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2024 PDA Annual Meeting

Mar 25 - Mar 27, 2024
Long Beach, CA

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  • The Americas
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Overview

PDA is thrilled to present an exclusive opportunity for you to enhance your professional skills and expertise, immerse yourself in the latest technologies and practices, and broaden your perspectives at the inaugural PDA Week, taking place in Long Beach, CA.

At the core of PDA Week is the reimagined 2024 PDA Annual Meeting. It has been revamped and rejuvenated with our members in mind, offering engaging activities that are truly one-of-a-kind.

Kickstart with the PDA 211.3 Quality and Compliance Management for Virtual Companies training course which will help provide a more thorough understanding of GCP, GLP, and GMP requirements to make better outsourcing decisions. Relax later in the evening at the refreshed PDA Awards Dinner* where everyone is welcome to register as a guest and celebrate our honored volunteers.

The week unfolds with facilitated roundtable* discussions that explore hot topics like professional development and global regulatory convergence, a visit to Dendreon’s* innovative science and cellular therapy manufacturing facility , and a captivating opening plenary session showcasing transformative approaches to the development of ultra-rare genetic diseases and super-orphaned drugs, setting the tone for the much-anticipated 2024 PDA Annual Meeting.

Throughout the week, don’t miss the new dynamic session format PDA is calling “Lightning Presentations” on topics like cessation of in vivo lot release testing and pre-filled syringe considerations for VHP, new guided poster tours, and the bustling Exhibit Hall filled with opportunities to learn and connect with experts and sponsors!

PDA Week concludes on a high note with a tour of Takeda’s* award-winning facility, the newly introduced PDA CDMO Workshop, the meticulously focused PDA 293 Essentials of Contamination Control Strategy Workshop*, and the comprehensive PDA 529 Technical Report No. 54: Foundations of Quality Risk Management* training course, ensuring a strong finish.

For the ambitious planners out there, stay tuned for the full PDA Week details of exciting sessions, Southern California adventures, and inspiring presentations that will fill up an entire week!

PROGRAM PLANNING COMMITTEE:

  • Kenneth Paddock, Baxter Healthcare (co-chair)
  • Sue Schniepp, Regulatory Compliance Associates, Inc. (co-chair)
  • Lisa Bennett, SeerPharma
  • Jennifer Cheung, WuXi Advanced Therapies
  • Stephanie Lee, Amgen, Inc.
  • Peter Makowenskyj, G-CON Manufacturing, Inc.
  • Kate Malachowski, Novavax
  • Amanda McFarland, ValSource Inc.
  • Catriona Murphy, Eli Lilly and Company
  • Ryan Murray, ValSource Inc.
  • Malav Parikh, Takeda
  • Divyang Patel, AtkinsRealis
  • Michele Simone, Bracco
  • Sebastian Tietz, Biopharma Excellence by Pharmalex
* Event/activity requires a separate ticket purchase. A portion of the proceeds will be donated to the Jette Christensen Early Career Professional Grant.
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Agenda

  • Day 1
  • Day 2
  • Day 3

  • SUNDAY, 24 MARCH

    14:00 – 19:00 | Registration Open
    Beat the Monday rush and enjoy light welcome refreshments when picking up your materials on Sunday afternoon!

    18:30 – 21:30 | PDA Awards Dinner (Ticket Required - Cocktail Attire)
    New this year – PDA has opened the annual Awards Dinner to all attendees! Purchase your ticket to join in the celebration and recognition of PDA's world-class volunteers. Start your PDA Week with food, fun, and networking!

    MONDAY, 25 MARCH

    07:00 – 19:00 | Registration Open

    08:00 – 10:00 | Pre-Meeting Hot Topic Breakfast Roundtables (Ticket Required)
    You asked, and PDA listened! Kick-off your Annual Meeting experience with PDA subject matter experts in these brand-new breakfast roundtables. Participation is limited to ensure a robust and engaging discussion. The Roundtables are guaranteed to sell out, so don't miss your chance to weigh in on these important hot topics!

    Roundtable 1: Speeding Innovation Through Global Regulatory Convergence
    Moderator: Amanda McFarland, MS,     Senior Consultant, ValSource Inc.

    Industry is often asked the ever-important question, "What regulatory changes would help companies speed drug products to the patients that need them and actively prevent drug shortages?"

    As the current process requires multiple, repetitive reviews between regulatory authorities (regional or local), significant delays often slow the introduction of novel, lifesaving products and the implementation of manufacturing innovation. Is there a better way to accomplish the scientific review required for new product applications and post-approval changes?

    Roundtable 2: Training of the Future
    Moderator: Kate Malachowski, PhD,     Associate Director, MS&T, Novavax

    The world continues to change with the implementation of greater digitalization and automation, as well as a changing workforce with differing learning styles. With all these changes, what will the training of the future look like? This roundtable will explore these questions and will attempt to answer this very elusive question.

    Roundtable 3: 503B Compounding Facilities
    Moderator: Susan J. Schniepp,     Distinguished Fellow, Regulatory Compliance Associates Inc.

    It has been just over 10 years since legislation went into effect that provided the U.S. FDA more oversight responsibility for 503B compounding facilities. Much has changed within this part of the industry, from evolving business models to new guidance and evolving expectations.

