Day 1 :
Keynote Forum
Donald Turner
Neosinus Health
Keynote: Emerging Platforms for Targeted and Optimized Brain Drug Delivery
Time : 06:00-06:40
Biography:
Don Turner has more than 28 years of experience building world-class companies, with a passion for commercializing innovations globally. He currently serves as the CEO for Neosinus Health and Board Member for UNC Center for the Business of Health. Previously, Don served as the SVP and Global Head of Commercialization for IBM Watson Health, Global Head of Commercialization at Merge Healthcare, Managing Director for Millennium Pharmaceuticals, Committee Chairman at Mass Biotechnology Council, and Advisory Board Member for Cisco Systems.
He received the CEO Monthly Magazine 2021 CEO of the Year Award for Best Drug Development Platform and will be featured on the cover of MedTech Outlook Magazine with a featured best-in-class story for the 2022 Drug Delivery Systems Special Edition. Don is an industry recognized thought leader and public speaker, with noted expertise in areas such as drug delivery, precision medicine, innovation commercialization, healthcare transformation, and digital health.
Abstract:
As noted by the World Health Organization, neurological and psychiatric disorders represent the greatest global economic and health burden, where more than 1 billion people are affected, and the number is rapidly growing because of the global pandemic. Even though this medical demand has been known for decades, the clinical development pipelines from the pharmaceutical industry are largely deficient, where the most recent commercialized drug for Depression was approved by the FDA after three decades of effort by the entire pharmaceutical industry. The lack of clinical advancements is not a strategic failure, but rather a direct result of well-known physiological impedance to drug delivery such as the first-pass effect and the blood-brain-barrier, which either produce significant side effects and/or prevent drugs from reaching the therapeutic target. Thankfully, researchers have discovered viable therapeutic pathways to bypass drug delivery barriers, and advancements in nanomedicine will further enable drug delivery, but the greatest potential resides in emerging non-invasive medical device innovations that will provide both targeted and fully optimized drug delivery. This keynote presentation will provide a view into the evolution of drug delivery, clinical dynamics that are motivating emerging classes of therapeutics, existing barriers that could impede advancements, and the latest developments that represent great potential for global health transformation. Specific examples of current research and development will be given, with a focus on the role of non-invasive medical devices to produce targeted and optimized drug delivery via local, systemic, and nose-to-brain routes. Lastly, the talk will discuss how emerging medical devices can also serve to substantially improve the well-known problem of treatment and medicine adherence, which itself is a $300 billion per year problem, and poor adherence will continue to impede even the greatest of advancements in drug delivery and nanomedicine if the problem is not resolved.
Keynote Forum
Thomas J webster
Interstellar Therapeutics,USA.
Keynote: 4D Printing: Advances in COVID-19 Therapies, Drug Delivery, Regenerative Medicine, and More
Time : 06:40-07:30
Biography:
Thomas J. Webster’s (H index: 107; Google Scholar) degrees are in chemical engineering from the University of Pittsburgh (B.S., 1995; USA) and in biomedical engineering from RPI (Ph.D., 2000; USA). He has served as a professor at Purdue (2000-2005), Brown (2005-2012), and Northeastern (2012-2021; serving as Chemical Engineering Department Chair from 2012 - 2019) Universities and has formed over a dozen companies who have numerous FDA approved medical products currently improving human health. Dr. Webster has numerous awards including: 2020, World Top 2% Scientist by Citations (PLOS); 2020, SCOPUS Highly Cited Research (Top 1% Materials Science and Mixed Fields); and 2021, Clarivate Top 0.1% Most Influential Researchers (Pharmacology and Toxicology).
Abstract:
While advances in biomaterials have helped the lives of millions over the past century, it is clear that we are at a crossroads for the future of global healthcare. Considering the COVID-19 pandemic, constant struggles with cancer, and an emerging crisis in antibiotic resistant bacteria, to just name a few on-going healthcare problems, we need innovative ideas. Non-medical fields have advanced considerably in new material design, from using sensors to drive cars and touch screen pads for electronics. Innovation in biomaterials has been lagging behind. This presentation will cover some of the more innovative biomaterials than can meet today's challenges including the use of implantable sensors, 4D printed materials in which material shape can be controlled remotely after implantation, smart nanomaterials that can seek out and passivate viruses and bacteria, and so much more. This presentation will also lay the foundation for what is needed for future biomaterial design, especially obtaining regulatory approval for interactive biomaterials
Keynote Forum
Dave Schoneker
Black Diamond Regulatory Consulting, LLC,USA.
