ABSTRACTS

Efficient Engineering Gidy Asrani, President, Pharmacon Today, the Industry cannot operate without qualified and experienced engineers. The pharmaceutical scientists have to intimately deal with different engineering aspects of the pharmaceutical operations. Sophistication and automation of sensitive and expensive instruments demand skills and care acquired by sensitization of engineering abilities. This interface of engineers with scientists is necessary to obtain synergy. This presentation endeavours to bridge the gap between these two important disciplines. We the Pharmacists: Empowered for Global Opportunities in Clinical Research Brijesh Regal, Managing Director, Apothecaries Limited, New Delhi The Indian scenario has all the features that pharmacy profession in India needs to reinvent itself and to reposition its practitioners - the pharmacists - as relevant members of healthcare profession and society. Pharmacists, with their broad based training, are best placed to perform the diverse and interdisciplinary tasks required to conduct clinical trials. The presentation elucidates how Indian pharmacists are poised to impact the global society by generating world class clinical research data at costs that would benefit the entire humanity, by making drugs more affordable. It is a billion dollars opportunity for India and an invaluable vehicle for pharmacists to present themselves as owners and facilitators of GCP processes. Medication Adherence to Long-Term Therapies and Pharmacoepidemiology Bruno Louis, Senior Clinical Pharmacist, Department of Pharmacy, S.Q. University, Muscat Pharmacoepidemiology is the study of the use and effects of drugs in large numbers of people. Effectiveness of treatment of a disease depends mainly on two factors: the efficacy of the treatment prescribed and the rate of adherence of the patient to this treatment. Many studies show that, poor adherence to the prescribed therapy as a major factor for hospital admissions. Assessing adherence pose a challenges for pharmacoepidemiologist as there is no "gold standard" for measuring adherence. A variety of strategies have been reported in the literature and these may be of little use in studies of large populations. One way is to capture the amount of time that an individual remains on chronic drug therapy and estimate persistence by survival analysis. The authors have used the above methodology to assess adherence of statin therapy in newly treated dyslipidemic patients and determined some factors associated with treatment discontinuity and non-persistence. The details of the methodology will be discussed. PET Evaluation of Cerebral Oxygen Delivery & Metabolism-Investigating Haemoglobin-Based Oxygen Carriers VD Awasthi, SW Yee, BA Goins and WT Phillips, Department of Radiology, University of Texas Health Science Centre at San Antonio, US. Despite the current optimism in combating transfusion-related microbial infections and ensuring educated, volunteer donor population, the world is still faced with two issues- bio-safety and inadequate availability of blood. The study results by the authors indicate that despite significant hemodilution by the presence of albumin, LEH improved cerebral oxygen metabolism better than other control fluids. Manufacturing technology, characterization and evaluation will be discussed. From European - Pharmacopoeia to EDQM Claude Coune, head, publication and IT division at EDQM headquarters, Strasbourg (France), member of the board of directors of EDQM Founded in 1964 by 8 pioneer countries, the European Pharmacopoeia evolved, along its forty years of existence, into EDQM, an Europe-wide organisation dealing with all aspects of the quality of medicines. It proved to be such a powerful and efficient tool for harmonising the different national pharmaceutical regulations in Europe that it now collaborates tightly with the European Medicines Agency (EMEA) and the European Union. EDQM is a fairly opened organisation, counting 34 member countries (from Europe) and 16 observers from all the continents of the world. Public Private Partnership: Its relevance in Drugs and Pharmaceutical R&D in India Prof. V.S. Ramamurthy, Secretary, Department of Science and Technology, Government of India The accumulated knowledge of traditional medicinal system and large bio-diversity of our country offer a great advantage to drug industry. However, at present, most of the Indian drug firms, due to their small size compared to international operators, are not in a position to invest in a viable new drug development programme - drug development being a risky, resource intensive and time consuming process. At the same time several Indian academic institutions and national laboratories have established impressive infrastructure and developed excellent expertise in selected areas of drug development. Certification Procedure Dr. Andrew McMath, Certification Unit at EDQM The EDQM has initiated an inspection programme for manufacturing sites covered by a CEP. As stated in Directives 2004/27/EC and 2004/28/EC, manufacturers are not inspected systematically; the choice is made according to the priorities set for the programme. This programme optimises the available inspection resources through close collaboration with the European authorities, as well as non-European inspection authorities. Competency assessment in South Australia - A system in Support