PDA Week 2024

2024 PDA Annual Meeting

Long Beach, CA
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Program Highlights

The 2024 PDA Annual Meeting is taking place in sunny Long Beach, CA. It would be a shame to miss exploring the city while you are there! Make sure you take advantage of our exciting tour options. If you’ve already registered for the meeting and don’t want to miss out, contact us at [email protected] to secure your spot now!

  • Midday Harbor Boat Tour
  • Midday Whale Watching and Dolphin Tour
  • Tuesday Night Trivia
  • Evening Dinner Cruise
  • Paint and Sip Soirée

Tour Information

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.

Activities and Networking Opportunities

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 Teitz, Consultant
Featured Sponsors
Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information
Featured Exhibitors
Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Standard Pricing

Standard Member Price

$2,595

GovernmentMember Only

$995

Health AuthorityMember Only

$995

Early Career ProfessionalMember Only

$1,495

StudentMember Only

$695

AcademicMember Only

$995

Non-Member

$2,995

See Qualifying Criteria for Member Types.

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].

Sunday, 24 March PDT

* Event/activity requires a separate ticket purchase. A portion of the proceeds will be donated to the Jette Christensen Early Career Professional Grant.

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! Sponsored in part by Novo Nordisk.

Monday, 25 March PDT

  • Registration Open

    Promenade Lobby

  • *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!

    Learn more
  • *Roundtable 1: Speeding Innovation Through Global Regulatory Convergence (Ticket Required) ( Room 101A)

    101A

    • Moderator: Amanda McFarland, MS, Senior Consultant, ValSource, Inc.

    • Presenter: Glenn E. Wright, MA, President and CEO, PDA

    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?

    Learn more
  • *Roundtable 2: Training of the Future (Ticket Required) (Room 102B)

    102B

    • Moderator: Kate Malachowski, PhD, Associate Director, MS&T, Novavax

    • Presenter: David B. Talmage, MBA, Vice President, Education, PDA

    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.

    Learn more
  • *Roundtable 3: 503B Compounding Facilities (Ticket Required) (Room 101B)

    101B

    • Moderator: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    • Presenter: Mike Porter, MS, Senior Director, Education, PDA

    • Presenter: Ian F. Deveau, PhD, Division Director, OC, CDER, U.S. FDA

    • Presenter: Jill R. Hammond, MPH, Director, Training & Regulatory Science, Compounding Quality Center of Excellence, Office of Compliance OC, CDER, U.S. FDA

    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.

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  • *Roundtable 4: Early and Mid-Career Professional Development (Ticket Required) (Room 102C)

    102C

    • Moderator: Divyang Patel, Senior Specialist, Commissioning, Qualification & Validation (CQV), AtkinsRéalis

    • Presenter: Ira Mann, President and Head of Referrals, 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.

    Learn more
  • *Site Visit: Dendreon Corporate Headquarters and Immunotherapy Manufacturing Facility (Ticket Required)

    Dendreon’s Seal Beach location houses both an immunotherapy manufacturing facility (IMF) as well as the corporate and commercial headquarters. Their flagship product was the first FDA-approved immunotherapy to harness the innate benefits of personalized cellular treatment made from a patient’s own immune cells. The 180,000+ square foot (16,723+ square meter) cGMP-compliant and FDA approved IMF specializes in autologous and allogeneic cell therapies.

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  • Group Power Walk (Free for all attendees and guests!)


    • Meet Up Location: PDA Registration Desk at the Long Beach Convention Center

    • Departure: 11:00

    • Return: 12:00

    • Clothing: Comfortable shoes and a light jacket are recommended

    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.

    Learn More
  • Speaker Ready (Promenade Lobby)

    Promenade Lobby

  • P1: Connecting Minds, Transforming Possibilities (Grand Ballroom)

    Grand Ballroom

    • 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.
    • Welcome from PDA Leadership and Meeting Co-Chairs

      • Chairperson: Anil Sawant, PhD, Senior Vice President, Global Quality Compliance, Merck & Co., Inc.

      • President: Glenn E. Wright, MA, President and CEO, PDA

      • Co-Chair: Kenneth Paddock, Quality Director, Sterility Assurance, Baxter Healthcare

      • Co-Chair: Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    • The Forgotten 10%: The Silent Rare Disease Epidemic

      • Presenter: Richard Horgan, MBA, Founder, President, and CEO, Cure Rare Disease

    • Overcoming Super Orphan Drug Production Challenges to Provide Life Saving Therapies to Patients

      • Presenter: Patrick Gavit, MS, Head of Manufacturing Science, Takeda

    • Q&A

  • Networking Break

  • A1: The Multiverse of Manufacturing Challenges (Room 101)

    Room 101

    • Moderator: Sebastian B. Teitz, PhD, Consultant, Consultant

    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.
    • Advancements and Challenges in Antibody-Drug Conjugate Manufacturing

