Operating a medical information function to field product queries.

Medical Affairs play an important function which is required for development and commercialization of medicines between patients, healthcare professionals and healthcare industry. Its professionals usually have responsibility for the following general areas include ensuring that their industries comply with all of the regulations and laws, and working with local, state and federal regulatory agencies such as the Food and Drug Administration or European Medicines Agency on specific issues affecting their business. Obtaining a new medicine to market is a unique process based on a number of requirements for supporting a product launch. New antibody drug conjugate treatments are used these days.

Management of Medical Affairs provides the quality clinical data by ensuring the adherence to SOPs and GCP under ICH recommendation guidelines and maintains the ICH-GCP compliance. Generally, Pharmaceutical industries have two types of scientific teams, one of Medical Affairs services and another for research and development. Research and development describes the initial stage of development and scientific method, as well as includes clinical trial runs, while its services provide scientific support for the end stage of development and post marketing. 

A function of its services includes delivering technical backing to internal teams as well as external consumers, and field-based medical information specialists who provide in-depth drug and disease information to health providers. Its services deliver information to ensure that consumer queries are adequately addressed and distribute data to health care providers in the community. Its team also frame plans, review, publications and report of important clinical trial results to the Pharmaceuticals and medical devices agency (PMDA), in scientific meetings or by providing journal articles etc.

Department of research and development of industry, may look to be an issue for someone else to handle in the far-distant future and at a much later time from launching a product into the market but even at laboratory or early development stages, biotechnology industries should understand the language of pharmaceutical industries and know how that industry operates and make early decisions regarding their investigations products that could lead to future success.

Global Allied Pharmaceuticals (GAP) has industry trained specialists in Medical Oncology.  In biotechnology, there is no real equivalent to medical affairs; still it plays an important role in the pharmaceutical industry that highlights its importance both in pre launch and during the launch of new medicine. We provide several services include Product Development & Commercialization, Market Access, Regulatory & Quality and Market Intelligence.

For more information, contact us at www.gapsos.com

Harsh cancer treatments and Immune oncology

Immune oncology also known as immunotherapy is the study of treatment of cancer by using immune system of body to fight against it. It is a type of therapy designed to encourage the body’s natural defense to altercate cancer. Substances which are either produced by body or in laboratory are used to boost, or regain body’s immunity. It is not exactly understood how this therapy works, it may work by accelerating immune system’s effectiveness at removing cancer cells, it may halt them from reaching other body parts, or it reduces the speed of growth of cancer cells.

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This type of treatment seems too good to be true, but is logical and based on simple concept, whereas, treatment like chemotherapy which is widely used to kill this disease but it can only work by hurting the body. To understand immunotherapy better lets discuss monoclonal antibodies which is a type of this therapy.

Monoclonal antibodies

Body’s immune system produces antibodies to fight against antigens which are foreign harmful substances. But cancer develops, because body’s immune system cannot identify the cancer cells as foreign element and does not destroy it. Monoclonal antibodies which are artificial antibodies are given to patients and act like antibodies naturally produced by immune system of patients body. These artificial antibodies given intravenously work by attaching themselves to cancer cells and target specific proteins which support the increase of cancer cells.

Getting attached to these cells they are supposed to accomplish some tasks. As the immune system is unable to detect harmful cancer cells usually and monoclonal antibodies tag them to specific parts of cancer cells which are not present in the healthy cells of a body and help defense system to destroy them.

Cancer cells grow faster than normal cells because they can make copies of the chemical found in the body called growth factor receptors and multiply themselves by sending signals to other cells. But monoclonal antibodies prevent these receptors to multiply the cells and not send more signals.

Also when radioactive molecules are attached to monoclonal antibodies, they directly deliver radiation to cancer cells and hence very low dose of radiation is used and helps healthy cells to remain unaffected which is another benefit of this treatment over chemotherapy which uses very large amount of radiation to kill cancer and kills several healthy cells also.

Although this therapy is new and still has to be worked upon various factors to be recognized and used worldwide, but it is becoming hope for cancer patients which have to undergo painful cancer treatments.

Save your life with early detection of Prostate cancer.

Prostate cancer is a malignant tumor. It initiates in the male genital gland which is situated between the base of the bladder and the penis. Prostate Specific Antigen (PSA) is a protein that is produced by prostate cells and secreted into the blood stream. Its level might be increased in many benign and malignant conditions such as prostate cancer, benign hyperplasia as well as infections or even prostate examination through digital rectal exam (DRE); however, its serum level has been suggested as a tumor marker for both prostate cancer screening and follow up respectively. There are various types of cells which found in the prostate gland, but most of the prostate cancer grows through the gland cells. These cells build the prostate fluid which is added to the semen. There are several options are available in the immune-oncology or immunotherapy to treat this type of cancers. These immune-oncology deliver the immunity to the patient body and also kill the cancerous cells. 

