Biography:

Vladimir P. Torchilin, Ph.D., D.Sc. is a University Distinguished Professor of Pharmaceutical Sciences and Director, Center for Pharmaceutical Biotechnology and Nanomedicine, Northeastern University, Boston. His interests include drug delivery and targeting, nanomedicine, multifunctional and stimuli-sensitive pharmaceutical nanocarriers, biomedical polymers, experimental cancer therapy. He has published more than 400 original papers, more than 150 reviews and book chapters, wrote and edited 12 books, and holds more than 40 patents. Google Scholar shows more than 60,000 citations of his papers with H-index of 107. He is Editor-in-Chief of Current Drug Discovery Technologies, Drug Delivery, and OpenNano, Co-Editor of Current Pharmaceutical Biotechnology and on the Editorial Boards of many other journals. He received more than $30 M from the governmental and industrial sources in research funding. He has multiple honors and awards and in 2011, Times Higher Education ranked him number 2 among top world scientists in pharmacology for the period of 2000-2010.

Abstract:

Tumor therapy, especially in the case of multidrug-resistant cancers, could be significantly enhanced by using siRNA down-regulating the production of proteins, which are involved in cancer cell resistance, such as Pgp or survivin. The even better response could be achieved is such siRNA could be delivered to tumors together with a chemotherapeutic agent. This task is complicated by the low stability of siRNA in the biological surrounding. Thus, the delivery system should simultaneously protect siRNA from degradation. We have developed several types of lipid-core polymeric micelles based on PEG-phospholipid or PEI-phospholipid conjugates, which are biologically inert, demonstrate prolonged circulation in the blood and can firmly bind non-modified or reversibly-modified siRNA. Additionally, these nano-preparations can be loaded into their lipidic core with poorly water-soluble chemotherapeutic agents, such as paclitaxel or camptothecin. In experiments with cancer cell monolayers, cancer cell 3D spheroids, and in animals with implanted tumors, it was shown that such co-loaded preparations can significantly down-regulate target proteins in cancer cells, enhance drug activity, and reverse multidrug resistance. In order to specifically unload such nano-preparations inside tumors, we made them sensitive to local tumor-specific stimuli, such as lowered pH, hypoxia or overexpressed certain enzymes, such as matrix metalloproteases. Using pH-, hypoxia-, or MMP2-sensitive bonds between different components of nano-preparations co-loaded with siRNA and drugs, we were able to make the systems specifically delivering biologically active agents in tumors, which resulted in significantly improved therapeutic response.

Biography:

Yuri L. Lyubchenko is Professor of Pharmaceutical Sciences at the University of Nebraska Medical Center, Omaha, NE, USA. His research focuses on understanding the fundamental mechanisms underlying health and disease, which are key to developing new and more effective diagnostics and medications. This primarily basic research allows him not only identify new drug targets for small molecule drugs, but it also leads to the development of the nanotools and methods to discover novel approaches for diagnostic, treatment and disease prevention and to more rapidly determine their efficacy at the molecular level.

 

Abstract:

Statement of the Problem: The amyloid cascade hypothesis is currently considered as the main model for a vast number of neurodegenerative diseases including Alzheimer’s, Parkinson’s, and Huntington’s diseases. Numerous studies have shown that amyloidogenic proteins are capable of spontaneous assembly into aggregates, and eventually form fibrillar structures found in amyloid or amyloid‐like deposits. However, there is a serious complication with translating current knowledge on amyloid aggregation in vitro to understand the aggregation process in vivo. If the critical concentration for the spontaneous aggregation of Aβ peptide in vitro is in the micromolar range, physiological concentrations of Aβ are in the low nanomolar range making impossible amyloids to assemble.

Methodology & Theoretical Orientation: We discovered a novel on- surface aggregation pathway that allows for spontaneous assembly of amyloid beta peptides at the physiological concentration range. We combined experimental studies involving single-molecule time-lapse AFM imaging with all-atom molecular dynamics simulations to characterize the on-surface self-assembly process of amyloid proteins. Experimental data demonstrate that on-surface aggregation occurs in the physiological range of concentrations of the proteins. Our combined experimental and computer modeling approaches demonstrate that the on-surface aggregation is a dynamic process, so the assembled aggregate can dissociate from the surface to the bulk solution. As a result, the dissociated oligomers can play roles of seeds for aggregation in the bulk solution, or start a neurotoxic effect such as phosphorylation of the tau protein to initiate its misfolding and aggregation. Both processes can lead to neurodegeneration.

