | Executive and Mid-Level Management | Manager/Leader/Supervisor | Manufacturing Application | Project Management | Risk Management | Scientist | Site Head/Plant Manager | Supply Chain | Technical Services

    Departments

    Compliance | Engineering | Executive Management | Information Technology | Laboratory Science | Manufacturing | Product Development | Quality | Research and Development | Regulatory Affairs | Technical Operations | Training | Validation

Got a Question? We have answers

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hyatt Regency New Orleans

601 Loyola Avenue
New Orleans, LA

Make a Reservation
Hyatt Regency New Orleans
  • Accommodations
    The Hyatt Regency New Orleans is the headquarter hotel for the 2023 PDA Annual Meeting!

    Rate: $255 USD for single/double occupancy, plus state and local taxes
    Cut-Off Date: Friday, 03 March 2023 (after this date the discounted PDA rate is no longer guaranteed)
    Check-In: 16:00
    Check-Out: 11:00

    Reservations

    Online: Click on the reservation link above
    Phone: +1 (504) 561-1234, make sure to give the PDA Group Code, G-PDAA, to receive the discounted conference rate

    Individual Cancellation

    72 hours prior to 23:59 local time of the day of arrival to check-in to avoid one night fee. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.

  • Amenities

    Discover the culture of the Crescent City at Hyatt Regency New Orleans. Centered downtown near Champions Square, Smoothie King Center, and minutes from the historic Mississippi Riverfront. There's no better place from which to explore the eclectic vibrancy of New Orleans.

    Hyatt Regency New Orleans is conveniently located near many popular attractions. They’re only a few minutes walk from the French Quarter and the Arts District. Or hop on the city’s famous streetcars — the Loyola line stops directly outside the hotel.

How to Get Here

By Air

Louis Armstrong New Orleans International Airport (MSY) is approximately 15 miles (24km) from the hotel and all major carriers service this airport. Taxi fares from MSY are approximately $36 one way, not including tip, and will take about 20 minutes.

By Car

Hyatt Regency New Orleans is located at 601 Loyola Avenue, New Orleans, LA 70113. Valet parking is offered at the hotel and there are several nearby parking lots, including the 1301 Girod Parking Garage that connects directly to the hotel. Contact Merit Parking to confirm pricing; +1 (504) 561-0575.

Other Options

Hyatt Regency New Orleans is happy to partner with a local shuttle service to make your trip to and from the Louis Armstrong New Orleans International Airport easy. To learn more, and reserve your spot at least 24 hours prior to your flight arrival time, visit airportshuttleneworleans.com/portals/hyatt-regency-new-orleans.

Directions

Registration Fees

Early Registration
REGISTRATION TYPE BY 05 FEBRUARY
Member $1,995
Non-Member $2,395
Gov./Health Authority/Academic (Member Only) $795
Early Career Professional (Member Only) $1,295
Student (Member Only) $495
Regular Registration
REGISTRATION TYPE AFTER 05 FEBRUARY
Member $2,495
Non-Member $2,895
Gov./Health Authority/Academic (Member Only) $895
Early Career Professional (Member Only) $1,395
Student (Member Only) $595

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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