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Agenda

Agenda

 

Agenda

As of Thursday, 9 January 2020
  • Agenda at a glance

    Sunday, March 29

    • Exhibitor Set Up

      1:00 p.m. – 7:00 p.m.
    • Registration Open

      4:00 p.m. – 7:00 p.m.
    • Speaker Ready Room Open

      4:00 p.m. – 7:00 p.m.
    • 2020 Annual Meeting Program Planning Committee F2F

      5:00 p.m. – 6:00 p.m.
    • PDA Awards Dinner (Invitation Only)

      6:30 p.m. – 9:30 p.m.

    Monday, March 30

    • Exhibitor Set Up

      7:00 a.m. – 4:00 p.m.
    • Registration Open

      9:00 a.m. – 5:00 p.m.
    • Speaker Ready Room Open

      9:00 a.m. – 5:00 p.m.
    • Welcome/Opening Remarks and P1: It’s Time to Get Personal with Patients

      1:00 p.m. – 3:00 p.m.
    • Refreshment Break

      3:00 p.m. – 3:30 p.m.
    • P2: Protecting Integrated Systems from External Threats

      3:30 p.m. – 5:00 p.m.
    • Grand Opening Celebration in Exhibit Hall

      5:00 p.m. – 6:30 p.m.

    Tuesday, March 31

    • Registration Open

      7:00 a.m. – 5:30 p.m.
    • Speaker Ready Room Open

      7:00 a.m. – 5:30 p.m.
    • Continental Breakfast

      7:00 a.m. – 8:00 a.m.
    • P3: A Tale of Two Facilities

      8:00 a.m. – 9:30 a.m.
    • Refreshment Break

      9:30 a.m. – 10:00 a.m.
    • Concurrent Sessions and Interest Groups

      10:00 a.m. – 11:30 a.m.
    • Networking Luncheon and Poster Presentations in Exhibit Hall

      11:30 a.m. – 2:00 p.m.
    • Concurrent Sessions and Interest Groups

      2:00 p.m. – 3:30 p.m.
    • Refreshment Break

      3:30 p.m. – 4:00 p.m.
    • Concurrent Sessions and Interest Groups

      4:00 p.m. – 5:30 p.m.
    • Reception

      6:00 p.m. – 9:00 p.m.

    Wednesday, April 1

    • Registration Open

      7:00 a.m. – 4:00 p.m.
    • Continental Breakfast

      7:00 a.m. – 8:00 a.m.
    • Speaker Ready Room Open

      7:00 a.m. – 12:00 p.m.
    • P4: Strategies for Developing Next Generation Medicine

      8:00 a.m. – 9:30 a.m.
    • Refreshment Break

      9:30 a.m. – 10:00 a.m.
    • Concurrent Sessions and Interest Groups

      10:00 a.m. – 11:30 a.m.
    • Networking Luncheon and Poster Presentations in Exhibit Hall

      11:30 a.m. – 2:00 p.m.
    • P5: Closing Plenary

      2:00 p.m. – 3:45 p.m.
  • Daily schedule

    Sunday, March 29

    • 1:00 p.m. – 7:00 p.m. | Exhibitor Set Up
    • 4:00 p.m. – 7:00 p.m. | Registration Open
    • 4:00 p.m. – 7:00 p.m. | Speaker Ready Room Open
    • 5:00 p.m. – 6:00 p.m. | 2020 Annual Meeting Program Planning Committee F2F
    • 6:30 p.m. – 9:30 p.m. | PDA Awards Dinner (Invitation Only)

    Monday, March 30

    • 7:00 a.m. – 4:00 p.m. | Exhibitor Set Up
    • 9:00 a.m. – 5:00 p.m. | Registration Open
    • 9:00 a.m. – 5:00 p.m. | Speaker Ready Room Open
    Welcome/Opening Remarks and P1: It’s Time to Get Personal with Patients
    1:00 p.m. – 3:00 p.m.
      Moderator
    • Melissa S. Seymour, MBA,Vice President, Global QC Operations, Biogen

    The pharmaceutical industry is in an unprecedented time of innovation and development; we are witnessing approvals of new modalities of drugs that are changing and saving lives in ways that have never been done before. In this session, we will hear a patient perspective on how innovation in our industry changes lives and how continued research and development is critical in helping more and more patients. We will also hear about new and innovative technologies currently under development. As in industry, our ultimate goal is to better the lives of the patients we serve. This session will provide a connection to our ultimate goal as we begin the conference.

