Stem Cell Technology

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Stem cell research is being hailed to answer many unanswered questions in modern medicine. The regenerative ability of stem cells brought a revolution in the world of medicine, in re-formation of many organs like heart, kidney, lungs, etc. But there is a dispute going on this regeneration process as the stem cells used for this process are derived from human embryo cells. The culturing and using of such stem cells is considered as unethical by many.

What are stem cells?

Stem cells are unspecialized cells that have two defining properties: the ability to differentiate into other cells and the ability to self-regeneration. The ability to develop into other cell types is called as totipotency which gives rise to a complete organ from a single cell. There are many types of stem cells depending upon the ability to differentiate into other cell types. There are totipotent stem cells, pluripotent stem cells, oligopotent stem cells, bi-potent stem cells, uni-potent stem cells, etc. The virtuous character of stem cells is self- regeneration; the ability to divide and produce more stem cells.

Role of stem cells in organ generation:

Stem cells have many applications in the medical science. One of the important clinical applications is regeneration of organs. A number of progenitor stem cells been identified which play a major role in organ regeneration. Progenitor cells are formed from the germ layer during the process of embryonic development. Progenitor cells are also known as precursor cells. The available literature says that the progenitor cells are formed as a result of asymmetrical division of the stem cells.

Stem cells are plenty during the developmental stages, but as most of the stem cells have differentiated and multiplied, there number falls in adults. This makes it extremely difficult to isolate stem cells from an adult organism, which is why scientists hope to use embryonic stem cells for therapy because embryonic stem cells are much easier to obtain.

Organ regeneration has long been believed to be through organ-specific and tissue-specific stem cells. Hematopoietic stem cells were believed to replenish blood cells, stem cells of the gut to replace cells of the gut and so on. Recently, using cell lineage tracking, stem cells from one organ have been discovered that divide to form cells of another organ. Hematopoietic stem cells can give rise to liver, brain and kidney cells. This plasticity of adult stem cells has been observed not only under experimental conditions, but also in people who have received bone marrow transplants. Thus it is likely that organ-specific progenitors and hematopoietic stem cells are involved in repair, even for other organ repair.

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Plagiarism in Scientific/Medical Writing

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Plagiarism is nothing but an “act of appropriation of another person’s ideas, processes, results, or words without giving appropriate credit”.
It can be categorized as:
a) Plagiarism of ideas and
b) Plagiarism of text (verbatim).
Plagiarism sabotages one’s abilities, integrity and analytical thinking process. It restricts the plagiarist from learning the intended lessons.

To avoid plagiarism is a difficult task but one only can master it with experience. Even an experienced professional writer fears accidental plagiarism. To avoid plagiarism while writing few basics should be considered, which are:

a) Be original, create a first draft without help and then start referring
b) Cite your work properly, offer due credit to author of your source information
c) Use of information is fine, but don’t copy interpretations
d) Avoid just paraphrasing, this means you are still cheating
e) Use of footnotes, endnotes and parenthetical reference helps to minimize plagiarism.

To be frank, no one expects to be 100% pure, but always put in your best to get the feel of being credible of whatever you have written.

Referencing as a solution:

Referencing is nothing but writing a full description of each source you have cited at the end of your work/article, under the heading References or Bibliography.

Why – the need to cite references?

• Strengthen your work on a factual basis

• Avoid plagiarism charges

• Put forth intenseness of your review of literature

• Offer due credit to consulted/cited authors

• To maintain track of your sources consulted during your research process.

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Role of Institutional Ethics Committee (IEC) in Clinical Trials

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Submitted by: Ms. Kalpana Peyyeti, BAMS, PGDCR – JLI Global Clinical Research Academy, Lakdi-ka-pul, Hyderabad

As per the WHO definition, a clinical trial is any research study that prospectively assigns human participants to one or more health related interventions to evaluate the effects on health outcome.

Ethics are concerned with the distinction between Right and Wrong, with moral choices, duties and obligations.

