Webcasts / Podcasts from the 2008 AAPS National Biotechnology Conference
Recorded at the Metro Toronto Convention Centre
Note: All media content contained herein, including mention of products and services, is the opinion of the original presenters and is not necessarily endorsed by AAPS. Content discussing legal issues is offered as general information only and is not to be construed as specific legal advice.
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Podcasts: Mp3 files of recorded lecture material
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Free-to-Members Webcasts:
The following session is free to members. Click on the link below and enter your AAPS member number and password.
The Plenary Session: Pharmaceutical Biotechnology: The Next Steps
Production of Biopharmaceuticals in Oilseed Plants
Maurice Moloney, Ph.D., SemBioSys Genetics
RNAi: An Opportunity for a New Class of Therapeutics
Akshay K. Vaishnaw, M.D., Ph.D., Alnylam Pharmaceuticals, Inc.
How to Produce Vaccines in Plants
Louis P. Vezina, Ph.D., Medicago
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Fee-Based Symposia:
The following symposia are fee-based and are available individually. Please click on the “REGISTER” button below each title for payment information and a form to be faxed in to AAPS. Upon receipt of payment, you will receive a special URL, username and password. To view content, enter the URL provided and insert the access codes provided in lieu of your member login.
Attendees, presenters and moderators of the 2008 AAPS National Biotechnology Conference and Exposition in Toronto may view all fee-based symposia listed below at no charge, upon receipt of registration form.
Quality by Design
This symposium will bring together industry and regulators to address the application of QbD to biopharmaceutical development. Topics will include definitions and concepts of quality by design, design space, and terminology. For example, a well defined design space encompasses critical process parameters and product quality attributes. Approaches to risk assessment will be addressed. The impact of quality by design to control strategies such as setting specifications and PAT will be presented. Recent case studies from industry on quality by design in an application will be reviewed, discussing strategy and placement in a CTD application. A return on investment perspective (e.g., post approval regulatory flexibility) will be presented. What are the challenges in implementing QbD by industry and by regulators? You will gain understanding of what types of data and relevant knowledge are used to determine design space ( e.g., platform strategy, DOE, literature sources) and how this knowledge can be extended across a platforms and be used to focus the scope of designed experiments and potentially impact validation exercises. You will gain regulatory perspectives from the US and Canada and well as other international experiences via the case studies and learn what options are being considered for regulatory submission and approval pathways? Consistency in the framework amongst different regulatory agencies will be compared.
- Blue Sky Quality by Design
Clarice Hutchens, Worldwide Pharmaceutical Sciences
- Implementatation of Quality by Design for Biologics
Ron Taticek, Ph.D., Genentech, Inc
- U.S. FDA Perspective on Quality by Design for Biologics
Barry Cherney, Ph.D., U.S. FDA
- Heath Canada Perspective on Quality by Design for Biologics
Anthony Ridgway, Ph.D., Health Canada
- Panel Discussion
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Protein Aggregation and Immunogenicity: Current Science and Regulations
Due to the molecular and structural properties of protein, it can form aggregates over time as a result of physical degradation. In the human body, such protein aggregates could enhance immune response causing undesired adverse effects. Therefore protein aggregation and immunogenicity is an important topic to be addressed during the biological product development both from CMC/Quality as well as clinical safety/efficacy perspectives. Understanding the mechanism of aggregate formation and the means of minimizing the aggregate formation continue to be of high priority to address this issue in biological products. In addition, efforts continue in the area of improving analytical methodologies for testing of potentially immunogenic aggregates. This symposium will provide the audience with current science and regulations related to protein aggregation and immunogenicity, and the information will be presented by invited speakers from the industry and regulatory agency. Case studies will be included.
- Aggregates in Monoclonal Antibodies: A Perspective on Lessons Learned
Ruth Cordoba-Rodriguez, Ph.D., U.S. FDA
- Measuring Protein Aggregation: A Comparison of Techniques
Mary Cromwell, Ph.D., Genentech, Inc.
