| 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 |
| 8:00 AM |
4:00 PM |
Registration |
| 8:30 AM |
9:00 AM |
Morning Coffee |
| 9:00 AM |
9:10 AM |
Day 2 Welcome and Introduction by Chairs: Raghu Shivappa, Takeda, & Rubi Burlage, Merck |
| 9:10 AM |
9:50 AM |
KEYNOTE: Incorporation of Data Analytics and AI into the CMC lifecycle for Biopharma Products, Brendan Hughes, Independent Consultant |
| 9:50 AM |
10:00 AM |
Stretch Break |
| 10:00 AM |
1:20 PM |
Session 1: Artificial Intelligence (AI) and digital tools for accelerating Biopharmaceutical Process Development and Manufacturing; |
| 10:00 AM |
10:05 AM |
Introduction by Session Chairs: Trevor Swartz, Genentech & Elçin Içten-Gençer, Amgen |
| 10:05 AM |
10:25 AM |
Building Teams and Setting Expectations in the Modern Era of AI/ML for Process Development, Jeremy Shaver, Pfizer |
| 10:25 AM |
10:45 AM |
AI Machine Learning Digital Twins to Accelerate Biopharmaceutical Development at Amgen, Elcin Icten Gencer, Amgen |
| 10:45 AM |
11:05 AM |
Accelerating Biopharmaceutical Process Development with Continuous Bioprocessing and Digital Twin, Ouwei Wang, Pow.bio |
| 11:05 AM |
11:35 AM |
Morning Coffee Break Sponsored by Takeda |
| 11:35 AM |
11:55 AM |
Use of AI, digital tools and advanced models for enhanced process understanding and Technology Transfers, Shailen Singh, Merck |
| 11:55 AM |
12:15 PM |
Sachin Mittal and Karthik Vaideeswaran, Merck |
| 12:15 PM |
12:35 PM |
Sponsored Talk: Model-driven genetic design and bioprocess optimization across modalities, Alec Nielsen, Asimov |
| 12:15 PM |
1:15 PM |
Q&A Panel Discussion |
| 1:15 PM |
1:20 PM |
Closing Remarks by Session Chair: Trevor Swartz, Genentech & Elçin Içten-Gençer, Amgen |
| 1:20 PM |
2:50 PM |
Lunch : Roundtable by Sanofi |
| 2:50 PM |
5:15 PM |
Session 2: Formulation, Drug Product, and Drug Delivery |
| 2:50 PM |
2:55 PM |
Introduction by Session Chairs: Dana Andersen, Denali Therapeutics, & Cleo Salisbury, Genentech |
| 2:55 PM |
3:15 PM |
Hypercon™ Microparticle Suspensions: a Novel Alternative for Subcutaneous Delivery of High Doses of Biotherapeutics, Victoria Sluzky, Elektrofi |
| 3:15 PM |
3:35 PM |
High-Volume Subcutaneous Formulations Using Platform Excipients: Development and Launch, John Eschelbach, Genentech |
| 3:35 PM |
3:55 PM |
Enabling Subcutaneous Delivery of Ultra-highly Concentrated Monoclonal Antibodies via Hydrogel Microparticles, Daniele Foresti, AcousticaBio |
| 2:25 PM |
2:45 PM |
Sponsored Talk: Subcutaneous Administration of Biologics: Formulation and Process Challenges, Parag Kolhe, Pfizer |
| 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: CMC Acceleration through Integrated Development, Manufacturing, and Delivery, Sherry Gu, Wuxi Biologics |
| 4:50 PM |
5:15 PM |
Q&A / Panel Discussion |
| |
|
|
| Start Time |
End Time |
|
| 4/11/2025 |
All Pacific Standard Time |
| |
|
Day 3 |
| 8:00 AM |
4:00 PM |
Registration |
| 8:30 AM |
9:00 AM |
Morning Coffee |
| 9:00 AM |
9:10 AM |
Day 3 Welcome and Introduction by Chairs: Raghu Shivappa, Takeda, & Rubi Burlage, Merck |
| 9:10 AM |
9:50 AM |
KEYNOTE: Angela Coxon, Amgen |
| 9:50 AM |
10:00 AM |
Stretch Break |
| 10:00 AM |
11:15 AM |
Facilitated Panel Discussion 1: BioPhy: Opportunities for accelerating Biopharmaceutical Process Development and Manufacturing (David Latshaw) |
| 11:15 AM |
11:45 AM |
Morning Coffee Break |
| 11:45 AM |
1:00 PM |
Facilitated Panel Discussion 2: McKinsey: Acceleration Levers and AI for Biotherapeutics: (Stuti Agarwal) |
| 1:00 PM |
2:00 PM |
Lunch |
| 2:00 PM |
5:35 PM |
Session 3: Business case for Sustainability |
| 2:00 PM |
2:05 PM |
Introduction by Session Chairs: Terrence Dobrowsky, Takeda, & William Clark, GSK |
| 2:05 PM |
2:25 PM |
Advancing Amgen Ecovation™ through Innovative Process Development for Biologics, Kyle McElearney, Amgen |
| 2:25 PM |
2:45 PM |
Ecodesign and Data Transparency: Keys to Reducing Bioprocessing Greenhouse Gas Emissions, Karl Britt, Cytiva |
| 2:45 PM |
3:05 PM |
Advancing 3R Principle for Animal Welfare in Quality Control Testing, Lindsey Silva, Genentech |
| 3:05 PM |
3:35 PM |
Afternoon Coffee Break |
| 3:35 PM |
3:55 PM |
Business Case for Sustainability in Bioprocessing Via the Use of Combined Continuous Chromatography and on-Demand, Inline Buffer Blending Systems, Vinit Saxena, Sepragen Corporation |
| 3:55 PM |
4:15 PM |
Measuring and achieving sustainability goals in biopharmaceutical manufacturing: A Case study comparing batch and integrated continuous biomanufacturing, Michael Coolbaugh, Sanofi |
| 4:15 PM |
4:35 PM |
Microbial Stem Cells: Asimica's Revolutionary Approach to Sustainable Biopharmaceutical Manufacturing, Nikolai Mushnikov, Asimica |
| 4:35 PM |
5:35 PM |
Q&A Panel Discussion |
| 5:35 PM |
5:50 PM |
Closing Remarks by the Chairs: Raghu Shivappa, Takeda, & Rubi Burlage, Merck |