    Welcome from PDA Leadership and the Program Planning Committee Co-Chairs
    1:00 p.m. – 1:30 p.m.
      Moderators
    • Jette Christensen, Chair, PDA Board of Directors
    • Richard Johnson, President and CEO, PDA
    • Aaron Goerke, PhD, Director, Head of MSAT, Singapore Technical Operations, F. Hoffman-La Roche
    • Melissa S. Seymour, MBA, Vice President, Global QC Operations, Biogen
    • 1:30 p.m. – 2:00 p.m. | Chris Heery, MD, Chief Medical Officer, Precision BioSciences
    • 2:00 p.m. – 2:30 p.m. | Tom Whitehead, Co-founder, Emily Whitehead Foundation
    • 2:30 p.m. – 3:00 p.m. | Q&A Panel

    3:00 p.m. – 3:30 p.m. | Refreshment Break

    P2: Protecting Integrated Systems from External Threats
    3:30 p.m. – 5:00 p.m.
      Moderator
    • Aaron Goerke, PhD, Director, Head of MSAT, Singapore Technical Operations, F. Hoffman-La Roche

    In the Industry 4.0 era, bio/pharmaceutical companies are increasing their digital footprints and adapting their technology and engagement environments to remain competitive and relevant. As information and assets of every company expand, they become another node in the network, thus the attack surface area increases exponentially. Technologies for Industry 4.0 will further intensify the need to be diligent in measures for internal security. All areas in production sites may be affected by cyber threats and infiltration by an attack may result in manipulation of data, production downtime, data loss, and loss of control of processes. Manufacturers are leveraging tools and methodologies to address the risk in their current manufacturing enterprise. Proactive remediation can also result in benefits such as improved robustness of automated assets and standardized services for easier and more efficient set up of new technologies. This session will discuss manufacturer progress, lessons learned, and strategies to address cyber risk. Come to learn and interact with companies that have experienced large impact and made great progress!

    • 3:30 p.m. – 4:00 p.m. | Michele D’Alessandro, Vice President, Merck & Co., Inc.
    • 4:00 p.m. – 4:30 p.m. | Tammy L. Steuerwald, JD, Head of Policy, International Markets, Roche Diagnostics
    • 4:30 p.m. – 5:00 p.m. | Q&A Panel

    5:00 p.m. – 6:30 p.m. | Grand Opening Celebration in Exhibit Hall

    Tuesday, March 31

    • 7:00 a.m. – 5:30 p.m. | Registration Open
    • 7:00 a.m. – 5:30 p.m. | Speaker Ready Room Open
    • 7:00 a.m. – 8:00 a.m. | Continental Breakfast
    P3: A Tale of Two Facilities
    8:00 a.m. – 9:30 a.m.
      Moderator
    • Kathy A. Demarest, Executive Director, Amgen Inc.

    Aging manufacturing facilities have become a major concern as the industry tries to keep pace with the advancements in technology while balancing costs. Modular facilities construction provides on-demand scaling of biopharmaceutical production and laboratory space. Flexible manufacturing models enable facility footprint reduction and increased efficiency. A hybrid manufacturing network of conventional and next-generation plants can best serve patient needs. In this session we explore the challenges of modernizing aging facilities and the next generation biotherapeutic advancements of modular manufacturing.

