Day 1 :
Keynote Forum
Carmen Tamayo
Heterogeneity LLC, USA
Keynote: Botanical drug development: Right and wrong on clinical studies
Time : 09:05-09:45
Biography:
Carmen Tamayo, MD directs the Canada Region of Heterogeneity, LLC. She is trained in Internal Medicine at the Central University of Venezuela. After moving to Canada with family, she completed Post-graduate studies in Public Health and Epidemiology at the University of Toronto. Since 1995, she has actively participated in policy and regulatory activities addressing traditional, complementary and alternative medicine (TCAM) research, with the Canadian National Cancer Institute. Her consulting has included government, industry, and nonprofit scientific organizations, including heterogeneity (since 2008), McMaster University Centre for Evidence Based Medicine, and the University of Western Ontario School of Medicine and Dentistry at the University of Western Ontario. For Health Canada’s Natural Health Products (NHP) Directorate, she served as Clinical Trial Project Coordinator for product review and assessment, collaborating in the agency’s development of a framework for NHP clinical trials. She has chaired and directed numerous programs and workshops as a member of the Drug Information Association (DIA), the International Pharmaceutical Federation (FIP), and the Latin American Phytomedicine Society (Sociedad Latinoamericana de Fitomedicina). She also serves as an expert reviewer for the World Health Organization and other international committees and several CAM and Phytotherapy journals, and is a past Co-editor of the Journal of Integrative and Complementary Medicine (JICM) – An international forum for evidence-based practices.
Abstract:
Medicinal plants are inexhaustible sources from which many of today’s most be useful drugs have been developed. While the majority of plant-based drugs are new (single) chemical entities (NCEs), a category of botanical drugs has recently reappeared in the US. Botanical drugs are defined as finished drugs for which the active ingredient is a complex, polymolecular drug substance. Although the criterion of adequate and well-controlled [clinical] studies remains a basis of new drug approval for the United States, botanical products pose unique challenges to clinical development due to their complex nature. This session will describe the clinical development of botanical drugs, with a focus on the US market. It will touch upon the differences between botanicals and NCEs and how these differences impact the types, designs, and even the timeline of clinical studies conducted for US drug development. Through examples, it will also relate some of the hurdles posed by complex botanical drugs which have been experienced in clinical studies of these products-both in research and in regulatory settings.
Keynote Forum
Freddie Ann Hoffman
Heterogeneity LLC, USA
Keynote: Regulatory considerations of botanicals as new drugs for the US market
Time : 09:45-10:25
Biography:
Freddie Ann Hoffman, MD founded HeteroGeneity in 2003; a Washington, DC-based consultancy focused on complex natural products, and is also its Managing Member. She has over 35 years of product development experience. She has a BS in chemistry from UCLA and received her MD and General Pediatric Residency training from the University of California at Davis. She completed a fellowship in Pediatric Hematology-Oncology at the National Cancer Institute (NCI), staying on to direct the Nutrition and Supportive Care Section of the Division of Cancer Treatment, and later, as Director of Extramural Clinical Trials of the Biological Response Modifiers Program. Leaving NCI in 1986, she served at FDA for nearly 14 years, as Chief of the Cytokines, Growth Factors and Oncologic Products Branch of the Center for Biologics Evaluation and Research, and later as Deputy Director of the Medicine Staff in the Office of the Commissioner. During her tenure, she formed and chaired an internal FDA Botanical Working Group which developed the botanical drug guidance, which the agency finalized in 2004. She also served in the Office of Dietary Supplements at the Center for Food Safety and Applied Nutrition, before moving to the private sector in 1999, joining Warner-Lambert Pfizer Consumer Healthcare, where she was Senior Medical Director for New Product Development. She continues to serve on numerous working groups, task forces, and boards of both government agencies and private companies. She has chaired and participated in numerous scientific, regulatory and policy forums addressing the development of polymolecular drugs and development of complex product. In 2014, she was an invited speaker at the 18th Presidential Commission on Bioethics (BRAIN initiative). She is a member of the American Society of Pharmacognosy and a past chair of the Drug Information Association’s Natural Health Products Track.
