Skip To The Main Content
Agenda

Agenda

 

Agenda

As of 15 February 2021 | All times listed are EDT
 
 
  • Agenda at a glance

    MONDAY, 15 MARCH

    • Opening Plenary

      10:00 – 11:30
    • Virtual Exhibition Experience and Posters

      11:30 – 12:30
    • Concurrent Sessions Live Panel Discussions and Q&A

      12:30 – 13:15
    • Connect & Network

      13:15 – 14:00
    • Virtual Exhibition Experience and Posters

      14:00 – 14:45
    • Concurrent Sessions Live Panel Discussions and Q&A

      14:45 – 15:30
    • Connect & Network

      15:30 – 16:15
    • Trivia with PDA

      16:15 – 17:15
    • Break

      17:15 – 20:15
    • Concurrent Sessions Live Panel Discussions and Q&A

      20:15 – 21:00
    • Connect & Network

      21:00 – 21:45
    • Virtual Exhibition Experience and Posters

      21:45 – 22:30
    • Concurrent Sessions Live Panel Discussions and Q&A

      22:30 – 23:15
    • Connect & Network

      23:15 – 00:00

    TUESDAY, 16 MARCH

    • Plenary

      10:00 – 11:30
    • Virtual Exhibition Experience and Posters

      11:30 – 12:30
    • Concurrent Sessions Live Panel Discussion and Q&A

      012:30 – 13:15
    • Connect & Network

      13:15 – 14:00
    • Virtual Exhibition Experience and Posters

      14:00 – 14:45
    • Concurrent Sessions Live Panel Discussion and Q&A

      14:45 – 15:30
    • Connect & Network

      15:30 – 16:15
    • Break

      16:15 –20:15
    • Concurrent Sessions Live Panel Discussions and Q&A

      20:15 – 21:00
    • Connect & Network

      21:00 – 21:45
    • Virtual Exhibition Experience and Posters

      21:45 – 22:30
    • Concurrent Sessions Live Panel Discussions and Q&A

      22:30 – 23:15
    • Connect & Network

      23:15 – 00:00

    WEDNESDAY, 17 MARCH

    • Concurrent Sessions Live Panel Discussions and Q&A

      10:00 – 10:45
    • Connect & Network

      10:45 – 11:30
    • Virtual Exhibition Experience and Posters

      11:30 –12:30
    • Concurrent Sessions Live Panel Discussion and Q&A

      12:30 –13:15
    • Connect & Network

      13:15 – 14:00
    • Closing Plenary

      14:00 – 15:45
    • Break

      15:45 – 20:15
    • Concurrent Sessions Live Panel Discussions and Q&A

      20:15 – 21:00
    • Connect & Network

      21:00 – 21:45
    • Virtual Exhibition Experience and Posters

      21:45 – 22:30
    • Concurrent Sessions Live Panel Discussion and Q&A

      22:30 – 23:15
    • Connect & Network

      23:15 – 00:00
  • Daily schedule

    Monday, 15 March

      10:00 – 11:30 | Opening Plenary

      John F. Kelly is Vice President, Quality Operations and Environment, Health & Safety, responsible for leading the overall Quality function for Pfizer and for leading global EHS across the Company. John is a member of the PGS Leadership Team. John is a member of the Pfizer PAC Board of Directors and past member of the Pfizer PAC Steering Committee and is Chairman of the Board of Directors of Zydus Hospira Oncology Private Limited, a joint venture between Pfizer and Zydus Cadila. He is also a member of the Board of Directors of The Patterson Club, Fairfield, CT, a member of the Board of Trustees of Wakeman Boys & Girls Club, a member of the Worcester Polytechnic Institute Engineering Dean’s Advisory Board, and past co-President of the Fairfield College Preparatory School Fathers’ Club. John joined Pfizer in 1982 as Plant Services Engineer at the Brooklyn, New York site. Prior to his current position, he held assignments in New York, (Technical Services, Plant Network Strategy, Strategy, Transitioning Sites), Brooklyn, New York (Engineering, Manufacturing), Barceloneta, Puerto Rico (Manufacturing, Quality Operations) and Vega Baja, Puerto Rico (Site Leader). He assumed his current position in 2017. John holds a B.S. in Chemical Engineering from Worcester Polytechnic Institute and an M.B.A. in Operations Management from Pace University.

      Dr. Jeffrey C. Baker received a bachelor’s degree in biochemistry and molecular biology at Northwestern University, doctorate in biochemistry from the University of North Texas, and completed post-doctoral studies at the University of California, Berkeley. He joined Eli Lilly & Co in 1988, led the development and launch of several first in class biologics and subsequently supported pharmaceutical and biopharmaceutical manufacturing as a senior technical lead in the global Manufacturing Sciences and Technology unit. Dr. Baker left Lilly to be Sr. Director of Manufacturing Science and Technology at AstraZeneca and, in 2011, was appointed Deputy Director of the Office of Biotechnology Products in the Center for Drug Evaluation and Research, FDA. Dr. Baker has been recognized with several citations for leadership and program development, most recently, with a 2018 FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology products through sustained creative leadership and collaboration.”

