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2022 Annual Meeting

2022 PDA Annual Meeting

Apr 04 - Apr 06, 2022
Dallas, TX

Level Up: Agility in the New Normal

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  • The Americas

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Program Highlights

Overview

The 2022 PDA Annual Meeting promises to have something for everyone!

This Conference will focus on the theme to Level Up: Agility in the New Normal! We will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes.

Dive into exciting interactive sessions and tracks especially designed for manufacturing leaders, technical experts/scientists, and early career professionals. No matter what your area of focus, you are sure to come away with tangible, practical solutions to improve your operations and your standing within your company.

Details on the intriguing lineup of sessions, speakers, and engaging networking activities are coming soon.

Agenda

  • Day 1
  • Day 2
  • Day 3
  • Monday, 04 April

    Plenary Session 1

    Moderators: Shelley Preslar, Azzur and Jason Kerr, Redica Systems

    13:00
    Welcome from PDA Leadership and the Program Planning Committee Chairs,

    13:30
    Jeffrey Baker, Consultant

    13:55
    Donna Boyce, Senior Vice President, Head of Global Regulatory Affairs, Pfizer

    14:20
    Panel Discussion and Q&A

    15:00 – 15:30 | Break

    Plenary Session 2

    Moderators: Kenneth Paddock, Baxter and Diane Paskiet, West Pharmaceutical

    15:30
    Ben Borgo, PhD, MBA, Head of Portfolio Management, Genome Engineering and Modulation, MilliporeSigma

    15:55
    Michael Brothers, Technical Program Manager, Chemistry and Devices, UES, Inc.(Invited)

    16:20
    Panel Discussion and Q&A

    17:00 – 18:30 | Grand Opening Celebration in Exhibit Hall

  • Tuesday, 05 April

    Plenary Session 3

    Moderators: Susan Schniepp, Regulatory Compliance Associates Inc. and Kakolie Banerjee, MilliporeSigma

    8:30
    Peter Hotez, Dean National School of Tropical Medicine, Baylor College of Medicine (Invited)

    8:55
    Robert Dean, Merck & Co., Inc.

    9:20
    Panel Discussion and Q&A

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

    10:45 – 12:15 | Concurrent Sessions

    ASEPTIC PROCESSING & STERILIZATION

    Concurrent A1
    Moderator: Amanda McFarland,
    Senior Consultant, ValSource Inc.

    10:45
    Strategies for Total Contamination Control in an Aseptic Environment
    Sheba Zaman,
    Head of Product Specialists and Training Services, Novatek

    11:05
    Contamination Control - A New Approach to the Reduction of 5-micron Particles
    Anne Marie Dixon-Heathman,
    President, Cleanroom Management Associates, Inc.

    11:25
    Changing the Face of Contamination Control using Physics
    Jeanne Moldenhauer,
    Vice President, Excellent Pharma Consulting

    11:45
    Panel Discussion and Q&A

    BIOPHARMACEUTICALS & BIOTECHNOLOGY

    Concurrent B1
    Moderator: Kakolie Banerjee,
    Scientist III, MIlliporeSigma

    10:45
    Process Intensification of Cell-based Vaccine Manufacturing
    William Whitford,
    Life Science Strategic Solutions Leader, DPS Group

    11:05
    What's Possible When Declaring An Acceptable Use of Design Space
    Jason Orloff,
    Vice President, PharmStat

    11:25
    Quality and Regulatory Shifts driving Implementation of Flexible Biopharmaceutical Manufacturing Systems/Continuous bioprocessing - Regulatory Harmonization and Industry Best Practices
    Janmeet Anant,
    Senior Regulatory Consultant, Millipore Sigma

    11:45
    Panel Discussion and Q&A

    MANUFACTURING SCIENCE

    Concurrent C1
    Moderator: Guido Kremer-van der Kamp,
    Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH

