Day 1 :
Keynote Forum
Anthony Serracino-Inglott
University of Malta, Malta
Keynote: International Harmonisation of Medicines’ Regulatory Affairs
Time : 09:25-09:50
Biography:
Anthony Serracino-Inglott studied at University of Malta and University of Cincinnati. He carried out research in clinical pharmacy with a completion of a residency programme under the supervision of the eminent Professor Don E Francke. He has started taking lectures and started his research work at the University of Malta where he established the Institute of Health Care now the Faculty of Health Sciences. He has been elected as a Chairman of the Medicines Authority.
Abstract:
Regulatory affairs started to get organised over 50 years ago following unfortunate incidents such as the thalidomide tragedy. The quality of medicines was established in different countries through the development of pharmacopoeias, such as the British and the United States pharmacopoeia. Pharmacopoeias were harmonised in regions such as the European Pharmacopoeia and on an international basis, the international pharmacopoeia. The regulation of production and the authority to market medicines were also harmonised in regions, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe. The authorisation of third countries to be able to produce and market their medicines in other regions is carried out by the regional bodies independently and with restricted cooperation. Attempts to harmonise the regulatory affairs internationally were made such as the use of ISO standards and ICH guidelines. If the regulatory forces are developed into a scientifically-based status and thus, the nomenclature from regulatory affairs to regulatory sciences could be rightly undertaken, then, the internationalisation and hence the harmonisation of regulatory sciences should follow with relative ease in the same way that the laws of science have been accepted internationally. If the rules of innovation, research and education were followed, using today’s technology and communication, the harmonisation process should become achievable. This is especially essential today where the science of pharmacovigilance is developing at a great pace. If pharmacovigilance is tackled on an international basis, then the benefits to the world community cannot be overestimated.
Keynote Forum
Mohamed T Khayyal
Cairo University, Egypt
Keynote: Evidence for the potential therapeutic usefulness of the multi-component herbal preparation, STW5, in protecting against radiation-induced intestinal mucositis
Time : 09:50-10:15
Biography:
Prof. Dr. Mohamed Taky El-Din Khayyal, emeritus Professor of Pharmacology, Faculty of Pharmacy, Cairo University, Egypt, was born on 26th October 1937. He obtained his B.Pharm Degree in 1958 from Alexandria University and his PhD from London University (UK) in 1964. He is presently President of the Egyptian Society of Pharmacology and is a member of many scientific societies, including the German Pharmacological and Pharmaceutical Societies, the American Gastroenterology Association, the German Society of Neurogastroenterology, and served as Councillor to the International Union of Pharmacology (2002 – 2010).He obtained Fellowships from Alexander von Humboldt Foundation, (1978), and Fulbright Foundation (1987).He has nearly 100 scientific publications in national and international Journals. His main interests lie in the field of inflammatory and gastrointestinal disorders, herbal medicine and the effects of radiation exposure. He is fluent in both spoken and written English, German, and French apart from his native tongue, Arabic.
Abstract:
Intestinal mucositis is a common adverse effect in patients undergoing radiotherapy and constitutes a treatment-limiting condition. Since no agents are yet known that can adequately guard against its development, the search continues to find safe and effective measures that could prevent this serious side-effect of radiation without affecting its anti-tumor activity. The present study was intended to investigate whether the herbal preparation, STW 5, could offer a potentially effective agent in this respect. STW5 is a multi-target herbal preparation consisting of standardized extracts of bitter candytuft (Iberis amara), lemon balm (Melissa officinalis), chamomile (Matricaria recutita), caraway fruit (Carum carvi), peppermint leaf (Mentha piperita), Angelica root (Angelica archangelica), milk thistle (Silybum marianum), celandine herb (Chelidonium majus), and liquorice root (Glycyrrhiza glabra). The preparation is of proven clinical efficacy in functional dyspepsia and irritable bowel syndrome. Intestinal mucositis was induced in rats by exposing them to different exposure levels of whole body gamma-irradiation. According to these results, a level of 6 Gy was used in later experiments. Rats were treated orally with STW 5 (5 or 10 ml/kg) for five days before and two days after irradiation. One day later, rats were sacrificed and segments of small intestine were examined histologically to assess mucosal integrity. Intestinal homogenates and serum samples were used to assess relevant parameters for mucosal functional activity, such as the brush border enzymes sucrase and alkaline phosphatase, citrulline and cholecystokinin, as well as different markers for inflammation, oxidative stress and apoptotic changes. Exposure to radiation produced dose-dependent extents of intestinal injury associated with changes in functional activity and apoptotic parameters with high radiation levels. Apoptosis was associated with an increase in cytosolic calcium, depletion of mitochondrial cytochrome c, B-cell lymphoma-2 and complex I. Oxidative stress parameters (reduced glutathione, thiobarbituric acid reactive substance and total nitrate/nitrite) were deranged. Inflammation markers (tumor necrosis factor and myeloperoxidase) and indices of intestinal damage (serum diamine oxidase) were increased. STW 5 protected to a large extent against histological changes and counteracted the deranged parameters indicative of apoptosis and of functional integrity. The findings provide strong experimental evidence for the potential therapeutic usefulness of STW5 in protecting against the development of radiation-induced intestinal mucositis and in preserving the functional activity of the small intestine in the face of radiation exposure.