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

    • 10:00 – 10:15 | Welcome from PDA Leadership and the Program Planning Committee Chair
    • Jette Christensen, PhD, Chair, PDA Board of Directors
    • Richard M. Johnson, President and CEO, PDA Chair
    • Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    • 10:15 – 10:40 | Moving at the Speed of Science: Pfizer-BioNTech COVID-19 Vaccine
      John F. Kelly
      , Vice President, Quality Operations and Environment, Health & Safety, Pfizer Global Supply
      10:40 – 11:05 | Deployment of New Technologies in Real World Biopharmaceutical Manufacturing
      Jeffrey C. Baker
      , Deputy Director, Office of Biotechnology Products, CDER, U.S. FDA
      11:05 – 11:30 | Live Panel Discussion and Q&A

    11:30 – 12:30 | Virtual Exhibition Experience and Posters

    11:45 – 12:15 | Press Conference

    12:30 – 13:15 | Live Panel Discussions and Q&A

    A1: Fueling the Second Wind for Aseptic Processing
      Moderator
    • Kenneth Paddock, Quality Director, Sterility Assurance, Baxter Healthcare

    Assessing sterility assurance in aseptic processing and managing the associated risks are critical activities in the pharmaceutical industry. This session will incorporate a thought-provoking discussion revolving around advanced aseptic processing technology and the associated quality risks in the current environment where smart manufacturing creates a more holistic and interconnected system. Concurrent with these advanced technologies, a systematic approach to techniques in aseptic processing, quality risk management, including assessments based on scientific data, will help participants understand how risk-based decisions may be taken.

    Aseptic Parametric Release
    Frederic Ayers, PhD, Research Scientist, Eli Lilly and Company

    Campaign Promise: Points to Consider When Designing a Multi-Batch Aseptic Processing Campaign
    Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource Inc.

    Lessons Learned from QRM Practitioners
    Tiffany  Baker, MBA, Consultant, ValSource Inc.
    Amanda M. McFarland, MS, Senior Consultant, ValSource Inc.
    Danica Brown, Consultant, ValSource Inc.

    Pre-use/Post Sterilization Integrity Testing - Results of the SFQRM
    Maik W. Jornitz, CEO, G-CON Manufacturing Inc

    B1: Tools and Methods to Enable Regulatory Excellence
      Moderator
    • Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems

    In a global and heavily regulated industry, pharmaceutical companies are dealing with a dynamic and complex regulatory landscape, as well as ever evolving compliance and regulatory requirements. In order to succeed, professionals need the right tools and methodologies to ensure that they are being proactive rather than reactive. This proactive paradigm shift can enable a smoother and more transparent era that avoids unnecessary costs and facilitates faster delivery to the patient. In this session, thought leaders will provide their knowledge management strategies, propose models to ensure proactive GMP compliance through comprehensive Quality Management Systems, and leverage prior data to establish product stability. Attendees will leave with a new toolbox of ideas to drive regulatory excellence, shorten timelines, and ultimately provide benefit to patients.

    Capturing and Monitoring Product Development Knowledge
    Rhonda Sundberg, MS, Principal Scientist, Biogen

    Evolution of Regulatory "Expectations" - Enabler or Block to an Effective PQS?
    Karen Ginsbury, BPharm, MSc, Owner, PCI Pharmaceutical Consulting Israel

    Taking Stability off the Critical Path of Product Development for Biological Medicinal Products
    Andrew C. Lennard, PhD, Reg CMC, Amgen

    13:15 – 14:00 | Connect & Network

    14:00 – 14:45 | Virtual Exhibition Experience and Posters

    14:45 – 15:30 | Live Panel Discussions and Q&A

    A2: Pragmatic Quality Risk Management: QbD Applications, Knowledge Management, and Risk Reduction
      Moderator
    • Amanda M. McFarland, MS, Senior Consultant, ValSource Inc.

    With each risk activity, comes the inevitable task of breaking the inputs and outputs into manageable (and actionable) pieces. In this session, Quality by Design (QbD) will be discussed from an applications perspective and give insight to the types of tools available to reap the benefits QbD. We will dive into Knowledge Management, the “orphan enabler”, as a means to drive more risk-based decision making. The session will conclude with an exploration risk reduction and how Bayesian statistics can deepen process understanding.

    Evolution of Analytical Strategies: QbD in Analytics
    Robert Mayer, PhD, Senior Fellow, Novartis

    Holding on to What You Know: Improving Knowledge Transfer to Reduce Risk and Benefit Patients
    Martin J. Lipa, Executive Director, Knowledge Management, Merck & Co., Inc.