    This roundtable will focus on the challenges 503B compounders are facing today. It is a chance to come together, have open discussions, and learn from one another. The roundtable will start with a 15-20 min presentation on how the industry in this area is evolving to set the stage for the roundtable discussion.

    Roundtable 4: Early and Mid-Career Professional Development
    Moderator: Divyang Patel,     Senior Specialist, Commissioning, Qualification & Validation (CQV), AtkinsRealis
    Discussion Leader: Ira Mann,     President, IQ Referrals

    Question: When should early career and mid-career professionals start thinking about their career and the steps they can take to enable and prepare for future opportunities?
    Answer:     Now, and always!

    As the saying goes, if you don't know where you're going, don't be surprised if you get lost. Careers can take different paths, some in the way you desire and some in unexpected ways. Preparing early is the best approach and, while it is never too late to act, it is best to begin preparing early in one's career.

    11:00 – 12:00 | Group Power Walk (Free for all attendees and guests!)
    Join the PDA Local Host Committee to kick off the meeting with a refreshing group walk! Embrace the opportunity to stretch your legs, connect with fellow attendees, and enjoy the crisp morning air as we explore the local surroundings. This leisurely stroll promises to invigorate both body and mind, setting the perfect tone for the exciting days ahead. Don't miss this chance to network, see the local area, and embark on a memorable journey as we start the meeting together. The walking route will be mostly flat and comfortable; walking shoes are recommended.

    13:00 – 15:00 | P1: Connecting Minds, Transforming Possibilities
    Moderator: Amanda McFarland, MS,     Senior Consultant, ValSource, Inc.

    Collaboration can bridge gaps in access to care, facilitate early diagnosis, and ensure timely access to treatments, ultimately improving the quality of life for rare disease patients. This opening plenary of the 2024 PDA Annual Meeting will illustrate partnerships are driving positive, patient-centric change in our industry.

    Participants will first hear from Rich Horgan, the Founder, President, and CEO of Cure Rare Disease. Recognized by Insider as one of the “30 Leaders Under 40 Transforming Healthcare in 2020” and, most recently, named on the 2021 Forbes “30 Under 30 List,” Mr. Horgan will share the story of his interdisciplinary collaboration vision. By creating a team of world-class researchers and clinicians, his organization has pioneered a novel framework to enable the development and financing of therapies for ultra-rare, genetic diseases.

    Next, Takeda’s Pat Gavit will provide insight into how their Los Angeles manufacturing facility, in partnership with the California Department of Public Health, produces a super-orphaned drug once every five years for infants suffering from infant botulism. Mr. Gavit will share how this transformative medicine is manufactured and the challenges Takeda faces to ensure supply continuity to patients.

    13:00 | Welcome from PDA Leadership and Meeting Co-Chairs
    Anil Sawant, PhD,     Chair, PDA Board of Directors and Senior Vice President, Global Quality Compliance, Merck & Co., Inc.
    Glenn E. Wright, MA, President and CEO, PDA
    Kenneth Paddock,     Quality Director, Sterility Assurance, Baxter Healthcare
    Susan J. Schniepp,     Distinguished Fellow, Regulatory Compliance Associates Inc. and Immediate Past Chair, PDA Board of Directors

    13:00 | The Forgotten 10%: The Silent Rare Disease Epidemic
    Rich Horgan, MBA,     Founder, President, and CEO, Cure Rare Disease

    14:10 | Overcoming Super Orphan Drug Production Challenges to Provide Life Saving Therapies to Patients
    Pat Gavit, MS,     Head of Manufacturing Sciences, Takeda

    14:30 | Q&A

    15:00 – 15:30 | Networking Break

    15:30 – 17:00 | Concurrent Sessions

    A1: The Multiverse of Manufacturing Challenges
    Moderator: Sebastian B. Teitz, Jr., PhD,     Director/Principal Consultant, Biopharma Excellence

    The production of biopharmaceuticals presents ever-evolving challenges, ranging from incremental changes to significant leaps over time. The contemporary manufacturing landscape is currently navigating challenges that necessitate simultaneous attention for the establishment of a forward-looking and sustainable manufacturing approach. In this session, the presenters will discuss the intricacies of manufacturing complex products, strategies to alleviate environmental burdens in production, and innovative solutions for formulation manufacturing.

    15:30 | Advancements and Challenges in Antibody-Drug Conjugate Manufacturing 
    Ashley Harp, PE,     Process Engineer, CRB

    15:50 | A Path Through the Sustainable Manufacturing Forest
    Ankur K. Shah, PE,     Lead Process Engineer, Arcadis DPS Group

    16:10 | Challenges and Solutions to Manufacturing of Ultra-High Concentration Antibody Formulations: Downstream Process to Fill-Finish Processing
    Vaibhav Deokar,     Principal Scientist, Lupin Limited

    16:30 | Q&A

    B1: QRM: The Evolution, Revolution, and Digital Solution
    Moderator: Stephanie Lee, MBS,     Operations Manager, Amgen Inc.