    10:45
    Mitigating Risk to Container Closure Integrity of a COVID-19 Vaccine Product During Ultra-Cold Chain Storage and Distribution: A Best Practice Holistic Science-Based Approach
    Derek Duncan,
    Director Product Line, Lighthouse Instruments
    Michael Edey, Principal Engineer, Component Control, Pfizer

    11:05
    Vaccine Development and Production Needs End-To-End Digitization to be Ready for the Next Pandemic
    Stefan Kappeler,
    Global Technology Manager for Biopharma & Life Sciences, Exyte Central Europe GmbH

    11:25
    Quality by Design for Adeno-Associated Virus Products - a Framework
    Britta Manser,
    Manager, Scientific Laboratory Services, Pall Corporation

    11:45
    Panel Discussion and Q&A

    QUALITY & REGULATORY

    Concurrent D1
    Moderator: Kristen Dowling,
    Senior Manager, Quality, Amgen

    10:45
    Protocol-Based Site Internal Audit Program: A Network-Wide Case Study
    Mary Farbman, PhD,
    Executive Director, Global Quality Compliance, Merck & Co, Inc.

    11:05
    Re-Imagine Audit: Bringing GxP Auditing into the Quality 4.0 Paradigm
    Bruce Loxley,
    Senior GMP Compliance Advisor, GSK Vaccines

    11:25
    The Link Between Patient Safety and Pharmaceutical Auditing During a Pandemic
    James Fries,
    CEO, Rx-360

    11:45
    Panel Discussion and Q&A


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

    13:45 – 15:15 | Interest Group Sessions

    IG1 - Biopharmaceutical Manufacturing

    Round Table Discussion to focus on Mobile Manufacturing Task Force

    IG2 - Process Validation and Data Science

    The Interest Group will be discussing the recently launched a survey on process validation approaches.

    IG3 - Quality Risk Management

    We will discuss risk based approaches to audits and inspection as well as have a panel discuss their experiences with remote inspections.

    IG4 - Visual Inspection

    This will be a good opportunity to review changes in US and EU regulations, USP <1970> and Annex 1. Let’s discuss advances in the use of AI in automated visual inspection. The points-to-consider paper that our team is developing should be published at about this time.

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

    16:00 – 17:30 | Concurrent Sessions

    ASEPTIC PROCESSING & STERILIZATION

    Concurrent A2
    Moderator: Shelley Preslar,
    President & COO, Azzur Training Center Raleigh LLC

    16:00
    Blended Training Approach to Minimize Human Error in Biopharmaceutical Manufacturing
    Benben Song, PhD,
    Global Product Manager, Pall Corporation

    16:20
    Training is More than a Checkbox - Examples and Case Study in Training Effectiveness
    George Bernstein, PhD,
    Managing Principal, Double Dragon Consulting

    16:40
    Implementation of VR and AR Tools for Error Reduction
    Humberto Vega,
    Sr. Director/Lead CTCC, BMS

    17:00
    Panel Discussion and Q&A

    BIOPHARMACEUTICALS & BIOTECHNOLOGY

    Concurrent B2
    Moderator: Kristin Valente,
    Director, Vaccine Technical Operations, Merck & Co., Inc.

    16:00
    Challenges and Opportunities in Implementing Next Generation Technologies for Drug Product Development and Manufacturing
    Nitin Rathore,
    Executive Director, Amgen Inc.

    16:20
    Advancing Cell Therapy Processing Using Evolving Equipment Technologies
    Aidan Harrington, PhD,
    Principal Consultant, DPS Group

    16:40
    Technology Roadmap Phorum Industry Vision 2.0
    Guido Kremer-van der Kamp,
    Senior Consultant - Global BioPharm Center of Excellence, Merck Chemicals GmbH

    17:00
    Panel Discussion and Q&A

    MANUFACTURING SCIENCE

    Concurrent C2
    Moderator: Arne Zilian,
    Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

    16:00
    Structured Data Frameworks to Enable Digital Tech Transfer
    Yashvinder Sabharwal, PhD,
    Chief Executive Officer, CherryCircle Software, Inc.