      • Presenter: Ashley Harp, PE, Process Engineer, CRB

    • A Path Through the Sustainable Manufacturing Forest

      • Presenter: Ankur K. Shah, PE, Lead Process Engineer, Arcadis DPS Group

    • Enhancing Manufacturing Processes to Match Increased Demand for Single-Use Systems

      • Presenter: Ashlan R. Ziegelmeier, MS, Technical Product Sales Specialist, Syntegon Pharma Technology

    • Q&A

  • B1: QRM: The Evolution, Revolution, and Digital Solution (Room 102)

    Room 102

    • Moderator: Stephanie N. 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 (ML), 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.
    • QRM Evolution: Unleashing the Learning Culture Advantage in Line with ICH Q9 R1 Innovations

      • Presenter: Lorianne Richter, Senior Director, GxP Quality Management Systems, ALX Oncology

    • Revolutionizing QRM: The Impact of AI and ML

      • Presenter: Ghada N. Haddad, PhD, Executive Director, Global Quality Transformation, Merck & Co., Inc.

    • Digital Transition to a Performance-Based QRM: A Case Study

      • Presenter: Yowvanaraj Gopal, Director Professional Services, ValGenesis

    • Q&A

  • C1: Streamlining the Processes to Enhance Product Quality (Room 104A)

    Room 104A

    • 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.
    • Platform Methodology to Meet the Needs of the “Simply Complicated” Physical Appearance Assessment

      • Presenter: Ying Wan, PhD, Senior Scientist, Merck & Co., Inc.

    • The Role of Cleaning and Associated Processes in Microbial Control of Product-Contact Surfaces

      • Presenter: Paul T. Lopolito, Technical Services Director, STERIS Corporation

    • Supporting Annex 1 Particle Reduction Requirements with Ready-To-Use Containers

      • Presenter: Dominique Bauert, Head of Business Development, SCHOTT Pharma

    • Q&A

  • D1: The Future of Pharmaceutical Drug and Combination Products: Where are We Headed and How Can PDA Help? (Room 104C)

    Room 104C

    • 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.
    • Ready or Not! The Next Wave of Novel Pharmaceutical Drug Product Innovation is Arriving

      • Presenter: Michael N Blackton, MBA, Founder and CEO, Blackfin Biopharm Advisors

    • The Brave New Future of Combination Products: What It Means for Manufacturing and the Patients That Use Them

      • Presenter: Maggie Bandel, MBA, PDA Combination Products Task Force Lead

    • PDA’s Role in Supporting Industry and Innovation

      • Presenter: Glenn E. Wright, MA, President and CEO, PDA

    • Q&A

  • Happy Hour in the Exhibit Hall

    Exhibit Hall A

  • Opening Reception - Sponsored in part by STERIS

    Pacific Ballroom

    The Opening Reception is included with all Full Meeting Registrations and Exhibitors. Guest tickets are available for purchase for $75. Sponsored in part by STERIS.

Tuesday, 26 March PDT

  • Group Meditation (Free for all attendees and guests!)


    • Time: 06:30

    • Meet Up Location: Pine Street Entrance to the Long Beach Convention and Entertainment Center

    • Meditation Location: Hyatt Regency Rainbow Lagoon Swan Boats

    • Clothing and Equipment: Casual comfortable clothing and a towel or yoga mat are recommended.

    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.

    Learn More
  • Continental Breakfast

    Promenade Lobby

  • Registration Open

    Promenade Lobby

  • P2: Artificial Intelligence: How to Unlock and Harness Your Unknown Potential (Grand Ballroom)

    Grand Ballroom

    • Moderator: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON

    Dive into the forefront of innovation as visionaries Dr. Sara Cook and Dr. Ravi Starzl explore the pervasive influence of Artificial Intelligence (AI) on critical aspects of the biotech and pharmaceutical industries. Participants will join these two leaders at the intersection of AI, data strategy, and computational analysis, as they unravel the immense potential of AI in CMC and its profound impact on drug discovery. Participants can expect an illuminating discussion on the impact of AI, exploring strategic applications that transcend traditional boundaries and propel the biotech and pharma industries into a new era of innovation.
    • Unleashing the Power of AI in CMC

      • Presenter: Sara Cook, PhD, President and Founder, IliaCook Consulting

    • Integrating AI for Impact in Drug Discovery: Strategic Insights, Case Studies, and Value Creation

    • Q&A

  • Networking Break in the Exhibit Hall - Sponsored in part by Enable Injections

    Exhibit Hall A

    Sponsored in part by Enable Injections.
  • Poster Presentations in the Exhibit Hall (Exhibit Hall A)

    Exhibit Hall A

    • (#02) A Model for a Risk-Based Deviation Investigation Process

      • Poster Presenter: Aaron Hubbell, Director, Life Sciences, Barry-Wehmiller Design Group

    • (#03) A New Calibration Technique for Light Obscuration Sensors to Improve Counting Accuracy of Aggregated Proteins

      • Poster Presenter: Mark Bumiller, Technology Manager, Entegris, Inc.

