Pregled predpisov za zdravljenje s celicami CAR-T in bakteriofagi

diplomsko delo

Sašo Brudar (Author), Aleš Podgornik (Mentor)

Abstract

CAR-T celična in bakteriofagna terapija spadata pod kategorijo personalizirane medicine. Na trgu so terapije personalizirane medicine nove in redke. Želja vseh udeležencev pri izvajanju in postavljanju terapij je uspešno zdravljenje pacienta. Uspešno zdravljenje pa dosežemo, če je terapija izvedena varno, kakovostno in učinkovito. Postavitev uporabnih predpisov, ki terapiji zagotavljajo doseg teh lastnosti, so zato ključnega pomena za izvajanje tovrstnih terapij. Problem, ki se poraja je kako oblikovati predpise, za terapije, ki niso enake tradicionalnim zdravilom in način zdravljenja. Pravni organi so terapije morali predpisati v določeno kategorijo predpisov. Predpisi morajo biti izpolnjeni, da je terapija lahko sploh odobrena za dajanje na trg in administracijo. Obe personalizirani terapiji sta podvrženi predpisom, ki se uporabljajo pri tradicionalnih zdravilih oz. zdravilih, ki niso personalizirane narave. Zaradi neuporabnih predpisov, se investitorji ne odločajo za investiranje v tovrstne terapije. Zato so tudi cene terapij visoke in posledično terapije niso dostopne širši javnosti. Nekatere države, katerim je interes izvajanje personaliziranih terapij so zaobšle podane predpise. Te so spremenili, postavili svoje ali pa se posluževali izjemnih primerov za izvajanje terapij. V prihodnje bo ob porastu personaliziranega zdravljenja morda potrebno postaviti predpise prav za to kategorijo medicine. Določene stopnje zdravljenja bi lahko poenotili, vendar bo za pravilno izvajanje posameznih terapij potrebno še dodati specifične predpise.

Keywords

biotehnologija;predpisi;CAR-T celice;bakteriofag;personalizirana medicina;

Data

Language:	Slovenian
Year of publishing:	2022
Typology:	2.11 - Undergraduate Thesis
Organization:	UL BF - Biotechnical Faculty
Publisher:	[S. Brudar]
UDC:	606:61:602.3:578.347:615.032(043.2)
COBISS:	125130755
Views:	49
Downloads:	6
Average score:	0 (0 votes)
Metadata:

Other data

Secondary language:	English
Secondary title:	Overview of regulations for CAR-T cell and bacteriophagic treatment
Secondary abstract:	CAR-T cell therapy and bacteriophage therapy fall under the category of personalised medicine. Personalised medicine therapies are new and rare on the market. The desire of all involved in the implementation and setting up of therapies is to treat the patient successfully. Successful treatment is achieved if the therapy is delivered safely, well and effectively. Setting useful regulations to ensure that therapies achieve these characteristics is therefore crucial for the implementation of such therapies. The problem that arises is how to design regulations, for therapies that are not the same as traditional medicines and treatments. The legal authorities had to prescribe the therapies in a specific category of regulations. These regulations must be met for the therapy to be approved for marketing and administration. Both personalised therapies are subject to the regulations that apply to traditional medicines or medicines that are not personalised. Because of the inapplicable regulations, investors are reluctant to invest in such therapies. This is why the prices of the therapies are high and why they are not accessible to the general public. Some countries with an interest in implementing personalised therapies have circumvented the rules. They have modified them, set up their own, or used exceptional examples to carry out therapies. In the future, with the rise of personalised medicine, it may be necessary to set regulations for this category of medicine. Certain treatment levels could be standardised, but specific regulations will need to be added to ensure the correct implementation of individual therapies.
Secondary keywords:	biotechnology;regulations;CAR-T cels;bacteriophage;personalized medicine;
Type (COBISS):	Bachelor thesis/paper
Study programme:	0
Embargo end date (OpenAIRE):	1970-01-01
Thesis comment:	Univ. v Ljubljani, Biotehniška fak., Študij biotehnologije
Pages:	1 spletni vir (1 datoteka PDF (VI, 18 f.))
ID:	16354563