- Regulatory Considerations for Assessment of Protein Aggregates in Monoclonal Antibodies
Michelle Frazier-Jessen, Ph.D., MedImmune
- Panel Discussion
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Strategic Approaches for Immunogenicity Assessment
Due to the nature of immune response and the limitation of current available technologies, immunogenicity assessment can be a very challenging task for new biological development. Immunogenicity assessment for each biotherapeutic is a program consisting of a serial of assays or methods which provide informatiom to define immune positive/negative results, characterize the nature of immune response and assess the clinical impact. Choosing appropriate approaches is critical for the program. This session will present strategies on how to assess immune response at different stages of biotherapeutic development from preclinical study to late phase clinical trial, including preparation of appropriate reference standards and control samples, and overcoming sample matrix inteference and improving endogenous drug tolerance.
- Assessing Imunogenicity in Nonclinical Studies
Bonita Rup, Ph.D., Wyeth Research
- Requirements for Detection Limits of Immunogenicity Assays
Lorin Roskos, Ph.D., MedImmune
- Neutralizing Antibody Assessments for Biologicals During Clinical Development
Shalini Gupta, Ph.D., Amgen, Inc.
- Assessing Immunogenicity in Clinical Programs: Defining an Informative Bioanalytical Strategy
Valerie Quarmby, Ph.D., Genentech, Inc.
- Panel Discussion
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Biomarkers and Decision Making During Drug Development
Pharmaceutical and biotech companies have been using biomarkers as translational tools for internal decision making. While there are clear examples in the immunology, CV and endocrine area, biomarker use in oncology remains a challenge. In addition, considerable confusion exists on the definition of biomarkers. This symposium will include talks geared towards definition of biomarkers and surrogate endpoints. Talks will feature examples showing the utility of biomarkers during drug development. Some examples include early predictions of activity, dose and regimen optimization, and understanding of MOA. Other talks will focus on practical challenges and issues related to clinical implementation of biomarkers in drug development.
- Biomarkers and Decision Making During Drug Development
William Manning, Ph.D., Genentech, Inc.
- Proteomic Profiling of Ascites to Identify Putative Biomarkers for Ovarian Cancer
Thomas Kislinger, Ph.D., University of Toronto
- Translation of Pre-clinical Pharmacodynamnic Biomarkers to the Clinic for the Development of Large Molecule Drugs in Autoimmune Diseases
Heleen Scheerens, Ph.D., Genentech, Inc.
- The Use of Healthy Volunteer Models of Disease States to Accelerate Early Clinical Development
John Connell, Ph.D., ICON
- Panel Discussion
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Stabilization, Characterization and Formulation Considerations of Biologics in Primary Containers
In the quest for building robust delivery systems for biologics, particular attention is given to how the chemical and physical structure of a complex molecule is influenced by the chemical and physical environment of the system. In order to understand the specific changes that lead to destabilization of biotech products, it is important to first characterize the systems as part of a preformulation effort so that appropriate stabilization materials and methodologies are implemented in the formulation and commercialization endeavor. Since a significant fraction of biologics are or start out as liquid formulations, there is a high propensity for an interaction between packaging materials and the product contained within ex. introduction of trace quantities of chemicals (monomers, metal ions etc.) or presence of physical charges at the product-package interface. These items, while not significant in themselves or of concern from a safety perspective, may, over time, predispose changes in complex molecules that result in product degradation. Product degradation may occur not just because of changes in chemical and primary structure but also due to subtle changes in secondary and tertiary physical structures of typical biotech products. These changes typically manifest themselves as aggregation (either particles or soluble aggregate formation), and discoloration due to light exposure. As part of the proposed session, we aim to provide common approaches and methodologies for studying biologic product-package interactions and application of the knowledge in product stabilization.
- Regulatory Perspective on Extractable and Leachable Substances in Primary Containers
Ingrid Markovic, Ph.D., U.S. FDA
- Formulation Considerations of Biiologics in Primary Containers
Manisha M. Dali, Ph.D., Bristol-Myers Squibb Company
- Challenges in Understanding Particle Formulation in Primary Containers for Monoclonal Antibody Formulations
Rahul S. Rajan, Ph.D., Amgen
- Biologics in Solution and Interaction with Container Closure Systems
Satish K. Singh, Ph.D., Pfizer
- Panel Discussion
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