Showing posts with label clinical affairs. Show all posts
Showing posts with label clinical affairs. Show all posts

Thursday, 29 January 2015

Cancer can be tough but there is something that can still break it.

Uterine cancer is one of the commonest gynecological cancers, especially in white Americans. It is the seventh most common disorder across the world.  It occurs most often in postmenopausal women (up to 80% of cases), about 5% diagnosed less than 40 years of age. According to the American Cancer Society (ACS), more than 52,500 newly cases are diagnosed, while more than 8,500 cases of deaths with uterine cancer that estimated in 2014. To increases survival rate of this cancer, researchers applied immunotherapy for the treatment of this cancer.

There is no effective screening programmed, but occasionally cervical smears containing endometrial cancer cells or double thickness endometrial ultrasonic thickness of 4mm or more indicates a need for endometrial sampling
www.gapsos.com
www.gapsos.com

The actual cause of this cancer is unknown. There can be no doubt that estrogen can alter the behavior of this tumour but there is still a question about estrogen as a primary causal agent. Estrogen secreting tumors of the ovary are associated with an increased incidence of endometrial carcinoma. Estrogen given alone as in postmenopausal Hormone Replacement Therapy (HRT).

Approximately 75% of cases of this cancer occur in the postmenopausal period when estrogen values are low and progesterone is absent. Null parity and polycystic ovary syndrome (PCOS) with defective progesterone synthesis carry an increased risk. After long term use of oral contraceptives (birth control pills) reduces the incidence of both endometrial and ovarian carcinomas.The usual presenting symptom of this cancer is postmenopausal bleeding which carries a 10% risk of associated malignancy in the absence of hormone replacement therapy. 

The treatment of uterine cancer with immunotherapy that involves Dentritic Cell immunotherapy, adoptive T cell therapy, and immune-modulator.  In dentritic cell immunotherapy, processed antigens have capability to enhance the potential of patient’s immune system to fight with specific cancer cells. Immature form of dentritic cells are loaded tumour antigens such as tumour lysate, which exist as mRNA. (Immatureforms of dentritic cells are able to capturedand processed antigens, after interaction with chemokine receptors and its ligands, this cell migrate to the lymph nodes). 

Global Allied Pharmaceuticals (GAP) has new technology to developed advanced treatment of uterine cancer on the basis of immune oncology and immunotherapy. GAP has a team of experts for conducting clinical trials for new immunotherapeutic cancer agents, which are used in immunotherapy.

For more information kindly visit us at www.gapsos.com

Monday, 26 January 2015

Immunotherapy increase the level of treatment for cervical cancer.

A slow growing cancercan be asymptomatic in early stages. Cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. Preceded by dysplasia, it changes precancerous on the cervix, towards invasive carcinoma.In United States, accounts for 86% of all cancers in women and the peak incidence between the age range of 50 to 55 years. The second most common cancer in the United States with more than 400,000 new cases diagnosed each year. It is observed that the incidence is very high in developing countries.Now, immunotherapy drug uses to saves more lives of cervical cancer patients.
 
www.gapsos.com
www.gapsos.com
Human Papilloma Virus (HPV) spreads through sexual intercourse; it is high risk strains 16 and 18, which cause 70% of all cervical cancer. Other risk factors include having sex an early age, multiple sexual partners, use of diethylstilbestrol drug during pregnancy, long term use of birth control pills, compromised immune system, infections with genital herpes or chronic chlamydial, poor living standards, smoking, and multiple pregnancies.

Early cervical cancer may be asymptomatic, but symptoms include continuous discharge from vagina, abnormal bleeding through vagina during periods, after intercourse, bleeding after menopause, longer and heavier periods than usual.Symptoms of advanced cervical cancer include pelvic pain, fatigue, back pain, single swollen leg, leg pain, heavy bleeding from the vagina, leakage of urine or feces from the vagina, bone fracture, and loss of appetite and weight loss.
This cancer isclassified into six histological types that involve Squamous cell carcinoma (85-90%, rise from ectocervix), Adenocarcima (10-15%, rise from endocervix, common in young groups), Adenosquamous (mix of endometriod and clear cell), Adenomamalignum (extremely well differentiated adenocarcinoma), Small cell carcinoma, and neuroendocrine carcinoma.

The Food and Drug Administration (FDA) approved many immunotherapeutic cancer agents for the treatment of cervical cancer after evaluation under clinical trials. Bevacizumab has received FDA approval for the treatment of metastatic condition of this cancer, in combination with Topotecan and Paclitaxel. Many immunotherapeutic cancer agents are still under evaluation of clinical trials for FDA approval such as ADXS11-001 (Lm-LLO-E7), E6 TCR, and HPV16 E7 peptide-pulsed autologous DCs.

Global Allied Pharmaceuticals (GAP) has new technology to developed advanced treatment based on immunotherapy and antibody drug conjugate. GAP has experts for conducting experiments and clinical trials of newly developed immunotherapeutic cancer agents that involves monoclonal antibodies, therapeutic vaccines, adoptive T cell therapy and many more.

Wednesday, 21 January 2015

Absolute Beginner’s guide to Immunotherapy treatments.



If you’re looking for an introduction to immunotherapy and its different applications, this blog-post will save you a lot of headache and will show the different applications of this type of treatment in layman language.

We’ll be introduced as to what is Immunotherapy, its different types and uses, and we’ll go through with only two types as a start.

First of all what is immunotherapy?
It is the treatment of any type of disease, through the enhancement,suppression, or induction of a response from the immune system. 
www.gapsos.com

And to simplify it even further, it’s used to either amplify or suppress an immunityeffect.
Now that we know what it’s about, let’s get to understand its different types as follows:
There are two main types: Activation & Suppression Immunotherapies, and other approaches which will introduce in other posts.

