2012 PDA Annual Meeting Session Recordings

Manufacturing Innovation: Achieving Excellence in Sterile and Emerging Biopharmaceutical Technology

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Non-member: $320

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Price of registration includes:

  • Eight (8) recorded sessions from the 2012 PDA Annual Meeting
  • Access to 16 downloadable presentation handouts
  • Unlimited playback of the recordings for 60 days from the day of purchase

B - Challenges in Manufacturing and QA/QC Part I

Personalized medicine represents an exciting future direction for the pharmaceutical business. It represents patient specific treatments tailored to each patient's cells and tissues. Current FDA approved personalized medicines are on the market for cancer. Other personalized medicines are in development with aspirations of commercial production in the near future. Along with the manufacturing of these types of products comes interesting and new challenges for both operations and quality departments. The rules for traditional biopharmaceutical manufacturing do not always apply. Compendial and regulatory requirements for aseptic manufacturing and quality testing of sterile products, which were created for traditional pharmaceutical manufacturing, need to be followed, yet often need to be implemented in a different way. In personalized medicine, lot release may need to take place in hours after production versus days, weeks or months after production. Investigations need to be opened, executed and completed in hours, not days to allow for product disposition. This recording exposes real life challenges related to quality control testing, quality assurance and manufacturing of personalized medicine products.

Presenters:

Greg Whitehead, Director, Corporate Quality Assurance, Dendreon Corporation
John E. Butler, PhD, Global Project Leader, Bayer Innovation GmbH

E - Challenges in Manufacturing and QA/QC Part II

Personalized medicine represents an exciting future direction for the pharmaceutical business. It represents patient specific treatments tailored to each patient's cells and tissues. Current FDA approved personalized medicines are on the market for cancer. Others personalized medicines are in development with aspirations of commercial production in the near future. Along with the manufacturing of these types of products comes interesting and new challenges for both operations and quality departments. The rules for traditional biopharmaceutical manufacturing do not always apply. Compendial and regulatory requirements for aseptic manufacturing and quality testing of sterile products, which were created for traditional pharmaceutical manufacturing, need to be followed, yet often need to be implemented in a different way. In personalized medicine, lot release may need to take place in hours after production versus days, weeks or months after production. Investigations need to be opened, executed and completed in hours, not days to allow for product disposition. This session will expose attendees to real life challenges related to quality control testing, quality assurance and manufacturing of personalized medicine products.

Presenters:

Michael Zdanowski, Director of Operations, National Cord Blood Program, New York Blood Center
Thomas Finn, PhD, CMC Reviewer, CBER, FDA

Plenary Session 2

What does the future of the biopharmaceutical industry look like?  This recording will address new trends in the industry.  It's a time of unprecedented opportunity with new medical needs of patients and emerging technologies such as personalized medicine and cell therapies to help meet those needs.  The presenters discuss the future of biologics and manufacturing processes, in addition to a novel bacterial contaminant in CHO cell culture processes that has implications for the biotech industry at large.

Presenters:

David Urdal, Chief Scientific Officer, Dendreon Corporation (retired)
Matt Croughan, PhD, Professor, Keck Graduate Institute of Applied Life Sciences
Anders Vinther, PhD, Vice President, Quality Biologics, Genentech

H - Manufacturing Innovation Part I

Manufacturing processes need to constantly improve to remain cost effective in a competitive marketplace, and to remain compliant in the face of increasing regulatory expectations. Large scale manufacturing innovation includes an increased use of Single-Use Systems, innovative bioprocessing technologies and outsourcing to contract manufacturing organizations (CMOs). This recording will examine two case studies which describe the implementation of Single-Use Systems technology. Examples are given of careful evaluation of new technologies and an implementation process employed to maximize innovative potential while minimizing disruption to existing operations and relevant elements of the Quality System.

Presenters:

Claire Frazier, Senior Associate Process Development Engineer, Grifols, Inc.
Chuck Hart, Director of Upstream Operations Manufacturing Cell Culture, Shire

K - Manufacturing Innovation Part II

This recording addresses improved upstream processing and contract manufacturing as two additional strategies to reduce cost of goods, while increasing efficiency and flexibility. The first presentation on high yield expression systems discusses how very high cell densities were achieved to increase product titer and how downstream processing was modified to purify high titer harvests. The technologies make use of Single-Use Systems and are integrated in the design of DSM's Biologics Plant of the Future, built in Brisbane, Australia. The second presentation on contract manufacturing analyzes and discusses lessons learned from a broad range of biopharmaceutical projects developed successfully at a CMO in collaboration with its contract givers.

