Day 3 :
- Track 7: Intellectual Property Management
Track 8: Marketing Authorizations, Advertising and Marketing Practices
Track 9: Drug Designing and Development
Location: Sciphol
Chair
Rajiv Mahendru
B.P.S. Government Medical College for Women, India
Co-Chair
Brian Hill
Brian Hill Consulting, USA
Session Introduction
Juhi Tiwari
Jayoti Vidya Peeth Womens’ University, India
Title: A review on autism
Time : 10:00-10:25
Biography:
Juhi Tiwari is an MPharm in pharmacology from Jayoti Vidya Peeth Womens’ University, Jaipur, India. She has attended National and International conferences and has published research paper on antipyretic effect.
Abstract:
Autism is a congenital neurological disorder characterized by impairment of socialization, abnormalities of communication, limited activity and curiosity. Clinical signs of Autism Spectrum Disorders (ASD) are frequently presented at 3 years of age with abnormalities in social, communication and play behaviour, though early indicators of autism can be detected as early as 14 months of age. Repetitive, stereotyped, and obsessive compulsive–like behaviours are also prominent features of the disorder and are oft en accompanied by cognitive impairment, seizures or epilepsy, gastrointestinal complaints, disordered sleep, and others are frequent problems in the clinical profiles of patients with autism. There are certain factors that contribute to the pathogenesis of ASD, such as dysfunctions of the serotonergic system, have been implicated in autism. The serotonergic system appears to be developmentally dis-regulated in autism. The study suggested that the clinical onset of autism appears to be preceded by two phases of brain growth abnormalities: a reduced head size at birth, then a sudden and excessive increase between 1–2 months and 6–14 months of age. Neuroimaging studies have shown that an abnormal pattern of brain overgrowth also occurs in areas of the frontal lobe, cerebellum and limbic structures between 2 and 4 years of age, a pattern that is followed by abnormal slowness in brain growth. Another study revealed that the oxidative stress might be unregulated in patients with ASDs, possibly due to decreased ability to neutralize free radicals. One study of autistic children and controls reported that plasma S –adenosyl homocysteine, which was used as an indicator of methylation ability, was signifi cantly lower in autistic children. Another study found reduced plasma levels of the key endogenous antioxidant S–adenosyl methionine. Other reviews suggested that the Erythrocyte Superoxide Dismutase (SOD) and the endogenous antioxidants plasma glutathione peroxidase and erythrocyte glutathione peroxidase (GSH-Px) were also signifi cantly reduced in autistic children. Increased mitochondrial metabolism and oxidized mitochondrial proteins in temporo-cortical gray matter in post-mortem samples from autistic patients as compared to controls was also seen. Calcitriol down-regulates production of inflamatory cytokines in the brain, which have been associated with autism. Vitamin D deficiency impairs glutathione metabolism, which may explain the link between autism and oxidative stress, as well as autism and mercury accumulation. Consumption of vitamin Dcontaining fish during pregnancy reduces autistic symptoms in children. It seems probable that autism’s neuro-developmental defect is ‘multi-domain’ in origin (rather than a single anomaly) and is, hence, distributed across numerous levels of study (genetic, immunepathogenic, etc.). A more defi nitive understanding of the pathogenesis could facilitate the development of better treatments for this complex psychiatric disorder.
Avong
Avong, Institute of Human Virology, Nigeria
Title: The effectiveness of the spontaneous reporting system
Time : 10:25-10:50
Biography:
Avong is a public health pharmacist, implementer of public health initiatives and a certified operational researcher. He holds a Bachelor of Pharmacy (BPharm) from the Ahmadu Bello University, Zaria, Nigeria and a Master of Public Health (MPH) from the University of the Western Cape, South Africa. He is also in the process of pursuing a PhD in Pharmacovigilance and Pharmaco-epidemiology. In 2009, he inspired the setting- up of the spontaneous reporting system (SRS) in two public health programs (ART and MDRTB) and supervised the collection and analysis of over 2000 individual case reports (ICRs) from these programs. He has published papers in ADRs and adherence to anti-retroviral therapy (ART). Furthermore, he has peer-reviewed many manuscripts and participated in several international researches like the START study, while contributing to the development of the current “Integrated National Guidelines for HIV Prevention Treatment and Care in Nigeria”. As the head of the Pharmacy Division and Associate Director with the Institute of Human Virology, Nigeria (IHVN) – a US PEPFAR and Global Fund implementing partner with over 200,000 HIV/AIDS patients in care, he oversees the delivery of pharmaceutical care service in all the grants. He served as the liaison officer between the Martindale Pharmaceutical Limited, UK and the Federal Government of Nigeria for the importation of Narcotics for the public sector in 2003/2004. His current interest is promoting pharmacovigilance in public health programs.
Abstract:
Background: Spontaneous reporting systems (SRS) as the United Kingdom Yellow Card Scheme for reporting suspected adverse drug reactions (ADRs), operate in most developed and developing countries. We tested the SRS in a national cohort of multi drug resistant tuberculosis (MDR-TB) patients in Nigeria. Methods: Using the Nigeria Yellow Form, we collected and analyzed suspected adverse drug reactions from MDR-TB patients undergoing the eight months intensive phase treatment. These patients were treated with a standard regimen, consisting of injectable Kanamycin, Amikacin or Capreomycin and oral Cycloserine, Levofl oxacin, Pyrazinamide, Prothionamide and Pyridoxine for at least eight months. Characteristics of AEs were documented and risk factors assessed. Results: We included 460 patients in the analysis: 62% were males; median age and weight were 33 years [Interquartile Range (IQR):28-42] and 51 kg (IQR: 45-59) respectively. Majority of the participants (44%) experienced AEs: four died of AEs associated conditions. Th e most commonly reported AEs were gastro-intestinal (n=100), neurological (n=75), ototoxic (n=72) and psychiatric (n=60). Ototoxic and psychiatric AEs were debilitating and required medical intervention and hearing aids. Most AEs occurred after 1-2 months of therapy; some treatment centers were twice as likely to report AEs compared with others, highlighting significant inconsistencies in reporting at different treatment centers. Patients with a higher body weight had an increased risk of experiencing AEs. No differences were observed in risk of AEs between HIV-infected and uninfected patients. Age was not significantly associated with AEs. Conclusion: The SRS proved effective at providing information on adverse drug reactions, which could aid post-marketing drug safety surveillance. Given its low cost, the SRS could be used in resource limited settings to detect, monitor and report ADRs, especially in public health initiatives like the anti-retroviral therapy programs.
