Expert in Clinical Pharmacology, Toxicology, Drug Development, Product Liability, Regulatory Affairs, Pharmaceutical Patents
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.
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.
Expert may consult nationally and internationally, and is also local to the following cities: Chicago, Illinois - Rockford, Illinois - Aurora, Illinois - Naperville, Illinois - Joliet, Illinois - Elgin, Illinois - South Bend, Indiana - Gary, Indiana - Milwaukee, Wisconsin - Madison, Wisconsin
|Year: 1969||Degree: Ph.D.||Subject: Pharmacology and Toxicology||Institution: Purdue University|
|Year: 1966||Degree: M.S.||Subject: Pharmacology & Medicinal Chemistry||Institution: Auburn University|
|Year: 1963||Degree: B.S.||Subject: Pharmacy||Institution: University of Missouri at Kansas City|
|Years: 1993 to Present||Employer: Undisclosed||Title: Founder and President||Department:||Responsibilities: IDDC Corporation is a contract research organization (CRO) which provides drug development, scientific consulting and litigation support services. The consulting services cover clinical pharmacology, toxicology, regulatory affairs and patents. Litigation support services includes drug-related medical malpractice, medication errors, product liability, alcohol and drug intoxications and Contract Research Organizations.|
|Years: 1987 to 1993||Employer: G.D. Searle & Co.||Title: Director of Clinical Research||Department: Clinical R & D||Responsibilities: Directed worldwide clinical research and development (Phases I-IV) on several drugs.|
|Years: 1985 to 1986||Employer: G.D. Searle & Co.||Title: Director, Cytotec Scientific and Medical Affairs||Department: Clinical R & D||Responsibilities: Directed Phase IV clinical research activities with misoprostol (Cytotec). Assisted in the worldwide launch of Cytotec.|
|Years: 1980 to 1985||Employer: G.D. Searle & Co.||Title: Assistant/Associate Director||Department: Gastroenterology Clinical Research||Responsibilities: Generated development plans, budgets, clinical protocols, study placements, study monitoring, preparation of clinical and regulatory reports.|
|Years: 1974 to 1980||Employer: G.D. Searle & Co.||Title: Chairman, Gastrointestinal Diseases Committee||Department: Preclinical Research & Development||Responsibilities: Directed research of a multi-disciplinary group (M.D., Ph.D. level scientists) which resulted in the discovery of several interesting drugs. Of these, one drug (Cytotec) was marketed.|
|Years: 1974 to 1980||Employer: G.D. Searle and Co.||Title: Group Leader||Department: Department of Pharmacology||Responsibilities: Planned, conducted and directed research in gastrointestinal pharmacology and physiology.|
|Years: 1972 to 1974||Employer: G.D. Searle and Co.||Title: Senior Research Investigator||Department: Department of Pharmacology||Responsibilities: Planned, conducted and directed research in gastrointestinal pharmacology and physiology.|
|Years: 1968 to 1972||Employer: Rohm & Hass Research Laborastories||Title: Senior Pharmacologist||Department: Research Division||Responsibilities: Directed and conducted research in gastrointestinal, cardiovascular and central nervous system pharmacology and toxicology.|
|Years: 2006 to 2011||Agency: FDA||Role: Advisor to the FDA||Description: Appointed by the FDA as a Special Government Employee (SGE) in the capacity of a consultant and to serve on the FDA Gastrointestinal Advisory Committee.|
|Years: 2015 to 2016||Agency: Federal Trade Commission||Role: NDA Reviewer||Description: To determine whether a pharmaceutical company has anti-competetive activities|
|Years||Country / Region||Summary|
|Years: 1998 to 1999||Country / Region: Italy||Summary: Provided consulting service for a major pharmaceutical company regarding a novel antibiotic with potential gastrointestinal applications.|
|Years: 1995 to 1998||Country / Region: Argentina||Summary: Provided consulting service for a pharmaceutical company in the field of prostaglandins.|
|Years: 1995 to 1998||Country / Region: Switzerland & USA||Summary: Provided consulting and research activities for a multinational pharmaceutical company concerning a drug being developed for the treatment of Parkinson's Disease.|
|Years: 1994 to 1999||Country / Region: Denmark||Summary: Carried out research at Urhuus University Medical School to characterize a drug useful for the prevention and treatment of esophageal ulcers. Served as a faculty research advisor to two postdoctoral students at the university.|
|Associations / Societies|
|Am Soc for Pharmacology & Experimental Therapeutics.
American Gastroenterolgical Association.
Am College of Gastroneterology (Fellow).
European Assoc for Gastroenterology & Endoscopy.
Association for Academic Minority Physicians.
|Licenses / Certifications|
|Adjunct Professor of Medicine, Loyola University-Chicago.
Adjunct Professor of Pharmacology.
Academic Editor for four biomedical jurnals.
Special Government Employee (FDA Advisory Committee & Consultant).
|Awards / Recognition|
|Won the Edgar M. Queeny Award (Monsanto, 1990) for distinguished achievements in science and business. Won the 1991 Distinguished Alumnus Award form Purdue University for outstanding scientific achievements
|Publications and Patents Summary|
|He has 110 publications and 10 US patents. He co-authored one book. He made 130 presentations at national and internationals biomedical conferences.|
|Expert Witness Experience|
|Drug injury causation, drug related medical malpractice, medication errors, drug product liability (warnings, designs, formulations, labelings), adverse effects of health and beauty products, forensic aspects of alcohol and drug intoxication, drug patent litigations and CROs activities. In States and Federal Courts|
|Training / Seminars|
|Many. See C.V. for additional details.|
|Led the research teams that discovered and developed misoprostol, a worldwide antiulcer drug. Served as a consultant to many pharmaceutical, biotechnology companies and to the FDA. See C.V. for additional details.|
|Other Relevant Experience|
|An active researcher and educator. Held adjunct faculty appointments in the fields of pharmacology and medicine. Currently serving as Adjunct Professor of Medicine at Loyola University Chicago|
|Arabic||He is fully proficient in Arabic.|
|French||He can read French. He was qualified to translate French into English with the use of a dictionary.|
|German||He can read German but with the aid of a dictionary. He was qualified to translate German into English with the use of a dictionary.|