    Modern Statistical Methods Accelerate Development & Reduce Risk
    Katherine E. Giacoletti, M. Statistics, Statistical Consultant, Partner, SynoloStats LLC

    B2: Flexible Facilities and Technologies: Innovative Options for the Future
      Moderator
    • Kristen Dowling, Senior Manager, Quality, Amgen

    The pandemic has shown that a more flexible, modern, and scientifically sound approach to manufacturing is required to allow for essential product manufacture, distribution, and availability. Due to the challenges with the time and cost required to build new manufacturing infrastructures, it is necessary to implement agile manufacturing designs and continue to find innovate ways to manufacture product. It is also important to harness new technologies that enable manufacturers to advance the production of high-quality drugs that are safe, effective, and delivered to a global patient population expeditiously. This session will focus on the benefits of new facility and manufacturing infrastructure options to increase production capabilities and flexibility. Discussions will also focus on new innovative technology such as Blow Fill Seal Aseptic Technology. Case studies will be presented to further understand the advancements of Blow Fill Seal Aseptic Technology and how this can improve the sterility of product.

    A Review of Innovative Facility Options in an Era of Urgent Capacity Needs
    Peter J. Makowenskyj, MEng, Director of Sales Engineering, G-CON Manufacturing Inc

    Blow Fill Seal Technology is Expanding its Reach into the Aseptic Processing World
    Leonard F. Pauzer, Director Process Technology, Integrated Project Services

    Novo Nordisk Approach to Modernizing Existing Facilities by Introducing New Innovative Technologies and Processes
    Thomas Busch, Project Director, Novo Nordisk A/S

    15:30 – 16:15 | Connect & Network

    16:15 – 17:15 | Trivia with PDA

    20:15 – 21:00 | Live Panel Discussions and Q&A

    A1: Fueling the Second Wind for Aseptic Processing
      Moderator
    • Kenneth Paddock, Quality Director, Sterility Assurance, Baxter Healthcare.

    Assessing sterility assurance in aseptic processing and managing the associated risks are critical activities in the pharmaceutical industry. This session will incorporate a thought-provoking discussion revolving around advanced aseptic processing technology and the associated quality risks in the current environment where smart manufacturing creates a more holistic and interconnected system. Concurrent with these advanced technologies, a systematic approach to techniques in aseptic processing, quality risk management, including assessments based on scientific data, will help participants understand how risk-based decisions may be taken.

    Aseptic Parametric Release
    Frederic Ayers, Research Scientist, Eli Lilly and Company

    Campaign Promise: Points to Consider When Designing a Multi-Batch Aseptic Processing Campaign
    Stephen E. Langille, PhD, Senior Microbiology Consultant, ValSource Inc.

    Lessons Learned from QRM Practitioners
    Tiffany Baker, MBA, Consultant, ValSource
    Amanda M. McFarland, MS, Senior Consultant, ValSource Inc.
    Danica Brown, Consultant, ValSource Inc.

    Pre-use/Post Sterilization Integrity Testing - Results of the SFQRM
    Maik W. Jornitz, CEO, G-CON Manufacturing Inc

    B1: Tools and Methods to Enable Regulatory Excellence
      Moderator
    • Jason Kerr, MBS, MBA, Senior GXP Specialist, Redica Systems

    In a global and heavily regulated industry, pharmaceutical companies are dealing with a dynamic and complex regulatory landscape, as well as ever evolving compliance and regulatory requirements. In order to succeed, professionals need the right tools and methodologies to ensure that they are being proactive rather than reactive. This proactive paradigm shift can enable a smoother and more transparent era that avoids unnecessary costs and facilitates faster delivery to the patient. In this session, thought leaders will provide their knowledge management strategies, propose models to ensure proactive GMP compliance through comprehensive Quality Management Systems, and leverage prior data to establish product stability. Attendees will leave with a new toolbox of ideas to drive regulatory excellence, shorten timelines, and ultimately provide benefit to patients.

    Capturing and Monitoring Product Development Knowledge
    Rhonda Sundberg, MS, Principal Scientist, Biogen

    Evolution of Regulatory "Expectations" - Enabler or Block to an Effective PQS?
    Karen Ginsbury, BPharm, MSc, Owner, PCI Pharmaceutical Consulting Israel

    Taking Stability off the Critical Path of Product Development for Biological Medicinal Products
    Andrew C. Lennard, PhD, Reg CMC, Amgen

    21:00 – 21:45 | Connect & Network

    21:45 – 22:30 | Virtual Exhibition Experience and Posters

    22:30 – 23:15 | Live Panel Discussions and Q&A

    A2: Pragmatic Quality Risk Management: QbD Applications, Knowledge Management, and Risk Reduction
      Moderator
    • Amanda M. McFarland, MS, Senior Consultant, ValSource Inc.

    With each risk activity, comes the inevitable task of breaking the inputs and outputs into manageable (and actionable) pieces. In this session, Quality by Design (QbD) will be discussed from an applications perspective and give insight to the types of tools available to reap the benefits QbD. We will dive into Knowledge Management, the “orphan enabler”, as a means to drive more risk-based decision making. The session will conclude with an exploration risk reduction and how Bayesian statistics can deepen process understanding.

