Wednesday, September 25, 2024 - Day Two of Main Conference - ET (Eastern Time, GMT-05:00)
Wednesday, September 25, 2024 - Day Two of Main Conference - ET (Eastern Time, GMT-05:00)
Ditch the data, hit the pavement: Let's get those neurons firing with a Fun Run!
All attendees are welcome to participate in our 5k walk/run. More details and sign-up form to follow.
- William H. Rushton, MS - Chromatography Support Scientist Process Chromatography, Bio-Rad Laboratories
- Guy Matthews - Director – Market Development Single Use Technology, FUJIFILM Irvine Scientific
- Priyanka Gupta - Business Title Senior Marketing Expert Bioprocess Solutions, Sartorius
- Himanshu Gadgil, Ph.D - CEO, Enzene Biosciences Ltd.
- Kartik Subramanian - Vice President, Bioprocess Development, AbbVie Bioresearch Center, USA
- Jon Coffman - Executive Director of Bioprocess Technology and Engineering, Astra Zeneca
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/Insider Editors & Thought Leaders.
- Mark Cobbold - Senior Vice President Discovery and Head of Oncology Cell Therapy - Oncology R&D, AstraZeneca
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/Insider Editors & Thought Leaders.
- Emmanuelle Cameau - Genomic Medicine Strategic Technology Partnership Leader, Cytiva
- Sara Miller - Associate Director, Product Offering Lead - Cell Therapy, Fujifilm Diosynth Biotechnologies
- Dan Stanton - Managing Editor, Bioprocess International
- Jorg Thommes, PhD - Manager, CMC Consulting
- Eric Neumann, Ph.D - CEO & Founder, AIDAKA LLC
- Derek Adams, PhD - CEO, Stellular Bio
- Kerry Love - Founder, CEO/President, Sunflower Therapeutics
- Michael Butler - Principal Investigator, NIBRT
- Mark Tie - Principal Scientist, Biogen
- How PAT provides deeper insights into the bioprocessing stages, leading to improved control and optimization
- Ensuring product quality and consistency through real-time monitoring and control
- Importance of robust data management and integration systems
- Real-world examples of PAT implementation in upstream bioprocessing, highlighting the benefits and challenges faced
- Addressing the cost implications of implementing PAT and demonstrating ROI
- Kurtis Denny - Senior Engineer I, Cell Culture Development, Biogen
- Min Cheol Kim - Process Engineer IV, Sanofi
- Sarah Harcum - Professor, Clemson University
- Naveen Singh - Senior Research Scientist I (Associate Director), Process Development, Gilead
- Irina Ramos, Ph.D - Director of Bioprocess Technology and Engineering, AstraZeneca
- Jay (Zizhao) Liu, Ph.D. - Senior Process Scientist, Downstream Sciences, Process Sciences Department, Regeneron
- Courtney Hazelton-Harrington - Senior Scientist, Research & Development, Lonza Biologics
- Jeff Johnson - President, Biotech Design, LLC
- Specific and strategic considerations for process and analytical development of advanced therapies
- Optimising and scaling-up of manufacturing operations post approval
- Preparing for regulatory filing
- Ciaran Brady - Vice President – Manufacturing Science and Technology (MS&T), Vertex Pharmaceuticals Inc.
Control and management of materials is a key pillar of GMP manufacturing. An initiative is in progress which aims to harmonize the approaches of material management between clinical and commercial Drug Substance production sites to increase efficiency and supply chain sustainability within the organization. We will present the background and drivers, strategies, and current status of this initiative.
- Dale R.Mowrey - Associate Director of Material Science, Teva Pharmaceuticals
- Elisabeth Krug - Executive Director, BRD Analytical Development, Eli Lilly & Company
- Patrick Gammell - VP, Head of Global Manufacturing Sciences, Biogen
- Greg Adams - Senior Director, Global Analytical Strategy & Development, FUJIFILM Diosynth Biotechnologies
- Nadine Ritter, Ph.D. - President and Analytical Advisor, Global Biotech Experts, LLC
- Jamie Doyle - Staff Analytical Scientist, Regeneron
- Timothy Nelson, MD, PhD - Founder & CEO, HeartWorks
- Amish Patel - SVP, Technical Operations, Calidi Biotherapeutics
This presentation will focus on the technical and manufacturing capabilities for cell therapy commercialization with discussion of CMC requirements, manufacturing launch readiness, and supply considerations. Specific considerations for a cell therapy and partnership with contract manufacturing organizations will also be discussed including lessons learned.
