Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 7th International Conference on Clinical Trials | Chicago, Illinois, USA
(10 Plenary Forums - 1 Event).

Day 3 :

Conference Series Clinical Trials 2018 International Conference Keynote Speaker Vinod Labhasetwar photo
Biography:

Vinod Labhasetwar, PhD, is a Professor of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, both in Cleveland, Ohio, USA. The primary research focus of his laboratory over the past 25+ years has been on nanoparticle-mediated drug delivery in the context of translational and clinical medicine, particularly focusing on disease conditions where no effective treatments yet exist. His team’s specific interests are in developing effective approaches to cancer therapy (against drug resistance and metastasis), cardiovascular diseases (particularly inhibition of restenosis), and facilitating neuromuscular repair mechanisms in stroke and spinal cord injury. Recently, his group’s efforts have been expanding into two new areas: retinitis pigmentosa, with the goal of slowing the progression of photoreceptor degeneration; and transplantation research, with the objective of extending the critical window of time for organ preservation. He has published over 180 peer-reviewed articles and book chapters. He is listed among the 2014 and 2015 Highly Cited Researchers by Thomson Reuters, based on the top 1% of citations during the past 10 years. He has over 25 issued US and international patents and 4 provisional the US patents filed/pending. He is Editor-in-Chief of Drug Delivery and Translational Research, an official journal of the Controlled Release Society.

 

Abstract:

Recent advances in membrane lipid research show the varied roles of lipids in regulating membrane P-glycoprotein function, membrane trafficking, apoptotic pathways, drug transport, and endocytic functions, particularly endocytosis, the primary mechanism of cellular uptake of nanoparticle-based drug delivery systems. Since acquired drug resistance alters lipid biosynthesis, understanding the role of lipids in cell membrane biophysics and its effect on drug transport is critical for developing effective therapeutic and drug delivery approaches to overcoming drug resistance. We show that epigenetic changes are responsible for altered lipid biosynthesis in acquired drug resistance, making the membrane compact and rigid, thus hindering the drug transport process. Two different novel strategies are being investigated to overcome drug resistance: (a) modulating the biophysical properties of membrane lipid of resistant cells using epigenetic drugs to facilitate drug transport and regain endocytic function and (b) developing effective nanoparticles based on their biophysical interactions with membrane lipids to enhance drug delivery to overcome drug resistance.

 

  • Clinical Trial Forecasting, Budgeting and Contracting | Novel Drug Delivery Systems| Drug Delivery Technology | Pharmaceutical Nanotechnology
Speaker

Chair

Prakash V Diwan

National Institute of Pharmaceutical Education and Research, India

Session Introduction

Rubina Fatima

MRM Collage of Pharmacy, India

Title: Advance microneedles integrated transdermal patch for fast onset of Ivermectin

Time : 11:10-11:30

Speaker
Biography:

Rubina Fatima was graduated in Bachelors of Pharmacy (B Pham) from MRM Collage of Pharmacy in 2012 and during her studies she got an opportunity from her institute to work as a “Trainee” in Quality control at Dr Reddy Laboratory. During her bachelor's she have successfully worked on project “Formulation and evaluation of mouth are dissolving tablet donepezil with superdisingredents” After her first achievement, she received her Pharmacy license from Pharmacy council of India (PCI). Later she moves forward in her career to pursue her Master in Pharmacy with a major in Pharmaceutics and successfully completed the same with a distinction in 2015. She is an Assistant Professor in MRM Collage of Pharmacy affiliated to JNTUH. She is an active researcher, a teacher of pharmaceutical and Alliance healthcare professional member.

 

Abstract:

The purpose of the study is to prepare an advanced transdermal delivery system contribution to medical practice; it has yet to fully achieve its potential as an alternative to oral, delivery and hypodermic injections. The importance of a transdermal delivery patch essentially provides rapid action with advance microneedles using photolithography based process, in which microneedles create micrometer-sized channels in the skin to deliver Ivermectin rapidly. While the reservoir patch holding the bulk of drug enables the higher drug loading and carries on to release the drug for a prolonged period. There are no significant changes in the physicochemical evaluation, in vitro drug release was studied by flow through diffusion cell with microneedles, horizontal type skin permeation, and skin irritation was performed in hairless albino rats. The formulation with Polyvinylpyrrolidone (PVP) shows a desirable result with fast release of Ivermectin. The results show that Ivermectin is safe and effective with advance microneedles integrated transdermal patch in the treatment of rosacea with few side-effects and good compliance with long-term efficacy.