Abstract:
Medicinal use of plant-based products has its origins in antiquity estimated to date back at least 60,000 years. Toda approximately 80% of the world’s population continues to utilize plants and plant products to treat or prevent clinical conditions. In the United States, plant-based medicines were a major part of pharmaceutical armamentarium that is up until the passage of the US Drug amendments of 1962. The drug amendments further established requirements for new drug approval in the US, specifically requiring that the US Food and Drug Administration must affirm the safety and efficacy of a new drug prior to market approval. It was not until FDA’s dissemination of its Botanical Drug Development Guidance document, several decades later, that the US development of botanicals as drugs has experienced resurgence. At present there are two FDAapproved new botanical drugs that are sold exclusively by prescription in the US. This session will discuss how the FDA defines a botanical and the implications of the US regulatory approach on the development and approval of this renewed drug category, along with some of the lingering hurdles to this special category of new drugs.
Keynote Forum
Gus R Rosania
University of Michigan, USA
Keynote: The fine balancing act of drug formulation R&D in academia
Time : 11:00-11:40
Biography:
Gus R Rosania as Principal Investigator of the Subcellular Drug Transport Lab, is transforming the development of new drug formulations, by elucidating the micro pharmacokinetic properties of drugs in their biological, tissue microenvironments. His research group has pioneered new cheminformatic (mathematical modeling and simulation-based) approaches to the design of small molecule drugs with optimal permeability and intracellular accumulation properties, as well as application of hyperspectral Raman imaging approaches to discover new transport and disposition mechanisms acting at cellular and subcellular levels. His major contributions to pharmaceutical sciences is that his research group has discovered the most potent small molecule drug targeting mechanisms that has ever been identified to date, by studying the mechanisms of intracellular drug crystal formation. This knowledge is now being applied to the invention of new pharmaceutical formulation approaches that are poised to transform the manner in which drugs and formulations are designed, developed and regulated.
Abstract:
Statement of the Problem: In universities, pharmaceutical scientists are encouraged to dream of building marvelous creations, such as self-propelled drug delivery systems, self-assembling nanoscale devices and stimulus-responsive drug targeting mechanisms. While immense efforts are spent on accomplishing these transformative feats in chemistry, engineering and biomedicine research labs, the resulting advances are often not practical to translate into the clinical arena.
Methodology & Theoretical Orientation: In order to realign academic, drug formulation research with the more practical considerations inherent to drug product development, many challenges that precede clinical translation must be taken into account and dealt with, at the earliest, inception phase of formulation design. In this regard, my research group has grounded itself in reality, by carefully studying the nanoscale transport and distribution properties of existing drugs, prior to launching itself into a new, formulation design project.
Conclusion & Significance: By pioneering the formulation and development of biomimetic drug complexes, we have been able to balance fundamental discovery-driven research and technological innovation, with the more mundane necessities and regulatory requirements underlying successful clinical translation (from scale-up to manufacturing; and, from sterilization to commercialization).
Keynote Forum
Hai-Feng Ji
Drexel University, USA
Keynote: Diphenyl α-Aminoalkylphosphonates as prostate-specific antigen antagonists
Time : 11:40-12:20
Biography:
Hai-Feng Ji is currently working as a Professor, in Department of Chemistry, and Drexel University. His research interests focused on drug discovery, MEMS devices, nanomaterials for energy and environmental applications, nanopillars and phosphene for energy applications, and surface chemistry. He is currently a Co-author of 160 peer-viewed journal articles and book chapters. He has an H-index of 30. He is an Editorial board Member of several chemistry journals.
Abstract:
Prostate cancer (PCa) is one of the most prevalent cancers diagnosed in adult males. Chemotherapy has been widely used for PCa treatments. Although therapies targeting the androgen receptor, an upstream regulator of PSA, have been effective in treating prostate cancer, the disease state sometimes progresses and results in castrate-resistant prostate cancer. Alternative therapies should be pursued for prostate cancer treatment, especially in the scenario where androgen deprivation fails. PSA is a serine protease that has been found to control the growth of cancer metastasis and proliferation. Regulated by androgen receptor-mediated transcription pathway, the primary role of PSA biologically is the liquefaction of semen via proteolysis of coagulating proteins Fibronectin and Semenogelin within the matrix. However, with elevated PSA levels, the protease has been shown to cleave insulin-like growth factor binding protein-3 (IGFBP-3), a modulator of Mitogenic proteins insulinlike growth factors (IGF) I and II. It has been demonstrated that the involvement of PSA with the IGF molecular system leads to the progression of prostate cancer, which can in turn metastasize into the patient’s lymph nodes and bone, causing osteoblastic lesions via PSA-activation of latent transforming growth factor beta (TGFβ) and proteolysis of IGFBP-5. In this work, AutoDock 4.2 molecular docking suite was utilized to model covalent and non-covalent binding of this class of inhibitors to predict crystallographic poses and compare experimental IC50 dose-response curves and in silico potencies for providing future more specific rational drug design. The modeling study introduces novel aminoalkylphosphonates as a potential drug candidate for targeting PSA by optimizing P1 binding affinities. Several lead compounds will be reported as potent inhibitors of PSA activity.
