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Fundamentals of Bioproduction Seminar Series
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| Bioproduction is an exciting new field which aims to provide
tools and theory to support the biotechnology manufacturing process. The
seminar series will focus on specific, critical issues unique to the
biotechnology industry. Seminars will feature talks from active researchers
in this field, as well as key industry representatives in biopharmaceutical
production. Topics will include biopharmaceutical production methods,
regulation and its impact, quality control issues, short and long term
planning as well as capacity expansion planning. The aim of the series will
be to provide a detailed set of research questions and directions in
bioproduction. |
| What will the forum discuss? |
| The Forum is problem focused. We are interested in practical problems facing industry, and developing mathematical models and tools to answer those practical problems.
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The issues we have already identified for research include:
- Issues of drug discovery and production scaleup under uncertainty
- Supply chain optimization, including outsourcing and reliability
- Operational production planning and scheduling
- Tactical production facility and logistics system design
- Strategic long-range planning and risk management
- Measuring and controlling supply chain and production uncertainty (Op Ex)
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| Who will be at the Forum? |
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The Forum is designed to be a meeting place for both Industry and Academia. We hope that through this forum, researchers and professionals will be able to come together to solve problems that the industry faces today. The audience is truly inter-disciplinary and will include graduate students from Industrial Engineering, Chemical Engineering, Economics, Computer Science, Bioengineering and other disciplines. Professors with an active research in this field will attend. There will also be attendees from a number of industries in the Bay Area.
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| September 5, 2007: Bioproduction Forum: Challenges and Opportunities for Lean Manufacturing in Biotechnology |
| Guest lecture by: Dr. Fadel Hamed and Jorge Vilalta |
| The Bioproduction Forum’s inaugural seminar starts Wednesday 5 September at midday. This week features two guest speakers from Genentech, Dr Fadel Hamed and Jorge Vilalta discussing Lean Manufacturing in biotechnology. Lean has been widely implemented across a diverse range of industries, notable examples including Toyota, General Electric and Motorola. In these industries it has shown the potential to dramatically reduce cycle times, waste and production defects. However a set of challenges unique to the biotechnology industry are potential obstacles to Lean’s successful implementation. Jorge and Fadel discuss what these challenges are and how they may be overcome. |
| September 12, 2007: Bioproduction Forum: Challenges and Strategies to manage Biopharmaceutical Operation & Planning |
| Guest lecture by: Thomas Panzer, VP of Global Supply Chain PS Biotech for Bayer Healthcare |
| The Bioproduction Forum’s keynote seminar features Thomas Panzer, VP of Global Supply Chain PS Biotech at Bayer Healthcare. In this role, Thomas oversees the manufacture of Bayer's biotech drug portfolio, with sales of over $2b annually. His group at Bayer Healthcare has pioneered the use of advanced planning and optimization techniques in the biotech industry. Thomas will discuss the impact of highly customized biopharma products on the supply chain network, as well as the effects of regulation in creating complexity. His talk will address techniques in process standardization, Op Ex and supply chain excellence initiatives which have been used at Bayer to address these issues. |
| September 19, 2007: Bioproduction Forum: The Future of Genomic Medicine |
| Guest lecture by: Robert Booth, Chairman of Virobay |
| The past 10 years have witnessed the emergence of a wide range of breakthrough technological advances in the life sciences. However many medical challenges remain and the productivity of the pharmaceutical industry appears to be in decline, with the number of compounds entering Phase 1 and Phase 2 trials declining significantly over the past 5 years. In this presentation, Robert Booth will describe how recent advances in industrial-scale genomics and proteomics, coupled with sophisticated bioinformatics, are allowing us to better understand how human variation relates to disease. This should allow the development of targeted therapies, which are based on an understanding of the underlying biology of disease and are coupled to a corresponding diagnostic test. The integration of these new platforms into the whole Research and Development process offers the prospect of improved productivity and efficiency. Ultimately, this new era of targeted medicine could result in the right medicines being delivered to the appropriate patients at the correct time. |
| September 26, 2007: An Automated Planning Engine for Biopharmaceutical Production |
| Guest lecture by: Prof. Rob Leachman, Industrial Engineering and Operations Research, University of California at Berkeley |
The management challenge to develop efficient and effective batch production schedules for Bayer’s Kogenate® biomanufacturing site in Berkeley is addressed. Seemingly a single-product manufacturing site, a surprising amount of planning complexity arises from the nexus of regulatory approvals differing across the various end markets and changing with time, variable outcomes of quality testing, processing and routing options, limited facility capacities, and the dynamic status of batches-in-progress. Even with leading enterprise management software applied to the task, the generation of a twelve-month batch production schedule for purification, filling-and freeze-drying and packaging facilities is a manual analysis engaging multiple planners for days or even weeks who cannot explicitly consider all possible alternatives. Worse, it is very difficult for them to ensure that no constraints were overlooked.
