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Literature DB >> 33714373

Gene therapy companies have an ethical obligation to develop expanded access policies.

Lisa Kearns¹, Carolyn Riley Chapman², Kenneth I Moch³, Arthur L Caplan², Tom Watson⁴, Andrew McFadyen⁵, Pat Furlong⁶, Alison Bateman-House².

Abstract

Entities: Chemical

Mesh：

Year: 2021 PMID： 33714373 PMCID： PMC8058481 DOI： 10.1016/j.ymthe.2021.03.008

Source DB: PubMed Journal: Mol Ther ISSN： 1525-0016 Impact factor: 11.454

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5 in total

1. Practical, legal, and ethical issues in expanded access to investigational drugs.

Authors: Jonathan J Darrow; Ameet Sarpatwari; Jerry Avorn; Aaron S Kesselheim
Journal: N Engl J Med Date: 2015-01-15 Impact factor: 91.245

2. What compassionate use means for gene therapies.

Authors: Carolyn Riley Chapman; Kenneth I Moch; Andrew McFadyen; Lisa Kearns; Tom Watson; Pat Furlong; Alison Bateman-House
Journal: Nat Biotechnol Date: 2019-04 Impact factor: 54.908

Review 3. Emerging Issues in AAV-Mediated In Vivo Gene Therapy.

Authors: Pasqualina Colella; Giuseppe Ronzitti; Federico Mingozzi
Journal: Mol Ther Methods Clin Dev Date: 2017-12-01 Impact factor: 6.698

Review 4. Early access programs: Benefits, challenges, and key considerations for successful implementation.

Authors: Sanjaykumar Patil
Journal: Perspect Clin Res Date: 2016 Jan-Mar

5. Expanded Access as a source of real-world data: An overview of FDA and EMA approvals.

Authors: Tobias B Polak; Joost van Rosmalen; Carin A Uyl-de Groot
Journal: Br J Clin Pharmacol Date: 2020-04-07 Impact factor: 4.335

5 in total

3 in total

Gene therapy companies have an ethical obligation to develop expanded access policies.

1. Practical, legal, and ethical issues in expanded access to investigational drugs.

2. What compassionate use means for gene therapies.

Review 3. Emerging Issues in AAV-Mediated In Vivo Gene Therapy.

Review 4. Early access programs: Benefits, challenges, and key considerations for successful implementation.

5. Expanded Access as a source of real-world data: An overview of FDA and EMA approvals.

1. Generating Evidence from Expanded Access Use of Rare Disease Medicines: Challenges and Recommendations.

2. Inadequate reporting quality of registered genome editing trials: an observational study.

3. Financial considerations in expanded access policy for gene therapies: A tough nut to crack?