    • (#04) An Alternative Approach to Standard Operating Procedures

      • Poster Presenter: Max Falcone, Analyst, Tunnell Consulting

    • (#05) Applying Holistic Sterile Manufacturing Design Principles to Build an Agile Combination Product Contract Manufacturing Facility Which Anticipates the Over the Horizon Compliance Requirements

      • Poster Presenter: Chad Hafer, MEng, Senior Manager Aseptic Operations, Kindeva Drug Delivery

    • (#06) Aseptic Transfer of RTU Containers in the Light of the New Annex 1

      • Poster Presenter: Christian Thieme, Sales Director - Americas, groninger & co. gmbh

    • (#07) Behavior of Molded and Tubular Vials During Depyrogenation

      • Poster Presenter: Kevin McLean, Quality and Technical Director - Americas, SGD Pharma

    • (#08) Benefits of Single-use for ATMPs in Regards to Annex 1

      • Poster Presenter: Juergen M. Metzger, Product Specialist/Senior Consultant Final Filling, Sartorius North America Inc.

    • (#09) Breaking Out of the Human Factors Study Loop, For the Benefit of Patients

      • Poster Presenter: Amy Lukau, Senior Human Factors Lead, Kindeva Drug Delivery

    • (#10) Centralized Vaporized Phase Hydrogen Peroxide (VH2O2) as Building Utility

      • Poster Presenter: Matt Hofacre, Senior Director, Technical Services, STERIS Corporation

    • (#11) Cleaning Considerations for Lipid Nanoparticles

      • Poster Presenter: Paul T. Lopolito, Technical Services Director, STERIS Corporation

    • (#12) Data Analysis: Trending and Pattern Recognition for Contamination Control

      • Poster Presenter: Susan B. Cleary, EMBA, Director of Product Development, Novatek International

    • (#13) Design Verification Testing of Auto-Injectors: Performing All Tests on a Single Unit to Reduce Sample Quantity and Increase Testing Throughput

      • Poster Presenter: Mike Ulman, PhD, Technology Manager, Packaging and Delivery Systems, West Pharmaceutical Services, Inc.

    • (#14) Developing Primary Packaging System for Nanosuspensions: Headspace Design Space Case Study

      • Poster Presenter: Liang Fang, PhD, Associated Director, Primary Packaging, GSK

    • (#15) Developing a Method to Learn Capper Settings to Handle Component Variations

      • Poster Presenter: Carolina Gonzalez Gaitan, PhD, Parenteral Packaging Scientist, Genesis Packaging Technologies

    • (#16) Developing a Risk Score for Critical Suppliers Using Artificial Intelligence (AI)

      • Poster Presenter: Michael de la Torre, CEO, Redica Systems

    • (#17) Evaluating Your Stopper: Proving Stopper Functionality for Real-World Use Cases Through <USP 382>

      • Poster Presenter: Todd D. Jasinski, Senior Specialist, Technical Product Development, West Pharmaceutical Services, Inc.

    • (#18) Exploratory Assessment of an On-Body Delivery System for Large-Volume SC Delivery: Facilitating Rapid Thermal Equilibration to Ambient Temperatures for Immediate Utilization Post-Refrigeration

      • Poster Presenter: Omar Rahman, PharmD, MPH, Medical Director, Medical Affairs, Enable Injections

    • (#19) Fused Quartz Vials: From Glass Science to Drug Containment Solution

      • Poster Presenter: Serena Panighello, PhD, EMEA TEC Research Scientist, Stevanato Group

    • (#20) Influence of Fill Volume and Vial Choice on Total Extractables and PH Shift During Storage

      • Poster Presenter: Fanny Lefaure, MSc, Projects and Processes Manager, SGD Pharma

    • (#21) High Cell Density Cryopreservation for Upstream Process Intensification Using LN2 Vapor Phase Stored Seed Train Intermediates

      • Poster Presenter: Ushma Mehta, MS, Regulatory Consultant, MilliporeSigma

    • (#22) High Yield Sterile Filtration of High Viscosity Pharmaceutical Formulations

      • Poster Presenter: Jack E. Kochevar, Process Engineer, Lifecore Biomedical

    • (#23) Identification of Foreign Particulate Matter in Assembled Autoinjectors Through Long-Time Tracking of Individual Particles’ Trajectories

      • Poster Presenter: Matthias Kahl, Head of R&D and Lab Services, WILCO AG

    • (#24) Implementing a Disinfectant Program for Advanced Therapy Medicinal Product Manufacturing

      • Poster Presenter: Dan A. Klein, MA, Senior Manager, Technical Services, STERIS Corporation

    • (#25) In-Line Real-Time Monitoring of Perfusion CHO Cell Culture Critical Process Parameters and Critical Quality Attributes Using Raman Spectroscopy and Chemometric Modelling

      • Poster Presenter: Janmeet S. Anant, PhD, Senior Regulatory Consultant, MilliporeSigma

    • (#26) Inert Gas Bleed Valve Location and the Impact on Lyophilization Chamber Pressure

      • Poster Presenter: Jason B. Angstadt, MS, Scientist III, Lyophilization Technology Inc.

