Innovation and competition in advanced therapy medicinal products

Author:

Seoane‐Vazquez Enrique1ORCID,Shukla Vaishali1,Rodriguez‐Monguio Rosa2

Affiliation:

1. Chapman University School of Pharmacy Irvine CA USA

2. Director of the Medication Outcomes Center School of Pharmacy University of California San Francisco CA USA

Publisher

EMBO

Subject

Molecular Medicine

Reference10 articles.

1. Bioequivalence: The Regulatory Career of a Pharmaceutical Concept

2. Cells as advanced therapeutics: State-of-the-art, challenges, and opportunities in large scale biomanufacturing of high-quality cells for adoptive immunotherapies

3. Food and Drug Administration (FDA)(2013)Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development. Available at:https://www.fdanews.com/ext/resources/files/10/10-28-13-Personalized-Medicine.pdf. Accessed January 15 2019.

4. Regulatory considerations for gene therapy products in the US, EU, and Japan;Halioua‐Haubold CL;Yale J Biol Med,2017

5. IQVIA Institute for Human Data Science(2017)Medicines Use and Spending in the US. Available at:https://www.iqvia.com/institute/reports/medicine-use-and-spending-in-the-us-review-of-2017-outlook-to-2022. Accessed: January 15 2019.

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