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Accelerating Innovation for Traditional and Novel Therapeuti
Accelerating Innovation for Traditional and Novel Therapeutics Manufacturing
The Biomanufacturing industry has made tremendous progress over the past thirty years in increasing the available manufacturing capacity and number of new biologics available for treatments. Along the way, multiple innovations in feedstock, processes, equipment and regulations have facilitated the growth of this industry. However the current situation with increasing pressure on costs, quality and speed requires a bold new approach. With this in mind, a cross industry stakeholder consortium consisting of biomanufacturers, suppliers and academia, facilitated by The Biophorum Operations Group (BPOG) kicked off a major effort 2 years ago to agree on a Technology Development Strategy in order to address the challenges faced by this industry. This effort recently culminated in a freely downloadable Technology Roadmap. The key aspects of the Roadmap which the consortium hopes will lead to accelerated innovation will be presented during the session. The Technology Roadmap also identified the need in future for smaller, more flexible manufacturing facilities in order to address the need for personalized treatments for patients. Two case studies for personalized treatments involving traditional protein based therapies and novel autologous cell therapies will be presented during this session. Examples of how both traditional and novel treatments will leverage the Roadmap will be included.

Rajesh Beri, PhD: Rajesh Beri is currently the Technical Director Bio Manufacturing in the Research & Technology Department for Lonza Pharma Biotech unit. His responsibilities include research, development and implementation of innovative technologies in Lonza's mammalian, microbial, cell and gene therapy manufacturing plants. In his previous role as Director, Manufacturing Sciences and Technology at Lonza Biologics, Portsmouth, NH, he managed a group of 45 scientists and engineers responsible for process transfer and scale up, process characterization, manufacturing and regulatory support. During his tenure as Director MSAT, Rajesh and his team successfully transferred 20 processes, performed process characterization of 10 processes and received approval for 5 products.

Monica Hueg: Monica Hueg is a Global Technology Partner within GMP and compliance at NNE Pharmaplan. She has more than 16 years of experience with production and construction of biotech, pharmaceutical and medical device facilities. During her professional career, Monica has built a broad and solid palette of theoretical expertise and practical experience within GMP and compliance. She has applied her ability to analyze, plan, implement and complete tasks in a wide range of projects within the pharma industry globally. For the past five years Monica's focus has been on providing consultancy services to facilitate strategic business decisions with special focus on quality and compliance. For instance, she has provided consulting in high-end strategic planning for future improvements to ensure compliance going forward often in connection with compliance gap analysis/assessments. Furthermore, Monica regularly teaches courses within GMP and compliance and has also developed a number of educational courses.

Behzah Mahdavi: Behzad Mahdavi, Ph.D., MBA is serving as Vice President of Strategic Innovation & Alliances at Lonza, one of the world's leading suppliers to the Pharma&Biotech and Specialty Ingredient markets and as a Chairman of the Board of Exosomics Siena an innovator leader in the field of Liquid Biospy. He began in his current position in 2010 after three years working as Head of Lonza Canada. Prior to joining Lonza, he was CEO of SAM Electron Technologies, a venture capital-backed company in the Life Sciences field, which was acquired in 2007 by a multinational company. During his entire career, Behzad worked for several private organizations, governmental companies and venture capital firms in different capacities as senior executive, advisor, CEO and board member.

Henriette Schubert: Henriette Schubert is Global Technology Partner at NNE A/S. As an expert with 20 years of experience within consultancy within the biotech, life science, pharmaceutical and biopharmaceutical industry, Henriette focuses on consulting assignments related to front end studies and facility design. At NNE, Henriette is heading Laboratory and Biocontainment Engineering standards, Development, and sets direction in projects globally. Qualified as an Architect (Cand. Arch/Architect MAA) in 1992 with a master degree from the Royal Danish Academy of Fine Arts in Copenhagen, Henriette has spent most of her professional career within Pharmaceutical, Biopharmaceutical and Biocontainment consulting.
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This is a self-paced, pre-recorded webinar that includes a downloadable presentation for note-taking.

Approximate Course Duration: 90 minutes (this is a self-paced course)

*NOTE*You will have 5 calendar days to access and complete this course from time of purchase.

Member Price: $ 49.00
Non Member Price: $ 149.00