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2019 Biopharmaceuticals Week

2019 PDA Virus Safety Forum

May 08 - May 08, 2019
Long Beach, CA

Next Generation Strategies for Viral Risk Mitigation

  • Conference
  • The Americas
Closed
Program Highlights

The 2019 PDA Virus Safety Forum is right around the corner! Stay tuned to this page for any updates as we get closer to the event. For questions, please feel free to contact us at your convenience.

Overview

Viruses are ubiquitous agents that can infect all forms of life, kidnap host cells, and outwit immune defenses. Strategies to harness the unique qualities of viral genome editing, while at the same time minimizing the risk for undesirable cellular consequences is the key to their use in biologic-based clinical products. As part of an ongoing commitment to viral use in biopharmaceutical manufacturing, the PDA will host the 2019 PDA Virus Safety Forum, May 8, as part of its inaugural 2019 PDA Biopharmaceuticals Week. This one-day event will feature a meeting of the Advanced Virus Detection Interest Group and plenary sessions on viral testing, mitigation, and clearance, as well as a panel discussion focused on technological advancements that can lessen the risk of contamination in biopharmaceutical products. Specific topics to be addressed include: facility segregation, virus detection (advanced technology and current assays), single-use technologies, and challenges in continuous manufacturing. We look forward to seeing you for this packed day of virus safety-filled discussion!

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Agenda

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  • Wednesday, May 8

    7:00 a.m. – 5:45 p.m.
    Registration Open

    7:00 a.m. – 8:45 a.m.
    Continental Breakfast

    7:30 a.m. – 8:30 a.m.
    Advanced Virus Detection Interest Group Breakfast Session (open to all attendees)
    Moderator: Arifa Khan, Senior Investigator, Supervisory Microbiologist, CBER, FDA

    The Advanced Virus Detection Interest Group is comprised of experts representing industry, academia, government agencies, and regulatory authorities who discuss the current thinking and plan efforts regarding applications of next generation sequencing for adventitious virus detection in biologics. The IG provides a forum for informal scientific discussions, knowledge exchange, and developing collaborative studies aimed at standardization of next generation sequencing technologies for adventitious virus detection in biologics. The group has focused on best practices for sample selection and processing, development of reference materials (model viruses and databases), optimization of bioinformatics pipelines, and designing follow-up strategies. The session will highlight the Interest Group's progress, achievements, and ongoing projects followed by audience participation for Q&A.

    7:30 a.m. – 8:30 a.m.
    Highlight of Interest Group Activities and Accomplishments plus Q&A Discussion
    Arifa Khan, Senior Investigator, Supervisory Microbiologist, CBER, FDA
    Dominick Vacante, PhD, Scientific Director, Janssen R&D, LLC         

    8:45 a.m. – 10:30 a.m.  
    P1: Virus Testing and Detection: Conventional Assays and New Technologies
    Moderator: Dominick Vacante, PhD, Scientific Director, Janssen R&D, LLC

    Strategies to mitigate risk of adventitious viruses in biologics include: using qualified raw materials; incorporating steps during the manufacturing for viral clearance; and extensive testing at various steps in the manufacturing process with the greatest potential for detection of contamination. Testing is aimed at detection of both known and unknown viruses. Broad virus detection is particularly important for safety of live products, since their manufacturing cannot generally include steps for viral inactivation and removal. Although the conventional assays have generally been effective for demonstrating absence of adventitious viruses, they are not sufficiently broad to detect known, unexpected viruses, and viruses that are distant to known viruses or novel viruses. This session will present perspectives on using conventional assays and next generation sequencing technologies for adventitious virus detection in biologics.

    8:45 a.m. – 9:00 a.m.
    Welcome and Opening Remarks from Conference Co-Chair
    Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc.

    9:00 a.m. – 9:25 a.m.
    High-Throughput Sequencing for Adventitious Virus Detection in Biologics
    Arifa Khan, Senior Investigator, Supervisory Microbiologist, CBER, FDA

    9:25 a.m. – 9:50 a.m.
    Adventitious Virus Detection by Next Generation Sequencing of Newly Synthetized RNAs (REPLI-VIR): Unambiguous Differentiation of Cell Infection from Carryover of Viral Nucleic Acids
    Marc Eloit, PhD, Founder and Scientific Advisor, PathoQuest and Head of Pathogen Discovery Laboratory, Institut Pasteur

