Tuesday, September 24, 2024 - Day One of Main Conference - ET (Eastern Time, GMT-05:00)
Tuesday, September 24, 2024 - Day One of Main Conference - ET (Eastern Time, GMT-05:00)
- Niklas Engler - Global Head and Vice President, Technical Development Portfolio and Projects, F. Hoffmann-La Roche
- Ron Weiss - Professor of Biological Engineering, MIT Synthetic Biology Lab
- Thomas Kelly - Director, Cell Engineering & Analytical Sciences, Johnson & Johnson Innovative Medicine
- Oren Beske, Ph.D. - Amalgamator of Business and Biology, ATUM
- Jianfa Ou - Principal Scientist, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb
- Vida Rahmatnejad - Upstream Process Development Scientist, Alexion
- Gisela Ferreira - Senior Director, AstraZeneca
- Steve Cramer, Ph.D. - Institute Professor, Isermann Department of Chemical and Biological Engineering, Rensselaer Polytechnic Institute
- Harun Ozbakir, Ph.D., - Senior Scientist, Process Development, Amgen
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
The focus on accelerated development of new modalities for advanced therapies and challenges with complex drug candidates has driven adoption of novel concepts and technologies in biopharmaceutical development and manufacturing. The active drug substances have become more structurally complex and R&D timelines continue to be compressed, the technologies necessary to provide safe, robust and economical access to these molecules needs to keep pace. Emerging technologies such as continuous processing, automation, high throughput experimentation, predictive modeling in an integrated fashion can expedite process development and commercial manufacturing while ensuring efficiency and delivering quality products. All these aspects help to minimize the time and cost associated with development and manufacture of drugs and bring medicines to patients more effectively. This presentation will share AbbVie’s strategy and experiences in integrating such end-to-end technologies into process development and manufacturing facilities and discuss the challenges and opportunities associated with our approaches.
- Moiz Diwan - Director, Purification Development, Biologics Development - Operations, AbbVie
Given the complexity of biological products, effective control strategy and life cycle management are critical to delivering quality products with intended efficacy. This presentation will focus on an overview and guidelines to develop and implements analytical control strategy approach to streamline and harmonize quality control testing and method life cycle.
- Udayanath Aich, Ph.D. - Director, Bristol Myers Squibb
We will explore how novel clarification technology, based on advanced synthetic fibrous chromatography materials, will enable new bioprocess strategies to address critical challenges in process simplification and intensification. We will illustrate how this platform can offer seamless implementation of chromatographic clarification from discovery to clinical and commercial manufacturing, providing consistent and high-quality clarified fluid and enhancing commercialization productivity.
- Masa Nakamura - Bioprocess Science Senior Specialist, Solventum
- Matthew Radle - Scientist, Analytical Sciences, AstraZeneca
- Courtney Hazelton-Harrington - Senior Scientist, Research & Development, Lonza Biologics
- Larry(Lei) Wang - Associate Scientific Fellow, Analytical Development, Takeda Pharmaceutical Company Limited
- Neeraj Agrawal - Director, Amgen
- Sung Hyun Choi, Ph.D. - Director & Head of R&D Center, Affyxell Therapeutics Co., Ltd.
- Marinna Madrid - Co-Founder & Chief Product Officer, Cellino
- Kathryn Golden - SVP, Technical Operations and Cell Manufacturing, bit.bio
- Tania Emi - Senior Scientist - Cell Process Development, Beam Therapeutics
- Ashish Saksule - Principal Scientist, Core Lead, Vertex Pharmaceuticals
- Nathalie Clement - Vice President of Vector Development, Siren Biotechnology, Inc.
- Stacie Seidel - Senior Director Molecular/Viral Vector Biology, elevatebio
- Janet Lee - Head of Cell Line Development, Samsung Biologics
- YeonTae Jeong - Head of Upstream Process Development, Samsung Biologics
- Camilla Domeneghetti - Biology Manager – Cell Line Development, Advanced Instruments
- Rick Zampa - Application Specialist, Advanced Instruments
- Jishna Ganguly - Expert Scientist, GSK
- Yi Li - Process Development Scientist, Amgen, Inc.
