Question

If you are a Director R&D Clinical Studies

Please answer the following questions No Plagiarism please

Try to use approximately 100 words each question

Please type

4.       What were the challenges in your past and present company?

5.       Can you describe the drug development process?

6.       What step is more promising/ challenging during drug development?

7.       Which step has more ethical issues and how have you overcome them?

8.       What do you suggest to people who want to pursue a career in clinical trials?

9.       How do we approach/ what aspect do we need to consider at the first step?

10.   What is the most difficult part of drug development?

11.   What step in the drug development is most costly?

Answer 1

If you are a Director R&D Clinical Studies

Please answer the following questions No Plagiarism please

Try to use approximately 100 words each question

Please type

4.What were the challenges in your past and present company?

Approvals by the government

Obtaining governmental approvals is the most often named hindrance in initiating the trial. Regulations often set difficulties in the implementation of the trial, but they provide safety and efficacy.

Site Selection

This is a multiple facet issue, because it not only includes the search of suitable site for the trial, but it might also expand beside the national level and reach the international market. It also features important points like management of the selected sites, poor quality of the work at the sites, data entry issues and not meeting the deadlines.

Clinical trial management

The clinical trial management of the project is ineffective, when the PM has not been supplied with the appropriate tools. These include specific software systems (like CTMS), that will make their planning more systematic and will line out, which criteria and steps of the project are met, and which need to be further finished out. The limited availability of tools for planning and documentation of the visits is also a major disadvantage, especially when investigators require specific number after every report period.

Management of performance

Vital for the clinical trial management is the transparency over the project and its performance. The factor here include: the importance of the current status in the course of the project, the cost control at any given time, project risks, adverse events or factors, not enough study participants at given location, and eventually exceeding the budgeted costs.

Time management

Time management is among the greatest challenges of the Clinical Research Organizations (CRO). The complexity it is multiplied by the number of multinational studies, project with hundreds of sites, and lack of synchronicity.

Data management

Reporting, management of data and documents is beyond disputes complex. However, it applies only to large and sophisticated studies. Its intricacy lies in the various data formats and document types that are used in one study. Different regulation requirements regarding the data are often hard to meet and comply with.

5. Can you describe the drug development process?

Across the drug industry there are several mandated processes that must be undergone before the final sale of a drug can begin on the market. There is five important step is there for drug development.

Discovery and Development

Each drug begins with discovery and development in a lab. Pharma companies spend millions of dollars on research and development that includes scientific study and development of drugs for new innovation. Funding can come from several areas including government, grants, and revenues

Preclinical Research

Once a drug discovery has been made it must go through both preclinical and clinical research with supporting reports tied to its review process. Preclinical research is a basic preliminary phase that involves testing the drug on animals and basic testing for safety flags. There is three phase in Preclinical research.

· Phase I: Determining the drug safety in humans

· Phase II: Determining an optimal dose

· Phase III: Determining statistically significant benefit of the drug therapy

Clinical Research

Clinical research can be one of the most important steps in a drug’s development. If a drug is cleared from preclinical trials, it moves on to clinical testing which involves human trials. Drug companies and the FDA have specific standards for clinical trials which include the professionals involved in the scientific testing, the selection criteria of the humans being tested, the setting in which the clinical tests take place, and more. Clinical trial registration is also required and heavily followed by pharma professionals across the sector.

FDA Review

The Food and Drug Administration is one of the primary regulators involved in all aspects of the drug market. The high standards for drug approval in the U.S. often lead drug development testing in the first three phases to last for approximately 10 to 15 years before approval. In phase four, companies submit fully documented research and findings to the FDA for review. If a submission is accepted, the FDA will provide a response within six to 10 months.

FDA Post-Market Safety Monitoring

There are several aspects of post-approval safety monitoring for a marketed drug. The FDA monitors all types of drug advertising for accuracy. It also monitors complaints and problems associated with a drug. As such it has the power to limit drug sales and/or offer warnings. In general, the FDA also does routine manufacturing inspections. Furthermore, the FDA is involved in the patent protections and generic drug transitions of all drugs.

6. What step is more promising/ challenging during drug development?

The most challenging step in the drug development process, is preclinical research. The translation of cellular or animal models to healthy human subjects and then to patients. Researchers cannot go directly into the patient population without knowing whether the biology of the animal models applies to healthy humans. The drug development process is exploratory; it is an iterative process of testing specific mechanistic hypotheses across cellular and animal studies, healthy human subjects, and clinical trials.