    • 8:00 a.m. – 8:30 a.m. | Mike Abernathy, Executive Director, Amgen
    • 8:30 a.m. – 9:00 a.m. | Industry Representative Invited
    • 9:00 a.m. – 9:30 a.m. | Q&A Panel

    9:30 a.m. – 10:00 a.m. | Refreshment Break

    10:00 a.m. – 11:30 a.m. | Concurrent Sessions and Interest Groups

    DEVELOPING NEW MODALITIES
    A1: Changes in Manufacturing and Quality Processes for Cell and Gene Therapy Products
      Moderator
    • Cori Sandy, Associate Director, Quality Systems, AveXis

    As we enter a new era in advance therapy medicinal product (ATMP) manufacturing, we learn of new challenges facing both the industry and regulators. Rapid product deployment to meet patient needs while adapting facilities and existing processes is a continuous challenge for companies stepping into the cell and gene therapy arena. This can include commonly used open systems which increases the opportunity for adventitious agents to be introduced, affecting sterility. Additionally, maintaining and monitoring the integrity of the cells as they advance through the manufacturing process can present challenges. Regarding the regulatory framework, understanding that there are countries still developing guidance and regulations and ones that have an existing framework have subtle differences between them. This session will focus on complexities associated specifically to manufacturing of cell and gene therapy products.

    • 10:00 a.m. | An Innovative Approach to a Gene Therapy Facility Start Up
      Tony Khoury, Project Farma
    • 10:30 a.m. | Advanced Therapies: Implementing Phase Appropriate Regulatory Requirements to Facilitate Successful Development and Release
      Aidan Harrington, DPS Group
    • 11:00 a.m. | Q&A Panel
    ENGINEERING DATA SOLUTIONS
    B1: Leveraging Data to Improve Efficiency and Effectiveness
      Moderator
    • Arne Zilian, PhD, Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

    This session will discuss practical applications of machine learning (ML) in pharmaceutical manufacturing. Presenters will share a case study showing, being in a situation of rapidly growing demand, how to improve outcomes like manufacturing efficiency and effectiveness, planning/execution, time to release, and process yield. Participants will leave with a better understanding of the technical, cultural, and financial challenges to be overcome when introducing ML tools in complex regulatory environments.

    • 10:00 a.m. | Learning from Introducing AI/ML based solutions at the Manufacturing Sites
      Fausto Artico, PhD, AI/ML Product Manager, GSK
    • 10:30 a.m. | An Advanced Process Control Framing to Application of Analytics and Modeling for Biopharma Manufacturing Processing
      Ramila H. Peiris, PhD, Applied Analytics and Operations Team Leader, Biogen
    • 11:00 a.m. | Q&A Panel

    11:30 a.m. – 2:00 p.m. | Networking Luncheon and Poster Presentations in Exhibit Hall

    2:00 p.m. – 3:30 p.m. | Concurrent Sessions and Interest Groups

    DEVELOPING NEW MODALITIES
    A2: Overcoming Challenges in Supply Chain for New Modalities
      Moderator
    • Shelley M. Preslar, MBA, PMP, Managing Partner, Azzur Group Raleigh

    There is no question that the development of recent drug product modalities has provided impressive additions to the patient treatment portfolio. With these scientific breakthroughs come significant changes to the traditional manufacturing process. Considerable differences can be found in the supply chain when considering the manufacturing of personalized medicine such as advanced therapy medicinal products (ATMPs). The supply chain must be completely mapped and controlled from the collection point through manufacturing and back to the patient to ensure that patient-specific treatments arrive at the correct patient within the limited window of time (commonly hours to days). This session will explore approaches to addressing these new supply chain considerations, while continuing to ensure a safe and effective patient treatment.

    • 2:00 p.m. | The Impact of Innovation on Building the Facilities of the Future
      John Khoury, Project Farma
    • 2:30 p.m. | Industry Representative Invited
    • 3:00 p.m. | Q&A Panel
    ENGINEERING DATA SOLUTIONS
    B2: Managing Data Flow in a Compliance Environment
      Moderator
    • Jason Kerr, MBS, Quality Assurance Specialist, Amgen, Inc.