Keynote Forum
Pardeep K Gupta
University of the Sciences in Philadelphia, USA
Keynote: Design of growth-hormone binding peptide and its use as a vehicle for nanoparticle-based delivery of human growth-hormone
Time : 10:15-10:40
Biography:
Dr. Pardeep Gupta the Burroughs Wellcome Professor at Philadelphia College of Pharmacy, University of the Sciences in Philadelphia. He earned his PhD degree in pharmaceutics from University of Wisconsin. He has published numerous scientific papers in the area of drug delivery. His work at the university has resulted in filing of two patent applications in the area of drug delivery. He served on the editorial board of Remington-The Science and Practice of Pharmacy and has authored chapters in several books.
Abstract:
A novel peptide that mimics the binding properties of growth hormone binding protein (GHBP) was designed and synthesized. This peptide, termed growth hormone binding peptide (GHBpep) contains the functional epitopes of GHBP that allow it to bind to GH. This peptide was studied for its binding to GH in solution to characterize its binding affinity and thermodynamics of the binding process. These studies show that GHBpep binds to GH in a 1:1 ratio. GHBpep was covalently linked to bio-functionalized biodegradable PLGA nanoparticles. Reversible binding of GH to immobilized GHBpep was studied using equilibrium binding studies. The results of these studies indicate that GH can be loaded onto functionalized biodegradable nanoparticles in a reversible manner, and can be used as a delivery system for GH.
Keynote Forum
V. Ravi Chandran
Life Enhancing Technologies LLC., USA
Keynote: Is there life beyond Science?
Time : 10:55-11:55
Biography:
Dr. V. Ravi Chandran is a distinguished alumni of the University of Florida, USA where he graduated with a PhD in pharmaceutical sciences in 1986. Since then, as an independent scientist and business leader, he has been engaged in pharmaceutical manufacturing, research and development of new drug molecules, hitech drug manufacturing and distribution in the USA, and has more than 25 patents for excess of 9000 new molecules in various countries including USA, Japan, Australia and others. With his breakthrough research in Anti-platelet drugs, Dr. Chandran demonstrated that to develop a new drug, it is not necessary to start with thousands of molecules. Instead, by combining ideas from a multidisciplinary approach, few drugs can be zeroed in on at a very early stage and carry them to final regulatory approval. Dr. Chandran is an experienced pilot, enjoys flying airplanes and helicopters as his hobby.
Abstract:
V Ravi Chandran has spent better part of the last 40 years contemplating the role of scientists in improving the quality of human life. During his scientific and business adventures, he realized that while his chosen field is intellectually satisfying, life beyond science could be more enthralling if science can be put to work to combat life’s idiosyncrasies. He will talk about a) Significant scientific breakthroughs he achieved in understanding cardiovascular diseases and their treatment; b) How one of his drugs, a Propofol derivative would have prevented the premature death of famous pop/rock star Michael Jackson; c) Serendipitous discoveries leading to the separation of racemic mixtures of wide chemical and therapeutic categories of drugs and the implications; d) First time development of narcotic strength pain killer without any addiction potential; e) How to zero in on few right molecules for a given treatment quickly using guerilla innovation and multi-disciplinary approach to drug discovery. From his life experiences, he will demonstrate that harder you work, luckier you get. Why all talented scientists must experiment with business ideas to appreciate the validation of good scientific discoveries in the marketplace will be explored. He will provide examples from his own life and present his case through a surprisingly unusual format.