    Evolution of Analytical Strategies: QbD in Analytics
    Robert Mayer, PhD, Senior Fellow, Novartis

    Holding on to What You Know: Improving Knowledge Transfer to Reduce Risk and Benefit Patients
    Martin J. Lipa, Executive Director, Knowledge Management, Merck & Co., Inc.

    Modern Statistical Methods Accelerate Development & Reduce Risk
    Katherine E. Giacoletti, M. Statistics, Statistical Consultant,Partner, SynoloStats LLC

    B2: Flexible Facilities and Technologies: Innovative Options for the Future
      Moderator
    • Kristen Dowling, Senior Manager, Quality, Amgen

    The pandemic has shown that a more flexible, modern, and scientifically sound approach to manufacturing is required to allow for essential product manufacture, distribution, and availability. Due to the challenges with the time and cost required to build new manufacturing infrastructures, it is necessary to implement agile manufacturing designs and continue to find innovate ways to manufacture product. It is also important to harness new technologies that enable manufacturers to advance the production of high-quality drugs that are safe, effective, and delivered to a global patient population expeditiously. This session will focus on the benefits of new facility and manufacturing infrastructure options to increase production capabilities and flexibility. Discussions will also focus on new innovative technology such as Blow Fill Seal Aseptic Technology. Case studies will be presented to further understand the advancements of Blow Fill Seal Aseptic Technology and how this can improve the sterility of product.

    A Review of Innovative Facility Options in an Era of Urgent Capacity Needs
    Peter J.  Makowenskyj, MEng, Director of Sales Engineering, G-CON Manufacturing Inc

    Blow Fill Seal Technology is Expanding its Reach into the Aseptic Processing World
    Leonard F. Pauzer, Director Process Technology, Integrated Project Services

    Novo Nordisk Approach to Modernizing Existing Facilities by Introducing New Innovative Technologies and Processes
    Thomas Busch, Project Director, Novo Nordisk A/S

    23:15 – 00:00 | Connect & Network

    Tuesday, 16 March

      10:00 – 11:30 | Plenary

      Dr. Morris is the Executive Director of the American Association of Pharmaceutical Scientists (AAPS). She leads the staff team that supports all operational aspects of the Association and works with the AAPS Board of Directors and other Volunteer Leadership Committees on the strategic and direction-setting activities that guide the work of the scientific society. Prior to that, she was Vice President of Scientific and Regulatory Affairs at the Parenteral Drug Association (PDA). Until 2018, Dr. Morris held several scientific senior leadership positions at the United States Pharmacopeia (USP), including as the Global Head of Biologics and Senior Vice President of Compendial Science. Before joining USP in 2003, Dr. Morris worked in the biopharmaceutical industry, with an expertise focus on analytical development and product characterization. She completed her postdoctoral research at the National Institutes of Health. She holds a Ph.D. in molecular virology from the Medical University of Luebeck, Germany, and a master’s degree in biology from the Carl von Ossietzky University of Oldenburg, Germany.

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

    • 10:00 – 10:15 | Day 1 Recap
    • Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    • 10:15 – 10:40 | Pharmaceutical Development through the COVID Future Lens
      Tina S. Morris, PhD
      , Executive Director, American Association of Pharmaceutical Scientists
      10:40 – 11:05 | Industry Representative Invited
      11:05 – 11:30 | Live Panel Discussion and Q&A

    11:30 – 12:30 | Virtual Exhibition Experience and Posters

    12:30 – 13:15 | Live Panel Discussions and Q&A

    A3: Advancing Cell and Gene Therapies in the New Normal
      Moderator
    • Melissa S. Seymour, MBA, Chief Quality Officer, Biogen

    This presentation will provide information and insight into recent and relevant regulations for ATMPs that can derail the approval process. From materials, cryopreservation, logistics, manufacturing, and facility design, this session will provide pragmatic strategies and tools to navigate the complex scientific and regulatory environment. Attendees will gain a greater understanding of ATMP cryopreservation, facility design, logistics, and regulatory classifications and will leave with the knowledge to assess complex subjects associated with ATMP production and have confidence in communication with regulators during interactions.

    An Innovative & Pragmatic Regulatory Approach to the Classification and Management of ATMP Materials
    Francesco Cicirello, Associate Director Quality Assurance, Adaptimmune

    BioPharma Cell and Gene Therapy Challenges and Solutions in an Ever-Evolving Regulatory Landscape
    Kevin Smyth, BE, MICHEME, CENG, Global Director Process Technology, Global Strategy and Technology Group, IPS-Integrated Project Services

    Cell Therapy Cryopreservation and Logistics: A Cold Subject Becomes a Hot Topic
    Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc.

    B3: Digital Revolution: Pharma Opportunities from Transformational Technology
      Moderator
    • Mirko Gabriele, Director of Technical Operations, Thermofisher Scientific

    The internet of things, digital platforms, data mining and analysis, pharma 4.0, and pharma artificial intelligence, are just few examples of concepts impacting drug manufacturing. The digital revolution has started, and companies need to be ready to leverage expertise and tools native of other environments to customize and support drug delivery. In this session, presenters will describe how ready and willing they are and how they can support our work. Attendees will hear about the theory of digitalization and discover exciting industry case studies.

