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IFPAC® - 2020

International Conference & Exhibition

February 23-26, 2020

Washington, D.C. U.S.A.

www.IFPACglobal.org

BIOTECHNOLOGY AT THE FOREFRONT

IFPAC-2020: CREATING CONNECTIONS

This 3.5 Day event includes powerful sessions, expert speakers, exhibition, and numerous networking opportunities. Participating in IFPAC is an opportunity to grow your network and generate in-depth, rich discussions that benefit the biotechnology, pharmaceutical, and related industries.

IFPAC-2020 is an opportunity to learn from your peers and make longstanding, meaningful connections.

OVERVIEW OF THE PROGRAM

Join Regulators, Industry Leaders, Renown Research Institutions, and Innovative Solution Providers.

Attend IFPAC-2020 and gain information from top industry experts across the globe who will be sharing current trends, best practices, case studies, and new technologies. Attendees come to hear from Industry, Academic, and Regulatory Leaders from across the globe covering critical and current topics.

Choose from 10 tracks and over 40 sessions filled with sharing ideas, roundtables, and Q&A.

You'll leave IFPAC-2020 with immediate solutions, long-term strategies, and the tools needed to prepare for the future.

Plus, a Pre-Conference Regulatory Workshop on Enabling Advanced Process Control Strategies through Modern Regulatory Pathways, and multiple Pre-Conference Short Courses available on Sunday, February 23rd.

Topics will Include:

IFPAC

· Manufacturing Technologies for Cell & Gene Therapies

· Cell & Gene Therapies / CAR T

· Lifecycle Management & Regulatory Framework

· Continuous Manufacturing in Biologics

· Advanced Biomanufacturing Technology & Innovation

· MS&T and Biologics

· BioSimilars

· Particles in Biologic Drug Products

· Single-Use Systems in Biopharmaceutical Product Manufacturing

· Real Time Monitoring / Real Time Analytics

· Data Infrastructure & Knowledge

· Quality Risk Management

· Industry 4.0 & Digital Manufacturing

· Lifecycle Management

· Emerging Regulatory Expectations - ICH Q12, ICH Q13, KASA…

· Analytical Technologies & Applications

· Control Strategy & Implementation

· Emerging/Innovative Technologies

· Analytical Technologies & Applications

· And More!

View the IFPAC-2020 Digital Program at www.IFPACglobal.org/program

REGISTER TODAY!

www.IFPACglobal.org/attendee-registration

PROGRAM HIGHLIGHTS

MS&T for Biologics

Chairs: Jose C. Menezes, Institute for Biotechnology & Biosciences, IST, University of Lisbon, Portugal, Ranjit Deshmukh, AstraZeneca, and Tony Wang, Amgen

Manufacturing Sciences & Technologies relate to science-based process and product understanding. It spans all stages from late stage development, through industrialisation and commercialization, of biologics. This session covers all aspects of Quality as a Manufacturing Science, as indicated in ICH Q8 through Q12 guidelines. Applications of QbD elements of biologics manufacturing, such as risk-assessments, PAT, DoE, control-strategy and lifecycle management initiatives, will be explored.

Speakers will include representatives from Amgen, Biogen, Eli Lilly, Kaiser Optical Systems, Novartis, Pall Corporation and 4Tune Engineering.

BioSimilars

Chairs: Antonio Moreira, University of Maryland - Baltimore County and Jose C. Menezes, Institute for Biotechnology & Biosciences, IST, University of Lisbon, Portugal

Across the globe, companies are investing in the development of biosimilars, thus making it a growing area of biological products. The US FDA has approved several products in recent years. This session will discuss various aspects of the analytical characterization and testing which represents the core foundation for the development of biosimilars.

Speakers will include representatives from the FDA, 4Tune Engineering, Global Biotech Experts, Ache Laboratories Farmaceuticos (Brazil), and more…

Advanced Biomanufacturing Innovation

Chair: Seongkyu Yoon, University of Massachusetts - Lowell

Biomanufacturing has become an emerging industry of strategic importance worldwide and is one of the key technology areas identified by the US Advanced Manufacturing Partnership (AMP) as an appropriate target for public-private investment to support advances in manufacturing and U.S. competitiveness. Session will seek to: 1) discuss the challenges and drivers of biomanufacturing in upstream, downstream and drug product processing, and 2) identify the major scientific/technological, operational and regulatory barriers to the adoption biomanufacturing in the biopharmaceutical industry.

Speakers will include representatives from the FDA, Ferring Pharmaceuticals, Genentech Inc., GlaxoSmithKline, Roche, Novo Nordisk, BMS, Amgen, Merck, Fujifilm, Sanofi, Applied Materials, Process Systems Enterprise (PSE), Sartorius Stedim, Sartorius Stedim Biotech, and Institute of Applied Biotechnology, Germany

Cell & Gene Therapies I & II

Chairs: Antonio Moreira, UMBC, Seongkyu Yoon, UMass-Lowell and Vaneeta Grover, GSK

Cell & Gene therapy is a quickly-evolving technology. This session will cover the technological challenges and engineering solutions for the advanced biomanufacturing of cell and gene therapies. Challenges requiring new paradigms in the manufacturing of the cell therapy products, recent advances in viral vector production, and emerging gene-editing tools and their deployment in human clinical trials are the main focus of the session.

Speakers will include representatives from the FDA, UMBC, 4Tune Engineering, Cell and Gene Therapy Catapult, Oxford Biomedica Limited, Aber Instruments Inc., and more.

Particles in Biologic Drug Products

Chair: Ashwinkumar Bhirde, FDA

The presence of particles in parenteral drug products is a critical quality attribute that directly impacts the quality, efficacy, and safety of the product. Particles in drug products can be unintentional effects of product, process, packaging, or contamination. Particles are found in all classes of drugs, including biotechnology products, and biologics. This session will 1) discuss analytical methods to detect, identify, characterize, and classify particles in biologic drug products; 2) discuss the regulatory considerations in conducting product quality review with regard to particles; and 3) discuss common concerns regarding particles in biologic drug products regulated by FDA.

Speakers will include representatives from the FDA/CDER, FDA/CBER, USP and NIST.

Smart Sensors for Bio-Processing

Chairs: Jagdish Tewari, Syros

Smart sensor applications in bio-processing are becoming increasingly essential and advanced. Real-time information from process sensors supports decision making and process control. Recent dramatic improvements in sensor technology including compactness and advanced microprocessor integration, particularly in wireless and microcontroller sensors, broaden the range of sensor applications in any field. Smart sensors are used for analog to digital conversion, digital processing, decision making, and two-way communications. This session will cover ways these smart sensors can benefit bio-processing.

Speakers will include representatives from DRS Daylight Solutions, Institute for Biotechnology & Biosciences, IST, University of Lisbon, Portugal, Novartis, University of Ottawa, Canada, GranuTools, University of Liege, Belgium, and Scientific Bioprocessing, Inc.

View More Details on Biotechnology at IFPAC-2020

www.IFPACglobal.org/biotechnology

IFPAC-2020 EXHIBITION

Represent your company amongst leaders! The three-day exhibition is an opportunity for generating innovative partnerships. Those companies interested in exhibiting or sponsorship are invited to contact exhibition management at info@ifpacnet.org to reserve your space. Visit www.IFPACglobal.org/exhibitors for more details and the exhibitor application form.

REGISTER TODAY!

Visit www.IFPACglobal.org and select "Attendee Registration"

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