Advancing manufacture of cell and gene therapies vi american university communications

Building on the strong momentum established at our previous meetings ( scale-up and manufacture of cell-based therapies), we are pleased to announce that the advancing manufacturing cell & gene therapy VI conference is scheduled for january 27-31, 2019, at the loews coronado bay hotel, california, USA. This conference is unique in the cell/gene therapy field, as it is focused on the technological challenges and engineering solutions for the robust and cost-effective manufacturing of cell and gene therapies. Moreover, owing to the restricted number of participants (~400), welcoming location and overall format, this conference is a valuable opportunity to showcase new and existing approaches with key academic and industrial leaders.

In addition to a comprehensive series of oral sessions speakers from academic and industrial groups, we have designed the conference to foster networking and facilitate informal discussion around key engineering advances and issues.

This will be enabled via several poster sessions, informal drinks and a focused workshop on viral manufacturing challenges & next generation technologies.

The cell therapy industry has advanced rapidly from demonstrating promising clinical data to achieving commercially approved products. Due to the unprecedented speed of this development, several challenges remain in the manufacture of these cell therapy products that must be resolved through development of new technologies and solutions from across our entire community. In this session, we will explore potential cell therapy technologies that can resolve these challenges.

Gene therapy has rapidly advanced over the last few years thanks to the creation and application of sophisticated gene-editing technologies. These technologies have brought significant advantages such as targeted gene insertion and improved safety profiles. As a consequence, and strengthened by shorter regulatory approval times, commercial development and time to clinic have seen rapid acceleration. This session aims to address recent advances in viral vector production, emerging gene-editing tools and their deployment in human clinical trials.

Genetic modification of cells offers the potential of designing cells for immunotherapy and regenerative medicine applications. Washington university psychiatry in recent years, advances in gene editing precision have revealed the true potential of cell therapies. To realize the full potential of cell therapies, more efficient and precise methods are needed to introduce exogenous or modify endogenous genes in the human genome.

• describe recent advances in gene modification of cells for therapy. Specific areas that could be explored include viral vector production; nonviral gene editing; and synthetic biology approaches to engineering therapeutic cells to improve their safety and potency.

As the cell therapy industry moves towards closed, automated processing and more product enter clinical development there is an increased requirement for tools and technologies to allow better control over the manufacturing process. This opens-up exciting opportunities to look at the how frameworks such as process analytical technologies (PAT) can be applied to improve product manufacture, how in-process analytics can be applied to support real time product release and how new analytical strategies can be developed to support adaptive manufacturing.

The continued efforts to drive down costs and improve efficiency of cell therapy process development and manufacturing require multiple, integrated IT strategies. This session will discuss big data strategies such as digital lab solutions for process development as well as electronic batch record/automated data capture for clinical and commercial manufacturing. Examples could include automation and real time process monitoring to speed problem solving and improve process robustness, while utilizing the latest process analytical technology. In addition, data mining capability and AI approaches across the cell manufacturing process can enhance identification of cqas and cpps and could be key to enhancing quality assurance. Data mining and AI can enable improved process understanding of complex interactions, such as the relationship of the patient incoming apheresis to the manufacturing performance and clinical outcome. The integration of data from genomic and metanomic approaches will also be discussed for the further progression of truly personalized approaches.

Key to the success of the advanced therapies sector are cost-effective manufacturing and sustainable commercialization models. Bioprocess modeling efforts have a critical role to play in enhancing predictive insight as well as providing line-of-sight to feasible business models.

• present applications of such modelling approaches with industrially-relevant case studies addressing manufacturing and supply chain decisions for cell and gene therapies are particularly encouraged. This can include techno-economic feasibility for achieving optimal cost of goods (COG) at the commercial scale, simulation models to enhance facility design and capacity management across global sites for scale-up and scale-out scenarios, asset strategies optimization, business models for point-of-care versus centralized distribution for global deployment, the financial impact of process choices on the product development lifecycle, and chemometrics for enhanced process understanding and root cause analysis.

The cell and gene therapy industry has advanced at an incredible speed over the last decade and now embraces a wider spectrum of advanced methodologies targeting several hematological malignancies and rare diseases, with powerful efficacy. American university student jobs patients are benefiting from these new therapies thanks to advances in fundamental underpinning science, new translational tools and technologies, adaptation of flexible regulatory frameworks and introduction of accelerated access pathways. This represents tremendous success for the industry but what are the current limitations in delivering these medicines to mainstream healthcare?

• focus on addressing how these new medicines will be delivered in the context of mainstream healthcare. Themes that might be explored include transformation of supply chain logistics; clinical infrastructure for delivery to patients; synergizing parallel services for end-to-end manufacture.

PURPOSE: the advancing manufacture of cell and gene therapies award recognizes outstanding contributors to the development and commercialization of cell-based therapies. Past recipients include bob nerem, kim warren, and peter zandstra. The award nominations will be judged according to criteria as set forth in this document.

The conference will take place at loews coronado bay hotel. Set on coronado bay directly across the street from silver strand state beach, the hotel is just over two miles to san diego national wildlife refuge complex. The hotel is set on a 15-acre peninsula with beach access via a pedestrian underpass. The multi-building, three-floor resort offers 439 rooms and suite that are light and airy. Room views include bay, marina, pool or gardens. There is free wi-fi and the rooms have keurig coffeemakers and ample outlets. The hotel has tennis courts, bicycle rentals, a fitness center, spa and three swimming pools. Both self and valet parking are available for an additional fee.

Please plan to fly into san diego international airport (SAN) as it is the closest to the conference venue. The loews coronado bay is located approximately 20 minutes from san diego international airport. Top 30 universities in uk the loews coronado bay resort does NOT offer a complimentary shuttle to and from the airport.

All conference fees are inclusive. They include registration, accommodations (sunday, monday, tuesday and wednesday nights), all meals with the exception of lunch on wednesday, excursion, taxes, and gratuities from the reception and dinner on sunday through breakfast on thursday. Incidental fees (telephone calls, faxes, spa, laundry, etc.) are billed to your personal account by the hotel.

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Engineering conferences international (ECI) is a global engineering conferences program, originally established in 1962, that provides opportunities for the exploration of problems and issues of concern to engineers and scientists from many disciplines.

The format of the weeklong research conference provides morning and late afternoon or evening sessions in which major presentations are made. Available time is included during the afternoons for ad hoc meetings, informal discussions, and/or recreation. This format is designed to enhance rapport among participants and promote dialogue on the development of the meeting. We believe that the conferences have been instrumental in generating ideas and disseminating information to a greater extent than is possible through more conventional forums.

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