Singles/Doubles
$159.00 + Taxes
Senior Director, Head of Cell Therapy Engineering and Process Development at Genentech
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Director, Commercial Technical Lead, Advanced Therapies at FujiFilm Biotechnologies
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Event Details
Friday, February 6, 2025 | 8:00 a.m. - 5:30 p.m.
Sheldon M. Schuster Campus Center, Founder's Room
Travel & Lodging
Doubletree by Hilton Hotel Claremont
555 W. Foothill Blvd., Claremont CA 91711
Center Overview
One of the most important teaching and research laboratories at KGI, the Amgen Bioprocessing Center serves as the basis for our bioprocessing programs.
Advisory Board
The Amgen Bioprocessing Center Advisory Board (ABCAB) consists of scientists, engineers, academics, and corporate executives who provide support and advice to KGI's Amgen Bioprocessing Center.
| Time | Activity |
|---|---|
| 8:00 am - 8:30 am | Check-in & Breakfast |
| 8:30 am – 8:40 am | Welcome & Agenda Review - ABCAB Chair |
| 8:40 am – 8:50 am | KGI Welcome - President |
| 8:55 am – 9:20 am | Speaker: Michael Betenbaugh |
| 9:25 am - 9:55 am | KGI Research Insights — AM
|
| 10:00 am - 10:25 am | Advancement of Process Analytical Technologies as an Enabler for Industry 4.0 Speaker: Andrew Maloney |
| 10:30 am - 10:40 am | Photo Session |
| 10:45 am - 11:45 am | Poster Session (TDP & Research) |
| 11:50 am - 12:50 pm | Lunch & Networking Session |
| 12:55 pm - 1:20 pm | Digital Twins in Biopharma: Driving Process Yield and Quality Improvement Speaker: Rui Wheaton |
| 1:25 pm - 1:55 pm | KGI Research Insights — PM
|
| 2:00 pm - 2:25 pm | What Skills Do We Need to Enable Cell Therapy in the Future? Speaker: David Shaw |
| 2:30 pm - 2:55 pm | Speaker: Sara Miller |
| 3:00 pm - 3:45 pm | Networking Event & Round Table Discussion |
| 3:50 pm - 4:00 pm | Poster Award |
| 4:05 pm - 4:25 pm | Wrap-Up & Close |
| 4:30 pm - 5:30 pm | Reception |
There is a 24hr cancellation policy for all reservations. And complimentary overnight parking.
The Amgen Bioprocessing Center (ABC) is the scientific and engineering infrastructure that KGI established in 2004 with a generous donation from the Amgen Foundation to bring together resources, people, and infrastructure with the sole purpose of educating scientists and engineers to manage complex biological processes scale-up. The ABC serves the community and biopharmaceutical industries by offering a full spectrum of training programs, which are designed for high-potential individuals to bridge the gap between traditional undergraduate programs in life sciences and engineering and the skills required for a successful career in biopharmaceutical and biomanufacturing industries.
The Amgen Bioprocessing Center Advisory Board (ABCAB) consists of scientists, engineers, academics, and corporate executives who provide support and advice to KGI's Amgen Bioprocessing Center. The current ABCAB board includes representatives from the following organizations:
| Amgen | Applied Intuition |
| Bill & Melinda Gates Foundation | BioProcess Advantage LLC |
| Bristol Myers Squibb | Catalent Pharma Solutions |
| Celltheon | Cytiva |
| FUJIFILM Biosciences | Genentech |
| Gilead Sciences | Great Blue Bioprocess Consulting, LLC |
| GSK | IPS Integrated Project Services |
| Keensight Capital | Kite Pharma |
| LE Growth Consulting | Matt Croughan Ph.D. Consulting |
| Moonlight Bio | Neurocrine Biosciences |
| Neuvogen, Inc. | NIIMBL |
| Pfizer | Sartorius |
| Solano College | Twist Bioscience |
| W. R. Grace | Xcell Biosciences |

Michael Betenbaugh is a professor of chemical and biomolecular engineering at Johns Hopkins University (JHU), Center Director of the Advanced Mammalian Biomanufacturing Innovation Center (AMBIC) and PI of the NSF-funded International Biomanufacturing Network (IBioNe). He is widely recognized as a pioneer of eukaryotic metabolic engineering and biomanufacturing. His research integrates systems biology with cellular, metabolic, and biochemical engineering to enhance a variety of production systems for biotechnology and biomedicine. His research areas include secretory pathway engineering, glycoengineering, anti-apoptosis strategies, and multi-omics modeling. A leader in industry–academic collaboration, he has received numerous honors and awards from AIChE, ACS BIOT, ECI CCE,and ESACT. He earned his BS from the University of Virginia and PhD from the University of Delaware.
Title: Analytics and Modeling for Characterizing Mammalian Bioprocessing for the AMBIC Community
Brief Description: Discussion of how analytical measurements and data are being integrated with mechanistic and hybrid models for characterizing and enhancing mammalian bioprocessing performance.