    9:50 a.m. – 10:15 a.m.
    Detection of Viral Contamination in Cell Culture by Targeted Amplicon Sequencing Using Automated Next Generation Sequencing Workflow
    Elena V. Bolchakova, PhD, Senior Staff Scientist, Thermo Fisher Scientific
    Pia N. Darker, MSc, Senior Product Manager, Pharma Analytics Group, Thermo Fisher Scientific

    10:15 a.m. – 10:30 a.m.
    Question and Answers/Discussion

    10:00 a.m. – 4:30 p.m.
    Exhibit Area Open

    10:30 a.m. – 11:15 a.m.
    Refreshment Break and Poster Presentations in Exhibit Area

    Poster Presentations

    The following posters will be presented during today's refreshment breaks
    1. Considerations for Validating Virus Filtration in Continuous Bioprocessing Applications
      Ross A. Turmell, Senior Scientist, Pall Corporation
    2. Alternative Detergents for Viral Inactivation
      Gabriella T. Perell, PhD, Postdoctoral Process Development Fellow, Amgen
    3. Beyond Animal Testing: Accelerating Cell Line Characterization by Replacing MAP/HAP with a Rapid Degenerate PCR and Fragment Analysis Sequencing Method 
      Afshin Sohrabi, PhD, Head Molecular R&D, MilliporeSigma

    11:15 a.m. – 12:45 p.m.   
    P2: Viral Mitigation: Critical Evaluation of Current Practice
    Moderator: Veronica L. Fowler, PhD, Senior Virologist, Merck & Co., Inc.

    Viruses are the most abundant class of biological entity on Earth. Did you know that your genome is part viral, and that you are persistently infected with at least two viruses as you read this? Viral contamination in pharma is reality, illustrated by numerous high-profile events. Prevention is governed by the robustness of viral mitigation strategies, and the viral awareness of the people involved.

    Within this exciting session, presenters will share case study experiences of their companies’ approach to the control of viral contamination, in terms of:

    • Prevention assumptions drawn from the control strategy
    • Critical evaluation of the risk mitigation
    • Identification of remaining risks
    • Strategies for addressing remaining risks

    11:15 a.m. – 11:40 a.m.
    Quality by Design: Rapid alternatives for an Animal-Free Biosafety Testing Strategy
    Sarah Sheridan, PhD, Principal Scientist, MilliporeSigma

    11:40 a.m. – 12:05 p.m.
    Best Practices for Viral Disinfection Studies in GMP Manufacturing Facilities
    Lorenzo Achenza, MS, Senior Scientist, MSD

    12:05 p.m. – 12:30 p.m.
    Assessment of Viral Inactivation of Cleaned Surfaces
    Paul Lopolito, Technical Services Senior Manager, STERIS Corporation

    12:30 p.m. – 12:45 p.m.
    Question and Answers/Discussion

    12:45 p.m. – 2:15 p.m.
    Networking Lunch

    2:15 p.m. – 3:45 p.m.
    P3: Virus Clearance: The Central Pillar of Pathogen Safety
    Moderator: Sebastian B. Teitz, PhD, Scientific Coordinator, ASAHI Kasei Bioprocess

    Impactful and tragic pathogen contamination events in the past lead us, the biopharma industry, into embracing a comprehensive virus safety strategy, commonly referred to as the “safety tripod” consisting of selecting, testing and clearance. The clearance pillar alone typically contributes an estimated 10,000-fold increase in safety assurance as compared to the pillars of selecting and testing combined.

    This session will look into the state-of-the-art technologies and the future of protecting patients from virus transmission through sound virus clearance concepts.

    2:15 p.m. – 2:40 p.m.
    Model Viruses in Viral Clearance Studies: Real Models?
    Horst Ruppach, PhD, Director Pathogen Safety, Charles River Laboratories

    2:40 p.m. – 3:05 p.m.
    High pH Inactivation of Enveloped Viruses in an Fc-Fusion Molecule Prone to Aggregation at Low pH
    Eric R.Weiss, PhD, Senior Scientist, MilliporeSigma

    3:05 p.m. – 3:30 p.m.
    From “Batch Mode” to “Continuous” Bioprocessing: How the Virus Filter Fits In
    Julie Kozaili, PhD, Scientist, Asahi Kasei Bioprocess

    3:30 p.m. – 3:45 p.m.
    Question and Answers/Discussion

    3:45 p.m. – 4:30 p.m.
    Refreshment Break and Poster Presentation in Exhibit Hall

    4:30 p.m. – 5:30 p.m.  
    P4: Think Tank: Practical Considerations and Applications for Viral Safety Challenges
    Moderator: Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc.

