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Bio-resources and biobanking
Identification of biotherapies
Drug design
Clinical validation
Production
Market access
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1 Research & innovation challenges
Need to adapt the funding for the scaling up of innovation, and ensure to keep the talent
Limited collaboration between academia, research institutions, and industry hinders the translation of research into marketable products
Challenges include patent filing, IP protection, and dependency on key technologies, particularly affecting SMEs.
A historical focus on R&D over manufacturing capabilities creates a gap in bioproduction readiness
Need for more public-private partnerships to accelerate technology transfer and commercialization
Focus groups
Technology transfer
This focus group tackles the challenges of technology transfer from research to industrial-scale production and strategies for successful commercialization of biomanufactured products.
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2Industrialisation challenges
Need to increase public-based investment on production capabilities
Need to adapt regulatory constraints
Need to secure biosourced resources supply chain, as well as the availability and sustainability of raw materials and critical components
Need to support pre-industrial and industrial scaling-up
Complexity of scaling up complex biomanufacturing processes for personalized therapies
Challenges include attracting CDMOs, accessing real estate for industrial plants, and trust issues between big players and small CDMOs
Access to pre-industrial GMP equipment is critical for achieving industrial scale bioproduction
Focus groups
Industrial and economic sovereignty
This group focuses on ensuring the European industrial sovereignty, addressing challenges related to the access to pre-industrial facilities and to scale up the bioproduction in Europe.
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3 Skills & talents challenges
Upskilling and re-skilling of labor forces from other industry sectors
Talent chase and high competition to attract digitally skilled workforce (digital twins, simulators, virtual & augmented reality)
Talent development: stretch vs future demand
Need for more entrepreneurship skills
Shortage of skilled professionals with expertise in advanced bioprocessing techniques
Lack of cross-disciplinary training programs that combine biology, engineering, and data science
Need for more specialized training education programs
Rapidly evolving technology landscape requiring continuous upskilling
Need for specialized training in regulatory compliance and quality control for biomanufacturing
Public concerns over drug pricing and the need to balance bioproduction costs with affordability impact acceptance
Focus groups
Talent attraction and retention
This group explores ways to develop strategies for enhancing specialized training programs, upskilling, and cross-disciplinary education to meet the evolving demands of the biomanufacturing workforce. The group also discusses how to attract, retain, and diversify the talent pool in biomanufacturing by addressing competition for skilled professionals and creating a conducive environment for career growth.
Public acceptance and access
This group explores ways to enhance public awareness about biomedicines and to improve the visibility of the biomanufacturing field, addressing the challenges of the affordability and acceptance of innovative biotherapeutics.
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4 Access to fundings challenges
Need to adapt the funding tools for the scaling up and growth of business
Need of larger investments from EU-based funds
Adaptation of regulatory constraints
Limited access to early-stage funding for biomanufacturing startups
Difficulty in securing venture capital investment due to the long development timelines of biomedicines
Challenges in navigating complex regulatory pathways and obtaining funding for clinical trials
Lack of funding options for scaling up production facilities to meet increasing demand
Limited tax incentives and reluctance of investors to accept long ROI periods hinder funding availability
Bureaucratic hurdles, slow digitalization, and concerns over drug pricing and tax policies complicate regulatory compliance and operational efficiency
Focus groups
Private and public fundings
This focus group delves into adapting funding tools, exploring new sources of funding, and establishing collaborations to support the scaling up of innovative biomanufacturing technologies and processes.
Regulation and market access
This focus group navigates the complex landscape of regulatory constraints and explores ways to harmonise regulations to support biomanufacturing growth and commercialization.
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