I will describe the structuring of the planning problem and as an operations research optimization problem. An optimization-based “Planning Engine” is described that generates efficient and effective processing schedules for the facilities in Bayer’s supply chain and an availability schedule for finished products against given demands. It precisely reflects constraints imposed by current and projected regulatory approvals, outcomes of quality testing, and processing options. Very large-scale mixed integer-linear programming problems are routinely formulated and solved by the Planning Engine, enabling a single planner to generate a very good 12-month production plan within a few hours.
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| October 3, 2007: Supply Chain Excellence in Bioproduction |
| Guest lecture by: Prasad Saraph, Bayer Healthcare |
| Supply Chain Excellence (SCE) is a relatively new area in Biopharmaceuticals (Operational Excellence being more common). As Biopharmaceuticals operations are maturing, the focus has started to sharpen on the wider issue of supply chain effectiveness and efficiency, both from cost perspectives as well as from flexibility/responsiveness perspective. SCE aims to tackle issues such as large inventory stocks and sluggish supply chains, as well as issues of reliability and long lead times which are prevalent in the industry. SCE spans multiple facets of biotech value chain covering organizational design, business processes and systems and tools. SCE at Bayer was launched in 2004-05 and is gaining momentum since then. This talk will provide background, lessons learnt and current issues being handled at Bayer SCE. |
| October 10, 2007: Adding Capacity to an Existing Biopharmceutical Plant: Strategies and Challenges for Growth |
| Guest lecture by: Andy Rammelmeier, VP of Manufacturing and Process Development, Biomarin |
| Shifting from a dedicated one-product facility to a multi-product facility poses many challenges. Andy's presentation will desribe the many considerations in making such a jump, including facility design, similarity in process technologies, campaign vs. concurrent manufacturing, and other controls to minimize cross contamination. Andy will also address strategies for managing growth within an existing plant, such as process improvements and plant upgrades, and when to consider other options, such as building or purchasing a 2nd plant and outsourcing.
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| October 17, 2007: Cost Drivers for Biopharmaceutical Process Design and Manufacturing |
| Guest lecture by: Scott M. Wheelwright, PhD. Strategic Manufacturing Worldwide, Inc. |
| Weekly Forum sessions are open to enrolled students, faculty and researchers, including industry representatives. |
| The design of manufacturing processes for biopharmaceuticals is driven by the cost of production. Several critical areas exert influence on the cost, including expression level and chromatography operations. The option of outsourcing is limited by regulatory requirements. In this seminar we will explore the major cost factors in biopharmaceutical manufacturing and how companies respond. |
| October 18, 2007: SPECIAL SESSION: Managing the Supply Chain Today and Tomorrow - The Challenges We Face |
| Guest lecture by: Tim Moore, Senior VP of Global Supply Chain for Genentech. |
| This special session of the Forum is open to all UC campus students. |
| Biopharmaceuticals have come of age over the past 10 years and are entering a new era of maturity. However, as the industry matures, competition will continue to increase, reimbursement and pricing pressures are more prevalent, government pressure to facilitate Follow-on-Biologics (FOB) is gaining momentum and regulatory scrutiny around manufacturing controls and safety will require the biopharmaceutical industry to more effectively manage their near term supply chain, while proactively preparing for future changes. This presentation will outline the key issues facing the Biopharmaceutical Industry today and tomorrow. |
| October 24, 2007: Global Regulatory Challenges to Bioproduction |
| Guest lecture by: Bob Kozak, Senior Director, Regulatory Affairs, Bayer Healthcare |
| Biotechnology manufacturing and development cannot overlook global regulatory requirements when planning how to achieve proof of concept and launch capabilities. There are many regulatory issues associated with bioproduction pillars such as recombinant living organism production, along with complex protein characterization and manufacturing processes. Strategic production planning, implementation and allocation require close partnership with global submission and approval requirements. Process and facility changes throughout life-cycle management are inevitable. Comparability evaluations, their licensure and differences between innovator process changes and biogenerics will be discussed. |
| November 7, 2007: Evolution of Biopharmaceutical Manufacturing |
| Guest lecture by: Tina Larson, Genentech |
| Biopharmaceutical manufacturing output has nearly doubled every decade since the 1980’s. From laboratory scale expression of miniscule quantities of human protein to plants pumping out metric tons of product, biopharmaceutical companies have evolved to meet the demands of an ever expanding, and ever more competitive, market. This presentation will look at how manufacturing operations must evolve to compete, with an emphasis on technology’s role in enabling world class manufacturing organizations. |
| November 14, 2007: Biopharmaceutical Product Economics |
