AccBio/QbD Conference Description & Program

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The theme of the AccBio/QbD 2013 is "Meeting Current Challenges in Therapeutic Protein Technical Development." The AccBio portion of the conference, co-chaired by Jim Thomas (Amgen) and Reed Harris (Genentech) is a unique conference that provides attendees with a multidisciplinary approach. High level talks by well known speakers will help to provide insight into accelerating biopharmaceutical development through different functional units such as process development and manufacturing. These talks will look at challenges and opportunities in biopharmaceuticals production, and focus on novel approaches and new technologies currently being developed (or used) that will be instrumental to increasing the speed and efficiency of making antibodies, therapeutic proteins and vaccines.  In addition a special 1 1/2 day conference on application of Quaility by Design will be chaired by Beth Junker (Merck). It focuses on the goal of reliably produced high quality therapeutics by biomanufacturers, which can be accomplished via scientific risk-based approaches starting with design efforts: from product conception through commercialization. 

This 4-day conference (February 24-27) will cover accelerating biopharmaceutical development, including areas like the breadth of the integrated technical development process. Bench to commercial manufacturing will be addressed; including technological advances in expression systems, process development, analytical, formulation and production important for accelerated commercialization. QbD will focus on how product attributes and processes relate to performance and innovations in biopharmaceutical processing, which allows for continuous improvements in therapeutic production.

AccBio/QbD Conference Program

Sunday, February 24, 2013

4:30 PM 4:45 PM Welcome by Conference Co-Chairs: Reed Harris and Jim Thomas
4:45 PM 5:45 PM Keynote Speaker: Kevin Bailey
5:45 PM 6:45 PM Rapid Fire Poster Session
6:45 PM 8:00 PM Welcoming Reception and Poster Session

Monday, February 25, 2013

8:00 AM 8:30 AM Breakfast

8:30 AM


Session 1: Accelerating Biopharmaceutical Development

Session Chairs: Jim Thomas (Amgen) and Reed Harris (Genentech)
8:30 AM 8:40 AM Welcome and Introductory Remarks
8:40 AM 9:20AM Ann Lee (Genentech)
9:20AM 10:00 AM Joe Miletich (Amgen)
10:00 AM 10:25 PM Coffee Break

10:25 AM

12:35 PM

Session 2: Expression Systems

Session Chairs: Tim Charlebois (Pfizer) and Thomas Ryll (Biogen Idec)
10:25 AM 10:30 AM Session Intro- Session Chairs
10:30 AM 11:00 AM Arvia Morris (Amgen): Efficient upstream process development programs generated using early molecule assessment and culture of continuous improvement
11:00 AM 11:30 AM Amy Shen (Genentech): Past and present strategies, challenges, and benefits of stable cell line development at Genentech
11:30 AM 12:00 PM Martin Allen (Pfizer): Streamlining the Discovery to Development Transition
12:00 PM 12:30 PM Rashmi Kshirsagar (Biogen Idec): Integration of Cell Culture Process Platform and Cell Line Expression Systems to accelerate Biopharmaceutical Development
12:30 PM 12:35 PM Session Close- Session Chairs
12:35 PM 1:30 PM Lunch

1:30 PM

4:10 PM

Session 3: Integrating Process Development: Upstream and Downstream Tech

Session Chairs: Brian Kelley (Genentech) and Nigel Titchener-Hooker (University College London)
1:30 PM 1:35 PM Session Intro- Session Chairs
1:35 PM 2:05 PM Rohin Mahtre (BiogenIDEC): Enhancing efficiency and control for a Biopharmaceutical manufacturing process
2:05 PM 2:35 PM Gene Schaefer (J&J): Challenges and Innovative Approaches to Improving the Efficiencies of Process Development and Tech Transfer
2:35 PM 3:05 PM Albert Schmelzer (MedImmune): Using Cell Culture Platform and High-Throughput Bioreactors to Streamline Upstream Process Development
3:05 PM 3:35 PM Mike Hoare (University College London): Speeding whole bioprocess solutions :the crucial interface linking the bioreactor to purification
3:35 PM 4:05 PM Dean Pettit (Amgen):  Upstream and Downstream Strategies to Actively Control of Product Quality Attributes 
4:05  PM 4:10 PM Session Close- Session Chairs
4:10 PM 4:40 PM Coffee Break

4:40 PM

6:20 PM

Session 4: Analytical Development and Product Characterization Strategies

Session Chairs: Mike Washabaugh (MedImmune) and Laura Bass (Pfizer)
4:40 PM 4:45 PM Session Intro- Session Chairs
4:45 PM 5:15 PM Rob Dufield (Pfizer): Analytical strategies enabling expedited development of therapeutic mAbs
5:15 PM 5:45 PM Qinjian Zhao (Xiamen University): Structural and functional analysis of recombinant virus-like particles (VLPs)
5:45 PM 6:15 PM Kuldip Sra (MedImmune): Development of a Seasonal Vaccine
6:15 PM 6:20 PM Session Close- Session Chairs