Conclusion & Significance: We posit that on-surface aggregation is the mechanism by which neurotoxic amyloid aggregates are produced under physiological conditions. A change in membrane properties leading to an increase in affinity of amyloid proteins to the membrane surface facilitates the assembly of stable oligomers. The proposed model is a significant departure from the current model as it directs the development of treatments and preventions towards approaches that control the cell membranes composition to prevent the on-surface aggregation process.

 

Biography:

Rashid Mahmood has a master degree in Analytical Chemistry and an MS in Total Quality Management. He has 15 years of experience of Pharmaceutical Quality Operations and has participated in many international conferences as a keynote speaker. He has presented various talks in USA & China on Cleaning Validation, cGMP Guidelines, Quality Risk Management, Role of Mass Spectrometry in Pharmaceuticals and on new Drug Delivery Systems. Currently, he is working as a Senior Executive Manager Quality Operations for Surge Lab. (Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parentrals) which is the best export-oriented company of Pakistan.

 

Abstract:

Hot melt extrusion (HME) is emerging technology which is gaining high importance in the pharmaceutical industry as a novel technique for the preparation of various dosage forms and drug delivery systems, for example, granules and sustained-release tablets. It is a fast-growing technology platform that is utilized to solve difficult formulation challenges, primarily in the area of solubilization. Due to fast processing, a high degree of automation, the absence of solvents, simple and continuous operation and ability to process poorly compactable material into tablet form are some of the main advantages offered over conventional processing by this emerging technique. Applications of HME in the pharmaceutical industry continues to grow and the recent success of this technique has made it a useful tool of consideration as a drug delivery solution. The use of hot-melt extrusion (HME) within the pharmaceutical industry is steadily increasing, due to its proven ability to efficiently manufacture novel products. HME involves the application of heat, pressure, and agitation through an extrusion channel to mix materials together, and subsequently forcing them out through a die. Twin-screw extruders are most popular in solid dosage form development as it imparts both dispersive and distributive mixing. It blends materials while also imparting high shear to break-up particles and disperse them. HME extrusion has been shown to molecularly disperse poorly soluble drugs in a polymer carrier, increasing dissolution rates and bioavailability.

 

Biography:

Arkesh Mehta serves as Chief Executive Officer of OncoBindi Therapeutics and a member of the company’s Board of Directors, bringing more than 30 years of experience in the biopharmaceutical industry to the company. He joined OncoBindi in 2016 as the company’s Founding Chief Executive Officer. He joined OncoBindi from Chikujee Therapeutics, where he served as Chairman & Chief Executive Officer, since 2014, prior to its acquisition by a group of investors from Germinate 360. Prior to joining Chikujee Therapeutics, he held senior management positions at Avanti Nano Sciences, BPI Technologies, and Avanti Therapeutics. In addition, he was a key member of the strategic leadership committees for Avanti Therapeutics and it's North American and worldwide partnerships. Prior to joining Avanti Therapeutics, he was the first CTO of the Biotechnology Industry Organization. He has held leadership program management positions at Office of R&D US EPA, Office of the Commissioner US FDA. His academic appointments include the head of Molecular biology section at Virginia State University and Associate Professor of Research at Cornell University. He received a PhD. in Microbiology from M.S. University and post-doctoral training from University of Mississippi Medical Center in Jackson, Mississippi.

 

Abstract:

While major progress has been achieved in research and development, the majority of new therapies continue to fail in human trials, despite showing promise in preclinical testing. As the Big Pharma model of producing a drug from soup to nuts has proven to be less effective at getting novel drugs to market, the drug discovery and development process have become fragmented. Additionally, as the science and regulatory requirements get more complex there is a need for more depth of expertise in each of these segments, which plays to the strengths of innovative companies. The years- to decades-long process can be complex, and there is nearly always a moment of uncertainty that a drug will succeed in the next phase of development. This long development pipeline faces increasing costs and additional challenges, including the lack of predictive validity of current animal models, insufficient knowledge regarding underlying mechanisms of disease, patient heterogeneity, lack of targets and biomarkers, a high rate of failed clinical trials, and regulatory challenges. To better understand how these challenges, create bottlenecks in the development pipeline, a cost-efficient and unified drug development architecture are critical for the success of sustainable biopharma companies.

This presentation introduces Aayush Biosphere’s Hyperscale™ Technology and the two ways it may be implemented: (a) Aayush BioSphere NanoBindi™ technology is a scale-out infrastructure based on the Patient's clinical preferences. (b) Aayush BioSphere NanoBindi™ technology is a clinical outcome focused solution that tightly integrates drug API (s), cell-specific targeting, on demand controlled release and full lifecycle management and analytics into a single platform across the precision therapeutic development. Built on Avanti Therapeutic's industry-leading technology, it allows Biopharma companies to significantly decrease complexity and cost while increasing both scalability and product pipeline agility.