Biography:
Your supply chain is critical to the success of your organizations business model. Whatever that may be! It is a fundamental pillar on which your organization can effectively provide quality products or quality services to your end customer or client. But! What if your supply chain is broken! What if one of your suppliers creates a situation that impacts not only your ability to supply your customer base but also significantly damages your brand reputation and company credibility? So! I ask you… ‘How well do you understand your vendor supply chain e.g. who is the actual manufacturer, what are the basics of how is the product made, what stages of the manufacturing process may use sub-contractors, who are the distributers and how is the integrity and quality of the supplied product controlled from the manufacturer and intermediaries to you’. How do you manage supply chain quality? How do you establish meaningful purchasing and quality agreements? How do you monitor supply chain quality? My aim in this presentation is to provide you some key areas you must consider when dealing with your supply chain; to introduce you to vendor quality agreements; and provide examples of supplier risk and monitoring techniques you can utilize in your organization to effectively manage your supply chain quality.
Abstract:
Your supply chain is critical to the success of your organizations business model. Whatever that may be! It is a fundamental pillar on which your organization can effectively provide quality products or quality services to your end customer or client. But! What if your supply chain is broken! What if one of your suppliers creates a situation that impacts not only your ability to supply your customer base but also significantly damages your brand reputation and company credibility? So! I ask you… ‘How well do you understand your vendor supply chain e.g. who is the actual manufacturer, what are the basics of how is the product made, what stages of the manufacturing process may use sub-contractors, who are the distributers and how is the integrity and quality of the supplied product controlled from the manufacturer and intermediaries to you’. How do you manage supply chain quality? How do you establish meaningful purchasing and quality agreements? How do you monitor supply chain quality? My aim in this presentation is to provide you some key areas you must consider when dealing with your supply chain; to introduce you to vendor quality agreements; and provide examples of supplier risk and monitoring techniques you can utilize in your organization to effectively manage your supply chain quality.
Sai Sankar Prabhu Kella
K. J. R. College of Pharmacy, India
Title: Stem cells and its basic use in medicinal field
Time : 11:30-11:55
Biography:
Sai Sankar Prabhu Kella is studying BPharm fi nal year at K. J. R. College of Pharmacy, affi liated to Andhra University.
Abstract:
Stem cells have the remarkable potential to develop into many different cell types in the body during early life and growth. In addition, in many tissues they serve as a sort of internal repair system, dividing essentially without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another type of cell with a more specialized function, such as a muscle cell, a red blood cell, or a brain cell. Stem cells are distinguished from other cell types by two important characteristics. First, they are unspecialized cells capable of renewing themselves through cell division, sometimes aft er long periods of inactivity. Second, under certain physiologic or experimental conditions, they can be induced to become tissue or organ-specific cells with special functions. In some organs, such as the gut and bone marrow, stem cells regularly divide to repair and replace worn out or damaged tissues. In other organs, however, such as the pancreas and the heart, stem cells only divide under special conditions. Until recently, scientists primarily worked with two kinds of stem cells from animals and humans: embryonic stem cells and non-embryonic “somatic†or “adult†stem cells. The functions and characteristics of these cells will be explained in this document. Scientists discovered ways to derive embryonic stem cells from early mouse embryos nearly 30 years ago, in 1981. The detailed study of the biology of mouse stem cells led to the discovery, in 1998, of a method to derive stem cells from human embryos and grow the cells in the laboratory. These cells are called human embryonic stem cells. The embryos used in these studies were created for reproductive purposes through in vitro fertilization procedures. When they were no longer needed for that purpose, they were donated for research with the informed consent of the donor. In 2006, researchers made another breakthrough by identifying conditions that would allow some specialized adult cells to be “reprogrammed†genetically to assume a stem cell-like state. This new type of stem cell, called induced pluripotent stem cells (iPSCs), will be discussed in a later section of this document. Stem cells are important for living organisms for many reasons. In the 3 to 5-day-old embryo, called a blastocyst, the inner cells give rise to the entire body of the organism, including all of the many specialized cell types and organs such as the heart, lung, skin, sperm, eggs and other tissues. In some adult tissues, such as bone marrow, muscle, and brain, discrete populations of adult stem cells generate replacements for cells that are lost through normal wear and tear, injury, or disease.
Amy Peterson
Quality Systems, USA
Title: Want to eliminate events & predict quality near misses; reduce deviation rate by >90% & gain >25% production effi ciency simultaneously?
Time : 11:55-12:20
Biography:
Amy Peterson is QA Manager at Quality Systems, USA.
Abstract:
Lessons learned from North America Commercial Nuclear: Design the Most Robust & Effective Deviation/CAPA System within the Pharmaceutical Industry, Predict but Monitor Effective Corrective Actions; Implement Quality Near Misses to Generate Preventive Actions, Encompass Adverse Human Error Trends; Utilize Error Prevention Techniques, Achieve Adherence to Standard Operation Procedures (SOP); Learn KEY Role of Human Factoring Processes and Instructions, Manage Human Error in Quality Systems to prevent events.
Wael Ebied
SQA Services Inc., USA
Title: New perspective on how to discover drugs from herbal medicines: Simulating wild animals self medication by human diseased-animal models to screen new therapeutics
Time : 12:20-12:45
Biography:
Wael Ebied has completed his BPharm from Tanta University with Postgraduate studies from Al-Azhar University School of Pharmacy. He is a certifi ed Senior Professional, SQA Services Inc., US leader in providing supply chain management, quality and engineering services to pharmaceuticals, medical devices and highly regulated industries. He has published more than 5 papers in reputed journals and has been serving as an Editorial Board Member of repute. He has more than twenty years’ experience in pharmaceutical industries, biotechnology, medical devices and APIs. He is an accomplished technical presenter with numerous projects, scientifi c publications, participated in 1 patent and was awarded 7 premiums.
