The third annual 2018 ISPE Europe Biotechnology Conference will be held in Lyon, a hot spot for the biotechnology industry in France, where five megatrends in the biotechnology industry will be highlighted and challenged. These five megatrends include:
Higher Complexity of Product Portfolio Demands Holistic Control Strategies
- More small products and always shorter product life cycles will increase the complexity of the portfolio. Personalized medicine will require new holistic manufacturing strategies. Continuous manufacturing for example needs to disclose smaller products and batches. Gene and cell therapy will initiate a new type of product and technical processes, factories will change their face, Pharma 4.0’s operations model will support this change management.
High Investment Needs Require Strategic Investment Management
- In order to address shorter product life cycles and the volatility of the markets investments need to be managed risk based. For this, excellent project management capabilities are requested in order to avoid wrong or too early capital binding. What can current simulation tools do to help in optimizing capital investment decisions?
Knowledge Management and Workforce 4.0 as Enablers
- New products and new technologies and an excellent project management need excellent know how transfer and different job profiles than today. More importance will be with the soft skills in order to address cross functional interaction, better understanding of the holistic picture of a value chain. Management and communication skills will be needed to explain more complicated projects to investment decision makers.
The Big Threat: Capacity Constraints
- Resources for product and process development often are requested from third parties, contract labs, contract manufacturers and others. Markets are short with experts in biotechnological operations, microbiology and virology. Industrial hygiene experts is another sector of shortages. On the agencies level there are limited numbers of reviewers which requires an excellent management of regulatory affairs in companies.
The License to Business: Quality and Regulatory
- The regulatory world needs to be continuously followed up, where new or updated regulation will have an impact on current or future operations. Not everything is of equal urgency therefore available resources have to be planned carefully and quality risk based. Current hot spots are: Annex 1, ATMP GMPs, ADC manufacturing in the light of how to manufacture high potent drugs in multipurpose factories - and how to bridge this with the other trend of higher complex portfolios. Last but not least: will the trend for Bio-similars continue and where are the pitfalls here
Panel discussions within the sessions will deliver interactive elements with biotechnology speakers, regulators, and key opinion leaders that will provide a platform for you to develop your own network of experts and stakeholders in biologics. ISPE's Young Professionals will also drive an interactive session with questions surrounding the future of operations as they are managing next generation of products, processes, and the facilities of the future.