 

Muhammad Umair Amin

Philipps University Marburg, Germany

Title: uptake of doxorubicin

Time : 11:30-11:50

Speaker
Biography:

Muhammad Umair Amin is Pharmacist by profession and has done his Master in Pharmaceutics. Currently he is doing PhD under DAAD/HEC Pakistan Scholarship program, in the supervision of Prof Dr Udo Bakowsky at Department of Pharmaceutics and Biopharmaceutics, Philipps University Marburg, Marburg, Germany. The major area of interest is development of drug carrier systems and characterization. Primary research goals are directed toward the fabrication of mesoporous inorganic drug delivery system and targeting of mesoporous nanoparticles loaded with anti-cancer drugs to resistant hypoxic tumor cells. Development of combine dosage form of Enzyme inhibitors and chemotherapeutic agent based mesoporous silica nanoparticles as a dosage form for better drug uptake, decreased tumor invasiveness and increased cytotoxic effects. He has an experience in research, teaching and administration in education institutions.

 

Abstract:

Delivery of chemotherapeutics, in higher doses to specific sites of action without side effects, is a big challenge. Recent developments in the field of nanotechnology, including the use of inorganic materials, have opened up new dimensions. Mesoporous silica nanoparticles as drug carrier address many problems related to chemotherapeutic targeting and delivery. Larger surface area and higher drug loading capacity, mechanical strength and stability, entrapping both hydrophilic and hydrophobic drugs, tailorable pore size and pore volume, inner and outer surface for modification and drug attachment, controlled particle size and distribution, lipid coating and gene delivery, make them a suitable candidate as a drug carrier. Hexagonal micelles of surfactants (CTAB: Cetyltrimethylammonium bromide) interact with silica source (TEOS: Tetraethylorthosilicate) to form a firm silica structure. Then removal of micelles leaves behind mesoporous silica nanoparticles. Mesoporous silica nanoparticle fabrication is based on hydrolysis and condensation reaction in a basic environment and a specific surfactant/silica molar mass ratio is crucial for the preparation of particles. Surfactant removal was confirmed by elemental analysis and the porous structure was confirmed by TEM images. Pore size was in the range of 2-3nm. Our studies have shown the high entrapment of doxorubicin in particles due to the availability of porous structure. Lipid coating of drug-loaded particles not only protects the drug from premature release in circulation but also due to the compatibility of a lipid bilayer with the cellular membrane, lipid-coated mesoporous silica nanoparticles enhance the cellular uptake of doxorubicin. In our studies, the lipid-coated silica nanoparticles have shown higher cellular toxicity as compared to non-lipid coated particles. Drug release profile and increase in cytotoxicity with time, support the hypothesis of sustained release of drug from lipid coated mesoporous silica nanoparticles.

 

Speaker
Biography:

Jalpa Suthar did her B.Pharm and M.Pharm from A R College of Pharmacy and completed Ph D in 2015 in Clinical Pharmacy from Charotar University of Science And Technology (CHARUSAT) Changa, Gujarat, INDIA. She is currently working as Assistant Professor, Department of Clinical Pharmacy & Pharmacology, Ramanbhai Patel College of Pharmacy, Charusat University..

 

Abstract:

Several tools have been introduced to evaluate the quality of prescribing. Study aim was to determine the quality of prescribing in hypertension and bronchial asthma in primary, secondary and tertiary health care setting using the new Prescription Quality Index (PQI) tool and to assess the reliability of this tool. A prospective cross-sectional study was carried out at selected PHCs, SHCs and THC facility for chronic conditions Patients with hypertension and bronchial asthma, attending out-patient departments of each health care facility for at least 3 months were included. Complete medical history and prescriptions were noted. Total and criteria wise PQI scores were derived for each prescription and prescriptions were categorized as poor, medium and high quality. A total 356 patients was included. Mean age was 57.7±14.7years (range 4–87 years) with 36% patients above 65 years of age. Mean total PQI score was 28.9±8.1. Of 356 prescriptions, 138 (38.8%) prescriptions were of high quality with PQI score ≥34. Prescribing quality in terms of PQI score showed significant difference between PHC, SHC and THC (P<0.0001). The prescribing quality between PHCs and SHCs did not differ significantly (P>0.05). The value of Cronbach’s α for the entire 22 criteria of PQI was between 0.68 to 0.89. As evaluated by PQI tool, the quality of prescribing at THC was better as compared to SHCs & PHCs. PQI was found to be a reliable tool for assessment of prescribing quality in chronic diseases.

 

Speaker
Biography:

Sid Chowdhury has completed his Bachelors in Pharmacy at the age of 22 years from Mumbai University, Mumbai and Masters of Science (MS) from Northeastern University, College of Professional Studies, Boston, MA. He is the Study Start-Up lead for Alkermes, a premier pharmaceutical company based out of the Boston metro area. He has been managing Study Start-Up for global Phase III CNS studies for more than 3 years and has been serving as a Clinical Trial Manager, Global Clinical Services.

