Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Johanna, I.; Daudeij, A.; Devina, F.; Nijenhuis, C.; Nuijen, B.; Romberg, B.; de Haar, C.; Haanen, J.; Dolstra, H.; Bremer, E.; Sebestyen, Z.; Straetemans, T.; Jedema, I.; Kuball, J.

doi:10.1016/j.iotech.2023.100411

Cited by 2 publications

(2 citation statements)

References 42 publications

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“…Diffusion theory emphasizes the importance of understanding how innovations spread through social systems and how adopters interact with them. Having a disruptive innovation without knowledge of how to access its market is predictive of failure 72,73 . The utility of an innovation may be demonstrated through experimentation; however, building access can be more challenging.…”

Section: Adoption and Diffusionmentioning

confidence: 99%

A Framework for Innovation in Obesity

Levine

2024

MRAJ

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The intersection of innovation and obesity presents a significant opportunity for businesses to address a pressing public health challenge while capitalizing on a growing market demand. This abstract explores the potential for businesses, both existing and new, to innovate within sectors such as food, healthcare, technology, and education to promote healthier lifestyles and combat obesity. With the obesity market estimated at $80 billion annually, entrepreneurs, healthcare providers, and technology developers have ample room for growth and innovation. Existing businesses can reformulate products, offer new services, and advocate for supportive policies, while new ventures can enter the market with innovative solutions targeting obesity-related services and products. Moreover, the DACMAR (Disrupt, Adopt, Collaborate, Manage, Adapt, and Resource) framework provides a structured approach for innovators to navigate the complexities of obesity management. Through the DACMAR framework, stakeholders can drive meaningful progress and innovation in addressing obesity. This framework emphasizes the importance of challenging the status quo, fostering partnerships, effective resource management, and dynamic adaptation to changing circumstances. Similarly, by applying the DACMAR framework's principles, investors can systematically rank different innovations in the obesity domain, ensuring market-readiness, identify go-to-market gaps and align investments with investors’ strategic objectives. This enables objective de-risking to improve investment returns. Furthermore, effective leadership is crucial in driving innovation and change, particularly in complex issues like obesity. Various leadership styles, including transformational, innovative, collaborative, servant, adaptive, and strategic, play essential roles in shaping the direction and impact of obesity prevention and treatment efforts. By leveraging diverse leadership approaches, stakeholders can work together to develop innovative solutions that improve outcomes for individuals and communities affected by obesity. Keywords: obesity, innovation, leadership, business

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Section: Adoption and Diffusionmentioning

confidence: 99%

A Framework for Innovation in Obesity

Levine

2024

MRAJ

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“…Academic institutions play a crucial role in the translational process, emphasizing a blend of scientific discovery and practical healthcare outcomes. These centers convert laboratory discoveries into viable therapies, integrating innovative treatment development within academic research frameworks, distinct from commercial pharmaceutical manufacturing [1]. However, ATMPs remain experimental, requiring an initial translation from laboratories to clinical trials to demonstrate safety and efficacy.…”

Section: Introductionmentioning

confidence: 99%

Integrating Artificial Intelligence for Academic Advanced Therapy Medicinal Products: Challenges and Opportunities

Aguilar-Gallardo,

Bonora-Centelles

2024

Applied Sciences

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Cell and gene therapies represent promising new treatment options for many diseases, but also face challenges for clinical translation and delivery. Hospital-based GMP facilities enable rapid bench-to-bedside development and patient access but require significant adaptation to implement pharmaceutical manufacturing in healthcare infrastructures constrained by space, regulations, and resources. This article reviews key considerations, constraints, and solutions for establishing hospital facilities for advanced therapy medicinal products (ATMPs). Technologies like process analytical technology (PAT), continuous manufacturing, and artificial intelligence (AI) can aid these facilities through enhanced process monitoring, control, and automation. However, quality systems tailored for product quality rather than just compliance, and substantial investment in infrastructure, equipment, personnel, and multi-departmental coordination, remain crucial for successful hospital ATMP facilities and to drive new therapies from research to clinical impact.

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Basics of advanced therapy medicinal product development in academic pharma and the role of a GMP simulation unit

Cited by 2 publications

References 42 publications

A Framework for Innovation in Obesity

A Framework for Innovation in Obesity

Integrating Artificial Intelligence for Academic Advanced Therapy Medicinal Products: Challenges and Opportunities

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