PDA Week 2025

PDT Daylight Time (UTC -7:00)

• 09:00 – 12:00

  PDA Chapter Council Meeting (Invite Only)

  • Chapter Representative:

    

    Betsy Anda-Harris, MS
    Site Based Compliance Manager, Johnson & Johnson

  • Chapter Representative:

    

    Virginia Andreotti-Jones
    Consultant, Quality Risk Management, ValSource, Inc.

  • Chapter Representative:

    

    Karin Baer
    VP Quality, Neuroderm

  • Chapter Representative:

    

    Monick Bassi de Paula, MBA
    QA Manager, Instituto Butantan

  • Chapter Representative:

    

    Stephen Beekman
    Inspection Readiness Site and Audit Support, Pfizer

  • Chapter Representative:

    

    Mirko Gabriele, PhD
    CEO, InfiniteVision

  • Chapter Representative:

    

    Aidan J. Harrington, PhD
    Principal Consultant, Arcadis

  • Chapter Representative:

    

    Martin S. Jenkins, PMP
    Senior Project Manager, Qualification and Validation, Circle MJ Consulting

  • Chapter Representative:

    

    Mylinh La, PhD
    Senior Laboratory Manager, CSIRO

  • Chapter Representative:

    

    Christopher Lewis
    Head of Quality, Umoja Biopharma

  • Chapter Representative:

    

    Bryan Lowery, MBA
    Vice President and General Manager mRNA and Plasmid Vaccine Production, BIOVECTRA

  • Chapter Representative:

    

    Rustom S. Mody, MMSM, MSc, PhD
    Senior Vice President and Head R&D (Biologics), Sun Pharmaceutical Industries

  • Chapter Representative:

    

    Tracy Moore
    Director, TM Pharma Group

  • Chapter Representative:

    

    Enith Morillo, MS
    Principal Consultant & Founder, Cadoret Global

  • Chapter Representative:

    

    Julian Petersen
    Head of Business Development, Groninger

  • Chapter Representative:

    

    Casey B. Poirier, MBA
    Account Manager, STERIS

  • Chapter Representative:

    

    Yashashvi Sarna
    Cell & Gene Specialist, FUJIFILM Irvine Scientific

  • Chapter Representative:

    

    Rumiko Shimazawa, PhD
    Associate Professor, Department of Clinical Pharmacology, Tokai University School of Medicine

  • Chapter Representative:

    

    Amy Stanton, MBA
    Quality Compliance Senior Manager, Amgen

  • Chapter Representative:

    

    Luis Fernando Wenzel
    Senior Manufacturing Manager, AbbVie

  • Chapter Representative:

    

    Jason L. Willett
    Midwest Manager, Veltek Associates, Inc.

  • Chapter Representative:

    

    Wayne K.H. Wu
    President, PDA Taiwan Chapter

• 11:30 – 13:00

  PDA Advisory Board and Chapter Council Joint Luncheon (Invite Only)

• 12:00 – 16:00

  PDA Science Advisory Board Meeting (Invite Only)

  • AB Chair:

    

    Gabriele Gori
    Senior Quality Advisor, Consultant

  • AB Vice-Chair:

    

    Ivy Louis, MPharm, MBA(HRM)
    Founder-Director, Vienni Training & Consulting LLP

  • AB Member:

    

    Frederic B. Ayers
    Senior Consultant - Microbiology, ValSource, Inc.

  • AB Member:

    

    Tiffany A. Baker, MBA
    Senior Consultant, ValSource, Inc.

  • AB Member:

    

    Greg Bassett, MBA
    VP Cell Therapy Global Drug Product Quality, Bristol Myers Squibb

  • AB Member:

    

    Thomas Damratoski
    Senior Vice President Biopharmaceutical Products, Civica Rx

  • AB Member:

    

    Cheryl E. Essex, MSc
    Head of Contamination Control, R&D Global Quality, Sanofi

  • AB Member:

    

    David L. Exline, MSFS
    President, Gateway Analytical

  • AB Member:

    

    Rhonda Ezell, MS
    Site Head of Quality, Alkermes

  • AB Member:

    

    Mauro Giusti, MSc
    Senior Director, Parenteral Technical Knowledge, Eli Lilly and Company

  • AB Member:

    

    Rishikesh Jaiwant, MSc
    Senior Director, Manufacturing and Operations, Baxter

  • AB Member:

    

    Beth Kirschenheiter
    Associate Director of Process Microbiology, Bristol Myers Squibb

  • AB Member:

    

    Austin Kuo, MS
    Executive Director - Sterility Assurance - Technical Services/Manufacturing Science, Eli Lilly and Company

  • AB Member:

    

    Gitte Letting, -
    Senior Principal Scientist, Novo Nordisk

  • AB Member:

    

    Bruce A. Loxley
    Regulatory Inspection Compliance Director, GSK

  • AB Member:

    

    Vincent O'Shaughnessy, MS
    Executive Director, Quality Site Head (ADL and ABR), Amgen

  • AB Member:

    

    Ken Paddock
    Director, Global Quality Sterility Assurance, Merz Aesthetics

  • AB Member:

    

    Julian Petersen
    Head of Business Development, Groninger

  • AB Member:

    

    Jim N. Polarine, MA
    Principal Consultant, STERIS

  • AB Member:

    

    Alexander Stoll, PhD
    Vice-President - Head of Competence Center Microbiology and Aseptic Technique, Fresenius Kabi

  • AB Member:

    

    Kristin N. Valente, PhD
    Executive Director, Purification of Late-Stage Vaccines & Biologics, Merck & Co., Inc.

  • AB Member:

    

    Rick J. Watson
    Director, Merck & Co., Inc.

  • AB Member:

    

    Rick J. Watson
    Director, Merck & Co., Inc.

• 13:00 – 17:00

  PDA Advanced Therapy Medicinal Products Advisory Board Meeting (Invite Only)

  • AB Chair:

    

    Maxwell De Long, MS, MechE
    Director and Senior Principal, Individualized Medicines, Genentech

  • AB Vice-Chair:

    

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

  • AB Member:

    

    Maria Amaya, PhD
    Lead External Advocacy North America (Quality Policy), Genentech

  • AB Member:

    

    Kurt A. Brorson, PhD
    Vice President Technical, PAREXEL

  • AB Member:

    

    Andrew C. Chang, PhD
    Vice President, Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Novo Nordisk

  • AB Member:

    

    Jennifer Cheung
    VP of Global Quality Assurance Operations, Gilead Sciences

  • AB Member:

    

    Jesper Davidsen, PhD
    Principal Scientist, Novo Nordisk

  • AB Member:

    

    Christopher Hwang, PhD
    Chief Technology Officer, Transcenta

  • AB Member:

    

    Guido Kremer-van der Kamp
    Senior Consultant - Global Scientific Leadership, Merck Chemicals GmbH

  • AB Member:

    

    Mahesh Krishnan, PhD
    Director - Global Vaccines and Biologics Commercialization, Merck & Co., Inc.

  • AB Member:

    

    Grace Lee, PhD, MBA, CQA
    Founder and Principal Consultant, Elevalue Consulting LLC

  • AB Member:

    

    Durga Prasad Madhavapeddi, MTech, PMP
    Sr. Engineer Validation (Strategic Projects), FUJIFILM Diosynth Biotechnologies

  • AB Member:

    

    Ingrid Markovic, PhD
    Senior Science Advisor, Office of the Center Director, ORO, CBER, U.S. FDA

  • AB Member:

    

    Tom Mayer, MBA
    Business Unit Manager, Sonceboz

  • AB Member:

    

    Morten Munk
    Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

  • AB Member:

    

    Sabrina Restrepo, PhD
    Executive Director - Quality Assurance, Merck & Co., Inc.

