2022 PDA Annual Meeting
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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.
Health and Safety
The safety and wellbeing of our participants is a top priority for PDA; therefore, we will be implementing the following guidelines for this in-person event:
Vaccination Requirement
Participants, including attendees, exhibitors, trainers, students, staff, guests, contractors, and vendors, must provide proof of vaccination after registering for an in-person event. Accommodation may be offered on a case-by-case basis for any in-person participant who is unable to be vaccinated due to disability or medical condition, or in connection with a sincerely held religious belief or practice, unless otherwise provided under applicable state or local law. Accommodation requests must be made no later than 18 March 2022.
For those registered for the in-person meeting, you will receive a link to upload and verify your vaccine status in early 2022.
Participants that are unable to meet the vaccine requirement or fail to get a PDA-approved accommodation request will not be granted admittance to the event.
Mask Requirement
If mandated by national, state, or local guidelines in effect during the dates of any meeting, PDA will require masks to be worn indoors regardless of vaccination status.
Additional Requirements
PDA will be making decisions on additional precautionary measures closer to the date of the event and in accordance with the latest CDC guidance, local requirements, and hotel policies.
Agenda
Discover What's Happening Each Day
MONDAY, 04 APRIL
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13:00 – 15:00 | P1: Moving Forward from Abrupt Regulatory Challenges to the New Normal The biopharmaceutical industry has a strong track record of regulatory submissions and approvals. These approvals typically leave folks in industry at the edge of our seats, but the pandemic has since brightened the spotlight for the whole world. Since the announcement of a public health emergency in January 2020, we are gingerly entering our third year with the hopes of a “new normal”. Throughout the years, we have seen changes to regulatory strategies that highlight the use of emergency use authorizations in hopes of thwarting the pandemic. Regulatory agencies have released new policies, flexibilities in procedures, and updates to guidances on the fly, but what are the lasting impact of these changes on our "new normal?”. This session will expand on the regulatory challenges we have endured and how we anticipate the future. |
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13:00 | Welcome from PDA Leadership and the Program Planning Committee Co-Chairs 13:30 | Jeffrey C. Baker, PhD, Senior Fellow, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) 13:55 | Donna Boyce, MS, Senior Vice President Global Regulatory Affairs, Pfizer Inc. 14:20 | Panel Discussion and Q&A |
15:00 – 15:30 | Networking Break
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15:30 – 17:00 | 15:30 – 17:00 | P2: Facing the Future In January 2020, the first U.S. case of COVID-19 was confirmed, declared a pandemic in March, and by April, nearly half of the world's population was under lockdown. After two years, the return to normal is still uncertain. The pandemic experience typified the need to be prepared for serious unanticipated events. Advanced technologies to detect threats and rapidly develop novel medicines for timely access to life- saving medicines are critical for the future. This session will take a look at the significant strides made in the development of gene therapies, new molecule delivery systems and CRSIPR technology. Surveillance is another matter that will be addressed as it relates to zoonotic infectious diseases and emergence of new variants. |
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15:30 | Benjamin Borgo, MS, PhD, MBA, Head of Portfolio Management and Product Development, MilliporeSigma 15:55 | Michael Brothers, PhD, Technical Program Manager/Principal Scientist, UES, Inc. 16:20 | Panel Discussion and Q&A |
17:00 – 18:30 | Grand Opening Celebration in Exhibit Hall
TUESDAY, 05 APRIL
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08:30 – 10:00 | P3 |
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08:30 | The Challenges and Rewards Developing a World-Changing Pharmaceutical Innovative and Disrupted Patient-Focused Solution 08:55 | Robert Dean, MBA, Director/Team Leader, Advertising and Promotion, Merck & Co., Inc. 09:20 | 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 AND STERILIZATIONA1: Game Plan: Progress to the Next Stage of Contamination Control The 2022 revision of Annex 1 is setting the stage for a comprehensive contamination control strategy. To progress our organizations to the next level, new and innovative ways of thinking need to be employed. In this session, the speakers will provide insight into state-of-the-art approaches for advancing contamination control through comprehensive analytics and trending, strategies for reduced particulate recovery, and advanced cleaning techniques using physics. |