    The pharmaceutical and healthcare industries are constantly changing, adapting, and advancing: the processes, systems, regulatory aspects – and quality risk management (QRM). In this informative session, experts will delve into the development of QRM and its role in risk-based decision-making and patient-focused learning culture, the current and future state of QRM through the lens of artificial intelligence (AI) and machine learning, and a case study focusing on a new digital framework and its impact on operational and regulatory compliance through continuous improvement and proactive risk management.

    15:30 | QRM Evolution: Unleashing the Learning Culture Advantage in Line with ICH Q9 R1 Innovations
    Lorianne Richter,     Senior Director, GxP Quality Management Systems, ALX Oncology

    15:50 | Revolutionizing QRM: The Impact of AI and Machine Learning
    Ghada N. Haddad, PhD,     Executive Director, Global Quality Transformation, Merck & Co., Inc.

    16:10 | Digital Transition to a Performance-Based QRM: A Case Study
    Yowvanaraj Gopal,     Director Professional Services, ValGenesis

    16:30 | Q&A

    C1: Streamlining the Processes to Enhance Product Quality
    Moderator: Kenneth Paddock,     Quality Director, Sterility Assurance, Baxter Healthcare

    Enhancements in product quality and increased efficiency can result from the integration of alternative production processes. Experts will address platform standardization of physical appearance assessments by providing a clear decision table of method selection based on test sample type, implement processes that can impact both product residual and microbial contamination of equipment surfaces further reducing turnaround times, and discuss strategies for controlling particle contamination using ready-to-use containers.

    15:30 | Platform Methodology to Meet the Needs of the "Simply Complicated" Physical Appearance Assessment
    Ying Wan,     Senior Scientist, Merck & Co., Inc.

    15:50 | Microbial Control of Product-Contact Surfaces Through Cleaning
    Antonio F. Ortiz,     Technical Services Manager, STERIS Corporation

    16:10 | Supporting Annex 1 Particle Reduction Requirements with Ready-To-Use Containers
    Dominique Bauert,     Head of Business Development, SCHOTT Pharma

    16:30 | Q&A

    D1: The Future of Pharmaceutical Drug and Combination Products: Where are We Headed and How Can PDA Help?
    Moderator: Glenn E. Wright, MA,     President and CEO, PDA

    This session will look at how PDA has and will continue to support the future of the pharmaceutical industry, the different types of novel drug products, and how combination products will continue to evolve to serve the needs of patients. 

    15:30 | Ready or Not! The Next Wave of Novel Pharmaceutical Drug Product Innovation is Arriving

    15:50 | The Brave New Future of Combination Products: What it Means for Manufacturing and the Patients That Use Them

    16:10 | PDA's Role in Supporting Industry and Innovation

    16:30 | Q&A

    17:00 – 18:30 | Happy Hour in the Exhibit Hall

    18:30 – 21:00 | Opening Reception
    The Opening Reception is included with all Full Conference registrations. Guest tickets are available for purchase for $75.

  • TUESDAY, 26 MARCH

    06:30 – 07:00 | Group Meditation (Free for all attendees and guests!)
    Discover tranquility and start your day with a group meditation session. Amidst the hustle and bustle of the meeting, take a moment to center yourself, clear your mind, and foster inner peace. Join the PDA Local Host Committee and like-minded participants in this serene early morning gathering to awaken your senses and enhance your overall Long Beach experience. Embrace the opportunity to recharge, find balance, and set a positive intention for the day ahead. Don't miss out on this serene and empowering start to your Tuesday. Casual comfortable clothing and a towel or yoga mat are recommended.

    07:00 – 18:30 | Registration Open

    07:00 – 08:00 | Continental Breakfast

    08:00 – 09:30 | P2: AI and Machine Learning
    Moderator: Peter J. Makowenskyj,     Director of Design Consulting, G-CON

    What’s data got to do with it? As an industry, we certainly have a lot of it, but do we use it effectively and efficiently? Can we learn better from other industries? In this session, we will hear from two experts on big data and how to use and model such data to drive business success and positive patient outcomes.

    08:00 | Ravi Starzl, PhD, Adjunct Professor, Language Technologies Institute, Carnegie Mellon University

    08:25 | Sara Cook, PhD, President and Founder, IliaCook Consulting

    08:50 | Q&A

    09:30 – 10:30 | Networking Break, Poster Presentations, and Guided Poster Walk in the Exhibit Hall
    On the Guided Poster Walk, poster presenters will give a 3-5 minute "Speedy Talk" about their project or research. Once completed, the poster presenters will have an opportunity to talk with attendees throughout the rest of the break.

    10:30 – 12:00 | Concurrent Sessions

    A2: Accelerating Pharmaceutical Manufacturing
    Moderator: Ryan Murray, MS,     Senior Consultant, ValSource, Inc.

    Join this session to hear about practical implementations, challenges, and successes in the ever-evolving pharmaceutical landscape. This session will examine the power of historical data, platform-based methodologies, and cutting-edge technologies. Participants will hear a case study on transitioning from traditional to agile manufacturing spaces, utilizing off-site solutions as well as the journey of creating a modular vaccine facility.

    10:30 | Answering the Call for Flexibility: Adaptive Robotics for ATMP Drug Products
    Josh Russell,     Vice President of Sales and Marketing, AST

    10:50 | Accelerating Biopharmaceutical Development Through Data-Driven Strategies, Platforms, and Technology Enablers
    Nitin Rathore,     Associate Vice President, Amgen Inc.