The four main principles of Biomedical Ethics are:

1. AUTONOMY.
2. NON-MALEFICENCE.
3. BENEFICENCE.
4. JUSTICE.

Institutional Ethics Committee (IEC) is the committee formed of a group of people who go through the research protocol / proposal and state whether or not it is ethically acceptable.
Looking into the history, ethics in medical practice were addressed in Charaka Samhita in 1600 BC which mentions the code of ethical conduct and also by Hippocrates in 600 AD. In first half of 20th century many medicines, vaccines were developed, based on trials on captive groups and prisoners without their consent with no concern for their health & welfare. Several unfortunate things occurred throughout the world like Nazi War Crimes during World War II where studies were done on prisoners at Nazi Concentration camps. After that in 1946 all Nazi doctors were trialed before international tribunal and also mishaps like the Tuskegee Syphilis Experiment 1932-1972 by U.S. Public Health Service where 399 African-American men in Alabama were experimented for Syphilis necessitated the need for and numerous codes of ethics which were:

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Misconceptions in HIV Vaccine Clinical Trials

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Vaccine clinical trials are long-term studies aimed at assessing the safety, efficacy and immunogenicity of a new vaccine product. Sometimes trials also assess how well the product meshes with existing healthcare delivery systems, such as national immunization programs.

The clinical trials that are conducted to prevent the transmission of Human Immunodeficiency Virus come under Vaccine Clinical Trials. These trials can benefit humans by reducing an HIV-negative individual’s risk of acquiring HIV; reducing an HIV-positive individual’s risk of transmitting HIV; and reducing HIV viral load in a person who received the intervention when he or she was HIV-negative, and later became HIV-positive through sexual or other exposure. But there are lot of misconceptions about HIV vaccine clinical trials since most people believe that participating in such trials increases the probability of HIV transmission.

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Role of Physicians in Clinical Research

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To define, ‘Clinical research involves the study of human beings in a systematic investigation of human biology, health, or illness, designed to develop or contribute to generalizable knowledge’. Clinical research includes a set of activities that are meant to test a hypothesis, formed on particular treatments/diagnostics/medical devices and so on. The conclusions drawn from such research, thereby contribute to generalizable knowledge which will be used to improve medical care or the public health and thus serve the common or collective good. Still, it has been a daunting question for physicians to understand, if there is any specialized role for them to play in such horizons? And to answer it correctly, yes, it is benefiting for a physician to update themselves with this innovative stream of healthcare R & D.

A physician can participate as an investigator in clinical trials, who can enroll his patients of clinical practice into clinical trials and help to diagnose, prevent, treat, or care for an illness or condition in a particular individual or a group of individuals with the goal of meeting the needs of and benefiting that individual(s). This has been the goal of physician’s all throughout. Once aware of research and its scope, a physician can tailor make his requirement and conduct realistic studies by himself. As for example an assessment of response to particular group of antibiotics in a particular age group can be conducted by the physician on his/her own. This certainly helps him/her in understanding and revising the modes of practice.

Clinical Research in recent era has been established as an industry of its own. With ever growing needs of health sector, Pharma industry invests billions in innovative research. A physician who better understands patients and pharmacological aspects of treatments are benefiting for the clinical research industry to host multiple positions. As a physician, one can hold positions such a medical monitor, clinical administrator, medical advisor and so on. In fact, through participation in good clinical research, a physician can upgrade themselves and achieve new heights. Physicians with good people management skills do especially well in the industry and eventually settle in senior management positions.

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Trends Of The Indian Pharmaceutical Regulatory System

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India is the 4th largest generic pharmaceutical market in the world and is consistently growing. Indian pharmaceutical products are exported to more than 200 countries around the globe including highly regulated markets of USA, Europe, Japan, Africa and Australia. Significant growth was witnessed in various therapeutic segments. Ranking 4th in terms of volume and 13th in terms of value in global pharmaceutical markets, the industry is growing at a fast pace and attracting attention and investments from some major global pharmaceutical companies.

Proper regulatory system ensures the quality, safety and efficacy, and standard of medicinal product for sales, importing, and manufacturing. India’s pharmaceutical industry is one of the most highly regulated industries in the country. Understanding the regulatory scenario is extremely crucial due to the rapid and ongoing changes and due to the burden on the regulatory bodies to ensure a healthy supply of quality drugs at affordable prices to the Indian masses.

REGULATORY ENVIRONMENT

The principal regulatory body involved in the approval of manufacture, drug development and marketing of quality drugs in India is The Central Drug Standards and Control Organization (CDSCO) under Ministry of Health and Family Welfare which works on developing standards and measures for ensuring the safety, efficacy and quality of drugs, cosmetics, diagnostics and devices in the country. It regulates the market authorization of new drugs and clinical trials standards; supervises drug imports and approves licenses to manufacture the products.