- Kenneth Green, PhD - Snr Dir MSAT, Vertex
- Sylvain Roy - CTO, ImmPACT Bio
- Brandon Haigh - Associate Director, Process Development, Cell Therapy, WuXi Advanced Therapies
Increasing demand for recombinant adeno-associated virus (rAAV) based gene therapies necessitates increased manufacturing production. Transient transfection of mammalian cells remains the most commonly used method to produce clinical-grade rAAVs due to its ease of implementation. However, transient transfection processes are often characterized by sub-optimal yields and low fractions of filled-to-total capsids, both of which contribute to the high cost of goods of many rAAV-based gene therapies. Analysis of our previously developed mechanistic model for rAAV2/5 production suggested that the inadequate capsid filling is due to a temporal misalignment between viral DNA replication and capsid synthesis within the cells and the repression of later phase capsid formation by Rep proteins. We experimentally validated this prediction and showed that performing multiple, time-separated doses of plasmid increases the production of rAAV. In this study, we utilize the insights generated by our mechanistic model to develop an intensified process for rAAV production that combines continuous perfusion, high cell density transfection, and re-transfection which resulted in increased titer and plasmid efficiency. Our results establish a new paradigm for continuously manufacturing rAAV via transient transfection that improves productivity and reduces manufacturing costs.
- Tam Nguyen - Scientist, BioNTech US / Massachusetts Institute of Technology
AAV has emerged as a significant therapeutic modality in gene therapy. Challenges such as poor yield and variable product quality persist in the viral vector manufacturing space and we have addressed these problems using our cell engineering technology. Our cell engineering platform for improved adeno-associated virus (AAV) manufacturing addresses the critical challenges in gene therapy manufacturing, and presents an innovative modality for improving cells for production of viral vector therapeutics. Our platform, yielding cells with improved AAV production and CQAs, can significantly bolster the efficiency and cost-effectiveness of gene therapy manufacturing, and can accelerate current development timelines. We used a directed-evolution approach based on repeated cell fusions to shuffle the cell genome, and amplify chromosomes of HEK-293 host cells. Engineered clones enriched for mitochondria phenotypes were isolated, then used as transient-transfection hosts, and for creating stable packaging and producer cell lines. For generation of stable packaging and producer cell lines, we developed a novel inducible system that maximizes the capabilities of the inherent viral production machinery. Engineered HEK-293 clones grown in suspension culture exhibited up to 15-fold productivity improvement via triple transient transfection for AAV1, AAV2, AAV5, and AAV9 serotypes with capsid titers as high as 1017 viral particles/L (vp/L)—at least 10-fold higher than current industrial manufacturing processes. Selection for certain mitochondria phenotypes resulted in a 2-fold improvement in full-to-empty ratio—up to 55% full in crude supernatants. Finally, our engineered stable packaging and producer cell lines achieved capsid titers of up to 1016 vp/L. We demonstrated a multi-modal cell-engineering platform that has significantly improved yield and manufacturability for transient transfection and for stable packaging and producer cell line methods. We further propose a model regarding the role of mitochondria for enhancing capsid percent-full. Taken together, our disruptive platform technologies provide solutions for meeting current—and future—gene therapy manufacturing challenges.
- Larry Forman - CEO, CHO PLUS
- Dan Stanton - Managing Editor, Bioprocess International
- Thomas DeLuca - Executive Director Sales North America, Single Use Support
- Kerry Love - Founder, CEO/President, Sunflower Therapeutics
- Securing investments in a cautious market – Insights, trends and predictions
- Overcoming regulatory hurdles – How and when to communicate and work with FDA
- FDA Just issued guidance on advanced technology – How will it benefit adoption
- How can policy clear the path for innovation?
- Lynne Frick - CEO & President, Cell X Technologies
Join us in the Exhibition Hall for Live Labs
Visit us for a tour of the hall to meet and engage with our exhibitors, hear quick-fire presentations, and enter into the Prize Draw for a chance to win prizes from the exhibitors you visit!
- Attracting, recruiting and retaining experienced staff remains a key priority for companies.
- Recruitment strategies: Actively seeking out talent from diverse backgrounds and ensuring that recruitment practices are free from bias.
