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October 8-12, 2012
Rhode Island Convention Center
Providence, Rhode Island
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Enhancing Manufacturing and Development Efficiency
- 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
Enhancing Manufacturing and Development Efficiency
Managing Global Manufacturing and Development Assets including Internal and Partners' Facilities
8:00
Chairperson's Opening Remarks
Ellen L. McCormick, Senior Director, BioSciences Manufacturing Group, Pfizer Inc
Ellen L. McCormick, Senior Director, BioSciences Manufacturing Group, Pfizer Inc
8:15
Balancing Platforming of Processes with Facility Capability - Getting the Most for your Development and Manufacturing Dollars
This presentation discusses the approaches we have used in Pfizer, spanning development through commercial supply, to balance process and facility. It will describe the key considerations that went into our analyses, how we chose to address them, and the results of our initiative.
Joost P. Quaadgras, Director of Strategic Projects, Bioprocess Services Group, Pfizer Global Supply, Pfizer Inc.
This presentation discusses the approaches we have used in Pfizer, spanning development through commercial supply, to balance process and facility. It will describe the key considerations that went into our analyses, how we chose to address them, and the results of our initiative.
Joost P. Quaadgras, Director of Strategic Projects, Bioprocess Services Group, Pfizer Global Supply, Pfizer Inc.
Unpublished Data
8:45
Managing Clinical Drug Product Manufacturing Networks
A key aspect of a successful early stage clinical drug product manufacturing network is the understanding and management of demand variability to minimize adverse impacts on network effectiveness. Strategies to increase both project predictability and manufacturing site flexibility should drive standardization of processes, use metric driven interfaces, and have clear lines of communication at decision making levels.
Gerry T. Boushelle, Global Master Planner, Biotherapeutics & Vaccines, Worldwide R&D, Business Strategy & Operations, Pfizer Inc.
A key aspect of a successful early stage clinical drug product manufacturing network is the understanding and management of demand variability to minimize adverse impacts on network effectiveness. Strategies to increase both project predictability and manufacturing site flexibility should drive standardization of processes, use metric driven interfaces, and have clear lines of communication at decision making levels.
Gerry T. Boushelle, Global Master Planner, Biotherapeutics & Vaccines, Worldwide R&D, Business Strategy & Operations, Pfizer Inc.
9:15
How Standardization Helps Manufacturing Networks Manage Through Constant Changes
Applying standardization to key areas in late phase drug development maximizes likelihood of success in CMC filing and commercialization. This talk will present high level concepts in some strategic areas to demonstrate the value of standardization in managing changes in clinical development timeline, technology development, and resource and asset availability leading up to final approval.
Amos M. Tsai, Ph.D., Principal Engineer, Process Development, Amgen
Applying standardization to key areas in late phase drug development maximizes likelihood of success in CMC filing and commercialization. This talk will present high level concepts in some strategic areas to demonstrate the value of standardization in managing changes in clinical development timeline, technology development, and resource and asset availability leading up to final approval.
Amos M. Tsai, Ph.D., Principal Engineer, Process Development, Amgen
9:45
Networking Refreshment Break
10:15
Case
Study
Balancing Contract Management with Internal Programs at an Innovator Company, a Case Study in Manufacturing Capacity UtilizationStudy
Managing manufacturing capacity is a formidable task for Biotech. Investing in manufacturing facilities prior to product approval is considered risky; however the inability to supply a product launch may lead to drug allocation and a failed launch. A case study will be presented in which a non-CMO organization successfully balanced contract manufacturing and internal production to optimize manufacturing capacity utilization and defray operations cost.
Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc.
10:45
Supply Chain Planning in an Exponential Growth Environment
As a company scales production for new products, the processes used for supply chain planning and supplier communication are critical to supporting the planned growth. Typically, suppliers do not have idle or excess capacity to support significant growth, so early communication and commitments may have to be made. The processes used for by Dendreon to support its growth from no sales in 2009 to a planned $350-$400 million in 2011 will be described.
Myles Marcus, Vice President, Supply Chain Management, Dendreon Corporation
As a company scales production for new products, the processes used for supply chain planning and supplier communication are critical to supporting the planned growth. Typically, suppliers do not have idle or excess capacity to support significant growth, so early communication and commitments may have to be made. The processes used for by Dendreon to support its growth from no sales in 2009 to a planned $350-$400 million in 2011 will be described.
Myles Marcus, Vice President, Supply Chain Management, Dendreon Corporation
11:15
Entering Developing Markets and Identifying Manufacturing Sites
The biopharmaceuticals industry is on the verge of a massive shift in distribution of global manufacturing capacity as regulations and emerging markets mature for these products. Local presence is necessary for market share. The presentation highlights main factors to consider when entering developing markets and identifying manufacturing sites. Topics include facility strategy, supply chain, science parks, regulatory, construction and operation.
Niels Guldager, Senior Technology Partner, NNE Pharmaplan, Denmark
The biopharmaceuticals industry is on the verge of a massive shift in distribution of global manufacturing capacity as regulations and emerging markets mature for these products. Local presence is necessary for market share. The presentation highlights main factors to consider when entering developing markets and identifying manufacturing sites. Topics include facility strategy, supply chain, science parks, regulatory, construction and operation.