    AI Application in CPV: Managing Biopharmaceutical Processes Understanding Their Complexity
    Toni Manzano, PhD, CSO and Co-Founder, Aizon

    Digital Transformation of Biologics Manufacturing & QC
    Vasu Rangadass, PhD, CEO, L7 Informatics, Inc.

    Embracing Pharma 4.0 - Ditch the Document for Data
    Gilad Langer, PhD, Industry Practice Lead, Tulip

    13:15 – 14:00 | Connect & Network

    14:00 – 14:45 | Virtual Exhibition Experience and Posters

    14:45 – 15:30 | Live Panel Discussions and Q&A

    A4: Production Design and Supplier Connectivity for Efficient Manufacturing
      Moderator
    • Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.

    Accessibility of life saving medicines depends upon timely product approvals and successful commercialization which is contingent upon manufacturing capacity and supply chain. Cross-functional communication will augment informed decisions and is a key factor for meeting the increasing production demands, especially with the advancement of novel and complex therapeutics. This session will bring to light manufacturing strategies to facilitate speed to market with consideration of material selection and supply management.

    Building the External Supplier Relationship: Ensuring a Safe and Productive Supply Chain
    Beth J. Haas, M.ChE, Principal Consultant, CAI, Inc

    How Do You Avoid Medical Device Recalls That Stem from Materials Issues?
    Jeff Ellis, PhD, Senior Technology Leader, EWI

    Production Design Strategies for Supply Agility and Resilience
    Leah Frautschy, ME, Senior Director of Equipment, Engineering and Automation, Clinical Supply Center, Genentech

    B4: Improving, Modernizing, Transforming – Process Validation Gets a (Much Needed) Upgrade
      Moderator
    • Amanda M. McFarland, MS, Senior Consultant, ValSource Inc.

    In this session, thought leaders introduce advanced ways of working in process validation. From automation, to data driven decisions and disrupting the norm—this session will challenge the current state of your process validation program and give you insight to advancement.

    Automated CPV Reporting: From Routine Compliance Exercise to State-of-the-art Process Monitoring
    Ashwin Monian, BS, Senior Engineering Specialist, Merck & Co., Inc.

    Risk-Based Cleaning Validation - Mathematics of Maximum Safe Carry over - Develop and Apply Limits
    Javier Cardenas, PhD, Senior Consultant, Azzur
    Susan B. Cleary, BCS, MBA, Director Product Development, Novatek International

    The Use and Misuse of Aseptic Process Simulations in the Validation of the Aseptic Processes
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    15:30 – 16:15 | Connect & Network

    16:15 – 20:15 | Break

    20:15 – 21:00 | Live Panel Discussions and Q&A

    A3: Advancing Cell and Gene Therapies in the New Normal
      Moderator
    • Melissa S.  Seymour, MBA, Chief Quality Officer, Biogen

    This presentation will provide information and insight into recent and relevant regulations for ATMPs that can derail the approval process. From materials, cryopreservation, logistics, manufacturing, and facility design, this session will provide pragmatic strategies and tools to navigate the complex scientific and regulatory environment. Attendees will gain a greater understanding of ATMP cryopreservation, facility design, logistics, and regulatory classifications and will leave with the knowledge to assess complex subjects associated with ATMP production and have confidence in communication with regulators during interactions.

    An Innovative & Pragmatic Regulatory Approach to the Classification and Management of ATMP Materials
    Francesco Cicirello, Associate Director Quality Assurance, Adaptimmune

    BioPharma Cell and Gene Therapy Challenges and Solutions in an Ever-Evolving Regulatory Landscape
    Kevin Smyth, BE, MICHEME, CENG, Global Director Process Technology, Global Strategy and Technology, IPS-Integrated Project Services

    Cell Therapy Cryopreservation and Logistics: A Cold Subject Becomes a Hot Topic
    Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc.

    B3: Digital Revolution: Pharma Opportunities from Transformational Technology
      Moderator
    • Mirko Gabriele, Director of Technical Operations, Thermofisher Scientific

    The internet of things, digital platforms, data mining and analysis, pharma 4.0, and pharma artificial intelligence, are just few examples of concepts impacting drug manufacturing. The digital revolution has started, and companies need to be ready to leverage expertise and tools native of other environments to customize and support drug delivery. In this session, presenters will describe how ready and willing they are and how they can support our work. Attendees will hear about the theory of digitalization and discover exciting industry case studies.

    AI Application in CPV: Managing Biopharmaceutical Processes Understanding Their Complexity
    Toni Manzano, PhD, CSO and Co-Founder, Aizon

    Digital Transformation of Biologics Manufacturing & QC
    Vasu Rangadass, PhD, CEO, L7 Informatics, Inc.