Keynote: New Concepts for Drug Product Innovation & Novel Excipients - FDA Novel Excipient Pilot Program
Time : 07:30-8:10
Biography:
David R. Schoneker is currently the President/Owner of Black Diamond Regulatory Consulting, LLC. With over 44 years of experience working in these areas, Dave has developed strong networks with trade associations, regulatory agencies and pharmacopeias around the world. He is also an Adjunct Professor at Temple University's School of Pharmacy in their RA/QA Master's Program teaching courses in Global Excipient Regulations and the Regulation of Dietary Supplements. Prior to August 2019, David R. Schoneker was the Global Regulatory Director – Strategic Relationships at Colorcon, Inc. He was at Colorcon from 1977 until 2019. Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee and serves as the Chair of the Excipient QbD/Composition Committee.
Abstract:
The need for Novel excipients is growing due to various formulation issues related to drug solubility, patient-centric considerations, unique needs in biologics and an increase in advanced manufacturing methods such as continuous manufacturing and 3D Printing. There has historically been significant uncertainty regarding the potential regulatory implications of using novel excipients and this has severely limited innovation in drug development. Due to this uncertainty and concerns about customer uptake, excipient manufacturers have also been reluctant to develop novel excipients. However, there is some big news on the horizon which could help resolve these uncertainties. On September 7, 2021, The U.S. FDA's Center for Drug Evaluation and Research (CDER) launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations. If this pilot program is successful, this program could be made permanent. This would provide a new pathway which would encourage the early development and use of novel excipients to facilitate advancing the next generation of medicines to patients and help stimulate excipient innovation in the global pharmaceutical industry. This presentation will summarize the current need for novel excipients and will outline the current FDA Pilot Program and its potential impact on drug development and innovation.
Keynote Forum
Shihab Uddin
Kyushu University,Japan.
Keynote: Lipid-based Ionic Liquid is a Novel Biocompatible Carriers for the Transdermal Peptide Drug Delivery
Time : 01:45-2:25
Biography:
Shihab Uddin has received his PhD in Engineering on Chemical System and Engineering (leading to Biomedical Engineering) from the Kyushu University, Fukuoka, Japan in 2021. Currently, he is working in the Kyushu University, Fukuoka, Japan as a postdoctoral research fellow in the Dept. of Applied Chemistry and very soon he will join in the University of the British Columbia, Vancouver, Canada as a postdoctoral research fellow at the faculty of the Pharmaceutical Sciences. He is a highly motivated and innovated research scientist with demonstrated academic and industrial experienced in synthetic/material chemistry, pharmaceutical-formulations, nano biotechnology, and lipid-based nano drug delivery. He is expert in synthetic biology, methods developments and validations, pharmacokinetics, pharmacodynamics, drug delivery, and targeted tumor immune therapy. He is serving as an editorial board member of “Pharmacotherapy and Pharma science Discovery” journal. He has several publications in well repeated journal of RSC, ACS, Springer, and Elsevier and many of them are noted as front cover pages. He is focusing his research on the developing and translating innovative drug delivery technologies to clinical use and educating the next generation of scientist in the drug delivery field.
Abstract:
Transdermal drug delivery system has become an attractive alternative to the conventional oral or needle-based delivery system because of their self-administration association, patient preferable, avoidance of first-pass metabolism, and achievement of controlled and sustained delivery for local or systemic action. The transdermal delivery of large hydrophilic molecules is challenging due to the inherent diffusive barrier of the skin. Recently, Lipid-mediated nanocarrier have attracted in transdermal drug delivery systems (TDDSs) because of their lipophilic character. To address this issue, a new biocompatible pharmaceutical formulation was developed and stabilized by a blend of lipid-based ionic liquids (LBIL-containing 1,2-dimyristoyl-sn– glycerol-3-ethyl-phosphatidylcholine as its cationic part and a fatty acid-stearic, oleic, or linoleic acid as its anionic part) and Span-20, which covered a hydrophilic peptide drug "Leuprolide acetate" and was dispersed in isopropyl myristate (IPM). This is the first-time reported application of LBILs, and the formulation was dubbed as ionic liquids in oil nano dispersions (IL/O-NDs).
For these purposes, a water-in-oil emulsion process was used to create the drug-IL complexes, which was then freeze dried to remove the water and cyclohexane. The complexes were then dispersed in isopropyl myristate (IPM) and stabilized with sorbitol laurate (Span-20). Ionic liquid-in-oil nano dispersions (IL/O-NDs) were made using different weight ratios of LBILs and Span-20 as the surfactant and co-surfactant, respectively. TDD and pharmacokinetic parameters were measured on the skin and in the blood of BALB/C mice using Frans-diffusion cells and an enzyme-linked immunosorbent assay (ELISA). Furthermore, the biocompatibility of IL/O-NDs was investigated using MTT-assay and skin histopathological observation on a human artificial lab-Cyte EPI model as well as a BALB/C mouse model.
