The Process of Getting New Drugs Approved in the United States

For the last 20 years, Robert Gadimian, has worked in the drug development and regulation sector, helping pharmaceutical companies get their products approved. In the United States, pharmaceutical companies must have their products approved by the FDA, and Robert Gadimian is extremely experienced with FDA guidelines.

The process for FDA approval involves five stages. The stages are as follows: discovery/concept, preclinical research, clinical research, FDA review, and FDA post-market safety monitoring.

The first thing a pharmaceutical company does is conduct laboratory tests. Then, the drug is carefully tested on – first on animals and then on human subjects. Afterward, FDA scientists review the research and guidelines the pharmaceutical company has compiled on how the drug will be used. The FDA’s goal is to determine whether the drug’s risks are higher than its potential benefits. They also verify that the drug can be manufactured in a way that ensures quality and safety. When the pharmaceutical company fulfills these conditions, the FDA allows the drug to be manufactured and marketed in the United States.

After production, the FDA continues to monitor the drug to make sure it does not cause health hazards.

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How Cystic Fibrosis Can Be Treated

President of the Burbank, California firm Perceptive-Regulatory Consulting the Robert Gadimian is an authority in pharmaceutical research. Also the leader of Rophe Pharma, presently, Robert Gadimian is working on a patent related to novel compounds that treat cystic fibrosis.

Cystic fibrosis is a hereditary illness that does not have a cure. However, there are ways to at least manage symptoms. Primarily, the disease affects the exocrine glands, causing the production of extremely thick mucus and leading to the blockage of some of the respiratory organs. Hence, one way to treat cystic fibrosis is to take medication to improve the function of these organs. These medications include antibiotics to tackle the respiratory infections that the disease may cause.

Another treatment approach is cystic fibrosis is pulmonary rehabilitation. This involves exercise, breathing techniques, nutritional advice, counseling, and education. Pulmonary rehabilitation is used to treat people with chronic respiratory diseases, and cystic fibrosis is no exception. Physical activity helps to clear the “frozen” mucus in the lungs, resulting in better breathing and, generally, better health.

Finally, there a few surgical procedures that can help in treating cystic fibrosis. They include nasal and sinus surgery, bowel surgery, lung transplant, and liver transplant.

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Common Causes of Acne

An independent regulatory affairs consultant with 20 years of experience working in the pharmaceutical industry, Robert Gadimian serves as president of Perceptive Regulatory Consulting, California. Robert Gadimian is actively involved in supplement research for common skin problems like acne.

Acne is a skin problem that can present with whiteheads, blackheads, rashes, inflammation, and sometimes deep lesions in some areas of the skin where oil-producing glands can be found. Acne can be mild, moderate, or severe. In severe acne, a person can suffer permanent scarring of the skin, which may be embarrassing. Generally, multiple factors play an important role in a person’s susceptibility to acne. These include:

1. Genetic predisposition – Genes can contribute to an assortment of factors that can cause acne or a person’s susceptibility to it. For instance, hormones, which are products of genes, can play an important role in acne formation.

2. Hormones – Significant or rapid hormonal fluctuation can cause acne. While this is common during adolescence (where sex hormones boost rapidly), women who are pregnant, in premenopause, or using hormonal birth control can have rapid hormonal fluctuation.

3. Follicular hyperkeratinization – Follicular hyperkeratinization refers to the abnormal shedding of skin cells near pores’ openings. When this occurs, the cells may clog the pore and get inflamed by oils and other substances that otherwise would have been excreted through the opening.

4. Bacteria – Propionibacterium acnes, a bacterium, can grow abnormally on the skin and cause inflammation and skin damage – acne. It can also trigger other acne risk factors like follicular hyperkeratinization.

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Diabetic Foot Ulcer – Symptoms, Complications, and Causes

A successful regulatory professional, Robert Gadimian draws on two decades of experience working in the pharmaceutical industry. Over the years, Robert Gadimian is involved in creating drug combinations to treat diabetic foot ulcers.

With a prevalence of 15 percent among diabetic patients, a diabetic foot ulcer is an open wound or sore that often develops around the foot’s bottom. At the initial stage, a diabetic foot ulcer can present with drainage from the foot (which makes socks wet), swelling, and sometimes redness. Diabetic foot ulcers result in infection and several other ulcer-related complications after some time, which may require hospitalization. In severe cases, patients are amputated as an intervention for complication progress. If the disease is detected early, chances of healing with treatment are possible, which will minimize the risk of infection.

A diabetic foot ulcer can occur in any diabetic patient. African Americans, Hispanics, Native Americans, and seniors, however, have higher risk factors. Likewise, diabetic patients undergoing insulin medication and patients with a diabetes-induced eye, kidney, or heart disease may develop the condition. Tobacco, alcohol, and obesity are some other risk factors. If a diabetic patient has a vascular disease, the chances of suffering complications from diabetic foot ulcers increase due to slower healing, including infection.

Generally, multiple factors can play an important role in the development of diabetic foot ulcers. Examples are foot deformities, poor circulation, irritation, duration of diabetes, and trauma. Diabetic foot ulcer patients slowly lose sensation in their foot which may cause subjecting of the foot to constant friction or pressure (2 causes of inflammation) without realizing. The inability to feel pain results from the disease’s neuropathy, which a podiatrist can assess using a painless instrument called a monofilament.

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The Role of Regulatory CMC in Pharmaceutical Development

Burbank, California, resident and independent regulatory consultant Robert Gadimian has extensive experience in the drug approval process. As part of his work, Robert Gadimian has familiarity with regulations related to Chemistry, Manufacturing, and Controls (CMC).

The role of regulatory CMC has become so important that the field is expanding to become its own sector. Called CMC Regulatory Affairs (RA), the field is an important part of drug and product development along the entire cycle of development, licensing, manufacture, and marketing. CMC RA is a governance process that guarantees drug development and manufacturing adhere to regulatory guidelines established by governing agencies such as the Food and Drug Administration.

The activities involved with CMC RA are twofold: manufacturing and quality control testing of the product. Other activities that occur include defining specifications and stability of the product, defining the place where the product is manufactured, and specifying the tools used to support the location where products are manufactured (i.e., facility design, operation, maintenance, and qualification).

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Rophe Pharma’s Cost-Effective Diabetic Foot Ulcer Treatment

An established pharmaceutical development leader, Robert Gadimian guides Perceptive Regulatory Consulting and provides client-tailored pathways toward meeting global compliance mandates. Robert Gadimian additionally helms Rophe Pharma, which has a number of innovative, patent pending products under development.

Among these is the diabetic foot ulcer treatment RPHE-3917, which combines a pair of already FDA approved products within a topical formulation. To date, only three diabetic foot ulcer treatments have been FDA approved. One is derived from cultured cells of the neonatal foreskin, while another comes from neonatal dermal fibroblasts. Both of these formulations have the drawback of being prohibitively expensive.

By contrast, RPHE-3917 is designed for ease of use and cost-effectiveness, with experimental data indicating consistently positive results. Generating a breadth of data on this formulation will enable intellectual property rights to be obtained. In addition, Rophe Pharma is working toward a patentable topical formulation for treatment of diabetic foot ulcer.

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