    16:20
    The Digital Gap in the Pharma Industry, Effects in Patients and the Recipe to Succeed in the Journey
    Toni Manzano,
    CSO and Co-founder, Aizon

    16:40
    What if Sterile Product Processing Equipment could “Talk”- New Technology Facilitating Process-Product Communication
    Mihaela Simianu, PhD,
    Executive Director, Merck & Co., Inc.

    17:00
    Panel Discussion and Q&A

    QUALITY & REGULATORY

    Concurrent D2
    Moderator: Mary Oates

    16:00
    The Role of Psychological Safety in Reducing “Human Error” and Advancing Quality Management Maturity (QMM)
    James Vesper, PhD, MPH,
    Director, Learning Solutions, ValSource, Inc.

    16:20
    Is Regulatory Intelligence Compatible with An Effective QMS?
    Karen Ginsbury,
    Owner, PCI Pharmaceutical Consulting Israel Ltd

    16:40
    Bringing Innovation to Regulatory Intelligence from Ideation to Success
    Bob Chaplinsky,
    Head of Quality Management Systems, UCB
    Michael de la Torre, CEO, Redica Systems

    17:00
    Panel Discussion and Q&A

    18:30 | Reception

  • Wednesday, 06 April

    08:30 – 10:00 | Interest Group Sessions

    IG5 - Packaging Science

    The pandemic has changed the world of pharmaceutical packaging by bringing new, complex therapeutic entities into the mainstream seemingly overnight. The packaging science community, after spending decades mastering the containment of protein drugs have suddenly found themselves forging into uncharted and unfamiliar fields. With a panel of expert guest speakers, we will explore the inter-relationships and distinctions between RNA, gene and cell therapies. We will discuss how the therapeutic entities, their production processes and distribution, dictate containment requirements including and beyond cold storage. For example, in viral vector manufacturing, challenges arise due to the constant balance between processing small batch sizes and ensuring the valuable product makes it into the freezer within the time that the product is still stable. Finally, we will discuss where commonalities exist between antibody therapies and advanced therapies which would allow the substantial packaging knowledge amassed to date to be translated and leveraged in this rapidly changing landscape.

    IG6 - Regulatory Affairs

    Companies depend on Agency Meetings like FDA’s pre-IND/EOP meetings or EMA’s Scientific Advice meetings to obtain guidance and alignment on drug development plans and to ensure a successful regulatory outcome at submission. For complex modalities like gene therapy or cell therapy, these meetings are also vital to ensure that the CMC/Assay development plans are on track and are meeting the latest Agency requirements. Moreover, these meetings are not only important for drug development plans but are increasingly important to investors as they look at Regulatory decisions to ascertain the viability of the program plans for financing. However, at times, the outcome of these meetings leave Sponsors with more questions than answers and at a cross roads for decision making. PDA’s Regulatory Affairs IG will host an interactive panel discussion with representatives from a Regulatory Agency and Industry, and use real world situations to illustrate and clarify the best practices or strategies for following up after a less-than-optimal US or EMA Regulatory Agency meeting to ensure a successful continuation of the drug development pathway.

    IG7 - Vaccines

    The ability to rapidly develop and manufacture mRNA vaccines with high efficacy against the SARS-CoV-2 virus is a tremendous public health accomplishment and has spurred widespread interest in mRNA vaccines for multiple infectious diseases and other indications. Other vaccine platforms and manufacturing technologies that have received less attention will also be important in the future to produce vaccines that can be rapidly manufactured at a low cost, with characteristics needed for easy storage and distribution. In addition, the Vaccine Interest Group has recently completed a Technical Report “Strategies for Vaccines Development and Lifecycle Management”. The TR identified three areas of focus to support rapid development and effective vaccine lifecycle management (robust control strategies, comparability assessments and leveraging prior knowledge). These enablers have been incorporated into examples as appendices to the TR and will serve as the base for an interactive discussion.