    • (#27) Isolator/RABS: Risk Minimization Through Correct Glove Management

      • Poster Presenter: Alex J. Kappani, Product Management, SKAN AG

    • (#28) Maintaining Superior Viral Vector Recovery in Cell and Gene Therapy Applications by Using Daikyo Crystal Zenith® Vials

      • Poster Presenter: Vidya Murthy, PhD, Director, Strategic Marketing, Advanced Therapies, West Pharmaceutical Services, Inc.

    • (#29) Manufacturing in Miniature: Drug Delivery via Microneedle Array Patches (MAP)

      • Poster Presenter: Andrew Riso, Director of Business Development, Kindeva Drug Delivery

    • (#30) Quality Culture: From Buzzword to What Works

      • Poster Presenter: Sean N R Lloyd, PgD, Principal Consultant, SRL Pharma Ltd

    • (#33) The Challenges of Testing Bacterial Spores in Disinfectant Coupon Studies to Meet CCS Compliance

      • Poster Presenter: James N. Polarine, Jr., Senior Technical Service Manager, STERIS Corporation

      • Poster Presenter: David Shields

    • (#34) Transforming Deviation Management for Expedited Closure and Product Release in Cell and Gene Therapy

      • Poster Presenter: Christian Spiak, Principal Consultant, Human Performance Business Area, CAI

    • (#35) Using Toxicological Risk Assessment to Minimize Cross-Contamination

      • Poster Presenter: Wendy Haines, PhD, DABT, ERT, ASQ CQA, ASQ FELLOW, Director of Toxicology & Quality Services, PharmEng Technology

    • (#36) Economic Benefits of an Original Container Closure During Combination Product Development: Expert-Modeled Scenarios Validated by Pharma

      • Poster Presenter: Mehul Desai, PharmD, MBA, Vice President, Medical Affairs, Enable Injections

    • (#37) Evaluation of New Sterilization Modalities that Enable Terminal Sterilization of Parenteral/Injectable Drug Products Traditionally Filled by Aseptic Manufacturing

      • Poster Presenter: Terrence Hollis, Senior Manager, Global Technology and Engineering, Pfizer Inc.

    • (#38) Comparing an Alternative Method to USP <71>; Validating Rapid Sterility Testing via Respiration Detection and its Testing Limitations

      • Poster Presenter: Melisa Byrd, Microbiology Supervisor, Element Materials Technology

    • (#39) Removal of Biofilm with Cleaning Agents in Pharmaceutical Processes

      • Poster Presenter: Kirsten Høstgaard-Jensen, PhD, Senior Principal Scientist, Novo Nordisk

    • (#40) NGS-Based Detection of Adventitious Virus in Cell-Based Pharmaceutical Products

      • Poster Presenter: Thomas Bovbjerg Rasmussen, PhD, Principal Scientist, Novo Nordisk

    • (#41) Advances in Filter Integrity Test Speed and Reliability

      • Poster Presenter: Christopher Carlson, Product Management, Meissner

    • (#42) The First Steps in the Journey to a Full Electronic Quality

      • Poster Presenter: Rebecca Walden, MSc FIBMS FAMLS CSci, Senior Quality Systems Specialist, Irish Blood Transfusion Service

    • (#43) Methodological Insight into Testing Long-Term Container Closure Integrity for Vial and Pre-Filled Syringe Systems: A Case Study with ETFE Film-Coated Components

      • Poster Presenter: Diaeddin Odeh, Applications Engineer, Aptar Pharma

    • (#44) Quality Culture Improvement in Governmental Biotech Manufacturer

      • Poster Presenter: Guilherme S. Mulé, Project Manager, Bio-Manguinhos / Fiocruz

    • (#45) Revolutionizing Local and Systemic Drug Delivery with Detachable Microneedle Technology

      • Poster Presenter: Naruchit Thanuthanakhun, PhD, CSO, Mineed Technology

    • (#46) Lyo and Non-Lyo Powders in Double Chamber Cartridges and Syringes

      • Poster Presenter: Marshall E. Rutter, Aseptic Applications Engineer, NJM Packaging (Representing Dara Pharmaceutical Packaging)

    • (#47) Developing HVAC Concept for New Aseptic Filling Facilities

      • Poster Presenter: Tobias Valentini, MS, Process Manager HVAC, Novo Nordisk

    • (#50) 3-D Anemometer: A Quantitative Adjunct to Smoke Studies

      • Poster Presenter: Jennifer A. Wagner, PhD, Microbiologist/Managing partner, OnSite-LLC

    • (#51) Sterile Transfer of RTU Packaging into Grade A with E-beam Technology in the Light of Annex 1