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10:45 | Strategies for Total Contamination Control in an Aseptic Environment 11:05 | Contamination Control: A New Approach to the Reduction of 5-Micron Particles 11:25 | Changing the Face of Contamination Control using Physics |
BIOPHARMACEUTICALS AND BIOTECHNOLOGYB1: Process Intensification: Increasing Yield per Unit Process intensification involves practices that improve product yield per unit, where “unit” could be time, consumables, resources, or footprint. Innovative upstream and downstream practices, such as use of perfusion bioreactors or continuous bioprocessing, can help achieve this goal. Benefits to intensified process include streamlined production, sustainability, reduced footprint and facility costs, and increased speed of production. In this session, we will be introduced to process intensification through an application using cell-based vaccine manufacturing. Subsequently, we will focus on best practices to validate the method using multivariate approach. Finally, we will learn about regulatory considerations. Each speaker will introduce us to implementation success stories and encourage a discussion on its application. |
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10:45 | Process Intensification of Cell-Based Vaccine Manufacturing 11:05 | Process Intensification: What's Possible When Declaring an Acceptable Use of Design Space 11:25 | Continuous Bioprocessing: Regulatory Harmonization and Industry Best Practices – Quality and Regulatory Shifts Driving Implementation of Flexible Biopharmaceutical Manufacturing Systems |
MANUFACTURING SCIENCEC1: Vaccine and Virus Products in Focus The Covid-19 pandemic redirected both industry and public focus on vaccines and viral products. In this session, speakers will share best practices for container integrity important for vaccine distribution and quality by design principles applied in viral product development. As the development and production of vaccines need to be prepared for the future, participants will also learn how this can be achieved through implementing end-to-end digitization. |
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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 11:05 | Vaccine Development and Production Needs End-To-End Digitization to be Ready for the Next Pandemic 11:25 | Quality by Design for Adeno-Associated Virus Products: A Framework |
QUALITY AND REGULATORYD1: Building Back Better: Innovative Options for Audits and Inspections Innovative options for audits and inspections have become increasingly important due to the recent challenges brought about due to the pandemic. This session will focus on auditing in the “new normal” by providing details on various techniques and technologies for effective use in audits and inspections. First, protocol-based site internal audits, including the pros and cons of this approach and how to implement protocol-based internal audit programs where appropriate, will be presented. Then, next-generation assessment technologies, such as automated harvesting data and artificial intelligence, can help auditors to zero-in on high patient safety risks, will be discussed. Finally, we will examine how onsite audits were affected during the pandemic, and how remote auditing was used throughout the industry. |
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10:45 | Protocol-Based Site Internal Audit Program: A Network-Wide Case Study 11:05 | Re-Imagine Audit: Bringing GxP Auditing into the Quality 4.0 Paradigm 11:25 | The Link between Patient Safety and Pharmaceutical Auditing during a Pandemic |
12:15 – 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall
13:45 – 15:15 | Interest Groups
INTEREST GROUPIG1: Biopharmaceutical Manufacturing
Roundtable discussion to focus on Mobile Manufacturing Task Force. |
INTEREST GROUPIG2: Process Validation and Lyophilization Process Validation IG Leader: Mauro Giusti, PhD, Advisor, Site External Network and President, PDA Italy Chapter, Eli Lilly Italia The Interest Group will be discussing the recently launched a survey on process validation approaches. |
INTEREST GROUPIG3: Quality Risk Management and GXP Auditing QRM IG Leaders:
GXP Auditing IG Leaders:
We will discuss risk-based approaches to audits and inspection as well as have a panel discuss their experiences with remote inspections. |
INTEREST GROUPIG4: 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 AND STERILIZATIONA2 |
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16:00 | Blended Training Approach to Minimize Human Error in Biopharmaceutical Manufacturing 16:20 | Training is More than a Checkbox: Examples and Case Study in Training Effectiveness 16:40 | Implementation of VR and AR Tools for Error Reduction |
