Outsourcing Manufacturing of Biopharmaceuticals
Event Information
Document Title
Agenda
| Day One Monday, March 2, 2009 | DAY ONE | DAY TWO | | ||||
| 7:00 | Registration and Coffee | |||
| 8:25 | Chairperson's Announcements & Introductory Discussion The biotech industry is renowned for its innovations in the world of pharmaceuticals. These innovations can either pave the way for or add complexity to manufacturing outsourcing. The conference sessions at this event have been designed to highlight new developments in the industry and provide practical tools and approaches to making the best manufacturing outsourcing decisions to fit your company's individual needs. Shelley Suggett, Senior Product Manager, Avastin Global Supply Chain, Genentech, Inc. | |||
| New Considerations for Making Difficult Outsourcing Decisions | ||||
| 8:45 | CMO Management - Challenges for Virtual Companies A virtual biotechnology company will outsource some or all of its process development and/or manufacturing activities related to its drug candidates to contract manufacturing organizations (CMO's). The long-term success of the company is therefore completely dependent on the performance of CMO's. The challenges for virtual companies in the proper establishment and management of CMO relationships and key components of successful CMO relationships will be discussed. David Hakes, Ph.D., Senior Director, Strategic Sourcing, Neose Technologies, Inc. | |||
| 9:15 | What Do We Keep In-House, What Do We Outsource - AND WHY? During the course of product development, decisions are made where to manufacture to support corporate objectives. Often, companies will take advantage of their own strengths and competencies and choose to manufacture in-house when feasible. In many biotechnology companies this may involve cell line development and biologic drug substance manufacture. Outsourcing of drug product manufacture, chemical synthetic processes and specialized container/closure and packaging, for example, is common. This presentation will provide insights into the process of in-house vs. outsourcing decisions. Art Blum, Senior Director of Regulatory Affairs, BioMarin Pharmaceutical Inc. | |||
| 9:45 | Building Tools for Risk Management and Assessment of CMO's This presentation will provide a practical approach for developing tools to use to manage risks associated with CMO selection and on-going management of CMO projects. The guidance provided will help sponsors set up tools that meet individual company needs and objectives to ensure success when choosing who to partner with and how to maximize the relationship. Roger Symczak, Product Management Team Leader, Genentech, Inc | |||
| 10:15 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| 11:00 |
Pharmaceutical companies are increasingly outsourcing their API's and excipients, especially to India and China. While the financial advantages are obvious, drawbacks and potential problems have received less attention. Case studies of adulterated heparin, glycerin and milk products will be examined to provide not only an explanation of the course of events but to consider what practical lessons can be drawn from them. The presentation will review whether greater attention to the concepts contained in Quality by Design and a commitment to building an ethical supply chain provide greater safeguards against adulterated and counterfeited API's and excipients. Michael N. Eakins, Principal Consultant, Eakins & Associates | |||
| 11:30 | Outsourcing a Viral or Toxic Product: Safeguarding Products and Facilities Drug candidates in the pharmaceutical and biopharmaceutical pipeline increasingly are being designed to treat diseases that require targeting, high potency, and often immune stimulation. We will discuss the facility design, equipment, and personnel training necessary for the safe handling and manufacturing of products such as viral vectors, highly potent API's, secondary metabolites and antibody drug conjugates (ADC's). David M. Backer, Director, Business Development and Marketing, SAFC Pharma, a part of the Sigma-Aldrich Group | |||
| 12:00 | Technology Workshop IBC's Technology Workshops offer supplier companies the opportunity to present product or service offerings directly to the audience at this conference. For more info on presenting please contact Kristen Schott at 508-614-1239 or kschott@ibcusa.com | |||
| 12:30 | Networking Luncheon in Exhibit Hall with Poster Viewing | |||
| 2:00 | Chairperson's Remarks Art Blum, Senior Director of Regulatory Affairs, BioMarin Pharmaceutical Inc. | |||
| Keynote Presentation | ||||
| 2:15 | The Changing Outsourcing Landscape - Strategic Drivers & Solutions Abstract to come. Arindam Bose, Ph.D., Executive Director of Biologics Strategy & Alliances, Worldwide Pharmaceutical Sciences, Pfizer Global R&D | |||
| 3:00 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| Featured Session | ||||
