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2021 BioManu-1988x680

2021 PDA BioManufacturing Conference

Biomanufacturing in a New Era

Sep 14 - Sep 15, 2021
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Online
  • Europe
Program Highlights

This event will take place in parallel with the 2021 PDA Lyophilization Conference!

If you sign up for this event, you will have the chance to check out the full program of the Lyophilization Conference!
Join us online and make the most of this very special 2-for-1 offer

Overview

Dear Colleague, 

We warmly invite you to join us online for the 2021 PDA BioManufacturing Conference to be held on 14-15 September 2021 as a Virtual Event! PDA Europe’s online platform will ensure a full conference experience with mulitple options to interact and connect. The program will be complemented by side events such as an interactive Vaccines Interest Group Session and a Live Poster Lounge offering Q&A opportunities with our poster presenters in a seperate video chat room!

This year’s conference will focus on Biomanufacturing in the New Era. While the COVID- 19 emergency has unquestionably defined the start of a new phase for biopharmaceuticals and related aspects in manufacturing, quality control and regulation, issues such as acceleration, product supply, manufacturing capacity, innovative technologies, high-throughput manufacturing and rapid analytical testing, product accessibility are not necessarily new.  The pandemic simply put into greater focus the relevancy and urgency of these issues and the need for industry to make necessary changes to speed delivery of pharmaceutical innovation.  In addition, the crisis has evidenced the need for flexible regulatory frameworks and concurrence across Health Authorities to support rapid access of vaccines and biotherapeutics as well as sustainable lifecycle management. The 2021 BioManufacturing Conference will emphasize many of these topics ensuring a balanced perspective from Academia, Industry representatives and Regulators from EDQM, EMA and the Swedish Medicines Agency! 

We look forward to welcoming you online!

Sincerely,

The Chairs

Michael De Felippis, PhD
Eli Lilly and Company

Cristiana Campa, PhD
GSK Vaccines

Agenda

  • Day 1
  • Day 2
  • Tuesday, 14 September 2021

    Module I: Welcome & Opening Plenary: Advancing Biomanufacturing in a New Era
    12:00 - 14:45 CEST

    11:00 - 12:00
    Conference Portal Opens: Create your User Profile & Get Oriented & Join the Virtual Exhibition
    Welcome & Introductions Falk Klar, PDA Europe
    Welcome from the Chairs

    Cristiana Campa, GSK Vaccines
    Michael De Felippis, Eli Lilly & Company
    Raf De Dier, Janssen J&J
    Anthony Cannon, MSD

    Advancing Biomanufacturing in a New Era

    LIVE Session Introduction
     
    Keynote: Reinventing Pharma through Digital and Analytics – Where We Are Today? McKinsey
    EMA’s Perspective on the SARS-CoV-2 Pandemic 
    EMA
    The EMA Acceleration Toolkit  Swedish Medicines Agency
    Short Break
    The Annex 1 Revison and the Impact on BioManufacturing Roche
    GSK
    Speed to Clinic and How Different Functions Interact to Make it Happen LONZA
    LIVE Q&A, Discussion


    Break & Virtual Exhibition

    14:45 - 15:45 CEST

    Module II: Analytical Technologies & Strategies & Innovations in BioManufacturing 
    15:45 - 18:00 CEST

    Transition to Parallel Tracks
    Track A - Analytical Technologies & Strategies Track B - Innovations in BioManufacturing 
    LIVE Session Introduction LIVE Session Introduction
    Regulatory Perspective on ICHQ14 Dutch Medicines Evaluation Board The Digital Twin: Drug Substance and Drug Product Journey GSK
    How Can ICHQ14 Support Development and Change Management of Analytical Procedures? F-Hoffmann La Roche on behalf of EFPIA Accelerating Process Development with an Insilico Twin of Process Platform DataHow
    Implementing mAb Process Improvements Using an Analytical Comparability Approach MSD Model-Based Process Space Identification Imperial College London
    Short Break Short Break
    An Update from the EDQM EDQM Requirements, Approaches and Regulatory Considerations for Process Intensification in Upstream and Downstream Processing
    Sartorius Stedim
    Enzene Biosciences 
     LIVE Q&A, Discussion Facility, Technology, and Manufacturing Strategy Comparisons for Next Generation Bioprocessing Eli Lilly & Company / University College Dublin
    LIVE Q&A, Discussion


    End of Conference Day 1 and Interest Group Meeting Vaccines 

    18:00 CEST

    Interactive Vaccines Interest Group Meeting 
    18:30 - 20:00 CEST

    Agenda is subject to change without notice, all speakers pending confirmation

  • Wednesday, 15 September 2021

    Interactive Poster Session
    10:00 – 11:30 CEST

    09:00 - 10:00 CEST
    Conference Portal Opens: Create your User Profile, Get Oriented and Join the Virtual Exhibition
    10:00 - 11:30 CEST

    LIVE Interactive Poster Lounge

    Engage in a live Q&A opportunity with our Poster Presenters in a separate video chat room!