BIOPHARMACEUTICALS AND BIOTECHNOLOGYB2: New Technologies in Bioprocessing The biopharmaceutical industry has evolved from traditional vaccines and therapeutic proteins to encompass a broad range of modalities, including mRNAs, cell therapies, and other advanced therapeutic medicinal products. All sectors of the industry are facing unprecedented pressure to increase agility and supply reliability, while reducing cost and speed-to-market. Technological evolution and introduction of novel technologies are required to meet these patient needs. In this session, we will share case studies of next generation technology implementation in both biologic drug product and cell therapy manufacturing processes. We will conclude by reviewing the shared vision from a cross-industry collaboration. |
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16:00 | Challenges and Opportunities in Implementing Next-Generation Technologies for Drug Product Development and Manufacturing 16:20 | Advancing Cell Therapy Processing using Evolving Equipment Technologies 16:40 | Technology Roadmap Phorum Industry Vision 2.0 |
MANUFACTURING SCIENCEC2: Transforming Product and Process Knowledge Acquisition to Become More Agile Agility in development and supply chain builds on good clinical and commercial process design and realization. In this session, technologies that have the ability to change the way we work in manufacturing science will be presented. The goals of these technologies are to enhance the knowledge of interactions between equipment, process, and product. |
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16:00 | Structured Data Frameworks to Enable Digital Tech Transfer 16:20 | The Digital Gap in the Pharma Industry: Effects in Patients and the Recipe to Succeed in the Journey 16:40 | What If Sterile Product Processing Equipment Could “Talk”?: New Technology Facilitating Process-Product Communication |
QUALITY AND REGULATORYD2: Regulatory Intelligence in the Digital Age: Friend or Foe? A blizzard of regulatory and quality information exists in the world of pharmaceutical manufacturing today, from both internal and external sources. This session will explain how to get the best internal data from personnel, will reimagine today’s regulatory intelligence process from start to finish, and will make the case for disrupting the status quo by driving to a single, globally harmonized Quality Management System. |
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16:00 | The Role of Psychological Safety in Reducing Human Error and Advancing Quality Management Maturity 16:20 | Is Regulatory Intelligence Compatible with an Effective QMS? 16:40 | Bringing Innovation to Regulatory Intelligence from Ideation to Success |
18:30 – 21:30 | Reception
WEDNESDAY, 06 APRIL
08:30 – 10:00 | Interest Groups
INTEREST GROUPIG5: 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. |
INTEREST GROUPIG6: Microbiology/ Environmental Monitoring In this Interest Group Meeting, participants will discuss PDA Technical Report No. 13 Revised, (TR 13) Fundamentals of an Environmental Monitoring Program. There are many aspects of the revision that are coordinated with the expectations of the draft EU Annex 1. |
INTEREST GROUPIG7: 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. |
INTEREST GROUPIG8: Facilities and Engineering
Vaccine Manufacturing: Case Study and Conversation on Increasing Speed-to-Market The focus of this Interest Group will be to discuss different approaches and methodologies to increase our ability to cut down the time it takes to get to market. The session will begin with a case study that presents one approach to significantly reducing the time to market when building a Vaccine Fill/Finish Greenfield Facility. Then participants will discuss ideas to help the industry increase time-to-market for new or renovated facilities. Is there any value in having vendors work together up front to have equipment that more readily integrates with each other? What about equipment that can be incorporated into predesigned modular facilities? With your valuable input, we can determine if there is value in having a deeper discussion (i.e., potential PDA project) around this idea of integrating, coordinating, prefabricating, or even prequalifying critical components of a facility ahead of the construction. |
10:00 – 10:45 | Refreshment Break, Tech Talks, and Poster Presentations in Exhibit Hall
10:45 – 12:15 | Concurrent Sessions
ASEPTIC PROCESSING AND STERILIZATIONA3: Cleanroom Manufacturing: A New Area Across Technology and Processes Parenteral manufacturing is an expensive and time-consuming process, with several stringent requirements needed to guarantee quality and safety of the medicine produced. The Covid-19 pandemic taught us that if from one side we need to preserve those quality and safety standards, from another we need to create an ecosystem able to react quickly to unforeseen events. This balance would give the pharmaceutical industry the ability to positively impact patients by offering new treatments faster. The presenters in this session will highlight innovative technical solutions to achieve this balance. With general technical concepts, case studies, and lessons learned, the audience will leave with actionable knowledge ready to implement in companies. |