| Traversing the Antibody Drug Conjugates Supply Chain Obstacle Course | ||||
| 3:45 | Session Moderator's Opening Remarks Antibody drug conjugates combine toxic-agent therapy with biotechnology-drug therapy. Therefore, it is common in the world of ADC product manufacturing for several CMO's to be necessary for a single ADC product. The talks in this session will draw from lessons learned from ADC case studies, including selecting a CMO and setting up and managing a complicated supply chain. Sloan Rausser, Associate Director, Manufacturing Operations, Genentech, Inc. | |||
| 3:50 |
Our philosophy is on defining and implementing business processes and systems to facilitate selection, implementation and management of our manufacturing contractors and collaborators. Specific challenges faced throughout the decision process for antibody drug conjugates is in understanding and finding the right balance of expertise at third party contractors (CMO's) that have both biological manufacturing and small molecule (highly potent) capabilities. This presentation will review the high level process, roles and tools that should be utilized in selection of CMO's that will support the development and/or manufacture of ADC's. Jennifer Rakow, Manager, Manufacturing Collaborations, Genentech, Inc. | |||
| 4:20 |
Antibody drug conjugates combine toxic-agent therapy with biotechnology-drug therapy. Therefore, it is common in the world of ADC product manufacturing for several CMO's to be necessary for a single ADC product. This discussion will provide the audience with a vicarious experience of running, crawling, and climbing the ADC obstacle course, including regulatory considerations when selecting a CMO and managing a complicated supply chain. Jonathan Harris, Senior Manager, Regulatory CMC, Genentech, Inc. | |||
| 4:50 |
As the facilitator in the manufacture of early to late phase clinical trial conjugates utilizing outsourced antibody, linker, and cytotoxic agents, we are faced with numerous manufacturing and quality assurance challenges. This presentation will highlight what we feel have been the most critical challenges we have faced in manufacturing antibody drug conjugates. Tom Lauzon, Executive Director Operations, ImmunoGen, Inc. Steven J. Ferris, Senior Director Quality Assurance, ImmunoGen, Inc. | |||
| 5:30 | Networking Cocktail Reception in Exhibit Hall with Poster Viewing | |||
| Day Two Tuesday, March 3, 2009 | DAY ONE | DAY TWO | | ||||
| 7:30 | Registration and Coffee | |||
| 8:30 | Chairperson's Opening Remarks Max S. Lazar, President, FDA Regulatory Compliance Consulting | |||
| The Evolution of Quality Assurance and Quality Control | ||||
| 8:45 | Inherent Risks Associated with Outsourcing Life is not without risk and outsourcing of products and services is part of life today. The pharmaceutical industry is not exempt from this exposure which can potentially impact a company, its products, intellectual property and its quality and reputation. This presentation will investigate the subject, and explore what can be done to mitigate the danger. Max S. Lazar, President, FDA Regulatory Compliance Consulting | |||
| 9:15 | Examining the FDA Globalization ACT of 2008 The Globalization Act of 2008 provides significant expansion of the FD&C Act, in an attempt to address ambiguities which may indirectly allow adulterated, contaminated, unapproved or otherwise unacceptable drugs, API's and devices into the United States. This presentation will discuss the changes to the Act, how far up the supply chain this may reach, and what FDA may expect manufacturers to require of their suppliers in the way of method validation, process validation, and country of origin labeling. Clinical trial materials and licensed products will be discussed. Arvilla Trag, President, Midwest Consulting Services | |||
| 9:45 |
As a result of the expansion of contract manufacturing sites throughout Asia, opportunities have grown to reduce costs and increase options for flexibility. However, many potential users of these services remain concerned with the perception of lack of quality in some products made in these countries. The experience of Baxter in procuring heparin is a case in point. One of the best ways to control quality and reduce risk is through partnership with qualified manufacturers. In this presentation we will discuss examples of successful partnerships and the key issues to address to ensure high quality production. Scott M. Wheelwright, Ph.D., President, Strategic Manufacturing Worldwide, Inc. | |||
| 10:15 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| Single-Use Manufacturing: Potential for Risk and Opportunity for Improved Quality | ||||