Abstract:
Humans have domesticated plants and animals since around 12,000 BCE, using selective breeding or artificial selection (as contrasted with natural selection). The process of selective breeding, in which organisms with desired traits (and thus with the desired genes) are used to breed the next generation and organisms lacking the trait are not bred, is the oldest form of genetic modification by humans. A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. GMOs are used in biological and medical research, production of pharmaceutical drugs, and experimental medicine (e.g. gene therapy). The term “genetically modified organism†does not always imply, but can include, targeted insertions of genes from one species into another. Genetically modified animals currently being developed can be used to research human diseases (for example, to develop animal models for these diseases). Transgenic animals are used as experimental models to perform phenotypic and for testing in biomedical research. Genetically modified (genetically engineered) animals are becoming more vital to the discovery and development of cures and treatments for many serious diseases. Zoopharmacognosy is a behaviour in which non-human animals apparently self-medicate by selecting and ingesting or topically applying plants, soils, insects, and psychoactive drugs to treat or prevent disease. Animals ingest non-foods such as clay, charcoal and even toxic plants, apparently to prevent parasitic infestation or poisoning. Self-medication in wild animals remains a controversial subject because evidence is mostly circumstantial or anecdotal, however, there are many purported examples. The methods by which animals self-medicate vary, but can be classified according to function as prophylactic (preventative, before infection or poisoning) or therapeutic (aft er infection, to combat the pathogen or poisoning). Although the underlying psychological and physiological mechanisms of such learned selfmedicating behavior are unclear, its adaptive value is proposed to be widespread, encompassing diseased laboratory animals. The proposal of this research article is: How human diseased-animal models will keep themselves well in an artificial wild and what we can learn from them in screening new therapeutics. The current objective is to test the hypothesis that zoopharmacognosy is operational in GMOs in artificial wild health. Once a molecular target of disease is revealed, one can use this perspective for identifying active ingredient(s) from herbal medicine in new drug discovery. The generation of transgenic animals by biotechnological techniques will provide human disease models for screening drugs of clinical interest with the help of zoopharmacognosy. Some of the compounds have been identified by zoopharmacognosy kill parasitic worms, and some of these chemicals may be useful against tumors. There is no question that the templates for most drugs are in the natural world. The question is how to discover using zoopharmacognosy by GMOs.
Nadeem Ahmad
Advanced product design services, Canada
Title: Formation of nucleation and coalescence of bubbles in different benzene and liquid solutions by liquid - liquid extraction using partial miscible mixtures
Time : 13:45-14:10
Biography:
Nadeem Ahmad works at Advanced Product Design Services, Canada.
Abstract:
Nucleation and coalescence are used in various chemical industries. Liquid-liquid extraction is a process in which a solute is transferred at a high mass transfer rate from a native solvent to a primary solvent which involves the addition of a primary solvent and a modifier. Extraction of efrotomycin from a fungal fermentation broth and that of beta-galactosidase from an aqueous suspension of disintegrated E. coli cells are the best examples of nucleation and coalescence of bubbles in different benzenes and liquid solutions by liquid-liquid extraction using partially miscible mixture. Conventional and high resilience foams are normally processed through the similar methods. Major factors contributing to the variation in the mechanical properties of these two types of foams are only the order of the chemical processes. During the nucleation, air is entered in the absence of surfactant. Mechanical energy of the mixing process and the surface tension of the surfactant determine the size of the foam cells. Growth of bubbles involves diffusion followed by the expansion of gas; surface tension is the cell size determining factor in this process. Growth of bubbles is followed by the process coalescence; it includes the breaking of the fluid layer between two bubbles. Coalescence may result in crack formation or collapse of the whole foam.
Damaris Silveira
University of Brasilia, Brazil
Title: Sharing regulatory data as tools for strengthening health systems in the region of the Americas
Time : 14:10-14:35
Biography:
Dr. Damaris Silveira is Professor at University of Brasilia, Brazil
Abstract:
Backgrounds: Regulatory transparency is an imperative characteristic of a reliable National Regulatory Authority. In the region of the Americas, the building process of an open government is still fragile and fragmented on Health Regulatory Agencies (HRA) even on Regional Reference Authorities (RRA). Purpose: This paper assesses the transparency status of RRA, focusing on some medicine life-cycle documents (Medicine Dossier, Clinical Trial Report, and Inspection report), as tools for strengthening health systems. Methods: Through a qualitative and descriptive evaluation of regulatory transparency on RRA, it was portrayed in two different branches: information public disclosure and inter-agency data and work sharing. Results: The risk benefits of information public disclosure were assessed considering the involvement and roles of multi-stakeholders (healthcare professionals, regulators, industry, community, and academics) bearing in mind the protection of commercially and personally confidential data. Inter-agency data and work sharing were inserted in the context of harmonization and co-operation projects that focus on regulatory convergence. Conclusions: Technical and practical engagements are proposed to improve and strengthen health systems in the region of the Americas through establishment of an openness directive over pharmaceutical regulatory environment. To successfully address these challenges is crucial that regional leadershipssteer and support collaborative regional alliances toward the development and establishment of a trustful regulatory environment as well as a sustainable public health system in the Latin America and the Caribbean, using as reference international successful initiatives besides taking into account domestic characteristics and experiences of each single country.