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Business Development at Clinical Trial Sites

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Business development from a clinical trial site perspective is increasing the probability of securing research studies needed by it to keep it in business. The process of acquiring a research study and securing the study is known as “Business Development”. In clinical research industry, all clinical trial personnel can contribute to this process. An active business development process increases the odds of finding the right studies.

Finding a research study for site is different from finding an appropriate research study for the site. There are many criteria involved in selecting an appropriate study for a site to conduct. An investigational clinical trial site may receive many feasibility requests from different clients like direct sponsors, Contract Research Organizations, etc., but not all lead to the selection of their site for the study. This is because of many reasons which include the following:

  • The investigational sites may not have the appropriate facilities required for a study conduct.
  • The investigational sites fail to reach the clients specifications inspite having all the required facilities.
  • Lack of trust worthy relationship between the site and its clients.

Business development can be compared with the process of drug development. Likewise, BD has many stages to generate a few suitable studies for a site. They include the lead generation, quality prospects, make the sale and build the relationship.

The marketing approach to lead generating is like retail marketing. The site, at first has to show the capability of their site in conducting a study through feasibility questionnaires. In general all the CROs and sponsor companies maintain a feasibility database of potential sites and update it regularly. When a new research is proposed, then the feasibility questionnaires would be sent to the appropriate sites in the database. If the site has any updated information to the one existing in the database, those should be highlighted in the feasibilities for updating in the CRO database.

The process of screening and converting a possible client (lead) into a likely client is called lead conversion. During the site’s response for a site feasibility questionnaire, contact information should be clearly mentioned for further communication and the communication should be with single person who is directly involved in the clinical trial conduct possibly with the site trial manager.

Once the feasibility questionnaire meets the sponsor/CRO specifications, next step is the site selection visit. The clinical trial monitor or clinical research associate meets the site personnel and checks with the required facilities for the trial conduct and confirms the site for the trial conduct.

Good performance generates repeat business from long term clients. It is much easier to secure new studies from satisfied clients. It is therefore essential to take on only suitable studies and then conduct them successfully.

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What is Nanotechnology? An Introduction:

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Nanotechnology is defined as the engineering of functional systems at the molecular scale. In lay terms, nanotechnology is the molecular level processing and development of devices to carryout biological functions in a simpler way. In medicine, nanotechnology is being used in the drug development process and research that involves the use of manufactured nano-robots to make repairs at the cellular level (Nano-medicine).

Nano-medicine has incredible potential for revolutionizing the therapeutics and diagnostics under the premise of developing ingenious nanodevices. Drug delivery nanosystems constitute a significant portion of nanomedicine. In nano drug delivery systems, the efficiency and availability of the drug are not based on the size of the nanoparticle. The drug delivery systems range from nano sized particles to micro particles in the range of 100 μm. Both nano- and micro scale systems have been extremely important in developing various clinically useful drug delivery systems.

Drug delivery system is one of the major areas where nanotechnology has been used to target a drug to the specific cells, tissues or organs. These nanoparticles are engineered in such a way that the drug is incorporated and they are targeted to the specific types of cells (such as cancer cells). This technique reduces damage to healthy cells in the body and allows for earlier detection of the disease. For example, nanoparticles that deliver chemotherapy drugs directly to cancer cells are under development. Tests are in progress for targeted delivery of chemotherapy drugs and their final approval for their use with cancer patients is pending.

Nanoparticles are used as drug reservoirs in targeted drug delivery systems. They are attached with ethylene glycol which prevents the white blood cells from recognizing the nanoparticles as foreign bodies after releasing them into the human body and assists nano particles in targeting the tumour tissues. This is at research level and the scientists are in continuous development of more effective methods to target nanoparticles that carry the therapeutic agent directly to the diseased cells.

The current drug delivery systems are useful to deliver a certain amount of drug that is therapeutically effective over an extended period of time. There is need to develop delivery systems that deliver the complete drug to show the therapeutic effect that increases the bioavailability of the drug. Such requirements can be met by the micro scale drug delivery systems manufactured by nanotechnology. In addition, little attention has been paid to the fact that the systems have to be introduced into the human body, requiring approval from the Food and Drug Administration (FDA).

Nanotechnology has many applications in therapy techniques, Diagnostic and Imaging techniques, anti-microbial techniques, cell repair using manufactured nano-robots, etc.

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