- Drug Discovery and NCEs | Quality by Design(QbD) Approach | API: Active Pharmaceutical Ingredients | Formulations and NDDS | Analytical Strategies for Pharmaceutical Products | Pharma Market Research
Location: Philadelphia, USA
Chair
Carmen Tamayo
Heterogeneity LLC, USA
Co-Chair
Hai-Feng Ji
Drexel University, USA
Session Introduction
Maysoon A Abujarad Alhuwitat
Amman Arab University, Jordan
Title: The extent of pharmaceuticals services quality on building a superior relationship between pharmacists and their customers
Time : 13:30-14:05
Biography:
Maysoon A Abujarad Alhuwitat has completed her Bachelor's degree in Pharmacy, and a Master’s degree of MBA, major Pharmaceutical Marketing. She had worked in the private sector pharmacies (individual & chain pharmacy) as pharmacist in charge for a period of one year 2013-2014, then she opened her own pharmacy with partner.
Abstract:
Background: Pharmacy is an important profession in Jordan whereby it plays a vital role in providing the pharmaceutical services required for the health care of patients and it is an effective factor in the economy and development of the nation. Therefore, it is important to focus on the relationship between pharmacists and their customers through providing high quality pharmaceutical services.
Objectives: The current study aimed at investigating the level of pharmaceutical services quality in Jordan and its effect on building a strong relationship between pharmacists and their customers "from the pharmacist’s' perspective", through customers' perceived value, satisfaction, loyalty and CRM.
Methods: This study is a descriptive and analytical one. A self-administrated questionnaire was distributed to a convenience sample of 110 pharmacists working in public pharmacies, to measure the impact of pharmaceutical services quality on building relationship with customers.
Results: There is a statistically significant effect of pharmaceutical services quality on building a strong relationship between pharmacists and their customers at level (α=0.05) from one dimension (Responsiveness). There is a statistically significant effect of pharmaceutical services quality on customers' perceived value, satisfaction and loyalty at level (α=0.05). Also, there is no statistically significant effect of pharmaceutical services quality on CRM at level (α=0.05).
Conclusion: Pharmacies sector should focus on the quality of pharmaceutical services provided to customers as a basic standard for building a strong relationship with customers because of the direct impact of these services on customers' perceived value, satisfaction and loyalty.
Imeda Rubashvili
Tbilisi State University, Georgia
Title: Development and validation of extraction procedures and quantitative determination methods of natural colorants obtained from agro-industrial waste materials using stepwise extraction techniques and high-performance liquid chromatography
Time : 14:05-14:40
Biography:
Imeda Rubashvili is an Assistant Professor, a Scientific Researcher at Ivane Javakhishvili Tbilisi State University and the Head of Validation Department of Pharmaceutical Company “Aversi-Rational” Ltd. He has published more than 30 scientific papers and participated in more than 30 international scientific conferences. He is the Member of the Council of Young Scientists of the Georgian National Academy of Sciences.
Abstract:
The manufacture of food products and dietary supplements using natural food colorants has been attracted attention in modern food industry. Carotenoids and anthocyanins as natural colorants show strong antioxidant and immunomodulation activities and may prevent degenerative diseases as well. The present research concerns the development of stepwise extraction procedures and HPLC analysis of carotenoids and anthocyanins containing agro-industrial waste materials (tangerine, orange peel and grape skin). Extractions were carried out in a dynamic supercritical fluid-carbon dioxide (SC-CO2) and ultrasound assisted extraction systems. The effects of operating pressure and temperature, extraction time, pH, flow rate of the SC-CO2, sample size and solvent nature used were investigated. The optimal conditions for extraction were found. The drying process of samples obtained from agro-industrial waste materials was studied as well. The main carotenoids-beta-carotene, lycopene and total anthocyanins obtained in organic extracts were quantified using new, rapid, effective and selective developed and validated HPLC methods. The HPLC methods were validated with respect to system suitability test, specificity, linearityrange, accuracy, precision, limit of detection (LOD) and quantitation (LOQ). The stability of solutions was studied as well. The calibration curves of developed HPLC methods are linear over a concentration range 0.08-6.50 μg/mL for beta-carotene (r2=0.9992), 0.34-200.20 μg/mL for lycopene (r2=0.9999); 0.04-80.50 μg/mL and 0.12-80.50 μg/mL for total anthocyanins expressed as cyanidine chloride (r2=0.9999) and kuromanine chloride (r2=0.9999); The average recovery equals to 106.8% for beta-carotene, 101.4% for lycopene, 95.62% for cyanidine chloride and 94.9% for kuromanine chloride.