Mamoona Firdous Naqvi
Gulf Pharmaceutical Industries, UAE
Title: Facial cosmetics & role of pharmacist in client education
Time : 14:35-15:00
Biography:
Mamoona Firdous Naqvi has professional experience stretched over 15 years mainly in regulatory affairs, business development and medical information with three leading organization Gulf Pharmaceutical - Julphar , Sanofi Aventis, Pakistan and Aga Khan Hospital one of the renowned hospital worldwide. In a affiliate role and regional role in some extent, she is highlighted with proven track record of achievements with consistent progression in the career, and she is equipped with dual qualifi cation–a pharmacist (graduate in pharmacy and Master in Pharmaceutical Sciences) and MBA in Marketing discipline (First class First, Gold Medallist). She has solid understanding of product development, good interpersonal skills, and has excellent communication skills with sensitivity for confidential information and socio-cultural issues, strong planning skills with proven competence in establishing new processes for faster market access, and she is expertise in develop and implement regulatory strategies, appreciation for cultural diversity and team work.
Abstract:
The skin is the body’s largest organ. Nevertheless, the importance of its functional role is oft en underestimated, and its care is taken for granted. Establishing a skin care regimen is important to maintain healthy, hydrated skin, and incorporating preventive measures can help reduce or eliminate exacerbating conditions that may make unprotected skin more susceptible to dermatologic problems. Pharmacists receive frequent requests for information about various skin care products available for cleansing, moisturizing, and photo protecting the skin. As accessible health care professionals, pharmacists are in a key position to educate patients about appropriate skin care, especially the necessity of using moisturizers several times a day to improve the skin’s appearance and texture and sustain its protective function. To understand the importance of moisturizing the skin and factors that may make the skin more susceptible to dryness, pharmacists must be familiar with the skin’s physiology. Such knowledge allows pharmacists to make appropriate recommendations to patients about skin care products. The goals of therapy are to restore the hydration and barrier function of the skin. To that end, the patient should be educated in how to establish a routine cleansing and moisturizing regimen. The Role of the Pharmacist: When counseling patients, pharmacists should take the opportunity to increase awareness about the importance of a daily skin care regimen and explain the consequences of not taking care of the skin. If necessary, pharmacists should refer patients to a dermatologist. Pharmacists can be instrumental in identifying individuals who may be at a greater risk for developing dry skin, particularly those currently taking prescription medications or those with certain medical conditions. For example, approximately 33% of patients with diabetes have some type of dermatologic disorder that is the result of or affected by the diabetes. Through pharmacists’ counseling, patients with diabetes can be reminded that, in addition to maintaining glycemic control, it is also imperative to adhere to a daily skin care regimen that includes mild cleansers and moisturizers to prevent further complications associated with dry skin. As health care professionals, pharmacists can provide expertise, knowledge, and advice to patients about skin care products and the health benefits of healthy, hydrated skin.
Lantider Kassaye Bekele
GlaxoSmithKline Ltd., Ethiopia
Title: Quality assessment and in vitro dissolution profi le: Comparison of different brands of amoxicillin
Time : 15:15-15:40
Biography:
Lantider Kassaye Bekele is a Pharmacist by profession and has completed his MSc degree in Pharmaceutical Analysis and Quality Assurance from Addis Ababa University, Ethiopia. He had worked in Food, Medicine and Healthcare Administration and Control Authority (FMHACA) of Ethiopia in different positions. He has published more than five scientific papers in the international journals in his field. He was the Chairperson of the National Technical Committee for Standards of Alcoholic Beverage. He has served as a Member of Pharma Forum Committee, Ethiopian Pharmaceutical Association. Moreover, he was a Member of Drug Advisory Committee of the Regulatory Authority. Currently, he is working for GlaxoSmithKline Ltd as Regulatory Executive for Ethiopia and Djibouti.
Abstract:
Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals manufactured below established standards of quality and therefore dangerous to patients’ health and ineffective for the treatment of diseases. Counterfeiting occurs both with branded and generic products. The 2008 report of WHO on the estimation of the proportion of counterfeiting by category revealed that the most counterfeited drugs were in the genito-urinary category (37 percent) followed by anti-infective (12 percent) and central nervous system drugs (12 percent). Amoxicillin is one of the most susceptible medicines for counterfeiting in Ethiopia because of its high demand in the market. Ten brands of amoxicillin in solid oral dosage forms were subjected to analysis according to USP (2011) monograph for identification, uniformity of dosage units, assay and dissolution performance. Results indicated that all of the samples were in accordance with the pharmacopoeia specifications. However, seventy percent of the tested products fulfilled dissolution test aft er stage II. And hence, more study was done on the dissolution profiles of the capsules. The in vitro dissolution profiles were compared using dissolution efficiency model. Only one of the eight brands was found to be similar with the innovator brand. Therefore, from the study, it can be understood that even though ninety percent of the tested samples were not identical with the innovator brand, they fulfill the pharmacopeial requirements. Further studies need to be done on other antiinfective, genito-urinary and central nervous system drugs. Remarkable attention should be given for expensive, highly demanded and easily degradable medicines in order to assess and look into the existence of counterfeit and sub-standard drugs.
Rashid Mahmood
Surge Laboratories Private Limited, Pakistan
Title: Quality risk management system
Time : 15:40-16:05
Biography:
Rashid Mahmood has 12 years diversified work endurance of Laboratory Management, Quality Assurance, Registration Affairs, GMP Requirements, Drugs Laws, Statistical Methodology, Method Validation, Process & Cleaning Validation, Certifi cate Courses on cGMP, cGLP, Process Validation, ISO/IEC 17025:2005, 14001:2004, OHSAS 18001:2007, and 9001:2008 QMS with strong scientifi c, analytical, statistical, planning, managerial and training skills. Currently he is working as a Senior Manager Quality Operations for Surge Labs (Pharmaceutical Plant) which is the best export oriented company in Pakistan.
Abstract:
In the pharmaceutical industry every product and every process is associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in -recent guidance as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk-based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most. QRM improves risk awareness and accelerates detection of potential issues by analyzing and comparing existing data from a quality perspective to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. In addition quality risk management improves decision making if a quality problem arises. It should include systemic processes designated to co-ordinate, facilitate and improve science-based decision-making with respect to risk. Quality Risk Management can be applied not only in the manufacturing environment, but also in connection with pharmaceutical development and preparation of the quality part of marketing authorization dossiers. The guideline applies also to the regulatory authorities in the fields of pharmaceutical assessment of the quality part of the marketing authorization dossier, GMP inspections and the handling of suspected quality defects. ICH Q9 - Quality Risk Management provides an excellent high-level framework for the use of risk management in pharmaceutical product development and manufacturing quality decision making applications. It is a landmark document in acknowledging risk management as a standard and acceptable quality system practice to facilitate good decision-making with regard to risk identification, resource prioritization, and risk mitigation / elimination, as appropriate.
