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Mark Your Calendar for 2012
October 8-12, 2012
Rhode Island Convention Center
Providence, Rhode Island
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BPI Goes Global!
August 21-22, 2012
Shanghai, China
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Keynote Presentations
- 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
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 2009The Patient Protection and Affordable Care Act (Affordable Care Act) contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that amends the Public Health Service Act (PHS Act) and other statutes to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference product. This talk provides an overview of the legislation and the Agency's implementation of the BPCI Act.
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.
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
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
Symposia: Monday | Main Conference: Tuesday | Wednesday | Thursday | Friday
Cell Culture Keynote Presentation
Unpublished Data
8:05
The International Chinese Hamster Ovary Genome Project: Where Do We Go from Here?A new era is about to begin in biotechnology community. Today, a quarter of all FDA approved new drugs are biopharmaceuticals, most of which are produced in Chinese hamster ovary (CHO) cells. Sequencing and characterizing CHO K1 and other related cell lines and tissues is being pursued in earnest by a variety of international groups. The impact that these events will have on biotechnology and bioprocessing is not yet clear. But it is likely that the sequencing of the CHO genome will transform the way in which cells and processes are analyzed and improved in future decades. This presentation will discuss ongoing efforts to characterize the genome, proteome, and other omics sources in the CHO community. How these changes may transform the way biotechnology problems are solved will also be discussed including representative examples from our laboratories and others. Reaping the greatest benefits of this information explosion will require the community to coordinate efforts in new and different ways. As a result, we will discuss ongoing efforts to organize, distribute, and share the rapidly expanding CHO genomics knowledge base in a framework that will provide users with the tools that will provide the greatest benefit to the entire biotechnology community.
Michael Betenbaugh, Ph.D., Professor, Chemical and Biomolecular Engineering, Johns Hopkins University
Vaccine Development & Production Keynote Presentations
8:05
Vac to the Future: Vaccines Bioprocessing and DevelopmentVaccines are the crown jewel in the accomplishments of biotechnology, impacting far more lives at far less cost than any other medical intervention. This talk will discuss the state-of-the-art in vaccine development and manufacturing, current issues, and future trends. Evolution of bioprocess and manufacturing requirements as they relate to products and new potential products will be emphasized.
John G. Aunins, Ph.D., Executive Scientific Director, Merck Research Laboratories
9:00
Public-Private Partnering for National Security & Public Health NeedsRobin A. Robinson, Ph.D., ASPR Deputy Assistant Secretary and BARDA Director, US Department of Health and Human Services
Recovery & Purification Featured Presentation
11:30
Fitting the Glass Slipper: Process Design, Plant Capacity, and Value RealizationA good fit between plant and process is critical in assuring robust high value operations. Understanding process fit using model systems, statistical analysis of process trends, and inclusion of plant capacity and throughput constraints in Quality by Design programs can anticipate plant performance, enable control and capability, and increase value from high fixed cost assets.
Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Keynote Presentation
4:45
The Impact of Antibody Drug Conjugates on Process Development and ManufacturingThe antibody-drug conjugate (ADC) concept is to use an antibody to deliver a cytotoxic drug selectively to a target such as a tumor-associated antigen. Such conjugates represent a broadly applicable approach to enhance the antitumor activity of antibodies and improve the tumor-to-normal tissue selectivity of chemotherapy. There is a rapidly growing number of ADC's moving through clinical development towards the marketplace. This talk will review the ADC field and focus on some of the unique challenges and opportunities from a process development and manufacturing perspective.
Morris Rosenberg, Ph.D., Executive Vice President, Process Sciences, Seattle Genetics
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