    11:10 | A Collaborative Approach to Agile Manufacturing
    Peter J. Makowenskyj,     Director of Design Consulting, G-CON
    William L. Mangum, Operations Director, Regional, IPS

    11:30 | Q&A

    B2: AI/ML in Pharmaceutical Quality: Advancements and Challenges
    Moderator: Malav Parikh, ME,     Director, Global Quality Compliance Systems, Takeda

    This session will cover the latest developments in AI/ML models for improving product quality/supply chain resilience. The presenters will review recently developed guidance documents and propose practical risk-based solutions for compliant implementation of AI/ML, including the importance of data integrity in the quality system. Attendees will gain insights into the latest trends and techniques in AI/ML, associated challenges and uncertainties, and how these advancements can be applied to revolutionize our industry. 

    10:30 | Bringing Pharmaceutical Quality Auditing into the Digital Age
    Melanie McIntosh, ASQ-CQE, CQA, CSSGB,     Senior Quality Assurance Specialist, PharmEng Technology

    10:50 | How AI Can Reveal Enforcement Trends in Data Integrity
    Michael de la Torre,     CEO, Redica Systems

    11:10 | Compliant Implementation of AI/ML Models in Commercial GMP
    Ulrich Köllisch,     Partner, GxP-CC GmbH

    11:30 | Q&A

    C2: Innovations in cGMP Facility Design and Digitization
    Moderator: Kate Malachowski, PhD,     Associate Director MS&T, Novavax

    This dynamic session will explore the synergistic relationship between cutting-edge technology and intelligent plant maturity assessment for the design and digitization of cGMP facilities. Experts will address how best practices and innovative design tools like AI minimize risks, enhance operational efficiency, and reduce construction costs, all while adhering to stringent regulatory requirements. The session also introduces the BioPhorum Digital Plant Maturity Model (DPMM) 3.0, highlighting its role in assessing plant maturity, developing strategic roadmaps, and influencing the biopharmaceutical industry's digital transformation.

    10:30 | Designing cGMP Facilities with Operations in Mind
    Jason E. Smith, PE, MBA, PMP,     Director, Barry-Wehmiller Design Group

    10:50 | Leveraging AI for Optimal cGMP Manufacturing Facility Design
    Patrick Traver, AIA,     US Director Process Architecture, Arcadis DPS Group

    11:10 | The BioPhorum DPMM, Version 3.0
    James Colley,     IT Phorum Director, BioPhorum

    11:30 | Q&A

    D2: Designing the Products and Processes of Tomorrow
    Moderator: Susan J. Schniepp,     Distinguished Fellow, Regulatory Compliance Associates Inc.

    The world keeps changing! This session will look at some of the challenges facing our industry and approaches being developed to overcome the complexity of new formulations, manufacturing floor operations, and quality expectations.

    10:30 | Two Steps Forward and One Step Back: Advances in Nanoparticle Delivery Vehicle Development

    10:50 | Next Generation of Platform ATMP-Integrated Manufacturing Operations for Cell Manipulation, Modification, and Expansion

    11:10 | Ensuring the Quality of Manufacturing Processes Through the Concepts of a Strong Quality Maturity Management Program

    11:30 | Q&A

    12:00 – 13:30 | Networking Lunch, Tech Talks, and Poster Presentations in the Exhibit Hall

    13:30 – 14:15 | Concurrent Interest Groups

    IG1: Data Governance, Management, Integrity, and Digitalization
     IG Leaders:

    • Kir F. Henrici, Chief Executive Officer, The Henrici Group
    • Ulrich Köllisch, Partner, GxP-CC GmbH

    IG2: Annex 1 Implementation and Quality Risk Management
    Annex 1 IG Leaders:

    • Marcia Baroni, MBA, VP Enterprise GxP Compliance & Systems, Emergent BioSolutions
    • Rebecca Brewer, VP Strategic Practices, Quality Executive Partners, Inc.
    • Gabriele Gori, SVP Global Quality and Chief Quality Officer, Biogen
    • Stephen Langille, PhD, Senior Microbiology Consultant, ValSource, Inc.

    QRM IG Leaders:

    • Amanda McFarland, MS, Senior Consultant, ValSource, Inc.
    • Malav Parikh, ME, Director, Global Quality Compliance and Systems, Takeda

    IG3: Visual Inspection of Parenterals
    IG Leader: John G. Shabushnig, PhD,     Principal Consultant, Insight Pharma Consulting, LLC

    Lightning Presentations: Session 1
    Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter Healthcare

    Join PDA's first ever Lightning Presentations session! These exciting presentations will use the Pecha Kucha presentation method which calls for telling a story using images rather than reading text from slides during a PowerPoint presentation. The Lightning Presentations will have 20 slides set to automatically advance after only 20 seconds of commentary per slide for a total presentation time of just 6 minutes and 40 seconds.