Tariq Jamshaid
Surge Laboratories Private Limited, Pakistan
Title: Pharmaceutics & novel drug delivery systems
Time : 16:05-16:30
Biography:
Tariq Jamshaid has 11 years diversifi ed work experience of Quality Control, Manufacturing Processes, Pharmaceutical Product Design & Development, Process Optimization, Laboratory Management, Drug Registration Processes, GMP Requirements, Drugs Laws, Statistical Methodology, Manufacturing Process Validation, Cleaning Validation, ISO 9001:2008 with strong scientifi c, analytical, statistical, planning, managerial and training skills. Currently he is working as a Sr. Manager Production & Development for Surge Laboratories Private Limited, Pakistan.
Abstract:
Novel Drug delivery System (NDDS) refers to the approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effects. NDDS is a system for delivery of drug other than conventional drug delivery system. NDDS is a combination of advance technique and new dosage forms which are far better than conventional dosage forms. Advantages of Novel Drug Delivery System are: Optimum dose at the right time and right location, Efficient use of expensive drugs, excipients and reduction in production cost, Beneficial to patients, better therapy, improved comfort and standard of living. Basic modes of novel drug delivery systems are: Targeted Drug Delivery System, Controlled DrugDelivery System and Modulated Drug Delivery System Factors affecting the design of controlled release products are: Physicochemical properties of a drug, Route of administration, Acute / Chronic therapy, Target sites, The Patient, The disease state/level. Classification of novel drug delivery system with reference to release control is: 1. Matrix diffusion types (In which rate of release is controlled by diffusion of dissolved drug in the matrix). a. Rigid Matrix Diffusion (in which insoluble plastic materials like PVP & fatty acids are used. b. Swellable Matrix Diffusion (in which Hydrophilic gums like guar gum, tragacanth, HPMC, CMC, Xanthan Gum & Polyacrilamides are used). These are also called Glassy Hydrogels and popular for sustaining/control the release of highly water soluble drugs. c. Reservoir System (in which polymer content in coating, thickness of coating & hardness of microâ€capsules control the release of the drug). 2. Dissolution Matrix Type (in which drug is homogeneously dispersed throughout in a rate controlling medium waxes like bees wax, carnuba wax, hydrogenated castor oil, which control the drug dissolution by controlling the rate of dissolution). a. Encapsulation (in which dissolution is controlled by dissolution controlling coating system like use of cellulose, Polyethylene. Glycols, polymethylacrylates and waxes. Dissolution rate also depend upon coating material stability and thickness of coating film. 3. Dissolution & Diff usion Controlled Release System (in which drug is encapsulated in partially soluble membrane, pores are created due to soluble parts of coating film which permits entry of aqueous medium into core and drug dissolution starts by diffusion of dissolved drug out of system. Mixture of water soluble PVP and water insoluble ethyl cellulose is used for this purpose). 4. Water penetration/Osmotic Pressure Controlled NDDS 5. Chemically controlled NDDS 6. Hydrogels (in which three dimensional structures of hydrophilic polymers having chemical and physical cross links provide a network structure to hydrogels. These are insoluble due to network structure and provide desirable protection of liable drugs, proteins and peptides). 7. Ion Exchange Resins Controlled Release Systems
Nadeem Ahmad
Advanced product design services, Canada
Title: Formation of nucleation and coalescence of bubbles in different benzene and liquid solutions by liquid - liquid extraction using partial miscible mixtures
Biography:
Nadeem Ahmad is a researcher at Advanced product design services, Canada
Abstract:
Nucleation and coalescence are used in various chemical industries. Liquid-liquid extraction is a process in which a solute is transferred at a high mass transfer rate from a native solvent to a primary solvent which involves the addition of a primary solvent and a modifier. Extraction of efrotomycin from a fungal fermentation broth and that of beta-galactosidase from an aqueous suspension of disintegrated E. coli cells are the best examples of nucleation and coalescence of bubbles in different benzenes and liquid solutions by liquid-liquid extraction using partially miscible mixture. Conventional and high resilience foams are normally processed through the similar methods. Major factors contributing to the variation in the mechanical properties of these two types of foams are only the order of the chemical processes. During the nucleation, air is entered in the absence of surfactant. Mechanical energy of the mixing process and the surface tension of the surfactant determine the size of the foam cells. Growth of bubbles involves diffusion followed by the expansion of gas; surface tension is the cell size determining factor in this process. Growth of bubbles is followed by the process coalescence; it includes the breaking of the fluid layer between two bubbles. Coalescence may result in crack formation or collapse of the whole foam.
Mamoona Firdous Naqvi
Gulf Pharmaceutical Industries, UAE
Title: Facial cosmetics & role of pharmacist in client education
Time : 14:35-15:00
Biography:
Mamoona Firdous Naqvi has professional experience stretched over 15 years mainly in regulatory affairs, business development and medical information with three leading organization gulf pharmaceutical - julphar , Sanofi aventis, pakistan and Aga khan hospital one of the renowned hospital worldwide , in affiliate role and regional role in some extent, highlight with proven track record of achievements with consistent progression in the career, equipped with duel qualification – a pharmacist ( graduate in pharmacy and master in pharmaceutical sciences ) and MBA in marketing discipline ( first class first,gold medallist )
Abstract:
The skin is the body\'s largest organ. Nevertheless, the importance of its functional role is often underestimated, and its care is taken for granted. Establishing a skin care regimen is important to maintain healthy, hydrated skin, and incorporating preventive measures can help reduce or eliminate exacerbating conditions that may make unprotected skin more susceptible to dermatologic problems. Pharmacists receive frequent requests for information about various skin care products available for cleansing, moisturizing, and photo protecting the skin. As accessible health care professionals, pharmacists are in a key position to educate patients about appropriate skin care, especially the necessity of using moisturizers several times a day to improve the skin\'s appearance and texture and sustain its protective function. To understand the importance of moisturizing the skin and factors that may make the skin more susceptible to dryness, pharmacists must be familiar with the skin\'s physiology. Such knowledge allows pharmacists to make appropriate recommendations to patients about skin care products. The goals of therapy are to restore the hydration and barrier function of the skin. To that end, the patient should be educated in how to establish a routine cleansing and moisturizing regimen. A variety of strategies can be incorporated into a daily routine to prevent and treat dry skin. Selection of proper cleansers and moisturizers is essential to ensuring healthy skin; thus, pharmacists should evaluate the patient\'s medical and medication history and inquire about the patient\'s current skin care regimen, including types of cleansers and/or moisturizers used and the frequency of use. Referral to a dermatologist is recommended for patients with severe dry skin.