      • Poster Presenter: Sebastian Hillbrand, Strategic Product Manager, SKAN AG

    • (#53) Identify and Eliminate Sources of Visible Particles

      • Poster Presenter: Fred Pisacane, President, Foamtec International WCC

    • (#54) How the SfSAP Regulatory WG is Developing Strategies for Enhancing Industry Training to Support the Reduction of Deficiencies

      • Poster Presenter: Arthur Dumba, Director, The Society for Sterility Assurance Professionals

    • (#55) Environmental Monitoring Results in Under an Hour Using a Flow Cytometry Rapid Microbiology Method (RMM)

      • Poster Presenter: Hayden Skalski, Global Product Specialist, Veolia Water Technologies and Solutions

    • (#56) Case Study: Compatibility Testing of W.L. Gore Pre-Filled Syringe Stopper Technology with Steris VHP Low-Temperature Deep Vacuum Terminal Sterilization Process

      • Poster Presenter: Juha P Mattila, Director, Sterilization Technologies, STERIS Corporation

    • (#57) Understanding Your Process Through RFID Technology

      • Poster Presenter: Kevin J. McMurtrie, Global Business Manager, Documentation/ Transfer Systems, Veltek Associates, Inc.

    • (#58) From Academic Studies to Validate Products: Bridging the Dead Valley

      • Poster Presenter: Rui S. Ferreira, DVM, MMed, PhD, Director, Center of Translational Science - CEVAP, Sao Paulo State University, Brazil

    • (#59) How Can Technology Be Used in Training and Development?

      • Poster Presenter: Ana Silvia S.B.S Ferreira, AD, MMe, PhD, Coordinator - Associate Professor, Center for Distance Education and Health Information Technology - Botucatu Medical School, Sao Paulo State University, Brazil

    • (#60) Digital platform prototype for a PAT tool lifecycle management

      • Poster Presenter: Rui César Silva, PhD, Senior Product Lifecycle Consultant, ValGenesis

    • (#61) Unlocking Acceleration of Biosimilarity Assessments

      • Poster Presenter: Yowvanaraj Gopal, Director Professional Services, ValGenesis

    • (#62) An Early Roadmap from Discovery to Clinical Trials: Genetic Medicines

  • Speaker Ready (Promenade Lobby)

    Promenade Lobby

  • Exhibitor Tech Talks (Exhibit Hall A)

    Exhibit Hall A

    • Rapid Micro Biosystems® Growth Direct® Rapid Sterility System

      • Tech Talk Presenter: Eric K. Chenelle, Product Manager, Rapid Micro Biosystems

  • Guided Poster Walk in the Exhibit Hall (Exhibit Hall A)

    Exhibit Hall A

    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.
    • (#03) A New Calibration Technique for Light Obscuration Sensors to Improve Counting Accuracy of Aggregated Proteins

      • Poster Presenter: Mark Bumiller, Technology Manager, Entegris, Inc.

    • (#08) Benefits of Single-use for ATMPs in Regards to Annex 1

      • Poster Presenter: Juergen M. Metzger, Product Specialist/Senior Consultant Final Filling, Sartorius North America Inc.

    • (#09) Breaking Out of the Human Factors Study Loop, For the Benefit of Patients

      • Poster Presenter: Amy Lukau, Senior Human Factors Lead, Kindeva Drug Delivery

    • (#10) Centralized Vaporized Phase Hydrogen Peroxide (VH2O2) as Building Utility

      • Poster Presenter: Matt Hofacre, Senior Director, Technical Services, STERIS Corporation

    • (#11) Cleaning Considerations for Lipid Nanoparticles

      • Poster Presenter: Paul T. Lopolito, Technical Services Director, STERIS Corporation

    • (#12) Data Analysis: Trending and Pattern Recognition for Contamination Control

      • Poster Presenter: Susan B. Cleary, EMBA, Director of Product Development, Novatek International

  • A2: Accelerating Pharmaceutical Manufacturing (Room 101)

    Room 101

    • 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.
    • Answering the Call for Flexibility: Adaptive Robotics for ATMP Drug Products

      • Presenter: Josh Russell, Vice President of Sales and Marketing, AST

    • Accelerating Biopharmaceutical Development Through Data-Driven Strategies, Platforms, and Technology Enablers

      • Presenter: Nitin Rathore, PhD, Vice President, Amgen Inc.