of Better Pharmacy Practice Dave Cosh, Peter Halstead, Tim Gross (Dave Cosh is fellow of the Pharmaceutical Society of Australia (PSA) and Society of Hospital Pharmacists of Australia (SHPA)) In 2004 the Pharmacy Board of South Australia (the registering body for South Australian pharmacists) introduced a program of mandatory competency assessment (ENRICH), which came into place in 2005. This paper describes the ENRICH program with a focus on how it has strengthened a relatively new form of pharmacy practice in Australia - medication review. Application of Nanopharmaceuticals in Cancer Manish Diwan, Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, Canada The pathogen mimicking biodegradable nanospheres was investigated as a nanotool to deliver vaccine antigens to DCs in an 'immunostimulatory microenvironment'. The study shows that these nanospheres were efficiently internalized by both mouse and human DCs, and were able to induce primary antigen-specific T cell responses ex vivo (human model) and in vivo (mouse model). Examples will be discussed from studies employing model as well as therapeutic antigens for e.g., tumour cell lysate proteins, MUC1 based peptide. Importantly, tumour challenge studies in immunized mice showed the rejection of a MUC1+ cancer in both wild type as well as transgenic animal model. These studies have important implications for the anti-cancer, anti-viral therapies requiring antigen delivery to DCs. Indian Pharmacopoeia Commission G N Singh, Director and Govt. Analyst, Central Indian Pharmacopoeia Laboratory, Ghaziabad The formation of an autonomous Indian Pharmacopoeia Commission (IPC) has been one of the most cherished dreams of the pharmaceutical professionals of the country. Initially funded through the World Bank supported Capacity Building Project for Food Safety and Quality Control of Drugs, the IPC is today a reality and is to start functioning immediately using the existing facilities of Central Indian Pharmacopoeia Laboratory (CIPL), Ghaziabad, UP. IP Commission is precisely meant for undertaking the task of setting standards for drugs. Role of Surfactant System of Lung in Pulmonary Oedema G. J. Rao Pulmonary surfactant is a lipoprotein. The lipids are phospholipids, the predominant being dipalmitoyl phosphotidylcholine (DPCC). The lipids lower the surface tension thereby preventing collapse of alveoli. Four types of surfactant proteins have been identified. Unabated surface tension forces were also speculated to cause pulmonary edema. High surface tension pulmonary oedema induced by the author and co-workers and by Nieman and Bredenberg provided experimental proof on the additional role of surfactant in the prevention of pulmonary oedema. They have also screened drugs used in edema to observe whether some of them have specific effects on surfactant system of lung so that they could be selectively used in pulmonary edema. These findings on the role of surfactant in prevention of pulmonary oedema as well as on possible special pharmacological agents useful in pulmonary edema would be discussed in the plenary lecture. MicroSeq Microbial identification System from Applied Biosystems Lidija Raicevic Maravic, EMT business development manager, EMT The MicroSeq System is the type of method recommended under FDA current Good Manufacturing Practices (cGMP) for drug manufacturers. Identification of bacteria using comparative sequence analysis provides unprecedented accuracy and reproducibility of results, especially for biochemically inert species, or "fall through" samples. Unlike other bacterial identification systems, no gram stain results, biochemical information, or special growth conditions are required for identification. Cardiovascular Adverse Effects of Atypical Antipsychotic Drugs: Application of Pharmaceutical Care Principles in Maintaining Schizophrenic Patient with Atypical Antipsychotic Pharmacotherapy G S SHANKAR, Asst Professor of Pharmacy, Practice-Clinical Psychopharmacology, College of Pharmacy, Western University, Pomona, US Atypical antipsychotic medications can cause cardiovascular side effects such as tachycardia, CAD, orthostatic hypotension, and arrhythmias. In rare cases, these medications can also cause Congestive Heart Failure, myocarditis and sudden death. Pharmaceutical Care services provided by clinical pharmacist, in a mental health facility, with careful assessment, proper monitoring, education and counselling, can have greater impact on total patient care and the healthcare expenditures of patients with schizophrenia. . Primary prevention is usually the best management option for these serious adverse effects. The Forthcoming Critical Issues Involving IPR in India A.M. Chakrabarty, Dept. of Microbiology & Immunology, University of Illinois College of Medicine, Chicago, IL 60612, US With increasing research expenditure in life sciences, the enactment of a Bayh-Dole type of legal framework for the ownership of the intellectual property by academe from government funded research and a clear delineation of benefit sharing under the traditional knowledge and convention on biological diversity, as well as with increasing interest for conducting human clinical trials in India under an acceptable data exclusivity protection, the Indian pharmaceutical industry is poised to become a major international force to be reckoned with. A well-defined and forward-looking set of