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Mark Your Calendar for 2012
October 8-12, 2012
Rhode Island Convention Center
Providence, Rhode Island
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Strategy Discussion Forums
- Agenda overview: Go to the agenda overview to view the detailed agenda for each track or symposium.
- To view the complete agenda: Please download the PDF brochure.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:00
Registration and Coffee
Strategy Discussion Forum
10:15- 11:45
Recent advances in both the upstream and downstream have led to a variety of new technologies promising more efficient processes. Nevertheless, the implementation of these technologies can be glacial as the risk adverse manufacturers often stick with the "tried and true." In this forum, we will discuss some of these new technologies as well as the challenges faced when adopting them. Through panelist feedback and audience participation, we will explore these issues in an open/interactive environment based on real world experiences and examples. This will provide invaluable feedback for anyone considering the development or implementation of a new biomanufacturing technology.
Moderator:
Peter Latham, President, Latham BioPharm Group
Panelists:
E. Morrey Atkinson, Ph.D., Chief Scientific Officer, Vice President of Research and Development, Cook Pharmica Mauricio Barraza, Senior Manufacturing Manager, Acceleron Pharma, Inc.
Timothy S. Charlebois, Ph.D., Vice President, Technology and Innovation Strategy, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.
Günter Jagschies, Ph.D., Senior Director, Strategic Customer Relations, GE Healthcare Life Sciences, Sweden
Christopher P. Johnson, Director, Procurement, Global Procurement Operations, Pfizer Inc.
Steven Kozlowski, M.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA
Luncheon Presentation (Space is limited)
12:15
Speaker TBD
Strategy Discussion Forum
1:30- 3:15
Global Advances in the Development and Regulation of Biosimilars
The emergence of the biosimilars sector continues to gain momentum with the ongoing commercial expansion of these products in Europe and Asia. This Strategy Discussion Forum will explore recent developments in this area, including: Draft EMA guidance on biosimilar monoclonal antibodies; global development and manufacturing strategies; development of biosimilars guidance in the US; European experience with biosimilar products; and originator company perspectives on biosimilars.
Moderator:
Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc.
Panelists:
Shin-Jae Chang, Ph.D., Vice President, Research & Development, Celltrion, Inc., Korea
Gustavo Grampp, Ph.D., Director, Regulatory Affairs, Amgen, Inc.
Esa Heinonen, M.D., Ph.D., Member of the EMA Working Group on Biosimilars, Head of Section 2, Marketing Authorizations, Finnish Medicines Agency (Fimea), Finland
Steven Kozlowski, M.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA
Jay S. Stout, Ph.D., Executive Director, Biologics Manufacturing Sciences and Commercialization, Merck & Co., Inc.
Ganesh Venkataraman, Ph.D., CSO, Momenta Pharmaceuticals (invited)
Joerg Windisch, Ph.D., Head Global Technical Development, Sandoz Biopharmaceuticals, Austria
The emergence of the biosimilars sector continues to gain momentum with the ongoing commercial expansion of these products in Europe and Asia. This Strategy Discussion Forum will explore recent developments in this area, including: Draft EMA guidance on biosimilar monoclonal antibodies; global development and manufacturing strategies; development of biosimilars guidance in the US; European experience with biosimilar products; and originator company perspectives on biosimilars.
Moderator:
Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc.
Panelists:
Shin-Jae Chang, Ph.D., Vice President, Research & Development, Celltrion, Inc., Korea
Gustavo Grampp, Ph.D., Director, Regulatory Affairs, Amgen, Inc.
Esa Heinonen, M.D., Ph.D., Member of the EMA Working Group on Biosimilars, Head of Section 2, Marketing Authorizations, Finnish Medicines Agency (Fimea), Finland
Steven Kozlowski, M.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA
Jay S. Stout, Ph.D., Executive Director, Biologics Manufacturing Sciences and Commercialization, Merck & Co., Inc.