Maysoon A Abujarad Alhuwitat
Amman Arab University, Jordan
Title: The extent of Jordanian pharmacists satisfaction on their labor right
Time : 14:40-15:15
Biography:
Maysoon A Abujarad Alhuwitat has completed her Bachelor's degree in Pharmacy, and a Master’s degree of MBA, major Pharmaceutical Marketing. She had worked in the private sector pharmacies (individual & chain pharmacy) as pharmacist in charge for a period of one year 2013-2014, then she opened her own pharmacy with partner.
Abstract:
Background: Pharmacists’ jobs in Jordan are important and contribute to the welfare of patients and citizens. Through interviews of a number of pharmacists it was felt that there is need to study their feelings about their rights and satisfaction.
Objectives: The aim of this study is to measure the perceptions of Jordanian pharmacists on attaining their rights, and the impact of these rights on their satisfaction.
Methods: The study is an observational one. A random sample of 49 pharmacists was chosen to fill a self- administered questionnaire covering the dimensions of pharmacists and their satisfaction. The study tested the following hypothesis: there is no significant impact (at level α=0.05) of Pharmacists’ rights on their satisfaction.
Results: The null hypothesis was rejected indicating a significant impact of pharmacists’ rights on their satisfaction. The results also showed that pharmacists were not highly satisfied, whereby they reported satisfaction mean of 2.8 out of 5. Pharmacists’ perception on salary was also low, (mean=2.71). Means and standard deviations of all questionnaire items are reported.
Conclusion: Based on the results of this research, there should be effort from the employers and the Jordan Pharmacists’ Association to develop higher understanding and regard toward Pharmacists’ rights, especially salary and working conditions which showed effect on satisfaction.
Rayhana Begum
Primeasia University, Bangladesh
Title: Coumaroyl Lupendioic acid attenuates oxidative stress in adjuvant induced arthritis
Time : 15:50:16:25
Biography:
Dr. Rayhana is a recognized expert in Extraction techniques (Column Chromatography, Flash Chromatography) use of ELISA, Immunohistochemistry, the measurement of pro-inflammatory cytokines, acute phase protiens and oxidative biomarkers for the determination of anti inflammatory and anti-arthritic activities of drugs and quantitative determination of drugs by spectrophotometer, HPTLC and HPLC. Study of Bioavailability and bioequivalence profile of drugs. After obtaining B.Pharm. Degree and M. Pharm Degree in Clinical Pharmacy and Pharmacology from the University of Dhaka in 2005 and 2006, respectively, she has been awarded the Ph.D Degree in Pharmacology by Hamdard University, NewDelhi, India in 2016.
Abstract:
The present study was intended to elucidate the effect of coumaroyl lupendioic acid, a new lupane-type triterpene isolated from Careya arborea (Lecythidaceae) stem bark, on the biomarkers of oxidative stress in Complete Freund's Adjuvant (CFA)- induced arthritic rats. Arthritis was induced by injecting 0.1 ml of CFA (5 mg/ml of heat killed Mycobacterium tuberculosis) into the sub plantar region of the left hind paw. Treatment with coumaroyl lupendioic acid (10 and 20 mg/kg, p.o.) and reference drugs (indomethacin and dexamethasone at the dose of 5 mg/kg, p.o.) were started on the day of induction and continued up to 28 days. The effect of coumaroyl lupendioic acid on oxidative indicators (e.g. nitric oxide, myeloperoxidase, malondialdehyde) and antioxidant enzymes (e.g. superoxide dismutase and glutathione peroxidase) was measured at the end of the study. Furthermore, ankle joints and spleen were collected and prepared for histological examination. The present study showed that the oxidative indicators such as nitric oxide, myeloperoxidase, malondialdehyde were downregulated by coumaroyl lupendioic acid. A significant upsurge in the level of superoxide dismutase and glutathione peroxidase was observed. Moreover, histopathological examination showed that the inflammatory cells infiltration, synovial hyperplasia and cartilage erosion had considerably improved on administration of coumaroyl lupendioic acid. In conclusion, our study strongly demonstrated that coumaroyl lupendioic acid has efficient scavenger and protective effect against oxidative stress elevated after CFA injection.