Niels Guldager, Senior Technology Partner, NNE Pharmaplan, Denmark
Luncheon Presentation (Space is limited)
12:15
Speaker TBD
Enhancing Manufacturing and Development Efficiency
Managing Supplier Relationships to Drive Competitive Advantage
1:30
Chairperson's Remarks
Sushil J. Abraham, Director, Global Process Engineering, Amgen Inc.
Sushil J. Abraham, Director, Global Process Engineering, Amgen Inc.
Unpublished Data
1:45
Case
Study
Managing Product Supply Risks and Transferring Legacy Molecules - A Recent Case StudyStudy
The case study covers risk mitigation strategies we have developed for commercial product supply. Topics to be covered include: multi-host production, viral segregation requirements, meeting current regulatory expectations, minimizing process changes, and the ability to respond quickly to manage emergency scenarios. The end goal is to ensure process and product comparability and speedy licensure of the secondary manufacturing site.
Sushil J. Abraham, Director, Global Process Engineering, Amgen Inc.
2:15
Bio Disposables Supply Risk and Cost Reduction - Creating Multi Sourcing as a Core Competency
Disposables replace a very standard and reliable option in our plants. Supply reliability, quality performance, and pricing (due to shift from capital to consumable) are critical to the long term success of the technology within Biotech manufacturing processes. Pfizer has taken a straight-forward approach to the new challenges that disposables present by establishing design standardization and multi-sourcing as core competencies.
Christopher P. Johnson, Director, Procurement, Global Procurement Operations, Pfizer Inc.
Disposables replace a very standard and reliable option in our plants. Supply reliability, quality performance, and pricing (due to shift from capital to consumable) are critical to the long term success of the technology within Biotech manufacturing processes. Pfizer has taken a straight-forward approach to the new challenges that disposables present by establishing design standardization and multi-sourcing as core competencies.
Christopher P. Johnson, Director, Procurement, Global Procurement Operations, Pfizer Inc.
2:45
Manufacturing and Quality Systems for Supply Chain Security with Single Use Technology
Acceleron has made non-clinical and GMP material in facilities based on single use technology for seven years. Over that time, a reoccurring issue is the assurance of the timely delivery of consistent, appropriately documented single use products to our facility. To maximize success, manufacturing and quality has had to implement systems which are supplier and product dependent. These supply chain challenges and the systems implemented will be reviewed and discussed, particularly focusing on areas where further standardization would be very beneficial.
Mauricio Barraza, Senior Manufacturing Manager, Acceleron Pharma, Inc.
Acceleron has made non-clinical and GMP material in facilities based on single use technology for seven years. Over that time, a reoccurring issue is the assurance of the timely delivery of consistent, appropriately documented single use products to our facility. To maximize success, manufacturing and quality has had to implement systems which are supplier and product dependent. These supply chain challenges and the systems implemented will be reviewed and discussed, particularly focusing on areas where further standardization would be very beneficial.
Mauricio Barraza, Senior Manufacturing Manager, Acceleron Pharma, Inc.
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
Enhancing Manufacturing and Development Efficiency
Achieving Rapid Process Development and Novel Technology Implementation
8:00
Chairperson's Remarks
Barak I. Barnoon, Director, Process Engineering and Informatics, Global Engineering, Pfizer Inc.
Barak I. Barnoon, Director, Process Engineering and Informatics, Global Engineering, Pfizer Inc.
8:15
BioProcess Platforms - Today's Fad or a Future Necessity
With the success of biotechnology products, and antibodies in particular, comes the ability to build on what's been learned and establish platform processes to support future development and manufacturing. This is only natural as we respond to the need to streamline the costs of and timelines for development. However, platform efficiencies must be balanced with the need to support new products, such as modified "antibody" frameworks, and the need to continually improve. The current state and future of bioprocess platforms will be discussed.
Martin Gawlitzek, Ph.D., Senior Group Leader, Genentech, Inc.
With the success of biotechnology products, and antibodies in particular, comes the ability to build on what's been learned and establish platform processes to support future development and manufacturing. This is only natural as we respond to the need to streamline the costs of and timelines for development. However, platform efficiencies must be balanced with the need to support new products, such as modified "antibody" frameworks, and the need to continually improve. The current state and future of bioprocess platforms will be discussed.
Martin Gawlitzek, Ph.D., Senior Group Leader, Genentech, Inc.
Unpublished Data
8:45
Case
Study
Identifying Key Process Constraints in Retrofitting a Perfusion-Based Biotech FacilityStudy
To increase the capacity of an existing facility, a process modeling analysis was performed using detailed models which incorporate historical processing data and variability, equipment, labor, and resources to simulate various processing scenarios. The analysis identified bottlenecks in the manufacturing facility and generated an equipment scope for a facility retrofit to process twice the bioreactor output.
Marisa Hewitt, Process Engineer II, Process Sciences, BioMarin Pharmaceutical, Inc.