Andy Maloney, Ph.D. is Principal Scientist in Process Development at Amgen Inc in Cambridge, MA, where he works on development and advancement of late-stage biologics drug substance programs as well as evaluation and implementation of process analytical technologies in these processes.
Andy obtained a Bachelor of Science degree in chemical engineering from West Virginia University, a Master of Chemical Engineering Practice degree in chemical engineering from the Massachusetts Institute of Technology (MIT), and a Ph.D. degree from MIT where he worked under the supervision of Prof. Richard D. Braatz on the development of process models and control strategies for the continuous manufacturing of pharmaceuticals. Outside of work Andy enjoys baking, cooking, reading, and board games.
Title: Advancement of process analytical technologies as an enabler for Industry 4.0
Brief Description: Process analytical technologies are a key enabler for advanced manufacturing processes, with demonstration and maintenance of the technologies being critical for implementation at scale. This presentation focuses on 2 case studies for PAT development, one utilizing direct measurement (i.e. glucose) and one utilizing indirect measurement (i.e. viable cell density) and the challenges and benefits of each approach.

Rui Wheaton is currently a principal scientist in the Digital Strategy and process optimization group at Bristol Myers Squibb. Her focus is advanced computational models and digital twins in manufacturing and process development. Prior to her current role, she has experience as a senior scientist in the Process Modeling and Data Scientist group at resilience and Process Engineer in the Manufacturing Technology Upstream group at Bristol Myers Squibb. Rui holds a Ph.D. in Chemical Engineering from Worcester Polytechnic Institute.
Title: Digital Twins in Biopharma: Driving Process Yield and Quality Improvement
Brief Description: This talk will explore the application of digital twin in monoclonal antibody (mAb) production, using large-scale production bioreactors as a case study. It will highlight how digital twin enables data-driven, real-time process control to enhance yield and product consistency.
The talk will introduce the key components of digital twin and how each component is designed and implemented in this use case. Practical insights into its daily application in GMP manufacturing at Bristol Myers Squibb will also be shared. As part of the Biopharma 4.0 vision, this approach exemplifies the integration of advanced analytics and automation to transform manufacturing operations.

David serves as the Head of Cell Therapy Engineering and Process Development at Genentech, Inc. His Process Development group is responsible for the design and optimization of robust cell culture processes, enabling the clinical and commercial manufacturing of Genentech's T cell and stem cell therapies. The team engages in extensive collaboration with internal Research groups, external Partners and Contract Development and Manufacturing Organizations (CDMOs) to facilitate the translation of scientific discoveries into scalable cell therapy products.
David actively participates in industry consortia, including the United States Pharmacopeia (USP), the Parenteral Drug Association (PDA), and BioPhorum, focused on establishing industry best practices and accelerating cell therapy therapies to the patient.
His professional tenure, spanning 24 years at Genentech/Roche, comprises of: the last seven years dedicated to Cell Therapy Process Development, eight years specializing in Chinese Hamster Ovary (CHO) Technology Development, and nine years as the Head of Molecular Biology and Protein Sciences at Roche Palo Alto.
Prior to joining Genentech/Roche, David held a position as Research Professor at the South Carolina Cancer Center, where his work concentrated on retroviral gene therapy. David earned a PhD degree in Biochemistry and Molecular Biology from the University of South Carolina and a BSc degree in Biochemistry from the University of British Columbia.
Title: What Skills Do We Need to Enable Cell Therapy in the Future?
Brief Description: Genentech/Roche has committed to an ambitious vision to enable Cell and Gene Therapy to positively impact patients. A brief overview of the Genentech Cell Therapy portfolio will be provided followed by opinions about what the future needs are to enable successful commercialization of Cell Therapy products.

Sara has worked in the biotechnology field for over 15 years and found her niche in CDMOs, having previously worked for Emergent BioSolutions, Patheon, and Cognate BioServices. As a part of Fujifilm Biotechnologies, Sara is the technical lead for the Advanced Therapies Commercial team, working with commercial and CMC roles to design solutions that meet customer needs and ultimately ensure patients receive life-saving therapies. Sara is passionate about cell therapy, proudly supporting the commercialization efforts of both autologous and allogeneic programs. She holds a Bachelor of Science from Grand Valley State University and a Master of Science from Johns Hopkins University.
Title: Gene Editing Technologies in the Future of Cell Therapy
Brief Description: As the cell therapy field evolves, gene editing is becoming a more common place strategy for allogeneic therapies. This session will explore the various gene editing technologies being used, how a CDMO like FUJIFILM is supporting customer's gene editing needs, and considers how these tools might evolve as the field matures.