  • AB Member:

    

    Lalit Saxena, MTech, MBA
    Team Lead- MSAT , Samsung Biologics

  • AB Member:

    

    Janeen Skutnik-Wilkinson
    Director, Global Quality, Regulatory Intelligence and External Engagement, Moderna

  • AB Member:

    

    Sebastian B. Teitz, PhD
    Senior Development Scientist, Novo Nordisk

• 13:00 – 17:00

  PDA Regulatory Affairs and Quality Advisory Board Meeting (Invite Only)

  • AB Chair:

    

    Denyse D. Baker, PE, RAC
    AVP Global Quality Compliance, Eli Lilly and Company

  • AB Vice-Chair:

    

    Eva M. Urban, MSc
    Senior Director, Risk Management, Bristol Myers Squibb

  • AB Member:

    

    Masahiro Akimoto
    Director, Quality Assurance Department, Heartseed Inc.

  • AB Member:

    

    Lisa Bennett, MSc
    Director, LB Consulting Australia Pty Ltd

  • AB Member:

    

    Chuck Bornhoeft, MS
    Vice President of Quality Operations, Rion

  • AB Member:

    

    Vinny Browning, MS
    Executive Director Quality Assurance, Amgen

  • AB Member:

    

    Austin G. Caudle, MSc
    Vice President, Project Farma

  • AB Member:

    

    Karolyn Gale, RAQC
    VP Regulatory Affairs, Emergent BioSolutions

  • AB Member:

    

    Beth J. Haas, MChE
    Owner/Consultant, Haas Pharma Consulting

  • AB Member:

    

    Kir F. Henrici
    Chief Executive Officer, The Henrici Group

  • AB Member:

    

    Hue Kwon, PhD
    Global Head Quality External Operations, SOBI

  • AB Member:

    

    Demetra Macheras, MBA
    Director, Regulatory Policy and Intelligence, Regulatory Affairs, AbbVie

  • AB Member:

    

    Antonella Maggio, CQA
    Senior Quality and Regulatory Compliance Consultant, Consultant

  • AB Member:

    

    Toni Manzano
    Co-Founder and CSO, Aizon

  • AB Member:

    

    Amanda McFarland, MS
    Senior Consultant, ValSource, Inc.

  • AB Member:

    

    Vishal Sharma, MS
    Cofounder - Director, Vienni Training & Consulting LLP

  • AB Member:

    

    Michele Simone
    Director, Corporate Quality Compliance, Risk Management, and Continual Improvement, Bracco

  • AB Member:

    

    Kelly Waldron, PhD
    Business Unit Manager, Quality and Manufacturing Science Consulting, ValSource, Inc.

  • AB Member:

    

    Kelly Waldron, PhD
    Business Unit Manager, Quality and Manufacturing Science Consulting, ValSource, Inc.

• 14:00 – 19:00

  Registration Open

• 14:00 – 19:00

  Speaker Ready Room Open

• 18:30 – 21:30

  PDA Awards Dinner (Ticket Required – Cocktail Attire)

PDT Daylight Time (UTC -7:00)

• 06:30 – 08:00

  PDA Member Lounge Open

• 07:00 – 19:00

  Registration Open

• 08:00 – 09:30

  Roundtable 1: Speeding Innovation Through Global Regulatory Convergence (Ticket Required)

  • Moderator:

    

    Julian Petersen
    Head of Business Development, Groninger

  • Discussion Leader:

    

    Cristiana Campa, PhD
    Technical R&D Advisor, GSK

  • Discussion Leader:

    

    Stephan K. Roenninger, Dr.-Ing.
    Director Compliance, External Affairs, Amgen

  Join your peers to discover, discuss, and dissect ideas and innovations that could move global regulatory convergence forward to accelerate treatments for patients with terminal illnesses and treatments targeted for future epidemics and pandemics.
• 08:00 – 09:30

  Roundtable 2: Strategies for Modern Knowledge Management Implementation (Ticket Required)

  • Moderator:

    

    Malav Parikh, ME
    Director, Quality Risk Management, Global Quality Compliance and Systems, Takeda

  • Discussion Leader:

    

    Martin J. Lipa, PhD
    Senior Research Fellow, Technological University Dublin Pharmaceutical Regulatory Science Team

  • Discussion Leader:

    

    James L. Vesper, PhD, MPH
    Director, Learning Solutions, ValSource, Inc.

  Management of product and product knowledge plays a critical role across the product lifecycle. However, knowledge management (KM) has not been fully realized in practice. This roundtable will explore the objectives of ICH Q10 and how to best implement KM to the benefit of the industry at large beyond the regulatory expectations.
• 08:00 – 09:30

  Roundtable 3: Developing the Next Generation of Pharmaceutical Professionals (Ticket Required)

  • Moderator:

    

    Kate Malachowski, PhD
    Director, MS&T, Novavax

  • Discussion Leader:

    

    Stephanie P. Kurtz, MS
    Strategic Account Executive, SQA Services

  • Discussion Leader:

    

    Robin Usselman
    Sr. Business Development Manager, USA & Canada, PBL (Performing Beyond Limits)

  This roundtable will explore strategies for early and mid-career professionals in the biopharmaceutical industry, focusing on skill development, career advancement, mentorship, and navigating industry challenges. Participants will share insights on fostering growth, building networks, and preparing for leadership roles in a dynamic and evolving sector.
• 08:00 – 09:30

  Roundtable 4: Effective AI Deployment in Drug Manufacturing (Ticket Required)

  • Moderator:

    

    Ryan Murray, MS
    Senior Consultant, ValSource, Inc.

  • Discussion Leader:

    

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

  • Discussion Leader:

    

    Toni Manzano
    Co-Founder and CSO, Aizon

  The integration of Artificial Intelligence (AI) into drug manufacturing is in its early stages, offering both immense opportunities and unique challenges. This roundtable is designed to explore strategies and identify potential barriers such as data quality, system complexity, and workforce readiness. Discussion will also delve into the regulatory landscape and the practical burdens of adopting this transformative technology.
• 09:45 – 12:15

  Mini-Workshop 1: Driving Global Vaccine Access and Acceleration: Exploring Enablers and Overcoming Challenges (Ticket Required)

  • Workshop Leader:

    

    Cristiana Campa, PhD
    Technical R&D Advisor, GSK

  • Workshop Leader:

    

    Sabrina Restrepo, PhD
    Executive Director - Quality Assurance, Merck & Co., Inc.