The experimental medicine approach, involves the ability to evaluate the effects of a putative therapeutic agent in humans and examine outcomes at various levels (e.g., behaviour, cortical activity, and brain imaging). The goal is to produce therapeutic change in a path physiologic process, quickly, and in a laboratory setting. This approach uses drugs as clinical probes in order to identify or verify a target and/or study mechanisms of disease, this approach examines the ability of a drug to act on a pathological target and affect a biological endpoint as measured by a biomarker.

7. Which step has more ethical issues and how have you overcome them?

Nowadays clinical research step has facing more ethical issues, the code of conduct to be followed by researchers and the other stakeholders in clinical research to uphold this basic commitment to safeguard the rights and safety of the research participants who play a central role in research without whom-either themselves, their data, or their biological samples-no research is possible. However, reviewing and constant monitoring of the research activities to ensure adherence to the principles laid down in these guidelines or policies or legislations are the main concerns of the Ethics Review Committees (ERC/EC), whether institutional or independent, which are entrusted with the responsibility of protecting the rights and safety of the research participants. There is a need for wider dissemination of these principles to all stakeholders of clinical research including the public at large and the participants in addition to the researchers, sponsors, institutions, members of ethics committees, regulators, and the policy makers, so that the rights of the research participants and the responsibilities of those involved in research are well understood by all concerned. This will lead to constant updating of guidelines, developing new guidelines, proposing new policies, and enacting appropriate regulations, so that the human research participants and the community rest assured that they are well protected while participating in any research.

8. What do you suggest to people who want to pursue a career in clinical trials?

Clinical research can make all the difference when it comes to saving peoples’ lives, or improving their quality of life. Not only do clinical trials trial new drugs and medicines for general use by the population, they also tackle diseases that were previously thought incurable. Even if the work you do might not result in an immediate breakthrough, it will be put in a database where other scientists can study your research and work towards making their own. A perfect example of this is the development of gene therapies which created quite a stir in the pharmaceutical industry in the 1990s. The efforts of clinical researches spanned three decades before the first gene therapy was approved and now we've seen treatments that can stave off blindness and improve the quality of life for people suffering from deadly muscle-wasting diseases.

If you choose to pursue a career in clinical research you can be sure that you'll make a difference in people’s lives, whether through curing patients in new ways, or working to combat increasingly-prevalent issues like antibiotic resistance, especially given that no new antibiotics have been discovered in over thirty years.

9. How do we approach/ what aspect do we need to consider at the first step?

Discovery often begins with target identification – choosing a biochemical mechanism involved in a disease condition. Drug candidates, discovered in academic and pharmaceutical/biotech research labs, are tested for their interaction with the drug target. Up to 5,000 to 10,000 molecules for each potential drug candidate are subjected to a rigorous screening process which can include functional genomics and/or proteomics as well as other screening methods. Once scientists confirm interaction with the drug target, they typically validate that target by checking for activity versus the disease condition for which the drug is being developed. After careful review, one or more lead compounds are chosen.

10.What is the most difficult part of drug development?

Preclinical research; essentially this includes animal testing on model organisms such as laboratory mice. Approximately 5% of new drugs pass preclinical trials. Passing this step means that the human-like animal model expresses the human disease, has been treated with the new drug, and has shown relatively insignificant side effects.

At this point in the development process, the new drug can finally move to clinical trials. These include:

· Phase I: Determining the drug safety in humans

· Phase II: Determining an optimal dose

· Phase III: Determining statistically significant benefit of the drug therapy

Not only is Phase III the most difficult step to successfully pass, it is also the least likely to be reached, and the most expensive of the three—a whopping 8% of new drugs reach this Phase, and an estimated $86 million is needed to see the Phase to completion. Timewise? A new drug is looking at at least 1.5 years in Phases I and II, with Phase III stretching to about 3 years by itself.

11.What step in the drug development is most costly?

40% of the costs of drug development comes from the Phase III trial. When look at a specific drug, that percentage balloons up to 90%.

The preclinical data also include animal testing, development, and lead optimization. Once you get down to it, drug discovery costs very little in the grand scheme of drug development.

The reason why everyone talks so much about drug discovery is because the difference between a 1 in 1000 shot chance of finding a drug and a 1 in 10,000 shot chance is worth several billion dollars since a good lead compound from a good assay will avoid a costly failure.