    13:30 | Quality Management Systems: Accelerated Pathways for Development, Scale-up, and Optimization
    Mandy Gervasio, MS,     Vice President, QA & Compliance, Comanche Biopharma

    13:37 | Delivering Value Through Quality External Engagement
    Cindy Capeloto,     Head of Quality External Engagement, Takeda

    13:44 | Is It a Quality Issue or a Manufacturing Defect? Fundamentals of Operations Partnership
    Cheryl Norder,     Vice President Global Quality, Phillips-Medisize, A Molex Company

    13:51 | Cessation of In Vivo Lot Release Testing
    Stephanie P. Kurtz, MS,     Strategic Account Executive, SQA Services

    13:58 | Pre-Filled Syringe Considerations for VHP Sterilization
    Juha P. Mattila, MEng,     Director, Sterilization Technologies, STERIS Corporation

    14:05 | Q&A

    13:30 – 15:00 | Mini Training Course: PDA TR70 Fundamentals of Cleaning and Disinfection for Aseptic Manufacturing (Ticket Required)

    14:15 – 14:30 | Transition to Next IG

    14:30 – 15:15 | Concurrent Interest Groups

    IG4: Advanced Manufacturing and Applied Process Digitalization
    IG Leader: Peter J. Makowenskyj,     Director of Design Consulting, G-CON

    IG5: Packaging Science
    IG Leaders:

    • Ana Kuschel, PhD, Principal Scientific Affairs, EU, West Pharmaceutical Services Deutschland GmbH & Co. KG
    • Anthony A. Perry, Regional Quality Director, Schott AG
    • Xu Song, MS, Director Process Engineering and Packaging, AstraZeneca

    IG6: Vaccines
    IG Leaders:

    • Jane L. Halpern, PhD, Executive Director, International AIDS Vaccine Initiative
    • Sabrina Restrepo, PhD, Director, Global Vaccines Technical Operations, Merck & Co., Inc.

    IG7: Process Validation
    IG Leader: Robert F. Dream,     Principal, HDR Company, LLC

    Lightning Presentations: Session 2
    Moderator: Lisa Bennett, GMP Senior Consultant and Trainer, SeerPharma

    PDA's Lightning Presentations will use the Pecha Kucha presentation method which calls for telling a story using images rather than reading text from slides during a PowerPoint presentation. Each presentation will have 20 slides set to automatically advance after only 20 seconds of commentary per slide for a total talk time of just 6 minutes and 40 seconds.

    14:30 | Sterility Testing of Cell and Gene Therapies
    Zachary Beck,     Senior Microbiologist, Group Leader III, Eurofins Lancaster Laboratories

    14:37 | Digitizing Process Specifications to Expediate Tech Transfers
    Sergio Diaz,     Product Marketing Manager, Emerson

    14:44 | Trends Driving Container Closure Integrity Testing and Positive Controls
    Ted Teitelman,     North American Sales Manager, Oxford Lasers

    14:51 | Analysis of a Robotic Hydrogen Peroxide System for Disinfecting Clean Rooms
    Prasanna K. Sistla,     Technical Director, VM Sciences

    14:58 | Improved Identification of Pharmaceutical Ingredients and Contaminants Using Artificial Intelligence and Machine Learning
    Matthew James McGann, MSc, Director,     Products and Markets, ImageProVision

    15:05 | Q&A

    15:15 – 16:00 | Networking Break, Tech Talks, and Poster Presentations in the Exhibit Hall

    16:00 – 17:30 | Concurrent Sessions

    A3: Biopharmaceutical Evolution: Stability, Contamination Solutions, and mRNA Triumphs
    Moderator: Jennifer Cheung, MS,     Vice President, Quality and Assurance and Regulatory Affairs, WuXi Advanced Therapies

    After delving into the critical realm of combination product stability with a comprehensive two-stage approach, the first presentation will emphasize the need for additional stability data to support post-market activities and underscore the importance of regulatory approval for shelf-life modifications. Next, a case study will show one company’s comprehensive approach to interpreting and implementing the Annex 1 contamination control strategy requirements. The final presentation will uncover the analytical tools driving the quality and consistency of mRNA-based vaccines and therapeutics and share insights into the progress made in building consensus on quality attributes and test methods.

    16:00 | Ensuring Robustness in Combination Product Stability
    Luis Montes,     Product Quality Principal Lead, Amgen, Inc.

    16:20 | Case Study on the Global Implementation of a Risk-Based Contamination Control Strategy
    Elizabeth Brockson, MPH-VPH,     Aseptic Processing and Sterility Assurance Lead, Takeda

    16:40 | Analytical Tools to Support Quality and Consistency of mRNA Vaccines and Therapeutics
    Diane McCarthy, PhD,     Senior Director, Science and Standards, Global Biologics, USP

    17:00 | Q&A

    B3: Revolutionizing Manufacturing: Patient Focus, Tech Excellence, and Intensified Processes
    Moderator: Catriona Murphy, MSc,     Senior Advisor QA/Qualified Person, Eli Lilly and Company

    Embark on a comprehensive exploration of key challenges in biopharmaceutical development, spanning three pivotal areas, and the patient-centric strategies shaping the next era of pharmaceutical manufacturing. The session will present a holistic perspective on navigating the convergence of knowledge, validation, and quality management for optimal outcomes.

    16:00 | Knowledge Management Best Practices for Preserving Biologic CQA Information
    Beth Fulton, MS,     Consultant, ValSource, Inc.