  With more emphasis on enhancing worldwide access to vaccines while simultaneously accelerating their development and launch, manufacturers and regulators are focusing efforts on developing best practices and shared understanding of the opportunities and challenges. This mini-workshop will explore innovations in vaccine production and delivery strategies and attendees will grapple with hands-on case studies to discover paths for success.
• 09:45 – 12:15

  Mini-Workshop 2: CDMO Selection and Tech Transfer Fundamentals (Ticket Required)

  • Workshop Leader:

    

    Maria Amaya, PhD
    Lead External Advocacy North America (Quality Policy), Genentech

  • Workshop Leader:

    

    Maxwell De Long, MS, MechE
    Director and Senior Principal, Individualized Medicines, Genentech

  • Workshop Leader:

    

    Morten Munk
    Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

  Outsourcing a pharmaceutical project is a strategic decision that has a huge influence on the long-term success of any project. This mini-workshop will focus on the critical steps following the decision to outsource – selecting the right partner for the project and determining technology transfer (TT) requirements. A hands-on exercise on selecting a CDMO (from RFP to scoring criteria) will guide attendees in the thought processes and pathways to select the best partner for the job.
• 11:00 – 17:00

  Speaker Ready Room Open

• 13:00 – 15:00

  P1: From Manufacturing Excellence to Patient Impact: The Future of GLP-1 Therapies

  • Moderator:

    

    Vanessa Vasadi Figueroa, MA
    Chief Microbiologist, VVF Science

  This opening plenary will examine the evolving landscape of GLP-1 therapies as both a market and technology disruption, combining insights into innovative manufacturing advancements alongside the important patient perspective. The presenters will explore how disruptive technologies are transforming the production of GLP-1 products, ensuring greater efficiency and quality, while also addressing the real-world impact of these therapies on patients’ everyday lives. The discussion will highlight opportunities to improve outcomes through collaboration between manufacturers, healthcare professionals, patients, and their providers.

  • 13:00 – 13:25

    Welcome from PDA Leadership and PDA Week Co-Chairs

    • Chairperson:

      

      Anil A. Sawant, PhD
      Senior Vice President, Global Quality Compliance, Merck & Co., Inc.

    • President:

      

      Glenn E. Wright, MA
      President and CEO, PDA

    • Co-Chair:

      

      Kate Malachowski, PhD
      Director, MS&T, Novavax

    • Co-Chair:

      

      Susan J. Schniepp
      Distinguished Fellow, Regulatory Compliance Associates Inc.

  • 13:25 – 13:50

    The Future of GMP Manufacturing: Disruptive Technologies in Peptide Synthesis and Continuous Processing

    • Presenter:

      

      Lorraine O'Shea, MS
      Small Molecule and Peptide Plant Manager, Eli Lilly and Company

  • 13:50 – 14:15

    The Evolution of GLP-1 Therapies: Empowering Patients and Transforming Diabetes and Obesity Management

    • Presenter:

      

      Lucia M. Novak, MSN, ANP-BC, BC-ADM
      President, Diabesity, LLC

  • 14:15 – 14:40

    Pharma Perspective on Manufacturing Excellence and Patient Impact

    • Presenter:

      

      Melissa S. Seymour, MBA
      EVP and Chief Quality Officer, Eli Lilly and Company

  • 14:40 – 15:00

    Q&A
• 15:00 – 15:30

  Networking Break

• 15:30 – 17:00

  A1: Disruptive Therapies

  • Moderator:

    

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

  This session will explore cutting-edge developments and new modalities in the ATMP or biopharmaceutical space. Experts will share insights into these emerging technologies, highlighting challenges, risks, opportunities, and best practices for bringing next-generation therapies to market.

  • 15:30 – 15:50

    Overview of Drug Modalities

    • Presenter:

      

      Wendy Haines, PhD
      Director of Toxicology & Quality Services, PharmEng Technology

  • 15:50 – 16:10

    It’s Just Dilute Liquid (Or Is It?): Why Understanding the Risks Matters in Antibody-Drug Conjugate Processes

    • Presenter:

      

      Ashley Harp, PE
      Process Engineer, CRB

  • 16:10 – 16:30

    Microbial Marvels: Live Biotherapeutic Products Leading the Charge Against Gut Diseases

    • Presenter:

      

      Ankur K. Shah, PE
      Lead Process Engineer, Arcadis

  • 16:30 – 17:00

    Q&A
• 15:30 – 17:00

  B1: Innovative Pharmaceutical Manufacturing Solutions

  • Moderator:

    

    Julian Petersen
    Head of Business Development, Groninger

  This session will focus on innovative approaches addressing modern pharmaceutical manufacturing challenges. Discussions will cover the justification and execution of simulated leachables testing when drug products are unavailable, the development of sustainable modular platforms for small batch production, and strategies for designing automation to meet stringent regulatory and quality standards. Through case studies and actionable guidance, attendees will learn how to align manufacturing innovations with compliance and quality objectives.

  • 15:30 – 15:50

    How to Handle Leachable Testing When a Drug Product is Not Available or Analytically Feasible: Guidance for Performing Simulated Leachables

    • Presenter:

      

      Sam Albeke
      Chromatography Manager, Element Materials Technology

  • 15:50 – 16:10

    Transforming Small Batch Drug Product Production with Modular Solutions: Flexibility and Sustainability in Pharma Manufacturing

    • Presenter:

      

      Erik Anderson
      Principal Engineer, Novavax

  • 16:10 – 16:30

    Specifying, Designing, and Developing Automation for Novel Products and Aseptic Processes

    • Presenter:

      

      David Phasey
      Projects Director, 3P innovation

  • 16:30 – 17:00

    Q&A
• 15:30 – 17:00

  C1: Enhancing Quality Maturity

  • Moderator:

    

    Ken Paddock
    Director, Global Quality Sterility Assurance, Merz Aesthetics

  This session will explore strategies and tools to elevate quality maturity in pharmaceutical manufacturing. Topics will include selecting impactful key performance indicators (KPIs) to drive positive organizational outcomes, leveraging collaborative technologies to enhance root cause analysis effectiveness, and using innovative inspection intelligence tools to prepare for regulatory inspections of sterile products. Through case studies and expert insights, attendees will gain practical approaches to integrating quality principles with manufacturing excellence.

  • 15:30 – 15:50

    Metrics Simplified! Avoiding the KPI Doldrums

    • Presenter:

      

      Ivailo Neov
      Director, Internal Manufacturing, Novavax

  • 15:50 – 16:10

    Improving Effectiveness of Root Cause Analysis Through Collaborative Technologies

    • Presenter:

      

      Jeff Lewis
      Director Global Manufacturing Sciences, Head of RAPID, Takeda

  • 16:10 – 16:30

    A Roadmap with Innovative Tools for Quality Leaders to Successfully Navigate Inspections for Sterile Products

    • Presenter:

      

      Raj Gulati, MPharm, MBA, MS
      Founder & CEO, Regunalys

  • 16:30 – 17:00

    Q&A
• 15:30 – 17:00

  D1: Ready, Set, Prep: Practical Tools for Audits and QRM/CMC Strategies in Contamination Control

  • Moderator:

    

    Stephanie N. Lee, MBS, PMP
    Strategic Planning & Operations Manager, Amgen

  This session will explore effective preparation strategies for GxP audits and inspections, including mock inspections and past audit reviews, while gaining insight into integrated CMC strategy and quality risk management (QRM) for contamination control. Participants will hear practical insights for getting audit-ready and learn new models for effective risk-based approaches, ensuring robust compliance and patient safety.

  • 15:30 – 15:50

    GXP Auditing and Inspections Preparation and Understanding

    • Presenter:

      

      Neal Siegel, PhD
      Consultant, The FDA Group

  • 15:50 – 16:10

    From Compliance to Confidence: Redefining Risk Management in Contamination Control

    • Presenter:

      

      Patrick Mains
      Senior Consultant, ValSource, Inc.

  • 16:10 – 16:30

    Integrated CMC Strategy: Ensuring Patient Safety Through Contamination Control

    • Presenter:

      

      Grace Lee, PhD, MBA, CQA
      Founder and Principal Consultant, Elevalue Consulting LLC

  • 16:30 – 17:00

    Q&A
• 17:00 – 18:30

  Happy Hour in the Exhibit Hall

• 18:30 – 21:00

  Opening Reception

  The Opening Reception is included for all full meeting registrants and exhibitors. Guest tickets are available for purchase for $75.