    • A Collaborative Approach to Agile Manufacturing

      • Presenter: Peter J. Makowenskyj, MEng, Director of Design Consulting, G-CON

      • Co-Presenter: William L. Mangum, Operations Director, Regional, Integrated Project Services, LLC

    • Q&A

  • B2: AI/ML in Pharmaceutical Quality: Advancements and Challenges (Room 102)

    Room 102

    • Moderator: Malav Parikh, ME, Director, Global Quality Compliance and 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.
    • Bringing Pharmaceutical Quality Auditing into the Digital Age

      • Presenter: Melanie McIntosh, ASQ-CQE, CQA, CSSGB, Senior Quality Assurance Specialist, PharmEng Technology

    • How AI Can Reveal Enforcement Trends in Data Integrity

      • Presenter: Michael de la Torre, CEO, Redica Systems

    • Compliant Implementation of AI/ML Models in Commercial GMP

      • Presenter: Ulrich Koellisch, PhD, Partner, GxP-CC GmbH

    • Q&A

  • C2: Innovations in cGMP Facility Design and Digitization (Room 104A)

    Room 104A

    • 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 will also introduce the BioPhorum Digital Plant Maturity Model (DPMM) 3.0, highlighting its role in assessing plant maturity, developing strategic roadmaps, and influencing the industry's digital transformation.
    • Designing cGMP Facilities with Operations in Mind

      • Presenter: Jason E. Smith, PE, MBA, PMP, Director, Barry-Wehmiller Design Group

    • Leveraging AI for Optimal cGMP Manufacturing Facility Design

      • Presenter: Patrick Traver, AIA, US Director Process Architecture, Arcadis DPS Group

    • The BioPhorum DPMM, version 3.0

      • Presenter: Christopher Sandusky, Director, Automation Solutions - Product & Lifecycle Management, Cytiva

    • Q&A

  • D2: Designing the Products and Processes of Tomorrow (Room 104C)

    Room 104C

    • 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.
    • Two Steps Forward and One Step Back: Advances in Nanoparticle Delivery Vehicle Development

      • Presenter: Alexander Aust, MS, MBA, CEO, Aust Business Solutions

    • Antibody-Drug Conjugates (ADC) Manufacturing Advancements and the Role CDMOs are Playing

      • Presenter: Javier Camposano, MBA, Vice President Operations, Samsung Biologics

    • Ensuring the Quality of Manufacturing Processes Through the Concepts of a Strong Quality Maturity Management Program

      • Presenter: Denyse D. Baker, PE, RAC, Associate Vice President, External Engagement and Advocacy, Global Quality Compliance, Eli Lilly and Company

    • Q&A

  • Networking Lunch in the Exhibit Hall

    Exhibit Hall A

  • Poster Presentations in the Exhibit Hall (Exhibit Hall A)

    Exhibit Hall A

    • (#02) A Model for a Risk-Based Deviation Investigation Process

      • Poster Presenter: Aaron Hubbell, Director, Life Sciences, Barry-Wehmiller Design Group

    • (#03) A New Calibration Technique for Light Obscuration Sensors to Improve Counting Accuracy of Aggregated Proteins

      • Poster Presenter: Mark Bumiller, Technology Manager, Entegris, Inc.

    • (#04) An Alternative Approach to Standard Operating Procedures

      • Poster Presenter: Max Falcone, Analyst, Tunnell Consulting

    • (#05) Applying Holistic Sterile Manufacturing Design Principles to Build an Agile Combination Product Contract Manufacturing Facility Which Anticipates the Over the Horizon Compliance Requirements

      • Poster Presenter: Chad Hafer, MEng, Senior Manager Aseptic Operations, Kindeva Drug Delivery

    • (#06) Aseptic Transfer of RTU Containers in the Light of the New Annex 1

      • Poster Presenter: Christian Thieme, Sales Director - Americas, groninger & co. gmbh

    • (#07) Behavior of Molded and Tubular Vials During Depyrogenation

      • Poster Presenter: Kevin McLean, Quality and Technical Director - Americas, SGD Pharma

    • (#08) Benefits of Single-use for ATMPs in Regards to Annex 1

      • Poster Presenter: Juergen M. Metzger, Product Specialist/Senior Consultant Final Filling, Sartorius North America Inc.

    • (#09) Breaking Out of the Human Factors Study Loop, For the Benefit of Patients

      • Poster Presenter: Amy Lukau, Senior Human Factors Lead, Kindeva Drug Delivery

    • (#10) Centralized Vaporized Phase Hydrogen Peroxide (VH2O2) as Building Utility

      • Poster Presenter: Matt Hofacre, Senior Director, Technical Services, STERIS Corporation

    • (#11) Cleaning Considerations for Lipid Nanoparticles

      • Poster Presenter: Paul T. Lopolito, Technical Services Director, STERIS Corporation

    • (#12) Data Analysis: Trending and Pattern Recognition for Contamination Control

      • Poster Presenter: Susan B. Cleary, EMBA, Director of Product Development, Novatek International

    • (#13) Design Verification Testing of Auto-Injectors: Performing All Tests on a Single Unit to Reduce Sample Quantity and Increase Testing Throughput

      • Poster Presenter: Mike Ulman, PhD, Technology Manager, Packaging and Delivery Systems, West Pharmaceutical Services, Inc.