    In this session, panel members and the audience will engage in discussions on advancements in virus detection technologies and methods for viral inactivation and removal, and their implementation and applications to mitigate risk of virus contamination in different biological products. Technologies to prevent potential virus contaminants entering the process stream will also be discussed.

    4:30 p.m. – 5:30 p.m.
    Panel Discussion with Session Moderators
    Veronica L. Fowler, PhD, Senior Virologist, Merck & Co., Inc.
    Arifa Khan, Senior Investigator, Supervisory Microbiologist, CBER, FDA
    Sebastian B. Teitz, PhD, Scientific Coordinator, ASAHI Kasei Bioprocess
    Dominick Vacante, PhD, Scientific Director, Janssen R&D, LLC         

    5:30 p.m. – 5:45 p.m.
    Closing Remarks from Conference Co-Chair
    Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    At the completion of this event, attendees will be able to:

    • Identify the risks and consequences associated with viral contamination throughout the biopharmaceutical lifecycle
    • Compare and contrast viral testing modalities from a regulatory, industrial, and research perspective
    • Discuss strategies to improve your risk-based quality assessments and best practices approaches to viral safety
    • Identify evidence-based approaches to prevent viral contamination in shared facilities
    • Summarize the most effective means to clear viral particles from finished product formulations
  • Who Should Attend

    Who Should Attend

    Job Functions
    Biologist | Consultant | Engineer | Technician | Scientist | Site Head

    Departments
    Biology | Compliance | Manufacturing | Microbiology | Development | Quality | Technical Operations | Validation

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ACPE # 0116-0000-19-021-L04-P | 0.575 CEUs
    Type of Activity: Knowledge

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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Travel

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.

Hilton Long Beach

701 West Ocean Boulevard
Long Beach, CA
Phone: +1 (562)-983-3400

  • Accommodations

    The cut off date has now past, however reservations can still be made on a space-and rate-available basis only. To make a reservation, please contact the Hilton Long Beach directly at +1 (562)-983-3400. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    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 72 hours prior to check-in to avoid cancellation fees.

  • Amenities

    Whether conducting business, keeping up with a fitness routine or looking to spend quality time with your family, our Long Beach, California hotel is here to help you make the most of your stay by offering the services you need, the amenities you expect, and the extras you deserve.

    Read more about the amenities offered at the Hilton Long Beach.

How to Get Here

By Air

The Hilton Long Beach is located less than an hour from three airports:

Long Beach Airport (LGB) is located 7 miles (about a 15 minute drive time) northeast of the Hilton Long Beach, an estimated $25 taxi ride.

Los Angeles International (LAX) is located 21 miles (about a 30 minute drive time) northwest of the Hilton Long Beach, an estimated $50 taxi ride.

John Wayne/Orange County Airport (SNA) is located 20 miles (about a 40 minute drive time) southeast of the Hilton Long Beach, an estimated $50 taxi ride.

By Car

Hilton Long Beach is located at 701 West Ocean Boulevard, Long Beach, CA 90831.

Take the 405 Freeway to the 710 Freeway South, the Long Beach Freeway. Once on the 710 South, exit Downtown/Broadway/Pine Avenue (exit is on the left side of the freeway). Make the next right on Magnolia and the next right on Ocean Blvd. Hilton is down two lights on the right hand side (the corner of Ocean and Golden Avenues).

PDA attendees will receive a discounted $15/day self-parking rate (garage and surface). Valet parking is also available at $28/day.

Other Options

More information coming soon.

Directions

Registration Fees

Early Registration
Registration Type Price by March 22
Member $1,095
Non-member $1,295
Young Professional Member † $548
Gov’t/Health Auth. Member $700
Gov’t/Health Auth. Non-member* $800
Academic Member $700
Academic Non-member* $800
Student Member $280
Student Non-member* $310








Regular Registration
Registration Type Price after March 22
Member $1,295
Non-member $1,495
Young Professional Member † $648
Gov’t/Health Auth. Member $700
Gov’t/Health Auth. Non-member* $800
Academic Member $700
Academic Non-member* $800
Student Member $280
Student Non-member* $310








* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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  • Brooke Schneider, CMP
    Manager, Programs
    Tel: +1 (301) 656-5900 ext. 111
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    Sr. Manager, Lecture Education
    Tel: +1 (301) 656-5900 ext. 151
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