Keeping the overall surfactant in IPM constant at 10%, a 5:5 wt. percent ratio of surfactant (IL) and cosurfactant (Span-20) in the IL/O-NDs significantly (p<0.0001) increased the physiochemical stability, drug loading capacity, and drug encapsulation efficiency. IL/O-NDs significantly increased in vitro and in vivo peptide delivery across the skin (p <0.0001) when compared to non-IL-treated groups. Based on the pharmacokinetic parameters, [EDMPC][Linoleate]/O-ND was deemed the most preferable LBIL-based formulation for a TDDS. When compared to the aqueous delivery vehicle, the transdermal delivery flux with [EDMPC][Linoleate]/O-ND was increased 65-fold. The IL/O-NDs were able to deform the lipid and protein arrangements of the skin layers, enhancing the peptide's transdermal permeation. The biocompatibility of the LBIL-based formulations was revealed by in vitro and in vivo cytotoxicity studies of the IL/O-NDs. These findings suggested that IL/O-NDs are potentially biocompatible carriers for lipid-peptide TDDSs.
Keynote Forum
Samer Fahmi Ismail Adwan
Queen’s University Belfast, UK.
Keynote: Fabrication of Nanoparticles for Delivery Across Microneedle Microporated Ocular Tissues
Biography:
Samer Adwan has completed his PhD at the age of 37 years from Queens University Belfast School of Pharmacy. He is working as assistant professor at Zarqa University School of Pharmacy. His research interest involves investigation of novel technologies and drug delivery systems for the treatment of ophthalmic diseases.
Abstract:
Nanoparticles (NPs) have the advantages of targeted drug delivery for extended periods and being patient friendly. This is crucial in chronic ocular diseases where continuous treatment is required to maintain the therapeutic concentration for a prolonged time. Improved delivery of NPs by loading in microneedle (MN) arrays was demonstrated by many research groups. Conventional rhodamine B-loaded poly(lactic-co-glycolic acid) (PLGA) NPs were fabricated by the solvent displacement method. The delivery of the particles was investigated using confocal laser scanning microscopy after application of the MN-NP dual delivery system. The images showed deeper fluorescence in the scleral tissue and localisation around the pores formed in the cornea after the application of MNs. Polymer based MN arrays were investigated in this study for the intrascleral delivery of rhodamine B-loaded NPs. The MNs were rigid after the application of different mechanical forces (Figure 1). Franz cell diffusion model was utilised to study the distribution of rhodamine B in ocular tissue, after the delivery of the MN-NP dual delivery system. Confocal microscopy imaging showed a more intense and deeper distribution of the particles in the scleral tissue, and there was localisation around the micropores created on the surface of the scleral tissue. Microporation of the corneal tissue showed localisation of the fluorescence around the micropores. Clinically, this would be of considerable value to be able to deliver a depot of the drug by deposition of drug-loaded NPs in the micropores formed in the sclera.
Keynote Forum
Tiyyaba Furqan
Comsats University Islamabad,Pakistan.
Keynote: Investigating the Binding Mechanism of hERG Potassium Channel using Scorpion and Sea Anemone Venoms as Therapeutic Agents
Biography:
Tiyyaba Furqan has completed her MS in Molecular Genetics from the Biosciences Department of Comsats University Islamabad, Pakistan during 2018-2020. After her graduation, she started working as a research assistant at the Biosciences lab under the supervision of Dr. Syed Muhammad Nurulain and Dr. Sidra Batool at Comsats University Islamabad, Pakistan. Her area of research includes the drug designing and development, computational analysis, neuroscience, and molecular genetics. For the past couple of years, she has been helping students in conducting their research and lab work, publishing their research, and focusing on skills acquisition. She has published a number of research articles as a first author as well as a coauthor in internationally recognized high impact factor journals. She has worked effectively and efficiently with international collaborators to complete her research studies. Her current research interests for PhD include pharmacology and pharmacogenomics for the treatment of various diseases.