    • (#14) Developing Primary Packaging System for Nanosuspensions: Headspace Design Space Case Study

      • Poster Presenter: Liang Fang, PhD, Associated Director, Primary Packaging, GSK

    • (#15) Developing a Method to Learn Capper Settings to Handle Component Variations

      • Poster Presenter: Carolina Gonzalez Gaitan, PhD, Parenteral Packaging Scientist, Genesis Packaging Technologies

    • (#16) Developing a Risk Score for Critical Suppliers Using Artificial Intelligence (AI)

      • Poster Presenter: Michael de la Torre, CEO, Redica Systems

    • (#17) Evaluating Your Stopper: Proving Stopper Functionality for Real-World Use Cases Through <USP 382>

      • Poster Presenter: Todd D. Jasinski, Senior Specialist, Technical Product Development, West Pharmaceutical Services, Inc.

    • (#18) Exploratory Assessment of an On-Body Delivery System for Large-Volume SC Delivery: Facilitating Rapid Thermal Equilibration to Ambient Temperatures for Immediate Utilization Post-Refrigeration

      • Poster Presenter: Omar Rahman, PharmD, MPH, Medical Director, Medical Affairs, Enable Injections

    • (#19) Fused Quartz Vials: From Glass Science to Drug Containment Solution

      • Poster Presenter: Serena Panighello, PhD, EMEA TEC Research Scientist, Stevanato Group

    • (#20) Influence of Fill Volume and Vial Choice on Total Extractables and PH Shift During Storage

      • Poster Presenter: Fanny Lefaure, MSc, Projects and Processes Manager, SGD Pharma

    • (#21) High Cell Density Cryopreservation for Upstream Process Intensification Using LN2 Vapor Phase Stored Seed Train Intermediates

      • Poster Presenter: Ushma Mehta, MS, Regulatory Consultant, MilliporeSigma

    • (#22) High Yield Sterile Filtration of High Viscosity Pharmaceutical Formulations

      • Poster Presenter: Jack E. Kochevar, Process Engineer, Lifecore Biomedical

    • (#23) Identification of Foreign Particulate Matter in Assembled Autoinjectors Through Long-Time Tracking of Individual Particles’ Trajectories

      • Poster Presenter: Matthias Kahl, Head of R&D and Lab Services, WILCO AG

    • (#24) Implementing a Disinfectant Program for Advanced Therapy Medicinal Product Manufacturing

      • Poster Presenter: Dan A. Klein, MA, Senior Manager, Technical Services, STERIS Corporation

    • (#25) In-Line Real-Time Monitoring of Perfusion CHO Cell Culture Critical Process Parameters and Critical Quality Attributes Using Raman Spectroscopy and Chemometric Modelling

      • Poster Presenter: Janmeet S. Anant, PhD, Senior Regulatory Consultant, MilliporeSigma

    • (#26) Inert Gas Bleed Valve Location and the Impact on Lyophilization Chamber Pressure

      • Poster Presenter: Jason B. Angstadt, MS, Scientist III, Lyophilization Technology Inc.

    • (#27) Isolator/RABS: Risk Minimization Through Correct Glove Management

      • Poster Presenter: Alex J. Kappani, Product Management, SKAN AG

    • (#28) Maintaining Superior Viral Vector Recovery in Cell and Gene Therapy Applications by Using Daikyo Crystal Zenith® Vials

      • Poster Presenter: Vidya Murthy, PhD, Director, Strategic Marketing, Advanced Therapies, West Pharmaceutical Services, Inc.

    • (#29) Manufacturing in Miniature: Drug Delivery via Microneedle Array Patches (MAP)

      • Poster Presenter: Andrew Riso, Director of Business Development, Kindeva Drug Delivery

    • (#30) Quality Culture: From Buzzword to What Works

      • Poster Presenter: Sean N R Lloyd, PgD, Principal Consultant, SRL Pharma Ltd

    • (#33) The Challenges of Testing Bacterial Spores in Disinfectant Coupon Studies to Meet CCS Compliance

      • Poster Presenter: James N. Polarine, Jr., Senior Technical Service Manager, STERIS Corporation

      • Poster Presenter: David Shields

    • (#34) Transforming Deviation Management for Expedited Closure and Product Release in Cell and Gene Therapy

      • Poster Presenter: Christian Spiak, Principal Consultant, Human Performance Business Area, CAI

    • (#35) Using Toxicological Risk Assessment to Minimize Cross-Contamination

      • Poster Presenter: Wendy Haines, PhD, DABT, ERT, ASQ CQA, ASQ FELLOW, Director of Toxicology & Quality Services, PharmEng Technology

    • (#36) Economic Benefits of an Original Container Closure During Combination Product Development: Expert-Modeled Scenarios Validated by Pharma

      • Poster Presenter: Mehul Desai, PharmD, MBA, Vice President, Medical Affairs, Enable Injections

    • (#37) Evaluation of New Sterilization Modalities that Enable Terminal Sterilization of Parenteral/Injectable Drug Products Traditionally Filled by Aseptic Manufacturing

      • Poster Presenter: Terrence Hollis, Senior Manager, Global Technology and Engineering, Pfizer Inc.

