module5

docx

School

Seneca College *

*We aren’t endorsed by this school

Course

Subject

Medicine

Date

Apr 3, 2024

Type

docx

Pages

Uploaded by GrandGerbilPerson1086

1) Who is accountable for the strategy and relationship with global Regulatory Agencies? Answer: Within most organisations, the Regulatory Affairs department or a related regulatory role is often responsible for strategy and contacts with international regulatory agencies. Depending on how the company is organised, the person in charge of this department may have a different title, although they are typically an executive-level role such as Chief Regulatory Officer (CRO) or Head of Regulatory Affairs. Depending on the industry and geographic scope of operations, these people are in charge of creating and implementing regulatory strategies to guarantee adherence to rules established by international regulatory agencies like the FDA (Food and Drug Administration), EMA (European Medicines Agency), MHRA (Medicines and Healthcare Products Regulatory Agency), and others. They also supervise communications and uphold connections with these organisations to enable approvals, respond to regulatory queries, and keep up with any changes in laws that might affect the company's goods or services. Frameworks for regulatory governance are becoming fundamental components of global civilization. Global governance frameworks have made their way from supply chains to the policies governing international organisations. These frameworks structure and direct a wide range of social exchanges, including those that are political, economic, legal, and cultural. In light of this, the goal of this special issue is to investigate the social praxis of regulatory governance as well as its complex meaning, potential, and influence. The special issue identifies three broad aspects of regulation and governance under the concepts of rules, resistance, and responsibility. This offers a theoretical and conceptual framework for understanding the phenomenon of regulatory governance. This is coupled with in-depth case studies on various regulatory governance contexts, such as the World Bank and agricultural reforms implemented(Kjaer & Vetterlein,2018).

2) What are the differences among pre-clinical and clinical (Phases 1-4) trials and what are Good Clinical Practices about? Answer: The drug before being approved for use in people, medical interventions such as medications, devices, or therapies must pass pre-clinical and clinical studies (Phases 1-4) to determine their safety and efficacy. Pre-clinical trials: Pre-clinical trials are investigations carried out in labs and on animals prior to the start of human testing(Clara ,2021). Pre-clinical trials are designed to collect preliminary information about the intervention's safety profile, possible efficacy, and mode of action. These studies assist researchers in determining dosages for human trials as well as any possible hazards or toxicities related to the intervention. The underlying evidence needed to get permission to undertake clinical studies on humans must be provided via pre-clinical trials (Clara ,2021). Phases 1-4 of clinical trials: Human volunteers and patients participate in clinical studies to assess the intervention's efficacy and safety.Phase 1: Mainly involves evaluating side effects, dose, and safety in a small number of well volunteers.Phase 2: Assesses safety and efficacy in a wider patient population with the intended

ailment.Phase 3: Entails extensive testing to verify effectiveness, track adverse events, and contrast the intervention with conventional therapies or a placebo.Phase 4: Following regulatory clearance, post-marketing surveillance is conducted to track the product's long-term efficacy and safety in a larger population. Good Clinical Practice (GCP) is an international collection of rules and guidelines that control clinical trial design, execution, performance, monitoring, auditing, documentation, analysis, and reporting. These principles guarantee the safety, well-being, and protection of trial subjects as well as the validity and dependability of clinical trial data (Altomonte,2023). Ethical conduct: Trial subjects' rights, safety, and well-being must be given top priority when conducting trials in line with ethical principles.Consent that has been given voluntarily and after being fully informed of the advantages and hazards, is required of study participants.Data integrity and confidentiality: Subject confidentiality must be upheld, and clinical trial data must be precise, comprehensive, and verifiable.Examiner ensuring that trials are carried out in accordance with GCP principles and relevant regulatory requirements rests with investigators and sponsors. 3) What are some leading reasons clinical trials fail? Answer: Merely one medicine candidate out of ten makes it through regulatory approval and clinical trial testing. Four major causes for this poor success rate was found in a investigation. The lack of clinical efficacy, or the drug's inability to have the desired impact in humans, was determined to be the cause of between of failures. Poor pharmacokinetic characteristics, or how well a drug is absorbed by and eliminated from the body, was also one of the reason. In contrast, uncontrollably high toxicity or side effects . Finally, a lack of economic interest and inadequate strategic planning were blamed for failures (Duxin Sun,2023).

