| Start Time |
End Time |
|
| April 9, 2025 |
All Pacific Standard Time |
| |
|
Day 1 |
| 1:00 PM |
4:00 PM |
Registration |
| 2:00 PM |
2:10 PM |
Conference Introduction by Chairs: Raghu Shivappa, Takeda, & Rubi Burlage, Merck |
| 2:10 PM |
2:50 PM |
KEYNOTE: Accelerating Multi-Specific Zoo's, Jamie Moore, Gilead Sciences |
| 2:50 PM |
3:20 PM |
Afternoon Coffee Break |
| 3:20 PM |
4:00 PM |
KEYNOTE: Investing in the future of Manufacturing: Practical Applications of AI and Analytics for Competitive Advantage, Bruce Lawler, MIT MIMO |
| 4:00 PM |
5:00 PM |
Poster Session and Cocktail Reception |
| |
|
|
| Start Time |
End Time |
|
| 4/10/2025 |
All Pacific Standard Time |
| |
|
Day 2 |
| 7:00 AM |
4:00 PM |
Registration |
| 7:30 AM |
8:00 AM |
Breakfast |
| 8:00 AM |
8:10 AM |
Day 2 Welcome and Introduction by Chairs: Raghu Shivappa, Takeda, & Rubi Burlage, Merck |
| 8:10 AM |
8:50 AM |
KEYNOTE: Incorporation of Data Analytics and AI into the CMC lifecycle for Biopharma Products, Brendan Hughes, Independent Consultant |
| 8:50 AM |
9:00 AM |
Stretch Break |
| 9:00 AM |
12:20 PM |
Session 1: Artificial Intelligence (AI) and digital tools for accelerating Biopharmaceutical Process Development and Manufacturing; |
| 9:00 AM |
9:05 AM |
Introduction by Session Chairs: Trevor Swartz, Genentech & Elçin Içten-Gençer, Amgen |
| 9:05 AM |
9:25 AM |
Building Teams and Setting Expectations in the Modern Era of AI/ML for Process Development, Jeremy Shaver, Pfizer |
| 9:25 AM |
9:45 AM |
AI Machine Learning Digital Twins to Accelerate Biopharmaceutical Development at Amgen, Elcin Icten Gencer, Amgen |
| 9:45 AM |
10:05 AM |
Accelerating Biopharmaceutical Process Development with Continuous Bioprocessing and Digital Twin, Ouwei Wang, Pow.bio |
| 10:05 AM |
10:35 AM |
Morning Coffee Break |
| 10:35 AM |
10:55 AM |
Selected Abstract: |
| 10:55 AM |
11:15 AM |
Selected Abstract: |
| 11:15 AM |
11:35 AM |
Sponsored Talk: Alec Nielsen, Asimov |
| 11:15 AM |
12:15 PM |
Q&A Panel Discussion |
| 12:15 PM |
12:20 PM |
Closing Remarks by Session Chair: Trevor Swartz, Genentech & Elçin Içten-Gençer, Amgen |
| 12:20 PM |
1:20 PM |
Lunch |
| 1:20 PM |
4:55 PM |
Session 2: Formulation, Drug Product, and Drug Delivery |
| 1:20 PM |
1:25 PM |
Introduction by Session Chairs: Dana Andersen, Denali Therapeutics, & Cleo Salisbury, Genentech |
| 1:25 PM |
1:45 PM |
Parag Kolhe, Pfizer |
| 1:45 PM |
2:05 PM |
John Eschelbach, Genentech |
| 2:05 PM |
2:25 PM |
Enabling Subcutaneous Delivery of Ultra-highly Concentrated Monoclonal Antibodies via Hydrogel Microparticles, Daniele Foresti, AcousticaBio |
| 2:25 PM |
2:45 PM |
Hyperchon™ microparticle suspensions: a novel alternative for subcutaneous delivery of high doses of biotherapeutics, Victoria Sluzky, Elektrofi |
| 2:45 PM |
3:00 PM |
Q&A / Panel Discussion |
| 3:00 PM |
3:30 PM |
Afternoon Coffee Break |
| 3:30 PM |
3:50 PM |
Sachin Mittal and Karthik Vaideeswaran, Merck |
| 3:50 PM |
4:10 PM |
Large Injections, Small Devices & Smart (RFID) Syringes, Adithiya Balasubramanian, Ten23 |
| 4:10 PM |
4:30 PM |
CMC Approaches for Acceleration of Manufacturing Capacity to Enable Launch of Beyfortus: A Case Study, Vinod Bulusu, AstraZeneca |
| 4:30 PM |
4:50 PM |
Sponsored Talk: Sherry Gu, Wuxi Biologics |
| 4:30 PM |
4:55 PM |
Q&A / Panel Discussion |
| 5:30 PM |
6:30 PM |
Cocktail Reception |
| |
|
|
| Start Time |
End Time |
|
| 4/11/2025 |
All Pacific Standard Time |
| |
|
Day 3 |
| 7:00 AM |
3:00 PM |
Registration |
| 7:30 AM |
8:00 AM |
Breakfast |
| 8:00 AM |
8:10 AM |
Day 3 Welcome and Introduction by Chairs: Raghu Shivappa, Takeda, & Rubi Burlage, Merck |
| 8:10 AM |
8:50 AM |
KEYNOTE: Scott Lute, FDA |
| 8:50 AM |
9:00 AM |
Stretch Break |
| 9:00 AM |
10:15 AM |
Facilitated Panel Discussion 1: BioPhy: Opportunities for accelerating Biopharmaceutical Process Development and Manufacturing (David Latshaw) |
| 10:15 AM |
10:45 AM |
Morning Coffee Break |
| 10:45 AM |
12:00 PM |
Facilitated Panel Discussion 2: McKinsey: Acceleration Levers and AI for Biotherapeutics: (Stuti Agarwal) |
| 12:00 PM |
1:00 PM |
Lunch |
| 1:00 PM |
5:10 PM |
Session 3: Business case for Sustainability |
| 1:00 PM |
1:05 PM |
Introduction by Session Chairs: Terrence Dobrowsky, Takeda, & William Clark, GSK |
| 1:05 PM |
1:25 PM |
Kyle McElearney, Amgen |
| 1:25 PM |
1:45 PM |
Ecodesign and Data Transparency: Keys to Reducing Bioprocessing Greenhouse Gas Emissions, Karl Britt, Cytiva |
| 1:45 PM |
2:05 PM |
Advancing 3R Principle for Animal Welfare in Quality Control Testing, Lindsey Silva, Genentech |
| 2:05 PM |
2:35 PM |
Afternoon Coffee Break |
| 2:35 PM |
2:55 PM |
Case Study: Economics and Sustainability of Intensified Campaign Manufacturing, Sean Anderson, Solventum |
| 2:55 PM |
3:15 PM |
Measuring and achieving sustainability goals in biopharmaceutical manufacturing: A Case study comparing batch and integrated continuous biomanufacturing, Michael Coolbaugh, Sanofi |
| 3:15 PM |
3:35 PM |
Microbial Stem Cells: Asimica's Revolutionary Approach to Sustainable Biopharmaceutical Manufacturing, Nikolai Mushnikov, Asimica |
| 3:35 PM |
3:55 PM |
Sponsored Talk: Pfizer |
| 3:55 PM |
4:55 PM |
Q&A Panel Discussion |
| 4:55 PM |
5:10 PM |
Closing Remarks by the Chairs: Raghu Shivappa, Takeda, & Rubi Burlage, Merck |