| Guest lecture by: Dr Brian Maiorella, UC Berkeley College of Chemistry |
| Annual therapeutic protein drug sales have reached $40 billion. One third of drugs in U.S. clinical trials are derived from the new biotechnology. But drug development is extremely challenging, with 90% of drugs failing during the pre-clinical and clinical development phases, and with the industry investing an average of over one billion dollars in research and development costs for each new approved drug. In this lecture, Dr. Maiorella will review the biopharmaceutical drug development process and will examine the cost of protein drug manufacturing as compared to development costs and drug sales price. He will highlight areas where engineers and allied scientists can improve the development process and contribute to superior drug products at acceptable cost, while he paints a picture of the stresses and rewards of a career in this field. |
| November 28, 2007: Benchmarking Best Manufacturing Practices - Lessons from the Semiconductor Industry |
| Guest lecture by: Prof. Rob Leachman, Industrial Engineering and Operations Research, University of California at Berkeley |
During the period 1991 - 2003 the speaker led an interdisciplinary worldwide study of major semiconductor manufacturers, measuring manufacturing performance and identifying the key managerial, technical and organizational practices underlying leading performance. The key practices, which may be grouped into six major thrusts, will be highlighted in this talk.
While there are many differences between semiconductor fabrication and bioproduction, there are likely important insights for the management of bioproduction that we can gain from understanding the findings in the semiconductor industry study. And the successful semiconductor industry effort suggests we could consider undertaking a similar study of the biotechnology industry. |
| December 5, 2007: Medicines for the Third World: OneWorld Health |
| Guest lecture by: Tue Nguyen, Vice President of Chemistry, Manufacturing and Controls, & John Graves, Institute for OneWorld Health |
This final Forum for the semester focuses on drug development and production targetted at third world diseases. This focus brings a set of challenges and business model very different from traditional Biotech / Pharma companies.
Tue Nguyen will give an overview of various programs at the Institute for OneWorld Health, a non-profit organization dedicated to neglected infectious diseases in the third world. Dr Graves will focus on the development of Paromomycin for Visceral Leishmaniasis in India. |
| Industry Outreach at Genentech: December 7, 2007: The role of simulation in model building and process analysis |
| Guest lecture by: Rick Johnston & Prof Lee Schruben, UC Berkeley |
Simulation tools can provide unique insights into plant performance and costing by showing the effect of process variability and allowing detailed 'what-if' scenario modeling. They can also help bridge the gap between process design and operations by integrating process performance data and allowing new technologies and unit operations to be modeled. This talk will outline the kinds of questions which can be answered by simulation models and how simulation technologies can augment existing models, including:
• Various types of process variability and their impact on scheduling and plant performance.
• Experimentation with new technologies and unit operations and their comparison against baseline performance.
• How simulation technologies might be integrated with existing Excel models.
• Validation of Models and Design of Experiments (DOE)
This Forum requires no background knowledge in simulation and is based on lessons learnt from Genentech's ongoing Technology of the Future simulation program.
This special Bioproduction Forum will be held on Genentech's campus.
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Research in Biopharmaceutical Operations Course
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| | This course is designed to set the research agenda on operational issues relating to biotechnology.
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| In this project course, interdisciplinary teams of talented students will collaborate together to outline the issues in one specific area of the Biotech industry. Working closely with extensive Industry and Academic support, teams will formulate questions and pose practical solutions. The aim will be to establish a set of research questions and initial approaches which are interesting to both academia and industry. |
| For Students: This is an exciting opportunity to learn in detail about the Biotechnology operations, as well as to gain important insights through one-on-one sessions with industry. The outcomes will also help establish research in the field. |
| For Industry Mentors: This is a unique chance to help formulate the research done by UC Berkeley, and gain knowledge of other academic toolsets which can be applied in the biotech field. |
| What will the course involve? |
Currently we have outlined areas of research in areas such as:
- Issues of drug discovery and production scaleup under uncertainty
- Supply chain optimization, including outsourcing and reliability
- Operational production planning and scheduling
- Tactical production facility and logistics system design
- Strategic long-range planning and risk management
- Measuring and controlling supply chain and production uncertainty (Op Ex)
We expect that these areas will be investigated in more detail in this research course.
