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.

www.gapsos.com

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.

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.

 

www.gapsos.com

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.

Visit www.gapsos.com for detailed version of this blog.

Frequently Asked Questions about Antibody Immunotherapy for Fetal Protection From Rh-related Hemolytic Diseases

If you’re expecting childbirth soon enough and you have a negative Rhesus factor in your blood and you’re in the dark when it comes to the effect of that if it turns out that your baby has a positive Rhesus factor, then this Q&A blogpost will serve you well in protecting yourself and your baby from hemolytic diseases that can be mild or fatal and also in your subsequent pregnancies in the future.

So what is antibody immunotherapy?

It’s the use of antibodies to override the basic functions of the immune system responses to be able to result in certain effects for the well-being of the patient, like the detection of pathogens or toxins or suppression of certain immune responses.

And how does it work?

Antibodies are proteins , and in its soluble secreted form it goes about finding antigens in pathogens or even the body’s cells that aren’t working correctly and then it binds to it , to either attack it directly or tag it so that the immune system can deal with it .

Also the B cells that produce these antibodies can differentiate into memory cells that help to remind the immune system whenever the antigen that was recognized before to be recognized again but much faster.

And what does this have to do with me if I’m pregnant and I have a negative Rh in my blood?

Rhesus factor is an antigen that’s present at the surface of red blood cells if you have a positive Rh factor , while if it’s negative , you don’t have it , and thus if your fetus has it and you don’t , and the fetus’s blood gets mixed with your system , your immune system will react to it as a foreign body and will develop antibodies to attack it based on binding with that antigen and it will also produce memory B cells to remember the antigen that was recognized whenever it presents itself again , and thus this could lead to hemolytic diseases for the new born that could be mild like anemia or fatal like heart failure , and of course the same risk in future pregnancies .

And is it possible to prevent this from happening?

In antibody immunotherapy it’s possible to do that as a form of immunosuppression that prevents this form of sensitization, and it occurs through the introduction of RhD inhibitors in the form of antibodies that prevent the production of both form of B cell production whether it’s antibodies or memory B cells, and such treatment happens before and immediately after birth to insure protection.

Global Allied Pharmaceuticals (GAP) is a pharmaceutical company, working to deliever immunotherapy services. Contact us on www.gapsos.com.