    IG8 - Facilities & Engineering

    IG will discuss with membership on thoughts to help increase speed to market utilizing some novel approaches. Discuss how to modularize, collaborate, pre-qualify, equipment trains to get them built, installed and validated faster - to increase time to market.

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

    10:45 – 12:15 | Concurrent Sessions

    ASEPTIC PROCESSING & STERILIZATION

    Concurrent A3
    Moderator: Mirko Gabriele,
    Senior Director, Global Sterile Strategy Technology & Innovation, ThermoFisher Scientific

    10:45
    Rethinking Facility and Process Flexibilities – Cleanroom Infrastructures in a New Era of Therapies
    Maik Jornitz,
    CEO, G-CON Manufacturing Inc.

    11:05
    A 3P Model to Sustainable cGMP Cleaning
    Elizabeth Rivera,
    Technical Services Manager, STERIS
    Paul Lopolito, Sr. Technical Services Manager, STERIS

    11:25
    Containment Strategy for new HPAPI Biopharma Facility: Case Study & Lessons Learned
    Morcos Loka,
    Training Manager & GMP Advisor, Minapharm

    11:45
    Panel Discussion and Q&A

    BIOPHARMACEUTICALS & BIOTECHNOLOGY

    Concurrent B3
    Moderator: Kenneth Paddock,
    Quality Director, Sterility Assurance, Baxter Healthcare

    10:45
    Automated Colony Counter: Successful Validation Experiences of an Eight Company User Group
    Vaishali Shah, MS,
    Head of Quality Systems & Compliance, Kite Pharma, A Gilead Company
    David Jones, Director of Industry Affairs, Rapid Micro Biosystems

    11:05
    Industry Working Group Collaboration: Speedbump Navigation During the Implementation of a Bio-Fluorescent Particle Counting System
    Philip Villari,
    Associate Principal Scientist, Merck and Co., Inc.
    Joanny Salvas, Senior Manager, Pfizer

    11:25
    A Rapid Microbial Detection Technology to Identify Water Purification Failures in Real Time
    Anthony Bevilacqua, PhD,
    Principal Scientist, Mettler-Toledo Thornton
    Tracy Ammann M.S., Sr. Microbiologist, Mettler-Toledo Thornton

    11:45
    Panel Discussion and Q&A

    MANUFACTURING SCIENCE

    Concurrent C3
    Moderator: Diane Paskiet,
    Director of Scientific Affairs, West Pharmaceutical Services, Inc.

    10:45
    Digital Transformation to Enable Near-real Time Monitoring of Product Quality and Analytical Method Performance for Improved Reliability, Efficiency and Agility
    Neeraj J. Agrawal,
    Sr. Manager, Amgen

    11:05
    RFID Tracking for Asset Management, Compliance Support, and Process Improvement. The Many Applications for RFID Technology within the Pharma/biotech Industry
    Kevin McMurtrie,
    Global Business Manager, Documentation/ Transfer Systems, Veltek Associates, Inc.

    11:25
    Unit Level Syringe Identification & Traceability
    Herve Soukiassian,
    Ass. Director Product Development PMO, BD

    11:45
    Panel Discussion and Q&A

    QUALITY & REGULATORY

    Concurrent D3
    Moderator: Susan Schniepp,
    Distinguished Fellow, Regulatory Compliance Associates, Inc.

    10:45
    Data Integrity Trends in 2021
    Ulrich Köllisch,
    Manager Data Integrity, GxP-CC

    11:05
    A Deep Dive into Industry-wide Recall Data: Leveraging an Expert Ontology and AI to Uncover Patterns and Insights
    Jerry Chapman,
    Senior GMP Quality Expert, Redica Systems

    11:25
    Analyzing Global FDA 483 Observation Trends (2018-2020)
    Steven Lynn,
    Executive Vice President, Pharmaceuticals, Regulatory Compliance Associates, Inc.