Presenters:

Rolf Douwenga, Vice President, Global R&D, DSM Biologics
Morten Munk, Vice President, Business Development, CMC Biologics

Breakfast Session: Quality and Regulatory Job Market Outlook 2012

The demand for Quality, Manufacturing, and Regulatory professionals is on the rise but also reflects the many dynamics affecting the Pharmaceutical industry today. Increased globalization is changing geographic trends for many parts of the biotechnology and pharmaceutical industries while emerging technologies such as cellular based therapies are creating demand and new hot spots. In addition, the growth of regulatory agencies and overall enforcement climate is creating new opportunities in the consulting and third party support industries. This recording features a panel of executives from biotech companies, consulting firms, and the public sector that discuss trends they see in job market for manufacturing, quality and regulatory arenas and the hiring profiles they will be looking for in 2012.

Topics in this recording include:

  • Career strategies for Quality, Manufacturing and Regulatory Professionals
  • Hiring trends in the pharma and biotechnology sector
  • Hiring trends in the consulting industry and public sector  
  • Skill sets and hiring profiles in demand
  • Skill sets needed for compliance companies

Panelists:

Steven Lynn, Office Director (Acting), Office of Manufacturing and Product Quality, Office of Compliance, CDER,  FDA
Morten Munk, Vice President, Business Development, CMC Biologics
Claudio Pincus, President, Quantic Group
Lisa Skeens, PhD, Vice President, Global Regulatory Affairs and Pharmaceuticals, Baxter Healthcare Corporation

R - Evolving Expectations for Biosimilars

In 2009 President Obama signed the Biologics Price Competition and Innovation Act, opening the pathway to licensure of biosimilars in the United States.  The European Union had published guidelines in 2005 and approved the first biosimilars as early as 2006.  Recently, there has been increasing information exchanged within the industry and in the press about the coming of copies of previously approved biologicals. 

Because of their complex structures, biological molecules cannot be presumed to be exactly the same as their targeted original versions.  Seemingly minor differences in structure might have a significant affect on therapeutic properties.  The question becomes "How similar is similar enough?"  Therefore, the path to approval for these generics will be much more difficult than their small-molecule generic counterparts.

This recording explores biosimilars from an industry perspective.  As biologics continue to replace small molecules on the list of largest-sellers, where will biosimilars fit in?

Presenters:

Thomas Schreitmueller, PhD, Head of Technical Regulatory Policy and Strategy Biologics, F. Hoffman-LaRoche Ltd.
Mark McCamish, MD, PhD, Head Global Biopharmaceutical Development, Sandoz International GmbH

Closing Plenary Session: How can Industry and Regulators Work Together to Make Changes and Develop new approaches in the Health Care Products Industry?

The health care product industry is facing changes and challenges as a result of innovative products, new technologies, expanded supplier networks, and the growing needs of public health.  "Tried and true" traditional methods may not offer the optimal approach to process design, manufacturing, process control, quality assurance, and regulatory compliance.  How will the industry and regulators change current approaches in order to meet these new challenges?   How can industry and regulators work together to make these changes and develop these new approaches?  How can industry and regulators anticipate the challenges they may face and the changes needed to meet those challenges in the future?  These and other related issues are addressed during this recording by our distinguished regulatory speakers and panelist.

Presenters:

Emily Shacter, PhD, Chief, Laboratory of Biochemistry, CDER, FDA
Steven Lynn, Office Director (Acting), Office of Manufacturing and Product Quality, Office of Compliance, CDER,  FDA
Andy Hopkins, Sterile Products Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)

Panelists:

Tor Graberg, Chair of PIC/s and Head of Inspection, Medical Products Agency (MPA)
Andy Hopkins, Sterile Products Inspector, Medicines and Healthcare Products Regulatory Agency (MHRA)
Steven Lynn, Office Director (Acting), Office of Manufacturing and Product Quality, Office of Compliance, CDER,  FDA
Emily Shacter, PhD, Chief, Laboratory of Biochemistry, CDER, FDA

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