Accelerating Biopharmaceutical Development:
This session will set the context and tone for the AccBio meeting and can be structured as case studies and/or a panel discussion where technologies and approaches are examined that have been successfully implemented to accelerate development and commercialization of protein therapeutics. Example topics include describing different business drivers for acceleration, infrastructure or techniques to accelerate development, maximizing high capacity production, and strategies to speed reliable technology transfer.
- Ann Lee, Genentech
- Joe Miletich, Amgen
Co-Chairs: Tim Charlebois (Pfizer) and Thomas Ryll (BiogenIDEC)
The focus of this session will be the use of expression systems to significantly accelerate development and eventual commercialization of protein therapeutics. Talks might include discussion of current use (or potential use) of novel expression systems for this purpose, or the use of conventional expression systems in a different manner to achieve acceleration.
- Amy Shen, Genentech- Past and present strategies, challenges, and benefits of stable cell line development at Genentech
- Rashmi Kshirsagar, Biogen Idec- Integration of Cell Culture Process Platform and Cell Line Expression Systems to accelerate Biopharmaceutical Development
- Martin Allen, Pfizer- Streamlining the Discovery to Development Transition
- Arvia Morris, Amgen- Efficient upstream process development programs generated using early molecule assessment and culture of continuous improvement
Integrating Process Development: Upstream and Downstream Technologies:
Co-Chairs: Brian Kelley (Genentech) and Nigel Titchener-Hooker (University College London)
Talks in this session will include new approaches to process development in both upstream and downstream areas that together present significant improvements to speed in the development and implementation of commercial drug substance processes. The use of automation and high-throughput systems, accelerated learning through data capture and mining, more reliable scale-down models and potentially disruptive technologies are examples of topics that should be considered for talks and discussion.
- Gene Schaefer (Johnson & Johnson)- Challenges and Innovative Approaches to Improving the Efficiencies of Process Development and Tech Transfer
- Rohin Mahtre (BiogenIDEC)- Enhancing efficiency and control for a Biopharmaceutical manufacturing process
- Dean Pettit (Amgen)- Upstream and Downstream Strategies to Actively Control of Product Quality Attributes
- Mike Hoare (University College London)- Speeding whole bioprocess solutions :the crucial interface linking the bioreactor to purification
Analytical Development and Product Characterization Strategies:
Co-Chairs: Mike Washabaugh (MedImmune) and Laura Bass (Pfizer)
In this session talks will be focused on new, more streamlined approaches to analytical method development and transfer for both product release and characterization. Examples would include eliminating some product release assays through more powerful MS methods, using platform analytical methods for speed of development and transfer and other strategies for rapid method development.
- Rob Dufield (Pfizer)- Analytical strategies enabling expedited development of therapeutic mAbs
- Qinjian Zhao (Xiamen University)- Structural and functional analysis of recombinant virus-like particles (VLP's)
- Kuldip Sra (MedImmune)- Development of a Seasonal Vaccine
Co-Chairs: John Carpenter (University of Colorado) and Ping Yeh (Amgen)
Talks in this session will discuss approaches for accelerating clinical and commercial development by quickly developing phase appropriate formulations. Tools and approaches for rapid formulation development capable of predicting long-term stability should be emphasized. Other example topics include: the relationship of formulation to molecule selection/optimization, approaches for achieving high concentration formulations, and strategies to gain acceptable expiry by filing.
- Vladimir Razinkov (Amgen)- High Throughput Formulation Development of Therapeutic Proteins
- David Volkin (University of Kansas)- Utility of High-Throughput Biophysical Analysis of Protein Stability during Formulation Development and Comparability Assessments
- Robert Muller (Roche)- Phase appropriate approach for formulation development
- Mark Brader (Biogen Idec)
Approaches to QbD for Externally Sourced Deliverables:
Co-Chairs: Abhinov Shukla (KBI Biopharma) and John Crowley (Lonza)
Application of QbD principles and methods can present special challenges when working with external CRO’s, CMO’s and other external partners. This session will cover experiences and potential approaches for managing QbD application in this important interface.
Lynn Conley (Biogen Idec)- Using a Statistical and Risk Based Approach to Improve Robustness And Control in a Late Stage Antibody Process
Using Prior Knowledge and Platform Manufacturing:
Co-Chairs: Narendra Bam (GSK) and Jon Coffman (Pfizer)
This session will focus on how best to leverage prior process, analytical and formulation knowledge toward acceleration of drug substance and drug product manufacture. The value of clear understanding of the link between process parameters and CQAs will also be explored. Some examples could be minimal or no process development for phase I material, more efficient process and product development and more streamlined process validation.
- Rick Caimi (GlaxoSmithKline)- Accelerating Early Phase Development through Efficient Implementation of Molecular Design and Platform Knowledge
- Jeff Salm (Pfizer)- Increasing Access to the Clinic with a Low Cost, Low Volume Manufacturing Process
- Geoff Hodge (XCellerex)
Approaches to Risk Management
Co-Chairs: Lynne Krummen (Genentech) and Anthony Mire-Sluis (Amgen)
Talks in this session will cover the considerations and approaches for managing risk in the context of QbD principles. Talks will include identifying and assessing risk and effectively managing it through understanding CQAs and process design space. Understanding and mitigating the risk introduced by raw materials will also be covered in this session.
- Gregg Nyberg (Amgen)- Development of Effective Control Strategies Using Product Quality Risk Assessment
- Ann Subashi (Pfizer)- Appropriate Use of Risk Management Tools in Biopharmaceutical Development
- Christoph Stark (Novartis)- Practical considerations to risk assessments for efficient use in pharmaceutical development and production
- Mary Cromwell (Genentech)
Translation to Operational Practice
Co-Chairs: Dean Pettit (Amgen) and Yuan Xu (Novartis)
Understanding how to apply QbD principles during the development and commercialization of protein therapeutics can be challenging and will be covered in this session. Examples of topics will include; how to customize investment in QbD from low demand to high demand products as well as during development & post-licensure, the appropriate mitigation efforts to reliably achieve known CQAs and how to integrate QbD into internal Quality Systems or management practices.
- Gregg Flynn (Amgen)- Assessing the Criticality of Product Quality Attributes
- Clinton Weber (CMC Biologics Organization)- Quality by Design Execution from a CMO Perspective
- Shan Jiang (Seattle Genetics)- Control Strategies for Antibody-Drug Conjugates Drug Product Manufacturing
This roundtable will consist of several 15-20 min short talks describing recent regulatory experiences with the FDA’s QbD pilot program. Afterwards, panelists will lead a discussion on current and future regulatory strategies for implementing QbD in regulatory filings. Session chairs to strive to set up open, frank and constructive environment with panelists.
- David Robbins (MedImmune)
- Lynne Krummen (Genentech)
- Kris Barnthouse (J&J Janssen) and Ranga Godavarti (Pfizer)
Rapid Fire Poster Session
This session provides authors five minutes to introduce their work using a single slide to the entire conference. Conference attendees will come away with an overview of all the posters ensuring they won’t miss advances important to their own work. This unique oral poster session will be followed by a poster session where you’ll have the opportunity to discuss each authors work in a one on one setting.
Chair: Greg Frank, Amgen