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10:45 | Rethinking Facility and Process Flexibilities: Cleanroom Infrastructures in a New Era of Therapies 11:05 | A 3P Model to Sustainable cGMP Cleaning 11:25 | Panel Discussion and Q&A |
BIOPHARMACEUTICALS AND BIOTECHNOLOGYB3: Navigating the Realm of Microbial/Rapid Technologies through Innovation and Collaboration The methodologies within the area of microbial growth detection and monitoring are constantly evolving based on the innovative technologies throughout the industry. In this session, the speakers will provide insight into modern microbial methods by discussing the validation process and regulatory acceptance for an automated colony counter utilizing a cross functional industry team, navigating speedbumps throughout implementation of a biofluorescent particle counting system, and a case study on rapid microbial detection for a purified water system. |
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10:45 | Automated Colony Counter: Successful Validation Experiences of an Eight Company User Group 11:05 | Industry Working Group Collaboration: Speedbump Navigation during the Implementation of a Bio-Fluorescent Particle Counting System 11:25 | A Rapid Microbial Detection Technology to Identify Water Purification Failures in Real Time |
MANUFACTURING SCIENCEC3: Responding to Patient Needs The aim of the 21st Century Cures Act is to enable the production of safe and effective medicines to improve patient experiences and outcomes. Patient-focused drug development is described in regulatory guidance as a multifaceted approach to link patient information with the product lifecycle. The connection of product design with manufacturing and timely access to medicines will also include the concepts for agile manufacturing. This session will focus on technologies designed for therapeutic outcomes and data capture across the manufacturing process up until the medicine is delivered to the patient. Presentations will cover biosensors for wearables, tracking critical assets to enhance manufacturing efficiencies, and preventing product mix-ups via primary container unit level tracking. |
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10:45 | Development of a Closed-Loop Wearable Injector System for Emergency Delivery of Naloxone
11:05 | RFID Tracking for Asset Management, Compliance Support, and Process Improvement 11:25 | Unit Level Syringe Identification and Traceability |
QUALITY AND REGULATORYD3: Data Integrity Trends, Patterns, and Insights There is an enormous amount of data being collected today, but what does it all mean? In this session, attendees will hear insights and analyses from three experts who have reviewed industry data trends in the areas of data integrity, regulatory observations, and recalls. Through the understanding of this data, and what it means, our industry can improve its compliance position and continuously improve to produce safe and effective medicine for patients. |
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10:45 | Data Integrity Trends in 2021 11:05 | A Deep Dive into Industry-Wide Recall Data: Leveraging an Expert Ontology and AI to Uncover Patterns and Insights 11:25 | Analyzing Global FDA 483 Observation Trends (2018-2020) |
12:15 – 13:45 | Networking Luncheon, Poster Presentations, and Tech Talks in Exhibit Hall
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13:45 – 15:15 | P4: The Future is Bright! Collaboration and Commitment Can Lead to Awe-Inspiring Results Through unprecedented professional collaboration, tremendous progress has been achieved in technology and science over the past few years. We’ve come together to create effective tools to fight a global pandemic. |
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13:45 | De-Risking Biopharmaceutical Manufacturing Innovation by Going First Together 14:10 | Medicine Manufacturing in the Hands of Clinicians: Pharmacy on Demand 14:35 | Panel Discussion and Q&A 15:05 | Closing Remarks from Co-Chairs and Adjournment |
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Venue Details and Accommodations
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.
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.
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.
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Pricing Options
Standard Registration
Member Price
$2,395Early Career ProfessionalMember Only
$1,195
Non-Member
$2,695
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
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