Login Register Cart 0
Generic placeholder image

Applied Drug Research, Clinical Trials and Regulatory Affairs

Editor-in-Chief

ISSN (Print): 2667-3371
ISSN (Online): 2667-338X

Back
Journal Home About Journal Editorial Board Current Issue Volumes/Issues
Subscribe
Mini-Review Article

Regulatory Aspects of Personalised Medicines

Author(s): Ishita Dhingra, Neel Mani and Arti R. Thakkar*

Volume 8, Issue 2, 2021

Published on: 23 February, 2021

Article ID: e301221191760 Pages: 7

DOI: 10.2174/2213476X07666210224094803

Price: $65

Abstract

The advent of big data analysis, genetic engineering and epigenetics has transformed the healthcare system by shifting the strategy for diagnosis, prevention and treatment of diseases from “one-size-fits-all” approach to “personalised” approach. Identification of biomarkers from molecular diagnosis has made tailoring of the medical treatment possible. Optimization of treatment decreases the costs related to the ineffective treatments and helps in avoiding possible side effects and adverse drug reactions. The efficient development of personalised medicine is largely dependent on the tools, sequencing techniques used and regulatory policies related to the personalised medicine products, tests and companion diagnostics. The uncertainties in the regulations governing personalised medicine should be eliminated and specific guidelines should be laid down by the respective regulatory authorities to bridge the emerging tools and technologies with the regulatory policies. Also, proper regulatory approval pathways for companion diagnostics will resolve the complications of organized development of therapeutic products and diagnostic tests.

Keywords: Personalised medicine, biomarkers, companion diagnostics, personalised medicine tests, regulatory policy, genetic engineering