    Break & Virtual Exhibition
    11:30 - 12:00 CEST

    Module III: Control Strategies & Strategies & Supply Chain and Facilities 
    12:00 - 13:45 CEST

    Transition to Parallel Tracks
    Track A
    Control Strategies
    Track B
    Supply Chain and Facilities
    LIVE Session Introduction LIVE Session Introduction

    Contamination Control Strategy in the Pharmaceutical Industry - Impact on Environmental Monitoring Program

    Sanofi Shortages of Critical Raw Materials and Managing Changes and Substitutions Eli Lilly & Company
    Defining Limits for Analytical Method Outputs as Part of a Risk-based Control System Novartis Prefabricated Solutions – De-Risking your Facility
    G-CON Manufacturing
    Detection and Minimization of Risks from Particulate Matter during BioManufacturing using Single-Use Systems Sartorius Stedim 
    Evolutive Vaccines Facilities: the Answer to Vaccine Manufacturing New Paradigms
    Sanofi Pasteur
    Quality by Design as Driving Principle to Enable a Rational and Accelerated Product and Process Development Pathway GSK Vaccines Development of Advanced Process Analytical Technology (PAT) Tools for Live Virus Vaccine Manufacturing MSD
    LIVE Q&A, Discussion LIVE Q&A, Discussion


    Break & Virtual Exhibition
    13:45 – 14:30 CEST

    Module IV: Drug Product and Stability Predictions & Tech Transfer – Regulatory and Technical Considerations
    14:30 – 16:10 CEST 

    Track A
    Drug Product and Stability Predictions 
    Track B
    Tech Transfer – Regulatory and Technical Considerations 
    LIVE Session Introduction
    LIVE Session Introduction

    Accelerated Predictive Stability for Biologicals and Vaccines

    Sanofi

    Much Needed Convergence of Post Approval Change Guidelines Worldwide

    MSD

    Patient Centric Specifications – Enabling and Accelerating Supply

    Moderna

    Leveraging Platform Knowledge to Streamline Commercialization and Enhance Productivity

    Eli Lilly & Company
     

    Latest Innovations in Biologic Stability Modelling using Bayesian Stats and AI Deep Learning?

     Amgen Improving Process Robustness at Launch and in Early Commercial Supply Through Effective Risk Assessment

    GSK

    LIVE Q&A, Discussion LIVE Q&A, Discussion


    Break & Virtual Exhibition

    16:10 – 16:40 CEST

    Module V: Closing Plenary: Learnings from the Pandemic and Looking Towards the Future 
    16:40 – 18:30 CET

    Transition to Plenary
    Closing Plenary: Learnings from the Pandemic and Looking Towards the Future 

    LIVE Session Introduction 

    Updates on the COVAX Initiative  Speaker invited
    Timely Global Access to Vaccines: First Learnings from COVID-19 Pandemic Sanofi
    Recent Activities from the PDA COVID Task Force Speaker invited
    LIVE Closing Panel Discussion
    LIVE Conference Summaries by the Chairs of the BioManufacturing and the Pharmaceutical Lyophilization Conferences

    Cristiana Campa, GSK Vaccines
    Michael De Felippis, Eli Lilly & Company
    Raf De Dier, Janssen J&J
    Anthony Cannon, MSD

    Thank You Remarks and Farewell Falk Klar, PDA Europe

    Agenda is subject to change without notice, all speakers pending confirmation

Highlighted Speakers

Cristiana Campa
Cristiana Campa
GSK Vaccines
Michael R.  De Felippis
Michael R. De Felippis
Eli Lilly and Company

Registration Fees

Register Now
Early Registration
Registration Type Price by 18 JULY 2021
Virtual Member €1.395
Virtual Non-Member €1.695
Virtual Govern./Health Authority/Academic
Young Professional (Member)
€600
All fees given in Euro


Regular Registration
Registration Type Price after 18 JULY 2021
Virtual Member €1.595
Virtual Non-Member €1.895
Virtual Govern./Health Authority/Academic/
Young Professional (Member)
€600
All fees given in Euro


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