- Michael Chen, PhD - CEO & Co-founder, Great Bay Bio
- Winnie Yeung - Scientist, Gilead
- Kyle McHugh - Associate Director, Biotherapeutics Process Development
- Nick Vecchiarello, Ph.D., - Assistant Professor, Chemical Engineering, University of Virginia
- Elise Woodall - Automation Engineer, AstraZeneca
- An update on NIIMBL’s activities working towards key fundamentals
- Security of supply chains
- Flexibility of facilities to match varied and changing demand across portfolios of products
- Faster development with supply chains that can match this
- Sustainability for raw materials, components, and energy
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
- Jeffrey Baker - Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT
- John Schiel, Ph.D. - Research Chemist, IBBR, National Institute of Standards and Technology
- Derek Ryan - Senior Director, Analytical Development, KBI BioPharma
- Brian Fahie, Ph.D. - Vice President, Global Head of Analytical Development, Biogen
- Tim Lauer - Senior Manager, Data Sciences, Attribute Sciences, Amgen
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
- Amir Hefni - CEO, Resolution Therapeutics
- Meghan Samberg - Chief Development Officer, Stemson Therapeutics
- Reducing wait times and logistical magnitude to reduce overhead costs
- Increasing accessibility, distributing to multiple locations closer to patient populations and remove transportation cost barriers
- How QC release testing and material kitting and management will be handled for POC manufacturing in this ecosystem.
- Establishing harmonized regulatory standards across different regions
- Implementing robust oversight mechanisms to ensure compliance with regulatory requirements and maintain product in a distributed manufacturing model.
- EMA vs FDA approach
- Peter Peumans - CTO Health, imec
- Amol Ketkar - CMTO (Chief Manufacturing and Technical Officer), Resolution Therapeutics
- A Representative from - :, Aldevron
- Jing Liao - Director of Vector Development and Operations, Alexion Pharmaceuticals
- Jin Sung Hong - Biologist, OTP, OCTHT, CBER, FDA
- Kevin E. Noonan, Ph.D. - Partner, McDonnell Boehnen Hulbert & Berghoff LLP
- Thomas Kelly - Director, Cell Engineering & Analytical Sciences, Johnson & Johnson Innovative Medicine
- Charles Mitchell - Senior Process Scientist, Cell Culture, Visterra Inc
- Pitchai Sangan - Associate Director of Cell Line Development, Boston Institute of Biotechnology, LLC
- Edward Chan - Technical Specialist, Genetech, Inc
- Bill Napoli - Principal Engineer, Sanofi
- Sanjay Nilapwar - Principal Scientist I, Purification Development, BioProcess Development, Operations Science & Technology – Biologics, Abbvie
- Dan Bracewell, Ph.D. - Professor, Department of Biochemical Engineering, University College London
- Wei Wang - Microbiologist, DMPQ, OCBQ, CBER, FDA
- Xiuju (Sue) Lu - Regulatory Reviewer, DMPQ, OCBQ, CBER, FDA
- Robert Brooks - Director, ADMA Biologics
- Thaddaeus Webster - Lead Scientist, Lonza Biologics
- Santosh Paidi - Technical Development Principal Scientist, Genentech
- Jeffrey Baker - Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT
- Navigating the complex grey area of manufacturing for Phase 1 and 2 trials
- Keeping efficiency while complying with limited guidance
- Need conversation between regulators and developers
- Lessons learnt and case studies from companies moving between clinical phases
- Therapeutic Developer/CDMO dynamics in the phase 1 and beyond
- How to best leverage CDMO expertise and capital efficiency
- Rachel Legmann - Senior Director of Technology, Gene Therapy, Repligen
- Sarah Thomas - Senior Vice President, Quality, REGENXBIO Inc.
- Kathryn Golden - SVP, Technical Operations and Cell Manufacturing, bit.bio
- Kate Rochlin - Chief Operating Officer, IN8bio, USA
- Shankar Swaminathan, PhD - Team Lead, Drug Product Development, CMC-Tech Ops, Astellas Institute for Regenerative Medicine
- Stella Lee, PhD. - Senior Scientist, , OTP, OGT, CBER, FDA
- What are the key criteria for choosing a cell or gene therapy manufacturing partner? (Expertise, capacity, regulatory knowledge, technology fit)
- Approaching start-up build from the ground up to develop new therapeutics
- Ensuring preparedness for CDMOs
- How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
- Best practices to ensure quality control and compliance throughout manufacturing.
- Building trust and transparency in long-term CGT manufacturing partnerships
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
- Carolina Alarco - Founder & Principal, Bio Strategy Advisors
- Stella Lee, PhD. - Senior Scientist, , OTP, OGT, CBER, FDA
- What are the key criteria for choosing a cell or gene therapy manufacturing partner? (Expertise, capacity, regulatory knowledge, technology fit)
- Approaching start-up build from the ground up to develop new therapeutics
- Ensuring preparedness for CDMOs
- How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
- Best practices to ensure quality control and compliance throughout manufacturing.
- Building trust and transparency in long-term CGT manufacturing partnerships
- Amish Patel - SVP, Technical Activity Operations, Calidi Biotherapeutics
- Carolina Alarco - Founder & Principal, Bio Strategy Advisors