Abstract:
Bioactive proteins and peptides from venom of different species have shown to possess potential for therapeutic uses in a number of diseases such as cancer, cardiovascular and neurological disorders as well as in metabolic and autoimmune diseases. Peptide toxins are used for prey acquisition, but also to deter potential predators and even to fight territorial disputes. Various peptide toxins separated from animals, attack for potassium channel inhibition with high affinity binding to different sites of KV11.1. Scorpion and Sea Anemone venom ligand residues interact at the different sites of voltage gated potassium channel inhibiting potassium channel by altering its function. The docking depicts the inhibitory potential of Scorpion and Sea Anemone venoms for the voltage gated potassium channel that provides therapeutic opportunity for treating several channelopathies like neurological disorders, cardiovascular disorders and metabolic disorders.the potassium ion (K+) channels, especially they play key role to inhibit the potassium voltage-gated channels K+ (KV). In this study, the BDS potassium channel toxin family from scorpion and gamma ktx family from sea anemone are used. The hERG channel is a voltage-gated potassium channel involved in cardiac action potential repolarization. The marginalized function of hERG extends ventricular action potentials, increase the QT interval in an electrocardiogram, and advances the risk for lethal ventricular arrhythmias. KV channels offer vast variety for development of new drugs for cancer, cardiovascular and neurological disorders, autoimmune and metabolic diseases.
This study focuses on the binding analysis of toxin ligands with human voltage-gated potassium channel receptor, through structural comparison, for their potential therapeutic use in treating several diseases. The ligands and the receptor dataset were retrieved for in silico analysis and docking experiments were performed to analyzed the binding interactions between them. The ligand dataset comprises of 31 proteins of Type 3 BDS toxin family form Sea Anemones and 11 proteins of Gamma ktx family from scorpions. The KV11.1 is used as receptor for identifying the interaction sites of the abovementioned ligands. Hex software is used to check each protein of BDS Type 3 Toxin Family and Gamma ktx, docked with receptor kv11.1, for identifying the residues involved in hydrogen bonding and hydrophobic interactions.
The analysis revealed that the protein venoms of sea anemone and scorpion have binding interactions with receptor binding sites. The structures of the BDS type 3 toxin family and Gamma ktx family are rich in dissulphide domain and the main protein venom residue Lysine (Lys 6, Lys 28, Lys 116 Lys 116 and Lys 101, was predominantly observed in binding interaction with KV11.1. The docking results revealed that Lysine is important for potassium channel inhibition with high affinity binding to different sites of KV11.1. Scorpion and Sea Anemone venom ligand residues interact at the different sites of voltage gated potassium channel inhibiting potassium channel by altering its function. The docking depicts the inhibitory potential of Scorpion and Sea Anemone venoms for the voltage gated potassium channel that provides therapeutic opportunity for treating several channelopathies like neurological disorders, cardiovascular disorders and metabolic disorders.
Keynote Forum
Vivek Gupta
St. John’s University, USA
Keynote: Nano-Repurposing Strategies for Enhanced Efficacy against New Indications
Biography:
Dr Vivek Gupta is an associate professor at St. John’s University. He is an experienced pharmaceutical researcher with interests in developing novel therapies for respiratory disorders. His expertise lies in the fields of novel drug discovery and repurposing, and non-invasive delivery of small and macromolecules via oral and inhalation routes. He also has significant research interest in the fields of pharmaceutical scalability, and nano-repurposing. Diseases of interest include lung cancer, pulmonary fibrosis, pulmonary hypertension, and mesothelioma. Dr. Gupta’s group has published >75 high-impact publications in peer reviewed journals like Journal of Controlled Release, Materials Science & Engineering C, Drug Discovery Today, to name a few. Dr. Gupta also serves on editorial boards of many peer-reviewed journals. Multiple technologies and therapies developed by Dr. Gupta’s group have been patented and are at various stages of preclinical/clinical development.
Abstract:
Drug repurposing may be defined as developing old drugs for new indications. These old drugs may include already commercialized products, and drugs in clinical development. Drug repurposing approach is very cost-effective in putting new drugs in market, especially for rare diseases. While promising, drug repurposing has several limitations while being developed for new indications, including different dose requirements, acute vs chronic treatment needs, limited safety by new administration route, and patentability pertaining to possible commercialization. Encapsulating repurposed drugs in site-specific nanocarriers may provide an alternative to overcome these limitations. Nano-encapsulation i.e., nano-repurposing will be able to avoid off-target localization, reduce dose exposure to the body; and will also provide a patentable IP based on novel delivery methods. Our research group at St. John’s University works in the domain of nano-repurposing for developing novel therapeutics for respiratory disorders, in a cost-effective fashion, that will also be scalable for commercial production. We aim to develop non-invasive ways of delivering therapeutics to the lungs by inhalation. In this presentation, I will present some of the recent works from our group, detailing about repurposing currently FDA-approved drugs for newer indications including lung cancer, mesothelioma, and breast cancer. I will also show some data about scale-up potential of formulation development approaches, employed by our group.