Tuesday, September 24, 2024 - Day One of Main Conference - EST/EDT (Eastern Daylight, GMT-4)
Tuesday, September 24, 2024 - Day One of Main Conference - EST/EDT (Eastern Daylight, GMT-4)
- 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
- 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. - Associate Director, Bristol Myers Squibb
- 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, Vector Development for Translational Gene Therapies, Siren Biotechnology
- 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
- 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
- Jeffrey Baker - Senior Fellow, NIIMBL; Strategic Advisor, CBI-MIT
- Santosh Paidi - Technical Development Principal Scientist, Genentech
- 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
- Jing Liao - Director of Vector Development and Operations, Alexion Pharmaceuticals
- Mark Tie - Principal Scientist, Biogen
- 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
Next generation manufacturing through implementation of advanced technologies is one of the current focus areas to enable agile, reliable, cost-effective, and timely production of biopharmaceuticals at highest quality standards. New modalities beyond standard mAB characteristics and complex supply chain logistics in a VUCA environment are factors to consider when designing the plant of the future and will impact the competitive advantage through application of advanced technology concepts. The talk will provide examples of deployment in context with business needs and added value.
- Marcel Tigges - Senior manager, Janssen
Shifting from batch to continuous manufacturing is a promising way of lowering manufacturing costs of by allowing operations to run simultaneously with reduced downtime, higher productivity, and at several-fold smaller scale. This is particularly promising for gene therapy products using recombinant adeno-associated viral vectors (AAV), as treatments currently cost up to USD 3.5 million per patient and have high cost-of-goods ranging up to USD 1 million per dose. In this talk, we present approaches for intensification of downstream AAV manufacturing processes using principles of continuous processing.
- Garima Thakur - Process Development Engineer III, Regeneron Pharmaceuticals
- Thaddaeus Webster - Lead Scientist, Lonza Biologics
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
- Tim Lauer - Senior Manager, Data Sciences, Attribute Sciences, Amgen
- 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
- 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
- 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
- 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