Program
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Sunday, March 12 |
|
| 2:00 PM - 7:00PM | Registration |
| 4:00 pm - 4:15 pm | Conference Open (Chairs, Steering Committee) |
| 4:15 pm - 5:00 pm | Atul Butte,University of California, San Francisco , "Translating a Trillion Points of Data into Therapies, Diagnostics, and New Insights into Disease" |
| 5:00 pm - 5:45 pm | Paul Mckenzie, Biogen "Driving Change in Pharmaceutical Development & Manufacturing Thru Innovation & Standards" |
| 5:45 pm - 6:15 pm | Rapid Fire Session |
| 6:15 pm - 8:15 pm | Poster Session |
Monday, March 13 |
|
| 7:30 AM - 12:00 PM | Registration |
| 7:30 am - 8:30 am | Breakfast |
| 8:30 pm - 9:15 am | Michael Mercaldi, Codiak “Towards Commercialization of Exosome Technology” |
| 9:15 am - 12:30 pm | Session 1: Trends, volume impact on strategy: Jon Coffman,Boehringer Ingelheim Kris Barnthouse, Janssen |
| 9:15 am - 9:45 am | Rashmi Kshirsagar, Biogen, Innovation and Investment in Process Sciences |
| 9:45 am - 10:15 am | Nihal Tucgu, Merck "Process Development Strategies: Fit for Diversity" |
| 10:15 am - 10:45 am | Break |
| 10:45 am - 11:15 am | Dean Pettit, Just, Engineering the Sequence of Broadly Neutralizing Antibodies Against HIV-1 to Improve Manufacturing and Stability Characteristics |
| 11:15 am - 11:45 am | Todd Luman, Boehringer Ingelheim - Flexible Process Development: Approaches in Process Development and Clinical Manufacturing allowing rapid process advancements and clinical supply |
| 11:45 am - 12:30 pm | Panel Discussion |
| 12:30 pm - 2:00 pm | Lunch |
| 2:00 pm - 5:15 pm | Session 2: Acceleration Strategies: Gene Schaefer,Janssen, Morrey Atkinson, Bristol-Myers Squibb |
| 2:00 pm - 2:30 pm | Latonia Harris, Janssen - Application of Lessons Learned from an Accelerated Development Project to Early and Late Stage Programs |
| 2:30 pm - 3:00 pm | Anurag Khetan, BMS, Living in the Age of Accelerations –BMS Initiatives to allow Rapid Development at all Phases of CMC |
| 3:00 pm - 3:30 pm | Break |
| 3:30 pm - 4:00 pm | Mike Laird - Genentech -Accelerating the Timeline to IND Submission using Targeted Integration Cell Line Development and Pool for Tox Strategies |
| 4:00 pm - 4:30 pm | Nick Warne, Pfizer, Delivering Flexible Dosage Forms for an Evolving Development Plan |
| 4:30 pm - 5:15 pm | Panel Discussion |
| 5:15 pm - 7:00 pm | Reception |
Tuesday, March 14 |
|
| 7:30 AM - 12:00 PM | Registration |
| 7:30 am - 8:30 am | Breakfast |
| 8:30 pm - 9:15 am | Reed Harris, Genentech "Defining Product Quality for Biotech Products" |
| 9:15 am - 12:30 pm | Session 3: What is Quality?: John Joly, Genentech, Patrick Swann,Biogen |
| 9:15 am - 9:45 am | Marisa Joubert, Amgen - "Evaluating Immunogenicity Risk Due to Host Cell Protein Impurities in Antibody-Based Biotherapeutics" |
| 9:45 am - 10:15 am | Tapan Das, BMS-Phase Appropriate Investment in CQA Assessment and Control Strategy |
| 10:15 am - 10:45 am | Break |
| 10:45 am - 11:15 am | Mary Denton, Pfizer-Tailored Strategies for Attaining Desired Product Quality Attributes: From Biosimilars to Platform Monoclonal Antibodies |
| 11:15 am - 11:45 am | Li Zang, Biogen-Applying LC-MS Multi-Attribute Method (MAM) to Accelerate Biopharmaceutical Development and Release |
| 11:45 am - 12:30 pm | Panel Discussion |
| 12:30 pm - 2:00 pm | Lunch |
| 2:00 pm - 5:15 pm | Session 4: Knowledge Management: Cenk Undey, Amgen and Rob Guenard, Biogen |
| 2:00 pm - 2:30 pm | Beth Junker, BioProcess Advantage, "A Technology Roadmapping Process to Transform the Biopharmaceutical Manufacturing Industry: Knowledge Management Highlights" |
| 2:30 pm - 3:00 pm | Kelvin H. Lee, University of Delaware "Opportunities for Collective Advancement in the Biopharmaceutical Manufacturing Community" |
| 3:00 pm - 3:30 pm | Break |
| 3:30 pm - 4:00 pm | Patrick Gammel, Amgen, "Leveraging prior knowledge and continued process verification to ensure process capability and manufacturability: a lifecycle approach to process designa |
| 4:00 pm - 4:30 pm | Dave Pollela, GSK, "Managing the supply chain of process knowledge across the development lifecycle" |
| 4:30 pm - 5:15 pm | Panel Discussion |
Wednesday, March 15 |
|
| 7:30 AM - 12:00 PM | Registration |
| 7:30 am - 8:30 am | Breakfast |
| 8:30 am - 12:00 pm | Session 5: Integration: What is right balance of speed, cost and quality: Aine Hanly, Amgen, Arup Roy, Eli Lilly and Company |
| 8:30 am - 9:00 am | Mike Defelippis, Lilly, Strategies for Establishing Clinically Relevant Specification Acceptance Criteria. |
| 9:00 am - 9:30 am | Art Hewig, Amgen, "Integrating Development Disciplines to Accelerate Development and Improve Product Quality for New Modalities" |
| 9:30 am - 10:00 am | Chuck Goochee, Jannssen, "Streamlining Tech Transfer" |
| 10:00 am - 10:30 am | Break |
| 10:30 am - 11:00 am | Duncan Low, Amgen, “Integrating technologies for rapid development and cost effective production”. |
| 11:00 am - 11:30 am | Turnkey Therapeutics Through Science Technology and Standardization - Hanne Bak, Regeneron |
| 11:30 am - 12:00 pm | Panel Discussion |
| 12:00 pm – 12:15 pm | Conference Wrap-up, closing remarks (Conference Chairs/Steering Committee) |