Boyd L. Summers
Weber State University Business Management, USA
Title: The values of quality practices
Biography:
Boyd L. Summers is a Quality Technology Consultant for BL.Summers.Consulting.LLC located in Seattle, Washington. He has 30 years of experience and continues to solve complex quality problems are addressed, resolved and compliant. author of the two software technology books titled; “software engineering reviews and audits.†and “effective methods for software and systems integration. boyd provides software articles to software engineering journals and magazines. topics include:system design, software requirements, software design, software test and evaluation, configuration management, quality assurance, process and product evaluations. applies processes in agile, lean and six-sigma including a software technology speaker at conferences and member of the American Society Quality (ASQ).
Abstract:
Quality Assurance personnel are trained and chartered to partner with companies and/or institutions to instill quality, maintain process and requirements compliance thru in-house quality audits, evaluations and provide quality oversight. Quality is a practice to exam processes to ensure conformance to required standards and contract requirements and to show the values of quality practices. For creating a community to working together and establish an inspired future and customers is important. Quality values drive the growth of people and businesses through personal and professional development focused on disciplined execution and quality. Companies and/or institutions must maintain historical records (electronic or paper) such that they accurately reflect the activities and status they represent. Records are required by Quality Assurance to audit and provide effective evaluation to ensure contract, and company requirements are retained by Quality Records.
Osemeke U. Osokogu
Erasmus Medical Center, Netherlands
Title: Impact of pediatric drug legislations on methods development for post-marketing safety surveillance: Opportunities and challenges
Biography:
Osemeke U. Osokogu completed his medical training at the University of Benin, Nigeria. He has received additional trainings in Statistics, Public Health, Pharmacovigilance and Pharmacoepidemiology from institutions in Belgium, France and the Netherlands. Currently, he is conducting pediatric drug safety research at the Department of Medical Informatics, Erasmus Medical Center (Rotterdam). He is about completing the requirements for a PhD degree. In addition to (co)-authoring (about to be) published manuscripts, he has peer-reviewed manuscripts for journals of international repute. He is non-executive director of a not-for-profit organization that aims to stimulate the conduct of health-related research within the African continent.
Abstract:
In order to generate pediatric-specific drug safety (and efficacy) evidence, the US Pediatric Research Equity Act (PREA) and the EU Pediatric Regulation were passed in 2003 and 2007 respectively. While some safety evidence may be generated from pre-marketing studies, important evidence regarding rare and delayed-onset adverse effects may be missed. Analysis of spontaneous reporting systems is the most common method for post-marketing drug safety surveillance, but unlike the general population, little research effort has focused on improving surveillance in the pediatric population specifically. Yet unlicensed and off-label drug use; and organ maturation and changing hormonal levels, both of which impact drug pharmacokinetics and Pharmacodynamics, predisposes this vulnerable population to adverse drug reactions. Available data may be used for pediatric drug safety monitoring but pediatric-specific methods are not available. Methods that have been applied to the general population may be tailored to the specific needs of the pediatric age group, however a pediatric-specific reference set of drug-adverse event associations is required. Osokogu et al. 2015 reported on the creation of such a reference set; currently it is being applied to evaluate the performance of selected signal detection methods. Preliminary results are promising, however there are challenges. Time is crucial to the definition and application of a reference set when such is used for methods’ evaluation. Yet, the confirmation of adverse drug events is country-specific. Age may impact methods’ performance. These (and other) challenges must be overcome if we are to improve drug safety monitoring in the pediatric population.
Biography:
Vladimir Popov is the Head of Clinical Pharmacology Department of Scientific Medical Center of JSC “Russian Railwaysâ€. He obtained his MD with an honorary degree, a Master of Internal Medicine, PhD in Cardiology. He has completed Doctor of Medical Science in 2007. He has over 18 years of experience in clinical trials. He has published more than 140 articles and abstracts and directed numerous symposia.
Abstract:
Over the last years a number of factors have an influence on the market of clinical trials and prompted changes. Drug developers tend to define intrinsic and extrinsic factors of interregional differences which can influence an outcome of international clinical trials. The increase in R&D costs should be taken into consideration because the activity of trials and developmental activity has been increasing over the last decade, but the number of new drugs’ approvals has officially decreased. Analysis of the results of inspections of FDA/EMA and Russian authorities over the last 5 years does not show an improvement in the quality of trials and clinical trials inspections by the IRB/IECs and Sponsor. The results of the FDA inspections related to the frequency of clinical investigator-related deficiencies based on post-inspection correspondence issued showed that the situation has not changed positively either; thus in 2011, out of 407 Domestic and Foreign inspections, 128 had findings (31%), and in 2014, out of 472 inspections - 171 (36%) had findings in the category “Protocol violationsâ€. The above-mentioned factors influence the clinical trials' quality and require the compliance to quality standards from all parties who organize and conduct clinical trials. The risk-based management, that is, one of approaches to solving the problem, has been implemented on a wide-scale. On the part of the regulatory authorities (FDA/EMA), regulatory-procedures harmonization is being introduced. The number of risk-based inspections, co-inspections of FDA/EMA/Russian regulatory authorities, is increasing; the training of inspectors is being harmonized.