    Embracing Pharma 4.0 - Ditch the Document for Data
    Gilad Langer, PhD, Industry Practice Lead, Tulip

    21:00 – 21:45 | Connect & Network

    21:45 – 22:30 | Virtual Exhibition Experience and Posters

    22:30 – 23:15 | Live Panel Discussions and Q&A

    A4: Production Design and Supplier Connectivity for Efficient Manufacturing
      Moderator
    • Diane M. Paskiet, MS, Director of Scientific Affairs, West Pharmaceutical Services, Inc.

    Accessibility of life saving medicines depends upon timely product approvals and successful commercialization which is contingent upon manufacturing capacity and supply chain. Cross-functional communication will augment informed decisions and is a key factor for meeting the increasing production demands, especially with the advancement of novel and complex therapeutics. This session will bring to light manufacturing strategies to facilitate speed to market with consideration of material selection and supply management.

    Building the External Supplier Relationship: Ensuring a Safe and Productive Supply Chain
    Beth J. Haas, M.ChE, Principal Consultant, CAI, Inc

    How Do You Avoid Medical Device Recalls That Stem from Materials Issues?
    Jeff Ellis, PhD, Senior Technology Leader, EWI

    Production Design Strategies for Supply Agility and Resilience
    Leah Frautschy, ME, Senior Director of Equipment, Engineering and Automation, Clinical Supply Center, Genentech

    B4: Improving, Modernizing, Transforming – Process Validation Gets a (Much Needed) Upgrade
      Moderator
    • Amanda M. McFarland, MS, Senior Consultant, ValSource Inc.

    In this session, thought leaders introduce advanced ways of working in process validation. From automation, to data driven decisions and disrupting the norm—this session will challenge the current state of your process validation program and give you insight to advancement.

    Automated CPV Reporting: From Routine Compliance Exercise to State-of-the-art Process Monitoring
    Ashwin Monian, BS, Senior Engineering Specialist, Merck & Co., Inc.

    Risk-Based Cleaning Validation - Mathematics of Maximum Safe Carry over - Develop and Apply Limits
    Javier Cardenas, PhD, Senior Consultant, Azzur
    Susan B. Cleary, BCS, MBA, Director Product Development, Novatek International

    The Use and Misuse of Aseptic Process Simulations in the Validation of the Aseptic Processes
    Hal Baseman, MBA, Chief Operating Officer, ValSource Inc.

    23:15 – 00:00 | Connect & Network

    Wednesday, 17 March

    10:00 – 10:45 | Live Panel Discussions and Q&A

    A5: Developing and Manufacturing Vaccines through Lessons Learned from Other Biologics
      Moderator
    • Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc.

    While vaccines have been key contributors to global human health since the early twentieth century, the past year has underlined their criticality. 2020 saw the development of nearly 70 vaccines to fight the Covid-19 pandemic, ranging from traditional live-virus and recombinant protein technologies to the inaugural approval of mRNA vaccines. In this session, we will explore new frontiers in vaccine development and manufacturing, with a focus on lessons learned from the biologic platforms. The Vaccine Interest Group (VIG) will review their recent Technical Report (TR) on vaccine development and lifecycle management and a case study in the application of a novel, rapid analytical method for vaccine fingerprinting will be discussed. Additionally, industry leaders will examine an innovative biologics case study assessing risk in lyophilized drug products and the application of QbD principles between biologics and vaccines. Attendees will leave these discussions with new perspectives on the next phase of vaccine development and manufacturing.

    Challenges and Progress in Vaccine Development
    Jane L. Halpern, PhD, Consultant, Self-Employed
    Sabrina Restrepo, PhD, Director, Merck & Co., Inc.

    Molecular Fingerprinting of Vaccines - Rapid Optical Technique for Vaccine QC
    Linda H. Kidder Yarlott, PhD, Life Science Business Development Manager, HORIBA Scientific

    Quality by Design- how to Successfully Accelerate Biopharmaceutical Products Development
    Cristiana Campa, PhD, Technical R&D Advisor and Fellow, GSK Vaccines
    M Amin Khan, PhD, VP, Vaccines R&D Acceleration, GSK Vaccines

    Risk Mitigation Through Physical and Chemical Testing: Lyophilized Drug Product Case Study
    Diego A. Zurbriggen, Technical Account Manager, West Pharmaceutical Services, Inc.
    Samantha Singer, MS, Scientist I/Project Director,Lyophilization Technology Inc.

    B5: Modern Toolkits for Enhancing People Competency, Improving Data Integrity through Culture Metrics
      Moderator
    • Ivy Louis, M.Pharm MBA(HRM), Founder-Director, VIENNI TRAINING & CONSULTING LLP

    Improvisation does not happen by itself, it happens only through change, but bringing change is a great challenge. The key to driving sustainable performance and health across all levels in an organization is a tall order, yet teams are doing this well, with new ways of revamping competency-building programs. These new approaches focus on helping employees develop the required knowledge, skills, and behaviors. This session is a must-go-to for all leaders in the operational domains because the speakers will share examples of failures. Listening to the speakers will help provide insights, tested tools, and pragmatic methodologies that will deliver for a higher success rate, regardless of the nature of the change program pursued. Aspects of leadership, elements of management, points for decision-making, must-haves for strategic planning, working in a matrix organization, and other skills related to organizational effectiveness will be the takeaways.

