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 (Merk). 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 PM4:45 PMWelcome by Conference Co-Chairs: Reed Harris and Jim Thomas
4:45 PM5:45 PMKeynote Speaker: Kevin Bailey
5:45 PM6:45 PMRapid Fire Poster Session
6:45 PM8:00 PMWelcoming Reception and Poster Session
 

Monday, February 25, 2013

8:00 AM8:30 AMBreakfast

8:30 AM

10:00AM

Session 1: Accelerating Biopharmaceutical Development

Session Chairs: Jim Thomas (Amgen) and Reed Harris (Genentech)
8:30 AM8:40 AMWelcome and Introductory Remarks
8:40 AM9:20AMAnn Lee (Genentech)
9:20AM10:00 AMJoe Miletich (Amgen)
10:00 AM10:25 PMCoffee Break

10:25 AM

12:35 PM

Session 2: Expression Systems

Session Chairs: Tim Charlebois (Pfizer) and Thomas Ryll (Biogen Idec)
10:25 AM10:30 AMSession Intro- Session Chairs
10:30 AM11:00 AMArvia Morris (Amgen): Efficient upstream process development programs generated using early molecule assessment and culture of continuous improvement
11:00 AM11:30 AMAmy Shen (Genentech): Past and present strategies, challenges, and benefits of stable cell line development at Genentech
11:30 AM12:00 PMMartin Allen (Pfizer): Streamlining the Discovery to Development Transition
12:00 PM12:30 PMRashmi Kshirsagar (Biogen Idec): Integration of Cell Culture Process Platform and Cell Line Expression Systems to accelerate Biopharmaceutical Development
12:30 PM12:35 PMSession Close- Session Chairs
12:35 PM1:30 PMLunch

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 PM1:35 PMSession Intro- Session Chairs
1:35 PM2:05 PMRohin Mahtre (BiogenIDEC): Enhancing efficiency and control for a Biopharmaceutical manufacturing process
2:05 PM2:35 PMGene Schaefer (J&J): Challenges and Innovative Approaches to Improving the Efficiencies of Process Development and Tech Transfer
2:35 PM3:05 PMAlbert Schmelzer (MedImmune): Using Cell Culture Platform and High-Throughput Bioreactors to Streamline Upstream Process Development
3:05 PM3:35 PMMike Hoare (University College London): Speeding whole bioprocess solutions :the crucial interface linking the bioreactor to purification
3:35 PM4:05 PMDean Pettit (Amgen):  Upstream and Downstream Strategies to Actively Control of Product Quality Attributes 
4:05  PM4:10 PMSession Close- Session Chairs
4:10 PM4:40 PMCoffee 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 PM4:45 PMSession Intro- Session Chairs
4:45 PM5:15 PMRob Dufield (Pfizer): Analytical strategies enabling expedited development of therapeutic mAbs
5:15 PM5:45 PMQinjian Zhao (Xiamen University): Structural and functional analysis of recombinant virus-like particles (VLPs)
5:45 PM6:15 PMKuldip Sra (MedImmune): Development of a Seasonal Vaccine
6:15 PM6:20 PMSession Close- Session Chairs
   

Tuesday, February 26, 2013

8:00 AM8:30 AMBreakfast

8:30 AM

10:40 AM

Session 5: Formulation Approaches

Session Chairs: John Carpenter (University of Colorado) and Ping Yeh (Amgen)
8:30 AM8:35 AMSession Intro- Session Chairs
8:35 AM9:05 AMVladimir Razinkov (Amgen): High Throughput Formulation Development of Therapeutic Proteins
9:05 AM9:35 AMDavid Volkin (University of Kansas): Utility of High-Throughput Biophysical Analysis of Protein Stability during Formulation Development and Comparability Assessments
9:35 AM10:05 AMMark Brader (Biogen Idec): Applicatoin of QbD Principles in Demonstrating Formulation Robustness and Container Closure Compatibility of a Prefilled Syringe Drug Product
10:05 AM10:35 AMRobert Muller (Roche): Phase appropriate approach for formulation development
10:35 AM10:40 AMSession Close- Session Chairs
10:40 AM11:00 AMCoffee 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 AM11:05 AMSession Intro- Session Chairs
11:05 AM11:35 AMAbhinav Shukla (KBI Biopharmaceuticals)
11:35 AM12:05 PMLynn Conley (BiogenIDEC): Using a Statistical and Risk Based Approach to Improve Robustness And Control in a Late Stage Antibody Process
12:05 PM12:35 PMJohn Crowley (Lonza)
12:35 PM12:40 PMSession Close- Session Chairs
12:40 PM1:40 PMLunch