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

Given this high failure rate, it is unclear if other facets of medication development are being neglected. However, it can be difficult to determine for sure if a selected molecular target is the most effective marker to test medications against. However, it's also feasible that the current drug optimisation procedure hasn't produced the most qualified candidates for advancement testing. When drug candidates advance to clinical trials, they must strike a careful balance between administering the medicine in a way that will cause the desired impact on the body and avoiding side effects. It is obvious that a drug's capacity to achieve that balance depends on how well it can identify and operate upon its intended target(Duxin Sun,2023). However, I think this component of drug performance has been overemphasised, as does my study team. Just as crucial is optimising a drug's tissue exposure and selectivity, or its capacity to reach diseased body parts in sufficient amounts while avoiding healthy body parts.For example, it can take years for scientists to figure out how to make drug candidates more potent and selective so that they have an effect on their targets at very low doses. However, this may come at the price of making sure that the proper bodily sections receive an adequate dosage of the medication without endangering healthy tissue. This uneven drug optimisation process, in my opinion and that of my research team, may bias the selection of medication candidates and have an impact on how well they finally do in clinical trials. 4) Find an example of a company that has recently released news that their clinical trial has demonstrated success or failure. Briefly describe the clinical result that has been reported. Based on this clinical trial result, what do you expect the next step for this company to be? (e.g. if they are reporting success in Phase 1 or 2, what will they need to do next? How will they get to this next step? If they are reporting failure in Phase 1, 2, or 3, what do you think might happen next?)

Include a screenshot and a link in your document. Be prepared to talk about your example in class. Answer: https://www.biospace.com/article/csl-heart-attack-hopeful-fails-to-meet-primary-endpoint-in- phase-iii-trial/?s=69 The largest-ever research conducted by Australian pharmaceutical company CSL Behring has failed, since it was found that their cholesterol efflux booster could not lower the risk of heart attacks. The business has been evaluating CSL112, commonly referred to as apolipoprotein A-I, in a research involving roughly 17,400 heart attack victims dispersed throughout 49 nations. In the AEGIS-II study,

the first subject received a dosage in 2018.However, CSL revealed in a release dated February 11 that the trial did not meet its primary goal, which was to demonstrate a decrease in the risk of significant adverse cardiovascular events after 90 days as compared to placebo. The company said, "There are no plans for a near-term regulatory filing as a result." CSL112 is CSL’s novel and proprietary formulation of the plasma-derived protein apolipoprotein A-I, which is the main component of high-density lipoprotein and is an important player in regulating cholesterol levels. The candidate works by boosting the body’s natural capability to remove cholesterol from plaques and carrying them to the liver for detoxification. They plan to apply these capabilities as well as plasma protein platform to future unmet medical need in cardiovascular and metabolic conditions as well as those in our other strategic therapeutic areas. In my view , I think company will carry out the CSL112 process because giving up in the phase 3 trail after failure is difficult for any company as these trails where going on from 2017 , Understanding more about CSL112 functions and the place where it is lagging behind is necessary . References:

Your preview ends here

Eager to read complete document? Join bartleby learn and gain access to the full version

Access to all documents
Unlimited textbook solutions
24/7 expert homework help

Article by Leon Altomonte (2023, December 13). Good clinical practice: An introduction. SafetyCulture. https://safetyculture.com/topics/good-clinical-practice/ Clara(2021, March 3). Clinical trial phases 1, 2, 3 & 4: Find FDA clinical trial phases . Clara Guides. https://guides.clarahealth.com/clinical-trial-phases/ Duxin Sun (2023). Professor of Pharmaceutical Sciences. 90% of drugs fail clinical trials – here’s one way researchers can select better drug candidates. The Conversation. https://theconversation.com/90-of-drugs-fail-clinical-trials-heres-one-way-researchers-can- select-better-drug-candidates-174152 Poul F.Kjaer & Antje Vetterlein(2018). Regulatory governance: Rules, resistance and responsibility. https://www.tandfonline.com/doi/full/10.1080/13569775.2018.1452527

module5

Related Documents