Andy Moreno
HSG/AME Certified Laboratories, USA
Title: The use of real-time polymerase chain reaction (rT-PCR) technologies to screen for the presence of total bacteria in a liquid sample
Biography:
Andy Moreno is a Bacterial Pathogen Surveillance Systems Engineer with HSG/AME Certified Laboratories, LLC. He works with food production managers to engage test and release programs to assure that food shipped to the market is not contaminated with food borne pathogens. He has worked at NASA, Thermo Finnigan, Cepheid, and other firms pursuing the direct application of solutions relating to scientific endeavors.
Abstract:
Microbiological data collected by traditional methods are inherently variable. The "plate count" is at best an interpretation of an approximation of the number of cells present. Colony Forming Units (CFU) method analysis is only an estimate of the number of cells present. It is a skewed estimate at best as the only cells able to form colonies are those that can grow under the conditions of the test (e.g., incubation media, temperature, time, oxygen conditions). Traditional methods require days before the results can be interpreted and reported to decision-makers in a production setting. The use of real-time polymerase chain reaction (RT-PCR) technologies with a total bacteria screen (TBS) assay permits the detection of the DNA of all bacteria within 35 minutes. The use of RT-PCR TBS assays allows process control/quality control managers precious time and additional specificity and sensitivity prior to decision-making.
Puthucode N Rajamani
Rajamani Group LLC, USA
Title: 21st century skills for managing healthcare professionals
Biography:
Puthucode N Rajamani is the President of “Rajamani Group, LLC†and is a Quality Assurance and Compliance Professional with expertise and a proven record of success in the Design and Implementation of Quality Systems and Manufacturing Systems. He has extensive experience working with both major pharmaceutical companies and contract manufacturers on a global basis. He has more than 40 years of industry experience and has worked in pharmaceutical research, development, and formulation, pharmaceutical and biotech production, project and process engineering, validation and process automation during his career at Pfizer Inc., Smith Kline Beecham, Baxter International, Squibb, Union Carbide, France, Italy, and Belgium Atomic Energy Consortium. He is presently providing consulting services to major Biotech and Pharmaceutical companies in all areas of regulatory and cGMP compliance.
Abstract:
Communication, after all, is the tool you use every day to build your closest relationships, and experts (as well as common sense) tell us that the right words, spoken in the right way, can work wonders on even the testiest interactions. So what is the problem? Most of us think we’re good communicators, but research shows we’re surprisingly unskilled at it. According to ground-breaking work in the field of neuroscience, however, it’s easy to retrain ourselves to speak and listen in a way that stimulates sympathy and trust in the other person’s brain in a matter of seconds. This presentation hopes to achieve the following listed objectives: • Building Cross Cultural Effectiveness • Profiles of National Cultures Using the Cultural Orientation Approach • Receptive to cross-cultural learning and maintains an open and productive attitude toward difference. • Avoids quick judgment • Tolerates ambiguity and complexity in cross-cultural social situations. • Remains patient with others. • Continually pursues learning about other cultures. • Maintain focus and prioritize work • Learn good decision making process in a consistent manner • Obtain cooperation by communicating the risks and gains of appropriate decisions • Effective management of communications both within and outside the organization. The 24 soft-skills identified here helps towards a better dialogue and communication with a friend, a spouse or a colleague at work.
Biography:
Anthia Zammit completed her Bachelor of Laws (LL.B), and Doctor of Laws (LL.D) degrees, at the University of Malta. She advises multinational mega-cap and start-up companies operating in healthcare, life sciences, biotechnology, and pharmaceutical industries. She has experience in global expansion in established and emerging markets; medicinal product launches, drug and vaccine licensing, regulatory compliance (EU-GMP and EU-GDP), pharmacovigilance, data privacy, pricing, and marketing. She worked at the Office of the CEO of Malta’s national competent authority, the medicines authority (the “Malta FDAâ€). Anthia Zammit regularly participates as a guest speaker at high-level conferences on invitation of the European Commission.
Abstract:
The World Health Organization views vaccines as an important solution to averting public health crisis. Under EU legislation, vaccines are defined as “medicinal productsâ€, and are as such subject to regulatory requirements. As pharmaceutical products, vaccines carry benefits as well as risks. In response to complications and diseases that occur following vaccination, various countries have implemented vaccine-injury compensation programs. In the US, the Vaccines Act of 1986, and the Supreme Court judgment Russell Bruesewitz et al v. Wyeth et al. (decided February 22, 2011), substantially reduced the pharmaceutical manufacturer’s civil liability, even for mandated drugs. What steps are being taken by the pharmaceutical industry to ensure a higher level of vaccines safety? The best age of tolerance to an antigen; the number of vaccines that have the best clinical outcomes; the spacing out of vaccines; the right dosage; and the lowering of mercury and aluminum levels would be revised and updated via legislation and policy. There should be a way for the regulators to step in and with their teams, define the nature of the vaccines, their quality free of potential toxic reagents, and how and when the vaccines should be delivered. This would however come at a substantial cost to stakeholders, particularly the pharmaceutical industry.
Biography:
Wael Ebied has completed his BPharm at the age of 23 years from Tanta University with Postgraduate studies from Al-Azhar University School of Pharmacy. He is a certified Senior Professional, SQA Services Inc., US leader in providing supply chain management, quality and engineering services to pharmaceuticals, medical devices and highly regulated industries. He has published more than 5 papers in reputed journals and has been serving as an Editorial Board Member of repute. He has more than twenty years’ experience in pharmaceutical industries, biotechnology, medical devices and APIs. He is an accomplished technical presenter with numerous projects, scientific publications, participated in 1 patent and was awarded 7 premiums.
