PDA/FDA Adventitious Agents and Novel Cell Substrate Conference Recordings

Web Code: AV-P1-11
Member /Non Member Price: $199

Registration includes:

  • 12 session recordings from the November 2011 conference (Sessions 2 & 9 not included) with audio presentation and slides advanced in real time
  • PDF handouts of every presentation
  • Unlimited access to all session recordings for 60 days

Recording Overview

The PDA/FDA Adventitious Agents and Novel Cell Substrates Conference Recording: Emerging Technologies and New Challenges was organized to provide a forum for discussion of new technologies for adventitious detection and to expand upon emerging issues related to novel cell substrates. Recent technological advances have resulted in novel virus detection methodologies and the ability to produce biological products for human use more efficiently and in a wider variety of cell substrates. Yet, alongside the benefits derived from these advances, come new challenges in ensuring biopharmaceutical product safety. If you missed the three-day conference that took place November 2-4, 2011, this recording will have a different focus each day and will conclude with an expert panel discussion to determine in which area consensus may be reached and identify issues that remain unsolved for further discussion. Focuses of this recording event include: the application of emerging molecular methods for adventitious agent detection, such as high throughput sequencing, virus microarrays and PLEX-ID; novel cell substrates and related potential safety and quality issues; and sources and mitigation of adventitious agents in raw materials. If you attended this event and found it would be beneficial to colleagues that could not attend, please forward the URL to this web page to them.

Target Audience

If you are a decision-maker at mid-level or senior level, or a professional working at site or corporate level in the following areas these recordings will be beneficial to you:

Departments:
Development of Pharmaceutical and Biopharmaceutical Products, Biotechnology, Vaccines, Manufacturing, Pathogen Safety Groups, Quality Assurance and Control, Formulation and Process Development, Risk Assessment, Academia, Regulatory Functions. Level of Expertise: Mid and Senior Level Professionals from the Pharmaceutical, Biopharmaceutical, and biological industry, Source Material Suppliers, and Regulators.

Recorded Sessions and Presenters

Opening Keynote Presentation
Johannes Löwer, MD,President, International Alliance for Biological Standardization (IABS)

Adventitious Agent Testing and Emerging Methods Part II
Ranga Sampath, PhD,Director, Science and Technology, Abbott-Ibis Biosciences
Tom Slezak, Associate Program Leader for Informatics,Lawrence Livermore National Laboratories
Marc Salit, PhD,Senior Manager, Quality Systems and Technical Services, Pfizer

Technologies and Application to Evaluation of Biological Materials Part I
John Kolman, PhD, Senior Director,BioReliance
Matt Friedenberg, PhD, Senior Director, Engineering, Gen-Probe Incorporated
Houman Dehghani, PhD, Director,Amgen, Inc

Technologies and Application to Evaluation of Biological Materials Part II
Charles Chiu, MD, PhD,Director, Viral Diagnostics and Discovery Center,University of California San Francisco
Paul Duncan, PhD, Senior Investigator, Vaccine Bioprocess R&D,Merck & Co., Inc.
Arifa Khan, PhD, Senior Investigator, CBER,FDA

Panel Discussion - Technical Challenges of New Methods
Barry Cherney, Deputy Director, Division of Therapeutic Proteins, CDER, FDA
Charles Chiu, MD, PhD,Director, Viral Diagnostics and Discovery Center,University of California San Francisco
Houman Dehghani, PhD, Director,Amgen, Inc
Matt Friedenberg, PhD, Senior Director, Engineering, Gen-Probe Incorporated
James Gilbert, PhD, Associate Director, Global QC Virology,Biogen Idec
Arifa Khan, PhD, Senior Investigator, CBER,FDA
John Kolman, PhD, Senior Director,BioReliance
David Onions, PhD, Senior Director,BioReliance
Marc Salit, PhD,Senior Manager, Quality Systems and Technical Services,Pfizer
Vahan Simonyan, PhD,Research Fellow, CBER, FDA

Day 2 Keynote Presentation
Marcie McClure, PhD, Professor, Department of Microbiology,Montana State University