PDT Daylight Time (UTC -7:00)

• 06:30 – 07:30

  PDA Member Lounge Open

• 07:00 – 08:00

  Continental Breakfast

• 07:00 – 18:30

  Registration Open

• 07:30 – 16:30

  Speaker Ready Room Open

• 08:00 – 09:30

  P2: Sustainability at Scale: Transforming Facilities and Mindsets in Pharma

  • Moderator:

    

    Sebastian B. Teitz, PhD
    Senior Development Scientist, Novo Nordisk

  Pharmaceutical manufacturing is one of the industries leading the charge toward a sustainable future and setting a new standard for environmental responsibility. In this plenary session, Jane Zhang will illustrate how procurement and supply chain innovation will drive transformative behavioral change within organizations. Phil Duncanson will unveil AstraZeneca’s ambitious sustainability journey, from modernizing aging facilities to creating a groundbreaking carbon-neutral site in Singapore. Attendees will gain actionable strategies to champion sustainability as a cornerstone of industry progress.

  • 08:00 – 08:25

    Driving Behavioral Change: Unlocking Sustainability Through Procurement and Supply Chain Innovation

    • Presenter:

      

      Jane Zhang
      Co-Founder & Co-CEO, ETCH Sourcing

  • 08:25 – 08:50

    From Labs to Leadership: A Vision for Carbon-Neutral Pharma Operations

    • Presenter:

      

      Phil Duncanson, PhD
      Senior Director, Global Quality Control, AstraZeneca

  • 08:50 – 09:30

    Q&A
• 09:00 – 16:15

  Exhibit Hall Open

• 09:30 – 10:30

  Networking Break in the Exhibit Hall

• 09:30 – 10:30

  Poster Presentations in the Exhibit Hall

• 09:30 – 11:00

  PDA Press Conference

• 10:30 – 12:00

  A2: Data Management and Lifecycle Strategies for Advanced Therapies

  • Moderator:

    

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

  This session will examine cutting-edge approaches to data management and lifecycle strategies in ATMP and biopharmaceutical manufacturing. Topics will include optimizing digital ecosystems for patient traceability, transitioning from batch to campaign filling modes, and leveraging pharmaceutical continuous manufacturing (PCM) for lifecycle management. Attendees will gain insights into integrating data-driven strategies with regulatory frameworks to enhance efficiency, compliance, and scalability.

  • 10:30 – 10:50

    A Concept for Optimized Digital Data Management: What is Required to Make the ATMP Industry Ready for the Future

    • Presenter:

      

      Judith Koliwer, PhD
      Senior Industry Advisor & Principal Consultant Advanced Therapies, Körber Pharma Software

  • 10:50 – 11:10

    Transitioning from Batch to Campaign Filling Mode – Walking Before Running, APS Qualifications, and Other Considerations

    • Presenter:

      

      Aidan J. Harrington, PhD
      Principal Consultant, Arcadis

  • 11:10 – 11:30

    PCM – An Agile Risk and Data-Driven Lifecycle Management Approach

    • Presenter:

      

      Margarida Ventura, MS
      Quality Risk Management Senior Consultant, ValGenesis

  • 11:30 – 12:00

    Q&A
• 10:30 – 12:00

  B2: Advancing Quality Control: Automated Visual Inspection in Parenterals

  • Moderator:

    

    Ryan Murray, MS
    Senior Consultant, ValSource, Inc.

  This session will explore cutting-edge advancements in automated visual inspection (AVI) for parenterals. Topics will include lifecycle and risk management for visible particles, reducing false rejects using data analytics and machine learning (ML), and a novel human-inspired inspection approach. Attendees will leave this session with enhanced knowledge of improving accuracy, efficiency, and compliance in AVI systems.

  • 10:30 – 10:50

    Lifecycle and Risk Management for Visible Particles in Parenterals - Industry Best Practices

    • Presenter:

      

      Antonio Burazer
      Global Head Visual Inspection & Particle LCM, Takeda

  • 10:50 – 11:10

    Enhancing AVI Accuracy: Reducing False Reject by Distinguishing Air Bubbles from Defects Using Data Analysis and ML

    • Presenter:

      

      Berwald Gomes, MSc
      Vision Engineer/Engineer Optical Control, Roche

  • 11:10 – 11:30

    Human-Inspired AVI: The Next Level of Parenteral Packaging Quality Control

    • Presenter:

      

      Chiara Sinito, PhD
      Head of AVI, WILCO AG

  • 11:30 – 12:00

    Q&A
• 10:30 – 12:00

  C2: Digital Transformation

  • Moderator:

    

    Malav Parikh, ME
    Director, Quality Risk Management, Global Quality Compliance and Systems, Takeda

  This session will delve into the impact of digital transformation on biopharmaceutical processes, highlighting innovations in contamination control, risk management in fill-finish, and streamlining technology transfers. Experts will discuss how digital tools are driving efficiency, reducing risk, and ensuring compliance across the manufacturing lifecycle.

  • 10:30 – 10:50

    Digitalization Strategies for Contamination Control Under Annex 1

    • Presenter:

      

      Sheba S Zaman
      Head of Product Specialists and Training Services, Novatek

  • 10:50 – 11:10

    QRM and QbD in Fill-Finish: Measure Risk Reduction Scientifically

    • Presenter:

      

      Sebastian Scheler, MSc
      Managing Director, Innerspace

  • 11:10 – 11:30

    A Digital Transformation Path for Better Technology Transfers

    • Presenter:

      

      Yowvanaraj Gopal
      Director Professional Services, ValGenesis

  • 11:30 – 12:00

    Q&A
• 10:30 – 12:00

  D2: Regulatory Insights and Challenges: Annex 1, PUPSIT, and Drug Compounding

  • Moderator:

    

    Susan J. Schniepp
    Distinguished Fellow, Regulatory Compliance Associates Inc.

  This session will address key regulatory challenges impacting the pharmaceutical industry. Topics will include insights from the Kilmer Community PUPSIT survey post-Annex 1 implementation, the evolving regulatory framework for compounded drugs, and findings from the PDA Annex 1 survey. Attendees will gain a deeper understanding of regulatory trends, compliance strategies, and their implications for patient safety.

  • 10:30 – 10:50

    PDA Annex 1 Survey

    • Presenter:

      

      Marcia C. Baroni, MBA
      VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

  • 10:50 – 11:10

    Does the Current Regulatory Framework Ensure the Safety of Compounded Drugs?
  • 11:10 – 11:30

    Results of the Kilmer Community PUPSIT Survey

    • Presenter:

      

      Maik W. Jornitz
      Principal Consultant, BioProcess Resources

  • 11:30 – 12:00

    Q&A
• 12:00 – 13:30

  Networking Lunch in the Exhibit Hall

• 12:00 – 13:30

  Poster Presentations in the Exhibit Hall

• 13:30 – 14:15

  IG01: Combination Products

  • Interest Group Leader:

    

    Maggie Bandel, MBA
    Global Head Lifecycle Management ATSC MSAT, Johnson & Johnson

• 13:30 – 14:15

  IG02: Drug Compounding

  • Interest Group Leader:

    

    Arie Anahory, MS
    Senior Director, Strategy and Customer Excellence, Regulatory Compliance Associates Inc.