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The course will be structured in three parts.
| 1. Literature Review |
In the first 6 weeks, teams will be formed and an initial literature review will be done.
- The course will provide a 90 minute ‘mixer’ event in the first week with a 45 minute overview of Bioproduction and the available topics for research, and 45 minutes of social time where people can introduce themselves and start to form groups.
- Week two will provide more detail of the topics for research. Before week three starts, the names of members in groups will be required.
- In week three a bidding competition will be conducted on the research topics. Groups will bid on three different research topics, in order of preference, with a reason for each topic choice and ideas for research.
- In weeks 3-6, a detailed review of literature will be done to determine all available research in academic papers, trade journals, consulting publications and white papers on the particular research area.
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| 2. Initial Academic Plan |
In the next six weeks, teams will focus on developing an academic plan in conjunction with their academic and industry mentors. This academic plan will include detailed interviews with industry on between one and three specific research ideas relating to the area.
- Gate 1: Teams will present ideas in weeks 6 through 8 (30 minutes each) and feedback will be given from other teams as well as from key course advisors
- Industry and academic leads will help establish research directions which have BOTH practical benefit and are new areas of academic research.
- Gate 2: A refined set of ideas will be presented in weeks 10-12 in the form of a presentation. The best presentations will be used for the Bioproduction Workshop in May.
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| 3. Academic Plan |
In the final weeks of semester, groups will present their completed Academic plans in a 20 minute presentation to a panel of both Industry and Academic representatives. The academic plan will not be a research paper, but will suggest one or more topics of research for further investigation. Plans will be judged on:
- Potential Academic merit: whether the research ideas presented are novel or would make original contributions to the field
- Potential Industry merit: whether the research ideas have practical value to the industry
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Previous speakers at the Bioproduction Forum include:
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Thomas Panzer
Speaker Date: September 12, 2007: Thomas Panzer is currently the Vice President of Global Supply Chain PS Biotech at Bayer Healthcare LLC, where he oversees the production of Bayer's multi-billion portfolio of biopharmaceutical products. He graduated from Technical University Dresden (Germany) with a degree in Mechanical Engineering.
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Tim Moore
Speaker Date: October 18, 2007:
Tim is the Senior Vice President of Global Supply Chain at Genentech, where he overseas production of Genentech's entire operations. He most recently held the position of vice president, Operations at ZLB Behring (formerly Aventis Behring) where he managed aseptic/biological manufacturing operations. Tim brings over 20 years of experience in the pharmaceutical/biological industry including engineering experience at Merck & Co.
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Tue Nguyen
Dr Tue H. Nguyen is currently Vice President at the Institute for One World Health (iOWH), a non-profit pharmaceutical company in San Francisco. iOWH’s mission is to develop safe and effective drugs for neglected diseases in developing countries. Before joining iOWH, he spent over twenty years at Genentech, a biotech pharmaceutical company in South San Francisco, progressing from Scientist to Director of Analytical Sciences, and Director of Pharmaceutical Research and Development. He participated in the development of several protein drugs currently used for the treatment of heart attack, cancer, asthma and age related macular diseases.
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Rob Leachman (UCB)
Rob Leachman is a Professor of Industrial Engineering and Operations Research at the University of California at Berkeley, where he serves as Director of the Competitive Semiconductor Manufacturing (CSM) Program. Dr. Leachman is the author of more than 50 technical publications concerning operations management and productivity improvement. He has supervised more than 30 PhD dissertations in the area. He also is President and CEO of Leachman and Associates LLC, a firm providing consulting and software for operations management to semiconductor manufacturers and other corporations.
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Andy Ramelmeier
Speaker Date: October 10, 2007:
Vice President, Manufacturing and Process Development at Biomarin: Dr. R. Andrew “Andy” Ramelmeier is an accomplished executive and technical leader with over 15 years experience in the development and manufacturing of biopharmaceuticals, including monoclonal antibodies, vaccines and therapeutic enzymes. Andy has a strong track record in strategic planning, building and sustaining organizations, building and running manufacturing facilities, developing and transferring biological processes from R&D to manufacturing, technical support of marketed products, and clinical supply chain.
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Scott Wheelwright
Speaker Date: October 17, 2007:
President and CEO of Strategic Manufacturing Worldwide, Inc.