    In the biopharmaceutical industry there are millions of ways that data can be generated, but in a dynamic regulatory environment, the ability of manufacturers to appropriately handle the flow of data becomes increasingly challenging. Some challenges are ensuring the integrity of the data in a compliant format, utilizing appropriate data sciences and methods to evaluate the data to provide a fruitful outcome, and integrating newer technologies to assist in the generation and evaluation of data. This session will explore new methods of capturing data and knowledge while remaining adaptable in a compliance environment for manufacturing, supply chain, quality and how advanced data analytics can foster culture of quality and quality metrics program within organizations.

    • 2:00 p.m. | Industry Representative Invited
    • 2:30 p.m. | Industry Representative Invited
    • 3:00 p.m. | Q&A Panel

    3:30 p.m. – 4:00 p.m. | Refreshment Break

    4:00 p.m. – 5:30 p.m. | Concurrent Sessions and Interest Groups

    DEVELOPING NEW MODALITIES
    A3: Aging Infrastructure Made New Again
      Moderator
    • Ghada N. Haddad, PhD, Executive Director, Global cGMP & Compliance Auditing Organization, Merck & Co. Inc.

    Aging infrastructure brings risk. Aging and poorly maintained infrastructure exposes companies to a number of risks. Deteriorating infrastructure can increase the risk of facilities, processes and systems to meet the demands of the company’s operational goals. The “c” in GMP stands for “current”. This means that companies should be using technologies and systems that are up to date in order to comply with the regulations and that systems and equipment should be adequate enough to prevent contamination, and to eliminate potential mix-ups for example. An older facility does not always mean an aging facility if companies have in place controls to ensure that the facility and processes continue to operate properly. In this session, learn how you can conduct a quality risk assessment exercise to understand the design, procedural, and qualification controls in place to ensure there are no potential risks to product quality and ultimately, to patient safety and if it’s time to rebuild or install new technology/new equipment to protect products, meet current regulations, and to keep up with today’s demands.

    • 4:00 p.m. | The Use of Robots in Aseptic Filling in Compounding Pharmacies, Are They Showing Industry the Pathway into the 21st Century?
      Chris J. Smalley, PhD, Compounding Pharmacist Advisor, ValSource LLC
    • 4:30 p.m. | Demonstrating Innovated Facility Modifications of Existing Facilities
      William J. Deckert, Global Consultant, CAI
    • 5:00 p.m. | Q&A Panel
    ENGINEERING DATA SOLUTIONS
    B3: Back to Future Basics: Securing GMP Foundations/Basics to Support Rapidly Evolving Technology
      Moderator
    • Kelly Waldron, PhD, Senior Consultant, ValSource LLC

    The pharmaceutical industry in 2020 looks drastically different to that of decades past. The excitement and promise of novel therapeutic modalities, artificial intelligence, machine learning, and Pharma 4.0 have captured industry’s attention. It is easy, in this world, to downplay or even neglect our roots – proven GMP foundations upon which these trending topics must rest. The future of industry will require the creative application of quality principles to our most essential processes, those common to all pharmaceutical processes in the world – basic GMPs. This session will share novel approaches to improve effectiveness and efficiency of GMPs to remind us of the power of these core principles.

    • 4:00 p.m. | Industry Representative Invited
    • 4:30 p.m. | Measuring the Unmeasurable: A tool for creating effective, measurable training content
      Katherine Hebert, Regeneron Pharmaceuticals
      Ashley Giambrone, Regeneron Pharmaceuticals
    • 5:00 p.m. | Q&A Panel

    6:00 p.m. – 9:00 p.m. | Reception

    Wednesday, April 1

    • 7:00 a.m. – 4:00 p.m. | Registration Open
    • 7:00 a.m. – 8:00 a.m. | Continental Breakfast
    • 7:00 a.m. – 12:00 p.m. | Speaker Ready Room Open
    P4: Strategies for Developing Next Generation Medicine
    8:00 a.m. – 9:30 a.m.
      Moderator
    • Morten Munk, Director – Global Alliance Manager, FUJIFILM Diosynth Biotechnologies

    Small molecule was the only player on the pharmaceutical field, until protein-based therapeutics revolutionized the health care space in the 1980s. Since then, these two therapeutic areas have developed tremendously and offer pivotal treatment options for patients all over the world.

