Wednesday 17th September - Main Conference Day Two - ET (Eastern Time, GMT-05:00)
- Fouad Atouf - Vice President, Science—Global Biologics, US Pharmacopeia
- Niklas Engler - Global Head and Vice President, Technical Development Portfolio and Projects, F. Hoffmann-La Roche
- James Warren, Ph.D. - Senior VP, Global CMC Development, Ultragenyx Pharmaceutical Inc.
- How to effectively adopt AI tools in the CGT space
- Opportunities for AI and machine learning in process development & manufacturing
- Real-world applications of AI in CGT pipeline development
- Case study insights on AI-driven innovation
Delivery of plasmid DNA enables systemic expression of therapeutic molecules, including but not limited to monoclonal antibodies, proteins and peptides. However conventional delivery techniques are limited by constraints of redosability and toxicity in their ability to delivery DNA effectively. Polymeric systems can overcome these constraints but have a very large design space. This presentation will describe how machine learning can leverage large design spaces for the design of polymeric delivery vehicles for a broad range of therapeutically relevant molecules in vivo.
- Shashi Murthy, PhD - CTO and Co-Founder, Nanite Inc.
- Pauline Schmit - Senior Scientist, nChroma Bio
- Mahesh Bule - Associate Director, Kite Pharma a Gilead Company
- Amy Shaw - Head of Process and Product Development, Takeda, USA
- Mark Farmery - Chief Development Officer, Anocca AB
- Defining point-of-care manufacturing and decentralized manufacturing
- Scaling with consistency: key elements for global standardization
- Tech & innovation: cutting-edge solutions for safe, efficient, and cost-effective decentralized manufacturing
- Overcoming obstacles to decentralised manufacturing to enable access to approved CGTs
- Differences in systems across decentralized cell therapy manufacturing models - how can we harmonize?
- Standardization vs a modular approach
- Equipment, data, and technologies
- Dialogue and collaboration between developer/practitioner to streamline eventual implementation
- Improving worldwide access: how can local manufacturers and supplier help?
- Real world experience with a decentralized cell therapy manufacturing platforms supporting Phase I/II clinical trials
- Francesca Vitelli, PhD - Former VP Cell Therapy and Viral Vector PD and MSAT, Intellia Therapeutics, Inc
- Ying Cai - MSAT Executive Director, Ultragenyx Pharmaceutical
- Nripen Singh - Head of Process Development, TRD CGT, Novartis
- Phillip Ramsey - Senior Vice President, Technical Operations, Sangamo Therapeutics
- Jordan Ball - Sr. Manager, Technology Transfer, Regeneron
Discover how Yokogawa’s BioPilot transforms bioprocessing with seamless digital integration and intelligent automation. By unifying real-time data acquisition and advanced process control, BioPilot empowers scientists to streamline cell culture and purification workflows—enhancing reproducibility, accelerating development timelines, and enabling effective decisions in cell line, media, and process development.
- Andreas Schaaf - CSO & Managing Director, Eleva GmbH
- Xiaodong Sun - Senior Scientist, Takeda
- Shu Yang - Senior Scientist, Pfizer
- Edwin Shen - Principal Scientist, Pfizer
- Prasad Pathange - Senior Manager, Bayer U.S.
• Recent advancements in Raman spectroscopy, near-infrared (NIR) spectroscopy, and IR spectroscopy
• Case studies on implementing high-throughput PAT for upstream process development
• Challenges and opportunities in scaling PAT for GMP bioreactors and downstream processes.
- Naveen Singh - Principal Scientist II, Process Development, Gilead
- Crystal Thomas - Principal Scientist, Purification Process Development, Sanofi
- Kate Zhao - Scientist I, Upstream Process Development, Alexion, AstraZeneca Rare Disease
- Kelvin Lee - Institute Director, NIIMBL
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
- Elisabeth Krug - Executive Director, BRD Analytical Development, Eli Lilly & Company
- Callum Chapman - Senior Director, Product Quality, AstraZeneca
- Kristy Wood, PhD - SVP, Technical Operations, Intellia Therapeutics
- Devyn M. Smith - Chief Executive Officer, Arbor Biotechnologies
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Shawn (Xueyuan) Wang - Director, Process Development, Kite Pharma
- Wonjong Si - Associate Director, Cell Therapy Platform Process, Bayer
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Improvements and innovations in cell line development & engineering to increase yields for gene therapies
- Application of producer cell lines to lower transfection vector costs: Data for large scale use of stable cell lines
- Scalability of producer cell lines? Case studies on experiences at larger scales
- Huize Yan - Process Development Scientist, Spark Therapeutics
Join leading experts for BioProcess Insider's comprehensive analysis of the current bioprocessing landscape, emerging trends, and future directions shaping biopharmaceutical manufacturing and development.