Dr. Wheelwright has over 20 years experience in solving the challenges companies encounter when bringing biotech and other medical products out of research and into the commercial marketplace. Dr. Wheelwright has led the development of products for cancer, wound healing, infectious diseases and cardiovascular therapy.
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Robert Booth
Speaker date: September 19, 2007
Dr Booth is an Operating Partner at TPG Ventures which is the venture capital operation within TPG’s global private investment organization. Dr Booth also serves as the Chairman of ViroBay Inc. a biotechnology company which he co-founded in 2006. Prior to joining TPG, Dr. Booth was the Chief Scientific Officer at Celera Genomics, where he was responsible for leading all discovery and development activities.
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Dr Robert Kozak
Speaker date: 24 October, 2007 Dr. Robert Kozak holds a position as Senior Director in Global Regulatory Affairs at Bayer HealthCare LLC in Berkeley, CA. He joined Bayer in 1993 during the global licensure of Kogenate®, a recombinant Factor VIII for Hemophilia A patients. He is currently responsible for biotech regulatory development of products. In addition, he chairs the cell bank committee and is the scientific chair of the original Bayer TSE program.
Prior to joining Bayer, Dr. Kozak was a tenured Biotech reviewer at CBER / FDA and Branch Chief of the Laboratory of immunoconjugates, Division of Monocolonal Antibody. He served on numerous IND, BLA committees, regulatory guidance committees, TSE / BSE and cell substrate committees.
Dr. Kozak is a microbiologist / immunologist from Cornell University Medical College and 4 years post doc in the Metabolism Branch of the National Cancer Institute, NIH studying cytokines receptors and directed radionuclide and toxin conjugate immunotherapy.
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Brian Maiorella
Speaker Date: November 14, 2007 Brian Maiorella is an adjunct professor in the UC Berkeley College of Chemistry, teaching biochemical process design and pharmaceutical product development strategy. Dr. Maiorella has 20 years of experience in the biopharmaceutical industry, with expertise in drug development portfolio management and optimization of the drug product development process. He retired in 2001 as vice president of process development at Chiron, where he had served on the corporate drug portfolio ranking team and on the management team overseeing all products in clinical development, while leading the division responsible for fermentation, purification, formulation and analytical development for recombinant therapeutic products. Dr. Maiorella is winner of the American Chemical Society William H. Peterson Award in biochemical engineering.
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Tina Larsen
Speaker date: November 7, 2007 Tina M. Larson is Associate Director of the Fermentation Manufacturing Science and Technology group at Genentech’s South San Francisco facility. She has supported manufacturing processes at Genentech for 11 years; working as an automation engineer and manufacturing scientist in both fermentation and purification operations. Her primary research interest is data technology development in manufacturing applications. She is actively involved in cross-industry discourse related to the field of process analytical technology, including membership on the steering committee for the Pharmaceutical Process Analytics Roundtable (PPAR).
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Linette Sun
Speaker date: November 28, 2007 Linnette Sun was formerly director of Medical Research and Economics, Health Economics, Pricing and Reimbursement at Baxter, Amgen, and Johnson & Johnson. Currently, she is working as a consultant with major biotech firms and pharmaceutical companies on issues regarding new product development, pricing and reimbursement.
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Prasad Saraph
Speaker Date: October 3, 2007 Prasad Saraph is a project manager for Bayer Healthcare, where he leads Supply Chain Excellence initiaves. He currently supervises 18 such projects across the entire supply chain with 11 project leads, 30+ core team members and 150+ stakeholders. He has degrees in Mechanical Engineering from GEC in Aurangabad, India and Industrial Engineering from IIT in Bombay, India, as well as an MS in Industrial Engineering and Operations Research from UC Berkeley.
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Jorge Vilalta
Speaker Date: September 5, 2007: Jorge Vilalta is Sr. Manager of Operational Excellence for Genentech’s Corporate Engineering group. Prior to joining Genentech, Jorge worked across multiple industries at various companies including Johnson & Johnson and The Boeing Co leading Lean Manufacturing initiatives.
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Dr. Fadel Hamed
Speaker Date: 5 September: Dr. Fadel Hamed is an ASQ certified Six Sigma Black Belt and Quality Engineer. He is the process owner for operational excellence methodology and training at Genentech. In his role as process owner, Dr. Hamed administers the LEAN/DMAIC methodology and is accountable for all aspects of operational excellence training and skill development. Prior to joining Genentech, Dr. Hamed worked across multiple industries at various companies including Amgen, Lambda Optics, and IBM. Dr. Hamed received his doctorate in mechanical engineering from the University of California, Berkeley.
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