  • Interest Group Leader:

    

    David Short
    Chief Quality Officer, QuVa Pharma

• 13:30 – 14:15

  IG03: Management of Outsourced Operations and Technology Transfer

  • Interest Group Leader:

    

    Maria Amaya, PhD
    Lead External Advocacy North America (Quality Policy), Genentech

  • Interest Group Leader:

    

    Morten Munk
    Director, Global Alliance Management, FUJIFILM Diosynth Biotechnologies

  • Interest Group Leader:

    

    Mirko Gabriele, PhD
    CEO, InfiniteVision

  • Interest Group Leader:

    

    Elizabeth Kramer, PhD
    Senior Director, Eli Lilly and Company

• 13:30 – 14:15

  IG04: Quality Risk Management and Supply Chain Management

  • Interest Group Leader:

    

    Malav Parikh, ME
    Director, Quality Risk Management, Global Quality Compliance and Systems, Takeda

  • Interest Group Leader:

    

    Henry Ames, MBA
    General Manager, Logistics Orchestration, TraceLink

• 13:30 – 15:30

  Mini-Training Course 1: Lyophilization (Ticket Required)

  • Instructor:

    

    Nathaniel Milton, PhD, RPh
    Professor of Practice - Industrial and Physical Pharmacy, Purdue University

  This mini-training course will help participants gain an understanding of the basic principles and practical aspects of lyophilization technology. Attendees will learn about the process and equipment, vacuum technology use for freeze drying, solidification during freezing, sublimation in primary drying, desorption during secondary drying, application of principles to product and process development, analysis of product characteristics, and process scale-up to production.
• 14:15 – 14:30

  Transition to Next IG

• 14:30 – 15:15

  IG05: Data Governance, Management, Integrity, and Digitalization

  • Interest Group Leader:

    

    Kir F. Henrici
    Chief Executive Officer, The Henrici Group

  • Interest Group Leader:

    

    Ulrich Koellisch, PhD
    Partner, GxP-CC

• 14:30 – 15:15

  IG06: Microbiology/Environmental Monitoring

  • Interest Group Leader:

    

    Kurt Jaecques, MA
    Global Quality Technical Senior Lead, GSK

  • Interest Group Leader:

    

    Kim Sobien, MBA
    Senior Consultant - Microbiology, ValSource, Inc.

• 14:30 – 15:15

  IG07: Process Validation

  • Interest Group Leader:

    

    Robert Dream
    Managing Director, HDR Company

  • Interest Group Leader:

    

    Mauro Giusti, MSc
    Senior Director, Parenteral Technical Knowledge, Eli Lilly and Company

• 14:30 – 15:15

  IG08: Sterile Processing/Parenteral Drug Manufacturing

  • Interest Group Leader:

    

    Julian Petersen
    Head of Business Development, Groninger

• 14:30 – 15:15

  Lightning Session 1

  • Moderator:

    

    Ken Paddock
    Director, Global Quality Sterility Assurance, Merz Aesthetics

  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 6 minutes and 40 seconds.

  • 14:30 – 14:35

    Session Introduction
  • 14:35 – 14:42

    A Risk Based Approach for Pre-Use/Post-Sterilization Integrity Test Simulation During Bacterial Retention Testing as Part of the Process Specific Filter Validation of Sterilizing Grade Filters.

    • Presenter:

      

      Yvonne Groß, Dipl.-Ing
      Senior Scientist, Sartorius Stedim Biotech

  • 14:42 – 14:49

    Successful In Situ Disinfectant Field Trials

    • Presenter:

      

      Dan A. Klein, MA
      Senior Technical Service Manager, STERIS

  • 14:49 – 14:56

    Smart Manufacturing with Intelligent Sensors

    • Presenter:

      

      Bethany Silva
      Industry Manager - Life Sciences, Endress+Hauser

  • 14:56 – 15:15

    Q&A
• 15:15 – 16:15

  Networking Break in the Exhibit Hall

• 15:15 – 16:15

  Poster Presentations in the Exhibit Hall

• 16:15 – 17:45

  A3: CMC Insights for Biosimilars and Container Closure Integrity Testing Advancements

  • Moderator:

    

    Sebastian B. Teitz, PhD
    Senior Development Scientist, Novo Nordisk

  This session will explore key aspects of CMC for biosimilars, including clone selection, manufacturing processes, and comparative assessments. It will address upcoming challenges in container closure integrity testing (CCIT) for low-temperature containers, biopharmaceutical compatibility, and delivery systems. Attendees will also learn about future innovations in CCIT and automated visual inspection (AVI) integration for automated, high-throughput inspection of low-volume solutions.

  • 16:15 – 16:35

    Key CMC considerations for Biosimilar Success

    • Presenter:

      

      Kurt A. Brorson, PhD
      Vice President Technical, PAREXEL

  • 16:35 – 16:55

    Vial Containment and Syringe Systems for Low Temperature Applications

    • Presenter:

      

      Page McAndrew, PhD
      Director, Scientific Communications, West Pharmaceutical Services, Inc.

  • 16:55 – 17:15

    A Novel Approach for CCIT and AVI of Fusion-Sealed Pre-Filled Syringes (PFS) with Opaque Suspensions

    • Presenter:

      

      Matthias Kahl
      Head of R&D and Lab Services, WILCO AG

  • 17:15 – 17:45

    Q&A
• 16:15 – 17:45

  B3: Transforming Contamination Control: Innovative Strategies, Technologies, and Risk Management

  • Moderator:

    

    Vanessa Vasadi Figueroa, MA
    Chief Microbiologist, VVF Science

  Contamination control remains critical to pharmaceutical manufacturing, with innovations and methodologies aimed at addressing regulatory compliance challenges and enhancing operational efficiency. This session will delve into real-time microbial monitoring using biofluorescence particle counters, environmental control and monitoring driven by quality risk management (QRM), and approaches to modernizing legacy systems through process modeling and AI-enabled automation. Each presenter will provide actionable insights and practical strategies for contamination control optimization.

  • 16:15 – 16:35

    Real-World Challenges – and Solutions – for the Use of Biofluorescence Particle Counters in Grade A Aseptic Filling Applications

    • Presenter:

      

      Manny Khera
      Head of Engineering - Aseptic Filling, Cytiva

  • 16:35 – 16:55

    Innovative Approaches to Environmental Risk Assessment and Sample Site Selection: Leveraging QRM for Effective Contamination Control

    • Presenter:

      

      Virginia Andreotti-Jones
      Consultant, Quality Risk Management, ValSource, Inc.

  • 16:55 – 17:15

    Improving Legacy Processes: A Case Study on Reducing Risks and Ensuring Regulatory Compliance

    • Presenter:

      

      Jeffrey Gensler
      VP Quality, Kindeva Drug Delivery

  • 17:15 – 17:45

    Q&A
• 16:15 – 17:45

  C3: Applied Artificial Intelligence

  • Moderator:

    

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

  Over the past decade, artificial intelligence (AI) has seen exponential growth throughout various industries. While we have seen a slower adoption rate in the biopharmaceutical industry, we are coming to an inflection point. In this session, participants will look at the different ways AI is being implemented in our industry within our current regulations.