Insect, Avian and Mammalian Cell Substrates Part I
Jonathan Stoye, PhD, Head of the Division of Virology, MRC National Institute for Medical Research
Celine Breda, Quality Director/Director Pharma Operations, Vivalis

Potential Safety and Quality Issues Related to Plants and Plant-based Products
Rosemarie Hammond, PhD, Research Plant Pathologist, USDA Agricultural Research Service
Yoseph Shaaltiel, PhD, Executive Vice President, Research and Development, Protalix Ltd
Vidadi Yusibov, PhD, Executive Director, Fraunhofer USA Center for Molecular Biotechnology
Victor Klimyuk, PhD,Director, Development, Icon Genetics GmbH

Panel Discussion
Daniel Adams, PhD, Chief Executive Officer,Protein Sciences Corporation
Howard Anderson PhD,Biologist, CDER,FDA
Celine Breda, Quality Director/Director Pharma Operations, Vivalis
Jane L. Halpern, PhD, Vice President, Regulatory Affairs, Novavax, Inc
Rosemarie Hammond, PhD, Research Plant Pathologist, USDA Agricultural Research Service
Pawan Jain, PhD, Biologist, CBER,FDA
Victor Klimyuk, PhD,Director, DevelIcon Genetics GmbH
Robin Levis,Supervisory BiologistFDA
Marcie McClure, PhD, Professor, Department of Microbiology,Montana State University
David Onions, PhD, Senior Director,BioReliance
George Rohrmann, PhD, Professor, Microbiology,Oregon State University
Yoseph Shaaltiel, PhD, Executive Vice President, Research and Development, Protalix Ltd
Jonathan Stoye, PhD, Head of the Division of Virology, MRC National Institute for Medical Research
Vidadi Yusibov, PhD, Executive Director, Fraunhofer USA Center for Molecular Biotechnology
Hannelore Willkommen, PhD, President, RBS Consulting

Adventitious Agents and Raw Materials Part I
Tara Tagmyer, PhD,Process Scientist, Vaccine Manufacturing Sciences & Commercialization,Merck & Co., Inc.
Ivar Kljavin, PhD,Associate Director, Product Quality Management,Genentech, Inc.
Rosemary Versteegen, PhD,Chief Executive Officer,International Serum Industry Association

Adventitious Agents and Raw Materials Part II
Mark Plavsic, PhD,Senior Director and Corporate Biosafety Advisor,Genzyme Corporation
Steven Lang, PhD,Associate Director, Biologics Research,Johnson & Johnson .
Qi Chen, PhD,Associate Director, Virology,Genentech, Inc

Expert Panel Discussion
Qi Chen, PhD,Associate Director, Virology,Genentech, Inc
Phillip Krause,Associate Director, CBER,FDA
Johannes Löwer, MD,President,International Alliance for Biological Standardization
Marcie McClure, PhD, Professor, Department of Microbiology,Montana State University
David Munroe, PhD, Director, Technology Development,SAIC-Frederick
David Onions, PhD, Senior Director,BioReliance
Mark Plavsic, PhD,Senior Director and Corporate Biosafety Advisor,Genzyme Corporation
George Rohrmann, PhD, Professor, Microbiology,Oregon State University
Amy Rosenberg, PhD, Supervisory Medical Officer, CDERFDA
Marc Salit, PhD, Senior Manager, Quality Systems and Technical Services, Pfizer
Ranga Sampath, PhD,Director, Science and Technology,Abbott-Ibis Biosciences
Tom Slezak,Associate Program Leader for Informatics,Lawrence Livermore National Laboratories
Jonathan Stoye, PhD, Head of the Division of Virology, MRC National Institute for Medical Research
Tara Tagmyer, PhD,Process Scientist, Vaccine Manufacturing Sciences & Commercialization,Merck & Co., Inc.
Rosemary Versteegen, PhD,Chief Executive Officer,International Serum Industry Association
Michael Wiebe, PhD,President,Quantum Consulting, LLC
Vidadi Yusibov, PhD, Executive Director, Fraunhofer USA Center for Molecular Biotechnology

Registration contact

Jason E. Brown
Senior Programs Manager
Tel: +1 (301) 656-5900 ext. 131
Fax: +1 (301) 986-1093
Email: brown@pda.org

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