Tuesday, February 26, 2013

8:00 AM 8:30 AM Breakfast

8:30 AM

10:40 AM

Session 5: Formulation Approaches

Session Chairs: John Carpenter (University of Colorado) and Ping Yeh (Amgen)
8:30 AM 8:35 AM Session Intro- Session Chairs
8:35 AM 9:05 AM Vladimir Razinkov (Amgen): High Throughput Formulation Development of Therapeutic Proteins
9:05 AM 9:35 AM David Volkin (University of Kansas): Utility of High-Throughput Biophysical Analysis of Protein Stability during Formulation Development and Comparability Assessments
9:35 AM 10:05 AM Mark Brader (Biogen Idec): Applicatoin of QbD Principles in Demonstrating Formulation Robustness and Container Closure Compatibility of a Prefilled Syringe Drug Product
10:05 AM 10:35 AM Robert Muller (Roche): Phase appropriate approach for formulation development
10:35 AM 10:40 AM Session Close- Session Chairs
10:40 AM 11:00 AM Coffee Break

11:00 AM

12:40 PM

Session 6: Approaches to QbD for Externally Sourced Deliverables

Session Chair: Abhinova Shukla (KBI Biopharma) and John Crowley (Lonza)
11:00 AM 11:05 AM Session Intro- Session Chairs
11:05 AM 11:35 AM Abhinav Shukla (KBI Biopharmaceuticals)
11:35 AM 12:05 PM Lynn Conley (BiogenIDEC): Using a Statistical and Risk Based Approach to Improve Robustness And Control in a Late Stage Antibody Process
12:05 PM 12:35 PM John Crowley (Lonza)
12:35 PM 12:40 PM Session Close- Session Chairs
12:40 PM 1:40 PM Lunch

1:40 PM

3:50 PM

Session 7: Using Prior Knowledge and Platform Manufacturing

Session Chairs: Narendra Bam (GSK) and Jon Coffman (Pfizer)
1:40 PM 1:45 PM Session Intro- Session Chairs
1:45 PM 2:15 PM Rick Caimi (GSK): Accelerating Early Phase Development through Efficient Implementation of Molecular Design and Platform Knowledge
2:15 PM 2:45 PM Jeff Salm (Pfizer): Increasing Access to the Clinic with a Low Cost, Low Volume Manufacturing Process
2:45 PM 3:15 PM Heather Flores (Genentech)- Accelerated Formulation Development for Antibody-Drug Conjugates (ADCs) 
3:15 PM 3:45 PM Geoff Hodge (Xcellerex): The Accelerated Manufacture of Pharmaceuticals Initiative
3:45 PM 3:50 PM Session Close- Session Chairs
3:50 PM 4:15 PM Coffee Break

4:15 PM

6:25 PM

Session 8: Approaches to Risk Management

Session Chairs: Lynne Krummen (Genentech) and Tony Mire-Sluis (Amgen)
4:15 PM 4:20 PM Session Intro- Session Chairs
4:20 PM 4:50 PM Gregg Nyberg (Amgen): Development of Effective Control Strategies Using Product Quality Risk Assessment
4:50 PM 5:20 PM Ann Subashi (Pfizer):Appropriate Use of Risk Management Tools in Biopharmaceutical Development
5:20 PM 5:50 PM Mary Cromwell (Genentech): The Development of a Rational Testing Strategy Using QbD: A Case Study
5:50 PM 6:20 PM Christoph Stark (Novartis): Practical considerations to risk assessments for efficient use in pharmaceutical development and production
6:20 PM 6:25 PM Session Close- Session Chairs
6:25 PM 6:35 PM QbD Welcome by Conference Chair: Beth Junker (Merck)
6:35 PM 7:35 PM Keynote Speaker: Ganesh Venkataraman Kaundinya (Momenta)
7:35 PM 8:15 PM Poster Session and QbD Welcome Reception
8:15 PM 9:15 PM Dinner

Wednesday, February 27, 2013

7:30 AM 8:00 AM Breakfast

8:00 AM

9:40 AM

Session 9: Translation to Operational Practice

Session Chairs: Dean Pettit (Amgen) and Yuan Xu (Novartis)
8:00 AM 8:05 AM Session Intro- Session Chairs
8:05 AM 8:35 AM Gregg Flynn (Amgen): Assessing the Criticality of Product Quality Attributes
8:35 AM 9:05 AM Clinton Weber (CMC Biologics Organization): Quality by Design Execution from a CMO Perspective
9:05 AM 9:35 AM Shan Jiang (Seattle Genetics): Control Strategies for Antibody-Drug Conjugates Drug Product Manufacturing
9:35 AM 9:40 AM Session Close- Session Chairs
9:40 AM 10:10 AM Coffee Break

10:10 AM

12:00 PM

Session 10: QbD Roundtable

Session Chair: Beth Junker (Merck)
10:10 AM 10:15 AM Session Intro-Session Chair
10:15 AM 10:35  AM David Robbins (MedImmune)
10:35 AM 10:55 AM Lynne Krummen (Genentech)
10:55 AM 11:15 AM Kris Barnthouse (J&J Janssen) and Ranga Godavarti (Pfizer): QbD Pilot Program: Key Learnings
11:15 AM 12:00 PM Panel Discussion
12:00 PM 12:55 PM Keynote Presentation: Barbara Rellahan (FDA)-Unique Challenges of Quality by Design (QbD) for Biotechnology Products: Lessons Learned from the OBP QbD Pilot Program
12:55 PM 1:00 PM Closing Remarks
1:00 PM 2:00 PM Lunch