    16:20 | The Integration of CSA into the CSV Projects
    Orlando Lopez,     Independent Consultant

    16:40 | Methods for Measuring the Quality Management Maturity of a Manufacturing Network
    Adam M. Caruso,     Associate Director, Strategic Programs and Regulatory Intelligence, Merck & Co., Inc.

    17:00 | Q&A

    C3: Navigating the Future of Pharma: Patient-Focused, Tech-Enabled, and Intensely Efficient
    Moderator: Michele Simone,     Director, Corporate Quality Compliance, Risk Management, and Continual Improvement, Bracco

    Join this session to learn about the coming together of patient-centric innovations, operational excellence through technology, and process intensification strategies, collectively shaping the future of pharmaceutical manufacturing. The presenters will highlight three distinct perspectives, each addressing pivotal aspects of innovation in the industry – why an integrated approach is paramount for the success of combination products; fostering a culture of continuous learning, improvement, and organizational excellence; and insights into the successful integration of process analytical technology (PAT) tools for enhanced process intensification.

    16:00 | Unlock the Potential: Integrated Development of High-Volume Drug/Device Combination Products
    Adithya Balasubramanian,     Director, ten23 Health AG

    16:20 | Embracing Innovation to Drive Operational Excellence
    Scot Lindsey,     Senior Vice President & Information Officer, M&Q, Eli Lilly and Company

    16:40 | Lifecycle Management PAT Implementation for Process Intensification
    Rui Almeida,     Director Product Life Cycle Management, ValGenesis

    17:00 | Q&A

    D3: The Case for Disruption: Challenging the Status Quo to Ensure a Viable Future
    Moderator: Josh Eaton,     Senior Director, Scientific and Regulatory Affairs, PDA

    Back by popular demand! This session will be an opportunity to discuss what needs to change in our industry and ideas for doing so, regardless of what, or how long, it would take to get there. The floor is open to topics including improvements to aseptic processing, updating regulatory requirements, and navigating post-approval changes (PAC) to next-generation technologies, and defining the ultimate desired state for sterile product manufacturing. A brief presentation will set the stage for an open forum to hear your views and ideas.

    16:00 | Panel Discussion

    16:00 – 17:30 | Mini Training Course: PDA TR13 Fundamentals of an Environmental Monitoring Program (Ticket Required)

    18:00 – 21:00 | Evening Tours (Ticket Required)

    19:00 – 22:00 | Documentary: Of Medicine and Miracles (Ticket Required)
    Moderator: Kenneth Paddock,     Quality Director, Sterility Assurance, Baxter Healthcare

    Join PDA in their first-ever "documentary deep dive" session! A special guest from the documentary team will be there in person to introduce the film and facilitate the post-screening discussion. Tickets include the film, discussion, and light refreshments.

    At the age of six, Emily Whitehead was diagnosed with leukemia and the lives of her and her parents were suddenly thrust into uncertainty. Through bracingly honest interviews and home videos, Of Medicine and Miracles details her family's experience bouncing from hospital to hospital, trying to stay hopeful amidst hopelessness, and their fateful correspondence with a doctor whose research could hold the key to her survival. But time is of the essence.

    A stunning feat of non-fiction filmmaking, Of Medicine and Miracles applies an acutely personal perspective to a highly publicized case, allowing Emily's parents to speak candidly about the American healthcare system, experimental cancer treatments, and their overwhelming love for their daughter. Academy Award winner Ross Kauffman's new documentary is a tear-jerking, heart-racing record of medical history that honors its subjects and their trauma while empowering future generations to attempt the impossible. – Cara Cusumano

  • WEDNESDAY, 27 MARCH

    07:00 – 08:00 | Group Yoga (Free for all attendees and guests!)
    Energize, rejuvenate, and embrace the day with a refreshing yoga session in the company of the PDA Local Host Committee and your fellow attendees. Whether you're a seasoned yogi or a beginner, this class offers a perfect opportunity to enhance your physical and mental well-being. Start your day with balance and positivity, ensuring you make the most of the conference ahead. Join us for this invigorating yoga experience, and greet Wednesday with a fresh, focused mindset. Casual comfortable clothing and a towel or yoga mat are recommended.

    07:00 – 16:00 | Registration Open

    08:00 – 09:00 | Continental Breakfast

    08:30 – 10:30 | Mini Training Course: Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators (Ticket Required)

    09:00 – 10:30 | Concurrent Sessions

    A4: What's in Your Toolbox? Analytical Tools, Strategies, and Manufacturing Facility Design Data for ATMP Development
    Moderator: Stephanie N. Lee, MBS,     Operations Manager, Amgen Inc.

    The field of gene therapy is rapidly developing and expanding, with many new and innovative therapies to treat disease. Experts in this session will share insights into techniques for manufacturing, testing, and qualification of adeno-associated virus (AAV) products. Additionally, best practices and strategies for navigating ATMP regulatory submissions, the importance of interpreting and applying multimodal CMC data, and its analyses for the advancement of ATMP-related manufacturing will be presented.