We’ll get to exploring them more in detail in other articlesbut before we’re capable of understanding them we have to understand what are immune modulators.

Immuno-modulators are mainly the active agents of this type of treatment, and they’re made of various preparations, that could be natural, synthetic or even recombinant, Cytokines are often the case, but let’s take a look at several examples of them:

1-Cytokines:Interferons, G-CSF
2-ChemoKines:CCL3, CCL26
3-Interleukins: IL2 – IL-12
4-others: cytosine phosphate guano sine,glucans.

What makes these type of active agents attractive for usage as a regimen is that they often have side effects that are not as strong or unfavorable as drugs and also create less resistance when it comes to microbial diseases.

The main type of treatment these immunomodulators are used for is called cell based immunotherapies , which has proven to be effective for some kind of cancer , Immune effector cells are like natural killer cells , dendritic cells ,  macrophages , cytotoxic t lymphocytes …etc. .
Mainly the way to work to protect the body is by targeting abnormal antigen on the surface of the cancerous cells that have mutated.

And thus in this blogpost you were introduced to what is Immunotherapy and its different types and how they actually battle different types of diseases by modification of the immune response and you understood the 2 main types briefly whether it’s activation or suppression and what exactly are immunomodulators , now you have a basic grasp of it .

Monday, 3 November 2014

Clinical trial types and how they differ from each other.

clinical affairs and Clinical Trials are undoubtedly essential in the restorative world since they help the specialists in creating better medicines. There are sure ailments today which still anticipate a cure or an enhanced treatment that can help spare the lives of patients. 

Such circumstance will specifically depend on what the clinical trials indicate about the medications that are constantly tried. The trials are carried out on new medications that have been produced or enhanced medications that are as of now being utilized by patients. 

The trials vary incredibly regarding their length and reason. The volunteers joining in the trials in this way need to be mindful of everything that they involve and pick the medicinal trials that are most suitable for them. Volunteering is however one of the best things that you can decide to do since you will be assuming a vital part in sparing the lives of ebb and flow and future patients experiencing assorted types of conditions and sicknesses. 
 
http://www.gapsos.com
www.gapsos.com
These trials are of two sorts. There are the stage one trials and the stage two trials. In face one; solid volunteers are utilized for the studies. They help in deciding the ingestion level of the medication being referred to, its connection with human body and even the symptoms that it could have. It is likewise amid this stage that the masters realize what impacts various types of nourishment have on the medication while in the body. It is a stage that aides in giving the bearings of utilization on the off chance that the medication turns out to be a superior treatment for what it are expected for. 

In the second stage, patients experiencing the condition the medication has been produced for are utilized. It is a stage that aides in figuring out if it have guaranteeing comes about the extent that treating that specific condition is concerned. The volunteers utilized for this stage are ordinarily those with moderate and gentle manifestations of the condition being referred to. The medications will generally be for hypertension, asthma and diabetes in addition to different conditions that individuals experience the ill effects of significantly. 

The two stages or sorts of clinical trials and Drug Safety Physician are vital and they are directed professionally. This implies that despite the fact that you could be a volunteer experiencing the condition the treatment is implied for, you can make certain that you won't wind up getting to be more broken down after the trials. The trials are however not an assurance that the debilitated volunteers will show signs of improvement from the treatment.

Contact www.gapsos.com for more information. Gapsos is a growing pharmaceutical company that conducts clinical trials to meet the unmet need of medicines.

Thursday, 11 September 2014

Medical affairs and its commercialization



Offering another pharmaceutical item for sale to the public is a novel procedure focused around various prerequisites for supporting an item dispatch. For R&D organization, propelling an item into business sector may appear to be an issue for another person to handle in the far-removed future and at a much later time. In any case even at lab or early improvement stages, biotechnology organizations ought to comprehend the dialect of pharmaceutical organizations and know how that industry works. Doing so helps biotech organizations settle on ahead of schedule choices with respect to their investigational items that could prompt future achievement. 

Here we concentrate on therapeutic undertakings and Drug Safety Physician, a basic piece of the pharmaceutical business. There is no true identical to medicinal undertakings in biotechnology, yet it plays a continually expanding and vital part in that industry also. The conventional bio assembling model incorporates two fundamental columns: a R&D association responsible for creating new items and a business association accountable for advertising and offering those items. Pharmaceutical assembling has a comparative part: an improvement bunch (in charge of getting FDA regard for medication items) and a business group (that businesses and offers those items). One major contrast, then again, is that the biopharmaceutical business fails to offer an extra gathering to go about as a scaffold in the middle of advancement and commercialization. This is the part of medical affairs.

Medical affairs initially developed as a response to expanding weights from controllers to discrete medicinal and business capacities. Organizations were encountering expanding interior requests to center the part of advancement on producing and creating new items instead of on overseeing items after FDA approbation. In the course of recent years, proceeded with administrative weight moved various business exercises to individuals with therapeutic skill, frequently to medicinal issues bunches. Subsequently medicinal undertakings has advanced into a different restorative association that frequently sits inside improvement associations however essentially deals with post endorsement exercises and has both the experimental and clinical mastery to help business items.

Medical affair functions incorporate; overseeing key thought-pioneer connections,  distributed information from corporate-supported trials ,introducing instructive data around an item or helpful scene, noting inquiries from human services suppliers in regards to item security or viability that is not tended to in an item's mark and supporting exploration activities outside marked signs for marketed item.