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Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimal analgesic and addiction potential. In particular, he led the research team that discovered and developed nufenoxole, an antidiarrheal drug. Nufenoxole possessed large separation between its desirable gastrointestinal (GI) constipating action from its undesirable central nervous system (CNS) actions, e.g., analgesia, primary dependence and respiratory depressant actions. Nufenoxole underwent clinical development but the drug was never marketed.

Expert has worked on development of drugs effective for the treatment and prevention of gastrointestinal(GI) mucosal toxicity induced by non-steroidal anti-inflammatory drugs (NSAIDs), which are widely used for the treatment of arthritis. Unfortunately, the desirable analgesic and anti-inflammatory actions of NSAIDs is often accompanied with gastrointestinal mucosal ulceration and ulcer related complications such as bleeding and perforations. He led the research teams that discovered and developed misprostol (Cytotec), an anti-ulcer drug with mucosal protective and gastric anti-secretory properties. Misoprostol is an analog of prostaglandin E1, which had proven clinical efficacy for the prevention of NSAID-induced GI mucosal toxicity.

He headed the research team that discovered and characterized pre-clinical and clinical efficacy of the anti-diarrheal drug nufenoxole, a novel investigational drug that was never marketed.

He has worked on the pharmacological investigation of anti-histamine (H2) receptor antagonists as potential drugs for the treatment of acid-peptic diseases in man. Histamine (H2) receptor antagonists are effective inhibitor of gastric acid secretion and such inhibition promotes ulcer healing in experimental animals and in man. Histamine (H1) activity, which is not relevant to gastric acid secretion, was also evaluated for such compounds. Histamine (H1) antagonists are effective in antagonizing the adverse actions of histamine in the respiratory tract and the skin.

Expert was actively involved in the pre-clinical and clinical research of bulk laxatives (e.g. Metamucil) and cathartics like the senna alkaloids. Cathartics are well established to promote intestinal secretion and/or inhibit intestinal water absorption, thus resulting in an increased fecal mass and relieving the constipation.

Expert investigated the actions of many drugs in animals and in man. Most drugs are used for either the diagnosis, prevention and/or treatment of many disease states. In pharmacology, a drug is defined as a substance, which can alter existing physiological function of a cell, an organ and/or an intact organism.

He has worked on the clinical pharmacological characterizations of many drugs at Searle and at other pharmaceutical organizations. As a consultant in drug development, clinical pharmacology and regulatory affairs, he advised pharmaceutical sponsors regarding the development plans and execution to permit product marketing approval by regulatory agencies.

Expert is an expert in preclinical and clinical drug development. Preclinical drug development is the process of characterizing the pharmacological and toxicological actions of a drug in intended for clinical use. The pre-clinical characterization employs laboratory animals. Clinical drug development investigates the actions of the drug in healthy subjects and in patients suffering from disease state. Ultimately, such characterizations and additional studies results in the submission of New Drug Application (NDA) to the FDA in the hope of obtaining marketing approval.

He is an expert in drug regulation, which consists of many steps that need to be met during pre-clinical and clinical drug development of drug candidates. Also, drug regulation applies to marketed drugs. The FDA and other world wide regulatory authorities govern all regulations with respect to the development and marketing of the drugs.

He is an expert in drug therapy, which is an integral part of pharmacology and therapeutics. All drugs have benefits for the treatment of a disease process but may also have potential risks related to such treatment. As an employee and/or consultant to pharmaceutical companies, great scientific efforts is devoted to investigate not only the benefits but also the risks of drug therapy. This is assessed during the pre-and post-market phase of the drug. Physicians must evaluate the benefits and risks for the drug that they intend to use for the treatment and prevention of a disease process in accordance with the complete prescribing information developed by the manufacturer and approved by the regulatory agencies.

A gastrointestinal drug is a drug effective in altering gastrointestinal (GI) physiological functions in a desirable manner. He was actively involved in pre-clinical and clinical GI research involving diseases of the stomach and intestine. He led the research teams that discovered a novel anti-diarrheal drug (nufenoxole) and an anti-ulcer drug (Cytotec).

A generic drug is not only chemically identical but also therapeutically equivalent to a branded drug and requires only the submission of Abbreviated New Drug Application (ANDA) to the FDA rather than a complete and lengthy New Drug Application (NDA), which is submitted with all new drugs. The sponsor of the generic drug must provide human pharmacokinetics data to the FDA showing that the generic drug dosage forms is bioequivalent (AUC and C max) to the branded drug. However for drugs that are not acting systemically or topical may require a prove of clinical efficacy investigations. Clinical efficacy investigations significantly increase the cost of such development of generic drugs.

An investigational drug is a drug in clinical development and which has an active IND filed with the FDA to permit clinical development leading to marketing authorization.

Investigational drug procedures are usually outlined by regulatory agencies. In the United States, an Inestigational New Drug (IND) application must be filed with the FDA by the pharmaceutical sponsor to begin the clinical development process. The FDA must notify the sponsor within 30 days after the submission of the application whether they have an objection with the IND, which must be resolved with the agency prior to the initiation of the clinical development.

Mucolytic drug is a drug effective for liquifying abnormal mucous secretion predominately in the respiratory system. Mucomyst (N-acetylcysteine), a mucolytic, is used for the treatment of cystic fibrosis, asthma, emphysema and chronic obstructive pulmonary disease (COPD).

New drug is either a new chemical entity or a drug previously approved for clinical indications other than those that it was originally approved for. Pharmaceutical and biotechnology companies are the major sources of new drugs in human therapeutics.

Opiates represents a pharmacological class of drugs derived from opium. It includes natural and synthetic derivatives of morphine. Opiates based drugs are effective for the treatment of severe pain often associated with major surgery and cancer. Opiates are also used for the treatment of diarrheal states. He was actively involved in the discovery of opiate based antidirrheal drugs that showed wide dissociation between peripheral (gastrointestinal) and central (analgesic) actions.

Over-the-counter (OTC) drugs represents drugs readily available to consumers without a prescription or authorization from physicians. Such drugs are usually safer than prescription based drugs and requires simple labeling to allow an average consumer to safely and effectively use such products. In the United States, many drugs are initially marketed as prescription based products but could be switched to OTC products, if it could be shown that such switch would not harm the average consumer in need for the use of such drugs. Furthermore, the FDA must approve the sponsor-initiated OTC clinical development and will also review the clinical plans, test results and the labels of all potential OTC products before granting marketing authorizations for such products.

OTC product development is a process that is negotiated between the pharmaceutical sponsor and the FDA with respect to marketing prescription-based products on an OTC basis.

Pharmaceutical product is a product developed by a pharmaceutical or biotechnology companies intended for the diagnosis, treatment and prevention of a disease.

Pharmacology is the science that deals with the action of drugs or chemical substances in the living cells, tissue, organs and intact organisms. Drugs are used in the diagnosis, prevention and treatment of a disease process. Pharmacology requires complete understanding of several basic medical sciences subjects that includes anatomy, histology, biochemistry, physiology, pathology and medicinal chemistry.

Array

Testified in a patent litigation suit concerning proton pump inhibitors as anti-ulcer drugs. He was deposed and subsequently testified in a Federal Court regarding the validity of prior art patents. Deposed in a medical malpractice suit as an expert witness regarding the use of a contra-indicated drug in obstetrics. Deposed in a product liability case concerning defective labeling of a medical food. Deposed in a product liability case regarding defective labeling of a central nervous drug which resulted in two wrongful deaths.