Ganesh Venkataraman, Ph.D., CSO, Momenta Pharmaceuticals (invited)
Joerg Windisch, Ph.D., Head Global Technical Development, Sandoz Biopharmaceuticals, Austria
3:15
Grand Opening of Poster and Exhibit Hall with Refreshments
Keynote Presentations
Chairperson: Howard L. Levine, Ph.D., President, BioProcess Technology Consultants, Inc.
4:00
Overview of Approval Pathway under Biologics Price Competition and Innovation Act of 2009Dr. Kozlowski will give an update on the new biosimilars statute.
Steven Kozlowski, M.D., Director, Office of Biotechnology Products, OPS, CDER, US FDA
4:35
EMA Draft Guideline on Biosimilar Monoclonal AntibodiesEU has been the pioneer in creating the regulatory framework for the development of biosimilar drugs. The overarching "Guideline on Similar Biological Medicinal Products" came into force in 2005, and the guidelines describing non-clinical & clinical and quality aspects of the development were available in 2006. In addition, there are a number of adopted product specific guidelines (e.g on erythropoetins, insulin, interferon alpha). Since then already 14 biosimilar products have been approved by the European Medicines Agency (EMA). Currently the Working Party on Biosimilar Medicinal Products (BMWP) is drafting a guideline on biosimilar monoclonal antibodies.
Esa Heinonen, M.D., Ph.D., Member of the EMA Working Group on Biosimilars, Head of Section 2, Marketing Authorizations, Finnish Medicines Agency (Fimea), Finland
5:10
Ready or not Biosimilars are Coming to U.S.Biosimilars have already become a common practice within the EU with a significant number of launches over the last five years. A wave of biosimilar products are expected to be submitted to the USFDA as the guidance are drafted and adopted. Technical, clinical, and manufacturing challenges will need to be overcome to allow satisfactory licensure of these products and open these markets to competition. This is expected to aid in reduced cost and improved patient access.
Jay S. Stout, Ph.D., Executive Director, Biologics Manufacturing Sciences and Commercialization, Merck & Co., Inc.
5:45
Networking Reception in Poster & Exhibit Hall
Sponsored by
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
7:30
Networking Coffee
Strategy Discussion Forum
10:30- 12:00
The broad acceptance of single-use technology in biopharma is driving innovation for the next generation disposable solutions. This session will highlight new technology, enhanced services, and discuss scalability and the economics of single-use systems.
Michael Radovan, Associate Director, Single Use Systems, Thermo Fisher Scientific
Barbara A. Paldus, Ph.D., CEO, Finesse Solutions, LLC
12:30
Networking Lunch in Exhibit and Poster Hall with Dedicated Poster Viewing
Poster presenters are requested to stand by their posters for discussion.
Poster presenters are requested to stand by their posters for discussion.
Keynote Presentations
4:15
Bioprocess Technology & Innovation: Strategic Imperative for Challenging TimesCan bioprocess innovation continue to be an important strategic advantage and generate value? What drivers should inform a meaningful technology and innovation strategy, and what approaches and infrastructure are needed to support it? The changing landscape has brought many new challenges, including vastly decentralized research and idea creation, virtual companies, novel treatment modalities, an expansion of viable production technologies, biosimilars, regionalization and globalization, and a complex regulatory and intellectual property environment. From the perspective of a large global biopharma company, developing and implementing an aggressive, multifaceted strategy is essential; examples and perspective on the journey will be provided.
Timothy S. Charlebois, Ph.D., Vice President, Technology and Innovation Strategy, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.
5:00
Integrating Two Biologics Manufacturing NetworksThe Roche Group acquired Genentech in March 2009, resulting in the integration of two distinct biologics manufacturing networks. The challenge of integrating these two organizations required addressing people, process and technologies across the entire supply chain from raw material sourcing through delivery to patients. The manufacturing operations of these two companies recognized that that integration takes as much focus on decision-making governance and company culture as it does on physical assets, operations and organization.