policy is mandatory for accomplishing these goals. Implementation of Home Medication Management Services to Community Based Patients Grant Kardachi, PSA (SA) President and Community Pharmacist In obtaining the respect of the medical practitioners, pharmacists must illustrate that they are adding value to the health outcome process and to achieve this, they must be up skilled. This can be achieved by further education and a key component, particularly in the early stages, is a structured mentoring process. Mentoring by skilled clinical pharmacists can add valuable support to the local community pharmacist. Improved quality of service will more quickly gain the respect of other health professionals and be more likely to sustain the process. The Indian Pharma Industry and the Global Generics Market Dr Hans Lofgren, Deakin University, Melbourne and Prabodh Malhotra, Victoria University, Melbourne, Australia This paper provides an assessment of the role of Indian firms in global generics markets, set against the backdrop of an analysis of the challenges associated with the WTO patent regime. Strong imperatives grounded in the principles of rational, evidence-based, and cost-effective use of medicines drive the increased use of generics across both highly regulated and developing country markets. The focus of the paper is on the contradictions and dilemmas of the integration of Indian pharmaceutical firms into global markets. Trends in Animal Models of Human Diseases Dr. S.Harinarayana Rao, Associate Research Director, Reliance Life Sciences, Navi Mumbai Considering the high cost and slow progress of the disease manifestation in rodents, efforts are on to identify lower organisms for their utility in drug screening. Zebrafish, Fruit fly and Caenorhoditis elegans have resulted as secondary screening systems to validate in vitro hits. Models for Parkinson's and Alzheimer's have been developed in flies and C. elegans. Among these non-conventional models, Zebrafish seems to be the most suitable, because it has similar organs found in mammals. Most human genes have homologues in Zebrafish. These small animal models are available through commercial suppliers. Housing and experimenting with these alternative model systems is cost effective and a high throughput screening can be achieved. Polymeric Microspheres in Medicine and Surgery A Jayakrishnan, Polymer Chemistry Division, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala The potential of microspheres per se as therapeutic substances has been investigated by us to treat ailments such as haemorrhages, haemostasis, arterio-venous malformations and tumours with a high degree of clinical success. Microspheres derived from biocompatible, non-biodegradable polymeric hydrogels have been used for the purpose. Biodegradable polymeric microspheres derived from the milk protein casein and the biodegradable polysaccharide chitosan have been shown to be effective for sustained delivery of many drugs including cytotoxics and steroids. After a brief overview of the potential of microsphere-based delivery systems in controlled drug delivery, the results of some of our studies will be presented and discussed. Recent Developments in US-FDA and International GxP Regulations and Guidelines Dr. Ludwig Huber, worldwide compliance fellow at Agilent Technologies The presentation will discuss highlights from the new regulations guidelines. Examples are initiatives of the FDA, International Conference for Harmonization (ICH), International Society for Pharmaceutical Engineering (ISPE), GAMP, USP and the SAFE (Secure Access for Every One) for risk based compliance, process analytical technology, equipment and computer validation and management of electronic records and signatures. The main focus will be to give recommendations on how to implement the regulations and guidelines in the most cost effective way using modern technologies. Combinatorial biosynthesis of natural products Kayser O, Department of Pharmaceutical Biology, GUIDE, University of Groningen, the Netherlands The first important step in the biosynthesis is forming of amorpha-4, 11-diene (AMD) from farnesyldiphosphate (FDD) by amorpha-4,11-diene synthase (AMDS). Cloning strategies of the AMDS gene and other upstream genes in the artemisinin biosynthesis are demonstrated. Futher background information about B. subtillis engineering and bacterial terpenoid pathway modification will be provided. Characterisation of catalytic activity and mode of catalysation of FDD to AMD is discussed based on site directed mutagenesis of AMDS proteins and 3D modelling of obtained mutants. Strategy for pharma SMEs V. Madhusudan, Chief Executive - Technical, Banner Pharmacaps (I) Private Ltd., Bangalore. Indian Pharmaceutical Industry's back bone is the SMEs account for 90% of manufacturing units, 70% of Production and Employees 66% of people. In order to maintain the status, SME has to continue to survive and contribute to the market which is estimated to grow two fold over the next 4 years. In today's Global and Domestic environment, the SMEs are undecided lot, looking for direction for the future. A SWOT of Indian Industry reveals various opportunities available for the future of Small & Medium Enterprises (SMEs). The presentation will examine each of the alternatives like exports, contract manufacturing, M&A reveals various challenges.One of the most SMART