Graphical Abstract

[1]
Personalized Medicine Coalition (PMC), The Age of Personalized Medicine. Available from: http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/pmc_age_of_pmc_factsheet.pdf [Accessed on: February 12, 2020].
[2]
U.S. Food and Drug Administration, Precision Medicine. Available from: https://www.fda.gov/medical-devices/vitro-diagnostics/precision-medicine [Accessed on: February 12, 2020].
[3]
Precision Medicine, Glimpses of the future from BOHEMIA study, European Commission. Available from: https://ec.europa.eu/info/sites/info/files/precision-medicine-targeted-scenario-14_2018_en.pdf [Accessed on: February 12, 2020].
[4]
Personalised Medicine Coalition (PMC), Mission. Available from: http://www.personalizedmedicinecoalition.org/ [Accessed on: February 13, 2020].
[5]
Personalised Medicine Coalition (PMC), The Basics. Available from: http://www.personalizedmedicinecoalition.org/Education/The_Basics [Accessed on: February 13, 2020].
[6]
Personalized Medicine Coalition (PMC), The Case for Personalized Medicine, 4th edition 2014. Available from: http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/pmc_the_case_for_personalized_medicine.pdf [Accessed on: February 13, 2020].
[7]
Personalized Medicine Coalition (PMC), Personalized Medicine at FDA, The Scope and Significance of Progress in 2019. Available from: http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/PM_at_FDA_The_Scope_and_Significance_of_Progress_in_2019.pdf [Accessed on: March 1, 2020].
[8]
Vaughan A, Yang IA. CRISPR-Cas9 technology: A new direction for personalized medicine in respiratory disease? Respirology 2019; 24(7): 614-5.
[http://dx.doi.org/10.1111/resp.13570] [PMID: 31033105]
[9]
Bock C. New Tools for Personalized Medicine, ICPerMed-First Research Workshop, Milano 2017. Available from: https://www.icpermed.eu/media/content/Tools%20for%20Personalized%20Medicine%20-%2026%20June%202017%20-%20Work%20Group%205%20Reporting%20Slides.pdf
[10]
Tebani A, Afonso C, Marret S, Bekri S. Omics-based strategies in precision medicine: toward a paradigm shift in inborn errors of metabolism investigations. Int J Mol Sci 2016; 17(9): 1555.
[http://dx.doi.org/10.3390/ijms17091555] [PMID: 27649151]
[11]
Meier L, Van De Geer S, Bühlmann P. The group lasso for logistic regression. J R Stat Soc B 2008; 70(1): 53-71.
[http://dx.doi.org/10.1111/j.1467-9868.2007.00627.x]
[12]
Regulation (EU) 2016/679 of the European Parliament and of the Council 2016. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32016R0679 [Accessed on: March 11, 2020].
[13]
LeCun Y, Bengio Y, Hinton G. Deep learning. Nature 2015; 521(7553): 436-44.
[http://dx.doi.org/10.1038/nature14539] [PMID: 26017442]
[14]
Vogenberg FR, Isaacson Barash C, Pursel M. Personalized medicine: part 1: evolution and development into theranostics. P&T 2010; 35(10): 560-76.
[PMID: 21037908]
[15]
Ćurčin V, Ghanem M, Guo Y, et al. In: Discovery net: towards a grid of knowledge discovery. Proceedings of the 8th ACM SIGKDD international conference on Knowledge discovery and data mining; 2002 July 23-26; Edmonton, Alberta, Canada. 2002; pp. 658-63.
[16]
Lee KY, Chung N, Hwang S. Application of an artificial neural network (ANN) model for predicting mosquito abundances in urban areas. Ecol Inform 2016; 36: 172-80.
[http://dx.doi.org/10.1016/j.ecoinf.2015.08.011]
[17]
Cirillo D, Valencia A. Big data analytics for personalized medicine. Curr Opin Biotechnol 2019; 58: 161-7.
[http://dx.doi.org/10.1016/j.copbio.2019.03.004] [PMID: 30965188]
[18]
Chadha K, Goswami K, Bhatia R, Jaggi P, Thakkar A. A review of in-vitro diagnostic kits and their regulation in the indian market. Appl Clin Res Clin Trials Regul Aff 2020; 7: 1.
[http://dx.doi.org/10.2174/2213476X07999201029212448]
[19]
U.S. Food and Drug Administration (FDA). Use of public human genetic variant databases to support clinical validity for genetic and genomic-based in vitro diagnostics 2018. Available from: https://www.fda.gov/media/99200/download [Accessed on: March 4, 2020].
[20]
US Food and Drug Administration (FDA), Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases 2018. Available from: https://www.fda.gov/media/99208/download [Accessed on: March 4, 2020].
[21]
U.S. Food and Drug Administration (FDA) vitro companion diagnostic devices - Guidance for industry and Food and Drug Administration staff 2014. Available from: https://www.fda.gov/media/81309/download [Accessed on: March 5, 2020].
[22]
Personalized Medicine Coalition (PMC), Paying for Personalized Medicine. Available from: http://www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/paying_for_personalized_medicine.pdf [Accessed on: March 5, 2020].
[23]
U.S. Food and Drug Administration. Paving the Way for Personalized Medicine 2013. Available from: https://www.fdanews.com/ext/resources/files/10/10-28-13-Personalized-Medicine.pdf [Accessed on: March 5, 2020].
[24]
U.S. Food and Drug Administration Asia Health Policy Program working paper-43. Available from: https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-entresto [Accessed on: December 10, 2020].
[25]
Asano H. Personalized and Precision Medicine in Japan. Asia Health Policy Program working paper-43 2017; July; 111-8.
[http://dx.doi.org/10.2139/ssrn.3000604]
[26]
European Commission. Personalized Medicine Available from: https://ec.europa.eu/health/human-use/personalised-medicine_en [Accessed on: March 10, 2020].
[27]
European Commission. Legal framework governing medicinal products for human use in the EU. Available from: https://ec.europa.eu/health/human-use/legal-framework_en [Accessed on: March 10, 2020].
[28]
European Commission, Medical Devices. Available from: https://ec.europa.eu/growth/sectors/medical-devices_en [Accessed on: March 10, 2020].
[29]
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices 2017. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0745-20170505&from=EN [Accessed on: March 11, 2020].
[30]
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices 2017. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02017R0746-20170505&from=EN [Accessed on: March 11, 2020].
[31]
Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials 2014. Available from: https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf [Accessed on: March 11, 2020].
[32]
Nofziger C, Papaluca M, Terzic A, Waldman S, Paulmichl M. Policies to aid the adoption of personalized medicine. Nat Rev Drug Discov 2014; 13(3): 159-60.
[http://dx.doi.org/10.1038/nrd4257] [PMID: 24577385]
[33]
Greenbaum D. Regulation and the fate of personalized medicine. Virtual Mentor 2012; 14(8): 645-52.
[PMID: 23351321]
[34]
Knowles L, Luth W, Bubela T. Paving the road to personalized medicine: recommendations on regulatory, intellectual property and reimbursement challenges. J Law Biosci 2017; 4(3): 453-506.
[http://dx.doi.org/10.1093/jlb/lsx030] [PMID: 29868182]

Rights & Permissions Print Cite
Article Metrics
61
© 2024 Bentham Science Publishers | Privacy Policy