 

Biography:

Jim Huang founded Ascendia after years of pharmaceutical R&D experience at Pfizer (ex-Wyeth), Baxter, AstraZeneca, and Roche. He has led the formulation development efforts for the successful transition of several oral and parenteral dosage forms from discovery through formulation, manufacturing, technical transfer and ultimately commercialization. He holds a Ph.D. in Pharmaceutics from the University of the Sciences in Philadelphia (formerly Philadelphia College of Pharmacy and Sciences) where he worked with Professor Joseph B. Schwartz.

 

Abstract:

There are many significant hurdles for a pharma or biotech company to overcome during the development process. The high failure rate in drug development shows that only 1 in 5,000 discovery compounds will reach the market, and one in every five drug candidates will gain approval. A dramatic increase in the percentage of the new chemical entities (NCEs) with poor physical, chemical, and biopharmaceutical properties (BCS II and IV) 4 in the drug pipeline has played a significant role in attributing to those high failure rates and increase in development timelines. About 50% of drugs on the market and nearly 90% of molecules in the discovery pipeline are poorly water-soluble. Administration of those compounds by parenteral route without causing injection site reaction and systemic toxicity effects constitutes another barrier. Numerous drugs associated with poor solubility and low bioavailability have been successfully formulated into drug products for clinical studies by a suite of available formulation technologies. Many marketed drugs have been successfully reformulated to improve efficacy, safety and patient compliance using the NDA 505(b)(2) regulatory pathway. Revitalization of older marketed drug products using innovative drug delivery technologies or platforms can provide new marketing exclusivity and new patent protection, and thus offer an effective tool for product life cycle management.

 

Biography:

Raymond C. Jagessar obtained his BSc (Distinction) in Chemistry/Biology from the University of Guyana (1992) and his Ph.D. from the UK (1995). He held three Post-Doctoral Research Fellowships (PDF) at various universities overseas. He has also won several international awards, amongst them are Chartered Chemist, CChem and Fellow of the Royal Society of Chemistry, FRSC, UK, Research and traveling Grants etc. His research interests are broad, covering the spectrum of Pure and Applied Chemistry, Chemical Biology and Pharmaceutical Chemistry. He has published over eighty (80) research articles, five book chapters and presented at conferences: locally and internationally. He is currently Professor in Chemistry at the University of Guyana (South America).

 

Abstract:

The aqueous and ethanolic extract of Passion fruit (Passiflora edulis Sims) was investigated in the absence and presence of transition metal salts using the Disc Diffusion Assay under aseptic conditions. For the ethanolic extracts, 1-3, the highest AZOI of 153.9mm² was induced by the sample (1), 0.015g/ml of the extract against C. albicans. The lowest AZOI of 15.9mm² was also induced by sample 3, 0.1g/ml of the ethanolic extract against K. pneumoniae. There seems to be a general increase in AZOI as the concentration of ethanolic extract increases. From the ethanolic extract, a white isolate crystallized and its antimicrobial activity was investigated at an increasing concentration (sample 4-5). For sample 4-5, the highest AZOI of 149.5mm² was induced by the aqueous solution at a concentration of 0.026g/ml against P. aeruginosa. The lowest AZOI of 30.7mm² was induced by the white isolate at a concentration of 0.052g/ml against K. pneumoniae. For sample 6 and 7, 0.1g of Zn (OAc)₂.2H₂O in 10ml aqueous extract and 1.0g of Zn(OAc)₂.2H₂O in 10ml of aqueous extract, it was observed that the highest AZOI of 67.2mm² was observed against E. coli. whereas the lowest AZOI of 21.6mm² was observed against C. albicans. The AZOI induced by sample 8, 1.0g of Zn (OAc)₂.2H₂O in 10ml of aqueous solution is greater than sample 7, suggesting that Zn(OAc)₂.2H₂O augment the antimicrobial activity of the aqueous passion fruit extract. Antimicrobial selectivity was also observed. For example, against S. aureus, sample (1) exhibit AZOI of 32.2mm² whereas against C. albicans, AZOI of 153.9mm² was observed. For all experiments conducted, antimicrobial activity seems to be less than that of the standard antibiotics: Ampicillin and Nystatin. Nevertheless, the ethanolic and aqueous extracts of green passion fruit can be used as a natural antibiotic against a range of bacteria-induced diseases.