  • 16:15 – 16:35

    Large Language Models in GMP - Risk Management and Validation

    • Presenter:

      

      Ulrich Koellisch, PhD
      Partner, GxP-CC

  • 16:35 – 16:55

    Quality Inspection Methods for DIP Products According to Pharmacopoeia Annex I and the Benefits of Implementing AI Technology within Traditional Algorithms

    • Presenter:

      

      Gianmarco Pincelli
      Technical Sales Manager, Bonfiglioli Engineering

  • 16:55 – 07:15

    AI-Driven Holistic Risk Management: Transforming Pharma Supply Chains

    • Presenter:

      

      Fabrizio Maniglio
      Industry and Business Development Director, Honeywell

  • 17:15 – 17:45

    Q&A
• 16:15 – 17:45

  D3: Proactive Data, Quality, and Risk Management for Business Sustainability

  • Moderator:

    

    Jennifer Cheung
    VP of Global Quality Assurance Operations, Gilead Sciences

  This session will explore the power of proactive data, quality, and risk management to achieve business sustainability in the pharmaceutical industry. Topics will include developing data and risk management driven strategies for supply chain resilience, leveraging quality risk management to achieve operational excellence and business growth, and utilizing advanced graph-based intelligence for quality assurance to increase business competitiveness. Attendees will gain actionable insights into aligning quality processes with business success and sustainability.

  • 16:15 – 16:35

    Data and Risk Management Challenges in the Evolving Drug Supply Chain

    • Presenter:

      

      Kellen Giroux, CQA, CQE
      Director, Quality Solutions, Network Partners Group

  • 16:35 – 16:55

    Quality Risks are Business Risks: Integrating QRM for Strategic Success

    • Presenter:

      

      Lori Richter, PhD
      Sr. Director, GxP Quality Management Systems, ALX Oncology

  • 16:55 – 17:15

    From Compliance to Competitiveness: The Power of Graph-Based Intelligence in Quality Assurance

    • Presenter:

      

      Mike Salem, MA
      Associate Director of Data Science - Quality Assurance, Gilead Sciences

  • 17:15 – 17:45

    Q&A
• 16:30 – 18:30

  PDA Member Lounge Open

• 18:00 – 20:30

  Architecture and Celebrity Homes Bicycle Tour (Ticket Required)

  Riders will get a unique glimpse into Palm Springs’ Hollywood history, architectural masterpieces, and destination highlights. The biking route includes the historic Palm Springs neighborhoods where riders will see examples of key architects important to the development of Palm Springs in the 1950s and 1960s as well as several celebrity homes. Bike helmets are required and provided.
• 18:15 – 20:00

  Local Beer Tasting and Dinner (Ticket Required)

  La Quinta Brewing Co. opened their doors in the fall of 2013 and has become a destination spot with continued growth in popularity. Participants will enjoy a delicious taco/nacho bar with chicken, beef, and vegetarian options with their choice of four (4) different 5 oz beers to taste from La Quinta Brewing Co.’s rotating selection of IPAs, porters, lagers, ales, wheat, and special seasonal beers. Don’t miss your opportunity to enjoy the laid-back desert lifestyle of Palm Springs while sipping craft beer with friends!
• 18:15 – 20:30

  Palm Springs Aerial Tram and Dinner (Ticket Required)

  The Palm Springs Aerial Tramway has the world’s largest rotating tram car and travels over 2.5 mi/4 km along the cliffs of Chino Canyon and it transports visitors to the pristine wilderness of the Mt. San Jacinto State Park and Wilderness Area. During the 10-min journey on the tram itself, tram cars rotate slowly, offering spectacular views of the valley below. At the tram’s Mountain Station (elevation 8,516 ft/2,596 m and 30 degrees cooler than the desert floor) guests will enjoy 180 degrees of spectacular views of the valley from the observation decks, watch two documentary films, visit the natural history museum, and enjoy dinner at Pines Café. This trek to the top of this famous mountain is truly a singular experience!
  
  Dinner includes a green salad, your choice of entrée with two sides, and a soft drink or water. Alcohol is available for purchase.
  • Entrée choices: baked herb chicken, creamy vegetarian lasagna with toasted parmesan cheese breadcrumbs, BBQ pork ribs braised and glazed in a smokey sauce, or beef burgundy braised in a cabernet wine
  • Side choices (up to 2): corn on the cob, fingerling potatoes, mashed potatoes, or roasted seasonal vegetables
• 18:30 – 20:30

  Wine and Watercolors (Ticket Required)

  Calling all artists for this fun and unique experience! Participants will craft beautiful greeting cards with watercolor paints while enjoying their choice of two (2) drinks (wine or beer) and a charcuterie board to snack on. Professional instruction and all supplies to make four (4) greeting cards per person will be provided (cards, pens, paints, brushes, and aprons).

PDT Daylight Time (UTC -7:00)

• 06:30 – 07:30

  PDA Member Lounge Open

• 07:00 – 08:00

  Continental Breakfast

• 07:00 – 15:30

  Registration Open

• 07:30 – 10:30

  Speaker Ready Room Open

• 08:00 – 09:30

  A4: Ensuring Quality and Potency in ATMP Manufacturing

  • Moderator:

    

    Ryan Murray, MS
    Senior Consultant, ValSource, Inc.

  This session will explore strategies for maintaining quality and potency in advanced therapy medicinal products (ATMPs). Topics will include developing science-based potency assays, implementing end-to-end product stewardship with modular technologies, and designing robust disinfectant validation programs for cleanrooms. Attendees will gain a deeper understanding of the unique challenges of ATMP production and compliance.

  • 08:00 – 08:20

    Potency Assurance for ATMPs

    • Presenter:

      

      Andrew C. Chang, PhD
      Vice President, Quality and Regulatory Compliance, Regulatory Policy and Intelligence, Novo Nordisk

  • 08:20 – 08:40

    A New Paradigm of Quality: ATMPs and Product Stewardship

    • Presenter:

      

      Josh Russell
      Vice President of Sales & Marketing, AST

  • 08:40 – 09:00

    Designing a Disinfectant Validation Program for ATMP Cleanrooms

    • Presenter:

      

      Jim N. Polarine, MA
      Principal Consultant, STERIS

  • 09:00 – 09:30

    Q&A
• 08:00 – 09:30

  B4: Primary Packaging

  • Moderator:

    

    Robin Usselman
    Sr. Business Development Manager, USA & Canada, PBL (Performing Beyond Limits)

  • 08:00 – 08:20

    Vial to Pre-Filled Syringe: Navigating Drug Product Development and Manufacturing - A Comprehensive Case Study

    • Presenter:

      

      Adithya Balasubramanian, MS
      Director, ten23 health

  • 08:20 – 08:40

    Primary Packaging Compliance: Regulatory Updates and Annex 1 Implementation Case Study

    • Presenter:

      

      Colleen O'Brien, MS
      Strategy and Technical Affairs, Gerresheimer

  • 08:40 – 09:00

    Case Study: Saturated Steam as an Alternative Sterilization Process to EtO for RTF Primary Containers

    • Presenter:

      

      Darren Beckett
      Sr. Training and Technology Center Manager, Fedegari Technologies, Inc.

  • 09:00 – 09:30

    Q&A
• 08:00 – 09:30

  C4: Quality Risk Management

  • Moderator:

    

    Kate Malachowski, PhD
    Director, MS&T, Novavax

  This session will provide a blueprint for advancing quality risk management (QRM) practices in the biopharmaceutical industry, including strategies for developing skilled risk assessment facilitators and optimized portfolios. It will also explore the evolving regulatory landscape for AI applications and associated risks. Participants will gain insights into improving risk management processes and navigating emerging industry challenges.

  • 08:00 – 08:20

    Regulations for AI Application: Do We Need More?