    Organization, Governance and Competency Development for Successful Parenteral Manufacturing
    Mauro Giusti, Advisor, Site External Network, Eli Lilly Italia

    The Modern Quality Professional Development Tool – Capability Uplift for Product Quality Leaders 
    Stephan Krause, PhD, Director of Product Quality, AstraZeneca

    The Role of Quality Culture in Assuring Data Integrity
    Christopher  J. Smalley, MBA, MS, PhD, Compounding Pharmacist Advisor, ValSource Inc.

    10:45 – 11:30 | Connect & Network

    11:30 – 12:30 | Virtual Exhibition Experience and Posters

    12:30 – 13:15 | Live Panel Discussions and Q&A

    A6: Leveraging Data Analytics along the Product Lifecycle
      Moderator
    • Arne Zilian, PhD, Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

    In this session, industry thought leaders will provide a review of novel data and risk management practices along the product lifecycle, including data integrity in clinical development facing new challenges in light of emerging disciplines of data generation; AI systems helping the industry to parse, categorize, and organize the high volume of agency enforcement documents, like 483 forms and GMP warning letters; and tools helping to assess supply chain maturity to avoid drug shortages.

    Data and Risk Management in the Final Frontier That Is Drug Supply Chain
    Christy Mazzarisi, Director & Quality Lead, CGI
    Renata E.  Skros, Senior Consultant, Q&M SME, CGI

    Enabling Quality and Regulatory Professionals with Structured Data and Actionable Insights Using AI
    Jerry L. Chapman, MBA, Senior GMP Quality Expert, Redica Systems

    Patient Reported Outcomes, RWE & Data: Safeguarding Integrity in the New Era of Clinical Development
    John Brennan, PhD, Independent Consultant, EAS Consulting Group

    B6: Achieving Maximum Flexibility in Pharmaceutical Manufacturing
      Moderator
    • Mary Oates, PhD, Senior Vice President, Global Quality, Emergent BioSolutions

    The urgent need for life-saving vaccines and therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing. Manufacturing multiple product types within a single facility, as well as the acceleration of alternate sterilization modalities to ensure availability of critical materials, have proven key to industry’s ability to successfully respond to the crisis. This session will highlight several risk-based strategies for achieving this much-needed flexibility.

    Case Study: Case Study: Risk-Based Approach for Evaluation of Cross-Contamination in Pharmaceutical Manufacturing
    Hanna R. Kviat Antonsen, QMS Specialist, Novo Nordisk A/S

    Cross Contamination Control Strategy in a Multiproduct Facility with BSL1 to 3 and Pandemic Products
    Michael O. Skidmore, MS, VP QA/QC, Quality Site Lead, Ology Bioservices, Inc

    Qualification of X-ray Sterilization for Single-Use Bioprocess Equipment
    James J. Hathcock, PhD, Senior Director, Regulatory and Validation Strategy, Pall Biotech

    13:15 – 14:00 | Connect & Network
      14:00 – 15:45 | Closing Plenary

      Dan Silvert is a behavioral expert, keynote speaker and executive coach. As President of Velocity Advisory Group, ranked 548 by the Inc. 5000 list of fastest growing companies in America, Dan has guided organizations through cultural transformations, building greater accountability into workplace culture, and leading change. Dan is the co-author of Taking Flight!, published in 9 languages. His latest book, The True Competitive Advantage, was released in January, 2018.

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

    • 14:00 – 14:15 | Day 2 Recap
    • Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates Inc.

    • 14:15 – 14:40 | Dan Silvert, President, Velocity Advisory Group
      14:40 – 15:05 | Industry Representative Invited
      15:05 – 15:30 | Live Panel Discussion and Q&A
      15:30 – 15:45 | Closing Remarks from Conference Chair

    15:45 – 20:15 | Break

    20:15 – 21:00 | Live Panel Discussions and Q&A

    A5: Developing and Manufacturing Vaccines through Lessons Learned from Other Biologics
      Moderator
    • Kristin N. Valente, PhD, Director, Vaccine Technical Operations, Merck & Co., Inc.

    While vaccines have been key contributors to global human health since the early twentieth century, the past year has underlined their criticality. 2020 saw the development of nearly 70 vaccines to fight the Covid-19 pandemic, ranging from traditional live-virus and recombinant protein technologies to the inaugural approval of mRNA vaccines. In this session, we will explore new frontiers in vaccine development and manufacturing, with a focus on lessons learned from the biologic platforms. The Vaccine Interest Group (VIG) will review their recent Technical Report (TR) on vaccine development and lifecycle management and a case study in the application of a novel, rapid analytical method for vaccine fingerprinting will be discussed. Additionally, industry leaders will examine an innovative biologics case study assessing risk in lyophilized drug products and the application of QbD principles between biologics and vaccines. Attendees will leave these discussions with new perspectives on the next phase of vaccine development and manufacturing.