Abstract:
Humans have domesticated plants and animals since around 12,000 BCE, using selective breeding or artificial selection (as contrasted with natural selection). The process of selective breeding, in which organisms with desired traits (and thus with the desired genes) are used to breed the next generation and organisms lacking the trait are not bred, is the oldest form of genetic modification by humans. A genetically modified organism (GMO) is any organism whose genetic material has been altered using genetic engineering techniques. GMOs are used in biological and medical research, production of pharmaceutical drugs, and experimental medicine (e.g. gene therapy). The term "genetically modified organism" does not always imply, but can include, targeted insertions of genes from one species into another. Genetically modified animals currently being developed can be used to research human diseases (for example, to develop animal models for these diseases). Transgenic animals are used as experimental models to perform phenotypic and for testing in biomedical research. Genetically modified (genetically engineered) animals are becoming more vital to the discovery and development of cures and treatments for many serious diseases. Zoopharmacognosy is a behavior in which non-human animals apparently self-medicate by selecting and ingesting or topically applying plants, soils, insects, and psychoactive drugs to treat or prevent disease. Animals ingest non-foods such as clay, charcoal and even toxic plants, apparently to prevent parasitic infestation or poisoning. Self-medication in wild animals remains a controversial subject because evidence is mostly circumstantial or anecdotal, however, there are many purported examples. The methods by which animals self-medicate vary, but can be classified according to function as prophylactic (preventative, before infection or poisoning) or therapeutic (after infection, to combat the pathogen or poisoning). Although the underlying psychological and physiological mechanisms of such learned self-medicating behavior are unclear, its adaptive value is proposed to be widespread, encompassing diseased laboratory animals. The proposal of this research article is: How human diseased-animal models will keep themselves well in an artificial wild and what we can learn from them in screening new therapeutics. The current objective is to test the hypothesis that zoopharmacognosy is operational in GMOs in artificial wild health. Once a molecular target of disease is revealed, one can use this perspective for identifying active ingredient(s) from herbal medicine in new drug discovery. The generation of transgenic animals by biotechnological techniques will provide human disease models for screening drugs of clinical interest with the help of zoopharmacognosy. Some of the compounds have been identified by zoopharmacognosy kill parasitic worms, and some of these chemicals may be useful against tumors. There is no question that the templates for most drugs are in the natural world. The question is how to discover using zoopharmacognosy by GMOs.
Thais dos Santos Paulino Soares
Federal University of Ouro Preto, Brazil
Title: Oral drug suspensions: Is in vitro dissolution testing relevant in predicting the in vivo performance?
Biography:
Thais dos Santos Paulino Soares did her Master’s degree in Pharmaceutical Sciences from the Federal University of Ouro Preto. She graduated in Pharmacy, also from UFOP, in 2013. Currently, she is pursuing MBA in Regulatory Affairs at the Instituto de Pós Graduação (IPOG), in Belo Horizonte, Brazil.
Abstract:
Dissolution testing conducted in physiological similar conditions is an useful tool in predicting issues related to pharmacokinetics, may indicate bioequivalence between certain products as solid oral dosage forms, and is employed to optimize the development and ensure the quality of drug formulations. According to Brazilian Health Surveillance Agency (Anvisa), European Medicines Agency (EMA) and Food and Drug Administration (FDA), comparative dissolution testing is required as a previous stage to the bioequivalence study between the new drug application (NDA) and abbreviated new drug application (ANDA), and also between NDA and similar (ANDA designated by a trademark) in Brazil. For oral suspensions, little information is available in the literature about the dissolution testing conditions, such as insertion and collection of the sample, influence of the system agitation, and others. In 1995, the first monograph including suspension dissolution testing was published in the United States Pharmacopeia (USP) 23. Dissolution testing was mentioned in one suspension monograph in Brazilian Pharmacopoeia 4th edition (2005) which was excluded in the 5th edition (2010). In USP 36 (2013), 12 suspension monographs include the test. Currently, 13 NDA, 17 ANDA and 9 similar oral suspensions are registered in Anvisa. Out of these, two (15.4%) NDA, three (17.6%) ANDA and one (11%) similar have monographs with dissolution test in USP 36. In this scenario, the establishment of the dissolution test conditions and its relevance in predicting in vivo performance of suspensions is paramount to subsidize their registration by the regulatory agencies.
Debi Silber
Lifestyle Fitness, Inc., USA
Title: Maximizing your impact: How to look, feel and live like a leader
Biography:
Debi Silber is an MS, RD, WHC, FDN The Mojo Coach, and currently is the President/CEO of Lifestyle Fitness, Inc. and the Founder of www.DebiSilber.com and www.TheMojoCoach.com. She is a recognized health, weight loss, fitness, wellness, lifestyle, personal development expert, speaker, consultant, coach and author of 2 books recommended by Brian Tracy, Marshall Goldsmith, Jack Canfield and many more. She branded The Mojo Coach because she has led countless others to achieve their ultimate body, mind, image and lifestyle; inspiring them to "get their mojo back" and helping them transform into their personal and professional best. In addition to being a highly credentialed and awarded Health Expert, she has her own line of deliciously healthy Mojo Fuel Barsâ„¢ and shakes and is a contributor to the Dr. Oz show, CBS, Shape, Self, Health, Working Mother, Psychology Today, WebMD, Yahoo Shine, Ladies Home Journal, MSN, Woman's World and Glamour to name a few.
Abstract:
Being an impactful leader takes improving both your inner and your outer game. It takes: (1) A lean, fit body filled with energy and vitality, (2) A mindset that propels you to be, do and have more, (3) A dynamic, charismatic and magnetic image that invites people to want what you have, (4) A lifestyle that not only supports but amplifies your growth. It’s not as hard as you think when you focus on 4 crucial areas that need to be strengthened in order to become your personal/professional best and Debi Silber, The Mojo Coach® will show you how. She’ll share the secrets and strategies you need to create a dynamic leadership presence along with the tools top leaders implement to create that winning edge. You’ll learn (1) The 4 crucial areas to strengthen in order to become your physical, mental and emotional best, (2) How your beliefs, behaviors, habits, relationships and stress level are causing health/wellness or illness/disease, and what to do about it, (3) How to purposefully, powerfully and passionately lead your group, team or simply your own children, (4) How to create a dynamic, charismatic and magnetic presence so you convey confidence and trust.