alternatives appears to be in the field of NDDS. The pre-requisites for work on NDDS are discussed in detail and some of the successful NDDS and plat form Technologies are discussed. Traditional Medicine/ Herbal Drugs: Challenges and Opportunities Prof. M.J.Nanjan, Director, TIFAC CORE in Herbal Drugs, JSS College of Pharmacy, Nilgiris, Tamil Nadu Is it possible to develop new quality control techniques for Ayurvedic polyherbal formulations and evolve new biomedical and chemical parameters in terms of efficacy of the products? Can we undertake studies to determine the truly active component(s) in these polyherbal formulations? Can we conduct reverse pharmacology on these and develop new leads/drugs? Is it possible to work out the chemical changes that occur at every stage of their preparation and isolate some active moieties from the final formulations? Is it possible to isolate bioactive metal complexes from herbomineral preparations? All these would be discussed. Pharmaceutical Institutions in Search of Perfection: Indian Pharmacopoeia Commission Dr. P R Pabrai, Ex-Director, Central Indian Pharmacopoeia Laboratory, Ex-Head - Corporate Quality Assurance, Ranbaxy Laboratories Ltd The proposal for setting up a Commission has been moving up and down in the Ministry of Health since then. Ultimately, the Ministry issued its Order for setting up the Indian Pharmacopoeia Commission. While this is gratifying the details of its working, management that has been proposed by the Ministry of Health are quite disturbing. It is proposed to discuss the limitations of the proposed arrangements and practical suggestions for making suitable alterations in them are proposed to be discussed during the presentation. Clinical Research: Present Status and Future Challenges Dr S K Gupta, Dean, Institute of Clinical Research (India) Pharmacy Professionals will play a vital role in clinical research. They will serve the clinical research industry in the capacity of clinical research managers, associates, monitors and experts in regulatory affairs. These job opportunities will provide them a very high salary and status. However, there is a need for specialized training in the field of clinical research at the designated institutions of clinical research. Cell Culture Systems For In Vitro Cytotoxicity Evaluations M. Raj Rajasekaran, Director, Urology Research Laboratories, University of California San Diego, US There is evidence to support the negative impact of certain drugs, free radicals, and other environmental toxins on the genitourinary (GU) system. In order to develop compounds to counteract the damaging effects of these toxins, it is important to determine the type and the intracellular location of specific toxic events. A cell culture model may be employed for this purpose to allow evaluation of specific damage at the cellular and subcellular level, and evaluation of the biochemistry of the damage. Study results suggest that GU smooth muscle cells are a viable model for the quantitative evaluation of in vitro cytotoxicity, and they are susceptible to environmental toxins such as peroxide, ethanol, and peroxinitrites. HPLC and SFC Purification of Pharmaceuticals-Real Life Case Studies! P. K. Dutta, Eka Chemicals AB, Separation Products, 445 80 Bohus, Sweden The presentation will include real life examples of method development for purification of pharmaceuticals by HPLC and SFC. The first example will deal with loadability and productivity calculations for a diasteromeric oxirane using normal phase HPLC. The other will deal with optimizing separation performance for ibuprofen using chiral SFC. Unique advantages and disadvantages of each of these techniques will be discussed. Bioinformatics - An Opportunity for Shortening the Drug Discovery Cycle Samir I. Patel, Co-Founder & president, BREZE, Inc., USA This presentation describes one of many opportunities for bioinformatics to shorten the process of pharmaceutical development dramatically with the use of emerging information technologies and tools for scientific computing, analysis and decision support. In turn, these new approaches promise to not only reduce the overall cost to take a product to market, but to also enable entirely new possibilities in scientific research. Computer Aided Drug Design Topological Indices and their Applications in QSAR Vijay Kumar Agrawal, QSAR and Computer Chemical Laboratories, APS University, Rewa, M.P., India The term molecular topography is applied to three-dimensional structure, whereas molecular topology, the set of atoms and connections, refers to the molecular structure as defined by Eliel. Whatever the consequences of each of these molecular aspects, the three-dimensional structure follows from the molecular topology. In the discussion of chemical graph theory, the focus of attention is on ways of characterizing the topology of molecules using numerical indices and applying these indices to investigation in QSAR. The paper will also discuss how topological indices are used for modelling the biological activities of various molecules. Changing Dynamics of the Pharmaceutical Business - Strategies for Survival & Growth Sachin C Itkar, Head - Innovative Packaging Solutions, Bilcare Limited, Pune The presentation will discuss the global pharma scenario and its changing dynamic & also highlight some of the survival and growth strategies for the Indian pharma companies.