9:15
Increasing Capacity and Improving Flexibility in a Bio-Manufacturing Plant
The ability to respond quickly to changes in production demand is critical to success in our industry. This session will focus on how one manufacturing facility leveraged improvements in plant technology, optimization of business processes, and utilization of human resources to increase capacity and enable fluctuation between high and low run rates
Elizabeth G. Kelly, Associate Director, Manufacturing, Genentech, Inc.
The ability to respond quickly to changes in production demand is critical to success in our industry. This session will focus on how one manufacturing facility leveraged improvements in plant technology, optimization of business processes, and utilization of human resources to increase capacity and enable fluctuation between high and low run rates
Elizabeth G. Kelly, Associate Director, Manufacturing, Genentech, Inc.
9:45
Networking Refreshment Break in Exhibit and Poster Hall
10:30
Shortening the Lead Time: A Modular Approach to Accelerated Production
Developing a modular data collection and deployment strategy can maximize process development timelines while retaining manufacturing flexibility and quality using various ERP/MES systems, and adhering to cGMP. Learn strategies for creating standard business modules, through which accuracy and consistency become the norm versus redundancy and transcription errors. Ultimately, achieve a high-throughput tech transfer mechanism that accelerates the pipeline into manufacturing.
Benjamin W. Drucker, Senior Supervisor, Engineering, Manufacturing Science and Technology, Genentech, Inc.
Developing a modular data collection and deployment strategy can maximize process development timelines while retaining manufacturing flexibility and quality using various ERP/MES systems, and adhering to cGMP. Learn strategies for creating standard business modules, through which accuracy and consistency become the norm versus redundancy and transcription errors. Ultimately, achieve a high-throughput tech transfer mechanism that accelerates the pipeline into manufacturing.
Benjamin W. Drucker, Senior Supervisor, Engineering, Manufacturing Science and Technology, Genentech, Inc.
11:00
Facility Design for Single Use Technologies
In an environment where both Industry and Regulatory expectations are evolving, the considerations and impacts of Single Use technologies on facility design for GMP manufacturing will be reviewed. The increased speed and reduced cost to install such facilities compared to traditional manufacturing facilities is extremely attractive. The impact that business and other drivers can have on the design will be discussed, together with aspects of facility / suite layout, construction, and operation. The flexibility and simplicity of the facility design can provide the ability to cope with the continued development of Single Use technologies and equipment. This and aspects of equipment selection will also be reviewed.
Stephen R. Hudd, Director, Global Engineering, Biogen Idec
In an environment where both Industry and Regulatory expectations are evolving, the considerations and impacts of Single Use technologies on facility design for GMP manufacturing will be reviewed. The increased speed and reduced cost to install such facilities compared to traditional manufacturing facilities is extremely attractive. The impact that business and other drivers can have on the design will be discussed, together with aspects of facility / suite layout, construction, and operation. The flexibility and simplicity of the facility design can provide the ability to cope with the continued development of Single Use technologies and equipment. This and aspects of equipment selection will also be reviewed.
Stephen R. Hudd, Director, Global Engineering, Biogen Idec
11:30
The Relationship between Quality Attributes and Manufacturing Process Parameters for Antibody Maytansinoid Conjugates
Wenjie Cheng, Ph.D., Scientist, Process Science and Engineering, ImmunoGen, Inc.
Wenjie Cheng, Ph.D., Scientist, Process Science and Engineering, ImmunoGen, Inc.
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.
Plenary Session
1:45
Chairperson's Remarks
Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc.
Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc.
2:00
Biotech Approaches to Target Alzheimer's Disease
Advances in understanding of Alzheimer's disease pathophysiology have led to disease modifying therapeutic interventions now being tested in the clinic. Furthermore, utilization of biomarker measures can provide evidence for an impact on disease biology in humans. This update will examine the promise and challenges of current passive and active immunization approaches that could potentially slow progression of Alzheimer's disease.
Husseini K. Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development, LLC
Advances in understanding of Alzheimer's disease pathophysiology have led to disease modifying therapeutic interventions now being tested in the clinic. Furthermore, utilization of biomarker measures can provide evidence for an impact on disease biology in humans. This update will examine the promise and challenges of current passive and active immunization approaches that could potentially slow progression of Alzheimer's disease.
Husseini K. Manji, M.D., F.R.C.P.C., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development, LLC
2:30
Case
Study
Biosimilars: European Experience, mAbs and New RegulationsStudy
The first biosimilar ever, a growth hormone developed by Sandoz, was approved in the EU in 2006. Since then the company has launched two additional products, an Epo and a G-CSF. The presentation will describe the experience gained with these products since their approvals, through post-approval studies and pharmacovigilance. It will also outline Sandoz' development concepts for biosimilar monoclonal antibodies, which will form the next wave of biosimilars, and Sandoz' thoughts on recent regulatory developments.
Joerg Windisch, Ph.D., Head, Global Technical Development, Sandoz Biopharmaceuticals, Austria
3:00
The Evolving Landscape of Companion Diagnostics in Drug Development
Ian McCaffery, Ph.D., Director of Medical Sciences, Amgen
Ian McCaffery, Ph.D., Director of Medical Sciences, Amgen
3:30
Networking Refreshment Break in Exhibit and Poster Hall
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
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