Even though we belongto the same specie we are not designed in the same manner when it comes togenetic level. the 3 billion base pairs present in us are responsible for20,000-25,000 protein coding genes. And as a result of this we need to groupthe population based upon some similarities and dissimilarities.
In order for apersonalized medicine to work on a selected group of population or individualwe have to first know if this is the right drug for the right person. And to dothat we need a reliable diagnostic test which gives a low number of falsepositive or false negative results. since a diagnostic test is the very firstapproach in determining if an individual has a problem or not. it needs to beconstantly updated and monitored. This job is being done by the FDA’s medicaldevice authority. They check thevalues of the devices based on · Analyticalvalidity:- specific test is suitable for its intended use· clinicalvalidity :- to check if the patient truly has the documented condition · clinicalutility:- usefulness of the test in improving the patients outcome The diagnostic testsused in personalized medicine are mostly IVD’swhich checks if theindividual has altered biomarkers. and the presence/absence of geneticsusceptibility biomarkers. IVD’S are marketed into IVD kits developed by aconventional device manufacturer and sold to labs, hospitals and physiciansoffices and LDTs are those that are designed, manufactured, and used by asingle laboratory.
However the FDA has control over the regulation of the LDT’Sso that they give accurate measurement values even when made by differentmanufacturers. The product interdependency plays a vital role in personalizedmedicine making sure the therapeutic intervention and the therapeutic product are beneficial to the user and not harm them.In cases where a test is essential for the safe and effective use of acorresponding therapeutic product, it is termed a “companion diagnostic.” companion diagnosticsare useful in when new medicine or new diagnostic devices are made usuallythese 2 are made by different organizations such things are termed asco-development. Development of companion diagnosticstogether with therapeutics should allow for more efficient studies with smallerpatient populations while also leading to more focused therapies that offerbetter outcomes, less toxicity, and fewer treatment delays. Clinical trials take place before a drugis being marketed to the targeted population.
These trails are in accordancewith the FDA’s “Enrichment Strategies for Clinical Trials” which is a draftintroduced in 2012 to choose the right people for the clinical trials so therewon’t be any bias. development.co-developments are regulated by Shepard programs by the FDA so that they stayin constant communication with the sponsors for tailoring to the needs of thepeople.Through suchstrategies Vemurafenib is a drug for treating latestage melanoma which was approved by FDA in near record time (3.6 months)through this process as a result the outcome for the prognosis for this diseasewas better.After the medicine is made it is labeledscientifically so that the prescribing physician can give the dosage dependingon the factors such as age region and race.
And drug is constantly updatedwhenever any new changes are made listing out the side effects and thecontraindications of the drugs. In order to prevent any mishap for theconsumers. Whenever the drug is updated after a newstudy the labeling is also updated so that it can carter to the needs of thepeople.Pharmacogenomics information can appear indifferent sections of the labeling Therapeutic Indications, Warnings andPrecautions.A guidance table is made which containsinformation of the time of approval of the drug, the disease which it treatsand the biomarker which Is related to the disease is also given so that thephysician can confirm if the concerned person has the disease before initiatingthe treatment. Apost marketing surveillance is done after the medicine is being released intothe market this collects the long-term data of the effects of the medication ondifferent population living in different sub continents and all the data isbeing collected and sent to the FDA.
This data includes the electronic data ofthe patient and what they were afflicted with before and after treatment. Thisis one in case if the marketed drug causes some adverse effects in the longrun. Even though clinical trials and studies are conducted before approving themedication by the FDA. These trails have been only undergone in a small groupof people in each phase when compared the huge population to whom thismedication is marketed to. So, the FDA has developed a sentinelsystem via FDA’s Mini-Sentinel pilot program, a large-scale working model ofthe eventual full-scale System. The Mini-Sentinel System provides secureaccess to the electronic health care information of more than 125 millionpatients, provided by 17 data partners nationwide.
The objective of FDA for medicinal Equipmentpost- advertise observation isthe production of a national system that serves four primary functions: 1) Communicates timely, accurate,systematic, and prioritized assessments of the benefits and risks of medicaldevices throughout their marketed life using high quality, standardized,structured, electronic health-related data2) Identifies potential safety signals innear real-time from a variety of privacy protected data sources 3) Reduces the burdens and costs ofmedical device post-market surveillance4) Facilitates the clearance and approvalof new devices, or new uses of existing devices. CDRHis pursuing four key proposed actions to help fulfill the vision for a NationalSystem: 1) Establish a unique device identifier(UDI) system and promote its incorporation into electronic health information.2) Promote the development of national andinternational device registries for selected products.3) Modernize adverse event reporting andanalysis.4) Create and utilize new techniques forprove age, union, and evaluation.
The patient follow-up registry will helpthe in keeping track of events that take place over the long-time due to actionof medication these things will be noted down and appropriate alterations willbe made to the personalized drug.