    • Presenter:

      

      Stephan K. Roenninger, Dr.-Ing.
      Director Compliance, External Affairs, Amgen

  • 08:20 – 08:40

    Developing Qualified Risk Assessment Facilitators at Takeda

    • Presenter:

      

      Joseph Horvath, PhD
      Head, Global Quality Risk Management, Takeda

  • 08:40 – 09:00

    Developing an Optimized Risk Assessment Portfolio—The QRM Master Plan

    • Presenter:

      

      Kelly Waldron, PhD
      Business Unit Manager, Quality and Manufacturing Science Consulting, ValSource, Inc.

  • 09:00 – 09:30

    Q&A
• 08:00 – 09:30

  D4: Innovative Technologies for Sterility Assurance and Aseptic Processing

  • Moderator:

    

    Yeissa M. Chabrier-Rosello, PhD
    Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

  This session will explore cutting-edge technologies and methodologies for achieving sterility assurance in pharmaceutical manufacturing. Topics will include new guidelines for RABS system design and operation, risk evaluation for transitioning to X-ray sterilization of single-use systems, and the benefits of low-energy electron beam technology for pharmaceutical packaging sterilization. Attendees will gain insights into advancing sterility assurance while addressing regulatory and sustainability challenges.

  • 08:00 – 08:20

    Sterility Assurance – Meeting an Unmet Industry Technical Need on Design and Operation of RABS Systems

    • Presenter:

      

      Bruce A. Loxley
      Regulatory Inspection Compliance Director, GSK

  • 08:20 – 08:40

    Evaluating Risks in Implementing X-Ray Sterilization for Single-Use Systems

    • Presenter:

      

      Samuel Dorey, PhD
      Principal Scientist Materials & Irradiation, Sartorius Stedim Biotech

  • 08:40 – 09:00

    Low Energy Electron Beams for the Sterilisation of Pharmaceutical Packaging

    • Presenter:

      

      Thomas Kroc, PhD
      US Representative, International Irradiation Association

  • 09:00 – 09:30

    Q&A
• 09:00 – 13:45

  Exhibit Hall Open

• 09:30 – 10:30

  Networking Break in the Exhibit Hall

• 09:30 – 10:30

  Poster Presentations in the Exhibit Hall

• 10:30 – 11:15

  IG09: Advanced Manufacturing and Applied Process Digitalization

  • Interest Group Leader:

    

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

  • Interest Group Leader:

    

    Toni Manzano
    Co-Founder and CSO, Aizon

• 10:30 – 11:15

  IG10: ATMP

  • Interest Group Leader:

    

    Rebecca D. Jordan
    Director, Global Cell Therapy Sterility Assurance Lead, Bristol Myers Squibb

• 10:30 – 11:15

  IG11: Facilities and Engineering

  • Interest Group Leader:

    

    Shelley M. Preslar, MBA
    CEO/Principal SME, Panacea Group

• 10:30 – 11:15

  IG12: Quality Systems

  • Interest Group Leader:

    

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

  • Interest Group Leader:

    

    Michele Simone
    Director, Corporate Quality Compliance, Risk Management, and Continual Improvement, Bracco

  • Interest Group Leader:

    

    Eva M. Urban, MSc
    Senior Director, Risk Management, Bristol Myers Squibb

• 10:30 – 12:30

  Mini-Training Course 2: Parametric Release of Pharmaceuticals Terminally Sterilized by Moist Heat (Ticket Required)

  • Instructor:

    

    Michael J. Sadowski
    Owner, Sterilexcellence

  This mini-training course will benefit organizations that are pursuing development of a parametric release moist heat sterilization program as well as organizations seeking to improve conventional moist heat sterilization programs. This lecture and discussion mini-training course will provide an introduction and overview of parametric release.
• 11:15 – 11:30

  Transition to Next IG

• 11:30 – 12:15

  IG13: Annex 1 Implementation

  • Interest Group Leader:

    

    Marcia C. Baroni, MBA
    VP Quality, Enterprise GxP Compliance & Systems, Emergent BioSolutions

  • Interest Group Leader:

    

    Stephen E. Langille, PhD
    Senior Microbiology Consultant, ValSource, Inc.

• 11:30 – 12:15

  IG14: Filtration

  • Interest Group Leader:

    

    Maik W. Jornitz
    Principal Consultant, BioProcess Resources

  • Interest Group Leader:

    

    William Peterson
    Director, Global QA, Merck & Co., Inc.

• 11:30 – 12:15

  IG15: Vaccines

  • Interest Group Leader:

    

    Cristiana Campa, PhD
    Technical R&D Advisor, GSK

  • Interest Group Leader:

    

    Sabrina Restrepo, PhD
    Executive Director - Quality Assurance, Merck & Co., Inc.

• 11:30 – 12:15

  Lightning Session 2

  • Moderator:

    

    Susan J. Schniepp
    Distinguished Fellow, Regulatory Compliance Associates Inc.

  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 6 minutes and 40 seconds.

  • 11:30 – 11:35

    Session Introduction
  • 11:35 – 11:42

    The Generated Pre-Trained Transformer Parallels Project: A Practical Method for Generative AI Integration into Workforce Development and Biomanufacturing Research and Manufacturing

    • Presenter:

      

      Richard Jaenisch, MPH
      Director of Education and Outreach, Open Biopharma Research and Training Institute

  • 11:35 – 11:42

    The Generated Pre-Trained Transformer Parallels Project: A Practical Method for Generative AI Integration into Workforce Development and Biomanufacturing Research and Manufacturing

    • Presenter:

      

      Richard Jaenisch, MPH
      Director of Education and Outreach, Open Biopharma Research and Training Institute

  • 11:42 – 11:49

    Particle Loss in Tubing During Airborne Particle Counting

    • Presenter:

      

      Michael J. Dingle
      Senior Product Specialist, TSI

  • 11:49 – 11:56

    Lean Approach to Analytical Panels to Support Cleaning Validation

    • Presenter:

      

      Brian Bosso
      Technical Service Manager, STERIS

  • 11:56 – 12:15

    Q&A
  • 11:56 – 12:15

    Q&A
• 11:30 – 12:15

  PDA Journal of Pharmaceutical Science and Technology—The Members' Journal

  • Moderator:

    

    Walter Morris
    Senior Director, Publishing, PDA

  In this session, participants will learn about the latest content published in the 79-year-old, peer-reviewed PDA Journal of Pharmaceutical Science and Technology (JPST), including updates on the new submission and reviewer site as well as the new reviewer management and recognition program. Hear from the winning authors (invited) of the 2024 Frederick Simon D. Simon Paper of the Year Award. All current and potentially interested authors and reviewers are especially invited to attend.

  • 11:30 – 12:00

    Editor's Perspective

    • Presenter:

      

      Shanker Gupta, PhD
      Editor-In-Chief, PDA Journal of Pharmaceutical Science and Technology

  • 12:00 – 12:15

    Q&A
• 12:15 – 13:45

  Networking Lunch in the Exhibit Hall

• 12:15 – 13:45

  Poster Presentations in the Exhibit Hall

• 13:45 – 15:15

  P3: From Burnout to Breakthrough: Inspiring Person-Centered Care

  • Moderator:

    

    Kate Malachowski, PhD
    Director, MS&T, Novavax

  Every healthcare professional has a crucial impact on person-centered care – including those who do not have direct patient contact. By specifically recognizing the ways that their work is directly tied to a human being, Allison will generate a deeper connection to the patient experience for each participant. This closing plenary session will address how fostering a culture of compassion, engagement, and innovation can combat burnout and create breakthroughs in patient-centered care. Participants will leave with a renewed sense of purpose, empowered by the knowledge that their contributions improve patient outcomes, enhance company culture, and drive both personal and organizational success.