 

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In 2015, American Cancer Society estimates 220,800 new cases and 27,540 deaths due to prostate cancer in the United States. In 2012, it was the third most indentified cancer after breast cancer or colorectal cancer with at 417,000 cases in the Europe. The age-standardized rate of incidence of prostate cancer was 83.8 per 100,000 and mortality rate of 9.7%, respectively and it accounts 13% of all the cancers and it occurs between age of 65 or older. The most common risk factors of prostate cancer are smoking, inflammation of the prostate, vasectomy, workplace exposures, obesity, gene changes, family history, diet, race/ethnicity, and age. The prostate cancer occurs due to the DNA alteration in the prostate cells. The prostate cancer can be diagnosed with the help of prostate-specific antigen (PSA) test of blood and digital rectal exam (DRE). 

The immunotherapy plays a important role in the treatment of prostate cancer. Sipuleucel-T (Provenge) is a vaccine which is most commonly used for the treatment of this cancer. This is a cancer vaccine that boosts the immunity of the body to treat this cancer in refractory and relapsed settings and particularly in castration resistant cases. There are several antibody drug conjugates, monoclonal antibody, kinase inhibitor drugs, vaccines, immunomodulators, mTOR drugs, and interleukins. All these immunotherapeutic are having specific potency to fight against the cancerous cells. These immunotherapeutic binds to different target and cure the prostate gland and destroy all the cancerous cells. Immunotherapy plays a effective role in the treatment of prostate cancer as compare to other treatments.

Are you a sufferer of it? Have a look and decide.

There are equivalent numbers of emotional symptoms associated with cancer, as there are the physical symptoms. Due to the availability of a number of cancer groups worldwide, a lot of awareness has spread among the people, regarding the physical symptoms of cancer. It is all because of their great work. However, the impact of the cancer and the associated treatment on the emotional aspects is mostly ignored and rarely addressed. When a cancer patient undergoes treatment, they should always tell others about their feelings, especially to their near ones. One should not feel shy. The feelings may be regarding the loss of interest of the person in the daily routine works, which usually they could have enjoyed, feeling scared, no knowledge about how to take the best care of oneself, or being afraid of, what future has in stock for us. One worse thing is that the treatment itself makes you sick. So, you need to switch to the better treatment options, like immunotherapy. Antibody-drug conjugate is the new treatment approach that is being accepted widely.

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With cancer, comes a lot of sorrow and grief – grief of the loss of the life that one could have enjoyed or hoped for, loss of the lovely relationships, job or a person’s place in the society, or at large, a community. The biggest loss is the loss of self confidence, which makes everything else, more difficult. For a woman, the biggest grief is not to be able to have their own children, not to have a family of their own, or getting love from their partners.

Due to fear, anxiety and embarrassment due to changes in the body caused due to the treatment, the emotional outburst is quite real and it can heavily alter the ability of the patient to fight and endure through the difficult phase of life. This is known as emotional trauma.

So, it is really important to take a good care of oneself along with talking about the cancer- be it with the near ones or in the support groups. Taking correct decision about treatment options can help to mitigate the anxiety, up to a certain level. The field of immune-oncology has proven to be successful to help the cancer patients to get relief from these adverse effects of conventional treatment. So, one just need to open their heart and mind to fight this deadly disease.

Pay us a visit on www.gapsos.com to get more information about our effective and quality services.

Frequently Asked Questions about Cellular Barriers in the Innate Immune System for Better Understanding Immunotherapy

If you’re trying to understand the functions of immune oncology cells that constantly come up as you study the different types of treatments of immunotherapy, then this Q&A blogpost will serve you well in understanding the basics when it comes to that specifically knowing what are white blood cells, their types & the function of the most basic form of defense of them.

So what is the innate immune system again?

Its part of the layered immune system, and it’s the first line of defense against all forms of pathogens & foreign bodies, and its defenses are mainly non-specific as opposed to the adaptive immune system which is the more advanced component of the immune system.

 

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And what exactly these cellular barriers?

These are the types of cells within the innate immune system that are responsible for the defensive immune response against the pathogens to be able to eradicate them completely and end the form of threat coming up.

And what are these cells?

Mainly it’s the leukocytes or white blood cells which are considered to be the second hand of the innate immune system and it has many types.

What are the types of the white blood cells?

Phagocytes (dendritic cells, neutrophils & macrophages),eosinophils,basophils, mast cells & NK cells.

And what is the main ways these cells attack the pathogens?

They’re mainly generic and are activated through what is called pathogen recognition receptors present of their cell’s surface and the ways through which they attack are 2 ways:

1-Attacking larger pathogens through contact.

2-Through the engulfment & killing of them.

And what are phagocytes?

These are immune cells belonging to the leukocytes that protect the body through ingesting harmful particles or pathogens.

And what is phagocytosis?

This is the function of phagocytes which is engulfment, and it’s considered to be the most basic form of defense in invertebrates & vertebrates alike.

And how does phagocytosis happens?

Mainly these phagocytes go about patrolling the body looking for pathogens to present themselves though they can also be called to certain locations through cytokines.

And when a pathogen is engulfed by a phagocyte it turns into a phagosome through becoming trapped in an intracellular vesicle and then turns into a phagolysosome through the fusion with another vesicle called lysosome.

The pathogen is eliminated through the digestive activity of enzymes or through the following of a respiratory bursting that leads to the release of free radicals into the phagolysosome.

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