 

Abstract:

Starting a global multicenter phase III study in Schizophrenia is challenging for many reasons. Understanding the patient population, regulatory landscape, access to clinics/physicians, study drug import/export permit and legal requirements are key during the planning phase of a global study. Selecting clinical trial sites are often a cumbersome process and traditional ways of conducting site feasibility are neither user-friendly nor time sensitive. In such situations, it is very important to be creative in finding ways to collect the same information in a time and cost effective manner while ensuring the quality is not compromised. We at Alkermes came up with creative methods of conducting site feasibility and selection which in return reduced our site selection timeline during conferences and investigator meetings. Negotiating clinical trial agreements and budgets could easily take months to finalize. Using tools such as smart budgets, grant plan parameters for fair market value have allowed Alkermes to expedite the budget negotiation process. Similarly, liaising directly with clinical trial sites that are huge academic institutions have reduced contract negotiation timelines. Revising requirement for site essential documents and using online cloud-based portals for document collection, tracking and tracking has improved site selection and startup. Use of technology such as remote study drug adherence or electronic-consents will reduce time lost and maintain. This presentation will showcase individual case studies of Study Start-Up challenges  and ways to overcome them maintain quality, time and costs.

 

 

Speaker
Biography:

Saad Ikram graduated among the top ten in his class from Baqai Medical University Karachi Pakistan in 2012. He then moved to the United Kingdom to pursue a career in surgery where he is now working as a Trust Grade Core-surgical Trainee level doctor under Mr. SM Ahmad(Consultant Colo-rectal Surgeon). Still, in his early years since graduation, he has developed a passion for the surgical sciences and has multiple case reports, clinical audits, literature reviews and poster presentations to his name and is actively involved in retrograde studies at his institution at present. Now looking for opportunities for oral and poster presentations at an international level.

 

Abstract:

Colonic polyps have widely been resected using endoscopic techniques which remains one of the most commonly employed therapeutic colonoscopic procedure. Other procedures namely Endoscopic Mucosal Resection (EMR), snare polypectomies and laparoscopic or open colonic resections for the larger polyps are all well documented in the literature and are in common use. With traditional methods such as simple polypectomies and EMR, documented complication rates among the vast literature, remains low and varies between 0 to 3.3%, however such methods are not suitable for polyps with a broad base and can be dangerous with higher rates of complications reported for polyps >3cm in size and when located in the thin-walled caecum. Further such techniques always carry a risk of incomplete resection. Recently, however, combined laparoscopic and endoscopic techniques have emerged for polyps not suitable for resection by endoscopy alone, advocating shorter hospital stay and lower risk of complications when compared to segmental colonic resections which were traditionally the treatment of choice for such polyps and involved a major procedure with high risks of complications. The laparoscopy-assisted colonoscopic resection of polyps is seen time and time again in the literature which involves assistance from a laparoscope while the polyp is removed via a snare by the endoscopist. This technique, although largely documented to be safer and less invasive when compared to segmental resections, also employs removal of the polyp in piecemeal making histological analysis of clear margins difficult and an added risk of delayed perforation due to diathermy injury. We describe a similar but alternative method involving wedge resection using a linear laparoscopic stapler with colonoscopic assistance which can ensure complete excision under direct vision and achieve similar complications rates. Following strict indications, we feel that this technique provides an excellent, safe and definitive excision method for such polyps.

 

Biography:

Mouloud Kecha was awarded a PhD from the University of Setif, Algeria in 2007. He spent two years during his doctoral research in Reims University (France); Laboratory of Industrial Microbiology (LMI) before starting his position of Senior Lecturer and then Professor in the University A.MIRA of Bejaia, Algeria. He has published more than 23 papers in different journals and has been serving as an editorial board member and reviewer.

 

Abstract:

Four polyketides were isolated from the algal-derived endophytic actinomycete Streptomyces sundarbansensis, which represents the lacking member in the recently reported series of phaeochromycins A–E. We also proposed a method based on the comparison of experimental IR spectra with the DFT ones calculated in order to establish the tautomeric forms for these metabolites. The results indicated a γ-pyrone structure for these compounds, in analogy to the related polyketides mutactin and SEK34. Due to this study, it is possible to suggest that also the known phaeochromycins were isolated mainly in this tautomeric form, differently by the structures reported until now. Evaluation of IC50 values on the pure and structurally defined metabolites as inhibitors of gram-positive and gram-negative bacteria, from where the new compound showed the highest and selective antibacterial activity against MRSA.