  • 13:45 – 14:30

    From Burnout to Breakthrough: Inspiring Person-Centered Care

    • Presenter:

      

      Allison Massari, MFA
      Keynote Speaker, Entrepreneur, and Interdisciplinary Artist, allisonmassari.com

  • 14:30 – 15:00

    Q&A
  • 15:00 – 15:15

    Closing Remarks from Co-Chairs
• 15:30 – 17:30

  PDA Member Lounge Open

• 15:45 – 17:45

  Mini-Training Course 3: Introduction to RABS and Isolators (Ticket Required)

  • Instructor:

    

    Anne Weeks
    Senior Commercial Applications Expert, MilliporeSigma

  This mini-training course will provide practical insights into the design, installation, and operation of barrier technology, specifically isolators. Participants will learn some basics about isolator design, operational requirements, cleaning and decontamination methods, and validation of isolators.
• 18:00 – 21:30

  Taste of the Desert Epicurean Tour (Ticket Required)

  Your "foodie" guides will introduce you to the Palm Springs Valley as you venture on foot (approx. 1.5 m/2.4 km) to locally owned restaurants to taste varied culinary delights. Between tastings, you will learn about the art, history, and culture of the area and some unique facts about each of the restaurants. With so much happening in Downtown Palm Springs, this tour offers an insiders’ take on the diverse culinary and cultural offerings of this famous destination. SAMPLE TOUR MENU – Restaurants and menus to be confirmed in early March 2025 • Tommy Bahama: Coconut Shrimp, Chicken Mango Salad, Mai Tai • Maracas: Variety of Street Tacos, Chips, Salsa, Margarita • Tutti Frutti: Date Shake and Fresh Fruit Frozen Yogurt Samples • Bill’s Pizza: Award-Winning 4 cheese Pizza on Sourdough Crust • Brandini Toffee: Toffee and Popcorn Tastings, Take Home Sample • Lulu California Bistro: Signature Triple Chocolate Cake

PDT Daylight Time (UTC -7:00)

• 07:00 – 16:00

  PDA Member Lounge Open

• 08:30 – 16:00

  Aseptic Processing Essentials Workshop - Separate Registration Required

  • Instructor:

    

    Hal Baseman, MBA
    Vice President, ValSource, Inc.

  This workshop is based on PDA Technical Report No. 22: Process Simulations for Aseptically Filled Products, as well as relevant topics from PDA Points to Consider for Aseptic Processing: Part 2, and the EMA draft Annex 1 revision. The workshop will address various elements required in the design and execution of aseptic process simulations to include personnel qualification, media selection and preparation, filling considerations, interventions, duration, and number of units filled, pre and post incubation inspections, incubation conditions, acceptance criteria and investigations and corrective actions. The use of risk-based decision making will be considered.

  Participants will also receive a free copy of PDA Technical Report No. 22: Process Simulation for Aseptically Filled Products.

  Workshop Information and Registration

• 08:30 – 16:00

  Contamination Control Strategy Essentials Workshop - Separate Registration Required

  • Instructor:

    

    Frederic B. Ayers
    Senior Consultant - Microbiology, ValSource, Inc.

  Learn not only the theory of developing a great contamination control strategy (CCS), but also how to translate that theory into actual practice. Gain the skills you need to create holistic contamination control strategies covering all aspects of the manufacturing operation, including facility design and utilities, environmental control, validation and monitoring, quality systems, people, and processes.

  This workshop is based on the PDA Technical Report No. 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing, which will be provided free to each participant as a tool to prepare for the workshop. Jumpstart your CCS understanding and how to apply it to your manufacturing facilities and processes in this world-class interactive workshop – your hands-on solution to developing and implementing a successful CCS!

  Workshop Information and Registration

• 08:30 – 16:00

  Pharma Manufacturing Code of Ethics – Your Responsibility to the Patient and Your Organization Training Course (Day 1) - Separate Registration Required

  • Instructor:

    

    Susan J. Schniepp
    Distinguished Fellow, Regulatory Compliance Associates Inc.

  • Instructor:

    

    Glenn E. Wright, MA
    President and CEO, PDA

  Ethics is an area of great importance in pharmaceutical manufacturing. Individuals including leadership involved need to understand their responsibility and accountability to the patient and the organization when performing their work activities. Pharmaceutical manufacturing is complex and if not executed with great care can result in patient injury and even death as has unfortunately been demonstrated throughout the history of the industry. This training course is designed to strengthen attendees' understanding of their responsibility and accountability as it relates to their role, whether it be on the floor or in support of the manufacturing operation.

  This training course will include group activities and case studies, as well as work with a clinical psychiatrist on rationalization and decision making.

  Participants will leave with a pharmaceutical manufacturing code of ethics for you and your company.

  Training Course Information and Registration

PDT Daylight Time (UTC -7:00)

• 08:30 – 16:00

  Measuring Quality Culture using PDA's Assessment Tool Training Course - Separate Registration Required

  • Instructor:

    

    David B. Talmage, MBA
    Vice President, Education, PDA

  Make sure your company stays ahead of the curve! Prepare for this reporting on quality culture with PDA’s comprehensive Quality Culture Assessment Tool, designed to guide your company to a better understanding of quality culture, how to assess it, and what actions to take to improve it.

  In this training course, you will learn how to use this tool to effectively collect verifiable data. As a result, the tool will allow you to facilitate positive culture changes and continuous improvement within your organization.

  The goal is to ensure that a quality mindset and behaviors are embedded into the daily work of the individuals involved in all functions to ultimately ensure the delivery of high-quality products to patients.

  Training Course Information and Registration

• 08:30 – 16:30

  Fundamentals of Quality Risk Management Training Course - Separate Registration Required

  • Instructor:

    

    Virginia Andreotti-Jones
    Consultant, Quality Risk Management, ValSource, Inc.

  • Instructor:

    

    Tiffany A. Baker, MBA
    Senior Consultant, ValSource, Inc.

  This training course will provide an overview of the quality risk management (QRM) process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the training course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle.

  This training course will further build on the conceptual lessons by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this training course will close out with evaluating the power of decision making in using a risk register and a best practice approach for building a QRM program at your company.

  Participants will also receive a free copy of PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

  Training Course Information and Registration

• 08:30 – 17:00

  Pharma Manufacturing Code of Ethics – Your Responsibility to the Patient and Your Organization Training Course (Day 2) - Separate Registration Required

  • Instructor:

    

    Susan J. Schniepp
    Distinguished Fellow, Regulatory Compliance Associates Inc.

  • Instructor:

    

    Glenn E. Wright, MA
    President and CEO, PDA

  Ethics is an area of great importance in pharmaceutical manufacturing. Individuals including leadership involved need to understand their responsibility and accountability to the patient and the organization when performing their work activities. Pharmaceutical manufacturing is complex and if not executed with great care can result in patient injury and even death as has unfortunately been demonstrated throughout the history of the industry. This training course is designed to strengthen attendees' understanding of their responsibility and accountability as it relates to their role, whether it be on the floor or in support of the manufacturing operation.

  This training course will include group activities and case studies, as well as work with a clinical psychiatrist on rationalization and decision making.

  Participants will leave with a pharmaceutical manufacturing code of ethics for you and your company.

  Training Course Information and Registration