| 11:00 | Single-Use Processes: Advantages with Outsourcing The need to manufacture large quantities of material in a short period of time is the goal for most companies striving to get their product into the clinic. Outsourcing is an important consideration for these projects. Single-use, disposable components and processes offer many advantages in the manufacturing of such biologics. This presentation will introduce and discuss real applications of single-use technology and the advantages that it brings to outsourcing. Leigh N. Pierce, President, PacificGMP | |||
| 11:30 |
When utilizing disposable technology to achieve increased processing speeds it is essential that the level of quality of the components and the tracking are in line with the project's desired outcome and all regulations. This presentation will highlight a case study where quality assurance requirements were balanced with the requirement for drug substance, to ensure the proper alignment with the sponsor's clinical demand. Matthew Hall, Senior Manager of Manufacturing, Xcellerex, Inc. | |||
| 12:00 | A Prospective Risk Assessment Methodology for Leachables and Extractables Due to the explosion of single-use components used in the manufacture of biopharmaceuticals, a method for evaluating the risk from leachables and extractables released into the process stream was developed. This systematic methodology utilizes a team based approach coupled with multiple levels of triage to ensure that highest levels of scrutiny are given to the riskiest components. Scott E. Haller, Supervisor, Process & Analytical Sciences, Regeneron Pharmaceuticals | |||
| 12:30 | Networking Luncheon in Exhibit Hall with Poster Viewing | |||
| Audience Interactive Panel Discussion | ||||
| 2:00 | Quality Assurance for Today's (and Tomorrow's) Outsourcing Partnerships Panelists will focus on strategies to address both familiar and nascent quality assurance challenges in outsourcing. We'll discuss successful approaches to quality oversight in emerging countries, the impact of current regulatory guidance documents, and practices to increase compliance in spite of tightened travel budgets. Audience questions and participation will be encouraged. Chairperson and Moderator: Jonathan M. Morse, RAC, Principal Consultant, Complya Consulting Group, LLC Panelists: Anne Marie Woodland, Executive Director, Quality, CombinatoRx, Inc. Ray Lockard, Director of Quality Assurance, Alnylam Pharmaceuticals Additional panelists to be announced | |||
| 2:30 | Technology Workshop IBC's Technology Workshops offer supplier companies the opportunity to present product or service offerings directly to the audience at this conference. For more info on presenting please contact Kristen Schott at 508-614-1239 or kschott@ibcusa.com | |||
| 3:00 | Networking Refreshment Break in Exhibit Hall with Poster Viewing | |||
| How to Achieve Success by Maximizing CMO Expertise | ||||
| 3:30 | Celltrion - Maximizing International Capabilities Biopharmaceutical manufacturing is undergoing a major paradigm change from unique manufacturing processes for each product, to uniform manufacturing systems applicable to a multitude of products. As in other aspects of the pharmaceutical industry, globalization of the supply chain is possible technically, acceptable by regulatory authorities and economically advantageous. Maximum benefits will accrue to companies that are agile and use worldwide capabilities to rapidly discover, manufacture and deliver new biopharmaceuticals to meet the needs of global health. Donald F. Gerson, Ph.D., President, Celltrion, Inc., Korea | |||
| 4:00 |
In 2007 Sandoz created a new business unit in order to focus its biotech business in two areas: Contract development and manufacture of recombinant products (technology: microbial and mammalian cell culture) and development and manufacture of our own biopharmaceuticals. The new business model allows Sandoz to offer its multipurpose facilities as well as know-how for third parties which will be illustrated by two case studies: flexible use of microbial production facilities in order to reduce manufacturing cost and the introduction of a new microbial expression system (NAFT) for recombinant manufacture of peptides at large scale. Friedrich Nachtmann, Ph.D., Head Biotech Cooperations, Sandoz, GmbH, Austria | |||
| 4:30 | Boehringer Ingelheim - Mastering Flexibility Process development is driven by the dual desire to secure rapid time to clinic and time to market with a pronounced focus on cost of goods. Integrated upstream and downstream processing based on platform technologies allows a robust scale-up into 15,000 L scale. Well established technology platforms allow for high titer fermentation processes to achieve 1-6 g/L protein expression in 11 days. The goal of purification development based on high throughput screening and on using different platform technologies is a robust, economical process to manufacture high product quantities at high overall yield (> 70 %) and with high product quality. Helmut Hoffmann, Ph.D., Head of Process Science, Boehringer Ingelheim GmbH, Germany | |||
| 5:00 | Close of Conference | |||
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