    09:00 | Analytical Tools to Support the Production and Characterization of AAV Therapeutics
    Anthony Blaszczyk, PhD,     Senior Scientist, USP

    09:20 | Developing an ATMP Regulatory Submission Strategy: Concepts That Work
    Janmeet S. Anant,     Senior Regulatory Consultant, MilliporeSigma

    09:40 | What New Therapeutic Modality CMC Challenges Tell us About Facility Design
    Paul Fleming,     Project Manager, Genesis AEC

    10:00 | Q&A

    B4: Navigating AI, Data Integrity, and Regulatory Challenges
    Moderator: Ryan Murray, MS,     Senior Consultant, ValSource, Inc.

    This transformative session will explore the evolving landscape of AI and the pressing need for regulation as data integrity challenges loom. Experts will look at the pitfalls of overregulation stifling innovation with a call for a genuine and fast dialogue to drive breakthrough changes in innovation, quality management systems (QMS), and inspections. The biologics and gene therapy sectors as well the critical role of contract manufacturing organizations (CMOs) will also be discussed.

    09:00 | AI, DI, and Overregulation: Impact on QMS
    Karen Taylor, MSc,     Owner, PCI Pharmaceutical Consulting Israel Ltd

    09:20 | Assessing the Quality Management Maturity of an ATMP CMO
    Londa Ritchey, MS, MBA,     Quality Director, PharmaLex

    09:40 | Ensuring Patient Access to Medicines Through RAPID Root Cause Analysis
    Paul Hanson, PhD,     Vice President, Head of Lifecycle Management, Innovation, and Strategy, Takeda

    10:00 | Q&A

    C4: Automation, Innovation, and Robotics for Annex 1 and CCS Compliance
    Moderator: Divyang Patel,     Senior Specialist, Commissioning, Qualification & Validation (CQV), Atkins Realis

    This spirited session will explore how advances in robotics and automation can support compliance with Annex 1 and CCS. Experts will discuss innovations in aseptic environments, including filling processes, equipment, and isolator work cells. Participants will also be able to engage in discussions regarding the potential transition from injectable pharmaceuticals to microneedle array patch (MAP) technologies.

    09:00 | Embracing Innovation to Meet the Requirements of Annex 1
    Brent Lieffers,     General Manager, Aseptic Filling, Cytiva

    09:20 | Robotics and Automation: Enabling Higher Quality and Annex 1 CCS Compliance
    Julian Petersen,     Head of Business Development, groninger & co. gmbh

    09:40 | The End of an Era: Injectable Pharmaceuticals as a Relic of the Past
    Jessica Chiaruttini, PhD,     Microbiology Consultant, ValSource, Inc.

    10:00 | Q&A

    D4: What is PDA Working On?
    Moderator: Josh Eaton, MS,     Senior Director, Scientific and Regulatory Affairs, PDA

    We have the answers, and it is exciting! Join us for an inside look at PDA activities and initiatives with our Technical Advisory Boards (ABs), Interest Group (IGs) Leaders, the PDA Training and Education Team, and PDA's Chapter Presidents.

    09:00 | PDA AB Overview and Updates: What are They, How Do They Work, and On What are They Focused?

    09:20 | PDA IG Overview and Updates: What They Are, What Makes a Successful IG Meeting, and How You Can Get Involved

    09:30 | PDA Training and Education Overview: What PDA is Doing in This Space, Future Plans, and How You Can Get Involved

    09:50 | PDA Chapters Overview: The Who, What, Why, and How to Get Involved in One of the 24 Chapters

    10:00 | Q&A

    10:30 – 11:30 | Networking Break, Tech Talks, and Poster Presentations in the Exhibit Hall

    11:30 – 12:15 | Concurrent Interest Groups

    IG8: Microbiology/Environmental Monitoring
    IG Leaders:

    • Kurt Jaecques, MA, Global Aseptic Technologies Lead Monitoring & Control, GSK Vaccines
    • Kim R. Sobien, Senior Consultant, ValSource, Inc.

    IG9: Annex 1 Implementation and Sterile Processing/Parenteral Drug Manufacturing

    • Annex 1 IG Leader: Marcia Baroni, MBA, VP Enterprise GxP Compliance & Systems, Emergent BioSolutions
    • Sterile Processing IG Leader: Julian Petersen, Director of Business Development and Product Management, groninger & co. gmbh

    IG10: Management of Outsourced Operations
    IG Leaders:

    • Maria Amaya, PhD, Lead External Advocacy North America (Quality Policy), Genentech
    • Morten Munk, Director - Global Alliance Management, Fujifilm Diosynth Biotechnologies

    IG11: Quality Systems
    IG Leaders:

    • Ghada N. Haddad, PhD, Executive Director, Global Quality Transformation, Merck & Co., Inc.
    • Michele Simone, Director, Corporate Quality Compliance, Risk Management, and Continual Improvement, Bracco
    • Eva M. Urban, MSc, Head Internal Audit & Compliance, CSL Behring

    IG12: Facilities and Engineering
    IG Leaders:

    • Shelley Preslar, MBA, PMP, President & COO, Azzur Training Center
    • Joachim Regel, Account Manager Biotech Account, Merck Chemicals GmbH

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

    13:45 – 15:30 | P3: A Legacy-Driven Mindset: Our Responsibility for Sustainability
    Moderator: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter Healthcare

    In the bio/pharmaceutical sector, achieving sustainability and lowering environmental impact can present a difficult challenge when balancing corporate and environmental interests. According to The Underswell’s Founder and Lead Instructor, Derek Sabori, while sustainability is a complex and urgent topic, it is also one of the biggest economic opportunities of our lifetime! This closing plenary will kick off with Mr. Sabori sharing stories of collaboration from the apparel industry on achieving confidence and competence on sustainability matters through a transformational learning system. Following these encouraging examples from outside our industry, closer-to-home sustainability case studies from SGD Pharma and Amgen will be shared. Participants will leave this closing session of the 2024 PDA Annual Meeting inspired and excited to make a positive difference in their organization’s sustainability legacy.

