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)
- Sarah Glaven - Principal Assistant Director, Biotechnology and Biomanufacturing, White House Office of Science and Technology Policy
Gather around the 'fire' for a captivating conversation with our Keynote Speakers. Gain candid insights, get inspired, and dive deeper in a relaxed, conversational setting hosted by BioProcess International/BioProcess Insider Editors & Thought Leaders.
- Sarah Glaven - Principal Assistant Director, Biotechnology and Biomanufacturing, White House Office of Science and Technology Policy
- Dan Stanton - Managing Editor, Bioprocess International
- 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
- Steven 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 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
- Jayesh Desai - Senior Scientist, Merck & Co., Inc.
- Wenyi Yee - Research Manager, Croda
- Garima Sinha - Lead Application Scientist, Croda
- Sethu Alexander - Associate Director, Analytical Development-VRA, Takeda Pharmaceuticals
- 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
- Nicola Ambler - Co-Founder, CGT Circle
- 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
- Philip Szymanski - Bioprocess Engineer, MilliporeSigma
- Guido Stroehlein - Vice President Life Sciences, JSR Life Sciences
- Janet Lee - Principal Scientist, Director of Cell Line Development, Samsung Biologics
- YeonTae Jeong - Principal Scientist, Upstream 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, Takeda
- Jinlai Wei - Research Scientist, R&D Analytical, FUJIFILM Irvine Scientific
- 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 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. - Global Head, Vice President, Biogen
- Tim Lauer - Senior Manager, Data Sciences, Attribute Sciences, Amgen
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
- Amir Hefni, PhD MBA. - 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
- Jin Sung Hong - Biologist, OTP, OCTHT, CBER, FDA
- Stuart Macnab - Manufacturing Sciences & Technology CMO Associate Director, Novartis Contract Manufacturing
- Shiliang Hu - Senior Scientist, Genomic Medicine, Alexion Pharmaceuticals
- Sha Sha - Senior Scientist, Upstream Process Development, Ultragenyx
CRISPR, a molecular technology developed by adapting a protective bacterial response to virus infection, provides previously unknown power and sophistication in editing genes in organisms from bacteria to man. Consequently, control over this technology, principally by patent protection, has engendered several waves of contested proceedings in the US and European patent offices, many of which are ongoing. Because there are multiple partied and multiple proceedings a definitive determination of who owns CRISPR patent rights and the accompanying royalties on licenses is something that will not be finally concluded for several years.
Nevertheless, or perhaps because of this situation the assignees of CRISPR inventors at several universities have engaged in a broad licensing regime covering application of the technology in medicine, agriculture, and other fields. This talk will walk through these regimes in light of the various academic and commercial interests and provide a glimpse at what may arise in future when these rights are more certainly established, as well as briefly touching on the existing companies that have already licensed CRISPR technology.
- Kevin E. Noonan, Ph.D. - Partner, McDonnell Boehnen Hulbert & Berghoff LLP
- Summarize key takeaways from discussions on accelerating CLD and FIH studies
- Encourage further exploration of innovative technologies and strategies for bioprocess development
- Highlight the importance of collaboration and shared learnings in advancing the field
- 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, Genentech, 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
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
- 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
- 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)
- Ensuring preparedness for CDMOs and supplier partnerships
- How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
- Best practices to ensure quality control and compliance throughout manufacturing.
- Approaching start-up build from the ground up to develop new therapeutics
- Building trust and transparency in long-term CGT manufacturing partnerships
- Amish Patel - SVP, Technical 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)
- Ensuring preparedness for CDMOs and supplier partnerships
- How can different stakeholders identify complementary strengths to build mutually beneficial partnerships?
- Best practices to ensure quality control and compliance throughout manufacturing.
- Approaching start-up build from the ground up to develop new therapeutics
- Building trust and transparency in long-term CGT manufacturing partnerships
- Amish Patel - SVP, Technical Operations, Calidi Biotherapeutics
- Carolina Alarco - Founder & Principal, Bio Strategy Advisors
- Chelsea Pratt, PhD - Biopharma Segment Marketing Manager, Bio-Rad Laboratories