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 PM1:45 PMSession Intro- Session Chairs
1:45 PM2:15 PMRick Caimi (GSK): Accelerating Early Phase Development through Efficient Implementation of Molecular Design and Platform Knowledge
2:15 PM2:45 PMJeff Salm (Pfizer): Increasing Access to the Clinic with a Low Cost, Low Volume Manufacturing Process
2:45 PM3:15 PMHeather Flores (Genentech)- Accelerated Formulation Development for Antibody-Drug Conjugates (ADCs) 
3:15 PM3:45 PMGeoff Hodge (Xcellerex): The Accelerated Manufacture of Pharmaceuticals Initiative
3:45 PM3:50 PMSession Close- Session Chairs
3:50 PM4:15 PMCoffee 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 PM4:20 PMSession Intro- Session Chairs
4:20 PM4:50 PMGregg Nyberg (Amgen): Development of Effective Control Strategies Using Product Quality Risk Assessment
4:50 PM5:20 PMAnn Subashi (Pfizer):Appropriate Use of Risk Management Tools in Biopharmaceutical Development
5:20 PM5:50 PMMary Cromwell (Genentech): The Development of a Rational Testing Strategy Using QbD: A Case Study
5:50 PM6:20 PMChristoph Stark (Novartis): Practical considerations to risk assessments for efficient use in pharmaceutical development and production
6:20 PM6:25 PMSession Close- Session Chairs
   
6:25 PM6:35 PMQbD Welcome by Conference Chair: Beth Junker (Merck)
6:35 PM7:35 PMKeynote Speaker: Ganesh Venkataraman Kaundinya (Momenta)
7:35 PM8:15 PMPoster Session and QbD Welcome Reception
8:15 PM9:15 PMDinner
   

Wednesday, February 27, 2013

7:30 AM8:00 AMBreakfast

8:00 AM

9:40 AM

Session 9: Translation to Operational Practice

Session Chairs: Dean Pettit (Amgen) and Yuan Xu (Novartis)
8:00 AM8:05 AMSession Intro- Session Chairs
8:05 AM8:35 AMGregg Flynn (Amgen): Assessing the Criticality of Product Quality Attributes
8:35 AM9:05 AMClinton Weber (CMC Biologics Organization): Quality by Design Execution from a CMO Perspective
9:05 AM9:35 AMShan Jiang (Seattle Genetics): Control Strategies for Antibody-Drug Conjugates Drug Product Manufacturing
9:35 AM9:40 AMSession Close- Session Chairs
9:40 AM10:10 AMCoffee Break

10:10 AM

12:00 PM

Session 10: QbD Roundtable

Session Chair: Beth Junker (Merck)
10:10 AM10:15 AMSession Intro-Session Chair
10:15 AM10:35  AMDavid Robbins (MedImmune)
10:35 AM10:55 AMLynne Krummen (Genentech)
10:55 AM11:15 AMKris Barnthouse (J&J Janssen) and Ranga Godavarti (Pfizer): QbD Pilot Program: Key Learnings
11:15 AM12:00 PMPanel Discussion
12:00 PM12:55 PMKeynote Presentation: Barbara Rellahan (FDA)-Unique Challenges of Quality by Design (QbD) for Biotechnology Products: Lessons Learned from the OBP QbD Pilot Program
12:55 PM1:00 PMClosing Remarks
1:00 PM2:00 PMLunch