- Mentorship programs: Pairing young professionals with seasoned executives to ensure the next generation of leadership is as diverse as the populations they serve.
- Early talent and how to invest and engage early to ensure we don’t leave people out of this potential pipeline.
- Consortiums and Associations - Investing in early career programmes to create employment pathways.
- Finding talent to fuel innovation - Increasingly seeking talent with AI and data skills in order to remain competitive as digital technology drives innovations
- How can pharma companies support early career scientists through non-traditional pathways into the industry?
- The impact of digitalisation: What skills will give new hires an edge?
- Industry growth and its implications for career development
- John Balchunas - Workforce Director, National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
- Angela Consani - CEO, Bioscience Core Skills Institute
- Jared Auclair - Vice Provost Research Economic Development, Director of Bioinnovation, College of Science at Northeastern University
- Leslie Isenhour - Dean – Biotechnologies Division, Wake Technical Community College
- Wendy Acton - HR Site Head, Amgen
- Sanjeev Gupta - Sr. Vice President and Head Biosimilars, Ipca Laboratories
- Dennis Pfaff - Investigator II, Novartis
- Gakuro Harada - Application expert, Yamaha Motor Co., Ltd.
- Zayla Schaeffer - Scientist, AstraZeneca
- Alex Williams - Senior Associate Scientist, Biologics Development, Global Product Development and Supply, Bristol Myers Squibb
- Naveen Singh - Senior Research Scientist I (Associate Director), Process Development, Gilead
- Christoph Herwig - Senior Scientific Advisor, Körber Pharma Austria GmbH, Austria
- Sushil Bhatia - Senior Process Scientist, Regeneron
The last twenty years of bioprocessing has seen significant advancement in robustness and speed to manufacturing in no small part due to templatization of processes and leveraging CHO cell lines and monoclonal antibody therapies. Traditional (non-mRNA) vaccine manufacturers target accelerated timelines as well, but rarely have a standard template of processing tools to rely on. This talk will discuss strategies developed for drug substance and drug product development which optimize development time, scalability and tech transfer success.
- Chase Orsello - Global Head, Bioprocess Development, Sanofi
- The importance and advantages of microbial systems in biopharmaceuticals
- Platform for non-mAb biopharmaceutical development
- High Throughput process development
- CASPON technology a solution for the development of therapeutic peptides
- Future prospects, such as sustainability and competitiveness
- Cécile Brocard - Director Downstream Development, DevOps Austria, Boehringer Ingelheim RCV GmbH & Co KG
- Johnson Varghese - Head of Analytical Sciences & Development, Beam Therapeutics
- Meghan Dewitt - Director, AstraZeneca
- Daniel Sayut - Senior Scientist, AbbVie
- Maroun Beyrouthy, Ph.D. - Senior Advisor, Eli Lilly and Company
- Brent Morse - Principal Consultant, Dark Horse Consulting Group
- David Lee - Executive Director, Analytical Chemistry, Mersana Therapeutics
- The development of first in class novel complexed miRNA-based cellular reprogramming therapeutics
- Exploring the use of miRNA for the treatment of Alzheimer’s Disease, Diabetes and Heart Disease
- Joseph Chalifoux - Founder & CEO, Athergen
- Overcoming hurdles of viral vectors for Gene Therapy by harnessing the power of non-viral DNA-based platforms for Advanced Therapeutics
- Advancing Beyond Lipid Nanoparticles: Innovative Strategies in Delivery Vehicles Technology
- Exploring the use of DNA-based therapeutics for the treatment of diabetes, anemia and cancer in animal and human health.
- Case Reports
- Martin Williams - Founder and CEO, SYTE.bio
Automation plays a key role in improving the quality and lowering the cost of cell therapy products. As new or improved processing and testing technologies enter the market, it’s important for firms that build these products to design and provide both digital and physical integration touchpoints for their systems and consumables. This overview will discuss some of these important design considerations that will allow for more effective implementation of automation and make it easier to adopt new technologies.
- Dmitry Fradkin - Director of Automation Systems Development, Kite Pharma
Allogeneic cell therapies present a unique challenge for drug product process development by combining aspects of autologous cell therapies and conventional biologic products. As production scale increases to that of a commercial, off-the-shelf therapy, new challenges emerge for expanding fill finish and cryopreservation capacity. This presentation will discuss the developments and considerations that are necessary for pursuing large scale, allogeneic cell therapy manufacturing.