    • (#38) Comparing an Alternative Method to USP <71>; Validating Rapid Sterility Testing via Respiration Detection and its Testing Limitations

      • Poster Presenter: Melisa Byrd, Microbiology Supervisor, Element Materials Technology

    • (#39) Removal of Biofilm with Cleaning Agents in Pharmaceutical Processes

      • Poster Presenter: Kirsten Høstgaard-Jensen, PhD, Senior Principal Scientist, Novo Nordisk

    • (#40) NGS-Based Detection of Adventitious Virus in Cell-Based Pharmaceutical Products

      • Poster Presenter: Thomas Bovbjerg Rasmussen, PhD, Principal Scientist, Novo Nordisk

    • (#41) Advances in Filter Integrity Test Speed and Reliability

      • Poster Presenter: Christopher Carlson, Product Management, Meissner

    • (#42) The First Steps in the Journey to a Full Electronic Quality

      • Poster Presenter: Rebecca Walden, MSc FIBMS FAMLS CSci, Senior Quality Systems Specialist, Irish Blood Transfusion Service

    • (#43) Methodological Insight into Testing Long-Term Container Closure Integrity for Vial and Pre-Filled Syringe Systems: A Case Study with ETFE Film-Coated Components

      • Poster Presenter: Diaeddin Odeh, Applications Engineer, Aptar Pharma

    • (#44) Quality Culture Improvement in Governmental Biotech Manufacturer

      • Poster Presenter: Guilherme S. Mulé, Project Manager, Bio-Manguinhos / Fiocruz

    • (#45) Revolutionizing Local and Systemic Drug Delivery with Detachable Microneedle Technology

      • Poster Presenter: Naruchit Thanuthanakhun, PhD, CSO, Mineed Technology

    • (#46) Lyo and Non-Lyo Powders in Double Chamber Cartridges and Syringes

      • Poster Presenter: Marshall E. Rutter, Aseptic Applications Engineer, NJM Packaging (Representing Dara Pharmaceutical Packaging)

    • (#47) Developing HVAC Concept for New Aseptic Filling Facilities

      • Poster Presenter: Tobias Valentini, MS, Process Manager HVAC, Novo Nordisk

    • (#50) 3-D Anemometer: A Quantitative Adjunct to Smoke Studies

      • Poster Presenter: Jennifer A. Wagner, PhD, Microbiologist/Managing partner, OnSite-LLC

    • (#51) Sterile Transfer of RTU Packaging into Grade A with E-beam Technology in the Light of Annex 1

      • Poster Presenter: Sebastian Hillbrand, Strategic Product Manager, SKAN AG

    • (#53) Identify and Eliminate Sources of Visible Particles

      • Poster Presenter: Fred Pisacane, President, Foamtec International WCC

    • (#54) How the SfSAP Regulatory WG is Developing Strategies for Enhancing Industry Training to Support the Reduction of Deficiencies

      • Poster Presenter: Arthur Dumba, Director, The Society for Sterility Assurance Professionals

    • (#55) Environmental Monitoring Results in Under an Hour Using a Flow Cytometry Rapid Microbiology Method (RMM)

      • Poster Presenter: Hayden Skalski, Global Product Specialist, Veolia Water Technologies and Solutions

    • (#56) Case Study: Compatibility Testing of W.L. Gore Pre-Filled Syringe Stopper Technology with Steris VHP Low-Temperature Deep Vacuum Terminal Sterilization Process

      • Poster Presenter: Juha P Mattila, Director, Sterilization Technologies, STERIS Corporation

    • (#57) Understanding Your Process Through RFID Technology

      • Poster Presenter: Kevin J. McMurtrie, Global Business Manager, Documentation/ Transfer Systems, Veltek Associates, Inc.

    • (#58) From Academic Studies to Validate Products: Bridging the Dead Valley

      • Poster Presenter: Rui S. Ferreira, DVM, MMed, PhD, Director, Center of Translational Science - CEVAP, Sao Paulo State University, Brazil

    • (#59) How Can Technology Be Used in Training and Development?

      • Poster Presenter: Ana Silvia S.B.S Ferreira, AD, MMe, PhD, Coordinator - Associate Professor, Center for Distance Education and Health Information Technology - Botucatu Medical School, Sao Paulo State University, Brazil

    • (#60) Digital platform prototype for a PAT tool lifecycle management

      • Poster Presenter: Rui César Silva, PhD, Senior Product Lifecycle Consultant, ValGenesis

    • (#61) Unlocking Acceleration of Biosimilarity Assessments

      • Poster Presenter: Yowvanaraj Gopal, Director Professional Services, ValGenesis

    • (#62) An Early Roadmap from Discovery to Clinical Trials: Genetic Medicines

  • Exhibitor Tech Talks (Exhibit Hall A)

    Exhibit Hall A