Tim Moore, Senior Vice President, Global Head, Pharmaceutical Technical Operations Biologics, Roche
5:45
Networking Reception in Poster and Exhibit Hall
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Strategy Discussion Forum
10:30- 12:00
Flexibility and Agility as Strategic Purpose, Time and Cost Savers as a Tactical Means to Get There
Panelists:
Barak I. Barnoon, Director, Process Engineering and Informatics, Pfizer Global Engineering, Pfizer Inc.
Timothy S. Charlebois, Ph.D., Vice President, Technology and Innovation Strategy, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.
David Peers, Senior Manager, Vacaville Manufacturing Science and Technical Support (MSAT), Genentech, Inc.
Natraj Ram, Ph.D., Senior Group Leader, Manufacturing Sciences, Abbott Bioresearch Center
Charles Sardonini, Ph.D., Associate Director, Cell Culture Development Group, Genzyme Corp.
- Isolated time savings relax the workday, grouped time savings unleash new capacity to run projects
- Cost dollars can generate five to ten fold more revenue dollars, flexibility and agility arise from well spent dollars
- High level decisions can both open up and block capability to create flexibility and agility at lower levels
- The workshop will discuss decision hierarchy effects, workflows, and tools that support the creation of flexibility / agility but also the limits that one needs to test in each project where the investment may not pay off.
Panelists:
Barak I. Barnoon, Director, Process Engineering and Informatics, Pfizer Global Engineering, Pfizer Inc.
Timothy S. Charlebois, Ph.D., Vice President, Technology and Innovation Strategy, BioTherapeutics Pharmaceutical Sciences, Pfizer Inc.
David Peers, Senior Manager, Vacaville Manufacturing Science and Technical Support (MSAT), Genentech, Inc.
Natraj Ram, Ph.D., Senior Group Leader, Manufacturing Sciences, Abbott Bioresearch Center
Charles Sardonini, Ph.D., Associate Director, Cell Culture Development Group, Genzyme Corp.
12:30
Networking Luncheon & Last Chance to Visit the Exhibit and Poster Hall
Strategy Discussion Forum
1:40- 3:15
For Biotech companies financing of biopharmaceutical process development is often a critical issue. While many CMOs offer a clear fee for service, others have different business models such as mix of fee for service with project specific investment or application of technologies resulting in attractive project timing and project cost or option on later licensing rights. This strategic discussion forum will offer perspectives on the available models and discuss the individual characteristics of each model. The discussion will allow potential customers the opportunity to express their needs and receive the information to help them determine which business model is the best fit for their company, in successful partnering with a CMO.
Moderator:
Klaus Binder, Ph.D., Binder Associates
Panelists:
Klaus B. Schoepe, Ph.D., Rentschler Biotechnologie
Larry Thomas, DSM Biologics
Ralf Otto, Ph.D., Boehringer Ingelheim
Troy Carpenter, MBA, President, Vetter Pharma International USA Inc.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Strategy Discussion Forum
10:15- 11:45
A panel of leading SUT developers and providers will discuss the underpinning reasons for the growth in usage and impact of SUTs for bioprocessing. As SUTs evolve from innovation to commercialization and industrialization, they are expected to grow in market share and importance. Industrialization brings new technical, operational, quality and market dynamics and the panel will examine ongoing SUT innovations and evolution. Other topics will include global supply chain security and the need for harmonized industry standards.
Discussion areas include:
- SUT Benefits
- Innovations
- Maximizing Sut Efficiency
- Supply Chain Integrity
- Need For Harmonization of Standards
- Looking Ahead - Market & Applications Outlook
Kevin Ott, Executive Director, Bio-Process Systems Alliance (BPSA)
Panelists:
Jerold M. Martin, Senior VP, Global Scientific Affairs, Pall Life Sciences
Mani Krishnan, Director, Single-Use Processing Systems, EMD Millipore
Jeffery L. Craig, Global Director, Business Development & Marketing, ATMI Life Sciences
Paul M. Priebe, Director, Fluid Management Technology, Sartorius-Stedim Biotech
12:15
Lunch on Your Own
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