    Challenges and Progress in Vaccine Development
    Jane L. Halpern, PhD, Consultant, Self-Employed
    Sabrina Restrepo, PhD, Director, Merck & Co., Inc.

    Molecular Fingerprinting of Vaccines - Rapid Optical Technique for Vaccine QC
    Linda H. Kidder Yarlott, PhD, Life Science Business Development Manager, HORIBA Scientific

    Quality by Design- how to Successfully Accelerate Biopharmaceutical Products Development
    Cristiana Campa, PhD, Technical R&D Advisor and Fellow, GSK Vaccines
    M Amin Khan, PhD, VP, Vaccines R&D Acceleration, GSK Vaccines

    Risk Mitigation Through Physical and Chemical Testing: Lyophilized Drug Product Case Study
    Diego A. Zurbriggen, Technical Account Manager, West Pharmaceutical Services, Inc.
    Samantha Singer, Scientist I/Project Director, Lyophilization Technology Inc.

    B5: Modern Toolkits for Enhancing People Competency, Improving Data Integrity through Culture Metrics
      Moderator
    • Ivy Louis, M.Pharm MBA(HRM), Founder-Director, VIENNI TRAINING & CONSULTING LLP

    Improvisation does not happen by itself, it happens only through change, but bringing change is a great challenge. The key to driving sustainable performance and health across all levels in an organization is a tall order, yet teams are doing this well, with new ways of revamping competency-building programs. These new approaches focus on helping employees develop the required knowledge, skills, and behaviors. This session is a must-go-to for all leaders in the operational domains because the speakers will share examples of failures. Listening to the speakers will help provide insights, tested tools, and pragmatic methodologies that will deliver for a higher success rate, regardless of the nature of the change program pursued. Aspects of leadership, elements of management, points for decision-making, must-haves for strategic planning, working in a matrix organization, and other skills related to organizational effectiveness will be the takeaways..

    Organization, Governance and Competency Development for Successful Parenteral Manufacturing
    Mauro Giusti, Advisor, Site External Network, Eli Lilly Italia

    The Modern Quality Professional Development Tool – Capability Uplift for Product Quality Leaders 
    Stephan Krause, PhD, Director of Product Quality, AstraZeneca

    The Role of Quality Culture in Assuring Data Integrity
    Christopher  J. Smalley, MBA, MS, PhD, Compounding Pharmacist Advisor, ValSource Inc.

    21:00 – 21:45 | Connect & Network

    21:45 – 22:30 | Virtual Exhibition Experience and Posters

    22:30 – 23:15 | Live Panel Discussions and Q&A

    A6: Leveraging Data Analytics along the Product Lifecycle
      Moderator
    • Arne Zilian, PhD, Manufacturing Science and Technology, Global Head Systems and Standards, Novartis

    In this session, industry thought leaders will provide a review of novel data and risk management practices along the product lifecycle, including data integrity in clinical development facing new challenges in light of emerging disciplines of data generation; AI systems helping the industry to parse, categorize, and organize the high volume of agency enforcement documents, like 483 forms and GMP warning letters; and tools helping to assess supply chain maturity to avoid drug shortages.

    Data and Risk Management in the Final Frontier That Is Drug Supply Chain
    Christy Mazzarisi, Director & Quality Lead, CGI
    Renata E. Skros, Senior Consultant, Q&M SME, CGI

    Enabling Quality and Regulatory Professionals with Structured Data and Actionable Insights Using AI
    Jerry L. Chapman, BS, MBA, Senior GMP Quality Expert, Redica Systems

    Patient Reported Outcomes, RWE & Data: Safeguarding Integrity in the New Era of Clinical Development
    John Brennan, PhD, Independent Consultant, EAS Consulting Group

    B6: Achieving Maximum Flexibility in Pharmaceutical Manufacturing
      Moderator
    • Mary Oates, PhD, Senior Vice President, Global Quality, Emergent BioSolutions

    The urgent need for life-saving vaccines and therapies as a result of the global pandemic has reinforced the criticality of flexibility in pharmaceutical manufacturing. Manufacturing multiple product types within a single facility, as well as the acceleration of alternate sterilization modalities to ensure availability of critical materials, have proven key to industry’s ability to successfully respond to the crisis. This session will highlight several risk-based strategies for achieving this much-needed flexibility.

    Case Study: Case Study: Risk-Based Approach for Evaluation of Cross-Contamination in Pharmaceutical Manufacturing 
    Hanna R. Kviat Antonsen, QMS Specialist,Novo Nordisk A/S

    Cross Contamination Control Strategy in a Multiproduct Facility with BSL1 to 3 and Pandemic Products
    Michael O. Skidmore, MS,
    VP QA/QC, Quality Site Lead, Ology Bioservices, Inc

    Qualification of X-ray Sterilization for Single-Use Bioprocess Equipment
    James J. Hathcock, PhD, Senior Director, Regulatory and Validation Strategy, Pall Biotech

    23:15 – 00:00 | Connect & Network