    During the last few years, an impressive number of new types of therapeutic products and technologies have emerged and offer new treatments for diseases. This includes personal treatment with genes and whole cells, combinations of small molecules and proteins, treatment with living microbial cells, and many other modalities.

    These new treatments and products are typically based on a more profound understanding of the diseases they aim to cure, and required deployment of new technologies, including a wide variety of digitalization technologies, to discover, develop, and produce those new products.

    This session will focus on some of some of these new pharmaceutical regimes and the challenges of making these products available to patients.

    • 8:00 a.m. – 8:30 a.m. | Patrick G. Buckner, Global Head of Industry Solutions - Life Sciences, Amazon Web Services (AWS)
    • 8:30 a.m. – 9:00 a.m. | Industry Representative Invited
    • 9:00 a.m. – 9:30 a.m. | Q&A Panel

    9:30 a.m. – 10:00 a.m. | Refreshment Break

    10:00 a.m. – 11:30 a.m. | Concurrent Sessions and Interest Groups

    DEVELOPING NEW MODALITIES
    A4: Modernizing Legacy Products
      Moderator
    • Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.

    The diversity of molecules in the pharmaceutical pipeline, and those that are approved for today’s therapies, are changing the regulatory landscape and are a catalyst for manufacturing modernization. Legacy manufacturing systems can be defined by age and/or the suitability of the total system with the molecule and its environment. The quality of pharmaceuticals can be compromised by using antiquated manufacturing equipment, components, and processes. The adaptation of legacy systems to innovative and novel pharmaceutical products may not be possible, regardless of the age. It is foreseeable that patient access to lifesaving medicines will depend upon modernization of manufacturing systems to advance pharmaceutical products for the 21st century. In this session, participants will learn about the risks associated with legacy manufacturing and emerging manufacturing technologies.

    • 10:00 a.m. | Post-Approval CMC Changes and Impact to Global Product Supply – balancing health authority’s imperative to protect their patients with industry’s goals to provide doses to meet them
      Kimberly Duffy, Executive Director, Global Regulatory Affairs Vaccines CMC, Merck and Co., Inc.
    • 10:30 a.m. | Industry Representative Invited
    • 11:00 a.m. | Q&A Panel
    ENGINEERING DATA SOLUTIONS
    B4: Innovative Approaches to Enable Real-Time Release
      Moderator
    • Kristin N. Valente, PhD, Director, Global Vaccine Technical Operations Laboratories, Merck & Co., Inc.

    ICH Q8 and EU GMP Annex 17 define real-time release testing (RTRT) as relying on process data (both measured material attributes and process controls) to ensure product quality. RTRT methodologies have become increasingly common with small molecules, and some initial successes have been demonstrated with therapeutic protein cell culture and chromatography; however, parenteral drugs continue to face challenges with traditionally lengthy release tests such as sterility and adventitious agent testing. Successful implementation of RTRT techniques requires both advanced analytical tools for attribute detection and state of the art mechanistic and empirical models for predicting process performance. This session will explore the blend of novel analytics with process models to enable real-time release. Innovations ranging from disruptive technologies to implemented manufacturing controls will be discussed.

    • 10:00 a.m. | Amgen’s experience on optimized testing strategies as well as application of novel technologies that can be applied to achieve real-time release testing. The development and current application of Raman technology and a Multi-attribute method based on mass spectrometry will be highlighted.
      Jette Wypych, Amgen
    • 10:30 a.m. | Industry Representative Invited
    • 11:00 a.m. | Q&A Panel

    11:30 a.m. – 2:00 p.m. | Networking Luncheon and Poster Presentations in Exhibit Hall

    • 2:00 p.m. – 3:45 p.m. | P5: Closing Plenary
    • 2:00 p.m. – 2:30 p.m. | Regulatory Representative Invited
    • 2:30 p.m. – 3:00 p.m. | Industry Representative Invited
    • 3:00 p.m. – 3:30 p.m. | Q&A Panel
    • 3:30 p.m. | Closing Remarks and Adjournment from Co-Chairs of the 2021 PDA Annual Meeting Program Planning Committee