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Pharmacoeconomic Considerations in CNS Drug Development

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Drug Delivery to the Brain

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 10))

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Abstract

Recent advances in understanding of the blood–brain barrier (BBB) suggest that we are entering an era in which basic discoveries of BBB structure and function may be parlayed into meaningful disease applications. The development of impactful human therapies is a difficult and lengthy process; nonetheless, many researchers desire to see their work applied to the treatment of human disease. Significant financial reward will follow functional solutions to BBB delivery challenges; however, validating a trans-BBB delivery strategy to support and sustain a clinical program is costly and risky and requires multidisciplinary expertise. Investigators must necessarily garner funding and expertise for such campaigns, mainly through government grants, private investment firms, and industrial partnerships. Among the many considerations for researchers looking to advance brain delivery technology are the commercial aspects of the technology and the requirements attached to the funding mechanisms for clinical development. Early choices about delivery modality and target therapy (indication) have important consequences for the development process. An understanding of the forces that currently drive the pricing of therapeutics and the factors considered by potential investors who can fund expensive clinical development programs is helpful for framing a discussion about the pharmacoeconomics of BBB delivery. Complex multimodal delivery technologies may have added challenges for demonstrating safety and significantly higher drug manufacturing costs that can influence the risk–benefit analysis made by potential investors. Both the therapeutic application and the delivery system influence the path to generating commercial or government interest in advancing a particular brain delivery approach toward the clinic.

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Abbreviations

BBB:

Blood–brain barrier

CNS:

Central nervous system

GMP:

Good manufacturing practice

NIH:

National Institute of Health

QALY:

Auality-adjusted life year

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Authors and Affiliations

  1. Pfizer Pharmatherapeutics Research, 700 Main Street, Cambridge, MA, 02139, USA

    David Gray

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  1. David Gray
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Correspondence to David Gray .

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Editors and Affiliations

  1. Pharmaceutical Biosciences, Uppsala University Pharmacokinetics and Drug Therapy, Uppsala, Sweden

    Margareta Hammarlund-Udenaes

  2. LACDR/Pharmacology, Leiden University, Leiden, The Netherlands

    Elizabeth C.M. de Lange

  3. Pharmaceutical Sciences Division, University of Wisconsin-Madison School of Pharmacy, Madison, Wisconsin, USA

    Robert G. Thorne

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© 2014 American Association of Pharmaceutical Scientists

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Gray, D. (2014). Pharmacoeconomic Considerations in CNS Drug Development. In: Hammarlund-Udenaes, M., de Lange, E., Thorne, R. (eds) Drug Delivery to the Brain. AAPS Advances in the Pharmaceutical Sciences Series, vol 10. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-9105-7_13

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