    11:45
    Panel Discussion and Q&A


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

    Plenary Session 4

    Moderators: Kristin Valente, Merck & Co., Inc. and Guido Kremer, Merck Chemicals GmbH

    14:00
    Kelvin Lee, Director, NIIMBL and Gore Professor, Chemical and Biomolecular Engineering, University of Delaware

    14:25
    John J. Lewin, III, PharmD, MBA, BCCCP, FASHP, FCCM, FNCS, Chief Medical Officer, On Demand Pharmaceuticals

    14:50
    Panel Discussion and Q&A

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

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Travel

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

Hyatt Regency Dallas

300 Reunion Boulevard
Dallas, TX
Phone: +1 (214) 651-1234

Make a Reservation
Hyatt Regency Dallas
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Hyatt Regency Dallas. The rate is $249 for single or double occupancy. Guestroom rates are subject to discounted resort fee ($20 per night) and state and local taxes.

    Reservations must be secured by Friday, 04 March 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 16:00; check-out time is 11:00.

    To make reservations, individuals may click on the reservation link above or call the Hyatt Regency Dallas at +1 (214) 651-1234. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival date, unless otherwise specified on your reservation information.

  • Amenities

    Located downtown next to an iconic Dallas landmark Reunion Tower, Hyatt Regency Dallas is a gateway to the best of the city. Live, work and be yourself at our inviting, contemporary hotel near the Dallas Convention Center and within walking distance of many tourist attractions, including Dealey Plaza and the Historic West End. Whether you are here to work or play, Hyatt Regency Dallas is designed to meet all of your needs.

How to Get Here

By Air

Dallas/Fort Worth International Airport (DFW) is approximately 20 miles from the Hyatt Regency Dallas and all major carriers service this airport. Dallas Love Field Airport (DAL) is approximately 7 miles from the Hyatt Regency Dallas. Alaska Airlines, Delta and Southwest service this airport. Taxi fares from DFW are approximately $45-50 one way, not including tip. Taxi fares from DAL are approximately $20-25 one way, not including tip. App based rides are available to/from the airport.

By Car

The Hyatt Regency Dallas is located at 300 Reunion Boulevard, Dallas, TX 75207. Valet Parking, operated by PMSI, is available at hotel entrance. In and out privileges for hotel guests only. Self-parking in the outdoor Radish Lot is conveniently located on the north end of the hotel at the intersection of Hotel Street and Reunion Boulevard West. In and out privileges for overnight guests only, operated by PMSI. Self Parking Overnight Guests Includes in & out privileges Daily Guest & Reunion Tower $19 Radish Lot, 0–4 hours | $9 Radish Lot, 4–8 hours | $13 Radish Lot, 8-24 hours | $19 B-Lot, 0–4 | $7 B-Lot, 4–8 hours | $13 B-Lot, 8-24 hours | $19 Valet Parking Overnight Guests |$32 + tax 0–4 hours | $22 4–8 hours| $26 8–24 hours | $32

Other Options

Amtrak: Connected to Hyatt Regency Dallas by way of underground walkway to Union Station. Please call 214 653 1101 for train information. Greyhound: The nearest Greyhound station is located at 205 S Lamar St. Please call 214 849 6831 for bus information. DART Light Rail Service: the hotel is conveniently connected to Union Station on the Red and Blue lines and is also a stop for TRE commuter rail to Fort Worth. Dallas Streetcar: This is a FREE service provided by DART that picks up at Union Station, connected to the hotel, and runs to the Bishop Arts District, one of Dallas' best areas for food, shops and galleries.

Directions

Registration Fees

Regular Price
Registration Type Early Registration After 06 February
Member $1,895 $2,395
Non-Member $2,195 $2,695
Govern./Health Authority/Academic (Member/Non-Member) $700 $700
Student (Member/Non-Member) $350 $350
Early Career Professional (Member Only) $1,195 $1,195

* For this member type or discount, online registration is not available, please contact [email protected].

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

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

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

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