- Lorena Pena - Scientist, Bristol-Myers Squibb
- Fernanda Sobreira - Associate Principal Scientist, Merck
- Lorraine Peters - Associate Scientist, AstraZeneca
- Coral Fung Shek - Process Development Associate Scientist, Amgen
- Xuan Han, PhD - Senior Scientist, Amgen
- Stefano Menegatti - Associate Professor, North Carolina State University
- Chase Herman, Ph.D. - Investigator, GSK
- Initiatives to reduce their carbon footprint and implement recycling programs
- Gregory Zarbis-Papastoitsis, Ph.D - Chief Process and Manufacturing Officer, Ankyra
- Jack Greene - Chief Technical and Manufacturing Officer, JucaBio
- Arvind Srivastava, Ph.D. - Senior Vice President, ThirdArcBio
- Anand Srinivasan - Vice President of Technology and Innovations, and Head of the Center for Innovations and Biodesign, BioBridge Global
- Ratnesh Joshi - Associate Director, Downstream Process Development, Editas Medicine
- Weiyi Li - Senior Manager, LNP Formulation, Prime Medicine, Inc.
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Shashi Prajapati - Director, Cell & Gene Therapies Analytical Development, Vertex Pharmaceuticals
- What is required for product characterization by regulatory authorities?
- Use of risk-based assessment to identify product CQAs
- In-process controls, stability, and release testing expectations from authorities
- How analytics can be used to support the move to “the product is the product”
- Development of rapid process characterization assays
- Lena Yang - Senior Scientist, Cell Therapy Analytical Development, Takeda
- Mariska ter Haak - Senior Director Analytical Development, IN8bio
Spotlight Presentation – Calling all Technology Thought Leaders!
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- David Dobnik - Scientific Associate, National Institute of Biology
In order to achieve development timelines, rapid process development can result in the sacrifice of capsid recovery in order to meet specifications. By establishing a strategy focused on critical process parameters, leveraging design of experiments strategies, and using statistically sound analytics, genome-containing capsid recovery can be optimized in recombinant AAV downstream unit operations.
- Hunter Reese - Scientist II, Asklepios Biopharmaceutical
- Junfen Ma - Head of Genomic Medicine Purification Process Development, Sanofi
- Hana Jug - Product Manager (Enveloped viruses, VLPs and EVs), Sartorisu BIA Separations
Panel Overview
Join industry leaders from Women in Bio and the Cell & Gene Therapy Circle for an insightful discussion on transformative DE&I initiatives reshaping pharmaceutical research and development. This panel explores how increased representation is driving innovation and improving patient outcomes across the industry.
- Song Zhiwei - Senior Principal Scientist, Nexa Biologics
- Jindou Shi - PhD Student, GSK Center for Optical Molecular Imaging, UIUC
- Yingnan (Michael) Si - Scientist, Sanofi
- Charles Sardonini, PhD - Consultant to the Biotechnology Industry, Sardonini Consulting, LLC
- Naveen Singh - Principal Scientist II, Process Development, Gilead
- Kabir Dhingra - Senior Scientist, Merck
- Regina Au - CEO, New Product Planning/Strategic Planning, BioMarketing Insight
- Kelvin Lau - Principal Engineer, Abbvie
- Hao Zhang - Sr. Principal Scientist, Amgen
- William Whitford - Founder, Oamaru BioSystems
- Internalising or externalising manufacturing – What are the decision points?
- How to select CDMO partners? – Industry criteria for selection
- When / what stage of development should you bring on second CDMO?
- Understanding CDMO capacities, timelines, and capabilities
- Qualification, and quality agreements for commercial manufacturing
- Tech transfer: best practices and risk management
- Strategies for transferring product from development phase to CDMO for large scale production: How to scale up?
- Lessons learnt from transferring to CDMO and vice versa
- Increasing skills and experience in manufacturing of next generation CGT products
- Partnership and communication – how to partner most effectively with CDMOs?
- Shankar Swaminathan, PhD - Team Lead, Associate Director Drug Product Development, Astellas Institute for Regenerative Medicine
- Jeff Masten - Senior Vice President CMC, Secretome Therapeutics
- Matthew Provencal - Executive Director Gene Therapy BDS Manufacturing, Sarepta
- Dong Xu, Ph.D. - Associate Director, Cell Therapy Analytical Development, TScan Therapeutics
What does MVM infectivity in HEK cells mean for your viral safety profile? Here we discuss detectability of MVM using adherent HEK cells and how to integrate MVM detection into your AAV Viral Safety Strategy.
- Dana Schreffler - Sr. Manager QC Viral Safety, Regeneron
Host cell DNA (hcDNA) levels in AAV-based in vivo gene therapies have substantial implications for a product’s safety profile, however the current industry baseline is very broad due to order-of-magnitude differences in dose level from product to product. To obtain a more valuable baseline, members of a BioPhorum industry collaboration were surveyed to assess normalized hcDNA levels to establish a range for current manufacturing practices. Based on the BioPhorum industry survey, health authority guidelines, and literature, this presentation will cover the challenges with hcDNA and summarize the survey results, including current practices from industry on hcDNA analysis, control and reporting. An approach for harmonized reporting of hcDNA for AAV, based on normalization, will be proposed, with the collective benefits outlined.
- Parag Kumthekar - Gene Therapy Downstream Process Development Lead, UCB Pharma
Join us for a compelling discussion featuring accomplished Latino leaders in biotechnology as they explore the critical importance of diversity in driving innovation, addressing health disparities, and creating a more inclusive industry landscape.