- Rae Stephenson - Senior Research Associate - Cell Therapy Drug Product, Sanofi
- Dan Zarraga - Head of GMU Drug Product · Biologics Drug Product Dev. & Manufacturing, Sanofi
Ultragenyx is developing an investigational gene therapy, UX701, an adeno-associated viral vector-based gene therapy product, for the treatment of Wilson disease. UX701 is an investigational AAV9 gene therapy designed to deliver a modified form of the ATP7B gene. Ultragenyx has initiated Cyprus2+, a seamless Phase 1/2/3 study of a single intravenous infusion of UX701 in Wilson disease (NCT04884815). UX701 leverages Ultragenyx’s proprietary producer cell line platform, Pinnacle PCL™. This presentation reviews our first late-stage development activities for our upstream Pinnacle PCL™ platform process including parameter risk assessment, scale-down model qualification, and process characterization, to establish process controls for the upstream unit operations in our 2000L manufacturing process. The process characterization studies help us understand our parameter space and mitigate operational and quality risks which are critical for successful implementation of a robust commercial manufacturing process to provide consistent product quality throughout the product’s lifecycle.
- Jun Li - Associate Director, Upstream Process Development, Gene Therapy, Ultragenyx Pharmaceutical
Abstract TBC
- Paetra Brailsford - Engineer III, Technical Development, Biogen
This presentation delves into the critical aspects of late-stage characterization for antibody-drug conjugates (ADCs) and their role in a robust analytical control strategy essential for successful marketing applications. Starting with an explanation of product characterization and its necessity, we outline its integration into the control strategy, highlighting its role from preclinical development through to commercial production.
Key topics include:
1.Product Characterization: Importance, steps, and impact on safety, efficacy, stability, and performance.
2.Control Strategy Integration: How characterization supports the Quality Target Product Profile (QTPP) and defines critical quality attributes (CQAs).
3.Case Study: An ADC characterization project at KBI Biopharma, showcasing methodologies, challenges, and data analysis.
This presentation emphasizes the essential role of comprehensive characterization in ensuring ADCs meet regulatory standards and therapeutic goals for patients with critical needs.
- Deanna Hunt - Senior Director, Business Development, KBI Biopharma
Analytical bottlenecks in bioprocessing result in the product being stalled between unit operations. Routinely these critical tests are not performed, creating process blind spots. Utilizing High Precision Tunable Laser Spectroscopy (HPTLS), we demonstrate how this rapid, quantitative analytical tool can be used to de-bottleneck and remove blind spots in bioprocessing.
- Bryan Hassell - Founder and CTO, Nirrin Technologies
- What contributes to fostering a truly inclusive work environment?
- Building and sustaining a truly inclusive workplace
- Why is there more focus on DE&I- what is contributing?
- Adopting employee-focused innovative initiatives
- While multinational pharma companies like these are devoting more resources to diversity and inclusion initiatives internally, what impact will this have more widely?
- Why diversity in pharma leadership matters
- What is driving DE&I for talent today?
- Continual education: Regular training sessions on unconscious bias, cultural sensitivity, and the importance of D&I for all employees.
- Embracing D&I will not only lead to a more inclusive industry but also a more prosperous and innovative one.
- Sarah Odeh - Executive Director, Medical Affairs TGaS Advisors, President & Board Chair, Women In Bio
- Nicola Ambler - Co-Founder, CGT Circle
- Quinnie Ng-Quinn - Director - Diversity, Equity and Inclusion, Pfizer
- Melissa Coe - Associate Vice-President, Eli Lilly and Company
- Piper Trelstad - Head of CMC, Bill & Melinda Gates Medical Research Institute
Stakeholders will work together in teams(participant from each category) during a brainstorming session to gain deeper understanding of issues and to offer ideas and solutions to spark positive change.
- Karin Plante - Senior Research Associate, Automation Lead, AAV Producer Cell Line Development, Sanofi
- Don Jarvis, Ph.D. - President, GlycoBac, LLC
The volumes of data generated by upstream bioprocesses during development, technology transfer and GMP production are only as good as the tools to make the data available for consumption and advanced data analytics. This talk will provide current highlights from our 12-year journey digitizing bench and pilot scale bioreactor processes to enable paperless data aggregation and generation of persona dashboards for daily analysis by data consumers and executives alike.