    13:45 | Derek A. Sabori, MBA, Senior Director, Communications at thinkPARALLAX and Founder and Lead Instructor, School of Understanding, The Underswell

    14:05 | Massine Yanat, Technical Support Service and Sustainability, North America, SGD Pharma

    14:30 | Margaret Faul, PhD, Vice President, Manufacturing and Clinical Supply, Amgen Inc.

    14:55 | Q&A

    15:25 | Closing Remarks from Meeting Co-Chairs

Highlighted Speakers

Sara Cook
Sara Cook
IliaCook Consulting
Margaret Faul
Margaret Faul
Amgen Inc.
Patrick Gavit
Patrick Gavit
Takeda
Richard Horgan
Richard Horgan
Cure Rare Disease
View All

Additional Information

  • Who Should Attend

    More information coming soon.

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.

Long Beach Convention and Entertainment Center (LBCEC)

300 E Ocean Blvd
Long Beach, CA

Westin Long Beach

333 E Ocean Blvd, Long Beach, CA 90802
+1 (562) 436-3000

Located in the thriving downtown district, steps from the Long Beach Convention & Entertainment Center, the Westin Long Beach is designed to maximize your potential. Whether you are staying for business deals or vacation, take time to explore the area, as the Queen Mary and the Catalina Express are just moments away. Return to the hotel and maintain your health at the WestinWORKOUT® Fitness Studio or take advantage of the sunny weather with a swim in the outdoor pool. The restaurant, Navy Proof Food & Spirits, delights your palate with California Coastal cuisine and craft cocktails. Business travelers appreciate our downtown event venues, including a ballroom that seats more than 1,000 attendees. At the end of the day, settle into hotel rooms and suites featuring spacious work areas, high-speed Wi-Fi, flat-screen TVs and the Westin Heavenly® Beds. Select accommodations offer calming views of the ocean for your stay in Long Beach, CA.

Rate: $249 plus applicable taxes and fees
Reservation Link: https://book.passkey.com/e/50719719
Reservation Phone: Coming Soon!
Cut-Off: Monday, 04 March 2024

Visit Marriott Bonvoy for more details on additional reward levels and program benefits.

Marriott Bonvoy

Renaissance Long Beach

111 E Ocean Blvd, Long Beach, CA 90802
+1 (562) 437-5900

Soak up California vibes at Renaissance Long Beach hotel – situated in the central downtown area, allowing you to immerse yourself in the neighborhood's artistic scene. From the eclectic design to our smiling team, the hotel near downtown Long Beach perfectly reflects the vibrant culture of our city. Satisfy your cravings at our on-site SIP Bar Lounge, which serves craft cocktails and California cuisine. Revel in the Pacific breezes from SIP's spacious outdoor patio or our rooftop pool with city views. At the end of the day, keep those California dreams going strong as you sink into plush bedding and surf the web with free Wi-Fi for Marriott Bonvoy members.

Rate: $269 plus applicable taxes and fees
Reservation Link: https://book.passkey.com/go/PDAMEETING2024
Reservation Phone: +1 (888) 236-2427
Cut-Off: Monday, 04 March 2024

How to Get Here

By Air

The three airports closest to the Long Beach Convention and Entertainment Center (LBCEC) are the Los Angeles International Airport (LAX - approx. 22 miles/35 km), the Long Beach Airport (LGB - approx. 10 miles/17 km), and the John Wayne (Orange County) Airport (SNA - approx. 32 miles/52 km).

By Car

The Long Beach Convention and Entertainment Center (LBCEC) is located at 300 E Ocean Boulevard, Long Beach, CA 90802. The LBCEC has 4,000+ parking spaces around the Center in three parking garages and one ground level parking lot. Rates vary and are in effect seven days a week.

Other Options

PDA’s recommended hotels, the Renaissance Long Beach and the Westin Long Beach, are within walking distance of the Long Beach Convention and Entertainment Center (LBCEC). Ride shares (e.g., Uber, Lyft, etc.) and bike shares are readily available around the hotels and LBCEC.

Directions

Registration Fees

Early Registration
Registration Type Early
  By 28 January
Member $2,095
Non-Member $2,495
Gov./Health Authority/Academic (Member Only) $895
Early Career Professional (Member Only) $1,395
Student (Member Only) $595
Regular Registration
Registration Type Regular
  After 28 January
Member $2,595
Non-Member $2,995
Gov./Health Authority/Academic (Member Only) $995
Early Career Professional (Member Only) $1,495
Student (Member Only) $695

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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