- Michelle Lafond - Vice President of Preclinical Manufacturing and Process Development, Regeneron
- Delia Lyons, MSc. - Principal Scientist II, Abbvie
- Juan Manuel Marin-Celis - Bio-Separations Scientist, Merck
The biopharmaceutical industry is increasingly confronted with the dual challenges of complex product demands and a volatile market landscape, necessitating unprecedented levels of supply chain agility and resilience. This presentation addresses the critical role of digital innovation in transforming biopharma supply chains, enabling them to adapt swiftly to market fluctuations and unexpected disruptions. We explore the integration of advanced technologies such as artificial intelligence (AI), and machine learning (ML) to enhance visibility, optimize operations, and improve decision-making processes. Through case studies and industry insights, we demonstrate how digital tools can facilitate precise inventory management, robust cold chain logistics, and regulatory compliance, thereby reducing waste and ensuring timely delivery of vital products.
- Imara Charles - VP, Process and Digital Excellence, Global Supply Chain, Bristol Myers Squibb
- Christopher Sandusky - Director, Automation Solutions - Product & Lifecycle Mngt, Cytiva
- Bo Liang - Staff Fellow, FDA/CBER
- Iain Farrance - Biologist, CBER, FDA
- Bo Liang - Staff Fellow, FDA/CBER
- Iain Farrance - Biologist, CBER, FDA
Aurion Biotech is taking their off-the-shelf, allogeneic cell therapy (AURN001) from the lab to clinical trials with the goal of becoming the first mass-scale cell therapy to help restore vision to 17M+ patients around the world with corneal endothelial disease. Building a mass scale cell therapy means:
- Fulfilling a significant unmet patient need caused by the global shortage of donor corneas for transplant, in ways that are accessible and equitable
- Navigating the highs and lows of manufacturing and scaling an allogeneic cell therapy for clinical trials, successfully managing a CDMO partner and establishing a development process that can be translated into a large-scale commercial product.
- Creating a breakthrough product that will transform the physician experience – one that is less complex and less invasive than corneal transplant (the current standard of care) and minimally invasive for patients.
- Eris Jordan - Global Vice President, Clinical and Medical Affairs, Aurion Biotech
- Dethardt Müller - Chief Technology Officer - CMC, Abalos Therapeutics GmbH
- How can early-stage/research professionals best prepare for GMP
- Critical aspects to keep in mind transitioning from early-stage development into more commercial manufacturing.
- Examples from experiences and lessons learnt
- Cross-team collaboration and pre-emptively preventing down the road bottlenecks
- Shashi Murthy, PhD - CTO and Co-Founder, Nanite Inc.
- Jared Auclair - Vice Provost Research Economic Development, Director of Bioinnovation, College of Science at Northeastern University
- Tushar Patel - Director, Analytical CMC Strategy, Vertex Pharmaceuticals
- Joel Itkin - Director, cGMP CleanSuites, SmartLabs
- How can early-stage/research professionals best prepare for GMP
- Critical aspects to keep in mind transitioning from early-stage development into more commercial manufacturing.
- Examples from experiences and lessons learnt
- Cross-team collaboration and pre-emptively preventing down the road bottlenecks
- Shashi Murthy, PhD - CTO and Co-Founder, Nanite Inc.
- Jared Auclair - Vice Provost Research Economic Development, Director of Bioinnovation, College of Science at Northeastern University
- Tushar Patel - Director, Analytical CMC Strategy, Vertex Pharmaceuticals
- Joel Itkin - Director, cGMP CleanSuites, SmartLabs
- Success stories: Meet 4 Latino leaders in Biotech
- In which ways have Latinos contributed to the Biotech industry?
- What are the consequences of years of limited diversity in the Biotech workforce?
- How lack of diversity might stifle innovation
- How can Latinos in the industry contribute to Health Equity?
- Why does diversity in general matter in Biotech?
- Carolina Alarco - Founder & Principal, Bio Strategy Advisors
- Carlos Bosques - CEO, FASI (Food Allergy Science Initiative)
- Jose Trevejo - Consultant and Entrepreneur, Singularity Bioconsulting LLC
- Jose Estabil - Chair and Co-Founder, Latinos in Bio
Each table from collaborative problem-solving reports and shares with the group and a discussion